UnitedHealthcare Part B Drug Coverage Update

Coverage Criteria for Medicare Part B Drugs

General Part B coverage rule

Covered when ALL of the following are met

Part B incident-to rule: Drugs/drugs are covered under Part B when furnished 'incident' to a physician's service and are 'Not Usually Self-Administered By the Patient.'

See Medicare Benefit Policy Manual, Chapter 15, §50

DME supply drugs (Part B)

Covered when ALL of the following are met

DME supply drugs: Payment may be made for drugs and biologicals necessary for the effective use of durable medical equipment that must be put directly into the equipment to achieve therapeutic benefit or proper functioning.

Refer to Medicare Benefit Policy Manual, Chapter 15, §110.3

Nebulizer inhalation drugs (Part B vs Part D)

Covered under Part B when used with nebulizer in the home; otherwise Part D

Nebulizer drugs: Certain inhalation drugs (e.g., albuterol sulfate, ipratropium bromide) are covered under Part B when used with a nebulizer in the home; if delivered by a metered dose inhaler or other non-nebulized administration they are Part D.home use with nebulizer

Compliance with DME MAC LCD for Nebulizers (L33370) where applicable

Infusion pump medications

Covered under Part B when administered via infusion pump in home or implantable pumps

Infusion pump rules: Drugs infused using an implantable pump are generally covered under Part B. External infusion pump therapy in the home is covered under Part B if included under the applicable Medicare DME MAC local coverage policy; other infusion methods (e.g., IV push) are generally billed to Part D.included in MAC local coverage

Refer to Medicare Claims Processing and local coverage policies

Immunosuppressive drugs after transplant

Covered when ALL of the following are met

Transplant-related immunosuppressives: Immunosuppressive drug therapy following a Medicare-covered organ transplant is covered. Covered drugs include FDA-approved drugs with labeling for preventing or treating rejection, drugs approved for use in conjunction with immunosuppressive therapy for rejection, or drugs determined by the DME MAC to be reasonable and necessary for preventing or treating transplant rejection during Medicare claim processing.post Medicare-covered transplant or MAC determination

See Medicare Benefit Policy Manual, Chapter 15, §50.5.1

Oral anti-cancer and oral anti-emetic drugs

Covered when specific clinical conditions are met

Oral anti-cancer drugs are covered under Part B when Medicare criteria are met (see Medicare Benefit Policy Manual, Chapter 15 §50.5.3) — typically when used for cancer treatment; Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) may apply.clinical indication for cancer treatment

Refer to Medicare Claims Processing Manual, Chapter 17, §80.1 and applicable LCDs/LCAs

Oral anti-emetics as full IV replacement: Oral anti-emetics are Part B-covered when used as a full therapeutic replacement for an intravenous anti-emetic within 48 hours of cancer treatment and the prescribing physician indicates on the prescription that it is being used 'as a full therapeutic replacement for an intravenous anti-emetic drug as part of a cancer chemotherapeutic regimen.' Otherwise bill to Part D.within 48 hours & prescriber statement on Rx

Part D sponsors should deny payment when Part B criteria are met

IVIG in the home (Part B)

IVIG in the home is covered under Part B when ALL of the following are met:

IVIG home coverage criteria: 1) Product is an approved pooled plasma derivative for treatment of primary immune deficiency disease; 2) Patient has a diagnosis of primary immune deficiency disease; 3) IVIG is administered in the home; 4) Treating physician has determined home administration is medically appropriate.

Refer to Medicare Benefit Policy Manual, Chapter 15, §50.6 and applicable LCDs/LCAs

Injectable osteoporosis drugs (home health)

Injectable osteoporosis drugs provided by a home health agency are covered when ALL of the following are met:

Home health agency osteoporosis injection criteria: 1) Member is unable to learn self-administration or is physically/mentally incapable and family/caregiver are unable or unwilling to administer the drug (documented by the home health agency); 2) Member sustained a bone fracture certified as related to post-menopausal osteoporosis by an allowed practitioner; 3) Member is homebound.

Refer to Medicare Benefit Policy Manual Chapter 7, §50.4.3

Oral anti-emetics as full IV replacement

Oral anti-emetics used in cancer treatment are billed to Part B when ALL of the following are true:

Oral anti-emetic Part B criteria: 1) The drug is related to cancer treatment; 2) It is used as a full replacement for an intravenous anti-emetic; 3) It is used within 48 hours of cancer treatment; 4) The prescriber indicates on the prescription that it is a full therapeutic replacement for an IV anti-emetic.48 hours

If not all criteria are met, bill to Part D; refer to Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C

Oral chemotherapy agents

Oral chemotherapy agents that have an infusible version are handled as follows:

Oral chemotherapy Part B criteria: If an oral agent is used for cancer treatment, Part B should be billed; if used for non-cancer indications, Part D should be billed. For oral agents with no non-cancer indications, Part D sponsors should not include them on formularies. Prior authorization may be used to obtain diagnostic information for billing determination.

Refer to Medicare Benefit Policy Manual, Chapter 15 §50.5.3 and local coverage guidance

Immunizations and Antigens/Antihistamines

Immunizations and antigens are covered under Part B when criteria are met:

Immunizations Part B criteria: Immunizations (e.g., pneumococcal, hepatitis B for high/intermediate risk individuals, influenza, COVID-19) are Part B-covered when Medicare criteria are met; pneumococcal and influenza vaccines are not Part D benefits because of Part B coverage.

For Hepatitis B, physician must determine risk level; refer to Medicare Benefit Policy Manual, Chapter 15, §50.4.4.2

Antigens/antihistamines Part B criteria: Antigens/antihistamines prepared and administered by a physician for a specific patient are Part B-covered when Medicare criteria are met; antigens would not be a Part D benefit because of Part B coverage.

Refer to Medicare Benefit Policy Manual, Chapter 15 §20.2 and §50.2

Drugs treated as hospital outpatient supplies

Certain drugs usually self-administered by the patient may be treated as hospital outpatient supplies (Part B) when they are integral to a procedure or directly related to it:

Examples considered supplies (Part B): Sedatives given in the preoperative area; mydriatic/anti-inflammatory/antibiotic ocular drops administered immediately before/during/after an ophthalmic procedure; contrast media integral to imaging; topical solutions used with photodynamic therapy furnished at the hospital; antibiotic ointments placed on a wound at the completion of a procedure — these should be billed as hospital supplies.

Hospitals should bill these as supplies and not separately bill the beneficiary except copayment

Examples not packaged as supplies: Drugs intended for continued use at home after hospital discharge, oral pain meds for headache during chemo, routine insulin/hypertension meds given preop, fentanyl patch or oral pain meds for outpatient presenting with pain, laxative suppository while waiting for unrelated x-ray — these are not considered packaged supplies.

These are not considered packaged supplies

Not Covered / Excluded

Coverage stance and conditions

General exclusions: Placebos; outpatient prescription drugs except those covered under the member's Part D benefit; drugs included on the CMS Self-Administered Drug Exclusion List; medications for sexual/erectile dysfunction; and medications for elective enhancement (e.g., weight loss, hair growth, cosmetic/anti-aging) are not covered under the Part B medical benefit.

See cited Medicare policy sections and CMS SAD exclusion guidance

Review and Off-label Coverage

Review and evidence requirements for new or off-label uses

Review at Launch (RAL): Providers are strongly encouraged to request a pre-service organization determination (Review at Launch) for Part B medications that are new to market, not yet reviewed by UnitedHealthcare, or lack an established utilization management strategy; reviews will reference NCDs/LCDs, FDA labeling, compendia, and current evidence-based literature.

Helps avoid coverage gaps if prior authorization becomes effective later

Off-label/unlabeled drug use: Off-label or unlabeled use of a Part B drug is not covered unless specific criteria are met; see the Unlabeled Use of a Part B Drug section for coverage criteria and guidelines.

Refer to Medicare Benefit Policy Manual and supporting policies

Utilization Management (Step Therapy & Dosing Limits)

Utilization management for injectables

Step therapy / Preferred therapies: Certain classes of medical benefit injectables include preferred and non-preferred therapies; non-preferred therapies generally require prior history of use of a preferred therapy and other criteria. Where Step Therapy is indicated in the drug table, refer to the UnitedHealthcare Medicare Advantage Drug Policy titled 'Medicare Part B Step Therapy Programs'.

Applies to some Medicare Advantage plans

Maximum Dosage and Frequency: Some medications have maximum dosage per administration and dosing frequency limits. Where listed, refer to the UnitedHealthcare Commercial Medical Benefit Drug Policy titled 'Maximum Dosage and Frequency' or product-specific policy.

LCD/LCA criteria apply if available

Supporting drug examples and administrative flags

Supporting policy flags and references for example drugs

Drug-specific flags: For individual listed drugs the policy indicates whether NCD/LCD/LCA exist, default policy for states without LCDs/LCAs, Review at Launch (RAL) requirement (Yes/No), Step Therapy (Yes/No), and Maximum Dosage and Frequency (Yes/No or refer to separate policy).

See supporting information/drug table entries for each drug (e.g., Yartemlea RAL=Yes; Wezlana/Yesintek Step Therapy=Yes; Nufymco RAL=Yes).

Drugs provided as supplies for durable medical equipment (DME) under Part B are payable only when furnished for use in the member's home. A hospital, skilled nursing facility (SNF) or similar institution cannot be considered the patient’s home for the Part B DME benefit. If a patient is in a hospital or SNF (including situations where Part A coverage is not in effect or has lapsed), inhalation or infusible DME supply drugs that would otherwise be Part B DME supplies are not covered under Part B and should be billed to Part D if covered there. Refer to the Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C for Part B versus Part D coverage issues.

Vitamin B12 injections administered to strengthen tendons, ligaments, or similar soft-tissue structures of the foot are not covered. The policy states there is no evidence these injections are effective for that purpose and that the treatment falls within the subluxation exclusion, so such uses are not considered reasonable and necessary.

Investigational or experimental drugs are excluded from Part B coverage. The policy refers to the Medical Benefit Policy Manual, Chapter 15, §50.4.3 and confirms that therapies considered investigational/experimental will not be covered.

Placebos are expressly excluded from Part B coverage and are not considered payable under the Medical Benefit Policy Manual, Chapter 15, §50 (Drugs and Biologicals).

Outpatient prescription drugs are generally excluded from the Part B medical benefit and are covered under the member’s Part D Prescription Drug Plan when applicable. Providers and pharmacists should consult the member’s Part D benefit to determine coverage eligibility and billing.

Medications used to treat sexual or erectile dysfunction and medications used for elective enhancement purposes (for example weight loss, hair growth, sexual or athletic performance, cosmetic or anti‑aging indications) are not covered under the Part B medical benefit.

UnitedHealthcare enforces the CMS Self‑Administered Drug (SAD) Exclusion List. Drugs included on that CMS list and other specified self‑administered drugs (for example PCSK9 inhibitors) are not covered under Part B and may be payable only under Part D where appropriate; providers should refer to the Medicare Coverage Database and the member’s Pharmacy Program materials for plan‑specific determinations.

When there is no applicable National Coverage Determination (NCD), Local Coverage Determination (LCD), or Local Coverage Article (LCA) found in the Medicare Coverage Database, the policy directs providers to follow the coverage rationale contained in this document. Where appropriate, UnitedHealthcare’s default commercial Medical Benefit Drug Policies may be used for states or territories without an applicable LCD/LCA; consult the referenced default policy and CMS documents for guidance.

Immunosuppressive drugs used specifically for prevention or treatment of organ transplant rejection after a Medicare‑covered transplant are covered under Part B. Drugs that are not directly related to rejection management (for example routine antibiotics or antihypertensives) are not covered under the transplant immunosuppressive benefit and may be payable under other benefits or Part D as applicable.

The policy explicitly states that Vitamin B12 injections for the purpose of strengthening tendons or ligaments in the foot are considered not reasonable and necessary and therefore not covered; providers should not bill Part B for these indications.

Off‑label or unlabeled uses of Part B drugs are not covered unless they meet the specific coverage criteria described in the policy (see the Unlabeled Use of a Part B Drug section). For new or unreviewed Part B medications, providers are strongly encouraged to request a pre‑service organization determination (Review at Launch) because off‑label uses will be evaluated against FDA labeling, compendia, NCDs/LCDs, and current evidence‑based literature.

Coding and Reference Identifiers

References to ICD-10 and NCDs/LCDs for IVIG and autoimmune blistering diseasesICD-10 | NCD | LCD

No codes listed

Supporting Examples of Specific Drugs/Medications - Antiemetics (injectable)mixed

Akynzeo	netupitant and palonosetron injection (listed in supporting examples)
Aloxi	palonosetron hydrochloride injection (listed in supporting examples)
Cinvanti	aprepitant injectable emulsion (listed in supporting examples)
Emend	fosaprepitant injection (listed in supporting examples)
Focinvez	fosaprepitant injection (listed in supporting examples)
Kytril	granisetron injection (listed in supporting examples)
Posfrea	palonosetron injection (listed in supporting examples)
Sustol	granisetron injection (listed in supporting examples)
Zuplenz / Zofran ODT / Zofran	oral/different formulations listed in supporting examples

Supporting Examples of Specific Drugs/Medications - Othermixed

Adakveo	crizanlizumab-tmca (listed in supporting examples)
Adzynma	ADAMTS13, recombinant-krhn (listed in supporting examples)

Example CPT/HCPCS Mentionmixed

11980	CPT code referenced for Testopel (testosterone pellet)
J3490	HCPCS code referenced for Testopel (testosterone pellet)

Medicare LCDs/LCA referencesmixed

L34007	First Coast LCD (A57778) referenced for Subcutaneous Immune Globulin (SCIG)
L35093	Novitas LCD (A56786) referenced for SCIG
L34771	WPS LCD (A57554) referenced for SCIG
L33794	CGS / Noridian DME MAC LCD (A52507) referenced for SCIG

Additional LCD identifiers citedmixed

A58578	Noridian references for Spinraza (A58578) / LCDs cited
A58579	Noridian reference for Spinraza
L36569	Noridian LCD references for testosterone (A57616, A55057)
L36538	Noridian LCD references for testosterone (A57615, A55056)
L39086	Palmetto LCD reference for testosterone (A58828)

Listed LCDs/LCAs for IVIG and relatedICD-10

L35891	Intravenous Immune Globulin (IVIG) LCD
L34007	Immune Globulin LCD
L39314	Off-Label Use of Intravenous Immune Globulin (IVIG) LCD
L34074	Immune Globulin Intravenous (IVIg) LCD
L34314	Immune Globulin Intravenous (IVIg) LCD
L35093	Immune Globulin LCD
L34580	Intravenous Immunoglobulin (IVIG) LCD
L34771	Immune Globulins LCD

inv-36: Oral anti-emetic time window

Oral anti-emetic time windowWithin 48 hours of cancer treatment

Billing consequenceIf criteria met and within 48 hours, bill to Part B; otherwise bill to Part D

Prescriber documentation requirementPrescriber must indicate on the prescription that the oral anti-emetic is being used 'as a full therapeutic replacement for an intravenous anti-emetic drug as part of a cancer chemotherapeutic regimen'

inv-37: Therapeutic replacement timeframe

Therapeutic replacement timeframeWithin 48 hours of cancer treatment

Provider and Claims Processor Actions

Step Therapy

Step Therapy Requirement

Certain Part B-covered medical injectables and supplies may be subject to utilization management programs. When a Step Therapy requirement is indicated (see the Other Examples of Specific Drugs/Medications table), providers must document prior use and failure/intolerance of preferred therapies before a non-preferred therapy will be approved. Refer to the UnitedHealthcare Medicare Advantage Drug Policy titled "Medicare Part B Step Therapy Programs" for program details and criteria.

Applies where Step Therapy = Yes in the Other Examples table (e.g., many antineoplastics, colony stimulating factors, IVIG, intravitreal VEGF inhibitors, gonadotropin releasing hormone analogs, rituximab, trastuzumab, and others).
Non-preferred medical injectables generally require documentation of prior use/failure of preferred therapies and other clinical criteria.
Step Therapy may apply to many injectable specialty drugs listed throughout the Other Examples table.

Documentation Required

LCD/LCA Compliance and Default Policy Cross-Reference

When an LCD/LCA exists for a drug or class, compliance with that LCD/LCA is required in the applicable jurisdiction. If no LCD/LCA applies in a state/territory, the default UnitedHealthcare Commercial Medical Benefit Drug Policy identified in the Other Examples table will be used to determine coverage and any Step Therapy requirements.

Definitions and Background

Background: Medicare Part B covers outpatient drugs that are furnished incident to a physician’s professional service and that are not usually self‑administered by the patient, commonly including infused and injected medications. Part D covers outpatient prescription drugs that meet statutory criteria; drugs payable under Part A or Part B are generally excluded from Part D. This policy clarifies the Part B versus Part D boundary for categories such as DME supply drugs, infusion pump medications, immunosuppressives post‑transplant, oral anticancer agents, and oral anti‑emetics.

inv-78: Part B vs Part D definition summary

Part B coverageCovers drugs furnished 'incident' to a physician's service and many infused/injected drugs that are 'Not Usually Self-Administered By the Patient.'

Part D coverageCovers outpatient prescription drugs available only by prescription and FDA-approved; drugs payable under Part A or B are excluded from Part D.

Key referenceSee Medicare Benefit Policy Manual, Chapter 15 §50 and Medicare Prescription Drug Benefit Manual, Chapter 6 Appendix C

inv-79: DME supply drugs (nebulizer) definition

Pre-Service Review Flags and Initial Criteria

Pre-service review/step therapy notes (RAL and step therapy flags)

Pre-service review and step therapy flags for new or referenced drugs

RAL requirement: Some drugs (for example, entries such as Yartemlea) have Review at Launch (RAL) = Yes and require a pre-service organization determination per the policy. Step therapy may also apply for listed agents per the drug-specific table.

See Supporting Information and Policy History for recently added RAL entries

Step Therapy Indicators and Cross-References

Step Therapy guidance	Notes / Action
Refer to UnitedHealthcare Medicare Advantage Drug Policy titled 'Medicare Part B Step Therapy Programs' for specific step requirements when an injectable medical benefit drug is subject to step therapy
A medical injectable is subject to step therapy when it is listed in the 'Other Examples of Specific Drugs/Medications' table and the Step Therapy column includes a referral to the Medicare Part B Step Therapy Programs policy

Products / Group	Step Therapy status
Antiemetics (injectable) — Akynzeo, Aloxi, Cinvanti, Emend, Focinvez, Kytril, Posfrea, Sustol, Zuplenz/Zofran
Step Therapy = Yes — Refer to the UnitedHealthcare Medicare Advantage Drug Policy titled 'Medicare Part B Step Therapy Programs'

Medications / Classes flagged	Step Therapy referral / note
Colony stimulating factors (e.g., Fylnetra, Neulasta, Nyvepria, Rolvedon, Ryzneuta, Stimufend, Udenyca)
Step Therapy = Yes — Refer to the UnitedHealthcare Medicare Advantage Drug Policy titled 'Medicare Part B Step Therapy Programs'

Products / Classes	Refer to Medicare Part B Step Therapy Programs
Gonadotropin releasing hormone analogs (Leuprolide)
Step Therapy = Yes — Refer to the UnitedHealthcare Medicare Advantage Drug Policy titled 'Medicare Part B Step Therapy Programs'

When entry states 'Step Therapy = Yes'	Action / Reference
Examples: Saphnelo, Skyrizi, Sodium hyaluronate injections, Soliris, Actemra/tocilizumab, Trastuzumab products, Tremfya IV, Ultomiris, Ustekinumab products
Providers should follow the UnitedHealthcare Medicare Advantage Drug Policy titled 'Medicare Part B Step Therapy Programs' for the step requirements listed for these products

Agents indicated for Step Therapy	Policy action / reference
Selected agents with Step Therapy indicated (e.g., some ustekinumab entries, eptinezumab/Vyepti, narsoplimab/Yartemlea)
Step Therapy indicated — refer to the UnitedHealthcare Medicare Advantage Drug Policy titled 'Medicare Part B Step Therapy Programs' for applicable prior authorization and step requirements; consider Review at Launch where indicated

Quantity Limits and Maximum Dosage/Frequency

inv-96: Various listed agents — refer to Maximum Dosage and Frequency policy

Policy cross-referenceVarious listed agents reference the UnitedHealthcare Commercial Medical Benefit Drug Policy titled 'Maximum Dosage and Frequency' for dosage/frequency limits.

ExamplesIncluded classes with maximum dosage references include certain pegfilgrastim/colony stimulating factors and bevacizumab products per supporting information.

Provider actionRefer to the Maximum Dosage and Frequency policy or specific product policy when dose or frequency exceeds typical limits.

inv-97: Infliximab, Vyvgart Hytrulo, Niktimvo subject to Maximum Dosage and Frequency policy

Drugs subject to Maximum Dosage and FrequencyInfliximab (e.g., Renflexis), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase), and Niktimvo (axatilimab-csfr) are listed as subject to the Maximum Dosage and Frequency policy.

Site of Care Requirements

Documentation Required

Ensure DME‑related drugs furnished for home use

Part B DME‑related drugs are covered when furnished for use in the patient's home; hospitals, SNFs and similar institutions are not considered the patient's 'home' for the Part B DME benefit.

Documentation Required

Document criteria for home IVIG to receive Part B coverage

IVIG is covered under Part B when administered in the home for treatment of primary immune deficiency disease provided the drug is an approved pooled plasma derivative, the patient has the diagnosis, it is administered in the home, and the treating physician has determined home administration is medically appropriate.

Documentation Required

Home health agency provision and homebound requirement for injectable osteoporosis drugs

Injectable osteoporosis drugs are covered when provided by the home health agency if the member cannot self‑administer (or caregiver unable/unwilling, documented by home health agency), has a fracture certified as related to post‑menopausal osteoporosis, and is homebound.

OpenPayer

Medications/Drugs (Outpatient/Part B)

Coverage Criteria for Medicare Part B Drugs

Coding and Reference Identifiers

Provider and Claims Processor Actions

Definitions and Background

Pre-Service Review Flags and Initial Criteria

Step Therapy Indicators and Cross-References

Quantity Limits and Maximum Dosage/Frequency

Site of Care Requirements