Colorado Rocky Mountain Health Plans Part B Coverage Update

Coverage Criteria — Medicare Part B and Part D Boundaries

General Part B coverage

Covered when consistent with Medicare coverage criteria and furnished incident to a physician's service for drugs not usually self‑administered:

Part B coverage general rule: Drugs furnished 'incident' to a physician's service and 'Not Usually Self-Administered By the Patient' (typically infusion or injection) are covered under Part B.

Includes some self‑administered drugs in specific exceptions; refer to specific lists.

DME and nebulizer drugs

DME-related drugs covered under Part B when used with DME in the home:

DME supply drugs: Drugs and biologicals that must be put directly into durable medical equipment to achieve the therapeutic benefit or assure proper functioning are payable under Part B.

Subject to Medicare Benefit Policy Manual Chapter 15 and applicable DME MAC LCDs (e.g., Nebulizers L33370).

Nebulizer inhalation drugs: Certain inhalation drugs used with a home nebulizer (e.g., albuterol sulfate, ipratropium bromide) are covered under Part B; if delivered by non‑nebulized means they are Part D.

Not covered under Part B when furnished in a hospital/SNF that is not the member's home; see Medicare Prescription Drug Benefit Manual Chapter 6 Appendix C.

Infusion pump medications

Infusion pump and pump‑delivered drugs:

Infusion pump medications: Drugs administered using an infusion pump are generally billed to Part B; implantable pump infusions are Part B; external pumps in the home are Part B if included under the applicable DME MAC local coverage policy.

IV push and other administration methods may be billed to Part D; facility/home status affects coverage.

Immunosuppressive drugs

Immunosuppressive drugs coverage rules:

Post-transplant immunosuppressives: Immunosuppressive drug therapy following a Medicare‑covered organ transplant is covered under Part B when FDA‑approved for preventing or treating rejection or when the DME MAC has determined the drug is reasonable and necessary for that purpose.

Oral/enteral compounded formulations derived from approved immunosuppressives are covered; Part D applies when no Medicare‑covered transplant is present.

Oral anti-cancer and oral anti-emetic drugs

Oral anti-cancer and anti-emetic drug coverage:

Oral anti-cancer drugs are covered when Medicare Benefit Policy Manual Chapter 15 criteria are met; Part B covers oral anticancer uses related to cancer treatment and conditions are satisfied; Part D may cover non‑cancer indications.

Local Coverage Determinations apply where relevant.

Oral anti-emetics full replacement: Oral anti‑emetics used as a full therapeutic replacement for an intravenous anti‑emetic within 48 hours of cancer treatment are payable under Part B if the prescribing physician indicates this use on the prescription; otherwise Part D applies.within 48 hours

Part D sponsors should deny payment if a Part B‑covered oral anti‑emetic is billed to Part D in this context.

Immunizations

Immunizations:

Immunizations covered: Immunizations such as pneumococcal, hepatitis B, influenza, and COVID‑19 are covered when Medicare criteria are met.

Refer to Medicare Benefit Policy Manual Chapter 15 for specific coverage criteria.

Oral anti-emetics as replacement for IV anti-emetics

Covered under Part B when ALL of the following are met:

Oral anti-emetic Part B criteria: (1) Drug is an oral anti‑emetic used as a full therapeutic replacement for an intravenous anti‑emetic; (2) furnished in the context of cancer treatment for use within 48 hours of cancer treatment; (3) 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'.48 hours

If any condition is not met, the drug is billed to Part D; Part D sponsors should deny payment when these Part B conditions are satisfied.

Immunizations (coverage depends on vaccine and patient risk)

Coverage depends on vaccine and patient risk:

Vaccine Part B criteria: Pneumococcal, influenza, and COVID‑19 vaccines are Part B when Medicare criteria are met; Hepatitis B vaccine is Part B when the patient is at high or intermediate risk as determined by the physician; otherwise Part D or PA may apply to confirm risk level.risk level

Refer to Medicare Benefit Policy Manual Chapter 15 and Medicare Prescription Drug Benefit Manual Chapter 6 Appendix C.

IVIG in the home (Part B vs Part D)

Coverage determination based on diagnosis:

IVIG Part B criteria: (1) IVIG is an approved pooled plasma derivative for treatment of primary immune deficiency disease; (2) patient has diagnosis of primary immune deficiency disease; (3) IVIG is administered in the home; (4) treating physician determines home administration is medically appropriate.

IVIG in the home for other diagnoses is typically Part D; refer to Medicare Benefit Policy Manual Chapter 15 §50.6 and applicable LCDs/LCAs.

Injectable osteoporosis drugs by home health agency

Covered under Part B when ALL of the following are met:

Osteoporosis injectable Part B criteria: (1) Member unable to self‑administer and caregiver unable/unwilling as documented by the home health agency; (2) member sustained a bone fracture certified as related to post‑menopausal osteoporosis by an authorized clinician; (3) member is Homebound.

Refer to Medicare Benefit Policy Manual, Chapter 7 §50.4.3 for covered osteoporosis drugs.

Drugs treated as hospital outpatient supplies (Part B billing)

Drugs are treated as supplies and billed under Part B when they are integral to a procedure or directly related to it (examples):

Examples treated as supplies: Sedatives for preoperative preparation; mydriatic/anti‑inflammatory/antibiotic ophthalmic drops administered immediately surrounding ophthalmic procedures; contrast media integral to diagnostic imaging; topical solutions used with photodynamic therapy; antibiotic ointments placed on wounds at procedure completion.

When drugs are integral to a procedure they are packaged into the hospital outpatient payment and billed as supplies; see Medicare Benefit Policy Manual Chapter 15 §50.2.

Coverage limits and exclusions (excerpt)

Covered under Part B only when Medicare criteria are met and not excluded; several classes are explicitly not covered under Part B

Part B coverage boundary: Outpatient prescription drugs are not covered under the medical benefit except medications/drugs specifically included under Part B criteria or those covered under the member's Part D benefit.

Providers should verify the member's Part D benefit for outpatient prescriptions.

Explicit exclusions: Medications for sexual/erectile dysfunction, elective enhancement (weight loss, hair growth, sexual performance, cosmetic, anti‑aging, mental performance), and drugs on the CMS Self‑Administered Drug Exclusion List are not covered under Part B.

ED drugs may be Part D when prescribed for FDA‑approved non‑ED indications (e.g., pulmonary hypertension); off‑label ED uses are not covered.

Off-label use: Off‑label or unlabeled drug use is not covered unless specific criteria are met; see the Unlabeled Use of a Part B Drug section for allowed uses and documentation requirements.

Refer to Medicare Benefit Policy Manual Chapter 15 for reasonableness and necessity guidance.

When to use NCDs/LCDs and supporting policies

Process for evaluating drugs when Medicare guidance exists or is absent

Oncology medications: Check for applicable NCDs, LCDs, or LCAs; if none exist, refer to supporting information or the UnitedHealthcare Commercial Oncology Medication Clinical Coverage policy for off‑label NCCN Category 2B indications.

Use CMS Medicare Coverage Database for contractor determinations and follow referenced commercial policies when LCDs/LCAs are absent.

Non-oncologic medications: Check NCDs/LCDs/LCAs; if none, refer to the relevant UnitedHealthcare Commercial Medical Benefit Drug Policy or use compendia and evidence‑based literature for coverage guidance.

Links to UnitedHealthcare Commercial Medical Benefit Drug Policies are provided in the document.

Administrative coverage flags

For each listed drug or drug class, the document provides the following administrative determinations:

Administrative flags per drug: Each drug/class entry includes (where applicable): NCD/LCD/LCA reference; Default Policy for States Without LCDs/LCAs; Review at Launch (RAL) status; Step Therapy applicability; Maximum Dosage and Frequency applicability.

Entries vary by drug; see supporting information table for per‑product flags.

Product example annotations / coverage cross-references

Drugs listed are covered per applicable Medicare/UnitedHealthcare rules when meeting the referenced local or commercial policy criteria

Per-drug annotation: For each named product, the document records: presence/absence of NCD/LCD/LCA; default UnitedHealthcare policy to apply if no LCD/LCA; Review at Launch status; Step Therapy designation; Maximum Dosage and Frequency applicability.

See specific drug lines in the supporting information table (chunks 126–136) for per‑product flags and default policy cross‑references.

Drugs and biologicals that are necessary for the effective use of durable medical equipment (DME) or that are intended for delivery via an infusion pump may be payable under Medicare Part B when furnished for use in the beneficiary's home. Examples include nebulizer inhalation drugs (e.g., albuterol sulfate, ipratropium bromide) when used with a home nebulizer and drugs administered using an infusion pump or implantable pump that are covered by the applicable DME MAC local coverage policy. Conversely, the same agents delivered by non-nebulized means (e.g., metered dose inhaler) or infused by other methods (e.g., IV push) are generally Part D or otherwise outside Part B. Home is required for the DME benefit; a hospital, SNF, or certain nursing facilities cannot be considered the patient's home for DME Part B coverage.

The policy lists common categories of outpatient drugs that are not covered under the Part B medical benefit: investigational or experimental agents and placebos; medications that are not reasonable and necessary for the claimed indication (for example, Vitamin B12 injections to strengthen tendons/ligaments of the foot are not considered reasonable and necessary); outpatient prescription drugs ordinarily provided under Part D; and drugs appearing on the CMS Self‑Administered Drug Exclusion List. Additionally, medications used for sexual/erectile dysfunction and those intended for elective enhancement (weight loss, hair growth, cosmetic or anti‑aging purposes, athletic or mental performance enhancement) are excluded from Part B coverage.

Medications whose primary purpose is elective enhancement or performance/appearance alteration are excluded from Part B. This includes drugs for erectile dysfunction when used for sexual performance enhancement (unless prescribed for an FDA‑approved non‑ED indication), weight‑loss agents, hair‑growth products, cosmetic/anti‑aging uses, and drugs intended to enhance athletic or mental performance. Such uses are not considered medically reasonable and necessary under the Part B benefit.

The document specifically notes safety and efficacy concerns for outpatient/home use of Primacor (milrinone); the line entry states there are safety and efficacy issues regarding milrinone use in the home setting and references the DME MAC LCD for external infusion pumps where applicable. Providers should treat Primacor home infusion requests with caution and follow the cited local coverage guidance.

When a Centers for Medicare & Medicaid Services National Coverage Determination (NCD), a Local Coverage Determination (LCD), or a Local Coverage Article (LCA) exists for a drug or indication, that Medicare determination takes precedence and governs coverage and payment. If no NCD/LCD/LCA is found after searching the Medicare Coverage Database, reviewers must apply the Coverage Rationale in this policy or follow the cross‑referenced UnitedHealthcare commercial medical benefit drug policy as instructed.

DME MAC jurisdiction assignments affect which local contractor issues LCDs/LCAs. For example, for Virginia the city of Alexandria and the counties of Arlington and Fairfax are excluded from Palmetto GBA jurisdiction and are included within Novitas Solutions, Inc. jurisdiction. Providers must use the appropriate MAC jurisdiction when identifying applicable LCDs/LCAs for Part B DME‑related drug coverage.

The policy gives a concrete example of a medication considered not reasonable and necessary: Vitamin B12 injections administered to strengthen tendons or ligaments of the foot. The policy cites lack of evidence for effectiveness and references NCD 150.6 concluding such injections are not medically necessary and therefore not covered.

Off‑label or unlabeled uses of Part B drugs are not covered unless they meet the specific criteria set out in the policy's Unlabeled Use of a Part B Drug section. Reviewers should apply the cited coverage criteria and referenced compendia/evidence when assessing unlabeled use requests; absent satisfied criteria, off‑label use is considered not covered.

The policy references multiple chapters of the Medicare Benefit Policy Manual to guide determinations of reasonable and necessary use, including Chapter 7 (Covered Osteoporosis Drugs) and Chapter 15 (Drugs and Biologicals, including sections on approved and unlabeled use and examples of not reasonable and necessary). These CMS manuals are the authoritative sources for many Part B coverage decisions and should be consulted alongside any applicable NCDs/LCDs/LCAs.

Coding and Reference Documents

References to code manualsmixed

No codes listed

Referenced NCDsmixed

NCD 250.3	Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases (referenced)
NCD 150.6	Vitamin B12 Injections to Strengthen Tendons, Ligaments, etc., of the Foot (referenced)

Antiemetics (injectable) listed examplesmixed

Akynzeo	netupitant and palonosetron injection (listed as an injectable antiemetic example)
Aloxi	palonosetron hydrochloride injection
Cinvanti	aprepitant injectable emulsion
Emend	fosaprepitant injection
Focinvez	fosaprepitant injection
Kytril	granisetron injection
Posfrea	palonosetron injection
Sustol	granisetron injection
Zuplenz, Zofran ODT, Zofran	other antiemetic examples listed

Other specific drugs/medications shownmixed

Adakveo	crizanlizumab-tmca
Adzynma	ADAMTS13, recombinant-krhn

Referenced NCDs/LCDs/LCAsmixed

NCD 110.10	NCD for Intravenous Iron Therapy (referenced for IV iron therapy for dialysis patients)
NCD 110.17	NCD for Anti-Cancer Chemotherapy for Colorectal Cancer (referenced for irinotecan)
NCD 200.3	NCD for Monoclonal Antibodies Directed Against Amyloid for Alzheimer's Disease
NGS L33394 (A52370, A52451, A52423)	NGS LCD references cited for various ophthalmologic and infliximab entries
Palmetto L39387 (A59160)	Palmetto LCD referenced for leuprolide-related entries
Palmetto A53387 / L37863 / L35677	Palmetto references cited for ophthalmologic VEGF inhibitors and Luxturna

Testopel coding referencesmixed

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

Examples with CPT/HCPCSCPT | HCPCS

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

Coding guidancemixed

CPT, CMS or other coding guidelines

References to CPT and CMS coding used for claims processing; no specific numeric codes listed in this section.

inv-33: Oral anti-emetic replacement window

Time windowOral anti-emetic qualifies as Part B replacement when furnished within 48 hours of cancer treatment.

Prescriber requirementPrescribing physician 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'.

Billing consequenceIf criteria are met, Part B is billed; Part D sponsors should deny payment if a Part B-covered oral anti-emetic is billed to Part D in this context.

inv-34: Maximum Dosage and Frequency reference

Provider Actions, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization to Confirm Transplant Status

Prior authorization is required in specific situations to confirm transplant status before billing under Medicare Part B. Providers should not rely on Part B claim rejection as a substitute — use prior authorization to document transplant coverage eligibility.

Use prior authorization to confirm Medicare-covered transplant status prior to billing Part B.
Pharmacists/providers must bill Part B only when documentation supports a Medicare-covered transplant; otherwise bill the Part D plan.

Billing Rule

Use Prior Authorization to Ensure Correct Part B/Part D Billing

Prior authorization programs should be used to ensure correct Part B vs Part D billing rather than routinely requiring Part B claim rejections. Prior auth can collect diagnostic or indication information to direct appropriate payer responsibility.

Initial Therapy Criteria and Review-at-Launch

Oral anti-emetic initial criteria

Initial therapy criteria for oral anti‑emetics when intended as Part B replacement for IV:

Initial coverage oral anti-emetic: Prescriber documents that the oral anti‑emetic is a full therapeutic replacement for an IV anti‑emetic as part of a cancer chemotherapeutic regimen and the drug is for use within 48 hours of cancer treatment.within 48 hours

If documentation or the 48‑hour window is not met, bill to Part D; prescriber must indicate replacement intent on the prescription to receive Part B payment.

Review at Launch (RAL)

Review at Launch (RAL) process applies to new Part B medications without an established utilization management approach:

RAL review recommended: Pre‑service organization determination is highly recommended for new‑to‑market Part B medications that have not undergone prior UnitedHealthcare review and lack an established utilization management strategy.

Step Therapy Tables and References

Use case	Guidance / action
Diagnostic overlap with Part B (e.g., transplant status, oral anticancer agents)	Prior authorization may be appropriate for Part D sponsors to verify Medicare-covered transplant status instead of requiring Part B claim rejections; use PA to determine correct payer and ensure appropriate billing (Part B vs Part D).
Oral anticancer agents with infusible equivalents	When an oral anti-cancer drug has other indications, prior authorization or other mechanisms may be used to obtain diagnostic information to ensure appropriate payment; if the drug’s only accepted indication is cancer treatment, Part B generally applies.

Prior authorization context	Policy guidance
Hepatitis B vaccine risk determination	Physicians determine level of risk; Part B billed for high or intermediate risk. For all other individuals, prior authorization programs may be used to confirm risk level to ensure appropriate payment source (Part B vs Part D).

Non-preferred injectable group	Prior therapy requirement / action
Oncology injectable antiemetics (NK1 RA, 5HT3 RA, and combinations) — e.g., Akynzeo, Aloxi, Cinvanti, Emend, Focinvez, Kytril, Posfrea, Sustol, Zofran products	Step therapy = Yes; non-preferred therapies generally require prior use/history of preferred therapy; refer to UnitedHealthcare Medicare Advantage Drug Policy titled 'Medicare Part B Step Therapy Programs' for specific step requirements and criteria.
Other non-preferred medical injectables listed across supporting tables (e.g., antineoplastic monoclonal antibodies, select immunomodulators, growth factors/CSFs, denosumab products)	May require prior use of preferred therapies and/or prior authorization per the referenced Medicare Part B Step Therapy policy; follow the payer’s step therapy rules.

Reference	Instruction
Medicare Part B Step Therapy Programs (UnitedHealthcare Medicare Advantage Drug Policy)	When step therapy is indicated for a drug or drug class, providers must refer to the UnitedHealthcare Medicare Advantage Drug Policy titled 'Medicare Part B Step Therapy Programs' for program requirements and prerequisites.

Trigger in list	Refer to policy
Drugs with Step Therapy = Yes in the tables (example: denosumab products, select biologics)	Refer to the UnitedHealthcare Medicare Advantage Drug Policy titled 'Medicare Part B Step Therapy' for details when Step Therapy = Yes is shown.

Classes flagged 'Step Therapy'	Action / cross-reference
Gonadotropin releasing hormone analogs (leuprolide), intravitreal VEGF inhibitors, FcRn blockers, select monoclonal antibodies and others noted in the tables	Providers should follow the UnitedHealthcare Medicare Advantage Drug Policy titled 'Medicare Part B Step Therapy Programs' for class-specific step therapy requirements.

Multiple drugs indicated	Instruction
Numerous agents across product lines (e.g., tocilizumab formulations, trastuzumab products, rituximab formulations, various monoclonal antibodies) listed as subject to Part B Step Therapy Programs	These products are referenced to the UnitedHealthcare Medicare Part B Step Therapy Programs; follow that policy for prior authorization/step requirements.

Products subject to Part B Step Therapy	Cross-reference / note
Examples include: tocilizumab (Actemra and biosimilars), trastuzumab products (Herceptin, Hylecta, biosimilars), Tremfya IV, Ultomiris, Vyepti, ustekinumab products and others listed	These products are indicated as subject to UnitedHealthcare Medicare Part B Step Therapy Programs; providers must refer to that policy for step definitions and required prior use.

Cross-reference scenario	Instruction / destination
States or items without applicable LCDs/LCAs or where the table directs to commercial guidance (examples: certain denosumab variants, Itvisma)	Refer to UnitedHealthcare Commercial Medical Benefit Drug Policies (for example: 'Oncology Medication Clinical Coverage', 'Denosumab', or the specific Itvisma policy) when no LCD/LCA exists or the table directs to commercial policy. See Policy History for revisions and specified cross-references.

Quantity Limits and Maximum Dosage Guidance

inv-93: Krystexxa; intravitreal VEGF agents; Ocrevus and others — refer to Maximum Dosage and Frequency policy

ActionRefer Krystexxa, intravitreal VEGF agents, Ocrevus and similar entries to the Maximum Dosage and Frequency policy when the entry notes 'Maximum Dosage and Frequency = Yes' or equivalent.

Krystexxa noteKrystexxa entries specify referral to the Maximum Dosage and Frequency policy in product annotations.

Intravitreal VEGF agentsIntravitreal VEGF inhibitors (e.g., ranibizumab, bevacizumab, aflibercept) in the table are annotated to refer to Maximum Dosage and Frequency.

inv-94: Multiple Part B biologics — refer to UnitedHealthcare Maximum Dosage and Frequency policy

ActionRefer multiple Part B biologics (listed with no LCD/LCA) to the UnitedHealthcare Maximum Dosage and Frequency policy when entries indicate Maximum Dosage and Frequency applicability.

Site of Care — Home, Infusion Centers, and Hospital Outpatient

Billing Rule

Home site-of-care required for DME-related, nebulizer, and infusion pump drugs

When DME-related drugs, nebulizer drugs, or infusion pump medications are furnished for use in the beneficiary's home, bill under Part B; these items are not covered under Part B when furnished in a hospital or SNF that cannot be considered the patient's home.

Billing Rule

Home administration determines Part B eligibility for IVIG and osteoporosis injectables

Home administration is a key determinant for Part B coverage of IVIG and certain injectable osteoporosis drugs; bill Part B only when the criteria for home administration and diagnosis are met.

Billing Rule

Hospital outpatient supplies are packaged into procedure billing (Part B)

Drugs that are integral to a hospital outpatient procedure are treated as supplies and packaged into the procedure payment and should be billed under Part B by the hospital.

Key Definitions

inv-72: Not Usually Self-Administered By the Patient

DefinitionNot Usually Self-Administered By the Patient: drugs typically administered by a clinician (infusion or injection) and furnished 'incident to' a physician's service.

'Usually' threshold'Usually' means more than 50% of Medicare beneficiaries who use the drug self-administer it; if so, the drug is excluded from Part B coverage.

Routes included/excludedInjectable drugs (including IV) are typically eligible under 'incident to'; other routes (oral, topical, suppositories) are generally considered self-administered except limited exceptions.

inv-73: Medically-accepted indication (Part D)

DefinitionMedically-accepted indication (Part D): a use that is FDA‑approved or supported by citations in recognized compendia (e.g., AHFS, DRUGDEX) as defined by statute.

Policy reference

Background — Purpose and Scope

Medicare Part B generally covers outpatient drugs that are not usually self‑administered by the patient and that are furnished incident to a physician's service (commonly infusion or injection). Part D covers outpatient prescription drugs that are ordinarily self‑administered. Specific clinical contexts (for example, immunosuppressive therapy after a Medicare‑covered organ transplant, IVIG in the home for primary immune deficiency, or an oral anti‑emetic used as a full replacement for an IV anti‑emetic in cancer treatment) can change whether a drug is payable under Part B or Part D, so reviewers must apply the policy criteria and relevant Medicare guidance to determine the benefit assignment.

Policy Revision History

2026-05-01revisionLatest

Revised coverage guidelines: updated denosumab product listings (Boncresa, Osvyrti, Bildyos, Bosaya, Conexxence, Enoby, Ospomyv) and added instructions to refer to UnitedHealthcare Commercial Medical Benefit Drug Policies (Denosumab and Oncology Medication Clinical Coverage) for states without LCDs/LCAs; added Itvisma instruction to refer to UnitedHealthcare Commercial Medical Benefit Drug Policy; updated gene therapy (ex vivo) list and added Waskyra; archived previous version MMP057.51.

OpenPayer

Medications/Drugs (Outpatient/Part B)

Coverage Criteria — Medicare Part B and Part D Boundaries

Coding and Reference Documents

Provider Actions, Prior Authorization, and Billing Guidance

Initial Therapy Criteria and Review-at-Launch

Step Therapy Tables and References

Quantity Limits and Maximum Dosage Guidance

Site of Care — Home, Infusion Centers, and Hospital Outpatient

Key Definitions

Background — Purpose and Scope

Policy Revision History