CurrentNeighborhood Health Plan of Rhode IslandPolicy 000826

Benefit Exclusion

Defines medications and medication-related products that are benefit exclusions (not covered) under Neighborhood Health Plan of Rhode Island pharmacy and medical benefits for Medicaid, Commercial, and INTEGRITY (Medicare-Medicaid) lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBenefit Exclusion

Policy CodePolicy 000826

Change TypeNo material change

Effective DateJul 26, 2019

Next Review Date

Key ActionDo not bill or dispense medications or products listed as benefit exclusions; claims will be denied when obtained at a pharmacy or billed under the medical benefit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleLists exclusions for Pharmacy, Medical, Commercial, and INTEGRITY benefits

>20Discrete excluded items or classes

Medicaid/Commercial/INTEGRITYLines of business governed

NCD/LCD refINTEGRITY governed by NCD/LCD

Benefit Exclusions — Coverage Criteria

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Medicaid pharmacy exclusions

The following are considered Benefit Exclusions and are therefore not covered by Neighborhood's Medicaid pharmacy benefit when obtained at a pharmacy:

Medicaid pharmacy exclusions (selected items): Biological products for allergy immunizations; blood fractions; biological products for vaccinations; compound medications that are not made up of at least one legend drug; drugs that have not been proven effective according to the FDA; drugs prescribed or dispensed outside of Health Plan dispensing guidelines; drugs used for cosmetic purposes; experimental drugs (including DESI-listed products); drugs or products whose manufacturer does not participate in the Medicaid Rebate Program (MDRP); medications provided while an enrollee is inpatient/institutionalized (hospital, nursing home, etc.); non-medical substances; off-label use of drugs unless mandated by laws pertaining to the treatment of cancer; therapeutic devices and appliances (except when used to administer insulin or for self‑administration of FDA‑approved injectable drugs); support garments and other durable medical equipment (except diabetic supplies); medications prescribed for sexual or erectile dysfunction (ED); medical marijuana; travel medications (including drugs used to prevent diseases not commonly encountered in the US, e.g., malaria, typhoid) and travel vaccines (note: ACIP travel vaccines are covered for Medicaid members); medications for infertility treatment.

Medicaid medical exclusions

The following are considered Benefit Exclusions and are therefore not covered by Neighborhood's Medicaid Benefit when billed directly by a provider (buy-and-bill or Medical Benefit):

Medicaid medical (buy-and-bill) exclusions (selected items): Products used for cosmetic purposes; experimental drug products or any product used experimentally (unless coverage is mandated by laws pertaining to the treatment of cancer); drugs or products whose manufacturer does not participate in the Medicaid Rebate Program (MDRP); medications prescribed for infertility treatment; medications prescribed for sexual or erectile dysfunction (ED); medical marijuana; travel medications (including drugs to prevent diseases not commonly encountered in the US, e.g., malaria, typhoid) (ACIP travel vaccines are covered for Medicaid members); off-label use of drugs unless mandated by laws pertaining to the treatment of cancer.

Commercial exclusions

The following are considered Benefit Exclusions and therefore not covered by Neighborhood's Commercial Benefit:

Commercial exclusions (selected items): Products used for cosmetic purposes; experimental drug products or products used experimentally (unless coverage is mandated by laws pertaining to the treatment of cancer); off‑label use of drug products when experimental or not supported (unless cancer‑mandated); medications prescribed for sexual and erectile dysfunction (ED); medical marijuana.

INTEGRITY exclusions

The following are considered Benefit Exclusions and therefore not covered by Neighborhood's INTEGRITY (Medicare‑Medicaid Plan) benefit:

INTEGRITY exclusions (selected items): Medications used for sexual or erectile dysfunction; medications used for the treatment of infertility; medications used for indications that are not FDA‑approved or compendia‑supported; medications used in a manner inconsistent with the requirements of a National or Local Coverage Determination (when such an NCD/LCD exists); Continuous Glucose Monitors that do not meet CMS' definition of a therapeutic CGM (e.g., FreeStyle Libre 3). Per 42 CFR 422.101, this policy applies to INTEGRITY only in the absence of an applicable NCD or LCD.

General exclusions

Additional general exclusions and conditions (cross-line items):

General exclusions: Compounded products that are not made up of at least one legend drug; prescription and OTC homeopathic drugs; non‑drug products such as therapeutic or other prosthetic devices, appliances, supports, and other non‑medical products (except diabetic supplies); drugs that cannot be lawfully marketed without FDA approval or whose approval has been withdrawn; prescriptions filled at pharmacies other than Neighborhood network pharmacies (except emergency care); prescription drugs when the same active ingredient is available OTC or when packaged with non‑prescription products; OTC drugs/products that are not listed on Neighborhood's formulary are not covered.

This policy identifies categories of medications, products, and related items that are considered Benefit Exclusions and therefore are not covered under Neighborhood Health Plan benefits. Exclusions include, but are not limited to: medications for infertility; medications for sexual or erectile dysfunction (ED); medical marijuana; experimental drugs or products used experimentally; off‑label uses that are not mandated by applicable cancer treatment laws; travel vaccines and travel medications for diseases not commonly encountered in the United States (e.g., malaria, typhoid); compounded products lacking at least one legend drug; non‑drug devices, appliances, and support garments (except certain diabetic supplies); and products from manufacturers not participating in the Medicaid Drug Rebate Program (MDRP).

Off‑label and experimental uses of drugs are treated as not covered unless coverage is specifically required by law for cancer treatment. Experimental drug products or products used experimentally are excluded across benefit lines unless a law mandates coverage for cancer care; similarly, off‑label prescribing is not covered except where cancer‑related statutes require it.

Provider Actions, Billing & Denials

Denial Risk

CGM exclusions for INTEGRITY

Certain Continuous Glucose Monitors (CGMs) are excluded from coverage under INTEGRITY when they do not meet the Centers for Medicare & Medicaid Services (CMS) definition of a therapeutic Continuous Glucose Monitor. Examples include CGMs that function solely as adjunctive/retrospective devices (e.g., some consumer-grade devices) and do not provide real-time therapeutic glucose data as defined by CMS. Providers should verify device classification and coverage status prior to ordering.

Example excluded device class: CGMs that do not meet CMS therapeutic CGM criteria (e.g., some Freestyle Libre models when classified as non-therapeutic).

Note

NCD/LCD precedence

When a National Coverage Determination (NCD) or Local Coverage Determination (LCD) exists for a medication, device, or service, that NCD/LCD takes precedence and governs coverage and medical necessity determinations for INTEGRITY members. This policy applies only in the absence of an applicable NCD or LCD.

Per 42 CFR 422.101, follow NCDs/LCDs where they exist; do not apply this policy in conflict with an applicable NCD/LCD.

Documentation Required

Where exclusions are documented

Exclusions and benefit-coverage details are documented in multiple member- and provider-facing resources. Providers should consult these sources for the official, current list of benefit exclusions prior to billing or dispensing.

Medicaid Member Handbook
Commercial Certificate of Coverage (COC)
Provider Manual/Provider Portal
Neighborhood Health Plan of Rhode Island formularies and benefit documents on nhpri.org

Denial Risk

Pharmacy benefit denials

If an excluded item is obtained at a pharmacy, the pharmacy claim will be denied as not covered under the pharmacy benefit. Providers and members should confirm coverage and preferred dispensing channel before procurement.

Pharmacy benefit denials will occur for items listed as benefit exclusions when dispensed at a pharmacy.

Denial Risk

Medical benefit denials

If an excluded item is billed directly by a provider under the medical (buy-and-bill) benefit, the claim will be denied as not covered. Providers must verify whether an item is a benefit exclusion or subject to prior authorization before billing under the medical benefit.

Medical benefit (buy-and-bill) denials will occur for items listed as benefit exclusions when billed by providers.

Definitions

Benefit Exclusion (definition)

DefinitionMedications or products that are not covered under the Plan’s pharmacy or medical benefits and are listed in member and provider documents as excluded from coverage.

ScopeApplies to items obtained at a pharmacy, billed by a provider (buy-and-bill/medical benefit), and across Medicaid, Commercial, and INTEGRITY lines of business as specified in this policy.

Common excluded categoriesIncludes infertility medications; sexual/erectile dysfunction drugs; medical marijuana; experimental or unproven drugs; compounded products lacking at least one legend drug; therapeutic devices/appliances (except certain diabetic supplies); travel vaccines/medications for diseases not common in the U.S.

Operational effectClaims for medications or products listed as Benefit Exclusions will be denied/not covered when obtained at a pharmacy or billed by a provider, per the applicable benefit line.

Reference guidanceExclusions and related details are documented in this policy and also listed in the Medicaid Member Handbook, Commercial Certificate of Coverage, and the Provider Manual.

MDRP non-participation (definition/notice)

DefinitionDrugs or products whose manufacturer does not participate in the Medicaid Drug Rebate Program (i.e., does not have a signed National Rebate Agreement on file with the Secretary of the U.S. Department of Health and Human Services).

Coverage consequenceProducts from manufacturers not participating in the MDRP are excluded from coverage under the Plan and will not be paid when obtained under the pharmacy or medical benefit.

Where referencedThis exclusion is listed among the explicit Benefit Exclusions for items obtained at a pharmacy and for items billed on the medical (buy-and-bill) benefit.

Regulatory noteThe policy cites the presence or absence of a signed National Rebate Agreement with HHS as the determinant of MDRP participation.

OpenPayer

Benefit Exclusion

Benefit Exclusions — Coverage Criteria

Provider Actions, Billing & Denials

Definitions

Background

Site of Care — Pharmacy Network & Coverage

Step-Therapy / Precedence Rules