CurrentASAMPolicy N/A

Medicare coverage, billing, limitations, and appeals for FDA‑approved injectable addiction medications

Explains Medicare and Medicare Advantage coverage, billing, limitations, and appeals processes for the three FDA‑approved injectable medications for addiction (Sublocade®, Brixadi®, Vivitrol®); intended for clinicians and ASAM members.

Policy Summary

PayerASAM

PolicyMedicare coverage, billing, limitations, and appeals for FDA‑approved injectable addiction medications

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionBill using professional service codes G2086 & G2087 and medication J/Q codes as specified per product; consult OTP codes when billed in an OTP.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA‑approved injectable medications discussed

Part BMedicare benefit

MA plans must coverMA coverage obligation

Prior auth allowedUtilization management

No OTP coverage for AUDOTP coverage limitation

Medicare Coverage Criteria and Limitations

Medicare coverage criteria and limitations

Medicare and Medicare Advantage coverage for FDA‑approved injectable addiction medications is subject to Part B eligibility, administration setting, and program‑specific limitations. Coverage is provided when the following conditions are met:

Beneficiary has Medicare Part B or is enrolled in a Medicare Advantage plan (MA plans must cover services and items available under Medicare Parts A and B).

Reference: Part B eligibility and MA equivalence requirement.

The medication is administered 'incident to' a physician's professional service. To qualify under the 'incident-to' provision, the FDA‑approved drug must be in a form not usually self‑administered and must be administered by the physician or auxiliary personnel employed by the physician and under the physician's supervision.

Incident‑to requirements for Part B coverage.

Coverage depends on the administration setting: physician office or hospital outpatient settings are covered under Part B; medications administered during hospital inpatient stay are covered under Part A; medications provided within an Opioid Treatment Program (OTP) are included in the OTP bundled rate (OTP covers OUD medications only; AUD injectable medications are not covered under OTP).

Policy Summary

PayerASAM

PolicyMedicare coverage, billing, limitations, and appeals for FDA‑approved injectable addiction medications

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionBill using professional service codes G2086 & G2087 and medication J/Q codes as specified per product; consult OTP codes when billed in an OTP.

SourceLink

On This Page

Billing, Codes, and Program Limitations

Outpatient administration/professional codesmixed

G2086	Professional service code (first code listed for administration)
G2087	Professional service code (second code listed for administration)

Brixadi medication codesmixed

J0577	Brixadi® medication code (example)
J0578	Brixadi® medication code (example)

Sublocade medication codesmixed

Q9991	Sublocade® medication code (example)
Q9992	Sublocade® medication code (example)

Vivitrol medication codemixed

J2315

Vivitrol® medication code

OTP coverage limitation — summary

Scope of OTP benefitOTP benefit covers services to treat opioid use disorder (OUD) only; medications provided inside an OTP are included in the program's bundled rate and should not be billed separately.

AUD injectable medicationsInjectable medications for alcohol use disorder (e.g., Vivitrol® for AUD) are NOT covered under the OTP benefit.

Cost-sharing under OTPNo cost-sharing is currently allowed under the Medicare OTP benefit.

Billing Rules, Prior Authorization, and Appeals

Billing Rule

Billing codes and setting-specific requirements

Bill using the professional service codes G2086 and G2087 for administration and the appropriate medication J/Q codes for each product; when the medication is provided inside an Opioid Treatment Program (OTP) the medication is included in the OTP bundled rate and should not be billed separately.

Use G2086 & G2087 for professional administration services.
Use the product-specific J/Q medication codes (e.g., J0577/J0578, Q9991/Q9992, J2315) as applicable.
Do not separately bill the medication when provided as part of an OTP bundled rate.

Prior Authorization

Utilization management and prior authorization

Plans may impose utilization management, including prior authorization, for these medications; CMS guidance states Medicare Advantage plans should not require prior authorization more than once per year.

Expect possible prior authorization requirements from traditional Medicare or MA plans.
Report any MA plan requiring prior authorization more than once per year to ASAM.

Denial Risk

Appeals / redetermination process

If coverage is denied, the provider or beneficiary can request an initial coverage determination and then seek a redetermination through the Medicare Administrative Contractor (for traditional Medicare) or the MA plan appeals process; clinicians may initiate appeals on behalf of patients.

An initial coverage determination must state reasons, how to get more information, and how to obtain a redetermination.
Clinicians can file redetermination requests for their patients and may contact ASAM for technical assistance (advocacy@asam.org).

Documentation Required

Incident-to coverage requirements

To qualify for Medicare Part B 'incident-to' coverage, the drug must be in a form that is not usually self‑administered and must be administered by the physician or by auxiliary personnel employed by and under the physician's supervision.

Confirm the medication is not usually self‑administered.
Ensure administration is performed by the physician or supervised auxiliary personnel to meet 'incident-to' requirements.

Key Terms and Product List

Products (brand-only)

Included products (brand-only)Sublocade®, Brixadi®, Vivitrol® — FDA‑approved injectable medications for addiction; these are brand name products with no generic equivalents.

Indications overviewSublocade® and Brixadi®: indicated for opioid use disorder (OUD); Vivitrol®: indicated for opioid use disorder (OUD) and alcohol use disorder (AUD).

No generics availableAll three products referenced are brand-only and do not have generic equivalents.

Coverage when drug is not usually self-administered (Part B / incident-to)

'Incident-to' Part B requirementTo qualify for Medicare Part B 'incident-to' coverage, the drug must be in a form that is not usually self-administered and must be administered by the physician or auxiliary personnel employed by and under the physician's supervision.

Part B applicabilityTraditional Medicare covers these injectable medications for beneficiaries with Medicare Part B when the incident-to conditions are met.

Administration settings and billing notesMedicare covers medications administered in hospital settings under Part A; when administered in an OTP, medications are bundled in the OTP rate and should not be billed separately.

OTP benefit: coverage and billing

OTP benefit scopeOpioid Treatment Program (OTP) benefit covers services to treat opioid use disorder (OUD) only; medications administered within an OTP are included in the bundled OTP rate and should not be separately billed.

Exclusion of residential servicesMedicare does not cover residential treatment programs (ASAM Level 3), though professional services delivered by physicians in those settings may be covered.

Medicare Part A coverage noteMedicare covers medications administered in hospital settings under the Part A benefit rather than Part B.