Human Immunodeficiency Virus (HIV) Preexposure Prophylaxis (PrEP) Drugs

Coverage

Documentation

  • Medical Records
    • The determination of whether an individual is at increased risk for HIV is made by the physician or health care practitioner who assesses the individual’s history. The beneficiary medical records must support the level of care provided, including the diagnosis.
  • Standard Written Order (SWO)
  • Proof of Delivery (POD)

Billing and Coding

Healthcare Common Procedure Coding System (HCPCS) for Drugs Used for PrEP for HIV

J0739 - Injection, cabotegravir, 1 mg, FDA approved prescription, only for use as HIV pre-exposure prophylaxis (not for use as treatment for HIV) Short Descriptor: Injection, cabotegravir, 1 mg

J0750 - Emtricitabine 200mg and tenofovir disoproxil fumarate 300mg, oral, FDA approved prescription, only for use as HIV pre-exposure prophylaxis (not for use as treatment of HIV)

J0751 - Emtricitabine 200mg and tenofovir alafenamide 25mg, oral, FDA approved prescription, only for use as pre-exposure prophylaxis (not for use as treatment of HIV)

J0799 - FDA approved prescription drug, only for use as HIV pre-exposure prophylaxis (not for use as treatment of HIV), not otherwise classified (NOC)

The DME MAC will accept and pay for NOC code J0799 when there is not a specific HCPCS code to be utilized. Suppliers are reminded that when submitting claims for items coded J0799, the supplier must include the following information on each claim:

  • Name of drug
  • Manufacturer name
  • Dosage strength

This information must be entered in the narrative field of an electronic claim (NTE 2300 or NTE 2400 of an electronic claim) or Item 19 of a paper claim.

Pharmacy Fee HCPCS for Drugs Used for PrEP for HIV

Q0521 - Pharmacy supplying fee for HIV pre-exposure prophylaxis FDA approved prescription drug

Billing Clarification

Supply fees (Q0521) not billed on the same claim as the oral PrEP drug will be denied as incorrect billing.

Deductible and coinsurance amounts do not apply to approved PrEP drugs or supply codes. Claims billed without an appropriate HCPCS and diagnosis combination will be denied CO (contractual obligation), Remittance Advice Remark Codes (RARC) M76: Missing/incomplete/invalid diagnosis or condition and Claim Adjustment Reason Codes (CARC) 16: Claim/service lacks information or has submission/billing error(s).

Covered Diagnosis Codes

There are multiple ICD-10 diagnosis codes that may be appropriate to use for HIV prevention services: Refer to the CMS PrEP for HIV & Related Preventive Services for details. Claims billed to the DME MAC without a covered diagnosis will be denied.

Fees

  • Pricing - View the quarterly pricing information for PrEP HIV

Exclusions from DME Benefit

Claims for G0011 and G0013 are not a DME benefit and should be billed to the Part A/B MAC as appropriate.

Resources

Last Updated Jun 18 , 2025