Preventive Services Guide

Pre-Exposure Prophylaxis Using Antiretroviral Therapy to Prevent HIV Infection

PrEP involves the use of antiretroviral drugs to decrease the risk of acquiring HIV. Under Section 1861(ddd)(1) of the Social Security Act (the Act), the CMS has the authority to add coverage of “additional preventive services” through the Medicare NCD process if certain statutory requirements are met: (1) reasonable and necessary for the prevention or early detection of illness or disability, (2) recommended with a grade of A or B by the USPSTF, and (3) appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

Eligibility Criteria

CMS covers HIV prevention services, including PrEP, for people with Medicare at increased risk of acquiring HIV. Physicians and health care practitioners assessing the individual’s history determine if an individual is at increased risk for HIV. To be eligible for counseling, individuals must be competent and alert during counseling.

Coverage Criteria

FDA-approved PrEP using antiretroviral drugs to prevent HIV in individuals at increased risk of acquiring HIV
Administration of injectable PrEP using antiretroviral drugs to prevent HIV
Supplying or dispensing the drug regardless of the route of administration (oral and injectable)
Individual counseling (up to 8 visits every 12 months), including:
- HIV risk assessment (initial or continued assessment of risk)
- HIV risk reduction
- Medication adherence
HIV screenings (up to 8 times every 12 months using FDA-approved laboratory tests and point-of-care tests)
Hepatitis B virus screening (one time only)

HCPCS/CPT Coding

PrEP for HIV Codes (Pharmacy, Physicians and Health Care Practitioners, Institutional Settings)

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

PrEP for HIV Supply Code (Pharmacy)

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

PrEP for HIV Counseling Codes (Physicians and Health Care Practitioners, Institutional Settings)

G0011 – Individual counseling for pre-exposure prophylaxis (prep) by physician or qualified health care professional to prevent human immunodeficiency virus (HIV), includes HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence, 15-30 minutes
G0013 – Individual counseling for pre-exposure prophylaxis (prep) by clinical staff to prevent human immunodeficiency virus (HIV), includes: HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence
PrEP for HIV Administration Code (Physicians and Health Care Practitioners, Institutional Settings)
G0012 – Injection of pre-exposure prophylaxis (prep) drug for HIV prevention, under skin or into muscle

Diagnosis Coding

Z11.3, Z11.4, Z11.59, Z20.2, Z20.5, Z20.6, Z20.828, Z20.89, Z20.9, Z29.81, Z32.00, Z32.01, Z32.02, Z72.51, Z72.52, Z72.53, Z72.89, Z79.899, Z86.59, Z87.898, F11.10, F11.20, F11.21, F11.90

Note: Additional ICD-10 codes may apply. Find individual change requests and specific ICD-10-CM service codes we cover on the CMS ICD-10 webpage. Find your Medicare Administrative Contractor's (MAC's) website for more information.

Who Can Bill

Pharmacies can bill for PrEP for HIV drugs if they're enrolled as one of the following:

DMEPOS supplier (CMS-855S)
Part B pharmacy supplier (CMS-855B)

Check to see if you’re enrolled by entering the pharmacy’s NPI in the search bar on the Data.CMS.gov Medicare Fee-For-Service Public Provider Enrollment website. Even if you provide vaccines, you’re not necessarily enrolled in Part B.

What Do I Need to Know about Billing?

If a physician or health care practitioner buys an injectable PrEP drug, submit claims to the A/B MACs.
If you’re enrolled as a DMEPOS supplier, submit claims for PrEP drugs and for supplying those drugs to your DME MAC. They’ll now process claims for PrEP drugs and the supplying of those drugs.
If you’re a Part B pharmacy supplier, submit claims for PrEP drugs and for supplying those drugs to your A/B MAC.
For the date of service on the claim, use the date the patient picks up the drug from the pharmacy or, if a mail-order pharmacy, the date you mail the drug. Don’t include span dates on the claim.
You may not need a claim for a supplying fee. If you do, use the same claim as the Medicare claim for the covered drug.
Include the name and NPI of the ordering or referring provider on the Part B claim.
See MLN Matters® MM13843: National Coverage Determination: 210.15: Pre-Exposure Prophylaxis for HIV Prevention for billing and payment requirements.

Frequency

HIV screenings: Up to 8 times every 12 months using FDA-approved lab tests and point-of-care tests
Individual counseling: Up to 8 visits every 12 months, including:
- HIV risk assessment (initial or continued assessment of risk)
- HIV risk reduction
- Medication adherence
Hepatitis B virus screening: one time only under this national coverage determination (NCD)

Note: Additional screening may be available under NCD: Screening for Hepatitis B Virus (HBV) Infection (210.6) as a separate benefit and continues to apply to eligible patients.

Cost Sharing

Coinsurance waived
Deductible waived