Purpose
Retroactively effective September 30, 2024, the purpose of this communication is to provide notice of the preventive coverage of pre-exposure prophylaxis for the prevention of HIV infection under the Company's medical benefit (Part B) for Medicare Advantage members.
Background
Human immunodeficiency virus (HIV) continues to be a serious public health issue, with an estimated 1.2 million individuals ages 13 years and older living with HIV in the United States. Antiretroviral therapy (ART) is known to reduce HIV-related morbidity and mortality. Pre-exposure prophylaxis (PrEP) involves the use of ART on an ongoing basis (e.g., daily or bimonthly) or before and after HIV exposure events to decrease the risk of HIV infection.
Emtricitabine (200 mg) with tenofovir disoproxil fumarate (300 mg), emtricitabine (200 mg) with tenofovir alafenamide (25 mg), and cabotegravir (600 mg) injection are approved by the U.S. Food and Drug Administration (FDA) for use as PrEP for the prevention of HIV.
Retroactively effective 09/30/2024, CMS covers PrEP as a preventive service using antiretroviral drugs (oral or injectable) approved by the FDA for the prevention of HIV infection in individuals at high risk of HIV infection based on the healthcare provider’s assessment of the individual’s history. In addition, CMS covers the following services that are integral to PrEP using antiretroviral drugs as a preventive service:
- Individual counseling visits, up to seven visits every 12 months, which includes HIV risk assessment (initial or continued), HIV risk reduction, and medication adherence
- HIV screening, up to seven times every 12 months
- Single hepatitis B virus (HBV) screening
Coverage Statement
MEDICATION FOR THE PREVENTION OF HIV
Retroactively effective September 30, 2024, emtricitabine (200mg) with tenofovir disoproxil fumarate (300mg), emtricitabine (200 mg) and tenofovir alafenamide (25mg), and injectable cabotegravir are covered as a preventive service under the Company's medical benefit (Part B) for the prevention of human immunodeficiency virus (HIV) infection for individuals who are considered high risk of HIV infection based on the provider's assessment of the individual's history.
All other indications for emtricitabine (200mg) with tenofovir disoproxil fumarate (300mg) and emtricitabine (200 mg) and tenofovir alafenamide (25mg) are not covered under the Company's medical benefit (Part B) but may be covered under an applicable pharmacy benefit (Part D).
SERVICES ASSOCIATED WITH PREP FOR THE PREVENTION OF HIV
Retroactively effective September 30, 2024, according to CMS, the following services for monitoring and pre-initiation of pre-exposure prophylaxis for the prevention of HIV are covered as a preventive service for individuals who are considered high risk for HIV infection.
- HIV Testing (up to 8 tests every 12 months)
- Hepatitis B Testing (one screening)
- Individual counseling visits for HIV assessment (initial or continued), HIV risk reduction, and medication adherence up to 8 visits every 12 months.
Coding
THE FOLLOWING HCPCS CODES ARE USED TO REPRESENT PRE-EXPOSURE PROPHYLASIS (PrEP):
SUBCUTANEOUS OR INTRAMUSCULAR ADMINISTRATION
G0012
ANTIRETROVIRAL THERAPY DRUGS
J0739
J0750
J0751
THE FOLLOWING HCPCS AND CPT CODES ARE USED TO REPRESENT SERVICES THAT ARE ASSOCIATED WITH PRE-EXPOSURE PROPHYLASIS (PrEP):
INDIVIDUAL COUNSELING
G0011
G0013
HEPATITIS B VIRUS (HBV) SCREENING
86705
86706
87340
87341
G0499
HUMAN IMMUNODEFICIENCY VIRUS (HIV) SCREENING
86689
86701
86702
86703
87389
87390
87391
87806
G0432
G0433
G0435
G0475
S3645
THE FOLLOWING ICD-10 DIAGNOSIS CODE IS USED TO REPRESENT PRE-EXPOSURE PROPHYLASIS (PrEP):
Z29.81