Feds issue new guidance on Medicare and private payer coverage of PrEP for HIV

Editor's note: This post was updated Dec. 20, 2024, with more information from CMS.

The Centers for Medicare & Medicaid Services (CMS) recently issued a final national coverage decision memo for preexposure prophylaxis (PrEP) antiretroviral drugs to prevent HIV infection. As of Sept. 30, Medicare Part B covers Food and Drug Administration (FDA)-approved PrEP and related services for individuals at increased risk of getting HIV with no cost-sharing (e.g., deductibles or co-pays). The physician or health care practitioner who assesses the patient’s history determines whether they’re at increased risk. Medicare previously covered FDA-approved oral or injectable HIV PrEP drugs under Medicare Part D.

If you’re assessing your patients for PrEP to prevent HIV, or they’re already using it, Medicare Part B now covers the following as additional preventive services:

• Up to eight individual counseling visits every 12 months,
• Up to eight HIV screening tests every 12 months,
• A single screening for hepatitis B virus.

Submit claims to your Medicare administrative contractor for the other covered services related to PrEP for HIV, such as counseling, laboratory and point-of-care screening tests, administration of an injectable HIV PrEP drug, and for the injectable HIV PrEP drug if you purchase it. Use the following billing and payment codes:

• J0739: Injection, cabotegravir, 1mg, FDA-approved prescription, only for use as HIV preexposure prophylaxis (not for use as treatment for HIV),
• G0011: Individual counseling for preexposure prophylaxis (PrEP) by physician or qualified health professional (QHP) 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,
• G0012: Injection of preexposure prophylaxis (PrEP) drug for HIV prevention, under skin or into muscle,
• G0013: Individual counseling for preexposure 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.

Multiple diagnosis codes may be appropriate when you’re billing for PrEP, including the following:

• Encounter for HIV preexposure prophylaxis (Z29.81),
• Encounter for screening for human immunodeficiency virus (Z11.4),
• Increased risk factors (e.g., Z20.6 for contact with HIV or Z72.5- for high-risk sexual behavior).

CMS issued more information in December, including a full National Coverage Determination (NCD) and a Medicare Learning Network (MLN) article. Highlights include the following:

• Clarification that the hepatitis B virus (HBV) screening is a one-time screening under this benefit. Medicare still covers screening for HBV infection under a different NCD (210.6). Medicare will deny claims for HBV screening with a primary diagnosis of Z29.81 if a PrEP for HIV service hasn't also been submitted.
• An additional PrEP drug code: J0799,  "FDA approved prescription drug, only for use as HIV pre-exposure prophylaxis (not for use as treatment of HIV), not otherwise classified."
• An expanded list of ICD-10 codes that will be accepted for PrEP coverage on or after Dec. 24, 2024. They're included in the MLN article and on the CMS PrEP page.

Private payer PrEP coverage

In a separate action that also affects PrEP coverage, the U.S. Departments of Labor, Health and Human Services, and Treasury issued a set of frequently asked questions (FAQs) on Oct. 21 explaining key aspects of the Affordable Care Act and Women’s Health and Cancer Rights Act. The FAQs offer specific guidance for private health plans and insurers to ensure adherence to current health care regulations, including how plans must cover preventive services like PrEP following updated recommendations.

Under the federal guidance, most private plans will have to cover without cost-sharing any services that the U.S. Preventive Services Task Force (USPSTF) has given an “A” or “B” grade. This includes PrEP, for which USPSTF has assigned an “A” grade for sexually active adults and adolescents who weigh at least 77 pounds, do not already have HIV, and are at increased risk for acquiring HIV. Most private plans that begin on or after Aug. 31, 2024, must therefore cover oral and injectable PrEP, as well as baseline and monitoring services, with no deductibles or co-pays. They also may not use medical management techniques to steer individuals who have been prescribed PrEP toward one of the three FDA-approved formulations over another.

The federal guidance encourages clinicians and coders to use modifier 33 to denote when preventive services were provided in accordance with “A” or “B” USPSTF recommendations.

Additional information

• CMS National Coverage Analysis Tracking Sheet
• CMS webpage on PrEP for HIV & Related Preventive Services
• Fact Sheet: Medicare Part B Coverage of PrEP for HIV Prevention
• Medicare Information for Patients

— Kent Moore, AAFP Senior Manager, Payment Strategies

Posted on Oct. 25, 2024