CMS Expands Medicare PrEP Coverage: What Billing Teams Need to Know About NCD 377

The Centers for Medicare & Medicaid Services has modified National Coverage Determination (NCD) 377 to formalize Medicare coverage for Pre-Exposure Prophylaxis (PrEP) for HIV prevention as an additional preventive service under Part B. This update, effective for dates of service on or after September 30, 2024, confirms coverage for FDA-approved antiretroviral drugs, associated counseling visits, HIV screening tests, and hepatitis B screening—all with no cost-sharing for the beneficiary. If your practice prescribes or counsels patients on PrEP, or if you're billing for HIV screening in a Medicare population, this policy directly affects your revenue cycle.

What CMS NCD 377 Covers for Medicare PrEP Services

CMS, operating under authority granted by § 1861(ddd)(1) of the Social Security Act, added HIV PrEP to the Medicare benefit category of "Additional Preventive Services." Coverage was established because PrEP meets the three statutory requirements: it is reasonable and necessary for prevention of illness, it carries a Grade A or B recommendation from the United States Preventive Services Task Force (USPSTF), and it is appropriate for Part A and Part B beneficiaries.

The policy covers three distinct service categories for individuals being assessed for or actively using PrEP to prevent HIV:

1. Counseling Visits
Medicare covers up to eight individual counseling visits every 12 months. Each visit must include HIV risk assessment (either initial or ongoing), HIV risk reduction counseling, and medication adherence support. Critically, counseling must be furnished by a physician or other qualified health care practitioner, and the individual must be competent and alert at the time counseling is provided. Those two conditions are documentation requirements your billing team should treat as medical necessity gatekeepers.

2. HIV Screening Tests
Up to eight HIV screening tests are covered every 12 months for individuals in the PrEP assessment or treatment cycle. Screening must use FDA-approved laboratory tests or point-of-care tests, applied consistent with FDA-approved labeling, and performed in compliance with Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. CLIA compliance is not optional—non-compliant testing sites cannot bill for these services.

3. Hepatitis B Virus (HBV) Screening
A single HBV screening test is covered. Note the limitation here: this is a one-time benefit under this NCD, not an annually recurring benefit like the HIV screening and counseling elements. Separate HBV coverage rules under other NCDs or statutes may still apply, but under NCD 377 specifically, HBV screening is a one-time covered service.

The Cost-Sharing Waiver: A Critical Billing Detail

One of the most operationally significant elements of NCD 377 is this: Medicare Part B coinsurance and deductible are waived for all covered PrEP services under this NCD. This places PrEP on par with other statutory preventive services like colorectal cancer screenings or mammography.

For billing teams, this means your claims system must be configured to apply zero cost-sharing at the point of adjudication for these services. If your practice management system is collecting coinsurance or applying deductibles to these encounters, you are creating compliance exposure and patient balance-billing issues that need immediate correction—especially given the retroactive coverage date of September 30, 2024.

What Is Not Covered Under NCD 377

The policy is explicit: preventive services are non-covered by Medicare unless specifically authorized through an NCD, another NCD, in statute, or in regulations. There is no catch-all coverage for PrEP-adjacent services that fall outside the three covered categories above. If a service is not specifically enumerated—additional lab panels, non-HIV-related counseling bundled into a PrEP visit, or HBV screening beyond the single covered instance—it does not fall under this NCD's umbrella.

This matters for practices that combine PrEP management with broader sexual health services. You need to separate and document covered NCD 377 services from other billable encounters to avoid bundling errors and payer audits.

Prior Authorization Under NCD 377

The policy does not mention prior authorization requirements for any of the covered services. The determination of whether an individual is "at increased risk for HIV acquisition"—the key eligibility criterion—rests with the treating physician or health care practitioner based on individual patient history. That clinical determination should be clearly documented in the medical record, as it establishes medical necessity and supports the claim in the event of a post-payment review.

Affected Codes

The policy document for NCD 377 does not list specific CPT or HCPCS codes. CMS has issued two transmittals with claims processing instructions: Transmittal 12987 and Transmittal 13209, both available through the CMS website. Billing teams should reference those transmittals directly to identify the applicable billing codes for PrEP drugs, counseling visits, HIV screening, and HBV screening, and to confirm modifier and revenue code requirements.

No ICD-10-CM diagnosis codes are specified in the policy document.

What Your Billing Team Should Do