Key facts for NCD 210.15
- Benefit category
- Additional Preventive Services
- Effective date
- 09/30/2024
- Implemented 04/07/2025
- Transmittal
- Transmittal 12987
- Versions published
- 1
- Manual chapter
- 210
- NCD Manual (Pub. 100-03)
TL;DR
NCD 210.15 sets Medicare's national policy for pre-exposure prophylaxis (prep) for human immunodeficiency virus (hiv) prevention under the benefit category "Additional Preventive Services", effective 09/30/2024 and implemented 04/07/2025. Effective for claims with dates of service on or after September 30, 2024, CMS covers PrEP using antiretroviral drugs approved by the U.S. Food and Drug Administration (FDA) to prevent HIV in individuals at increased risk of HIV acquisition. The… It has been revised once since publication and binds every Medicare Administrative Contractor nationally.
Item or service described
A. General
Pre-exposure prophylaxis (PrEP) involves the use of antiretroviral drugs to decrease the risk of acquiring human immunodeficiency virus (HIV). Under § 1861(ddd)(1) of the Social Security Act (the Act), the Centers for Medicare & Medicaid Services (CMS) has the authority to add coverage of “additional preventive services” through the Medicare national coverage determination (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 United States Preventive Services Task Force (USPSTF), and (3) appropriate for individuals entitled to benefits under Part A or enrolled under Part B.
Indications and limitations of coverage
B. Nationally Covered Indications
Effective for claims with dates of service on or after September 30, 2024, CMS covers PrEP using antiretroviral drugs approved by the U.S. Food and Drug Administration (FDA) to prevent HIV in individuals at increased risk of HIV acquisition. 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. CMS also covers furnishing HIV PrEP using antiretroviral drugs, including the supplying or dispensing of these drugs and the administration of injectable PrEP.
For individuals being assessed for or using PrEP to prevent HIV, CMS covers all the following as an additional preventive service:
a) Up to eight individual counseling visits, every 12 months, that include HIV risk assessment (initial or continued assessment of risk), HIV risk reduction, and medication adherence. Counseling must be furnished by a physician or other health care practitioner. Individuals must be competent and alert at the time that counseling is provided.
b) Up to eight HIV screening tests every 12 months.
c) A single screening for hepatitis B virus (HBV).
These screening tests are covered when the appropriate FDA-approved laboratory tests and point of care tests are used consistent with FDA-approved labeling and in compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations.
C. Nationally Non-Covered Indications
Preventive services are non-covered by Medicare unless specifically covered in this NCD, any other NCD, in statute, or regulations.
D. Other
Medicare Part B coinsurance and deductible are waived for this preventive service.
Text reproduced from the CMS Medicare Coverage Database record for NCD 210.15 version 1. View the original on cms.gov.
Revision history
09/2025 - Transmittal 13400 issued September 05, 2025, is being rescinded and replaced by Transmittal 13438, dated September 30, 2025, to add a new attachment to ensure the functionality of the NCD zip URL is working properly and to update the Policy section. All other information remains the same.
The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 coding changes specific to NCDs. ( TN 13438 ) (CR14197)
08/2025 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 coding changes specific to NCDs. ( TN 13375 ) (CR14197)
12/2024 - The purpose of this Change Request (CR) is to announce that CMS has determined that Pre-Exposure Prophylaxis (PrEP) using antiretroviral drugs to prevent Human Immunodeficiency Virus (HIV) is covered as an additional preventive service under §1861(ddd)(1) of the Social Security Act (the Act). ( TN 12987 ) (CR13843)
How this NCD shows up on remittances
A service denied under a National Coverage Determination returns CARC 50 (not deemed medically necessary) with remark N386 (decision based on an NCD); a denial citing a local policy instead carries N115. Because NCDs bind nationally, the appeal path is documentation that the patient meets the indications above, not a contractor-policy argument.
How QuickIntell applies NCD 210.15
QuickAuth checks the ordered service and diagnosis against NCD and LCD criteria before the encounter, QuickCode validates the diagnosis pairing on the claim, and QuickRCM routes CARC 50 denials with the policy text and the covered-code list attached so the appeal starts with evidence.
Frequently asked questions — NCD 210.15
What does NCD 210.15 cover?
Effective for claims with dates of service on or after September 30, 2024, CMS covers PrEP using antiretroviral drugs approved by the U.S. Food and Drug Administration (FDA) to prevent HIV in individuals at increased risk of HIV acquisition. 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. CMS also… The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database.
When did NCD 210.15 take effect?
The current version (1) is effective 09/30/2024, implemented 04/07/2025, published in transmittal 12987. This is the only published version.
Does a Local Coverage Determination override NCD 210.15?
No. A National Coverage Determination binds all Medicare Administrative Contractors; an LCD can only address services or circumstances the NCD leaves open. Claims denied under this NCD typically return CARC 50 with remark N386 (NCD) rather than N115 (LCD).
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database NCDs via the CMS Coverage APIVersion API snapshot 2026-09-27 · effective 2026-09-20 · file national-coverage-ncd.jsonSHA-256 a90fadfd264b9ef4…
Disclaimer
This page reproduces the CMS National Coverage Determination text and, for laboratory NCDs, the CMS ICD-10 edit lists, as an operational reference. Coverage decisions depend on the full policy, the claim and the contractor; nothing here is legal, clinical or billing advice. CPT codes are shown as numbers only; CPT descriptors are copyright AMA.