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National Coverage Determination (NCD)

Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention

210.15

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Tracking Information

Publication Number
100-3
Manual Section Number
210.15
Manual Section Title
Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention
Version Number
1
Effective Date of this Version
09/30/2024
Ending Effective Date of this Version
Implementation Date
04/07/2025
Implementation QR Modifier Date

Description Information

Benefit Category
Additional Preventive Services


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

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.
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
12987
Coverage Transmittal Link
https://www.cms.gov/files/document/r12987NCD.pdf
Revision History

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)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention 1 09/30/2024 - N/A You are here
CPT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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