25-042 Find Out What Changed: New Coverage Requirements for PrEP
Date: 02/24/25
Affected PPGs must ensure their claims payment systems reflect changes for injectable PrEP drugs
As of September 30, 2024, there is a change in the way Medicare covers antiretroviral therapy that is approved by the U.S. Food and Drug Administration (FDA) to prevent HIV infection in individuals at high risk of acquiring HIV. Use of these drugs to prevent HIV infection is known as pre-exposure prophylaxis (PrEP).
How this affects PPGs
Participating physician groups (PPGs) that have risk for injectable drugs in their Medicare Division of Financial Responsibility (DOFR) must pay affected codes per Centers for Medicare & Medicaid (CMS) requirements. The Plan encourages such PPGs to be aware of the new benefit so they can update their claims payment systems accordingly.
What are the changes?
CMS released guidance finalizing National Coverage Determination (NCD) 210.15. This NCD outlines Medicare coverage for PrEP using antiretroviral drugs to prevent HIV in individuals at increased risk of HIV acquisition. The updated guidance requires sponsors to cover these services with $0 cost share, beginning on September 30, 2024:
- FDA-approved PrEP using antiretroviral drugs
- Administration of injectable PrEP using antiretroviral drugs to prevent HIV
- Supplying or dispensing the drug regardless of the route of administration (oral and injectable)
- Individual counseling (up to 8 visits every 12 months), including:
- HIV risk assessment (initial or continued assessment of risk)
- HIV risk reduction
- Medication adherence
- HIV screenings (up to 8 times every 12 months using FDA-approved lab test and point-of-care test)
- Hepatitis B virus screening (1 time only)
Based on new Medicare coverage rules, drugs prescribed for PrEP will be covered under Medicare Part B without cost sharing (i.e., deductibles or copays) as an additional preventive service. PrEP drugs will no longer be covered under the Medicare Part D benefit. Drugs for HIV treatment and HIV post-exposure prophylaxis (PEP) will remain coverable under Medicare Part D.
The table below lists the drugs that are FDA-approved to be used as PrEP for HIV prevention. Please note that some of these drugs are also FDA-approved to be used for HIV treatment.
Brand drug name | Generic drug name | FDA-approved use |
|---|---|---|
Apretude® | cabotegravir | PrEP for HIV prevention |
Descovy® | emtricitabine and tenofovir alafenamide |
|
Truvada® | emtricitabine and tenofovir disoproxil fumarate |
|
emtricitabine and tenofovir disoproxil fumarate | emtricitabine and tenofovir disoproxil fumarate |
|
- As of September 30, 2024, Apretude will no longer be covered under Medicare Part D since it is only FDA-approved for PrEP for HIV prevention.
- In addition, Descovy, Truvada, and generics for Truvada will be covered only under Medicare Part B when used for PrEP for HIV prevention but will remain covered under Medicare Part D when used for HIV treatment.
A diagnosis code should be included on all prescriptions if prescribing one of these drugs for PrEP for HIV prevention.
Resources
For more information on the NCD and related information visit the following web pages:
Topic | URL |
|---|---|
CMS PrEP coverage information | |
| CMS PrEP Tracking Sheet | CMS website |
CMS memo to Medicare Advantage organizations, dated October 1, 2024 | |
CMS memo encouraging Medicare Advantage plans and Part D sponsors to work with pharmacies and other interested parties to prepare for the transition in coverage for PrEP from Part D to Part B, dated August 1, 2024 |
Additional information
If you have questions regarding the information contained in this update, contact the Provider Services Center by email, by telephone or through the provider portal.
Provider Services
Line of business | Phone number | |
|---|---|---|
Medicare (Individual & Employer Group) (Wellcare By Health Net) | ||
Medicare Supplement |
This information applies to Participating Physician Groups (PPGs).