TL;DR: The Centers for Medicare & Medicaid Services modified NCD 335 governing HIV screening coverage, with an effective date of January 9, 2026. Here's what billing teams need to know before submitting claims.
CMS HIV screening coverage policy under NCD 335 Medicare has defined rules about who qualifies, how often, and under what circumstances. This update clarifies and restates those criteria — and if your team isn't billing this correctly right now, you're either leaving money on the table or heading toward a claim denial. This policy does not list specific CPT or HCPCS codes, so we'll cover how to handle that below.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Screening for the Human Immunodeficiency Virus (HIV) Infection |
| Policy Code | NCD 335 |
| Change Type | Modified |
| Effective Date | January 9, 2026 |
| Impact Level | Medium |
| Specialties Affected | Primary care, internal medicine, OB/GYN, infectious disease, FQHCs, RHCs, preventive care |
| Key Action | Audit your HIV screening billing against the NCD 335 criteria, especially age thresholds and the at-risk documentation requirements for patients outside the 15–65 standard window |
CMS HIV Screening Coverage Criteria and Medical Necessity Requirements 2026
NCD 335 is the National Coverage Determination governing Medicare coverage of HIV screening under the Additional Preventive Services benefit category. CMS first began covering HIV screening on December 8, 2009. The coverage criteria have been in place since April 13, 2015, and this 2026 update reaffirms and clarifies those rules.
The coverage policy applies to all Medicare beneficiaries enrolled under Part A or Part B. Coverage is voluntary — the patient must agree to the screening. The test must be ordered by the beneficiary's physician or practitioner within the context of a healthcare setting, and performed by an eligible Medicare provider using FDA-approved laboratory or point-of-care tests, consistent with FDA-approved labeling and CLIA regulations.
Standard Coverage: Ages 15–65
CMS covers one annual HIV screening for all adolescents and adults between ages 15 and 65. This applies regardless of perceived risk. No additional medical necessity documentation is required for this population beyond confirming the patient's age.
One screening per year. That's the limit for this group.
At-Risk Coverage: Outside the 15–65 Window
For patients younger than 15 or older than 65, the medical necessity standard shifts. CMS covers one annual screening for these patients only if they meet the criteria for increased risk of HIV infection.
The coverage policy defines increased risk as any of the following:
| # | Covered Indication |
|---|---|
| 1 | Men who have sex with men |
| 2 | Men and women having unprotected vaginal or anal intercourse |
| 3 | Past or present injection drug users |
| 4 | Men and women who exchange sex for money or drugs, or have sex partners who do |
| 5 | Individuals whose past or present sex partners were HIV-infected, bisexual, or injection drug users |
| 6 | Persons with a history of other sexually transmitted infections, or who request testing for STIs |
| 7 | Persons with a history of blood transfusions between 1978 and 1985 |
| 8 | Persons with new sexual partners |
| 9 | Persons who request an HIV test despite reporting no individual risk factors |
| 10 | Persons who, based on individualized physician interview and examination, are deemed to be at increased risk |
That last criterion is the catch-all — and it matters for reimbursement. The practitioner must assess the patient's history and document the determination of increased risk. This isn't a checkbox. It's a clinical judgment call that needs to be in the chart.
Pregnancy Coverage
Pregnant Medicare beneficiaries have separate, expanded coverage. CMS covers up to three HIV screenings per pregnancy. Specifically:
| # | Covered Indication |
|---|---|
| 1 | One screening during the first trimester (or at the first prenatal visit if the patient presents after the first trimester) |
| 2 | One screening during the third trimester (for patients at increased risk) |
| 3 | One screening at labor or delivery (for patients who have not been previously tested during the pregnancy and present in labor) |
This is a distinct benefit from the standard annual screening. Don't assume the annual screening rule applies to your pregnant patients.
USPSTF Grade A Basis
CMS anchors this coverage policy on the United States Preventive Services Task Force Grade A recommendation. The USPSTF Grade A covers screening for all adolescents and adults ages 15–65, younger adolescents and older adults at increased risk, and all pregnant women. When the USPSTF moves, CMS typically follows — and the Grade A designation here provides a stable reimbursement foundation.
CMS HIV Screening Exclusions and Non-Covered Indications
This policy doesn't include a long exclusions list, but there are clear non-covered scenarios that will generate a claim denial if you're not watching for them.
Frequency limits. CMS covers a maximum of one annual screening for the standard population (ages 15–65) and for at-risk patients outside that window. Billing a second screening in the same year for a non-pregnant beneficiary — without documentation of a separate clinical indication that meets a different benefit category — will result in a denial.
Missing at-risk documentation for patients outside 15–65. If you're billing an HIV screening for a 72-year-old or a 14-year-old and the chart doesn't document a specific increased-risk factor, CMS has no basis to pay. The medical necessity documentation isn't optional for this population.
Tests that don't meet FDA/CLIA standards. Coverage applies only to FDA-approved laboratory and point-of-care tests used consistent with FDA-approved labeling, and in compliance with CLIA regulations. If your facility's test or testing process doesn't meet these standards, coverage doesn't apply.
Screening ordered outside a healthcare setting. The order must come from the beneficiary's physician or practitioner within the context of a healthcare setting. At-home or community-based screenings ordered outside that structure don't qualify under this NCD.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Annual screening, ages 15–65, regardless of risk | Covered | NCD 335 — no specific CPT listed in policy | One screening per year max; voluntary |
| Annual screening, under 15 or over 65, at increased risk | Covered | NCD 335 — no specific CPT listed in policy | Document specific increased-risk factor in chart |
| Screening for pregnant Medicare beneficiaries — first prenatal visit or first trimester | Covered | NCD 335 — no specific CPT listed in policy | Up to three screenings per pregnancy |
| Screening for pregnant Medicare beneficiaries — third trimester (at increased risk) | Covered | NCD 335 — no specific CPT listed in policy | Requires increased-risk documentation |
| Screening for pregnant Medicare beneficiaries — at labor/delivery (if not previously tested) | Covered | NCD 335 — no specific CPT listed in policy | Applies when no prior screening in current pregnancy |
| Second or additional annual screening, non-pregnant beneficiary | Not Covered | N/A | Frequency limit is one per year |
| Screening for under 15 or over 65 without documented increased-risk factors | Not Covered | N/A | Medical necessity documentation required |
| Testing using non-FDA-approved or non-CLIA-compliant tests | Not Covered | N/A | Fails coverage requirements on test standards |
CMS HIV Screening Billing Guidelines and Action Items 2026
The core coverage structure here isn't new — it's been in place since 2015. But this January 9, 2026 effective date signals a modification, which means now is the right time to audit whether your team is billing this correctly.
| # | Action Item |
|---|---|
| 1 | Verify you're using the right CPT codes for HIV screening claims. NCD 335 does not list specific CPT or HCPCS codes in the policy document. HIV screening billing typically runs through codes like 86703 or 87389, but your Medicare Administrative Contractor (MAC) determines which codes they accept under this NCD. Check your MAC's LCD or billing guidelines for HIV screening to confirm the applicable codes before the next claim goes out. |
| 2 | Audit age-split claims separately. Pull claims for HIV screenings billed for patients under 15 or over 65. For each one, confirm the chart documents a specific increased-risk factor. If it doesn't, you have a medical necessity problem — and if claims have already been paid, you may have a repayment exposure. Talk to your compliance officer if you find a pattern here. |
| 3 | Build a pregnancy-specific workflow. The three-screening-per-pregnancy benefit is frequently underused or misbilled. If your practice sees pregnant Medicare beneficiaries, build a tracking mechanism that flags which of the three screenings has been billed per pregnancy. Don't collapse pregnancy screenings into the annual benefit — they're separate. |
| 4 | Document increased-risk determinations as a discrete chart element. The practitioner's determination of increased risk for patients outside the 15–65 window needs to be findable on audit. A note buried in a narrative paragraph isn't enough. Work with your clinical team to build a discrete documentation field — or at minimum a standardized phrase — into the visit note template. |
| 5 | Confirm FDA/CLIA compliance for any point-of-care testing. If your practice uses rapid point-of-care HIV tests, verify those tests carry FDA approval and that your facility's CLIA certificate covers the test category. This is a background requirement, but it's one auditors check. Your compliance officer should have this documentation on file. |
| 6 | Check your MAC's HIV screening policies directly. This NCD sets the floor. Your MAC may have an LCD or article that adds requirements, restricts codes, or clarifies billing rules specific to your region. Pull the current MAC guidance and compare it against what your team is doing. |
Prior authorization is not required under this NCD for the standard annual screening. But that doesn't mean you'll never see a prior auth request — supplemental Medicare Advantage plans sometimes add prior authorization layers on top of traditional Medicare NCD coverage. If you bill any Medicare Advantage volume, verify those plan-level rules separately.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for HIV Screening Under NCD 335
Covered CPT/HCPCS Codes
The NCD 335 policy document does not list specific CPT or HCPCS codes. This is not unusual for NCD-level policies — code-level specificity is typically handled at the MAC level through local coverage determinations or billing articles.
For HIV screening billing, contact your MAC directly or review their HIV screening LCD/article to get the exact codes they require. Common codes used in HIV screening billing include laboratory codes for antigen/antibody combination testing, but do not assume a code applies without MAC confirmation.
| Code | Type | Description |
|---|---|---|
| Not specified in NCD 335 | — | See MAC-level LCD or billing article for applicable CPT/HCPCS codes |
Key ICD-10-CM Diagnosis Codes
NCD 335 does not list ICD-10-CM codes. Diagnosis coding for HIV screening typically uses Z-codes for screening encounters and contact/exposure history codes. Confirm applicable diagnosis codes with your MAC guidance and standard ICD-10-CM coding conventions for preventive screening.
| Code | Description |
|---|---|
| Not specified in NCD 335 | See MAC billing guidelines for applicable diagnosis codes |
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