National Coverage Analysis (NCA) Tracking Sheet

Screening for the Human Immunodeficiency Virus (HIV) Infection

CAG-00409R

Issue

Effective January 1, 2009, CMS is allowed to add coverage of "additional preventive services" if certain statutory requirements are met, as provided under section 101(a) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Among other things, this new benefit allows CMS under 42 CFR 410.64 to cover "additional preventive services", if it determines through the NCD process that the service is recommended with a grade A (strongly recommends) or grade B (recommends) rating by the United States Preventive Services Task Force (USPSTF) and meets certain other requirements.

As of December 2009, and based on the 2007 USPSTF recommendations in conjunction with studies and guidelines published at that time, CMS covers both standard and FDA-approved HIV rapid screening tests for: (1) annual voluntary HIV screening of Medicare beneficiaries at increased risk for HIV infection per USPSTF guidelines, and (2) voluntary HIV screening of pregnant Medicare beneficiaries when the diagnosis of pregnancy is known, during the third trimester and at labor. Section 210.7 of the Medicare National Coverage Determinations (NCD) Manual establishes conditions of coverage for screening for the Human Immunodeficiency Virus (HIV) infection.

In April 2013, the USPSTF revised its Grade "A" recommendation for routine HIV screening to cover all adolescents and adults ages 15 to 65 years, without regard to perceived risk behavior. The grade "A" recommendation also covers those outside this age range who are at increased risk for infection. The HIV Testing Reimbursement Working Group, a sub-group of the HIV Healthcare Access Working Group and the Federal AIDS Policy Partnership, submitted an NCD reconsideration request asking CMS to review new scientific evidence and to adopt the USPSTF's most current evidence-based recommendations.

Benefit Category

Additional Preventive Services

Requestor Information

Requestor Name Requestor Letter
The HIV Testing Reimbursement Working Group, a sub-group of the HIV Healthcare Access Working Group and the Federal AIDS Policy Partnership View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
08/04/2014
Expected NCA Completion Date
04/29/2015
Public Comment Period
08/04/2014 - 09/03/2014
Proposed Decision Memo Due Date
Proposed Decision Memo Released
01/29/2015
Proposed Decision Memo Public Comment Period
01/29/2015 - 02/28/2015
Decision Memo Released
04/13/2015
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Stuart Caplan
Lead Medical Officers
Susan Miller, MD

Medicare Benefit Category Determination Date

Actions Taken

August 4, 2014

CMS initiates this NCA on screening for HIV infection. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days.

CMS considers all public comments and is particularly interested in comments that include clinical studies and other scientific information that provide evidence for improvement in short and long term outcomes related to this screening service.

Instructions on submitting public comments can be found at http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

January 29, 2015

April 13, 2015