Screening for the Human Immunodeficiency Virus (HIV) Infection

A. General

Infection with the human immunodeficiency virus (HIV) is a continuing, worldwide pandemic described by the World Health Organization as "the most serious infectious disease challenge to global public health". Acquired immunodeficiency syndrome (AIDS) is diagnosed when a HIV-infected person’s immune system becomes severely compromised and/or a person becomes ill with a HIV-related opportunistic infection. Without treatment, AIDS usually develops within 8-10 years after a person’s initial HIV infection. While there is presently no cure for HIV, an infected individual can be recognized by screening, and subsequent access to skilled care plus vigilant monitoring and adherence to continuous antiretroviral therapy may delay the onset of AIDS and increase quality of life for many years.

Significantly, more than half of new HIV infections are estimated to be sexually transmitted from infected individuals who are unaware of their HIV status. Consequently, improved secondary disease prevention and wider availability of screening linked to HIV care and treatment would not only delay disease progression and complications in untested or unaware older individuals, but could also decrease the spread of disease to those living with or partnered with HIV-infected individuals.

The HIV antibody testing first became available in 1985. These commonly used, Food and Drug Administration (FDA)-approved HIV antibody screening tests – using serum or plasma from a venipuncture or blood draw – are known as EIA (enzyme immunoassay) or ELISA (enzyme-linked immunosorbent assay) tests.

Developed for point-of-care testing using alternative samples, six rapid HIV-1 and/or HIV-2 antibody tests – using fluid obtained from the oral cavity or using whole blood, serum, or plasma from a blood draw or fingerstick – were approved by the FDA from 2002-2006.

Effective January 1, 2009, the Centers for Medicare & Medicaid Services (CMS) is allowed to add coverage of “additional preventive services” through the national coverage determination (NCD) process if certain statutory requirements are met, as provided under section 101(a) of the Medicare Improvements for Patients and Providers Act. One of those requirements is that the service(s) be categorized as a grade A (strongly recommends) or grade B (recommends) rating by the US Preventive Services Task Force (USPSTF). The USPSTF strongly recommends screening for all adolescents and adults at risk for HIV infection, as well as all pregnant women.

B. Nationally Covered Indications

Effective for claims with dates of service on and after December 8, 2009, CMS determines that the evidence is adequate to conclude that screening for HIV infection is reasonable and necessary for early detection of HIV and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B. Therefore, CMS proposes to cover both standard and FDA-approved HIV rapid screening tests for:

1. A maximum of one, annual voluntary HIV screening of Medicare beneficiaries at increased risk for HIV infection per USPSTF guidelines as follows:

• Men who have had sex with men after 1975
• Men and women having unprotected sex with multiple [more than one] partners
• Past or present injection drug users
• Men and women who exchange sex for money or drugs, or have sex partners who do
• Individuals whose past or present sex partners were HIV-infected, bisexual or injection drug users
• Persons being treated for sexually transmitted diseases
• Persons with a history of blood transfusion between 1978 and 1985
• Persons who request an HIV test despite reporting no individual risk factors, since this group is likely to include individuals not willing to disclose high-risk behaviors; and,

2. A maximum of three, voluntary HIV screenings of pregnant Medicare beneficiaries: (1) when the diagnosis of pregnancy is known, (2) during the third trimester, and (3) at labor, if ordered by the woman’s clinician.

C. Nationally Non-Covered Indications

Effective for claims with dates of service on and after December 8, 2009, Medicare beneficiaries with any known diagnosis of a HIV-related illness are not eligible for this screening test.

Medicare beneficiaries (other than those who are pregnant) who have had a prior HIV screening test within one year are not eligible (11 full months must have elapsed following the month in which the previous test was performed in order for the subsequent test to be covered).

Pregnant Medicare beneficiaries who have had three screening tests within their respective term of pregnancy are not eligible (beginning with the date of the first test).

D. Other

N/A

(This NCD last reviewed November 2009.)

02/2010 - Effective Date: 12/08/2009. Implementation Date: 07/06/2010. (TN 113) (CR6786)

03/2010 - Transmittal 113, dated February 19, 2010, is rescinded and replaced with Transmittal 118, dated March 23, 2010. Edits have been made to the Business Requirements to provide consistency between the two manuals (Pub. 100-04 and 100-03). See Pub. 100-04, Transmittal 1935, dated March 23, 2010, for further details. All other material remains the same. (TN 118) (CR6786)

02/2011 - Transmittal 118, dated March 23, 2010, is rescinded and replaced with Transmittal 131, dated February 23, 2011, to revise the descriptors of the 3 HIV screening codes to align with the descriptors in the official code files. All other material remains the same. (TN 131) (CR6786)

03/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/07/2013 Effective date: 10/1/2015. (TN 1199) (TN 1199) (CR 8197)