CMS Proposes Coverage Decision Regarding HIV Screening

The Centers for Medicare and Medicaid Services (CMS) proposes increased coverage of HIV screenings with changes to the Medicare National Coverage Determinations Manual, Section 210.7. The CMS indicates sufficient evidence justifies screening all individuals between ages15 and 65 regardless of risk. The CMS is proposing coverage of screening via the Food and Drug Administration (FDA) approved laboratory tests and point-of-care tests (subject to FDA and CLIA requirements) under the following conditions:

• Up to one voluntary annual screening for individuals between 15 and 65 regardless of risk;
• Up to one voluntary annual screening for those under 15 or over 65 if there is increased risk of infection such as those having intercourse, injection drug users, individuals who had blood transfusions between 1978 and 1985, individuals with new sexual partners or partners who were HIV infected or drug users; and
• Up to three voluntary HIV screenings for pregnant women (at time pregnancy is diagnosed, in the third trimester, and/or at labor).

Currently, the existing coverage determination covers claims since 2009 for up to one annual voluntary screening for those at risk of infection and up to three voluntary screenings for pregnant women This proposed expansion to include screenings regardless of risk is based on recommendations from the U.S. Preventive Services Task Force (USPSTF), which found evidence demonstrating that earlier treatment reduces the risk of HIV progressing to AIDS. Unfortunately, the CMS notes that HIV infection can occur years before symptoms appear, therefore late detection is common and many HIV-infected individuals in the U.S. are unaware they are infected. Additionally, the CMS indicates that individuals between ages 18 and 65 who report they haven’t been screened for HIV claim the reason for failing to be screened is they didn’t consider themselves at-risk for HIV infection. The CMS claims 35 million people are infected with HIV worldwide including about 1.2 million U.S. residents. It says “one in seven of those individuals are unaware of their infection.” Centers for Disease Control and Prevention (CDC) data backs the CMS’s estimates. The CDC reported that in 2010, there were about 47,500 new cases of HIV infection and since the 1990s there have consistently been nearly 50,000 new cases every year. As of the end of 2011, there were 1.2 million HIV-infected people in the United States and 14 per cent didn’t know they were infected, according to the CDC. In support of the proposed screening guidelines, the CMS explained its criteria for evaluating the reasonableness of screening tests. They include: > Whether the test is easy to administer and can be used by paraprofessionals; > If patients would be willing to take the test (because participation is voluntary); > Whether the test is accurate; > The cost of the test relative to the benefit of early detection; > Consistency of test results; and > “Sensitivity and specificity” of the test. In other words, how well the test correctly identifies patients with the disease and rules out those who aren’t infected (thus avoiding false positives and false negatives). The CMS is asking for public comment on these proposed screening recommendations. The comment period is 30 days beginning with the Jan. 29 release of the coverage proposal. Takeaway: The CMS recognizes the value of early detection and treatment for HIV and is expanding coverage for screenings to include individuals between 15 and 65, regardless of risk.