Screening for the Human Immunodeficiency Virus (HIV) Infection

The Centers for Medicare & Medicaid Services (CMS) is expanding coverage in section 210.7 of the Medicare National Coverage Determinations (NCD) Manual.  CMS has determined that the evidence is adequate to conclude that screening for HIV infection for all individuals between the ages of 15 and 65 years, as is recommended with a grade of A by the United States Preventive Services Task Force (USPSTF), is reasonable and necessary for the early detection of HIV and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

CMS shall cover screening for HIV with the appropriate U.S. Food and Drug Administration (FDA) approved laboratory tests and point of care tests, used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations, when ordered by the beneficiary’s physician or practitioner within the context of a healthcare setting and performed by an eligible Medicare provider or supplier for these services, for beneficiaries who meet one of the following conditions:

1. Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for all adolescents and adults between the age of 15 and 65, without regard to perceived risk.
2. Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for adolescents younger than 15 and adults older than 65 who are at increased risk for HIV infection.  Increased risk for HIV infection is defined as follows:
   • Men who have sex with men
   • Men and women having unprotected vaginal or anal intercourse
   • 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 who have acquired or request testing for other sexually transmitted infectious diseases
   • Persons with a history of blood transfusions between 1978 and 1985
   • Persons who request an HIV test despite reporting no individual risk factors
   • Persons with new sexual partners
   • Persons who based on individualized physician interview and examination are deemed to be at increased risk for HIV infection.  The determination of “increased risk” for HIV infection is identified by the health care practitioner who assesses the patient’s history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.  The medical recommendation should be a reflection of the service provided.
3. 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.

TO:		Administrative File: (CAG-00409R)      
      
FROM:	Tamara Syrek Jensen, JD      
		Director, Coverage and Analysis Group      
      
		Joseph Chin, MD, MS      
		Acting Deputy Director, Coverage and Analysis Group      
      
		Lori Ashby, MA      
		Acting Director, Division of Medical and Surgical Services      
      
		James Rollins, MD, PhD      
		Director, Division of Items and Devices      
      
		Stuart Caplan, RN, MAS       
		Lead Analyst, Division of Items and Devices      
      
		Susan Miller, MD      
		Lead Medical Officer, Division of Items and Devices      
      
SUBJECT:	Decision Memorandum for Screening for Human Immunodeficiency Virus (HIV) Infection                  
      
DATE:		April 13, 2015

I. Decision

The Centers for Medicare & Medicaid Services (CMS) is expanding coverage in section 210.7 of the Medicare National Coverage Determinations (NCD) Manual. CMS has determined that the evidence is adequate to conclude that screening for HIV infection for all individuals between the ages of 15 and 65 years, as is recommended with a grade of A by the United States Preventive Services Task Force (USPSTF), is reasonable and necessary for the early detection of HIV and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

CMS shall cover screening for HIV with the appropriate U.S. Food and Drug Administration (FDA) approved laboratory tests and point of care tests, used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations, when ordered by the beneficiary’s physician or practitioner within the context of a healthcare setting and performed by an eligible Medicare provider or supplier for these services, for beneficiaries who meet one of the following conditions:

1. Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for all adolescents and adults between the age of 15 and 65, without regard to perceived risk.
2. Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for adolescents younger than 15 and adults older than 65 who are at increased risk for HIV infection. Increased risk for HIV infection is defined as follows:
   • Men who have sex with men
   • Men and women having unprotected vaginal or anal intercourse
   • 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 who have acquired or request testing for other sexually transmitted infectious diseases
   • Persons with a history of blood transfusions between 1978 and 1985
   • Persons who request an HIV test despite reporting no individual risk factors
   • Persons with new sexual partners
   • Persons who based on individualized physician interview and examination are deemed to be at increased risk for HIV infection. The determination of “increased risk” for HIV infection is identified by the health care practitioner who assesses the patient’s history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan. The medical recommendation should be a reflection of the service provided.
3. 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.

II. Background

The following acronyms are used throughout this document. For the convenience of the reader, they are listed here in alphabetical order.

Abbreviations

Introduction

In 2005, the USPSTF provided a Grade A recommendation that clinicians screen for HIV in all adolescents and adults at increased risk for HIV infection, as well as all pregnant women. At that time, the USPSTF made no recommendation for or against routine HIV screening in adolescents and adults not at increased risk for HIV infection (Grade C recommendation) [USPSTF 2005].

After a formal evidentiary review, CMS accepted those recommendations and in NCD 210.7 stated that coverage would be extended to: “A maximum of one, annual voluntary HIV screening of Medicare beneficiaries at increased risk for HIV infection…”, as well as “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.” The NCD further defines those characteristics which demonstrate that a Medicare beneficiary is at “increased risk.” These include:

• 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 transfusions 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 [Medicare National Coverage Determinations Manual, Section 210.7].

In April 2013, the USPSTF updated these recommendations and stated: “The USPSTF recommends that clinicians screen for HIV infection in adolescents and adults aged 15 to 65 years. Younger adolescents and older adults who are at increased risk should also be screened (Grade A recommendation). The USPSTF recommends that clinicians screen all pregnant women for HIV, including those who present in labor who are untested and whose HIV status is unknown (Grade A recommendation) [Moyer 2013].

Definition

HIV is an infection caused by a retrovirus that affects the immune system. There are two types of HIV infections, HIV-1 and HIV-2. HIV-1 is the most common type both globally and in the United States and causes acquired immunodeficiency syndrome (AIDS). HIV-2 is less common and had been originally confined to West Africa, though now can be found throughout the world [Fauci 18e]

The hallmark of HIV disease is a profound immunodeficiency resulting from the progressively declining numbers of infection fighting CD4 T-cell lymphocytes; a condition, which if left untreated, leads to premature death. At the time of acute infection, symptoms can resemble that of infectious mononucleosis; however, a high incidence of nonspecific or atypical symptoms can make the recognition of patients with primary HIV disease difficult. Most patients spontaneously clinically recover from this portion of the disease. Over the course of years though, virus replication is ongoing in the infected individual. As host CD4 levels decline, there is an accompanied rise in the plasma HIV RNA concentration. Once CD4 counts fall below certain thresholds, persons are at high risk to develop opportunistic infections (OIs) and neoplasms that are AIDS defining illnesses. The length of time from initial infection to the development of AIDS defining disease varies, but the median for untreated patients is approximately ten years. Thus a person may be infected with HIV for years before the condition is suspected. Though the symptoms of HIV disease can appear any time during the course of the infection, in general, once the CD4 count is below 200/µl, more severe and life threatening complications occur [Chou 2005, Flexner 12e; Fauci 18e; Nguyen 2008].

Risk

HIV infection is transmitted by sexual contact, blood and blood products, and by infected mothers to infants, intrapartum, perinatally or via breast milk [Fauci 18e]. According to the CDC, in the U.S. in 2010, men who have sex with men (MSM) had 63% of all new HIV infections, even though they made up only approximately 2% of the population. Persons with injection drug use constituted 8% of new HIV infections [HIV A-Z Topics, Basic Statistics 2014]. Other persons at high risk for HIV infection are those individuals who have acquired or request testing for other sexually transmitted infections (STIs) [Moyer 2013].

Behavioral risk factors for HIV include: having unprotected vaginal or anal intercourse, having sexual partners who are HIV-infected, bisexual, or injection drug users; and exchanging sex for drugs or money [Moyer 2013].

Notwithstanding the above, it is important to note that the pattern of HIV transmission in the U.S. has changed over time. Between 1985 and 2009, the estimated percentage of AIDS diagnosis attributed to heterosexual contact has increased from 3% to 31% [Fauci 18e].

Epidemiology

As of 2013, it is estimated that approximately 35 million people are living with HIV worldwide [Global Health Observatory 2014]. In the United States the condition continues to be a serious public health issue. In the United States about 1.2 million people are living with HIV infection, and approximately one in seven of those individuals are unaware of their infection [HIV A-Z Topics, Basic Statistics 2014]. Over the past decade, the number of people living with HIV has increased, while the annual number of new infections has remained relatively stable at about 50,000 [U.S. Statistics 2012; Moyer 2013].

HIV infection disproportionately impacts identifiable racial and ethnic groups. African Americans, more than any other racial/ethnic group, bear the most severe burden of HIV in the United States followed by those who are Hispanic. In 2010, African Americans made up about 12% of the population of the United States, but accounted for almost half of all new HIV infections (44 %). In that same year, Hispanics and Latinos made up approximately 17% of the population in the United States, but represented 21% of those with new HIV infections in the country [HIV A-Z Topics, Basic Statistics 2014].

Both the incidence and prevalence of HIV infection are also increasing in the “elderly”. The age of 50 is not commonly used to describe those who are elderly in the medical literature; however, since this is much older than the average person with HIV infection who is approximately 30 years old, the CDC frequently uses this age as a cut off to describe the older population with this disease [Nguyen 2008]. In the 46 states with long established confidential name based HIV infection reporting, the CDC estimated percentage of persons aged 50 years or older living with diagnosed HIV infection was 32.7% in 2009, increased from 28.6% in 2007 [HIV Surveillance Supplemental Report 2013]. Of the estimated total 1.1 million persons with HIV infection living in the United States in 2010, people aged 55 and older accounted for 217,000 or 19% of the persons living with the disease [HIV Among Older Adults 2013]. It is estimated that by 2015, 50% of the HIV infected persons in the United States will be 50 years of age or older [Adekeye 2012; Kirk 2009].

Laboratory Screening Tests

HIV antibody testing first became available in 1985 [Decision Memo (CAG-00409N), 2009].

In June 2014, the CDC and the APHL issued a recommended algorithm for HIV testing by laboratories in the U.S. This sequence of analysis for the diagnosis of HIV is based on tests of serum or plasma specimens from persons aged 2 years and older, approved by the FDA as of December 2012, as well as scientific evidence, laboratory experience and expert opinion gathered from 2007-2013 [Laboratory Testing for the Diagnosis of HIV Infection 2014]. The algorithm can be obtained at: http://www.cdc.gov/hiv/pdf/HIVtestingAlgorithmRecommendation-Final.pdf.

Previous guidelines on this topic recommended testing sequences which detect HIV antibodies only. However, as studies from populations at high risk for HIV demonstrate that the sole use of antibody testing can miss a considerable percentage of HIV infections, the CDC/APHL recommendations also include tests for HIV antigen and HIV nucleic acid. In short, the algorithm begins with a combination immunoassay, that detects both HIV-1 and HIV-2 antibodies as well HIV-1 p24 antigen. No further testing is required for specimens which are nonreactive on the initial assay. However specimens that are reactive are recommended to be tested with an FDA-approved antibody immunoassay that differentiates HIV-1 antibodies from HIV-2 antibodies. Specimens that are reactive in the initial antigen/antibody combination immunoassay but non- reactive or indeterminate on the HIV-1/HIV-2 differentiation immunoassay are recommended to be tested with an FDA-approved HIV-1 nucleic acid test [Laboratory Testing for the Diagnosis of HIV Infection 2014].

Using this algorithm averted missed HIV diagnoses in two studies; 32% in an emergency department in Phoenix in patients aged 18-64 years (from July 2011 to February 2013), and 9% in a study conducted in three areas of the country (New York City, North Carolina and San Francisco) in patients older than 12 (from September 2011 through September 2012). Thus this algorithm using the combination antigen-antibody tests is thought better able to avoid false negatives results early in the course of HIV infection than do previously recommended testing sequences which detect HIV antibodies only [Bartlett 2014; Morbidity and Mortality Weekly Report 2013].

Treatment

To reduce the incidence of HIV infection, various strategies have been employed. These have included behavioral changes (e.g., condom use, access to sterile paraphernalia for IV drug users, etc.) as well as biomedical therapies (e.g., male circumcision) [Piot 2013]. However the cornerstone of treatment is the pharmacologic ability to suppress virus replication as much as possible, for as long as possible. Though drug therapy is not curative, antiretroviral therapy (ART) for the treatment of HIV infection has improved steadily since its initial offering in the mid 1990’s. It is currently generally accepted that ART has significantly reduced HIV-associated morbidity and mortality throughout the United States and the world, and has transformed HIV disease for many, into a chronic, manageable condition [Flexner 12e; Fauci 18e]. The USPSTF has found convincing evidence that identification and treatment of HIV infection is associated with a markedly reduced risk for progression to AIDS, AIDS related events and death in individuals with immunologically advanced disease (defined as a CD4 count < 0.200 x 10⁹ cells/L). The USPSTF has also stated that the evidence is adequate to demonstrate that beginning ART earlier, when CD4 counts are between 0.200 and 0.500 X 10⁹ cells/L and patients are more likely to be asymptomatic and their infection detected by screening rather than symptoms noted at clinical presentation, is also associated with less risk of AIDS related events or death. Moreover, the USPSTF has found convincing evidence that the use of ART is associated with a substantially decreased risk for transmission from HIV infected persons to their uninfected heterosexual partners [Moyer 2013].

III. History of Medicare Coverage

Pursuant to §1861(ddd) of the Social Security Act, CMS may add coverage of "additional preventive services" if certain statutory requirements are met. Our regulations provide:

§410.64 Additional preventive services

(a) Medicare Part B pays for additional preventive services not described in paragraph (1) or (3) of the definition of “preventive services” under §410.2, that identify medical conditions or risk factors for individuals if the Secretary determines through the national coverage determination process (as defined in section 1869(f)(1)(B) of the Act) that these services are all of the following:

(1) Reasonable and necessary for the prevention or early detection of illness or disability.
(2) Recommended with a grade of A or B by the United States Preventive Services Task Force.
(3) Appropriate for individuals entitled to benefits under part A or enrolled under Part B.

(b) In making determinations under paragraph (a) of this section regarding the coverage of a new preventive service, the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such services and may take into account the results of such an assessment in making such national coverage determinations.

Currently, screening for HIV is covered by Medicare per the 2005 Grade A recommendations of the USPSTF.

1. Current Request

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.

2. Benefit Category

In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B and must not be otherwise excluded from coverage. Since January 1, 2009, CMS is authorized to cover "additional preventive services" if certain statutory requirements are met as provided under §1861(ddd) of the Social Security Act.

IV. Timeline of Recent Activities

V. Food and Drug Administration (FDA) Status

In general, diagnostic laboratory tests are regulated by the FDA. Laboratory tests that can detect the presence of HIV antibody and antigen are approved and available.

HIV antibody testing first became available in 1985. Commonly used, FDA-approved HIV antibody screening tests – using serum or plasma from a blood draw – are known as EIA (enzyme immunoassay) or ELISA (enzyme-linked immunosorbent assay) tests. Laboratory results of EIA or ELISA antibody tests may not be available for a week or more.

Developed for point-of-care testing using alternative samples, thirteen 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 finger stick – were approved by the FDA from 2002- 2013. Results can be available within approximately 20 minutes. All these tests have to be performed by authorized personnel only.

In 2010, the FDA approved, for the first time, an HIV diagnostic test that detected both antibodies and antigen. In 2013, the FDA approved the first rapid antigen-antibody test, which also was the first test designed to distinguish between acute and established HIV-1 infection [Personal Communication FDA 2014].

The Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assay is available at:

http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm080466.htm

VI. General Methodological Principles

When making national coverage determinations concerning additional preventive services, CMS applies the statutory criteria in §1861(ddd) of the Social Security Act and evaluates relevant clinical evidence to determine whether or not the service is reasonable and necessary for the prevention or early detection of illness or disability, is recommended with a grade of A or B by the USPSTF, and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B of the Medicare program.

Public comment sometimes cites the published clinical evidence and gives CMS useful information. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. CMS uses the initial public comments to inform its proposed decision. CMS responds in detail to the public comments on a proposed decision when issuing the final decision memorandum.

VII. Evidence

A. Introduction

Consistent with §1861(ddd)(1)(A) and 42 CFR 410.64(a)(1), additional preventive services must be reasonable and necessary for the prevention or early detection of illness or disability. With respect to evaluating whether screening tests conducted on asymptomatic individuals are reasonable and necessary, the analytic framework involves consideration of different factors compared to either diagnostic tests or therapeutic interventions. Evaluation of screening tests has been largely standardized in the medical and scientific communities, and the "value of a screening test may be assessed according to the following criteria:

1. Simplicity. In many screening programmes more than one test is used to detect one disease, and in a multiphasic programme the individual will be subjected to a number of tests within a short space of time. It is therefore essential that the tests used should be easy to administer and should be capable of use by para-medical and other personnel.
2. Acceptability. As screening is in most instances voluntary and a high rate of co-operation is necessary in an efficient screening programme, it is important that tests should be acceptable to the subjects.
3. Accuracy. The test should give a true measurement of the attribute under investigation.
4. Cost. The expense of screening should be considered in relation to the benefits resulting from the early detection of disease, i.e., the severity of the disease, the advantages of treatment at an early stage and the probability of cure.
5. Precision (sometimes called repeatability). The test should give consistent results in repeated trials.
6. Sensitivity. This may be defined as the ability of the test to give a positive finding when the individual screened has the disease or abnormality under investigation.
7. Specificity. This may be defined as the ability of the test to give a negative finding when the individual screened does not have the disease or abnormality under investigation." [Cochran 1971].

As Cochrane and Holland noted, evidence on health outcomes, (i.e., “evidence that screening can alter the natural history of disease in a significant proportion of those screened"), is important in the consideration of screening tests since individuals are asymptomatic and "the practitioner initiates screening procedures” [Cochran 1971].

Four of the seven criteria cited above as reasonable and necessary for screening tests (i.e., accuracy, precision, sensitivity and specificity) reflect a screening test’s ability to minimize the harm of testing inaccuracy, especially from false positive or false negative results [Cochrane 1971]. Screening test compliance with these criteria is within the scope of FDA review of in-vitro diagnostic devices and the FDA has only reviewed evidence on the approved label indications for these tests.

USPSTF Recommended Preventive Services

The USPSTF functions as an independent panel of non-Federal experts in prevention and primary care. The USPSTF Procedure Manual can be found at: http://www.U.S.PreventiveServicesTaskForce.org/uspstf08/methods/procmanual.htm.

B. USPSTF Grade Definitions

The USPSTF assigns one of five letter grades to each of its recommendations (A, B, C, D, I). In July of 2012, the grade definitions were updated to reflect the change in definition of and suggestions for practice for the grade C recommendation.

The following tables from the USPSTF website provide the current grade definitions and descriptions of levels of certainty. (http://www.uspreventiveservicestaskforce.org/uspstf/grades.htm)

Grade Definitions After July 2012

Levels of Certainty Regarding Net Benefit

* The USPSTF defines certainty as "likelihood that the USPSTF assessment of the net benefit of a preventive service is correct." The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service.

C. U.S. Preventive Services Task Force Recommendations for HIV Screening

The current USPSTF recommendations for HIV screening are as follows:

• The USPSTF recommends that clinicians screen for HIV infection in adolescents and adults aged 15 to 65 years. Younger adolescents and older adults who are at increased risk should also be screened. (Grade A recommendation)
• The USPSTF recommends that clinicians screen all pregnant women for HIV, including those who present in labor who are untested and whose HIV status is unknown. (Grade A recommendation)

D. Literature Search

In addition to the prerequisite USPSTF recommendation, CMS must consider not only whether an additional preventive service is reasonable and necessary for the prevention or early detection of illness or disability, but whether the service is appropriate for individuals entitled to benefits under part A or enrolled under part B of the Medicare program.

CMS performed its literature search using Ovid, during the fall of 2014. We searched for and considered articles in peer reviewed journals and guidelines from 2004 to 2014. This evidence usually concerned the characteristics of individuals diagnosed with HIV infection and/or clinical health outcomes associated with screening for HIV infection that typically are objective in nature. To ensure that the information was relevant to the Medicare population, we considered only those articles which investigated or reported on a population specific to the United States. Furthermore, our review allowed for direct evidence only, meaning that articles depending upon mathematical simulation models for their conclusions were not included in our review.

Primary search terms included “HIV infection and early diagnosis” as well as “HIV infection and late diagnosis”. Citations indicating articles were available in English and had been published in the last 10 years were reviewed. Bibliographies of the retrieved papers were searched for other relevant citations. We also reviewed the bibliographies of the pertinent Morbidity and Mortality Weekly Reports of the CDC.

E. Discussion of Evidence

This section provides a summary of the evidence we considered during our review. The evidence reviewed includes the published medical literature concerning the late diagnosis of HIV, focusing on the population group aged 15 to 65 years.

CMS searches for and considers literature articles, reports and guidelines that present evidence rather than present a review or a commentary. This evidence must concern clinical health outcomes associated with screening for HIV infection that typically are objective in nature, such as rates of late diagnoses of HIV infection. Consequently, we do not consider evidence from studies that evaluate screening test strategies. Lastly, for additional preventive service NCDs under § 1861(ddd)(2), we may assess the predicted outcomes and expenditures as part of our determination.

1. Questions:

2. External Technology Assessments (TA)

CMS did not commission an external TA on this topic.

3. Internal TA

Study Investigations

Buchacz K, Armon C, Palella FJ, Baker RK, Tedaldi E, Durham MD, Brooks JT. CD4 Cell Counts at HIV Diagnosis among HIV Outpatient Study Participants, 2000-2009. AIDS Research and Treatment. 2012: Article ID 869841.doi:10.1155/2012/869841.

This purpose of this prospective observational cohort investigation was to study the characteristics of the participants of the HIV Outpatient Study (HOPS) who were diagnosed with HIV infections during 2000-2009. Of specific interest was the median CD4 count at diagnosis and the proportion of patients diagnosed with CD4 counts < 200 cells/mm³ (also termed “late HIV diagnosis”) during this time period.

The HOPS sites have included 10 clinics (university, public and private) in eight cities across the United States (Tampa, Florida; Washington, DC; Denver, Colorado; Stony Brook, New York; Oakland, California; Walnut Creek, California; Philadelphia, Pennsylvania; Chicago, Illinois). The investigation was limited to those patients who had been diagnosed with HIV infection during 2000-2009, within six months before entry into care at the HOPS site (also termed a “recent diagnosis”). Furthermore the patients must have had a complete record of antiretroviral use (if applicable) and have had a CD4 count measured sometime within 3 months after the diagnosis of HIV infection was made and before any antiretroviral treatment was received.

During 2000-2009, 3670 individuals were seen at the HOPS HIV clinics; 1223 (33%) demonstrated a recent diagnosis of HIV. Of these persons, 936 (77%) exhibited a CD4 count documented within three months of the HIV diagnosis before the individual had received ART. Laboratory analysis demonstrated 337 (36%) of these individuals to be exhibiting a late HIV diagnosis. (Thirty nine percent of patients diagnosed in 2000-2001 and 35% of patients diagnosed in 2008-2009 demonstrated this characteristic.) In multivariate logistic regression analyses, not being a MSM, being 35 years or greater and being of a nonwhite race, was associated with a late HIV diagnosis and CD4 count < 200 cells/mm³. The authors also documented that over one half of the population with available CD4 count data was diagnosed with a HIV infection and a CD4 count < 350 cells/ the mm³. Further relevant information from this investigation is noted below.

Characteristics of HOPS Site Patients Diagnosed with HIV Infection Within 6 Months Before Study Entry with available CD4 Count Data, 2001, 2009 and All Years

In summary, the authors noted that older age (≥ 35 years of age) is associated with a late diagnosis of HIV infection. They surmised that this finding was due to the fact that younger persons have had less of a lifetime opportunity, once infected by HIV, to progress to low CD4 cell counts. They also highlighted that approximately one third of the studied patients with available laboratory testing who were diagnosed with HIV infection demonstrated a CD4 count < 200 cells/mm³ within the 3 months of the HIV diagnosis and over one half of the same population was diagnosed with a HIV infection and a CD4 count < 350 cells/ the mm³, all while still ART naïve.

The authors believed that these findings were of concern because they precluded appropriate treatment of the disease before CD4 counts had dropped below recommended treatment levels for initiation of ART. They stated that these results supported universal routine HIV testing as standard of care for all adolescents and adults seen in health care settings, regardless of reported HIV risk.

Hall HI, Geduld J, Boulos D, Rhodes P, An Q, Mastro TD, Janssen RS, Archibald CP. Epidemiology of HIV in the United States and Canada: Current Status and Ongoing Challenges. Journal of Acquired Immune Deficiency Syndromes. 2009:51(S1);S13.

The purpose of this study was to report on the trends in HIV and AIDS diagnosis in both the United States and Canada since ART became widely available, post 1996. (We report on only that data pertinent to this NCA, i.e., the data from the United States.) HIV with AIDS is defined as a CD4 count of less than 200 cells per microliter or a CD4 T-cell percentage of total lymphocytes of less than 14. Late diagnosis of HIV (defined as those individuals diagnosed with AIDS within twelve months of their HIV diagnosis) was calculated over 2001-2005. Information was obtained from CDC data available from 33 U.S. states with confidential name-based HIV reporting.

The authors state that in the United States between 2001 and 2005, the overall incidence of AIDS has remained relatively stable. However a larger proportion of individuals were diagnosed with HIV within the year before AIDS diagnosis among those younger than 30 and older than 50 years of age as compared to those middle aged. Furthermore they found that a larger proportion of individuals were diagnosed with HIV within the year before AIDS diagnosis among those exposed through heterosexual contact or men having sex with men, as compared with those individuals who are injection drug users. The authors also noted that in the United States, a large proportion of persons were diagnosed late in the course of the HIV disease process (54.3%). The data is summarized in the chart below.

Number and Percentage of AIDS Cases First Diagnosed with HIV within One Year Before AIDS Diagnosis in 33 United States (2001-2005)

The authors noted that in the United States, African Americans and Latinos are disproportionately affected by HIV diagnosis.

Hall HI, Halverson J, Wilson DP, Suligoi B, Diez M, Le Vu S, Tang T, McDonald A, Camoni L, Semaille C, Archibald C. Late Diagnosis and Entry to Care after Diagnosis of Human Immunodeficiency Virus Infection: A Country Comparison. PLOS ONE. 2013: 8(11); e77763.

Data from HIV surveillance systems around the world was used to determine the percentage of individuals diagnosed with late HIV as well as the percentage linked to care after the diagnosis was made, as evidenced by the availability of CD4 counts and viral loads. The United States information, presented here, was gathered from the CDC National HIV Surveillance System. However, CD4 and viral load test results were only complete from 14 areas. Late diagnosis of HIV infection was defined as presenting with a CD4 count < 200 cells/µL or presence of opportunistic illness within 3 months of being newly diagnosed with HIV. Entry to care was defined as at least one CD4 or viral load test within three months of diagnosis. The pertinent findings are summarized below.

Number of people diagnosed with HIV infection and percentage with CD4 < 200 or diagnosed with OI at or within 3 months of HIV diagnosis in the U.S.* Characteristic Diagnosed with HIV infection, total number Diagnosed with AIDS within 3 months of HIV diagnosis (%)

Total population

43,130

28.7

Age, years

0-9

179

7.3

10-19

2,110

12.8

20-29

13,179

16.8

30-39

10,427

29.9

40-49

9,995

37.3

50+

7,240

42.1

Transmission Category

MSM

25,892

26.7

IDU

3,470

39.1

MSM-IDU

1,329

28.0

Heterosexual

12,184

30.4

Other

256

22.1

The authors also assessed the percentage of persons diagnosed with AIDS in 2010, within 12 months of being newly diagnosed with HIV. The results of this analysis are shown below.

Percentage of people diagnosed with HIV infection within 12 months preceding AIDS diagnosis, among people diagnosed with AIDS in 2010 in the U.S..

The following data was presented by the authors to demonstrate linkage to care.

Number of people diagnosed with HIV infection and percentage who had a CD4 and/or viral load test within 3 months of HIV diagnosis in the U.S.*

*Includes persons with HIV infection diagnosed in 14 jurisdictions of the United States and reported by 12/31/2011, with statistical adjustment applied.

The authors note that the percentage of persons diagnosed late in this country (within three months of a HIV infection) was higher than that in Canada, France Italy or Australia. Late diagnosis was also generally higher among those who were older.

Hanna DB, Pfeiffer MR, Torian LV, Sackoff JE. Concurrent HIV/AIDS Diagnosis Increases the Risk of Short-Term HIV-Related Death among Persons Newly Diagnosed with AIDS, 2002-2005. AIDS Patient Care and STDs. 2008:22;17.

The purpose of this retrospective cohort study was to assess the contribution of concurrent HIV/AIDS diagnosis, sociodemographic factors and CD4 counts to HIV related mortality in those New York City (NYC) residents aged 13 or older newly diagnosed with AIDS between January 2002 and June 2005, reported to the New York City Department of Health and Mental Hygiene as of September 30, 2006. The definition of an AIDS diagnosis included a positive test for HIV infection, and either the diagnosis of an OI and/or a CD4 count less than 200 cells per microliter or less than 14% of total lymphocytes. Concurrent HIV/AIDS diagnosis was defined as an AIDS diagnosis occurring within one month of the initial diagnosis of HIV infection. Of those studied (n=15211), a concurrent HIV and AIDS diagnosis was made in 24.7% of individuals with newly documented AIDS. Other pertinent results demonstrated the following:

Characteristics of Persons 13 Years and Older Newly Diagnosed with HIV or HIV/AIDS in New York City, January 2002 – June 2005.

The authors noted that of the 2036 deaths that occurred in the follow up period, 1527 (75%) were HIV related. Among those with concurrent HIV/AIDS, 55.7% of all HIV related deaths occurred in the four months after AIDS diagnosis, compared to 36.7% among nonconcurrent diagnoses. Concurrent HIV/AIDS diagnoses were associated with more than twice the risk of HIV related death within the four months after diagnosis compared to a nonconcurrent diagnosis (HR 2.27, 95% CI 1.94-2.65). However, after four months there was no significant increase in the risk of HIV related death associated with concurrent disease (HR 1.12, 95% CI .77-1.61).

Furthermore the authors emphasized that when persons with CD4 counts of 100-199 cells/µl at AIDS diagnosis were compared with those individuals with CD4 counts less than 50 cells/µl, the latter group were more than twice as likely to die of an HIV related death (HR 2.28, 95% CI 1.96-2.64).

The authors also stated that these results did not change substantially when the interval between the diagnosis of HIV infection and AIDS was expanded to six and twelve months. From these findings, the authors concluded that late diagnosis was the most important modifiable risk associated with short term HIV related mortality in persons newly diagnosed with AIDS in the time period studied. Based on this result, they supported initiatives that promote early diagnosis of HIV infection, including incorporating HIV testing into routine medical care. They state that facilitating early diagnosis of HIV may reduce the mortality due to HIV infection by allowing early pharmacologic treatment before progression of immunosuppression places those infected at risk for OI and death.

Jenkins TC, Gardner EM, Thrun MW, Cohn DL, Burman WJ. Risk-Based Human Immunodeficiency Virus (HIV) Testing Fails to Detect the Majority of HIV-Infected Persons in Medical Care Settings. Sexually Transmitted Diseases.2006:33(5);329.

The purpose of this retrospective review study was to evaluate opportunities for earlier HIV diagnosis within Denver Health, a comprehensive urban health care system with patient access points including a 350 bed hospital, emergency room, urgent care center, 10 community health centers, 11 school based clinics, subspecialty clinics, and the public health department sexually transmitted disease clinic. Patients who were newly diagnosed with HIV infection between September 2001 and December 2003 and either tested positively within the Denver Health system or obtained HIV care there were found through the use of a comprehensive public health surveillance databank. From this population, those patients who participated in one or more clinical encounters in the 3 years before the HIV diagnosis was made were identified. The authors defined clinical indicator conditions associated with chronic HIV infection to include pneumonia, oral infections (candidiasis or hairy leukoplakia), night sweats, seborrheic dermatitis, unexplained fever, unexplained weight loss and herpes zoster. A sexually transmitted disease was also considered to be a marker of increased risk of HIV infection.

Three hundred forty-eight patients were found to have a diagnosis of HIV infection. One hundred twenty of these individuals (34%) had participated in at least one clinical encounter in the Denver Health system during the 3 years prior to the diagnosis. Among this group, there was a median prior visit count of 2 (range 1-29). Thirty-four percent of these patients had experienced five or more visits to the Denver Health system in the three years before diagnosis. There were no significant differences in age, race, primary language or HIV risk transmission factors between patients with/without prior encounters. However, a significantly higher proportion of patients with prior encounters were female.

Of the 120 patients with a prior clinical encounter in the Denver Health system, 111 had baseline CD4 cell counts available for review; 32 of these patients (29%) had a baseline CD4 count indicative of AIDS (less than 200 cells/mm³ ) at the time of HIV diagnosis. In an adjusted analysis, older age and being Spanish speaking were independently associated with late diagnosis. Specifically, for every 10 year increase in age, the odds of having AIDS at initial diagnosis of the HIV infection were 1.8 times (95% CI 1.0-3.1) higher. Thirty-three (28%) of the 120 patients presented with either a clinical indicator or a sexually transmitted disease; 6 of these patients refused HIV testing at a visit before the diagnosis of HIV infection was made.

The most frequent diagnosis at the prior encounters were infections (found at 27% of the visits), including routine upper respiratory infections (n=37), soft tissue infections (n=30), sexually transmitted infections (n=19) and dermatologic infections (n=17). Orthopedic and trauma related visits were also common, occurring at 17% of the prior visits. Fourteen (12%) of the 120 patients had at least one visit that met the definition of potentially being seen during an acute seroconversion illness (fever, fatigue, sore throat, myalgias, weight loss, rash). In 3 out of 14 of these visits, the provider considered HIV infection; one out of these three patients refused HIV testing.

The majority of patients with prior encounters were seen in either an urgent care center or in an emergency room; others were seen at least once in a primary care clinic (29%) or an inpatient admission (16%). Only 6% of the 120 patients were seen for a prior visit in a sexually transmitted disease clinic. Further results are provided below.

Characteristics of Patients Diagnosed with HIV Infection, Denver Health, 2001-2003

Predictors of Late Diagnosis (CD4 count < 200/mm³ ) in 111 Patients with HIV infection With Prior Clinical Encounters and Baseline CD4 Count

The authors note that one third of patients with newly diagnoses HIV infection had previously received care within their own health care system during the three years prior to the diagnosis being made. However, less than 30% of these patients presented with an HIV clinical indicator or sexually transmitted disease before diagnosis. Though infections were the most common reason for the prior encounters, most of the infection related diagnoses made at the prior encounters were not considered to be associated with HIV immunodeficiency. The authors conclude that targeted testing based on clinical presentation is not likely to result in substantially earlier HIV testing. Instead routine screening could be more effective in this endeavor.

Linley L, Prejean J, An Q, Chen M, Hall HI. Racial/Ethnic Disparities in HIV Diagnoses Among Persons Aged 50 Years and Older in 37 U.S. States, 2005-2008. American Journal of Public Health. 2012: 102 (8); 1527.

The goal of this analysis was to describe trends in diagnosis of HIV infection among persons aged 50 years and older and note differences in this population group versus those who are age 13 to 49 years old. The data analyzed was that of 37 States that had established confidential name based HIV reporting at least six months prior to 2005. Those individuals counted in the study were aged 13 years or older whose HIV diagnosis had been made during 2005 through 2008 and reported to the CDC through June 2009. Cases of infection were counted by year of earliest reported diagnosis. Age groups were based on the date of the first documented HIV diagnosis. A diagnosis of HIV was considered late if AIDS was diagnosed within 12 months after the date of HIV infection.

From 2005-2008, 25,002 individuals 50 years of age or older were diagnosed with HIV infection; 131,810 individuals between the ages of 13 and 49 years were also diagnosed with the infection. The average annual rate of diagnosis (per 100,000 persons) was 30.2 for the younger group and 9.8 for the older group, making the rate for younger persons 3.1 times that of the older group and significantly higher (p<.001). Most of the diagnosed HIV infections found among those age 50 and above, were in the group of individuals aged 50 to 64 years (89%). This age group on average demonstrated an annual rate of diagnosis 5.8 times the rate for those aged 65 and greater (15.0 vs. 2.6; p <.001).

The authors also found that those individuals over the age of 50 were almost twice as likely to receive a late diagnosis of HIV infection as compared to the younger age group. They surmised that there were several reasons for this occurrence, including:

• Those who are older may be less aware of their risk for HIV as much of the preventative education has been historically aimed at younger age groups.
• The stigma of HIV infection may create a barrier to testing.
• Symptoms of HIV infection may be similar to common complaints of the older population and therefore physicians may not consider HIV immediately in their differential.
• Physicians may not consider the potential for HIV in their older patients.

Myers JE, Braunstein SL, Shepard CW, Cutler BH, Mantsios AR, Sweeney MM, Tsoi BW. Assessing the Impact of a Community-Wide HIV Testing Scale-Up Initiative in a Major Urban Epidemic. Journal of Acquired Immune Deficiency Syndromes. 2012:61(1);23.

Among the goals of this study was the use of New York City HIV surveillance data to evaluate changes in the percentage of individuals concurrently being diagnosed with HIV and AIDS from the Bronx between the years 2005 and 2009. The Bronx, an area of high HIV prevalence and death rate, launched an initiative in June 2008, with one of its goals to screen every resident in the borough who had never been previously tested for the disease. In the population of interest (Bronx adults aged 18-64), concurrent diagnosis was defined as an AIDS diagnosis made within 31 days of an HIV diagnosis, adjusting for reporting lag.

All laboratories in New York State are required to report the diagnosis of HIV and AIDS to health authorities. This mandatory reporting includes all HIV-related illnesses, all positive Western blot tests for HIV antibody, all viral loads, CD4 values and viral genotypes. Laboratory data concerning New York City HIV cases was obtained from the NYC HIV Surveillance Registry, a record of all persons diagnosed in New York City with HIV since the year 2000 and AIDS, since 1981.

In addition, the authors used a telephone survey instrument to randomly chose non-institutionalized adults 18 years or older, in order to collect self-reported information regarding HIV health related behaviors. Specifically questions about HIV testing in 2005 and 2009 included whether or not the respondent had ever been tested for HIV infection and if so, had ever then been tested in the past 12 months.

Survey sample sizes were 1224 in 2005 and 1232 in 2009. Estimates of the proportion of the Bronx adult population reporting HIV testing ‘in the past twelve months’ increased between 2005 and 2009, from 36.9% (95% CI: 33.5-40.5) to 48.8% (95% CI:45.0-52.7), a relative increase of 32.2% (P < 0.001). The authors also reported the following results for the years 2005 and 2009:

Concurrent HIV/AIDS Diagnosis Among Bronx Adults Aged 18-64 years, 2005 Versus 2009

The authors noted that there was a decrease in concurrent HIV/AIDS diagnosis in 2009 as compared with 2005. Despite this, some groups maintained high proportions of concurrent diagnoses in 2009, including those who were 45-64 years of age and those with heterosexual or unknown transmission risks. The authors believed that a key finding of their research was that a decrease in the concurrent diagnosis of HIV/AIDS occurred with increases in testing. They stated that this result supports the viewpoint that increased population testing could facilitate the identification of persons with HIV infection earlier in the course of the disease.

Schwarcz S, Hsu L, Dilley JW, Loeb L, Nelson K, Boyd S. Late Diagnosis of HIV Infection, Trends, Prevalence and Characteristics of Persons Whose HIV Diagnosis Occurred Within 12 Months of Developing AIDS. Journal of Acquired Immune Deficiency Syndromes. 2006:43(4);491.

The authors desired to determine the prevalence of late diagnosis of HIV infection in a city with high prevalence of AIDS and where a large proportion of the at-risk population has been tested. Towards that end, the investigators used the San Francisco AIDS case registry to identify those individuals who were diagnosed with AIDS within a 12 month period after the documentation of a first positive HIV test. They also examined various trends manifested by these individuals who were termed ‘late testers’. San Francisco residents who were 13 years of age or older, diagnosed with AIDS between 2001 and 2005 and reported through March 27, 2006, were included. The definition of a late tester was a person whose initial HIV diagnosis occurred 12 months or less before the diagnosis of AIDS was given. The date of HIV diagnosis was determined by identifying the earliest of a patient’s self-report of a positive HIV antibody test, use of antiretroviral therapies, documentation of a CD4 or viral load test, or documentation of a positive HIV antibody test.

Between January 1, 2001 and December 31, 2005, 2243 persons in San Francisco were diagnosed with AIDS and reported to the San Francisco Department of Public Health by March 27, 2006. Of these individuals, 95% were included in the analysis (n=2139). Within this group 38.8% of the AIDS patients (n=830) were late testers. The authors noted that this proportion was stable over time.

Among the characteristics associated with an increased likelihood of being a late tester was the acquisition of the HIV infection through a heterosexual contact or being reported without a risk factor. Though the total numbers of men who had sex with men and/or used injected drugs were found at a greater frequency in the study population, the percentage of this population of individuals who were late testers was less than those reported as heterosexual or having no risk factors. The chart below indicates the pertinent findings for this review.

Late Testing Among Persons with AIDS in San Francisco between 2001 and 2005

The authors noted that late testing in San Francisco occurred more frequently among those individuals who were persons of color, younger than thirty years of age at the time of their AIDS diagnosis, among those whose risk was a heterosexual contact or without a reported risk factor, and individuals whose AIDS diagnosis included an OI. Though these results may not be generalizable to the entire United States, the authors stated that expansion of testing services for HIV should be considered, particularly in settings likely to test persons who do not consider themselves to be a high risk for HIV infection.

Trepka MJ, Fennie KP, Sheehan DM, Lutfi K, Maddox L, Lieb S. Late HIV Diagnosis: Differences by Rural/Urban Residence, Florida, 2007-2011. AIDS Patient Care and STDs. 2014:28;188.

This purpose of this retrospective cohort study was to analyze both individual and community level characteristics associated with the late diagnosis of HIV in both urban and rural areas of Florida. Late diagnosis of HIV infection is defined as an AIDS diagnosis within three months of the HIV diagnosis.

The study population consisted of those individuals 13 years or older who were reported with an HIV infection for the first time during 2007-2011. Records were obtained from the Florida Department of Health Enhanced HIV/AIDS Reporting System. A new case of HIV infection was one where the individual’s medical record or laboratory report indicated evidence of a confirmed positive HIV test or a detectable viral load. The AIDS case definition was one where the individual’s medical record demonstrated an AIDS defining illness, a CD4 count < 200 cells/µl or a CD4 percent of total lymphocytes < 14. Follow up AIDS diagnosis data was available for at least one year.

Twenty five thousand five hundred and eighty five cases were analyzed. Of these 2.9% of the individuals resided in a rural area; 97.1% resided in an urban area of Florida. Overall, 27.6% of the persons studied experienced a late diagnosis of HIV. It was more likely that those living in a rural area demonstrated this diagnosis (35.8%) than those individuals living in an urban area (27.4%). (p < 0.0001). Other pertinent results are below.

Characteristics of People With and Without Late HIV in Rural and Urban Florida, 2007-2011 (n=25585)

The authors note that in a multilevel logistic regression model, being in the age groups of 40-59 and 60 years or older versus being 13-19 years of age, was associated with a late HIV diagnosis in rural areas of Florida. In the state’s urban areas, being 20-39, 40-59, or older than 60 years of age was also associated with HIV infection. In only the urban areas of Florida did they note that the heterosexual mode of transmission was associated with HIV transmission.

The authors further noted that that their finding of 27.6% of all reported cases in this study experiencing a late HIV diagnosis was similar to the 25.5% of individuals with the same definition of late diagnosis (AIDS diagnosis within three months of HIV diagnosis) used in a 2010 CDC report on the subject. The CDC report included individuals from 12 states, the District of Columbia and San Francisco. They also stated that their finding of late diagnosis being associated with older adults is consistent with other studies performed in the United States. They believed health care providers may be less likely to consider HIV infection in older individuals who themselves may perceive their risk of the disease to be low.

Moreover, in this study, the authors maintained that the late HIV diagnosis was associated with heterosexual transmission in urban areas as compared with MSM and IDU transmission and that this too was consistent with other studies in the United States. They believed this occurrence may be due to individuals with high risk heterosexual activity not recognizing themselves to be at risk for HIV infection.

Weis KE, Liese AD, Hussey J, Gibson JJ, Duffus WA. Associations of Rural Residence With Timing of HIV Diagnosis and Stage of Disease at Diagnosis, South Carolina 2001-2005. The Journal of Rural Health. 2010:26;105.

The purpose of this study was to investigate the association of rural residence in South Carolina with the timing and stage of HIV infection at diagnosis. Data was analyzed from the South Carolina HIV/AIDS Reporting System (HARS), a confidential name based reporting database maintained since 1986 by the South Carolina Department of Health and Environmental Control. South Carolina residents, eighteen years of age or older, newly diagnosed with HIV infections from January 2001 and December 2005, were included in the study. AIDS diagnoses reported from January 2001 through December 2006 were included in the analysis to allow for one year follow up. Late diagnosis was defined as an individual developing AIDS within one year of their first positive HIV test. The first CD4 count of these individuals was also analyzed. None of the data in this investigation was obtained from patients who had yet received treatment for their infection. Urban counties were defined as those in which its largest city had at least 25000 inhabitants; if this criterion was not met, the county was considered rural.

From January 2001 to December 2005, 4137 residents of the state of South Carolina, aged 18 years or older, were newly diagnosed with HIV infection and included in this analysis. Pertinent data is shown below.

Characteristics of Persons Newly Diagnosed with HIV Infection by Place of Residence, South Carolina, 2001-2005

The authors also note that 65% of those newly diagnosed with HIV infection (n=4137) had an initial CD4 count reported to HARS within one year of their diagnosis. The median CD4 count of those persons demonstrating AIDS ≤ 1 year from the diagnosis of HIV was 85 cells/µl; among those with HIV only diagnosed meaning no diagnosis of AIDS made after the first positive HIV test; n=1791), the median CD4 count was 471 cells/µl (p < 0.0001).

The authors stated that during the time period studied, 43% of newly diagnosed HIV infected individuals in South Carolina were considered to be diagnosed late in their infection. They also concluded that the reasons for late diagnosis in rural areas are multifactorial, ranging from those characteristics inherent to the area (e.g., low educational levels, high unemployment, poverty, relative geographic inaccessibility of appropriate medical services, etc.) to those traits specific to the HIV infection (e.g., fear of stigmatization, concerns related to lack of confidentiality, etc.). The authors believed that potential strategies to reduce the proportion of those persons discovered with late HIV include adoption of opt-out universal HIV screening.

Yang B, Chan SK, Mohammad N, Meyer JA, Risser J, Chronister KJ, Wolverton ML, Arafat RR, Hwang L. Late HIV diagnosis in Houston/Harris County, Texas, 2000-2007. AIDS Care. 2010:22(6);766.

This cross sectional study evaluated the prevalence of late HIV diagnosis and the associated risk factors in Houston, Texas. A late HIV diagnosis was defined as an AIDS diagnosis within 3 months of an HIV diagnosis. AIDS defining conditions included opportunistic infections, a laboratory test demonstrating an absolute CD4+ T-cell count < 200 cells/µL or a CD4+ T-cell percentage less than 14%. The study population of 9964 people was comprised of residents of Houston/Harris County, Texas who were 13 years or older , diagnosed with HIV infection between 2000 and 2007, and reported to the Houston Department of Health and Human Services (HDHHS) by June 30, 2008.

Within the time period studied, 3178 (31%) of all newly reported HIV infected persons developed an AIDS diagnosis within three months of HIV diagnosis. The proportion of late HIV diagnosis was similar across years. Pertinent results are below:

Characteristics of those ≥13 years old newly diagnoses with HIV/AIDS in Houston/Harris County Texas, 2000-2007

The authors made note of the factors that differentiated those with late diagnosis from those without. People who were 40 years of age and older made up almost 46% of those persons with late HIV, but represented only 29% of the entire population investigated. Hispanic individuals comprised 30.9% of individuals with late HIV infection, but only 21.4% of the total population studied. Moreover the odds of having late HIV increased with age. For every 10 year increase in age, the adjusted odds of presenting with a late HIV diagnosis increased 1.5 times. Those with unknown or other risk factors (besides men having sex with men and/or injection drug use, or high risk heterosexual contact) made up 26.1% of the late HIV diagnosis population. Those with high risk heterosexual contact made up 27.5 % of the late HIV diagnosis population.

The authors concluded that approximately one third of the individuals diagnosed with HIV infection in their area during 2000-2007, fulfilled the criteria for late HIV infection. Prominent among those more likely to receive this diagnosis were individuals who are Hispanic, persons who are heterosexual, and people who are older. They stated that longer periods of undiagnosed infection increase the possibility to transmit the disease as well as limit the time period to benefit from treatment. Early access to HIV testing and retention to care could decrease the prevalence of AIDS and resulting opportunistic infections.

Predicted Outcomes and Expenditures of HIV Screening

Fleishman JA, Yehia BR, Moore RD, Gebo KA, HIV Research Network. The Economic Burden of Late Entry into Medical Care for Patients with HIV Infection. Medical Care. 2010: 48(12);1071.

This study performed a review of medical records in order to compare direct medical expenditures for patients with HIV infection as a function of CD4 count at initial presentation to care, in a large multistate HIV cohort between 2000 and 2007. Data from 10 sites of the HIV Research Network (HIVRN), a network of HIV care providers from across the United States, was analyzed for the period between January 1, 2000 and December 31, 2007. Study subjects included patients newly enrolled between 2000 and 2006, and receiving primary HIV care at one of the designated sites. Service utilization was counted from the enrollment date to either day of death or to December 31, 2007. Sites included those located in the East (6), Midwest (1), South (1) and West (2). The outcome measure was cumulative expenditures for HIV related medical services, calculated in 2006 dollars. Services included pertinent inpatient stays and outpatient visits, laboratory tests and prescribed antiretroviral medications or medications taken for prophylaxis of opportunistic infections. Expenses for emergency services, home care, social services and long term care were excluded because these data were not available at all HIVRN sites. Medical services received outside the HIVRN also were not included.

Presentation status was based on the first recorded CD4 test (initial CD4) for each patient after the enrollment date into the HIVRN. Early presenters were defined as those individuals with initial CD4 counts > 500 cells/mm³. Late presenters were those individuals whose cell counts were ≤ 200 cells/mm³.

Included patients were 18 and older and had at least one calendar year in which both an outpatient visit and CD4 count were recorded. Those persons who received HIV care before enrolling in the HIVRN were excluded as were those with interrupted care.

The total sample of persons studied was 8348. Of these, initial CD4 tests revealed 43.1% were late presenters and 18.7% were early presenters. For all periods of time, treatment expenditures were greater for late, rather than early presenters. For those persons with less than one year of care, this difference was $27,275; for those persons with up to 5 years of care, this difference was $61,615; for those persons with up to eight years of care, the difference was $49,105. Older patients, especially those over 50, had higher HIV related costs than those aged less than 31. Individuals who were late presenters were also more likely to die than early presenters (14.04% vs. 3.84%). Other results pertinent to this review are below:

Associations Between CD4 Cell Count at Entry and Patient Characteristics

The authors concluded that persons with HIV infection who were classified as late presenters incur higher cumulative direct HIV treatment costs than those who present earlier in their disease, regardless of the time in care over the first 7-8 years of treatment. They believed that early entry into care could help to prolong the medical course of patients at reduced levels of aggregate expenses.

4. Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) Meeting.

CMS did not hold a MEDCAC meeting on this topic.

5. Evidence-based clinical guidelines

A number of evidence based guidelines were identified.

Marrazzo JM, del Rio C, Holtgrave DR et al. HIV Prevention in Clinical Care Settings, 2014 Recommendations of the International Antiviral Society-U.S.A Panel. Journal of the American Medical Association. 2014:312(4);390.

In order to formulate its recommendations, the members of the International Antiviral Society-U.S.A Panel performed a systematic literature review for published data using Medline and EMBASE. Hand searches were also conducted for newly published reports and abstracts from scientific conferences. Based on this information, recommendations were made by full panel consensus and rated according to strength of the recommendation and quality of supporting data.

The Panel recommendations pertinent to this NCA include:

• All adults and adolescents should be offered HIV testing at least once.
  Rating: AIII (A indicates strong support; III indicates the recommendation is based on the panel’s analysis of the accumulated available evidence)

Qaseem A, Snow V, Shekelle P, Hopkins Jr R, Owens DK, for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Screening for HIV in Health Care Settings: A Guidance Statement From the American College of Physicians and HIV Medicine Association. Annals of Internal Medicine. 2009:150;125.

This guidance statement has as its target population, all individuals age greater than 13 years, seen in healthcare settings. It was derived from an evaluation of the guidelines concerning screening for HIV developed by the United States Preventative Task Force (as amended April 2, 2007) and the CDC (as published in 2006). These two guidelines were reviewed independently by four co-authors using the Appraisal of Guidelines Research and Evaluation (AGREE) method and an evaluator agreed upon stratification methodology. (The AGREE instrument asks questions in six domains: scope and purpose; stakeholder involvement; rigor of development; clarity and presentation; applicability; and editorial independence. Guidelines are scored in each domain.) The authors also reviewed studies regarding the cost effectiveness of HIV screening.

From this review, the conclusions of the Clinical Efficacy Assessment Subcommittee of the American College of Physicians (ACP) were:

Guidance Statement #1: ACP recommends that clinicians adopt routine screening for HIV and encourage patients to be tested.

The rational for this guidance includes the following:

1. Early identification and treatment of HIV infection provides substantial health benefit by extending years of life.
2. Risk based screening has not been successful in the identification of substantial numbers of persons with HIV early in the disease process. Additionally 10-25% of people who test positive for HIV report no high risk behaviors.
3. Strong evidence exists that indicates screening for HIV is cost effective.

Guidance Statement #2: ACP recommends that clinicians determine the need for repeat screening on an individual basis.

The rational for this guidance includes the following:

1. Higher risk patients should be tested more frequently than lower risk individuals. The decision to retest those individuals not at high risk for HIV infection should be based on clinical judgment.

The guidance statement was also endorsed by the HIV Medicine Association.

USPSTF

Moyer VA on behalf of the U.S. Preventive Services Task Force. Screening for HIV: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine. 2013:159(1);51.
In 2005, the USPSTF strongly recommended that all adolescents and adults at increased risk be screened for HIV infection, as well as all pregnant women. However, at that time, the USPSTF made no recommendation in support of or against the routine screening for HIV in adolescents and adults who were not perceived to be at increased risk for the infection. The rationale for that decision in 2005 included:

• Screening in individuals without known risk factors was thought to produce a yield less than targeted screening.
• There was insufficient evidence to conclude that initiation of ART in patients with CD4 counts greater than 0.200 X 109 cells/L would result in improved
• outcomes.
• There was insufficient evidence that knowledge of HIV status would result in decreased HIV transmission.

For this review, the USPSTF evaluated new evidence on the effectiveness of treatment in those individuals infected with HIV and with CD4 counts greater than 0.200 X 10⁹ cells/L as well as the effects of screening, counseling and ART use on risky behavior and HIV transmission risk. The USPSTF also reviewed the long term cardiovascular harms of ART.

In the updated recommendations of 2013, the USPSTF notes that there is convincing evidence that the identification and treatment of HIV infection is associated with a markedly reduced risk for progression to AIDS, AIDS related events and death in persons with advanced disease, defined as a CD4 count < 0.200 X 10⁹ cells/L. Moreover, the USPSTF states that adequate evidence exists to demonstrate beginning ART when CD4 counts are between 0.200 and 0.500 X 10⁹ cells/L (when individuals with HIV are likely to be asymptomatic and therefore more apt to have their infection detected by screening as opposed to clinical presentation) is associated with a reduced risk for AIDS related illnesses or death. Furthermore the USPSTF discovered convincing evidence that the use of ART is associated with a substantially decreased risk for transmission from HIV positive individuals to uninfected heterosexual partners.

In its consideration regarding the age range in which screening should be provided, the USPSTF noted that HIV prevalence decreases markedly after the age of 65. However data from 2011 demonstrated that almost half of high school students in the U.S. had engaged in sexual intercourse and one-third were sexually active. Of those individuals who had been sexually active, one-third had participated in sexual intercourse before the age of 16. Furthermore, though adolescents and young adults comprise one-quarter of the sexually experienced population of the U.S., the USPSTF notes they account for almost one half of all newly acquired cases of sexually transmitted diseases.

Based on this information, the USPSTF recommends that clinicians screen adolescents and adults aged 15 to 65 years for HIV infection. Younger adolescents and older adults who are at increased risk should also be screened (Grade A recommendation). The USPSTF states that persons at increased risk for HIV infection and/or exhibit behavioral risk factors for the disease include: MSM and active injection drug users; those who have acquired or request testing for other sexually transmitted diseases; those having unprotected anal or vaginal intercourse; those who have sexual partners who are HIV infected, bisexual or injection drug users; those who exchange sex for drugs or money; and those who request HIV testing in the absence of reported risk factors. Individuals not at increased risk of HIV infection include persons who are not sexually active, those who are sexually active in exclusive monogamous relationships with uninfected partners, and those who do not fall into any of the above mentioned categories.

The USPSTF also states that given the paucity of available evidence for specific screening intervals, a reasonable approach may be to screen adolescent and adult patients to identify those individuals who are already HIV positive with repeated screening of individuals known to be at risk or engaging in risky behaviors and those who live in high prevalence areas. Routine rescreening may not be necessary for individuals who have not been at increased risk since they were found to be HIV-negative. However, the USPSTF notes that adolescents and adults may not disclose their HIV risk factors upon direct questioning.

The USPSTF also recommends that clinicians screen all pregnant women for HIV, including those who present in labor who are untested and whose HIV status is unknown (Grade A recommendation). Furthermore the USPSTF states that women screened during a previous pregnancy should be rescreened in subsequent pregnancies.

CDC

Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB, Clark JE. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. MMWR.2006: 55(RR14);1.

Between 2004 and 2006, the Centers for Disease Control convened a series of meetings with health-care providers, researchers, professional associations, community organizations, public health-care agencies, local health officials, as well as persons living with HIV infection to provide advice concerning how best to expand HIV testing. The final recommendations pertinent to this NCA are as follows:

Screening for HIV Infection

All patients seeking treatment for STDs, including all patients attending STD clinics, should be screened routinely for HIV during each visit for a new complaint, regardless of whether the patient is known or suspected to have specific behavior risks for HIV infection.

Repeat Screening

6. Public Comments

Public comments sometimes cite the published clinical evidence and give CMS useful information. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. CMS uses the initial public comments to inform its proposed decision. CMS responds in detail to the public comments on a proposed decision when issuing the final decision memorandum.

Initial Public Comments

CMS received three (3) comments. Each commenter advocated for coverage for screening for HIV. The complete comments can be viewed at: http://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx?NCAId=276

Public Comments on Proposed NCD

CMS received sixteen (16) public comments. All but one commenter supported expanding coverage for screening for HIV. Among the commenters, 8 were from national organizations (including the requestor), 3 were from professional societies, and the balance were from other parties with interest in the proposed decision. The issues of concern expressed by the commenters are summarized below.

The complete comments can be viewed at http://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx?NCAId=276

1. Comment: One commenter stated that the USPSTF and CDC HIV screening recommendations did not limit such testing to primary care settings or primary care providers. It was suggested that CMS conform to this same model.

   CMS Response: The NCD states that to be covered, HIV screening must be performed (among other criteria) “...when ordered by the beneficiary’s physician or practitioner within the context of a healthcare setting and performed by an eligible Medicare provider or supplier for these services...”. This limitation does not mean that such testing may only be performed in a primary care environment, by a primary care provider. We acknowledge that Medicare beneficiaries receive health care services through a continuum of settings. As long as the provider/setting can fulfill the criteria set forth in the NCD, the testing will be covered.

2. Comment: One commenter stated that CMS should provide coverage for HIV screening for all beneficiaries at least once in a lifetime, regardless of age.

   CMS Response: Current guidelines from the USPSTF do not recommend screening for HIV in all individuals at least once in a lifetime, regardless of age. Based on our analysis of the published evidence and the USPSTF recommendations, we determined that the statutorily defined criteria to add preventive services were met to expand HIV screening for individuals aged 15 to 65 years regardless of risk. Additional Medicare coverage is afforded to individuals younger than age 15 or older than age 65 if those individuals are at increased risk. The available published evidence does not support expanded screening for all individuals regardless of age as the commenter suggested.

3. Comment: One commenter requested that CMS further expand coverage of HIV screening to persons older than 65 years of age.

   CMS Response: Based on our analysis of the published evidence and the USPSTF recommendations, we determined that the statutorily defined criteria to add preventive services were met to expand HIV screening for individuals aged 15 to 65 years regardless of risk. The available published evidence does not support expanded screening for all individuals.

   We note, however, that Medicare beneficiaries older than 65 could obtain coverage for an appropriate screening test if they are at increased risk for HIV infection. This would include individuals who request an HIV test despite reporting no individual risk factors. Under this revised NCD, Medicare covers HIV screening on an annual basis for any individual older than 65, who presents with the characteristics of increased risk as defined in the NCD or is identified as being at high risk for the infection based on an individualized physician interview and examination. The determination of increased risk for HIV infection is identified by the health care practitioner who assesses the patient’s history.

4. Comment: One commenter noted that Medicare funding is to be earmarked for the elderly and suggested we were diverting Medicare funding to test younger individuals. The commenter believes that this is not an appropriate use of Medicare funding.

   CMS Response: CMS is not using Medicare funds to finance HIV screening for individuals who are not entitled to benefits under Part B of the Medicare program. Though the majority of Medicare beneficiaries are over the age of 65, approximately 16-17% of the Medicare population is younger. These individuals are either disabled or are receiving benefits due to a diagnosis of end stage renal disease or amyotrophic lateral sclerosis [2014 CMS Statistics, Department of Health and Human Services]. Within this younger population, early testing for HIV infection is appropriate in order to decrease the morbidity and mortality of the disease, as well as to decrease its transmission. Therefore, we find the evidence is sufficient to determine that HIV screening in persons aged 15 to 65 years without regard to perceived risk behavior is reasonable and necessary and appropriate for the prevention or early detection of illness or disability in Medicare beneficiaries.

5. Comment: One commenter expressed concern regarding testing an individual annually who is outside of the high risk categories (listed in conditions 2 and 3 of the proposed decision) if that person initially screens negative for HIV. The commenter encouraged CMS to consider a broader interval (such as every 2 to 5 years) for re-testing low risk individuals. Other commenters, however, noted that the CDC recommends testing those identified as high risk at least annually, and suggests three- and six-month intervals for certain groups at high risk for sexually transmitted infections. Therefore, these commenters would prefer to see reimbursement not limited to just one test per year for high risk individuals.

   CMS Response: Based on our analysis, we believe annual testing (a maximum of one screening per year) is appropriate. We recognize that the recommendations of the Centers for Disease Control and Prevention are not identical to the recommendations of the USPSTF with respect to the frequency of testing. Under the Medicare statute, section 1861(ddd), the grade A or B recommendations of the USPSTF are prerequisites to Medicare coverage. The USPSTF noted that it is reasonable to rescreen groups at very high risk for new HIV infection at least annually. We did not find any high quality studies that showed improved health outcomes with more frequent testing. Individuals and practitioners, however, are not required to test annually, and may choose a longer period for retesting.

6. Comment: A few commenters requested coding and reimbursement changes to accompany the new coverage provided by this NCD.

   CMS Response: Requests for changes in coding and reimbursement are beyond the scope of this NCD. We will consider the commenters suggestions as we develop specific implementing instructions for Medicare contractors.

VIII. Analysis

National coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act. §1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Since January 1, 2009, CMS is authorized to cover "additional preventive services" (see Section III above) if certain statutory requirements are met as provided under §1861(ddd) of the Social Security Act. Our regulations at 42 CFR 410.64 provide:

CMS notes that any effect of the use of these screening tests is their coordination with treatment. CMS concludes that FDA approval or clearance of screening tests used consistent with FDA approved labeling provides a greater likelihood that a potential harm of screening testing, that is, taking action based on inaccurate screening test results, can be avoided. We further conclude that compliance by testing laboratories with CLIA regulatory requirements provides an additional, on-going safeguard for screening test quality. CMS considers these conditions essential to maximize patient safety.

In addition, CMS acknowledges that the USPSTF is charged with conducting rigorous reviews of scientific evidence to create evidence-based recommendations for preventive services that should be provided in the primary care setting. In addition, the USPSTF Procedure Manual outlines the process for evaluating the quality and strength of the evidence for a service, determining the net health benefit (benefits minus harms) associated with the service, and judging the level of certainty that providing these services will be beneficial in primary care.

1. Is the evidence sufficient to determine that HIV screening without regard to perceived risk behavior is recommended with a grade of A or B by the USPSTF for any indications?

In 2005, the USPSTF strongly recommended that all adolescents and adults at increased risk be screened for HIV infection, as well as all pregnant women. However, at that time, the USPSTF made no recommendation in support of or against the routine screening for HIV in adolescents and adults who were not perceived to be at increased risk for the infection. The rationale for that decision in 2005 included:

• Screening in individuals without known risk factors was thought to produce a yield less than targeted screening.
• There was insufficient evidence to conclude that initiation of ART in patients with CD4 counts greater than 0.200 X 10⁹ cells/L would result in improved outcomes.
• There was insufficient evidence that knowledge of HIV status would result in decreased HIV transmission [Moyer 2013].

In contrast, in the updated recommendations of 2013, the USPSTF notes that there is convincing evidence that the identification and treatment of HIV infection is associated with a markedly reduced risk for progression to AIDS, AIDS related events and death in persons with advanced disease, defined as a CD4 count < 0.200 X 10⁹ cells/L. Moreover, the USPSTF states that adequate evidence exists to demonstrate beginning ART when CD4 counts are between 0.200 and 0.500 X 10⁹ cells/L (when individuals with HIV are likely to be asymptomatic and therefore more apt to have their infection detected by screening as opposed to clinical presentation) is associated with a reduced risk for AIDS related illnesses or death. Furthermore the USPSTF discovered convincing evidence that the use of ART is associated with a substantially decreased risk for transmission from HIV positive individuals to uninfected heterosexual partners.

In its consideration regarding the age range in which screening should be provided, the USPSTF noted that HIV prevalence decreases markedly after the age of 65. However data from 2011 demonstrated that almost half of high school students in the U.S. had engaged in sexual intercourse and one third were sexually active. Of those individuals who had been sexually active, one third had participated in sexual intercourse before the age of 16. Furthermore, though adolescents and young adults comprise one quarter of the sexually experienced population of the U.S., the USPSTF notes they account for almost one half of all newly acquired cases of sexually transmitted diseases.

Based on this evidence and their findings that the overall harms of screening for and treatment of HIV infection in adolescents, adults and pregnant women are small, the USPSTF concluded with high certainty that the net benefit of screening in these population groups is substantial.:

• The USPSTF recommends that clinicians screen for HIV infection in adolescents and adults aged 15 to 65 years. Younger adolescents and older adults who are at increased risk should also be screened. (Grade A recommendation)
• The USPSTF recommends that clinicians screen all pregnant women for HIV, including those who present in labor who are untested and whose HIV status is unknown. (Grade A recommendation)

Consequently CMS has found that the evidence is sufficient to determine that the USPSTF recommends HIV screening with a grade of A for the individuals described above.

2. Is the evidence sufficient to determine that HIV screening without regard to perceived risk behavior is reasonable and necessary for the prevention or early detection of illness or disability?

It is now generally accepted that without treatment, most HIV infected persons will eventually progress to AIDS related illnesses and premature death. The use of ART can help to prevent the mortality and morbidity associated with HIV infection and change what was once an almost certain deadly illness into a chronic and manageable condition [Flexner 12e; Fauci 18e]. Furthermore, because appropriate treatment with ART generally inhibits the virus replication in the body, viral load remains low. This occurrence is widely acknowledged to be the mechanism by which ART reduces transmission of HIV to sexual partners [Panel on Antiviral Guidelines for Adults and Adolescents 2014].

The evidence presented demonstrates that the late discovery of HIV infection is common throughout the United States; and occurs frequently in those who span an age range from teenage years to those who are “older” (meaning in the fifth and sixth decades of life), those who live in both rural and urban settings, and those persons who represent various racial and ethnic groups. In fact, depending on the definition used, we note that approximately 25-50% of those persons documented with an HIV infection in the United States are diagnosed late in their disease course. This finding cuts across those persons with generally known risk behaviors for the disease as well as those who are heterosexual or with unknown (or unrecognized) behaviors that make them targets for the infection.

We acknowledge that most of the studies presented in the Evidence Section above have limitations. For example, authors document missing demographic and laboratory data, and admit that the accuracy of personal information may be constrained by patient self report. However, as we have stated, we recognize the harshness of the findings in these studies; that late diagnosis of HIV is common in this country and is associated with significant morbidity and mortality.

The cost analysis we examined also demonstrated constraints. Not all health care expenditures were collected (e.g., emergency room care, non-HIV care providers, home care services, etc.). Furthermore, those costs that were analyzed originated only from a network of providers who specialize in HIV care. Results may have been different if patients were treated in settings where less expertise was available. But in that case, we would likely expect less efficiency of care resulting in higher costs. Moreover, data was gathered for a finite period of time as opposed to over the ‘lifetime’ of the disease process. Cumulative expenditures would be expected to increase the longer a patient survived and received treatment. However the authors noted that the total time in care was similar across all CD4 groups. Also the evidence indicates that the cumulative direct medical care for those individuals with a late diagnosis of HIV infection versus those persons with an earlier diagnosis were higher, with a substantial portion of costs in both groups occurring in the earlier years after diagnosis. Therefore we believe that earlier entry into the health care system is likely not only to result in prolonged lifespan for HIV infected patients, but also a reduction in healthcare costs.

Therefore, because the use of ART can help to prevent the mortality and morbidity associated with HIV infection as well as decrease the rate of transmission of the disease, we believe late diagnosis of HIV infection in those who are already immunologically suppressed and/or symptomatic with the consequences of the disease, represents missed opportunities to provide timely initiation of ART or prophylaxis for OIs. However, essential to earlier treatment is the assumption that patients with HIV infection can be identified earlier in the course of their disease. We acknowledge that an additional limitation of most of the studies noted above is that the reason why HIV testing was “late” is unknown. Several reasons for this occurrence have been suggested: fear of loss of confidentiality; decreased access to care; the social stigmatization of those who are infected; lack of awareness of the risks incurred in the sexual contact of new partners; fear of recognition of undocumented immigration status; etc. We also recognize that the gains achieved from the use of ART may not affect the progression of the disease in everyone.

Further we are aware that early diagnosis of this disease is not necessarily the lynchpin to the eradication or control of HIV. Diagnosis is only the first step in the continuum of care of this disease which includes linkage to appropriate medical services to patients, adherence to pharmacologic and other treatment techniques and lifetime retention in the medical system to help decrease the morbidity and mortality resulting from HIV infection, increase quality of life for those infected and reduce or prevent the disease from spreading. Yet without knowledge of one’s status of HIV disease, none of the measures pertinent to the care of the HIV patient and the prevention of the disease’s transmission can occur.

We have already noted that one in seven persons in the U.S. living with HIV does not know they are infected. Of those who are aged 18 to 65 years who state they have never been tested for the disease, more than half (57%) say it is because they do not see themselves at risk [HIV Testing in the United States 2014]. Combining this lack of personal risk knowledge together with the evidence that large proportions of individuals in this age group living in the U.S. are diagnosed late in the course of their HIV infection, CMS finds itself in agreement with the USPSTF recommendations. Therefore we believe that the evidence is sufficient to determine that HIV screening in persons aged 15 to 65 years without regard to perceived risk behavior is reasonable and necessary for the prevention or early detection of illness or disability.

Furthermore, based on our prior decision, we believe that the evidence is sufficient to determine that HIV screening is reasonable and necessary for pregnant women when the diagnosis of pregnancy is known, during the third trimester and at delivery.

3. Is the evidence sufficient to determine that HIV screening in persons without regard to perceived risk behavior is appropriate for individuals entitled to benefits under Medicare Part A or enrolled under Part B.?

Most of the evidence presented does not specifically evaluate the Medicare beneficiary. However, though the majority of Medicare beneficiaries are over the age of 65, approximately 16-17% of the Medicare population is younger and are either disabled or receiving benefits due to a diagnosis of end stage renal disease or amyotrophic lateral sclerosis [2014 CMS Statistics, Department of Health and Human Services]. Within this younger population, early testing for HIV infection in order to decrease the morbidity and mortality of the disease, as well as to decrease its transmission, is applicable to any age group. Therefore we find the evidence is sufficient to determine that HIV screening in persons aged 15 to 65 years without regard to perceived risk behavior is reasonable and necessary and appropriate for the prevention or early detection of illness or disability in Medicare beneficiaries.

However, as is reported by the USPSTF and noted in the evidence above, HIV prevalence markedly decreases after age 65. Therefore it is unknown if those Medicare beneficiaries older than 65 also are appropriate for HIV screening regardless of perceived risk. In the future we are prepared to reopen this decision if evidence pertinent to this topic arises.

Furthermore, while we are expanding HIV screening to those beneficiaries between the ages of 15 and 65 regardless of perceived risk, based on our prior decision, it is appropriate to maintain our coverage of HIV screening for Medicare beneficiaries who are:

• Adolescents younger than 15 and adults older than 65 who are at increased risk for HIV infection or
• Pregnant women when the diagnosis of pregnancy is known, during the third trimester and at delivery.

Disparities in HIV Screening

HIV does not spread in a homogeneous method throughout the United States [Fauci 18e]. The estimated incidence of HIV has remained stable in recent years, with approximately 50,000 new cases per year. Compared with those of other races and ethnicities, African American individuals continue to experience the highest burden of HIV in the United States. Though representing approximately 12% of the population, African Americans accounted for approximately 44% of the new HIV infections in 2010. Similarly those who are Hispanic/Latinos represent approximately 17% of the population, but accounted for an estimated 21% of new HIV infections in 2010 [HIV A-Z Topics, Basic Statistics 2014]. As demonstrated by the evidence above, high rates of late diagnoses occur in these groups as well as other racial and ethnic groups.

Summary

Approximately 1.2 million people in the United States are living with HIV infection and this number is expected to grow over time. However a large proportion of those persons infected with the organism remain unaware of their status. Without treatment, HIV infection will eventually manifest itself as a disease which leads to AIDS and eventual death.

Though there is no cure, through the use of ART, there is the ability to transform HIV disease from a deadly illness into a chronic, manageable condition. Moreover, the use of ART can reduce the risk of transmission of the HIV organism from infected to uninfected persons. Furthermore, beginning pharmacologic therapy earlier than previously realized, when patients are more likely to be asymptomatic and their infection detected by screening rather than symptoms, is associated with less risk of AIDS related events or death.

Therefore CMS concludes that screening for HIV infection provides direct benefit to the Medicare population. Screening is appropriate for both those individuals with high risk behavior as well as pregnant women. Furthermore screening for those individuals between the ages of 15 and 65, regardless of perceived risk, is also endorsed.

IX. Conclusion

The Centers for Medicare & Medicaid Services (CMS) is expanding coverage in section 210.7 of the Medicare National Coverage Determinations (NCD) Manual. CMS has determined that the evidence is adequate to conclude that screening for HIV infection for all individuals between the ages of 15 and 65 years, as is recommended with a grade of A by the United States Preventive Services Task Force (USPSTF), is reasonable and necessary for the early detection of HIV and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

CMS shall cover screening for HIV with the appropriate U.S. Food and Drug Administration (FDA) approved laboratory tests and point of care tests, used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations, when ordered by the beneficiary’s physician or practitioner within the context of a healthcare setting and performed by an eligible Medicare provider or supplier for these services, for beneficiaries who meet one of the following conditions:

1. Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for all adolescents and adults between the age of 15 and 65, without regard to perceived risk.
2. Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for adolescents younger than 15 and adults older than 65 who are at increased risk for HIV infection. Increased risk for HIV infection is defined as follows:
   • Men who have sex with men
   • Men and women having unprotected vaginal or anal intercourse
   • 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 who have acquired or request testing for other sexually transmitted infectious diseases
   • Persons with a history of blood transfusions between 1978 and 1985
   • Persons who request an HIV test despite reporting no individual risk factors
   • Persons with new sexual partners
   • Persons who based on individualized physician interview and examination are deemed to be at increased risk for HIV infection. The determination of “increased risk” for HIV infection is identified by the health care practitioner who assesses the patient’s history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan. The medical recommendation should be a reflection of the service provided.
3. 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.

A.     General

Human Immunodeficiency Virus (HIV) is an infection caused by a retrovirus that affects the immune system. HIV infection causes acquired immune deficiency syndrome (AIDS), a disease which severely compromises an individual’s immune system. It is generally accepted that antiretroviral therapy (ART) has significantly reduced HIV-associated morbidity and mortality throughout the world and the United States, and has transformed HIV disease for many, into a chronic, manageable condition. There is also evidence that the use of ART is associated with a substantially decreased risk for transmission of the virus to uninfected persons.

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 requirements are met. See 42 C.F.R.§410.64. One of those requirements is that the service(s) be categorized as a Grade A (strongly recommends) or Grade B (recommends) rating by the United States Preventive Services Task Force (USPSTF). The USPSTF has given a Grade A recommendation to screening for HIV in:

• All adolescents and adults between the ages of 15 to 65 years,
• Younger adolescents and older adults who are at increased risk of HIV infection, and,
• All pregnant women.

B.     Nationally Covered Indications

Effective for claims with dates of service on and after April 13, 2015, CMS proposes that the evidence is adequate to conclude that screening for HIV infection for all individuals between the ages of 15 and 65 years, as recommended with a Grade of A by the USPSTF, 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.

CMS proposes to cover screening for HIV with the appropriate U.S. Food and Drug Administration (FDA)-approved laboratory tests and point-of-care tests, used consistent with FDA-approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations, when ordered by the beneficiary’s physician or practitioner within the context of a healthcare setting and performed by an eligible Medicare provider for these services, for beneficiaries who meet one of the following conditions:

1. Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for all adolescents and adults between the age of 15 and 65, without regard to perceived risk.
2. Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for adolescents younger than 15 and adults older than 65 who are at increased risk for HIV infection. Increased risk for HIV infection is defined as follows:
   • Men who have sex with men
   • Men and women having unprotected vaginal or anal intercourse
   • 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 who have acquired or request testing for other sexually transmitted infectious diseases
   • Persons with a history of blood transfusions between 1978 and 1985
   • Persons who request an HIV test despite reporting no individual risk factors
   • Persons with new sexual partners
   • Persons who based on individualized physician interview and examination are deemed to be at increased risk for HIV infection. The determination of “increased risk” for HIV infection is identified by the health care practitioner who assesses the patient’s history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan. The medical recommendation should be a reflection of the service provided.
3. 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 April 13, 2015:

-Medicare beneficiaries with any known diagnosis of a HIV-related illness are not eligible for this screening test.

-Medicare beneficiaries between the ages of 15 and 65 who have had a prior HIV screening test within one year are not eligible for HIV screening (i.e., at least 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).

-Medicare beneficiaries younger than 15 or older than 65, at increased risk for HIV-related illnesses, who have had a prior HIV screening test within one year are not eligible for HIV screening (i.e., at least 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 the three specified screening tests within their respective term of pregnancy are not eligible for further HIV screening during their pregnancy. However, for each term of pregnancy, the beneficiary may have the three specified screening tests.

D.     Other

N/A

(This NCD last reviewed April 2015.)

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