National Medical Policy

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1 National Medical Policy Subject: Policy Number: HIV Testing and Counseling NMP422 Effective Date*: May 2008 Updated: April 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Screening for the Human Immunodeficiency Virus (HIV) Infection; Human Immunodeficiency Virus (HIV) Testing (Diagnosis); Human Immunodeficiency Virus (HIV) Testing (Prognosis Including Monitoring): National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* X Other MM9403 Screening for the Human Immunodeficiency Virus (HIV) Infection: Education/Medicare-Learning-Network- MLN/MLNMattersArticles/Downloads/MM9403.pdf None Use Health Net Policy Instructions HIV Testing and Counseling Apr 16 1

2 Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers human immunodeficiency virus (HIV) testing medically necessary for screening individuals for HIV infection. Health Net, Inc. also considers rapid HIV testing for screening a medically necessary alternative to enzyme immunoassays. Clinical studies have demonstrated that the sensitivity and the specificity of rapid HIV tests are comparable to those of enzyme immunoassays. Based on the recommendations from the Centers for Disease Control, Health Net, Inc. considers screening for HIV infection for any of the following medically necessary: 1. Patients aged years in all health-care settings, unless the patient declines (opt-out screening) Health care settings include hospital emergency rooms, urgent-care clinics, inpatient services, STD clinics or other venues offering clinical STD services, tuberculosis (TB) clinics, substance abuse treatment clinics, other public health clinics, community clinics, correctional health-care facilities, and primary care settings 2. All patients initiating treatment for TB 3. All patients seeking treatment for STDs, including those attending STD clinics, regardless of whether the patient is known or suspected to have specific behavior risks for HIV infection 4. Individuals at high risk for HIV infection at least annually (e.g., injection-drug users and their sex partners, persons who exchange sex for money or drugs, sex partners of HIV-infected persons, and men having sex with men (MSM) or heterosexual persons who themselves or whose sex partners have had more than one sex partner since their most recent HIV test) 5. All pregnant women unless the patient declines (opt-out screening) Screening should be included in the routine panel of prenatal screening tests Testing should be performed as early as possible in the pregnancy. HIV Testing and Counseling Apr 16 2

3 Repeat screening in the third trimester is recommended in areas with elevated rates of HIV infection among pregnant women. Whenever possible, uncertainties regarding laboratory test results indicating HIV infection status should be resolved before final decisions are made regarding reproductive options, antiretroviral therapy, cesarean delivery, or other interventions. Any woman with undocumented HIV status at the time of labor should be screened with a rapid HIV test unless she declines (opt-out screening). If the confirmatory test result is not available before delivery, immediate initiation of appropriate antiretroviral prophylaxis should be recommended to any pregnant patient whose HIV screening test result is reactive to reduce the risk for perinatal transmission 6. Woman's whose HIV status is unknown at the time of delivery, immediately postpartum with rapid HIV testing unless she declines (opt-out screening). 7. Newborns as soon as possible after birth, with rapid HIV testing, when the mother's HIV status is unknown postpartum, so that antiretroviral prophylaxis can be offered to HIV-exposed infants. Women should be informed that identifying HIV antibodies in the newborn indicates that the mother is infected. The benefits of neonatal antiretroviral prophylaxis are best realized when it is initiated <12 hours after birth 8. Infants whose HIV exposure status is unknown and who are in foster care when the biologic mother has not been tested, with rapid HIV testing. 9. Diagnostic Testing in individuals with signs or symptoms consistent with HIV infection or an opportunistic illness characteristic of AIDS or who have a compatible clinical syndrome and who report recent high-risk behavior. When acute retroviral syndrome is a possibility, a plasma RNA test should be used in conjunction with an HIV antibody test to diagnose acute HIV infection 10. Screening for patients in non-clinical settings (e.g., community-based organizations, outreach settings, or mobile vans) serving client populations at increased behavioral or clinical HIV risk HIV rapid testing should be considered in clinics where a high proportion of patients do not return for HIV test results 11. Individuals who have had a blood transfusion between 1977 and 1985 Important Note: Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in health-care settings. Note: Repeat screening of persons not likely to be at high risk for HIV should be performed on the basis of clinical judgment The U.S. Preventive Services Task Force (USPSTF) recommends clinicians screen for HIV infection in adolescents and adults ages 15 to 65 years. Younger adolescents HIV Testing and Counseling Apr 16 3

4 and older adults who are at increased risk should also be screened. (Grade: A Recommendation) The US Preventive Services Task Force (USPSTF) recommends 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.) Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes 042 Human immunodeficiency virus (HIV) disease V01.7 Contact with or exposure to other viral diseases V08 Asymptomatic human immunodeficiency virus (HIV) infection Status V73.89 Special screening examination for other specified viral diseases ICD-10 Codes B20 Human immunodeficiency virus (HIV) disease Z11.59 Encounter for screening for other viral diseases Z20.6 Contact with suspected exposure to human immunodeficiency virus (HIV) Z21 Asymptomatic human immunodeficiency virus [HIV] infection status CPT Codes HTLV or HIV antibody, confirmatory testing (e.g., Western Blot) HIV HIV HIV-1 and HIV-2, single assay Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; HIV-1 (code description revised in 2016 see below) Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; HIV-2 (code description revised in see below) HIV-1, quantification, includes reverse transcription when performed HIV-2, quantification, includes reverse transcription transcription when performed 2016 Revised CPT Codes HIV Testing and Counseling Apr 16 4

5 87390 Infectious agent antigen detection by immunoassay technique, e.g., enzyme immunoassay (EIA), enzyme linked immunosorbent assay (ELISA), immunochemilumino assay (IMCA) qualitative or semiquantitative, multiple-step method;hiv Infectious agent antigen detection by immunoassay technique, [e.g., enzyme immunoassay (EIA), enzyme linked immunosorbent Assay (ELISA), immunochemilumino assay (IMCA) qualitative or semiquantitative, multiple-step method; HIV-2 HCPCS Codes G0432 G0433 G0435 S3645 Infectious agent antigen detection by enzyme immunoassay (EIA) technique, qualitative or semi-quantitative, multiple-step method, HIV-1 or HIV-2, screening Infectious agent antigen detection by enzyme-linked immunosorbent assay (ELISA) technique, antibody, HIV-1 or HIV-2, screening Infectious agent antigen detection by rapid antibody test of oral mucosa transudate, HIV-1 or HIV-2, screening HIV-1 antibody testing of oral mucosal transudate 2016 HCPCS Code G0475 HIV antigen/antibody, combination assay, screening. Scientific Rationale Update April 2016 Buzi et al (2016) described the process of implementing HIV services into family planning clinics and how to train staff in routine, opt-out testing. This study used HIV screening data from 10 family planning clinics serving adolescents and young adults in Houston, Texas. A total of 34,299 patients were tested for HIV during a 48- month study period, from January 2010 through December Patients tested included minors <18 years of age (25.5%), males (22.8%), and individuals who had missed opportunities for HIV testing at other health-care settings. From the opt-in period ( ) to the routine, opt-out period ( ), the yearly average number of tests administered more than doubled; the yearly average increased again by 50% from the routine, opt-out period to the routine, rapid period ( ). Eighty-eight (0.3%) patients were diagnosed with HIV, a higher seropositivity rate than CDC's recommended threshold of 0.1% for settings where routine screening is warranted. The authors concluded routine, opt-out HIV testing integrated into family planning clinics increased rates of testing acceptance, receipt of test results, and HIV-positive diagnoses among adolescents and young adults. Signer et al (2016) evaluated two approaches for implementing routine HIV screening in an inner-city, academic emergency department (ED). These approaches differed by staffing model and type of HIV testing technology used. The programmatic outcomes assessed included the total number of tests performed, proportion of newly identified HIV-positive patients, and proportion of newly diagnosed individuals who were linked to care. This study examined specific outcomes for two distinct, successive approaches to implementing HIV screening in an inner-city, academic ED, from July 2012 through June 2013 (Program One), and from August 2013 through July 2014 (Program Two). Program One used a supplementary staff-only HIV testing model with point-of-care (POC) oral testing. Program Two used a triage-integrated, nurse-driven HIV testing model with fourthgeneration blood and POC testing, and an expedited linkage-to-care process. During Program One, 6,832 eligible patients were tested for HIV with a rapid POC oral HIV test. Sixteen patients (0.2%) were newly diagnosed with HIV, of whom 13 HIV Testing and Counseling Apr 16 5

6 were successfully linked to care. During Program Two, 8,233 eligible patients were tested for HIV, of whom 3,124 (38.0%) received a blood test and 5,109 (62.0%) received a rapid POC test. Of all patients tested in Program Two, 29 (0.4%) were newly diagnosed with HIV, four of whom had acute infections and 27 of whom were successfully linked to care. We found a statistically significant difference in the proportion of the eligible population tested-8,233 of 49,697 (16.6%) in Program Two and 6,832 of 46,818 (14.6%) in Program One. These differences from Program One to Program Two corresponded to increases in testing volume (n=1,401 tests), number of patients newly diagnosed with HIV (n=13), and proportion of patients successfully linked to care (from 81.0% to 93.0%). The authors concluded integrating HIV screening into the standard triage workflow resulted in a higher proportion of ED patients being tested for HIV as compared with the supplementary staff-only HIV testing model. New rapid fourth-generation testing technology allowed the identification of acute HIV infection and same-visit confirmation of a positive diagnosis. Scientific Rationale Update April 2015 Updated Recommendations from the CDC on Laboratory Testing for the Diagnosis of HIV Infection (June 2014) include the following recommendations: 1. Laboratories should conduct initial testing for HIV with an FDA-approved antigen/antibody combination immunoassay* that detects HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen to test for established HIV-1 or HIV-2 infection and for acute HIV-1 infection. No further testing is required for specimens that are nonreactive on the initial immunoassay. 2. Specimens with a reactive antigen/antibody combination immunoassay result (or repeatedly reactive, if repeat testing is recommended by the manufacturer or required by regulatory authorities) should be tested with an FDA-approved antibody immunoassay that differentiates HIV-1 antibodies from HIV-2 antibodies. Reactive results on the initial antigen/antibody combination immunoassay and the HIV-1/HIV-2 antibody differentiation immunoassay should be interpreted as positive for HIV-1 antibodies, HIV-2 antibodies, or HIV antibodies, undifferentiated. 3. Specimens that are reactive on the initial antigen/antibody combination immunoassay and nonreactive or indeterminate on the HIV-1/HIV-2 antibody differentiation immunoassay should be tested with an FDA-approved HIV-1 nucleic acid test (NAT). A reactive HIV-1 NAT result and nonreactive HIV-1/HIV-2 antibody differentiation immunoassay result indicates laboratory evidence for acute HIV-1 infection. A reactive HIV-1 NAT result and indeterminate HIV-1/HIV-2 antibody differentiation immunoassay result indicates the presence of HIV-1 infection confirmed by HIV-1 NAT. A negative HIV-1 NAT result and nonreactive or indeterminate HIV-1/HIV-2 antibody differentiation immunoassay result indicates a false-positive result on the initial immunoassay. 4. Laboratories should use this same testing algorithm, beginning with an antigen/antibody combination immunoassay, with serum or plasma specimens submitted for testing after a reactive (preliminary positive) result from any rapid HIV test. Prekker et al (2015) evaluated the feasibility and yield of the CDC recommendation of routine opt-out HIV screening in health care settings in the emergency department (ED) and to compared it to the expected yield of physician-directed testing. This is a cross-sectional study in an urban ED during random shifts over 1 HIV Testing and Counseling Apr 16 6

7 year. Patients were ineligible for screening if they were younger than 18 years or older than 64, a prisoner, a victim of sexual assault, in an ED resuscitation room, or had altered mental status. Research associates administered rapid HIV tests and conducted standardized interviews. The patients' ED physician, blinded to the HIV result, was asked if they would have ordered a rapid HIV test if it had been available. Of 7756 ED patients, 3957 (51%) were eligible for HIV screening, and 2811 (71%) of those did not opt out. Routine testing yielded 9 new HIV cases (0.32% of those tested; 95% confidence interval, 0.16%-0.63%). Physician-directed testing would have missed most of these infections: 2 of the 785 patients identified by physicians for testing would have been newly diagnosed with HIV (0.25%; 95% confidence interval, 0.04%-1.0%). Of the 9 new HIV cases, 5 established HIV care, and their median CD4 count was 201 cells/μl (range, cells/μl). The authors concluded routine opt-out HIV screening was feasible and accepted by a majority of ED patients. The yield of this strategy only modestly exceeded what may have been observed with physician-directed testing. Pottie et al (2014) assessed the effects of rapid voluntary counselling and testing (VCT) for HIV on HIV incidence and uptake of HIV/AIDS services in people at high risk for HIV exposure in a Cochrane systematic review and meta-analysis. The authors included controlled studies that compared rapid VCT with conventional testing among people at risk for HIV exposure. Two reviewers extracted data. They used Cochrane risk of bias tool and GRADE criteria: risk of bias, inconsistency, indirectness, imprecision and publication bias. For observational studies they used the Newcastle-Ottawa Scale. They used the PRISMA-Equity reporting guideline. From 2441 articles, they included 8 randomized controlled trials and 5 observational studies. Rapid VCT was associated with a threefold increase in HIV-testing uptake (relative risk (RR)= % CI 1.69 to 5.16) and a twofold increase in the receipt of test results (RR=2.14, 95% CI 1.08 to 4.24). Women accepted testing more often than men in rapid VCT arm, but no differences in effect for age or socioeconomic status. Observational studies also showed rapid VCT led to higher rates of uptake of testing. Heterogeneity was high. A cluster-randomized trial reported an 11% reduction in HIV incidence in intervention communities (RR=0.89, 95% CI=0.63 to 1.24) over 3 years trial. The reviewers concluded rapid VCT in health facilities and communities was associated with a large increase in HIV-testing uptake and receipt of results. This has implications for WHO guidelines. The routine use of rapid VCT may also help avoid human rights violations among marginalized populations where testing may occur without informed consent and where existing stigma may create barriers to testing. Scientific Rationale Update April 2014 In April 2013, the U.S. Preventive Services Task Force (USPSTF) made the following recommendations: Clinicians screen for HIV infection in adolescents and adults ages 15 to 65 years. Younger adolescents and older adults who are at increased risk should also be screened. (Grade: A Recommendation) 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.) Scientific Rationale Update April 2013 Metsch et al (2012) examined the effectiveness of risk reduction counseling and the role of on-site HIV testing in drug treatment. Between January and May 2009, they randomized 1281 HIV-negative (or status unknown) adults who reported no past- HIV Testing and Counseling Apr 16 7

8 year HIV testing to (1) referral for off-site HIV testing, (2) HIV risk-reduction counseling with on-site rapid HIV testing, or (3) verbal information about testing only with on-site rapid HIV testing. They defined 2 primary self-reported outcomes a priori: receipt of HIV test results and unprotected anal or vaginal intercourse episodes at 6-month follow-up. The combined on-site rapid testing participants received more HIV test results than off-site testing referral participants (P<.001; Mantel-Haenszel risk ratio=4.52; 97.5% confidence interval [CI]=3.57, 5.72). At 6 months, there were no significant differences in unprotected intercourse episodes between the combined on-site testing arms and the referral arm (P=.39; incidence rate ratio [IRR]=1.04; 97.5% CI=0.95, 1.14) or the 2 on-site testing arms (P=.81; IRR=1.03; 97.5% CI=0.84, 1.26). The authors concluded the study demonstrated on-site rapid HIV testing's value in drug treatment centers and found no additional benefit from HIV sexual risk-reduction counseling. Patel et al (2012) evaluated the sensitivity for early HIV infection of several rapid tests and third- and fourth-generation assays compared with nucleic acid amplification testing (NAAT). Sensitivity for early HIV infection was evaluated using 62 NAAT-positive/WB-negative or indeterminate specimens from the CDC Acute HIV Infection study. Specimens underwent third-generation testing with Genetic Systems 1/2+O and rapid testing with Multispot HIV-1/HIV-2. A subset was also tested with four FDA-approved rapid tests and Determine HIV-1 Antigen/Antibody Rapid Test and Architect HIV Antigen/Antibody Combo, both fourth-generation tests. Of 99,111 specimens screened from April 2006 to March 2008, 62 met the definition for early HIV infection (60 NAAT-positive/seronegative and 2 NAAT-positive/Western blot indeterminate). Third-generation testing correctly detected antibody in 34 specimens (55%; 95% confidence interval (CI): 42-67); Multispot detected antibody in 16 (26%; 95% CI: 16-38). Of the 62 specimens, 33 (53%) had sufficient quantity for further testing. Rapid test sensitivities for early HIV infection ranged from 22-33% compared with 55-57% for the third-generation assay and 76-88% for the fourthgeneration tests. Investigators concluded many rapid HIV tests failed to detect half of the early HIV infection cases in whom antibody was present. Programs that screen high-incidence populations with rapid tests should consider supplemental testing with NAAT or other antigen-based tests. They noted the data support the need for more sensitive antigen-based point-of-care screening tests for early HIV infection. Scientific Rationale (Update February 2010) The Centers for Medicare and Medicaid Services (CMS) has determined that the evidence is adequate to conclude that screening for HIV infection, which is recommended with a grade of A by the U.S. Preventive Services Task Force (USPSTF) for certain individuals, 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. Specifically, CMS believes that both standard and FDA-approved rapid HIV screening tests simple, acceptable, accurate, cost-effective screening tests, exhibiting high sensitivity and high specificity, plus reactive preliminary positive/false positive rates, which are capable of being clinically managed by confirmatory testing and access to care are appropriate for HIV screening and reasonable to be covered for Medicare beneficiaries. Medicare Effective January 1, 2010, standard and U.S. Food and Drug Administration (FDA)- approved (HIV) rapid screening tests are a covered benefit for Medicare Advantage members as noted below: HIV Testing and Counseling Apr 16 8

9 1. Annual voluntary HIV screening of Medicare beneficiaries at increased risk for HIV infection per USPSTF guidelines, including: Men who have had sex with men after 1975; Men and women having unprotected sex with multiple partners; Past or present injection drug users; Men and women who exchange sex for money or drugs, or have sex partners who do; Individuals whose past or present sex partners were HIV-infected, bisexual or injection drug users; Persons being treated for sexually transmitted diseases; Persons with a history of blood transfusion between 1978 and 1985; Persons who request an HIV test despite reporting no individual risk factors, since this group is likely to include individuals not willing to disclose highrisk behaviors. 2. Voluntary HIV screening of pregnant Medicare beneficiaries when the diagnosis of pregnancy is known, during the third trimester, and at labor. Scientific Rationale - Initial According to the Centers for Disease Control and Prevention (CDC), human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS) remain leading causes of illness and death in the United States. Treatment has improved survival rates dramatically, especially since the introduction of highly active antiretroviral therapy (HAART), however, progress in effecting earlier diagnosis has been insufficient. The objectives of the CDC recommendations are to increase HIV screening of patients, including pregnant women, in health-care settings; foster earlier detection of HIV infection; identify and counsel persons with unrecognized HIV infection and link them to clinical and prevention services; and further reduce perinatal transmission of HIV in the United States. Screening early in pregnancy enables HIVinfected women and their infants to benefit from appropriate and timely interventions (e.g., antiretroviral medications, scheduled cesarean delivery, and avoidance of breastfeeding.) All individuals who are recommended or who request HIV testing should receive information regarding the HIV test, its benefits and consequences prior to testing. Screening should be voluntary and undertaken only with the patient's knowledge and understanding that HIV testing is planned. Consent for HIV screening in healthcare settings should be incorporated into general consent for medical care rather than using a separate written consent form. Previous CDC and U.S. Preventive Services Task Force (USPSTF) guidelines for HIV testing recommended routine counseling and testing for persons at high risk for HIV and for those in acute-care settings in which HIV prevalence was >1%, however, these guidelines proved difficult to implement for a variety of reasons. The revised CDC recommendations advocate routine voluntary HIV screening as a normal part of medical practice, similar to screening for other treatable conditions. Per the CDC, HIV infection is consistent with all generally accepted criteria that justify screening: 1) HIV infection is a serious health disorder that can be diagnosed before symptoms develop; 2) HIV can be detected by reliable, inexpensive, and noninvasive screening tests; 3) infected patients have years of life to gain if treatment is initiated early, before symptoms develop; and 4) the costs of screening are reasonable in relation to the anticipated benefits. Among pregnant women, screening has proven substantially more effective than risk-based testing for detecting unsuspected maternal HIV infection and preventing perinatal transmission. HIV Testing and Counseling Apr 16 9

10 The central goal of HIV screening in health-care settings is to maximize the number of persons who are aware of their HIV infection and receive care and prevention services. When HIV infection is diagnosed, patients should be encouraged to disclose their HIV status to their spouses, current sex partners, and previous sex partners and recommend that these partners be tested for HIV infection. Health departments can assist patients by notifying, counseling, and providing HIV testing for partners without disclosing the patient's identity. HIV counseling consists of two components: provision of information and prevention counseling. HIV counseling seeks to reduce HIV acquisition and transmission by helping to identify the specific behaviors putting the individual at risk for acquiring or transmitting HIV and committing to steps to reduce this risk. In an effort to remove a potential barrier to HIV testing in busy healthcare settings, prevention counseling need not be conducted in conjunction with HIV diagnostic testing or HIV screening programs. The benefit of providing prevention counseling in conjunction with HIV testing is unclear. Prevention counseling in all settings for persons at high risk for HIV and in nonmedical settings is still encouraged. HIV counseling with testing has been demonstrated to be an effective intervention for HIV-infected participants, who increased their safer behaviors and decreased their risk behaviors. Carefully controlled, theory-based prevention counseling in STD clinics has helped HIVnegative participants reduce their risk behaviors compared with participants who received only a didactic prevention message from health-care providers. Timely access to diagnostic HIV test results improves health outcomes. Diagnostic testing in health-care settings continues to be the mechanism by which nearly half of new HIV infections are identified. HIV-1 testing consists of initial screening with an enzyme immunoassay screening assay (EIA) to detect antibodies to HIV-1. Reactive EIA results are retested in duplicate. If the result of either duplicate test is reactive, the specimen is reported as repeatedly reactive and undergoes confirmatory testing with a more specific supplemental test (e.g., Western blot or, less commonly, an immunofluorescence assay [IFA]). Only specimens that are repeatedly reactive by EIA and positive by IFA or reactive by Western blot are considered HIV-positive and indicative of HIV infection. Specimens that are repeatedly EIA-reactive occasionally provide an indeterminate Western blot result, which might represent either an incomplete antibody response to HIV in specimens from infected persons or nonspecific reactions in specimens from uninfected persons. Generally, a second specimen should be collected >1 month later and retested. An HIV test should be considered positive only after screening and confirmatory tests are reactive. Rapid serologic tests have become standard assay in most parts of the world, to improving access to testing in both clinical and non-clinical settings and increasing the number of people who learn their results. Prior to rapid testing, many persons tested in nonclinical settings did not return for their test results. Studies have demonstrated that the sensitivity and specificity of rapid HIV tests are comparable to those of EIAs often used for screening, with a high, negative predictive value. The sensitivity and specificity of the rapid tests is consistently greater than 99%. Rapid HIV testing in nonclinical settings aims to increase knowledge of HIV status among many groups. Studies at CDC-funded sites showed that persons tested at nonclinical (outreach) sites were 2 times as likely as persons tested at conventional (CDCfunded) testing sites to report high-risk heterosexual contacts and 3 to 4 times as likely to report injection drug use or male-to-male sex. In addition, the rate of HIVpositive test results in nonclinical settings is generally high and consistently higher HIV Testing and Counseling Apr 16 10

11 than at conventional testing sites. Like conventional HIV EIAs, rapid HIV tests are screening tests that require confirmation if reactive (either Western blot or immunofluorescence assay [IFA].) Several rapid HIV antibody tests are now FDA approved in the United States. They are interpreted visually and require no instrumentation. Sites offering rapid HIV testing must periodically run external controls (known HIV-positive and HIV-negative specimens) and provide persons who undergo rapid testing a subject information sheet. At this time, the FDA approved tests include the following: 1. OraQuick ADVANCE Rapid HIV-1/2 Antibody Test (OraSure Technologies, Inc.); specimens include blood, plasma or saliva. 2. Uni-Gold Recombigen HIV (Trinity Biotech); specimens include blood, plasma and serum 3. Reveal G-3 Rapid HIV-1 Antibody Test (MedMira, Inc.); specimens include plasma and serum 4. MultiSpot HIV-1/HIV-2 Rapid Test (BioRad Laboratories); specimens include serum only 5. Clearview HIV 1/2 STAT-PAK (Inverness Medical Professional Diagnostics); utilize whole blood samples only 6. Clearview COMPLETE HIV ½ (Inverness Medical Professional Diagnostics) In general, rapid testing leads to a result in 5 to 40 minutes, depending upon the assay and specimen used. The OraQuick, Multispot and the HIV 1/2 Stat-Pak test have the ability to detect both HIV-1 and HIV-2. The OraQuick Advance HIV 1/2 test is the only test that can be performed on oral fluids. Review History May 2008 Medical Advisory Council, initial approval November 2008 Added CA regulatory update to disclaimer February 2010 Added Medicare criteria April 2010 Added 2010 HCPCS codes, effective April 5, 2010 April 2011 Update. Added Medicare Table with link to NCD and CMS Manual. No revisions. April 2012 Update no revisions April 2013 Update no revisions. Code updates April 2014 Update Added the updated USPSTF recommendations from 2013 to screen for HIV infection in adolescents and adults ages 15 to 65 years. Younger adolescents and older adults who are at increased risk should also be screened. Code updates April 2015 Update no revisions April 2016 Update no revisions. Code Updates This policy is based on the following evidence-based guidelines: 1. Centers for Disease Control and Prevention. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings Sept. 55(RR14);1-17. Available at: 2. Centers for Disease Control and Prevention. Revised Guidelines for HIV Counseling, Testing, and Referral. 2001, Nov. 50(RR19);1-58. Available at: 3. Centers for Disease Control and Prevention. Revised Recommendations for HIV Screening of Pregnant Women. 2001, Nov. 50(RR19); Available at: Centers for Disease Control and Prevention. Rapid HIV Testing. HIV Testing and Counseling Apr 16 11

12 4. U.S. Preventive Services Task Force. Screening for Human Immunodeficiency Virus Infection. July Centers for Disease Control and Prevention. HIV Counseling with Rapid Tests. Last modified Mar World Health Organization. HIV testing and counseling. Available at: 7. Centers for Disease Control and Prevention. Rapid HIV Testing in Non-Clinical Settings. Apr The U.S. Preventive Services Task Force (USPSTF) Recommendation Statement Screening for HIV. April Update April Centers for Disease Control (CDC) and Prevention, Sexually Transmitted Diseases Treatment Guidelines Available at: Bransson BM, Owen SM, Wesolowski LG., et al. Centers for Disease Control and Prevention (U.S.); Association of Public Health Laboratories. June Available at: World Health Organization. Consolidated guidelines on HIV testing services. July Available at: References Update April Bares S, Eavou R, Bertozzi-Villa C, et al. Expanded HIV Testing and Linkage to Care: Conventional vs. Point-of-Care Testing and Assignment of Patient Notification and Linkage to Care to an HIV Care Program. Public Health Rep Jan-Feb;131 Suppl 1: Buzi RS, Madanay FL, Smith PB. Integrating Routine HIV Testing into Family Planning Clinics That Treat Adolescents and Young Adults. Public Health Rep Jan-Feb;131 Suppl 1: Crumby NS, Arrezola E, Brown EH, et al. Experiences Implementing a Routine HIV Screening Program in Two Federally Qualified Health Centers in the Southern United States. Public Health Rep Jan-Feb;131 Suppl 1: Dietz PM, Van Handel M, Wang H, et al.. HIV Testing among Outpatients with Medicaid and Commercial Insurance. PLoS One Dec 14;10(12):e Galbraith JW, Willig JH, Rodgers JB, et al, Evolution and Escalation of an Emergency Department Routine, Opt-out HIV Screening and Linkage-to-Care Program. Public Health Rep Jan-Feb;131 Suppl 1: Hempling MC, Zielicka-Hardy A, Ellis JP, et al. Routine HIV testing in the Emergency Department: feasible and acceptable? Int J STD AIDS Oct Lucas KD, Eckert V, Behrends CN, et al. Evaluation of Routine HIV Opt-Out Screening and Continuum of Care Services Following Entry into Eight Prison Reception Centers - California, MMWR Morb Mortal Wkly Rep Feb 26;65(7): O'Connell S, Lillis D, Cotter A, et al. Opt-Out Panel Testing for HIV, Hepatitis B and Hepatitis C in an Urban Emergency Department: A Pilot Study. PLoS One Mar 11;11(3):e Signer D, Peterson S, Hsieh YH, et al. Scaling Up HIV Testing in an Academic Emergency Department: An Integrated Testing Model with Rapid Fourth- Generation and Point-of-Care Testing. Public Health Rep Jan-Feb;131 Suppl 1:82-9. References Update April Jensen TO, Robertson P, Whybin R, et al. A Signal to Cut-off Ratio in the Abbott Architect HIV Ag/Ab Combo Assay that Predicts Subsequent Confirmation of HIV- 1 Infection in a Low-prevalence Setting. J Clin Microbiol Feb 11 HIV Testing and Counseling Apr 16 12

13 2. Pottie K, Medu O, Welch V, et al. Effect of rapid HIV testing on HIV incidence and services in populations at high risk for HIV exposure: an equity-focused systematic review. BMJ Open Dec 15;4(12):e Prekker ME, Gary BM, Patel R, et al. A comparison of routine, opt-out HIV screening with the expected yield from physician-directed HIV testing in the ED. Am J Emerg Med Jan Shih HI, Ko NY, Hsu HC, et al. Rapid Human Immunodeficiency Virus Screening in an Emergency Department in a Low HIV Seroprevalence Region. Jpn J Infect Dis Feb 13 References Update April Becker ML, Thompson LH, Pindera C, et al. Feasibility and success of HIV pointof-care testing in an emergency department in an urban Canadian setting. Can J Infect Dis Med Microbiol Spring;24(1): Egan DJ, Cowan E, Fitzpatrick L, et al. Legislated human immunodeficiency virus testing in new york state emergency departments: reported experience from emergency department providers. AIDS Patient Care STDS Feb;28(2): Goodhue T, Kazianis A, Werner BG, et al. 4th generation HIV screening in Massachusetts: a partnership between laboratory and program. J Clin Virol Dec;58 Suppl 1:e Knapp H, Hagedorn H, Anaya HD. A five-year self-sustainability analysis of nurse-administered HIV rapid testing in Veterans Affairs primary care. Int J STD AIDS Jan Pilcher CD, Louie B, Facente S, et al. Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco. PLoS One Dec 12;8(12):e References Update April Akhter S, Gorelick M, Beckmann K. Rapid human immunodeficiency virus testing in the pediatric emergency department: a national survey of attitudes among pediatric emergency practitioners. Pediatr Emerg Care Dec;28(12): Chou R, Cantor A, Bougatsos C, Zakher B. Screening for HIV in Pregnant Women: Systematic Review to Update the U.S. Preventive Services Task Force Recommendation [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Nov. 3. Chou R, Cantor AG, Zakher B, Bougatsos C. Screening for HIV in pregnant women: systematic review to update the 2005 U.S. Preventive Services Task Force recommendation. Ann Intern Med Nov 20;157(10): Christopoulos KA, Zetola NM, Klausner JD, et al. Leveraging a rapid, round-theclock HIV testing system to screen for acute HIV infection in a large urban public medical center. J Acquir Immune Defic Syndr Feb 1;62(2):e Donnell-Fink LA, Arbelaez C, Collins JE, et al. Acceptability of fingerstick versus oral fluid rapid HIV testing: results from the universal screening for HIV infection in the emergency room (USHER Phase II) randomized controlled trial. J Acquir Immune Defic Syndr Dec 15;61(5): Donnell-Fink LA, Arbelaez C, Collins JE, et al. Acceptability of Fingerstick vs. Oral Fluid Rapid HIV Testing: Results from the Universal Screening for HIVinfection in the Emergency Room (USHER-Phase II) Randomized Controlled Trial. J Acquir Immune Defic Syndr Jul Feldman M, Wu E, Mendoza M, et al. The prevalence and correlates of receiving confirmatory HIV test results among newly diagnosed HIV-positive individuals at a community-based testing center. AIDS Educ Prev Oct;24(5): HIV Testing and Counseling Apr 16 13

14 8. Ganguli I, Collins JE, Reichmann WM, et al. Missed opportunities: refusal to confirm reactive rapid HIV tests in the emergency department. PLoS One. 2013;8(1):e Granade TC, Nguyen S, Kuehl DS, Parekh BS. Development of a novel rapid HIV test for simultaneous detection of recent or long-term HIV type 1 infection using a single testing device. AIDS Res Hum Retroviruses Jan;29(1): Haukoos JS, Hopkins E, Bender B, et al. Comparison of Enhanced Targeted Rapid HIV Screening Using the Denver HIV Risk Score to Nontargeted Rapid HIV Screening in the Emergency Department. Ann Emerg Med Mar;61(3): Hodder SL, Justman J, Hughes JP, et al. HIV acquisition among women from selected areas of the United States: a cohort study. Ann Intern Med Jan 1;158(1): Metsch LR, Feaster DJ, Gooden L, et al. Implementing rapid HIV testing with or without risk-reduction counseling in drug treatment centers: results of a randomized trial. Am J Public Health Jun;102(6): Patel P, Bennett B, Sullivan T, et al. Rapid HIV screening: missed opportunities for HIV diagnosis and prevention. J Clin Virol May;54(1):42-7. References Update April Albrecht E, Frascarolo P, Meystre-Agustoni G, et al..an analysis of patients' understanding of 'routine' preoperative blood tests and HIV screening. Is no news really good news? HIV Med Mar Anoje C, Aiyenigba B, Suzuki C, et al. Reducing mother-to-child transmission of HIV: findings from an early infant diagnosis program in south-south region of Nigeria. BMC Public Health Mar 12;12(1): Copeland B, Shah B, Wheatley M, et al. Diagnosing HIV in Men Who Have Sex with Men: An Emergency Department's Experience. AIDS Patient Care STDS Feb Herbert R, Ashraf A, Yates T, et al. Nurse-delivered universal point-of-care testing for HIV in an open-access returning traveller clinic. HIV Med Mar Patel P, Bennett B, Sullivan T, et al. Rapid HIV screening: Missed opportunities for HIV diagnosis and prevention. J Clin Virol Feb Søgaard OS, Lohse N, Ostergaard L, et al. Morbidity and Risk of Subsequent Diagnosis of HIV: A Population Based Case Control Study Identifying Indicator Diseases for HIV Infection. PLoS One. 2012;7(3):e White DA, Scribner AN, Martin ME, Tsai S. A Comparison of Patient Satisfaction with Emergency Department Opt-In and Opt-Out Rapid HIV Screening. AIDS Res Treat. 2012;2012: References Update - April Haukoos JS, Hopkins E, Conroy AA, et al. Routine opt-out rapid HIV screening and detection of HIV infection in emergency department patients. JAMA Jul 21;304(3): Torres M. Rapid HIV screening in the emergency department. Emerg Med Clin North Am May;28(2): Qaseem A, Snow V, Shekelle P, et al. Clinical Efficacy Assessment Subcommittee, American College of Physicians. Screening for HIV in health care settings: A guidance statement from the American College of Physicians and HIV Medicine Association. Ann Intern Med. 2009;150(2): Palfreeman A, Fisher M, Ong E. HIV Testing Guidelines Writing Committee. Testing for HIV: Concise guidance. Clin Med. 2009;9(5): Poljak M, Smit E, Ross J European Guideline on HIV testing. Int J STD AIDS. 2009;20(2): HIV Testing and Counseling Apr 16 14

15 6. Barclay J. Application of HIV Testing Guidelines in Clinical Practice Reviewed References Initial 1. Gallant J. HIV Counseling, Testing, and Referral. Am Fam Physician 2004;70: , Center for Medicaid and Medicare Services. NCD for Human Immunodeficiency Virus (HIV) Testing (Diagnosis) June United States Food and Drug Administration. Center for Biologics Evaluation and Research. Multispot HIV-1/HIV-2 Rapid Test. 4. United States Food and Drug Administration. Center for Biologics Evaluation and Research. Premarket Approval Information Devices. OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. 5. United States Food and Drug Administration. Center for Biologics Evaluation and Research. Premarket Approval Information Devices. OraQuick Rapid HIV-1 Antibody Test. 6. Greenwald J, Burstein G, Pincus J, Branson B. A Rapid Review of Rapid HIV Antibody Tests. Current Infectious Disease Reports 2006;8: King SM. Evaluation and treatment of the human immunodeficiency virus-1-- exposed infant. Pediatrics 2004 Aug;114(2): Guenter D, Greer J, Barbara A, et al. Rapid point-of-care HIV testing in community-based anonymous testing program: a valuable alternative to conventional testing. AIDS Patient Care STDS Mar;22(3): Ehrenkranz PD, Ahn CJ, Metlay JP, et al. Availability of rapid human immunodeficiency virus testing in academic emergency departments. Acad Emerg Med Feb;15(2): Branson BM. State of the art for diagnosis of HIV infection. Clin Infect Dis Dec 15;45 Suppl 4:S Kissin DM, Akatova N, Rakhmanova AG, et al. Rapid HIV testing and prevention of perinatal HIV transmission in high-risk maternity hospitals in St. Petersburg, Russia. Am J Obstet Gynecol Feb;198(2):183.e Learmonth KM, McPhee DA, Jardine DK, et al. Assessing Interpretation Proficiency of Rapid HIV Assays in Non-Laboratory Settings: Ensuring the Quality of Testing. J Clin Microbiol Mar Wesolowski LG, Mackellar DA, Ethridge SF, et al. Repeat Confirmatory Testing for Persons with Discordant Whole Blood and Oral Fluid Rapid HIV Test Results: Findings from Post Marketing Surveillance. PLoS ONE Feb 6;3(2):e Centers for Disease Control and Prevention (CDC). Rapid HIV testing in emergency departments--three U.S. sites, January 2005-March MMWR Morb Mortal Wkly Rep Jun 22;56(24): Anaya HD, Hoang T, Golden JF, et al. Improving HIV Screening and Receipt of Results by Nurse-Initiated Streamlined Counseling and Rapid Testing. J Gen Intern Med Apr Holtgrave D, McGuire J. Impact of counseling in voluntary counseling and testing programs for persons at risk for or living with HIV infection. Clin Infect Dis Dec 15;45 Suppl 4:S Fenton KA. Changing epidemiology of HIV/AIDS in the United States: implications for enhancing and promoting HIV testing strategies. Clin Infect Dis Dec 15;45 Suppl 4:S Burrage JW, Zimet GD, Cox DS et al. The Centers for Disease Control and Prevention revised recommendations for HIV testing: reactions of women attending community health clinics. J Assoc Nurses AIDS Care Jan- Feb;19(1): Haukoos JS, Hopkins E, Byyny RL et al. Patient acceptance of rapid HIV testing practices in an urban emergency department: assessment of the 2006 CDC HIV Testing and Counseling Apr 16 15

16 recommendations for HIV screening in health care settings. Ann Emerg Med Mar;51(3):303-9, 309.e Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection Centers for Medicare and Medicaid Services Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. HIV Testing and Counseling Apr 16 16

17 Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. HIV Testing and Counseling Apr 16 17