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WHY SCREENING Routine screening for HIV can save lives, just like routine screening for colon cancer, breast cancer or heart disease. Just like these conditions, HIV can be detected before symptoms appear, thereby gaining a patient years of life if treatment is started early. Just like these conditions, treatment of HIV is more difficult once symptoms appear. Just like these conditions, 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. Protect Baltimore 26 OVERVIEW OF ROUTINE HIV SCREENING Routine HIV screening in primary care is important because risk-based assessments may miss patients with HIV infection.4 Routine HIV Screening The Maryland Department of Health and Mental Hygiene, the Centers for Disease Control and Prevention and the US Preventive Services Task Force recommend that all health care professionals: “in all health care settings(e.g. hospitals, urgent care or emergency departments, inpatient services, community health centers and clinics, correctional healthcare facilities, and primary care settings) offer diagnostic HIV testing and HIV screening as part of routine clinical care for individuals ages 13–65.” 3 High risk patients who fall outside this age range should also be screened. All pregnant women, regardless of risk factors, should be screened for HIV. (See Frequency of HIV Screening). 27 Protect Baltimore OVERVIEW OF ROUTINE HIV SCREENING CONTINUED HIV Screening for High Risk and Vulnerable Individuals If an individual is known to be at high risk for HIV, he or she should be screened at least annually, ideally every three months. Examples of individuals who may be at high risk include: patients being treated for other STIs (Sexually Transmitted Infections), injection-drug users and their sex partners, persons who exchange sex for money/ drugs, men who have sex with men, persons who themselves or whose partners have had more than one sex partner since their most recent HIV test, sex/needle sharing partners of HIV-infected persons,3 patients with tuberculosis. Types of Tests HIV infection is diagnosed with 1) a rapid screen on site or 2) an Enzyme-linked immunosorbent assay(ELISA) with confirmation by Western blot or indirect immunofluorescence assay. Acute HIV infection requires a plasma HIV RNA test to detect viral load. The tests each offer different advantages. Rapid tests can be well-suited for patients that might not return to get the results. See chart on page 31 for more detail about types of HIV tests. Screening for Acute (Recent) HIV Infection Acute HIV infection is the period of time immediately following infection prior to the presence of antibodies. This period between infection and the presence of antibodies is the window period (see graph on page 31). If a patient presents with flu-like symptoms and has a history of high risk behaviors, suspect acute HIV infection. These cases are quite rare. Both an HIV RNA(viral load) test and an antibody test are required when acute HIV infection is suspected (See Recent HIV Infection later in this section). Retention in Care for HIV Infected Individuals Reassure patients that adherence to antiretroviral (ART) medications will allow them to live a long and productive life. The belief that HIV infection quickly leads to death can hinder patients’ motivation to change high-risk behaviors such as unsafe sex and needle sharing. Protect Baltimore 28 FREQUENCY OF HIV SCREENING Ages 13-65 Years The U.S. Centers for Disease Control and Prevention (CDC) recommends screening all patients and repeating screening annually, if the patients are engaged in any ongoing risky behavior associated with HIV infection, including unprotected sex. Patients with Risk Factors Listed Below The Baltimore City Health Department recommends that the following patients be tested at least annually, ideally every 3 months: Injection drug users(IDUs) and their sex partners • People who exchange sex for money or drugs • Men who have sex with men (MSM) • Heterosexual individuals who have had, or whose sex partners have had, more than one sex partner since their most recent HIV test • Sex/needle sharing partners of HIV-infected persons Patients with Symptoms and Signs of Acute HIV Infection Patients presenting with flu-like symptoms(below) and have a history of high risk behaviors should be tested with BOTH an antibody and plasma HIV RNA test.5 Symptoms may include: Fever • Malaise • Rash • Pharyngitis • Lymphadenopathy • Aseptic meningitis Pregnant Patients Screen as early as possible during pregnancy. Maryland state law requires HIV screening as a part of the routine prenatal blood screens unless the patient opts out. HIV screening should be offered in the third trimester of pregnancy and during labor and delivery for patients with an unknown or undocumented HIV status.6 Patients Seeking Treatment for Sexually Transmitted Infections (STIs): See Appendix Patients with Tuberculosis Screen all patients initiating TB treatment for HIV. Screen annually, or every three months if they are engaged in any of the above risk behaviors. 29 Protect Baltimore RECENT(ACUTE) HIV INFECTION As many as 50% of HIV transmissions occur during the acute and early stages of the illness7 Acute HIV Infection Defined Acute HIV infection is the period immediately following infection with HIV, prior to the appearance of HIV antibodies. This period usually lasts 6 to 8 weeks. During this time, the level of virus increases rapidly in the blood. Between 5 and 30 days after infection, flu-like symptoms (fever, malaise, lymphadenopathy, rash) can appear and last for several weeks. Suspect acute HIV infection if a patient presents with flu-like symptoms and history of high risk behaviors. Acute HIV infection is also called Primary HIV infection, early or recent HIV infection, acute retroviral syndrome and acute HIV syndrome. Transmission and Acute HIV Infection Patients with acute HIV infection are at particularly high risk of transmitting HIV because of the high viral levels. Testing and Acute HIV Infection Finding a patient in the acute stage of HIV infection is a rare event. HIV antibodies can take up to three months to appear. Most standard HIV tests such as a rapid HIV test or ELISA/Western Blot tests respond to HIV antibodies. Patients with acute HIV infection will generally receive negative or indeterminate results from these two types of tests. If acute HIV is suspected, use an HIV RNA test in combination with an HIV-1 antibody test.5 The HIV RNA test can detect HIV viral load; a high viral load is indicative of HIV infection (see Providing Test Results in Section 4). Protect Baltimore 30 TYPES OF HIV TESTS TEST TYPES ELISA (Enzyme Plasma HIV RNA HIV-1/2 Ag/Ab (viral load test) (4th Generation) Rapid Test linked immune absorbent assay) Western Blot Initial HIV screening Initial HIV screening Confirmatory test Identify acute/recent HIV infection DETECTS HIV antibodies HIV antibodies HIV antibodies Amount of HIV (viral load) in the blood. HIV-1 and HIV-2 Antibodies, HIV-1 p24 Antigen SOURCE OF SAMPLE Finger prick or oral fluids Blood, urine or oral fluids Blood Blood Blood PROCESSED BY A LAB No Yes Yes Yes, may require specialized lab Yes TIME FOR RESULTS 20 minutes or less 2—14 days 2–14 days 1–3 weeks USE Identify HIV infections (Acute infections are determined if HIV RNA is reactive) Up to 1 hour (Additional testing needed, if reactive) Testing Timeline Source: Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. Available at http://stacks.cdc.gov/ view/cdc/23447. Published June 27, 2014. Accessed November 1, 2015. 31 Protect Baltimore PRE–TEST INFORMATION AND PATIENT CONSENT As of July 1, 2015, HIV testing in health-care settings is optout. Patients must be informed that they will be screened for HIV along with routine blood tests unless they decline to have the test. Before undergoing HIV testing, pre-test information must be provided to the patient orally, in written form, or by/through the use of videos. If a patient declines HIV testing, it must be documented in the medical record. *Providers working with adolescent patients (<18 years) should discuss that reproductive health services may appear on an explanation of benefits that their parents or guardians could receive. See appendix for considerations unique to adolescent patients. Pretest Information Must Include: An explanation of HIV infection; The meaning of positive and negative test results; Their ability to ask questions and to decline HIV testing. Obtaining Informed Consent When HIV testing is performed, consent for HIV testing is by law in Maryland (effective 7/1/2015) a part of the patient’s general informed consent for medical care as is done for other screening and diagnostic tests (i.e. Opt Out). This means that HIV testing does not need to be singled out in the general consent form but rather it is covered under the broader general consent language for services provided at the facility. A health care provider may not be required to obtain consent using a separate form. Providers must also inform the individual either verbally or in writing that the test will be performed unless they decline. Protect Baltimore 32 Patients under 18 can consent to an HIV test and treatment. Patients must be capable of consenting. Patients need to know they can refuse an HIV test without penalty. In non-health care settings, such as venue testing or in Community Based Organizations, consent must be provided in writing. The Health Department's HIV informed consent form must be used. HOW TO OFFER A ROUTINE HIV TEST Sample Script for Routine HIV Screening As part of routine care, we screen all patients between 13 and 65 years of age for HIV at least once, whether or not they think they are at risk. *For minors, remember to discuss EOB documents as a potential breach of confidentiality. We do this to help keep our patients healthy. There are excellent treatment options and catching it early can be a life saver. This pamphlet tells you about HIV and why you should be screened. We are giving it to all our patients. I would be glad to answer any questions you have. Like all medical screens, the results will be confidential.* You can decline the test and it will not affect the care you receive today. If patient declines: Would you read the pamphlet about HIV and we’ll talk about it next time? Are there concerns you have about the test? What NOT to Say: If a patient asks for an HIV test, make sure NOT to... » ask why » act surprised » ask what they have been up to » dissuade them 33 Protect Baltimore PART 3: HOW TO BILL HOW TO BILL: CODING GUIDELINES Medicare HCPCS codes Test product Code G0432 G0433 G0435 Description 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 CPT ®codes Test product Code 86689 86701 86703 87534 Rapid test modifier 92 92 87535 87536 87389 Description Antibody; HTVL or HIV antibody, comfirmatory test (e.g, Western Blot) Antibody; HIV-1 Antibody; HIV-1 and HIV-2, single assay Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe technique Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, amplified probe technique Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, quantification Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semi-quantitative, multiple-step method; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result 87390 92 Infectious agent antigen detection by enzyme immunoassay technique, qualita tive or semi-quantitative, multiple step method; HIV-1 Code 36415 Description Collection of venous blood by venipuncture Code 99385 Description Initial comprehensive preventive medicine service evaluation and management 18–39 years of age (new patient) Initial comprehensive preventive medicine service evaluation and management 40–64 years of age (new patient) Periodic comprehensive preventive medicine reevaluation and management 18–39 years of age (established patient) Periodic comprehensive preventive medicine reevaluation and management 40–64 years of age (established patient) Office or other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician. Test administration Office service 99386 99395 99396 9921199215 Protect Baltimore 36 Case Scenario The following guidelines are from the AMA and the American Academy of HIV Medicine to help providers bill for HIV screening. A private practice physician sees a 20-year-old single male for a physical examination before his senior year of college. The patient, who is not an established patient, has had multiple sexual partners, both male and female. The physician performs the HIV rapid test. To bill use: ICD-10-CM Diagnosis Codes Z00.00 Encounter for routine general adult medical examination Z11.4 Encounter for screening for human immunodeficiency virus (HIV) Z72.89 Other problems related to lifestyle (since patient is asymptomatic but in a known high risk group) Z71.7 HIV Counseling (if counseling is provided during the encounter for the test or after the results are available) Z21 Asymptomatic HIV infection status if the results are positive but the patient is asymptomatic Z20.6 Contact with and (suspected) exposure to human immunodeficiency virus (HIV) Z79 Long term (current) drug therapy. Includes long term (current) drug use for prophylactic purposes, PrEP, PEP, nPEP. Z79.899 Other long term (current) drug therapy B20 Human Immunodeficiency Virus [HIV] disease/returning patient informed of his/her positive test result, AND patient is symptomatic. CPT Codes 1. Test product 86701 with modifier 92 for the antibody HIV-1 test or 86702 with modifier 92 for the antibody HIV-1 and HIV-2 single assay 87389 for the HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result 2. Office service » 99385 if the patient is new for initial comprehensive preventive medicine service evaluation and management or 99395 if the patient is established for periodic comprehensive preventive medicine reevaluation and management » 99211-99215 for the evaluation and management of an established patient if the results are positive and HIV counseling is provided 37 Protect Baltimore PART 4: HOW TO PROVIDE HIV TEST RESULTS Positive test results must be given in person. Preliminary positives must be confirmed. A positive preliminary test and negative Western Blot should be followed with plasma HIV RNA testing to rule out acute infection. When an individual receives a positive test result, providers are required by law to refer the individual to treatment and supportive services. RAPID AND ELISA: NEGATIVE What it Means This test did not find HIV antibodies in the blood. While this result most likely means a patient does not have HIV, this test cannot detect recent infection (i.e. exposure that occurred in the past 3 months). Next Steps If the patient has engaged in high risk activities in the past three months, have them retested in three months. If acute HIV suspected, order plasma HIV RNA test. What to Say If no high risk behavior: “The results are negative. This almost always means you do not have HIV. No further testing is needed unless you think you have been exposed in the past three months. What questions do you have about staying HIV negative?” If high risk behavior: “A negative test means you do not have HIV infection; however the test may not show recent infection within the past 3 months. To be certain that you do not have HIV, I recommend getting another test 3 months after your last exposure. Can I help you figure out when that would be? We can make an appointment for you based on that.” If acute HIV suspected: “Because of your symptoms, I’m going to use another way to detect whether HIV is present. This test looks for the HIV virus in your blood and is better at finding a recent infection.” Protect Baltimore 40 RAPID AND ELISA: INDETERMINATE What it Means An indeterminate test means that it cannot be determined from the results whether the patient is HIV positive or negative. Next Steps Offer to test again. If acute HIV suspected, order plasma HIV RNA test. What to Say “This test was neither positive nor negative. This happens sometimes and could result for a number of reasons. We are going to test again to try to get a clearer answer.” If acute HIV suspected: “Because of your symptoms, I’m going to use another way to detect whether HIV is present. This test looks for the HIV virus in your blood and is better at finding a recent infection.” 41 Protect Baltimore RAPID AND ELISA: POSITIVE What it Means The test detected HIV antibodies in the blood. This is a preliminary positive test and an indication the patient has HIV. In order to establish a confirmed positive, a confirmatory test needs to be conducted, such as a Western Blot. In the case of a positive ELISA, the lab should conduct this confirmatory test automatically. If the result is from a rapid test, a confirmatory test needs to be ordered. A confirmatory test does not occur automatically with a rapid test. Next Steps With positive rapid test, order confirmatory test; draw blood if needed With positive ELISA, laboratory will automatically perform confirmatory test Inform patient of results in person in a private area Give patient time to react to initial news Emphasize confirmation is needed Emphasize HIV is treatable For pregnant patients: Connect with HIV provider Start combination ART treatment as soon as possible Protect Baltimore 42 What to Say “Your preliminary test result was positive. This means you probably have HIV. We won't know for sure if you are infected with HIV until we get the results from your confirmatory test. However, it is very likely (99%) that that test will be also be positive. It will take about 1-2 weeks to receive these results. It is important to return for the results of this test.” “This is a serious infection, but people today are living longer healthier lives with medication that can keep the immune system strong. It is a good thing to know; this can get you on the path to treatment. HIV is treatable. Knowing you have HIV can help you take precautions to prevent passing it to others.” “There are all kinds of support available and we will help connect you to services that can help you through this.” “How are you feeling? What are your questions?” "What will you do after you leave here? Who will you talk to about this?" For pregnant patients: “ Your preliminary HIV screening result was positive. You may have HIV infection. We need to do a second (or confirmatory) test, but it is important to start medication to reduce the risk of passing HIV to your baby while we wait for the result.” If appropriate: “It is important to delay breast-feeding until we have the second test result.” 43 Protect Baltimore WESTERN BLOT: NEGATIVE What a Negative Western Blot Means This test did not detect HIV antibodies in the blood and most likely indicates original antibody results were false positive. This test cannot detect infection that has occurred in the last 12 weeks. Next Steps If no signs, symptoms or risk factors for HIV, share negative results with patient. If acute HIV infection suspected, order plasma HIV RNA or retest in 6 weeks. What to Say If no signs, symptoms: “The second test came back negative. No further testing is needed unless you think you may have been exposed in the past three months. We can test again in six weeks to make certain if you would like.” If acute HIV is suspected: “The second test was negative, but this test can’t always detect early infection. Because of your symptoms, we are going to order another test that works a different way to detect the virus.” Protect Baltimore 44 WESTERN BLOT: INDETERMINATE What an Indeterminant Western Blot Means An indeterminate test means that it cannot be determined from the results whether the patient is HIV positive or negative. Next Steps Repeat test in 6 weeks. If acute HIV infection suspected, order plasma HIV RNA test What to Say “These test results were indeterminate. That means we could not tell from this test whether you have HIV or not. We will need to retest in 6 weeks. Let’s schedule an appointment.” If acute HIV is suspected: “These results are indeterminate. That means the test does not indicate whether you have HIV or not. Because of your symptoms, I’m going to use another way to detect whether HIV is present. This test looks for the HIV virus in your blood and is better at finding a recent infection.” 45 Protect Baltimore WESTERN BLOT : POSITIVE What a Positive Western Blot Means In combination with a positive rapid or ELISA test, a positive confirmatory test indicates infection with HIV. It does not indicate the stage of disease. Next Steps Link Patient to HIV Primary Care If the patient agrees to treatment, you are required by law to refer the patient to care. There are several Baltimore City treatment and case management centers that provide medical care and case management services for HIV and AIDS patients (See HIV Treatment Providers list in next section). Provide Counseling » Learning to Cope Discuss ways to handle the emotional consequences of learning about a positive test result. » HIV is a Manageable Disease Assure the patient that, with good medical care and patient adherence, people with HIV stay healthier and live longer. » Risk Reduction Discuss how to prevent the spread of HIV to others. » Partner Notification Urge patients to notify their partners. See Partner Notification Options in the next section. Protect Baltimore 46 What to Say In a private area alone with the patient (unless patient requests presence of another person): “These tests confirm that you have HIV infection.” Allow patient time to react. Shock and disorientation are common reactions. Remain calm and nonjudgmental. Pay attention to the placement of chairs. Ensure that both you and client have access to a door. If appropriate, say “Tell me about your reaction. Is this a surprise or something you were expecting?” Even if patient does not show signs of shock or disorientation, do not try to give too much information at once. Adjust accordingly if concern exists that the patient will not return for more information. Key next steps may need to be written down and supportive material offered. Have up-to-date information on hand. Offer reassurance that HIV does not mean AIDS and it is not a death sentence: “People with HIV who receive the care they need can live long and healthy lives. With proper treatment you can as well. Even if you don’t feel sick now, starting treatment right away will help you in the long run.” “What questions do you have now?” 47 Protect Baltimore WESTERN BLOT: POSITIVE CONTINUED “It is normal to have more questions as time passes. Please make sure you ask your health care providers.” “There are all kinds of services and support in Baltimore to help you through this. I will help link you with someone who can help you take advantage of these resources.” Talk to the patient about notification and reporting. (see Notification in the next section) “It will be important to notify sex partners so they can get tested, too. I always encourage my patients to consider working with the Health Department. They can notify your partners without disclosing your identity. Someone from the Health Department should be contacting you shortly.” “The results of these tests will be kept confidential. According to the law, we have to report any confirmed HIV cases to the Health Department” Get the patient connected to care; the more active referral the better for the patient: Make a phone call to make an appointment for the patient while in the office. If you are near a treatment center, see if a case manager can help escort the patient there to get started. The next section guides you through the steps of connecting an HIV+ patient to care. Protect Baltimore 48 PLASMA HIV RNA: UNDETECTABLE What it Means No copies of the HIV virus were detectable in the blood. While the results most likely mean the person does not have HIV, the test can not detect virus levels in the first days of exposure. Next Steps Share results with patient Offer antibody retest for concerned patients For patients with high risk behaviors: Retest with antibody test (rapid or ELISA) in 4-12 weeks What to Say For patients with no risk factors and negative antibody test: “This test did not detect any virus in your blood. Most likely, this means you do not have HIV. To be sure, we can schedule another appointment to test for antibodies in 4-12 weeks. Would you like to schedule an appointment?” For patients with high risk behaviors: “This test did not detect any virus in your blood. Because you may have been recently exposed, I recommend another test in 4-12 weeks. When is a good time to come back in?” 49 Protect Baltimore PLASMA HIV RNA: POSITIVE What it Means A high viral load has been detected. In combination with a negative or indeterminate HIV antibody test (e.g. Rapid or ELISA), the positive test is indicative of acute (recent) HIV infection. Next Steps Diagnose acute HIV infection Inform patient of results in person in a private area Help connect to treatment/ offer treatment for all non-pregnant patients Follow up with HIV antibody tests at 3 and 6 months For pregnant patients: Connect with HIV provider Start combination ART treatment as soon as possible Protect Baltimore 50