Coverage Policy Manual
Policy #: 2022028
Category: PPACA Preventive
Initiated: January 2022
Last Review: July 2022
  PPACA: Prevention Of Human Immunodeficiency Virus (HIV) Infection, Preexposure Prophylaxis

Description:
The Federal Patient Protection and Preventive Care Act was passed by Congress and signed into law by the President in March 2010. The preventive services component of the law became effective September 23, 2010. A component of the law was a requirement that all “non-grandfathered” health insurance plans are required to cover those preventive medicine services given an “A” or “B” recommendation by the U.S. Preventive Services Task Force.
 
Plans are not required to provide coverage for the preventive services if they are delivered by out-of-network providers.
 
Task Force recommendations are graded on a five-point scale (A-E), reflecting the strength of evidence in support of the intervention. Grade A: There is good evidence to support the recommendation that the condition be specifically considered in a periodic health examination. Grade B: There is fair evidence to support the recommendation that the condition be specifically considered in a periodic health examination. Grade C: There is insufficient evidence to recommend for or against the inclusion of the condition in a periodic health examination, but recommendations may be made on other grounds. Grade D: There is fair evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination. Grade E: There is good evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.
 
Those preventive medicine services listed as Grade A & B recommendations are covered without cost sharing (i.e., deductible, co-insurance, or co-pay) by Health Plans for appropriate preventive care services provided by an in-network provider. If the primary purpose for the office visit is for other than Grade A or B USPSTF preventive care services, deductible, co-insurance, or copay may be applied.

Policy/
Coverage:
Effective January 1, 2022
 
The following services will be provided at no cost share for individuals at high risk of HIV acquisition who are receiving preexposure prophylaxis (PrEP) with effective antiretroviral therapy (Note: The medications for antiretroviral therapy are available through the pharmacy benefit and are not covered under the medical benefit.):
 
**Frequency of testing will be per CDC guidance**
 
    • HIV testing
    • Screening for Hepatitis B
    • Screening for Hepatitis C
    • Screening for Chlamydia
    • Screening for Gonorrhea
    • Screening for Syphilis
    • Creatinine with Calculated Estimated Creatine Clearance (eCrCl)
    • Pregnancy testing for females (xx chromosome)
    • Trichomonas testing for females (xx chromosome)
    • Adherence/Behavioral Counseling with office visit
 
The appropriate ICD-10 codes to report these services are T76.51XA, T76.51XD, T76.52XA, T76.52XD, W46.0XXA, W46.0XXD, W46.1 XXA, W46.1XXD, Z00.00, Z00.01, Z04.81, Z11.3, Z11.4, Z11.59, Z20.2, Z20.5, Z20.6, Z20.828, Z20.89, Z20.9. Z57.8, Z70.9, Z71.7, Z71.89, Z72.51, Z72.52, Z72.53, Z72.89, Z72.9, Z73.9, Z77.21, Z77.9, Z79.899.
 
Codes that may be used to report these services include 81025, 82565, 82570, 82575, 86592, 86689, 86701, 86702, 86703, 86803, 87270, 87320, 87340, 87389, 87390, 87490, 87491, 87521, 87535, 87806, 87808, 87590, 87591, 87592, 87800, 87801, 87810, 87850, 99211, 99212, 99213, 99214, 99215, 99401, 99402, 99403, 99404, G0432, G0433, G0435, G0445, G0472, G0499, or S3645.
 
When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be billed with Modifier ‘-33’. The correct coding as listed for both ICD-10 and CPT or HCPCS codes is also required.

Rationale:
The USPSTF recommends that clinicians offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of HIV acquisition (Grade A) (USPSTF, 2019).
 
An estimated 1.1 million individuals in the United States are currently living with HIV, and more than 700,000 persons have died of AIDS since the first cases were reported in 1981 (CDC, 2019; CDC, 2017). In 2017, there were 38,281 new diagnoses of HIV infection reported in the United States; 81% (30,870) of these new diagnoses were among males and 19% (7312) were among females (CDC, 2017). Although treatable, HIV infection has no cure and has significant health consequences.
 
Although the USPSTF found inadequate evidence that specific risk assessment tools can accurately identify persons at high risk of HIV acquisition, it found adequate epidemiologic data on risk factors that can be used to identify persons at high risk of acquiring HIV infection (USPSTF, 2019).
 
The USPSTF found convincing evidence that PrEP is of substantial benefit for decreasing the risk of HIV infection in persons at high risk of HIV infection, either via sexual acquisition or through injection drug use. The USPSTF also found convincing evidence that adherence to PrEP is highly correlated with its efficacy in preventing the acquisition of HIV infection.
 
The USPSTF found adequate evidence that PrEP is associated with small harms, including kidney and gastrointestinal adverse effects.
 
The USPSTF concludes with high certainty that the net benefit of the use of PrEP to reduce the risk of acquisition of HIV infection in persons at high risk of HIV infection is substantial.
 
The USPSTF recommends that the following persons be considered for PrEP:
 
1. Men who have sex with men, are sexually active, and have 1 of the following characteristics:
    • A serodiscordant sex partner (ie, in a sexual relationship with a partner living with HIV)
    • Inconsistent use of condoms during receptive or insertive anal sex
    • A sexually transmitted infection (STI) with syphilis, gonorrhea, or chlamydia within the past 6 months
2. Heterosexually active women and men who have 1 of the following characteristics:
    • A serodiscordant sex partner (ie, in a sexual relationship with a partner living with HIV)
    • Inconsistent use of condoms during sex with a partner whose HIV status is unknown and who is at high risk (eg, a person who injects drugs or a man who has sex with men and women)
    • An STI with syphilis or gonorrhea within the past 6 months
3. Persons who inject drugs and have 1 of the following characteristics:
    • Shared use of drug injection equipment
    • Risk of sexual acquisition of HIV (see above)
 
Once-daily oral treatment with combined tenofovir disoproxil fumarate and emtricitabine is the only formulation of PrEP approved by the US Food and Drug Administration (FDA) for use in the United States in persons at risk of sexual acquisition of HIV infection. However, several studies reviewed by the USPSTF found that tenofovir disoproxil fumarate alone was also effective as PrEP, and CDC guidelines note that, given these trial data, tenofovir disoproxil fumarate alone can be considered as an alternative regimen for high-risk heterosexually active men and women and persons who inject drugs (CDC, 2017).
 
According to its product label, tenofovir disoproxil fumarate/emtricitabine may be considered for use as PrEP during pregnancy (Gilead Sciences, 2018). No trials of oral PrEP included pregnant women; however, pregnancy is associated with an increased risk of HIV acquisition (Mugo, 2011). CDC guidelines recommend shared decision making for pregnant women who are considering starting or continuing PrEP during pregnancy.
 
Adolescents at high risk of HIV acquisition could benefit from PrEP, and tenofovir disoproxil fumarate/emtricitabine is approved by the FDA for use as PrEP in adolescents who weigh at least 35 kg (Gilead Sciences, 2018).  In addition, young men who have sex with men are at particularly high risk of HIV acquisition (CDC, 2019). However, no randomized clinical trials (RCTs) of PrEP enrolled adolescents. Limited data suggest that PrEP use is not associated with significant adverse events in adolescents but may be associated with slightly less bone mineral accrual than would be expected (Hosek, 2017). The USPSTF suggests that clinicians weigh all these factors when considering PrEP use in adolescents at high risk of HIV acquisition. In addition, clinicians need to be aware of any local laws and regulations that may apply when providing PrEP to an adolescent minor.
 
Consistent use of condoms decreases risk of HIV acquisition by approximately 80% and reduces the risk of other STIs (Patel, 2014). The USPSTF recommends intensive behavioral counseling to reduce behaviors associated with increased risk of STIs and HIV acquisition and to increase condom use among adolescents and adults at increased risk of STIs (LeFever, 2014). The CDC has made several recommendations, including abstinence, reducing one’s number of sex partners, and consistent condom use, to decrease risk of STIs, including HIV (CDC, 2016). The CDC also recommends syringe service programs (ie, needle exchange programs) to reduce the risk of HIV acquisition and transmission among persons who inject drugs (CDC, 2018). The Community Preventive Services Task Force has also issued several recommendations on the prevention of HIV and other STIs (Community Guide, 2019). Postexposure prophylaxis, started as soon as possible after a possible exposure event, can also decrease the risk of HIV infection.
 
Before prescribing PrEP, clinicians should exclude persons with acute or chronic HIV infection through taking a medical history and HIV testing. The 2-drug antiretroviral regimen used in PrEP, when used alone, is not an effective treatment for HIV infection, and its use in persons living with HIV can lead to the emergence of, or selection for, drug-resistant HIV infection. It is also generally recommended that kidney function testing, serologic testing for hepatitis B and C virus, testing for other STIs, and pregnancy testing (when appropriate) be conducted at the time of or just before initiating PrEP. Ongoing follow-up and monitoring, including HIV testing every 3 months, is also suggested. The time from initiation of PrEP to achieving protection against HIV infection is unknown. Pharmacokinetic data suggest that maximum levels of tenofovir diphosphate (the active form of tenofovir) is reached in 7 days in rectal tissue and in 20 days in blood (peripheral blood mononuclear cells) and vaginal tissue (CDC, 2017). Patients can continue PrEP as long as high risk of HIV acquisition continues. Patients may discontinue PrEP for several reasons, including personal preference, decreased risk of HIV acquisition, or adverse medication effects.
 
The USPSTF Final Recommendation Statement encompasses FDA-approved PrEP antiretroviral medications, as well as the following baseline and monitoring services:
 
1. HIV testing: Persons must be tested and confirmed to be HIV uninfected before starting PrEP and tested again for HIV every three months while taking PrEP so that, if they have become infected, the medication can be stopped promptly before it could cause a harmful drug resistance to develop.
2. Hepatitis B and C testing: Persons should be screened for hepatitis B virus (HBV) at baseline for the initiation of PrEP consistent with CDC guidelines, so that when the PrEP medications, which suppress HBV replication in the liver, are stopped, persons can be monitored to ensure safety and to rapidly identify any potential injury. Additionally, persons should be screened for hepatitis C virus (HCV) infection at baseline and periodically consistent with CDC guidelines. Screening for HCV infection is indicated for all people with ongoing risk of contracting HCV.
3. Creatinine testing and calculated estimated creatine clearance (eCrCl) or glomerular filtration rate (eGFR): For persons taking PrEP, their estimated eCrCl or eGFR must be measured and calculated at the beginning of treatment to assess if kidney function is in the range for safe prescribing of PrEP medication. Creatinine and eCrCL or eGFR should be checked periodically consistent with CDC guidelines while on PrEP medication to assess for potential kidney injury and to ensure that it is safe to continue PrEP medication.
4. Pregnancy testing: Persons with childbearing potential taking PrEP must be tested for pregnancy at baseline and should be tested again periodically thereafter consistent with CDC guidelines until PrEP is stopped so that pregnant patients, together with their health care providers, can make a fully informed and individualized decision about taking PrEP.
5. Sexually transmitted infection (STI) screening and counseling: Persons taking PrEP must be screened for STIs at baseline and should be screened periodically thereafter consistent with CDC guidelines, which may require multiple anatomic site testing (i.e., genital, oropharyngeal, and rectal) for gonorrhea and chlamydia, and testing for syphilis, together with behavioral counseling, which are recommended to reduce the risk of STIs, the presence of which may increase the likelihood of acquiring HIV sexually.
6. Adherence counseling: Persons taking PrEP must be offered regular counseling for assessment of behavior and adherence consistent with CDC guidelines to ensure that PrEP is used as prescribed and to maximize PrEP’s effectiveness
 
The 2017 CDC guidelines recommend PrEP with tenofovir disoproxil fumarate/emtricitabine as an HIV prevention option for men who have sex with men, heterosexually active men and women, and persons who inject drugs who are at substantial risk of HIV infection, with tenofovir disoproxil fumarate monotherapy as an alternative for heterosexually active men and women and persons who inject drugs and who are at substantial risk (CDC, 2017). The American College of Obstetricians and Gynecologists suggests that, in combination with other proven HIV-prevention methods, PrEP may be a useful tool for women at highest risk of HIV acquisition and that such women should be considered candidates for PrEP (ACOG, 2014). 2016 World Health Organization guidance recommends offering PrEP containing tenofovir disoproxil fumarate as an additional prevention choice for persons at substantial risk of HIV infection (provisionally defined as HIV incidence higher than 3 cases/100 person-years) as part of HIV prevention approaches (WHO, 2019).

CPT/HCPCS:
81025Urine pregnancy test, by visual color comparison methods
82565Creatinine; blood
82570Creatinine; other source
82575Creatinine; clearance
86592Syphilis test, non treponemal antibody; qualitative (eg, VDRL, RPR, ART)
86689Antibody; HTLV or HIV antibody, confirmatory test (eg, Western Blot)
86701Antibody; HIV 1
86702Antibody; HIV 2
86703Antibody; HIV 1 and HIV 2, single result
86803Hepatitis C antibody;
87270Infectious agent antigen detection by immunofluorescent technique; Chlamydia trachomatis
87320Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Chlamydia trachomatis
87340Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; hepatitis B surface antigen (HBsAg)
87389Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result
87390Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; HIV-1
87490Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, direct probe technique
87491Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, amplified probe technique
87521Infectious agent detection by nucleic acid (DNA or RNA); hepatitis C, amplified probe technique, includes reverse transcription when performed
87535Infectious agent detection by nucleic acid (DNA or RNA); HIV 1, amplified probe technique, includes reverse transcription when performed
87590Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, direct probe technique
87591Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, amplified probe technique
87592Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, quantification
87800Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; direct probe(s) technique
87801Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; amplified probe(s) technique
87806Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies
87808Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; Trichomonas vaginalis
87810Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; Chlamydia trachomatis
87850Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; Neisseria gonorrhoeae
99211Office or other outpatient visit for the evaluation and management of an established patient, that may not require the presence of a physician or other qualified health care professional.
99212Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. When using time for code selection, 10-19 minutes of total time is spent on the date of the encounter.
99213Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and low level of medical decision making. When using time for code selection, 20-29 minutes of total time is spent on the date of the encounter.
99214Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and moderate level of medical decision making. When using time for code selection, 30-39 minutes of total time is spent on the date of the encounter.
99215Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and high level of medical decision making. When using time for code selection, 40-54 minutes of total time is spent on the date of the encounter.
99401Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 15 minutes
99402Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 30 minutes
99403Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 45 minutes
99404Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 60 minutes
G0432Infectious agent antibody detection by enzyme immunoassay (eia) technique, hiv 1 and/or hiv 2, screening
G0433Infectious agent antibody detection by enzyme linked immunosorbent assay (elisa) technique, hiv 1 and/or hiv 2, screening
G0435Infectious agent antibody detection by rapid antibody test, hiv 1 and/or hiv 2, screening
G0445High intensity behavioral counseling to prevent sexually transmitted infection; face to face, individual, includes: education, skills training and guidance on how to change sexual behavior; performed semi annually, 30 minutes
G0472Hepatitis c antibody screening, for individual at high risk and other covered indication(s)
G0499Hepatitis b screening in non pregnant, high risk individual includes hepatitis b surface antigen (hbsag), antibodies to hbsag (anti hbs) and antibodies to hepatitis b core antigen (anti hbc), and is followed by a neutralizing confirmatory test, when performed, only for an initially reactive hbsag result
S3645Hiv 1 antibody testing of oral mucosal transudate

References: ACOG Committee(2014) ACOG Committee Opinion no 595: Committee on Gynecologic Practice: preexposure prophylaxis for the prevention of human immunodeficiency virus. Obstet Gynecol. 2014;123(5):1133-1136.

Centers for Disease Control and Prevention (CDC), US Public Health Service(2019) Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2017 Update: A Clinical Practice Guideline. CDC website. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. Published March 2018. Accessed April 16, 2019.

Centers for Disease Control and Prevention (CDC).(2019) Diagnoses of HIV Infection in the United States and Dependent Areas, 2017. CDC website. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2017-vol-29.pdf. Published November 2018. Accessed April 16, 2019.

Centers for Disease Control and Prevention (CDC).(2019) Estimated HIV Incidence and Prevalence in the United States, 2010–2016. CDC website. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-24-1.pdf. Published February 2019. Accessed April 16, 2019.

Centers for Disease Control and Prevention (CDC).(2019) HIV and Youth. CDC website. https://www.cdc.gov/hiv/pdf/group/age/youth/cdc-hiv-youth.pdf. Published April 2019. Accessed April 16, 2019.

Centers for Disease Control and Prevention (CDC).(2019) How you can prevent sexually transmitted diseases. CDC website. https://www.cdc.gov/std/prevention/default.htm. 2016. Accessed April 16, 2019.

Centers for Disease Control and Prevention (CDC).(2019) Syringe services programs. CDC website. https://www.cdc.gov/hiv/risk/ssps.html. 2018. Accessed April 16, 2019.

Centers for Medicare & Medicaid Services (CMS).(2022) FAQS About Affordable Care Act Implementation Part 47. July 19, 2021. https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-47.pdf. Accessed July 6, 2022.

Gilead Sciences.(2019) Truvada prescribing information. Gilead Sciences website. https://www.gilead.com/~/media/Files/pdfs/medicines/hiv/truvada/truvada_pi.pdf. 2018. Accessed April 16, 2019.

HIV/AIDS, STIs and pregnancy. The Community Guide website. https://www.thecommunityguide.org/topic/hivaids-stis-and-pregnancy. Accessed April 16, 2019.

Hosek SG, Landovitz RJ, Kapogiannis B, et al.(2017) Safety and feasibility of antiretroviral preexposure prophylaxis for adolescent men who have sex with men aged 15 to 17 years in the United States. JAMA Pediatr. 2017;171(11):1063-1071

LeFevre ML. US Preventive Services Task Force.(2014) Behavioral counseling interventions to prevent sexually transmitted infections: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161(12):894-901.

Mugo NR, Heffron R, Donnell D, et al.(2011) Partners in Prevention HSV/HIV Transmission Study Team. Increased risk of HIV-1 transmission in pregnancy: a prospective study among African HIV-1-serodiscordant couples. AIDS. 2011;25(15):1887-1895.

Patel P, Borkowf CB, Brooks JT, Lasry A, et al.(2014) Estimating per-act HIV transmission risk: a systematic review. AIDS. 2014;28(10):1509-1519.

US Preventive Services Task Force (USPSTF).(2022) Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis. June 11, 2019. Recommendation: Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis | United States Preventive Services Taskforce (uspreventiveservicestaskforce.org). Accessed July 6, 2022.

World Health Organization (WHO).(2016) Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach. 2nd ed. WHO website. https://www.who.int/hiv/pub/arv/arv-2016/en/. Published June 2016. Accessed April 16, 2019.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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