Academy Guidelines and Recommendations for Oral Pre-Exposure Prophylaxis (PrEP)
OVERARCHING BARRIERS TO PrEP UPTAKE AND RETENTION
- Frequency of in-person medical appointments
- Frequency of laboratory monitoring and HIV/STI testing
- Patient costs of labs and follow-up care
- Incapacity for oral, rectal, and vaginal self-swabs for STIs in many commercial labs
- Confidentiality concerns for young PrEP candidates who are on their parents’ health insurance
- Inconsistent messaging about who could benefit from PrEP
- Extensive and time-consuming CDC Guidelines (94 pages) is daunting for new prescribers
- Prescribing providers are understaffed for patient tracking and retention needs for patients lost to PrEP care
ORAL PrEP - WHO QUALIFIES
All sexually active adults and adolescents should be asked if they have heard about PrEP and given information on PrEP in a non-stigmatizing way.
All sexually active adults and adolescents should be asked if they have heard about PrEP and given information on PrEP in a non-stigmatizing way.
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F/TDF Daily: All sexually active adults and adolescents (>35kg/77lbs) who report sexual behaviors that place them at ongoing risk for exposure to HIV and acquisition and/or anyone who asks for PrEP
F/TDF Event/2:1:1 Dosing (off label): Only for adult MSM who have sex less than two times per week and can anticipate sex
F/TAF Daily: Only Cisgender Men or Transgender Women
The efficacy and safety of other daily oral antiretroviral medications for PrEP, either in place of or in addition to, F/TDF or F/TAF, have not been studied extensively and are not recommended.
CLINICAL ELIGIBILITY FOR ORAL PrEP - ALL OF THESE CONDITIONS MUST BE MET
- Negative HIV antigen/antibody test laboratory (preferred) with reflex confirmation or blood rapid test for patients who have NOT taken oral PrEP in the past three months or injectable PrEP in the past 12 months
- No signs/symptoms of acute HIV infection
- Estimated creatinine clearance ≥ 30 ml/min
- For F/TDF the creatinine clearance should be >60 ml/min
- No contraindicated medications
FOLLOW-UP CARE
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Every 3 months/90 days
- HIV Ag/Ab test and HIV-1 RNA assay, medication adherence and behavioral risk reduction support
- Bacterial STI screening and testing for MSM and transgender women who have sex with men (oral, rectal, urine, blood)
- Assess renal function for patients ≥50 years or who have an eCrCl <90 ml/min at PrEP initiation
- Bacterial STI screening and testing for all sexually active patients (vaginal, oral, rectal, urine as indicated) and blood
- Assess renal function for all patients
- Chlamydia screening heterosexually active women and men (vaginal, urine)
- Assess weight, triglyceride and cholesterol levels for patients on F/TAF
RECOMMENDED BILLING AND CODING
GUIDANCE
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In light of the US Preventive Services Task Force’s "A" grade of oral PrEP, the Academy recommends using the ICD-10 Codes
with the 33 modifier to maximize patient savings. Modifier 33 is a
CPT modifier used to identify medical care whose primary purpose is delivery of
an evidence-based service, based on recommendations from the US Preventive
Services Task Force. You may also want to use Modifier 90 when laboratory
procedures are performed by a party other than the treating or reporting
physician and the laboratory bills the physician for the service.
- Z20.2 – Contact with and suspected exposure to infections with a predominantly sexual mode of transmission
- Z20.6 – Contact with and suspected exposure to human immunodeficiency virus (for serodiscordant couples)
- Z29.8 – Other Specified Prophylaxis
- Z29.9 – Unspecified Prophylaxis
- Z70.8 – Safe Sex and STI Prevention Counseling
- Z72.51 – High-risk heterosexual behavior (recommend not using considered to be stigmatizing)
- Z72.52 – High-risk homosexual behavior (recommend not using considered to be stigmatizing)
OTHER CONSIDERATIONS TO EXPAND PrEP ACCESS AND RETENTION
- Prescribers DO NOT have to see patients every 90 days IF requisite laboratory monitoring and testing results are not abnormal. Consider standing lab orders for patients and issue 90-day refills upon receipt of labs.
- For adolescent males under the age of 19, prescribers may want to offer F/TAF preferentially, as bone density scores did not improve upon stopping F/TDF and lower bone density is correlated with adherence.
- For males who opt for event-based (2:1:1) dosing, prescribe an initial 90 day supply and follow recommended 90-day follow-up care, but communicate with patients regarding the need for additional prescribed doses.
- Consider standardizing follow-up care orders in electronic medical records systems.
- Include the whole care team in offering information about PrEP.
- Familiarize yourself with taking a sexual history that is non-stigmatizing and shaming. Consider training on implicit bias and non-stigmatizing language to talk with patients openly and honestly about their sexual behaviors.
- Decouple medical visits with laboratory monitoring by incorporating telemedicine visits, standing lab orders, walk-in lab appointments, at-home HIV testing and swabbing to decrease patient time burdens.
- If the patient is established and routinely getting laboratory monitoring and HIV/STI testing, remove follow-up burdens. See the patient in person once per year or every six months.
- Prescribe PrEP for EVERY patient who asks for PrEP.