Questions about the HHS Ready, Set, PrEP Program

1. How can health centers get a supply of Truvada for the Ready, Set, PrEP program?
   Work with your patients to figure out if PrEP medication is right for them. With a prescription, uninsured HIV-negative patients can obtain free Truvada or Descovy for PrEP at getyourprep.com or by calling 1-855-447(HHS)-8410. 
   
   
2. How much do patients/health centers pay for PrEP now – in other words, how much would be saved by getting patients to access PrEP through the HHS program rather than 340B?
   Currently costs for PrEP medications vary according to the purchasing/distribution mechanism; however, there is no charge to the patient or to the health center for the medications under the HHS Ready, Set, PrEP program. 
   
   
3. A. Should FQHCs (and other CEs) to be trying to become part of the distribution network that HHS is building for this program?
   Health centers are an important part of Ready, Set, PrEP, from identifying eligible patients to providing ongoing care and support. Recognizing the importance of expanded access to HIV PrEP medications, CVS Health, Walgreens, and Rite Aid have donated their dispensing services to HHS. Beginning no later than March 30, 2020, as part of these donations, qualified patients can obtain the PrEP medications at the more than 21,000 combined CVS Health, Walgreens, and Rite Aid locations throughout 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands or through mail order—all at no cost to patients.
   
   B. If not, will we be required to send our patients to outside pharmacies if they want to get free PrEP through the HHS program?
   Currently health centers may access the HHS Ready, Set, PrEP program or the Gilead Advancing Access program to get free PrEP medications for patients. Once the new distribution network is established, patients can receive PrEP medications through mail order and at specific dispensing pharmacies. Health centers will also be able to continue to utilize the assistance programs listed on the National Alliance of State and Territorial AIDS Directors’ website: https://www.nastad.org/prepcost-resources/prep-assistance-programs.
   
   C. What other issues should we be considering?
   HRSA continues to encourage health centers to participate in the Ready, Set, PrEP program and to expand their HIV prevention activities, including supporting routine opt out testing and PrEP navigation services.
   
   
4. What is the patient’s responsibility with Ready, Set, PrEP?  Does it include lab fees, office visits, and medication dispensing fees?
   All medications, including dispensing fees and mail-order fees, are fully covered for qualified participants. However, the costs of necessary clinic visits and lab tests may vary depending on a provider’s location and cost sharing requirements. Pharmacies that have donated their services also intend to take appropriate steps to promote patient adherence to the PrEP regimen.
   
   
5. Is there a PrEP curriculum available for Community Health Workers?
   Health centers may participate in the HHS-funded Project ECHO/New Mexico AIDS Education and Training Center's HIV Prevention teleECHO sessions on the first Tuesday of each month. Sessions include brief prevention-related didactics and case discussions on risk assessment, screening test interpretation, HIV PEP, HIV PrEP, and STI screening and treatment. These sessions are open to qualified health care professionals, including primary care providers, mental health and substance use treatment providers, pharmacists, nurses, medical assistants, case managers, community health workers, outreach educators, and other health care workers involved in treating or preventing HIV. TeleECHO sessions are not open to the general public or to patients.
   
   Additionally, the World Health Organization developed a module that provides information on PrEP to be considered in community-led activities that aim to increase knowledge about PrEP and generate demand and access.
   
   
6. Is Ready, Set, PrEP available at this time? If not, when is the roll-out date?
   The program was rolled out on December 3, 2019. See https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/prep-program for more information. If an individual qualifies, they can receive medication through this program as of December 3, 2019. With a prescription, uninsured HIV-negative patients can obtain free Truvada or Descovy for PrEP at www.getyourprep.com or by calling 1-855-447(HHS)-8410.
   
   
7. The entire state of SC is targeted for the Ending the HIV Epidemic. Does this imply that all SC health centers that apply will be approved for funding?
   HRSA identified 11 health centers in South Carolina that are eligible to apply for PCHP funding in FY 2019 on the basis that they are co-funded by both the HRSA Health Center Program and the Ryan White HIV/AIDS Program. Ending the HIV Epidemic: Plan for America is a 10-year initiative. Although the exact timeframe for awarding additional funds has not been determined, HRSA anticipates providing resources to all health centers in the geographic focus areas, including South Carolina, in future phases of the initiative.
   
   
8. We are a health center that has very few patients with HIV. What would be the benefit to our clinic of the PrEP?
   The number of health center patients diagnosed with HIV is not indicative of the number of persons in your service area who may benefit from PrEP medication. Prevention of HIV should be a routine part of primary care. By screening for HIV and assessing risk, clinicians can identify those who can benefit from PrEP medication. Any licensed primary care provider can prescribe PrEP medication. In addition to risk-based testing, routine, opt-out HIV testing for patients over age 13 is recommended by the Centers for Disease Control and Prevention (CDC).
   
   
9. We are a community without chain pharmacies - how can we get our independent pharmacies involved? How can our health center be involved in this program and ensure that our providers are involved in the patient’s care? Critically important for our integrated program approach.
   Currently, patients can access PrEP medication at over 60,000 pharmacies across the U.S. (50 states, the District of Columbia, and Puerto Rico), including national chains and independent operators. Recognizing the importance of expanded access to HIV PrEP medications, CVS Health, Walgreens, and Rite Aid have donated their dispensing services to HHS. Beginning no later than March 30, 2020, as part of these donations, qualified patients can obtain the PrEP medications at the more than 21,000 combined CVS Health, Walgreens, and Rite Aid locations throughout 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands or through mail order—all at no cost to patients.
   
   
10. I understand Truvada can cost up to $2,000 monthly, and this out of pocket expense can hamper a lot of people from taking PrEP treatment to prevent HIV infection. What additional options might a person utilize if determined not eligible for participation in the Ready, Set, PrEP program (remember: a drug doesn’t do much good if people don’t take it).
    Patients who are not eligible for the Ready, Set, PrEP program should explore eligibility for Gilead’s Advancing Access program (https://www.gileadadvancingaccess.com/), which has a co-pay coupon program along with a patient support program for the uninsured, or the programs listed here: https://www.nastad.org/prepcost-resources/prep-assistance-programs.
    
    
11. As a pharmacist at an FQHC without a Ryan White program, how can we be impactful in this effort?
    State legislation varies; however, states with Clinical Laboratory Improvement Amendments (CLIA) waivers and/or prescribing authority either through a Collaborative Practice Agreement (CPA) with a physician or through state legislative authority can allow pharmacists to be better integrated into HIV/PrEP care. At a minimum, pharmacists can help monitor and improve adherence rates—both for PrEP in at-risk populations as well as for viral suppression in HIV+ patients—and assist patients to navigate the various programs available from the drug manufacturers (e.g., Gilead’s Advancing Access Program).
    
    
12. Can pregnant women take PrEP?
    PrEP medication may be an option to help protect women and their unborn children from getting HIV while they try to get pregnant, during pregnancy, or while breastfeeding. For more complete information, please see Section 5 of the 2017 update to CDC’s guidelines: https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-provider-supplement-2017.pdf.