6/25/2020 UPDATE:

Stores enrolled by the 10^th of each month will become active in the program on the 1^st of the following month. 

Please check back often for additional FAQs or contact your RSM for more information. 

The United States Department of Health and Human Services (HHS) has developed the Ready, Set, PrEP program to help eligible uninsured people who are at risk of HIV infection gain access to no-cost Pre-exposure Prophylaxis (PrEP) medication.  

This program is part of the “Ending the HIV Epidemic: A Plan for America” that was announced in the February 2019 State of the Union Address. That plan has goals to reduce the incidence of HIV by 75% in the next 5 years, and 90 % in the next 10 years. 

HHS is partnering with Gilead, the manufacturer of medications approved for PrEP, and select pharmacies to create the access for patients in need. Gilead is donating medication for up to 200,000 patients per year through 2030. Pharmacies wishing to participate must agree to donate/waive their dispensing fee associated with filling PrEP medications for eligible patients and must agree to accept reimbursement equal to the wholesale acquisition cost (WAC) (i.e. the list price of the drug).  

HHS invited Health Mart to participate as the exclusive independent pharmacy provider along with a few chains. 

Where can I get more information about the Ready, Set, PrEP program?  

Click HERE.  

How long will this program last?  

HHS will continue to update this program as progress toward the national public health goals are measured and may change the timing. Currently, the Ready,Set, PrEP program is planned for 10 years. Gilead and HHS signed a 10 year agreement for medication donation. Participating pharmacies are asked to sign the joinder agreement that has one-year renewable participation terms.

What other retail pharmacies are participating?  

HHS has informed us that Walgreens, CVS and Rite Aid are authorized participating chain pharmacies. Health Mart is the only independent franchise that has been approached at this time.  

How will my patients know my store is involved in this program?  

Patients who complete the eligibility process with HHS will be given a list of approved pharmacies. HHS will also provide a pharmacy locator on the Ready, Set, PrEP page. The local clinic provider will also help the patients find a convenient pharmacy.  

Will the pharmacies know when a patient has been assigned to them?

Patients won’t be assigned. They will have access to a directory of nearby participating pharmacies from which they can choose to bring their prescription. 

Please note that it will be a good business practice for the enrolled pharmacies to collaborate with the federally qualified medical centers where the majority of these patients will originate. Prescribers will be asked where they should go as with any other prescription.

If I chose not to join now, can I join later?  

HHS is working to set up a reliable network of pharmacies to provide convenient access and allow patients to choose where they fill their prescription. 

All stores who enroll by the 10^th of each month will become active in the program on the 1^st of the following month. 

Why do I have to purchase the product if Gilead is donating it for the Ready, Set PrEP program?

Gilead and HHS are responsible for deciding how the donated medication can get to the pharmacies serving patients in the Ready, Set, PrEP program. There are some details about the options they have in the agreement between HHS and Gilead that is included for reference in the enrollment packet for your review. Today, HHS and Gilead have determined that the best way to get the needed medications to the pharmacies nearest the patients in need is to use existing distribution methods the network pharmacies have selected (their own wholesalers or warehouses). Gilead and HHS opted for the Trial Card voucher payment method to manage Gilead’s donation and the transaction due to the pharmacies. HHS or Gilead may change the process as the program continues to grow. 

What does it mean to donate dispensing fees for eligible patients? 

HHS values the role of the pharmacist in providing care to patients in need of medications and understands that dispensing fees are needed. To allow the resources for the Ready, Set, PrEP program to reach as many underserved patients as possible in this important public health initiative, HHS is requiring participating pharmacies to donate (i.e., waive) dispensing fees for the transaction.  Participating pharmacies will also be required to accept reimbursement for each eligible prescription at Wholesale Acquisition Cost (WAC). By signing the donation agreement, it means your pharmacy is willing to not bill or receive any dispensing fee when filling PrEP medications for eligible patients.

What are the terms for reimbursement?  

Claims for eligible PrEP medication prescriptions will be processed through Trial Card. Pharmacies payments are made at WAC twice a month, and will be included in existing PDMI payments. View a sample Trial Card voucher HERE.

How will my participation in this program impact my GCR/GPR? 

There is no GPR impact with the program. McKesson will partner with you if your mix is impacted by the program. Your RSM will provide details if needed.

Will a pharmacy’s participation in the PrEP program result in underwater claims (i.e., will the pharmacy lose money by participating)? 

Work with your RSM to understand the financial implications of participation on your store.  In general, a pharmacy’s contracted cost of goods (available in McKesson Connect) for PrEP medication will be less than the product’s WAC. 

Will my store see any DIR fees or claw backs from the reimbursement? 

No, this program is not adjudicated through any public or private payor program. Reimbursement is set at WAC. 

Will I get a dispensing fee in addition to the WAC reimbursement?  

No. In order to participate and enroll, your pharmacy must agree to donate all dispensing fees to the program and forgo the addition of dispensing fees to the claims for prescriptions filled to eligible patients (as stated in the Pharmacy Donation Agreement materials sent via DocuSign).  

Are there any fees associated with my store processing the voucher? 

The fees are determined by the existing transaction fee in your current PDMI agreement. To know your fee exactly, please refer to your PDMI agreement or contact your PSAO for specifics. 

How do I know if a patient is eligible? 

Eligible patients will visit your pharmacy with a prescription and a Trial Card voucher which indicates all requirements have been met. Your pharmacy can accept the prescription and voucher and know the patient is eligible.

What does the patient need to do to become eligible? 

Individuals who are at risk for HIV infection and do not have prescription insurance may be eligible to participate in Ready, Set, PrEP. The patient must first work with a prescriber who will follow the most current PrEP clinical guidelines. All people who start PrEP medications must be HIV negative and be willing to be retested every 90 days. After the prescriber confirms the patient is a candidate for treatment, they must enroll to receive the voucher to get the medication at no cost. Enrollment can happen online at GetYourPrEP.com or by calling 855-447-8410. Complete details are available HERE.  

How can I help a patient who is interested in the program but has insurance?

Because patients with insurance are not eligible for the Ready, Set, PrEP program, you can encourage them to speak with their healthcare provider about treatment options with financial assistance programs for insured patients.

How do I process the claim using the voucher?  

This program will be using the Trial Card voucher.  PDMI is their processor.  Process the voucher similarly as you do others. The Trial Script voucher will contain your processing information: BIN: 610020 Group: 9999 4069.

If a patient shows up without their voucher information, what do I do?

The patient can call the program and a representative will be able to look up their information and provide the voucher processing information.  Here’s the phone number and website: 

1-855-447-8410
https://www.getyourprep.com/

What are the Steps to Take to Enroll as a Participating Network Pharmacy Location?

1. Be an active Health Mart pharmacy.
2. Read the FAQs to understand the program.
3. Be a member of an approved PSAO: Health Mart Atlas and EPN
4. Read and sign the Joinder to the agreement between Health Mart and HHS (via a DocuSign form sent to you by email). 
   
   Basic terms of the Joinder:

• Agree to donate/waive your pharmacy’s dispensing fees for filling PrEP prescriptions for eligible patients as a part of the partnership. Dispensing fees will not be paid for these transactions.
• Accept reimbursement for the dispensed medication calculated at WAC.
  
  Please note: There is a requirement to sign an amendment to the existing PDMI agreement. Your PSAO has taken care of this requirement for their members. If the terms and conditions are agreeable, the pharmacy can enroll by signing the joinder agreement sent via DocuSign prior to the deadline.

How can my store receive the Joinder agreement? 

• Contact your sales representative to initiate the process.  
• Check your email for a DocuSign envelope from  Health Mart Operations @mckesson.com.  
• Review the entire packet of documents focusing specifically on the agreement between HHS and Health Mart.  Sign the joinder indicating you agree to the terms of that agreement.  Other documents are included as background since they are mentioned in the Health Mart agreement.
• Your enrollment information will be shared with Trial Script and HHS. You will be added to the PrEP network and their locator.  
• Stores who enroll by the 10^th of the month will be active in the pharmacy locator on the 1^st of the following month. For example, if you sign up on June 5^th, you will be active and ready to accept patients’ prescriptions July 1^st.    

If I sign the agreement and then decide I don’t want to participate, can I cancel? 

Each pharmacy may terminate the joinder for any reason at any time with 90-days written notice to Health Mart (“No cause termination”). If a pharmacy exercises this “No cause termination” it must use its best efforts to assist their patients in finding an alternative pharmacy that can fill their prescriptions.

What medications are used for PrEP? 

Two medications are currently FDA approved for Pre-exposure Prophylaxis (PrEP) treatment. Truvada® and Descovy® are manufactured by Gilead. Initial prescriptions for Ready, Set, PrEP will be written for Truvada®. Gilead will begin the donation with Truvada® but reserves the right to donate Descovy®as available. Descovy® was approved in 2019 and contains the same dose of emtricitabine as Truvada® but includes a prodrug form of tenofovir that allows a lower therapeutic dose.

What kind of volume can I expect if I participate in this program?

Store volume will vary as it is dependent upon the number of at risk individuals within your market as well as the number of other pharmacies enrolled in the Ready, Set , PrEP program. For example if you already have a high HIV prescription volume you could potentially expect to see Ready, Set, PrEP patients.

 

Will my DC have Truvada® and Descovy® available?  

All impacted DCs will stock the product.  Keep in mind since this is a new program there will be a volume estimate, but the intent is to ensure there is plenty of inventory to fulfill the needs.

Am I required to order Truvada® to have in stock once I enroll as a network pharmacy? 

Ordering product to have on hand in anticipation of new customers is not required. All decisions about product inventory are left to each pharmacy and should fit into your expectations for customer service. The agreement requires the pharmacy to “take appropriate steps” to promote adherence. Pharmacies should utilize their current mechanisms for ensuring patient adherence, including management of on-hand inventory as appropriate. 

How do I return the product to McKesson if needed?  

Unneeded PrEP medication inventory can be returned according to your normal McKesson return procedures.  

Can a patient return the product to my pharmacy?

Patient returns of medications previously dispensed are not accepted as stated in the agreement. 

Can I market this program?  

HHS needs to approve consumer marketing that mentions this program as specified in the agreement. Approved materials are available HERE. 

What happens if I choose to terminate from the Health Mart franchise or my PSAO? 

This program is available only to Health Mart pharmacies who use an approved PSAO.  If a pharmacy no long meets one of these requirements, their association with this program will be terminated.