Questions and Answer_Jan 20_ 2020.pdf

SOLICITATION #75R60220R00001

QUESTIONS AND ANSWERS

The questions below were received from direct market research, Industry Day and Preproposal Conference, and the Request for Proposal.

1. Would HRSA consider a small business alternative?

Response: This is a full and open competitive requirement. Small business are encouraged to participate.

2. How long would the Gilead PrEP enrollment website share enrollment data with a 3rd party?

APIs, sFTP, other?

Response: There will be no Gilead PrEP enrollment website under the RFP. The selected awardee(s) will build and administer the enrollment website.

3. Tell us about your data integration experience with the database for the Gilead PrEP enrollment website?

Response: Pursuant to the distribution agreement, Gilead has provided us information about, among other things, enrollment, dispenses, and participants in the program.

4. Does this include all costs? Including hub services, PBM, disruption (at pharmacy or mail order), etc.? Or is the under $200 costs more associated with the pharmacy disruption?

Response: Under the distribution agreement with Gilead, the redemption fee per voucher was $204. That cost compensated two main entities. First, it compensated the “Wholesale distributor for performing the function that was illustrated in the slide entitled, “Dispense at Brick-and-Mortar Pharmacy with WAC Reimbursement,” explained on industry day, and set forth in the RFP. Second, it compensated the pharmacy for its dispensing services.

5. We are a Federally Qualified Health Center with an outpatient pharmacy. I was reading about the Ready Set Prep program and we are interested in providing prep treatment for our patients. Could you please explain the requirements and process (both for the pharmacy and clinic) to be able to provide PREP treatment to our patients?

Response: Please contact OASH/Office of Infectious Disease and HIV/AIDS Policy (OIDP) and visit HIV.gov to learn more about PrEP. To the extent you wish to provide pharmacy services for PrEP and charge costs to a HRSA FQHC grant, please contact your cognizant Grants Management Officer (GMO) for further information.

6. Can you clarify more HB?

Response: Patients receiving Product under Gilead’s (Medication Assistant Program) MAP during the past 12 months are not eligible to receive PrEP under the HHS Donation Program. In the event a patient who had previously enrolled in Gilead’s MAP is no longer eligible for MAP but otherwise qualifies as a Qualified Eligible Patient as stated under this contract, such patient shall be permitted to enroll in the HHS Donation Program. The goal is to expand overall patient access.

7. For this contract, can a Government Agency submit a proposal (i.e., County Health Department)?

Response: State or local governments are permitted to bid on federal procurement contracts (though we note that for cost-reimbursement contracts, they are subject to different cost principles, as set forth in FAR subpart 31.6). Grantees may also bid on federal procurement contracts, if consistent with the terms of their grant.

8. Factor F is a little confusing because in my experience, the QASP is usually the government's document, while the offeror has a QCP? I think Sample Templates (QASP) are important to share.

Response: It is not always the case that the Government provides the QASP. If the Offeror is submitting a PWS, the Government may request the Offeror to submit a QASP based on the PWS as is in this procurement. See Attachment L

9. Is there a page limit for Past Performance volume?

Response: No

10. On PP volume, are past performances from subcontractor teammates allowed?

Response: Yes

11. Is the government open to extending past performance within 5 years?

Response: No

12. The RFP document under review so far, has this document been release publically or are we yet to see it published somewhere?

Response: It’s on the beta.sam.gov site. It was released on December 13, 2019.

13. I’m just going to ask a question about the small business participation requirement. I saw that it was encouraged, but not mandated. Is that…can you help me better understand?

Response: Large businesses are required to submit subcontracting plans for contract actions above the $700,000. The Small Business Program Office can assist firms who are looking for capable small firms for sub-contracting. Wayne Berry (HRSA Small Business Specialist) offers his services to anyone along with the Small Business Administration subnet, where there’s a list of vendors who offer their services for subcontracting. You can contact Wayne via email at wayne.berry@hhs.gov and via cell at 202-390-5801.

14. For this contract, can a Government Agency submit a proposal (i.e., County Health

Department)?

Response: See response to question #7 mailto:wayne.berry@hhs.gov

15. Is this contract going to be under any contract vehicle?

Response: No. It is a FAR Part 15, Negotiated contract.

16. What is the scope of the population that will be served? Any regions?

Response: This is a national program. The population are uninsured, at-risk individuals who meet the eligibility requirements set forth in the RFP.

17. NDA: Is HHS willing to execute an NDA prior to submission of our proposal?

Response: HHS does not execute non-disclosure agreements with offerors on federal procurements. Please note, however, that bid and proposal information submitted by offerors is protected from disclosure pursuant to the Procurement Integrity Act, 41 U.S.C.

§§ 2101-07. For more information on the Procurement Integrity Act, please see https://www.justice.gov/jmd/procurement-integrity.

18. As part of the “Qualified Eligible Patient” validation (in reference to section 1c of the

Donation), what is the current process for validating that the patient has undergone appropriate laboratory testing, quarterly testing necessary and is HIV negative?

a. Does the physician need to provide and/or validate this information?

Response: The current process relies primarily on patient attestation and valid prescriptions. A valid prescription requires appropriate testing.

19. What is current process to confirm the patient doesn’t have insurance? Does the current process involve patient attestation? If so, are you aware of what percentage of patients are validated through attestation vs a system generated response?

Response: The patient attests and there is electronic verification. The vendor queries databases to determine if the patient is insured.

20. How under the current process does the vendor validate the prescription before running the test claim?

Response: The prescription is validation that the patient has a valid prescription; no test claims are run as this population is uninsured.

21. What is the current process to ensure that no claim is submitted to any insurer (in reference to Appendix A of the Donation Agreement)?

Response: Gilead is the current contractor. Gilead has waived its rights to enforce Appendix A under its distribution agreement. Gilead further agreed that using the enrollment form that Gilead had developed satisfies HHS’s obligations under the Donation Agreement, Appendix A, Section 2.

22. What is a “grantee” or “subgrantee” site (in reference to section 1c in Appendix A)?

Response: The pharmacy network shall include the donating pharmacies and at least one mail-order pharmacy that can reach the eligible patient population.

https://www.justice.gov/jmd/procurement-integrity

23. E-prescription process – what is the current model?

Response: There is no formal e-prescription process at the vendor level.

a. Does the current process involve a triage to transfer the prescription?

Response: No.

b. Does the current process involve the patient taking the voucher to a pharmacy?

Response: Yes.

24. Is the current cost approx. $200 per prescription? Would you be able to break out the $200 and/or can you rank by percentage of spend? See answer to question 4.

a. Wholesaler cost

b. Pharmacy cost

c. Voucher processor cost – is this a coupon card or a voucher in the current process?

d. Current administrator cost

e. Audit process cost – has this process been established yet? If so, what is the process?

f. Other costs

Response: Please see response to question #4

25. We have many manufacturers that use a consignment model which has lower overhead costs, how would we go about approaching Gilead for a consignment model?

Response: Offerors may describe a consignment model or any other model in its proposal that meets the requirements in the Statement of Objectives. HHS will consider such models in its evaluation of proposals. Based on HHS discussions with Gilead, it will permit a consignment model for at least the mail-order pharmacy.

26. What is the current percentage of portal use vs call for enrollment? Is it being used by both patients and physicians?

Response: 10% call center --90% portal

a. What is the current % of patients that are enrolling but deemed not eligible?

Response: 28%

b. Are there cases where physicians are enrolling patients but then those prescriptions don’t get filled?

Response: There are cases of patients enrolling and not filling

c. If a patient has not had the necessary tests, will we be doing any work to follow-up?

Response: If the patient does not have the necessary tests the patient cannot receive a prescription. The prescription verifies the testing has occurred.

NOTE: These are preliminary figures for the first couple of months of the program. These numbers may change as the program matures.

27. What is the current process for refills? Will there be follow-up adherence calls or are refills driven by patient requests?

Response: As part of their donations, the pharmacies will take appropriate steps to promote adherence to the PrEP regimen. Such steps may include, but are not limited to, regular reminders by test, calls, or other appropriate communications.

The contemplated distribution network will also have a mail-order pharmacy. Please consider how you will work with the donating pharmacies and the mail-order pharmacy to coordinate and optimize patient adherence.

28. How would the Gilead PrEP enrollment website share enrollment data with a 3rd party? APIs, sFTP, other?

Response: HHS expects that Gilead will no longer provide the website after September 30, 2020. Please describe how your proposal would handle enrollment data as required under the RFP.

29. Tell us about your data integration experience with the database for the Gilead PrEP enrollment website?

Response: See response to question #3.

30. Does the $200 per bottle/fill include all costs? Including hub services, PBM, disruption (at pharmacy or mail order), etc.? Or is the under $200 costs more associated with the pharmacy disruption?

Response: See response to question #24.

31. Adherence: Please confirm that QEP adherence to PrEP regimen in terms of text/phone, etc.

reminders is the responsibility of the dispensing pharmacy. We have these types of adherence reminders and can include them in our proposal if requested.

Response: See response to question #27. Please include and separate the cost associate with that “add-on” service.

32. Course of therapy/re-fills: From what we can tell patient need to take PrEP therapy continuously/consistently for the drug to be effective. The voucher that would be issued is valid for 30/60 days. What is the process for a “re-fill” after that 30 or 60 day period? Does the patient simply present the same voucher information to the dispensing pharmacy? Or does the patient need to re-enroll/re-apply for a new voucher?

Response: The voucher good for one year with six month behind the scenes eligibility check

33. General – Approximately how many patients are anticipated to participate?

Response: The donation agreement provides for a maximum of 200,000 patients per year

34. General – Are there any limitations by time or the number of prescriptions filled over the life of the contract for an eligible patient?

Response: As long as the patient remains uninsured, HIV negative, and has a valid prescription, the patient is eligible to obtain PrEP medications.

35. Are patient’s and/or prescriber’s signatures required (DocuSign)?

Response: Offerors may proposed the method(s) that are allowed under pertinent laws;

the Gilead Donation Agreement; and the RFP.

36. How will proposed costs/prices be evaluated? In section M, offerors are informed that cost and the evaluated price “will be evaluated for fairness and reasonableness.” See M.6. But in Section L, offerors are informed that proposed costs will be subject to “a complete analysis to establish that the proposed costs are reasonable and realistic.” L.6.b. Will proposed costs and prices be evaluated for both reasonableness and realism, as Section L indicates, or reasonableness, but not realism, as indicated by Section M?

Response: See revised solicitation.

37. Is it the Agency’s intent to adjust offeror’s prices to determine an evaluated price that will be used in making best value determinations? Section M.6 refers to an “evaluated price” suggesting that the agency may make some adjustment to an offeror’s submitted prices.

But there is no other mention of the agency adjusting submitted prices for use in source selection.

Response: No. The agency does not intend to adjust prices, but rather conduct a price reasonableness based on the market prices for this type of services.

38. Given that competition is anticipated for this procurement, why is cost/pricing data required given the prohibition in FAR 15.403-1(b)(1) and (c)(1)?

Response: The Contracting Officer may request non-certifying cost/pricing data to determine soundness of proposed cost/price.

39. Section B.1 of the RFP states that “the Government will apply a preference for fixed price proposals.” But Section M, Evaluation Factors, says nothing about the existence of such a preference, including how it would be applied. Will the Government apply a preference for fixed price proposals in making its award determination(s) and if so how will that be done?

40. Given the ability of offerors to submit proposals use a wide variety of pricing methodologies, how does the Agency intend to ensure that: (a) offerors are competing on a common basis and (b) the evaluation will accurately reflect the relative prices the Government can expect to pay?

Response: The Government provided a Statement of Objectives (SOO) to ensure that the Offerors are competing for common objectives. The solutions will vary by Offeror and so will the proposed pricing however, the Government has stated its order of importance in M.4 and the cost/pricing data will allow for a fair and reasonable determination. Also, from the market research, we understand that the industry is familiar with the customary pricing methodologies. If a proposed model deviates from those methodologies, please provide HHS with a basis to evaluate how those alternative pricing structures provide better value.

41. Can HHS confirm that the Section 508 accessibility requirements only apply to public facing websites, and would not impact the awardees internal software and websites?

Response: Per the RFP, Section 508 accessibility requirements apply to public facing websites as well as materials provided to the Department as a deliverable. Please see RFP, Section F.4, All digital content or communications materials produced as a deliverable under this contract must conform to applicable HHS Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. The contractor is responsible for remediating all deliverables that do not comply with the applicable requirements as identified in the HHS Section 508 checklists.

Awardees internal software and websites are not required to be 508 compliant, so long as such software and websites are not public facing and is not provided or shared with agency officials as a deliverable, or to fulfill deliverable requirements.

42. Our parent company is already operating under a government-approved, company-wide, commercial plan. Please confirm that this commercial plan meets the small business subcontracting obligations set forth in the RFP.

Response: Offerors are required to complete the Subcontracting form attached to the solicitation.

43. Page 6, Objective 3: Call Center – Is the use of an interpreter line for the call center an acceptable solution to meet the requirement of accessibility in English and Spanish?

Response: The use of an interpreter would likely be responsive to the Government’s minimum requirements, but HHS would need to fully evaluate this element of the proposal in accordance with Sections L and M of the proposal, as well as in comparison to solutions offered by other offerors.

44. Page 17, Number 11, Contractor Non-Disclosure Agreement – Can HHS confirm this is required of each employee that would have access to any non-public information (as opposed to the contractor)?

Response: This would be required of all personnel employed by the contractor to carry out the contract, whether such personnel are employees of the contractor or are independent subcontractors.

45. Please confirm that supplier will not have to manage patient testing information on baseline or follow up labs.

Response: Offerors must provide the information required in the RFP. HHS relies on prescriptions and attestations to support the testing requirements.

46. Please confirm estimated patient counts in Y1, Y2.

Response: Year 1: 10,000 and Year 2: 20,000-25,000.

47. Please confirm hours of operation, there are two hours of operation noted within documentation provided.

Response: The current program has the following hours of operation for the call center 9am ET-8 pm EST Monday-Friday. HHS is looking for maximum flexibility for our clients with regards to access to this program. Of course the online portal will be 24/7 access for potential enrollees.

48. Is the 14-day pharmacy reimbursement required or can we propose an alternative?

Response: The reimbursement must be no later than 15 days after a pharmacy submits a claim for reimbursement.

49. Section 2, “HHS may engage with third-party vendor to contract with pharmacies to dispense Product to patients.” and continues to say under the first bullet in Section 2 that Gilead will reimburse dispensing pharmacy for Product cost which will be the wholesale acquisition cost. Now my confusion is on the “network pharmacy”.

What is defined as a network pharmacy? Today all pharmacies can dispense and get reimbursed for medication provided to those without insurance under Gilead’s current Advancing Access program, they don’t need to be in any “network”.

Response: For purposes of this RFP, “Network Pharmacies” is defined as CVS, Walgreens, Rite Aid, Health Mart Systems, Inc.’s participating franchisee pharmacies, and any other pharmacies that have signed Pharmacy Donation Agreements with HHS for purposes of donating dispensing services to HHS.

50. Has HHS defined what it considers “existing commercial channels” or just a general statement? Finally, under the third bullet in Section 2, that the donation is not intended to obtain unreasonable reimbursements from Gilead beyond customary reimbursements in commercial transactions, including those that involve the 340B program.

Response: Please refer to the First Amendment of the Donation Agreement, Section 2 for the definition of “existing distribution model,” which is a “critical element” to the distribution network. HHS has not defined the term “existing commercial channels” and uses the term in the RFP as a broad reference to the various vendors involved in drug distribution in the commercial market. In addition, we confirm that the donation agreement in question is not intended to obtain unreasonable reimbursements from Gilead beyond customary reimbursements in commercial transactions, including those that involve the 340B program.

51. Based on the language used, it’s my understanding that 340B reimbursements would be the same as they are today with Advancing Access or is 340B excluded from this program?

Response: This contract is not intended to have any effect or relationship with the 340B program. Furthermore, Gilead will not change its free-drug program eligibility requirements or cap the number of enrollees in its free-drug program because of the HHS free PrEP program.

52. Vouchers/BIN: Is it HHS desire that contractor generates the unique vouchers / BIN’s correct, or will these be provided/generated by HHS/Gilead?

Response: The contractor.

53. Is HHS against 100% mail-order solutions?

Response: No. HHS intends to use brick and mortar pharmacies in the interest of reaching the greatest population of program beneficiaries possible. HHS, however, does want to have mail order solutions available to program beneficiaries and thus HHS is interested in working with partners or contracting with vendors that only provide mail order solutions (see, e.g., SOO Objective 10, Establish and Administer Network of Mail Order Pharmacies).

We expect any proposal to dispense at brick-and-mortar pharmacies with WAC reimbursement pursuant to the First Amendment to the Donation Agreement and to include a mail-order option. For the mail-order option, please provide pricing for (1) actual-acquisition cost reimbursement as well as (2) a consignment/replenishment model. If the vendor is only interested in one reimbursement model for the mail-order pharmacy, please say so.

54. Is HHS considering multiple contractors or just one contractor for the entire bid?

Response: HHS will consider multiple contractors. However, HHS has a strong preference for contractors that can perform multiple objectives, and the Government will apply such a preference in the evaluation process.

55. NDA: Is HHS willing to execute an NDA prior to submission of our proposal?

Response: See response to question #17

56. Is there an incentive provided to participating pharmacies?

Response: As explained on industry day, each RFP will be evaluated on its own merits.

Whether or not a bidder is also a donating pharmacy will have no impact on that evaluation.

57. What happens to a pharmacy if it is a 340b pharmacy?

Response: Qualified Eligible Patients receiving donated Product may not be considered 340B eligible patients for that Product. Gilead will not change the eligibility requirements for its free-drug program or cap the number of enrollees in that program because of the HHS free PrEP program.

58. Can the dispenser be a provider in a secure medical clinic and not a designated pharmacy?

Response: No. Gilead will not change the eligibility requirements for its free-drug program or cap the number of enrollees in that program because of the HHS free PrEP program.

59. Objective 4: Online Portal, pages 46-47, what organizations would data be collected through the Online Portal be shared with? How and through what process is this data shared with those organizations?

Response: HHS would use that information to carry out its public-health functions. As appropriate, HHS may use aggregate data to inform the public about the progress of the program.

60. Objective 4: Online Portal, pages 46-47, what process and external systems are used to determine patient eligibility through the Online Portal?

Response: For insurance status, the system relies on a combination of attestation and electronic verification. For medical eligibility, HHS solicits proposals about how and when to use e-prescriptions. Please see the slide “Patient Journey: Web Portal or Call Center.”

61. Objective 4: Online Portal, pages 46-47, where is the portal hosted and can the Government describe the current infrastructure? Will that change?

Response: Gilead and its subcontractors currently host the portal. HHS is not wedded to a particular hosting location so long as the portal performs the functions set forth in the RFP.

62. Objective 4: Online Portal, pages 46-47, can the Government describe the technology stack the current Online Portal is implemented on, including languages, frameworks and platforms as applicable?

Response: The current configuration should restrict the proposal. The limitations on the proposed portal is set forth in the RFP.

63. Objective 4: Online Portal, pages 46-47, is it the Government’s expectation the portal will be redesigned or will remain in its current implementation?

Response: HHS solicits proposals that center on patient and connecting patients to necessary care and support. In this regard, HHS seeks to improve wherever it can. HHS discussed a few potential options on industry day, including a pharmacy locator. The slide, “Patient Journey: Web Portal or Call Center” sets forth other possibilities. But ultimately, HHS seeks industry expertise on how to best serve the needs of this population and end the HIV epidemic.

64. Objective 4: Online Portal, pages 46-47, will the selected partner be responsible for cleansing and de-identifying data for reporting purposes?

Response: the reporting requirements do not ask for patient-specific identifying data.

65. Objective 4: Online Portal, pages 46-47, can the government describe reports/data stakeholders are interested in reporting on now and in the future?

Response: Please reference the RFP and Statement of Objectives for pertinent reports and data stakeholders will be interested in.

66. Objective 4: Online Portal, pages 46-47, does the government have any technology preferences? Can the government identify and other systems the data reporting or online portal platforms need to integrate with?

Response: The government is open to considering any technology solutions proposed; there is currently no other need to integrate with online portals or systems.

67. Objective 5: Wholesaler Logistical Services, page 47, does the government require the offeror to store medications?

Response: The wholesaler and the mail-order pharmacy will likely store medication.

68. Objective 5: Wholesaler Logistical Services, page 47, does the government require the offeror to have a DEA registration and license for this opportunity?

Response: The entity performing the wholesaler function must abide by all laws.

69. Section L, is the government accepting partial bids on sections of the work outlined in this

SOO?

Response: Offerors are being given the opportunity to submit Objective Technical Proposals (Volume II) for a single objective, multiple objectives, or all objectives.

70. Sections L, L.1.11, L.1.14, L.3.4, L.3.7, Bullet 5, our understanding is that the Government would like each Objective to stand-alone in its own section within Volume II. Is this correct to place the responses to evaluation criteria A to F in a separate Section and reference each Objective to this Section in their Factor D?

71. Sections L, L.1.11, L.1.14, L.3.4, L.3.7, Bullet 5, our understanding is that the Government would like each Objective to stand-alone in its own section within Volume II. Would the government like the consolidated PWS to reside as a separate section after the Objective Sections/Sub-volumes and then have each Objective reference it in their Factor E?

72. Section L.3/6/Factor C (RFP p.42), is it acceptable to only submit PATs for user systems (HW & SW only)?

Response: The product assessment template are required for all public-facing or internal (to the government) systems or products acquired through this contract.

73. Section L.4 (RFP pg.52), should we expect to get any additional Orals instructions in the scheduling letter?

74. Of the security, confidentiality, and integrity of PII and PHI, all objectives list activities that may involve the collection, storage or transmission of PII and/or PHI of a QEP. Will the safeguard and compliance requirements be included in all the objectives where PII and/or PHI are handled?

Response: The safeguard and compliance requirements apply to all of the objectives where PII and/or PHI are handled, and in any instance where data is stored, processed and transmitted on behalf of HHS; please refer to the privacy and security requirements described in Attachment A, section J.

75. Will the vendor have a direct contractual relationship with BMS Gilead Life Sciences?

Response: No. The contract relationship is with HHS.

76. What is the underlying platform for the existing Gilead Life Sciences?

Response: This question is too vague to be answered.

77. Are there existing pharmacy contracts the vendor will need to take over?

Response: Currently, we are not aware of any, but they maybe be some in the future.

78. Are the activities in the option years the same as the base year?

79. Will Gilead continue to administer any or all of the Gilead Patient Assistance Program over the course of the 5 year POP?

Response: Gilead will not change the eligibility requirements for its free-drug program or cap the number of enrollees in that program because of the HHS free PrEP program. Gilead will provide reimbursement or consignment in accordance with the Gilead Donation Agreement.

80. What does HHS consider a valid source/apparatus for payer enrollment information (that will allow validation of the patient not having prescription drug coverage) that would be available to the awardee?

Response: Based on market research, HHS understands that there are multiple vendors that can quickly and electronically verify whether an individual lacks prescription drug coverage by querying various data bases. The current HHS distribution network through Gilead uses such a service provider. HHS expects that those with expertise and experience in the area to submit proposals. Potential bidders might consider working with such vendors to submit a joint proposal.

81. Would HHS consider electronic validation of patient income to determine patient eligibility into the program if there is no known solution to validate the patient doesn’t have Rx drug coverage?

Response: See response to question #80.

82. Adherence- want to confirm that QEP adherence to PrEP regimen in terms of text/phone, etc. reminders is the responsibility of the dispensing pharmacy. From what we can tell patient needs to take PrEP therapy continuously/consistently for the drug to be effective.

The voucher that would be issued is valid for 30/60 days. Does HHS envision a process where the voucher will be good for a specified period of time (i.e. ~180 days) and good for a specific number of refills within that period of time? And in terms of therapy beyond the first time a voucher is issued does HHS envision a process where the patient would “re-attest/re-qualify” before a voucher expires and that same (previously issued) voucher be extended for another ~180 days? Or would the patient need to completely re-apply for a new voucher? Would HHS be willing to sign a CDA before the proposal is submitted?

Response: See response to question (s) #4, 23, 32, 52 prior answers.

83. To confirm, a patient attestation confirming that he/she has taken an HIV test (with an appropriate negative result) will suffice for that part of the eligibility requirement, correct?

Response: A patient should not be given a prescription without first having results from the requisite tests.

84. Can we get clarification on distribution of product? in the RFP document- slide 11 states “HHS bears all other costs: verifying patient eligibility, enrolling eligible patients, building a network of participating pharmacies, distributing the donated medication, and processing claims.” Then on slides 22 and 23 it states “Donating pharmacy dispenses out of customary, commercial inventory and obtains replacement bottles through usual channels.” Please clarify as these statements seem contradictory.

Response: The pharmacy receives reimbursement or replacement from Gilead. If it receives reimbursement, the pharmacy may use that reimbursement to purchase a replacement bottle. Please see the diagrams on the slides, “Dispense at Brick-and-Mortar Pharmacy with WAC Reimbursement” and “Dispense at Mail-Order Pharmacy with Reimbursement or Backfill.”

85. For the purpose of this proposal, is it correct to assume that we will reach 200,000 QEPs receiving PrEP medicines by the beginning of Year 2?

Response: No; however HHS is striving to meet that goal.

86. For the purpose of this proposal, is it correct to assume that we will distribute 2.4M bottles of PrEP medicines by the end of Year 2? No. But HHS hopes so.

Response: No; however HHS is striving to meet that goal.

87. The current incumbent was awarded on a sole source, is that correct?

88. If that’s the case, that bid or that contract as it relates to this new contract are there major differences now compared to the old or are they very similar?

Response: The basic need to distribute PrEP is the same; however, the solicitation and associated supporting documents have changed.

89. Is that incumbent currently eligible to be a prime or are they OCI’d out because they have an unfair disadvantage?

Response: The incumbent has advised HHS that it will not submit a proposal on the RFP, but will continue to support the program with the donation of free product during the commitment term. HHS appreciates Gilead’s donation in support of the President’s Initiative to the end the HIV Epidemic as HHS seeks a longer-term enrollment and distribution network.

90. At the bidder level, just speaking for myself, we have to have confidence that we have a shot or we wouldn’t be able to invest our time and resources because we just can’t. So what we’re looking for is just confidence that we can compete and can be evaluated on those merits.

Response: To encourage competition, direct market research was conducted. Additionally, we held an Industry Day and Preproposal Conference. We expect robust competition.

Please also see prior answer.

91. I wanted to know if you are contemplating any small business set asides for this opportunity. A lot of small businesses are agile in these small communities, just wanted to know if there was any consideration.

Response: Based on the market research, a determination was made for this procurement to be full and open. We are not preventing any small businesses from submitting proposals, we’re open to that, but we did not do a 100% set aside, because the market indicated that we should move forward with a Full and Open Competition.

92. I noticed that on one of the PrEP landing pages there is a note for patients that they can have their eligibility checked in real time if provide their name, birthdate and social security number. I was curious if HHS allowing access to a public data base or what resources are being used to do that in real time assessment?

Response: See response to question #80.

93. Will the evaluation team include and consultants outside of this room that will be considered to give input in rewarding the contract? So will you be using consultants or will this be an HHS decision without any outside consultant?

Response: This will be an HHS decision. The HHS technical evaluation panel will consist of federal employees.

94. When submitting the pricing, should the pricing be submitted as a per bottle price, should it be submitted as a transaction fees dose, specifically how do you want the pricing to be submitted as the redemptions come through for the prescriptions?

Response: See response #24, 40. For pricing, Offerors have the flexibility to provide the best value pricing scheme for the government to consider and determine price reasonableness. The government seeks innovation, so if you do deviate from the industry standards, please provide enough detail so that the government can determine if it is actually a better deal than an Offeror submitting a pricing proposal on standard industry whether it’s per bottle, per verification, etc. Predictability is very important for the government. The more predictability you give the government, the better.

95. As a company that currently does not do business with the government, what are the minimum required steps in order to bid and be considered for the contract? So there’ll be several organizations that have not worked with government before, so to be certified and be able to bid, what are the minimal required steps?

Response: To do any business with the federal government, you must be registered in the System for Award Management (SAM) and have an accounting system that manages and accepts federal funds.

96. So currently you’ve got CVS, Rite Aid, and Walgreens. Is there a plan to expand beyond those three distribution channels within the pharmacy network and if so, is that going to be expected of the bidders or is that something that HHS is going to take on?

Response: We will soon announce additional donating pharmacies. As set forth in the RFP, the vendor must work with these donating pharmacies. And if you know of a pharmacy that is interested in joining CVS, Rite Aid, Walgreens, Health Mart, and other pharmacies to end the HIV epidemic, please direct them to HHS as quickly as possible.

97. One of the things I’m trying to reconcile with is that as I read the RFP, I’ve not read the latest release that came out, but what I thought I read that there are two phases, the first phase you will deemed technically acceptable or unacceptable to make it the next phase, if that’s correct for the orals?

98. That said, if there’s so much room or liberty for innovation and pricing, but pricing is not currently being evaluated for that acceptability. Where is sort of the opportunity to demonstrate that creativeness and innovation to your advantage to make it to phase two?

99. Just wanted to understand that I heard that this is going to be awarded to all contractors and also there are nine objectives. So how is this going to be awarded in the sense if one person really makes a phase 1 and they have offered six out of the nine, and the other one is also offering maybe two of the six and the rest. How are you going to pick which contractor gets which objective and how does the selection work? Are they supposed to team up? You let them work it out? I’m not very clear on how this thing is going to work out?

Response: The Government has a strong preference for contractors that can perform multiple objectives, and the Government will apply such a preference in the evaluation process. The Government is encouraging teaming arrangements.

100. A follow up to what you were just discussing. The nine objectives that are listed, just to make sure I heard what you said clearly, will the response be required to address all of them or as you just said, you can address some of them, just make sure you address some really well?

Response: Offerors can address a single objective, multiple objectives, or all of the objectives. The Government will give a high importance to an Offeror that addresses more objectives.

101. Are there, for you, if you could pull out four, maybe there are four that are most important.

Or are they all just that’s kind of for us to determine?

Response: All of the objectives have equal importance.

102. Specifically on page 55 of the RFP, the RFP references “ABC”. The question that I’m asking, it says provide….it’s section L6, C2, provide dispensing fee, product shipping and if applicable, fee for working with ABC and donated products. Is that ABC Amerisource Bergen Corporation for ABV a generic input?

Response: It is a generic input.

103. You mentioned that the six month extension is something that you’re pretty sure you’re going ahead and do so with that being said, do you know if you are going to have a single source or prime to be able to do all this, when would the contract be awarded so that individual group can start investing for the build because this would be quite a substantial build?

Response: Offerors can address a single objective, multiple objectives, or all of the objectives. The Government will give a high importance to an Offeror that addresses more objectives. We estimate the evaluation will conclude the week of 2/21 with oral presentations taking place the last week in February. We are estimating to have a system fully tested and online by 9/30/2020.

104. Do you have an anticipated volume of bottles that you think will be distributed in year 1 going through 4?

Response: The Gilead Donation Agreement allows for 30- or 60-day supplies, at the discretion of the prescriber for up to 2000,000 eligible patients annually. Historical trends showed that there will be less than full adherence across the population.

105. I didn’t see much technical integration. Is this whole solution going to be stand alone or d does it talk to any existing HHS platforms or processes?

Response: It stands alone.

106. So, given the length and duration of the donation, is the original contract going to be awarded for a set number of years? So is it going to be for up to four years and then there would be an additional bid post that?

Response: The proposed period of performance is for a 12 months base and 4 -12 months options.

107. Has the Ready Set PrEP Program been communicated to the Federally Qualified Health Centers (FQHC) and Community Health Centers (CHC)?

108. As these drugs are medically necessary for prevention of HIV, it is not in the best interest of the patient to withhold dispensing due to Federal Holidays and other government closures. Please confirm the requirement in section F.3 of the RFP is not applicable to services proposed.

Response: HHS confirms that F.3 is not applicable to the dispending of the product.

Section F.3 is only applicable to the extent a contractor would be required to work in a federal office for purposes of performing the contract.

109. In order to expedite the PrEP delivery process to Qualified Eligible Patients, would DHHS consider amending its existing agreement for retail delivery to include Mail Order services?

Response: The Gilead Donation Agreement allows for that arrangement.

110. Attachment A-Statement of Objectives contains several requirements that may require comment. What portion of the proposal (Volumes I – V) should include these remarks?

Response: Please include these remarks at Volume II, “Technical Approach.”

111. Section H - Special Contract Requirements, Section I - Contract Clauses and other select portions of the RFP may require comments regarding FAR clauses. Where these remarks should be placed? In the Letter of Transmittal?

Response: Please add to the letter of Transmittal.

112. In the submission order should the Letter of Transmittal precede Volumes I – V?

113. Should Section K Representations and Certifications be included in Volumes I-V? If so, please indicate where.

Response: Representation and Certifications should be included in Volume IV.

114. Please provide additional instructions on how Offerors can confirm their CPARS ratings. The website did not seem to provide a search tool.

Response: If you have a CPARS rating the system should allowed you to view and print the rating. See revised instructions in RFP L.5.

115. Page 55 of the RFP indicates that Offerors should include a Copy of the current agreement on indirect cost rates. Please provide further details on this requirement and its applicability to this project given that different cost models could be presented.

Response: Indirect cost rates need only be provided if an offeror is a proposal for a cost reimbursement type contract. Please note that if offeror does not have an indirect cost rate agreement you may submit your proposed rates; however be mindful that you will be required within he first 90 days after the effective date of this contract to initiate a request for indirect cost rate agreement from our cognizance audit agency (in this case NIH). This information need not be provided to the extent offerors are submitting fixed price proposals.

116. Will HHS consider a non-centralized model for home delivery supported by a centralized patient support (toll-free) number?

Response: Yes. Please explain how this could work with a consignment/replenishment model, where Gilead delivers the drugs to one place.

117. For mail (home delivery), is AAC+ fee or product replacement + fee the only two contracting/pricing options. Yes. Is WAC reimbursement an option?

Response: No.

118. Are all rxs filled for 30 days of supply, or are other multiples of 30 allowed?

Response: 30- or 60-day supply, as determined by the prescriber.

119. Does HHS have a rump up projection on volume?

Response: See response to questions #46.

120. What does HHS predict as the retail/home delivery mix?

Response: Market research was mixed. This is an area where HHS would appreciate industry input from entities that have experience with this patient population and PrEP regimen. HHS invites cost models that incorporate that experience.

121. RFP P. 11- 12 Given the nature of services being sought, would DHHS consider removing

Section 508 from the RFP?

Response: No. Section 508 is a legal requirement, but please see response to question # 41.

122. When submitting the pricing, should the pricing be submitted as a per bottle price, should it be submitted as a transaction fees dose, specifically how do you want the pricing to be submitted as the redemptions come through for the prescriptions?

Response: See responses #21 and 36. For pricing, Offerors have the flexibility to provide the best value pricing scheme for the government to consider and determine price reasonableness. The government seeks innovation, so if you do deviate from the industry standards, please provide enough detail so that the government can determine if it is actually a better deal than an Offeror submitting a pricing proposal on standard industry whether it’s per bottle, per verification, etc.