AoI A006 Clarification Questions_Answers.docx

1. Agreement with distributor – is the pharmacy expected to incur additional costs or is the ‘last mile’ funded by the program?

A) All dispensing costs, to include “last mile”, will be reimbursed.

1. What volume will be allocated and at what frequency?

A) TBD – Will be based on solution brief responses and negotiated awards.

1. How will ‘equitable distribution’ be measured and how should this be balanced against ensuring availability in ‘hot-spots’?

A) TBD – Will be based on solution brief responses and negotiated awards.

1. What is the intake process/patient journey for the scripts? Is there a manufacturer hub to triage the scripts from physician/patient to the selected pharmacies and how is that determined?

A) TBD – Will be based on solution brief responses and negotiated awards.

1. No cost to patient or third party – will this all be billed directly to HHS eg no commercial payors involved?

A) At this time, all reimbursement is expected to come directly from the Federal Government.

1. How will patient outreach be measured?

A) TBD – Will be based on solution brief responses and negotiated awards.

1. What additional FDA provisions are there?

A) We will not know the specifics of FDA requirements until (and if) they issue the EUA and associated Fact Sheets.

1. Confirm the product and handling characteristics?

A) Product cannot be confirmed at this time. Can only share that it is not anticipated that any special handling (e.g., cold chain, refrigeration) for these products.

1. Weekly reporting – signal when 75% of funds are expended; what are these funds for and how will they be distributed?

A) Funds are those that are on contract. Funding distribution will be based on solution brief responses and negotiated awards.

1. Can you provide more detail on how the offer will be marketed

1. Will there be an opportunity for cost recovery on O/H?