Mail_Order_RFP_QA_Final_4.22.xlsx

XLSX spreadsheet 22 KB Posted Apr 22, 2019

Attached to: Last Mile - Mail Order Pharmacy Federal contract opportunity
Solicitation number: 19-100-SOL-00017
Issued by: Department of Health and Human Services Immediate Office of the Secretary

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Responses to first round of questions received

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Other files attached to Last Mile - Mail Order Pharmacy, newest first.
File	Type	Posted
Mail_Order_RFP_QA_Round_2.pdf	PDF	May 3, 2019
Last_Mile_Solicitation_Final.pdf	PDF	Mar 29, 2019

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Q&A

Number	RFP Reference	RFP Requirement	Question	Answer
1	NA	NA	I am hoping to find out if there is an incumbent contractor currently performing these services, if similar services have been performed in the past, or if this is a new requirement. If there is an incumbent, could you please provide the contract or task order number?	This is a brand new requirement. There is no incumbent or past contract number.
2	Page 10, 3.1 Proof of Concept.	The proof of concept test shall be for residential delivery of antibiotics for post exposure

prophylaxis (PEP) during a public health emergency to current customers in 7 metropolitan cities (Chicago, Los Angeles, New York City, San Francisco, Denver, Kansas City, and the National Capital Region which include populations in District of Columbia, Virginia, and Maryland).

Please provide the zip codes for the metropolitan areas included in this solicitation. Metropolitan areas are a vague area reference. This will help to quantify how many addresses and members we have in each area. Offererors should use residential zip codes in the following areas:

_County of Los Angeles _City of Chicago _NYC to include all Five Boroughs(Manhattan, Brooklyn, Queens, Bronx, Staten Island) _City of Washington, DC _Denver MSA to include:

.. Boulder County ..Broomfield County ..Clear Creek County ..City/County of Denver ..Elbert County ..El Paso County ..Gilpin County ..Jefferson County ..Park County ..Tri-County (Adams, Arapahoe, Douglas) _San Francisco MSA to include ..San Francisco ..Marin County ..San Mateo County ..Alameda County ..Contra Costa County ..The San Jose, Sunnyvale and Santa Clara MSA consists of the following counties: (Santa Clara; San Benito) _Kansas City MSA to include:

..Caldwell County ..Cass County ..Clay County ..Clinton County ..Jackson County ..City of Kansas City ..Platte County

3			Given an anthrax attack on one of the listed metropolitan areas, we need to estimate the number of shipments and bottles [that] will be required in the first 24 hours for capacity planning. Should we assume we will need capacity to ship to 100% of our members in a metropolitan area in 24 hours? If not, 75%, 50%, 25%? We need some direction since adding capacity will be a material cost in the proof of concept phase.	100% of your members including other household residents. This is outlined in Section C of the SOW.
4	Page 3, B.3 CLIN structure	All CLINS “Not to Exceed” column	In the CLIN structure, the government provides a space for “Not to exceed”. What is the purpose of this field if we are supposed to put something there? In pharmacy contracts, they are typically IDIQ since pharmacy prescriptions are an unknown quality. Please explain what your objective is with this field and the pros/cons of using or not using this field?	The Not to Exceed Amount is a maximum dollar value or order quantity that cannot be exceeded under that CLIN. It is intended to protect both the financial interest of the Government and to prevent the Offeror from being asked to perform tasks for which they are not capable. Its inclusion is required unless services are proposed on a firm fixed price basis.
5a			Is the government asking our ability to track members we shipped product to? What data fields do you want?	Yes. We would like to understand your current capabilities in terms of tracking the number of households in your customer database (address, head of household or POC). Also, which product the customer received and how quickly this information can be provided during this public health emergency.
5b			Is the Government asking us to perform a proactive DUR without contacting the patients to determine the right antibiotic?	A government developed screening algorithm will be shared to help make product selection. (See page 10, 2nd paragraph under "Phase 2".
5c			Will the government provide us with criteria to use when evaluating existing drugs taken and allergies?	Yes; A government developed screening algorithm will be shared to help make product selection.
5d			Are you asking us to contact members via telephone, mail, or email asking each patient these 4 – 6 questions? Is shipment of antibiotics contingent on each person answering the 4 – 6 questions?	Yes. We are interested in learning about what the vendor's capability to assess household details prior to an event, describe the methods or processes to track customer level information, and ability to add triage protocols (series of 4-6 questions provided by CDC) to help determine what drugs each person should receive. No, shipment is not contingent on answering these four questions. However, there will be a Government-provided algorithm to assist with making the determination of who shoud receive shipment.
6	Page 9, Phase 1 and 2		Is the government furnishing standard language to include in each mail order shipment that explains the emergency, purpose of prescription, explanation if the drugs have an expiration date, phone number for questions, follow-up shipment to expect, etc…?	We will work with the vendor to determine what forms of written communication will go with each shipment. The government's communication strategy will include various forms of mass media communications (such as print, broadcast, radio, satellite, internet or other electronic means, videos/DVDs or direct communication from public health agencies).
7	Page 23, SECTION I – CONTRACT CLAUSES		Is the government indemnifying each contractor in the event of an adverse drug interaction, loss of life, and any legal action as a result of executing this contract given the emergency conditions we would be supporting? If not, what can the government do to mitigate our risk in a well-intended emergency response?	Medical countermeasure distribution for this public health emergency qualify for the immunity protections of the Public Readiness and Emergency Preparedness (PREP) Act, provided that a PREP Act declaration for the product described in the EUA has been issued by the Secretary of HHS, and the product is used in accordance with the PREP Act declaration.

ADD PREPAct Hyperlink.

https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx

	8	Page 53, L.7.2 PACKAGING OF PROPOSAL, Business Proposal	• “…information requested in the SOW associating cost with identified task and all labor categories and labor rates for work under a prospective contract- maximum 20 pages total. (The cover page and table of contents do not count toward this total.) The business proposal shall include unburdened and built up rates for any and all positions that could potentially work on any part of a resultant award under this solicitation.” Also page 55, ARTICLE L.10. OTHER ADMINISTRATIVE DATA speaks to the requirement for cost accounting and GAAP requirements.	This is a FAR Part 12 commercial contract competed in the open market to derive a market price. Requiring cost, labor categories, rate build-up, and overhead rates is not the way mail order services are priced in the commercial market. Not all contractors have cost accounting systems. Will you consider dropping the requirement for the above mentioned cost items and accept a firm fixed price for IDIQ as currently outlined in your CLIN table?	Yes. Firm Fixed Price is acceptable.
	9	NA	NA	Will the government be handling all patient telephone, email, web site inquiries associated with these shipments? If not, please provide contractor requirements and estimated inquiry rates so we can estimate our call volume, web volume, staffing, and other associated costs. Since we are sending out paperwork in each package, we normally would include our web site for FAQs, customer support phone number, etc…	We will work with the vendor to determine what forms of written communication will go with each shipment. The government's communication strategy will include various forms of mass media communications (such as print, broadcast, radio, satellite, internet or other electronic means, videos/DVDs or direct communication from public health agencies).
	10	Page 12 “ARTICLE F.6. OBSERVANCE OF LEGAL HOLIDAYS”		Will the government please address in the event of a declared emergency that spans a legal holiday, what is your expectation for contractors who are in their 24 hour or 144 hour deadline window? Does the government expect contractors to work on holidays? If so, please revise this language for holiday pay if the contractor is directed to work over a holiday	In the event of a declared emergency that spans a holiday(s), the contractor will still be expected to meet the required response deadlines. The language in Section F.5 of the solicitation does not mean that the contractor will not be paid for its performance over a holiday(s). It simply means the contractor will not receive additional pay beyond what is standard because they are being asked to work over the holiday.
	11	Page 12, “ARTICLE D.3. GOVERNMENT ADDRESS	• ASPR will inform the Contractor of the address where to ship any purchased equipment or supplies. Addresses may vary depending on where the items are needed.	Could you please be more specific about the equipment or supplier that are contemplated to be handled here? Are you simply referring to the antibiotics in this solicitation or something else? If something else, please be specific so costs can be calculated.	Yes, only antibiotics.
	12a	Page 9, 3. Objectives, Phase 1	• “Within 24 hours of receiving Government owned antibiotics, the vendor shall deliver…”.	All contractors will be using largely the same shippers capable of overnight shipments. Has the government had prior discussions with FedEx, UPS, USPS regarding their support for this shipping and door-to-door delivery?	No. This is ultimately the offeror's responsibility. The Government is willing to take part in such discussions with these vendors if requested post award. All concerns should be documented in your proposal. You should not wait for the USG to engage with this industry for such a need.
	12b			Have these shippers agreed to support delivery in an anthrax affected zone given their delivery people receiving the antibiotic first?	It is the offeror's responsibility to address the carriers capabilities. The government cannot address this with the carriers.
	12c			Will air respirators be required to protect delivery personnel who are outside for an extended period of time? If so, who is responsible for providing those to potentially thousands of delivery personnel? Please advise if this is the responsibility of the contractors or government to have these discussions.	The USG (CDC, NIOSH) provides guidance and recommendations on occupational risk for delivery personnel, depending on the type and severity of event. It is not the Government's responsibility to provide these items for contract delivery personnel.
	12d			Has the government explored the option of using government owned aircraft to transport mail order antibiotics from contractor’s mail order facilities to the areas affected? If not, is this a conversation contracts should initiate or the government will take the lead?	The Government owned aircraft is not an option in support this response. However the Government may be able to coordinate with FAA to gain access to priority flights.
	13	Page 11, 3.4 Yearly Exercises	• “The possible exercises this contract may be involved with are 1) a readiness call to determine when the product could begin deployment along with estimated timeline; 2) a staging call in which product is packaged and loaded, awaiting transport; 3) a deployment call in which an order is issued and product is shipped.”	Each of these 3 readiness activities has different degrees of labor impact, impact to production mail order delivery, and disruption to our other business. As an example, item 2 costs vary if the government wants 100 bottles prepared for shipment vs. 5,000. Please add more detail around duration of test, units processed, measures of success, and other cost impacting activities. We can then estimate our costs for each type of test.	Exercise #1: This should involve little work. Determines awardee's readiness level to respond to an actual request. This exercise activity simply involves a readiness call and requires no product handling or movement. Exercise #2: Product will be prepared and moved to a designated location on-site where product will be staged. No shipments will occur. Exercise #3: A set amount of mock product will be used for full deployment of product to predetermined locations. The amount of product for each exercise will be determined at the time of exercise however we will not ask that you exceed 25% of the offerors customer base for each respective jurisdiction. Success is demonstrated by the offerors ability to meet the objectives as stated in Section C3 of the SOW.
	14	Page 51, ARTICLE L.2. COMMUNICATIONS AND QUESTIONS	• All Questions must be received by no later than __3___ PM EST on __April 10, 2019__.	Due to the nature of this RFP where we need to develop solutions to scale our mail order systems, proactively run DUR, select the appropriate drug in advance, plan to pause our other customer’s mail order prescriptions, etc… we would like to request another round of bidders questions due one week after the government response to contractor bidders’ questions. Also, depending upon government responses that may require more work on contractor’s responsibilities, the April 29 deadline may be restrictive to robust and creative solutions.	Revised.
	15a	NA	NA	Our pharmacies are overseen by State Boards of Pharmacy and must comply with both Federal and state pharmacy laws. As such, shipping medications to patients without their request or consent brings up a series of challenges in terms of complying with these regulations.
Given that HHS is a Federal entity, do Federal laws supersede any applicable state laws that we would have to follow when it comes to dispensing these drugs?	One aspect of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 is that it allows for emergency dispensing (including mass dispensing) of approved MCMs during an actual CBRN emergency event without requiring an individual prescription for each recipient of the MCM and without all of the information otherwise required to be provided when dispensing the MCM under section 503(b)(2) or 520(e) of the FD&C Act if (a) permitted by the law of the state in which the emergency dispensing occurs or (b) in accordance with an emergency dispensing order issued by the FDA Commissioner. Emergency dispensing under this provision will not result in the product being considered unapproved or deemed adulterated or misbranded under the FD&C Act because it is not dispensed with an individual patient prescription. [section 564A(d) of the FD&C Act]
	15b	NA	NA	Will the agency be coordinating the implementation of this program with applicable state agencies and partners for visibility purposes?	Yes, the Government will provide coordination with state and local partners.
	15c	NA	NA	Can you share any agreements that may be in place with state entities that would authorize an external contractor to participate in this program?	No. We do not have any agreements with outside contracts relating to states however this is the Government's objective and we will handle accordingly.
	15d	NA	NA	For audit trail purposes its assumed that we would need to load some kind of “RX” for each person that is dispensed the medication. Is there a Medical Director or other clinician from the agency that we could record as the “physician of record” for these dispensing’s?	Physician of Record would be the the State's Health Officer, within the state it is dispensed, and will be provided at time of event.
	15e	NA	NA	If there is a situation where a member medically cannot take either drug to be shipped via this program, will there be other options available for those one-off cases?	Some individuals will need to go to a dispensing location due to their contraindications. The Government will try to reach these individuals through media and public health communication campaigns. We welcome comments from the vendor on how they may be able to coordinate or assist with this as they work to reach individual households.
	15f	NA	NA	Would there be any requirement for the contractor to work with a physician to obtain a separate prescription for that patient?	No
	16			Is the offeror site required to maintain specific certification standards outside of cGMP and necessary pharmacy distribution licensure/permit requirements? (i.e. VAWD, ISO13485)	No.
	17			Is there a regional proximity requirement of the offeror site, with respect to each of the metropolitan distribution areas? If so, what is the maximum radius of acceptability from the various city centers?	No.
	18a			Within page 9, Section C (Objectives), it is stated that the offeror will obtain information from existing customers regarding household occupants. 1) Will the Government provide a listing or data on occupants in the targeted metropolitan areas into which the offeror will distribute products to? 2) If so, will the Government have a requirement for offeror to extract all additional household occupants from this initial list through a form of query? 3) For example, will the Government provide state or federal database access (i.e. Census, IRS, USPS residential listing, etc.)?	1) No, we will not provide a listing or data on occupants.

2) Yes, this is a requirement.

3) No, however we are requesting if the occupant has others living with them at that household we could send product to.

18b			What is the acceptable delivery parameter in distribution events within both phase 1 & phase 2 (90% coverage, 95% coverage, etc.)?	100%
19			Will the Government require offeror to be HIPAA compliant and have validated systems?	No
20			Are the products (Ciprofloxacin HCL 500mg & Doxycycline Hyclate 100mg) stored and distributed in finished dosage bottles (20 CT/100 CT)? Will the Government require dispensing or breaking of finished dosage bottles to lesser quantities to be dispensed?	Only bottles of 20 and 100 count will be used. The bottles of 20 and 100 count provided by the Government are in finished packaging.
21			If breaking finished dosage to lesser quantities is needed, could this be done by a pharmacy tech or does the Pharmacist in Charge have to be onsite?	In terms of products provided by the Government, this will not be expected by the vendor.
22			Will additional products be required for distribution within this program and what other cities would potentially be considered within this program?	There is the potential that other similar antibiotics or formulations could be added through modification at a later date.
23			Are the current DSCSA (Drug Supply Chain Security Act) serialization tracking requirements needed for the products within the program?	We expect to be exempt from the serialization.
24			If offeror intakes product at the bottle/finished dosage level, is there a requirement for pharmacist led distribution to the user?	No
25			Is this program exempt from pharmacist dispensing requirements (Stafford Act)?	A Pharmacist in Charge is not required for the distribution of these medical countermeasures.
26			Within page 58, Section M (Technical Plan & Capability), to what extent will the offeror be required to repackage and relabel products in the program?	Not required. However, there may be a means in which repackaging/relabeling by vendor is required if vendor is proposing an innovative approach.
27			What will be the offeror liability for damaged, lost, or undeliverable products?	The Government will include standard GFP clauses in the contract.
28			What is the total replacement value of all products within the program?	The question is not relevant. The vendor is not liable for all of the products in the program.
29			What will be the offeror liability for courier refusal to deliver into affected area?	No liability. (Force Majure)
30			What will be the requirements in delivery of Shelf-Life Extended Products?	No differing or other requirements.
31	Page 9, 3. Objectives, Phase 1	“Within 24 hours of receiving Government owned antibiotics, the vendor shall deliver…”.	• This requirement states the ‘delivery’ presumably to the member’s door must happen within 24 hours. Please consider limiting this 24 hour period starting with drug delivery to our dock from SNS and completing with the shipment is out our mail order doors. This is all a contractor can directly control. At this point, it is up to the various carriers, geography, and weather to delivery as quickly as possible.	Offeror needs to address this in their proposal. Ensure you list the potential risks and the mitigation plan. We must prepare in advance as much as possible but understand that during an emergency, there are outside factors out of the contractor's control. The solicitation encourages offerors to propose alternate and innovative solutions that may address some of these issues in advance through actions such as pre-positioned product or Vendor Managed Inventory that may help expedite delivery.
32	Page 9, Phase 1	• The Government would like a solution in which the offeror obtains information from existing customers regarding household occupants in advance	• This would be an unprecedented question for a PBM to ask for the number of people in household beyond those insured with our plan. Also, contractors will not have a list of current drugs or allergy profile on these additional members which would be a large risk on our part. We would need to hear the government’s solution to indemnify and hold our company harmless in the event of harm or death.	We are requesting for information on others in your customers household. This is in an attempt to increase the coverage of this preparedness effort. The Prep ACT covers anyone in the dispensing cycle. This will cover the vendor. Once awarded, the Government would be happy to coordinate a meeting with our Legal team to discuss in-depth.
33			Does past performance obtained via CPARS meet the past performance requirement in the contract even though the format is different from what was included in Attachment #3 to the solicitation?	Yes, Past Performance obtained via CPARS satisfies the past performance requirment. Attachment #3 was only included as a possible alternative if a contractor does not have enough relevant CPARS reports.

https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx

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