SPE2DX24R0001 AMENDMENT 0003.pdf

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Pharmaceutical Prime Vendor Global GEN V Solicitation
Solicitation number
SPE2DX-24-R-0001_SOLICITATION
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About this file

This document is Amendment 0003 to the Solicitation SPE2DX-24-R-0001 for the Pharmaceutical Prime Vendor Global GEN V requirement. The solicitation is issued by the Defense Logistics Agency Troop Support Medical for a Pharmaceutical Prime Vendor Generation V (PPV-G GEN V) contract. The amendment provides changes to the solicitation, including updates to the Statement of Work, Pricing, and other sections. Key details include revised proposal due dates, adjustments to pricing and delivery terms, and modifications to specific product and service requirements. This amendment provides further details and clarification to the overall solicitation for the PPV-G GEN V contract.

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Other files

File Type Posted
SPE2DX24R0001 revised by Amendment 0008.pdf PDF
SPE2DX24R0001 AMENDMENT 0008.pdf PDF
SPE2DX24R0001 AMENDMENT 0007.pdf PDF
SPE2DX24R0001 AMENDMENT 0006.pdf PDF
Attachment 9 - NIST SP 800-171 Assessment Summary updated Amendment 0006.xlsx XLSX spreadsheet
SPE2DX24R0001 AMENDMENT 0005.pdf PDF
SPE2DX24R0001 AMENDMENT 0004.pdf PDF
Attachment 6 - PPV-G PVR-WRM Requirements Spreadsheet Updated Amendment 0004.xlsx XLSX spreadsheet
Amendment 0004 Submitted Questions and Answers.pdf PDF
Amendment 0004 Language -solicitation changes.pdf PDF
SPE2DX24R0001 Revised by Amendment 0004.pdf PDF
Attachment 2 - PPVG GEN V - Price Proposal Submission Spreadsheet updated Amendment 0004.xlsx XLSX spreadsheet
Attachment 3 - PPV-G Specialty Drug List 3.27.24.xlsx XLSX spreadsheet
SPE2DX24R0001 AMENDMENT 0002.pdf PDF
SPE2DX24R0001 AMENDMENT 0001.pdf PDF
Attachment 2 - PPVG GEN V - Price Proposal Submission Spreadsheet.xlsx XLSX spreadsheet
Attachment 8 - NIST SP 800-171 System Security Plan Template.docx DOCX document
Attachment 11 - NIST.SP.800-171(r2) Publication.pdf PDF
Attachment 5 - Preservation Packaging Packing Labeling and Marking PPPLM.pdf PDF
Attachment 6 - PPV-G PVR-WRM Requirements Spreadsheet.xlsx XLSX spreadsheet
Attachment 9 - NIST SP 800-171 Assessment Summary.xlsx XLSX spreadsheet
SPE2DX24R0001 Final 3.13.24.pdf PDF
Attachment 7 - PPV-G Day-to-Day Requirements Spreadsheets.xlsx XLSX spreadsheet
Attachment 1 - PPVG GEN IV 2023 SALES BY NDC.xlsx XLSX spreadsheet
Attachment 10 - NIST SP 800-171 Assessment Methodology.pdf PDF
Attachment 3 - PPV-G Specialty Drug List.xlsx XLSX spreadsheet
Attachment 4 - Discrepancy Report Template.XLSX XLSX spreadsheet
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Amendment 0003 Submitted Questions and Responses

1. SOW Section 1.A – Program Overview

a. Question: Would you provide a listing of current shipping addresses (locations PPV must deliver product to)?

i. Answer: We cannot provide a list of specific locations until award. The number of customers per location is as follows:

1. North/EUCOM - 332

2. South/SOUTHCOM – 320

3. West/PACOM - 393

ii. Action: No action needed.

2. SOW Section 1.C. - Backup Supplier

a. Question: Please confirm there is only one BS for all regions and not a BS for each region?

i. Answer: Yes, there is only one back-up supplier that supports all primary supplier regions (North/EUCOM, West/PACOM, South/SOUTHCOM, and Fleet CONUS & OCONUS).

3. SOW Section 1.F.1 - Holding Orders

a. Question: Consider allowing a holding period of 30 days specifically for specialty products.

i. Answer: Please review page 33 of the SOW which states that the PPV will place the order for the item into their system as a backorder item to potentially stand in line until product becomes available up until 180 days (60 days for CII narcotics) has passed whichever comes first.

4. SOW Section 1.L. - Program Items

a. Question: Can the Government provide more details regarding the “Pharmaceutical-related products” that are covered by the scope of this contract?

i. Answer: The general list of Pharmaceutical-related products are located on the PPV overview portal. These may be accessory type items needed for pharmaceuticals such as bottles and labels. Also, Over the counter drugs that have been approved by DHA for use by the Military Treatment Facilities.

b. Question: On the DLA Pharmaceutical Prime Vendor Overview portal (see RFP

pg. 10), there is a listing 63 PPV Program Items, and 73 items that are excluded from the PPV Program Items. Can the Government confirm that the “Pharmaceuticals-related products” only refers to the 63 items that are currently on the PPV Program items list?

i. Answer: The list on the portal provides the general categories of items, not the number of items.

5. SOW Section 1.M. Specialty Pharmaceuticals

a. Question: Please also consider removing "final determination will be made by Contracting Officer" and allow for an appeals process when there is a disagreement between Vendor and DLA. Additionally, please add mutually agreed upon third party data sources and subject matter experts.

i. Answer: The contracting officer shall make the final determination.

Specialty items will be uniform across all programs as indicated in the medical master catalog.

b. Question: We respectfully seek additional clarification and refinement of the statement in Section M, which mentions that certain unique specialty treatments such as gene and cell therapies are considered outside the scope of the Prime Vendor contract, subject to determination by the Contracting Officer. We request more explicit information regarding the specific criteria or factors involved in making this determination. Please consider removing "subject to determination of the Contracting Officer"

i. Answer: The contracting officer shall make the final determination.

Specialty items will be uniform across all programs as indicated in the medical master catalog.

6. SOW Section 1.N – Implementation Plan

a. Question: Can DLA confirm if the Implementation Plan and COOP are both due 15 calendar days after receipt of award notification, and not during bid submission on 4.29.24?

i. Answer: Yes, the Implementation Plan and COOP are both due 15 calendar days after award notification.

ii. Action: No action needed

7. SOW Section 2.D.3.d – Contractor’s Regional DAPA

a. Question: “If the contractor has a published Price & Product Catalog, the product price shall not exceed the lower of either: the Average Wholesale Price (AWP) less 15%; or A price that is determined fair and reasonable based on a comparison of the same items sold under the same or similar contract terms and conditions to similar commercial customers” Can the Government define “similar contract terms and conditions” and “similar commercial customers”? What is the source of this information?

Per the RFP, an item must have both an NDC and AWP in Medispan to be eligible for a Regional DAPA. Accordingly, is there still a need to compare the same items sold under similar contract terms?

Since all Regional DAPA items have an AWP, can the price ceiling be limited to the AWP less 15%?

i. Answer: The Government utilizes pricing available from the current Pharmaceutical Wholesalers. No, there may be situations in which AWP minus 15% is not appropriate of which the Pricing Team Contracting Officer will determine pricing as F&R based upon all available data. The language is correct.

8. SOW Section 2.G – Order Placement/ Delivery

a. Question: Please consider modifying this language to only allow for holding order for Scheduled Controlled Substance orders placed via CSOS/NORA as manual orders will not be supported.

i. Answer: While the CSOS/NORA process is preferred, we must allow for a manual process if deemed necessary.

9. SOW Section 2.G.9 - Delivery of Routine Orders

a. Question: The PV can charge the ship a re-stocking fee from the ship’s credit account. Would you please describe the process if the ship does not have sufficient credit funds available on their credit account?

i. Answer: Refer to the Contracting Officer for resolution.

b. Question: We request that DLA consider eliminating the need for contracting officer approval and fee negotiation for emergency shipments beyond the two provided at no additional charge. The challenges arise from factors such as shipping distance and order volume, making it difficult to determine exact charges in advance of shipment and order processing. It is also important to note that emergency orders shipped outside of the customer's regional servicing Distribution Center (DC) are not considered as one of the free emergency orders.

Question is referencing “as negotiated” statement in this section - “Any additional emergency shipments requested by the ordering facility exceeding the two per month at no additional charge shall be charged to the ordering facility’s account, including all applicable transportation and handling costs, as negotiated, and approved by the Contracting Officer.” The company has standard fees for any additional emergency shipments and called out if “as negotiated” should be removed since we don’t negotiate those fees. The fees are standard across all of customers.

i. Answer: All costs must be determined to be fair & reasonable. Any additional fees must be reviewed and approved by the Contracting Officer.

The Contracting Officer may work with the vendor to establish standard fees during the implementation of the contract.

10. SOW Section 2.G.14.e – Receipt of Orders for Schedule II Controlled Substances

a. Question: Can the Government confirm that the PPV is only required to provide the transactions on the DEA ARCOS report that are related to the sales to DLA customers?

i. Answer: Confirmed.

11. SOW Section 2.O.3 - Drop Shipments

a. Question: Considering the complexities involved in determining precise freight charges, particularly when they are passed down from the manufacturer, we kindly request your consideration in reevaluating the need for written approval in cases where freight fees exceed $100.

i. Answer: We no longer request written approval.

12. SOW Section 2.P - Invoicing Discrepancies

a. Question: Given the complexities involved in resolving invoice disputes and ensuring accuracy, we believe that additional time beyond the existing 12-month window is necessary. Would DLA consider extending this timeframe?

i. Answer: We will not be extending the 12-month period.

13. SOW Section 2.S.6 - Shortages/Other Discrepancies

a. Question: We request DLA's guidance and clarification on whether there is room for flexibility within the SOW to allow the PPV to deny shortage claims when compelling evidence supports that the customer has received the full shipment, such as a signed manifest.

i. Answer: No guidance required; this will be reviewed on a case-by-case basis.

14. SOW Section 4 - Enhanced MILSTRIP Process

a. Question: We request DLA's clarification regarding Fast Pay net 15 days for orders under $35,000. Is this only applicable for U.S. Naval ships for Fleet Contract?

i. Answer: Yes, this is only applicable to Fleet MILSTRIP orders.

15. SOW Section 6.A.1 Credit Accounts

a. Question: In section 6A.1. on Credit Accounts, there is reference to incentive rebates or credits from manufacturers. Please clarify the approach to negotiations with manufacturers for contract pricing referenced in number 7 on pages 5-6. It is our expectation that the lowest net contract price is inclusive of any incentive rebates or credits from manufacturers and those rebates are visible to the PPV-G via the daily file. If manufacturer incentive rebates are provided outside of the pricing passed to the PPV-G, it creates unaligned incentives and can place unnecessary burden and risk on the PPV-G. If DLA does not include incentive rebates into the contract price passed to the contractor, please consider allowing for a modification/exclusion of distribution fee because the USG would be receiving a higher distribution fee from the PPV-G on a price that is not reflective of lowest acquisition cost due to the incentive rebate from the manufacturer.

i. Answer: Normally the lowest price is reflected in the catalog, any credits or incentives after the fact would be handled on a case-by-case basis.

16. SOW Section 6.H - Unliquidated Credit Account Balances

a. Question: We kindly request that DLA consider revising or removing Section H, specifically addressing Unliquidated Credit Account Balances-Interest.

Alternatively, we propose revising this section to reflect the current prompt payment rates for the applicable period.

i. Answer: This cannot be removed based on the Renegotiation Act.

17. SOW Section 11 Electronic System Requirements

a. Question: Would the Government be willing to share the EDI Implementation

Guide with prospective offerors rather than the stated 10 days after contract award?

i. Answer: We cannot provide that until time of implementation.

18. SOW Section 11.C.1 – DLA Troop Support Catalog Data Transmissions to the PPV

a. Question: Can you please clarify if you truly only want 8 files or will there still be individual catalogs created in this process?

i. Answer: We do not want individual catalogs for each customer. This can be clarified during implementation.

19. SOW Section 11.F.1.b – EDI 855 – Purchase Order Acknowledgement

a. Question: Could you please clarify if the SOW language is flexible regarding the handling of rejected but shipped lines? Specifically, we would like to inquire if you would consider it permissible for the customer to submit an offline non-submit 1155 to pay for these lines in cases where they still wish to keep the product.

i. Answer: Once an order is killed, it should not be shipped. It is the Prime Vendors responsibility to not ship cancelled orders.

20. SOW Section 11.G. PPV Contractor's Electronic Price and Product Catalog

a. Question: Will DLA further define "delivered unit price". We interpret this to mean the invoice price, but request clarification. Additionally, can DLA clarify what the incentive agreement and price. We interpret this to mean contract price and contract cost, but request clarification. Regarding Delivered Price, can you please further clarify what that is to include/exclude would that be equal to the “invoiced price” to the customer?

i. Answer: Delivered price is the same as invoiced price.

21. SOW Section 11.I.2 - Real Time Price Verification

a. Question: Could you please provide further details on the process for addressing and resolving challenges to prices as stated in DLA's contract requirement?

Specifically, we would like to understand the timeline and procedure for submitting an 824 challenge in case of a decline from DLA. Additionally, it would be helpful to know what recourse is available if a challenge is declined by DLA, ensuring timely payment for services rendered.

i. Answer: The DLA Troop Support PPV Price Adjudication Branch plans to work with the PPV to resolve all discrepancies within 90 days after receipt of the monthly data. The PPV Contracting Officer will have the final decision in any disputes between the PPV and the DLA Troop Support PPV Price Adjudication Branch.

22. SOW Section 12.A.1 – PPPL&M Modification

a. Question: Would DLA consider a green initiative and utilize electronic packing lists that would be available through a Prime Vendor hosted site?

i. Answer: Not currently.

ii. Action: No action needed

23. Substitution Process – Multiple areas in SOW

a. Question: Please clarify the substitution process. Will there be a pre-authorized substitution list for automatic substitutions, or will every substitution need to be approved by the contracting officer/facility? Page 130 – When is it acceptable for the code ‘IS Item Accepted-substitution made’ to be used on the 855 EDI transaction.

i. Answer: Automatic substitutions are not authorized unless specifically approved by the Contracting Officer.

24. SOW Section 16 – Cybersecurity

a. Question: (combined) DLA does not have the three clauses below included in our contract, but they are requiring us to provide a NIST assessment in accordance with the clauses. would DLA consider adding DFARS 252.204-7012, 252.204- 7019, and 252.204-7020 to the solicitation?

i. Answer: At this time, we will not be adding the clauses since they are not applicable to solicitations and contracts for commercial off the shelf items (COTS). Based on the criticality of this program and with anticipated new DoD cybersecurity requirements being implemented during the life of any resultant contract, this procurement has custom language to ensure that any awardee is prepared to successfully implement new and evolving DoD cybersecurity requirements. The custom Cybersecurity requirements in the solicitation are based on NIST language contained in existing DoD clauses but contains differences, so the clauses will not be incorporated at this time. That may change in the future based on any DoD mandates, including any associated with upcoming CMMC implementation. although these clauses do not apply, we recognize the importance of cybersecurity and are using a modified version of NIST requirements as a technical factor.

25. FAR 52.212-1 Addendum #2 Solicitation Provisions- Preparation & Organization of Proposals

a. Question: Can you please clarify if there might be an error in the referenced regulation & if this should be a reference to FAR 52.219-9 instead of FAR 52.212-1?

i. Answer: This is not an error. The language on page 5 says "instructions for submitting the subcontracting plans are included in FAR 52.212-1 (addendum #2) which is the instructions for offerors. This is just how we expect plans to be submitted, not the clause they adhere to.

26. Miscellaneous

a. Question: Will the pre-proposal slides be made available?

i. Answer: No, but all the questions will be addressed via amendment and all the information is available in the solicitation.

ii. Action: No action needed.

b. Question: Will you be able to complete all actions by the end of the current contract?

i. Answer: We are working towards that.

27. Subcontracting

a. Question: From the pre-proposal conference, can you please reference the FAR/DFARS clause referencing a 5% goal for small business subcontracting?

i. Answer: DFARS 219.705-4 (d)

b. Question: Considering that the contractor is obligated to procure products from the specified sources mentioned in the Statement of Work (SOW), could the products be excluded from the subcontracting requirements, because there is no subcontracting opportunity available making it difficult to achieve a 2.5% subcontracting goal if they are mandated to purchase exclusively from government vendors/contracts?

i. Answer: Please review FAR 52.219-9. There are two options with subcontracting plans: Individual plans cover the entire contract period (including option periods), applies to a specific contract, and has goals that are based on the offeror's planned subcontracting in support of the specific contract, except that indirect costs incurred for common or joint purposes may be allocated on a prorated basis to the contract. Commercial plans cover the offeror’s fiscal year and that applies to the entire production of commercial products and commercial services sold by either the entire company or a portion thereof (e.g., division, plant, or product line). The commercial plan shall relate to the offeror’s planned subcontracting generally, for both commercial and Government business, rather than solely to the Government contract.

c. Question: What portion or percentage of the projected annual pharmaceutical expenditure is estimated to be open for competition, allowing for potential alternative sourcing options beyond the specified government vendors/contracts?

i. Answer: Review FAR 52.219-9. For commercial plans, Commercial plans overs the offeror’s fiscal year and that applies to the entire production of commercial products and commercial services sold by either the entire company or a portion thereof (e.g., division, plant, or product line). The commercial plan shall relate to the offeror’s planned subcontracting generally, for both commercial and Government business, rather than solely to the Government contract.

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