OA&L - OA - NAC - FSSS - Schedule 65 I B SIN 42-2A

National Acquisition Center - Federal Supply Schedule Service
Pharmaceuticals - FSC 65 I B Special Item Number 42-2A
Single Source Innovator, Multiple Source Innovator, Biological & Insulin Pharmaceutical Products

Year-End Public Law Timeline for 2008

October - Public Law Instruction letter will be sent to all vendors from the Pharmacy Benefits Management Team (PBM)
November 1st - Letter will be sent from Assistant Director of Pharmaceuticals, Dental & Other Medical Supplies to all vendors
November 17th - November 15th is the last legal day to submit pricing calculations to PBM, however due to the 15th falling on a Saturday the date has been extended to November 17th to be the FINAL DAY for pricing submissions to PBM.
December 5th - LAST DAY to submit FCP pricing to your assigned Contracting Officers to assure a January 1, 2009 effective date

2009 Dear Manufacturer Letter (114kb)

2009 Public Law Pricelist Instructions (80kb)

Sample Public Law Pricing Spreadsheet (194kb)

Public Law Price Updates and PPA Submission Letter

Request for Modifciation Forms and Product/Pricing Spreadsheets
(Only to be used for Public Law Season starting November 15 thru December 31)

Public Law Request for Modification Form - Price Increase (53kb)
Public Law Request for Modification Form - Price Reduction (66.5kb)

Please note that all requests for modification must be completed in its entirety and submitted using the applicable modification request form and associated spreadsheet as provided below.

An Interim agreement is a letter contract which establishes a “binding commitment” when immediate performance is required. The interim agreement is created to allow sufficient time to negotiate and award a new FSS contract.

Q. What are the Provisional, Temporary and Permanent Federal Ceiling Price (FCP)?

Q. Is there a grace period for submitting the NFAMP data for the different stages (provisional, temporary, permanent)? If so, what is it?

A total of 45 days (30 days plus a 15-day grace period) is allowed for temporary non-FAMP reporting, after 30 days of new drug commercial sales have occurred. However, 45 days is the maximum time allowed, and extensions should not be requested.

Q. Can a negative FCP result? Why does this happen and what type of pricing does it lead to?

Negative FCPs can result when a company raises the price of an item dramatically from one benchmark quarter to the next (beyond the allowable Consumer Price Index for All Urban Consumers (CPI-U) increase). When a company has a negative FCP, this will be represented as an FSS price of $0.01.

Q. What are the guidelines for covered products transferred from one company to another?

In the year of a covered drug transfer, the annual non-FAMP reported the following November must include sales from the full 12-month period, even if the drug was marketed under two different NDCs during the period. So, if the drug falls into the category described above, then the annual non-FAMP filed next November must be a blend of the prior drug company’s and the new drug company’s wholesale sales of the identical drug during 10/1/20xx thru 9/30/20xx.

Table x - Transferred Covered Drug Pricing

Date of Transfer

FCP Calculation in Year of Transfer

FCP Calculation for Next Calendar Year

FCP Calculation for Third Year After Transfer

1st, 2nd, 3rd Quarter

Transferee’s sales capped at Transferor's FCP.

Transferee calculates and submits FCP for next year in November.

Transferee’s FCP based on statutory calculation only.

FCP does not include additional discount based on increase over CPIU.

Transferee’s FCP based on lower of statutory calculation or prior year FSS price plus CPIU (unless first year of multi-year contract).

Includes additional discount.

4th Quarter

Transferee’s sales capped at Transferor’s FCP.

Transferee’s sales capped at Transferor's new FCP (submitted prior November).

Transferee calculates and submits FCP for next year.

Transferee’s FCP based on statutory calculation only.

FCP does not include additional discount based on increase over CPIU.

While the Public Law Act and its statutorily imposed calculations establish FCP for the Big Four agencies it did not establish what the price should be for other government agencies (OGA). Since an offeror is not required to offer FCP to OGAs the concept of Dual price (and dual pricelist) was born. Under dual pricing, OGAs will pay a price that is strictly based on FSS negotiation policy. In other words, the contracting officer will negotiate dual pricing based on the commercial sales practice data (CSP) disclosures and the goal of obtaining discounts greater than or equal to the offeror’s most favored customer (MFC) discounts.

Provisional FCP is based on a calculation that excludes sales data. Furthermore, the creation of this concept was to benefit the manufacturer and the Government by having the covered drug available at product launch rather than 30 - 45 days later. By offering the product at provisional pricing, it is understood that the pricing is to be available to all FSS users. More importantly and to the point, FSS policy requires that we base our negotiations on the full disclosure of commercial sales practice (CSP) data from the offeror which includes sales history. Contractors wishing to incorporate dual pricing under their contract must show that the NDC has substantial (significant) commercial sales to their standard commercial customers (e.g. GPOs, Hospitals, etc.). To ensure the negotiated terms and conditions are fair and reasonable, the FSS needs to review the CSP and determine that the data is reflective of the mfg’s full commercial discounting policy which may not be born out of the first 30 days of sales activity or indicative by early commercial agreements with insignificant actual sales history.