Office of Procurement, Acquisition and Logistics (OPAL)

Stipulated in Public Law 102-585, Section 603 all brand name drugs must be made available for purchase under the 65 I B Schedule program at a not to exceed price as a condition for receiving payment from certain entities.

All affected suppliers must submit a proposal for a VA Schedule contract. We developed the Interim Agreement (IA) process to bridge the gap while negotiating a VA Schedule contract. The IA gives both the FSS Service and the supplier the time needed to move through the new offer review process, negotiations, and award of a new contract while allowing the supplier to immediately meet the requirements of P. L. 102-585.

This year we streamlined our interim agreement process for new suppliers and/or suppliers of new brand name drugs. As part of this process, suppliers are required to provide our office with

• All relevant information regarding the affected drugs;
• Relevant information on the company adding the items;
• Contact information for the company adding the items; and
• Registration in the Government’s System Award Management (SAM) database

Upon receipt of this information we will provide your company with the relevant paperwork required to execute an interim agreement. Submit all interim agreement related inquires, comments, and documentation to interim_agree.ammhinfss@va.gov

In addition to meeting the requirements of the 65 I B Schedule program, manufacturers of covered drugs must enter in to a Master Agreement (MA) and a Pharmaceutical Pricing Agreement (PPA) with the VA.

• Master Agreement.The Master Agreement stipulates that covered drugs must be made available on the VA Schedules program and outlines the vendor’s responsibilities & obligations associated with the PL. Specifically, the MA instructs vendors to enter into a Pharmaceutical Pricing Agreement and requires them to submit non–FAMP data to the VA to establish federal ceiling prices (FCP). The terms and conditions of this agreement are non–negotiable and the same for all 65 I B contractors. This is an evergreen document and, as such, does not expire.
• Pharmaceutical Pricing Agreement.Through the Pharmaceutical Pricing Agreement, contractors agree that the annual FCP for each covered drug constitutes the maximum price that may be charged to the Government. Through Addendum A to the PPA, contractors provide a complete list of their available covered drugs. This list includes the product names, all applicable NDC numbers, and the current FCP for each drug. Contractors are required to update the PPA annually during the Public Law season.

Since implementation of P.L. 102-585, section 603, VA has issued numerous policy documents in the form of Dear Manufacturer Letters (DML). DMLs provide insight into VA’’s current thoughts on issues and offer guidance and best practices with respect to the administration, promulgation, and compliance with the law. Download the archive all DML’s issued by VA since 1992.

Download the 2023 P.L. 102-585 Covered Drug Pricing Request for Modification. We will only process RFMs submitted using this year’s forms.

Send requests ammhin.pl102585@va.gov and cc your assigned contract specialist. To ensure receipt of your firm’s request for modification, the Subject Line must have the following identifying information: RFM-Contract Number-PL2023

Continue to send all non-Public Law modifications to the FSS Help Desk, fss.help@va.gov.

Modification requests submitted with missing or inaccurate information; or changes to the spreadsheet submitted after November 21, 2022 may have an adjusted effective date of January 15, 2023 or later. As a result, your firm may be subject to the penalties outlined in PL 102-585.

This is an abbreviated timeline. See the PBM and FSS Guidance for full instructions and due dates.

October 1, 2022—Instruction letter will be sent to vendors by NAC (FSS DML).

October 15, 2022—PBM Dear Manufacturer Letter (DML) and workbook distribution to vendors by PBM.

October 29, 2022—Last day for companies to submit methodology change requests and related 3Q OLD restatements under (proposed) new methodology; this is also the last day companies may report any disputes identified in the company workbook (FSS Disputes, omissions and 3Q disputes unrelated to methodology change).

October and November 2022—Submission and Verification of 2023 FCP by PBM and forwarded to assigned CO.

November 15, 2022—Deadline for reporting annual Non-FAMP to PBM.

November 21, 2022—Deadline to submit a properly prepared Request for Modification (RFM) package to incorporate updated pricing into your FSS contract. To ensure receipt of your firm’s RFM, the subject line must have the following identifying information: RFM Contract Number PL2023. Email your completed package to ammhin.pl102585@va.gov and to your assigned Contract Specialist. Note that the authorized official that signed your firm’s Pharmaceutical Pricing Addendum (PPA) for 2023 FCPs (or an authorized successor) must prepare and sign a new PPA addendum as part of the package.

NOTE—Due to the large number of pricing updates, it is imperative for vendors to submit signed modification and updated Pharmaceutical Pricing Agreement (PPA) no later than November 21, 2022, to ensure Public Law compliance.