Public Law 102-585 is the Veterans Health Care Act of 1992; this law was enacted on November 4, 1992. Section 603 of this law applies to the prices certain agencies pay for pharmaceuticals. The Secretary of Veterans Affairs has the statutory responsibility for implementing and enforcing Section 603 of this act.
Public Law 102-585 only applies to SIN 42-2A single source innovator, multiple source innovator, biological and insulin pharmaceutical products, under Schedule 65IB, Drugs, Pharmaceuticals, & Hematology Related Products.
One of the main purposes of the Veterans Healthcare Act is to control the prices of covered drugs purchased by certain Government agencies, including the Department of Veterans Affairs, the Department of Defense, Public Health Service/Indian Health Service, and the Coast Guard. Each of these “Big 4” agencies receives special pricing discounts on pharmaceuticals in accordance with this Public Law.
Covered drugs include:
Big 4 pricing for covered drugs is capped at no greater than 76% of the non-Federal Average Manufacturer Price (non-FAMP); therefore, under Public Law 102-585, Big 4 customers must receive at least a 24% discount from the net prices wholesalers pay to manufacturers for covered drugs. This is the Federal Ceiling Price.
The FCP is the maximum price that a manufacturer may charge for a covered drug sold to the Big 4 Federal entities engaged in providing healthcare services — VA, DoD, PHS/HIS, and the Coast Guard. The FCP is effective for a calendar year, or that portion of a calendar year in which the covered drug is marketed.
The calculation for the FCP is: (annual non-FAMP x 0.76) — any additional discounts. The Industrial Funding Fee is not included in the FCP.
The Big 4 include the Department of Veteran Affairs (VA), Department of Defense (DoD), Public Health Services (PHS), including Indian Health Services, and the Coast Guard. State Veteran Homes who have a sharing agreement with the VA and have elected options 2, 3 or 4 (VHA IL 10-99-001), and the division of Immigration Health Services that purchases drugs for use in their clinics.
The Federal Ceiling Price (FCP) only applies to Big 4 sales; therefore, manufacturers may offer one price to all FSS customers (FCP or lower), or they can have offer one price for the Big 4 (FCP or lower) and a negotiated FSS price that applies to all other Government agencies.
Yes, all manufacturers must calculate and report the non-Federal Average Manufacturer Prices (non-FAMP) and the Federal Ceiling Price (FCP) for all new covered drugs after one full calendar quarter or sales. The permanent calculated FCP will remain effective until annual pricing updates become effective the following year. No annual non-FAMP report will be required for new drugs that do not have at least one full calendar quarter of sales.
To comply with PL requirements, manufactures must enter in a Master Agreement (MA) and a Pharmaceutical Pricing Agreement (PPA) with the VA, whereby they agree to offer all covered drugs to the Big 4 on their VA Federal Supply Schedule contracts at no more than their calculated Federal Ceiling Price. The MA is Evergreen and the terms and conditions are the same for every manufacturer. The PPA Addendum A must be revised annually.
If a manufacturer does not comply with the requirements of Public Law 102-585, it is not only precluded from selling to the Big 4, but it is also prevented from receiving payment for the purchase of covered drugs from buyers under Medicaid, or any entities that receive funders under the Public Health Service Act.
The Pharmaceutical Pricing Agreement and modification to update contract pricing go in to effect January 1 of each year. See the Public Law 102-585, Veterans Health Care Act of 1992 page for additional information on the annual Public Law process.
For non-transferred covered drugs, they can only be deleted from contract upon confirmation that all stock has been completely exhausted from the supply chain and/or inventory (i.e. upon expiration of the last lot manufactured, or upon confirmation that all wholesalers have a “0” count of the drug with all of their distribution centers). Transferred covered drugs can be deleted from the transferor’s contract once they are added to the transferee’s contract. See the 10/15/1997 Dear Manufacturer Letter issued by the Office of General Counsel for additional information in this regard. However, if the transferee does not obtain the right to market the transferor’s labeler code, then the transferor’s labeler code NDCs must remain on the transferor’s contract.
If a drug manufacturer has a covered drug that is routed outside of the Pharmaceutical Prime Vendor programs through either a specialty pharmacy or specialty distributor, this information must be communicated to the VA’s PBM and FSS offices so that the appropriate contracting actions can be taken by the VA. Please note that the drug manufacturer will be responsible for ensuring that specialty pharmacy/specialty distributor complies with the terms and conditions of the manufacturer’s FSS contract when filling prescriptions/accepting and filling orders.
After reviewing information from DHS/ICE, on April 25, 2012, VA’s General Counsel issued a memo to VA’s Office of Acquisitions, Logistics, and Construction, stating that DHS/ICE’s Health Service Corps is not entitled to receive FCPs on covered drug orders. They no longer are considered to be a functional element of the Public Health Service (PHS or HRSA), one of the statutory beneficiaries of FCPs. (DHS is not a statutory beneficiary of FCPs.)
Based on VA’s October 2009 “Dear Manufacturer Letter” and 2009 posted “FAQ” answers, VA’s P.L. 102-585 § 603, Policy Group has concluded that TRRx utilization data from all calendar quarters of 2008 and calendar quarters 1 & 2 of 2009 should have no place in 2012 non-FAMP computations. In other words, this old TRRx utilization need not be excluded from 2012 non-FAMP-eligible sales totals.
This report is for your reference only. You should verify that all applicable covered drugs are already on contract and that they are listed at the correct price. Work with your assigned contract specialist and PBM to fix any error identified on the report.
Our intent is to provide all contractors with their FCP calculations spreadsheet prior to the modification submission deadline; however, this is not always the case. If you have not yet received this email then you need to:
The full text of this clause is available in Exhibit 02 of the current 65 I B solicitation.
For purposes of PL 102-585 pricing updates, 2014 is considered the “first year”. This means that the Consumer Price Index (CPI-U) will not be factored into your firm's non-FAMP pricing, nor will it serve as the cap to your updated pricing. As such, this year’s Public Law price analysis mirrors that of a standard price change request — we will review your previous commercial price list(s) to verify any price changes to items and make a fair & reasonable price determination.
Submit your 2009 commercial price list.
Insert the authorized signatory’s name on page 4 of the RFM.
The your Summary of Award & any executed modification documentation related to items subject to PL 102-585 identify your tracking customer and ratio by individual line item.
Yes, we recommend you submit this information as it allows your contract specialist to review your documentation and work with you to correct any errors.
Yes, if your products have both FCP increases and decreases then you must complete both the Price Reduction & the Price Increase sections of the RFM.
Yes, we recommend that you include all covered drugs as the Addendum sets forth all FCPs. Work with your assigned contract specialist to update the PPA to include new drugs and for instructions on how to handle partially exempt drugs.
Submit a product addition modification through the FSS Help Desk. Do not include these NDCs in your Public Law pricing update mod request as these products are not subject to the year-end pricing update process.
As this is the first year there is no limit on any potential price increase. To increase your price we need to review your commercial list price to determine price reasonableness.