Breadcrumb

Manufacturers Failed to Make Some Drugs Available to Government Agencies at a Discount as Required

Report Information

Issue Date
Report Number
22-01624-143
VISN
1
State
District
Continental
VA Office
Veterans Health Administration (VHA)
Report Author
Office of Audits and Evaluations
Report Type
Review
Major Management Challenges
Benefits for Veterans
Recommendations
8
Questioned Costs
$0
Better Use of Funds
$0
Congressionally Mandated
No

Summary

Summary

The Veterans Health Care Act of 1992, passed to help control the cost of pharmaceuticals purchased by the federal government, mandates that manufacturers discount drugs they sell to VA, the Department of Defense (DOD), the Public Health Service, and the Coast Guard. In return, manufacturers gain the business of supplying the largest government agencies with needed drugs and become eligible to participate in and receive funds from federal government-funded programs including Medicare and Medicaid. The public law places responsibility for compliance on manufacturers. If they do not offer their drugs as required by the law, the government cannot purchase much-needed drugs at lower prices. The OIG found manufacturers did not make 22.8 percent of drugs covered by the law available on the Federal Supply Schedule as required by the public law. This resulted in an estimated $28.1 million in overcharges to VA and the DOD. To reduce noncompliance and keep drugs more affordable, the OIG made eight recommendations including communicating exemptions given to makers of certain classes of drugs, conveying the process for requesting exemptions, and formalizing the internal process for granting exemptions. VA should also follow up with makers of the covered drugs identified in the report as not commercially sold in the event they have become available, or newly launched to ensure they have an established annual ceiling price and are available on the FSS. VA should also request self-audits by noncompliant manufacturers identified by the OIG.

Open Recommendation Image, SquareOpenClosed and Implemented Recommendation Image, CheckmarkClosed-ImplementedNot Implemented Recommendation Image, X character'Closed-Not Implemented
No. 1
Open Recommendation Image, Square
to Acquisitions, Logistics, and Construction (OALC),Veterans Health Administration (VHA)
Issue guidance clarifying that allergens are exempt from the public law and include how the determination was reached.
No. 2
Open Recommendation Image, Square
to Acquisitions, Logistics, and Construction (OALC),Veterans Health Administration (VHA)
Formalize and communicate the process for manufacturers to request exemptions.
No. 3
Open Recommendation Image, Square
to Acquisitions, Logistics, and Construction (OALC),Veterans Health Administration (VHA)
Formalize the internal process for granting exemptions.
No. 4
Open Recommendation Image, Square
to Acquisitions, Logistics, and Construction (OALC),Veterans Health Administration (VHA)
Establish a procedure for monitoring covered drugs identified in this report as not commercially sold.
No. 5
Open Recommendation Image, Square
to Acquisitions, Logistics, and Construction (OALC),Veterans Health Administration (VHA)
Develop a procedure to monitor covered drugs identified in this report as newly launched to ensure they have an established ceiling price, and make certain they are made available on the Federal Supply Schedule at the end of the 75-day period.
No. 6
Open Recommendation Image, Square
to Acquisitions, Logistics, and Construction (OALC),Veterans Health Administration (VHA)
Request that noncompliant manufacturers identified by the Office of Inspector General conduct a self-audit and submit their findings for remediation.
No. 7
Open Recommendation Image, Square
to Acquisitions, Logistics, and Construction (OALC),Veterans Health Administration (VHA)
Engage with the Food and Drug Administration to ensure that when manufacturers request new national drug codes, they are made aware of the public law requirements.
No. 8
Open Recommendation Image, Square
to Acquisitions, Logistics, and Construction (OALC)
Require contracting staff at the National Acquisition Center to conduct a covered drug check for all of a manufacturer’s drugs when any pharmaceutical Federal Supply Schedule proposal or product addition modification is submitted.
Total Monetary Impact of All Recommendations
Open: $ 28,100,000.00
Closed: $ 0.00