Merle M. DeLancey Jr. and Craig Stetson*
This is the first in a series of blog posts concerning the audits and investigations related to the contracts and grants awarded, and relief funds provided, in response to the COVID-19 pandemic. As of February 2021, pursuant to the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), which created the Paycheck Protection Program (“PPP”) and supplemental funding such as the Families First Coronavirus Response Act, the United States government has made available an estimated four trillion dollars in relief funds to businesses and individuals, and the Biden administration is proposing roughly two trillion dollars more.
In addition to the relief funds, the Government has easily awarded more than billions in pandemic-related contracts for everything from vaccines to PPE to hand sanitizers. These levels of funding and spending are unprecedented and have been made at breakneck speed (for the government). Based on these factors and lessons from the past, audits of relief recipients and contractors to confirm appropriate use of government funds are inevitable. And the government has said as much. Of course, if an audit reveals potential wrongdoing or malfeasance, relief recipients and contractors should expect follow-on investigations and enforcement activity.
This first post identifies the myriad of entities that are or will be reviewing—and potentially investigating—relief recipient and contractor representations made to obtain, and subsequent use of, government funds.
Continue reading “COVID Audits and Investigations: The Enforcers”
Merle M. DeLancey Jr., Jay P. Lessler, and James R. Staiger
The Federal Circuit’s recent decision in Acetris has left many contractors scratching their heads and asking questions. To recap, on February 10, 2020, the Federal Circuit held that, under the Federal Acquisition Regulation (“FAR”), to qualify as a “U.S.-made end product” under the Trade Agreements Act (“TAA”), a drug must be either “manufactured” in the United States or “substantially transformed” in the United States. (See Federal Circuit Holds Generic Drugs Manufactured in the U.S. from API Produced in India Qualify for Sale to U.S. under Trade Agreements Act (Acetris Decision).) This is a stark change from the Government’s long-held position that manufacturing and substantial transformation were one in the same.
As a result of the Acetris decision, federal contractors seeking to comply with or maintain compliance with the TAA are facing many questions. Some of the more prominent questions are below. Continue reading “After Acetris Decision, Trade Agreements Act Compliance Questions Abound: Contractors Need Guidance”
Merle M. DeLancey Jr., Jay P. Lessler, and James R. Staiger
Earlier today, the United States Court of Appeals for the Federal Circuit issued a decision that is sure to send shockwaves through the generic drug industry. In Acetris, the Federal Circuit held that a generic drug manufactured in the United States complied with the Trade Agreements Act (“TAA”) and could be sold to the Department of Veterans Affairs. The court made this determination even though the drug’s active pharmaceutical ingredient (“API”) came from a non-designated country, India. In reaching its decision, the court broke away from longstanding Customs and Border Protection (“CBP”) precedent that the country where the API was produced dictated the location of “substantial transformation” and thus the country of origin for any resulting drug. The court held that under the Federal Acquisition Regulation (“FAR”), to qualify as a “U.S.-made end product” under the TAA, a drug must be either “manufactured” in the United States or “substantially transformed” in the United States—but not be both.
For years, generic drug manufacturers that manufacture drugs in the United States from API produced in India and China have been precluded from selling their drugs to the U.S. Government under the TAA. The Federal Circuit’s Acetris decision opens up the U.S. Government market for generic drugs manufactured in the U.S. from API produced in India and China.
Dominique L. Casimir
Contractors are well aware that being suspended or debarred renders them ineligible for federal contracts and subcontracts. Many contractors may believe that suspension and debarment are not realistic risks for them if they already have a robust ethics and compliance program or strong internal controls. Nevertheless, the risk of suspension and debarment can crop up suddenly and unexpectedly, such as when misconduct has been concealed or errors have gone undetected. For this reason, contractors should have a baseline understanding about what to do if they must engage with a Suspending and Debarring Official (“SDO”). This post explores ten common misconceptions about suspension and debarment, with the aim of helping contractors understand the landscape and respond effectively.
Common Misconception #1: We have already settled with another agency and paid a fine, so we will not be suspended or debarred. Continue reading “Examining and Dispelling Common Misconceptions about Suspension and Debarment”
Robyn N. Burrows
The Supreme Court in Food Marketing Institute v. Argus Leader Media, No. 18-481 (U.S. June 24, 2019) recently relaxed the standard for withholding confidential information under Exemption 4 of the Freedom of Information Act (“FOIA”)—a major win for contractors that regularly submit sensitive business information to the government.
Exemption 4 protects from disclosure trade secrets and commercial or financial information that is privileged or confidential. For the past 45 years, courts have been guided by the stringent “competitive harm” test first enunciated in National Parks & Conservation Association v. Morton, 498 F.2d 765 (D.C. Cir. 1974). This test allowed an agency to withhold information as “confidential” only if disclosure would (1) impair the government’s ability to obtain necessary information in the future, or (2) cause substantial harm to the competitive position of the person from whom the information was obtained. Many businesses objected to this test as overly burdensome and causing confusion about the showing required to establish substantial competitive harm. Continue reading “The Supreme Court Expands the Meaning of “Confidential” Information under FOIA Exemption 4”
Brian S. Gocial and Stephanie M. Harden
As government contractors know well, a robust compliance program can be critical—both in preventing, detecting, and resolving compliance problems and in working with agencies and/or the Department of Justice (“DOJ”) to resolve compliance issues when they arise. Though DOJ has previously issued guidance on how it evaluates corporate compliance programs, on April 30, 2019, it greatly expanded upon its earlier guidance with a lengthy new guidance document. The document is notable for its emphasis not just on the design of compliance programs, but also on their effectiveness in practice. The document is a useful benchmark for contractors to evaluate their compliance programs, as well as to demonstrate their affirmative responsibility to agencies when facing agency-level investigations.
The guidance document focuses on three central questions:
- Is the corporation’s compliance program well designed?
- Is the corporation’s compliance program implemented effectively?
- Does the compliance program actually work in practice?
The following outline provides a summary of the various factors DOJ discusses in connection with each of these questions—and more information on each topic can be found here.
Contractors should assess how their own compliance programs measure up against these factors: Continue reading “What Contractors Should Know about DOJ’s Revised Guidance on Evaluations of Corporate Compliance”
Merle M. DeLancey Jr.
If you’re like me, it’s the time of year when you clean out your garage and closets and do all those outside projects you delayed until the weather warmed up. If you are a government contractor, you should consider this to be the season to do some spring cleaning in terms of your government contract compliance programs and procedures. Not to be an alarmist, but there are numerous areas you can review now and, if you should find some compliance deficiencies, you still have ample time to get your house in order before an agency audit or the deadline for submission of certain government reports.
Set forth below is a list of areas you may want to clean up: Continue reading “Spring Cleaning for Government Contractors? Think Compliance.”
Merle M. DeLancey Jr.
On March 25, 2019, the Office of Federal Contract Compliance Programs (“OFCCP”) issued a Corporate Scheduling Announcement List (“CSAL”) for FY 2019. As it announced in February, OFCCP changed how it notifies government prime contractors and subcontractors that they may be subject to a compliance review. Rather than sending the traditional advanced notification letters, OFCCP posted the FY 2019 CSAL on its website. In addition to the CSAL, OFCCP also posted its Scheduling Methodology, CSAL Frequently Asked Questions (“FAQs”), Corporate Management Compliance Evaluation (“CMCE”) FAQs, and a link to its Section 503 Focused Review page.
OFCCP significantly increased the number of contractors potentially subject to review to more than 3,500. OFCCP’s CSALs for FY 2018 and 2017 identified 1,003 and 802 contractors, respectively. Continue reading “OFCCP Releases FY 2019 CSAL”
Justin A. Chiarodo and Philip Beshara
It is no secret that deregulation is a top priority for the Trump Administration and the Republican-led Congress. In the early weeks of governing together, President Trump and House Speaker Paul Ryan have dusted off the Congressional Review Act (“CRA”) as the tool of choice for undoing federal rules and regulatory initiatives implemented by the Obama Administration. The little-known but important law, enacted by President Clinton in 1996, provides Congress with the ability to enact legislation overturning certain federal agency rules. In the more than two decades on the books, the CRA has only been used to overturn a federal rule on one occasion when, in 2001, President George W. Bush signed a resolution overturning an ergonomics rule issued by the preceding administration. However, despite its past obscurity, the CRA is now more important than ever. Continue reading “How a Clinton-Era Law Could Reduce Regulations on Government Contractors under President Trump”
Justin A. Chiarodo and Philip Beshara
The government recently issued long-awaited amendments to the National Industrial Security Program Operating Manual (“NISPOM”). The amendments, known as Conforming Change 2, are targeted at combating insider threats and impose several new requirements warranting immediate action by contractors holding facility clearances.
There are four key elements to Change 2: (1) a mandated Insider Threat Program (“ITP”); (2) new cyber incident reporting requirements; (3) newly defined NISPOM components; and, (4) an updated standard for foreign-owned or controlled companies seeking access to proscribed information. We summarized these changes and provide implementation suggestions below.
I. Insider Threat – Mandated Insider Threat Program
Change 2 requires cleared contractors to have a written Insider Threat Program plan no later than November 30, 2016. The ITP must detect, deter, and mitigate insider threats consistent with the ITP requirements currently imposed on executive branch agencies (as set forth in Executive Order 13587 and the National Insider Threat Policy and Minimum Standards for Executive Branch Insider Threat Programs). Continue reading “NISPOM Conforming Change 2: What You Need to Know”