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Alex Hastings advises clients across a broad range of government contracting issues, including advising clients in transactional matters involving government contractors and assisting defense contractors and pharmaceutical companies in securing and performing government contracts.

Mr. Hastings also advises clients concerning best practices in e-discovery. He assists in investigations and litigations that involve complex e-discovery issues and has represented clients in matters involving the U.S. Department of Justice, Securities and Exchange Commission and the United States International Trade Commission.

Mr. Hastings’ government contracts experience includes advising clients regarding new developments in regulatory requirements, including the Federal Acquisition Regulation’s (FAR) anti-human trafficking requirements and the FAR and Bayh-Dole Act’s intellectual property provisions. Mr. Hastings also provides due diligence regulatory advice to clients contemplating the acquisition of government contracting entities or assets.

Mr. Hastings’ e-discovery experience includes advising a wide-array of clients on best practices in information governance and document collection and assisting clients develop effective mobile device and document management policies.

Mr. Hastings also maintains an active pro bono practice and routinely writes on issues related to government contracts and e-discovery.

 

Over the last few weeks, much attention has been paid to California’s recently enacted SB 17, legislation that requires pharmaceutical manufacturers to report certain price increases of prescription drugs and, in some cases, provide a justification for such increases. The legislation also requires health insurers and health plans to report additional rate information to state agencies. California’s push to impose disclosure of prescription drug pricing information is part of a growing trend of proposed and enacted legislation across the country purportedly aimed at increased price transparency and control.
Continue Reading California Law Aims to Scrutinize Drug Pricing

The U.S. Government’s research and development (“R&D”) spending is on the rise.  For instance, the U.S. Government spent $139 billion in on R&D in FY 2015 and approximately $148 billion in FY 2016.  It is slated to spend as much as $154 billion on R&D in FY 2017.  With this funding comes great opportunities

In its Report on the National Defense Authorization Act for Fiscal Year 2018, the Senate Armed Services Committee (the “Committee”) included an “Item of Special Interest” directing the DoD to exercise its rights under the Bayh-Dole Act “to authorize third parties to use inventions that benefited from DOD funding whenever the price of a drug, vaccine, or other medical technology is higher in the United States” as compared to prices in foreign countries.  This directive does not have the force of law, and was included as an item of special interest after an amendment to incorporate the clause into the NDAA failed.  However, it represents an example of efforts to use the Bayh-Dole Act to influence drug product pricing. 
Continue Reading Senate Committee Directs DoD to Reduce Drug Prices

The Department of State has released its 2017 Trafficking in Persons (“TIP”) Report.  As with prior versions of the annual report, the State Department reviewed efforts made by more than 180 countries to address the minimum Prosecutorial, Protective, and Preventative standards necessary for effective anti-trafficking measures, as these standards are outlined in the United States’ Trafficking Victims Protection Act (“TVPA”).

The release of the report is notable because it can directly impact contractors’ diligence obligations for supply chain review under the Federal Acquisition Regulation (“FAR”) Human Trafficking Rule (located at FAR § 52.222-50).  As we have highlighted in previous articles, for those contractors required to submit compliance plans to the government, such plans should be appropriately shaped to the “nature and scope of activities to be performed for the Government . . .  and the risk that the contract or subcontract will involve services or supplies susceptible to trafficking in persons.”  See FAR § 52.222-50(h)(2)(ii).  Additionally, as set forth in a recent proposed memorandum, which remains the clearest articulation of the government’s views on supply chain diligence obligations to date (covered in a prior post), contractors are expected to take steps to “identify high-risk portions of [their] supply chain[s].”


Continue Reading Department of State Releases 2017 TIP Report

The Section 809 Panel recently released an interim report and supplement (the “Interim Report”) advocating in broad strokes for a host of improvements to the Department of Defense’s (“DoD”) acquisition system to better streamline the process and increase industry offerings to the government.  The NDAA for FY 2016 established the Section 809 Panel to address “fundamental problem[s]” in the means by which the DoD acquires goods and services to support its warfighters.  Indeed, in meeting with over 200 government and industry representatives, the Interim Report found that the DoD’s acquisition system creates obstacles that make it unattractive for small and large businesses alike to offer their goods and services to the government.  The Interim Report explains that “the United States’ ability to maintain technological, military, and economic superiority is being challenged,” as our adversaries are recognizing vulnerabilities in our forces and modernizing their militaries in response.  Thus, according to the Interim Report, DoD’s acquisition procedures must be improved to achieve “a degree of agility that DoD is not currently able to deliver.”
Continue Reading Section 809 Panel Urges Congress to Bring DoD Spending into the 21st Century

Last Thursday, President Trump and his senior advisors met with representatives of organizations committed to fighting human trafficking. As reported by several news outlets (e.g., AP, NYT, and Reuters), the President stated during the meeting that he would commit the “full force and weight” of the U.S. government against what he views as an “epidemic” of human trafficking around the world.  He explained that he would “direct the Department of Justice, Department of Homeland Security, and other federal agencies that have a role in preventing human trafficking to take a hard look at the resources and personnel that they are currently devoting to this fight.”  He noted that these agencies “are devoting a lot, but we are going to be devoting more.”  The next day, President Trump appeared to reiterate his commitment on Twitter.

Continue Reading Trump’s Commitment Against Human Trafficking Brings Greater Uncertainty for Contractors

On December 7, the Office of Management and Budget, the Department of Labor, and the Office to Monitor and Combat Trafficking in Persons in the Department of State, issued a proposed memorandum titled “Anti-Trafficking Risk Management Best Practices & Mitigation Considerations.”  The document is intended, at least in part, to “promote clarity and consistency in the implementation of anti-trafficking requirements” imposed by Executive Order 13627, Title XVII of the FY 2013 National Defense Authorization Act, and the implementing regulatory provisions applicable to all federal contractors at FAR 22.17 and FAR 52.222-50.  Although the guidance document is in draft form, it is important for contractors to consider closely because it (1) outlines the government’s contemplated expectations on anti-trafficking risk mitigation, and (2) informs agencies that they may immediately take the contents of the memorandum “into consideration in applying the anti-trafficking requirements in the Federal Acquisition Regulation.”

In addition to reiterating the basic requirements of the anti-trafficking FAR rule (which we have covered in other posts), the memorandum outlines a series of “best practices and mitigation considerations” designed to inform contracting officers’ assessments of whether contractors are effectively carrying out their compliance responsibilities.  Although the guidance states that it is “not intended to augment or otherwise change existing regulatory requirements,” it does specify that, in the event the government becomes aware of a trafficking violation, a contractor’s compliance with the practices identified in the guidance are to be construed as mitigating considerations weighing in the contractor’s favor.  
Continue Reading New Guidance on Contractor Risk Management Under the Human Trafficking Rule Released

The Government Accountability Office (“GAO”) recently released a study of the Office of Federal Contract Compliance Program’s (“OFCCP” or the “Agency”) oversight functions for fiscal years 2010 to 2015.  GAO’s report explains that “OFCCP has not found violations in the vast majority of its compliance evaluations,” noting that in the time period GAO studied, OFCCP found violations in 17% of evaluations.  GAO pointed out that OFCCP resolved 99 percent of these violations through agreements between the agency and contractor that outlined remedial measures. 
Continue Reading The GAO Is Not Down With OFCCP: Report Criticizes Agency’s “Weak” Compliance Evaluations and May Trigger Increased Contractor Oversight

Last week, the Federal Acquisition Regulation (“FAR”) Council issued a Final Rule to implement regulations adopted by the Small Business Administration in 2013.  The Final Rule significantly amends FAR Parts 19 and 52 by imposing additional small business-related obligations on prime contractors and clarifying the consequences of failing to satisfy those obligations.  The Final Rule largely tracks the proposed rule, which we previously discussed.  It will be effective November 1, 2016.
Continue Reading Changes to Small Business Subcontracting On the Horizon

Last week, in Universal Health Services Inc. v. U.S. ex rel. Escobar, the Supreme Court unanimously affirmed the viability of the “implied false certification” theory of False Claims Act liability, at least in certain circumstances.  Writing for a unanimous Court, Justice Thomas explained that a defendant can face FCA liability under an implied certification theory where two conditions are satisfied:

  1. The claim asserts a request for payment and makes specific representations about the goods or services provided, and
  2. The failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes those representations misleading half-truths.

This portion of the ruling was not unexpected given the overwhelming acceptance of implied certification among the Circuit courts. But, more importantly, out of concern that the statute be applied too broadly, the Court also explained at length that the “materiality” standard in the statute is a “demanding” one, and set a high bar for the Government and relators to demonstrate materiality of the alleged non-compliance. Indeed, the Court rejected the argument that the materiality of an undisclosed violation of law, regulation, or contract depends entirely on whether the provision in question was designated by the Government as a “condition of payment.”  Instead, the Court explained that the ultimate test is not whether the condition of payment is expressly designated as such, but “whether the defendant knowingly violated a requirement that the defendant knows was material to the Government’s payment decision.”  Op. at 2 (emphasis added).
Continue Reading Supreme Court on False Claims Act: Implied Certification OK, But Materiality Is No Gimme