Targeting Generic Drug Prices

Merle DeLanceyJames Staiger, Jennifer Daniels

For years, states and the federal government focused their drug pricing enforcement efforts on higher priced and more expensive branded drugs. Not surprisingly, private qui tam lawyers followed on the coattails of these government enforcement efforts. The focus on branded drugs was not wrongheaded. States, the federal government, and qui tam plaintiffs were handsomely rewarded for such efforts, as in the multiple Average Wholesale Price (“AWP”) cases against brand manufacturers. However, while regulators focused on brands, they subsequently found that the pricing for generic drugs had increased unimpeded. In more recent years, the focus has shifted to generic drug price increases. For example, effective for the first time at the start of 2017, the Medicaid Program applied an inflation penalty component to Medicaid rebate payments for generic drugs. Historically, the inflation penalty applied only to branded drugs. The inflation penalty provides that when a drug’s price increases faster than the increases in the Consumer Price Index for All Urban Consumers, a manufacturer is required to pay an additional Medicaid rebate amount to state Medicaid programs. Continue reading “Targeting Generic Drug Prices”

How Is Your Domestic Preference Compliance? President Trump Signals More Scrutiny of “Buy American, Hire American” Practices

Justin A. Chiarodo and Stephanie M. Harden

President Trump signed an Executive Order yesterday, marking another step forward in his promotion of “Buy American” and “Hire American” policies. The Executive Order focuses on two areas: cracking down abuse of the H-1B guest worker program and promoting the purchase of American products in federal procurements. We tackle in this post the “Buy American” portion of the Executive Order, which is of particular importance to federal contractors. Continue reading “How Is Your Domestic Preference Compliance? President Trump Signals More Scrutiny of “Buy American, Hire American” Practices”

President Trump Rolls Back Obama-Era Fair Pay and Safe Workplaces Rule

Stephanie M. Harden and Alexander H. Berman

On Monday, March 27, President Trump exercised his authority under the Congressional Review Act (“CRA”) to nullify the Obama-era Fair Pay and Safe Workplaces Rule, which was promulgated pursuant to President Obama’s 2014 Executive Order 13673. The rollback, which has been much anticipated by the contracting community, is part of a push by the Trump administration and the 115th Congress to scale back a number of contracting regulations that were put into effect under the Obama administration (for more on this topic, see our prior post here).

President Trump’s March 27th signing of the resolution—which effectively removes the rule from the books—follows the passage of a joint disapproval of the rule by the House and Senate. Though the rule’s reporting requirements and arbitration prohibitions had already been blocked in October 2016 by a district judge in the Eastern District of Texas, the CRA resolution, now bearing a Presidential signature, fully nullifies the entire rule and all of its requirements on federal contractors—including its paycheck transparency provisions, which were previously left intact by the court in Texas. Indeed, pursuant to the CRA, a rule that is nullified using this process “shall be treated as though such rule had never taken effect.” 5 U.S.C. § 801(f). Continue reading “President Trump Rolls Back Obama-Era Fair Pay and Safe Workplaces Rule”

How a Clinton-Era Law Could Reduce Regulations on Government Contractors under President Trump

Justin 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”

Managing the Export Controls Minefield (Part 1 in a Series)

David Yang and Christian N. Curran 

yangcurranDespite recent political shifts away from globalization, international trade remains a bedrock of the U.S. economy, and companies doing business in the United States must be cognizant of the intricate set of export control regulations promulgated by the U.S. government. In today’s rapidly changing economy, it is more important than ever for companies to thoroughly assess their connections to the international marketplace. While the Obama Administration took strides toward simplifying the export control process, U.S. export control regulations remain complex due to the multiple government stakeholders involved, resulting in varying interpretations, policies, and agendas. Export control violations can still carry serious ramifications for a company’s business practices both inside and outside the United States. Accordingly, the first of this three part series begins by identifying whether your business may be subject to the U.S. export controls regime. Our next two installments will then, respectively, address: (Part 2) practical strategies for addressing risk mitigation; and (Part 3) enforcement actions by the government. Continue reading “Managing the Export Controls Minefield (Part 1 in a Series)”

DHS Contractor? Pricey New Cybersecurity Requirements (and Hidden Risks) May Await You

Justin Chiarodo

Justin A. ChiarodoThe Department of Homeland Security (“DHS”) recently issued three new proposed cybersecurity regulations for DHS contractors which warrant careful attention. Although a freeze on new regulations by the Trump administration will likely delay any final agency action, and extensive comments and meaningful changes to any final rules are expected, these new regulations could radically impact the compliance landscape for DHS contractors. As with recent cybersecurity amendments to the Federal Acquisition Regulation (“FAR”) and Defense Federal Acquisition Regulation Supplement (“DFARS”) (which we’ve covered here and here), these proposed rules seek to impose more safeguarding, handling, reporting, and training requirements on covered contractors. We continue to see cybersecurity as a major business risk in the industry today, and recommend contractors pay close attention to their operational, technology, and risk management practices relating to cybersecurity. We highlight the key elements of the proposed rules below. Continue reading “DHS Contractor? Pricey New Cybersecurity Requirements (and Hidden Risks) May Await You”

Does Your Cybersecurity Program Satisfy Recent DFARS Amendments?

Justin Chiarodo

There is no question cybersecurity is a critical compliance and risk area for federal contractors. A seemingly endless stream of cyberattacks—on corporate databases, government servers, even baby monitors—shows the breadth of these problems and the need for action. Government contractors have the added challenge of specialized regulatory obligations, with compliance (or non-compliance) having a direct impact on the value of their business. Continue reading “Does Your Cybersecurity Program Satisfy Recent DFARS Amendments?”