New DOD Class Deviation Changes Debriefing Process

Scott Arnold

The United States Department of Defense (“DOD”) has amended the process for debriefings required under Federal Acquisition Regulation (“FAR”) 15.506 to allow for offeror questions related to the debriefing. Offerors are allowed up to two business days following a debriefing to submit written questions, and the agency has up to five business days after receipt of the questions to submit written responses. The agency must hold the debriefing open until it delivers its written responses to the disappointed offeror. The new process applies to all DOD debriefings required under FAR 15.506.

The purpose of this new rule implementing section 818 of the 2018 National Defense Authorization Act (“NDAA”) is to improve the quality of debriefings and reduce the number of situations where disappointed offerors feel compelled to protest because the information they receive in debriefings is insufficiently detailed to convince them that the selection decision was fair. More fulsome debriefings should allow offerors to make more informed decisions about whether to protest. Continue reading “New DOD Class Deviation Changes Debriefing Process”

New Medicaid Rebate Agreement

Merle M. DeLancey

On March 23, 2018, the Centers for Medicare & Medicaid Services (“CMS”) announced the introduction of a new Medicaid National Drug Rebate Agreement. The new Agreement incorporates legislative and regulatory changes, including, for example, the Affordable Care Act, which have occurred since the original Agreement was published in 1991.

Manufacturers currently participating in the Medicaid Program have until October 1, 2018, to sign the new Agreement. Failure to enter into a new Agreement by October 1, will result in termination of a manufacturer’s existing Agreement.

While the new Agreement does not contain significant changes from the existing Agreement, several changes are worth noting and repeating: Continue reading “New Medicaid Rebate Agreement”

Do Federal Supply Schedule Contracts Still Have Value?

Merle M. DeLancey

Over the past several months, there has been a confluence of congressional and agency actions that will have a significant impact on Federal Supply Schedule (“FSS”) contract holders. These changes are so significant that they will likely cause companies with FSS contracts to question whether having an FSS makes sense. These changes could also cause companies to restructure the segments of their companies that are responsible for selling to the federal government.

Order Level Materials

In late January 2018, the General Services Administration (“GSA”) issued its Order Level Materials (“OLM”) final rule. This rule allows agencies to purchase supplies or services in direct support of a task or delivery order placed against FSS contract or Blanket Purchase Agreement (“BPA”). OLMs are subject to special ordering procedures. See GSAR 552.238-82. For example, the OLMs cannot have been known when an FSS contract or BPA was awarded. OLMs (excluding travel) cannot exceed 33.33 percent of the total value of the applicable task or delivery order. Whether an FSS holder is required to obtain competitive quotes for an OLM order depends upon the value of the order and the FSS holder’s purchasing system. Continue reading “Do Federal Supply Schedule Contracts Still Have Value?”

The Government’s Use of Data Analytics to Identify Healthcare Fraud

Merle M. DeLancey, Jr.

No one knows exactly how much fraudulent conduct costs the United States healthcare system. Some suggest it may cost Medicare, Medicaid, and private insurers $100 billion each year. Regardless of the exact amount, everyone agrees that the fraudulent activities result in more expensive healthcare and possibly the deprivation of healthcare for some.

The Department of Justice (“DOJ”) and agency inspectors general have recovered billions of dollars based upon demonstrated or alleged healthcare fraud. These cases and investigations, however, have generally been limited to a specific company or class of providers. Government investigators have struggled for years with how to identify fraudulent practices in government healthcare programs involving large volumes of claims. Continue reading “The Government’s Use of Data Analytics to Identify Healthcare Fraud”

Buy American, Hire American: Will It Impact a Government Contractor’s Ability to Store Data Offshore?

Merle M. DeLancey, Jr. and Lyndsay A. Gorton

Buy American and hire American. The concept is easy, but the implementation can be far more complicated, particularly in the current government contracting world where waivers to those requirements have become common. In an attempt to strengthen the commitment to buying American and hiring American, on January 26, 2018, a bipartisan group of ten Senators sent a letter to President Trump urging him to “keep the promises” that he had made in April 2017 to buy American and hire American. The letter follows Senators Rob Portman (R-OH), Sherrod Brown (D-OH), Lindsey Graham (R-SC), and Chris Murphy’s (D-CT) introduction of the bipartisan BuyAmerican.gov Act of 2018 on January 9, 2018. This new legislation seems to be an effort to codify President Trump’s April 18, 2017, Buy American and Hire American Executive Order (the Executive Order), and slow what the BuyAmerican.gov Act Press Release calls the “excessive number of waivers” to the Buy American laws. Since President Trump signed the Executive Order, much has been written about the potential effects of that Executive Order. However, the potential impacts on government contractors who maintain or store data relating to their performance of federal government contracts have been largely disregarded. Continue reading “Buy American, Hire American: Will It Impact a Government Contractor’s Ability to Store Data Offshore?”

2017 Was a Busy Year for State Imposition of Drug Manufacturer Price Disclosure Obligations and 2018 Isn’t Looking Much Better

Merle M. Delancey, Jr.

Although several bills were introduced in Congress and President Trump has complained that drug prices are way too high, during 2017, the federal government did not pass any law nor implement any policy requiring drug manufacturers to disclose information concerning price increases. As a result, state legislatures have stepped in to fill this void. Unlike Congress, state legislatures have been much more aggressive in taking on drug price increases. Continue reading “2017 Was a Busy Year for State Imposition of Drug Manufacturer Price Disclosure Obligations and 2018 Isn’t Looking Much Better”

Navigating Violations in the Export Controls Minefield (Part 3 in a Series)

David Yang

In the first two parts of this series, we covered companies’ obligations under U.S. export control laws, such as the Export Administration Regulations (“EAR”) governed by the Department of Commerce, Bureau of Industry and Security (“BIS”), and military or defense exports governed by the International Traffic in Arms Regulations (“ITAR”) under the auspices of the State Department’s Directorate of Defense Trade Controls (“DDTC”), and common ways to mitigate your organization’s risk against violations. Unfortunately, no compliance program can prevent all violations, and this final part of our series addresses the key considerations your organization should keep in mind in the event you discover that an apparent violation may have occurred. How your company addresses apparent violations are as important as anything else, because they end up determining the repercussions that your organization may face from these and other enforcement agencies. Continue reading “Navigating Violations in the Export Controls Minefield (Part 3 in a Series)”