Category: Merle M. DeLancey Jr.

Trade Agreements Act Compliance: Some Welcome News for Some Federal Contractors, But Will It Last?

Merle M. DeLancey Jr.

Recently, the United States District Court for the District of Columbia dismissed a qui tam action involving allegations of fraud in connection with country of origin requirements imposed by the Trade Agreements Act (“TAA”). United States ex rel. Folliard v. Comstor Corp., 308 F.Supp.3d 56 (D.D.C. 2018).

Comstor involved a False Claims Act (“FCA”) action filed by a serial whistleblower who alleged two contractors violated the FCA by selling non-TAA compliant products on their General Services Administration (“GSA”) Federal Supply Schedule (“FSS”) contracts to federal government customers. Depending on the dollar value of the acquisition, most procurements are subject to either the Buy American Act (“BAA”) or TAA. Currently (2018), the BAA applies to supply procurements valued at or below $180,000. Accordingly, the TAA currently applies to such procurements valued in excess of $180,000. GSA has determined the TAA applies to FSS contracts. Continue reading “Trade Agreements Act Compliance: Some Welcome News for Some Federal Contractors, But Will It Last?”

New Medicaid Rebate Agreement

Merle M. DeLancey Jr.

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 Jr.

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”

Compounding Pharmacies Should Expect Greater Scrutiny as Government Healthcare Budgets Get Squeezed

Merle M. DeLancey Jr.

As Congress continues to grapple over healthcare reform, there are many uncertainties. However, one thing is clear: as government healthcare funding shrinks, federal and state enforcement agencies will continue to target compounding pharmacies for potential fraud.

Compounded drug use and related government spending, particularly on topical creams and ointments, has skyrocketed. Many argue that drug compounding regulation remains murky, making it too easy to prosecute traditional compounders. Compounding advocates suggest regulation of compounders has been heavy-handed and ignores the multiple benefits associated with compounding. Continue reading “Compounding Pharmacies Should Expect Greater Scrutiny as Government Healthcare Budgets Get Squeezed”

Targeting Generic Drug Prices

Merle M. DeLancey Jr., James R. Staiger, and Jennifer J. 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”

DOJ’s New Healthcare Fraud Target—Medicare Advantage Insurers

Merle M. DeLancey Jr.

The government continues to seek ways to rein in healthcare costs. Now it has set its sights on the Medicare Advantage Program. Medicare Advantage Plans, sometimes called “Part C” or “MA Plans,” are offered by private companies approved by Medicare. If you join a Medicare Advantage Plan, you still have Medicare, but you get your Medicare Part A (Hospital Insurance) and Medicare Part B (Medical Insurance) coverage from the Medicare Advantage Plan and not original Medicare. Medicare Advantage Plans may also offer extra coverage like dental, vision, hearing, and wellness programs. Continue reading “DOJ’s New Healthcare Fraud Target—Medicare Advantage Insurers”

Critical GAO Bid Protest Deadlines and Timeline

Merle M. DeLancey Jr.

Almost daily, clients call our office seeking to protest the award of a federal government contract. Unfortunately, sometimes these calls are too late. While contracts can be protested at the agency level, the Court of Federal Claims, and the Government Accountability Office (“GAO”), GAO protests are the most common. The deadlines by which a protester must take certain actions to file a timely protest are confusing. Below we address some of the trickier and/or mandatory deadlines a potential protester must meet to file a timely protest, and we provide a useful sample timeline for protesters to follow during this critical process. Continue reading “Critical GAO Bid Protest Deadlines and Timeline”

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