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”

DOJ’s New Healthcare Fraud Target—Medicare Advantage Insurers

Merle DeLancey

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”

GSA’s Transactional Data Reporting Rule Ushers in a New Era

Merle M. DeLancey Jr.Justin Chiarodo and Philip Beshara

Merle DelanceyJustin A. Chiarodo CC2030E479B404E304DCCE7B55CFAC26

Last month, the General Services Administration (“GSA”) finalized a rule marking what the agency describes as the most significant development to its Schedules program in over two decades. The rule completely changes how GSA will analyze vendor pricing for products and services.

Under the rule, vendors will eventually be required to submit monthly transactional data reports with information related to orders and prices under certain GSA Schedule contracts and other vehicles. Along with the implementation of the new Transactional Data Reporting (“TDR”) requirement, GSA will relieve vendors from two preexisting compliance burdens—eliminating the Commercial Sales Practices (“CSP”) and Price Reductions Clause (“PRC”) reporting requirements when vendors begin submitting transactional data.

While vendors should welcome the relief provided from the elimination of two burdensome regulations, the shift to TDR will not be without cost and risk; and, the eventual efficiencies promised by GSA remain to be seen. Indeed, the impact of the change will likely extend beyond compliance burdens, with potential effects varying from the nature of False Claims Act suits to the potential publication of competitive information.

We summarize these and other key takeaways from the new rule below, and answer questions important to vendors as GSA rolls out this significant development. Continue reading “GSA’s Transactional Data Reporting Rule Ushers in a New Era”

How UHS v. U.S. ex rel. Escobar Will Impact Government Contractors

David Yang and Christian N. Curran

David YangChristian N. CurranOn June 16, 2016, the Supreme Court issued its decision in Universal Health Services, Inc. v. United States ex rel. Escobar, holding that “implied certification” is a valid theory of liability under the False Claims Act (“FCA”), and further concluding that a failure to comply with a contract requirement, regulation, or statute may support a false claims case even if the provision is not an “express condition of payment.” While the unanimous opinion settles the debate over the viability of the implied certification theory, its reliance on a subjective materiality standard will likely make FCA cases more difficult to resolve on the pleadings and also increase the number of FCA cases filed. Continue reading “How UHS v. U.S. ex rel. Escobar Will Impact Government Contractors”

Supreme Court to Hear Important False Claims Act Case

Adam Proujansky

Lasproujanskyt week, the Supreme Court granted certiorari to resolve an important issue for government contractors that has split the lower courts:  what standard governs whether a court should dismiss a False Claims Act (“FCA”) lawsuit
brought against a government contractor by a private qui tam relator because the relator violated the FCA seal requirement.

The FCA sets forth a number of procedural requirements for a qui tam action, including that a relator’s complaint “shall be filed in camera, shall remain under seal for at least 60 days, and shall not be served on the defendant until the court so orders.” 31 U.S.C. § 3730(b)(2).  This seal requirement gives the Government a chance to investigate the claim and determine whether to intervene in the qui tam action and/or bring criminal charges against the defendant, and prevents reputational harm to the defendant while the investigation takes place.  Although the statute provides that the complaint shall remain under seal for at least 60 days, the time may be extended, and the complaint often remains under seal for months or even years.  During this potentially lengthy sealing period, relators sometimes intentionally or inadvertently violate the seal and disclose the lawsuit.  When this happens, defendants invariably move for dismissal of the qui tam action for violation of this statutory requirement. Continue reading “Supreme Court to Hear Important False Claims Act Case”

Supreme Court to Resolve Circuit Split, Decide Viability of Plaintiff-Friendly Implied Certification Theory for FCA Liability

Daniel Broderick

BroderickDWith the filing of relators’ brief in United Health Services, the Supreme Court is one step closer to resolving one of the most controversial issues in False Claims Act (“FCA”) jurisprudence:  whether “implied certification” is a valid liability theory under the FCA.

Under the implied certification theory, the plaintiff may allege that, by submitting any claim for payment to the government, a contractor impliedly certifies compliance with all applicable statutory, regulatory, and contractual requirements.  Thus, under this theory, even where the contractor provided all of the goods and services for which it seeks payment, the government is allegedly wronged because it would not have paid for the items or service if it was aware of the contractor’s noncompliance with these other requirements.

Because the FCA makes it unlawful to knowingly submit a false or fraudulent claim for payment to the government—and imposes treble damages plus civil penalties ranging from $5,500 to $11,000 per claim—plaintiffs  are strongly incentivized to assert the “implied certification” theory, which does not require the more difficult showing of an express false statement.  Not surprisingly, the aggressive use of the implied certification theory has contributed to much of the recent increase in government enforcement actions and billions of dollars in recovery, including by settlements designed to avoid the legal uncertainty and the potentially significant damages and penalties under the FCA.  The Supreme Court agreed in December to hear the case to resolve a circuit split as to whether implied certification is viable. Continue reading “Supreme Court to Resolve Circuit Split, Decide Viability of Plaintiff-Friendly Implied Certification Theory for FCA Liability”

Sixth Circuit Brings False Claims Act Damages Back Down to Earth

Heather L. Petrovich

In a welcomed decision, the Sixth Circuit placed sensible parameters on damages in False Claims Act (“FCA”) cases, which will significantly reduce exposure for contractors.  In United States ex rel. Wall v. Circle C Construction, LLC No. 14-6150, 2016 WL 423750 (6th Cir. Feb. 4, 2016), the Sixth Circuit rejected the government’s argument that where the contractor’s alleged fraud or false certification induced the government to enter into the contract or was a condition for participation or eligibility, damages should be treble the full contract value, even if the work has been performed to the government’s satisfaction.

Under the FCA, while the government may recover “3 times the amount of damages which the Government sustains because of the act,” 31 U.S.C. § 3729(a), damages are not defined and have thus led to varying formulations among the circuits.  Wall involved a construction contract for Army warehouses and required the contractor to certify compliance with certain minimum wage requirements, but a subcontractor paid its employees less than the required minimum. Even though there were no performance issues with the work itself, and instead of seeking damages based on the subcontractor’s compensatory shortfall, the government argued, and the district court agreed, that damages should be treble the full contract value.  This resulted in assessed damages that were approximately 76 times more than the subcontractor’s wage deficit, which was the actual harm to the government. Continue reading “Sixth Circuit Brings False Claims Act Damages Back Down to Earth”