The Department of Justice (DOJ) recently announced that it had recovered more than $2.8 billion from False Claims Act (FCA) cases in the 2018 fiscal year. Although this number continues a multi-year downtrend in overall FCA recoveries, healthcare fraud remains a major DOJ focus. Of the $2.8 billion, $2.5 billion was extracted from various segments of the healthcare industry, including through major settlements with pharmaceutical and medical device manufacturers.
Health policy issues are high on the agenda of the new Congress. The stated priorities for the new House majority include reducing drug prices, defending the Affordable Care Act, addressing the opioid abuse crisis and investigating the pharmaceutical industry. Given the potential for at least some bipartisan cooperation on each of these priorities, stakeholders in the healthcare industry should be prepared for legislative and regulatory opportunities and challenges.
The Department of Justice (DOJ) recently stepped in to seek the dismissal of high-profile False Claims Act litigation being pursued by relators after the government initially declined to intervene. The DOJ's recent action, which pertains to approximately a dozen lawsuits involving pharmaceutical manufacturers and third-party service providers, is further evidence that the Granston Memo, in which the DOJ articulated clearer standards for seeking dismissal of non-intervened cases, has real teeth.
The Department of Justice (DOJ) recently announced that it had intervened in a False Claims Act suit against Sutter Health and its affiliate Palo Alto Medical Foundation. This intervention is the latest example of the DOJ's aggressive enforcement under the False Claims Act in the Medicare Advantage space.
The five US federal agencies responsible for implementing the Volcker Rule have individually released a related notice of proposed rulemaking. The notice proposes amendments to the Volcker Rule regulations that would implement two statutory changes required by the Economic Growth, Regulatory Relief and Consumer Protection Act. Comments in response to the notice must be received by the agencies within 60 days of its publication in the Federal Register.
The government has intervened in a qui tam suit against a compounding pharmacy and its private equity fund owner in which it is alleged that the pharmacy filed claims with Tricare that were rendered false by kickbacks. The opinion provides further guidance as to the circumstances under which a private equity fund investor may incur False Claims Act liability as a result of its active involvement in a portfolio healthcare company that submits allegedly false claims.
In the recent election, the Democrats captured a majority in the House of Representatives and Representative Maxine Waters (D-Calif) is now in line to lead the House Financial Services Committee. As such, it is expected that a significant shift in legislative efforts relating to the financial services industry will occur. During the first Financial Services Committee hearing since the election, Waters announced that deregulation efforts are finished.
Former Bayada Home Health Care employees recently alleged that the company had falsely billed Medicare for patients that it had known were not "homebound". Bayada moved to dismiss the suit on the ground that each employee had signed a separation agreement releasing Bayada from "any and all claims" prior to filing the False Claims Act lawsuit. With no binding Third Circuit precedent, the district court looked for guidance among other circuits that pre-filing releases can bar False Claims Act claims.
Evidence is mounting that the Department of Justice (DOJ) is willing to pursue private equity funds in False Claims Act cases, particularly ones based on alleged violations of healthcare fraud and abuse laws. Earlier in 2018, the DOJ intervened for the first time in one such False Claims Act case against a private equity sponsor, the fund's portfolio pharmacy and two pharmacy employees.
In July 2018 the Office of the Comptroller of the Currency (OCC) announced its decision to begin accepting applications from fintech companies for special purpose national bank charters (the Fintech Charter Decision). The New York State Department of Financial Services recently filed a federal court complaint seeking to enjoin further actions by the OCC to implement the Fintech Charter Decision and related actions, arguing that such acts are lawless, ill-conceived and destabilising for financial markets.
The US District Court for the District of Columbia recently vacated CMS's 2014 final overpayment rule, applicable to the Medicare Advantage programme, granting summary judgment to UnitedHealthcare that the final rule violated the Medicare statute, was inconsistent with the Affordable Care Act and the False Claims Act and violated the Administrative Procedures Act. Because the decision vacates the overpayment rule entirely, further rulemaking may be necessary.
The Department of Justice (DOJ) and the Environmental Protection Agency's (EPA's) criminal office recently announced criminal charges against employees of an oil and gas operation for tampering with and disabling pollution controls and on-board diagnostic (OBD) systems on the company's truck fleet. The EPA and DOJ are expected to continue to shift towards mobile source enforcement, particularly regarding OBD systems.
The Office of the Comptroller of the Currency (OCC) recently announced – to much anticipation – that it will begin accepting applications from fintech companies for special purpose national bank charters (commonly referred to as 'fintech charters'). However, state banking regulators are likely to once again challenge the OCC's authority to grant fintech charters, which could create some uncertainty for early applicants.
The White House Council on Environmental Quality recently published an advance notice of proposed rulemaking in the Federal Register, seeking comment on how best to update its implementing regulations for the National Environmental Policy Act. The Trump administration has identified the National Environmental Policy Act process as a key contributor to slowing down infrastructure projects and has floated changes to it on several occasions.
The Agency for Toxic Substances and Disease Registry recently released a draft toxicological profile for perfluoroalkyl compounds which asserted that they may be harmful to human health at low levels. Due to their non-stick properties, perfluoroalkyl compounds have been used as non-stick coatings for cookware, as paper and cardboard surface coatings and in firefighting foam.
The US District Court for the Southern District of Georgia recently enjoined the Environmental Protection Agency's rule defining the term 'waters of the United States' under the Clean Water Act, which establishes the act's jurisdictional reach. The court determined that the plaintiffs were likely to succeed on the merits of their case and faced a substantial threat of irreparable injury without the preliminary injunction.
The Environmental Protection Agency recently approved Oklahoma's proposed permitting programme for the disposal of coal combustion residuals (CCR) in landfills and surface impoundments, making the state the first to have a federally approved CCR disposal programme under Subtitle D of the Resource Conservation and Recovery Act.
Farm worker groups recently sued the Environmental Protection Agency (EPA), claiming that the agency had failed to publish national training materials that provide guidance to agricultural field workers on how to best protect themselves against harmful exposure to pesticides. The suit alleges that the EPA's responsibility to develop and publish these materials was triggered by the federal Agricultural Worker Protection Standard.
The US Court of Appeals for the District of Columbia Circuit recently upheld the Environmental Protection Agency's (EPA's) 2016 amended Clean Air Act regional consistency regulations. These regulations state in relevant part that the EPA will apply decisions of the US Supreme Court or DC Circuit on Clean Air Act matters uniformly across its 10 regions.
Environmental Protection Agency (EPA) Administrator Scott Pruitt recently announced his intention to initiate the process to propose to list the fluorochemicals perfluorooctanoic acid and perfluorooctane sulfonate as hazardous substances for the purposes of some federal environmental statutes, including the Comprehensive Environmental Response, Compensation and Liability Act (or Superfund).