The False Claims Act (“FCA”) is one of the United States Government’s most powerful tools for fighting fraud. In fact, the Department of Justice recovered nearly $1.8 billion under the FCA for health care fraud and $1.6 billion in FCA qui tam relator cases in the 2020 fiscal year. Keeping the enforcement of fraud in mind, underlying all FCA qui tam suits is successfully pleading with particularity under Federal Rule of Civil Procedure 9(b). This requirement has led many U.S. District Courts to dismiss qui tam cases at the pleading stage and U.S. Courts of Appeals to affirm those decisions. The upshot is that amid changes to the Stark Law and Anti-Kickback law, the continuation of COVID-19 related fraud, and the continuing splits in the Federal Circuit regarding pleading standards, the ground may begin to shift for compliance officers, attorneys, and general counsels in health care organizations.
The Competitive Health Insurance Reform Act of 2020 (“CHIRA”) was signed into law on January 13, 2020, shifting not only how health insurance markets operate but lowering the bar for federal government agencies to bring successful actions against anticompetitive behavior. Prior to becoming law, health insurance companies retained robust antitrust exemptions under the McCarran-Ferguson Act (the “Act”). While it does not completely eliminate antitrust exemptions, the passage of CHIRA sent a strong signal that the federal government intended to promote competitive conduct in health insurance markets and limit the scope of these antitrust exemptions. While the upshot is that consumers may benefit from increased access and potentially lower cost, the health insurance industry must begin to adjust its conduct or face contentious litigation.
Complex litigation in data breach disputes is not surprising due to the reliance on information technology infrastructure. The Identity Theft Resource Center defines a data breach as “an incident in which an individual name plus a Social Security number, driver’s license number, medical record or financial record is potentially put at risk because of exposure.” However, the issue that challenges most plaintiffs’ in a data breach lawsuit is the ability to establish an injury-in-fact sufficient to support Article III standing. Injury-in-fact is harm that is concrete and particularized, and actual or imminent. Currently, the United States Court of Appeals fails to uniformly decide this issue, creating “splits” in the Circuits regarding Article III standing in data breach litigation. The Supreme Court ruled in fact-distinguishable cases concerning standing, but not in the data breach litigation context. Until the Supreme Court renders guidance, Americans face significant judicial patchwork in privacy protection.
Signed by President Obama on March 23, 2010, The Affordable Care Act (“ACA”) provided a monumental change to healthcare. The ACA created access, added provisions to improve quality, and created cost containment measures. However, the ACA created a quintessential question of Federalism. As it exists today, the Supreme Court will listen to oral arguments in November on the constitutionality of the ACA, in California v. Texas. If the Court decides that the ACA is unconstitutional, millions of Americans who are insured under the Act will lose coverage. Additionally, aside from access, the ACA includes regulatory laws such as Section 1557’s nondiscriminatory provisions, and amendments to the False Claims Act & HIPAA.
The effects of COVID-19 create numerous hospital financial management issues. One specific issue is hospitals maintaining financial stability. As the United States adjusts to the pandemic, hospitals have the burden of navigating their purpose, mission, and values while maintaining operations. The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) is a comprehensive bill that includes provisions that financially assist healthcare providers. Nevertheless, as with all federal assistance, compliance with specific conditions is required. As the pandemic continues, if hospitals accept federal help to stabilize finances, awareness, and increasing training to comply with federal guidelines is crucial.