In a letter released Thursday, April 16, 2020, the U.S. Attorney for the Eastern District of Pennsylvania called on area hospitals, health systems, and other providers to join the government's fight against coronavirus-related fraud. Hospitals, providers, and other health care institutions are on the front lines of the coronavirus pandemic and know first-hand the challenges in obtaining critical supplies. They also are in a unique position to identify COVID-19-related fraud, such as offers to sell non-existent or fake equipment and price gouging of supplies.
Eastern District of Pennsylvania Refuses to Keep FCA Qui Tam Complaint Under Seal to Facilitate Government's Settlement Negotiations
On October 16, 2018, the District Court for the Eastern District of Pennsylvania denied the government's requested eleventh extension of the seal in a five-year-old False Claims Act qui tam case. The court ruled that the government's desire to continue settlement negotiations with the defendant, who had been given a copy of the complaint with the court's permission, did not constitute "good cause" to extend the seal, as required by the FCA.
OIG 15-Year Exclusion for False Claims Act Violations by Lab Company and its CEO Sends Warning to FCA Defendants
On August 17, 2018, a Department of Health and Human Services ALJ affirmed HHS OIG's 15-year exclusion of BestCare Laboratory Services, Inc. and its CEO from federal health care programs pursuant to the OIG's permissive exclusion authority. The exclusion was based on BestCare's submission of false claims for mileage reimbursement which violated CMS billing restrictions and formed the basis of a qui tam False Claims Act action, culminating in a $30 million damages award.
On January 8, 2018, Bloomberg Law's Privacy & Data Security publication released its "Domestic Privacy Profile" for Pennsylvania, for which I served as Bloomberg's subject matter expert practitioner. The publication is extremely comprehensive in scope, but I'd like to take the opportunity to highlight one Pennsylvania case that it discusses, which is currently before the state Supreme Court and could have a significant impact on privacy and data security litigation in Pennsylvania.
Third Circuit Rejects FCA Claims of Medicare Part D Fraud Applying Post-Escobar Materiality Bar; Acknowledges Validity of Government Knowledge Inference Defense
Earlier this month the United States Court of Appeals for the Third Circuit ended a long-fought False Claims Act case of alleged Medicare Part D fraud, holding that a pharmacy benefit manager's limited non-compliance with pharmacy claims processing requirements was not material to Medicare's payment decisions within the meaning of the Supreme Court's Escobar decision. On November 16, 2017, in United States ex rel. Spay v. CVS Caremark Corporation,Â the Third Circuit affirmed the district court's summary judgment dismissal in its second significant post-Escobar materiality decision. Interestingly, the appellate court veered away from the district court's holding that the "government knowledge inference" defense precluded liability for the PBM and instead found that the Relator failed to demonstrate that the alleged non-compliance met the Escobar materiality threshold.
With other members of our Firm's Regulated Cannabis Group, I recently co-authored an article for the Life Sciences, Pharmaceuticals, and Health Care Supplement of The Legal Intelligencer. We examined Pennsylvania's April 2016 medical marijuana law from four essential legal standpoints - professional liability, health care law, employment law, and enforcement - and the related implications for health care providers in the state.
On August 4, 2016, the Department of Health and Human Services, Office of Civil Rights (OCR) announced that Advocate Health Care Network, Illinois' largest hospital chain, agreed to pay $5.5 million to resolve multiple alleged violations of the Health Insurance Portability and Accountability Act (HIPAA). This settlement is the largest HIPAA-related settlement in OCR history, and comprises more than a quarter of the nearly $20 million that the government has collected in HIPAA-related enforcement actions in 2016 alone.
Along with my Post & Schell colleagues, Matt Newcomer and Carolyn Kendall, I recently co-authored an article for Law360 that examined the U.S. Supreme Court's decision in Universal Health Services Inc. v. Escobar. We focused on the Court's rejection of a bright-line rule on the False Claims Act's materiality standard and adoption of a fact-specific standard that will need to be litigated on a case-by-case basis.
On June 10, 2016, the Third Circuit Court of Appeals upheld a 2015 decision that dismissed allegations of kickbacks in violation of the False Claims Act (FCA) against Pottstown Memorial Hospital (Pottstown). The decision, concerning physician â€œon callâ€ contracts, provides important guidance about the drafting of hospital-physician contracts in a competitive environment.
Plan Ahead, Stay On Top of Government and Tech Changes, and Be Ready to Call the FBI: Key Lessons from the PHI Protection Network Conference
Late last week, the health care data security community gathered in Philadelphia for the PHI Protection Network Conference. The diverse group of speakers included in-house data security officers, technology consultants, academics, attorneys, and a variety of influential federal government representatives. I was in the audience. A handful of key themes were reiterated in various ways throughout the two-day gathering.
In recent weeks, corporations have pushed back against Departments of Justice (DOJ) and Health and Human Service (HHS) efforts to expand False Claims Act (FCA) remedies to conduct beyond the FCA's explicit reach. Yet a huge incentive exists for DOJ to push the FCA envelope: DOJ's recently released 2015 Civil Division fraud recoveries - totaling over $3.5 billion - establish a six-year trend of recoveries in excess of $3 billion annually.
U.S. Supreme Court to Decide the Viability of the Implied Certification Theory of False Claims Act Liability
On December 4, 2015, the U.S. Supreme Court agreed to consider a challenge to the federal government's hotly-contested and Circuit-splitting â€œimplied certificationâ€ theory of False Claims Act (FCA) liability. The implied certification theory has been a versatile and lucrative tool for whistleblowers and for the government, and a Supreme Court ruling on the viability of this prosecution theory may provide clearer boundaries and more certainty for those who do business with the government.