Companies should prepare for increased regulatory scrutiny into healthcare transactions and increased emphasis on compliance programs.
The Federal Trade Commission (FTC), the Department of Justice (DOJ), and the...more
The US regulators have been particularly focused on new players in the health tech space and the novel regulatory issues their products present within the existing legal framework. While the market is ripe with opportunity...more
The 11th Circuit’s long-awaited AseraCare opinion requires more than mere disagreement regarding clinical judgment to prove falsity under the False Claims Act.
The 11th Circuit rejected the government’s theory of falsity...more
On September 19, 2016, the U.S. District Court for the District of Columbia (D.D.C.) refused to stay a highly anticipated case seeking to force the government to comply with statutory deadlines governing the Medicare appeals...more
Over the past decade, health care providers seeking to challenge Medicare claim denials have faced increasing delays in reaching what many consider the most important step in the Medicare appeals process - a hearing before an...more
8/16/2016
/ Administrative Appeals ,
Administrative Law Judge (ALJ) ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Claim Denial Letters ,
Due Process ,
Exhaustion Doctrine ,
MACs ,
Medicare ,
Medicare Appeals Council ,
Preliminary Injunctions ,
Provider Payments ,
Recovery Audit Contractors (RACs) ,
TRO ,
Ultra Vires ,
Writ of Mandamus
Court has the opportunity to assess the use of statistical sampling/extrapolation as a method to prove FCA liability or damages.
Courts require that plaintiffs prove each element of a legal claim with evidence — mere...more
On September 3, 2014, U.K.-based medical device maker Smith & Nephew (the ‘‘Company’’) agreed to pay $8.3 million (plus an additional $3 million in attorney’s fees) to resolve a lawsuit filed under the federal civil False...more