On October 21, 2014, the U.S. Department of Justice (“DOJ“) announced that two Kentucky-based cardiologists agreed to pay $380,000 to resolve qui tam allegations of purported Stark Law and Anti-Kickback Statute violations (thereby resulting in a False Claims Act violation). The cardiologists purportedly entered into sham management agreements with a…
On June 28, 2014, Governor Snyder signed a new comprehensive law imposing significant regulations on compounding pharmacies and pharmacists that compound both sterile and non-sterile pharmaceuticals including criminal sanctions for certain violations. This new law took September 26, 2014 (i.e., 90 days from the date it was signed into law).…
On September 23, 2014, Governor Snyder signed a new law requiring pharmacy technicians to be licensed in the State of Michigan. This new law is take effect on December 22, 2014 (i.e., 90 days from the date it was signed into law). Pharmacy technicians will be required to submit an…
On October 3, 2014, the Office of Inspector General published a proposed rule to amend the safe harbors under the Anti-Kickback Statute, as well as to revise the definition of “remuneration” under the Civil Monetary Penalties regulations and add a gainsharing CMP provision into the regulations. If adopted, the final…
The Department of Justice’s (“DOJ“) Criminal Division announced, through its Assistant Attorney General, Leslie R. Caldwell, that the DOJ is closely scrutinizing civil False Claims Act investigations and lawsuits for criminal conduct. Speaking at the Taxpayers Against Fraud Education Fund’s annual conference in Washington D.C., Ms. Caldwell asked attorneys contemplating…
In an attempt to combat prescription drug abuse, on August 22, 2014, the U.S. Drug Enforcement Administration (“DEA”) published a final rule (here) elevating Hydrocodone-combination products (“HCPs”) to the more restrictive schedule II category of drugs under the Controlled Substances Act (“CSA”). Since the enactment of the CSA in 1971,…
On September 4, 2014, the Department of Health & Human Services, Centers for Medicare & Medicaid Services (“CMS”), published a final rule (See, 79 FR 52910) modifying the Medicare and Medicaid Electronic Health Record Meaningful Use Incentive Program (“EHR Meaningful Use Incentive Program”). The reason for the modification is that…
On August 12, 2014, the Office of Inspector General (“OIG“) posted new guidance for contractors self-disclosing violations of federal criminal law involving fraud, conflict of interest, bribery, or gratuity violations or violations of the civil False Claims Act in connection with U.S. Department of Health and Human Services contracts or…
One of the most widely viewed False Claims Act (FCA) cases filed against a hospital is coming to an end–Florida hospital, Halifax Health, is preparing to pay $1 million to settle a $73 million dollar Medicare overbilling case. Potentially, maximum damages in the trial could have exceeded $200 million, which…
Companies doing business in highly-regulated industries, including the health care industry, were left holding their breath after a D.C. district court ruled that the attorney-client privilege doctrine did not attach to a company’s internal investigation conducted under the direction of in-house legal counsel. United States ex rel. Barko v. Halliburton…