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). The law was in response […]
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 application for licensure, have graduated […]
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 rule would have a major […]
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 filing qui tam lawsuits to […]
As expected, the U.S. Department of Health and Human Services (“HHS“) officially set the ICD-10 compliance date for October 1, 2015. Previously, providers and payors had until October 1, 2014 to transition from the ICD-9 to the ICD-10 Procedure Coding System. However, the Protecting Access to Medicare Act of 2014 prevents HHS from adopting ICD-10 […]
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, HCPs have been classified as […]
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 health care providers were unable […]
With the fight against prescription drug abuse reaching an all-time high, health insurance plans are now taking a proactive role in attempting to reduce the quantity of some of the most abused drugs in the marketplace. As of September 2, 2014, Blue Cross Blue Shield of Michigan (BCBSM) commercial plans (non-Medicare) will implement new quantity […]
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 subcontracts. The Federal Acquisition Regulation […]
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 would then be followed by […]
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