Health Care

Recently, South Carolina U.S. District Judge Joseph Anderson, Jr. issued an opinion in which he struggled with how to handle a non-intervened qui tam brought under the Federal False Claims Act (FCA).

On June 23, 2015, the OIG issued two reports focusing on fraud, waste, and abuse in the Part D program, the first “Ensuring the Integrity of Medicare Part D” and the second “Questionable Billing Practices and Geographic Hotspots Point to Potential Fraud and Abuse in  Medicare Part D.”

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until November 1, 2015 (Compliance Policy).

Late last week, the United States Department of Justice (DOJ) and the Michigan Attorney General (AG) filed suit against four southern Michigan hospitals, alleging that they secretly agreed not to compete with each other in violation of Section 1 of the Sherman Act and Section 2 of the Michigan Antitrust Reform Act.

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA).

Health care is big business in Massachusetts, and it is a highly regulated business. But Governor Charlie Baker hopes to simplify the Massachusetts regulatory regime.

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s prescription drug advertising regulations, along with FDA’s interpretations of the law as put forth in guidance documents and warnings to industry.

Over two and one-half years after it was initially filed, an antitrust suit brought by plaintiff ambulatory surgery centers (“ASCs”) against health insurers and a trade association of competing health systems is finally moving forward.

The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10.  Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B Program.

As we discussed yesterday, the Medicare Fraud Strike Force’s eighth annual nationwide takedown resulted in charges in 17 districts against 243 individuals for approximately $712 million in false billings.

Earlier today, Attorney General Loretta Lynch announced the largest coordinated crackdown in the Medicare Fraud Strike Force’s eight-year history.  The government brought charges against 243 individuals for approximately $712 million in alleged Medicare fraud.

On Monday, during the annual meeting of the American Medical Association (AMA) House of Delegates, the delegates voted to table a proposed measure to adopt ethical guidelines for physicians who provide telemedicine services.

On Friday, Mintz Levin published an advisory on CMS’s proposed Medicaid Managed Care rules. This advisory provides contextual background, a helpful overview of the rule’s contents, and an in-depth discussion of some of the rule’s key provisions.

Last week, Mintz attorneys Bruce Sokler and Timothy Slattery published an advisory regarding the Second Circuit's highly anticipated decision in State of New York v. Actavis PLC.

In a fraud alert released today, the OIG warns that physician compensation arrangements, such as medical directorship compensation, may potentially violate the anti-kickback statute.

On June 4, 2015, the Center for Medicare & Medicaid Services ("CMS") released the highly anticipated Final Rule ("Final Rule") updating the Medicare Shared Savings Program ("Shared Savings Program").

The recent influx of state legislation on biologics and biosimilars may actually hinder rather than advance the use of biosimilars. Our colleagues Theresa Carnegie, Joanne Hawana, and Ellyn Sternfield discuss this issue in a recent article published in BNA’s Medicare Report.

On May 27, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published a 653-page proposed rule affecting the thirty-nine states (plus the District of Columbia) that use managed care organizations (“MCOs”) to administer their Medicaid benefits.

On June 1st, the Centers for Medicare and Medicaid Services (CMS) released a State Medicaid Director Letter (SMD Letter) providing guidance to states on the criminal background check and fingerprinting requirements for Medicaid provider enrollment.

Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that would have prevented prescribing via telemedicine.