Health Care

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. 

Yesterday, ML Strategies posted its Health Care Update and Telehealth Policy Alert. This publication provides timely information for those who are already in, or contemplating entering, the telehealth space.

The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Semiannual Report to Congress (“Report”), summarizing OIG’s activities for the six-month period ending on March 31, 2015.

Whether you are on the defense side or the relator side of the qui tam world, you can count the Supreme Court’s opinion in Kellogg, Brown & Root Services, Inc. v. United States ex. Rel. Carter as a win and a loss.

The Federal Trade Commission (“FTC” or “Commission”) filed an administrative complaint last week challenging the proposed $1.9 billion merger of Steris Corporation (“Steris”) and Synergy Health plc (“Synergy”), charging that the transaction would significantly reduce future competition in regional markets for radiation sterilization services.

Earlier this month, HHS Secretary Silvia Burwell made a game-changing announcement about the Obama Administration’s most significant alternative payment model (APM). 

The Federal Trade Commission (“FTC”) accepted on Tuesday from Reynolds American Inc. (“Reynolds”) and Lorillard Inc. (“Lorillard”), subject to final approval, a Consent Order settling the agency’s significant competitive concerns with Reynolds’s proposed $27.4 billion acquisition of Lorillard by requiring the divestiture of four cigarette brands to Imperial Tobacco Group PLC. (“Imperial”).