Based on OIG enforcement action excerpts for the past week, tips for staying ahead in healthcare regulatory compliance efforts include:
For many years, healthcare providers – particularly children’s hospitals – took comfort in a belief held widely throughout the healthcare industry that the Stark Law did not apply to Medicaid. That belief has now been challenged by several district court cases involving alleged False Claims Act violations, most recently in U.S. v. All Children’s Health System.
Several parts of the America Invents Act (the “AIA”) became law on Sept. 16, 2012, sparking some of the most meaningful changes to patent law seen in decades. One hot provision in the new law is the ability for one to challenge a patent’s validity in a new inter partes review (“IPR”) process. This legal tool could prove to be very valuable in solving some of the biggest business challenges facing generic pharma. This post addresses the business case for generic pharma using the IPR process.
Smartphones and tablets are quickly becoming the ubiquitous tool for both personal and business activities. The convenience of the platforms, their mobility, and their ability to tie into the Internet means not only is the adoption rate of these devices outpacing the adoption of standard PCs worldwide, but they present a growing opportunity for mobile application developers.
The U.S. Department of Justice issued a press release (the “press release”) covering today’s announcement by Attorney General Eric Holder and Department of Health & Human Services (HHS) Secretary Kathleen Sebelius that Medicare Fraud Strike Force operations in six cities resulted in charges against 90 individuals, including 27 doctors, nurses and other medical professionals, for their alleged participation in fraud schemes involving approximately $260 million in Medicare false claims.
On April 1, 2014, the Department of Labor’s Office of Federal Contract Compliance Programs agreed to the dismissal of its December 2008 complaint against Florida Hospital of Orlando. This action follows DOL’s March 11, 2014 agreement to a five-year moratorium on compliance and enforcement actions against Tricare service providers. These developments reflect a significant rollback of OFCCP’s prior position as to the scope of its jurisdiction. In his March 11, 2014 letter to Congress, Secretary of Labor Thomas Perez recognizes that Congress had intended to limit OFCCP’s jurisdictional authority over Tricare healthcare providers.
In an unprecedented move, on April 8, 2014, the Office of the Inspector General (“OIG”) posted a notice of termination of one of its previously issued advisory opinions. Specifically, the OIG issued a Final Notice of Termination of Advisory Opinion No. 11-18 (“Notice of Termination”). The OIG issued Advisory Opinion 11-18 on November 30, 2011 (“Advisory Opinion”). Under the proposed arrangement, the Requestor, a publicly traded company that provides web-based business services to physician practices, would provide a new service to its existing customers, called “Coordination Service,” to facilitate the exchange of information between the ordering (or referring) healthcare practitioners and providers (“Ordering Health Professionals”) and receiving healthcare practitioners and providers. Ordering Health Professionals could refer patients to other healthcare professionals who were existing subscribers of Requestor’s services (“Trade Partners”) or to healthcare professionals not currently receiving Requestor’s services (“Non-Trading Partner”).
This article was originally published by the American Health Lawyers Association. Copyright 2014, American Health Lawyers Association, Washington, DC. Reprint permission granted.
Recently, the Obama Administration released its fiscal year 2015 budget proposal, which includes several proposals of special interest to children’s hospitals. The Budget proposes several new and strategic investments in the nation’s health care…
This morning, March 3, at what was to be the commencement of the jury trial in U.S. ex rel. Baklid-Kunz v. Halifax Hospital Medical Center (Case No: 6:09-cv-1002-Orl-31TBS), the parties informed the Court that they had reached a tentative settlement. The parties were given until March 10, 2014 for file a Joint Motion to …
A recent OIG Advisory Opinion (Adv. Op. 13-15) is, to a certain degree, more interesting for one of its footnotes than the body of the opinion itself. The footnote addresses a hotly debated issue, originally raised in an OIG Management Advisory Report (MAR) in 1991. That MAR took the position that an agreement between a hospital and a hospital-based physician group was a “suspect arrangement” under the Anti-Kickback Statute because the physician group was essentially required to split its revenue with the hospital–including requiring the group to provide uncompensated services to the hospital.
The OIG modified this position somewhat in the Supplement Compliance Program Guidance for Hospitals in 2005. In that compliance guidance, the OIG stated that an exclusive arrangement that required a hospital-based physician group to provide “reasonable administrative or limited clinical duties directly related to the hospital-based profession services at no or a reduced charge” would be permissible. The Compliance Guidance cautioned, however, that uncompensated or below-market-rate services would still be subject to “close scrutiny.”
