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.
In a recent article in Health Value Digest, Tiffany Hetland explored two items a hospital should have on its checklist when acquiring a physician practice: a billing and coding audit and a review of documentation practices. The article is below.
Hospital acquisitions of physician practices have been on the rise for some time. At…
The HHS OIG released its Work Plan for FY 2014 three months ago and is hard at work investigating the issues highlighted in its annual publication. The OIG’s annual Work Plan lists current and new projects it will address during 2014, and is an excellent source for healthcare facilities to use in identifying potential compliance risk areas. The Work Plan has a number of items that impact children’s hospitals. Whether you immediately added these issues to your organization’s list of potential risk areas or still haven’t had the opportunity to review this year’s Work Plan, we recommend that you do not lose sight of these issues.
When inter partes review actions first became available in 2012, no generic pharma companies availed themselves to this litigation tool. Not until 2013 did a generic pharma company first seek inter partes review (“IPR”) of a brand drug patent in Apotex Inc. v. Alcon Pharmaceuticals, Ltd., IPR2013-00012 and -00015. In response to Apotex’s petition for inter partes review, the Patent Trial and Appeal Board (“PTAB”) ruled there was a reasonable likelihood that the two challenged patents were invalid for obviousness. Interestingly, a U.S. District Court previously determined that one of the patents was not invalid based upon the same prior art references. Id. at Paper 43; March 19, 2013.
“End-users, sysadmins, and developers lead the pack when it comes to mucking things up, though pretty much all of us are guilty.” These are simple, yet telling, words from the 2014 Data Breach Investigations Report released this week by Verizon.
The report statistics indicate:
A deluge of patent applications were filed at the United Stated Patent and Trademark Office on the day before central provisions of the new America Invents Act (AIA) went into effect on March 16, 2013. This rush to file indicates many inventors wish to preserve their patent status under the pre-AIA provisions.
The first-to-file provisions apply to any patent application that contains OR CONTAINED AT ANY TIME a claim having an effective filing date on or after March 16, 2013, and also apply to any patent application claiming priority of another application/patent that contains OR CONTAINED AT ANY TIME such a claim. America Invents Act § 3(n)(1) (emphasis added).
