Articles and Blogs

The Centers for Medicare & Medicaid Services (CMS) has unofficially announced it will not be enforcing the upcoming March 23rd compliance program requirements until final regulations are published.  As required under the Affordable Care Act, nursing facilities are required to have a compliance program in place by March 23, 2013.  Despite ambiguity in the actual statute, which…Read More

Competing Sequester Alternatives Rejected On February 28, the U.S. Senate rejected competing sequester replacement proposals killing the last legislative options prior to the spending cuts going into effect on March 1. The Senate voted on both a Republican and Democrat plan designed to help the parties position themselves after the budget cuts begin to take effect.

The Food and Drug Administration (“FDA”) is seeking comments on a draft guidance entitled “Design Considerations for Devices Intended for Home Use.”  The draft guidance urges manufacturers to “design out” product risks and consider usability and training for medical devices intended for use in a home environment.  The deadline for submitting comments on the document…Read More

Appellate Court Cases Three appellate-level FCA cases were reported in January and February 2013. Only one, U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, Inc., was selected for publication. All three cases addressed Rule 9(b)’s requirement that allegations of fraud be lead “with particularity.” The cases, read together, highlight the differences among Circuits in…Read More

Last April, we told you about the EEOC’s updated Enforcement Guidance regarding an employer’s use of arrest and conviction records when making employment decisions.   On January 29, 2013, the OFCCP issued its own guidance on this topic in the form of Directive 306.  Federal contractors and subcontractors who are being investigated by OFCCP should expect…Read More