Health Law Advisor

The U.S. Court of Appeals for the First Circuit recently provided important clarity—and welcome relief—for clinical laboratories facing False Claims Act (“FCA”) allegations based on a lack of medical necessity for processing tests ordered by a physician. In a case of first impression, United States ex rel. OMNI Healthcare, Inc. v. MD Spine Solutions LLC,[1] the First Circuit held that clinical laboratories may rely on an ordering physician’s determination that lab tests billed to Medicare are medically necessary. The First Circuit held that laboratories need not second-guess a physician’s certification absent red flags or suspected improper conduct. While the First Circuit’s decision does not relieve clinical laboratories of their existing obligation under the FCA to ensure they are not submitting a false claim to government payors, it provides much-needed clarity for clinical laboratories across the country on what constitutes the knowing submission of false claims to the government and highlights several practical takeaways for managing compliance risk.

On September 20, 2018, the U.S. Food and Drug Administration (“FDA”) released draft guidance “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank” (“Guidance”). The purpose of this Guidance is to explain FDA’s protocol in (1) determining how the centers will identify whether responsible parties failed to comply with submission and certification requirements to the ClinicalTrials.gov or submitted false or misleading documents to the data banks and (2) deciding when, why, and what civil monetary penalties will be assessed against the ...

In a landmark decision, the U.S. Court of Appeals for the Seventh Circuit, sitting en banc, held that discrimination on the basis of sexual orientation is covered under Title VII of the Civil Rights Act’s protections against discrimination on the basis of sex.

In Hively v. Ivy Tech Community College of Indiana, Kimberly Hively, a lesbian part-time professor at Ivy Tech, applied for but was denied several full-time positions with the college. After her employment was later terminated, she filed a lawsuit alleging that she was denied promotion and then terminated because of her ...

Our colleague Marc A. Mandelman, a Member of the Firm at Epstein Becker Green, has a post on the Financial Services Employment Law blog that will be of interest to many of our readers in the health care industry: “8th Circuit Rules Parties to Corporate Transactions Cannot Contract Around the WARN Act Sale of Business Exception ”

Following is an excerpt:

In a rare case interpreting the Worker Adjustment and Retraining Notification (“WARN”) Act “sale of business” exception, the U.S. Court of Appeals for the 8th Circuit recently held in Day v. Celadon Trucking Servs ...