Health Law Advisor

Surprisingly amidst the Federal Bureau of Investigation (FBI) uproar, President Trump today signed an executive order addressing cybersecurity for the federal government and critical infrastructure, along with international coordination and cyber deterrence. The substance of the order, which is about to be made public, comes from various press releases and interviews with administration officials. The order is composed of three sections on cybersecurity and IT modernization within the federal government, protecting critical infrastructure, and establishing a cyber ...

A recent settlement demonstrates the importance of compliant structuring of lending arrangements in the health care industry. The failure to consider health care fraud and abuse risks in connection with lending arrangements can lead to extremely costly consequences.

On April 27, 2017, the Department of Justice ("DOJ") announced that it reached an $18 Million settlement with a hospital operated by Indiana University Health and a federally qualified health center ("FQHC") operated by HealthNet. United States et al. ex rel. Robinson v. Indiana University Health, Inc. et al., Case No. 1:13-cv-2009-TWP-MJD (S.D. Ind.).  As alleged by Judith Robinson, the qui tam relator ("Relator"), from May 1, 2013 through Aug. 30, 2016, Indiana University Health provided HealthNet with an interest free line of credit, which consistently exceeded $10 million.  It was further alleged that HealthNet was not expected to repay a substantial portion of the loan and that the transaction was intended to induce HealthNet to refer its OB/GYN patients to Indiana University.

While neither Indiana University Health nor HealthNet have made any admissions of wrongdoing, each will pay approximately $5.1 million to the United States and $3.9 million to the State of Indiana. According to the DOJ and the Relator, the alleged conduct violated the Federal Anti-Kickback Statute and the Federal False Claims Act.

For more details on the underlying arrangement and practical takeaways . . .

On May 9, 2017, Scott Gottlieb, M.D. was confirmed by the Senate as the new Commissioner of the Food and Drug Administration ("FDA").  As Commissioner, he will be immediately responsible for shaping FDA policy on a number of current issues, including addressing and implementing several mandates stemming from the 21st Century Cures Act, ("Cures Act"), which was signed into law on December 13, 2016 with tremendous bipartisan support. The Cures Act contains over 200 sections that create new obligations for FDA; however, most pressing for Commissioner Gottlieb are three requirements ...

An employee on an extended medical leave to recuperate from shoulder surgery posts pictures of his active Caribbean vacation. His employer is justified in terminating him, right?  Maybe not.

On April 19, 2017, the Eleventh Circuit reversed a trial court ruling and held that a former employee had raised a genuine issue of material fact regarding whether he was terminated in retaliation for using FMLA despite the former employee posting pictures from various vacations on Facebook during his time off of work to recuperate from surgery. This case, Jones v. Gulf Coast Health Care of ...

At the American Telemedicine Association’s (“ATA”) recent conference in Orlando, a panel of strategic investors discussed the growth of the telehealth industry. The panel delved into topics such as the driving forces for telehealth and which telehealth programs they believe have the ability to gain traction across a broad universe of stakeholders. Based on firsthand experience with deals that have worked, and those that have not, the panel shared their insights and discussed lessons learned, which in turn provided listeners with interesting insight regarding the future ...

Our colleague Steven M. Swirsky, a Member of the Firm at Epstein Becker Green, has a post on the Management Memo blog that will be of interest to many of our readers in the health care industry: “OSHA Withdraws 'Fairfax Memo' – Union Representatives May No Longer Participate in Work Place Safety Walkarounds at Non-Union Facilities.”

Following is an excerpt:

On April 25, 2017, Dorothy Dougherty, Deputy Assistant Secretary of the Occupational Safety and Health Administration (“OSHA”) and Thomas Galassi, Director of OSHA’s Directorate of Enforcement Programs, issued a ...

On April 20, 2017, in Marshall v. The Rawlings Company LLC, No. 16-5614, slip op., (6th Cir. April 20, 2017) the Sixth Circuit Court of Appeals, which covers federal courts in Kentucky, Michigan, Ohio and Tennessee, for the first time adopted the cat’s paw theory of liability in the context of a retaliation claim brought under the Family Medical Leave Act (FMLA), 29 U.S.C. § 2601 et seq.  The term “cat’s paw” was coined by Judge Richard Posner of the Seventh Circuit and introduced in Shager v. Upjohn Co., 913 F.2d 398 (7th Cir. 1990) as a standard by which liability may be imputed to an ...

Since 2000, the number of wage and hour cases filed under the Fair Labor Standards Act (“FLSA”) has increased by more than 450 percent, with the vast majority of those cases being filed as putative collective actions.  Under 29 U.S.C. § 216(b), employees may pursue FLSA claims on behalf of “themselves and other employees similarly situated,” provided that “[n]o employee shall be a party plaintiff to any such action unless he gives his consent in writing to become such a party and such consent is filed in the court in which such action is brought.”  Despite the prevalence of FLSA ...

Executive Order Delay Trumps Administration Policy Development

President Trump's first hundred days did not produce the event that most people in the cybersecurity community expected – a Presidential Executive Order supplanting or supplementing the Obama administration's cyber policy – but that doesn't mean that this period has been uneventful, particularly for those in the health care space.

The events of the period have cautioned us not to look for an imminent Executive Order. While White House cybersecurity coordinator Robert Joyce recently stated that a forthcoming ...

Earlier this month, the U.S. Access Board announced that the U.S. Department of Veteran Affairs (“VA”) will adopt the new Accessibility Standards for Medical Diagnostic Equipment.

As mentioned in our January 31, 2017, blog post, “The U.S. Access-Board Releases Long-Awaited Final Accessible Medical Diagnostic Equipment Standards,” the Access Board released its new Accessibility Standards for Medical Diagnostic Equipment (the “MDE Standards”) at the beginning of the year, with an effective date of February 8, 2017.

Despite the February “effective date,” ...