Articles and Blogs

Executive Summary The Food and Drug Administration (“FDA”) released five regulatory and guidance documents pertaining to compounding in an effort to provide clarity to pharmaceutical stakeholders.  The documents, issued pursuant to the Drug Quality and Security Act (“Act”), describe expectations regarding compliance with current good manufacturing practices (“cGMPs”) for compounding outsourcing facilities and standards for…Read More

On July 21, 2014, the Indiana Court of Appeals issued an opinion in Giles v. Anonymous Physician I, refusing to extend the physician patient relationship to a hospitalist asked to consult on a patient – the hospitalist refused the consult because the patient’s primary care provider had not approved hospitalist care for his patients.  Plaintiff…Read More

 On July 22, 2014, the Wisconsin Supreme Court released Masri v. State of Wisconsin Labor and Industry Review Commission, 2014 WI 81, in which it held that an unpaid intern was not an “employee” subject to anti-retaliation protection under Wis. Stat. § 146.997, Wisconsin’s whistleblower protection law for health care employees. Asma Masri, a former…Read More

The Seventh Circuit reversed a district court’s decision finding that it lacked jurisdiction over a whistleblower’s claim under the False Claim Act’s public disclosure bar. In U.S. ex rel. Heath v. Wisconsin Bell, Inc., the Court held that even though the Complaint relied in part upon publicly available information, the Relator’s allegations rested upon a…Read More

Congress Objects to Possible Changes to Medicare Group Appeals Process On July 23, Senate Commerce Committee member Dan Coats (R-IN) and House Ways and Means Committee member Todd Young (R-IN) sent a joint letter to CMS Administrator Marilyn Tavenner raising concerns over a provision in the FY 2015 Hospital Inpatient Prospective Payment Systems (“IPPS”) proposed…Read More

On Wednesday, July 15, Governor Beshear filed emergency regulations establishing new health facility licensure categories called “behavioral health services organizations” and “residential crisis stabilization units.” Beshear states that these new health facility licenses will increase Kentuckians’ access to mental health treatment and will help them avoid higher levels of care. 902 KAR 20:430E establishes minimum…Read More

A recent case from the Northern District of Texas is a great reminder of a very important lesson – it’s not just the large class/collective action FLSA lawsuits that can be costly. In Black v SettlePou, Inc. (Case No.3:10-CV-1418-K), Ms. Black sued her Texas employer in federal district court, claiming that she was improperly classified…Read More

Moving Target of Compliance Over the past few years, we have written about the NLRB’s focus on private employer social media policies (see the references to our past HR Insights Blog posts below).  The decisions are hard to reconcile, and employers (and their advisors) are left to guess what may be seen by the NLRB to…Read More

Hall Render Meets with Energy and Commerce Committee Staff on Telemedicine Initiative On July 15, Hall Render attorneys John Williams, Jeff Short and Michael Batt met with professional staff at the House Energy and Commerce Committee to discuss what steps Congress can take to remove the legislative and regulatory barriers that currently impede the advancement…Read More

On July 15, a new law in Kentucky took effect that expands the prescribing authority for advanced practice registered nurses (“APRNs”). Kentucky Revised Statutes 314.042 allows APRNs that have been prescribing non-scheduled legend drugs under physician supervision for four years to prescribe these drugs without physician oversight. Proponents of the law say that the change…Read More