Articles and Blogs

On September 5, 2014, the Indiana Court of Appeals issued an opinion affirming the trial court’s grant of summary judgment in favor of the hospital defendant.  Plaintiff asserted teaching hospitals have a duty to specifically identify on its consent forms (both by name and qualification) all medical personnel, including interns and residents, that may... READ MORE

OIG recently issued Advisory Opinion 14-06, determining that a proposed arrangement for patient referrals to a specialty pharmacy had the potential to generate prohibited remuneration under the Anti-Kickback Statute.  The proposed arrangement involved a specialty pharmacy paying a support services fee to local retail pharmacies when the local pharmacies referred patients to the specialty... READ MORE

Estheticians wishing to offer laser tattoo removal should remember that the procedure requires more than just a new machine; it also requires the presence of a physician. Kentucky law expressly prohibits estheticians practicing in the state from performing laser treatments unless practicing under the immediate supervision of a licensed physician. The term immediate supervision... READ MORE

Executive Summary On August 4, 2014, the United States Department of Justice (“DOJ”) announced a settlement of a staggering $98.15 million with the nation’s largest operator of acute care hospitals (“Health System”).  The settlement resolves multiple lawsuits filed under the qui tam (whistleblower) provisions of the federal False Claims Act that prohibits a person... READ MORE

On August 5, 2014, the Centers for Medicare & Medicaid Services (“CMS”) released the 2015 Inpatient Prospective Payment System (“IPPS”) Final Rule (“Final Rule”).  Among other changes in the Final Rule, CMS is adopting updated labor market area delineations based on the 2010 census to take effect on October 1, 2014.  Hospitals should review... READ MORE

Executive Summary On July 28, 2014, the Department of Health and Human Services Office of Inspector General (“OIG”) released Advisory Opinion No. 14-05 (“AO 14-05”), addressing one of OIG’s favorite foci, federal health care program “carve out” arrangements.  AO 14-05 was issued in response to a pharmaceutical manufacturer’s (“Company”) request for review of its... READ MORE

Executive Summary In the FY 2015 Inpatient PPS Final Rule, CMS did not finalize problematic changes to the cost reporting requirements that the agency introduced in the proposed rule.  On behalf of clients of Hall Render and Baker Healthcare Consulting, Hall Render previously opposed the proposed rule in comments to CMS and consultations with... READ MORE

Executive Summary On July 29, 2014, legislation designed to both combat prescription drug abuse and ensure patient access to prescription drugs advanced by voice vote in the House of Representatives. This legislation, bolstered by bipartisan sponsorship from Reps. Marsha Blackburn (R-TN), Judy Chu (D-CA), Tom Marino (R-PA) and Peter Welch (D-VT) is designed to... READ MORE

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... 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... READ MORE