Articles and Blogs

Introduction Effective July 1, 2013, pharmacists in Indiana are able to administer additional vaccines to patients beyond the flu and shingles vaccines that they have been able to administer historically.  On April 29, 2013, Governor Michael Pence signed House Bill 1464 into law, which now allows pharmacists to administer immunizations for pneumonia; tetanus, diphtheria... READ MORE

Executive Summary On October 24, 2013, the Office of the Inspector General (“OIG”) released the results of a study beginning in the fall of 2012 on implantable spinal devices supplied to hospitals by physician-owned distributors (“PODs”). The OIG report entitled “Spinal Devices Supplied by Physician-Owned Distributors: Overview of Prevalence and Use OEI-01-11-00660” (“Report”) can... READ MORE

The U.S. Food and Drug Administration (“FDA”) recently celebrated the 20th anniversary of its MedWatch program, which gathers and shares important safety information about FDA-regulated products.  FDA gathers some of this safety information through reports of adverse health effects related to drugs, medical devices, biologics, dietary supplements and human tissue/cellular products submitted by health... READ MORE

Earlier this year, a federal court called into question the tax treatment of physician loans, a practice common among hospitals and physician groups to attract top talent. READ MORE

The U.S. Food and Drug Administration (“FDA”) has issued draft guidance on its Investigational Device Exemption (“IDE”) process for medical devices, titled Decisions for Investigational Device Exemption Clinical Investigations.  The draft guidance introduces a new pre-decisional IDE review process, through which medical device sponsors can seek the FDA’s input on significant issues before submitting... READ MORE

On August 19, 2013, the Centers for Medicare and Medicaid Services (“CMS”) published in the Federal Register the 2014 acute care hospital and long-term care hospital inpatient prospective payment system final rule (“Final Rule”) effective on October 1, 2013.  As part of the Final Rule, CMS formulated a “2-midnight presumption” and a “2-midnight benchmark”... READ MORE

Executive Summary On September 23, 2013, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (“Proposed Rule”) enumerating the details of the pending prospective payment system (“PPS”) for Federally Qualified Health Centers (“FQHCs”).  This Proposed Rule was developed in response to a mandate established in the Patient Protection and Affordable Care... READ MORE

On August 19, 2013, the Centers for Medicare and Medicaid Services (“CMS”) published the acute care hospital and long-term care hospital inpatient prospective payment system final rule for fiscal year 2014 (“Final Rule”).  Under one new provision in the Final Rule, if a Medicare Part A claim for inpatient hospital services is denied because... READ MORE

On September 13, 2013, the Centers for Medicare & Medicaid Services (“CMS”) issued a Medical Learning Network Letter (“Letter”) addressing new guidance for meeting the annual reporting requirements for physician-owned hospitals.1  The Letter affects hospitals with physician ownership and/or investors wishing to rely on the whole hospital or rural provider exception to the Stark... READ MORE

Hall Render is pleased to announce that two of our shareholders, Gerald L. Stovall and Gregg M. Wallander, were recently named the Best Lawyers® 2014 “Lawyers of the Year” (Copyright 2013 by Woodward/White, Inc., of Aiken, SC).  Stovall, who leads the firm’s construction law practice, was named the Best Lawyers 2014 Louisville Construction “Lawyer of... READ MORE