Articles and Blogs

The Health and Human Services Office of Inspector General (“OIG”) remains concerned with potential prescription drug abuse. The Centers for Disease Control and Prevention estimates that approximately seven million people in the U.S. misused prescription drugs in 20101 and has characterized prescription drug abuse as an epidemic. Due to concerns of prescription drug abuse... READ MORE

Background The Centers for Medicare & Medicaid Services (“CMS”) recently issued two advisory opinions regarding arrangements where for-profit clinical laboratories would provide certain devices without charge to physicians, including physicians that made referrals to the entities.1 These advisory opinions were the first issued by CMS in over two years. Though the arrangements discussed in... READ MORE

As part of the 2014 inpatient prospective payment system final rule, CMS formulated a “2-midnight presumption” and a “2-midnight benchmark” (collectively the “2-Midnight Rule”) to guide admitting practitioners and review contractors on when it is appropriate to admit a patient as a hospital inpatient.  In the last few days, CMS posted a series of... READ MORE

The Internal Revenue Service recently announced the retirement plan limits for 2014, some of which are unchanged from 2013.  The Social Security Administration has also announced the Social Security wage base for 2014.  The following are some key retirement plan dollar limits for 2014 for retirement plan sponsors and participants, along with the prior... READ MORE

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