Articles and Blogs

Year: 2013

Robert Markette Joins the Indianapolis Office of Hall Render

[04/23/13]

Posted on April 23, 2013 in Firm News

Published by: Hall Render

Hall Render is pleased to announce of counsel attorney Robert W. Markette, Jr., J.D., has joined the firm’s Indianapolis office. Markette practices in Hall Render’s Health practice group where he focuses on representing home health, hospice and private duty providers in all aspects of their operations.  He works with clients on issues related to... READ MORE

OIG Issues Updated Self-Disclosure Protocol

[04/22/13]

Posted on April 22, 2013 in Health Law News

Published by: Hall Render

Executive Summary On April 17, 2013, the Office of Inspector General (“OIG”) issued an updated version of its Self-Disclosure Protocol (“Protocol”).  In 1998, the OIG published the original Protocol to establish a process for health care providers to voluntarily identify, disclose and resolve instances of potential fraud involving federal health care programs, particularly with... READ MORE

This Week in Washington – April 19, 2013

[04/19/13]

Posted on April 19, 2013 in Federal Advocacy

Written by: John Williams

HHS Inspector General Revises Self-Disclosure Protocol On April 17, the HHS Office of Inspector General (“OIG”) released a revised self-disclosure protocol (PDF) called the OIG Provider Self-Disclosure Protocol.  The protocol describes what a hospital must confide to the government in order to avoid prosecution or get a possible reduction in penalties. READ MORE

FDA to Allow Use of Validated Symbols When Labeling Medical Devices and Biological Products

[04/19/13]

Posted on April 19, 2013 in Health Law News

Published by: Hall Render

The U.S. Food and Drug Administration (“FDA”) wants to give manufacturers of medical devices in vitro diagnostics (“IVDs”) and biological products the authority to use certain symbols and images on their product labeling to convey safety information and instructions for use. A proposed rule published April 19 would revise the agency’s regulations at 21... READ MORE

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IRS Issues CHNA Proposed Regulations and Guidance on 501(r) Noncompliance Penalties

[04/16/13]

Posted on April 16, 2013 in Health Law News

Published by: Hall Render

The Internal Revenue Service (“IRS”) published proposed regulations (“Proposed Regulations”) on April 5, 2013 that expand upon and provide clarification for the community health needs assessment (“CHNA”) requirements of Section 501(r)(3) of the Internal Revenue Code (the “Code”). The Proposed Regulations also provide guidance on how and when penalties may be imposed for failing to... READ MORE

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National Healthcare Decisions Day – April 16, 2013

[04/15/13]

Posted on April 15, 2013 in Health Law News

Published by: Hall Render

Executive Summary April 16, 2013 is National Healthcare Decisions Day. The goal of the day is to encourage Americans to think and talk about their health care goals and communicate their health care decisions by executing advance health care directives. READ MORE

Hall Render Ranked First in “Top Workplaces” for Third Consecutive Year

[04/15/13]

Posted on April 15, 2013 in Firm News

Published by: Hall Render

Hall Render is proud to announce the firm has been ranked first in the midsize company category of the Indianapolis Star‘s “Top Workplaces” for the third year in a row. The firm is the first company to maintain a number one ranking for three consecutive years.  Hall Render also won in the employee appreciation... READ MORE

April False Claims Act Update

[04/15/13]

Posted on April 15, 2013 in False Claims Act Defense

Written by: David B. Honig

Introduction Three cases are addressed in a review of the False Claims Act decisions of the past month. The first, US v. Anchor Mortage Corp., is a significant Seventh Circuit case addressing the proper treble damages calculation under the statute. The second, US ex rel. Carter v. Halliburton, considers the application of the Wartimes Suspension... READ MORE

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This Week in Washington – April 12, 2013

[04/12/13]

Posted on April 12, 2013 in Federal Advocacy

Written by: John Williams

Obama Releases HHS Budget for FY 2014 On April 10, HHS posted a 126-page summary of President Obama’s fiscal year (“FY”) 2014 budget for the agency. The budget proposes $5.6 billion in Medicare payment cuts for FY 2014. Hospital-related cutbacks were proposed for graduate medical education, critical access hospitals and bad debt payments. READ MORE

Off-Label Use of Medical Products: Warranty and Indemnification Considerations in Purchase Agreements

[04/11/13]

Posted on April 11, 2013 in Health Law News

Published by: Hall Render

When you purchase an item, you assume that it can be used in any reasonable manner and the warranties will apply.  The same is true of buyers of medical products.  Take the humble tongue depressor.  Regulated by the Food and Drug Administration (“FDA”) pursuant to 21 C.F.R. § 800.6230, the tongue depressor is “…a... READ MORE