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Health Law News

Selecting a Developer for Health Care Building Projects

[10/16/14]

Posted on October 16, 2014 in Health Law News

Published by: Hall Render

Selecting the most qualified real estate developer for a health care development project starts with a properly conceived and structured Request for Proposal (“RFP”). Health care real estate projects typically have longer project timelines because there are numerous additional considerations involved in such projects. A properly crafted RFP requires thoughtfulness, foresight and experienced legal... READ MORE

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Ebola Preparedness – Detect, Protect and Respond: Next Steps for Health Care Providers and In-House Counsel

[10/13/14]

Posted on October 13, 2014 in Health Law News

Published by: Hall Render

As American health care gains some experience with Ebola patients, it is time to take the lessons learned from the facilities that first cared for patients with this disease to prepare your facility: The first domestic transmission of Ebola has been confirmed.  Donning and removing personal protective equipment (“PPE”) is a key risk for... READ MORE

Are Major Changes Coming to Home Health Conditions of Participation?

[10/10/14]

Posted on October 10, 2014 in Health Law News, Long-Term Care, Home Health & Hospice

Published by: Hall Render

Deep Dive #1:  The Proposed QAPI Standard The Centers for Medicare & Medicaid Services (“CMS”) released revised home health conditions of participation (“proposed CoPs”) on October 6, 2014.  Home health agencies (“HHAs”) and the health systems or providers with which they work should take a close look at the proposed changes, as they will... READ MORE

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DEA Final Rule Reschedules Hydrocodone Combination Products from Schedule III to Schedule II

[10/10/14]

Posted on October 10, 2014 in Health Law News

Published by: Hall Render

Executive Summary On August 22, 2014, the Drug Enforcement Administration (“DEA”) released its final rule rescheduling hydrocodone combination products (“HCPs”) from Schedule III to Schedule II of the Controlled Substances Act (“Final Rule”). This Final Rule went into effect on October 6, 2014 and applies to all persons who manufacture, distribute, dispense, import, export,... READ MORE

FDA Issues Guidance for Cybersecurity in Medical Devices

[10/09/14]

Posted on October 9, 2014 in Health Law News

Published by: Hall Render

Executive Summary While the notion of malicious hacking of a medical device has been a recent topic in fictional  television shows, it became a public reality in October 2013 when former Vice President Dick Cheney revealed that his cardiologist modified Cheney’s heart defibrillator to disable a wireless feature and prevent hacking of the device.... READ MORE

CMS Receives Comments to Proposed Rule Affecting Physician-Owned Hospital Expansion Exception

[10/08/14]

Posted on October 8, 2014 in Health Law News

Published by: Hall Render

Background Recent public comments to the Centers for Medicare & Medicaid Services (“CMS”) shed light on the frustrations faced by physician-owned hospitals trying to expand.  On July 14, 2014, CMS issued a proposed rule to make changes to the data sources that may be used for physician-owned hospital expansion requests under the physician self-referral... READ MORE

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Michigan Passes Law Requiring Licensure for Pharmacy Technicians

[10/07/14]

Posted on October 7, 2014 in Health Law News

Published by: Hall Render

Executive Summary On September 23, 2014, Michigan passed Public Act 285 (“Act”), which requires pharmacy technicians who perform certain functions to be licensed in the State of Michigan. Previously, individuals working as pharmacy technicians were not required to be certified or licensed to perform duties essential to their profession. In considering this new licensure... READ MORE

Ebola Preparedness: Considerations for Clients and In-House Counsel

[10/03/14]

Posted on October 3, 2014 in Health Law News

Published by: Hall Render

As American hospitals admit the first confirmed Ebola patient diagnosed in the U.S., and a second possible patient, providers and counsel need to work with their clients to prepare for the possibility of a patient presenting at their facility. Here are some considerations for initial steps: Update contact information for your local public health officer and... READ MORE

The Top 5 Regulatory Issues Affecting Hospital Leasing Arrangements

[10/03/14]

Posted on October 3, 2014 in Health Law News

Published by: Hall Render

Over the past decade, hospitals have become increasingly regulated. In response, most hospitals have elected to implement corporate compliance programs. While these programs serve an important purpose, most fail to specifically address an area that is highly regulated – the leasing of hospital real estate. Managing hospital leasing arrangements can be extremely tedious work... READ MORE

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DOJ Announces All False Claims Act Qui Tam Cases Will Be Reviewed by the DOJ’s Criminal Division

[10/01/14]

Posted on October 1, 2014 in Health Law News

Published by: Hall Render

Executive Summary A spokesperson for the Criminal Division of the U.S. Department of Justice (“DOJ”) announced on September 17, 2014 at the Taxpayers Against Fraud Education Fund conference that all new qui tam (i.e., whistleblower) complaints filed under the False Claims Act (“FCA”) will be reviewed by the Criminal Division of the DOJ.  While... READ MORE

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