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Health Law News

DOJ Settles with Lab that “Fostered a Culture of Non-Compliance and Greed”

[12/14/15]

Posted on December 14, 2015 in Health Law News

Published by: Hall Render

Executive Summary Recently, the U.S. Department of Justice (“DOJ”) announced a $256 million settlement with one of the nation’s largest urine drug testing (“UDT”) laboratories (“Lab”).  According to a False Claims Act (“FCA”) complaint in intervention filed by the U.S., from January 1, 2008 through May 20, 2015, the Lab “systematically” billed the federal... READ MORE

2016 Non-Monetary Compensation to Physicians (And Chance to Review 2015)

[12/09/15]

Posted on December 9, 2015 in Health Law News

Published by: Hall Render

Executive Summary Under the federal Stark Law, hospitals may provide non-monetary compensation to physicians up to an aggregate amount of $392 for calendar year 2016, remaining the same from the previous calendar year.  The dollar limit for 2016 “medical staff incidental benefits” (e.g., meals, parking and other items or incidental services that are used... READ MORE

Medicare Part D Fraud and Specialty Drugs Highlighted in OIG’s 2016 Work Plan

[12/09/15]

Posted on December 9, 2015 in Health Law News

Published by: Hall Render

Executive Summary Recently, the Department of Health and Human Services Office of Inspector General (“OIG”) released its Work Plan for Fiscal Year 2016 (“Plan”).  The Plan provides insight into OIG’s potential audit and enforcement activities for the next fiscal year.  While the Plan addresses several different provider types, this article addresses the Plan’s initiatives... READ MORE

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FTC Challenges West Virginia Hospital Acquisition Despite Attorney General Approval

[12/02/15]

Posted on December 2, 2015 in Health Law News

Published by: Hall Render

Executive Summary On November 6, 2015, the FTC challenged the proposed acquisition of St. Mary’s Medical Center by Cabell Huntington Hospital in Huntington, West Virginia on the grounds that the proposed acquisition would create a “natural monopoly” and violate the federal antitrust laws. In its complaint, the FTC alleged that the proposed acquisition is... READ MORE

501(r) Compliance Deadlines Draw Near

[12/01/15]

Posted on December 1, 2015 in Health Law News

Published by: Hall Render

With the arrival of December, the deadline for full compliance with most aspects of Internal Revenue Code Section 501(r) is now just one month away for many tax-exempt hospital organizations. The specific deadlines will vary, however, based upon a hospital’s tax year and other factors. Hospital leadership should take this opportunity to confirm the... READ MORE

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Department of Health and Human Services Issues Draft Guidance on Preparing Adequate IRB Minutes

[11/30/15]

Posted on November 30, 2015 in Health Law News

Published by: Hall Render

New draft guidance (“Draft Guidance”) from the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) strongly highlights the need for Institutional Review Boards (“IRBs”) overseeing human subject research to keep detailed minutes of their meetings. Doing so, according to the Draft Guidance, will demonstrate to the IRBs’ research... READ MORE

Provider-Based: The Visiting Specialist Solution to CMS’s Evolving Exclusive Use Standard

[11/24/15]

Posted on November 24, 2015 in Health Law News

Published by: Hall Render

While hospitals have spent much of November 2015 grappling with the fallout of the Budget Act’s restriction on off-campus hospital outpatient departments (“HOPD”) (see Hall Render’s previous articles on the restriction, available here and here), another provider-based issue has quietly gone viral among interested parties, as well as being reported in local news outlets. ... READ MORE

CMS Issues Final Rule on Comprehensive Care for Joint Replacement

[11/23/15]

Posted on November 23, 2015 in Health Law News

Published by: Hall Render

On November 16, 2015, the Centers for Medicare & Medicaid Services (“CMS”) issued a public inspection copy of the Final Rule related to the mandatory bundled payment program known as the Comprehensive Care for Joint Replacement (“CJR”) Model.  The CJR Model is a retrospective bundled payment program for lower extremity joint replacement (“LEJR”) procedures... READ MORE

CMS Finalizes Rule Affecting Holdovers in Space Leasing Arrangements Under the Stark Law

[11/23/15]

Posted on November 23, 2015 in Health Law News

Published by: Hall Render

Overview On October 30, 2015, the Centers for Medicare & Medicaid Services (“CMS”) announced the final rule (“Final Rule”)1 in follow up to the proposed rule published in July 2015 pertaining to payment policies under the Physician Fee Schedule for CY 2016 (“Proposed Rule”). In addition to changes to the Physician Fee Schedule and other... READ MORE

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IRS Revises Tax-Exempt Bond Regulations for Increased Flexibility of Equity Allocations and Creation of Joint Ventures with For-Profit Entities

[11/20/15]

Posted on November 20, 2015 in Health Law News

Published by: Hall Render

On October 27, 2015, the IRS released final allocation and accounting regulations for tax-exempt bonds (the “New Regulations”).  The New Regulations, which can be found here, make three major changes for issuers and borrowers of tax-exempt bonds, in that they:  (1) increase flexibility for how qualified equity is allocated to projects financed both with... READ MORE

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