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Health Law News

FDA Will Stop Enforcing Regulatory Requirements for Many Medical Image and Data Systems

[07/11/14]

Posted on July 11, 2014 in Health Law News

Published by: Hall Render

The Food and Drug Administration (the “FDA” or “agency”) recently released a draft guidance document (“Draft Guidance”) in which the agency proposes to stop enforcing the regulatory requirements applicable to several types of devices and software that transfer, store, convert, format and display medical data.  This Draft Guidance, if finalized, will apply to Medical... READ MORE

Practical 501(r) Compliance: Constraints on Patient Charges and Collection Activities

[07/10/14]

Posted on July 10, 2014 in Health Law News

Published by: Hall Render

This Health Care Tax News article is Part IV in a series discussing the proposed regulations under Code Section 501(r).  Part I provided a general overview of why Hospital Organizations should move forward to comply with the proposed regulations, Part II provides an overview of preparing for a Community Health Needs Assessment and Part III... READ MORE

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Practical 501(r) Compliance: Reviewing and Rethinking the Financial Assistance Policy

[07/09/14]

Posted on July 9, 2014 in Health Law News

Published by: Hall Render

This Health Care Tax News article is Part III in a series discussing the proposed regulations under Code Section 501(r).  Part I provided a general overview of why Hospital Organizations should move forward to comply with the proposed regulations and Part II provides an overview of preparing for a Community Health Needs Assessment. The... READ MORE

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Practical 501(r) Compliance: The Community Health Needs Assessment

[07/08/14]

Posted on July 8, 2014 in Health Law News

Written by: Carmichael, Jeffrey L.

This Health Care Tax News article is Part II in a series discussing the proposed regulations under Code Section 501(r).  The previous installment provided a general overview of why Hospital Organizations should move forward to comply with the proposed regulations and can be accessed by clicking here.  Following enactment of the Affordable Care Act (“ACA”)... READ MORE

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Practical 501(r) Compliance: Why Hospital Organizations Should Comply Now with the Proposed Regulations

[07/07/14]

Posted on July 7, 2014 in Health Law News

Published by: Hall Render

This Health Care Tax News article is Part I in a series discussing the proposed regulations under Code Section 501(r). Since the Affordable Care Act (“ACA”) imposed four significant new requirements on tax-exempt Hospital Organizations, the IRS has offered various forms of guidance for complying with the new law, including two detailed sets of proposed... READ MORE

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IRS Releases Form 1023-EZ Exemption Application

[07/03/14]

Posted on July 3, 2014 in Health Law News

Published by: Hall Render

On several occasions over the past year, the IRS has publicly expressed its intention to clear a significant backlog of exemption applications.  With its July 1 release of Form 1023-EZ, a shorter exemption application form for small nonprofits, the IRS took a significant step towards reducing this backlog. READ MORE

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HIPAA Harmonization Act Changes Rules Regarding Mental Health Treatment Record Privacy in Wisconsin

[06/30/14]

Posted on June 30, 2014 in Health Law News

Published by: Hall Render

Governor Scott Walker recently signed into law the HIPAA Harmonization – Mental Health Care Coordination Act (2013 WI Act 238, the “Act”).  The Act is intended to alleviate barriers to coordination of care for patients receiving mental health treatment by aligning aspects of Wisconsin’s mental health privacy laws with the Federal Health Insurance Portability... READ MORE

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D.C. Circuit: Compliance Investigations Are Privileged

[06/28/14]

Posted on June 28, 2014 in False Claims Act Defense, Health Law News

Written by: Drew B. Howk

Yesterday, the D.C. Circuit issued a much-anticipated decision regarding whether or not internal compliance investigations were privileged. Two recent lower court decisions had ruled that such compliance investigations were not privileged because they were for business rather than legal purposes. The D.C. Circuit disagreed and found that such compliance investigations are for legal purposes... READ MORE

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OIG Releases Special Fraud Alert Revisiting Laboratory Payments to Referring Physicians

[06/27/14]

Posted on June 27, 2014 in Health Law News

Published by: Hall Render

Executive Summary On June 25, 2014, the U.S. Department of Health and Human Services Office of the Inspector General (“OIG”) released a Special Fraud Alert (the “Alert”) addressing Laboratory Payments to Referring Physicians.  The Alert supplements previous guidance and is the latest in a series of advisories, dating back to 1994, discussing the fraud... READ MORE