King & Spalding

1180 Peachtree Street NE
Atlanta, Georgia 30309, United States

  • 404 572 4600
  • 404 572 5100

Hospital Settles Provider-Based Compliance Investigation for $3.3 Million

A New York State hospital has agreed to pay the U.S. Department of Justice more than $3.3 million to resolve an investigation conducted by the HHS-OIG and U.S. Attorney’s Office for the Northern District of New York into whether…more
| Administrative Law, Health

CMS and OIG Extend Interim Final Rule Regarding Waivers of Fraud and Abuse Laws For ACOs

On October 17, 2014, CMS and OIG jointly published a notice extending the effectiveness of a November 2011 interim final rule establishing waivers that protect qualifying accountable care organizations (ACOs) from liability…more
| Business Organizations, Health

The General Data Protection Regulation - Update on the latest developments

Introduction - The European data protection directive is already one of the most stringent data protection laws in the world. Europe is set to have an even more rigorous data protection law with the introduction of the…more
| Commercial Law & Contracts, Consumer Protection, Privacy, International Law & Trade, Science, Computers, & Technology

CMS Provides for Greater MAC Involvement in ALJ Hearings

CMS recently issued Transmittal 543, Change Request 8501 in which it instructs Medicare Administrative Contractors (MACs) to, among other things, defend their medical review decisions through the Administrative Law Judge (ALJ)…more
| Administrative Law, Health

Health Headlines: Also in the News - October 2014 #2

CMS Announces Changes to the Nursing Home Quality Rating System – On October 6, 2014, CMS announced upcoming changes to the nursing home five-star quality rating system. The changes include revising the scoring methodology and…more
| Health

ITC Section 337 Update – October 2014

Conference on Subpoena Practice in Section 337 Investigations – On October 14, 2014 (2:00 – 4:00 p.m.), a conference was held in the Commission’s Main Hearing Room on subpoena practice in Section 337 Investigations. The…more
| Antitrust & Trade Regulation, Civil Procedure, Intellectual Property, International Law & Trade

Georgia Department of Community Health Ruling Jeopardizes FTC Action Against Phoebe Putney Health System, Inc.

On October 6, Ellwood F. Oakley III, an administrative hearing officer at Georgia’s Department of Community Health, reversed an initial staff determination that a new Certificate of Need (CON) would not be required if Phoebe…more
| Administrative Law, Antitrust & Trade Regulation, Mergers & Acquisitions, Health

FDA Publishes Four Key Supplemental Proposed Rules Under the Food Safety Modernization Act

The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. This groundbreaking piece of legislation is aimed at improving FDA’s capacity to prevent, detect, and respond to…more
| Administrative Law, Agriculture, Commercial Law & Contracts, Consumer Protection

FDA Issues Final Medical Device Recalls Guidance - Explains How to Distinguish Enhancements from Recalls

On October 15, 2015, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements (“Final…more
| Administrative Law, Science, Computers, & Technology

Federal Bills Pursue Comprehensive Data Breach Notification

The recent string of wide-scale data breach disclosures by major retailers has led to a growing call for federal legislation to protect consumer information and establish uniform data breach notification…more
| Commercial Law & Contracts, Finance & Banking, Consumer Protection, Privacy, Health

IRS Proposes Key Changes to Schedule H's Community Health Needs Assessment and Financial Assistance Policy Questionss

On October 8, 2014, the IRS released drafts of the 2014 Form 990, Schedule H and Instructions, proposing significant changes related to a hospital facility's compliance with Section 501(r) of the Internal Revenue Code. These…more
| Health, Taxation

CMS Reopens Application Period for Meaningful Use Hardship Exception

CMS Reopens Application Period for Meaningful Use Hardship Exception - the period during which certain eligible providers may request a hardship exception from qualifying as a Meaningful User under the Medicare EHR Incentive…more
| Health

Health Headlines: Also in the News - October 2014

On September 30th, the Food and Drug Administration (FDA) released draft guidance concerning the proposed oversight framework for regulating laboratory developed tests…more
| Health, Science, Computers, & Technology

CMS Proposes Revisions to Home Health Conditions of Participation

On October 9, 2014, CMS published in the Federal Register a Proposed Rule that would revise the home health Conditions of Participation (CoPs). The home health CoPs have not been updated since 1989. Although CMS previously…more
| Health

CMS Issues New Cost Reporting Instructions

CMS recently released a transmittal updating Chapter 40 of the Provider Reimbursement Manual and the Hospital and Hospital Health Care Complex Cost Report (Form CMS-2552-10)…more
| Health
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