King & Spalding

1180 Peachtree Street NE
Atlanta, Georgia 30309, United States

  • 404 572 4600
  • 404 572 5100

CMS Launches $840 Million “Transforming Clinical Practice Initiative”

On October 23, 2014, CMS announced it would begin accepting applications for its “Transforming Clinical Practice Initiative,” a four-year initiative authorized by the Affordable Care Act. The new Initiative is designed to…more
| Health

Health Headlines: Also in the News - October 2014 #3

CMS Allocates Additional Support for ACOs – On October 15, 2014, CMS announced that it will allocate up to $114 million towards 75 ACOs in order to encourage development in areas lacking the care models. CMS said that the…more
| Business Organizations, Health

Report Shows CMP Enforcement Actions On the Rise Against Part C and Part D Sponsors

A new report issued October 16, 2014 by the Medicare Parts C & D Oversight and Enforcement Group (MOEG) reveals that civil monetary penalty (CMP) enforcement actions in these two programs more than tripled from 2012 to 2013. The…more
| Health, Science, Computers, & Technology

FDA Issues Cybersecurity Guidelines - Manufacturers of Medical Devices Encouraged to Develop Cybersecurity Controls

The Food and Drug Administration (FDA) issued guidelines this month recommending that manufacturers develop a set of cybersecurity controls in the design of medical devices capable of connecting to the Internet, a network, or…more
| Administrative Law, Privacy, Health, Science, Computers, & Technology

Williams v. FDIC (In re Positive Health Management) - Lender Forced to Return Payments Made by Non-Borrower

On October 16, 2014, the United States Court of Appeals for the Fifth Circuit entered an order requiring a real estate lender, First National Bank (the “Lender”), to refund certain mortgage payments it received from Protective…more
| Bankruptcy, Commercial Law & Contracts, Finance & Banking, Real Estate - Commercial

FDA Holds Webinar Discussing Final Guidance on Custom Device Exemptions - Restrictions Loosened but Exemption Remains Narrow

On October 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) held a webinar for industry to explain the guidance document, Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff…more
| Administrative Law, Health, Science, Computers, & Technology

CMS Withdraws Medicare Secondary Payer Proposed Rule

The Office of Management and Budget (OMB) has withdrawn an Advanced Notice of Proposed Rulemaking (ANPRM) in which CMS planned to address how Medicare’s interest should be protected in situations where future medical costs are…more
| Civil Remedies, Health

Medical Devices and Cybersecurity Risks - DHS investigates at-risk devices

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical…more
| Administrative Law, Privacy, Health, Science, Computers, & Technology

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
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