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The Federal Government Holds Individuals Responsible for Involvement in Corporate Healthcare Fraud and Abuse

In September 2016, three corporate officers in two healthcare fraud and abuse cases settled allegations that they were personally liable for violations of federal fraud and abuse laws. These settlements come one year after...more

Health Care E-Note - November 2016

You just formed your medical practice inAlabama, and you either chose a professional corporation (a “PC”) or an LLC. If you went with a PC, you got to choose between an “S” corporation (“S corp”) or a “C” corporation (“C...more

Renewed Perils from “Zeroing Out” a Corporation at Year-End

Physicians who are involved in the financial management of their practices are all too familiar with the year-end scramble to “zero out” the corporation’s profits. Under this technique, a physician practice that is structured...more

Investing in Cuban Health Care Biotech Industries

The Obama Administration made significant new regulatory changes to allow certain investment opportunities in the Cuban health care and biotech industries. While many barriers remain, US firms in the health care industry...more

Independent Medical Staff Denied Title VII Protection

It has not been unusual for employed physicians to seek the protection provided to independent medical staff members through the due process procedures provided by medical staff by-laws. The case of Levitin and Chicago...more

[Webinar] Post-Election Webinar - November 9th - 11:00a.m. EST

As the dust settles after the presidential candidates’ first debate, BakerHostetler’s Federal Policy team continues to analyze the impact of the 2016 election on federal policy issues. After all the votes are counted, please...more

OCR Explains How Information Blocking Violates HIPAA

The US Department of Health and Human Services Office for Civil Rights recently posted guidance clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a...more

Recent Settlements Demonstrate the Reach and Versatility of the FCA

In recent years, civil enforcement efforts involving the FCA have grown significantly. Today, the FCA impacts a vast array of businesses, as it is commonly used to redress false claims for government funds involving...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Defending parallel proceedings: key considerations and best practices

Parallel proceedings refer to two or more concurrent investigations or litigations arising out of a common set of facts. These proceedings can involve any combination of criminal, civil, or administrative authorities, as well...more

European Health Care Compliance Challenges (And Solutions)

Life sciences and health care companies (“health care companies”) rightly invest a significant amount of time and money into ensuring compliance with health care regulations in the countries in which they are based, but...more

Healthcare Legal News: Volume 6, Number 2

Restrictions on Fees Permitted under HIPAA for Copies of Medical Records - When health care providers provide copies of medical records to an individual patient or to third parties at the direction of that individual...more

Big Pharma, undeterred, racks up a half-billion dollars in regulator penalties

Big Pharma’s dubious hype of its sometimes risky products marched on last week, with the industry racking up a half-billion in regulator penalties and settlements but no seeming end to its questionable strategies and...more

Deal Watch: Teva and Celltrion Announce Biosimilar Commercial Partnership

Teva Pharmaceutical Industries Ltd., Celltrion, Inc. and Celltrion Healthcare announced that the companies have entered into an exclusive partnership to commercialize two of Celltrion’s biosimilar candidates: CT-P10, a...more

Guidelines for Written Information Security Policies

Although federal law only requires that financial institutions and health care providers maintain a written information security policy or “WISP,” approximately thirty four states have enacted legislation that requires...more

Former CEO of Health System Agrees to Pay $1 Million to Settle False Claims Act Case with U.S. Department of Justice

In the most recent example of its continued effort to hold individuals accountable for corporate misconduct, the U.S. Department of Justice (“DOJ”) announced on September 27, 2016, that the former CEO of Tuomey Healthcare...more

Corridors - October 2016 - News for North Carolina Hospitals

Proposed 2017 Hospital OPPS Rule Would End Medicare Payments to Many Off-Campus Facilities at the Same Levels as Hospital-Based Outpatient Departments - Published on July 14, 2016, CMS’s proposed 2017 Hospital...more

Changes to Compensation Rules for Tax-Exempt Hospitals

The IRS has proposed new rules that will require tax-exempt hospitals (and other tax-exempt entities) to review a variety of compensation arrangements to avoid unintended tax consequences. This article will provide a brief...more

[Event] Long-Term Care Conference - October 18th, Richmond, VA

Williams Mullen's Long-Term Care Conference will provide health care executives with the latest information on how to mitigate professional liability and regulatory risks; manage employment law matters, including overtime,...more

Is your cybersecurity upgrade FDA reportable?

In today’s marketplace, technology evolves at a rapid rate, and must adapt to changing circumstances, such as threats to cybersecurity. For device companies, some types of modifications to devices post-market - potentially...more

Deal Watch: Teva and Regeneron Announce Fasinumab Collaboration

On September 20, Teva Pharmaceutical Industries Ltd. and Regeneron Pharmaceuticals, Inc. announced an agreement to develop and commercialize fasinumab, an investigational NGF antibody currently under development by Regeneron...more

DOJ and States Challenge Health Insurer Mergers

Following more than a year of regulatory review, in late July 2016 the Department of Justice (DOJ) Antitrust Division and a number of states filed actions seeking to derail both the Anthem/Cigna and Aetna/Humana mergers. In...more

Dismissing Lawsuits Against Owners of New York Nursing Homes

There are many state and federal statutes which provide personal liability against the owners of businesses that are operated through corporate or other legal forms such as Limited Liability Company’s (“LLC’s”). One such...more

Managing the Transition to Transformation: Corporate Governance and the Transition to Transformation

McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery...more

Also In The News - Health Headlines - August 2016 #4

CMS Reports ACO Savings and Improved Quality of Care – CMS issued a press release on August 25, 2016 announcing the 2015 performance year results for the Medicare Shared Savings Program and the Pioneer Accountable Care...more

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