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The Yates Memo and Big Pharma: Individual Prosecutions for Corporate Misconduct

By Dustin Aponte, Dr. Saul Helman, and Jennifer Mitchell

The Yates Memo sends an unmistakable message to corporate decision makers.


American Bar Association House of Delegates Update

By Grant C. Killoran

At the Midyear Meeting, the ABA House of Delegates approved a number of reports featuring policy initiatives proposed by the Section of Litigation and the Health Care Section.


Vanessa's Law: Health Canada's Policy Shift Toward Transparency

By Sarah E. Whitmore

Vanessa's Law is a policy shift toward transparency that has significant implications for the health industry, particularly drug and medical device manufacturers.


Recent Developments in Traumatic Brain Injury Litigation

By Francis H. "Rasch" Brown III

TBI-associated cases number in the millions. TBI settlement payouts number in the millions, too.


Timeshare Arrangements Exception to Stark Law Offers Opportunities in Rural/Underserved Communities

By Roger R. Clayton, Greg Rastatter, J. Tyler Robinson, and Amee Lakhani

Timeshare arrangements can facilitate part-time or periodic access to physicians who otherwise could not maintain a full-time practice in the community.


The Emergence of Ransomware as a Threat to Healthcare Providers

By Adam B. Peck and Eric W. Shannon

Hospitals have been a frequent and well-publicized target of ransomware attacks.


What Healthcare Litigators Can Learn from FTC's Recent Challenges to Provider Mergers

By Andrew Kasper

A look at the FTC's four most recent challenges to healthcare mergers.


An Industry Crash Course for the Aspiring Healthcare Litigator

By Eric W. Shannon

Junior litigators often assume that, to become a healthcare practitioner, they must have a strong understanding of the many facets and intricacies of the healthcare industry from day one. This is not true.


It's the Hard-Knock Life: The Rough-and-Tumble over Orphan Drug Pricing

By Mark P. Goodman, Maura K. Monaghan, Kristin D. Kiehn, Jacob W. Stahl, and Kaitlin T. Farrell

Constituencies that disagree with regulations issued by HHS are likely to have more opportunities to challenge their validity.


Speedy Returns: The 60-Day Rule

By Maura K. Monaghan, Kristin D. Kiehn, Jacob W. Stahl, and Young-Hee Kim

The first and only court decision on the "60-Day Rule" highlights the importance of quickly identifying and repaying Medicare/Medicaid overpayments.


On the Clock: Failure to Timely Refund Overpayments Leads to FCA Exposure

By Anna Grizzle, Brian Roark, and Julia Tamulis

The silence breaks over section 6402(d) of the PPACA.


American Bar Association House of Delegates Update

By Grant Killoran

At the ABA Annual Meeting, the House considered a number of recommendations, including some that may be of interest to healthcare litigators and young lawyers.


Advising Long-Term-Care Clients: Ten Tips to Lower Litigation Costs

By Christy T. Crider

The reality of caring for our elderly in today's litigation climate is that eventually your client's long-term-care facility will be sued.


2014 Healthcare False Claims Act Developments

By Georgia Pham

Unique applications of federal fraud and abuse laws and a growing circuit split.


The Constitutional Framework for Public Health Responses to Disease Outbreaks

By Christa D. Wittenberg

The proper role of the government in responding to public health threats has been much debated in recent months.


American Bar Association House of Delegates Update

By Grant Killoran

The House of Delegates adopted recommendations that may be of interest to healthcare litigators.


The ACA's Muddled Application of the FCA to Health-Insurance Exchanges

By Christopher R.J. Pace

An example of the ACA's rushed enactment and poor drafting is a new section that purports to apply the False Claims Act to health-insurance exchanges.


Emerging Litigation Threats for Physician Relationships in a Post-ACA World

By Emre N. Ilter

Healthcare providers have historically not viewed physicians as likely whistleblowers, but that is changing.


The Growing Threat of Qui Tam Litigation Against Healthcare Providers

By Amandeep S. Sidhu

The ACA ushered in four changes that are favorable to relators and could add risk exposure to providers.


Developments in Establishing and Preserving Privilege

By Kaitlin Harvie and Matthew M. Curley

Several recent decisions serve as cautionary tales.


Navigating the Uncertain World of Off-Label Promotion

By Wendy Weiss and Dustin Aponte

Recent developments have questioned the scope of the First Amendment's right of free speech.


Opening Pandora's Box: The Open Payments Reporting Requirements

By Christian Dingler

Techniques to help ensure that the submission of Phase 2 transactions is as timely, complete, and accurate as possible.


ACA Preemption and How a Missouri Order Will Impact Health Litigation

By John W. Polonis

The ruling may cause state legislators to act cautiously before considering laws designed to obstruct implementation of the ACA.


Demystifying the Advance Health-Care Directive

By Carrie L. Anderson

Be prepared in the event you cannot make decisions on your own.


Group Health Insurers Can Be Sued for Negligence of Providers in Their Networks

By Kristina N. Holmstrom

Plaintiffs injured by medical malpractice typically look to recover against the doctors and medical facilities that treated them, not to the insurer that paid for the substandard treatment. In Nevada, however, this is changing.


Fighting Medicare Fraud under the False Claims Act

By Lauren Perkins Allen

A qui tam action under the FCA effectively thwarts those who commit Medicare fraud.


Recent Considerations in Life-Sciences Sales Training

By Dylan J. Steinberg

Two appellate decisions have changed how companies ought to approach their sales-training programs.


HIPAA Rule Updated for the First Time since Inception

By Sachin Shah

Patients gain control while negligent providers get stiffer penalties.


The Updated Provider SDP: To Disclose or Not to Disclose?

By Ardith Bronson and Pravin Patel

A provider should engage counsel early on to perform an appropriate risk-benefit analysis before making any disclosures to the OIG.


Affordable Care Act's Impact on Life Sciences

By Matthew P. Amodeo, Jennifer R. Breuer, Anna Schwamlein Howard, and Robyn S. Shapiro

The Supreme Court’s Patient Protection and Affordable Care Act decision will have a positive effect on the life sciences industry, but may cost the manufacturing sector billions over the next decade.


The Rise of Government Action Against the Individual

By Christine C. Levin and Evan W. Davis

An increase in enforcement action against individual defendants may put people—and not the companies they represent—in expanding government crosshairs.


Recent Developments in Recovery Audit Contracting

By Nicholas M. Hudalla, Kelly McCloskey Cherf, and Limo T. Cherian

An update on new programs from the Centers for Medicare and Medicaid Services shows how agencies hope to recover over $1 billion in overpayment funds from health care providers.


Jumping Through Hoops: HIPAA Obstacles to Medical Research

By Sachin Shah

As billions of dollars are spent on medical research annually, obstacles presented by HIPAA—and possible solutions—must be examined in greater detail.


Legal Life Sciences Tips and Trends

By Lauren Silvis and Sara Beardsley

Health care reform, court decisions, and shifts in the industry have created a new climate for life sciences companies, which will need a wide range of tools to address this new environment.


Health Care in the High Court

By Nabilah Irshad

The Supreme Court is hearing oral arguments concerning one of the most contentious pieces of legislation this election cycle: The Patient Protection and Affordable Care Act .


The Federal Health-Care Act Heads to the Supreme Court

By Norayr Zurabyan

The U.S. Supreme Court has granted certiorari to hear the Patient Protection and Affordable Care Act case from the Eleventh Circuit, amid presidential elections.


Violations of Payment/Participation Conditions as Predicates for False Claims

By Katherine A. Lauer, Jason M. Ohta, and Amy E. Hargreaves

The distinction between a condition of payment and a condition of participation should continue to be particularly significant in FCA actions.


Expertly Impeaching the Medical Expert

By James V. Painter

Attorneys should research potential sources that can be utilized to expertly impeach medical experts.


Courts Grapple with the Enforceability of Nursing Home Arbitration Clauses

By Joanne Snow

The enforceability of mandatory arbitration agreements in the patient admission process will continue to be fought in the courts.


False Claims Act Expands Liability for Inadvertent Stark Law Violation

By Katherine A. Lauer, Michael P. Myers, and Scott W. Morris

Many of the changes to the False Claims Act address and expand the types of entities and conduct subject to the FCA's reach.


Interagency Medicare Fraud Initiative Expands Ongoing Enforcement Activity

By Bary M. Sabin, Alice S. Fisher, and Daniel Meron

The Health Care Fraud Prevention and Enforcement Action Team (HEAT) will battle fraud in Medicare and Medicaid programs.


Federal Stimulus Package Broadens HIPAA Rules and Adds New Security Breach Notification Requirements

By Nestor J. Rivera

Changes to the HIPPA Privacy Rule impact covered entities and/or business associates and how they handle the use, disclosure, or request of a patient's protected health information and/or electronic health record.


Using Voluntary Disclosure to Resolve Anti-Kickback Statute Liability

By Katherine A. Lauer and Elizabeth A. Gobeski

Given the severe penalties available under the AKS, providers have a strong incentive to minimize liability for AKS violations.