Stuart M. Gerson

Stuart M. Gerson

Epstein Becker Green

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DOJ Focuses on Individual Accountability: New Guidance for Corporate Investigations Places Pressure on Companies and Boards to Put...

On September 9, 2015, the Department of Justice (“DOJ”) issued new guidance on individual accountability for corporate wrongdoing. In the memorandum and an accompanying speech by the Deputy Attorney General Sally Q. Yates,...more

9/29/2015 - Attorney-Client Privilege Board of Directors C-Suite Executives Chief Compliance Officers Corporate Misconduct Criminal Prosecution DOJ Enforcement Actions Government Investigations Healthcare New Guidance Yates Memorandum

The Clock’s Running Fast: SDNY Is First to Interpret “Identification” Under the FCA’s “60-Day Rule” for Government Overpayments

On August 3, 2015, in United States ex rel. Kane v. Healthfirst, Inc., et al., No. 1:11-cv-02325 (S.D.N.Y. Aug. 3, 2015), the United States District Court for the Southern District of New York issued the first reported...more

8/11/2015 - Affordable Care Act CMS Defense Strategies False Claims Act (FCA) Health Care Providers Healthcare Medicaid Medicare Overpayment Qui Tam

Spotlight on Responsibility and Accountability: OIG’s New Compliance Guidance for Health Care Governing Boards

On April 20, 2015, the Office of the Inspector General of the U.S. Department of Health and Human Resources (“OIG”), in collaboration with the American Health Lawyers Association, the Association of Healthcare Internal...more

5/4/2015 - Board of Directors Chief Compliance Officers Corporate Governance Corporate Integrity Agreement Health Care Providers Healthcare Hospitals New Guidance OIG

Supreme Court Rules That Providers and Suppliers Cannot Challenge Medicaid Reimbursement Rates in Federal Court

On March 31, 2015, a 5-4 plurality of the Supreme Court of the United States ruled that Medicaid providers do not have a private right of action under the Medicaid statute to challenge reimbursement rates. The Supreme Court’s...more

4/14/2015 - Appeals Armstrong v Exceptional Child Center Health Care Providers Healthcare Medi-Cal Medicaid Physician Medicare Reimbursements Private Right of Action SCOTUS Supremacy Clause

No State Action Antitrust Immunity for North Carolina Dental Board: Implications for the Health Care Sector

On February 25, 2015, the Supreme Court of the United States held that the North Carolina Dental Board (“Board”) was not insulated from federal antitrust liability under the so-called “state action” doctrine when it engaged...more

3/18/2015 - Antitrust Litigation Antitrust Provisions FTC Healthcare Licensing Rules NC Board of Dental Examiners v FTC Restraint of Trade SCOTUS State Action Immunity State Agencies

Supreme Court Removes a Major Hurdle for Administrative Agency Rulemaking

On March 9, 2015, the Supreme Court ruled unanimously that when a federal administrative agency wants to amend or repeal an “interpretive rule,” it does not have to follow the notice-and-comment procedures set forth in the...more

3/12/2015 - Administrative Procedure Act DOL FLSA Mortgage Loan Officer Paralyzed Veterans Doctrine Perez v Mortage Bankers Assoc Rulemaking Process SCOTUS Statutory Interpretation Wage and Hour

Five Health Care Developments Important to Employers

Perhaps never before have employers faced so many challenges when it comes to health care issues affecting their workforce. Congress may try to amend the Affordable Care Act (“ACA”). The Supreme Court of the United States is...more

2/26/2015 - Affordable Care Act DOL EEOC Employer Group Health Plans Flexible Spending Accounts GINA Health Insurance Health Savings Accounts HIPAA Individual Mandate Preexisting Conditions SCOTUS Tax Credits Telehealth Telemedicine Wellness Programs

HEAL Advisory: Whistleblowers Rewarded Again by SEC and the Judiciary

On August 29, 2014, two whistleblower developments of particular interest to health care and life science entities emerged from the Securities and Exchange Commission ("SEC") and the Eighth Circuit Court of Appeals,...more

9/11/2014 - SEC Whistleblower Awards Whistleblowers

HEAL Advisory: How Big Is Halbig? The Potential Effects of This Major Ruling Are Numerous and Significant

On July 22, 2014, the U.S. Court of Appeals for the D.C. Circuit and the U.S. Court of Appeals for the Fourth Circuit issued conflicting opinions on a key aspect of the Affordable Care Act ("ACA"). The cases are Halbig v....more

7/30/2014 - Affordable Care Act Appeals Barack Obama Employer Mandates En Banc Review Halbig v Burwell Health Insurance Health Insurance Exchanges Healthcare Reform King v Burwell SCOTUS Subsidiaries Tax Credits

How Big Is Halbig? The Viability of the ACA’s Employer Mandate Hangs in the Balance

For employers with employees in the 36 states with a federally facilitated exchange, the question arises how the Halbig decision impacts their decision and strategy to provide health coverage to their employees when the...more

7/23/2014 - Affordable Care Act Employer Mandates First Glance Halbig v Burwell King v Burwell Legal Perspectives

DC Circuit Strongly Reaffirms the Applicability of the Attorney-Client Privilege to Internal Compliance Investigations

Especially in the District of Columbia Circuit, the home base for many fraud cases in which the government is opposed to health care providers and defense contractors, there had been considerable doubt that the...more

7/2/2014 - Attorney-Client Privilege Compliance False Claims Act (FCA) Internal Investigations KBR (formerly Kellogg Brown & Root) Work-Product Doctrine

Act Now Advisory: As Defendant, Obama Administration Takes Narrower View of Whistleblower Protections Than as Enforcer - Will This...

Employers attempting to manage corporate compliance programs while balancing privacy concerns and whistleblower protections might find a certain irony, perhaps empathy, in the Obama administration's recent petition for U.S....more

3/7/2014 - CFTC Confidentiality Agreements Dodd-Frank Lawson v FMR NTSA Retaliation Sarbanes-Oxley SCOTUS SEC Separation Agreement Training Transportation Security Administration Whistleblower Protection Policies

Eighth Circuit Adopts Novel False Claims Act Fraud-in-the-Inducement Theory Long Espoused by Government

On October 15, 2013, a divided three-judge panel of the United States Court of Appeals for the Eighth Circuit rendered a federal False Claims Act ("FCA") judgment against Bayer Healthcare Pharmaceuticals ("Bayer"), based on a...more

11/12/2013 - DOD False Claims Act (FCA) Fraud Fraudulent Inducement Prescription Drugs Qui Tam

Supreme Court Opinion in Sebelius v. Auburn Regional Medical Center Rejects a Challenge by Hospitals to Medicare's SSI Fraction...

A unanimous Supreme Court has issued its opinion in Sebelius v. Auburn Regional Medical Center, No. 11-1231 (Jan. 22, 2013), rejecting a challenge by hospitals to Medicare's Supplemental Security Income ("SSI") fraction...more

1/25/2013 - Equitable Tolling Hospitals Medicare Overpayment Reimbursements

Second Circuit Rules That Certain Speech Regarding the Off-Label Use of Drugs Is Protected Under the U.S. Constitution

In a long-awaited decision, on December 3, 2012, a divided panel (2–1) of the U.S. Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia, a former pharmaceutical sales representative for Jazz...more

12/13/2012 - Commercial Speech FDA FDCA Free Speech Marketing Off-Label Promotion Off-Label Use Pharmaceutical Industry

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