Amanda S. Marshall
Former U.S. Attorney
(Local Counsel)
Lynette Byrd
Former Assistant
U.S. Attorney
Roger Bach
Former Special
Agent
(OIG & DEA)
Joe Brown
Former U.S. Attorney
Dr. Nick Oberheiden
Attorney & Founder
CMS and DOJ Target Healthcare Providers Offering Sanexas Pain Management and Treatment Services
The Centers for Medicare and Medicaid Services (CMS) and U.S. Department of Justice (DOJ) are targeting healthcare providers that offer Sanexas pain management and treatment services to their patients. Targeted healthcare providers face substantial risks—including the risk of recoupment liability, Medicare exclusion, criminal fines, and even federal imprisonment in some...
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What to Do If You Receive a FINRA 8210 OTR Letter
Securities professionals who are being scrutinized by FINRA will likely first learn of an investigation when they receive an 8210 Letter, also known as an On-the-Record (OTR) Notice. The letter will describe the information being requested, and the recipient has to supply it or face repercussions. Financial advisors and registered...
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Subpoenaed to Testify Before the SEC? Here’s What to Expect
If you’ve been subpoenaed to testify before the U.S. Securities and Exchange Commission (SEC), you need to make sure you are thoroughly prepared. Testifying before the SEC can be a daunting experience—even for seasoned securities industry veterans and company executives. Since testifying is typically an all-day event, it can be...
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FDA Counterfeiting Investigations: What Manufacturers and Health Care Providers Need to Know to Avoid Allegations of Fraud
Drug manufacturers have an obligation to secure U.S. Food and Drug Administration (FDA) approval before distributing their products in the United States, and health care providers have an obligation to ensure that they are only prescribing and dispensing FDA-approved drugs. When counterfeit ingredients and drugs enter the market, the risks...
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Crisis Management: Working With (Not Against) the Media
In many cases, corporate crises will result from media coverage. Even if a published story isn’t the cause of a crisis, media coverage can exacerbate the reputational and financial risks involved. As a result, establishing a favorable relationship with the media is often a critical aspect of crisis management. Too...
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Media Communications – Legal and Ethical Considerations for Lawyers
Introduction As attorneys, we are often confronted with the difficult question of how to respond to inquiries from the media. Due to the public nature of our courts and legal system, the filing of a lawsuit, indictment, or other legal proceeding can immediately result in a deluge of inquiries from...
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FDA Warning Letters (Overview & Response Strategies)
The U.S. Food and Drug Administration (FDA) is tasked with enforcing several federal laws, most notably the Food, Drug, and Cosmetic Act (FD&C) and certain parts of the Public Health Service Act. The scope of these laws is massive, so the FDA has had to rely on less conventional enforcement...
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Cryptocurrency and AML: What Do Institutional Bankers Need to Know?
Since its advent, cryptocurrency has served as a means for parties to conduct illicit transactions with limited oversight from federal regulators and financial institutions. The recent emergence of cryptocurrency as both a mainstream investment vehicle and means of payment has presented unprecedented challenges for federal regulators and financial institutions as...
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The IRS is Cracking Down on Cryptocurrency Tax Compliance in 2023
Cryptocurrency tax compliance has been a priority for the Internal Revenue Service (IRS) for several years. While the IRS has long held the position that cryptocurrency is a form of "property" for federal income tax purposes, it has failed to provide clear guidance on many cryptocurrency-related issues—including issues related to...
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Florida Lawmakers Attempt to Pass Legislation Regulating Pharmacy Benefit Managers
In recent years, the role of pharmacy benefit managers (PBMs) occupy has grown significantly. However, as their role—and power that comes along with it—grows, the regulation of PBMs has been slow to follow. In fact, PBMs are not regulated on the federal level, and many states stay out of the...
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