Featured Articles:

New U.S. Sanctions Against Nicolás Maduro Place Venezuelan Oil Squarely in the Crosshairs

Noah Smith, an Associate at The Volkov Law Group, joins us for an interesting post on OFAC’s new Venezuela sanctions.  Noah can be contacted at nsmith@volkovlaw.com. Venezuela is undergoing a political upheaval. Since his rise to power in 2013, the embattled Venezuelan President Nicolás Maduro has precipitated a humanitarian crisis that has driven some 3 million Venezuelans to flee abroad. Widespread protests have erupted (yet again) against the country’s chronic violence,...

Episode 76 — Review of 2018 AML Enforcement and Compliance Trends

Global prosecutors and regulators continued to increase anti-money laundering enforcement and regulatory actions.  Global and US regulators have increasingly focused on beneficial ownership and transparency requirements.  In 2018, FinCEN’s Customer Due Diligence rule went into effect.   US prosecutors also brought several significant AML criminal prosecutions against large banks; the SEC has increased AML enforcement as part of reviews of internal controls.  Regulators brought enforcement actions...

Hospitals and Physician Relationships – Navigating Stark, AKS and Fraud Risks (Part III of III)

Chief compliance officers at hospitals face a crushing burden of risks.  The HHS-OIG has vigorously scrutinized hospitals compensation of physicians, especially for potential anti-kickback and Stark law violations.  Most of these suspect situations involve compensation for physician practice groups.  Unlawful compensation and influence arrangements have involved favorable leasing and facility payments, such as below-market office leasing arrangements in exchange for exclusive referral of patients to...

Pharmaceutical and Medical Device Company Payments to Healthcare Professionals (Part II of III)

Given the significant risks posed by transfers of money and other items of value to physicians, pharmaceutical and medical device companies have to implement appropriate controls governing such payments.  The federal Anti-Kickback Statute (“AKS”) prohibits the offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate federal health care program business.  The statute defines “anything of value” broadly; criminal penalties...

Focusing on “Payments” to Healthcare Professionals (Part I of III)

The United States healthcare industry poses an infinite number of risks when it comes to interactions with healthcare professionals.  Given the aggressive regulation and enforcement of prohibitions against kickbacks and referrals, healthcare companies have to devote significant resources and strategies governing interactions with physicians. First, healthcare provides, pharmaceutical and medical device companies have a variety of legitimate reasons for relationships with physicians.  They work closely...

Export Control Reform: Major Changes for ITAR Regulations for Firearms Industry

Colleen Hurson, Of Counsel at The Volkov Law Group joins us for her first posting on the blog concerning export control reform measures applicable to the firearms industry. Colleen has substantial experience in handling export control and sanctions compliance for clients subject to the State Department’s ITAR regulations and Commerce Department’s EAR regulations. Colleen can be reached at churson@volkovlaw.com. This week the Trump Administration is...

Webinar: Anti-Corruption Compliance in Pharma and Medical Device Industries

Webinar: Anti-Corruption Compliance in Pharma and Medical Device Industries February 26, 2019, 12 Noon EST Sign up HERE FCPA enforcement against drug and device companies continues at a robust rate. Given the high-risk nature of pharmaceutical and medical device industries and significant interactions with foreign government officials, drug and device companies face a number of challenges in designing and implementing effective anti-corruption compliance programs.  Join...

It is 2019 . . . Do You Know Where Your Data Is?

We are living in a rapidly changing world (trite, I know) where companies have to focus on data privacy and security for a variety of reasons.  Consumers and constituents are concerned about the safety and privacy of personal and financial information.  In this era of “sharing” and posting of private information, consumers and constituents have broad and reasonable expectations concerning their personal and financial information....

Episode 75 — 2018 False Claims Act Review

The Justice Department reported its 2018 fraud statistics showing $2.8 billion in recoveries under the False Claims Act.  While this number is staggering, fiscal year 2018 recoveries were down from than $500 million from fiscal year 2017.  Nonetheless, companies in the healthcare, defense and financial industries continue to face significant False Claims Act risks. In this episode, Michael Volkov interviews Jessica Sanderson, Of Counsel, at...

The Requirement for a Proactive Audit Program

As compliance programs (and the profession) continue to mature, there is growing interest in the need for measurement, monitoring and auditing of compliance programs.  This is a natural evolution in the lifecycle of a compliance program. Once a CCO has operationalized a company’s compliance program, the next challenge logically is to design strategies to ensure proper operation.   The elements of an effective compliance program include...