Life Science Compliance Update

March 20, 2017

Accountability: The shifting landscape of compliance responsibilities

Shifting-sands

The meaning of effectiveness of healthcare compliance programs has shifted in recent years. This article examines that shift and what it means for the role of the Compliance Officer including the need to evaluate and oversee a portfolio of risks.

Now that we are two months into the new year, this is a good time to reflect and examine the effectiveness of healthcare compliance programs. The measure of what “effective” means has changed dramatically in recent years. When the PhRMA Code on Interactions With Health Care Professionals (“Code”) was published in 2002, and for many years after, effectiveness was essentially defined by a company’s compliance department as adhering to the OIG’s Seven Elements of an Effective Compliance Program, as well as providing review and approval of individual activities or transactions. It was essentially the compliance department’s responsibility to “police” the organization and prevent them from making poor decisions. Today’s measure of effectiveness still hinges on decision-making, but the accountability is more squarely placed on the shoulders of the decision makers.

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March 08, 2017

Former Tenet Healthcare Executive Charged

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John Holland, former senior executive of Tenet Healthcare Corporation, was recently indicted for his alleged role in a $400 million scheme to defraud. The indictment alleges that the scheme to defraud victimized not only the U.S. government, but also the Georgia and South Carolina Medicaid programs, and prospective patients of Tenet hospitals.

The indictment was filed on January 24, 2017, in the Southern District of Florida, and charges Holland with one count of mail fraud, one count of health care fraud, and two counts of major fraud against the United States.

Holland previously served as a senior vice president of operations for Tenet Healthcare Corporation’s Southern States Region, and as chief executive officer of North Fulton Medical Center, Inc., in Roswell, Georgia. The indictment alleges that from roughly 2000 through 2013, Holland engaged in a scheme to defraud the United States (as well as Georgia and South Carolina Medicaid programs), by causing the payment of bribes and kickbacks in return for the referral of patients to North Fulton Medical Center, Inc., and other Tenet hospitals in the Southern States Region, including Atlanta Medical Center, Inc., Spalding Regional Medical Center, Inc., and Hilton Head Hospital.

From roughly 2007 through 2013, Tenet maintained and operated an affiliated billing center in Boca Raton, Florida, that assisted in processing for payment Medicaid billings for the aforementioned hospitals. Holland allegedly took affirmative steps to conceal the scheme, including circumventing internal accounting controls and falsifying Tenet’s books, records, and reports. These kickbacks and bribes helped Tenet bill the Georgia and South Carolina Medicaid programs over $400 million, and Tenet obtained more than $149 million in Medicaid and Medicare funds, based on the resulting patient referrals.

According to the allegations, Holland, among other things, made false and fraudulent statements to the Department of Health and Human Services Office of Inspector General (HHS-OIG) in connection with Tenet’s 2006 Corporate Integrity Agreement (the CIA), in which he falsely certified to HHS-OIG that Tenet was in compliance with the terms of participation in the Medicare and Medicaid Programs and the terms of the CIA, when in fact he knew that Tenet was paying for illegal patient referrals. Holland’s certifications were included as part of Tenet’s yearly annual reports that were mailed to the HHS-OIG monitor located in Miami Lakes, Florida. Throughout the duration of the CIA from 2007 through 2011, Tenet received over $10 billion in payments from federal health care programs – monies that Tenet would not have received had the company been excluded from participation in federal health care programs, the indictment alleges.  

On Oct. 19, 2016, North Fulton Medical Center, Inc. and Atlanta Medical Center, Inc. both pled guilty to conspiring to defraud the United States and to violating the Anti-Kickback Statute (AKS). Tenet subsidiary Tenet HealthSystem Medical, Inc. (and its subsidiaries (THSM)) also entered into a non-prosecution agreement (NPA) with the government at that time. Under the terms of the NPA, THSM and Tenet will avoid prosecution if they, among other requirements, cooperate with the government’s ongoing investigation and enhance their compliance and ethics program and internal controls. 

Tenet also agreed to retain an independent compliance monitor to address and reduce the risk of any recurrence of violations of the AKS by any entity owned in whole, or in part, by Tenet. Tenet and its subsidiaries also agreed to pay over $513 million to resolve the criminal charges and civil claims arising from the matter. Holland is the first executive from Tenet to face the charges individually.

“These charges underscore our continued commitment to holding both individuals and corporations accountable for their fraudulent conduct,” said Acting Assistant Attorney General Blanco.  “We will follow the evidence where it takes us, including to the corporate executive ranks.”

February 28, 2017

Qordata Hosting Compliance Insights Webinar March 1

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On Wednesday, March 1, 2017, qordata is hosting a webinar, titled, “Making Analytics Work at Merck USA.” The webinar features Wendy Derosa, Associate Director, Data Analytics and Transparency at Merck USA and Bryan Timer, Associate Director, Data Analytics & Transparency at Merck USA.

The journey between understanding the compliance requirements behind CMS Submission, and integrating that with Merck’s internal systems resulted in a successful intersection of technology, legal and sales. Attendees of this webinar will learn how Ms. Derosa and Mr. Timer took a global challenge and turned it into a success story for Merck USA and its counterparts across the world.

Agenda of Webinar

This webinar will take a high-level approach to Compliance. The presenter will share her own experiences in joining this role as the Sunshine Act was being introduced in USA. Attendees will benefit from learning how a global organization such as Merck was able to combine resources from technology, operations, sales and legal to roll out a precise and multi-channel reporting solution.

The webinar will be conducted as an exchange of questions and answers between both Merck representatives and Mohammad Ovais, Founder and CEO of qordata. Responses may be as detailed as possible, and will include input from slides. The total duration per question is framed within 5 minutes, so that the topic may be covered holistically and in-depth.

The agenda will focus on the following topics:

  • Challenges of introducing an internal compliance reporting mechanism in a multi-market organization like Merck
  • Integrating technology with sales, operations and compliances for timely identification and redress of data errors
  • Transition from basic internal reporting to a culture of advanced spend analytics
  • Tools and resources for enhancing compliance program

Expected Takeaways from the Webinar

With speakers like Ms. Derosa and Mr. Timer, attendees can expect to:

  • Acquire insights into how technology integrated with sales, compliance and operations can assist in timely identification of data errors
  • Learn about tools and resources that assist in formulating sophisticated compliance programs
  • Acquire detailed information about how data analytics helped Merck USA with its compliance efforts

If you are a decision maker responsible for designing and executing internal compliance structures within the realm of the global Compliance, Technology, Internal Audit and Marketing C-Suite, you are highly encouraged to attend. Life Sciences Industry participants seeking solutions to program challenges will benefit from the compliance-analytics experience at Merck USA.

If you are interested in attending this webinar, you can register for free here.

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