The Best of HCCA’s Research Compliance Conference, 2021

The HCCA’s national conference focusing on Research Compliance was recently held as a virtual conference from June 14 - 16, 2021. It was yet another great conference that delivered a tremendous amount of helpful information. While I can’t wait to get back in person to these events, I can’t thank the HCCA or the speakers enough for delivering another knock-out performance.

Because I know not everyone can attend every conference, and even if you did, you probably weren’t able to attend every session, so I thought I’d summarize the highlights from those sessions I was able to attend at this year’s HCCA Research Compliance Conference.

Sites Beware: How to Prepare for the (Maybe) Upcoming Changes in Medicaid

Kelly Willenberg, CEO, Kelly Willenberg and Associates

Ryan Meade, Fellow, University of Oxford

Session Description:

• • Analyze potential impact to sites research billing process and coverage analysis
  • Discuss how the legislation fits into the federal and state Medicaid legal framework
  • Examine possible actions that state needs to take based on the language of the legislation

As most of us involved in clinical trials billing know, Medicare has a policy of covering certain medical costs associated with certain qualifying clinical trials. However, the question that almost always immediately follows is, “Does Medicaid cover routine costs associated with clinical trials?” The answer most compliance professionals have had to give is “there is no definitive answer.”

In this presentation, Ryan Meade and Kelly Willenberg shared information about a new law that is attempting to more definitively answer this Medicaid question by allowing Medicaid to cover routine costs in a clinical trial.  The speakers shared potential problems with the legislation and offered suggestions to compliance personnel in navigating the nuances.  The law can be found here where you can download the PDF (2,124 pages), and find the law on page 1,808.

Considerations in Building a Foreign Influence Compliance Program

Janice Grace, Director, Office of Sponsored Projects Administrant, Mayo Clinic

Kathleen McNaughton, Administrator, Mayo Clinic

Will McIntire, Research Counsel, Boston Medical Center

Callan Stein, Partner, Troutman Pepper Hamilton Sanders

Session Description:

• • Understand the Government’s (especially NIH, NSF, and DoD) recent focus on increased transparency concerning foreign elements and connections in applications for research grants
  • Identify and overcome operational challenges to maintaining foreign influence compliance
  • Mitigate legal exposure for investigators/institutions by implementing an effective foreign influence compliance program

For the last two or three years, the research community has been hearing a lot about foreign influence with regards to federally-funded research. Recently, it has taken on a ‘foreign espionage’ flavor, with the federal government investigating and enforcing federally-funded research heavily over the last couple years.

Much of this focus began with a letter published by the director of the NIH in August of 2018. In 2019, the year following that letter, the NIH investigated nearly 200 scientists from more than 65 institutions for failing to report foreign connections. The speakers from this session reported the NIH has continued these reviews and investigations, and in April 2021, they said that they had identified over 500 scientists of concern.

In addition to explaining the purpose of the disclosure requirements relating to foreign influence, the session covered ways to identify and overcome some of the operational challenges to maintaining a foreign influence compliance program. They also identified steps to mitigate legal exposure for investigators and institutions by implementing an effective foreign influence compliance program.

The Vital Role of Whistleblower Scientists in Exposing Fraudulent Research During the Pandemic

Elisabeth Bik, Science consultant, Self employed

Mary Inman, Partner, Constantine Cannon LLP

Session Description:

• • Understand the compliance risks posed by scientists’ ability to bypass the peer-review process and expedite publishing of COVID-19-related research
  • Identify types of COVID-19 research fraud from real-world examples presented by whistleblower and scientific sleuth, Dr. Bik.
  • Learn techniques for how to handle internal whistleblower complaints of research fraud and obviate need for WB employee to proceed externally by contacting government authorities

This session was probably my favorite session of the entire conference...

We often hear of the best practices we can implement to prevent whistleblowers from inside our organizations, but this session focused on how compliance programs can mitigate external whistleblowers.

One of the speakers, Mary Inman, is an attorney specializing in representing whistleblowers, while the other, Elisabeth Bik, is a scientist who privately investigates fraudulent research. Dr. Bik is a perfect example of an “external” whistleblower. Meaning she is not an employee, or insider of the organization, but rather she uses her scientific expertise to identify flaws, and even intentional fraud, in published scientific papers.

According to Dr. Bik, scientific articles frequently have published microscopic pictures of various findings within cells or biological tissues. Dr. Bik examines the photographs for inappropriate duplication, of uses or photoshopped results that support the conclusions of the research in a fraudulent way. When inappropriate use is identified, Dr. Bik will alert the publishing journal and/or individuals publishing the research. She publicly exposes the problems with the research, which Mrs. Inman then explained how “external” whistleblowers like Dr. Bik might have legal standing to file a case.

Research Year in Review 2020-2021

F. Lisa Murtha, Partner, Moses & Singer, LLP

Session Description:

• • Understand new research-related laws, regulations, agency guidance, enforcement cases, and other updates in research over the last year
  • Review OIG and DOJ cases as well as enforcement at the agency level: OHRP, ORI, FDA, ETC.
  • How should we shift our research compliance focus in light of the new laws, regs, and guidance?

The “Research Year-in-Review” is an annual presentation that is always on my list of favorites. It is typically presented by Lisa Murtha and covers the significant research compliance findings, audits, enforcement actions, and/or legislation that were highlighted since the previous year’s review.

Here are a few of those highlights that caught my eye:

• • Clinical Trials of Medical Products during COVID-19 PHE (Issued in March 2020; finalized on July 2, 2020; last updated on January 27, 2021)
  • Guidance for Civil Money Penalties Relating to Clinical Trial.gov Data Bank (Issued in August 2020)
  • Notice of Noncompliance Against Acceleron Pharma, Inc. (Issued on April 27, 2021). “The first-ever FDA issued Notice of Noncompliance. Issued after the drug maker did not comply with its legal reporting obligations for clinical trials upon earlier receipt of the Pre-Notice of Noncompliance…”
  • OIG Issued Special Fraud Alert on Speaker Programs (You can watch the Healthicity on-demand webinar where we presented on this topic here.)
  • DOJ Enforcement Action for Fraud Against a Doctor and Members of a Miami Clinical Research Lab--A federal grand jury in Miami, Florida returned an indictment on May 11, 2021 charging a Florida woman with conspiracy to falsify clinical trial data regarding an asthma medication.
  • University of Texas Health Science Center—Office of Research Integrity (ORI) found that Dr. Yibin Lin, Ph.D., former postdoctoral fellow, McGovern Medical School, UTHealth, engaged in research misconduct in. Specifically, ORI found that Dr. Lin knowingly and intentionally falsified, fabricated, and plagiarized data and text reported in 14 published papers (which have been retracted).

Conclusion

If you missed the conference, or weren’t able to attend any of the above sessions, but would like to dive in deeper, the HCCA posts the handouts on its web site and also offers recordings of the presentations for sale.