Interview/Attorney: Charles “Chuck” Bell, RN JD
© 2009 The Medical-Legal News
As a manager in PricewaterhouseCooper’s Global Pharmaceutical Practice group, Chuck Bell has more than 15 years of experience managing advisory services for major clients in the life sciences sectors. He has managed numerous Independent Review Organization teams for several large clients in promotional, off-label and sales and marketing reviews at TAP and Schering-Plough. He has also managed IRO teams for other clients, such as Fresenius, Wal-Mart and Eckerd, submitting over 20 IRO reports. Additional work includes proactive internal reviews for regulatory compliance, sales and marketing assessments, controls around dissemination of scientific materials and internal investigations for compliance, both civil and criminal in nature.
Chuck’s current role includes working with client service teams with diverse industry experience to execute work plans that identify state controls and monitoring procedures, as well as gap analysis, with industry best practices. Prior to joining the firm, Chuck spent five years as an RN working at academic medical centers in critical care. Chuck can be contacted firstname.lastname@example.org.
Medical Attorney Charles Bell on Compliance Assessment.
Q: Tell us a bit about your background, how you became interested in law and the area of law you chose.
A: Early in my career I was on a team to gather evidence to respond to Medicare false claims by reviewing medical records for regulatory compliance for in-patient psychiatric services. From there I went on to acute care services, long-term care, home health, ambulance, out-patient dialysis, physician services, institutional pharmacies, retail pharmacies and pharmaceutical and bio-tech manufacturers. Some were civil investigations and some were criminal.
Q: What do you do, generally, in compliance work?
A: The OIG is looking for compliance with industry guidance and regulations, i.e., federal pricing for meds, promotional activities, payments to healthcare practitioners, grants for education and research, relationships with HCPs for consulting services, dissemination of scientific information, etc. I look for compliance program effectiveness through systems (process) reviews and transaction testing
Q: Please describe a case or two (or three) that were memorable for some reason.
A: Whether civil or criminal, the core principles of compliance investigations are the same when fact-gathering: identify the data points required by regulators, thoroughly review all supporting documentation and utilize technology and sampling methodology. A thorough understanding of the underlying systems, processes and controls that go into the supporting documentation is critical to knowing the strengths and weaknesses of the data.
For large Independent Review Organization (IRO) work associated with Corporate Integrity Agreements (CIAs), I have assembled multiple teams with varied skill sets including coders, clinicians (nurses), IT support (to construct and manage the databases) and statisticians to draw samples and industry subject matter.
Q: What’s a sure-fire way (or two or three) to negotiate with the OIG?
A: Be able to demonstrate the effectiveness of your compliance program. Go beyond having the seven elements of the program in place. Show the processes and controls in place, the technology solutions implemented and the monitoring — whether it’s done at the business level or the compliance level. Demonstrate the investment in people and technology processes that give the comfort level for identifying non-complianct behavior, and demonstrate by example how the behavior was addressed. Have results, both proactive and reactive, that demonstrate the success of the program. For example, take case examples of issues, how they were identified, the processes for investigating, the resources involved and the resolution. Don’t be afraid to show what worked as well as what has not worked. Explain where additional investment has provided results and where additional resources have not provided results.
Q: What’s a sure-fire way (or two or three) to lose for the defense?
A: A great way to fail at negotiations is to assume that good intentions will give you credibility. A story will not carry the argument without documentation of results. A third party (legal or consultant) with experience and industry knowledge adds credibility, especially when accompanied by testing results.
Q: So if they are out of compliance, then what?
A: Recent fines have been over $1 billion (Eli Lilly for Zyprexa). There have been criminal prosecutions (TAP and Perdue).
Q: In your cases do you use records reviewers, coders, lawyers, accountants or other experts? Please talk about what may have gone right (and wrong) with any of the aforementioned litigation support people.
A: Yes, successful teams have a variety of skill sets in order to look at issues from different perspectives and experiences. Depending on the case, I like to have a variety of backgrounds and credentials including internal audit, IT, clinical (including nurses, coders, etc.) and legal. A great need exists for individuals who can extract information from medical records and have an understanding of how controls in a process are documented.
Q: Do you find experts and other litigation consultants usually easy to work with, or do you find them to be aggravating? Do you think they teach you the project, or do you feel you wind up teaching them the project?
A: Some consultants have brought experience or perspective that has helped the case. However, in general I feel that we have to teach the project.
Q: Where do you see compliance cases and any other such health-related litigation headed in the future?
A: I don’t see the OIG slowing down on their caseload. I consistently hear that there are numerous cases in line to settle and that the settlements are growing larger and requiring large IRO projects to fulfill the CIA requirements.