© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. Hot Topics In Clinical Research: Knowing the Risks, Applying the Law To ask a question during the presentation, click the Q&A menu at the top of this window, type your question in the Q&A text box, and then click Ask. After you click Ask, the button name will change to Edit. Questions will be queued and most will be answered at the end of the meeting as time allows. Molly Huggins Smith Moore Leatherwood LLP 2800 Two Hannover Square Raleigh, NC T: (919) Presented by: Christee Laster Smith Moore Leatherwood LLP 1180 West Peachtree Street NW, Suite 2300 Atlanta, GA T: (404)

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® On the Menu Today: I.Publication II.Conflicts of Interest III.Medicare Billing

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication: Issues and Considerations Tax status of Institution and compliance therewith. Investigator publication expectations. Compliance with journal requirements.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication: Issues and Considerations Sponsors interest in protecting confidential or proprietary information. Sponsors interest in proper completion of the Study. Accuracy and integrity of publications.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication Rights: Building the Contract Provision Step 1: Do you need the right to publish the study results? If so, affirm the right to publish. Upon completion of the Study, Institution and Investigator shall have the right to publish the results of the Study in accordance with the terms of this Agreement.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication Rights: Building the Contract Provisions Step 2: Permit Sponsor an opportunity to review and comment, but Institution/Investigator should retain editorial control. Institution or Investigator shall provide Sponsor with a copy of any proposed publication or presentation at least thirty (30) days in advance of submission to a journal, editor, or other third party. Sponsor shall have thirty (30) days to respond with any comments or requested revisions. Institution and Investigator shall consider the requested revisions in good faith.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication Rights: Building the Contract Provisions Caution! Do you see the problem with these provisions? Section A: Confidentiality. Confidential Information shall mean information disclosed by Sponsor to Institution under this Agreement and any and all information arising from performance of the Study. Section B: Publication. Sponsor shall have the right to require the removal of any Confidential Information from the proposed publication.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication Rights: Building the Contract Provision Be careful to ensure that the contract does not contradict itself. Suggested work arounds: (1) Sponsor shall have the right to require the removal of any Confidential Information from the proposed publication, other than Study results and background information required for publication.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication Rights: Building the Contract Provision or (2) Confidential Information shall mean information disclosed by Sponsor to Institution under this Agreement and any and all information arising from performance of the Study, other than Study results published in accordance with the terms of this Agreement.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication Rights: Building the Contract Provision Step 3: Provide Sponsor with an opportunity to take steps to protect proprietary information. If Sponsor determines that the proposed publication or presentation contained patentable or otherwise proprietary information that requires protection, Institution and Investigator shall delay the publication or presentation for up to an additional sixty (60) days to permit Sponsor an opportunity to seek such protection.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication Rights: Building the Contract Provisions Step 4: If applicable, account for multi-center studies. Because this is a multi-center Study, Institution and Investigator shall not publish their sites Study results until the publication or presentation of the multi-center results. Notwithstanding the foregoing, if a multi-center publication is not submitted for publication within twelve (12) months after the conclusion, abandonment, or termination of the Study at all sites, or upon Sponsor notice that there will be no multi-center publication, Institution or Principal Investigator may publish the Study results as set forth herein.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication Rights: Building the Contract Provisions Common question: When is a Study completed at all sites? Alternatives: –Database lock (preferred) –Specific date

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication Rights: Building the Contract Provisions What time period is reasonable: 12 months, 18 months, 24 months? Document: –Number of sites –Number of expected subjects –Complexity of analysis

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Publication Rights: Final Considerations Preserve publication opportunities: –Require registration of Study on a public clinical trials registry –Require compliance with ICJME guidelines –Reserve copyright ownership of all publications

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Conflicts of Interest Everyones Watching: –IOM reports –OIG reports –Sen. Grassley! Understanding the Conflict: –Know the Rules/Standards: NIH/FDA/NSF AAMC/AAU

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Conflicts of Interest Nature of the Conflict: –Consulting fees –Payments for recruiting subjects –Travel expenses –Royalties or other IP interests –Credit for published works

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Conflicts of Interest Whats at Stake? Suspension of research funding Risk to human subjects Anti-Kickback violations Litigation Professional reputation False Claims Act liability, as amended Physician Payments Sunshine Act of 2009

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Conflicts of Interest Managing Conflicts: –Infrastructure Create the internal policies … and follow through Know who, when and how Communicate enforcement protocols Require disclosure on an ongoing basis Internal, random audits Acknowledge and report noncompliance

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. The Big Picture: Why Getting It Right Matters to Institutions The False Claim Act (31 U.S.C. §§ and 42 U.S.C. § 1320A-7a(a)) imposes criminal and civil liability for submitting false claims to the federal government for payment. Civil penalties range from $5,000 - $11,000 per claim, trebled. Criminal penalties can be up to 5 years imprisonment, $25,000 fine, and mandatory expulsion from Medicare.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. The Big Picture: Why Getting It Right Matters to Institutions Improper submission of a claim for items and services provided pursuant to a clinical trial can subject the institution to allegations of submitting false claims. This is an area of high internal scrutiny within institutions. Not an area where many institutions are willing to take the risk of getting it wrong.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. Medicare Billing: The Basics The fundamental rule: Medicare may be billed for items and services provided during a clinical trial that constitute routine billable costs. Medicare should not be billed for standard of care items and services. Standard of care and Routine Billable Costs are not the same.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. Suggestions Research finance department should perform a Medicare coverage analysis for every clinical trial. Address those items and services that do not constitute routine billable costs in budget negotiations at the front end.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. Budget Negotiations: A Common Hurdle Investigational Items and Services For those items and services that the institution determines are investigational in its Medicare coverage analysis, should the institution take a bill first approach before billing the sponsor? Doing so incurs risk of FCA violation.

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Questions?

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Please join us for our next Hot Topics segments: –Subject Injury & Medicares Secondary Payor Rule –O.I.G. Enforcement

© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. ® Molly Huggins Smith Moore Leatherwood LLP 434 Fayetteville Street, Suite 2800 Raleigh, NC T: (919) F: (919) Christee Laster Smith Moore Leatherwood LLP 1180 West Peachtree Street NW, Suite 2300 Atlanta, GA T: (404) F: (404)