Negotiating Clinical Trial Contracts In A Minefield: The Stark Rule, Anti-Kickback Statue, False Claims Act and Medicare Secondary Payer Rule

Robert (Bob) Romanchuk

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Anti-Kickback Statute (AKS)

The US Federal Anti-Kickback Statute is a law that forbids taking kickbacks in return for referring individuals to the federal healthcare programs like Medicare and Medicaid. The law specifically forbids soliciting or receiving any remuneration (including kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind. It also forbids taking (in return for referrals) purchasing, leasing, ordering, or recommending purchasing, leasing, or ordering, or to purchase, lease, or order, any good, facility, services or item.

The Anti-Kickback Statute also specifies the penalties for violations of the law: fines of up to USD 25,000 or imprisonment for up to 5 years or both.

The aim of the Anti-Kickback Statute is to protect federal healthcare programs (Medicare and Medicaid) from abusive practices and cost increases.

The law applies to Bureau of Primary Health Care (BPHC) grant-funded service delivery programs.

False Claims Act (FCA)

The False Claims Act, first enacted in 1863 and amended multiple times before being significantly modified in 1986, 2009 and 2010, is a US law that prohibits individuals and private businesses that have federal contracts from defrauding the government. Tax fraud is not covered under the law.

The 2010 Patient Protection and Affordable Care Act also made clear through amendments to the Social Security Act that any claim violating the Anti-Kickback Statute would also constitute a fraudulent claim that violated the FCA.

Medicare Secondary Payer Rules and Clinical Trials

The Medicare Secondary Payer (MSP) rules were clarified in a letter dated April 13, 2004 by the Office of Financial Management of the Centers for Medicare and Medicaid Services (CMS). The letter confirmed that Medicare would only be the secondary payer in clinical trials where the sponsor takes up the responsibility for patient costs for research related injuries to clinical trial participants. This decision was made since sponsor agreements that did cover patient costs in such situations became, in essence, an insurance plan or policy under which payment could be reasonably expected to be made when an injury occurred during clinical trials.

This webinar will provide a basic understanding of regulations and statutes that people involved in the clinical research contract negotiation process must be aware of. You will learn how to negotiate for and create federally complaint agreements and thus avoid the risk associated with violations.

Course Objective

Payment for work done in the execution of a clinical trial would seem to be a straightforward proposition, but in the U.S. a multitude of regulations and statutes and their associated risk can turn contract and budget negotiation into a minefield. Such regulations include the Stark Law, the Anti-kickback Statute, the False Claims Act and Medicare Secondary Payer Rule. All parties involved in the clinical research contract negotiation process must be well versed in these rules in order to create federally complaint agreements and thus avoid the risk associated with violations.

Violations of these rules in the course of clinical research have resulted in heavy fines and penalties for well-known and respected institutions.

This 90-minute session will provide a basic understanding of these rules and how they impact clinical research contracts and budgets. The knowledge gained from this training will allow participants and their institutions to expertly negotiate compliant contracts and thus better manage the associated risk. By attending this training, you will not only be well informed, but learn how to implement practical, workable solutions and negotiate risk-free clinical trial contracts.

Course Outline

  • Stark Law and Clinical Research.
  • The Anti-kickback Statute (AKS) and its implications.
  • The False Claims Act (FCA) and clinical trial billing.
  • The Medicare Secondary Payer Rule (MSPR) and its impact on clinical research contracts.
  • Contract and Budget hot spots.
  • Processes for compliance and risk mitigation.
  • Case exercise.

At the end of this session, attendees will be able to:
  • Recount the implications of Stark Law, the AKS, FCA and MSPR on clinical trial contracts and payments.
  • Identify contract and budget hot spots and how to manage them.
  • Create processes that assure institutional compliance.
  • Demonstrate these skills with a live case exercise.

Target Audience

This webinar will provide valuable assistance to all personnel involved in the research enterprise, including:

  • Research Administrators
  • Clinical Research Contract professionals
  • Sponsor Contract Managers
  • Compliance professionals
  • All professionals involved in the business aspects of clinical research

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Robert (Bob) Romanchuk,

Bob Romanchuk, is a clinical research professional with over a decade of experience in a broad range of clinical research infrastructure building, operation and management of both IRBs and research programs. This includes assembling and managing an IRB, building a cardiovascular research center for a large community hospital and creation and operation of a central research office for a 13 hospital system across North Carolina, South Carolina and Virginia. His certifications include CIP (Certified IRB Professional), CHRC (Certification in Health Research Compliance), CCRC (Certified Clinical Research Coordinator) and CCRCP (Certified Clinical Research Contract Professional). He has presented numerous times nationally on the subjects of clinical trial billing, human subjects’ protections and the creation and operation of centralized research offices.

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