Marketing your Medical Device in the new FDA/OIG Enforcement Environment: Part 4 of 4

  • On: October 7, 2014 at 11:10AM
  • Category: Conferences

Part IV will be a graduate-level course in the Anti-kickback Statute, False Claims Act (as it relates to reimbursement), Foreign Corrupt Practices Act (tangentially) and the Physician Payment Sunshine Act and how they all relate to one another. As the income of physicians and clinical practices are increasingly being squeezed by the Patient Affordable Care Act, physicians are looking for ways to shore up lost or declining income. They are turning to industry for consultancies and/or setting up their own businesses to try to maintain their income or grow it, as most people want to do the longer they work. In addition, there are continuing conventional ways in which companies retain and work with health care professionals, providing them remuneration. This puts pressure on companies, especially marketing, sales, compliance, legal and management to examine these arrangements to determine if they are lawful and if the company can participate.

We will address the scope of these statutes and the regulations and cover a wide variety of topics including the following:

  • -Physician consultancies

  • -Speaker’s bureaus

  • -Stock and stock options

  • -Referral dinners

  • -Co-marketing between device companies and clinical practices

  • -Clinical versus “seeding” trials

  • -Physician-owned distributorships (PODS)

  • -Intraoperative neuro-monitoring companies (IOMs)

  • -Speaker’s bureaus

  • -Physician-run medical meetings for which they seek sponsorship fees

  • -Royalty arrangements

We will also address how to lawfully promote your device without running afoul of the False Claims Act where physicians can be taught to inappropriately prescribe off-label uses of product and seek an inappropriate claim for reimbursement or teach physicians to inappropriately upcode, miscode, stretch codes, add inappropriate modifiers, or suggest inappropriate care settings which can result in a False Claims Act case. We will cover what your sales and marketing organization can and cannot do, such as the creation of pro formas or return on investment (ROI) analyses.

We will briefly touch upon the FCPA as U.S.-based conduct and standards are applied to international activity under this U.S. law with an extra-territorial reach.

We will then delve into how reporting under the Physician Payment Sunshine Act, and hospital and managed care policies in reaction to the Act, are dramatically changing the landscape and the manner in which companies and physicians are choosing to interact with one another.

Helping clients be appropriately aggressive, yet compliant. TM