Clinical Trial Billing Under Medicare Negotiate Your Trial Budget to Avoid OIG Penalties

Held Aug. 25, 2011

The challenges of segregating standard of care charges from those payable by a sponsor have led health care organizations to develop their own customized, paper-intensive, manual work flows … which frequently result in more confusion and errors.

Here’s how to avoid billing irregularities in your organization.

As a clinical trial sponsor negotiating a trial budget, you need to clearly understand what costs are billable to third-party payers, including Medicare and Medicaid, before you allocate money to your sites.

But the process of determining which costs are billable and which are not involves analyzing hundreds of items and services provided during the trial.

If you don’t fully understand those costs, you risk under- or over-paying your sites, leaving you wide open for a bad billing investigation by the Office of Inspector General (OIG).

And sponsors that face charges of aiding and abetting false claims (based on what your site improperly billed) risk criminal and civil penalties — and up to treble damages.

Why take that chance?

Instead, learn how to negotiate clinical trial budgets that will ensure your sites comply with Medicare and the Federal False Claims Act.

In this 90-minute webinar, Kevin Eskew and Lisa Murtha discuss the Medicare Clinical Research Coverage Policy — how to negotiate a clinical trial budget that keeps your sites operating and billing in compliance. Learn which costs are billable to third-party payers and why sites have trouble billing appropriately.

Sign up your entire team to discover:

  • Dynamics, accountabilities and regulations of clinical trials billing
  • Details on the implications and impact of CMS’s Clinical Trials Coverage Policy
  • Common areas of risks and challenges for operationalizing key dimensions of the policy
  • Strategic options and best practices for reducing risk and effectively managing clinical trial billing processes

The Clinical Trial Billing Under Medicare webinar is convenient to attend. All that’s required is that you be in front of a computer monitor at the appointed time, whether you’re at the office or telecommuting from your office-in-home.

Of course, Mr. Eskew and Ms. Murtha will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in clinical trial billing will benefit from taking part in this event — and they can do so at a cost that won’t break your budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.

  • Compliance officers
  • Executive management
  • General/corporate counsel
  • Investigators
  • QA/QC personnel
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Study site personnel
  • Study sponsors

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Kevin R. Eskew is a Managing Director in SNR Denton’s Health Care Group. The focus of Kevin’s more than 13 years in healthcare has been in compliance program management, design and improvement as well as in research process improvement.  His work experience has spanned financial, operational, organizational enhancement engagements in varied settings, including health systems (large, small, community and public), pharmaceutical companies, and research universities. 

He has given speeches and authored articles for a number of professional organizations on topics primarily focused on the optimal approach to research management.  Other presentations have targeted issues such as compliance program effectiveness and strategies for improving research patient billing compliance efforts.

Lisa Murtha, Esq. is a member of Sonnenschein’s Health Care Group.  Ms. Murtha has more than 23 years of experience working on complex clinical research and healthcare compliance issues.  She focuses her practice on clinical research compliance, which includes human subject protections, effort reporting, scientific misconduct, conflicts of interest, and clinical trial billing and process improvement.  She is an expert on the Medicare rules related to clinical trials billing.  Ms. Murtha also provides guidance regarding revenue cycle work, billing and coding issues, internal investigations, corporate governance/ethics, and HIPAA related matters. 

Ms. Murtha is a founding and former board member of the Health Care Compliance Association and the Society of Corporate Compliance and Ethics. Prior to her consulting career, Ms. Murtha worked as the Chief Compliance Officer for the University of Pennsylvania and University of Pennsylvania Health System, and prior to that as the Corporate Compliance Director for Pennsylvania Blue Shield (focusing primarily on Medicare Carrier Contract Compliance). Ms. Murtha is a former board member of the International Association of Privacy Officers.

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