The process of determining which costs are billable to Medicare and which are not involves analyzing hundreds of items and services provided during a clinical trial.

If you don’t fully understand the process of conducting a Medicare cost analysis, you risk under- or over-paying your sites, creating unexpected expenses and leaving yourself open to unlimited liability in cases of injuries to study subjects.

And in a worst case scenario, sponsors that face charges of aiding and abetting false claims (based on what your sites billed improperly) also risk criminal and civil penalties.

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 with the FDAnews management report Billing Medicare for Clinical Trial Costs.

It addresses the challenges in implementing clinical trial billing policies and rules for areas such as contracting, budget development, anticipating Medicare coverage, charge capture billing, reconciliations, and required compliance activities.
                        
You’ll get the answers to your toughest questions, including:

• How does Medicare view research-related injuries, and how should that impact your planning for liability coverage?
• What level of therapeutic benefit must be promised by a trial for Medicare to pay?
• At what stage of a trial should devicemakers contact Medicare about payment?
• How can you ensure that proper billing policy is translated into practice?
• What are the best practices for ensuring non-approvable costs are scrubbed from bills before submission?
• For billing purposes, how do you treat routine care provided to research subjects vs. research-specific care? Where do you draw the line between the two?
• Suppose you suspect Medicare billing compliance failures or fraud? Are you obligated to investigate, audit or report?
• To what level of detail should informed consent documents address costs, both covered and noncovered?

And the list goes on and on. This standout report also covers:

• Medicare regulations for clinical trials billing — an overview in plain English
• Impact and implications of the Centers for Medicare and Medicaid Services (CMS) Clinical Trials Coverage Policy
• Common compliance challenges in implementing policies
• Best practices for reducing risk and effectively managing clinical trial billing processes
• And much more

The consequences of not understanding Medicare’s requirements can be severe. Why risk fines, sanctions, bad publicity and distractions? Don’t delay. Order your copy of Billing Medicare for Clinical Trials Costs today.

The editors of FDAnews have created this management report especially for:

• Compliance officers
• Executive management
• General/corporate counsel
• Investigators
• QA/QC personnel
• Regulatory/legislative affairs professionals
• Risk management specialists
• Study site personnel
• Study sponsors
• Billing and Coding Personnel
• Consultants/service providers

Buy Now
Billing Medicare for Clinical Trials Costs is available in print or PDF format for $397. Act now: place your order here.

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