InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.
As we approach the fourteenth anniversary of the effective day of the final rule for Medicare coverage of routine costs in qualified clinical trials (click here for more information), it is useful to reflect at how little we have progressed toward a rational and efficient system of taking insurance coverage into account in budgets.
Although the stated purpose of the rule was to address under-enrollment of Medicare beneficiaries in clinical trials, it has evolved into a complex set of processes designed to avoid the legal and financial risks of inappropriately billing government and commercial insurance payers. The process begins with an analysis of the protocol to determine which items and services can legitimately be billed to the payer. Medicare is the typical billing standard. At this first step – the so-called Coverage Analysis – inefficiency and inconsistency reign supreme.
Inconsistency is achieved because the concept of “routine care” is conflated with “standard-of-care,” which may either be non-existent, or if codified, rejected by some clinical investigators, even in a single healthcare system/hospital network. The result is that different investigators (and their institutions) are willing to bill payers and sponsors inconsistently for the same procedure in a clinical trial. Sponsors mostly go along.
Inefficiency results from the fact that sites are burdened by the need to do their own Coverage Analyses, a time-consuming exercise if done systematically and adequately documented. And the cost ($2,000 to $5,000) – site-by-site – is billed back to the sponsor.
To avoid this time-and-resource-consuming component of study start-up, sponsors/CROs could provide sites with a Coverage Analysis for each clinical trial together with their budget offer. This could be done a manner akin to centralized, independent IRB review, accommodating the small variability required by a handful of Medicare Administrative Contractors across the US. A few large hospital systems have taken a similar, centralized approach for trials done at multiple facilities. But why not do this upstream?
Why have sponsors/CROs avoided Coverage Analyses? The primary reason, I suspect, is that they’re not asked to pay for one at many sites; those that don’t do the analysis don’t bill for it. Also, the impact on overall startup time may not be apparent. Nevertheless, institutions (hospitals and academic medical centers) – which generally comply with the rule – tend to be slow to start-up; Coverage Analysis is a component. Perhaps we will reach financial tipping point, where it become obvious that a centralized, sponsor-driven approach makes sense?
InSites is a monthly column written by TIRS Editorial Board member Stuart Horowitz, PhD, MBA. Dr. Horowitz is President, Institutions & Institutional Services at WIRB-Copernicus Group.