The Basics of Coverage Analysis

Posted by PFS Clinical on Feb 23, 2017 8:57:18 AM

As medicine continues to advance by the work of research institutions around the nation, the topic of billing compliance has become a highly prevalent matter in research administration. As such, institutions are looking for ways to ensure compliance, one of which is coverage analysis.

Coverage analysis is the process of reviewing a clinical trial protocol and determining which items and services can be billed to the study sponsor, and which can be billed to insurance. Though tedious, the process is crucial to the administrative wellbeing of a study, and can prevent costly errors that lead to billing non-compliance.

Medicare has strict rules that state a provider cannot receive payment from one party for a service and bill Medicare for that same service. Also known as “double billing,” this process is a severe form of Medicare fraud. However, by conducting a coverage analysis, you can avoid this mistake.

Read More

Topics: Coverage Analysis

Complion CEO to Speak at 11th Clinical Trial Billing & Research Compliance Conference

Posted by Abbie Hosta on Feb 16, 2017 12:30:52 PM

Complion Founder and CEO Rick Arlow along with Candida Barlow, MSN, RN, Director of Clinical Research, St. John Clinical Research Institute, will be presenting a session entitled A 360-Degree View of the Paperless Clinical Trial Office on Monday, March 6, 2017 at 1:30PM at the 11th Clinical Trial Billing & Research Compliance Conference, March 5-9, 2017 in Houston, TX.

This event continues to be the top billing compliance event in the country. Hear from representatives from CMS, sponsors, community hospitals, physician practices, NCI, CTSU and academic medical centers, as well as Medicare contractors

Taking place in an intimate, relaxed setting, this conference is ideal for engaging and networking. View the agenda and lineup of expert faculty or visit for more information.

Read More

Topics: Events, Billing Compliance

Why are Sites Slow to Adopt Paperless Technologies?

Posted by Abbie Hosta on Feb 10, 2017 8:20:16 AM

What would keep clinical trial site staff from using technological tools they know to be important factors in successful trial management?

According to a recent post from ACRP, one reason is the lack of clear understanding about U.S. Food and Drug Administration regulations regarding document management in clinical trials.

“Many clinical trial practitioners believe FDA still wants to see certain documents in paper form, and it is not always clear what the agency’s expectations are.”

Another reason cited in the blog post for the foot-dragging on the adoption of electronic tools is simple human aversion to change.

Read More

Topics: Paperless Clinical Trials

Understanding the Role of IRBs in Clinical Research: A Quick Guide

Posted by Complion on Jan 16, 2017 8:11:37 AM

The ultimate goal of clinical research is to provide relief from, if not outright cures for, the various maladies and infirmities that plague human beings. In the ever-evolving world of research, history has shown that human frailties of another variety can sometimes send the pursuit of that goal down a less noble path. Effective regulation helps to ensure that that ultimate goal remains dominant among the many motivations that drive research.

Institutional review boards are an important example of regulatory efforts to insure the protection of the rights of human research subjects, as well as the protection of the patients who will ultimately benefit from the treatments resulting from that research.

Read More

Topics: Clinical Research Ethics, Human Subject Protection, Compliance

A History of Clinical & Human Subject Research

Posted by Complion on Jan 4, 2017 4:11:17 PM
“Discovery consists of seeing what everybody has seen and thinking what nobody has thought.”
-- Albert Szent-Gyorgy (1893-1986), winner of the 1936 Nobel Prize for Physiology and Medicine

In light of the remarkable level of technological complexity and sophistication in today’s clinical research it can be too easy to lose sight of the fact that the roots of today’s research are long and deep, spanning centuries. Each breakthrough, each moment of discovery in that long history was, as Nobel laureate Albert Szent-Gyorgy describes, a moment in which someone looked at what others had already seen and saw something new.

Read More

Topics: Clinical Research Ethics