The Medicare Secondary Payer rule (“MSP”) amended the Social Security Act (Section 1862(b)) to define circumstances when Medicare has an obligation to pay only after a primary payer has paid, or can reasonably be expected to pay for a billable item or service. The intention was to shift costs from government-payer coverage to private, third-party insurance, if an individual has dual coverage. MSP outlines how these dual benefits are coordinated, but how is this applied in the context of clinical research?
While speed and efficiency are vital aspects of any study start-up, approaching the process with only these goals in mind can create issues that can set you back and impact the overall success of your studies. Fortunately, evaluating some of the details underlying your start-up timelines can remove the potential for certain missteps. With these things in mind, here are five tips for improving your study start-up timelines:
A frequent question asked in our industry is: "How much should we pay investigators for their work on a clinical trial, and what methodology should be used?" While this question seems straightforward, it is quite complex. The amount and method by which you pay investigators can play a big role in the success, or lack thereof, of your research department.
For the average person, understanding Medicare can be confusing and complicated. However, for people in the world of clinical research administration, understanding Medicare is a necessity in order to maintain billing compliance. Medicare rules are the foundation for clinical trial billing compliance, so understanding how Medicare can impact your research is crucial. To understand how Medicare impacts clinical trials, you must first understand what Medicare is, how it is broken up, and what makes a clinical trial qualified to receive Medicare coverage.
The use of mobile health in clinical trials has been consistently growing for the last few years, and for good reason.mHealth has been gaining popularity in clinical trials because of its ability to gather general health data, as well as monitor real-time patient vital signs. mHealth technologies can benefit clinical trials in many ways by enhancing data collection, improving patient enrollment and engagement, and the lowering the cost of trials.
Clinical trial agreements are notorious for their complex and often confusing payment terms. Those terms make it difficult for research institutions to accurately track how much is owed to them by sponsors/CROs and if they have been paid correctly for a study. Effectively managing your receivables can change the way your institution does business, and it has many benefits.
Negotiating clinical trial budgets is often a lengthy back-and-forth process between the institution and sponsor/CRO. Consequently, this process can greatly delay study start-up. Here are five tips for more effective and efficient budget negotiations:
The National Cancer Institute (NCI) Cancer Centers Program, which is responsible accrediting high performance cancer centers, is a leading voice in the nation’s cancer research effort. There are currently sixty-nine NCI-Designated Cancer Centers that form the nexus of the NCI’s initiatives for studying and combatting cancer. While there are many cancer centers in existence, becoming NCI-accredited is one of the most rigorous and prestigious designations in the country.
Developing an internal budget can be a complex process, but it’s important for many reasons. First, the internal budget allows the research office to see the actual cost to conduct a study. Additionally, the internal budget is often more detailed than the budget provided by the sponsor. Your internal budget might vary from other institutions due to specific processes, and it can be built in an excel document or directly into a CTMS. Developing an internal budget allows for additional comments and clarifications that may not be possible to add to the sponsor’s template. Lastly, an internal budget can be formatted to meet any specific internal needs. A good example of this might be including specific formulas to account for how much money should be allocated to the PI, the nurse or coordinator, or to cover various departmental fees.
This blog post was provided to PFS Clinical by Complion, Inc.
In an effort to reduce the time and expense associated with paper-based systems, more sites and institutions are looking to implement paperless technologies to manage regulatory and trial documentation.
One of the negative aspects of clinical trials is the possibility that a patient will suffer an injury or illness as a result of their study participation. As such, one of the most important pieces of a contract is the subject injury language. ‘Subject Injury’ is defined as an injury, illness, adverse event/reaction, or death caused by a study subject’s involvement in a clinical research study. Prior to the study, the research site and the study sponsor should come to an agreement on what exactly constitutes a Subject Injury, and who pays in the event of a Subject Injury.
Within the past two years, investigator initiated trials (IITs) have seen a remarkable renewed interest. While research offices are doing their best to support these endeavors, the additional administrative responsibilities involved are often unfamiliar to research offices. Consequently, mistakes made during the initial development and start-up stages can cause compliance and financial ramifications. Here are four common mistakes to look out for when conducting an IIT study:
A Clinical Trial Management System (CTMS) is a computer software system that manages data within a clinical trial. The system centralizes the administrative components of each study, including billing, reporting and tracking. Many research sites, institutions, sponsors, and CROs use these systems to monitor clinical trials. Below are 3 key benefits of implementing a CTMS.
With the advancement of medicine over the past several years, it is no surprise that clinical research has become more complex. In conjunction with these advancements, hospitals and health systems are making significant changes to their research operations.
When the Health Insurance Portability and Accountability Act (HIPAA) went into effect over 10 years ago, it was met with great apprehension and concern from those in the healthcare industry. Today, it is one of the most important legal and ethical guidelines in the industry. How has HIPAA evolved since its inception? Let’s step back to examine a few key points in its development.
National and Local Coverage Determinations (NCDs and LCDs) are two of the most important aspects of Medicare coverage. Both NCDs and LCDs are released by Centers for Medicare and Medicaid Services (CMS) to standardize Medicare coverage for certain medical tests and procedures. These determinations outline the conditions in which a service is considered to be covered by Medicare.
Much has been written about the changing clinical research landscape, and more importantly, the implications these changes are having on small, independent research sites. The first major change was the implementation of preferred site programs by many larger contract research organizations (CROs). The second, and more recent development, is the actual acquisition of research sites and site networks by CROs. Separate of both of these trends, is the premise that “big data” will give larger health systems a competitive advantage, allowing them to reestablish their dominance in Phase II and III research. Each of these themes are explored in greater detail below.
Developing a coverage analysis (CA) can be a very tricky task, especially for a novice analyst. Nonetheless, it is crucial to conduct CAs in order to ensure billing compliance. There are several important items that need to be considered while building a CA. This list is not meant to focus on every single one of these items, but to highlight a few important items that should be considered while building a CA.
In the early 1960’s, changes in federal regulations sparked a revolution in drug research and development, particularly in regard to clinical trial testing when Investigational New Drug designations (INDs) and New Drug Applications were implemented.
Then in 1965, Medicare, the national social insurance program, was established.