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.
Medicare is a single-payer, national social insurance program administered by the U.S. federal government that began with the Social Security Amendments of 1965. Under President Lyndon B. Johnson, Congress enacted Medicare under the Social Security Act to provide health insurance to people age 65 and older, regardless of medical history or income. Medicare also covers people with certain disabilities, people with end-stage renal disease, and certain qualifying clinical research studies.
Medicare is broken up into four main parts: Part A, Part B, Part C, and Part D. Part A is considered hospital insurance, and covers inpatient hospital stays, skilled nursing facility care, and hospice care. Part B is considered medical insurance, and it covers certain physician services, outpatient care, preventative services, and medical supplies. Part C, also known as Medicare Advantage Plans, is a Medicare health plan offered by a private company that contracts with Medicare. Medicare Advantage Plans provide people with the benefits of Part A and Part B, while also providing added perks such as having access to health maintenance organizations or special needs plans. The final part is Part D, which provides coverage for prescription drugs. Generally, Medicare will cover items and services that are reasonable and necessary for the patient based on their signs and symptoms.
There are several Medicare rules and regulations that apply to clinical trials. Some of these rules and regulations are research-specific and some apply to all Medicare patients. The research specific rules apply to trials that Medicare determines are qualifying. In a qualifying clinical trial, Medicare will cover the routine costs associated with the study., The instructions to determine whether a trial qualifies or not can be found within the National Coverage Determination, also known as NCD 310.1. There are four base requirements in the NCD 310.1 that need to be true for a clinical trial to be considered qualifying. The first requirement is that “the subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category”. Medicare covers more than 70 categories, and these can all be found in NCD 310.1. The second requirement is that “the trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent”. To qualify for Medicare coverage, the purpose of the clinical trial must be to improve outcomes for patients while also gaining data to send to the FDA for efficacy and safety improvements. The third requirement is that “trials of therapeutic interventions must enroll patients with the diagnosed disease rather than healthy volunteers.” The fourth requirement is that the clinical trial must be deemed. When a clinical trial is deemed, it means that the protocol has the seven desirable characteristics as established by the NCD 310.1. Trials conducted under an IND, funded by a governmental agency, funded by a cooperative group supported by a governmental agency, and IND exempt studies are considered automatically deemed to meet the seven desirable characteristics. If any of these four requirements are not met, the clinical trial will not qualify for Medicare coverage.
If the clinical trial qualifies for Medicare coverage, researchers must follow all of Medicare’s normal rules in additional to their research rules. The research rules expand coverage. Per NCD 310.1, Medicare will cover items that would be provided absent a study, items required for the provision of the investigational item, and “items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications.”
Medicare can be very complicated, but understanding the basics behind how Medicare impacts clinical research studies can help researchers run their clinical trials more effectively and compliantly. For more information on Medicare and how it affects clinical trials, visit https://www.medicare.gov/coverage/clinical-research-studies.html.
The use of mobile health in clinical trials has been consistently growing for the last few years, and for good reason. Mobile health technologies, often referred to as “mHealth,” is the general term for technologies used in medical care. mHealth can range from applications on mobile phones, tablets, and computers, to wearable devices, such as smart watches and fitness bands. 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.
mHealth technologies offer many benefits for clinical trials, and one of the main benefits it offers is its ability to collect more frequent, higher-quality data. Clinical trials count on reliable data, and mHealth has the ability to optimize clinical trial data through higher-quality data collection. Improved data quality has many benefits for clinical trials, including being able to produce study results in a shorter period of time. More mHealth technologies are also implementing advanced measurement technologies that can collect patient data from almost anywhere, such as silicon-based microneedles to obtain fluid readings. These kinds of technologies have the power to revolutionize clinical trials by being able to collect patient data remotely, which can make data collection easier and faster.
mHealth is also opening avenues for more efficient and optimized subject enrollment and engagement. Subject enrollment is one of the main obstacles facing clinical trials, and by introducing mHealth into patient recruitment, researchers can reach a brand-new group of potential patients. In one study done by Stanford University, over 10,000 patients were enrolled overnight by using Apple’s ResearchKit medical research platform (1). Subject engagement is also a large problem in clinical trials, and researchers are very confident that mHealth technologies will greatly increase patient engagement by making patient engagement easier and less time-consuming. Researchers are using mHealth to administer online patient surveys and assessments, as well as online patient education, which is making clinical trials much more accessible to patients.
mHealth also has many benefits for the costs of clinical trials. Research is notoriously expensive and can go on for very long periods of time. But mHealth technologies are cutting back the costs of clinical trials by allowing automatic feeds of biometric data into health systems, which minimizes office visits, physician-administered procedures, and the cost of data entry. By making clinical trials more efficient, mHealth can greatly cut back on administrative costs and in turn, make clinical trials more effective and less costly.
The clinical trial space provides a great channel to leverage mHealth technologies to increase patient enrollment and engagement, improve data collection, and reduce the costs of clinical trials, and there are many areas of opportunity to introduce mHealth technologies into the world of clinical trials. mHealth technologies have many benefits for clinical trials, and as mHealth technologies improve, we will surely be seeing them implemented in the clinical space more and more.
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. These benefits include: improving cash flow, collecting all owed revenue, and generating financial insights to make informed business decisions.
CenterWatch, a company that provides a variety of clinical research products and services, periodically conducts a survey of research sites and institutions to better understand the clinical trial landscape. In 2004, they conducted a survey to identify their chief operating concerns. At that time, “Slow Payments/Reimbursements” was identified as the leading concern. In 2010, they conducted a similar survey, and “Slow Payments/Reimbursements” remained the number one concern. Clearly, this problem is not going away, and many institutions feel this is their primary barrier to improving business outcomes.
There are many misconceptions about payments and reimbursements. The top 2 are that the sponsors/CROs automatically pay on time and accurately for work performed, and the second is that when invoices are submitted, they’re paid immediately. The misconception that sponsors/CROs pay on time and pay accurately for the work performed is very common; however, only 72% of sites are paid on-time, and only 70% of patient payments are paid correctly (PFS Clinical Internal Analysis). Additionally, approximately 33% of invoices need to be resubmitted to the sponsors/CROs before payment is received (PFS Clinical Internal Analysis).
Institutions may have blind spots related to their clinical trial receivables process. Many times, constrained resources without clear responsibilities inadvertently create financial liabilities for the research organization. These resources may lack the proper clinical knowledge to accurately recognize revenue for the trial. Additionally, CTMS systems, if not implemented correctly, can create data inconsistencies that cause financial errors. Organizations need to develop a thorough process and provide proper training for research receivables to be managed appropriately.
With this information in mind, how do institutions organize for success? One option is to establish a “research only” lock box for the receipt of study receivables. By having a dedicated lock box, institutions can minimize the co-mingling of funds with other business operations. Having a dedicated lock box also provides an efficient vehicle for the dissemination of payment details. This lock box can help you institute a disciplined process for reconciling receivables. Some examples of this include a customized CTMS financial module, Excel spreadsheets, or outsourcing to a receivables management vendor. In each of these options, maintaining patient information and visit details is crucial to the success of the research institution.
-Push for monthly payment terms during contract negotiations
-Understand the payment terms for your studies; clarify in writing as needed
-Maintain a reconciliation log to tie out all payments
-Have a "research only" lock box
-Request payment details from the sponsor
-Assume your CTMS system will automatically and accurately track your receivables
-Entrust the entire receivables management process to a study coordinator
-Assume that the sponsor/CRO will pay you correctly
-Presume that if you send in invoices you will be paid
-Wait too long after your close-out visit to complete the final reconciliation
If you have any questions regarding managing your clinical trial receivables or any other questions, email PFS Clinical at email@example.com.
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:
- Prioritize negotiations on non-negotiable items. Focus your negotiation efforts on institutional budget requirements and patient care items that will not be covered by the patient’s insurance. A common non-negotiable item is study start-up. Many institutions have a threshold dollar amount for start-up that must be obtained to move forward with the study. For this reason, focus heavily on negotiating for the full start-up amount. This may mean not spending as much time negotiating other fees like IND safety reports. It is also important to focus on items not covered by the patient’s insurance. For example, if an angiogram is non-covered in the study situation, focus the per-patient budget negotiations on making sure the angiogram is covered by the sponsor.
- Use the coverage analysis as a negotiating tool. Institutions and sponsors typically differ in their interpretation of items that are billable to the patient. If the institution determines that most items cannot be billed to the patient in the coverage analysis, this has a significant impact on the budget. It’s possible that the per-patient total could double or even triple because of different interpretations of standard of care. Most sponsors and CROs will ask why the item cannot be billed to the patient. Reference the coverage analysis when explaining why the item needs to be sponsor-paid. The argument used for why the item is not billed to the patient can also be used as a negotiation argument. Quoting limiting Medicare rules always makes a strong case for why the sponsor should cover the cost of the item.
- Show a sense of urgency when you work with the sponsor or CRO. If they know that you are motivated to the get the budget negotiations done quickly, then they are more likely to respond faster and help you expedite the process. Communicate your timelines with the sponsor or CRO right away. If they do not expect the negotiations can be completed in that timeframe, then this can be communicated to others working on other areas of study start-up. Following up with the sponsor regularly also shows a sense of urgency. Check in with them at least once a week, and respond to edits as quickly as possible. If there are significant edits, it is a good idea to pick up the phone and talk through the edits, which leads into my next tip. . .
- Call the sponsor or CRO. Writing out explanations via email can take hours depending on the number of edits. The same edits can usually be discussed within a half hour over the phone. It is not uncommon for more than one person at the institution and sponsor or CRO to review the budget edits. By having a phone call, everyone who is involved in the budget negotiations can be present. This often prevents double review by both parties. After the phone call, it is important to follow-up with the sponsor or CRO via email to document items that were discussed, especially if you agreed to keep certain fees in the budget or agreed on a dollar amount.
- Have fee documentation ready. Many sponsors will request letterhead documentation for site fees, especially administrative fees. It can be beneficial to develop a documentation template that can be used across multiple studies. You may need more than one template if different departments have different fees and others have separate templates for observational and interventional studies. Having a standard documentation form is a major efficiency and helps make sure costs are covered. If you save the documentation as a PDF that can be sent with every budget, you no longer need to re-write the fees and justification for every study. Documentation is also frequently required for the sponsor to cover certain fees or dollars amount.
After negotiations have been finalized and the budget is ready to go into the contract, complete a careful review of the budget. Make sure the payment terms were reviewed, the billing designations match the coverage analysis, and that all your edits were incorporated. Typically, budget negotiations have several comments and edits, so they can look pretty messy by the time you finish negotiating. Review the cleaned-up version closely to make sure all the changes were incorporated. Once this is complete, you are ready to finalize the budget.
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.
History of the NCI Cancer Centers Program
In the early 20th century, cancer was considered a mysterious and pervasive disease. Great minds became attracted to the prospect of conquering the unknown, and with new technology available to them, a handful of laboratories grew to become a network of universities, hospitals and institutions. Physicians and scientists from overarching interdisciplinary projects began collaborating to drive innovation in cancer research.
In 1930, Congress passed the Ransdell Act that created the National Institutes of Health (NIH). This legislation marked a change in attitude of the scientific community toward public funding of medical research. Just five years later, the NCI was created as a part of the NIH with full support from every senator in Congress. This unanimous front against cancer revealed growing concern over the invasive disease. Shortly thereafter, a number of governmental grants started a snowball effect in the cancer research community, producing a number of discoveries and treatments.
The NCI’s role has evolved from authorizing grants for research to encompassing all aspects of cancer awareness and treatment. The NCI has also cultivated an environment in which top-tier cancer research institutions can be recognized, supported and funded. In 1967, eight cancer centers were the first to receive research support from the NCI. Soon after, the NCI established the notion for accreditation based on the criteria set forth by the National Cancer Advisory Board. Over time this evolved into a set of guidelines and requirements that the NCI uses to accredit designated cancer centers today.
NCI Accreditation Today
NCI cancer centers are most often affiliated with university medical centers, though some are stand-alone institutions. NCI-Designated Cancer Centers all focus on some combination of laboratory research (cells or animals), population science (large groups of people) and clinical research (testing treatments on volunteers or patients).
Currently, there are three designations recognized by the NCI:
- Basic Laboratory Cancer Centers conduct only laboratory research and do not provide patient treatment.
- Cancer Centers are recognized for their scientific leadership, resources, and the depth and breadth of their research in basic, clinical and/or population science.
- Comprehensive Cancer Centers hold the most rigorous designation. These centers demonstrate an added depth and breadth of research, as well as substantial transdisciplinary research that bridges these scientific areas. Institutions must pass a thorough review to receive this designation.
Achieving NCI Accreditation
In order to achieve NCI-designation, a cancer center must prove itself capable of making significant strides against cancer, as well as act as a hub of ground-breaking treatments and care for the community. Though there isn’t a specific set of standards that an institution must follow, the review process for achieving the designation is regarded as extremely rigorous.
Although NCI-Designated Cancer Centers have greater responsibility to serve their surrounding communities, the benefits are also significant. According to the NCI, funding “supports shared research resources, provides developmental funds to advance scientific goals, and fosters cancer programs that draw investigators from different disciplines together.” Further, for the select few able to attain the NCI designation, the revenue implications are substantial—millions of dollars in funding for research infrastructure allows these institutions to attract patients and top investigators.
Above all, the NCI Cancer Centers Program serves as one of the anchors in the nation’s cancer research effort. With the help of NCI grants, hundreds of research studies are underway at any given time, from basic laboratory research to assessments of revolutionary cancer therapies. The rapid pace at which NCI-Designated Cancer Centers are discovering new treatments has translated into improved cancer diagnosis and treatments across the world.
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.