Greenphire welcomes Kimberly Irvine of the Biomedical Research Alliance of New York (BRANY) as a guest writer for this post:

Once an organization makes the decision to participate in a clinical trial, one of the most critical points is the budgeting process at the beginning. According to the Tufts Center for the Study of Drug Development, the number of procedures on patients enrolled in clinical trials increased from 96 in 1999 to 158 in 2005. Each of those anticipated visits and procedures must be taken into account in the budget process to ensure adequate reimbursement.

Research departments that do not adequately budget and anticipate operational requirements may find themselves paying unanticipated costs that were not covered in the contract with the sponsor.

To begin the budgeting process, the site needs to gather the necessary tools: the study protocol, a budget spreadsheet, a schedule of CRA visits, investigator meetings and the site’s research fee schedule.

Additionally, research professionals need to consider additional costs in the budget:

•Transportation support (such as debit or gas cards and bus passes) for study participants

•Costs to attend the investigator meeting, including possible temporary staff to cover the office if research staff also attend the meeting

•Administrative fees for time and effort associated with study start-up (completing regulatory documents, revising ICF’s, preparing the IRB submission)

•Staff time for completing study documentation, even after enrollment is closed

•Additional supplies or equipment required to properly conduct the trial, such as a dedicated refrigerator or freezer

Sites usually receive payment for work based on the completion of their case report forms. Most study sponsors or CROs do not require invoices in order to release payment to a site, however the practice of generating invoices may set a best practice standard and allow better management of accounts receivable.

Study staff must be diligent and thoughtful in preparing for a clinical trial. Proactively taking these and other issues into consideration can save a lot of time and aggravation in the long term, and result in a productive relationship with research sponsors.

For more information contact Kimberly Irvine at kirvine@brany.com or visit www.brany.com

The Biomedical Research Alliance of New York (BRANY) is a preeminent clinical trials service provider, offering an array of comprehensive and efficient support services to organizations conducting research. BRANY specializes in research billing compliance, consulting, education and auditing services.

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“Our alliance with Merge enables us to collaboratively bring an innovative and complementary set of technologies to the clinical research industry, driving additional efficiency to sponsors, CROs and sites on a global basis,” said Greenphire CEO Sam Whitaker. “Our integrated functionality with Merge adds value to existing Merge and Greenphire clients, and offers operational efficiencies which our industry has never achieved previously.”

The functionality achieved through this strategic partnership will streamline implementation processes and create additional efficiencies for clients, enabling users to automate research site and clinical vendor payments in local currency through Greenphire’s centralized, global web-based payment engine. It will also streamline setup times, decrease sponsor, site and CRO administrative burdens on an on-going basis, reduce payment administration costs and timelines, and increase site satisfaction. Additionally, centrally automating global clinical payments will significantly reduce costs for both sponsors and CROs by electronically automating what have historically been multi-step and manual payment administration processes.

“This partnership demonstrates that Merge is committed to addressing the needs of our clinical trials customers, specifically those who have asked for an integrated site payment system for their clinical programs,” said Jeff Surges, CEO of Merge Healthcare. “We’re looking forward to working with Greenphire and to improving workflow processes and efficiencies for our clients.” To date, Merge is already using the integrated functionality to execute three unique projects, with several more planned for 2012.

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Greenphire welcomes Amber Lowe, Technical Support Specialist at Bio-Optronics as a guest writer for this post:

While working with many research facilities, we have learned that one of the biggest problems for sites is tracking their finances. The entire process, from negotiating a new contract to tracking what has been paid and what is owed, is difficult to manage due to many factors. Most studies have very specific, often confusing, contract terms for situations such as screen failed patients and optional procedures. There may be a holdback percentage that is withheld from payments until the end of the trial. Payments that are received are not itemized to let the site know exactly what is being paid for. Sites also have many costs that they need to track separately from their revenue, such as patient stipends and payments to partners.

CTMS programs have helped many sites track these items as well as many other challenges that sites face every day. At the beginning of the process, a good CTMS provides tools to quickly evaluate how much a study will cost the site running it, to ensure that they can negotiate the best rate with the sponsor to cover those costs. It provides various snapshots and forecasts to allow the site to determine if the study is a good option for them. It also allows the site to specify what they need to pay out from a study – automating the process so that sites can see what they owe for patient stipends, provider reimbursements, or payments to outside vendors. There are no unpleasant surprises when you use a CTMS to track your costs proactively.

It is important for any system to include the flexibility to account for the many exceptions that sites encounter, while also maintaining accuracy. A good CTMS’ tools help to automate that flexibility, letting the user relax because the system remembers. For example, specific contract terms for screen failures or other special statuses can be set up. These terms are presented in a way that is easy for users to understand and set up, allowing them reassurance that they are not overstating their revenue for these special cases; while at the same time, ensuring that they are getting paid for everything they should be.

Implementing a CTMS has helped many sites find out that they still have a balance owed to them, enabling them to recover those otherwise lost funds. Sites can also use the reports to look for the reasons why they may not have been paid the full amount. Is there a problem with items that need to be invoiced not being invoiced, so the sponsor doesn’t even realize they owe additional money? Is the site encountering a large number of deviations from the protocol? Is the site recruiting the best patients for the study, and is it using advertising money wisely?

Every site knows that making sure their finances are in order is key to their business being successful. A good CTMS that both tracks the finances and helps illuminate the roots of financial success or failure is instrumental to providing the peace of mind of having the financial house in order.

For more information contact Maria Durkin at mdurkin@bio-optronics.com or visit www.bio-optronics.com

Bio-Optronics, Inc. develops, deploys, and operates software products and custom information technology solutions to help healthcare professionals manage and optimize workflow, thus enhancing quality, productivity, and patient and staff satisfaction. For 25 years, Bio-Optronics has demonstrated leadership in innovation, expertise in workflow and integration, and a focus on unparalleled customer service.

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Keep up to date with the latest Greenphire corporate news online:

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2011 has been a busy and exciting year for Greenphire! Here are a few highlights:

In November, Greenphire was selected by AlwaysOn as a Venture Summit Mid-Atlantic 100 Award Winner for leadership in developing innovative clinical technologies.

In September, Greenphire closed a Series A financing of $1.5 million in growth capital led by FirstMark Capital, dramatically opening opportunities to expand sales and R&D investment in early 2012.

In July, Greenphire signed its 100^th clinical research site client, Montefiore Medical Center. Greenphire’s established site business complements a base of over 50 sponsor and CRO clients. 

In June, Greenphire unveiled the eClinicalGPS technology at the annual Drug Information Association event in Chicago. The eClinicalGPS is the first technology platform that automates all global clinical payment activity into local currency from a single currency account.

In March, CEO Sam Whitaker was nominated for the Partnerships in Clinical Trials Hall of Fame Award for Technology and Innovation, a prestigious recognition from one of the most established organizations in the clinical research industry.

Greenphire initiated several strategic partnerships with leading clinical technology providers including Almac Clinical Technologies, Merge Healthcare, Bio-Optronics, Mytrus, BRANY, Wells Fargo, and Citigroup.

Greenphire successfully expanded its user base to academic research centers and universities, with notable adoptions by Dartmouth College, Tufts University, the University of Kansas, the University of Kansas Medical Center, the University of Southern California, and the University of Cincinnati.

Greenphire’s ClinCard System was adopted by the world’s largest pharmaceutical sponsor, Pfizer, in the first-ever “virtual” clinical trial, wherein patients participate remotely and receive automated and real-time payments through Greenphire’s ClinCard System. 

Greenphire’s staff size doubled during 2011 from 10 to over 20 employees and will continue to grow with several new hires planned for early 2012.

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Greenphire welcomes Alex Morillo, MCA Service Program Director at the Biomedical Research Alliance of New York (BRANY) as a guest writer for this post:

It seems basic enough: payers, including the federal government, should not be billed for services that are already paid by someone else or are not provided for the direct benefit of the patient.

But in the world of clinical trials, it is much more complex than it sounds.

However, it is important to understand the risks. Without a specific process, policy and procedure in place, an organization runs the risk of an audit, a whistleblower lawsuit, significant fines or even criminal prosecution. From the time an organization considers a trial in the institutional review board (IRB) process through the study completion, documentation must be thorough and airtight.

This is a concern not only for academic institutions. Over the last few years, community hospitals have become more engaged in clinical research. While academic centers account for the majority of federally funded research, community hospitals and independent clinical practices are increasingly sites for trials funded by pharmaceutical and medical device companies. Even academic medical centers, with fully staffed research offices, have run afoul of regulatory agencies. Some academic medical centers have paid high-profile settlements in the millions of dollars.

Non-compliant billing is subject to severe penalties, as well as civil and criminal actions, under the False Claims Act. Additionally, private insurers could allege insurance fraud for improper billing.

Meanwhile, it is important that compliance and risk management play a role throughout the process beyond the initial coverage analysis and continues through the revenue cycle.

•Patients who are study participants should be flagged, and patient visits or encounters that are research-related need to be identified so those charges are segregated.

•On order sets, procedures that are covered by the protocol should be identified so they appear on the bill.

•An appropriate coding system for diagnosis and condition are required for Medicare beneficiaries participating in a qualifying trial.

•Verify all bills for encounters identified as research visits prior to issuing the bill.

Recommendations

Centralize—centralizing the process of collecting and archiving all the relevant components, such as protocol, consent, sponsor budgets, contracts, FDA letters, etc., can ensure a degree of consistency in the review process. Some institutions are considering centralized MCAs, similar to central IRBs, which have been demonstrated to accelerate the start of studies at many institutions.

Standardize—establish a standard operating process (SOP) that defines the procedure from the time a provider sees a patient when the service is provided, to how the service is documented and communicated to the payers. This should include how institutional electronic health records and clinical trial databases should communicate with each other.

Educate—provide ongoing education to research personnel – experience and knowledge vary widely from one institution to another, and there is a shortage of well-trained analysts with this expertise. Providing continued education to staff may mitigate the risk of mistakes. Additionally, research and billing staff should understand regional and state differences in coverage.

Collaborate—work with the investigator to review the informed consent carefully to clarify costs, FDA status, visits and procedures; you should also review the entire protocol, not only the schedule of events. Additionally, work closely with the study sponsor to differentiate between routine care and care provided by the sponsor.

Validate—Medicare and Medicaid services have to be done for reasonable and necessary purposes. Identify what’s billable to payers and to the sponsor. When you submit a claim be sure to have validated documentation.

Investigate–Conduct periodic audits. The frequency depends on the volume of studies at your organization. Generally semi-annual audits allow for early identification of issues that may be brewing.

Conclusion

Being a clinical trial site has many benefits for clinicians, patients and organizations. But there are many potential pitfalls when it comes to appropriate documentation and billing. Organizations that are research sites should work closely with investigators to develop specific and detailed processes to ensure compliance.

Determining the eligibility of a clinical study’s related tests, procedures or interventions for Medicare coverage requires a detailed review of the clinical events specified in the protocol to determine which can be reimbursed by Medicare or third party payers. This process, called Medicare Coverage Analysis (MCA), can be cumbersome and time-consuming, yet essential.

For more information contact Alex Morillo at amorillo@brany.com or visit www.brany.com

The Biomedical Research Alliance of New York (BRANY) is a preeminent clinical trials service provider, offering an array of comprehensive and efficient support services to organizations conducting research. BRANY specializes in research billing compliance, consulting, education and auditing services.

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Looking for your feedback–Has anything changed in the last 18 months?

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