Revenue integrity on the cutting edge: Managing billing compliance for clinical research

Managing clinical research billing and compliance is a delicate operation for revenue integrity. Compliance pitfalls such as improper billing or False Claims Act violations abound and can easily swallow up a clinical research program if revenue integrity doesn’t implement sound processes and strong procedures.

Clinical research drives revolutions in care delivery and hospital operations. Participating in clinical research is a boon to providers and patients, who get access to cutting-edge treatments and expertise. University health systems and teaching hospitals often have robust clinical research programs, but even a health system or clinic group not affiliated with a university can join a clinical research study and reap the benefits.

Whether your organization is considering dipping into clinical research or has an established program, take stock of what your billing team needs to effectively and compliantly manage clinical research claims.

Lessons learned

Although at one time the domain of a smaller pool of providers and patients, legislation enacted over the past 20 years has improved patients’ ability to participate in clinical research. But as new organizations and patients joined clinical research studies, the challenge of compliantly billing for these unique services became apparent.

In 2005, Rush University Medical Center in Chicago reached a $1 million settlement with the federal government for improperly billing Medicare for noncovered services during the course of a clinical research study, according to an article published in the November 2006 issue of the Journal of Oncology Practice. Medicare maintains a specific set of billing and coverage rules for clinical research studies, and an internal audit at Rush revealed that the organization had billed and been paid for services that were not covered under those rules. Rush took action, putting a bill hold in place for clinical research claims and self-disclosing the overpayment to CMS. Other provider organizations took note, and Rush’s fumble became the industry’s go-to case study, says Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP, owner of Kelly Willenberg and Associates in Greenville, South Carolina.

“At the time that Rush self-disclosed, it became apparent that everybody needed to take notice of clinical trial double-billing,” Willenberg says. “What I mean by that is you cannot receive payment from a sponsor—including pharmaceutical companies or a government sponsor—under a federal grant and then turn around and also submit the claim to Medicare.”

To address the lessons learned from the Rush settlement, organizations began going the extra mile to ensure due diligence and put sound, compliant billing practices in place. One key method developed was the coverage analysis, Willenberg says. A coverage analysis evaluates what items, services, and procedures will be covered by the research grant and then examines each eligible patient’s potential insurance coverage for clinical research studies. Although many payers look to Medicare’s rules for coverage of clinical research, each commercial payer, Medicare Advantage, and state Medicaid program will have their own unique rules down to the health plan level, she says.

“There could be so many different variances, and that is why this best practice of doing a coverage analysis and having a billing compliance program at an institution warrants you to have the due diligence in place to ensure that, no matter what the plan is, you have a heads-up,” Willenberg says. “You do your pre-authorization and your pre-certification with the intention of this coverage analysis. It is your tool to allow you to validate what is allowed to be billed.”

A look into analysis

So, how does an organization conduct a thorough coverage analysis? The first step starts before the study is even launched. The organization must know every item, service, and procedure that will be performed, the ICD-10 and CPT®/HCPCS codes that the study sponsor approves for use in the study protocol, and the coding and charging implications of each service or item. Put the details under a microscope, Willenberg advises. Some procedures might be done in conjunction with others, and that will change how the procedure is charged. A CT scan with contrast will have the CPT code and charge for the CT and an additional charge for the contrast. Make sure any questions that arise are brought to the attention of the study sponsor and resolved.

“It is down to that line-item review being done by someone before the study opens so you know exactly what is going to show up on a claim at the end of the process, and you are validating every patient at every time point on the study,” Willenberg says.

Sometimes what appears on the claim won’t match what’s approved per the study protocol and the organization’s coverage analysis. In that case, take a look at what charges are specifically associated with the study. Pick out charges for services and items that are not part of the study or that are research-related only and should be pulled off the clinical research study claim, Willenberg says.

Some charges might need to be billed separately. The clinical research protocol will describe specific services that will be paid for by the sponsor, but other medically necessary services could be performed. Clinicians refer to these routine services that fall outside the scope of the clinical research study as standard of care, although that is not a formal CMS term. If an organization is participating in a clinical research study on an investigational IV drug, the study protocol might specify that the drug and its administration will be covered. The provision of the investigational drug can be billed to the payer in a qualifying trial. The same goes for anything required to monitor the patient or treat any toxicity caused by the drug. Although monitoring for and treating toxicity would be providing services within the protocol, for reimbursement purposes it would be considered a routine cost. For a Medicare patient, these services would be billable to Medicare if they are not paid for by the study sponsor. The same logic would apply to billing a commercial payer. Ultimately, the organization’s goal is the same as it is for submitting any claim: Bill the correct payer for only the correct services and don’t bill the patient for items or services he or she should not be billed for. Bill consistently to all payers, but keep in mind that for Medicare patients some services might be limited under a Medicare rule or a local coverage determination.

A team effort

A broad range of departments and disciplines have at least some involvement in ensuring clinical research study claims are appropriately generated and billed out. The revenue integrity department plays a keystone role, coordinating information from the clinical research team, compliance, finance, and billing. A spirit of collaboration will drive success and satisfaction within the clinical research program, says Garland Goins, MBA, director of revenue and documentation integrity of the patient revenue management organization at Duke University Health System in Durham, North Carolina. Goins’ department oversees compliant and accurate billing for research studies to ensure not only that patients are properly enrolled, but that the manufacturer or grant sponsor is appropriately charged and standard-of-care charges are applied correctly. This is a tall order: Duke is a major participant in clinical research studies, and a myriad of compliance and legal considerations apply, from billing to patient privacy. To help manage the burden, Duke’s cross-divisional team includes a review board on the revenue integrity front that works with Duke’s office of clinical research. The office of clinical research performs centralized functions such as budgeting and negotiating with sponsors. It acts as the principal impetus to work with the clinical teams and create the study protocols. Goins’ team includes stakeholders in billing and IT and provides support for charges greenlit for use within each specific grant.

“With each new study there is a billing component in our Epic system, and there are some IT analysts on our team that work to build the billing timeline, study administration records, and other rules and groupers and items that help streamline the billing once the patients are enrolled,” says Ryan McGuire, manager of clinical trials billing at Duke University Health System.

Sophisticated software greatly improves workflow and productivity, and it enhances value for the organization and the patient, but it can’t simply be set up and left to run itself. Dedicated IT team members will need to use their skills and specialization to ensure the software is able to meet the entire clinical research team’s needs. Julie McCauley, senior clinical trials research protocol IT coordinator of clinical trials billing and patient revenue management organization at Duke University Health System, works with Goins and McGuire to adjust the system to optimize workflows. She ensures that all work queues are set up for easy staff review and that research protocols are correctly built in the system to allow for accurate charge assignment.

Duke uses Epic’s research module to help streamline management of research accounts and claims creation. Duke will also be implementing Forte’s Research System OnCore, a clinical trials research management system, to boost the experience for patients and assist with other operational needs. McCauley has been heading up implementation and staff training for OnCore, a process that has involved collaborating with multiple stakeholders.

An eye on claims

McGuire’s billing team monitors middle revenue cycle charge review and assignment. After the charges flow through the system, his billing team takes a look to ensure the charges that the sponsor agreed to pay for and the charges that will be billed as standard of care have the correct billing modifiers and that other required information is applied to the claim.

There are two modifiers billing will need to monitor for clinical research study claims: -Q1 (routine clinical service provided in a clinical research study that is in an approved clinical research study) and -Q0 (investigational clinical service provided in a clinical research study that is in an approved clinical research study). These are Medicare-specific modifiers, McGuire notes, although they also have some applicability to Medicare Advantage plans.

Other claim items billing staff should review are the use of condition codes and the diagnosis code. ICD-10-CM code Z00.6 (encounter for examination for normal comparison and control in clinical research program) should appear on the claim in a secondary position if the claim is for a research-related visit, McGuire says. Inpatient claims related to clinical research might need to use condition code 30 (non-research services provided to all patients, including managed care enrollees, enrolled in a qualified clinical trial).

There will also be a designated spot on the claim for the unique identification code given to each clinical study record registered on Each code begins with NCT followed by an eight-digit number (e.g., NCT00000419). This is called the NCT number and is required on any claim submitted to a government payer and some commercial payers. It lets the payer know which clinical research trial the visit is associated with, McGuire adds.

Billing challenges

The peculiarities of clinical research study billing can persist even after a particular study closes. A patient might have participated in a clinical research study that closed, but the payer might require that certain information related to the study, such as Z00.6 in the secondary position and modifiers -Q1 or -Q0, still appear on the claim, Goins says. These are referred to as registry accounts, and if staff aren’t careful or the edits and work queues aren’t correctly set up in the EHR, these accounts can get caught up in a work queue loop and create a block for coding and billing.

“The codes themselves would come across with the -Q0 on it but none of the other indicators,” McCauley says. “We look up to find what registry this might be included in, and that’s where we are capturing and tracking those registry accounts.”

Another common snag is preauthorization. Because missing preauthorization can cause costly denials and delays further down the line, many organizations such as Duke have optimized their EHR to flag accounts for preauthorization and minimize exclusions to the rule. However, in a clinical research study, that overwhelming need for preauthorization isn’t as strong, Goins points out, because the study sponsor has already made a blanket agreement to pay for the charges described in the research protocol. Ideally, the system can be adjusted to make allowances for clinical research accounts while still enforcing strong preauthorization for other accounts.

A final claim check will ensure the claim goes out the door as clean as possible. At Duke, as the claim is generated, Epic runs one final check to determine whether the account is flagged as research-related, and if so, whether it has all the necessary data elements. “If it doesn’t, our team will investigate which elements are missing, correct it, submit it, or potentially identify where the system didn’t append it properly or in an excepted manner and can highlight it to fixing broader issues as well,” McGuire says.

A broad impact

Once you dive deeper into the clinical research process, you’ll find that it has tentacles in every component of the revenue cycle. If certain accounts or encounters aren’t properly linked, this creates the potential for improper billing, Goins says. Pulling together a multidisciplinary team and meeting regularly to discuss and act on problems that arise is a must.

Patients are at the heart of the industry, and revenue integrity must focus on bringing that patient-centric approach to its role in in the clinical research process. Working with the principal investigators, the research sponsors, and other stakeholders will ensure that protocols are developed appropriately, charges and order sets are complete and correct, patients aren’t incorrectly billed, and clinical research can continue to advance patient care.

“It’s been immensely better with very deliberate and focused attention on inserting ourselves into the beginning of the process and seeing it all the way through,” Goins says. “So, from when the principal investigator sits down and begins to formulate what they want to do, the clinical trials billing team is front and center from a technology build perspective, a medical coder competency perspective, and just overall leadership and guidance. We’re right there.”

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