Site-Level Change Model And Successful Strategies For Medicare Compliance In Clinical Trials

When setting up operations for clinical trials, clinical research sites must consider both the clinical and administrative functions involved, from pre-award to post-award study activities. Effective execution of these tasks helps ensure clinical research sites adhere to regulatory standards and optimize the efficiency of the compliance process. Compliance with Medicare billing is of particular importance.

While the Medicare standard for coverage of items and services in qualifying clinical trials is those that are considered reasonable and necessary, it is important to note that not all necessary items and services may be covered. NCD 310.1, established by the Centers for Medicare & Medicaid Services (CMS), outlines the specific clinical trial costs that Medicare will cover.

Medicare coverage is determined by three key factors:

• compliance with federal and state laws,
• adherence to the Medicare national coverage determination, and
• consideration of local coverage decisions.

Additionally, the care provided must also be reasonable and conform to accepted medical practices.

Clinical Trial Compliance Change Model

To ensure Medicare billing compliance, sites must establish a culture that prioritizes adherence and maintaining order and preparedness throughout the clinical trial. Organizations should begin by assessing their current operational status and then proceed to do the following:

Create a well-organized operational compliance plan that involves closely monitoring research activities throughout the stages of pre-study, study, and post-study.

The compliance model establishes an atmosphere conducive to change within the organization. The entire team must engage in both initiating and upholding the momentum of change.

Utilizing a change model entails various factors, among which is the identification of insurance-covered costs by the Medicare Coverage Analysis (MCA) to enable budgeting and financial strategizing. Sites must adhere to guidelines that prohibit invoicing for items or services already covered by the sponsor, those promised as free, or those without therapeutic value.

This practice plays a key role in averting financial setbacks by guaranteeing proper reimbursement for routine care provided during clinical trials, thereby aiding in efficient financial management and mitigating risks. Accurate and timely recording of charges for services and procedures is fundamental for effective resource allocation.

Establish a centralized billing unit to ensure consistency, enhance efficiency, and standardize diverse tasks related to research billing.

These tasks include supporting the MCA, crafting budgets, negotiating, invoicing, implementing contractual agreements, and reviewing claims. This dedicated office collaborates with various clinical departments to tailor plans that align with compliance requirements.

Ensure the budget, MCA, informed consent document, and clinical trial agreement are aligned.

This alignment facilitates the review process and improves operations. Medicare contractors expect that clinical research sites will establish an MCA and uphold meticulous billing practices to ensure accuracy and transparency. These practices should be integrated into the audit work plan for thorough oversight.

Secure support from stakeholders, particularly clinical investigators, and maintain compliance standards with well-maintained and comprehensive documentation.

Establishing the tone of an organization has a profound impact on awareness and adherence to control practices among its employees. This sets the groundwork for all facets of internal control, imparting a sense of order and discipline throughout the organization.

Uniformly implement robust policies and procedures, including standardized operating protocols.

Your compliance program should align with federal guidelines to ensure regulatory adherence.

In line with the clinical trial policy, Medicare may cover the routine costs associated with specific items and services for qualifying clinical trials, subject to meeting the criteria for routine cost definition.

Understand the distinct roles and responsibilities.

By clearly documenting and defining these roles and responsibilities, organizations can effectively maintain compliance. A thorough understanding of coverage options can help reduce financial barriers for patients, increase their participation in clinical trials, and improve access to necessary treatments.

Have internal protocols for performing audits, reconciliations, and monitoring activities.

Site staff must understand the claim adjudication process, including common reasons for denials such as demographic errors, incomplete insurance details, lack of preauthorization or precertification, medical necessity evaluations, incomplete orders, incorrect coding, and insufficient pre-bill editing procedures. Sites should adopt a bill hold system for segregating standard of care charges and incorporate MCA as a core component. By enabling the bill hold feature, charges related to a particular encounter can be placed on hold automatically, thereby preventing them from being processed through the regular billing queue.

Consider the following essential factors when reviewing claims on bill hold:

• Verification of Third-Party Charges. Confirming the intended payer for charged items and services is crucial during the claims review process. This could be a third-party payer like an insurance company or sponsors. Make sure the correct payer is identified, as this will help ensure proper reimbursement and avoid any billing errors.
• Clinical Research Flag (EMR). Incorporating a clinical research flag within the EMR system is critical for associating patient encounters with research projects. The flag signals a patient's enrollment in a clinical trial, integrating research into standard clinical workflows.
• Use of Q0/Q1 Modifier. The Q0 modifier is utilized for investigational or experimental services provided within a Medicare-approved clinical research study for data collection purposes. On the other hand, the Q1 modifier is designated for routine clinical services offered in conjunction with the research study that would have been provided to the patient regardless of their participation in the trial. It is important to use the Q1 modifier only for routine care and not for services solely aimed at data collection without any impact on the patient's clinical treatment.
• Billing Code System. Accurate coding plays a crucial role in the submission of claims to third-party payers. This process includes the proper identification of procedures, diagnoses, specific devices, supplies, and equipment obtained for the client. Patient diagnoses are outlined by ICD-10 codes, procedures and services are identified by CPT codes, and hospitals utilize MS-DRG codes to categorize inpatient stays for payment computations based on diagnoses and procedures and HCPCS codes for medical equipment and supplies.
• Provide NCT Identifier Number. It is crucial to include the accurate National Clinical Trial (NCT) identifier number in claims related to clinical trials to identify the specific trial associated with the services rendered
• Align Items & Services with MCA. Verifying alignment with MCA is beneficial in demonstrating adherence to contractual obligations and reducing billing discrepancies that may result in claim rejections.
• Review Conduct and Process. Understanding who conducts the review of research claims and the process involved in completing the review are key components in the claim review process.

Track and recover payments in a timely manner to maintain efficient management of accounts receivable.

This includes monitoring the amount due, payment deadlines, and receipt of payments. The billing team should promptly generate bills and collect payments, ensuring that the billing process is monitored regularly once a clinical trial is open for enrollment. Monthly reviews of reports and running queries are imperative for maintaining financial oversight and accuracy in billing procedures.

Check that the tests and procedures documented in the EMR align with the financial records in the clinical trial management system (CTMS).

Any discrepancies in billing procedures during the trial should be resolved by requesting and initiating amendments from the sponsor.

Do not underestimate the unique skillsets needed for auditing and monitoring.

Effective management of appeals for denied claims is crucial and should not be overlooked. Understanding and addressing claims denials are essential for enhancing the overall billing process. Ensuring accuracy in patient identification information during preregistration and registration is crucial. Claims must contain the required codes and modifiers, while also being checked for any outstanding or invalid claims data. Regularly reviewing and updating the chargemaster, as well as providing staff with continuous education on coding and charge communication, are important for ensuring timely updates to the service or department.

Optimize workflow to maintain accurate research documentation in the EMR.

Peer reviews should be carried out, involving staff in the review process. Verification is required to ensure that all clinical documentation submitted corresponds with authorizations. Corrective actions tackle immediate issues, while preventive actions focus on maintaining long-term compliance.

Initiate a financial discussion with the patient as early as possible, before any financial obligation is incurred.

Conclusion

In the complex landscape of clinical trials, meticulous management of compliance and operations stands as a cornerstone for safeguarding participant safety and upholding the integrity of study outcomes.

By assembling a collaborative and diverse team representing the business office, service lines, staff, billing, investigational pharmacy, patient financial services (PFS), health information management (HIM), funding sources, physician practices, and patients, a robust foundation for research compliance is laid. Striking a harmonious balance between specialized roles and a centralized point of contact necessitates a judicious allocation of organizational resources.

By methodically assessing roles, processes, and implementing technology-driven efficiencies, the collective expertise of these individuals is harnessed to execute their duties with precision and efficacy, ensuring the ethical conduct and operational excellence of clinical trials. 

References:

1. CMS Publication 100-08, Medicare Program Integrity Manual, Chapter 13 – Local Coverage Determinations, §13.5.4.
2. Verma SK. Unveiling the Core of Clinical Research Operations. ACHE of Greater Philadelphia, Spring newsletter, May 2025.
3. Verma SK. Managing the Clinical Research Revenue Cycle to Improve the Bottom Line by Understanding Financial Strategies and Budget Negotiations. SOCRA Source Journal. 2021, Aug, issue 1

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