Key considerations for practice administrators in clinical trial research

The Medical Group Management Association’s most recent MGMA Stat poll asked healthcare leaders: Does your practice participate in clinical trials? In response, 35% answered “yes,” while 65% answered “no.”

This poll was conducted on August 27, 2019, with 1,266 applicable responses.

There are multiple components to establishing and monitoring business processes to ensure effective and efficient clinical operations in a healthcare organization, and one of them is understanding the principles of clinical trials research.

As noted by consultant Michelle Rozmarenowski McDaniel, MS, MBA, MHP, FACMPE, in her ACMPE Fellowship paper, the reasons for engaging in clinical research go beyond benefits to individual patients — research helps advance medical science in a given specialty, piques a provider’s professional interest and often results in substantial financial reimbursement by the trial’s sponsor.

Engaging in clinical research often depends heavily on a medical practice’s effort and ability to support those activities, especially as they relate to administrative burden and revenue cycle management. With most practices working with one or more EHRs nowadays, clinical research workflows have been one of many to transition from paper to digital. “The translation of past workflows into a new EHR environment is not intuitive,” McDaniel noted, “and practice operations teams require guidance and support in that effort.”

Additionally, there are elements of clinical study design that are out of the hands of medical practice leaders that may contribute to a lack of effectiveness in research. A recent study of 36 years of trials on autism treatments found a lack of consistency in the tools to measure efficacy, and that 69% of those tools were used only in a single trial.

Where physician practice leaders can exercise the greatest degree of influence in successfully participating in clinical trial research is ensuring that the organization recognizes and is prepared for the investment of resources so that the research work is efficient and financially sustainable without putting undue burdens on practice operations.

In many respects, this includes the practice administrator assessing whether health IT infrastructure and EHR(s) are up to the task of storing and transmitting research data efficiently, securely and in a way that ensures any revenues associated with the research work can be accurately billed.
Addressing this area is central to the ultimate goals of building medical knowledge. Prior to the widespread adoption of EHRs and the ability to digitally transmit clinical research data, rates of adoption and implementation of evidence-based best practices from such research were low.
To that end, government-registered studies of digital health technology have been on the rise in recent years, and artificial intelligence (A.I.) is seen as a potent new tool in reshaping clinical trial design.

While technology improves and new solutions are developed to update workflows, there remain other major considerations for practices that want to participate in clinical trials:

• Knowing the law: There are multiple federal and state regulations regarding billing for clinical trials, in addition to various professional standards of ethics for clinicians participating in research.
  • Know the trial’s qualification: The Centers for Medicare & Medicaid Services (CMS) published a National Coverage Decision that allows Medicare coverage for the routine costs of “qualifying” clinical trial services, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. Practices should verify if a clinical research study meets CMS’ qualifying criteria before billing for any items or services. Additional resources can be found on CMS’ clinical trial policies webpage, including a clarification memo regarding payment.
  • Covered costs: Even for qualifying trials, costs or services must meet their own criteria to be covered. Practices should also ensure that billing requirements are met, which include mandatory inclusion of the clinical trial number and other documentation requirements outlined in the Medicare Claims Processing Manual, Ch. 32 Section 69.
• Staffing and time: Generally, physician participation is required as the principal investigator of the trial research, but the amount of documentation required in many trials will necessitate a nonphysician provider (a registered nurse, for example) committing significant time to understanding and completing necessary work to ensure reimbursement.
• Insurance requirements: Some entities that work with medical practices will request that the practice obtain a product liability insurance policy. Practice leaders should examine whether a general policy includes this coverage or if it is beyond the scope of the existing policy.
• Billing: If a research sponsor provides an item at no cost or agrees to compensate the practice for an item or service, the practice should carefully review the terms of the study to determine whether it should not bill either insurance or the patient who is a subject in the study for that item or service.

Additional resources:

• “Medicare Coverage Related to Investigational Device Exemption (IDE) Studies” (CMS)
• “Clinical Research Billing: EHR Optimization Recommendations for Non-Academic Medical Practices” (ACMPE Fellowship paper)

 Would you like to join our polling panel to voice your opinion on important practice management topics? MGMA Stat is a national poll that addresses practice management issues, the impact of new legislation and related topics. Participation is open to all healthcare leaders. Results of other polls and information on how to participate in MGMA Stat are available at: mgma.com/stat  

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