Clinical research brings exciting opportunities for patients and healthcare institutions to gain insights and answers about the safety and effectiveness of drugs and other therapies. But clinical research also brings a host of regulatory risks, including billing compliance. Effective auditing requires understanding the background and basics of clinical research billing, the internal controls in the research revenue cycle, the most significant billing risks, and simple approaches for auditing to enhance compliance.

Clinical trials are complex and regulated, require the recruitment and retention of patients, and involve specialized roles and responsibilities.

Participants

Clinical trial sponsor – The clinical trial sponsor is often a pharmaceutical company, medical device manufacturer or government agency such as the National Institutes of Health (NIH), and may also be a principal investigator. The sponsor designs the study to address key research or medical questions. The clinical trial sponsor, Medicare, the healthcare provider institution, and other payers pay for the costs associated with the treatment under study.

Principal investigator – The principal investigator (PI), usually a physician, runs the clinical trial. The other clinical researchers can include doctors, scientists, nurses, and other research staff. The PI is responsible for overseeing and carrying out the clinical trial protocol.

Research subjects – The research subjects are patients who receive the clinical trial treatments and any routine medically necessary care.

Healthcare providers – Healthcare providers deliver both clinical trial treatments and any routine medically necessary care. They bill the sponsors, Medicare and other payers for the costs they incur in providing the clinical trial treatments and routine care.

Payers – Payers, including Medicare, typically reimburse for routine patient costs as defined by the Centers for Medicare and Medicaid services (CMS), such as doctor visits, hospital stays or tests that are the costs of medical care that patients would have received if they were not in the clinical trial.

Regulatory background

Prior to 2000, Medicare and private payers did not reimburse research-related items and services that occurred in clinical trials. In the early 2000s, CMS released the National Coverage Determination (NCD) − Routine Costs in Clinical Trials (NCD 310.1), also known as the Clinical Trial Policy (CTP).

The CTP provided new guidance on Medicare coverage of services performed within the confines of a clinical trial. Medicare allows reimbursement of specified routine costs in qualifying clinical trials, including reasonable and necessary items and services used to diagnose and treat complications arising from participation in all qualifying clinical trials.

In order for the services to be potentially billable to Medicare, NCD 310.1 requires that a clinical trial must be a qualifying clinical trial (QCT). If the study is determined to be a QCT, Medicare will pay for certain routine costs if no other Medicare rules limit coverage and no payment will be received from another funding source for that item or service.

Medicare is the largest payer of healthcare services and has the most sophisticated rules for clinical trial billing. Many third-party payers have adopted billing guidance based on Medicare's regulations.

Coverage analysis

To comply with NCD 310.1 and other federal and state regulations surrounding clinical research billing, healthcare institutions have established processes to ensure appropriate billing. One industry standard tool in these processes includes a coverage analysis (CA). A CA is a systematic review of research-related documents to determine the Medicare billing status of both the study and the items and services provided to the research subjects as required by the study.

The primary study documents that are utilized for the CA include the Study Protocol, Informed Consent Form (ICF), Clinical Trial Agreement (CTA) and any other relevant funding documents.

The primary purpose of a CA is to determine:

  • Whether the trial qualifies for Medicare coverage
  • Which routine care costs providers may bill to Medicare or other insurers and, conversely, which costs must be paid by the clinical trial sponsor or healthcare provider institution
  • Whether Medicare rules allow for coverage of the specific routine costs within the clinical trial
  • The application of the cost language of associated study documents (e.g., ICF, CTA and other relevant funding documents) to the CA

The CA can also be used to judge the financial viability and status of the clinical trial, as a budgeting and billing tool, a method to assist with managing compliance risks associated with research services, and for auditing and monitoring.

Development of a CA

Meet Medicare qualifying criteria

For any items or services to be potentially billable to Medicare, a clinical trial must meet CMS's qualifying criteria, which requires a two-part test:

Part one of the test is determining if the study is deemed to meet the seven desirable characteristics. Deemed studies include studies that fall into one of the four following categories:

  • Trials funded by NIH, Centers for Disease Control (CDC), Agency for Health Research and Quality (AHRQ), Centers for Medicare and Medicaid Service (CMS), Department of Defense (DOD) and Veterans Administration (VA)
  • Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA
  • Trials conducted under an investigational new drug application (IND) reviewed by the FDA
  • Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1)

Part two of the qualifying test is to verify that the study also meets all three of the necessary requirements:

  • Investigates an item or service that Medicare reimburses (falls into a Medicare benefit category)
  • Enrolls patients with diagnosed disease
  • Has therapeutic intent

Analyze items for proper billing

Once the determination is made that a study is a QCT, the individual items and services occurring in the clinical trial (i.e., those that are required by the study protocol) are analyzed for potential coverage. The item or service must be something that Medicare routinely covers for its beneficiaries. If the item or service would not be covered outside the trial, then it would not be covered within a clinical trial. NCD 310.1 provides this guidance and structure for determining what services will be covered or not covered during a clinical trial.

For a nondevice clinical trial, you will need to thoroughly understand NCD 310.1 for an accurate analysis of whether certain items or services are billable. When determining the qualifying status of a device clinical trial, reference the coverage rules from regulations (21 CFR 812) and the Medicare Benefit Policy Manual, Chapter 14. If a device study qualifies, the remaining logic from NCD 310.1 may be applied (i.e., routine costs, Medicare rules, application of funding documents).

CMS identifies three categories of routine costs that will be covered during a clinical trial:

  • Items or services that are typically provided absent a clinical trial (e.g., conventional care)
  • Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications
  • Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service, particularly for the diagnosis or treatment of complications

NCD 310.1 specifically addresses the following items as noncovered services:

  • The investigational item itself unless it is otherwise covered outside of the trial
  • Items and services provided solely for data collection, that are not used in direct clinical management
  • Items and services provided free of charge by the sponsor

Footnote

1. See page 2 at https://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/Downloads/finalnationalcoverage.pdf

To view the full article, click here

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.