Clinical Research Billing Compliance
Patient Zero Billing Review
Clinical research billing is a critical compliance concern for any academic medical center or research organization, and a key component of the Research Compliance program at UC Davis Health. To ensure compliance with clinical research billing regulations, the Patient Zero Billing Review was developed and implemented in 2016.
The Patient Zero Billing Review was developed to ensure that items and services provided to research participants are accurately and appropriately billed. Under the Patient Zero Billing Review, Compliance conducts routine reviews of the first subject enrolled in a research study. The focus of the program is to review a study’s general research billing components for the first enrolled subject to assess compliance.
The review incorporates the study’s compliance with the following UC Davis Health Policies and Procedures (P&P):
- P&P 1502 (Charging for Research Studies)
- P&P 2306 (Legal Medical Record Content/Core Elements)
- P&P 2317 (Documentation of Research Patient Status in the Electronic Medical Record)
- P&P 2410 (Allowable Uses and Disclosures for Protected Health Information); and applicable federal rules and regulations.
One of the primary billing compliance pitfalls consists of double billing or “double dipping”. For example, if a claim is submitted and paid by a third party payer or Medicare and the sponsor reimburses for all or some of the same service, this is considered double dipping and may constitute fraud. Another area of risk in research is the provision of free or discounted services for research participation. Waiving of co-payments and fees or providing free or discounted transportation to subjects in clinical trials may be allowed under new safe harbors to the anti-kickback statute (PDF)
At UC Davis Health, the coverage analysis (CA) is completed in the Bridge and is required to be completed for all studies that:
- Have patient care services billed to patients, insurance, or study accounts within the Epic Billing System; and
- The sponsor does not pay for all items and services that will be rendered during the study.
The CA consists of two parts:
- Coverage Analysis Bridge questionnaire: a series of questions that determine whether a study is deemed "qualifying" or "non-qualifying", based upon Medicare requirements for coverage.
- Billing Grid: spreadsheet mapping what clinical procedures could be billed to a third party (such as Medicare and insurance companies) and what procedures must be covered by the financial sponsor.
More information on coverage analysis is available in the UC Davis Health Clinical Research Guidebook. See Coverage Analysis, Budgets and Contracts - UC Davis Clinical Research Guidebook - Confluence.
In 2008, CMS finalized the Clinical Trial Policy (National Coverage Determination 310.1) which expands the coverage of certain “routine care services” that are provided as part of a Qualified Clinical Trial . Research units are required to develop a coverage analysis of each interventional research study to determine which services are billable and which are not. It is important to note that not every routine service that is billable outside of a research study, is necessarily billable as part of a research study.
For a Qualified Clinical Trial, certain study-related patient care costs, called “routine costs”, may be eligible for Medicare Coverage per the Medicare Clinical Trial Policy. Any clinical trial receiving Medicare coverage of routine costs must meet the following three requirements:
- Reporting of the 8-Digit Clinical Trial Number (NCT#) on Billing Claims: Effective January 1, 2015, Center for Medicare and Medicaid Services (CMS) will require a clinical trial identifier be reported on all billing claims for items and services related to a qualifying clinical trial. To register your study and obtain an NCT#, go to: https://clinicaltrials.gov/ At UC Davis Health, to ensure accurate billing, please be sure to input the NCT# in the Bridge prior to uploading your study to EMR.
- Medicare Advantage Billing: For beneficiaries enrolled in a Medicare Advantage (MA), research items and services must be billed as follows:
Type of Clinical Trial
Where to Submit Claim
IDE (Category A and Category B)
Clinical Trials that Qualify for Coverage under the Clinical Trial Policy
Clinical Trial that Qualify for Coverage Under a Specific National Coverage Determination (NCD)
MA plan unless CMS determines that the significant cost threshold is exceeded (“significant cost” is adjusted yearly by CMS)
Requirements for billing for Category A or B IDE covered services can be found in the Medicare Claims Processing Manual, Transmittal 2955 (PDF). For additional information on coverage of research items or services as part of an NCD, see CMS’s website on coverage with evidence development.
- Billing for Devices Used in Clinical Trials: The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) allowed Medicare payment of the routine costs of care furnished to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies. Effective January 1, 2015, CMS finalized changes to the IDE regulations (42 CFR § 405 Subpart B) by adding criteria for coverage of IDE studies, and changed from local Medicare Administrative Contractor (MAC) review and approval of IDE studies to a centralized review and approval of IDE studies. An approval for a Category A (Experimental) IDE study will allow coverage of routine care items and services furnished in the study, but not of the Category A device, which is statutorily excluded from coverage. An approval for a Category B (Nonexperimental/investigational) IDE study will allow coverage of the Category B device and the routine care items and services in the trial.
Prior to beginning a clinical trial involving an investigational device, approval for reimbursement must be obtained from the CMS for costs related to the device study. Coverage is contingent on the Medicare contractor's approval of the application for reimbursement. For additional information and forms see: https://www.cms.gov/Medicare/Coverage/IDE/index.html