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Compliance Program

Compliance Program

Research Billing Compliance

Clinical trial billing is a critical compliance concern for any academic medical center or research organization. The Research Billing Compliance Program (RBCP) was developed to ensure that items and services provided to research participants are accurately classified as covered versus non- covered services and billed appropriately. To determine whether items and services are covered versus non-covered, a mandatory Coverage Analysis must be performed. 

The RBCP includes review of randomly selected protocols to determine the accuracy of billing activity. Reviews compare the protocol criteria to patient medical record documentation and billing activity consisting of professional and facility fees charged to patient and bulk accounts. The primary focus of these reviews is to ensure that study participants or third-party payors are not billed for services that are considered experimental and that the sponsor is not billed for items and services routinely provided in the course of patient care. Other areas included in the review is a validation that a National Clinical Trial Number (NCT#) is applied to claims submissions as well as a review of consent form (ICF) documentation (The ICF review consists of validating that all signed consents and HIPAA authorizations are documented in the record).  When the Research Billing Compliance review is completed a report is generated which includes guidance regarding any necessary steps to be taken to ensure study compliance.

Avoid Clinical Research Billing Compliance Pitfalls

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. The waiving of co-payments and offering free services to volunteers in clinical trials is a violation of government regulations. (http://oig.hhs.gov/fraud/docs/alertsandbulletins/SABGiftsandInducements.pdf)

How does one avoid these pitfalls? One of the primary mechanisms to avoid clinical billing risks is the completion of a coverage analysis (CA) for all clinical trials at the Health System.

Mandatory Coverage Analysis

What is a Coverage Analysis? A Coverage analysis is a tool that consists of two parts:

(1) Qualifying Clinical Trial (QCT) form, which is a series of questions that determine whether a study is deemed "qualifying" or "non-qualifying", based upon CMS requirements for coverage.
(2) 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. To learn more about the Coverage Analysis process, visit: http://intranet.ucdmc.ucdavis.edu/researchbudgeting/coverageanalysis/index.shtml - (Staff Only)

Mandatory 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/ services related to a qualifying clinical  (both drug and device) trial(s). To register your study and obtain an NCT#, go to: https://clinicaltrials.gov/

What We are doing now

If your study is registered on ClinicalTrials.gov and is assigned an NCT identifier number, that NCT identifier number should be reported on all related claims as long as the patient is a study participant.z

If your study is not yet registered on ClinicalTrials.gov, you can assign a "dummy" identifier number to the study related claims. At UCD, we dummy code: 9999999 until the January 2015 mandate begins.

Medicare Coverage for “Qualifying Clinical Trials”– Routine Costs

CMS’ Requirements for Coverage for certain “routine care services” in Relation to a Clinical Trial

In 2008, CMS finalized the Clinical Trial Policy (National Medicare Coverage Determination (also called National Medicare Clinical Trial Policy NCD 310.1) which defines the coverage for certain “routine care services” that are provided as part of a 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. 

A “Qualified Clinical Trial” is a clinical study that meets stated regulatory requirements to be eligible for Medicare coverage of certain study-related patient care costs, called “routine costs”, under the Medicare Clinical Trial Policy. Any clinical trial receiving Medicare coverage of routine costs must meet the following three requirements:

(1)  The subject or purpose of the trial must be an evaluation of an item or service that falls within a Medicare benefit category and is not statutorily excluded from coverage (e.g. cosmetic surgery, hearing aids)
(2) The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent
(3) Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.

The three requirements above are insufficient by themselves to qualify a clinical trial for Medicare coverage of routine costs. Clinical Trials should also have the following desirable characteristics, however, some trials, as described below, are presumed to meet these characteristics and are automatically qualified to receive Medicare coverage:

(1) The principle purpose of the trial is to test whether the intervention potentially improves the participants’’ health outcomes;
(2) The trial is well-supported by available scientific and medical information or is intended to clarify or establish the health outcomes of interventions already in common clinical use;
(3) The trial does not unjustifiably duplicate existing studies;
(4) The trial design is appropriate to answer the research question being asked in the trial;
(5) The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully;
(6) The trial is in compliance with Federal regulations relating to the protection of human subjects; and
(7) All aspects of the trial are conducted according to the appropriate standard of scientific integrity.

Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are:

(1) Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA;
(2) Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA;
(3) Trials conducted under and investigational new drug application (IND) reviewed by FDA; and
(4) Drug trials that are exempt from having an IND under 21 CFR 312.2 (b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that time the principal investigators of these trials must certify that the trials meet qualifying criteria in order to maintain Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status.

Medicare Advantage Billing

Risk avoidance:  pay attention to those beneficiaries who are enrolled in a Medicare Advantage Plan. When billing for research-related injuries, the CMS Medicare as Secondary Payer Rule (“MSP”) is triggered.
Medicare Advantage billing is complicated. The rules require that protocol- scheduled services be billed to Medicare prime as opposed to the Advantage “plan” and any services that are unrelated to the research protocol be billed to Medicare Advantage.  Essentially, this is done so that CMS can track the amount it is paying to support research and because many Medicare Advantage plans do not have the claims processing capability to handle required modifiers used to denote “research”, such as a V70.7 code placed in the secondary diagnosis position or a Q1 or Q0 modifier to denote either a standard of care services (e.g. Q__) or a research related services (e.g. Q__).
For example, when CMS MSP rule states that when a beneficiary has insurance that is supplemental to Medicare coverage, their other insurance must be billed first and then Medicare stands in the secondary position. 

Billing for Devices Used in Clinical Trials

Prior to beginning a clinical trial involving an investigational device, approval for reimbursement must be obtained from the local Medicare contractor (Noridean) for costs related to the device study.  Medicare may provide reimbursement for some investigational devices and related services. Services may be furnished in preparation for device use, contemporaneously with, and necessary to the use of the device, and as follow-up care after device use. Coverage is contingent on the Medicare contractor's approval of the application for reimbursement.