Clinical Research Administrative Review and Analysis

Over the past several years, the federal government has placed greater emphasis on regulations related to financial accountability for the conduct and payment of clinical research.  Many academic medical centers have begun assembling programs to address the concerns of the government and have implemented safeguards to ensure that clinical care provided to subjects in research studies is paid by and billed to the appropriate entities.  The University of Maryland School of Medicine (UM/SOM) has implemented programs and policies to assist our affiliated Healthcare Provider Organization’s clinical research billing compliance initiatives.  Our affiliated Healthcare Provider Organizations have developed processes and safeguards to comply with federal regulations and policies related to coverage for investigational research and adopted Medicare coverage analyses as the principal tool for managing clinical research billing compliance.  The Medicare coverage analyses brings together a variety of information to identify what items and services should be billed to the study or may be billed to payors for the typical subject in a clinical research study.  Each Medicare coverage analysis is unique to each research study and the CCT begins the process of assembling the necessary information for the Healthcare Provider Organizations.

The CCT clinical trial analysts review the industry sponsored clinical research protocol to assist the investigator with determining if the research study meets the criteria for a Qualifying Clinical Trial as defined by the CMS under its Clinical Trial Policy.  If a clinical research study does not meet the criteria of a Qualifying Clinical Trial under the CMS Clinical Trial Policy, then none of the items and services required by the research protocol can be billed to Medicare.  The results of these analyses are subsequently communicated to our affiliated Healthcare Providers Organizations and are critical to ensuring our affiliates have the necessary information to appropriately bill clinical research.

Online Training

All UMB School of Medicine faculty and staff involved in the conduct of and/or administration of clinical research are required to complete the mandatory general education for Clinical Research Billing.  Click on the link below to access the training.

•  NEW - Clinical Trials Billing Online Education

Clinical Research Administrative Review and Analysis Forms & Worksheets

Below are links to CCT Administrative Review forms and worksheets.  Please contact the the Center for Clinical Trials at 410-706-2328 regarding the use of these forms.  

(Click on a link to download document to your computer)

Clinical Research Administrative Review Document Checklist

Preliminary Medicare Coverage Analysis: Drug/Biologic Trials

Device Trial Worksheet

UMMC and UPI Research Participant Registration Form -  All patients enrolled in School of Medicine  research studies must be registered with UMMC and UPI on the same day the patient is enrolled in the study. 

Clinical Research Billing Plan

Internal Study Budget Template

What is a Qualifying Clinical Trial?

Qualifying Clinical Trials, as defined by Medicare, must meet all three requirements in Part I and be a "Deemed" trial.

Part I

A Qualifying Clinical Trial is a trial that must meet these three requirements:

• The investigational item or service falls within a Medicare benefit category
• The trial must have therapeutic intent
• 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.

Part II

The above three requirements are not enough to qualify a trial for coverage of "routine costs".  A qualifying trial is also a trial that is "Deemed" by the AHRQ to meet Medicare’s seven desirable characteristics of a clinical trial.  To be considered "Deemed", the trial must meet one of the following:

• Trial is funded by NIH, CDC, AHRQ, HCFA, DOD, VA
• Trial is supported by centers or cooperative group that is funded by NIH, CDC, AHRQ,  HCFA, DOD, VA
• Trial is conducted under an investigational new drug application (IND) reviewed by the FDA
• Drug trial is exempt from an IND under 21 CFR 312.2(b)(1)

Routine Costs

Under the July 2007 Clinical Trial Policy (NCD 310.1), the Medicare Program covers "routine costs of qualifying clinical trials"…"as well as reasonable and necessary times and services used to diagnose and treat complications arising from participation in all clinical trials."   The term “routine costs” is a defined term under the Clinical Trial Policy.

Routine costs, as defined by Medicare, include: 

• Items or services that are typically provided to Medicare beneficiaries absent a clinical trial
• Items or services required solely for the provision of the investigational item/service, clinically appropriate monitoring of the effects of the item or service, or the prevention of complications
• Items or services needed for the reasonable and necessary care arising from the provision of an investigational item or service –e.g. for the diagnosis or treatment of complications.

Investigational Item or Service

The July 2007 Clinical Trial Policy clarified that Medicare considers the investigational item or service to be a “routine cost” if the investigational item or service is covered by Medicare outside of clinical trial. 

Consequently, the item or service that is being studied (e.g., the drug or device) can be covered by Medicare during the research study if the exact same item or service would be covered by Medicare if it were used the same way and for the same purpose to treat or diagnose a patient who is not enrolled in a clinical research study.