Research Billing Compliance at MedStar Health

Research compliance encompasses a wide variety of issues including research billing. Billing compliance ensures all services in a trial are paid for by helping to reduce double billing and preventing billing for services that are not covered by the trial or are not medically necessary for the research subject. Accurate billing in research is a complex and challenging process that requires a diverse group of professionals across MedStar Health to work cohesively and collaboratively with one another. We at the Research Institute seek to ensure that we have an efficient and compliant approach to billing compliance.

The research coordinators have the most critical step in the clinical research revenue cycle process. Research subject visit tracking directly drives financial management and compliance. This is the first line of defense against erroneous billing. Subject visits must be logged in OnCore within one business day to ensure timely review by the MHRI revenue cycle team for MedStar Health to maintain compliance with the Centers for Medicare and Medicaid Services (CMS) Clinical Trial Policy.

MHRI strives for efficient, compliant and transparent research billing by providing monthly metrics and encourages internal audits. In FY20, MedStar Health completed two internal research billing compliance audits which were favorable. In addition, Research Operations provides monthly metrics showing corrections made to a subject’s account before a bill is automatically sent to Medicare or a commercial payor. 

Thank you to the research coordinators and the Research Institute research revenue cycle team for all the hard work you put in daily! Know that it is recognized and greatly appreciated.

If you have any questions about research billing compliance or the process within OnCore, please contact [email protected].

Conflict of Interest Questionnaire for MedStar Health Researchers Joins with Georgetown

As of July 1, 2020, a single COI platform is available to all Researchers employed by MedStar Health (to include those located at MedStar Georgetown University Hospital (“MGUH”) or elsewhere on the Georgetown University campus). With the launch of a single COI platform for MedStar Health employed Researchers, the need for separate submissions through a MedStar Health platform and a Georgetown University platform will be eliminated. Both Georgetown University and MedStar Health have agreed to use the MedStar Health COI Platform for MedStar Health employed Researchers. The Questionnaire will be accessible to Researchers to submit disclosures throughout the entire fiscal year (July 1st – June 30th).

The COI-Smart platform will meet both organizations’ research COI reporting requirements. This new process will eliminate the Georgetown University COI disclosure for those Researchers who formerly completed a MedStar Health COI questionnaire and a Georgetown University questionnaire. MedStar Health and Georgetown University COI reviewers will have access to the information reported, will review transactions and implement a consolidated research management plan.

At the onset of a new study routing through MedStar Health/MedStar Health Research Institute or Georgetown University, in accordance with current practices, Researchers must update their COI questionnaire or verify that it is up-to-date. You will access the COI system in the same manner that you have in the past. If you held a research role at MedStar in fiscal year 2020 (FY20), you may have already entered data into the COISmart system during the fiscal year. If you have completed the questionnaire as a researcher during FY20, a link to the conflict of interest disclosure should have been sent to you.

MedStar Health policies require that all individuals engaged in the conduct of research complete the annual conflict of interest disclosure. The annual research conflicts of interest disclosure process is designed to manage financial and nonfinancial research interests. 

MGUH Researchers may contact Mary Schmiedel at [email protected] to establish a COI-Smart COI account. If you have any questions on the COI-Smart application, please contact Carol Mason at [email protected] or 410-772-6607 or Lauren Brummell at [email protected] or 410-772-6578.





Conflict of Interest Questionnaire for MedStar Health Researchers

MedStar Health policies require that all individuals engaged in the conduct of research complete the annual conflict of interest disclosure. The annual research conflicts of interest disclosure process is designed to manage financial and nonfinancial research interests. As you probably know, MedStar Health Research Institute is required to manage conflicts of interests as a condition of receiving federal funding for research.

If you held a research role at MedStar in fiscal year 2020 (FY20), you may have already entered data into the COISmart system during the fiscal year. If you have completed the questionnaire as a researcher during FY20, a link to the conflict of interest disclosure will be sent to you in July. You will be required to ensure that the disclosure on file for FY20 accurately reflects any external relationships you have for the entire fiscal year. When you receive that email in July, please follow the link in that email to certify your previous disclosure if it already reflects all external relationships you have had during FY20. Use the “revision” links in the questionnaire to update your answers if necessary and resubmit the questionnaire to ensure that it accurately reflects a full fiscal year of reporting (July 1, 2019, through June 30, 2020).  As a researcher, the FY 2021 questionnaire is also available for you to complete between July 1, 2020, and June 30, 2021.

If you have any questions about the conflict of interest policy or accessing the COISmart system to make disclosures, contact Christine Kyak, Entity Compliance Officer at (202) 510-6876 or [email protected].

Sorting out Single IRB Review: What Investigators Need to Know at MHRI

As of January 2018, most non-exempt multi-site human subjects research (HSR) projects funded through NIH agencies require single IRB review. Additionally, in recent years, there has been an increasing trend toward the use of a single IRB (sIRB) review for multi-site HSR projects funded through other sources.  Specifically, many commercial sponsors prefer single IRB review for their multi-site projects.

Finally, the revised common rule includes a requirement for single IRB review of most federally funded multi-site non-exempt human subjects research projects. Initially, the Office of Human Research Protections (OHRP) indicated only that compliance with this common rule requirement was required starting on January 20, 2020. In a recent communication OHRP clarified that although sIRB review is required for all federally funded multi-site non-exempt HSR projects, the agency has granted an exemption for all projects approved prior to January 20, 2020. This eliminates the need to transition currently approve projects from review by multiple IRBs to sIRB review.

For all future federally-funded projects, it is strongly suggested that investigators include IRB review fees in the budget for their grant proposals. In most cases it is assumed that sIRB review will be conducted by a commercial IRB (such as WIRB or Advarra) or a larger academic/medical institution IRB. In some limited cases, the MHRI IRB may agree to serve as the IRB of record for a multi-site HSR project but this will not be the norm.

In all cases (regardless of funding) for which a MedStar investigator intends to request the MHRI IRB serve as the IRB of record, they must submit a request to the ORI office. The request must be submitted before the investigator commits the MHRI IRB to the responsibility of serving as IRB of record for other sites and before discussing reliance with any outside institution. The request should include a copy of the research protocol, an indication of the source of funding (if any), a list of all sites that may be engaged in the project, and the scope of involvement for each site. The ORI Director will evaluate the request and in consultation with the Institutional Official determine if the request will  be approved or should be declined.

This process is similar to  that for investigators requesting reliance on an external IRB. When an investigator would like to rely on an external IRB for review of their non-exempt HSR project, a request to cede review must be submitted to ORI in advance. In the case of the commercial IRBs for which there is a master reliance agreement (currently WIRB and Advarra), the investigator may simply submit an external IRB application through the Huron system. For other IRBs, a reliance agreement must be executed for each individual project. In the event that MedStar has not previously had an agreement with the intended external IRB, a request should be submitted to the ORI by email. The ORI Director will evaluate the request and in consultation with the Institutional Official determine if the request may be approved or should be declined. If approved the organization will be added to the Huron system and the investigator may submit the external IRB application for the project.

Please note that in most cases request for reliance involving exempt HSR projects will not be approved. Generally speaking, it is more efficient for these projects to be reviewed individually by each institution and most institutions have not been willing to enter into a reliance agreement for these projects.

In all cases, requests for reliance (either for the MHRI IRB to serve as the IRB of record or for MedStar to rely on an external IRB) will be considered with regard to the need for reliance, the feasibility of the arraignment and nature of the project. Ultimately the determination of reliance is left to the discretion of the ORI Director and the Institutional Official.

If you have any questions regarding this process, please contact MHRI’s ORI Director, Jim Boscoe, at [email protected].

Update to Research Conflict of Interest Policy

The MedStar Health policy and procedures related to conflict of interest for researchers have been updated. It is every researcher’s responsibility to ensure that they are familiar with the applicable policies and procedures for conflict of interest within MedStar. The four documents for research conflict of interest that researchers should review and be familiar with are:

Any individual participating in the conduct of research within MedStar Health should complete the Fiscal Year 2020 conflict of interest questionnaire. After completing your disclosure, you may be contacted by Research Compliance to discuss a management plan. Not all disclosures require management plans for research. If you have any questions about what to disclose, who needs to disclose, or how to disclose, reference the Research COI FAQs.

It is important that disclosures accurately reflect the relationships that researchers have with external entities. These disclosures should be consistent with what the researcher has disclosed to researcher sponsors, regulatory agencies and collaborating institutions. Updating the MedStar conflict of interest questionnaire is not a substitute for also updating conflict of interest questionnaires that may be required by other organizations.

If you have any questions about the updated policy and procedures, or the MedStar conflict of interest questionnaire and process, please contact the Research Compliance Program at [email protected]

Conflict of Interest Disclosures: More Than Just Your Institution

Sometimes it can feel that you are asked to do conflict of interest disclosures everywhere you turn. Whether it’s research related, required by your entity, or part of a relationship with an outside company, everyone asks for different information in different formats and for different timeframes. We know it can be frustrating! Recent news has reminded us how important it is to accurately disclose all financial relationships and interests in all of the places you are required to do so.

It is imperative that you keep your MedStar conflict of interest disclosures up to date. Additionally, it is your responsibility to ensure that you have accurately and consistently disclosed financial interests when you publish or present research. Individuals who completed the FY19 disclosure before July 1, 2019 must now go into the system to certify that the information entered previously is accurate for the entire fiscal year, or update as needed. The instructions for certifying your disclosure or revising the disclosure as needed are available here. As a researcher, the FY 2020 questionnaire is available for you to complete between July 1, 2019 and June 30, 2020.

Do you have a question about your conflict of interest obligations at MedStar? We can help! Questions about the conflict of interest process, disclosures, and requirements for research can be addressed by the Research Compliance Program at [email protected]. Questions about the MedStar conflict of interest process outside of the research context can be addressed by your entity compliance officer.

New Policies & Procedures for MedStar Health

MedStar Health Research Institute regularly updates, revises and creates new policies for the operational efficiency of MHRI. This month, the following policies were established or updated.

MedStar Health Introduces New Personal Use of Drugs and Alcohol in the Workplace Policy
HR 306 – Drug & Alcohol-Free Workplace

You can find all Human Resources policies on the myHR portal, under Tools & Resources > HR Policies.

New MHRI Policies
IAC.O-004: Reporting Animal Welfare Concerns
ORG.O-003: Individual Conflicts of Interests/Conflicts of Commitments in Research

New MHRI Procedures
IAC.O.004.01: Investigating and Reviewing Animal Welfare Concerns
IAC.O-003.01: Post-Approval Monitoring Procedure
ORG.O-003.01: Research Conflict of Interest Committee
ORG.O-003.02: Research Conflict of Interest Disclosure
ORG.O-003.03: Research Conflict of Interest Non Compliance

All MHRI policies and procedures can be found on MHRI’s StarPort Policies Portal.

Office of Research Integrity Updates

The Office of Research Integrity continues to work on improving the human subject protection research program and is preparing for enhancements to be made to the Huron Electronic IRB system (eIRB) this fall. We think you’ll be pleased!

These updates (8 and 9) will bring our system up to date with the latest version of the application and will provide several small enhancements and bug fixes.  Most of these changes are on the back end and will not modify the investigator team user experience with some exceptions listed below:  

  • Redesigned SmartForm for Submission of External IRB review
    • Improved user experience for External IRB studies
  • Redesigned SmartForm
    • A left navigator replaces the Jump-To menu and provides helpful status icons, the integrated Compare feature replaces View Differences, and slide-in views replace pop-ups, to improve the user experience.
  • Review Tracker
    • A new mode for reviewing projects features a single-page view of the entire SmartForm, ability to mark sections as reviewed, inline comparison with previous versions, and change indicators to narrow the scope of follow-up reviews.
  • Print Packets
    • All project types now support print packets that are available from within the SmartForm. Print packets provide new options for printer-friendly versions of projects including adding table of contents and related projects.  

The upgrade is anticipated to take place in the last week of September 2019.   The upgrade will take just a few hours and will be scheduled overnight so that system downtime will be limited.  You will be notified when the date has been finalized.  In addition, stay tuned for more details including webinar dates where the upgrade will be discussed, training provided and you will have a chance to ask any questions. 






MedStar Welcomes James Boscoe as Office of Research Integrity Director

James (Jim) Boscoe has joined MedStar Health Research Institute as the Director of Office of Research Integrity (ORI).

Jim joins us from The Johns Hopkins University School of Medicine, Office of Human Subjects Research and Institutional Review Boards where he was the IRB Operations Manager. Jim received his M.A. and B.A. in Psychology from the University of Maryland. He is a certified Institutional Review Board (IRB) professional with a history of administrative, research and clinical experience in hospital, residential, and academic settings.

Jim will manage the day-to-day activities of the Office of Research Integrity (ORI). He will be responsible for human research policy, oversight, education and training, IRB management, extramural relations, and oversight of the Institutional Animal Care and Use Committee (IACUC). He will serve as the liaison for MHRI to the Georgetown University Medical Center (GUMC) IRB office.

Jim Boscoe can be reached at [email protected].






Conflict of Interest Questionnaire for MedStar Health Researchers

MedStar Health policies require that all individuals engaged in the conduct of research complete the annual conflict of interest disclosure. The annual research conflicts of interest disclosure process is designed to manage financial and nonfinancial research interests. As you probably know, MedStar Health Research Institute is required to manage conflicts of interests as a condition of receiving federal funding for research.

If you held a research role at MedStar in fiscal year 2019 (FY19), you may have already entered data into the COISmart system during the fiscal year. If you have completed the questionnaire as a researcher during FY19, a link to the conflict of interest disclosure will be sent to you in July. You will be required to ensure that the disclosure on file for FY19 accurately reflects any external relationships you have for the entire fiscal year. When you receive that email in July, please follow the link in that email to certify your previous disclosure if it already reflects all external relationships you have had during FY19. Use the “revision” links in the questionnaire to update your answers if necessary and resubmit the questionnaire to ensure that it accurately reflects a full fiscal year of reporting (July 1, 2018, through June 30, 2019). The instructions for certifying your disclosure or revising the disclosure as needed are available here. As a researcher, the FY 2020 questionnaire is also available for you to complete between July 1, 2019, and June 30, 2020.

If you have any questions about the conflict of interest policy or accessing the COISmart system to make disclosures, contact the Research Compliance Program at [email protected].