Companies that sponsor drug or medical device research may ask Johns Hopkins to disclose “economic data” (e.g., charge or billing data) related to the subjects of a study that the company has funded. Although the analysis of such data may be described in the study protocol or the study consent form, before releasing subjects’ economic data Hopkins must first determine whether these data will be used for research or for reimbursement purposes.
For example, in certain cases, the company intends to submit economic data to the federal Centers for Medicare and Medicaid Services (CMS) or another insurer, in support of the company’s position on the appropriate level of reimbursement for the investigational device. CMS does not require manufacturers to submit economic data for this purpose, and this use would not be considered “research,” in part because the company has no intention to publish the results of its economic analyses.
1. Research Use. If a sponsor is requesting economic data for a research purpose, as evidenced by the study protocol, and the disclosure of economic data is described fully in the consent/authorization form, Johns Hopkins may release charge, billing, or reimbursement information containing PHI to the sponsor if the protocol is approved by the IRB.
2. Non-research Use. If it is not clear that the sponsor intends to use economic data for research, Johns Hopkins may not rely on the research authorization/consent form to release billing, charge, or reimbursement information (even if the ICF mentions that economic data will be released). In this circumstance, a sponsor has the following options:
- Aggregate data only. Johns Hopkins may provide summary or aggregate economic data that do not contain individual-level data fields.
- Separate authorization for economic data. A sponsor may elect to have subjects sign a separate, HIPAA-compliant authorization to disclose the economic data. Signing this authorization must be optional and not a condition of participating in the study, and the IRB must approve a “change in research” for this purpose. Economic data may be provided only for those subjects who sign the authorization.
3. Process. The PI should consult with the OHSR or IRB counsel to determine whether a sponsor is requesting economic data for a research purpose or for reimbursement-related activities. If the purpose is research, the PI should document this in an email and communicate the result to Martha Weiner in the JHM Office of Clinical Research Billing & Quality Assurance (CRB&QA). If the OHSR determines that the request is NOT for a research purpose, the PI must communicate with the sponsor to decide whether data may be provided in aggregate form, or whether a separate authorization is required to release individual economic data. If aggregate data do not meet the sponsor’s requirements, the PI must obtain IRB approval to use a separate HIPAA authorization for release of economic data. The PI must provide CRB&QA a copy of this authorization, signed by each subject in the study
4. Costs. CRB&QA may establish fees for assembling or aggregating economic data, depending upon the scope of the sponsor’s request. It is the PI’s responsibility to determine whether CRB&QA will impose any charges for this service, and to notify The Johns Hopkins University Office of Research Administration when the sponsored research must be modified to reflect these additional costs.