1. Office of Research Administration Clinical Research Support Services
Clinical Research Revenue Cycle Orientation
Clinical Research Support Services
Office of Research Administration Clinical Research Support Services
750 East Pratt Street
Baltimore, Maryland 21202
/office
Prospective Reimbursement Analysis & Budgeting

2. Clinical Research Revenue Cycle Orientation
Clinical Research Support Services
Office Organization
Director:
Sr. Clinical Research Coverage Analysts:
Karen Roz
Tracy McCracken
Genea Smith
Associate Director
Leslie Woytowitz
Lisa Wallace
Dawn Young
Clinical Research Support Services Manager
Clinical Research Coverage Analysts:
Cindy Elliott
Mario Adrien
Linda Wilkins
Sr. Grants and Contracts Analyst
Sarah Pennington
Erika Maden Gailunas
Administrative Assistant
Financial Manager
Julie Meise
Linda Provenza
Prospective Reimbursement Analysis & Budgeting

4. Agenda PRA – what is it? Why you need a PRA
Medicare NCD – how does this affect my study?
PRA Development Process

5. So, What exactly is a PRA ?? P = Prospective R = Reimbursement
A= Analysis
Formal definition –
A systematic review of a clinical research study protocol, draft contract and sponsor budget, proposed Informed Consent Form (ICF) cost language and other study documents, such as Notice of Grant Award (NOGA), Investigator’s Brochure (IB) and information regarding the FDA status of the investigational item(s).

6. How do I know if my study requires a PRA
PRAs are necessary for all research studies that have the potential to generate a Johns Hopkins Medicine patient bill and require participants to sign an ICF.
All study applications submitted through eIRB are reviewed for PRA determination – CRSS makes this determination
to CRSS mailbox for request of budget development

7. What Documents are Required for the PRA process?
Study Protocol
Draft Contract and Sponsor Budget
Informed Consent
Notice of Grant Award (NOGA)
Investigator’s Brochure:
Status of FDA study drug submission
Based on a review of these documents, a coverage determination is made for each patient care item and service provided as part of the study.

8. Related Benefits and Regulatory Considerations
Charge segregation has always been a goal for Johns Hopkins, the need to develop a formal PRA process became more acute when CMS issued a Clinical Research Policy National Coverage Decision (NCD) in September
Clinical Trial Billing Errors Generate Multi-Million Dollar Fines
Office of Inspector General (OIG) has initiated audits resulting in significant settlements
Emory University To Pay $1.5 Million To Settle False Claims Act Investigation August, 2013
Rush University Medical Center Settlement: Improper Medicare Billing in Clinical Trials December, 2005
Commercial payors
More vigilant
Tend to follow CMS NCD guidelines

9. Medicare National Coverage Determination (NCD) 310
Medicare National Coverage Determination (NCD) Routine Costs Clinical Trials
September, 2000 Medicare implemented
Medicare (NCD) Routine Costs Clinical Trials
Which states Medicare will cover items and services for :
Conventional Care
Clinically Appropriate monitoring or prevention of the effects of an investigational item or service
And ..typically provided absent a clinical trial

10. Costs maybe covered, IF……..
The study meets Medicare & Medicaid Services Mandatory criteria for coverage:
The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category
(e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids).
A few of these Covered benefits include:
Drugs and Biologicals
Ambulatory Services
Immunosuppressive Drugs
Audiology Services
Inpatient Hospital Services
Colorectal Cancer Screening Tests
Physicians’ Services
Critical Access Hospital Services
X-ray, Radium, and Radioactive Isotope Therapy
Diagnostic Laboratory Tests
Diagnostic Services in Outpatient Hospital
Diagnostic X-ray Tests

11. The trial must have therapeutic intent…
And not designed to exclusively test for toxicity or disease pathophysiology.
Trials of therapeutic intervention must enroll patients with a diagnosed disease (rather then healthy volunteers).

12. And Deeming Criteria
Trial is funded by NIH, CDC, AHRQ, CMS, DoD, or VA OR
Trial is funded by a center or cooperative group funded by one of the government agencies listed above OR
Trial is conducted under an Investigational New Drug application (IND) reviewed by the FDA OR
Drug trial is exempt from having an IND under 21CFR 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 trial must be reassessed for qualifying criteria in order to maintain Medicare Coverage of routine costs. (Applies to future status of the trial and will not be used to retroactively change the earlier ‘deemed’ status.)

13. If the study meets all of these Mandatory Criteria
Medicare may cover item and services
That are otherwise available to Medicare beneficiaries (and is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms
Typically provided absent a clinical trial (e.g. conventional care).
Required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent)
Clinically appropriate monitoring of the effects of the item or service.
Needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications

14. But we’re not billing the patient
All costs covered by study
A PRA is still required to ensure proper delineation of charges:
Ensure participants are not inappropriately billed.
Improve overall research billing process.
Minimize risk of billing issues

15. A. Process Summary PRA Initiation
eIRB/CRSS has an integrated workspace in which all studies enter the CRSS workspace for PRA determination.
Budget Development Request
IRB application must be started in order to obtain an IRB#.
Principal investigator (PI) sends a budget development request and the required documents to CRSS ).
Study may remain in “Researcher Prep” until ready for full IRB submission
CRSS Analyst Assigned –
CRSS analyst is assigned
CRSS analyst require the following documentation:
- Most recent protocol;
- Draft contract and sponsor budget;
- Proposed ICF cost language;
- NOGA (if the study is government funded);
- Investigator’s Brochure (IB) (if applicable); and
- Any information regarding the FDA status of the investigational item(s) (if applicable).

16. B. PRA Development C. Review and Approval CRSS Analysis
Training checked / Notifications sent
Clinical Research Billing Orientation (CRBO) - consenting study team members
Clinical Research Management System (CRMS) - PI
Creates PRA Memo
PRA Billing Grid delineation of charges for items and services.
C. Review and Approval
Draft PRA to PI/Research team for review.
- PI may requests/ suggest revisions:
a. Revision of the PRA in consultation with the PI as necessary.
b. Revised draft(s) to the PI for review and approval.
c. Process repeats until the PI approves the draft.
-When PI approval is granted:
a. PI approved draft PRA forwarded to IRB.

17. D. Finalization and Communication of PRA
Notification from IRB of study approval
Executed contract from ORA
Before PRA is finalized
Comparison of the final documentation (IRB approved protocol and executed contract with budget).
If revisions to the PRA are required, the CRSS analyst sends the revised PRA to the PI for approval.
Language in Protocol, Executed Contract, PRA – Finalized PRA uploaded to eIRB along with
Clinical Research Insurance and Research Participant Financial Responsibility Information
Change in Research (CIR)
Protocol/ ICF language amended.
Notification received through eIRB.
Determination of PRA changes required.
Process repeats until PI approval received and.