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 410-361-8372/office CRSS@jhmi.edu Prospective Reimbursement Analysis & Budgeting

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

Agenda PRA – what is it? Why you need a PRA Medicare NCD 310.1 – how does this affect my study? PRA Development Process

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).

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 Email to CRSS mailbox for request of budget development

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.

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) 310.1 in September 2000 . 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

Medicare National Coverage Determination (NCD) 310 Medicare National Coverage Determination (NCD) 310.1 Routine Costs Clinical Trials September, 2000 Medicare implemented Medicare (NCD) 310.1 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

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

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).

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.)

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

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

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 (CRSS@jhmi.edu ). 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).

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.

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.