Navigating Medicare Billing Guidelines in Clinical Trials

1. Navigating Medicare Billing Guidelines in Clinical Trials

2. Presenters Beth Delair, JD, RN Project Lead, Billing Compliance Katie Richter Director, Strategic Site Operations

3. Agenda • Define Medicare Coverage Analysis (MCA) • Outline reasons for performing a MCA • Discuss risks of not performing a MCA • Examine the Medicare Clinical Trial Policy • Analyze how MCA fit into the research billing compliance process • Discuss integration of MCA into contract and budget negotiations

4. What is a Medicare Coverage Analysis? • A document that identifies and analyzes who the appropriate payor (i.e. Sponsor, Medicare or third party payor) is for each item and service required by a clinical research trial • It is the basis of research billing compliance operations processes

5. Sample Medicare Coverage Analysis

6. Polling Question How many of your institutions perform Medicare Coverage Analyses as part of your research billing compliance program?

7. Why Perform a Medicare Coverage Analysis? • Guides billing department • Reduces risk for improper billing • Becomes basis for effective auditing and monitoring of research billing practices • Expedites pre-certification process • Assists in budget negotiations with the Sponsor/CRO

8. Risks of Not Performing Medicare Coverage Analysis Civil Fines Costs associated with investigation Increased governmental scrutiny Risks Institutional and/or PI debarment Risks Reputational harm Costs to Implement corrective action plan Loss of governmental funding Criminal Penalties

9. Medicare Billing Rules for Clinical Trials • Clinical Trial Policy (NCD 310.1) • Established criteria under which Medicare would provide coverage for its beneficiaries involved in clinical trials • General Rule: Medicare will pay for the “routine costs” of “qualifying clinical trials”

10. What is a Qualifying Clinical Trial? Medicare Benefit Category • The subject or purpose of the trial must be the evaluation of the a Medicare benefit category

11. What is a Qualifying Clinical Trial? Medicare Benefit Category Therapeutic Intent • Trial must have therapeutic intent; it cannot exclusively test toxicity or disease pathophysiology

12. What is a Qualifying Clinical Trial? Medicare Benefit Category Diagnosed Disease Therapeutic Intent • Must enroll patients with a diagnosed disease

13. What is a Qualifying Clinical Trial? Medicare Benefit Category Diagnosed Disease Therapeutic Intent Deemed Trial must be “deemed”… but what does it mean to be “deemed”?

14. What does it mean to be “Deemed”? Trials with the seven desirable characteristics described by Medicare Trials funded by the NIH, CDC, AHRQ, CMS, DOD, and VA Trials supported by centers or cooperative groups funded by one of the above governmental entities Trials conducted under and IND reviewed by the FDA Drug trial that are exempt from having an IND under 21 CFR 312.2.(b)(1)

15. What is a Qualifying Clinical Trial? Medicare Benefit Category Therapeutic Intent Diagnosed Disease Deemed Qualifying Clinical Trial

16. Pop Quiz #1 Is the following trial is considered a “qualifying clinical trial”? Trial #12345, sponsored by the NCI, is evaluating the safety and toxicity of Drug XYZ in patients with metastatic adenocarcinoma of the colon

17. Pop Quiz #1 - Answer Medicare Benefit Category Diagnosed Disease Therapeutic Intent Deemed Not a Qualifying Clinical Trial

18. What is a Routine Cost?

19. Pop Quiz #2 True or False? Patients with colorectal cancer enrolled on Trial #45678 receive the experimental Drug ABC combined with the standard regimen of FOLFOX. The intravenous infusion of Drug ABC is considered a routine cost.

20. Pop Quiz #2 - Answer The Medicare Clinical Trial Policy covers “items and services required solely for the provision of the investigational item or service” on qualifying clinical trials. It would cover the tubing, fluids, nursing, etc. needed for the administration of the experimental Drug ABC.

21. What about non-Drug Trials? • Device Trials • Coverage for items/services on device clinical trials depends on whether the device itself is covered • Surgical Trials • Often do not fit drug or device guidelines • Appeal to the local Medicare contractor

22. Medical Device Trials • Significant Risk Devices • Category A • Category B • Non-Significant Risk Devices • Humanitarian Use Devices

23. Significant Risk Devices • Experimental • Innovative devices for which safety and effectiveness have not been established • Never covered by Medicare Category A • Non-Experimental • Incremental risk is the primary risk in question (i.e. underlying questions of safety and efficacy of that device type have been established) • Possibly covered by Medicare • Local Medicare contractor makes the determination Category B

24. Non-Significant Risk Devices • Responsibility of the hospital’s Institutional Board (IRB) to make risk determination • Medicare contractors treat as a Category B device for coverage determination purposes

25. Humanitarian Use Devices • Sponsor does not have to demonstrate effectiveness, just that they are safe • Medicare contractors often treat HUDs similar to Category B devices

26. Medicare Billing Rules for Medical Devices • General Rule • If Medicare does not provide coverage for a medical device, then none of the items/services “furnished in preparation for the use of a non-covered device, services furnished contemporaneously with and necessary to the use of a non-covered device, and services furnished as necessary after care that are incident to recovery from the use of the device” are covered Items/ Services THEN IF Device

27. Surgical Trials • Often do not meet “deemed” status • Industry-sponsored • Investigator-initiated • Only way to have these trials qualify is to submit them to the local Medicare contractor • Medicare contractor may or may not choose to cover the trial

28. Pop Quiz #3 True or False: A trial involving patients with pancreatic cancer that is sponsored by the NCI and tests the safety and efficacy of full vs. partial pancreatectomy qualifies for Medicare reimbursement

29. Pop Quiz #3 - Answer • TRUE • Falls under a Medicare benefit category – inpatient/outpatient services • Enrolls patients with a diagnosed disease – pancreatic cancer • Has therapeutic intent – testing the efficacy of full vs. partial pancreatectomy • Is deemed – sponsored by the NCI

30. Miscellaneous Medicare Coverage Rules • Medicare only pays for items or services that are medically necessary • Medicare will not pay for items and services that it has no obligation to pay for (ex: are provided or paid for by the sponsor)

31. Research Billing Compliance Process Subject Identification/ Registration Medicare Coverage Analysis Front End Process Elements of Research Billing Compliance Program Coding/ Billing/Claims Preparation Training and Education Auditing and Monitoring Back End Process

32. Incorporating MCAs into Research Billing Compliance Process Research Account Set-up Study Billing Plan Contract/Grant Costs/ Charges Informed Consent Form Medicare Coverage Analysis Protocol Budget Front End Process FDA Documents Overhead Rate

33. Integration of MCAs into Budget and Contract Contract/Grant Costs/ Charges Informed Consent Form Medicare Coverage Analysis Protocol Budget FDA Documents Overhead Rate

34. Integration of MCAs into Budget and Contract Gather all documents required to initiate study Analyze Protocol Review ICF Review Contract Draft Coverage Analysis Build Budget ICF changes approved by Sponsor Budget Negotiated Contract Negotiated Coverage Analysis Completed Budget Finalized CTA Fully Executed IRB approved Begin Enrolling Subjects

35. Key Learning Points • Medicare Coverage Analysis is a vital component of clinical research billing compliance • Lack of/poor MCA processes can lead to institutional damage on multiple levels • MCAs can be used as a building block for budget and contract negotiations

36. Questions? Beth Delair bdelair@pharmaseek.com Katie Richter krichter@pharmaseek.com