1. ©2012 PhramaSeek Financial Services, LLC Navigating Medicare Billing Guidelines in Clinical Trials

2. ©2012 PhramaSeek Financial Services, LLC Presenters Beth Delair, JD, RN Project Lead, Billing Compliance Katie Richter Director, Strategic Site Operations

3. ©2012 PhramaSeek Financial Services, LLC 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. ©2012 PhramaSeek Financial Services, LLC 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 What is a Medicare Coverage Analysis?

5. ©2012 PhramaSeek Financial Services, LLC Sample Medicare Coverage Analysis

6. ©2012 PhramaSeek Financial Services, LLC Polling Question How many of your institutions perform Medicare Coverage Analyses as part of your research billing compliance program?

7. ©2012 PhramaSeek Financial Services, LLC 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 Why Perform a Medicare Coverage Analysis?

8. ©2012 PhramaSeek Financial Services, LLC Risks of Not Performing Medicare Coverage Analysis Reputational harm Increased governmental scrutiny Costs to Implement corrective action plan Costs associated with investigation Risks Institutional and/or PI debarment Loss of governmental funding Civil Fines Criminal Penalties Risks

9. ©2012 PhramaSeek Financial Services, LLC 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” Medicare Billing Rules for Clinical Trials

10. ©2012 PhramaSeek Financial Services, LLC 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. ©2012 PhramaSeek Financial Services, LLC 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. ©2012 PhramaSeek Financial Services, LLC What is a Qualifying Clinical Trial? Medicare Benefit Category Therapeutic Intent Diagnosed Disease Must enroll patients with a diagnosed disease

13. ©2012 PhramaSeek Financial Services, LLC What is a Qualifying Clinical Trial? Medicare Benefit Category Therapeutic Intent Diagnosed Disease Deemed Trial must be “deemed”… but what does it mean to be “deemed”?

14. ©2012 PhramaSeek Financial Services, LLC 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. ©2012 PhramaSeek Financial Services, LLC What is a Qualifying Clinical Trial? Medicare Benefit Category Therapeutic Intent Diagnosed Disease Deemed Qualifying Clinical Trial

16. ©2012 PhramaSeek Financial Services, LLC 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. ©2012 PhramaSeek Financial Services, LLC Pop Quiz #1 - Answer Medicare Benefit Category Therapeutic Intent Diagnosed Disease Deemed Not a Qualifying Clinical Trial

18. ©2012 PhramaSeek Financial Services, LLC What is a Routine Cost? Routine Costs Are: Items/services that are typically provided absent a clinical trial Items/services required solely for the provision of the investigational item Clinically appropriate monitoring of the effects of the item or service, or the prevention of complications Items/services needed for the reasonable and necessary care arising from the provision of the investigational item/service, in particular for the diagnosis or treatment of complications Routine Costs Are Not : The investigational item or service, itself unless otherwise covered outside the clinical trial Items and services provided solely for the purpose of research Items or services provided by the Sponsor free of charge

19. ©2012 PhramaSeek Financial Services, LLC 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. ©2012 PhramaSeek Financial Services, LLC 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. ©2012 PhramaSeek Financial Services, LLC 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 What about non-Drug Trials?

22. ©2012 PhramaSeek Financial Services, LLC Significant Risk Devices – Category A – Category B Non-Significant Risk Devices Humanitarian Use Devices Medical Device Trials

23. ©2012 PhramaSeek Financial Services, LLC Significant Risk Devices Experimental Innovative devices for which safety and effectiveness have not been established Never covered by Medicare 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 Category A

24. ©2012 PhramaSeek Financial Services, LLC Responsibility of the hospital’s Institutional Board (IRB) to make risk determination Medicare contractors treat as a Category B device for coverage determination purposes Non-Significant Risk Devices

25. ©2012 PhramaSeek Financial Services, LLC Sponsor does not have to demonstrate effectiveness, just that they are safe Medicare contractors often treat HUDs similar to Category B devices Humanitarian Use Devices

26. ©2012 PhramaSeek Financial Services, LLC 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 Medicare Billing Rules for Medical Devices THEN Items/ Services DeviceIF

27. ©2012 PhramaSeek Financial Services, LLC 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 Surgical Trials

28. ©2012 PhramaSeek Financial Services, LLC 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. ©2012 PhramaSeek Financial Services, LLC 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. ©2012 PhramaSeek Financial Services, LLC 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) Miscellaneous Medicare Coverage Rules

31. ©2012 PhramaSeek Financial Services, LLC Research Billing Compliance Process Elements of Research Billing Compliance Program Front End Process Subject Identification/ Registration Coding/ Billing/Claims Preparation Back End Process Auditing and Monitoring Training and Education Medicare Coverage Analysis

32. ©2012 PhramaSeek Financial Services, LLC Incorporating MCAs into Research Billing Compliance Process Front End Process Research Account Set-up Study Billing Plan Budget Overhead Rate Costs/ Charges Medicare Coverage Analysis Contract/ Grant Informed Consent Form Protocol FDA Documents

33. ©2012 PhramaSeek Financial Services, LLC Integration of MCAs into Budget and Contract Budget Overhead Rate Costs/ Charges Medicare Coverage Analysis Contract/ Grant Informed Consent Form Protocol FDA Documents

34. ©2012 PhramaSeek Financial Services, LLC Integration of MCAs into Budget and Contract Gather all documents required to initiate study Review ICF Draft Coverage Analysis Review Contract Build Budget ICF changes approved by Sponsor Coverage Analysis Completed Budget Negotiated CTA Fully Executed Contract Negotiated Budget Finalized IRB approved Begin Enrolling Subjects Analyze Protocol

35. ©2012 PhramaSeek Financial Services, LLC 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. ©2012 PhramaSeek Financial Services, LLC Questions? Katie Richter krichter@pharmaseek.com Beth Delair bdelair@pharmaseek.com