What is a Qualifying Clinical Trial?
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Navigating Medicare Billing Guidelines in Clinical Trials ©2012 PhramaSeek Financial Services, LLC Presenters Beth Delair, JD, RN Project Lead, Billing Compliance Katie Richter Director, Strategic Site Operations ©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 ©2012 PhramaSeek Financial Services, LLC 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 ©2012 PhramaSeek Financial Services, LLC Sample Medicare Coverage Analysis ©2012 PhramaSeek Financial Services, LLC Polling Question How many of your institutions perform Medicare Coverage Analyses as part of your research billing compliance program? ©2012 PhramaSeek Financial Services, LLC 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 ©2012 PhramaSeek Financial Services, LLC Risks of Not Performing Medicare Coverage Analysis Costs associated with investigation Civil Fines Increased governmental scrutiny Risks Institutional and/or PI debarment Loss of governmental funding Criminal Penalties Reputational harm Costs to Implement corrective action plan ©2012 PhramaSeek Financial Services, LLC 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” ©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 ©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 ©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 ©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”? ©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) ©2012 PhramaSeek Financial Services, LLC What is a Qualifying Clinical Trial? Medicare Benefit Category Therapeutic Intent Diagnosed Disease Deemed Qualifying Clinical Trial ©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 ©2012 PhramaSeek Financial Services, LLC Pop Quiz #1 - Answer Medicare Benefit Category Therapeutic Intent Diagnosed Disease Deemed Not a Qualifying Clinical Trial ©2012 PhramaSeek Financial Services, LLC What is a Routine Cost? Routine Costs Are: Routine Costs Are Not: • 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 • 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 ©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. ©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. ©2012 PhramaSeek Financial Services, LLC 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 ©2012 PhramaSeek Financial Services, LLC Medical Device Trials • Significant Risk Devices – Category A – Category B • Non-Significant Risk Devices • Humanitarian Use Devices ©2012 PhramaSeek Financial Services, LLC Significant Risk Devices Category A Category B • 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 ©2012 PhramaSeek Financial Services, LLC 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 ©2012 PhramaSeek Financial Services, LLC 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 ©2012 PhramaSeek Financial Services, LLC 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 IF Device THEN Items/ Services ©2012 PhramaSeek Financial Services, LLC 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 ©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 ©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 ©2012 PhramaSeek Financial Services, LLC 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) ©2012 PhramaSeek Financial Services, LLC Research Billing Compliance Process Medicare Coverage Analysis Front End Process Training and Education Subject Identification/ Registration Elements of Research Billing Compliance Program Auditing and Monitoring Coding/ Billing/Claims Preparation Back End Process ©2012 PhramaSeek Financial Services, LLC Incorporating MCAs into Research Billing Compliance Process Contract/ Grant Costs/ Charges Informed Consent Form Protocol FDA Documents Study Billing Plan Medicare Coverage Analysis Research Account Set-up Budget Front End Process Overhead Rate ©2012 PhramaSeek Financial Services, LLC Integration of MCAs into Budget and Contract Contract/ Grant Costs/ Charges Informed Consent Form Protocol FDA Documents Medicare Coverage Analysis Budget Overhead Rate ©2012 PhramaSeek Financial Services, LLC Integration of MCAs into Budget and Contract Gather all documents required to initiate study Review ICF Review Contract Analyze Protocol Draft Coverage Analysis Build Budget ICF changes approved by Sponsor Contract Negotiated Coverage Analysis Completed IRB approved CTA Fully Executed Budget Negotiated Budget Finalized Begin Enrolling Subjects ©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 ©2012 PhramaSeek Financial Services, LLC Questions? Katie Richter krichter@pharmaseek.com Beth Delair bdelair@pharmaseek.com ©2012 PhramaSeek Financial Services, LLC
