©2012 PhramaSeek Financial Services, LLC Navigating Medicare Billing Guidelines in Clinical Trials
Dec 23, 2015
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Presenters
Beth Delair, JD, RNProject Lead, Billing Compliance
Katie RichterDirector, Strategic Site
Operations
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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
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• 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?
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Polling Question
How many of your institutions perform Medicare Coverage Analyses as part of your research billing compliance program?
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• 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?
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Risks of Not Performing Medicare Coverage Analysis
Reputational harm
Increased governmental
scrutiny
Costs to Implement corrective action plan
Costs associated with
investigation
RisksInstitutional
and/or PI debarment
Loss of governmental
funding
Civil Fines
Criminal Penalties
Risks
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• 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
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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
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What is a Qualifying Clinical Trial?
Medicare Benefit
Category
Therapeutic Intent
• Trial must have therapeutic intent; it cannot exclusively test toxicity or disease pathophysiology
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What is a Qualifying Clinical Trial?
Medicare Benefit
Category
Therapeutic Intent
Diagnosed Disease
• Must enroll patients with a diagnosed disease
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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”?
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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)
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What is a Qualifying Clinical Trial?
Medicare Benefit
Category
Therapeutic Intent
Diagnosed Disease
Deemed
Qualifying Clinical Trial
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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
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Pop Quiz #1 - Answer
Medicare Benefit
Category
Therapeutic Intent
Diagnosed Disease Deemed
Not a Qualifying
Clinical Trial
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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
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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.
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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.
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• 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?
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• Significant Risk Devices– Category A– Category B
• Non-Significant Risk Devices• Humanitarian Use Devices
Medical Device Trials
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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
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• 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
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• 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
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• 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
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• 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
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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
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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
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• 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
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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
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Incorporating MCAs into Research Billing Compliance Process
Front End Process
Research Account
Set-up
Study Billing
Plan
Budget
OverheadRate
Costs/ Charges
Medicare Coverage Analysis
Contract/Grant
Informed Consent
Form
Protocol
FDA Documents
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Integration of MCAs into Budget and Contract
Budget
OverheadRate
Costs/ Charges
Medicare Coverage Analysis
Contract/Grant
Informed Consent
Form
Protocol
FDA Documents
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Integration of MCAs into Budget and Contract
Gather all documents required to initiate study
Review ICFDraft 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
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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