Navigating Medicare Billing Guidelines in Clinical Trials

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Navigating Medicare Billing Guidelines in Clinical Trials


Presenters

Beth Delair, JD, RNProject Lead, Billing Compliance

Katie RichterDirector, Strategic Site Operations


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


• 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?


Sample Medicare Coverage Analysis


Polling Question

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


• 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?


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


• 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


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



Medicare Benefit

Category

Therapeutic Intent

• Trial must have therapeutic intent; it cannot exclusively test toxicity or disease pathophysiology



Medicare Benefit

Category

Therapeutic Intent

Diagnosed Disease

• Must enroll patients with a diagnosed disease



Medicare Benefit

Category

Therapeutic Intent

Diagnosed Disease Deemed

Trial must be “deemed”…but what does it mean to be “deemed”?


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)



Medicare Benefit

Category

Therapeutic Intent

Diagnosed Disease

Deemed

Qualifying Clinical Trial


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


Pop Quiz #1 - Answer

Medicare Benefit

Category

Therapeutic Intent

Diagnosed Disease Deemed

Not a Qualifying

Clinical Trial


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


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.



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.


• 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?


• Significant Risk Devices– Category A– Category B

• Non-Significant Risk Devices• Humanitarian Use Devices

Medical Device Trials


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


• 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


• 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


• 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


• 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


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



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


• 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


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


Incorporating MCAs into Research Billing Compliance Process

Front End Process

Research Account

Set-up

Study Billing

Plan

Budget

OverheadRate

Costs/ Charges


Contract/Grant

Informed Consent

Form

Protocol

FDA Documents


Integration of MCAs into Budget and Contract

Budget

OverheadRate

Costs/ Charges


Contract/Grant

Informed Consent

Form

Protocol

FDA Documents


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


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


Questions?

Katie [email protected]

Beth [email protected]