Overview September 2014. Budget & Contract ICF Coverage Analysis ProtocolUB’s Sponsors Invoicing Physician office Payer Issues © 2014 Kelly Willenberg,

Clinical Trial Billing Compliance

Overview

September 2014

FRAGMENTED FINANCIAL INFORMATION

Budget &

Contract ICF

Coverage

AnalysisProtocol UB’s Sponsors

InvoicingPhysician office

Payer Issues

© 2014 Kelly Willenberg, LLC

Institution

PatientPayer

Sponsor

CRO

Investigator(s)

FDA

Ancillary

IRB/EC

PFS

HIM

Registration

Key Players


Pharmacy

ResearchAdmin

Healthcare ResearchFinancial Compliance Risks


FCA Violations

Double DippingPayments from sponsors and from 3rd party payers for same item/service

InducementInvestigator incentives may entice stacking of patients in studies

KickbackResidual research account balances

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Common Current State of Research in Community Hospitals


Physicians/InvestigatorsAre conducting Clinical Trials independent of Hospitals

Reasons:• Independence • Lack confidence in Hospital’s ability • Control of grants/study funds • Circumvent hospital bureaucracy• Decrease paperwork conducting Clinical Trials independent of Hospitals

HospitalsResearch financial compliance programs may not be operationally effective and/or efficient Causes:• Ownership & Accountability • Policies and Procedures • Centralization • Resources • Physicians trust lacking• Management of grant/study funds research billing compliance Programs may not be operationally effective and/or efficient

External Parties Are approaching the investigator directly

Goals:• The PI knows sooner • Immediate results • Decrease paperwork • Decrease costs• Maintain control• Reduce accountability and scrutiny• Circumvent the hospitalapproaching the investigator directly

Frequent Issues Investigators will use the IRB submission as

the protocol◦ Calendar of events “loose” which makes budgeting

a challenge, coverage analysis impossible Assume that everything in the protocol is

conventional care or “standard of care” and therefore billable

Confusion about drug supplies◦ In IIT trials the drugs are sometimes not billable

and reimbursable Collaborating with team to decide on budget


Read the protocol and review the proposed budget sent by the sponsor

Determine if the trial is qualified under Medicare guidelines

Decide what are considered patient services that are standard of care and what are research patients services

Do a Coverage Analysis

September 2014

What should you do First?

Perform Qualifying Clinical Trial (QCT) Analysis

Develop grid to match schedule of events Identify items or services “hard-wired” free

into protocol Determine items and services that are

routine costs Determine if routine costs are covered by

Medicare

General Order of steps


Check proposed contract to determine if offered budget covers items and services that are not billable

Negotiate contract/budget against the Coverage Analysis

Finalize necessary sections of informed consent

Finalize and lock grid once study approved to be used as translation tool for billing and reimbursement.

General order of steps



Clinical Trials Policy – CMS Policy (July 2007) that provides guidance regarding Medicare beneficiaries participating in Clinical Trials and routine costs http://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/index.html

Routine Costs: items and services that are provided to the patient even if s/he was NOT in a clinical trial, conventional care

Routine Costs are defined, specified and documented in the Trial documents prior to the beginning of the Trial: a thorough coverage analysis

September 2014

Assessing Routine Costs

http://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/index.html

What is an Coverage Analysis? A Coverage Analysis will determine whether

any procedures may be billed to Medicare (and by extension to other insurance companies)

This presentation does not cover MCA’s but demonstrates why doing an MCA important when completing a budget

This is the first step to doing a proper budget


Coverage Analysis

Is the study “qualifying” under the guidelines?

What are the “routine” costs?

Which of the above are covered by Medicare?

How is the costs worded in the contract and consent?


POSSIBLE CLINICAL TRIAL BILLING ERRORS

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• Billing for services not rendered• Billing for services that are already paid by the

sponsor or promised free in the informed consent• Billing for services that are for research-purposes

only or are part of a non-qualifying clinical trial• Billing Medicare for device trials without MAC

approval letter in hand• Bill Medicare Advantage Plans (Part C) when claims

should be directed to the Medicare Administrative Contractor

©Kelly Willenberg, LLC 2014

POSSIBLE CLINICAL TRIAL BILLING ERRORS

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• Billing for items or services not supported by required documentation• A proper, signed order• Adequate documentation of medical necessity for the

item or service• Documentation of study participation, as required

• Billing without proper codes, modifiers or NCT #• Waiving/paying/reimbursing subject co-pay or

deductible obligations

©Kelly Willenberg, LLC 2014

© 2013 Kelly Willenberg, LLC16

The 8-digit clinical trial number must be reported on all claims (Medicare beneficiaries, Traditional and Managed Care) associated with clinical trial participation

• National Clinical Trial (NCT) number NCT12345678• Also known as the Clinicaltrials.gov Identifier

Effective Date: Services on/after January 1, 2014• Voluntarily reported since January 2008

Claim types: Both hospital/technical and professional

September 2014

Mandatory Reporting of NCT Number – MM8401

CMS will use this number to identify all items and services provided to Medicare beneficiaries (Traditional and Managed Care) during their participation in a Medicare qualifying clinical trial, study, or registry

Permits CMS to:• Better track payments• Ensure that the information gained from the research

is used to inform coverage decisions• Make certain that the research focuses on issues of

importance to the Medicare population

September 2014

Why?

September 2014

Clinical Trials.gov NCT Number

http://ClinicalTrials.gov website

NCT Number

http://clinicaltrials.gov/

ICD-9-CM Diagnosis Code V70.7 (Examination of a participant in a clinical trial); ICD-10 coming 2015

Revenue Code 0624 for FDA Investigational Devices, as applicable

Condition Code 30

Q0 and Q1 modifiers, as applicable (outpatient claims only)

NCT number

Report in UB-04 Form Locators 39-41

September 2014

Required data Elements for reporting: Hopsitals

ICD-9-CM Diagnosis Code V70.7 (Examination of a participant in a clinical trial); ICD-10 coming in 2015

Revenue Code 0624 for FDA Investigational Devices, as applicable

Q0 and Q1 modifiers, as applicable (outpatient claims only)

NCT number

Report in CMS-1500 Field 19

September 2014

Required Data Elements for Reporting: Physician Practices

• If some, but not all of the required elements (NCT #, ICD-9 code, modifiers, revenue codes, condition codes) are reported, the claim will be stopped and returned to the provider (RTP)

• Possible RTP statements:• “Claim lacks information which is needed for adjudication

…..”• “Missing/incomplete/invalid Investigational Device

Exemption number for FDA-approved clinical trial services”• “Your claim contains incomplete and/or invalid information,

and no appeal rights are afforded because the claim is unprocessable ….”

September 2014

What happens if we don’t report?

Questions

Kelly Willenberg, MBA, BSN, CHRC, [email protected]

864-473-7209


mailto:[email protected]

http://www.kellywillenberg.com/

Documents

Overview September 2014. Budget & Contract ICF Coverage Analysis ProtocolUB’s Sponsors Invoicing Physician office Payer Issues © 2014 Kelly Willenberg,