research matters · 2019-10-01 · • research billing compliance update • irb – janice...

Research MattersJune 20, 2017

WelcomeRob Herzog, VP Research Operations

DevotionGiselle Whiskey – TRI-MD

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The earth is the Lord’s and everything in it. The world and all it’s people belong to Him.

New International Version (NIV)

Psalm 24:1

http://www.letterstotheexiles.com/wp-content/uploads/2016/11/god-creation-man.jpg

Each of you should use whatever gift you have received to serve others, as faithful stewards of God’s grace in its various forms.

New International Version (NIV)

1 Peter 4:10

…you should use whatever gift you have received

…to serve as faithful stewards

of God’s grace in its various forms

Leadership Message

Rob HerzogVice President

Research Operations

Steven Smith Chief Scientific

Officer

Monica ReedChief Learning

Officer

About UsResearch Information Systems (ResIS)

• Director: Lance McCain• Sr. Manager: Susan Mitchell• CTMS: 4 FTE’s• EDC: 1 FTE’s• LIMS: 1 FTE’s• Analytics: 3 Dedicated FTE’s

– 40 System-Wide FTE’s

• 2007: EMR (Cerner)• 2010: Clinical Trials (Cerner)• 2011: EDC (Discovere)

Analytics (iDiscover)• 2015: Bio Bank (StarLIMS)• 2016: CTMS (Clinical Conductor)

EDC (OpenClinica)IDS (Vestigo)

• 2017: Analytics Institute (Oracle)• 2018: Genomics (TBD)

Team… Research Journey…

1012/12/2016

Ambulatory EMR

CTMS Hospital EMREDC

Translational Research

Bio Bank Analytics

Analytics

ResearchMart

Outbound

Partnerships

Results

Registries

Research InfrastructureImplementing

Leveraging

StudyBuild

Rese

arch

Inst

itute

Cancer

Children’s

Neuro

Surgery

ThrombosisTranslational

RadiologyRobotics

Transplant

Pharmacy

CV

CREATION

Endoscopy

Ortho

Celebration

Winter Park

Nursing

Education

Tampa

AnalyticsAMITA

OtherPremier

PressGaneyClaims

Pop HealthHomeCare

4 EMR’s

Self-ServiceQlikView

OBIEE

SASIRB

Cohort Query

Research Mart 1.0Governance

Execute

Prioritize

Initiatives-SOP’s-Partnerships-Registries-Mart Data Additions

Data Requests

Execute

IRB Approval

FeasibilityAssessment

-Data Elements-Destination-Purpose-Urgency

Data Tables

Demographics

Clinical Trials

Encounters

Diagnoses

Vitals

Conditions

Labs

Meds

Procedures

Outcomes

Billing

Rese

arch

Inst

itute

Cancer

Children’s

Neuro

Surgery

ThrombosisTranslational

RadiologyRobotics

Transplant

Pharmacy

CV

CREATION

Endoscopy

Ortho

Celebration

Winter Park

Nursing

Education

Tampa

AnalyticsAMITA

Research Services Updates

• OSP – Regina Tan• ORI – Christina Jackson

• Research Billing Compliance Update

• IRB – Janice Turchin• SOP and Communication Update

Office of Sponsored Programs

Regina Tan• Quick Updates

Office of Sponsored Programs Announcements

Budget SpecialistJanice Popovich

Study BuildersAndrzej (ahn – jay) Dziekonski (ja – con – ski)

Ehsen (eh – sen) Malik (ma – leek)

Steven Truong (tr – uh –ng)

OSP

Team A

IIT/IIS Grants and Contracts - Funded

Studies

Team B

Industry-Sponsored Studies

CTMSStudy Builders

IIT/IIS Internally -Funded Studies

Regina Tan

Leerin Shields

Michelle Kilponen

TBA

QuilinMars

Bianca Maldonado

AndrzejDziekonski

EhsenMalik

Steven Truong

Janice Popovich

Jessica Hyacinthe

Meghan Brodie

OSP: Office of Sponsored Programs

Institutional Review Board (IRB) Update

Michelle McKinney & Janice Turchin• SOP Update• IRB Communication Change• IRB Actions & Letters• Revised Common Rule

SOP UpdateHRP-143 Daily TasksWhat has changed?• Conditional Approval by the convened board

• IRB will send a reminder if conditions are not met within 90 days

• Submissions pending Exempt or Expedited review• IRB will notify if modifications to secure approval are not met within

30 days• IRB will withdraw package 15 days after notification

Why?• Increase the quality and timeliness of IRB review

Effective July 1, 2017

HRP - 143

IRB Communication ChangeInitial review of new projects• Letter will be published listing required modifications, missing

documents, training, etc.• Instead of project message or published Word document

• Letter will include a due date – per HRP-143

Why?• Better audit trail & record keeping• Ease of finding requests• Consistency• Formal communication to sponsor

Effective July 1, 2017

IRB Actions & Letters• Extremely important that you read

the published letters!• Two notifications sent for every

submission:• Board Action

• IRBNet has a limited choice.• Don’t assume that

“Acknowledged” or “Approved” means nothing else is needed.

• Board Document Published• Be sure to download and

read. • IRB might be requesting more

information. Could be a deadline!

Board Action:

Document Published:

Letter:

Revised Common Rule• Overview provided at Research Matters in March• Regulations likely go into effect 1/2018• IRB office continues steps to review and draft revised

policies in anticipation• Your input will be invited

• Informed Consent – New “Key Information” Section -mandatory

• Final rule does NOT strictly specify what is appropriate “key information.”

Office of Research Integrity (ORI) Update

Christina Jackson• Research Billing Compliance

• Notification process• Training Sessions

• Today!• 6/21 @ 3:00 pm• 6/22 @ 9:30 am• 6/23 @ 10:00 am

RESEARCH BILLING COMPLIANCE:

RESEARCH ACCOUNT NOTIFICATION PROCESS - HOW & WHY?

Christina JacksonFlorida Hospital Research Institute (FHRI)

Office of Research Integrity (ORI)June 2017

RESEARCH BILLING COMPLIANCE-WHY?

Florida Hospital Imperatives

•Improve People Systems - design tools that help our team to thrive.

•Manage Risk - drive a focus on ethics and careful planning that ensure predictable results.

OBJECTIVES

•Review basic research billing requirements

•Understand responsibilities related to research billing compliance

•Review research patient account notification process

•Successful completion of Quiz

MEDICARE

June, 2000

Executive memo issued directing DHHS to, “explicitly authorize (Medicare) payment for routine patient care costs…… and costs due to medical complications associated with participation in clinical trials.” CMS responded by issuing the National Coverage Determination (NCD) in September, 2000.

WHAT THEY THOUGHT THEY DID

WHAT THEY ACTUALLY DID…

GOOD INTENTIONS

•Intent was to increase participation and access to clinical trials

•Establish a tracking system for Medicare •Payments to track clinical trial spending, to which Medicare contributes financial support.

MEDICARE CLINICAL TRAIL POLICY-NATIONAL COVERAGE DETERMINATION (NCD) § 310.1Effective July 9, 2007•Defines the scope of, and criteria for, coverage for Medicare beneficiaries who enroll in clinical research.

•Provides the rules for institutions to determine the items, services, and procedures – if any- that will be reimbursed by Medicare.

•Defines “Routine Costs”•Provides criteria for “Deemed & Qualifying”

SEPARATING PATIENT BILLS

Most clinical trials contain a mixture of routine and non-routine care and the standard treatment regimen that a patient would receive is modified in a manner that requires the costs for the care to be reimbursed by multiple payers—usually the sponsor of the clinical trial and the patient’s insurer.

Can be difficult to sort!

NATIONAL CLINICAL TRIAL (NCT) NUMBER

The national clinical trial (NCT) number is a number assigned by ClinicalTrials.gov

Effective January 1, 2014:

CMS requires that the NCT number be reported on claims for items and services that are provided in clinical trials and are qualified for coverage.

BILLING CODES AND MODIFIERSCMS MEDICARE CLAIMS PROCESSING

MANUAL

Modifiers: January 1, 2008Q0-Investigational ItemQ1-Routine Item

Codes: Z00.6 (ICD-10) diagnosis code, October 1, 2015Condition code 30-Outpatient Clinical Trial Services

FH PFS AND FHMG BILLING RESPONSIBILITIES

Billable to Medicare and/or Third Party Payer

Not Billable to Medicare/Insurance

Sponsor to ReimburseRoutine Care Items Non-routine Care Items

Deemed & Qualifying

Place account/bill on “Hold” Place account/bill on “Hold”

Determine routine care items on account related to research participation

Create Research Account

Claims must contain: NCT# and Scrub bill of non-billable items

Applicable Billing Codes & Modifiers

Release any billable charges with NCT#, and proper Codes and Modifiers

FALSE CLAIMS ACT AND DOUBLE BILLING

Provision most commonly used for prosecuting health care fraud:

“knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval”

“Knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim”

RUSH $1M SETTLEMENTDECEMBER, 2005

•Improperly billed Medicare for physician and hospital cancer research services as routine costs that were not reimbursable under the Medicare Clinical Trial Policy

•Double billing•Voluntary self-disclosure to DOJ in 2003•Was among the first settlements related solely to Medicare’s CTP on clinical trials

•Was principally the result of offices not knowing what the other was doing

EMORY UNIVERSITY $1.5M SETTLEMENT

•Falsely billing Medicare and Medicaid for clinical trial services that were not permitted by the Medicare and Medicaid rules.

•The clinical trial sponsor agreed to pay for services which in some instances was not ever invoiced by Emory to the sponsor per the contract.

•Some services promised free in the informed consent.

EASY TARGET?

NOTIFICATION OF RESEARCH PATIENT ACCOUNT

Communication is the key

to an effective Billing

Compliance Program

WHEN DO I NOTIFY?

FH PFS and FHMG (for FHMG patients) must be notified of all research patient visits. See Research Account Notification Process document. This document will be posted on the ORI page in the InSite Research Services website.

HOW DO I NOTIFY?

Current process of notification is via email:

FH.PFS.Research.Studies@flhosp.org FH Patient Financial Services to flag hospital account

FHMG.Revenue.Cycle.Directors@Flhosp.orgTo flag FHMG account

FH.FRI.Billing@flhosp.orgTo flag radiology account

ADDITIONAL HELPFUL PRACTICES IN BILLING COMPLIANCE

• Subject Enrollment log - Gives you the ability to quickly provide information regarding patient visits necessary for billing compliance purposes.

• Improves awareness of items that need to be invoiced to sponsor.

• Invoicing/reconciliation - Managers/Coordinators please notify research finance specialist when a research service has occurred that can be invoiced to sponsor.

MORE UPDATES TO COME

MANDATORY COMPLIANCE QUIZ

Closing RemarksRob Herzog

Thank You for Attending!

Our next Research Matters meeting will be in August…

Details will be released soon!

60% transparency

Impact StoryHow We Make a Difference

TBD???

Lorraine HicksonDr. Magnuson

Celebration HealthFirst site in the world to use DaVinci robot under

“glove tactic” for head & neck

50% transparency

70% transparency

80% transparency

95% transparency