research matters · 2019-10-01 · • research billing compliance update • irb – janice...
TRANSCRIPT
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
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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:
[email protected] FH Patient Financial Services to flag hospital account
[email protected] flag FHMG account
[email protected] 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