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Clinical Research Billing & Compliance. September 2010. Executive Memorandum.

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executive memorandum
Executive Memorandum
  • President Clinton signed an executive memorandum on June 7, 2000 directing the Secretary of Health and Human Services to “explicitly authorize (Medicare) payment for routine patient care costs. . .and costs due to medical complications associated with participation in clinical trials”.

Source: CMS Transmittal AB-00-89

covered routine costs
Covered Routine Costs
  • All items and services that are otherwise generally available to Medicare beneficiaries, including:
    • Those provided absent a clinical trial (e.g., conventional care)
    • Those required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent)
    • Those required for clinically appropriate monitoring of effects of investigational item or service, or prevention of complications
    • Those needed for reasonable and necessary care, for diagnosis or treatment of complications
what happens when you don t get it right
What Happens When You Don’t Get It Right?
  • Northwestern University $5.5 million settlement
  • John Hopkins $2.6 million settlement
  • Hospital Settlement $5.4 million cardiac device settlement
  • TJU $2.6 million settlement
  • Univ of Louisville Mandated to review 1,151 open studies
  • Beth Israel Deaconess $920,000 settlement
  • Medical College of Georgia $6.1 million settlement
  • Univ of CA at San Diego $4.7 million settlement
  • Mayo $6.5 million
  • University of Alabama $3.4 million
  • Dr LaHaye $1.1 million settlement
  • Yale University 194,000
  • Rush University More than $ 1 million

* Exclusion from government contracting, subcontracting or involvement in procurement programs can also be imposed

clinical research improvements
Clinical Research Improvements
  • Instituted steeper clinical discounts for professional and hospital fees for clinical research
  • Reduced turnaround time on new applications to IRBMED and redesigned internal processes, enabling more timely launch of studies
  • Launched clinical research pricing tool to assist study teams in preparing study budgets
  • Offered training workshops for faculty on the nuts and bolts of billing calendars
  • Improved access to clinical research support services by moving MICHR, IRBMED, CRAO and CCC Clinical Trials Office to NCRC
  • Implemented lean initiative to remove bottlenecks and increase efficiency of billing calendar workflow
  • Partnered with Hospital to fund mechanism for payment for subject injury when not covered by sponsor (includes NIH)
  • Established CRAO as a module within eResearch
  • Concluded strategic assessment of clinical research enterprise. Plans now underway:
    • Virtual home for study coordinators to enhance their knowledge, ability, and impact
    • Clinical Research Support Unit to establish best practices, tools, and resources
    • Demonstration project with DRDA to reduce the contract and regulatory approval processes timelines
  • Signed contract with eThority to provide robust clinical trials software application
clinical research improvement patient complaints 2007 2010

Clinical Research Improvement Patient Complaints 2007-2010

Note: data prior to 2007 was not being tracked with any regularity.

what is ethority
What is eThority?
  • Clinical trials software application for budgeting, billing calendar, enrollment, reporting, and analysis for all clinical trials activity
  • Easy-to-use, Citrix-based software for large, experienced investigative teams; individual junior investigators; and everyone in between
  • Vendor with successful track record of software implementations at UMHS
  • Enable researchers to create more timely and accurate budgets, improving negotiation with sponsors
  • Develop standard and consistent work to enable faster review and reduce administrative burden
  • Ensure appropriate billing for items and services, enhancing compliance
  • Provide researchers with single application in which to build budgets and billing calendars
    • Provide direct access to CPT and CDM codes and discounted pricing
    • Enable study budget and billing calendar to be automatically populated
  • Enable researchers to look at financial feasibility of protocol and understand changes required to improve financial performance
  • Provide improved reporting capabilities for better ongoing management of activity
  • Executive Sponsors: D Spahlinger, S Kunkel
  • Project Leads: S Silver, T Grieb
  • Steering Committee: S Silver, T Grieb, J Bell, M Ceo, B Davies, D Gipson, G Hiller, B Johnson, A Lok, T Marks, A Milliman, T Shanely, G Vuocolo-Branch
  • Development & Implementation: Members from MSA/FGP, CRAO, ProFee Billing, Internal Medicine, MSIS, MICHR, eThority
  • Several sub-teams focused on Clinical Systems, Calendar/Budget Design & Subject Enrollment, Education/Training, IT Implementation, CRB Database, Charge Master & Bundling, and Communications
future state
Future State
  • Uniform budget/billing calendar development with single entry
  • User-obvious design with built-in wizards
  • Searchable pricing with smart charge master
  • Subject enrollment and reporting
  • Enhanced financial analysis and reporting capabilities
  • Improved billing compliance and reduced subject complaints

Thank you for your advice and guidance!Mat InnesBenjie JohnsonAndree JoyauxMelissa KarjalaJack KufahlSarah KyleKim LeppertAnna LokJill MalayangTom MarksJim MaszaticsBrett MillerAmy Milliman

Shari Barnett Mary Hill Samya Nasr

Rick Bluhm Glen Hiller Sandy O’Holleran

Kerri Briesmiester Mei-Lan Huang Carolyn Pappas

David Browning Rebecca Hughes Paulina Radenbaugh

John Burnett Judy Rotthoff

Maria Ceo Marifelice Roulo

Karis Crawford Tom Shanley

Sarah Faix Nan-Sheng Sheng

Mary Greer Jane Sierra

Jaimee Gauthier Sam Silver

Steve Gendler Monica Stiddom

Debbie Gipson Karen Strode

David Golden Gina Vuocolo-Branch

Teri Grieb Mariella Wells

Cathy Handyside Peg White

Jan Hewett Sandy Wilcock

Diane Hilfinger

crao ancillary committee useful tips
CRAO Ancillary Committee Useful Tips
  • 5 core documents required at time of IRB application submission
    • Billing Calendar
    • Informed Consent
    • Protocol
    • Budget (internal/external) when applicable
    • Contract when applicable

Note: Draft versions accepted and satisfactory for CRAO review

crao ancillary committee useful tips cont d
CRAO Ancillary Committee Useful Tips (cont’d)
  • All applicable documents are reviewed for harmony
    • Revisions are made to BC and inconsistencies are shared with study team
  • Budgets assist the CRAO review with the assignment of routine care vs. study
    • Assist in determining study is exempt from CRAO review and no BC is needed
  • If your study does not have a budget and/or contract, note in correspondence within eRRM , e.g., internally funded and/or NIH
compliance challenges
Compliance Challenges
  • Recovery Audit Contractor (RAC) Program
    • Authorized by Congress to identify improper Medicare payments (overpayments and underpayments)
  • Office of Inspector General (OIG)
    • OIG duties carried out through nationwide network of audits, investigations, inspections and other mission-related functions performed by OIG components
    • OIG has an annual work plan and targets specific issues, etc.
compliance risks
Compliance Risks
  • CMS-False Claim Act (highlights)

(a) Any person who…

(1) knowingly presents, or causes to be presented, to an officer or employee of the United States Government or a member of the Armed Forces of the United States a false or fraudulent claim for payment or approval;

(2) knowingly makes, uses, or causes to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the Government;

(3) conspires to defraud the Government by getting a false or fraudulent claim paid or approved by the Government

is liable to the United States Government for a civil penalty of not less than $5,000 and not more than $10,000, plus 3 times the amount of damages which the Government sustains because of the act of that person . . . .

compliance wake up call
Compliance Wake Up Call
  • Rush University Settlement
    • Allegations
      • Improperly billed Medicare for physician and hospital research services as routine care costs under NCD
      • Absence of “synchronization of the Medicare rules, the compensation arrangements with the sponsors, and the financial discussion in the informed consent”
    • Voluntary self-disclosure to DOJ
      • Refund Medicare overpayments plus 50% penalty ($1 million)
      • 3-year Certification of Compliance Agreement (CCA)
      • Require clinical trials to receive a coverage analysis
routine costs do not include
Routine Costs Do NOT Include
  • Investigational item or service itself
  • Items & Services:
    • For which there is no Medicare benefit category or are statutorily excluded
    • Furnished solely to satisfy data collection and analysis not used in clinical management
    • Customarily provided by research sponsor
    • Provided solely to determine eligibility
clinical research billing
Clinical Research Billing
  • Accurate billing of I/S for participants in clinical trials
    • Standard of Care I/S billed to 3rd party payers
    • Research I/S billed to trial sponsors
  • Billing Calendar (BC) also used to allocate appropriate modifier (Q0,Q1) to subject’s medical claim to reflect and investigational device or routine care services provided during approved clinical trial
billing for routine clinical research
Billing for Routine Clinical Research
  • Q0 – For investigational item or service provided during or as part of an approved clinical research study
  • Q1 – For routine item or service provided during or as part of an approved clinical research study

Pub. 100-04, Transmitttal:1418, January 18, 2008, Change Request:5805 Effective Date January 1, 2008.