USING KAISER PERMANENTE HEATLHCONNECT EPIC to FACILITATE RESEARCH STUDY MANAGEMENT

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USING KAISER PERMANENTE HEATLHCONNECT (EPIC) to
FACILITATE RESEARCH STUDY MANAGEMENT

• Ted Palen, PhD, MD, MSPH
• Colorado Permanente Medical Group
• Deanna Kurz, BA, CCRP
• Institute for Health Research
• Denver, CO

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Acknowledgements

• Alice Alexander
• Revenue Cycle Analyst

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Issues with non-standardized documentation

• Billing errors
• Patients enrolled in research studies have
  received bills for services related to the
  research
• Need
• Standardized medication orders
• Immunizations formatted to account for research
  related administration
• Laboratory and radiology orders associated with
  research should not generate copays
• Formatting of SmartSets to account for billing
  issues
• Mixed visits versus Research only encounters
• Research related procedures and orderables within
  a mixed visit may
• Generate a bill to a patient if not formatted
  correctly
• Creates downstream accounting problems

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Compliance with QO Modifier Code

• Add Q0 Modifier code to orders
• Q0
• A claim that contains an investigational
  clinical service must use the Q0 modifier on the
  HCFA 1450 form (for facilities) or HCFA 1500 form
  (for physicians).
• Physician practices must enter Q0 in the
  modifier section of the Medicare claim form for
  CPT code 33249 (full system implant) or 33240
  (replacement generator).
• Hospitals must enter the Q0 in the modifier
  section of the Medicare claim form for CPT Codes
  33249 (full system implant) and CPT code 33240
  (replacement).
• The Q0 modifier should be used in the same way
  that the QR modifier was previously used
• Q0 - Investigational clinical service provided in
  a clinical research study that is in an approved
  clinical research study
• Investigational clinical services are defined as
• items and services that are being investigated as
  an objective within the study
• Investigational clinical services may include
  items or services that are approved, unapproved,
  or otherwise covered (or not covered) under
  Medicare.
• The Q0 modifier replaces QA and QR.

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Compliance with Q1 Modifier Code

• Add Q1 modifier to orders
• A claim that contains a routine clinical
  service must use the Q1 modifier on the forms
• Q1 - Routine clinical service provided in a
  clinical research study that is in an approved
  clinical research study
• Routine clinical services are defined as
• those items and services that are covered for
  Medicare beneficiaries outside of the clinical
  research study
• are used for the direct patient management within
  the study
• do not meet the definition of investigational
  clinical services
• Routine clinical services may include items or
  services required solely for the provision of the
  investigational clinical services
• administration of a chemotherapeutic agent
• clinically appropriate monitoring, whether or not
  required by the investigational clinical service
  (e.g., blood tests to measure tumor markers)
• items or services required for the prevention,
  diagnosis, or treatment of research related
  adverse events (e.g., blood levels of various
  parameters to measure kidney function)
• The Q1 modifier replaces QV.

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Other Research Issues

• What about Data collected for a particular study
  only
• How should it be hidden from use in other
  studies and queries
• Ongoing discussion
• Continuation of KP members enrolled in studies
  who lose KP
• Continue using their MRNRequires documentation
  in a Research Encounter
• Enrolling non-KP members in studies
• Use of Reserve MRNs
• Remove V code for research at end of study
• Kathy McGinnis from National Revenue Cycle
  Division
• April 9th, 230 pm
• Discuss how to standardize research documentation
  across KP

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KPHC and IHR

• Inform KPHC early proposal development
• Type of study
• Impact on KPHC
• KPHC resources
• Formatting data
• Data collection methodology
• SmartSets
• Questionnaires
• Documentation flowsheets
• SmartText
• Edit/Enter results
• Other?
• Access to data
• Access to Test Environment

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Patient Research Encounters

• Goals
• Scheduling Research Encounters
• Set-up Research Accounts in Epic
• Triggering Research Encounters
• Documenting Research Encounters
• Orders
• Medications
• Procedures
• Research Modifiers and Codes
• Track Research Billing Information
• Use of Research Data for Reporting

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Research Account Ledger
IRB approval
Inform KPHC
Enroll Patients
Reconcile Accounts
? Mixed visit ?
Trigger Research Encounter
Reports
Document Research Encounter
Research database Track Res. Studies Orders/Result
s Dx
Track utilization of Ancillary Services
Reimburse Ancillary Dept.
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Research Schedule Template
For separate research dedicated blocks in
schedule OR For intermingling research and
normal scheduled patients
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Display Research Schedule Template
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Edit Research Schedule Template
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Edit Research Schedule Template
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Edit Research Schedule Template
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Research Schedule Template
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Research Accounts from General Ledger
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Set-up Research Account in Epic
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Set-up Research Account in Epic
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Scheduling a Research Appointment
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Scheduling a Research Appointment
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Scheduling a Research Appointment
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Scheduling a Research Appointment and Associate
it with Study Account
General Ledger Research Account List
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Scheduling a Research Appointment
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Patient Check-in
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Patient Check-in0.00 Co-pay for Research Visit
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Viewing Researchers Schedule
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Viewing Researchers Schedule(with patient snap
shot)
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Triggering a Research Encounter from Researchers
Schedule
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Triggering a Research Encounter
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Documenting a Research Encounter
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Documenting a Research EncounterUsing Visit
Navigator
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Order Entry
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Assign Research Class to Order
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Assign Research Class to Order
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Add Study Medications to Kaiser Formularyusing
Kaiser naming standards
STUDY ltSTUDY NAMEgt ltDRUG NAMEgt
ltSTRENGTH(S)/PLACEBOgt ltDOSAGE FORMgt
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Order Study Medications
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Assignment of Modifier Codes for Medicare Patients

• Q0 - Investigational clinical service provided in
  a clinical research study that is in an approved
  clinical research study. Q0 replaces QA and QR.
• Q1 - Routine clinical service provided in a
  clinical research study that is in an approved
  clinical research study. Q1 replaces QV.
• Source Centers for Medicare and Medicaid
  Services
• http//www.cms.hhs.gov/ContractorLearningResources
  /downloads/JA5805.pdf

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Q0 Modifier

• Investigational clinical services
• items and services that are being investigated as
  an objective within the study
• Investigational clinical services may include
• items or services that are approved, unapproved,
  or otherwise covered (or not covered) under
  Medicare

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Q1 Modifier

• Routine clinical services
• items and services covered for Medicare
  beneficiaries outside of the clinical research
  study
• are used for the direct patient management within
  the study
• do not meet the definition of investigational
  clinical services
• Routine clinical services may include
• items or services required solely for the
  provision of the investigational clinical
  services (e.g., administration of a
  chemotherapeutic agent)
• clinically appropriate monitoring, whether or not
  required by the investigational clinical service
  (e.g., blood tests to measure tumor markers)
• items or services required for the prevention,
  diagnosis, or treatment of research related
  adverse events (e.g., blood levels of various
  parameters to measure kidney function).

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Identifying Medicare Patients
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Identifying Medicare Patients
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Assignment of Modifier Codes
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Assignment of Modifier Codes
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Assignment of Modifier Codes
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Assignment of Modifier Codes
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Assignment of Modifier Codes
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Modifier Assignments in Billing System
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CLINICAL TRIAL PARTICIPANT EXAMINATION V70.7

• Routine costs submitted to carriers for services
  furnished to Medicare beneficiaries
• who are healthy, control group volunteers
  participating in qualifying diagnostic clinical
  trials
• Used in conjunction with line item Q1 modifier
• Submitted as the primary diagnosis
• Source Centers for Medicare and Medicaid
  Services
• http//www.cms.hhs.gov/ContractorLearningResources
  /downloads/JA5790.pdf

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CLINICAL TRIAL PARTICIPANT EXAMINATION V70.7

• If submitted to carriers as a secondary diagnosis
• It is not consider service furnished to a
  healthy, control group, diagnostic trial
  volunteer
• Instead, processed as a therapeutic clinical
  trial service
• with condition code 30 (qualifying clinical trial)

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Entering V-codes for Participants in a Clinical
Trial
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HEALTH EXAMINATION OF DEFINED SUBPOPULATION
V70.5

• For clinical trial bills for managed care
  enrollees to be paid
• providers must report condition code 30
• Non-research Services Provided to a Patient
  Enrolled in a Qualified Clinical Trial
  (effective with the 2001.2 systems release)
• ICD-9 code V70.5
• the second or subsequent diagnosis code

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V70.5

• Attestation that the service meets the Medicare
  coverage criteria
• Q1 procedure code modifier
• V70.5 diagnosis code
• Services furnished to a beneficiary
• who is participating in a qualifying clinical
  trial
• represents a routine cost of patient care,
  including
• treatment of complications arising from
  participation in a qualifying clinical trial)
• Items and services that are provided solely to
  satisfy data collection and analysis needs and
  are not used in the clinical management of the
  patient are not covered and may not be billed
• Source Centers for Medicare and Medicaid
  Services
• http//www.cms.hhs.gov/ClinicalTrialPolicies/Downl
  oads/programmemorandum.pdf

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Medicare Coverage for Clinical Trials

• Qualifying Trial
• Evaluates a Medicare Benefit
• Has a Therapeutic Intent
• Enrolls Diagnosed Beneficiaries
• Has Desirable Characteristics. The desirable
  characteristics are listed in the NCD.
• Deemed Trials
• Trials funded by the National Institutes of
  Health (NIH)
• Centers for Disease Control and Prevention (CDC)
• Agency for Healthcare Resesarch and Quality
  (AHRQ)
• CMS
• Department of Defense (DOD)
• Department of Veterans Affairs (VA)
• Trials supported by centers or cooperative groups
  that are funded by the NIH, CDC, AHRQ, CMS, DOD
  and VA
• Trials conducted under an investigational new
  drug application (IND) reviewed by the Food and
  Drugs Administration (FDA)
• Drug trials that are exempt from having an IND
  under 21 CFR 312.2(b)(1)
• Self-Certified Trials
• No trials are covered based upon
  self-certification at this time.

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Routine Costs

• Routine costs do NOT include (and are therefore
  are not covered)
• The investigational item or service, itself
• Items and services
• For which there is no Medicare benefit category,
  or
• Which are statutorily excluded, or
• That fall under a national noncoverage policy
• Items and services furnished solely to satisfy
  data collection and analysis needs that are not
  used in the direct clinical management of the
  patient (e.g. monthly CT scans for a condition
  usually requiring only a single scan)
• Items and services customarily provided by the
  research sponsors free of charge for any enrollee
  in the trial
• Items and services provided solely to determine
  trial eligibility
• Routine costs DO include (and are therefore
  covered)
• Items or services that are typically provided
  absent a clinical trial (e.g., medically
  necessary conventional care)
• Items and services required for the provision of
  the investigational item or service (e.g.,
  administration of a non-covered chemotherapeutic
  agent)
• Items and services required for the clinically
  appropriate monitoring of the effects of the item
  or service, or the prevention of complications
• Items and services that are medically necessary
  for the diagnosis or treatment of complications
  arising from the provision of an investigational
  item or service.

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Entering V-codes for Medicare Members in a
Clinical Trial
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Entering V-codes
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Add V-code to Problem List
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Clinical Trial Participant Notation on Problem
List
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Using Epic for Research Documentation

• Set-up Research Schedule Template
• Combined appointment template or Study specific
  blocks
• Set-up Research Encounter type
• Study providers list
• Department locations
• Visit Navigator defaults
• Smartsets, Smart texts, letters to support study
  specific objectives
• Using Research Encounter type
• No co-pay
• Extract research study specific data
• Research Visit type
• Chief Complaint
• Research Study (reason for visit field)
• V70.7, V70.5 codes in Diagnosis field
• Order Class Research
• Order Modifiers Q0, Q1

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Using Epic for Research Documentation

• Using Research billing account association
• Reimburse ancillary departments for utilization
  costs from study funds
• Separate study procedures costs from routine
  utilization costs
• Documentation of HMO members and non-members
  enrolled in clinical trials
• Use of Reserve MRN for non-Kaiser members in
  research
• Fulfill Research Compliance Regulations
• Track Medicare Study Costs, Utilization and
  Reporting
• Support the submission of CMS claim forms

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PHI

• Can the EMR be used to collect all research data?
• Study Data collected is IRB approved for use in
  current study only
• If collected and coded, would it or could it be
  used again for other study activities
• How could it be hidden from use in other
  studies and queries?
• Does this EMR research data need to be managed
  and if so by whom?
• Does accurate coding help resolve this dilemma?

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PHI (Contd)

• Can or does research documentation need to be
  hidden for release of medical records request?
• What are the state policies on providing
  insurance to those who have participated in a
  research study?
• If coded properly can the research documentation
  be removed from the medical records prior to
  releasing the information?

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Other Things to think about

• Continuation of members enrolled in studies who
  change insurance or providers
• Continue using their current MRN?
• What billing ramifications are there if only
  study activities are covered?
• Can the system be set up to assure only covered
  study activities are being completed?
• Enrolling non-KP or uninsured patients in
  studies?
• Use of Reserve or temporary MRNs,
• Who trains the analysts and data abstractors on
  PHI regulations and requirements?

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Things we haven't thought about
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Discussion/Questions
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Discussion/Questions