NCURA Adapting Recovering Repositioning Advancing

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NCURAAdaptingRecoveringRepositioning Advancing

• Prospective Reimbursement Analysis for Clinical
  Trials
• Jennifer Lanter, Associate Director, Research
  Billing Office,
• The Ohio State University Health System
• Suzanne Liv Page, J.D., Director, Clinical
  Research Initiation Services,
• University of Miami
• Karen Roz, Associate Director, Clinical
  Research Support Services,
• Johns Hopkins Medicine

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Objectives

• Review Medicare Clinical Trial Billing Rules.
• Understand the PRA research billing implications
  and impact to studies.
• Gain better understanding of how to perform
  document a Prospective Reimbursement Analysis
  (PRA).
• Learn how to determine standard of care vs.
  research by using resources to justify decisions.
• Learn how to use the determinations to improve
  budgeting process.

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Medicare National Coverage Decision (NCD) for
Clinical Trials

• Created to encourage clinical trial participation
  of senior citizens with Medicare coverage when
  certain criteria are met.
• Effective for items and services furnished on or
  after September 19, 2000, Medicare covers the
  routine costs of qualifying clinical trials, as
  such costs are defined below, as well as
  reasonable and necessary items and services used
  to diagnose and treat complications arising from
  participation in all clinical trials. All other
  Medicare rules apply.
• 1862(a)(1)(e) of the Social Security Act
• www.cms.hhs.gov/ClinicalTrialPolicies

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3 Part Process to Qualifying Clinical Trials (QCT)

• Part 1 Ensure Trial Qualifies for Coverage of
  Routine Costs.
• Part 2 Ensure Routine Costs Meet Criteria for
  Coverage.
• Part 3 Ensure Claims are Coded Correctly and
  Proper Documentation is in Medical Record.

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Part 1 QUALIFYING STUDIES

• A study is deemed as qualifying when
• Evaluates a Medicare Benefit Category
• Therapeutic Intent
• Enrolls Diagnosed Beneficiaries
• AND
• Is funded by one of six federal agencies or is
  under an Investigational New Drug (IND)
  application or is IND Exempt or is under Coverage
  with Evidence Development (CED)

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Part 2 Routine Costs

• In QCTs, Medicare allows expanded coverage
  beyond usual or conventional care that is
  billable.
• Usual/Conventional Care Medically reasonable
  and necessary items and/or services which would
  be provided absent a clinical trial.
• Expanded Care Examples- Administration of the
  investigational item, Clinically appropriate
  monitoring, Prevention, diagnosis and treatment
  of complications. Also includes the Item or
  service under investigation if otherwise covered
  outside of the trial.

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Part 3 Coding Claims

• Medicare requires providers to add the V70.7
  diagnosis code and Q0/Q1 modifiers to claims that
  contain services associated with QCTs.
• Serves as attestation that services performed
  were provided as part of a qualifying study.
• Medicare uses this information to report to
  Congress.
• In Addition, the Trial Name, Sponsor Name
  Sponsor-assigned protocol number must be included
  in the medical record. A copy of the informed
  consent must be readily available if requested.
  Providers may be asked to submit a detailed
  itemization of services billed as routine costs.
• These regulations require providers delivering
  services to identify ALL study services being
  billed to Medicare.

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NCD Medicare Decision Tree, Part 1
Determination of QCT
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NCD Medicare Decision Tree, Part 2 Determination
of Routine Costs
Rev.6/19/06
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Provider Billing Workflow
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What is a Prospective Reimbursement Analysis
(PRA)?

• A PRA is the process of evaluating and
  documenting clinical trial against Medicare and
  third party payer rules.
• PRAs help assure clinical research billing is
  accurately applied to the research study or third
  party insurance.
• Reduces provider risk for non-compliance with
  federal insurance (Medicare, Medicaid) rules.

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When is a PRA needed?

• If it is possible for a charge to be captured in
  a billing system, then a PRA is typically
  created.
• Institutions may develop specific decisions trees
  to identify when a PRA is not needed (for
  example studies using existing specimens).

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Required Documentation to Complete a PRA

• Research Protocol
• Informed Consent Document (IC)
• Investigators Brochure, if applicable
• Funding Information (Contract, Grant, Budget)
• FDA Documentation (e.g. IND, IDE, 510k approval)
• Clinical Practice Guidelines
• Peer Reviewed Articles
• Medicare Benefit Policy Manual
• NCD 310.1 Routine Costs in Clinical Trials
• Local Coverage Decisions

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Prospective Reimbursement Example (PRA)

• A Phase 2 Study to Assess the Safety and
  Efficacy of Drug1 in Kidney Transplant Recipients

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INSTITUTION SCHOOL OF MEDICINE
PRA Memo Header
    Clinical Trial Summary Report Institution
ID - 98765   Date March 5, 2010
D R A F T
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Memo Issues Summary
This Medicare coverage analysis is intended as a
general guideline for use in determining which
items and services are billable to Medicare based
on current benefit policies, coverage
determination, coverage decisions, and federal
guidelines. All items and services that are
billable to Medicare must be supported by medical
necessity in the clinical documentation and are
not limited to what appears on this grid. The
clinical needs of the individual patient and the
judgment of the clinical provider ultimately
determine medical necessity.   A review of the
documents provided has led to the determination
that this is a Qualifying Clinical Trial and
routine care items are billable to Medicare, as
described in the attached billing grid.
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Study Identifying Information

• Name of Study (Protocol Name)
• Phase of Study
• Identification Number
• IRB Number
• Department
• Principal Investigator (PI)
• Sponsor
• Funding Agency
• Location of study
• Status of Study
• Contract Status
• Informed Consent Status
• Study Documents (IND)

A Phase 2 Study to Assess the Safety and Efficacy
of Drug1 in Kidney Transplant Recipients
II
1234-AB-C567
123456789
Surgery
John Smith, M.D.
ABCD Pharmaceutical
ABCD Pharmaceutical
Hospital XYZ, Outpatient clinic ABC
Pending IRB review
Pending negotiations
Pending IRB Review
IND 200,200
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Documents Received for Reimbursement Analysis
Review

• Study Protocol
• ISN/Protocol 1234-AB-C567
• Incorporating amendments 1, 2, and 3
• Dated February 11, 2008
• Clinical Trial agreements/Notice of Grant Award
• Draft CSA, not dated. Include budget and payment
  terms
• Informed Consent Document
• Draft ICF, incorporating Amendment 1, 2, and 3
  dated 12/03/08

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Investigational Item or Service Analysis
Questions
What is the investigational item or service?
What is the FDA status of the investigational item or service?
Does a CMS Benefit Policy, NCD, or LCD allow coverage of the investigational item or service?
Answer
DrugsDrug1, Drug2, Drug3, Drug4.
Drug1 is not approved by FDA for treatment of kidney transplant recipients. Operating in clinical trials under IND 200,200. Drug2 is approved by FDA for prophylaxis of organ rejection in patients receiving allogenic liver or kidney transplants. Drug3 is approved by FDA for prophylaxis of organ rejection in patients receiving allogenic renal, cardiac, or hepatic transplants. Drug4 is approved by FDA for treatment of solid organ transplant immunodeficiency white cell disorders and in renal transplantation in combination with triple immunosuppressive therapy. FDA Drugs
No for Drug1 Yes for Drug2, Drug3 and Drug4 (Medicare Benefit Policy Manual, Ch. 15, Sec. 50.5.1 and Medicare Prescription Drug Benefit Manual, Ch. 6), but Drug1, Drug2 and Drug3, will be provided by sponsor free of charge per ICF, Sec. Costs.
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Qualifying Clinical Trial Analysis
Requirement
Does the investigational item or service fall into a Medicare benefit category?
Does the study have therapeutic intent in the objective?
Does the study enroll patients with diagnosed diseases?
Is the study a deemed trial?
Is the study a qualifying clinical trial?
Yes No Comment
X The investigational product is a member of Medicare benefit category Drugs and Biologicals.
X Yes, studys objectives are to assess the safety and efficacy of Drug1 in combination with calcineurin inhibitor (CNI) minimization compared to a comparator regimen to assess the safety and efficacy of Drug1 in a regimen without Drug3 compared to a comparator regimen to assess the safety and efficacy of different Drug1 dosing regimens with CNI minimization (Protocol, Sec IV Synopsis).
X Yes, study enrolls the patients with the diagnosis of being a recipient of a kidney transplant from non-HLA identical related living donor, a non-related living donor, or deceased donor (Protocol, Sec. 3.2).
X Yes, study is conducted under IND 200,200.
X Yes
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Sponsor Agreement (Grant Contract ) Review

• The clinical trial agreement specifies payment
  for
• the following participant care costs
• As set forth in Exhibit A Payment Terms of
  CSA. The Per Subject Fee (as defined in
  Exhibit A) is intended to compensate Study Site
  for the time and materials, supplies and
  resources utilized by the Study Site in carrying
  out the Protocol.
• The maximum per subject fee for this study is
  17,000

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Informed Consent Review

• In the Informed Consent Form Draft dated
• 12.03.08, the financial disclosure language
  states
• that the participant and their insurer will not
  be
• billed for
• Study drug Drug1 for the duration of the study.
• Following drugs Drug2, Drug3 for the duration
  of the study.
• Any tests or procedures that are required by the
  study, which are not part of the routine care of
  kidney transplant patients.

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Items and Services Analysis
Routine Care Standards Used
National Kidney Foundation Chronic Kidney
Disease A Guide to Select NKF KDOQI Guidelines
and Recommendations 2006
National Institute for Clinical Excellence
(NICE), London (UK) Immunosuppressive therapy
for renal transplantation in adults
Items and Services
See attached billing grid.
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Sources of Information for PRA Billing Grid

• Protocol schedule of assessments (events),
  detailed information on assessments
• Informed consent detailed information on flow
  of clinical assessments
• PRA Memo locations of services, clinical
  guidelines to define routine services

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Sources of Information for PRA Billing Grid
(continued)

• Principal Investigator and the study team
  clarification of clinical assessments
• Medicare Internet Only Manuals (IOMs)
• Medicare Coverage Database - National and Local
  Coverage Determinations (NCDs, LCDs)

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Building PRA Billing Grid

• Copy Schedule of Assessments table from the
  Protocol into Excel spreadsheet
• If table is not available or cannot be copied,
  create the table in Excel spreadsheet and
  populate all necessary fields
• Create header with the Protocol name and
  identifying number and Medicare coverage
  disclaimer

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Building a PRA Billing Grid (continued)

• Copy footnotes from the Protocol into PRA Billing
  Grid or enter them manually
• Place the legend of the abbreviations used in the
  Billing Grid as bottom footnotes
• Make determination for each item on the grid
  whether it is non-billable, billable to
  Medicare/Third Party carrier, or Sponsor

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Building a PRA Billing Grid (continued)

• Determine and enter the location of service for
  each item on the grid
• Insert comments for each item on the grid
  justifying the determination made regarding to
  whom service will be billed.
• If billable to Medicare use Medicare coverage
  information (IOMs, NCDs, LCDs) to justify your
  determination

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PRA Billing Grid
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PRA Billing Grid - Header
Title
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PRA Billing Grid
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PRA Billing Grid Schedule
Study Schedule
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PRA Billing Grid
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PRA Billing Grid Study Assessments
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PRA Billing Grid
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PRA Billing Grid - Footnotes
Footnotes
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PRA Billing Grid
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PRA Billing Grid Locations and Comments
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MEDICARE COVERAGE INFORMATION

• Medicare Benefit Policy Manual, Ch. 11 ESRD
• Medicare Benefit Policy Manual, Ch. 15, Sec.
  50.5.1 "Immunosuppressive Drugs"
• Medicare Prescription Drug Benefit Manual, Ch.6.
• NCD 310.1 "Routine Costs in Clinical Trials"

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PRA Billing Grid
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PRA Billing Grid Billing Determination
Grid Center
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Document Communicate

• Documenting each step of the PRA serves as an
  excellent communication tool and billing guide
  for key personnel
• Coordinators
• Contracting personnel
• Department Administrators
• Grant Administrators
• Providers
• Helps everyone ensure the billing is done right!
• Also serves as a great auditing tool!

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Questions?

• Jennifer Lanter jennifer.lanter_at_osumc.edu
• Suzanne Liv Page SPage3_at_med.miami.edu
• Karen Roz rozka_at_jhmi.edu