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Clinical Trials: Cost Coverage and Implications for the Clinical Trials Nurse. Objectives. Discuss the costs and health care plan coverage issues associated with clinical trial participation. Identify the key components of the Medicare 2000 National Coverage Decision.

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Presentation Transcript
objectives
Objectives
  • Discuss the costs and health care plan coverage issues associated with clinical trial participation.
  • Identify the key components of the Medicare 2000 National Coverage Decision.
  • Properly identify standard of care costs from research costs per regulations and link it to the budgeting, negotiation and payment process.
  • Describe systems for accurate research billing and common pitfalls
the ties that bind
The Ties that Bind
  • Clinical Research is important to cancer treatment
    • Improved cancer care with new therapies
    • Defined standards for optimal cancer treatment
    • Provides options when there are no known treatments for a disease
    • Provides a potentially more effective and less toxic treatment

(American Society of Clinical Oncology, 2003; Association of Academic Health Centers, 2009)

understanding the landscape
Understanding the landscape
  • Complex infrastructure
  • Little noted and rarely studied
  • Rapidly changing environment in recent years as a result of
    • Increased research activity
    • Mounting regulatory requirements
    • Escalating costs

(American Society of Clinical Oncology, 2003; Association of Academic Health Centers, 2009)

costs coverage
Costs & Coverage
  • Cancer patients who enroll in clinical trials may face the critical issue of how to cover the costs of care
  • Health insurance coverage may not include some or all of the costs associated with participation in a clinical trial
  • Some plans may define clinical trials as “experimental” or “investigational”

(Association of Academic Health Centers, 2009; National Cancer Institute, U.S. National Institutes of Health, 2009)

what is the legislation
What is the Legislation?
  • Federal
    • National Coverage Decision on Clinical Research (Clinical Research Policy)
      • Billing for Clinical Services in a Clinical Trial
      • Notification to Subjects regarding Costs
  • Local
    • Local Medicare Review Policies (LMRP’s)

(CMS Medicare National Coverage Determinations Manual, 2009)

the era of managed care
The Era of Managed Care
  • Managed Care Organizations and Health Insurance companies determine the services they will pay for by developing a coverage policy that is applied to all members
    • Established Service
    • Investigational Service

(Emanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003, National Cancer Institute, U.S. National Institutes of Health, 2009)

established versus investigational
Established:

A service is designated “established” if there is sufficient scientific data to support that it is safe and effective.

Investigational:

A service for which the health plan declares insufficient scientific data to support safety and efficacy.

Leads to payment denial

Lengthy and often unsuccessful appeal process

Established Versus Investigational

(Emanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003, National Cancer Institute, U.S. National Institutes of Health, 2009)

clinical trial criteria for coverage
Clinical Trial Criteria for Coverage
  • Sponsorship
    • Some plans may cover costs of trials sponsored by organizations that provide rigorous scientific review and regulatory oversight such as the NCI, according to standards set by the health plan.

(National Cancer Institute, U.S. National Institutes of Health, 2009)

clinical trial criteria for coverage10
Clinical Trial Criteria for Coverage
  • Trial phase and type
    • Some plans may cover patient care costs only for the clinical trials they judge to be "medically necessary" on a case-by-case basis. The phase of the trial may also affect coverage; for example, while a plan may be willing to cover costs associated with phase III, which include treatments that have already been successful with a certain number of people, the plan may require some documentation of effectiveness before covering a phase I or phase II trial.

(National Cancer Institute, U.S. National Institutes of Health, 2009)

clinical trial criteria for coverage11
Clinical Trial Criteria for Coverage
  • Cost "neutrality“
    • Some health plans may provide limited coverage for trials they consider cost-neutral (i.e., not significantly more expensive than the treatments considered standard).

(National Cancer Institute, U.S. National Institutes of Health, 2009)

clinical trials billing
Rose Ermete RN, BSN, OCN, CCRP

Oncology Research Nurse

St. Mary Mercy Hospital

Clinical Trials Billing
clinical trials billing overview
Clinical Trials Billing Overview
  • The Importance of Compliance
  • Billing Rules
  • Systems to ensure appropriate billing
why is this important
Why is this Important

(Meade , 2009; Pitler & Bloom 2006; Barnes & Korn 2005)

  • Data Mining by CMS
    • Evaluation of all Claims with Modifiers
    • Assessment across the institution
  • The Cost of Non-Compliance
    • Criminal & Civil Penalties
    • Ability to conduct Federally Funded Research
    • Exclusions from Medicare/Medicaid
    • Adverse Public Relations
    • Qui Tam: Whistle blowers
false claims settlements
False Claims Settlements

Compliance Rules = Fraud Rules

The False Claims Act :Civil Penalties for persons who knowingly make or cause to be made, false claims to the government.

Services paid for by sponsor

Services promised for free in the Informed Consent

Services that are for research purposes only

Services that are part of a non-qualifying clinical Trial

Fraudulent Claims :

Liable to the US Government for civil penalty of not less than $5,000 and not more than $10,000 plus 3 X the amount of damages.

( Beach & Strehlow, 2006; Meade, 2006; FCA, 2007)

slide17

Partial List of OIG/DOJ Investigations

  • Rush University 1.0 million settlement
  • New Jersey Medical 2.0 million settlement
  • Johns Hopkins 2.6 million settlement
  • Beth Israel Deaconess 3.2 million settlement
  • University of Alabama 3.4 million settlement
  • Cornell University 4.3 million settlement
  • UCSD 4.7 million settlement
  • Northwestern University 5.5 million settlement
  • Medical College of Georgia 6.1 million settlement
  • Mayo Clinic 6.5 million settlement
  • Yale University 7.6 million settlement

(Based on information from: Schwab, 2009 & TAF, 2008)

lessons from rush
Lessons from Rush

Inspection Findings:

Billed third parties for sponsor paid services

Billed for services promised for free in the informed consent

Billed for services that did not meet the definition of routine costs

Coordination & Communication

No Centralization of billing process

Lack of Coordination between research and billing department

The settlement indicates what the government is looking for from providers who conduct clinical trials.

Centralization & documentation

Oversight throughout institution

Monthly account/reconciliation

(Schwab, 2009; Boyd & Meade, 2007; Pfadenhauer, 2006)

billing rules
Billing Rules

Basic Rules:

No double dipping

If the service if provided free, you cannot bill for it (Secondary-payer rule)

Must be an already covered service

The National Coverage Decision (NCD)

Covers routine costs of qualifying clinical trials

Coverage discretion is up to local Medicare contractors

Medicaid is different – does not address research

Insurance Companies: 29 states require commercial insurance cover clinical trials.

(Barnes & Korn, 2005 ;CMS Medicare National Coverage Determinations Manual, 2009; Meade 2006)

states requiring health plans to cover patient care costs in clinical trials
States Requiring Health Plans to Cover Patient Care Costs in Clinical Trials

(National Cancer Institute, 2009)

the patient protection affordable care act of 2010
The Patient Protection & Affordable Care Act of 2010

Signed into law March 23, 2010; Public Law No: 111-148

In General – If a group health plan or a health insurance issuer offering group or individual health insurance coverage provides coverage to a qualified individual, then such plan or issuer:

May not deny the individual participation in a clinical trial referred to in subsection (b)(2)

Subject to subsection (c), may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and

May not discriminate against the individual on the basis of the individual’s participation in such trial.

Limitations – subsection (c)

HR 3590 Sec.10103 & 2709 retrieved from: http://frwebgate.access.gpo.gov

pending legislation
Pending Legislation

Improving Access to Clinical Trials Act (S.1674)

Introduced by Senator Ron Wyden (D-Oregon),

Exempt the first $2,000 a year in compensation for clinical trial participation from determining Social Security Insurance or Medicaid benefits

Currently pending before the Senate Finance Committee

what is a qualifying trial
What is a Qualifying Trial?

Three Requirements

The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category and is not statutorily excluded from coverage

The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent

Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers

Deemed Studies

Trials funded by NIH, CDC, AHRQ, CMS, DOD and VA

Supported by centers or cooperative groups that are funded by the above

Conducted under an IND reviewed by the FDA

IND exempt studies

(Pitler & Bonomi, 2006; CMS National Coverage Determination Manual, 2009; Barnes & Korn, 2005)

what is a qualifying trial26
What is a Qualifying Trial?

Seven Desirable Characteristics

Principal purpose has to test if the intervention potentially improves the subjects health outcomes

Well-supported by available scientific and medical information or intended to clarify or establish the health outcomes of interventions already in common clinical use

Does not unjustifiably duplicate existing studies

Design is appropriate to answer the research question being asked

Sponsored by a credible organization or individual capable of executing the proposed trial successfully

Compliance with Federal regulations relating to the protection of human subjects

Conducted according to the appropriate standards of scientific integrity

Deemed Clinical Trials are deemed by CMS as inherently having these characteristics

(Boyd & Meade, 2007; CMS Medicare National Coverage Determinations Manual, 2009; Lanter, 2008)

coverage under the ncd ctp
Coverage under the NCD (CTP)

What is Covered

Items and services provided absent of a clinical trial

Required solely for the provision of the investigational item

Reasonable and necessary care for the diagnosis or treatment of an illness or injury

What is not Covered

Data Collection and analysis

Items and services customarily provided by the research sponsors free of charge

Items and services provided solely to determine trial eligibility

The investigational item or service itself, unless otherwise covered outside the clinical trial

A Medicare benefit category does not exist for the service

(Barnes & Korn, 2005; CMS National Coverage Determination Manual, 2009)

routine vs standard of care
Routine vs. Standard of Care

Routine Care:

Services that would take place as a result of a regular course of treatment for cancer care, However:

Consistency doesn’t always exist, just because it is routine in one practice, does not mean it will be covered.

National Therapeutic Standards

NCCN Guidelines

ACOS Guidelines

Peer Reviewed Journal

Not all routine care is covered

Routine Costs also include:

Reasonable & necessary to diagnose or treat

Services required for the clinically appropriate monitoring or diagnosis of the effects of the item or service, or prevention of complications.

(Barnes & Korn, 2005, Meade, 2009; MLN Matters MM6431, 2009; Pitler & Ponomi, 2006; Seiner & Murtha, 2006; Turgon & Welter, 2008)

gratuitous services
Gratuitous services

Items provided gratuitously without regard to beneficiaries ability to pay

Anti- Kickback Statute 42 U.S.C. § 1320a-7b

Provides for penalties against anyone who knowingly and willfully receives, gives, solicits or offer any payment or other form of remuneration with the intent to induce or influence the purchase, order, or referral of drugs, devices, products, services or other items reimbursable under a federal health care program

Penalties for violations of the statue include a fine of not more than $25,000 or imprisonment for up to five years, or both.

(AKS, 2007; CMS Medicare Benefit Policy Manual, 2009; MLN Matters SE0822., 2009)

coding rules
Coding Rules

Secondary diagnosis code: V70.7

Examination of participant in a clinical trial

Used for inpatient & outpatient

Healthcare Common Procedure Coding System (HCPCS) modifier:

Q0: Investigational clinical services defined as those items and services that are being investigated as an objective within the study.

Q1: Constitute medically necessary routine patient care or treatment of complications arising from a Medicare beneficiary's participation in a Medicare-covered clinical trial.

HCPCS modifiers are only used in the outpatient setting

8 Digit clinical trial number is optional

Inpatient or outpatient

(CMS Medicare Claims Processing Manual, 2009; Creighton University, Use of the Q0 & Q1 Modifiers)

strategies for compliance
Strategies for Compliance

Challenges

Billing systems

Decentralization

Identifying the research patient

Budgets

Part of Institutional Compliance Program

Communication and Coordination are essential!

Identify Team members: everyone needs to know their role

Centralization

Institution wide process

Research Billing Effects all phases of a research project

Centralized around the institution’s core values of integrity, accountability and quality

DOCUMENTATION

(Lester, 2009;Nelson, 2009; Pfadenhauer, 2006; Steiner & Murtha, 2006)

developing a process
Developing a Process

Mapping the Process – Flowchart

Step by step process

Who pays for what, and how are charges routed to the appropriate payer

Patient identification

Specify payment procedures

Coverage Analysis

A systematic review of study related documents to determine which items are billable to Medicare (Billing Plan)

Standardized throughout institution, all team members should have access to.

(Barnes & Korns, 2005; Kulko, 2009; Nelson, 2009; Pitler & Bonomi, 2006; Steiner & Murtha, 2006)

coverage analysis con t
Coverage Analysis con’t

Maintain a current list of hospital charges for frequent tests and procedures

Identify sources of funding for each item/service

Protocol

Contract

Informed Consent

Budget

Identify costs not covered

Non-routine costs

Costs with no Medicare benefit category

Data Management costs

slide34

Hypothetical MCA: Manage the Information

M=Medicare

S=Sponsor

ICF=Free in Informed Consent

NB=Not billable to Medicare

Note: Figure courtesy of Meade, 2009. Used with Permission.

34

34

billing grid example
Billing Grid Example

Note: Figure courtesy of Lanter, 2008. Used with permission

charge identification models
Charge Identification Models

Front-end Process

Identifies patient upfront

Study specific order forms / charts

Coverage Analysis in chart with central repository

Back-end Process

Review charges after service rendered

Hold on patient’s account for review against coverage analysis

Designated reviewers

(Boyd & Meade, 2007; Kulko, 2009; Nelson, 2009)

evaluation
Evaluation

Audit Mechanisms

Include a sample of active and past years accounts and protocols

Compare accrual information and protocol documents to funds billed and received.

Review invoice details to confirm that services were not billed to Medicare or other third party payers in error

Document findings, and implement procedures to correct problems

Self- Report errors

(Meade, 2006; Turgon & Welter, 2008)

clinical trial budgeting negotiations
Clinical Trial Budgeting & Negotiations

Denise Friesema, MS, RN, OCN

Director, Clinical Research Operations

University of Chicago Medical Center

types of trials sponsorship
Types

Drug Studies

Device Studies

Registry Studies

Observational Studies

Sponsorship

Cooperative Agreements (eg CALGB, SWOG, GOG, RTOG)

Industry Sponsored

Investigator Initiated

Federal Grants & Subcontracts

Types of Trials & Sponsorship
three main types of support provided by a sponsor
Three Main Types of Support Provided by a Sponsor
  • $$$
  • Drug
  • Device

Support = Contract

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

what is a clinical trial agreement the contract
What is a Clinical Trial Agreement? “The Contract”
  • A legally binding formal agreement between the “Sponsor” and the “Institution”
  • Sponsor may provide
    • Study drug or device
    • Financial Support
    • Proprietary Information
  • Institution may provide
    • Data
    • Publication/Input into Publication
    • Intellectual Property

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

why do we need a contract
Why do we need a contract?
  • Define the scope of work
    • Parties, performance period, Responsibilities
  • Protect rights of all parties
    • Publication, Patents/Inventions/Intellectual Property
  • Secure Confidential Information
    • HIPAA, Confidentiality

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

why do we need a contract44
Why do we need a Contract?
  • Payment for work completed
    • Budget/Staff support
  • Compliance
    • Indemnification, Best efforts/Protocol compliance
  • Preparation for the Unexpected
    • Subject Injury, Termination

Bottom Line = Reconcile Institutional policies with the needs of the Sponsor

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

sections of the agreement
Acknowledgments & Responsibility

Terms & Termination Clause

Payment/ Reimbursement of Costs

HIPAA

Publication

Intellectual Property

Confidentiality/ Proprietary Information

Indemnification

Insurance

Subject Injury

Sections of the Agreement

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

clinical trial budget basics
Important Questions

Are the scientific value and ethical quality of the study acceptable?

Do I have an adequate pool of potential subjects?

Does the proposed budget support the work described in the protocol?

If the answer to any of these questions is no, decline the trial.

Clinical Trial Budget Basics

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

clinical trial budget basics47
Clinical Trial Budget Basics
  • Important to remember: the budget should reflect the proposed work in the protocol not the sponsor’s proposed budget
  • Review the schedule of visits in the protocol and begin drafting a budget (note: perform this step regardless of whether or not you have received the sponsor’s budget)

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

4 components of a budget
Study Initiation / Start Up Fees

a) IRB

b) CCTO

c) Pharmacy

d) CRC

e) Other…

2) Clinical Care Expenses

Items deemed research related on the schema

by PI

3) Study Implementation & Oversight Expenses

a) Staff time

b) Supplies

c) Parking stickers

d) Other….

4) Indirect Costs

25% Non-Federally Funded

53.5% Federally Funded

4 Components of a Budget
identify the costs
Administrative Costs

Patient Care Costs

Trial Costs

Identify the Costs
administrative costs
Clinical Trial Office Fees

Additional regulatory submissions (amendments, SAEs)

Institutional Fees

IRB

Pharmacy Fees

Indirects

Non-refundable!

Administrative Costs

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

direct versus indirect
Direct versus Indirect
  • Direct costs
    • Expenses directly related to the trial
      • Personnel
      • Supplies & Equipment
      • Laboratory Costs
  • Indirect costs
    • Costs incurred not directly related to the trial
    • Referred to as institutional overhead
      • Building maintenance
      • Departmental administration
      • Basic utilities
      • Rent for office/laboratory space
    • Vary from institution to institution
      • Average is about 20-40%

(

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

patient care costs
Procedures by Coordinator, PI, and Hospital Costs/Fees

Example: lab draw

- Coordinator collects sample

- Hospital analyzes sample

- PI interprets analysis

- Core or Central Labs

Hospital Procedures-know the contact for prices; research rates, if any; costs to the research, i.e. charge vs. cost

Profee costs

Assign costs to the ENTIRE procedure

Patient Care Costs

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

trial costs
Screening Logs

Screen Failures

Electronic Data Management Training

Recruitment

Storage

Other study visits

Monitor visits

Study initiation (all-inclusive)

Trial Costs

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

trial costs investigator
Protocol Development

Site Initiation Visit

Protocol amendment management

External safety reports

Monitor site visits

Conference Calls

Trial Costs: Investigator

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

trial costs the coordinator
Regulatory

Files-electronic and hard copy binders

Communication-phone, fax, email

Case Report Form-data entry and maintenance

Scheduling-subject visits and procedures

Sponsor queries

Tracking

Trial Costs: The Coordinator

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

staff labor training
Staff Labor & Training
  • Hardest portion of budget to estimate
  • Potentially greatest source of error
  • Considerations:
    • Complexity of studies
    • Data Monitoring
    • Reporting of Unexpected Problems
    • Patient Follow-up

(Johnson, G.P., 2003; O’Brien, J.A., 2007)

staffing
Staffing
  • Published literature is lean
  • No guidance on what maximum workload is in terms of coordinator to subject or coordinator to protocol ratios
  • Questions to Ponder
    • What number of staff do you need?
    • When is it time to add additional staff?
    • How do you allocate resources fairly?
    • What is the maximum number of studies or subjects that can be safety and effectively managed by one person?

(Gwede, C.K., Johnson, D., & Trotti.A, 2000a; Johnson, G.P., 2003; O’Brien, J.A., 2007)

staffing58
Staffing
  • Current Methods
    • Trial & Error
    • Crisis Management
      • Burnout
      • Staff turn over
      • Juggling of studies from one coordinator to the next
    • Appearance

(Fowler, D.R., & Thomas, C.J., 2003; Gwede, C.K., Johnson, D.J., Roberts, C., Cantor, A.B., 2005; Gwede, C.K., Johnson, D., & Trotti.A, 2000a; Johnson, G.P., 2003; O’Brien, J.A., 2007)

staffing59
Staffing
  • Current methods are suboptimal
  • Current methods lead to plummeting morale
  • Current methods lead to training and re-training which is costly and time-consuming
  • Current methods result in regulatory non-compliance & poor quality work
  • Current methods are inequitable measures

(Fowler, D.R., & Thomas, C.J., 2003; Gwede, C.K., Johnson, D.J., Roberts, C., Cantor, A.B., 2005; Gwede, C.K., Johnson, D., & Trotti.A, 2000a; Johnson, G.P., 2003; O’Brien, J.A., 2007)

staffing60
Staffing
  • Use a quantitative approach
  • A business approach is needed based on information and a decision making process
  • Use activity based costing (the bean counters way)
    • Estimate costs
    • Allocate the FULL cost of the project (direct labor, material, fixed and variable overhead)
    • Allocate staff on the basis of how the product actually consumes or causes activities

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

studies on workload management
Studies on Workload Management
  • Literature is sparse
  • Utilization of accrual data (numbers)
  • Acuity or Points scale/system
  • Time and Task
  • Variables
utilization of accrual data
Utilization of Accrual Data
  • Simply the numbers
    • How many studies
    • How many accruals
    • How many staff
  • Does not account for
    • Time required for tasks
    • Screen failures
    • Drop outs

(Gwede, C.K., Johnson, D.J., Roberts, C., Cantor, A.B., 2005; Gwede, C.K., Johnson, D., & Trotti.A, 2000a)

publicized benchmarks
NIH/NCI

1 FTE manages 25 patients on study and 50 in follow up

Not clear if this is data management along or also includes nursing and regulatory tasks

Society of Clinical Research Associates (SoCRA)

1 FTE handling ALL responsibilities (regulatory, patient care, data management, sponsor audits) could effectively manage @ 30 new patients per year

Publicized Benchmarks
acuity complexity or points
Acuity, Complexity or Points?
  • CCIRC Algorithm
  • Fowler & Thomas
  • NCI Trial Complexity Elements & Scoring Model
ccirc algorithm
CCIRC Algorithm
  • Cancer Clinical Investigations Review Committee, 1992
  • For use in cooperative groups to determine budget allotments
  • Inappropriately adopted by sites to assess productivity and make day to day staffing decisions
  • Credits based on number of patients and phase of study
      • 1 credit for each treatment accrual (including supportive care, chemoprevention)
      • .5 credit for non-treatment accrual (survey & lab)
      • .25 for each follow up case (data submitted at least once a year)
    • 1.0 FTE = 40-50 credits (new accruals and/or follow up)

(Gwede, C.K., Johnson, D., & Trotti, A., 2000a)

fowler thomas acuity scoring
Fowler & Thomas: Acuity Scoring
  • Task Time
    • Procedures
    • Time involved to enroll 1 subject
  • Protocol Acuity Score
    • Multiplied by contracted/anticipated number of subjects to determine a score
    • Coordinator workload evaluated by score and new protocols assigned accordingly

(Fowler, D.R., & Thomas, C.J., 2003)

time task
Time & Task
  • Gwede et al
    • Self reported workload study of CRC’s affiliated with RTOG
      • 265 coordinators, 107 responded
      • 40.4 % response rate
    • Time required to complete tasks over number of patients
    • Intensity over effort spent
    • No clear recommendation on formula
    • Urgent need for practical and meaningful tools

(Gwede, C.K., Johnson, D., & Trotti, A., 2000b)

time task68
Time & Task
  • Devine et al
    • Percentage of time spent on tasks
    • Focusing on tasks rather than accruals is correct approach
    • No definitive recommendation on tool

(Devine, S., Nagel, K., Benson, L., & Krailo, M., 2005)

ncic study roche et al
NCIC study (Roche et al)
  • Task Oriented Time Measures
  • In general, NCIC study supports that workload varies by task, phase of study, sponsor type, and stage of protocol

(Roche, K., Paul, N., Smuck, B., Whitehead, M., Zee, B., Pater, J., et al., 2002)

ncic study
NCIC Study
  • NCIC study, treatment stage of protocol:
    • Handling of special procedures (35.9 min +/- 39.6) and documentation (35.3 min +/- 40.5) were most time consuming tasks
    • Industry studies were more labor intensive than studies with other sponsors (p<.0002 pair-wise)

(Roche, K., Paul, N., Smuck, B., Whitehead, M., Zee, B., Pater, J., et al., 2002)

ncic study71
NCIC Study
  • Local studies required significantly less time (p<.0001)
  • Phase I, I/II, II studies most intensive compared to phase III (p<.0001)

(Roche, K., Paul, N., Smuck, B., Whitehead, M., Zee, B., Pater, J., et al., 2002)

eortc
EORTC
  • Berridge & Coffey
    • Most recently published work…June 2008
    • Time spent on activities
    • Identify all main tasks and subtasks from beginning to end

Berridege, J., & Coffey, M., 2008)

nci complexity scoring
NCI Complexity & Scoring
  • Recommendation from the Clinical Trials Working Group (CTWG)
  • Align reimbursement with trial complexity
  • Standardized list of key trial elements
    • Most time consuming and complex components of the work
    • Each elements has a standard, moderate and high level
  • Total complexity score is utilized to compare and rate trial complexity

http://restructuringtrials.cancer.gov/

complexity elements
Complexity Elements
  • Number of Study Arms
  • Informed Consent Process
  • Registration/ Randomization
  • Complexity of Investigational Treatment
  • Length of Investigational Treatment
  • Feasibility & Personnel Impact
  • Data Collection Complexity
  • Follow-Up Requirements
  • Ancillary Studies
  • Participant Feasibility & Enrollment

http://restructuringtrials.cancer.gov/

utilization
Utilization
  • Assists evaluation of need for new staff
  • Balances workload between current staff
    • Those with high acuity give registration potentials to those with lower level
  • Management assessment tool
  • Staff Effort Calculations for budget
budget considerations
Budget Considerations
  • Pre-initiation work
  • Start-up meetings
  • Monitoring visits
  • Close-out visits
variables the hidden work
Variables…the hidden work
  • Screen Failures
  • Queries
  • Long-term follow-up
  • Phone calls
  • Re-consenting
  • Enrollment logs
clinical care expenses
Clinical Care Expenses

The Separation of Charges

Research Related Services

versus

Clinically Indicated Services

(Standard of Care- SOC)

(CMS Medicare National Coverage Determinations Manual, 2009).

types of charges
Types of Charges
  • Research (RES) Items- on the schema needed only for research purposes
    • Either due to nature of service or frequency
  • Standard of Care (SOC) Items- usual & necessary services & costs
  • Q1- SOC as called for by Schema- usual and customary services that are also called for by the Schema.
    • Referred to as SOC as a component of a research study
    • At discharge, requires the use of a Q1 modifier and the diagnosis code V70.7 (listed as secondary diagnosis)
    • These are the items left UNCIRCLED on the reviewed schema

(CMS Medicare National Coverage Determinations Manual, 2009).

billing rules80
Billing Rules
  • All services rendered should be charged.
  • A Cost associated with a trial can only be recovered in its entirety once.
  • Sponsors should be considered the payer of choice for all trial related charges and ideally, should cover all of the costs of conducting the clinical trial.
    • Never bill insurance first to see if that will pay- Charges are either Standard of Care or Research related- there is no “if then” in research billing, that is considered:
      • Double Dipping
      • Fraud
  • NEVER bill a patient or their insurance for a research related charge

(

(CMS Medicare National Coverage Determinations Manual, 2009, O’Brien, J.A., 2007)

designation of charges
Designation of Charges

Utilizing the attached treatment schema, please circle the tests and/or procedures  that are research only related for the medical condition being researched in this trial.   

The identified tests/procedures will not be billed to the patient's third party payer and will be billed to the sponsor/trial. The identified tests and/or procedures are considered to be research only and required by the trial and not part of the usual care of a patient with this medical condition.  

All other services are considered usual/standard patient care. Services considered “billable” (usual/standard) should meet criteria such as:        

  • The services are considered safe and effective based on authoritative evidence as generally accepted by the medical community       
  • The services are considered customary, reasonable and necessary     
  • The services are not unproven or experimental in nature.  

In addition, services identified as billable must be supported by past billing practice.  That is, upon review, the composite of patient records of patients not on a clinical trial would  indicate the same services (and level of services) rendered. 

sponsor s budget
Compare with your budget

Is Per Subject costs equivalent?

Is overhead accurately represented?

Are costs at the study level comparable?

Review

Negotiate-be sure to provide flexibility for re-negotiation

Sponsor’s Budget

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

negotiating tips
Negotiating Tips
  • Provide detailed, line-item cost for each activity.
  • Use the words, “Our costs of participating in the trial”
  • Remember, the Sponsor wants the site and the PI involved in the trial as a thought leader.

(Business-Higher Education Forum,Washington D.C., 2001; Mello, M.M., Phil, M., Clarridge, B.R., Studdert, D.M., 2005; Paller, M.S., Hostetler, L.,Dykhuis, D.A., 2002)

budgets basics summary
Budgets Basics Summary
  • All costs must be funded
    • Investigators time
    • Staff time
    • Supplies
    • Other resources
      • Laboratory
      • Clinic space
      • Pharmacy
budget reminders
Budget Reminders
  • Accrual targets
    • If you can’t meet or exceed your target don’t open it!
    • Don’t open it for < 5 subjects per year
  • Amendments & Safety Reports
    • Expect multiple
      • Adversely affects budget and human resources
    • Negotiate for additional payments with significant revisions or quantity of external reports

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

budget reminders92
Budget Reminders
  • For multi-year trials, consider adding an inflation rate of 10% to the per-completed-subject cost.
  • Cost of providing health care services increases over time so you need to cover future expenses

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

payment terms
Schedule of payments (e.g. annually, quarterly, after CRF completion, after monitor visit)

Determine what payments can be invoiced (e.g. invoice for per subject payments, invoice one-time costs)

Payment Terms

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

payment terms94
It is reasonable and common to have the sponsor make a 1st payment including:

One-time non-refundable start up fees

Full price for 1-3 completed patients up front

Payment Terms

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

tracking payments
Maintain a running financial statement

Electronic calendar of when payments are due

Prepare invoices for all payments

Communicate with Grants and Contracts

Tracking Payments

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

projections
Projections
  • Done at least quarterly
    • Allows for balance & ability to accept new studies
    • Achieve balance between overextending resources or having underutilized personnel
  • Components:
    • Number of staff
    • Study intensity
    • Personnel needed for upcoming studies
    • Anticipated study revenues

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; Emmanuel, E.J., Schnipper, L.E., Kamin, D.Y., Levinson, J., & Lichter, A.S., 2003; Johnson, G.P., 2003; O’Brien, J.A., 2007)

common problems concerns
Common Problems & Concerns
  • Documentation
  • Billing Errors
  • Auditing for Compliance

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

documents
Documents
  • Sponsor Contract & Budget
  • Protocol
  • Delineated Schema of Events
  • Institutional Line Item Budget
  • IRB approved Informed Consent

Harmonization

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)

billing errors
Billing Errors
  • Type A—Research
    • Items reimbursed by the sponsor or deemed not medically necessary during the schema review were billed to the subject/insurance
  • Type B
    • Standard of Care services are billed and paid by research
auditing for compliance
Auditing for Compliance
  • Initiated after study commences
  • All documentation reviewed to establish harmonization and note any inconsistencies
  • Utilize a subject list and audit all or a selection of subjects bills from date of informed consent to determine accuracy with research delineated schema

(Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., & Collard, C.D., 2004; Business-Higher Education Forum, Washington D.C., 2001; O’Brien, J.A., 2007)