Clinical Trials: Cost Coverage and Implications for the Clinical Trials Nurse.

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.

• 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• 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• 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• 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?• 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• 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

(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

• 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)


• 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.



• 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).


Clinical Trials Billing

Rose Ermete RN, BSN, OCN, CCRP

Oncology Research Nurse

St. Mary Mercy Hospital

Clinical Trials Billing Overview• The Importance of Compliance• Billing Rules • Systems to ensure appropriate billing

Note: Image courtesy of CartoonStock.com. Used with permission.

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

Why is this Important• 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

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

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.

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

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

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

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

Note: Image courtesy of CartoonStock.com. Used with permission

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

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.

(National Cancer Institute, 2009)

States Requiring Health Plans to Cover Patient Care Costs in Clinical Trials

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

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)

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

Note: Image courtesy of CartoonStock.com. Used with permission.

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

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

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

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

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

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

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.

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

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.

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

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

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

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

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

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.

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

Note: Figure courtesy of Meade, 2009. Used with Permission. 34

Code Infusion 1 Infusion 2 2 weeks 12 weeks 24 weeks Comment

Physical Exam

99201-99215

M M M M

EKG 93000 M M M

Drug 123 J0123 S S

Infusion 96400 M M

Urinalysis 81000 NB NB

Ultrasound 93990 ICF

Patient Diary N/A NB NB NB NB

34

M=MedicareS=SponsorICF=Free in Informed ConsentNB=Not billable to Medicare

Hypothetical MCA: Manage the Information

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

Billing Grid Example

Screen -1 0 1 2 3 10 28 90 120 180 270 365Consent xInc/Exc xMd Hx x xVital signs x x x x x x x x x x x x xPE x x x x x x x x x x x x xAE x x x x x x x x x x x x xHeme § x x x x x x x x x x x x xCoag ¶ x x x x xChem * x x x x x x x x x x x x xUA x x x x x x x x x xEKG x xCXR xx xAngio xMed Disp. x x x x x

Standard of Care

Clinical Trial Internal Budget Template EXAMPLE of Payer Determinations

Study CalendarVisit Days

Research Related or Paid for by the Sponsor

A. PER PARTICIPANT / PER ARM COSTS

Standard of Care (SOC) Vs. Research (R)

Visit 1/ Day 0 = Hosp IP

Visit 2/ Day 1 Visit 3 / Mth 1 Visit 4 / Mth 3 Visit 5 / Mth 6Visit 6 / Yr 1 = Final

VisitRow Totals

ITEMS & SERVICESInformed Consent R $0.00Inclusion/Exclusion R R $0.00Chart Review R R $0.00Medical History R R $0.00Physicial Exam* SOC & R SOC R SOC SOC SOC $0.00Vital Signs SOC & R SOC SOC R SOC SOC SOC $0.00Concominant Meds R R R R R R R $0.00A/E Reporting R R R R R R $0.00Clinic Visit SOC & R R SOC SOC SOC $0.00Pharmacy Fees R R R R R R $0.00Chest X-Ray SOC & R SOC SOC SOC $0.00EKG SOC & R SOC R R R R SOC $0.00Cardiac Angiogram SOC & R SOC R $0.00Drug Accountability Logs R R R R R R $0.00CK-MB SOC & R SOC SOC R R R R $0.00EKG Professional Read SOC & R SOC R R R SOC SOC $0.00Study Coordinator Time R R R R R R R $0.00PI Time* R R R R R R $0.00Dry Ice R R R R R $0.00Participant Stipends R R R R R $0.00Participant Travel/Parking R R R R R $0.00Central Lab Processing Time R R R R R $0.00

$0.00$0.00$0.00$0.00$0.00$0.00$0.00

Sub-Total Per Participant Costs $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00

Plus F&A Overhead Rate $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00

TOTAL PER PARTICIPANT COSTS $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00

Protocol Budget Calendar

Contract No: 10000 Protocol No: XYZ Department: Research Sponsor: Pharma

Protocol Target Accrual: 10 PI: Investigator, Principal Accrual to Date: Status: Feasibility Assessment

Study Title: SAMPLE: Phase II, Double-Blind, Placebo-Controlled, Randomized, Multicenter Efficacy trial of XXX in participants with acute decompensated ischemic congenstive heart failure.

Schedule of Events

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

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

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

(Meade, 2006; Turgon & Welter, 2008)

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

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

Three Main Types of Support Provided by a Sponsor• $$$

• Drug

• DeviceSupport = 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”• 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


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


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


Sections of the Agreement• Acknowledgments &

Responsibility• Terms &

Termination Clause• Payment/

Reimbursement of Costs

• HIPAA

• Publication• Intellectual Property• Confidentiality/

Proprietary Information

• Indemnification• Insurance• Subject Injury


Clinical Trial Budget BasicsImportant 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• 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)


4 Components of a Budget1) Study Initiation / Start

Up Fees a) IRB b) CCTO c) Pharmacy d) CRC e) Other…

2) Clinical Care ExpensesItems deemed research related on the schema

by PI

3) Study Implementation & Oversight Expensesa) Staff timeb) Suppliesc) Parking stickersd) Other….

4) Indirect Costs25% Non-Federally Funded53.5% Federally Funded

Identify the Costs• Administrative Costs

• Patient Care Costs

• Trial Costs

Administrative Costs• Clinical Trial Office

Fees– Additional regulatory

submissions (amendments, SAEs)

• Institutional Fees– IRB

– Pharmacy Fees

– Indirects

• Non-refundable!

(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 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%

(


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


Trial Costs• Screening Logs

• Screen Failures

• Electronic Data Management Training

• Recruitment

• Storage

• Other study visits

• Monitor visits

• Study initiation (all-inclusive)


Trial Costs: Investigator• Protocol

Development• Site Initiation Visit• Protocol amendment

management• External safety

reports• Monitor site visits• Conference Calls


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


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• 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)

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)

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)

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


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• 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

Acuity, Complexity or Points?• CCIRC Algorithm

• Fowler & Thomas

• NCI Trial Complexity Elements & Scoring Model

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

• 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• 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 & 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)

• 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, 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)


NCIC Study

– Local studies required significantly less time (p<.0001)

– Phase I, I/II, II studies most intensive compared to phase III (p<.0001)


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• 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• 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

• 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• Pre-initiation work

• Start-up meetings

• Monitoring visits

• Close-out visits

Variables…the hidden work• Screen Failures

• Queries

• Long-term follow-up

• Phone calls

• Re-consenting

• Enrollment logs

Clinical Care Expenses

The Separation of Charges The Separation of Charges

Research Related ServicesResearch Related Services

versusversus

Clinically Indicated ServicesClinically Indicated Services

(Standard of Care- SOC)(Standard of Care- SOC)

(CMS Medicare National Coverage Determinations Manual, 2009).

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 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)

Schema Review Memo

Designation of ChargesUtilizing 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.

Schema

Internal BudgetPatient Care Costs

Internal BudgetStaff Effort

Models for Effort Calculation

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 Budget

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• All costs must be funded

– Investigators time

– Staff time

– Supplies

– Other resources• Laboratory

• Clinic space

• Pharmacy

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


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


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• 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


Tracking Payments• Maintain a running

financial statement• Electronic calendar

of when payments are due

• Prepare invoices for all payments

• Communicate with Grants and Contracts


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


Common Problems & Concerns

• Documentation

• Billing Errors

• Auditing for Compliance


Documents• Sponsor Contract & Budget

• Protocol

• Delineated Schema of Events

• Institutional Line Item Budget

• IRB approved Informed Consent

Harmonization


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• 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


Clinical Trials: Cost Coverage and Implications for the Clinical Trials Nurse.

Documents

national institutes

clinical services

clinical trials nurse

national cancer institute

research costs

health plan

clinical trial criteria

clinical trial participation