Clinical Research Billing Compliance Transition/Training ...

10/31/2014

1

©2014 Kelly Willenberg, LLC

1

2014 IACRN Annual Conference

Research Compliance

Kelly Willenberg, MBA, BSN, CHRC, CHC

1

Overview

Are there risks in research compliance?

How do I identify these risks?

What are some common concerns in compliance?

Are there tools to help identify or solve compliance risks?

How does compliance affect me in research?


2

2

Points to keep in mind

In compliance always “Do the Right Thing”

Remember that the costs of non-compliance is high!

©2014 Kelly Willenberg, LLC 3

10/31/2014

2

What is Research Compliance?

Research compliance can help to ensure proper scientific, ethical and regulatory requirements are followed in research protocols and can promote research integrity through a standardized process.

Research compliance can address any or all of the following in an institution or hospital: Institutional Review Board and human subject protection, HIPAA, post approval monitoring, biohazard or radiation safety, billing, contracts, grants management, research overview, clinical trials conduct, personnel, award closeout and quality assurance.

Research Risks

The first step of research compliance is knowing which laws apply to your activity

The second step of research compliance is to figure out what that means

The third step is to assess your risks


The trouble with research regulations…..


6

10/31/2014

3

Confusing rules… ©2014 Kelly Willenberg, LLC 7

Contradictory rules… ©2014 Kelly Willenberg, LLC 8

Multiple rules to get to one answer…


10/31/2014

4

The Office of Research Integrity within the United States Department of Health and Human Services defines nine core areas in the responsible conduct of research:

1. Human subjects 2. Conflicts of interest and commitment 3. Mentor training and responsibility 4. Publication practices and responsible

authorship 5. Data management, acquisition, sharing &

ownership 6. Research involving animals 7. Research misconduct 8. Peer review 9. Collaborative Science

11

Establish Basic Rules for the Conduct of Clinical Trials

Regulatory/HIPAA: OHRP, IRB, AHHRPP, NIH

Regulatory oversight for life of the study for both employed and non employed groups

Create a liaison to IRBs especially if you use commercial IRBs and establish guidelines for reporting

Assert research credentialing and training requirements for all staff

Establish criteria for claims review and reimbursement

Maintain enforcement with the rules by setting examples

Facilitating Compliance for Research Standardize SOP’s system wide

Provide mentoring to new clinical research coordinators

Network with sponsors/CRA’s about other areas in organization conducting research

Create consistent policies

Promote transparency to ensure credibility

Establish policies and procedures to make roles clear, responsibilities known and accountability validated

Perform compliance self monitoring of clinical research studies, both for-cause and not-for-cause

10/31/2014

5

Common Research Compliance Concerns


Best Compliance Program Operationally

There is not one, it’s yours because you are driving it

There is not an “ out of the box” or “one-size-fits-all” way to manage compliance and integrity

Institution Must Haves

Substance Structure

Commitment Responsibility

10/31/2014

6

Success or Barrier

Administrative Buy In

History of the Organization

Existing structure and culture

Size and scope of the research program

Size of the Institution

Availability of resources

Importance of research program

17

Risks in Research

Research and related rules are complex

There is significant pressure on regulators to make things right where public perception is that they have gone very wrong

Education and ongoing training are lacking and sometimes unfunded

Physician-investigators do not understand compliance

Administrative support is sometimes absent

Non-compliance consequences are not appreciated

Priority for research is different for everyone

What is the PRICE of Non-

Compliance?

Potential financial risk

Regulatory issues and problems

Institutional values are lost are altered

Cultural priorities and fear of change limit growth

Exposure which can damage an Institution

10/31/2014

7

Payback, penalties or fines

Audits from other federal agencies

Accreditation status jeopardized

Loss of Federal Grants

Loss of Key Opinion or Thought Leaders

Bad Press and Public Relations

COST OF NON COMPLIANCE

Four Necessary Elements Pieces of the Compliance Paradigm

Pieces of the Compliance Paradigm

Communication Transparency

Enforcement Education

Compliance Paradigm

10/31/2014

8

Where Does the Clinical Research Coordinator Fit In?


23

CRN’s Should Take the CREDIT!

Communication

Regulation

Education

Determination

Integrity

Transparent

Which Rules Apply?

Studies that involve

drugs or devices

(Industry OR PI Initiated)

Behavioral/Social Science Research

21 CFR – FDA (GCP, GMP

or GTP Regs)

ICH GCP

Institutional Policies

IRB rules

45 CFR 46 – DHHS

NIH Guidelines

45 CFR 46 – DHHS

Institutional Policies

IRB rules

NIH guidelines

10/31/2014

9

Challenging Roadmap Ahead Requires careful review, periodic assessment and diligent

effort

Research represents an area that is often targeted as high risk at many organizations

Risks can change as research changes

Ever increasing focus on translational research and new ways of advancing science

Research compliance is a specialty and a liability as the risks in this space are considerable

Fragmented Information in Clinical Trials Management

Budget Contract Coverage Analysis

Protocol UB’s Invoices

to Sponsors

Physician office

IRB

Two Hot Areas of Research Compliance for CRNs

Human Subjects Protection

Clinical Trial Billing


10/31/2014

10

Ongoing priorities for the OHRP’s Division of Compliance Oversight

Findings in recent determination letters….

◦ Research conducted without IRB review and/or approval

◦ Failure of IRB to review HHS grant applications

◦ Lacking sufficient information to make determinations required for approval

◦ Approval of research not approved by the IRB

◦ Inadequate continuing review

◦ Failure to report unanticipated problems, noncompliance, suspensions, terminations, etc. to IRB, IO, or OHRP

◦ Failure of Investigator to obtain legally effective and/or to document Informed Consent or of the IRB to waive requirements

◦ Failure to provide a copy of the signed ICF to the subject (or their representative)


Common Clinical Trial Billing Errors

• Billing for services not rendered

• Billing for services that are already paid by the sponsor or promised free in the informed consent

• Billing for services that are for research-purposes only or are part of a non-qualifying clinical trial

• Billing Medicare for device trials without MAC approval letter in hand

• Bill Medicare Advantage Plans (Part C) when claims should be directed to the Medicare Administrative Contractor


Common Clinical Trial Billing Errors

• Billing for items or services not supported by required documentation

• A proper, signed order

• Adequate documentation of medical necessity for the item or service

• Documentation of study participation, as required

• Billing without proper codes, modifiers or NCT#

• Waiving/paying/reimbursing subject co-pay or deductible obligations


10/31/2014

11

Clinical Trial

Billing Process

Coverage Analysis

Performed

Budget, Contract,

Consent Review

Subject Registration and

Tracking

Medical Documentation

for Medical Necessity

Charge Capture, Segregation,

Research Pricing

Medicare MAP Commercial

Payers

Audit and Review

31 ©Kelly Willenberg, LLC

WHAT IS A COVERAGE ANALYSIS (CA)?

Systematic review of research-related documents to determine the Medicare billing status of both the study itself and the items and services provided to the research subjects that are outlined in the research documents over the course of the study

Review based on thorough research, supported by industry guidelines which meet the “generally accepted in the medical community” standard and are compliant with government regulations

Provides subjects with an accurate accounting of their financial liability before they enroll

Provides an accurate assessment of the true costs of the clinical trial with potential increased revenue

Protects your institution from violations of the False Claims Act and other regulations by showing due diligence

32 ©Kelly Willenberg, LLC 2014

33

10/31/2014

12

IDE COVERAGE PRINCIPLES SUMMARY Category A Category B

• Trials involve immediately life-threatening condition

(if trial was initiated before January 1, 2010)

• All trials

• Device not covered

• Device covered if not provided free by sponsor or promised free

• Reimbursement may not exceed amount for comparable

marketed device

• Routine care services covered • Routine care services covered

• Medicare contractor approval required • Medicare contractor approval required

Device is never covered

Services

• IDE Number

• ICD-9 Code V70.7 (Secondary diagnosis)

• Q0 or Q1 Modifier

• Physician Services

• Outpatient Services

• Condition Code 30 (outpatient only)

• NCT#

Device

• IDE number

• HCPCS device code (if applicable) (Physician and outpatient)

• Q0 (Physician and outpatient)

• Charges or token charge (outpatient)

Services

• IDE Number

• ICD-9 Code V70.7 (Secondary diagnosis)

• Q0 or Q1 Modifier

– Physician Services

– Outpatient Services

• Condition Code 30 (outpatient only)

• NCT# 34

Routine Costs

Items or services that are typically provided absent a clinical trial (e.g., conventional care);

Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and

Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service, in particular, for the diagnosis or treatment of complications.

35

Achieving Compliance: The 3 C’s

◦ Coordination of study information

◦ Communication of study information

◦ Collaboration and clarity of study documents


10/31/2014

13

Roles & Responsibilities

Research compliance is a community effort: ◦ Hospital

◦ Physician

◦ CRO

◦ Academic Institution

◦ Sponsor

All have different responsibilities and obligations arise from different sources: ◦ Statutes

◦ Regulations

◦ Government guidance

◦ Contracts

◦ Ethics responsibilities


Other Areas for Research Compliance

Scientific Misconduct

Conflict of Interest


Example of Scientific Misconduct

Bryan William Doreian, Ph.D., Case Western Reserve University

ORI found that the respondent engaged in RM by falsifying data related to studies funded by NIH, National Heart, Lung and Blood Institute, and NINDS.

His research must be supervised indefinitely, his employer must certify the accuracy of his experiments, he may not provide advisory services to PHS and his paper was retracted.


10/31/2014

14

Example of Conflict of Interest

A researcher conducts a clinical trial which is sponsored by any person or organization with a financial interest in the results of the trial.


Protocol Adherence

A procedure, treatment, or visit called for by the protocol is conducted outside of the required time frame and this has clinical consequence; poses risk of harm to subject or others and/or is thought to be impactful to the scientific integrity of the study.


Tools to Assess Risks ©2014 Kelly Willenberg, LLC 42

10/31/2014

15

43

Risk Area Identified

Improper

Payment or

Legal/

Regulatory

Violation

Adverse

Publicity

Possible

Financial

Impact

Government

Focus

Overall Risk

Measurement

Priority

Ranking

RANKING SCALE Low 1 </=1% of Gross Revenue

2 1-3% of Gross Revenue

Medium 3 3-5% of Gross Revenue

4 5-7% of Gross Revenue

High 5 >7% of Gross Revenue

44

Topic Repu

tatio

n

Fin

anci

al

Lega

l

Ris

k Im

pact

Like

lihoo

d

Dete

ctab

ility

Vuner

abili

ty

Cont

rols

Ris

k

Priori

tiza

tio

n

Sco

re (R

PS

)

Comments

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

0 0 0

45

10/31/2014

16

Who Do We Need At the Table?

Hospital Areas

Principal Investigator

Clinical Research Coordinator

IRB process

Budget negotiators

Clinical Trial Agreement negotiators

Grant administration

Health Information Management/IT

Registration/Scheduling/Authorizations

Medical center billing and coding

Physician professional fee billing and coding

Study fund managers

Managed care contract negotiators ….and others!

©2014Kelly Willenberg, LLC 46

Village People

Construction Worker

We have lots of work to do…

Harley Rider

We are way cool…

10/31/2014

17

We fight with the Cowboys….

Indian ©2014Kelly Willenberg, LLC 49

Cowboys rule….

Cowboy ©2014Kelly Willenberg, LLC 50

Navy Corpsman ©2014Kelly Willenberg, LLC 51

We fight with the Cowboys….

We have structure, but….

10/31/2014

18

https://www.youtube.com/watch?v=CS9OO0S5w2k

Feeling the Pulse of Clinical Research Nursing: Impact and Value Through Caring, Communication and Compliance

©2014Kelly Willenberg, LLC 52

Questions?


Kelly Willenberg, MBA, BSN, CHRC, CHC

Kelly Willenberg, LLC

864-473-7209

Creating a Reesearch Billing Infrastructure for Non Profit Comm Hosp SOCRA 2014.ppt

Clinical Research Billing Compliance Transition/Training ...

Documents

Transcript of Clinical Research Billing Compliance Transition/Training ...