Microsoft PowerPoint - W7_PayerIssuesDenials

Payer Issues, Denials and

Process for Clinical Trials:

How to Audit for Lost Revenue!

HCCA Compliance Institute – April, 2018

Kelly M Willenberg & Wendy S Portier

Kelly Willenberg & Associates, LLC

Disclaimer

 No legal advice is provided.

 Please seek legal representation to have your questions clarified or

discussed.

 The information, thoughts and opinions provided here are not legal

advice: consult your institution’s legal, compliance and other

appropriate leaders and, at their discretion, your local Medicare

Administrative Contractor (MAC), for any specific billing questions

or issues

Objectives

 Review claims submitted on trials that were denied and

understand why

 Discuss clinical trial billing audit tools, best practices and

processes

 Understand the risk for your hospital and how it impacts revenue

Speakers

Kelly Willenberg, DBA, MBA, BSN, CHRC, CHC, CCRP

P 864.473.7209

kelly@kellywillenberg.com

Kelly Willenberg is the owner of Kelly Willenberg, LLC. Kelly has extensive knowledge in clinical trials management and research

compliance, including all aspects of clinical trial billing compliance. She has over 30 years of clinical research experience and billing

compliance. She has a Bachelor’s Degree in Nursing, a Masters and a Doctorate in Business Administration. She is an experienced

oncology nurse with the majority of her experience in oncology, pediatrics, school nursing and cardiac rehab. Kelly worked for over

twelve years at Vanderbilt University Medical Center. She established the enterprise wide billing compliance program at Vanderbilt and

served as the first Director of Billing Compliance in 2002. She also served as the Director of the Clinical Trials Office for the Cancer Center

managing a Community Oncology Research Program (CCOP and an affiliate network throughout the southeast while at Vanderbilt and

was an active member of the nursing committees in the cooperative groups). cooperative groups).

Kelly is a frequent presenter and speaker at the Oncology Nursing Society, Academy of Health Care Administrators, American Society of

Clinical Oncology, Association of HealthCare Internal Auditors, MAGI, The Society of Clinical Research Associates, Association of Clinical

Research Professionals, ExL Events, HCCA, and other professional organizations. She assisted in writing the Research Compliance

Professional’s Handbook for Healthcare Compliance Association (HCCA). She served as an editor for the 3rd Edition of the Manual for

Clinical Trials Nurses for ONS. She has a bi-monthly column in Compliance Today titled “Research Reflections”. She is a Certified Clinical

Research Professional (CCRP), Certified as a Healthcare Research Compliance Professional (CHRC) and Certified in Healthcare Compliance

(CHC).

Speakers

Wendy Portier, MSN, RN, CHC, CHRC, CCM

Consultant

P 504.782.1328

wendy@kellywillenberg.com

Wendy Portier has over 25 years of experience in health and managed care including: Health Care Compliance, Research Compliance,

Consulting, Clinical Research, Critical Care Nursing, Quality, Utilization Management, Case Management and Disease Management.

Having worked on the provider, researcher, payer and sponsor sides, Wendy has a unique perspective and extensive knowledge regarding

clinical research compliance. Her specific research compliance experience includes: implementing process improvements, leading

government inspections & responses, auditing, monitoring, implementing compliance programs and improving the research billing

revenue cycle – from coverage analysis & budgets, authorizations, claims review to denials & appeals management.

Wendy obtained a Bachelor of Science in Nursing from Nicholls State University and a Master of Science in Nursing in Clinical Research

Management from Duke University. She also completed a Health Care Corporate Compliance - Post Graduate Certificate Program at

George Washington University in Washington, DC and holds several health care related certifications. Wendy has lectured locally,

nationally and internationally on various topics related to clinical research, health care auditing and health care compliance.

Polling Question –

Who do we have in the audience?

Why are Clinical Trials Important?

 Key research tool for advancing medical knowledge and patient care

 Clinical trials show us what works and what does not work

 Clinical trials answer 2 important questions:

1. Does the new treatment work in humans?

2. Is the new treatment safe?

 New treatments must pass many tests before they get to the public at large

 Examples:

 Asthma treatment

 Hormone therapy

 High-dose chemotherapy & bone marrow transplant

 Help healthcare decision makers direct resources to the strategies

and treatments that work best

Identifying essentials of research

billing compliance assurance

Clinical Trial Billing Compliance -

Synchronous Work Flow is Key

 Vetting & Feasibility Analysis

 Coverage Analysis & Billing Plan

 Budgeting, Pricing & Contracting

 IRB Approval

 Enrollment & Informed Consent

 Identification, Registration,

Scheduling & Tracking

 Authorization & Documentation for

Medical Necessity

 Charge Capture

 Charge Segregation

 Claims Submission

Compliant

Billing

Clinical trial revenue continuum

Coverage Documents

Budget

Contract

Consent

Study Account Setup

Charge Capture and Bill

Hold

Financial Management

Study Account Close Out

Coverage Analysis

Account Monitoring

Site Initiation

Start

End

Coding, Billing and

Invoicing

Drugs/Biologics vs. Devices vs. CED

Front End Process

Back End Process

What Does It Take to Get Clinical Trial Billing

Compliance Right?

 A broad understanding of

many fragmented,

disconnected processes and

systems

 An appreciate of many events

that take place before and

after billing

 Correctly debiting a study

account and billing a third

party (insurance, patient, etc.)

 Four main reasons for

incorrect billing:

1. Technological error

2. Human error

3. Training

4. Awareness

The most basic basics!

Clinical trial billing compliance:

Primary rules*, 1

“Clinical Trials Policy”: National Coverage Determination 310.1

Defines qualifying clinical trials and types of routine services

Investigational Device Guidelines

Defines device and routine service billing requirements

*Other laws, regulations, rules also are relevant but are largely

captured by 310.1 and claims requirements

Clinical trial billing compliance:

Primary rules*, 2

Medicare claims processing rules

 Research-specific and non-research-specific: all relevant rules to be met

 Federal payers follow Medicare; Medicaid may have specific alterations

False Claims Act protects federal taxpayers from overpayment for services

provided:

 Overpayments result from false claims made by federal service providers

 In health care billing, an overpayment occurs when a federal insurer pays for a

clinical service that was not allowable

 Rules stipulate requirements for reporting and correcting overpayments

*Other laws, regulations, rules also are relevant but are largely captured by

310.1 and claims requirements

NCD 310.1: What is a Qualifying Clinical Trial?

NCD 310.1: What are 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 non-

covered 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.”

Research billing compliance assurance

Although there are many nuances, in a nutshell:

• Do not bill patient/insurance for services that are:

• Not medically necessary

• Otherwise not allowable / non-covered services / statutorily excluded

• Promised by the sponsor (contract) / budget

• Provided solely to satisfy data collection

• Promised by the consent form

• Apply the Medicare-specified research modifications as applicable

• Follow all other Medicare rules

Areas to watch in research billing and finance

• Inadequate financial accounting

• Research subjects not identified

• Document non-concordance: Protocol,

Coverage Analysis, Budget, Contract, ICF

• Charge capture/billing for research

related services and routine costs, study

drugs and devices

• No monitoring of billing inquiries

• Poor budget process, lack of proper

accounting and invoicing to Sponsors

• Claims lack proper research coding: dx,

modifiers, CCs, and NCT # on claim

• Charge segregation occurring between

research and payer or Medicare and

Medicare Advantage

• Communication on denials management

not thorough or lack of attention to detail

Research billing audit goals

Although there are many nuances, and scope depends

upon specific institutional goals, in a nutshell:

• Identify system or human error in research billing

• Make repayments if overpayments are found, following

required timelines

• Identify underpayments and invoice/bill as possible

• Correct process errors or gaps

• Educate users as applicable

• Conduct follow-up review to assure sufficient remediation

• Document quality assurance diligence

Audit scope and planning

Before audit can be planned, identify

standards

1. Audits are designed to track and evaluate existing processes and

their results

2. In order to identify audit scope, need to have evaluated the

potential failure of existing process(es) to provide intended results:

risk assessment of entire process

3. In order to evaluate existing processes, need to compare to

minimum necessary to achieve compliance assurance: regulations,

other external requirements, and organizational policies

What does clinical research billing compliance assurance require?

Types of clinical trial billing audits

 Process / Internal Control

 Study Level (Document Concordance & Coverage Analysis Validation,

Invoicing)

 Patient Level (Claims, Denials, Invoicing)

Audit scope: preliminaries

Stakeholders and auditors, internal and external

Depends upon the content scope

Skill set to be parallel to content: e.g., denials

review requires person with denials experience

Do internal audit or compliance departments have

authority?

Is Office of General Counsel to be consulted?

Decision to go external may be related to risk

assessment results

Audit scope: preliminaries, 1

Time span

Are you auditing a process improvement?

Do you want to see before and after or just after?

Are you performing it for cause and need a specific time

point?

Sample size

Determining significant sample

Unless reviewing a process only, number of studies?

If conducting billing review, number of patients, number of

claims?

Audit scope: preliminaries, 2

Interviewees, assistants and notifications

Depends upon the content scope

Will involve those according to assigned operational tasks

Leadership channels to be considered

Audit scope: one or all of the following, 1

Coverage analysis

Is the coverage analysis concordant with study documents?

(protocol, ICF, budget, contract, coverage analysis)

Does the study qualify for billing?

Do the justifications support billing the subject’s insurance?

Were all costs included?

Document concordance

Are all study documents concordant? (protocol, ICF, budget,

contract, coverage analysis)

Do study documents contain clear language?

Audit scope: one or all of the following, 2

Subject identification

Are the subjects identified “flagged” in the systems?

Was the “flag” applied timely?

Claims review

Did the claim go to the appropriate payer? (Medicare,

Medicare Advantage, Sponsor, Commercial Insurance, etc.)

Does the claim contain correct coding? (Z00.6, Q1, Q0,

CC30, IDE#, Rev Code 256/624, NCT#, etc.)

Does the medical record documentation support medical

necessity?

Audit scope: one or all of the following, 3

Payer selection

Audit Medicare/Medicaid only or include commercial

payers?

If commercials payers to be included, do you want

A different sample size?

A subset of them?

Invoicing

Did invoicing occur?

Was invoicing timely?

Was the proper amount billed?

Was overhead included?

Audit scope: one or all of the following, 4

Denials

Are research related denials identified?

What causes research related denials?

Who manages research denials?

Areas to understand prior to audit testing

 Operations

Charge segregation

Registration

Charge Capture

Billing

 Financial Management

Budgeting, Pricing,

Contracting

Accounts Receivable

Professional Fees

 Compliance Management

Investigations & Monitoring

Training

 Personnel

Roles & Responsibilities

Communication

What areas at your organizations do you understand fully?

Summary: how to audit a clinical trial, 1

 Take the standard steps:

Risk assessment

Objectives: what are we trying to achieve?

Scope: what and who are to be included in the audit?

Approval(s) required: Identify necessary authorities, advisors,

stakeholders

 Create an audit plan

What is the objective of each step?

Does the step tie to the overall audit objective?

Summary: how to audit a clinical trial, 2

 Conduct sample selection

 Request and review documents

Study Level – protocol / study documents, ICF, CTA, budget, CA,

IND/IDE

Patient Level – UBs/1500s, EOBs, study accounts, subject calendars,

EMR

 Perform interviews and testing

Documentation

Work papers

Data collection

 Write a report

Four audit planning exercises:

Bill hold and subject identification

Invoiceable items

Research billing audit

Claims and denials review

Audit planning: bill hold and subject

identification Exercise

You have implemented a “bill hold” triggered by CRCs entering the

subject’s name into a database upon informed consent

The hold is critical to ensure all billable items/services are reviewed and

directed appropriately to payers/sponsors, but you have limited resources

 How would you approach with audit?

 What activities/areas would you include in the audit?

 What activities/areas would you not include in the audit?

 What is the objective of your audit?

 How would you choose your sample?

Audit planning: invoiceable items

Exercise

The organization includes many invoiceable items in all budgets

and just implemented a new invoicing process

You need to determine if invoicing and receivables improved after

implementing the new invoicing system on 1/1/2016

 How would you approach this audit?

 What time period would you choose to audit?

 How would you choose your sample?

 Who would you interview for this audit?

 What systems would you need access to perform the audit?

 Considering the organization includes many invoiceable items in budgets, what

recommendations would you give regarding invoiceable items in general?

Audit planning and testing: research billing audit

Exercise

You determine a “soup to nuts” research billing audit is desirable

Place the following activities in the correct audit planning order and indicate why

you placed one item before another

 Review claims

 Perform document concordance

 Review subject “flagging”

 Select the sample: studies and subject to review

 Determine audit scope and objectives and plan the audit

 Conduct interviews

 Request documents (ICF, protocols, budgets, contracts, coverage analysis)

 Determine if the coverage analysis is correct

 Identify the “source of truth” for the claims review

 Determine error calculation

Audit planning: claims and denials review, 1

Exercise

The organization has received several patient complaints about

denials related to clinical-trial procedures in a device study

You need to determine if research-related payer claims are billed

to the appropriate payer

 How would you approach this review?

 What may cause a denial?

 What documents would you need to perform the review?

Document Concordance

Auditing

Term alert: document concordance

We use “document concordance” to refer to a key

and complex practical requirement in research billing: the

consistency and accuracy of all study-initiation and

continuation documents relevant to billing for protocol-

specified clinical services

Without concordance,

accurate billing is impossible

( – or accidental)

Example: document concordance and content review

Compare key documents

• Contract

• Budgets (Internal and External)

• Informed Consent Form (ICF)

• Coverage Analysis

• Protocol

Are there any discrepancies between the documents?

Were there any discrepancies on the Coverage Analysis?

Did the budget contain invoiceable items?

Were there any additional regulatory issues identified?

• Did the contract or ICF contain language the violate the Medicare Secondary Payer

Rule?

• Did the ICF contract Medicare Advantage language for drug trials?

Sample checklist

IRB #: 12-00000 PI Name: MD

Study Name: XYZ Study Consistency Checklist Date:

Issue

Agreement /

Budget Date

ICF Version/Date:

Protocol

Reviewer

A. Confidentiality

Describe how data or information will be shared between INSTITUTION, or sites and the research sponsor.

N/A

YES

YES XXX

B. Benefits of Taking Part in the Study

Describe benefits of participating for the subject and/or others in the context of therapeutic intent.

XXX

C. Research vs. Conventional Care

The procedures that will be performed during the course of the trial that are considered to be part of the

subjects’ conventional care and that would be performed anyway notwithstanding the research study are

differentiated from the procedures that will be performed during the course of the study that are for

research purposes only.

N/A YES N/A XXX

D. Additional Costs

Subjects will be required to bear additional costs beyond those associated with their conventional care as a

result of participating in the study.

N/A

N/A XXX

E. Subject Compensation

Subjects will be compensated for agreeing to participate in the trial.

N/A N/A

N/A XXX

F. Research Related Injury

Identify the individual or entity responsible for the costs of any research-related injuries to subjects.

N/A N/A N/A XXX

G. Future Use Of Data

Are subjects asked or expected to donate data, materials, samples etc. to databases or tissue repositories

and if the sponsor receive any future rights to the data or materials collected in the course of the study?

N/A YES YES XXX

H. Study is registered at clinicaltrials.gov and statement is in the ICF

(Input Registration Number)

XXX

I. Medicare Advantage statement included in the ICF

XXX

Insurance Claims Review &

Exercises

Billing grid/sponsor budget review

Exercise

What’s missing/incorrect?

Blue = billing grid; orange = sponsor budget

S = Sponsor Paid

M = Medicare/ 3

Party Payer

Summary: Medicare requirements – drug trials

Claim Type Coding Requirements Location on Claim

Technical

UB-04

(CMS1450)

- Z00.6 – Secondary Diagnosis

- Modifier Q0 & Q1 as needed

(Outpatient Only)

- Q0 – Investigational Clinical

Service (Drug)

- Q1 – Routine Costs

- Condition Code 30 “Qualifying Clinical

Trial”

- Rev Code 256 – Drug Trial

- NCT # (www.clinicaltrials.gov)

- Field 66

- Field 44

- Field 18 - 28

- Field 42

- Field 39; D4 & Value Code = 8 digit NCT#

Professional

CMS1500

- Z00.6 – Secondary Diagnosis

- Modifier Q0 & Q1 as needed

- Q0 – Investigational Clinical

Service

- Q1 – Routine Costs

- NCT # (www.clinicaltrials.gov)

- Field 21

- Field 24.D – Modifier

- Field 19 (Use CT pre-fix on paper claim

only)

Summary: Medicare requirements – device trials

Claim Type Coding Requirements Location on Claim

Technical

UB-04

(CMS1450)

- Z00.6 – Secondary Diagnosis

- Modifier Q0 & Q1 (Outpatient Only)

- Q0 – Investigational Clinical Service (Procedure)

- Q1 – Routine Costs

- Condition Code 30 “Qualifying Clinical Trial”

- Condition Code 53 – Free Devices (Outpatient only)

- NCT # (www.clinicaltrials.gov)

- Value Code FD (Free Device as part of a trial, Outpatient Only)

- Rev Code 0624 – Device Trial

- Device charge – list as non-covered (token) charge if device

is provided at no cost

- Rev Code 278 – Medical/Surgical Supplies: Other Implants

- IDE Number

- Category B IDE device HCPCS code, as applicable

- Generally, Category A not reported on institutional claim. Follow

Medicare’s specific instructions for the trial

- Field 66

- Field 44

- Field 18 - 28

- Field 39; D4 & Value Code = 8 digit

NCT#

- Field 39; Credit amount for device

- Field 42

- Field 47 & 48

- Field 42

- Field 43

- Field 44

Professional

CMS1500

- Z00.6 – Secondary Diagnosis

- Modifier Q0 & Q1 as needed

- Q0 – Investigational Clinical Service (Procedure)

- Q1 – Routine Costs

- NCT # (www.clinicaltrials.gov)

- IDE Number

- Field 21

- Field 24.D – Modifier

- Field 19; Use CT pre-fix on paper

claim only

- Field 23

Medicare Q&A 2014

Mandatory Reporting of NCT# Identifier on Medicare Claims*

*https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Downloads/Mandatory-Clinical-Trial-

Identifier-Number-QsAs.pdf

Billing grid/claim

Exercise

What’s missing/incorrect?

Blue = billing grid; orange = payer claim

S = Sponsor Paid

M = Medicare/ 3

Party Payer

Invoicing Review & Exercises

Example: invoiceable items, 1

Review contracts, budgets, coverage analysis for invoiceable items

Identify activities that are invoiceable

 Conduct a process audit

 Conduct internal control testing

 For example:

 External vendor invoices – PEAR* groups

 Items/services performed for specific cases

 Was overhead included?

* Pathology, Emergency, Anesthesia, Radiology

Example: invoiceable items, 2

The budget indicates payment upon invoice for

certain activities and items/services, such as:

 Serious Adverse Event (SAE) reporting

 Re-consent of subjects

 Items/services conducted for research

purpose only

How do you know when:

 An SAE occurs?

 Subjects are re-consented?

 A CT scan is conducted for study purposes

only?

Example:

lost revenue and billing risks

1. Collect key documents – contract, budget, coverage analysis, informed consent

form and protocol

2. Perform a “document concordance” review

3. Establish the “source of truth” for the audit

4. Audit the coverage analysis

5. Use the original coverage analysis versus revised coverage analysis

6. Identify invoiceables

7. Determine how subjects are identified in systems

8. Gain system access needed to perform the audit

9. Follow orders / claims / invoices through the systems and review for correct

billing/payer, coding, etc.

10. Review denials

11. Calculate error rates / overpayments / underpayments

Invoicing exercise

Insurance Denials

General Causes for Denials: Pre & Post Service

Not a covered benefit

Not enough information

Not medically necessary

Lack of pre-authorization

Complete disconnect between

hospital and physician billing

Documentation by physicians

inadequate in some instances

Coverage Determinations:

LCD prohibits payment

Ordered test with certain ICD-9 / ICD-10

codes and there is an LCD that prohibits

payment

Coding:

Government codes on commercial payer

claims

Z00.6 not in secondary position so it is

removed from the claim by coders

Lack of NCT# when there is a Z00.6 and a

condition code 30

Improper coding for commercial payers

Medicare Denials

The Medicare beneficiaries enrolled in the trial would not be held liable (i.e., would be held

harmless from collection) for the costs consistent with provision of §1879, 1842(l) or

1834(j)(4) of the Act, as applicable.

Where appropriate, the billing providers would be held liable for the cost and fraud

investigations of the billing providers and the trial’s PI may be pursued. (NCD 310.1)

Advanced Beneficiary Notices (ABNs)

Common findings

Auditing clinical trial billing and finance:

common findings, 1

 Non-employed physician group not notified of clinical trial / subject

 Under budgeting

 Lack of fund accounting

 Excessive residual balances and no residual funds policy

 Claims submission errors

 Misdirection of charges – double billing

 Denials

For example: pre-authorization, investigational article

 Coding errors and mismatches

IDE, NCT numbers on claim no CC or Q-modifiers

IV administration with no study drug on claim

 No follow-up on denials; write-offs

Auditing clinical trial billing and finance:

common findings, 2

 Charges not posted in billing systems

 Billing of professional (pro) and technical (tech) charges not

coordinated. For example, pro charge is billed:

to insurance and tech charge is billed to sponsor/research

to Medicare and tech charge is billing to Medicare

Advantage

with clinical trial coding but the tech charge lacks coding

 “Off the books” research activities

 Patient reimbursements held or not paid

Wrapping up

Not to be a broken record, but…

 Audit planning effort cannot be underestimated!

 Scope and objectives follows responsible risk assessment

 Thorough knowledge of billing regulations and rules, as well as

institutional policies, is crucial

 Matching audit to auditors and interviewees is key to planning

 Did we mention that audit planning is really important?

Kelly Willenberg, DBA, MBA, BSN, CHRC, CHC, CCRP

Owner, Kelly Willenberg and Associates, LLC

P 864.473.7209

kelly@kellywillenberg.com

Wendy Portier, MSN, RN, CHRC, CHC, CCM

Consultant

Kelly Willenberg and Associates, LLC

wendy@kellywillenberg.com

504-782-1328