Clinical Research Billing Basics & How to Develop a Coverage Analysis

(1)

4147 N Ravenswood Ave Ste. 200

Chicago, IL 60613 888.739.8194

Clinical Research Billing Basics

&

How to Develop a Coverage Analysis

Julie Colasacco & Michael C. Roach

Presented at

Virginia Commonwealth University

August 29, 2013

(2)

Chicago, IL 60613

Goals

• Raise Awareness

(3)

Important Terms & Acronyms

• Clinical Research Billing – CRB

• Medicare Clinical Trial Policy – CTP

• Qualifying Clinical Trial – QCT

(4)

Overview

1. Regulatory risks of clinical research billing non-compliance

2. The importance of a Coverage Analysis (CA) for compliance

3. An overview of Medicare rules for billing during clinical research studies

4. The “basics” of billing for research team members

5. How the budget structure influences what can be billed to insurance

6. How the language of the Informed Consent Form influences what can be

billed to insurance

7. What does Medicare mean by a “qualifying clinical trial”?

8. What does Medicare mean by “routine costs”?

9. The importance of the research coordinator in ensuring clinical research

billing is compliant

10. Tips on protocol design for investigator-initiated studies to improve

budgeting and billing

11. The role of the study calendar in clinical research billing

(5)

Overview

13. Pause for Questions

14. Introduction to the Coverage Analysis: Purposes

15. Review of forms needed

16. Development of a Coverage Analysis

• Step 1: Draft a grid

• Step 2: Review ICF

• Step 3: Review CTA/Budget

• Step 4: QCT Analysis

• Step 5: Which are “routine costs”?

• Step 6: How to document reasoning

• Step 7: Coding the CA

(6)

Chicago, IL 60613

1. Regulatory risks of clinical

research billing non-compliance

(7)

Risks Associated With Non-Compliance

• CRB risks can be grouped:

1. Billing for services that are already paid by the sponsor (double

billing)

2. Billing for services promised free in the informed consent

3. Billing for services that are for research-purposes only

4. Billing for services that are part of a non-qualifying clinical trial

5. Billing Medicare Advantage Plan when claim should be directed

(8)

Challenges

Cause of most research billing non-compliance:

• Breakdown in coordination

Important information to coordinate

• What research studies are being conducted at the facility?

• Which patients are enrolled in a research study?

• Which services should be charged to payors

and which charged to study account?

• Sponsor, grant, internal account

• Informed consent language

• Clinical trial agreement language

• Protocol Language

(9)

Coordination

• Who impacts research billing?

• Principal Investigator

• Clinical Research Coordinator – vital communication coordinator

• IRB process

• Budget negotiators

• Clinical Trial Agreement negotiators

• Grant administration

• Information Technology

• Health Information Management

• Registration/Scheduling

• Medical center billing and coding

• Physician professional fee billing and coding

• Study fund managers

• Managed care contract negotiators

• ….and others!

(10)

Current Research Regulatory

Environment

$0.0

$1.0

$2.0

$3.0

$4.0

$5.0

$6.0

$7.0

$8.0

Yale

Mayo Clinic

Rush University

Northwestern University

Tenet Healthcare (Norris Cancer Ctr)

Cases of improper clinical trials billing

(11)

4147 N Ravenswood Ave Ste. 200 Chicago, IL 60613 888.739.8194

2. The importance of a

Coverage Analysis (CA)

(12)

What is a Coverage Analysis?

• 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 required by the study

• A tool to coordinate information for purposes of:

• Budgeting

• Billing

(13)

What a Coverage Analysis is not

• Guarantee of coverage in all cases

• Substitute for the pre-authorization process

• Based on individual investigators’ decisions or billing practices

• Substitute for the practice of medicine or physician judgment

• Treatment plan

(14)

Hypothetical CA: a way to coordinate information

Code

Infusion

1 Infusion

2 2 weeks

12 weeks 24 weeks Comment

Physical

Exam

99201-

99215

RC

EKG

93000

_RC

Drug 123

J0123

_SB

Infusion

96400

_RC

Urinalysis

81000

_NB

Ultrasound 93990

_ICF

Patient

Diary

N/A

NB

RC=Routine Care

SB=Sponsor Billed

ICF=Free in Informed Consent

NB=Not billable to Medicare

(15)

Chicago, IL 60613 888.739.8194

3. An overview of Medicare rules

for billing during clinical

(16)

True or False?

• Medicare pays for standard of care during

research studies.

• False: Medicare pays for

“routine costs” during

“qualifying clinical trials”

(17)

True or False?

“My friend in California says this service is covered

when she provides it, so it’s covered for us, too.”

Maybe:

Medicare Administrative Contractors (“MACs”) can

issue local coverage determinations (“LCDs”) that limit

coverage in their area

.

If your friend has a different MAC, you may not be able

to bill a service that she can.

Possible for your friend to have a different MAC even if

she works at a facility down the street from you

(18)

True or False?

“We have billed for this service hundreds of

times and the claim is always paid by Medicare,

so it must be covered.”

False: You cannot assume that just because

Medicare has been paying for a service that it

is a covered service

(19)

True or False?

“You are making clinical decisions when you

decide something is not billable to Medicare.”

False. Decisions about whether a service is

covered is not a clinical decision. It is a

decision based on an analysis of the billing

rules and coverage determinations made by

CMS and Medical Directors at MACs.

(20)

Medicare’s CRB Framework

Medicare requires a five-part process for clinical research services coverage:

1. Does the study “qualify” for coverage?

2. What items and services are “routine costs”?

3. Do Medicare rules allow coverage of specific “routine costs” within a research

study?

4. What is paid for by the sponsor?

(21)

Chicago, IL 60613 888.739.8194

4. The “basics” of billing

for research team

(22)

Billing Basics

• Before getting into the details of CRB, it is

important to step back and understand:

• The billing system in the U.S.

• The structure of the Medicare Program

• Medicare is a driver of reimbursement across

many payors, particularly for CRB

• Understanding some of the basics helps with budgeting,

putting the CRB rules in context, and improves claims

management

(23)

Structure of Medicare reimbursement for

an outpatient service

Service

Technical

component

Professional

component

Medicare pays a technical component and professional component for

all Part B services. Who receives which component depends upon the

(24)

Service provided in a physician office setting

Service

Technical

component

Professional

component

Medicare pays

physician both

components in

one payment

(25)

Service provided in a hospital outpatient setting

Service

Technical

component

Professional

component

Medicare pays

hospital

Medicare pays

physician

(26)

The Legal Structure of Medicare

• To understand Medicare research billing rules,

it is important to step back and understand the

legal structure of Medicare

• Statutory basis for Medicare coverage follows

this principle:

• Medicare covers items and services that are

“reasonable and necessary to diagnose or treat illness

or injury”

(27)

The Hierarchy of Medicare Rules

The Statute

National – CMS

• National Coverage Determinations (“NCDs”)

• www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx

• Manuals (e.g., Medicare Benefit Policy Manual, Medicare Claims

Processing Manual)

Local - MACs

• Local Coverage Determinations (“LCDs”)

• Medical Director “articles”

• Medical Director “rulings”

“Reasonable & Necessary Rule”

(28)

Medicare Contractors Have Wide Discretion

Example: CyberKnife

No national uniform policy; regional decision

“Geography Has Role in Medicare Cancer

Coverage,” NYT December 16, 2008

“[G]eography may play as big a role as medicine in determining which

men diagnosed with prostate cancer are eligible for CyberKnife. As it

turns out, Medicare pays for the treatments in 33 states — but not in 17

others.”

“Our guidance to them is that if there’s no evidence it works, they shouldn’t

pay for it,” said Dr. Steve Phurrough, Medicare’s coverage director in

Washington. “The CyberKnife is a good example of a technology where you

can review the evidence and come to different conclusions.”

(29)

Implications of hospital vs. physician

billing in CRB process

• The “answer” in the CA will be the same for hospital billing

and physician billing – but how the charges are presented on

the claim forms will look very differently

• Hospital billing and physician billing should usually match

during a research study – with respect to when services are

charged to the study account and when the item or service is

billed normally

• Payment for hospital services versus physician services

varies immensely

• Budgeting must take into account both the hospital charge

(30)

Chicago, IL 60613

5. How the budget

structure influences what

can be billed to insurance

(31)

Medicare’s CRB Framework

Medicare requires a five-part process for clinical research services

coverage:

1. Does the study “qualify” for coverage?

2. What items and services are “routine costs”?

3. Do Medicare rules allow coverage of specific “routine costs” within a

research study?

4. What is paid for by the sponsor?

(32)

First things first:

What is a clinical trial agreement?

A clinical trial agreement (CTA) sets out the obligations of

parties involved in a research study

The CTA sets out:



what services are to be performed



“who does what”



“who owns what”



how much money will be paid for which services



“extra” regulatory obligations the parties will take on



the “rules of the road” between the parties

(33)

Why is the CTA important for the

research billing process?

• Whatever is paid for by the sponsor in the CTA cannot

be billed to the subject or the subject’s insurer

• If the CTA is not clear on what is being paid for by the

sponsor, the document may be misinterpreted both by

the sponsor and by regulators in the event of an audit

• The information in the CTA on what the sponsor is

paying for must be communicated to the billing process

• Institutions may suffer unintended consequences based

(34)

Non-industry contracts

• The concepts in this presentation apply equally to contracts

for funding support with non-industry sponsors

• Most CRB compliance risks can occur without respect to

whether the sponsor is industry, government, or a private

foundation

• Negotiators of government contracts should coordinate with

the individuals who negotiate the budget and be cognizant of

their impact on the CRB process

• Offices within organizations that deal with government

(35)

What and where is the “study

budget”?

• The study budget for industry-sponsored studies is

typically an appendix or exhibit to the CTA and serves as

the compensation detail

• The study budget and the main body of the contract are

part of the same document – they will be interpreted

together

(36)

Operational issues that could impact the

CRB process

Many clinical trial agreements have been

negotiated in “parts”

• One person negotiates the main body

• Another person negotiates the “budget”/compensation

• Protocol is incorporated but may not be reviewed carefully by

either person, particularly if there is no formal MCA process in

place

Fundamental principle of Clinical Trial Agreements

– Singularity:

• A CTA is one contract with many parts

• Interpreted as a single legal document

(37)

Bringing a CRB perspective early to

a CTA

• Best practice CRB processes analyze both the main body of the

CTA and the “study budget” exhibit from a billing perspective

• Goal: Clarity in the final documents

• If sponsor is paying for all services, then the CTA and study budget

should be clear and that should be reflected in a Medicare Coverage

Analysis (MCA) or other communication tool to inform the CRB process

• If sponsor is only paying for some of the protocol services, then the

study budget should be clear as to which services are being paid for so

there is no confusion in developing the MCA

• Ambiguities in the CTA and study budget will usually be interpreted by

(38)

Main body of the CTA:

Case studies of language

Examples of clauses (risky language):

• “Payment for Study services are set out in Exhibit B. Such

compensation constitutes payment for all of the Institution’s costs for

conducting Study services.”

• “Sponsor agrees to pay Institution in accordance with Exhibit B.

Institution agrees not to bill any third-party payer for services

required by the Study.”

• “Exhibit A sets out the payment schedule to Institution for Study

services. Unscheduled imaging services shall be invoiced to

sponsor at $350 per service.”

(39)

Main body of the CTA:

Case studies of language

Examples of clauses (neutral language):

• “

During the term of the Study, Sponsor agrees to provide financial support

for the Study in accordance with the budget set out in Exhibit A.”

• “Payment to Institution for items provided and services performed by

Institution during the Study are set out in Exhibit A.”

• Negotiations will not always be able to produce completely neutral language

in the main body of the CTA; if the main body contains discussion of

specifics of the financials, then be precise and ensure that the main body of

the CTA and the study budget language do not contradict each other

(40)

Structure of Financial Provisions:

Compensation Exhibit/“Study Budget”

There is no standard approach to the Compensation Exhibit – each

sponsor tends to have its own format

Some structures utilized:

• Payments for “research service” at milestones

• Note: Is “research service” defined? Be clear which services are

considered research services

• Spreadsheet with payments based on schedule of events

(41)

Structure of Financial Provisions:

Compensation Exhibit/“Study Budget”

• Consider adopting a consistent approach for the compensation

exhibits: the more detail on which services are being paid for, the

better

• The MCA can serve as a tool for budgeting and lends itself to be

used as the compensation exhibit

• Negotiating Suggestion: Watch out for footnotes! Avoid footnotes in

(42)

Operational issues that could impact the

CRB process

Many clinical trial agreements have been negotiated in

“parts”

• One person negotiates the main body

• Another person negotiates the “budget”/compensation

• Protocol is incorporated but may not be reviewed carefully by

either person, particularly if there is no formal MCA process in

place

Fundamental principle of Clinical Trial Agreements –

Singularity:

• A CTA is one contract with many parts

• Interpreted as a single legal document

(43)

Tips on protocol design for

investigator-initiated

studies to improve

budgeting and billing

(44)

The design of the study impacts billing

3 Items to think about in protocols:

1. Loose use of the term “research”

• If the service is being used for research purposed

and clinical care, then discuss the clinical care

• When a protocol only talks about the research

aspects of a service, an auditor could ignore the

clinical usefulness of the services

(45)

The design of the study impacts billing

3 Items to think about in protocols:

2. Stating a potential benefit

• If protocol or informed consent form states that the

subject will receive no benefit from the study, then no

services will be billable

• Describe in the protocol and the informed consent

any potential benefit (though do not guarantee

(46)

The design of the study impacts billing

3 Items to think about in protocols:

3. What are the objectives in a Phase 1 study?

• Is it necessary in the study to state principal and

secondary objectives of the study? Or can all

objectives be stated without rank?

• Some Medicare Contractors and auditors have

denied coverage to Phase 1 studies when

measurement of therapeutic outcome is not a primary

objective or a clearly articulated objective

(47)

Chicago, IL 60613 888.739.8194

6. How the language of the

Informed Consent Form

influences what can be

billed to insurance

(48)

Medicare’s CRB Framework

Medicare requires a five-part process for clinical research

services coverage:

1. Does the study “qualify” for coverage?

2. What items and services are “routine costs”?

3. Do Medicare rules allow coverage of specific “routine costs”

within a research study?

4. What is paid for by the sponsor?

(49)

Role of the Informed Consent Form

Interpreting the ICF

• ICF interpreted for MCA from the perspective of the subject

• Plain meaning of the words used in the informed consent

• Promises made to subject regarding what is free must be kept

• If two sentences in Costs section could reasonably be

interpreted in a way that they contradict each other, then

re-word

(50)

Research Informed Consent:

Context

OHRP & FDA Rules:

45 CFR 46.116 & 21 CFR 50.20: “The information that is

given to the subject or the representative shall be in language

understandable to the subject or the representative.”

Goal: Language in 6

th

_{to 8}

th

_{grade reading level}

Government reviews and audits of ICF:



Interpreted from the perspective of the subject



The ICF means what it says: assumes plain meaning of the

(51)

ICF & Added Costs Section

Regulation:



45 CFR 46.116(b)(3) & 21 CFR 50.25(b)(3) require the ICF

include, when appropriate, “any additional costs to the subject

that may result from participation in the research”

If the “added costs” section of the informed consent form states that an

item or service will not be charged to the patient, then the provider

cannot bill for that service

Note: The regulation does not require that the ICF list the services that

are or are not charged, rather it requires the ICF to list the “additional

costs” the patient will incur as a result of participating in the study

(many routine costs are not costs resulting from participation)

(52)

Problematic Added Costs Language

“You or your insurer will have no costs for participating in this research

study.”



(Subject/insurer may not be billed for any protocol-required items or

services, nor for complications/injuries or other costs associated with

participation)

“Your routine medical care will be billed in the usual way. However, you

will not be charged for any study visits or services.”



(

Inconsistent terms within the same document)

“You will be responsible for the costs of any services you would have

received if you did not enroll in this research study. However, you will

not be billed for any lab services or imaging services.”

(53)

Added Costs Section Contemplating

the CRB Process

Language which keeps the ICF “neutral”:

“You will be responsible for the costs of services required by the research

study that are routine to treat your condition. You will not be responsible for

the costs of services that are required only because you are enrolled in the

research study.”

Language which specifically identifies services that will not be billed (if

IRB desires specifics)

“You will be responsible for costs for care you would have received if you

were not enrolled in this research. However, you will not be responsible for

the costs of the CT scan conducted at the start of each drug cycle.”

(54)

Chicago, IL 60613

Medicare CRB Rules:

(55)

In a Nutshell

Medicare covers “routine costs” in a “qualifying

clinical trial” but note that all other Medicare

(56)

Chicago, IL 60613 888.739.8194

7. What does Medicare

mean by a “qualifying

(57)

“Qualifying” Status

Research study must meet CMS’ “qualifying clinical trial”

criteria for any items and services in the study to be

confidently covered.

• Government and Drug Trials: CMS Clinical Trial Policy (NCD

310.1)

• Device Studies: Device study coverage rules from regulations

and Medicare Benefit Policy Manual

• 42 CFR Part 405, Subpart B (42 CFR 405.201 et seq.)

• Ch. 14 of the Medicare Benefit Policy Manual

(58)

Qualifying Clinical Trials ("QCTs")

Part 1 – “Deemed Studies”

These studies are “deemed” to have 7 characteristics CMS wants

to see in a study it will cover

1. Studies funded by NIH, CDC, AHRQ, CMS, DOD, and VA

2. Studies supported by centers or cooperative groups funded by

NIH, CDC, AHRQ, CMS, DOD, and VA;

3. Studies being conducted under an IND application; or

4. IND exempt studies under 21 CFR 312.2(b)(1)

(59)

Qualifying Clinical Trials (“QCTs”)

Part 2 – “Necessary Requirements”

1. The study must investigate an item or service that

Medicare pays for (falls in a benefit category)

2. The study must enroll patients with diagnosed disease

(60)

Benefit Category Test

• NCD 310.1 lists 72 benefit categories

(61)

Diseased Subjects Test

Medicare only covers items and services that are

reasonable and necessary to “diagnose or treat” illness or

injury (with limited exceptions)

• Requirement comes from Medicare statutory principles

CA documents the subjects’ diagnosis

CTP: “Trials of diagnostic interventions may enroll healthy

patients in order to have a proper control group.”

(62)

Therapeutic Intent Test

For the time being, application of therapeutic intent criterion

is deferred to local Medicare Contractors

Principally an issue for Phase I drug studies

• Can be vast differences from one Medicare

contractor to another

(63)

Therapeutic Intent

There are two discussions of therapeutic intent in the CTP:

• “

The trial must not be designed exclusively to test

toxicity or disease pathophysiology. It must have

therapeutic intent.”

• “The principal purpose of the trial is to test whether the

intervention potentially improves the participants'

(64)

Qualifying Clinical Trial Test - Recap

It is really a four part test:

• Is the trial one of the “deemed” studies?

• Does the trial assess something in a Medicare Benefit

Category?

• Does the trial enroll people with diagnosed disease?

• Does the trial have therapeutic intent?

(65)

“Qualifying”/Approved

Device Trials

(66)

Device Trials

Always check with your Medicare

Administrative Contractor is Palmetto for

the Richmond Virginia area for their

(67)

Category A Experimental Devices

Generally not covered

• However, Medicare may cover routine costs, if the

device is used for a life-threatening condition.

• Medicare contractor decides

(68)

Category B Non-Experimental Devices

These devices can be covered under Medicare.

• FDA approved IDE study protocols restrict

investigational devices shipment to a limited number of

clinical sites for testing on a specific number of patients.

• Medicare coverage is based on the device continuing to

(69)

Clinical Trials Billing

Medicare may cover procedures using devices with an IDE

that have been categorized as non-experimental

/investigational (Category B)

Medicare only covers those procedures if:

• They involve a device the FDA has determined is

non-experimental/investigational (Category B), and

• The device is furnished in accordance with

(70)

Chicago, IL 60613

8. What does Medicare

mean by “routine

(71)

“Routine Costs” from the Medicare CTP

“Items or services that are typically provided absent a clinical trial (e.g.,

conventional care);

[Note: Not the same as “standard of 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.”

(72)

Routine Costs – Short Version

1. Detection, prevention, or monitoring of complications;

2. Administration of investigational item; or

(73)

Detecting, preventing, or monitoring

complications

Identify nexus between the item or service and a

known potential side effect of the item or service

• What are the potential side effects of the drug?

• What are the potential complications of use of the

(74)

Detecting, preventing, or monitoring

complications

Places in which CAs identify potential side effects

• Protocol

• Informed Consent

• Product Label

• Drug compendium discussion

• AHFS-DI– American Hospital Formulary Service Drug Information

• NCCN – National Comprehensive Cancer Network Drugs & Biologics

Compendium

• Thompson Micromedex DrugDex

(75)

Administration of Investigational Item

What is required to administer the investigational

item?

• Surgery?

• Infusion?

Note: must be something that would be covered

outside of study if similar therapy or procedure

occurs.

(76)

Conventional Care

CAs should identify objective practice

guidelines

1. Professional association guidelines (e.g., National

Comprehensive Cancer Network/NCCN)

2. Peer-reviewed literature

3. Significant textbooks

4. Disease-based associations

5. NIH recommendations

(77)

Conventional Care: Example

NCCN Practice Guidelines for Cancer of the Oropharynx: follow-up

Physical exam –

Year 1: every 1-3 months

Year 2: every 2-4 months

Years 3-5: every 4-6 months

> 5 Years: every 6-12 months

(78)

Additional

Note: “All Other Medicare Rules

Apply”

Coverage is available if Medicare covers the

“routine cost” outside of clinical trial

MCA applies normal Medicare rules on top of any

item or service identified as a “routine cost”

(79)

Other Medicare Rules

Example: Rule against coverage of

self-administered drugs (Medicare Benefits Policy

Manual, Ch. 15, Sec. 50.5)

• Exception examples:

• anti-emetics;

(80)

Routine Costs vs. Standard of Care

Just because the physician normally performs a service at

a given frequency for similar patients not on trial does not

mean the service qualifies as a routine cost

E.g., PSA exams for prostate cancer patients

• Study calls for monthly PSA

• Physician typically does monthly PSA and argues they are

therefore “conventional care” and consequently “routine costs”

• NCCN guidelines call for every 3 months

• No other objective evidence produced by physician to support

(81)

Routine Costs vs. Standard of Care

EKG performed 3 days after each infusion of

cardio-toxic drug during trial

• Routine cost: detecting and monitoring known

side effects

Also performed at annual follow-up visits for life

Is EKG at follow-up a routine cost?

(82)

Chicago, IL 60613

9. The importance of the

research coordinator in

ensuring clinical

research billing is

(83)

(84)

Chicago, IL 60613

10. Tips on protocol

design for

investigator-initiated studies to

improve budgeting and

billing

(85)

The design of the study impacts billing

3 Items to think about in protocols:

1. Loose use of the term “research”

• If the service is being used for research purposed

and clinical care, then discuss the clinical care

• When a protocol only talks about the research

aspects of a service, an auditor could ignore the

clinical usefulness of the services

(86)

The design of the study impacts billing

3 Items to think about in protocols:

2. Stating a potential benefit

• If protocol or informed consent form states that the

subject will receive no benefit from the study, then no

services will be billable

• Describe in the protocol and the informed consent

any potential benefit (though do not guarantee

(87)

The design of the study impacts billing

3 Items to think about in protocols:

3. What are the objectives in a Phase 1 study?

• Is it necessary in the study to state principal and

secondary objectives of the study? Or can all

objectives be stated without rank?

• Some Medicare Contractors and auditors have

denied coverage to Phase 1 studies when

measurement of therapeutic outcome is not a primary

objective or a clearly articulated objective

(88)

Chicago, IL 60613

11. The role of the study

calendar in clinical

(89)

Chicago, IL 60613 888.739.8194

Study Calendars

• Study calendars help orient

reviewers to where the subject is in

the study

• The study calendar helps to sync

the schedule of events with the CA

• Example: A charge for a CBC on

(90)

Hypothetical CA

Code

Baseline

C1 W1

C1W2

C1W3

C1W4

C2W1

C2W2

Physical

Exam

99214

S

P

S

P

CMP

S

P

S

P

CBC

S

P

S

P

Blood

Draw

S

P

S

P

DEXA

scan

S

P

Study

Drug

S

Admini

stration

P

(91)

Collecting Protocol Event Dates

John

Smith

ICF:

8/14/12

Code

Baseline

C1 W1

C1W2

C1W3

C1W4

C2W1

C2W2

Physical

Exam

8/16/12

9/2/12

9/9/12

9/16/12

10/6/12

10/13/12

CMP

8/16/12

9/1/12

9/9/12

9/16/12

10/6/12

10/13/12

CBC

8/16/12

9/1/12

9/9/12

9/16/12

10/6/12

10/13/12

Blood

Draw

8/16/12

9/1/12

9/9/12

9/16/12

10/6/12

10/13/12

DEXA

scan

8/18/12

9/21/12

Study

Drug

9/2/12

9/9/12

10/6/12

10/13/12

Admini

stration

9/2/12

9/9/12

10/6/12

10/13/12

(92)

Chicago, IL 60613

12. Improving

communications during

the research study

(93)

Reality…

• This isn’t going to happen overnight

• Try piloting ideas for CRB claims management

• Do not be afraid to re-think plan after results of piloting

• Personal Observation: We have yet to see a CRB

(94)

The importance of databases

• Sharing information and communication is a

critical feature of managing clinical research

billing

• Databases and an information platform are

(95)

The importance of databases

What information to collect?

• Study identification

• IRB status

• Subject enrollment

• Study calendars

• Coverage Analyses

(96)

Chicago, IL 60613

(97)

Workshop Discussion

(98)

4147 N Ravenswood Ave Ste. 200 Chicago, IL 60613

14. Introduction to the

Coverage Analysis:

Purposes

(99)

Screening

C1W1

C1W2

C1W3

C1W4

C2

W1

C2

W2

C2

W3

C2

W4

After

Discontinuation

Phys

Exam

99201-99215

X

ECG

93000

X

Echo

cardiogram

93000-93014

X

Chest

CT or MRI

71250-71270,

71550-71552

X

Abdominal CT

or MRI

74150-74170,

74181-74183

X

Pelvis CT or

MRI

72192-72194,

72195-72197

X

Bone Scan

78300-78306

X

CBC w/diff

85025

X

Comprehensive

Metabolic

Panel

80053

X

Study Drug

J9999

X

(100)

Screening

C1W1

C1W2

C1W3

C1W4

C2

W1

C2

W2

C2

W3

C2

W4

After

Discontinuation

Phys

Exam

99201-99215

P

NB

ECG

93000

P

NB

Echo

cardiogram

93000-93014

P

S

NB

Chest

CT or MRI

71250-71270,

71550-71552

P

NB

Abdominal CT

or MRI

74150-74170,

74181-74183

P

NB

Pelvis CT or

MRI

72192-72194,

72195-72197

P

NB

Bone Scan

78300-78306

P

NB

CBC w/diff

85025

P

S

P

S

NB

Comprehensive

Metabolic

Panel

80053

P

S

P

S

NB

Study Drug

J9999

S

P

S

(101)

15. Review of forms

needed

(102)

First Question

(103)

Basic Documents Needed

• Protocol

• CTA/Budget – Funding Document

• Informed Consent Form

• IND Status – drug study

(104)

General Order of Steps for Developing an CA:

Proposed Study :

1. Develop grid

2. Perform QCT analysis

3. Identify items and services “hard-wired” free into protocol

4. Determine items and services that are routine costs

5. Determine if routine costs are covered by Medicare

6. Check proposed contract to determine if offered budget covers items and

services that are not billable

7. Negotiate contract/budget

8. Finalize “added costs” section of informed consent

(105)

Chicago, IL 60613 888.739.8194

Sections 16

Development of a Coverage Analysis

Step 1: Draft a grid

Step 2: Review ICF

Step 3: Review CTA/Budget

Step 4: QCT Analysis

Step 5: Which are “routine costs”?

Step 6: Document reasoning

(106)

General Order of Steps for Developing an

CA: Active Study

1. Develop grid

2. What items and services are promised free in the informed consent?

3. What items and services are paid for by the sponsor?

4. Qualifying clinical trial (QCT) analysis

5. Determine items and services that are routine costs

6. Determine if routine costs are covered by Medicare

7. Apply Medicare rules to the routine costs

(107)

(108)

Document the QCT Analysis Process

Question

Yes

No

Comment

Deemed study?

Item or service falls

within a benefit

category?

Enrolls subject with

diagnosed disease?

Study designed with

therapeutic intent?

Qualifying Clinical

Trial?

(109)

Document the QCT Analysis Process

Question

Yes

No

Comment

Deemed study?

_X

_{IND # 55,512}

Item or service falls

within a benefit

category?

X

Drugs & Biologicals

Enrolls subject with

diagnosed disease?

X

Crohn’s Disease – Include direct quote

_{from protocol and reference page}

number

Study designed with

therapeutic intent?

X

“To determine the efficacy of [study

_{drug] in minimizing occurrences of}

abdominal pain over 24 week period.”

Qualifying Clinical

(110)

Recall: Device Trial Qualifying

Status

Device Trial Coverage: Coverage deferred to Medicare Contractor approval or

local rules

Category A IDE: covered when studying a life-threatening condition

Category B IDE: generally covered

PMA: generally covered with approval and may not always need approval

Note: Carotid Artery Stent PMAs must be approved by the Medicare Contractor

Misc Situations:

Labeled Use: generally covered because the study is likely not

“investigating” the device, but collecting outcomes data

(111)

Document Device Trial Qualifying

Question

If the device has an IDE what

_{category is it?}

Comments

Does the device

have an IDE?

Yes

Category A

Category B

No

Question

If the device is FDA approved is it

being studies on-label or

off-label?

Comments

Is the device

approved by the

FDA?

Yes

On-Label

Off-Label

No

Coverage Eligibility Summary

Question

Yes No Supporting Explanation

Is the study

eligible for

coverage?

(112)

“Routine Cost”

Short version approach to “routine costs” used in MCAs:

1. Detection or prevention of complications

2. Conventional care

3. Administration of investigational item

If study documents are not clear: will each subject enrolled

in the study need the item or service for the patient’s

clinical management?

(113)

Which of the events are justified for billing under

the coverage rules as “routine costs”?

Code

Infusion 1

Infusion 2

2 weeks

12 weeks

24 weeks

Physical

Exam

99201-

99215

RC

EKG

93000

_RC

Drug 123

J9999

_SB

Infusion

96400

_RC

Urinalysis

81000

_NB

Ultrasound

93990

_ICF

Patient Diary

N/A

_NB

RC=Routine Care

SB=Sponsor Billed

ICF=Free in Informed Consent

NB=Not billable to Medicare

(114)

Document Reasoning

EKG: “The EKG in this study is conventional

care. Practice Guidelines for treatment of XYZ

Condition recommend EKG at this frequency.

[Cite Guidelines].”

(115)

Document Reasoning

EKG: “The EKG in this study is to detect

complications. The study drug has known

cardiotoxic effects. Protocol, p. 65.”

(116)

Chicago, IL 60613

(117)

Research Coding

Principal matters:

• V70.7 diagnosis code

• Q0/Q1 modifiers

• Condition Code 30 (research setting)

(118)

Where to find the rules

Medicare Claims Processing Manual



Chapter 32, Section 69.6



“Requirements for Billing Routine Costs in Clinical

Trials”



Note: references to these research coding rules

are scattered throughout Medicare rules and

commentary, but the Claims Processing Manual

(119)

ClinicalTrials.gov number

When a study is registered with clinicaltrials.gov (a

website managed by the NIH), it is assigned an 8

digit number

Providers may report the clinicaltrials.gov number on

the claim form, but this is strictly voluntary today.

New guidelines go into effect January 1, 2014

CMS conducts monthly aggregations of claims using

the clinicaltrials.gov code

(120)

V70.7

“Examination of participant in clinical trial.”

Used as the secondary diagnosis for all claims with

research-related items and services.

Note: If used as the primary diagnosis, then the claim

will be rejected.

Used for inpatient and hospital outpatient claims and

physician billing.

(121)

Q0/Q1

Modifiers placed after CPT code on:

Hospital outpatient claims

Physician billing claims

Not used in inpatient hospital claims

Not used for services on claims which are not

related to the research study

(122)

Q0/Q1

Q0 – “Investigational clinical service provided in a

clinical research study that is in an approved clinical

research study.”

Q1 - “Routine clinical service provided in a clinical

research study that is in an approved clinical

(123)

Q0

“Investigational clinical services are defined as those items

and services that are being investigated as an objective

within the study. Investigational clinical services may

include items or services that are approved, unapproved, or

otherwise covered (or not covered) under Medicare.”

Examples:

• Study drugs that are billable

• Category B devices

• Investigational devices with Medicare approval

• Laboratory tests which are identified in the objectives as

(124)

Q1

“Routine clinical services are defined as those items and services that

are covered for Medicare beneficiaries outside of the clinical research

study; are used for the direct patient management within the study;

and, do not meet the definition of investigational clinical services.

Routine clinical services may include items or services required solely

for the provision of the investigational clinical services (e.g.,

administration of a chemotherapeutic agent); clinically appropriate

monitoring, whether or not required by the investigational clinical

service (e.g., blood tests to measure tumor markers); and items or

services required for the prevention, diagnosis, or treatment of research

related adverse events (e.g., blood levels of various parameters to

(125)

Condition Code 30

• Used on the claim form whenever a V70.7 is

used

(126)

A note on the medical record

Section 69.3 of Ch. 32 also contains the following:

“The billing provider must include in the beneficiary's

medical record the following information:

trial name,

sponsor, and

sponsor-assigned protocol number.

This information does not need to be submitted with

the claim but must be provided if requested for

(127)

Add-on that applies to all:

Identifying treatment of complications

Note that in some studies, the sponsor will pay for unscheduled events

and treatment of complications.

A system needs to be devised to identify these

Suggestion:

• Flag studies in database which pay for treatment of complications

or unscheduled events

• Batch ED census and bump against subject database for the

flagged studies

• Hold charges for any matched

(128)

Useful for

Effective CRB Claims Management

Database of research studies

Database of research subjects

CAs/tool

(129)

Chicago, IL 60613 888.739.8194