Transcript Clinical Trials must meet the requirements of Medicare

Clinical Research
Billing & Coding
1
PREPARED BY:
SUZAN BRUCE, CPC
CLINICAL TRIALS OFFICE, UC DAVIS
Medicare National Clinical Trial
Policy
2
Medicare Clinical Research Coverage
3
 Clinical Trials must meet the requirements of Medicare National Clinical
Trial Policy #310.1 to qualify for coverage of extra patient care services in
a clinical trial
 To determine if a clinical trial qualifies for coverage Research
Physician/Staff perform an analysis of clinical trial services vs
requirements of policy
 Analysis is a two step process (Coverage Analysis)
 Step 1 determines if clinical trial meets the requirements of policy
 Step 2 is a listing of patient care services by CPT code and clinical trial
modifiers
Medicare Coverage Analysis
4
 Performed for all clinical research studies anticipating patient care billing
 A clinical trial must meet certain criteria in NCD 310.1 to qualify for
reimbursement
 A coverage analysis is performed to determine if your trial meets these
requirements
 Coverage Analysis is a process performed by most institutions across the
United States
5
What is covered in a clinical trial?
6
 Medicare:


As a general rule, covers “routine costs” during “qualifying clinical trials”
Routine costs=diagnosing, treatment, monitoring, investigational drug or
device administration costs, complications
 Medi-Cal:

Requires coverage of cancer clinical trials but mostly silent for non-cancer
 Commercial Insurance:

State requirement to cover cancer clinical trials but for non-cancer it is a
matter of contract and coverage policy
What does Medicare/Insurance or Study pay for?
7
Research
costs
Patient care purely research- paid by Financial
sponsor/Study
Expanded costs
Conventional Care Costs
Medicare expands their coverage for routine costs to
monitor, diagnose, treat patients during a clinical trial
paid by Insurance/Medicare/Pt Acct
Medicare /Commercial Insurance/Pt Acct covers
services “standard of care” typically used to treat a
patient
Items and services NOT billable to Medicare
8

The investigational item or service itself, unless otherwise covered
outside of the clinical trial

Items and services provided solely to satisfy data collection and
analysis needs and that are not used in the direct clinical
management of the patient (e.g., monthly CT scans for a condition
usually requiring only a single scan)

Items and services customarily provided by the research sponsors
free of charge for any enrollee in the trial
How to report clinical trial services on claim form
9
 Extra services are needed to monitor, diagnose, treat patients in a clinical
trial (e.g. labs, Xrays, surgery, infusions)
 National clinical trial policy states coverage is allowed if requirements are
met
 Clinical trial services must be identified on a claim form
 Services are reported on a claim using clinical trial modifiers (Q0(zero),Q1)
 Modifiers needed to identify which services on a claim form are part of a
clinical trial
 Diagnosis code V70.7 is report in secondary position, condition or disease is
primary
Diagnosis Code V70.7
 ICD-9 Code V70.7 = Examination of participant or control
in clinical research
 This diagnosis code is reported for all qualifying clinical trial
claims that have any charges billed to a payer that are related to
the patient’s participation in a clinical trial
 This diagnosis code is applied the following charges:
 Inpatient
 Outpatient
 Facility Fees
 Professional Fees
10
Diagnosis Code V70.7
11

Diagnosis code V70.7 Examination for participant in clinical trial shall be
reported as the secondary diagnosis (Medicare)

Diagnosis code ICD-10 = Z00.6 Encounter for examination for normal
comparison and control in clinical research program
Modifier Q0/Q1
12
 Q0: Investigational clinical service in a Research Study
 Q1: Routine clinical service in a Research Study

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
 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 measure kidney function)
Things to know:
13
 The Q0/Q1 modifier are Medicare specific and should only be used for
charges being submitted to Medicare
 These modifiers apply to both facility and professional fees for outpatient
charges and professional fees only for inpatient charges
 If more than one modifier applies to a charge, modifiers affecting payment
should always be first
 Medicare may reject claims with the V70.7 diagnosis code if there are no
charges with a Q0/Q1 modifier
 Q = Qualified
 Q modifiers indicate that the principal investigator (physician) attests that
the clinical trial qualifies for coverage
EXAMPLES OF WHEN TO USE MODIFIERS, DX AND CONDITION CODES
14
The patient is in a dermatology research study where some charges are billed to
Medicare and some are billed to a Big Pharma (financial sponsor). The Billing Grid
indicates that the sponsor pays for a C-Spine and DEXA bone density scan every
month because these X-rays are needed for research only. A CBC, Metabolic Panel
and an office visit are considered routine standard of care services and would
routinely be provided whether this patient was in a study or not.
C-SPINE
72020
$8.00
Bill to Big Pharma
No Q modifier
DEXA
77080
$4.00
Bill to Big Pharma
No Q modifier
CBC
85004
$5.00
Bill to pt’s account
Q1 modifier
Metabolic Panel
80053
$19.50
Bill to pt’s account
Q1 modifier
Clinfee Lvl 3 Est
99213
$16.00
Bill to pt’s account
Q1 modifier
• The encounter for the patient’s individual account is coded with V70.7 in the secondary
position
15
The patient is in an investigational drug research study for cancer. An investigational
drug is provided for free by the sponsor and all other drugs are billed to patient’s
insurance (Medicare). All billable drugs are FDA approved and part of the investigation.
“Q0” modifier identifies these billable drugs as part of the “objective” of the investigation
Chemo Infusion 0-1 Hr
96413
$7.50
Bill to pt’s account
Q1 modifier
Temozolomide
J9328
$7.00
Bill to pt’s account
Q0 modifier
Irinotecan
J9206
$4.00
Bill to pt’s account
Q0 modifier
Bevacizumab IND#7921
N/A
Provided free by
sponsor
N/A
Patient Visit
99215
Bill to pt’s account
Q1 modifier
$23.00
• The encounter for the patient’s individual account is coded with V70.7 in the secondary position
and is reported on the hospital claim and professional claim
Take-away Points
16
 Clinical Trial must meet requirements of National Medicare Clinical Trial Policy
#310.1 to bill for extra coverage
 A Coverage Analysis can be performed to mitigate billing errors and compliance
risks
 Clinical Trial diagnosis code V70.7 applies to inpatient, outpatient, facility and
professional fees
 V70.7 diagnosis code must be in the secondary position (Medicare)
 Q0/Q1 modifiers apply to both facility and professional fees for outpatient charges
and professional fees only for inpatient charges
 Modifiers should be ordered with payment affecting modifiers first
 The Q0/Q1 modifiers are Medicare specific and should not be used for other
payers
 ICD 10 diagnosis code Z00.6
Compliance
17
Billing violations under the False Claims Act
18
 Biggest risk violation of “False Claims Act” - Federal law prohibits knowingly
making or causing a false claim to be submitted
 False claim in clinical trial=billing insurance for items and services already
paid by sponsor



U of Alabama $3.4 million, 2005
Rush University $1 million, 2005
Tenet Healthcare System, Norris Cancer Center $1.9 million, 2010
Why is clinical trial billing at risk for
compliance errors?
19
 National coverage policy expands reimbursement of the extra patient care
services needed to monitor, treat, diagnose, and administer investigational
drug or device
 These services may not typically be covered by insurance – except when
they are part of a clinical trial
 Services identified on claim form with clinical trial modifier (Q1 or Q0) and
V70.7 diagnosis code must be documented appropriately as part of a clinical
trial
 Coverage Analysis identifies billable services
 Rules are complex- errors easily made during billing
Why is research billing compliance critical?
20
 Coverage Analysis reduces the risk of audits and investigations by identifying
clinical trial services billable to insurance or financial sponsor
 Federal payers (including Medicare and Medicaid) are on the look out for
billing irregularities and inaccuracies
 CPT codes, diagnosis codes, modifiers, are tools to track irregularities
 Double billing, over billing and irregular-billing practices have been the
subject of numerous Office of Inspector General (OIG) and Department of
Justice (DOJ) investigations
The 3 C’s of Research Billing Compliance
21
 Coordination of study information across multiple study documents
 Communication of relevant study information to the billing process
 Cooperation among departments and offices that may not usually work
together
Are there exclusions or limitations on coverage?
22

CMS Online NCD and LCD database

Medicare Benefits Policy Manual

NCCI edits
Resources
23
Websites
CMS overview on clinical trial policy
http://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/inde
x.html?redirect=/ClinicalTrialPolicies/
Clinical Trial Policy
http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?NCDId=1&ncdver=2&fromdb=true
Medicare Noridian
https://med.noridianmedicare.com/web/jeb
QUESTIONS
Suzan Bruce
[email protected]