Transcript So you`re in charge of clinical trials? What now?

I have to do a
Coverage Analysis
before I complete my
Clinical Trial Budget?
David Whaley, J.D.
Clinical Trials & Contract Coordinator
LSU Health Sciences Center –
Stanley S. Scott Cancer Center
Research Billing Rules
• There is not one place to go for all rules
that cover clinical research billing:
• Statutes
• Regulations
• CMS National Coverage Determinations
NCD)
• CMS Manuals
• Local Coverage Determinations (LCD)
What is a Coverage Analysis?
Based on Medicare’s Clinical Trial
Policy, National Coverage Decision
310.1 (NCD 310.1) the Medicare
Coverage Analysis (MCA) is one of the
most useful documents for building a
clinical trial budget and clinical trial
billing compliance.
Why do we care about billing
compliance?
FALSE CLAIMS ACT:
No proof of specific intent to defraud is required in order to
violate the act.
PENALTIES
$5,500 to $11,000 for each claim,
Possible treble charges (re-pay three times the amount of the
claim),
Possible criminal charges,
Possible exclusion from Federal Healthcare Programs
Examples
Rush University Medical Center- $1 million settlement in 2005 for
improperly billing services as routine costs under the Medicare
Clinical Trial Policy.
USC Norris Cancer Center- $1.9 million dollar settlement , billed
for services paid by sponsor and billed for services in nonqualifying trial.
University of Alabama- $3.39 million settlement for falsely billing
Medicare for procedures also billed to the sponsor
Emory University- $1.5 million settlement for falsely billing
Medicare and Medicaid for clinical trial services that were not
permitted.
National Coverage Decision
Indications and Limitations of Coverage
Effective for items and services furnished on or
after July 9, 2007, Medicare covers the routine
costs of qualifying clinical trials, as such costs are
defined below, as well as reasonable and
necessary items and services used to diagnose
and treat complications arising from participation in
all clinical trials. All other Medicare rules apply.
National Coverage Decision
Routine costs of a clinical trial include all items and services
that are otherwise generally available to Medicare
beneficiaries (i.e., there exists a benefit category, it is not
statutorily excluded, and there is not a national non-coverage
decision) that are provided in either the experimental or the
control arms of a clinical trial except:
• 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); and
• Items and services customarily provided by the research sponsors
free-of-charge for any enrollee in the trial.
National Coverage Decision
Routine costs in clinical trials include:
• 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.
Routine Costs
Any clinical trial receiving Medicare coverage of
routine costs must meet the following 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 (e.g., physicians'
service, durable medical equipment, diagnostic test) and is not
statutorily excluded from coverage (e.g., cosmetic surgery, hearing
aids).
• 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. Trials of diagnostic
interventions may enroll healthy patients in order to have a proper
control group.
Desirable Characteristics
The three requirements above are
insufficient by themselves to qualify a clinical
trial for Medicare coverage of routine costs.
Clinical trials also should have the following
desirable characteristics; however, some
trials, as described below, are presumed to
meet these characteristics and are
automatically qualified to receive Medicare
coverage:
Desirable Characteristics
• The principal purpose of the trial is to test whether the
intervention potentially improves the participants' health
outcomes;
• The trial is well-supported by available scientific and
medical information or it is intended to clarify or establish
the health outcomes of interventions already in common
clinical use;
• The trial does not unjustifiably duplicate existing studies;
• The trial design is appropriate to answer the research
question being asked in the trial;
Desirable Characteristics
• The trial is sponsored by a credible organization or
individual capable of executing the proposed trial
successfully;
• The trial is in compliance with Federal regulations
relating to the protection of human subjects; and
• All aspects of the trial are conducted according to the
appropriate standards of scientific integrity.
Qualifying Trials
Effective September 19, 2000, clinical trials that
are deemed to be automatically qualified are:
• Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA;
• Trials supported by centers or cooperative groups that are
funded by the NIH, CDC, AHRQ, CMS, DOD, and VA;
• Trials conducted under an investigational new drug
application (IND) reviewed by the FDA; and
• Trials conducted under an investigational new drug
application (IND) reviewed by the FDA; and
• Drug trials that are exempt from having an IND under 21 CFR
312.2(b)(1) will be deemed automatically qualified until the
qualifying criteria are developed and the certification process
is in place.
Really?
What does all this mean, and how do we
know if we are billing correctly?
Let’s summarize, look at some examples
and tools to help with the process.
Clinical Trial Policy 310.1
• Established criteria under which Medicare
would provide coverage for beneficiaries
enrolled in a clinical trial
• Medicare will pay for “routine cost” of
“qualifying clinical trials”
What is a Qualifying Trial?
Medicare Benefit Category
• The subject or purpose of the trial must be
for the evaluation of a Medicare Benefit
Category.
Medicare Benefit Category
Generally does it fall into one of these:
1. Drugs, biologics and therapeutics;
2. Laboratory and diagnostic services
3. Medical and surgical procedures
4. Diagnostic imaging
5. Medical devices and prosthetics
6. Durablr medical equipment
What is a Qualifying Trial
• Must fall into a Medicare Benefit Category
plus it must have therapeutic intent.
• Generally must have therapeutic intent; it
cannot exclusively test toxicity or disease
pathophysiology.
Therapeutic Intent
Sounds easy enough. BUT:
• The American Society of Clinical Oncology
and other cancer organizations have
released position statements that Phase I
oncology trials do have therapeutic intent.
• Medicare has not made a determination.
What is a Qualifying Trial?
Medicare Benefit Category +
Therapeutic Intent +
Diagnosed Disease
• The study must enroll patients with a
diagnosed disease.
What is a Qualifying Trial?
Medicare Benefit Category +
Therapeutic Intent +
Diagnosed disease +
Deemed
• The trial must be “Deemed”?
What makes a Trial Deemed?
Trial must have the seven desirable
characteristics as defined by Medicare:
1. Principal purpose is to test whether the
intervention potentially improves participants’
outcomes
2. Trial is well supported by scientific and medical
information or is intended to clarify or establish the
health outcomes of interventions already in
common use.
3. Trial does not unjustifiably duplicate existing
studies;
What makes a Trial Deemed?
4. The trial design is appropriate to answer the
research question
5. Trial is sponsored by a credible organization or
individual capable of successfully executing the
trial;
6. Trial is in compliance with Federal Regulation
relating to the protection of human subjects;
7. Trial is conducted according to the appropriate
standards of scientific integrity.
Studies that are Deemed
1. Studies funded by NIH, CDC, AHRQ,
CMS, DOD or VA;
2. Studies supported by centers or
cooperative groups funded by NIH, CDC,
AHRQ, CMS, DOD or VA;
3. Studies conducted under an IND
application;
4. IND exempt studies
Deemed
• If your study is funded or sponsored by
one of those groups or falls into one of the
categories it is deemed to have the seven
desirable characteristics.
Deemed and Necessary
If the study falls within one of the 4 types of
trials deemed to meet 7 desirable
characteristics, AND the study meets all 3
necessary requirements:
1. Medicare Benefit Category +
2. Have therapeutic intent +
3. Enroll patients with a diagnosed
disease
= Qualifying Trial
Form in question format
Louisiana State University
Health Sciences Center
Stanley S. Scott Cancer Center
Principal Investigator:
Sponsor:
Protocol Number:
Medicare NCD 310.1 Routine Costs in Clinical Trials defines a qualifying trial as one
that meets all of the three criteria in PART I below, plus one of the criteria outlined in
PART II. If a clinical trial does not meet the criteria for qualifying trials, then none of the
trials routine costs may be billed to Medicare, and the principal investigator must obtain
funding from another source to cover these costs. (See attached explanation of NCD
310.1)
Form in question format
Part I REQUIREMENTS FOR MEDICARE COVERAGE OF ROUTINE COSTS
1.
Y__ N__
Does the investigational item or service fall within a Medicare
benefit category?
If Y go to 2; if N the study is not a qualifying trial.
2.
Y__ N__
Does the trial have therapeutic intent?
If Y go to 3; if N the study is not a qualifying trial.
3.
Y__ N__
Does the trial enroll patients with a diagnosed disease?
If Y go to Part II; if N the study is not a qualifying trial.
Part II DETERMINATION OF DEEMED TRIAL
4.
Y__ N__
Is the study funded by NIH, CDC, AHRQ, CMS, DOD, or VA?
If N go to 5, if Y the study is a qualifying trial.
5.
Y__ N__
Is the study funded by a cooperative group that receives funding
from NIH, CDC, AHRQ, CMS, DOD, or VA?
If N go to 6; if Y the study is a qualifying trial.
6.
Y__ N__
Is the study conducted under an investigational new application
(IND) reviewed by the FDA?
If N go to 7; if Y the study is a qualifying trial.
7.
Y__ N__
Is the study exempt from an IND under 21 CFR 312.2(b)(1)?
If N the study is not a qualifying trial; if Y the study is a qualifying trial.
Form in question format
Part III
I have reviewed the above analysis, and I agree with the following determination:
___ This clinical trial meets Medicare criteria for qualifying trials.
___ This clinical trial does not meet Medicare criteria for qualifying trials.
___________________________________________
Principal Investigator Signature
___________________________________________
Date
APPENDIX A: Schedule of Treatment and Evaluations
Screening -21 Days
Signed informed consent
S
Review inclusion/exclusion
S2
Medical history
1
Cycle 1
Cycle 2
Cycle 3
Cycle 4
Cycle 5
Cycle 6
End of Study or
Early
Follow-up12 Comments
Termination
Paid for by sponsor as part of the clinical trial
S2
Paid for by sponsor funding
NB
Physical examination
NB
Height (cm)
NB
Weight (kg)
NB
Karnofsky PS
M
M
M
M
M
M
First exam is not billable, appears to be only to determine
eligibility for the clinical trial, other office visit billable, routine
care, would be required for the monitoring of the effects of the
investigational item.
M
Part of an office visit, not separately billable
NB
NB
NB
NB
NB
NB
Part of an office visit, not separately billable
M2
M2
M2
M2
M2
M2
Necessary for the administration of the drug, not separately
billable, necessary for the calculation of the dose, administration
of the study drug is billable
NB
NB
NB
NB
NB
NB
NB
NB
S
S
S
S
S
S
S
S
Paid for by sponsor as part of the clinical trial
M
NCCN guidelines do not specifically address KS; however, soft
tissue sarcoma guidelines support CT/MRI at workup. CT/MRI
should both be done depending on where lesions are locatedl
Journal of Clinical Oncology, Vol 16, No7 (July) 1998: pp 24452451/ HIV Medicine (2008) 9, 336-388/ NCCN guidelines
EXTSARC-1,
M
310.1 required to monitor the effects of the investigational drug to
check for cardiotoxicity
M
310.1 required to monitor the effects of the drug to check for
cardiotoxicity
BSA calculation
Vital signs3
Part of an office visit, not separately billable
Part of an office visit, not separately billable
Tumor measurements4
M
ECG
M
ECHO (with ejection fraction)
M
CBC w/differential & plts5
M
M
M
M
M
M
M
M
310.1 required to monitor the effects of the drug, routine care
would be done absent a clinical trial
Serum chemistries5,6
M
M
M
M
M
M
M
M
310.1 required to monitor the effects of the drug, routine care
would be done absent a clinical trial
Urinalysis7
M
M
Routine care (same as above)
Serum/urine pregnancy test
ALDOXORUBICIN administration
Concomitant medications
9
M
M
M
S2
Strictly for inclusion/exclusion for the clinical trial
M
M
M
M
M
M
S2
S2
S2
S2
S2
S2
S2
S
S
S
Adverse events10
S
12
M
S
14
Biopsy of tumor
Telephone follow-up
M
S
S
S
S
Billable as routine under 310.1
Paid for through sponsor funding
S
S
S
Paid for through sponsor funding
Paid for by sponsor as part of the clinical trial
S
Paid for by sponsor as part of the clinical trial
Routine Costs
Routine costs can be billed to Medicare
for patients enrolled in this clinical trial.
What are Routine Cost?
You can bill more than you think!
• This is not billing for “Standard of Care”
• You can bill for any item or service needed for
the reasonable and necessary care arising from
the provision of the investigational item or
service AND for the diagnosis or treatment of
complications AND clinically appropriate
monitoring of the effects of the item or service or
prevention of complications.
Examples
• A patient is enrolled in a clinical trial and
receives the study drug in combination
with standard chemotherapy. Is the
intravenous infusion of the study drug
considered routine cost?
YES
• You may bill for the infusion of the
standard drug AND the investigational
drug.
• REMEMBER: Medicare Clinical Trials
Policy covers items or services required
solely for the provision of the
investigational item or service.
Example
• Patient is enrolled in a clinical trial for
breast cancer, the investigational drug can
cause heart arrhythmias. The protocol
requires a ECG before enrolling the
patient, after the third dose and at end of
study. Can you bill Medicare for these
ECG’s?
YES
• It is allowable to bill for tests to detect and
treat complications related to the use of
the study drug.
Just Routine Care
Also remember routine care can be billed to
Medicare.
• For example the protocol requires CT of
the chest abdomen and pelvis every three
months, NCCN guidelines state a CT of
the Chest abdomen and pelvis should be
done every 90 days. This is billable, would
do this whether the patient is on study or
not.
Abbreviated version of Routine
1. Conventional care
2. Administration of Investigational item
3. Detection or prevention of
complications
Conventional Care
• Items or services typically provided absent
a clinical trial, do not use the tern
“standard of care” Conventional care is
broader and more objective. It more
accurately equates to the “national
standard of billable items or services”
Conventional Care
The MCA should identify the objective
guidelines to support the designation of
“conventional care”
– professional association guidelines
– Peer-reviewed literature
– Disease associations
– NIH recommendations
ASK THE P.I. FOR GUIDELINES
Coding
• Clinical Trial Number (value must be used
on UB-04)
• Revenue Codes for Devices and supplies
(0624 & 0278)
• Condition Code 30- qualifying clinical trial
• Diagnosis Code V70.7- examination of
participant in a clinical trial
Coding
• HCPCS Modifier Q0- Investigational
clinical service provided in a clinical
research study that is an approved clinical
research study
• HCPCS Modifier Q1- Routine clinical
service provided in a clinical research
study that is an approved clinical research
study
Caveat
This has been a very introductory session.
Hopefully I have pointed out issues that are
important , and everyone understands the
extreme importance of completing an MCA.
Bibliography
• Phases of Clinical Trials: http:// www. cancer. gov/
clinicaltrials/understanding/what-is-a-clinical-trial)
• Common Per Patient Costs: University of Utah Health
Sciences Center; “Budget Development & Negotiations”
http://uuhsc.utah.edu/clinicalTrials/finanAdmin/budgetnegotiate.html (10 November 2004)
• Screen Failures and Early Termination: Office of Clinical
Trials: handbook, part2: “Evaluating Budgets”
http://research.unc.edu/oct/handbook_part_2.html (5
November 2004)
• Phase IV Trials: (http:// www. cancer. gov/
clinicaltrials/understanding/what-is-a-clinical-trial)
Contact
David Whaley, J.D.
Clinical Trials Coordinator
LSU Health Sciences Center Stanley S. Scott Cancer Center
504-210-2825
[email protected]