CRC Basic 2.0
Medicare Coverage Analysis
Suzan Bruce PRA IV, CTSC
April 18, 2014
Clinical Trial Resource Group
 Consulting and Assistance creating Coverage Analysis
 In Service training tailored for your clinical trial
 Training and Education presentations CTSC website
 Request services CTSC Webpage
 Application for Resource Use (AFRU)
Three helpful resources
 CTSC Website
 UCD Clinical Research Guidebook
 Process Maps
http://www.ucdmc.ucdavis.edu/ctsc/area/clinicaltrials/
Outline
 Medicare Clinical Trial Policy
– Regulatory Requirements
 Compliance
– Importance
 Coverage Analysis
– Process Steps
 Billing EPIC
– Procedures and Supporting Tools
Medicare
Clinical Trial Policy
Why emphasize Medicare billing
rules for clinical research services?
 Medicare is the principal billing rule
 Medicare rule used by many commercial payers to base their
coverage decisions
 Several states have passed legislation requiring commercial
payers to follow Medicare rules
– Reference: Medicare national clinical trial policy #310.1 issued by the
Centers for Medicare & Medicaid Services (CMS) under the U.S.
Department of Health & Human Services (DHHS) 2007
What is the Medicare Clinical Trial
Policy?
 Expands coverage for patient care services in a
clinical trial
What are the policy requirements?
 Clinical trials with billable patient services must meet certain
requirements to “qualify” for coverage
 If qualified, Medicare will cover routine costs
 Principal investigator is responsible to correctly identify when the
trial meets the qualifying criteria.
 If incorrect:
–
–
–
–
Medicare would deny coverage
Beneficiaries would not be liable
Provider would be liable for the costs
Fraud investigations may be pursued
Requirements for Investigational
Drug Trial
 Purpose of 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 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.
 Not clear? Ask for help!
Requirements for Investigational
Device Studies
 Approval by local Medicare carrier Noridian
 PI must request and receive Medicare approval
 Approval letter must be sent to billing office
 Form submittal process located on CTSC website
What services does Clinical Trial
Policy cover?
 Coverage is expanded to cover extra patient care
services in a “qualified” clinical trial
 Routine costs = items or services typically provided
(e.g. standard of care)
 Provision of investigational item (e.g. “infusion” of
study drug)
 Clinically appropriate monitoring:
– Monitoring for the effects of investigational item (e.g. blood tests, EKG, etc.)
– Prevention of complications (e.g. blood tests, EKG, etc.)
– Items and services needed for diagnosis and treatment of complications
 These services may not typically be covered by insurance –
except when they are part of a clinical trial
What does Medicare/Insurance or
Study pay for?
Research
costs
Expanded costs
Conventional Care Costs
Financial sponsor/Study
Insurance/Medicare/Pt Acct
Insurance/Medicare/Pt Acct
What is not covered?
 The investigational item or service-unless it’s covered
outside a clinical trial
 Items or services:
– solely for research (e.g. data collection)
– paid by the sponsor
– promised free in the informed consent
We can be reimbursed by Medicare

Medicare pays for health care items and
services that fall within a designated benefit
category (Link QCT Form)

Patient care that is reasonable and
necessary for prevention, diagnosis, or
treatment (signs, symptoms)

Some services excluded from coverage by
national non-coverage policy (e.g., comfort
items, cosmetic surgery, hearing aids)

Clinical Trial policy expands reimbursement
for services not ordinarily covered to clinically
manage a patient - but paid for in a “qualified”
clinical
COMPLIANCE
Compliance Issues
 Clinical trial billing is at high risk for compliance errors
b/c of the complexities of the billing
 False Claim =
– Reporting services for payment on non-qualifying trial
– Billing insurance for services that are already paid by
the sponsor (double billing)
– Billing insurance for services promised free in the
informed consent
– Billing insurance for services that are for
research‐purposes (data collection) only
How do I ensure compliant billing?
 Perform comprehensive Coverage Analysis (see CTSC for assistance)
 Assure processes are in place to comply with research billing rules
– Communicate study information to:
•
•
Scheduling and registration
Hospital and professional billing offices
 Harmonization of relevant portions of study documents in
accordance with research billing rules
 Reduces risks of inappropriate billing to insurance/patient
COVERAGE ANALYSIS
What is a Coverage Analysis?
 Process of determining and documenting
whether a clinical trial:
– Is qualified under the Medicare Clinical Trial Policy
– Which items/services are billable to third party/study
sponsor
When is Medicare Coverage
Analysis required?
 Required for all clinical research studies with billing to third
party or sponsor
 Analysis is 2 step process to determine if your trial meets the
national requirements
 University of California Office of the President requires Coverage
Analysis for all clinical research studies which could generate
charges in either the hospital or physician billing systems
How do I create the Coverage
Analysis?
 1st step– Qualification Form
– PI determines the answers
 2nd step– If qualified-Billing Grid



Template available CTSC website
http://intranet.ucdmc.ucdavis.edu/researchbudgeting/coverageanalysis/index.shtml
Request assistance AFRU
Who creates the Coverage
Analysis?
 Collaboration CRC, CTSC Coder, Budget
Analyst, PI, Research Staff, Billing Staff
 Requires knowledge of:
– Billing rules what/how services happen
– Medicare qualification and coverage
rules (drugs and devices)
– Who will be billed for the services
 For assistance:
suzan.bruce@ucdmc.ucdavis.edu
Preliminary Analysis
First, let’s determine which trials have
billable services
Does your trial have billable
services?
 QCT Form asks
 Does trial include patient
care services billed
through UCDHS?
– Procedures
– Visits
– Diagnostic tests
– Services scheduled and
billed UCDHS
 Non billable services?
– Form or survey only
Billable Services
 Will these
services create
a billing code?
 If yes, check the
box, continue to
next section
 If no, check the
box, stop
What if my trial is 100%
sponsored?
100% Sponsored Studies
 If yes, check the
box, STOP
 Trial does not
qualify for
insurance coverage
 If no, check the
box-proceed to
next question
How do I determine if the study
qualifies?
 Qualifying Clinical Trial Form (QCT)
 Questionnaire asks
– Benefit
– Therapeutic
– Treat a diagnosed disease or condition
– Deemed to qualify or have desirable characteristics
 By answering questions you’ve analyzed whether or not your trial
qualifies for reimbursement
 If qualified- list study procedures in a Billing Grid
Is trial’s purpose a Medicare benefit?
Benefit Category link in
QCT Form
 Medicare typically covers medically necessary services
needed for prevention, diagnosis, or treatment
Therapeutic Intent?
The primary objective is to compare
the early clinical efficacy of
Dalbavancin/Placebo to the
comparator regimen for the treatment
of patients with a suspected or proven
Gram positive abSSSI

There must be therapeutic intent to benefit the patient

Therapeutic intent = benefit to specific research patient in the trial they are
participating (drug or device study)

No therapeutic intent= studies only collecting data, no therapeutic
outcome, only benefits future patients
Does trial meet requirements for
coverage?
 Trial must have:
– Services that are a benefit
– Therapeutic Intent
– Enroll patients with disease/condition
Is the trial deemed?

If “yes” to any 1 of 4 questions-trial automatically qualifies for coverage
(plus 3 requirements in section 1)

You’ve determined the trial qualifies
– Yes, you meet requirements in section 1
– Yes, if “deemed”
– Create Billing Grid
Step 2: Billing Grid
Let’s test your
understanding…
How many steps in the Coverage
Analysis process?
 TWO Steps
 Qualification
 If qualified, Billing Grid
Clinical Outcome Review of Patients
Undergoing Bariatric Surgery; The UC
Davis Experience
Do you think this trial includes billing for patient
care services?
If no billing occurs does the trial need to qualify for
the billing of patient care services?
Do you need to complete the preliminary analysis?
“Accuracy of Cardiac Screening in the Pediatric Emergency
Department: the PED SCReeN Project (Screening for Cardiac
Risk in Novel patients)”
1.
Describe the study format (e.g., pilot, phase I, phase II, multi-center, randomized, double-blinded, etc.).
This single-center, observational study will have two components:
1.
Prospective data will be collected on a questionnaire to be given to the treating physician after regular care has
been delivered. Pertinent clinical information and responses regarding medical decision making will be elicited.
1.
Data will be gleaned from the electronic medical record (EMR) after the episode, such as ECG tracings, age, weight
and height, and access to medical care (insurance status).
This study is investigator-initiated and there will be no source of external funding.
Data collection or pt care services needed to clinically manage
the patient in a clinical trial?
If no billing occurs does the trial need to qualify for the billing
of patient care services?
Do you need to complete the preliminary
analysis?
A Phase 3 Randomized, Double Blind, Double Dummy Study to Compare the
Efficacy and Safety of Dalbavancin to a Comparator Regimen (Vancomycin and
Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure
Infections
 Does the trial include billing of patient
care services?
 See schedule of events
When do you submit a QCT Form?
 Yes, if patient care services will be billed through UC
Davis billing system
 Yes, if my clinical trial is 100% sponsored
 Yes, if billing to patient’s insurance
Billing Grid =Billing Plan
STEP 2: Billing Grid

Identify the services billable to insurance or services paid by the
study
• Billing Grid is based on the schedule of events
• Lists all services with CPT codes
• CPT codes apply billing rules to the protocol
• Can assist in budgeting process
• Tool for billing reconciliation
• Provides documented reasoning why services are billed
 Information consistent in Contract, Informed Consent, Billing Grid
What is the purpose of a Billing Grid?
 Tool to identify billing of patient care services separate the charges
 Lists protocol required CPT codes and indicates who will be billed
(sponsor or insurance billing)
 Lists how clinical trial services are reported on a claim
 Billing codes attest the trial qualifies for coverage
 MR documentation should be clear the service is part of clinical trial
Billing Grid - example
Find costs via Coverage Analysis
 Before budget - can ensure feasibility
 Complete the Coverage Analysis early in process
– Know if clinical trial qualifies for coverage
– Identify CPT billing codes/costs
– Which services are billable to insurance
– Uncover hidden costs
– Convert CPT codes into dollar values
Coverage Analysis must be completed prior to Bridge submission
Find Research Costs
 Cost Query Tool
 CTSC webpage
http://ctsc-stage.ucdsom.ucdavis.edu/ucdrc/ucdRCosts.aspx
Why is it important to identify all
services in the protocol?
 Bundled Services = Hidden Costs
– Billing Codes “part of” the main service but not
identified individually
 If not identified, these costs can lead to a budget
shortfall
 CTSC provides CPT coding expertise
For coding help contact Suzan Bruce at CTSC suzan.bruce@ucdmc.ucdavis.edu
Modified Studies
 Must update Billing Grid if modification includes changes to
billing codes
 Keep updated Billing Grid in the “Bridge”
Billing Grid continued…
 Use the BG to prepare internal budgets
–
–
–
–
Look up clinical trial costs by CPT code in Cost Query Tool
Billing, Consent Form, CTA match
Base External budget on internal budget
Negotiate with sponsors
 Use BG to schedule study services and place
orders
– On research or insurance account
– Track pt completion of each visit
 Use BG to compare billing statements
– ID billing corrections
– Generate invoices
– Track Accounts Receivable
NEW! EPIC Billing
New Submission Process
 QCT and Coverage Analysis Entered in Bridge
– After April 28th enter QCT answers directly into Bridge database
• https://ctscassist.ucdmc.ucdavis.edu/redcap/
• User agreement
• https://ctscassist.ucdmc.ucdavis.edu/redcap/surveys/?s=INFGig
– Must complete or study will be unavailable in EMR
– Register for Phase 2 of EPIC EMR billing
• http://intranet.ucdmc.ucdavis.edu/emr/projects/P_New_Dest/Rese
arch.shtml
SOP #4 Coverage Analysis
SOP #13 Create and Manage Research Studies in EMR/EPIC
http://intranet.ucdmc.ucdavis.edu/ctsc/area/clinicaltrials/sops/index.shtml
Conclusions

Coverage Analysis is a tool to
compliantly manage the many
processes involved in clinical trial
billing

Billing Grid is a tool to examine
many elements of budgets and
billing from feasibility to invoicing
 Call for help early
Questions?
Contact information
Suzan Bruce, CPC
Research Abstractor
Clinical Trials, CTSC
TEL: (916)703-0120
EMAIL: suzan.bruce@ucdmc.ucdavis.edu