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
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?
Conventional Care Costs
Expanded costs
Research 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 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
See Clinical Trials Newsletters for articles relating to these compliance issues
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
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: [email protected]
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
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?
Medicare typically covers medically necessary services needed for prevention, diagnosis, or treatment
Benefit Category link in QCT Form
Therapeutic Intent?
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
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
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
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)”
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?
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.
2. 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.
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
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
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 [email protected]
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 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/Research.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, CPCResearch AbstractorClinical Trials, CTSCTEL: (916)703-0120EMAIL: [email protected]