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

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? Financial sponsor/Study 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 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

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?  1 st step- – Qualification Form – PI determines the answers  2 nd step- – If qualified-Billing Grid  Template available CTSC website   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:

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?  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

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)” 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. 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.

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

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

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 User agreement – Must complete or study will be unavailable in EMR – Register for Phase 2 of EPIC EMR billing arch.shtml SOP #4 Coverage Analysis SOP #13 Create and Manage Research Studies in EMR/EPIC

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)