Clinical Trial Billing Audits at Yale: Processes and Findings

1. Clinical Trial Billing Audits at Yale: Processes and Findings November 10, 2011

2. Objective • The purpose of this in-service is to inform you about the current: • policies for billing for services for clinical trial patients • why it is important to get billing right • audit processes • audit findings • method to assist in avoiding inappropriate billing

3. Clinical Research Medical Billing Compliance Officer and Staff • Carmencita (Menchu) Rubin, CPC – Anesthesia, Neurology, Neurosurgery, Surgery-Trauma/Critical Care • Theresa (Terry) Turcio, RN, CPC – Internal Medicine (Sections of Pulmonary and Critical Care, Oncology, Cardiology), Clinical Trials and Human Medical Research Billing • Patricia (Pat) Waleski, CPC – Emergency Medicine, Genetics, Obstetrics and Gynecology, Yale School of Nursing, Occupational Medicine, Internal Medicine (Sections of Nephrology, Rheumatology ) and checks excluded person list • Luz (Lucy) Wozdusiewicz, RN BSN – Orthopedics, Surgery, Clinical Trials and Human Medical Research Billing Compliance Coordinator: Anthony (Tony) Fusco, MS

4. The Office of Inspector General (OIG) , Department of Justice and FDA may fine or disqualify a research center, investigator and staff if they repeatedly or deliberately fail to comply with applicable regulatory requirements. The Yale Medical Group (YMG) screens all Yale employees against the OIG’s excluded persons list. Part of Yale’s agreement to accept Medicare, Medicaid payments and NIH funds is to not employ persons who are on this list.

5. Today’s Topics: • Policies regarding medical billing for clinical trials • the National Coverage Determination • CMS’s investigational devices trial regulations • private insurers’ pre-authorization requirements • 2. Audit processes • Audit findings • Diagnostic and procedural coding requirements • Anti Kickback Statute • False Claims Act • 4. PPM

6. How is it determined if standard of care associated with a clinical trial is covered by insurers? The federal government issued the National Coverage Determination (NCD) or Clinical Trial Policy (CTP) effective for services rendered as of 9/19/00. Although designed to address appropriate clinical trial billing for Medicare and Medicaid, it dictates much of the policy for private insurers and state regulations. YMG considers federal, state, specific insurer guidelines and regulations when billing clinical services for patients in clinical trials. Medicare’s policy outlines if routine clinical care costs associated with a clinical trial subject may be paid by Medicare.

7. National Coverage Determination (NCD) • The term “Medicare Qualifying Trial” infers that it is expected Medicare will cover the standard of care (routine care) costs associated with the subject’s participation in the trial. • There are 4 requirements that the trial must meet in order to be considered a Medicare Qualifying trial: • 1. The trial must have therapeutic intent. It cannot be designed to exclusively test toxicity or disease pathology. • 2. Trials of therapeutic intervention must enroll people with diagnosed disease; and if healthy controls are enrolled, they must be assigned to a proper control group. • 3. The purpose of the trial must be evaluation of an item or service that falls within a Medicare Benefit category and is not statutorily excluded from coverage (i.e. Medicare does not cover cosmetic surgery). • 4. The clinical trial must be “deemed”.

9. The False Claims Act (FCA) • The False Claims Act (FCA) was originally enacted to prevent inflated bills from being submitted to the Federal government during the Civil War. • The FCA makes it illegal to submit false or fraudulent claims for payment to Medicare or Medicaid. • Investigators may be prosecuted under the FCA for submitting claims for services even though they had already received payment for the same services from a sponsor for the same service.

10. Questions

11. What is Medicare’s payment policy for costs associated with clinical trials? The National Coverage Determination (NCD) for Routine Costs in Clinical Trials; also known as Clinical Trial Policy (CTP)

12. Medicare routinely covers what costs in a Qualifying Clinical trial? • Routine Care not covered by the sponsor

13. When a subject has Medicare, what CPT code billing modifier must be added to the invoice for routine care services associated with a clinical trial subject ? Q1

14. The subject’s medical record should contain • Trial name • Sponsor • Sponsor Protocol Number

15. THE END Thank you for coming today!