Medical Billing Compliance

Clinical Trial Billing Audits at Yale: Processes and Findings

November 10, 2011

Medical Billing Compliance

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

Medical Billing Compliance

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

Medical Billing Compliance

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.

Medical Billing Compliance

1. Policies regarding medical billing for clinical trials

a) the National Coverage Determination

b) CMS’s investigational devices trial regulations

c) private insurers’ pre-authorization requirements

2. Audit processes

3. Audit findings

a) Diagnostic and procedural coding requirements

b) Anti Kickback Statute

c) False Claims Act

4. PPM

Today’s Topics:

Medical Billing Compliance

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.

How is it determined if standard of care associated with a clinical trial is covered by insurers?

Medical Billing Compliance

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”.

National Coverage Determination (NCD)

Medical Billing Compliance

Medical Billing Compliance

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.

Medical Billing Compliance

Questions

Medical Billing Compliance

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)

Medical Billing Compliance

Medicare routinely covers what costs in a Qualifying Clinical trial?

• Routine Care not covered by the sponsor

Medical Billing Compliance

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

Medical Billing Compliance

The subject’s medical record should contain

• Trial name

• Sponsor

• Sponsor Protocol Number

Medical Billing Compliance

THE ENDThank you for coming today!