Billing Compliance In Clinical Research                         

Medicare Coverage of Investigational Devices

Category B FDA approval only confirms a device’s eligibility for Medicare coverage and reimbursement.  It does not guarantee automatic reimbursement by the Medicare carrier.  Before patient enrollment, the study must be approved by the Medicare carrier.  Our local Medicare contractor, National Government Services (NGS), is responsible for the hospital services at New York Presbyterian and the physician services at Columbia University Medical Center . NGS must review the device and its use to make a final determination on reimbursement during the clinical trial.

To facilitate their review of our request for reimbursement approval, you should use this template to develop the cover letter that is jointly submitted by the Principal Investigator and New York-Presbyterian Hospital.

To view the Medicare Policy on Coverage of Investigational Device Trials, click here: http://www.empiremedicare.com/news/nynews07/100207inv.htm

Overview:

Clinical research is a study, funded by an industry, nonprofit foundation, governmental agency or other source, which is designed to answer a specific question about the safety and/or efficacy of drugs, devices, treatments, diagnostics, preventive measures or interventions in human subjects.   

Objective:

To establish uniform policies and operational procedures for billing clinical services provided to subjects who participate in research studies and thereby help ensure that Columbia University Medical Center (CUMC) adheres to the laws and regulations that govern medical billing practices in this area.

Introduction:

Billing for clinical services provided to patients enrolled in research studies is complex because often more than one entity is responsible for the costs incurred in a trial. The protocol for a research study, for example, may include routine medical treatment (standard of care) for a condition which the patient would receive whether or not he is enrolled in the trial. Generally, these routine costs may be billed to the patient or his insurer.  In cases where a sponsor provides funding for items that are normally considered standard of care, however, the patient or his insurer may not be billed for these services.

Many times, protocols for clinical research include services, drugs, devices or treatments that are solely for research purposes. As a general rule, these costs are paid by the sponsor and may not be billed to the patient or his insurer.

Costs related to complications caused by participation in a research study may be the responsibility of the sponsor, the patient or his insurer. The investigator/sponsor contract and the informed consent signed by the research subject should clearly reflect who will bear these costs.

As early as possible, generally during the development of the research budget, the principal investigator establishes which services are routine and which are research related. This determination must take place before patients are enrolled in the study.

Finally, it is important that a satisfactory plan be in place to ensure that all services are billed to the proper party throughout the study.

The following research billing policy applies to all clinical research studies at CUMC.

Policy: 

It is the policy of CUMC that faculty, providers and staff work together to ensure that clinical services associated with a research study are billed appropriately and in compliance with relevant laws and regulations.  Any research related billing must be coded and charged based on actual services rendered; must be allowable by regulations governing medical billing practices; and must be consistent with the informed consent signed by the research subject. As research billing is subject to the same federal regulations that apply to patient claims submitted from private practice, it falls under the University Billing Compliance policy.  Please see the Columbia University Billing Compliance manual at the website.    http://www.cumc.columbia.edu/dept/compliance/pdf/Columbia%20Compliance%20Manual.pdf

Roles and Responsibilities:

Research patients often receive services from different departments and many people. Therefore, the first step in establishing an effective research billing policy is to identify the responsibilities of all parties to ensure that billing for services provided to patients will be routed appropriately.

The Principal Investigator (PI) together with the study sponsor is responsible for the terms and conditions of the research project and its related budget. The PI must understand and comply with all rules for billing Medicare, Medicaid and third party insurers for services provided in the context of clinical research. He is responsible for identifying which services are billable to insurance and which services will be covered by the grant. The PI, or other designated person, should discuss fees and payment arrangements for ancillary services with appropriate department personnel and maintain records related to the research study.

Department administrators and Billing Managers are responsible for making certain that services for patients enrolled in research studies are billed and recorded in accordance with the assessments made by the PI.

Study Coordinators are responsible for tracking patients enrolled in studies, scheduling appointments and maintaining records in accordance with the instructions of the PI.

Ancillary Departments, working in conjunction with the PI, are responsible for establishing procedures to ensure ancillary services are billed appropriately to the grant, the patient or his insurance as determined by the PI.

Resources:

The following departments serve as resources to PIs undertaking clinical research:

Research Administration (RA) is a centralized departmental resource that serves the scientific community at Columbia University. It employs professionals in the fields of research grants administration and finance and related technology. These individuals are assigned to work in a variety of areas including Business Development and Project Planning;  Education and Compliance; Proposal Development; and Post-Award Grants Management.

The Clinical Trials Office is the main administrative arm of clinical research at CUMC. Their staff provides assistance and support in every aspect of protocol development, contract negotiations, budgeting solutions and trial maintenance.  

The Office for Billing Compliance helps evaluate proposed billing on new research studies, assists with establishing billing procedures for trials, reviews selected studies across all departments to ensure billing compliance, and provides research billing compliance training.

Plan:

The PI, in conjunction with the sponsor, prepares a research protocol and other supporting information that establish the framework of the research study and the procedures and services that will be administered to the study subjects.

Initial Billing Related Assessments

To ensure billing compliance, the PI should:

1. Create an events schedule from the protocol. This produces a clear, visual picture of what services will be provided and when

2. Determine which services, if any, fall under the  definition of standard of care (Click here to view a sample of the "Criteria for Determining Standard of Care in a Research Study") As this is not always a simple task, the PI should consider:

• Any written policies that may exist which outline how patients are routinely treated for "XYZ" disease.
• Treatments given to patients with the same diagnosis who are NOT enrolled in a research study. Particular consideration should be given to the number of times a service is rendered under routine care of the patient. For example, if one X-Ray every year is standard of care for a particular diagnosis, and the study requires six X-Rays per year, only one of these will fall under standard of care and the other five should be covered by the grant.

3. Examine the sponsor contract and budget to verify what the sponsor will cover.

• Are there adequate assurances that all services included in the events schedule will be paid by either the sponsor or insurance?
• What items are "free" to all study subjects? Even if these services would normally be considered standard of care, if the sponsor is paying for them, they may not be billed to the patient or his insurer.
• What has the sponsor agreed to pay if there are complications from the patient’s participation in the study?  Sometimes sponsors will agree to pay only for serious adverse events and other times they will pay for all complications.

4. Arrange for services that will be provided by ancillary departments:

• Inform the ancillary department whether the service is insurance billable or payable by the grant to prevent accidental double billing.
• Establish a procedure to notify the ancillary departments, in writing, of all patients enrolled in the research study and what services are to be provided.   
• Establish a process for the ancillary department to collect payment from the grant if the service may not be billed to insurance

5. Complete a Separation of Allowable Charges worksheet to clearly identify items that will be paid by the patient or his insurer and those that will be paid by the grant.

6. Review the informed consent to verify that the services the patient will receive are consistent with the protocol and budget and who has payment responsibility. It is crucial that the wording in the "Costs" section be as specific as possible. If the informed consent says there is no cost to the subject, then neither the patient nor his insurer may be billed.

Billing Process

 There are several things that make establishing an effective research billing policy difficult:

1. Patients enrolled in research studies may receive both standard of care and research related services on the same day and sometimes it is not easy to differentiate between the two.
2. The billing process for clinical research touches many people in different departments; therefore, effective communication is essential to proper billing.
3. Billing systems are not set up to handle the intricacies of research billing and often must be modified to accommodate the process.

As the University continues to examine its resources, programs, and systems that deal with all aspects of Research Compliance, the recommended billing process may change. In the meantime, using our current billing resources, departments may use the following process to bill for clinical services provided to patients enrolled in research studies.

Once a patient has consented to participate in human subject research, the appropriate department personnel should:  

• Register the patient into University’s billing system (IDX) with a financial status classification (fsc) of "Grants" (#92- GR) and enter the 7-ledger account number of the study into the certificate number field. The IRB number of the approved protocol should be entered into the group field. Enter the effective date as the date the patient was enrolled in the study.
• If a patient is already registered in IDX, add the "GR" fsc (92) using the ADD command and enter the 7-ledger account number of the study into the certificate number field. The IRB number of the approved protocol should be entered into the group field. . Enter the effective date as the date the patient was enrolled in the study. Once the GR fsc has been added, change the order of the fsc’s on the account using the CHANGE ORDER command. The "GR" fsc should not appear first.
• Notify any ancillary departments that will be providing services that the patient has enrolled in the study.  Provide information on the study name, the patient name, MRN#, service(s) that will be provided, and whether the services are insurance or grant billable.
• When the patient presents for each visit, determine whether it is standard of care (billable to insurance) or study related (billable to the grant).
• Charge Enter study related services from a study encounter form or dictation which are NOT billable to insurance or the patient (as identified by the PI) into the IDX system as grant billable services using the GR fsc
• Charge Enter study related services from a study encounter form or dictation that is eligible for billing to the patient or his insurance into the IDX system using the patient’s insurance fsc. REMEMBER that if the insurance provider is Medicare, the QV modifier must be appended to the line item service.  This is used to identify and report routine care services for Medicare recipients enrolled in qualifying clinical trials.
• Claims for Category B Devices require additional information and should be submitted as follows:
  1. Physicians must place the IDE# of the Category B device in Item 23 of the
  CMS-1500 claim form, or the electronic equivalent.
  2. Appropriate ICD-9-CM codes and the CPT/HCPCS codes that relate to the IDE
  must be reported on the claim.
  3. Modifier QA must be appended to the CPT/HCPCS codes.
  
  
• Claims for the routine services performed in a clinical trial where a Category A is used for a patient with a life-threatening condition also have additional requirements and should be submitted as follows:
  1. Physicians must place the IDE# of the Category A device in Item 23 of the
  CMS-1500 claim form, or the electronic equivalent.
  2. The appropriate CPT/HCPCS codes and ICD-9-CM V70.7 must be reported.
  3. The modifier QV must be appended to the CPT/HCPCS codes.
         
• When a patient is referred to an ancillary department for a previously arranged study service, notify the appropriate person in the ancillary department when the patient will actually present for the service so that it may be billed appropriately to the patient’s insurance or the grant.
• Run monthly reports from IDX and reconcile the study related services (posted to GR fsc or posted with a QV modifier).
• Submit invoice IDI transfer request for services provided.
• Post "payment and adjustments" in IDX.

Research Billing Compliance Risks

The following constitute research billing compliance problems:  

• The process of submitting a claim to a third party payer "in the hopes that they will pay" is not consistent with the National Coverage Determination. The sponsor responsibility may not be contingent upon payer determination.
• Waiving Medicare co-payments and/or deductibles.
• Up coding billable services to Medicare.
• Inadequate medical record documentation.
• Billing Medicare for:

- Investigational, drug, devices or procedures
- Research specific services (e.g. trial eligibility)
- Items or services provided for data collection
- Routine care in non-qualifying trial
- Routine care not covered by Medicare
- Services the sponsor pays for or the sponsor provides free of charge

Enforcement

The Office for Billing Compliance has full authority to review all research-related documents, financial records, contracts, and other information necessary to ensure compliance with regulatory requirements pertaining to research. The Office will review a number of research studies across all departments and divisions each year to monitor compliance with applicable regulations and this policy.

The Billing Compliance Manager will obtain a list of subjects enrolled in selected research studies from each clinical department.  The Compliance Office will review these patients’ accounts to determine if:

• The charges are study or non-study related
• The charges are billed to the appropriate entity
• The charges were not double billed
• The services were coded correctly
• Services that were non-study related were documented, coded and billed appropriately.

Records Management

The PI should maintain the following records with respect to research studies and will make these documents available to the Office for Billing Compliance upon request:

• Copy of the approved study protocol, informed consent and budget
• The study/protocol number as assigned by the CUMC IRB
• A list of the subjects enrolled in the study including first, middle and last name, and Medical Record Number (MRN) and/or IDX number
• A description of the type and frequency of tests, treatments, procedures and services required by the study, that are considered to be funded by the Sponsor and those that are considered to be "Standard of Care" and therefore payable by the patient or third party payer (Separation of Allowable Charges)
• Study encounter forms, requisitions for ancillary services and other documentation completed for such subjects and patients, including case report forms.