Integrated Policy for Clinical Research Billing Compliance

Integrated Policy for Clinical Research Billing Compliance

Abstract:
This policy requires relevant administrators and employees of UAB and UABHSF to ensure that clinical services associated with research studies are billed appropriately and in compliance with relevant laws, regulations, and contractual obligations.
Effective Date:
12/10/2007
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff
Material Original Source:

University of Alabama at Birmingham/UAB Health System

INTEGRATED POLICY FOR CLINICAL RESEARCH BILLING COMPLIANCE

December 10, 2007

Purpose

This policy establishes uniform requirements for billing clinical services for subjects who participate in research studies that may potentially generate claims to participants or third party payers for any items or services designated as part of a research protocol. It seeks to ensure that UAB and UABHS adhere to laws, regulations, and requirements governing research billing practice.

Applicability

This policy applies to all operating units of UAB, including those units that furnish clinical services, such as University Hospital; to UAB Highlands; and to the Kirklin Clinic and other clinical facilities owned by the University of Alabama Health Services Foundation that are managed by UAB Health System.

Policy

It is the policy of UAB and UABHS that faculty investigators, academic departments, administrative units, healthcare entities and associated staff members coordinate their activities to ensure that clinical services associated with research studies are billed appropriately and in compliance with relevant laws, regulations, and contractual obligations. UAB and UABHS have developed comprehensive processes to communicate information and train the relevant workforce on proper clinical research billing activities and to monitor and reconcile financial information. Individuals involved in the conduct of clinical research, registration of participants, ordering of research items and services, coding research services, and billing for research items and services will comply with this policy and the roles, responsibilities and procedures described herein. Corrective and disciplinary action may be taken for violations of this policy including, but not limited to, suspension of study activities, suspension of billing to participants and third parties and reassignment of claims from billing entities to research accounts, and/or employment action.

Roles/Responsibilities

Since many departments and units of UAB and UABHS-managed entities provide services which create billing obligations to research participants, it is important to establish the roles and responsibilities of stakeholders in the clinical trials billing process in order to make the process transparent and efficient.

Principal Investigator (PI) and Research Staff
The PI (including research staff designated by the PI) is responsible for project budget development for each study and assuring that steps for accurate billing are taken in the manner described by this policy. The PI is responsible for the following specific steps: 1) providing to the Office of Human Research (OHR) the study protocol (including amendments for addition or deletion of clinical items/services), proposed clinical trial agreement (CTA) (if any), proposed informed consent document (IC) (including amendments related to adding or deleting clinical items/services), schedule of events (i.e. clinical interventions/interactions and research activities designated by the protocol) with each event assigned to a standard treatment or research category to obtain a prospective coverage analysis of billable clinical services, and a copy of the budget request page included in the GCRC application, if applicable; 2) reviewing and accepting the billing matrix generated by OHR for the project; 3) communicating study and participant visit information to the UAB Healthcare entities; and 4) verifying claims from healthcare entities for accuracy and processing payments.

Departments
The Department Chair, in collaboration with the Center Director where applicable, and the School Dean, are responsible for establishing and maintaining an environment for clinical research that requires all members of the research team to be both knowledgeable of and compliant with all policies and regulations governing the conduct of research. The approval of a protocol by the Chair acknowledges that the Principal Investigator and research team are both knowledgeable and in compliance. Departments may implement additional procedures to assist the investigator and department in both fiscal and operational management of clinical research projects. A departmental Chair may delegate responsibilities under this policy but the Chair remains ultimately responsible for compliance with this policy.

Office of Human Research (OHR)
The Office of Human Research is responsible for performing a prospective coverage analysis for each clinical study, developing a specific billing matrix which utilizes UAB designated research rates, finalizing and approving a billing plan delineating those services which should be billed to the study versus the participant or third party payor as standard care, and communicating the results of the prospective coverage analysis and approved billing plan to the PI, UABHS healthcare entities, OCGA, and IRB as appropriate. In addition the OHR is responsible for the overall operation (coordination, education, and oversight) of the University wide electronic clinical trials management system.

UABHS Healthcare Entities
Healthcare entities are responsible for receiving and processing participant visit information and coding and generating claims in accordance with applicable billing regulations and contractual obligations.

Office of Grants and Contracts Administration (OGCA)
OGCA is responsible for ensuring no contract is executed without notice of the existence of an approved billing plan and making the executed contract available to the OHR.

Institutional Review Board (IRB)
The OIRB is responsible for ensuring that the results of OHR preliminary review of the informed consent documents are incorporated in the IRB review process.

General Clinical Research Center (GCRC)
GCRC is responsible for providing the OHR with award information pertaining to payment of items and services for research studies.

Office of Research Compliance (ORC)
The ORC advises all stakeholders under this policy (investigators, OHR, healthcare entities, etc.) regarding billing for proposed research studies, assists with establishing procedures for all phases of clinical trial billing, performs monitoring and auditing of the clinical trial billing process to ensure compliance with billing regulations and this policy, and provides research billing compliance training.

Procedure

UAB is implementing an electronic software product for clinical trials management and currently transitioning from a manual to an electronic process for clinical trials billing. These procedures represent key operational steps in the clinical trials billing process and cover both manual and electronic methods currently in use. All responsible parties are expected to incorporate these operational steps into their current processes and modify processes as necessary to achieve the goals of this policy. Procedural steps for responsible parties may be delegated to other parties by written agreement between the parties and approval by the director of the OHR.

Principal Investigator and Research Staff
The Principal Investigator (or designee:)

Prospective Billing Coverage Analysis
  • Submits electronically copies of proposed CTA (if any), proposed Informed Consent document, research protocol, schedule of events (i.e. clinical interventions/ interactions and research activities designated by the protocol) with each event assigned to a standard treatment or research category.
  • Receives and reviews preliminary billing matrix from Office of Human Research and accepts the billing matrix by signing and returning approval to the OHR.
  • Sends the following modifications to the research study to OHR for inclusion in the SiteMinder budget:
    • Protocol amendments for addition or deletion of clinical procedures or ancillary services (e.g. radiology, lab, cardiographics, etc.) ;
    • Changes in sponsor funding for study clinical procedures or ancillary services (e.g. radiology, lab, cardiographics, etc)
Initiation of Siteminder electronic clinical trials management system
  • Establishes study in Siteminder using basic prescribed study information;
  • Forwards above to OHR for entry of clinical billable items/services in SiteMinder;
  • Adjusts, as applicable, charges for clinical billable items/services after receipt of Siteminder budget from OHR;
  • Adds itemized research activities not designated as clinical billable items/services;
  • Forwards budget to OHR for additional review and finalization;
Transmittal of Study Activity to Billing Entities
(Manual Method)
  • Completes relevant portion of clinical trial billing notice at the time of IRB approval and faxes form to a designated Fax number to notify billing entities of the study approval.
  • Completes on or before each protocol-designated visit a CTBN for each participant that includes:
    • Patient and study identifying information;
    • Each protocol designated item/service provided at the visit;
    • Party to whom related charges should be billed.
(Electronic Method)
  • Creates patient record and associates it with study in Siteminder;
  • Schedules subject appointments in Siteminder;
  • Verifies completed appointment in Siteminder which electronically transmits CTBN to billing entities;
Study Financial Management
  • Creates electronic invoices to sponsors for payment using Siteminder (optional);
  • Posts receipt of payments from sponsor in Siteminder (optional);
  • Allocates payments from sponsor to specific visits in Siteminder (optional);
  • Generates financial reports in Siteminder (e.g. budget vs. actual invoice statement) (optional);
Processing Study Payments
  • Receives and processes claims from billing entities for payment by study using the following steps:
    • Comparing the claim with the study budget for correctness;
    • Working with billing entities to correct inaccurate claims, as necessary;
    • Processing payments to billing entities.

Office of Human Research
The Office of Human Research:

Prospective Coverage Analysis
  • Enters receipt of study in electronic tracking database and assigns OHR number;
  • Performs preliminary review of the proposed clinical trial agreement (CTA) and informed consent document (IC) to determine whether:
    • Study qualifies for coverage under applicable CMS Clinical Trial Policy (CTP);
    • Any protocol designated items/services will be billed to participants or third party payors as routine costs as defined by the CTP;
      • Routine costs exclude the following:
        • Investigational item or service unless the item or service is otherwise covered outside of the clinical trial;
        • Items and services provided solely to satisfy data collection and analysis needs and is not used in the direct clinical management of the patient; and
        • Items and services provided by the research sponsor free of charge for any enrollee in the trial.
    • CTA and IC are consistent regarding what items the sponsor is providing free of charge to all study subjects;
    • CTA and the "additional cost" section of the IC are consistent regarding items/services to be billed to participants or third party payors as routine costs;
    • CTA and IC are consistent regarding costs related to items and services needed for reasonable and necessary care arising from the provision of the investigational item or service - in particular, for the diagnosis and treatment of complications;
    • CTA requires UAB to warrant or obligate itself to bill study items/services in accordance with a directive from the sponsor;
    • Billing compliance language should be included in IC;
  • Communicates results of preliminary review to PI, IRB and OCGA;
  • Refers any concerns or questions regarding problematic language to Office of Research Compliance for review, advice and collating;
  • Develops billing matrix by:
    • Performing detailed prospective coverage analysis on each protocol designated item and service based on investigator-assigned category of routine cost or research;
    • Obtaining research pricing for those services to be paid for by the study; and
    • Assigning appropriate CPT/charge codes for routine costs.
  • Completes billing matrix electronically and forwards to PI for review and acceptance;
  • Receives accepted billing matrix from PI and approves study in electronic database;
  • Forwards approved billing matrix to PI and billing entities with notice to OGCA
Siteminder Budget Development
  • Enters clinical billable items/services in Siteminder budget;
  • Finalizes budget in Siteminder which is electronically transmitted to billing entities;
  • Makes modifications/amendments to Siteminder budget, if needed, and notifies PI;
  • Reviews executed contract, approved informed consent, and approved billing plan for accuracy and consistency.
  • Refers to the Office of Research Compliance for review and resolution:
    • Any inconsistencies noted in review of the executed contract, approved informed consent, and approved billing plan; and
    • Any CTA language requiring UAB to warrant or obligate itself to bill study items/services in accordance with a directive from the sponsor.

Healthcare Entities
Healthcare Entities:

HSF/MSO
  • Creates study in IDX electronically from SiteMinder or manually from CTBN study notification;
  • Establishes a patient "case" in IDX either electronically from SiteMinder data feed of manually from the manual CTBN
  • Receives scheduled subject appointments electronically or via manual CTBN;
  • Matches scheduled subject visits in Siteminder to scheduled visits in IDX;
  • Receives completed appointment information electronically or via manual CTBN;
  • Processes charges as directed on the CTBN;
  • Generates claims to appropriate payers; and
  • Receives and post payments accordingly.
Hospital Lab
  • Creates a lab billing account in HQ from manual CTBN or SiteMinder data feed;
  • Collects electronic or manual CTBN information;
  • Verifies lab charges on manual or electronic CTBN are accurately assigned to the correct account.
Hospital PFS
  • Receives electronic or manual CTBN;
  • Identifies clinical trial accounts in HQ using SiteMinder data feed of scheduled appointments or manual CTBN;
  • Reviews specific items/services provided via electronic or manual CTBN;
  • Reviews patient account in HQ with corresponding CTBN;
  • Generates claims to appropriate payers;
  • Receives and posts payments accordingly.

UAB Administrative Units
UAB Administrative Units:

Office of Grants and Contracts Administration
  • Verifies billing matrix approval prior to executing contract;
    • Notifies PI, OHR, and ORC if unable to verify billing matrix approval.
  • Forwards or otherwise makes available executed contract to OHR;
  • Forwards contract amendments or otherwise notifies and makes available contract modifications related to provisions of clinical procedures or ancillary services (e.g. radiology, lab, cardiographics, etc.) to OHR.

Institutional Review Board (IRB)
  • Incorporates results of OHR preliminary review as part of the IRB review process;
  • Forwards or otherwise makes available approved informed consent to OHR;
  • Forwards protocol amendments/modifications related to addition or deletion of clinical procedures, or ancillary services (e.g. radiology, lab, cardiographics, etc.) to OHR.

Expected Time Frames for Completion of Key Procedural Steps
In order to establish consistent performance measures for accomplishing the key procedural steps identified in this policy, the responsible parties will adhere to the expected time frames listed in Table 1 attached to this policy.

Implementation

The Senior Vice President/Dean of the School of Medicine is responsible for implementation of this policy as it pertains to the OHR and investigators. The Vice President for Research and Economic Development is responsible for implementation of this policy as it pertains to UAB central administration units. The CEO of UABHS is responsible for implementation of this policy as it pertains to UABHS entities. This policy may be modified by concurrence of all individuals responsible for implementation. The Office of Research Compliance and UABHS legal counsel are responsible for ongoing review to ensure that this policy is consistent with current legal and compliance requirements.

Table 1 - Expected Time Frames for Completion of Key Procedural Steps

Procedural Step

Responsible Party

Expected Time Frame (Working Days)

Prospective Coverage Analysis (FAP)

OHR

2-15

Confirmation of Billing Plan by Investigator

Investigator

3

Study Entry into SiteMinder

OHR

1-2

Review of Final Budget in SiteMinder

Investigator

3

Create Patient Record in SiteMinder

Investigator

Immediately after consent

Schedule Research Appointment in SiteMinder

Investigator

At least 1 day before visit or on date of service if enrolled that day.

Transmit manual CTBN

Investigator

On or before date of service

Create Electronic CTBN (Update Research Appointment in SiteMinder)

Investigator

1-2 days post visit

Delivery of Claims for Study Services

Billing Entities

60

Payment of Study Claims to Billing Entities

Investigator/Department

120