Policy YSM2102 Medical Billing Compliance for Clinical Services Provided to Subjects Who Participate in Clinical Trials and Other Research Studies

Transcription

1 Policy YSM2102 Medical Billing Compliance for Clinical Services Provided to Subjects Who Participate in Clinical Trials and Other Research Studies Responsible Office(s) Responsible Official(s) Yale Faculty Practice Patient Financial Services YSM Grants and Contracts Yale Faculty Practice Director and Associate Dean for Clinical Affairs Executive Director of YSM Grants and Contracts Effective Date 11/1/00, with phased implementation Last Revision 9/19/00 Scope This policy establishes compliance requirements for the medical billing of clinical services provided to subjects who participate in a clinical trial or other research study (hereinafter collectively called clinical research study or research study ). It is applicable to all Yale School of Medicine departments involved in research studies that require or offer clinical diagnosis, treatment, observation or other clinical services as an integral part of the study. Over the longer-term, YSM seeks to capture additional management information regarding the conduct of clinical trials and other research studies to enable the School to further nurture its revenue streams in this area, advance its negotiating position with sponsors of such studies, promote efficient medical billing compliance reviews, and provide other information that will be useful for management purposes. Toward this end, YSM has commenced a study to evaluate its information requirements in this area and to evaluate alternative models for business processes and electronic systems that will allow YSM to achieve these management information objectives in a logical, cost-effective manner. The scope of this policy may be modified upon the conclusion of this study to require additional policies and procedures designed to capture incremental, value-added management information with respect to the conduct of these studies in a uniform, electronic format. Reason for the Policy This first issuance of this policy has been developed to help ensure that clinical services associated with a research study are not billed inappropriately or in duplicate to a patient or third-party payor and that the University adheres to all regulations governing medical billing practices in this area. Definitions Clinical Research study A clinical research study (or research study as used in this policy and its accompanying procedures) is a clinical trial or other research study sponsored by a private sponsor, nonprofit foundation, governmental agency, or other funding source, which is designed to test the safety, and/or effectiveness of therapeutic, diagnostic, or preventive interventions that may eventually be used in humans.

2 Responsible Official A senior member of management who serves as the owner of an institutional and/or divisional business process, and, as such, is responsible for developing, promoting the effective implementation of, and monitoring compliance with policies and related procedures for such process. Responsible Office A department that generally works under the purview of the Responsible Official to manage the day-to-day operational activities for a respective business process. Policy Statement The Principal Investigator (PI), in conjunction with the Sponsor, shall prepare a research protocol and other supporting information that establishes the framework of the research study and the procedures and services that will be administered to study subjects under the definition of the study. It is the responsibility of the PI to identify those tests, treatments, procedures and services that are research related and ineligible for billing to the patient or third party payer on a research encounter form, requisition for ancillary services and other forms, as applicable, upon rendering or requesting such study-related services. If a PI provides a clinical service to a study subject that is not covered by, or is unrelated to, the research study, the PI must ensure that a separate, standard encounter form, requisition for ancillary services or other applicable form is completed for that service. Department administrators are responsible for implementing, documenting and communicating quality assurance procedures within their departments to verify that study-related services which are ineligible for billing to a patient or third-party payer (as identified by the PI) are not entered into the IDX system as billable services. It is the joint responsibility of the Executive Director of YSM Grants and Contracts and the YFP Executive Director of PFS, in consultation with the YFP Compliance Officer, to develop procedures and training programs to promote the effective and timely implementation of this policy. It is the responsibility of the PI or designee to maintain records related to the research study in accordance with the accompanying procedures and to make such records available to the YFP Compliance Office upon request. The YFP Compliance Office will perform compliance reviews of clinical services provided to research study subjects to monitor compliance with this policy and applicable medical billing requirements governing this area. Special Situations/Exceptions In the event that an unusual situation arises that may justify an exception to this policy or its accompanying procedures, all such exceptions must be approved by the YFP Director and Associate Dean for Clinical Affairs in consultation with the YSM Executive Director of Grants and Contracts, as appropriate. Page 2 August 5, 2000

3 Procedures PI Identification of Study Related Services and Departmental Quality Assurance PFS (in conjunction with a steering group assigned to implement this policy) will work with department administrators to establish and implement standards for research study encounter forms, requisitions for ancillary services and other forms, as applicable, that will enable the identification of study-related patients and services. The PI will identify the tests, treatments, procedures and services that are study-related and ineligible for billing to the patient or third-party payer on the research encounter form, requisition for ancillary services or other forms, as applicable, upon rendering or requesting such study-related services. If a physician provides a service to a study subject that is not covered by and/or is unrelated to a research study, the physician must complete a separate standard encounter form, requisition or other forms as appropriate for that service. The department administrator will implement and document quality assurance procedures to monitor that study-related services which are ineligible for billing to a patient or third-party payer (as identified by the PI on the respective form) are not entered into the IDX system or other applicable patient billing system as charges which qualify for billing to the patient or a third party medical payer. Retaining Documents The PI or designee should maintain the following records with respect to research studies that include the provision of clinical services and will make these documents available to the YFP Compliance Office upon request: A list of the subjects enrolled in the study including first, middle and last name, address and date of birth. A description of the type and frequency of tests, treatments, procedures and services required by the study, and as such, are considered to be funded by the Sponsor. The study/protocol number as assigned by the YSM Grants and Contracts. Encounter forms, requisitions for ancillary services and other documentation completed for such subjects and patients, including case report forms. Compliance Reviews The YFP Compliance Office will perform compliance reviews of clinical services provided to research study subjects to monitor compliance with this policy and applicable medical billing requirements governing this area. The Compliance Annual Audit Plan will include individuals who are enrolled in research studies where the sponsor is reimbursing some or all of the tests, procedures or services required by the research study. The Compliance Officer will, upon request, obtain a list of subjects enrolled in research studies from each clinical department. A sample of subjects will be selected for review in accordance with appropriate sampling techniques. The Compliance Office will review the subject s accounts to determine if: The charges are study or non-study related Page 3 August 5, 2000

4 The charges are billed to the appropriate entity The charges were not double billed by Yale The services were coded correctly Services that were non-study related were documented, coded and billed appropriately. The Sponsor Contract and the Medicare National Coverage Decision, which was released in August 2000, will be used as a guide for determining the appropriate entity for reimbursement. Related Information Policy YSM2101: Financial Administration of Clinical Trial Agreements YSM Web sites: Medical Billing Compliance Contacts Subject Contact Phone Interpretation of this policy and accompanying procedures Executive Director of YFP Patient Financial Service Executive Director of YSM Grants and Contracts Standards for Encounter Forms, Requisitions and other applicable forms Executive Director of YFP Patient Financial Services Medical Billing Compliance YFP Compliance Officer Roles and Responsibilities Executive Director of Patient Financial Services in Partnership with the Executive Director of YSM Grants and Contracts, and in collaboration with the YFP Compliance Officer Develop and maintain procedures and training programs to enable the timely and effective implementation of this policy. Develop standards for research encounter forms, requisitions for services and other related forms to capture study-related subjects and services; work with department administrators, other School administrators, YNHH and other parties, as appropriate, to promote the timely implementation of such standards. Lead the study to evaluate management information requirements for research studies and the evaluation and selection of alternative business process models and systems that will enable YSM to capture additional value-added management information in this area in a cost-effective manner. Provide guidance to PI s, study coordinators, department administrators and other designees on topics encompassed in this policy and its related procedures. Page 4 August 5, 2000

5 Principal Investigator (With Support from the Study Coordinator or Other Designees, as Appropriate) Prepare research protocols and other supporting documents that set forth the research protocol and the types and frequency of tests, procedures, and services that are associated with the clinical trial or research study. Participate in the development of research encounter forms, requisitions for services and other required forms, as applicable. Identify services as study-related and properly complete the research encounter forms, requisition for ancillary services and other forms, as appropriate for the service. Maintain documents supporting the study as set forth in the attached procedures and in accordance with the contractual provisions of contracts with external sponsors. Department Administrator or Designee Work with PFS to modify or create a research encounter form, requisition for ancillary services and other forms, as applicable, that will enable the identification of study-related subjects and services that are not billable to the patient or third-party payer. Implement, document and communicate quality assurance procedures to determine that studyrelated services that are ineligible for billing to a patient or third-party payer (as identified by the PI) are not erroneously entered as billable charges in the IDX system or other applicable billing system. YFP Compliance Officer Design and oversee the performance of compliance reviews of services provided to study subjects to monitor compliance with this policy and applicable medical billing regulations governing this area. Revision History First issuance 11/00 Forms and Exhibits none Page 5 August 5, 2000