Coverage Analysis. Purpose

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1 Coverage Analysis Purpose The purpose of this policy is to provide a method for researchers to perform a Coverage Analysis (CA) for clinical research conducted at Mission Hospital, Inc., Memorial and St. Joseph campuses, and other locations where services of the Hospital are provided. The primary objective of the CA is to ensure that all costs of a clinical trial are billed to the appropriate payer whether it is the sponsor, a third-party payer, or the patient. Since clinical research often takes place in conjunction with the routine clinical care of patients, it is imperative to ensure that billing for both routine and research services/items are handled appropriately and in compliance with all applicable statutory requirements. Policy Mission Hospital, Inc. ( Mission ) strives to comply fully with all rules and regulations governing research billing. This policy provides a uniform method for performing the Coverage Analysis (CA). The CA must be completed by the Principal Investigator (or his/her delegate) and submitted to the Research Institute with the initial administrative review packet for all clinical research that either (1) bills research-related protocol items/procedures/services to a third party payer, including Medicare, or (2) requires Mission to perform any of the research-related protocol items, procedures or services. The Centers for Medicare & Medicaid Services (CMS) National Coverage Decision for Routine Costs in Clinical Trials only allows for coverage of routine costs during a qualifying clinical trial. Many other third party payers follow Medicare s rules and regulations; thus this policy applies to all Clinical Research conducted at Mission. The determination of qualifying research is determined by answering a series of questions on the form, Request to Conduct Research at Mission Hospital, available from the Research Institute. Medicare will not pay routine costs that are paid for by the sponsor, promised free in the informed consent document, not ordinarily covered by Medicare, or performed solely to determine trial eligibility or for data collection or analysis. The CA should be done in parallel with budget development to allow contract negotiators to know what items and services can appropriately be billed to third party payers. Conducting the CA before the budget is finalized helps to ensure the research Sponsor adequately covers study costs. The CA process is a vital component of Mission s research compliance program. Properly performed CAs are necessary to protect the researchers and institution against violations of the False Claims Act and other regulations. Additional references and resources are provided in the last section of this policy to aid researchers in completing CAs. Page 1 of 5

2 Definitions CTP, Clinical Trial Policy, the most recent version of the National Coverage Decision on the Routine Costs of Clinical Trials, effective July LCD, Local Coverage Determination, addresses national or local policy gaps that may result in billing for services or items that could be considered neither reasonable nor necessary. LCDs supplement the Clinical Trial Policy. NCD, National Coverage Analysis, gathers input from Medicare, experts, and the public to formulate rules about coverage. Routine Care, items or services typically provided for the patient s diagnosis outside of a clinical trial, e.g. conventional care. Procedures When completing these procedures, refer to the sample CA (Appendix). 1. Create the CA grid if the research attempts to bill study-related protocol items/procedures/services to a third party payer or requires Mission to perform any of the study-related protocol items/procedures/services. 2. Identify each item, service, or procedure to be performed during the course of the research study in the first column of the grid (Column A). a. Review all study information (protocol, clinical trial agreement, informed consent, etc.) and list all items, services, and procedures. b. Include the specific testing required by the protocol specified in the study schedule (i.e. laboratory testing, radiology testing, neurological testing, vascular laboratories) and the associated services required to execute each service or procedure (i.e. the surgical procedure need to implant a device, the IV infusion of a drug, the venipuncture associated with a lab test). c. List tasks performed by study staff such as: a. Conducting the informed consent process (initial and continuing) b. Determining inclusion/exclusion criteria c. Collecting necessary medical history and concomitant medications d. Conducting physical examinations e. Performing vital signs f. Collecting procedural data g. Monitoring adverse events h. Making required follow-up telephone calls i. Completing case report forms j. Preparing for monitoring visits k. Participating in monitoring visits l. Ensuring device and/or drug accountability Page 2 of 5

3 m. Collecting other study related information requiring time expenditures (i.e. patient surveys, obtaining test results, obtaining copies of medical records) 3. List the CDM and/or CPT codes beside each item (COLUMN B). Mark N/A for any items for which there are no CDM and/or CPT codes (i.e. study staff tasks). 4. Determine the study visit schedule and list each time in ROW 1, starting at the third column (Column C). Be sure to provide each time point required by the protocol. Note the timeline, or study schedule, given in the protocol may omit necessary visits such as telephone follow-ups. 5. Determine whether the items at the specific visits are research-related or routine care. Research costs should be charged to the study Sponsor. Only items that are routine care (i.e. care and treatment that would have been performed as a matter of conventional care in the absence of a clinical trial) may normally be charged to third party payers (government or private). 6. In the appropriate COLUMN and ROW, mark each task/procedure during a visit with one of the following: a. S-PI for task/procedure rendered by the principal investigator (PI) and/or study coordinator that is covered by the study Sponsor b. S-MH for task/procedure rendered by Mission Hospital and its associated facilities that is covered by the study Sponsor c. S-OF for task/procedure rendered by an outside facility not affiliated with Mission Hospital that is covered by the study Sponsor d. Free for an item that is provided free of charge by the Sponsor (i.e. drug, device, central lab processing) e. B-PI for task/procedure rendered by the principal investigator (PI) and/or study coordinator that is billable to the patient or insurer f. B-MH for task/procedure rendered by Mission Hospital and its associated facilities that is billable to the patient or insurer g. B-OF for task/procedure rendered by an outside facility not affiliated with Mission Hospital that is billable to the patient or insurer h. Leave cell blank if the task/procedure does not occur at a specific visit. 7. For any item that is billable to the patient or the patient s insurer, supply the reference in the References column as to why it is to be considered routine care. For example, list the procedure as routine care per the guidelines of the leading authority in the medical field (i.e. the American Heart Association). A resource for various guidelines can be found at Cite the version and date of all documents reviewed as supporting evidence. 8. The principal investigator signs and dates the grid indicating his/her approval following the completion of the CA. References The Centers for Medicare & Medicaid Services National Coverage Decision for Routine Costs in Clinical Trials., NCD , A310%2E1%3A2%3ARoutine+Costs+in+Clinical+Trials Page 3 of 5

4 Amit, Ofer. The what, why and how of Medicare Coverage Analysis- Part I. Health Care Compliance Association, October Pawlowski, Kristen. The what, why, and how of Medicare Coverage Analysis- Part II. Health Care Compliance Association, December MLN Matters Number SE0822 Clarification of Medicare Payment for Routine Costs in the Clinical Trial, Page 4 of 5

5 ================================== Appendix Sample Coverage Analysis Study Visits ROW 1 ROW 2 Column A Column B Column C Column D Column E Column F Column G Column H Task/Procedures Obtaining Informed Consent Code (CPT and/or CDM) N/A Infusion Day 1 S-PI Infusion Day 2 Page 5 of 5 2 weeks 12 weeks 24 weeks References ROW 3 Physical Exam B-OF B-OF B-OF B-OF ROW 4 EKG B-MH B-MH B-MH ROW 5 Investigational Drug N/A Free Free ROW 6 Infusion B-MH B-MH ROW 7 Urinalysis S-MH S-MH ROW 8 Ultrasound B-MH ROW 9 Patient Questionnaire N/A S-PI S-PI S-PI S-PI Per the National Kidney Per the National Kidney Per the American Society of Diagnostic and Interventional Nephrology - Professional Association Association for Vascular Access - Professional Association, 2008 Per National Kidney N/A Not Applicable Free Provided free of charge by the Sponsor (i.e. drug, device, central lab) S-PI Rendered by PI and/or Study Coordinator and paid by the sponsor B-PI Rendered by the PI and/or Study Coordinator and billable to the patient or insurer S-MH Rendered by Mission Hospital and paid by the sponsor B-MH Rendered by Mission Hospital and billable to the patient or insurer S-OF Rendered by an outside facility and paid by the sponsor B-OF Rendered by an outside facility and billable to the patient or insurer (Note: This is an example of a CA for a fictitious study. We make no representations that the codes and/or guidelines referred to are correct.)

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