Clinical Research Billing New England Healthcare Internal Auditors Fall Conference

Clinical Research Billing New England Healthcare Internal Auditors Fall Conference December 3, 2015 YOUR MISSION OUR SOLUTIONS All Rights Reserved. Use and distribution are prohibited without written agreement with Huron. Huron is a management consulting firm and not a CPA firm. It does not provide attest services, audits, or other engagements in accordance with the AICPA's Statements on Auditing Standards. Huron is not a law firm; it does not offer, and is not authorized to provide, legal advice or counseling in any jurisdiction.. Welcome and Introductions Beth Belt Beth Belt Director Huron Consulting Group P 617-226-5508 C 781-696-9163 F 617-226-5555 bbelt@huronconsultinggroup.com Beth has over 15 years of experience in healthcare regulatory compliance. She has served on engagements for healthcare systems, academic medical centers, community hospitals, and renal dialysis facilities. Beth advises clients within compliance, operations, and research departments for the healthcare provider community, including development and implementation of processes associated with the clinical trial revenue cycle and related Medicare regulations. Prior to providing compliance and research advisory services, Beth held several key positions at Dana Farber Cancer Institute, including the Administrator for the Center for Clinical and Translational Research, Project Manager for the Clinical Trial Billing Project, as well as the Billing Compliance Manager. 2 1

Welcome and Introductions Avery Bullock Avery Bullock Analyst Huron Consulting Group C 678-708-2881 abullock@huronconsultinggroup.com Avery is an Analyst in our Research Services group focusing on clinical research and research administration transformations. She has experience with the financing, administration, operations, and compliance aspects of the research enterprise at universities, academic medical centers, research institutes, and hospitals. She has worked largely in clinical research billing and clinical research financial management, and performed clinical research billing audits at a number of institutions. 3 Overview of Clinical Research Billing 2

Overview of Clinical Research Billing The research billing process (depicted on the left) is complex and requires coordination and harmonization between partnering institutions (the hospital and physician practices). The steps in the process are as follows: Coverage Analysis Budgeting and Contracting Identifying Research Patients Registration and Admission Charge Segregation Coding Claims Processing and Invoicing Study Close-out and Residual Balances 2015 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 5 Importance of a Clinical Research Billing Compliance Program 3

Importance of a Research Billing Compliance Program Historical Context of Medicare and Clinical Trials 2007: CMS made slight changes to the Clinical Trial Policy (CTP) 2005: Rush University Settlement drew attention to the CTP 1995 2000 2005 2011 1995: Medicare coverage of investigational devices 2011: HHS Secretary Kathleen Sebelius announced that HHS has begun several initiatives to address inconsistencies in clinical research billing compliance 7 Importance of a Research Billing Compliance Program Why is this important? University of Alabama Birmingham $3.4 Million (2005) Weill Cornell Medical Center $4.3 Million (2005) Public Settlements Rush University Medical Center $1 Million (2005) Tenet Healthcare System Norris Cancer Center $1.9 Million (2010) Emory University $1.5 Million (2013) 8 4

Importance of a Research Billing Compliance Program Consequences of Not Having a Billing Compliance Program Civil Fines Costs Associated with Investigation Criminal Penalties Loss of Governmental Funding Consequences Increased Governmental Scrutiny Under Billing Loss of Trust by Sponsor and Participants 9 Costs to Implement Corrective Action Plan Importance of a Research Billing Compliance Program Benefits of Having a Billing Compliance Program Increased Revenue Opportunities Benefits Early Detection of Items and Services Non-Covered Trust of Sponsors and CRO s Tool to Ensure Compliant Claims Processing 10 5

Overview of Applicable Rules and Regulations Overview of the Regulations and Guidelines Clinical Trial Policy, 2007 Medicare s current Clinical Trial Policy (CTP) as of July 9, 2007 www.cms.gov/medicare/coverage/clinicaltrialpolicies/index.html Effective for items and services furnished on or after September 19, 2000 Medicare covers the routine costs of qualifying clinical trials, as such costs are defined below, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply. What is covered by Medicare: Items and services typically provided absent a clinical trial; Items and services required for provision of an investigational item or service (e.g. administration of a non-covered chemotherapy), clinically appropriate monitoring if effects of item/service, or prevention of complication; and Items and services needed for the reasonable and necessary care arising from provision of an investigational item/service, in particular, for the diagnosis and treatment of complications from participation in the research protocol. 12 6

Overview of the Regulations and Guidelines Clinical Trial Policy, 2007 What is covered (continued) If the investigational item itself would be covered outside of the trial, it is still covered within the trial. The investigational item could also be covered as part of a Coverage with Evidence Development Trial. www.cms.gov/medicare/coverage/coverage-with-evidence-development/index.html 13 Overview of the Regulations and Guidelines Clinical Trial Policy, 2007 What is not covered? Items and services typically provided solely to satisfy data collection and analysis needs and are not used in the clinical management of the patient (e.g. monthly CT Scans for conditions usually requiring a scan every three months); and Items and services customarily provided by research sponsors free of charge for any enrollee in the trial. 14 7

Overview of the Regulations and Guidelines Clinical Trial Policy, 2007 What is a Qualifying Clinical Trial? Purpose of the trial must be for the evaluation of an item or service with a benefit category; Must have therapeutic intent; Must enroll patients with a diagnosed disease; and Must be deemed (i.e. must meet the seven desirable characteristics defined by the CTP). 15 Overview of the Regulations and Guidelines Clinical Trial Policy, 2007 Seven Desirable Characteristics The principal purpose of the trial is to test whether the intervention potentially improves the participants' health outcomes; The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use; The trial does not unjustifiably duplicate existing studies; The trial design is appropriate to answer the research question being asked in the trial; The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully; The trial is in compliance with Federal regulations relating to the protection of human subjects; and All aspects of the trial are conducted according to the appropriate standards of scientific integrity. 16 8

Overview of the Regulations and Guidelines Clinical Trial Policy, 2007 Effective September 19, 2000, clinical trials that are deemed to be automatically qualified (i.e. automatically meet the seven desirable characteristics) are: Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA; Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA; Trials conducted under an investigational new drug application (IND) reviewed by the FDA; and Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1). 17 Overview of the Regulations and Guidelines Clinical Trial Policy; Investigational Device Trials The CTP does not withdraw coverage from Investigational Device Exemptions (IDE) Category B trials, but there have been reports of Medicare contractors denying these trials because the support for therapeutic intent was insufficient. The Second Consideration of the Clinical Trial Policy in 2007 (that was not implemented) included the following statements: This policy is not applicable to, and does not change Medicare coverage according to the regulations on Category A and Category B IDE found in 42 CFR 405.201-405.215, 411.15, and 411.406. Since humanitarian use devices (HUDs) with an FDA approved humanitarian device exemption (HDE) are not addressed in this policy, local contractors may continue to make determinations about the coverage of HUDs. 18 9

Overview of the Regulations and Guidelines CMS Investigational Device Trials, 2015 Effective as of January 1, 2015, interested parties (i.e. study sponsors) that wish to seek Medicare Coverage must submit a request electronically or by hard copy for review and approval to the central CMS office as published in the CMS Medicare Benefit Policy 100-02, Chapter 14- Medical Devices, 20.1 and per the Physician Fee Schedule CY2014 Final Rule. Documents to be submitted include the following: Request letter that includes the scope and nature of the study and how the study meets the Medicare Coverage IDE Study Criteria that is consistent with the previously mentioned seven desirable characteristics and deemed trials and is provided in the next slide; FDA approval letter; IDE study protocol; One IRB approval letter; NCT number; and Supporting documentation, as appropriate. CMS will post IDE study approvals on the CMS Coverage website. Healthcare providers and Medicare Contractors must check the site prior to submitting claims or making payment. 19 Overview of the Regulations and Guidelines CMS Investigational Device Trials, prior to 2015 For IDE studies approved by the FDA prior to January 1, 2015, providers that have been or will participate in these IDE trials and anticipate filing Medicare claims should continue to submit their requests to their Medicare Administrative Contractor (MAC). Documents currently may include, but are not limited, to the following: Submission Checklist; Name and Narrative Description of Device; Study Protocol; Informed Consent Form; Un-redacted/Unconditional FDA Approval Letter; and IRB Approval Letter. 20 10

Overview of the Regulations and Guidelines Affordable Care Act Impact of the Affordable Care Act on Clinical Trials Section 2709 applies to all approved clinical trials. An approved clinical trial, as defined in the statute, is a phase I, II, III, or IV clinical trial that relates to the prevention, detection or treatment of cancer or other life-threatening diseases that also satisfies one of three requirements: 1. The trial is federally funded; 2. The trial is conducted under an investigational new drug application; or 3. The trial is exempt from such an investigational new drug application. 21 Overview of the Regulations and Guidelines Affordable Care Act Impact of the Affordable Care Act on Clinical Trials In a provision of the Act, insurers are prohibited from denying or limiting coverage for routine clinical care for individuals enrolled on a clinical trial that would otherwise be provided if the individual was not a study participant. If a group health plan or a health insurance issuer offering group or individual health insurance coverage provides coverage to a qualified individual, then such plan or issuer may not: 1. Deny the individual participation in the clinical trial; 2. Deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and 3. Discriminate against the individual on the basis of the individual s participation in such trial. 22 11

Clinical Medicare Claims Processing Manual, Chapter 32 Item Routine Costs submitted by Physicians on CMS 1500 Routine Costs submitted by Institutions UB-04 CMS 1450 Medicare Requirement(s) ICD-10 Diagnosis code Z00.6 Examination for normal comparison and control in clinical research program ICD-9-CM Diagnosis code V70.7 Examination of participant in clinical trial reported as a secondary (prior to 10/1/2015) CPT Code Modifier (outpatient claims only) Q0 Modifier Investigational clinical item or service Q1 Modifier Routine clinical service All of the above Condition Code 30 Qualifying clinical trial Revenue Code 0624 FDA Investigational Devices Reported on all outpatient claims even if the device is provided free of charge. If provided at no cost, must report a token charge (e.g. $1.00 or $00.01) in the non-covered charge field Reported only on inpatient claims if the device is not provided free of charge 24 12

Medicare Claims Processing Manual, Chapter 32 Item Medical Records Registry Number Device Trials Medicare Requirement(s) Must include: Trial Name Trial Sponsor Sponsor-Assigned Protocol Number 8-digit National Clinical Trial (NCT) identifier number is required as of January 1, 2014 (and Value Code D4 on an institutional claim only) Exceptions- Studies that have been approved through the Coverage with Evidence Development (CED) may require this for coverage and payment purposes IDE number assigned by the FDA Reported in field 43 on a UB-04 Reported in item 23 on a 1500 claim form Value Code FD reported on claims when certain IDEs are provided free of charge as part of a device study Condition Code 53 reported on outpatient claims for initial placement of a medical device when the device is furnished without cost and provided as part of a device study (effective July 1, 2015) 25 Medicare Claims Processing Manual, Chapter 32 Type of Study Hospital Charges (UB-04) Inpatient Claims Hospital Charges (UB-04) Outpatient Claims Professional Charges (CMS-1500) Qualifying Clinical Trial Medicare Clinical Trial Policy Instructions apply to conventional care, including treatment of complications Billing provider must include in the medical record the following information: trial name, trial sponsor, and sponsor-assigned protocol number ICD-10 diagnosis code Z00.6 as the secondary diagnosis code for trial participation and comparison controls (post 10/1/2015) ICD-9 diagnosis code V70.7 as the secondary diagnosis code for trial participation Condition Code 30 (qualifying clinical trial) reported at the claim level for both trial participants and healthy controls NCT# Include Z00.6, Condition Code 30 and NCT# regardless of whether all services on the claim are related to the clinical trial or not ICD-10 diagnosis code Z00.6 (V70.7 ICD-9) as the secondary diagnosis code for trial participation ICD-10 diagnosis code Z00.6 (V70.7 ICD-9) as the primary diagnosis code for healthy controls only Q1 Modifier- for both participants and healthy controls- apply to each item or service identified as conventional care only on line items related to the clinical trial Q0 Modifier- for each service identified as investigational Condition Code 30 (qualifying clinical trial) reported at the claim level for both trial participants and healthy controls NCT# Include Z00.6, Condition Code 30, NCT# regardless of whether all services on the claim are related to the clinical trial or not Note: CMS will return claims as unable to process if the Z00.6 and NCT# are not on claim with the Condition Code 30 ICD-10 diagnosis code Z00.6 (V70.7 ICD-9) as the secondary diagnosis code for trial participation ICD-10 diagnosis code Z00.6 (V70.7 ICD-9) as the primary diagnosis code for healthy controls only Q1 Modifier- for both participants and healthy controls- apply to each item or service identified as conventional care only on line items related to the clinical trial Q0 Modifier- for each service identified as investigational NCT# preceded by CT 26 13

Chemotherapy Drug Case Study Overview Protocol Title: A Phase I Study of Bendamustine Plus Ibrutinib in Untreated Older Patients ( 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL) Sponsor: ABC Pharmaceuticals PI: John Doe, MD Facility Location: New York Investigational Item: Ibrutinib Qualifying Clinical Trial: Yes NCT: 12345678 On Cycle 1 Day 1, the protocol requires a Complete Blood Count (CBC), IV administration of Bendamustine and Ibrutinib as well as reviewing any Adverse Events What items and services for Cycle 1 Day 1 are billable to the insurance (Medicare) or sponsor? 27 Chemotherapy Drug Case Study Is the CBC billable to Medicare? CBC CPT Codes: 85025-85027, 85007 This test is done on the first day of each treatment cycle for the clinical management of the patient and to detect, monitor, and treat potential side effects of the study medication (Protocol) The study drug and the accompanying regimen of chemotherapy drugs are known to cause hematological toxicities (ICF) Sponsor agrees to reimburse Institution for blood panels that are not standard of care and are required by the Protocol (Budget) Related information found in relevant documents 1. Support for Medicare Coverage 2. Identification of Limitations on State Local Coverage Determination (LCD) or National Coverage Determination (NCD) 3. Conventional Care Reference (As appropriate) YES NCD 190.15 Indications for hemogram or CBC related to red cell (RBC) parameters of the hemogram include signs, symptoms, test results, illness, or disease that can be associated with anemia or other red blood cell disorder. NCD 310.1 Clinically appropriate monitoring of the effects of the item or service, or the prevention of complications. None YES, this service is covered and billable to Medicare 28 14

Chemotherapy Drug Case Study Cycle 1 Day 1 - Billing Designations - A Coverage Analysis should be done for each item Complete Blood Count 85025 Venipuncture 36415 Bendamustine J9033 Ibrutinib J9999 IV Administration 96413, 96415 Review of Adverse Events - Ibrutinib and Adverse Events are paid by the sponsor - CBC, Venipuncture, Bendamustine and IV Administration are billable to Medicare 29 Chemotherapy Drug Case Study UB-04 Clinical Trial Identifiers 131 (1) Condition Code 30 in Box 18 5/1/2015 5/1/2015 30 D4 12345678 (2) Value Code D4 (3) 8-digit NCT identifier number in Box 39 300 LABORATORY 36415Q1 5/1/2015 1.000 30 00 0 00 305 LAB/HEMATOLOGY 85025Q1 5/1/2015 1.000 58 00 0 00 335 CHEMOTHERAP-IV 96413Q1 5/1/2015 1.000 1401 00 0 00 0 00 335 CHEMOTHERAP-IV 96415Q1 5/1/2015 3.000 1620 00 0 00 636 N463459039602 J9033Q1 5/1/2015 199.000 28060 74 636 N456520944327 J9999Q0 5/1/2015 2.000 1.00 1 00 (4) Modifier Q1 or Q0 in Box 44 as MEDICARE 36415 = Venipuncture 85025 = CBC 96413 = Chemotherapy Infusion, Up to 1 Hour 96415 = Chemotherapy Infusion, Each Additional Hour J9033 = Bendamustine, 180 Mg (Drug) C9110 Z006 (5) ICD-10 code Z00.6 in the secondary position in Box 66 (ICD-9 code V70.7 for claims prior to 10/1/2015) C91.10 = Chronic lymphoid leukemia 30 15

Chemotherapy Drug Case Study CMS Form 1500 Clinical Trial Identifiers (1) 8-digit NCT identifier number in Box 19 with CT attached. Electronic version 837P does not require CT (2) ICD-10 code Z00.6 in the secondary position in Box 21 (ICD-9 code V70.7 for claims prior to 10/1/2015) CT12345678 C91.10 = Chronic lymphoid leukemia C91 10 Z00 6 05 01 15 05 01 15 36415 Q1 1, 2 30 00 1 (3) Modifier Q1 or Q0 in Box 24.D 15 01 05 01 05 15 85025 Q1 1, 2 58 00 1 36415 = Venipuncture 85025 = CBC 31 Heart Device Case Study Overview Protocol Title: AVERT Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN Sponsor: Osprey Medical, Inc. PI: Jane Doe, MD Facility Location: New York Investigational Item: Osprey AVERT System Device IDE: G12345 Device Category: B NCT: 23456789 On the Implant Procedure day, the protocol requires a Percutaneous Coronary Intervention (PCI), Anesthesia, Transthoracic Echocardiography (TTE) and the Osprey AVERT System What items and services for the procedure are billable to the insurance (Medicare) or sponsor? 32 16

Heart Device Case Study Implant Procedure Day - Billing Designations - A Coverage Analysis should be done for each item Percutaneous Coronary Intervention (PCI) Anesthesia TTE Osprey AVERT System - Osprey AVERT System, PCI, Anesthesia and TTE is billable to Medicare NOTE: NGS has an LCD (L27360) for the TTE 33 Heart Device Case Study UB-04 Example Clinical Trial Identifiers 8/1/2015 8/1/2015 131 (1) Condition Code 30 in Box 18 (2) Condition Code 53 after 7/1/2015 30 53 D4 23456789 FD 15000 250 PHARMACY 8/1/2015 120.000 100.00 0.00 360 OPERATING 8/1/2015 1.000 24000.00 0.00 ROOM 92920Q1 370 ANESTHESIA 00562Q1 8/1/2015 120.000 3200.00 0.00 483 ECHOCARDIOLOGY 93303Q1 8/1/2015 1.000 1200.00 0.00 624 G12345 C9899Q0 8/1/2015 1.000 1.00 1.00 (3) Value Code D4 and (4) 8-digit NCT identifier number in Box 39 (5) Value Code FD when certain IDEs are provided free of charge (6) Revenue Code 624 with token charge (e.g. 1.00) in Box 42 (7) IDE number assigned by the FDA in Box 43 (8) Modifier Q1 or Q0 in Box 44 MEDICARE 92920 = PCI 00562 = Anesthesia 93000 = Transthoracic Echocardiography C9899 = Investigational Device Z006 (9) ICD-10 code Z00.6 in the secondary position in Box 66 (ICD-9 code V70.7 for claims prior to 10/1/2015) NGS has an LCD (L27360) for the TTE. Review to determine if primary diagnosis code for trial participant supports coverage by Medicare. 34 17

Heart Device Case Study CMS Form 1500 Clinical Trial Identifiers (1) 8-digit NCT identifier number in Box 19 with CT attached. Electronic version 837P does not require CT (2) ICD-10 code Z00.6 in the secondary position in Box 21 (ICD-9 code V70.7 for claims prior to 10/1/2015) NGS has an LCD (L27360) for the TTE. Review to determine if primary diagnosis code for trial participant supports coverage by Medicare. CT23456789 Z00 6 (3) Modifier Q1 or Q0 in Box 24.D 08 01 15 08 01 15 93303 Q1 2 1200 00 1 93303 = Transthoracic Echocardiography 35 Clinical Research Billing Auditing 18

Clinical Research Billing Audits Initial Steps Clinical research billing audits can vary in scope and scale. Before beginning any research billing audit, auditors may want to review policies and procedures related to clinical research billing in order to understand the processes in place at your organization and, if necessary, meet with key individuals who are integral to clinical research billing processes. Policies and Procedures should include, but is not limited to, the following key elements: Determination of a Qualifying Clinical Trial; Conducting a Coverage Analysis; Appropriate language in the cost section of the Informed Consent Form; Clinical Trial Patient Registration- Identification of potential clinical trial patients at the time of consent and at time of enrollment/disenrollment; Tracking and monitoring or clinical trial participants and related patient care items and services; Identification and segregation of routine and research-sponsored patient care items or services; Coding and billing for claims submitted associated with clinical trial participation, including patients enrolled in Medicare Advantage Plans; and Auditing and monitoring of claims submitted for charges related to clinical trial participation. 37 Clinical Research Billing Audits Understanding the Processes Clinical Research Process Revenue Cycle Process Scientific, COI, Feasibility, and IRB Review Patient Identification Registration & Admission Charge Segregation Coding Claim Processing & Invoicing Sign CDA Protocol Review/ Decision to Proceed Initiate Regulatory, Financial, and Legal Review CA and Budget Development Study Initiation Consent and Enroll Patients Visit and Milestone Tracking Sponsor Invoicing Study Close-Out Legal/ Contracting Coverage analysis development and budgeting and contracting are key components of the clinical research billing process. CAs and budgets are important tools that allow research billing reviewers to correctly process claims. When patients are consented and enrolled they are identified in the financial system as research subjects to allow for a detailed review of claims. Charge segregation, coding, processing of claims, and invoicing the sponsor are billing processes that take place as patients take part in the study. As the study team completes final reports for the sponsor, accounts are balanced and closed in the financial system. 38 19

Clinical Research Billing Audits Initial Steps Once auditors are familiar with the processes and procedures in place, they should consider the scope of the audit they wish to perform, which can be determined by how many different areas of the clinical research billing process an auditor wishes to review. Reviews can be targeted, examining only one or two areas of the research billing process; or Reviews can be broad and examine most or all areas of the research billing process. 2015 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 39 Clinical Research Billing Audits Targeted Audits A targeted research billing audit typically focuses on a small portion of the broader research billing process. Should a targeted audit reveal any concerns, the scope of such an audit can be broadened based upon the findings. One example of a targeted audit is a review of Coverage Analyses ( CA ). A CA review can include: Comparing items and services listed in the CA to those that are listed in the protocol; Ensuring that the schedule of events in the protocol matches the timeline in the CA; Examining national and local coverage determinations for items and services in the CA to see if they support the billing designations in the CA; and Confirming that CPT/HCPCS codes are included in the CA for all items and services and that they accurately reflect the services described. Should a review of CAs for a certain study team, disease area, or sponsor have findings that are considered material, the targeted audit could be expanded into a more comprehensive research billing audit in those targeted areas. 40 20

Clinical Research Billing Audits Targeted Audits 41 Clinical Research Billing Audits Broad Audits A broader research billing audit could examine most, if not all, areas that are integral to the research revenue cycle at an institution. A clinical research revenue cycle assessment is one example of a broader audit, in which an assessment could be performed of the numerous upstream processes from patient consent through claim submissions to identify the root causes for incorrect claim submissions. Interviews could be conducted with staff who are integral to the research revenue cycle process, including the following key areas: Study Teams, Research Finance, Patient Financial Services, and Patient Registration. A detailed claim review includes selecting a sample of claims associated with clinical trial participants. The sample can be tailored to select claims that reflect higher risk for error, claims specific to a payer class, or claims submitted within a specific time frame. Selected claims can then be reviewed using the CA and other protocol related documents to assess which items and services are billable, and thus should have been on the claim, and which items and services are not billable, and thus should not have been on the claim. 42 21

Clinical Research Billing Audits Broad Audits Example scope of audit: During the assessment of the sample, the following aspects of each claim will be reviewed to determine: If the dates of service for the claim correspond to clinical trial visits; If the services listed on the claim for a clinical trial visit accurately reflect designations listed in CA and/or budget; If there are services on the claim which should have been removed prior to billing; If there are services on the claim unrelated to the clinical trial visit; If the claim shows the correct use of Diagnosis Code Z00.6/V70.7, Condition Code 30, and the Q0/Q1 modifiers; and If the clinical trial number is included on claims filed with Medicare. 43 Clinical Research Billing Audits Final Thoughts Research billing audits, both targeted and broader in scope, represent a selective inquiry into a complicated process that depends on many different departments, personnel, and processes functioning correctly. Beginning with a targeted audit in an area deemed to be more vulnerable can allow an auditor to gauge the levels and areas of risk, and where to turn their focus if necessary. Broader audits allow a more global picture of the research billing process at an institution, and can give auditors insight into what areas of the process may introduce more risk at their institution. Questions? 44 22

Appendix Resources JK: The Qualifying Clinical Trial- Medicare Billing Guidelines, July 2014 http://www.ngsmedicare.com, Select Jurisdiction K Part A, Training Events Calendar, Attachments for this Event National Government Service Part A Article for Investigational Device Exemption Requests - Medical Policy Article (A45910) http://www.ngsmedicare.com Mandatory Reporting of Clinical Trial Identifier Numbers on Medicare Claims-Qs & As http://www.cms.gov/medicare/coverage/coverage-with-evidence- Development/Downloads/Mandatory-Clinical-Trial-Identifier-Number-QsAs.pdf Claims Processing Manual 104, Chapter 32, Section 67-69: No Cost Claims, Investigational Device Exemption, Qualifying Clinical Trials https://www.cms.gov/manuals/downloads/clm104c32.pdf 46 23

Resources CMS Transmittal on New HCPCS Modifiers When Billing for Patient Care in Clinical Research Studies https://www.cms.gov/transmittals/downloads/r1418cp.pdf CMS Guidance is found in the Benefit Policy Manual (BPM) Chapter 14: Medical Devices www.cms.gov/manuals/downloads/bp102c14.pdf 42 CFR 405.209 Payment for a Non-Experimental/Investigational (Category B) Device http://edocket.access.gpo.gov/cfr_2002/octqtr/42cfr405.209.htm Clinical trials website: http://www.clinicaltrials.gov List of devices in which Value Code FD is required when device is provided at no cost http://www.cms.gov/medicare/medicare-fee-for-service- Payment/HospitalOutpatientPPS/index.html 47 Billing and Coding Definitions for the Non-Biller ICD-10-CM Diagnosis Code - The International Classification of Diseases, Tenth Revision, Clinical Modification that is currently used to report diagnostic information on claims. ICD-10- CM (tenth version) replaced ICD-9-CM this October CPT/HCPCS Code - Codes that represent procedures, products, or services that may be provided to Medicare beneficiaries and to individuals enrolled in private health insurance programs 48 24

Billing and Coding Definitions for the Non-Biller Modifier - Provides the means by which the reporting physician or provider can indicate that a service or procedure performed has been altered or modified by a specific circumstance, but not changed in its definition or code Only reported on outpatient or physician claims Proper use of modifiers is essential for submitting correct claims Certain modifiers are used by Medicare and other third party payers for payment purposes, whereas others are used for reporting and data collection purposes only Q0 and Q1 are examples of modifiers used by Medicare only for data collection purposes and at this time do not result in payment decisions o Q0 Modifier Investigational item/service, e.g. Investigational drug J9999Q0 o Q1 Modifier Routine item/service, e.g. Physical Exam 99215Q1 49 Billing and Coding Definitions for the Non-Biller Revenue Code - A four digit code that is submitted by institutional providers and represents a specific location or type of service provided Payer billing requirements for revenue codes may vary Example: Medicare accepts revenue code 0624 for IDEs, but many other payers allow for this to be billed using revenue code 0278, Other Implants Condition Code - Code reported in UB-04 fields 18-28 to describe any conditions or events that apply to the billing period, e.g. Condition Code 30, Qualifying Clinical Trial Value Code - A two digit or alphanumeric code that is reported in UB-04 fields 39-41 and is used to report additional information that applies to the billing period D4 is reported when the clinical trial number assigned by the National Library of Medicine (NLM)/National Institutes of Health (NIH) is reported on the claim. Refer to other third party payer-specific policies for reporting requirements FD is reported by institutional providers to indicate the cost reduction or cost of certain devices provided free of charge 50 25

Billing and Coding Definitions for the Non-Biller Charge Description Master (CDM) - a comprehensive listing of items billable to a hospital patient or a patient's health insurance provider CDM includes, but is not limited to, the following items: CPT/HCPCS Code, Revenue Code, and price CDM may include certain modifiers (e.g. Q0 associated with an IDE) Certain institutions have a Research CDM specific to procedures, products, or services provided to clinical trial participants 51 Billing and Coding Definitions for the Non-Biller Charge Description Master (CDM) - a comprehensive listing of items billable to a hospital patient or a patient's health insurance provider. CDM includes, but is not limited to, the following items: CPT/HCPCS Code, Revenue Code, and price CDM may include certain modifiers (e.g. Q0 associated with an IDE) Certain institutions have a Research CDM specific to procedures, products, or services provided to clinical trial participants 52 26

Research Basics for Non-Research Professionals Food & Drug Administration (FDA) Clinical Investigation Agency of the United States Department of Health and Human Services Responsible for protecting and promoting public health through the regulation and supervision of food, drug, and insecticides. In relation to clinical trials, the FDA ensures the adherence to the principles of Good Clinical Practice and adequate human subject protection. FDA has defined clinical investigation to be synonymous with research Clinical investigation - any experiment that involves a test article and one or more human subjects and that either must meet the requirements for prior submission to the FDA or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. 53 Research Basics for Non-Research Professionals Regulatory Terms Test article - any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act. Human subject - an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient. Office for Human Research Protections (OHRP) Provides leadership in the protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services. Helps ensure this by providing: Clarification and guidance Developing education programs and materials Maintaining regulatory oversight Providing advice on ethical and regulatory issues in biomedical and social-behavioral research 54 27

Research Basics for Non-Research Professionals Investigational Site Institutional Review Board (IRB) The clinical research site is the actual location where the patients participating in the study are seen Examples of research sites: Academic Medical Centers Hospitals Private Physician Practices Dedicated Research Facilities An independent committee established to review and approve research involving human subjects Primary purpose is to protect the rights and welfare of the human subjects Ensures that potential research-related risks are minimized and that there is full disclosure so that volunteers can make an informed decision about whether or not to participate Can be local or central 55 Research Basics for Non-Research Professionals Principal Investigator (PI) Sub-Investigator (Sub-I or Co-I) Responsible for personally conducting or supervising the conduct of humansubjects research and for protecting the rights, safety, and welfare of the subjects enrolled in the research. The PI must ensure that all humansubjects research is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations and institutional policies and requirements. Work closely with the PI to help conduct patient screening, treatment visits, data collection, and other necessary processes throughout the duration of a trial. 56 28

Research Basics for Non-Research Professionals Study Coordinator Study Subject or Participant The clinical research coordinator is responsible for conducting the clinical trial under the supervision of the PI. Examples of a coordinator s responsibilities include submitting regulatory documents, scheduling patient visits, managing patient recruitment, and coordinating monitoring visits. Patient enrolled in a clinical trial who volunteers to receive an investigational treatment. Participant can be diagnosed with a disease or a healthy volunteer. Participant must sign an informed consent (ICF) to participate. Participant must meet protocol inclusion/exclusion criteria to enroll. 57 Research Basics for Non-Research Professionals Sponsor Contract Research Organization (CRO) The organization that initiates a clinical trial. Ultimately responsible for management of the entire trial including: Selecting qualified investigators Ensuring proper monitoring of the trial Ensuring that the trial is conducted in accordance with the protocol Ensuring that the FDA and all participating investigators are informed of any significant new risks with respect to the study drug/device Types Pharmaceutical, biotechnology, or medical device companies Governmental agencies (ex: NIH) Health care institutions such as AMCs Individual researchers An organization contracted by the sponsor to assume various aspects of the clinical research process. CROs employ various clinical research associates (CRA), biostatisticians, medical writers, project managers, and similar clinical research professionals to support the conduct of clinical trials. 58 29