September 20, Kelly Willenberg, MBA, BSN, CHC, CHRC. Kelly Willenberg, LLC

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1 September 20, 2012 Kelly Willenberg, MBA, BSN, CHC, CHRC 1 1

2 Understand the importance of research billing compliance and how that impacts the hospital and your practice Understand how billing can advance or hinder clinical trial participation 2 2 2

3 Errors in billing Medicare for items or services relative to clinical trials could result in allegations under the False Claims Act ( FCA ) Many health care and research fraud cases are brought under the FCA Public Settlements University of Alabama settlement for $3.4 million, 2005 Weill Cornell Medical Center settlement for $4.3 million, 2005 Rush University Medical Center settlement for $1 million, 2005 Tenet Healthcare System, Norris Cancer Center for $1.9 million, 2010 Medicare can audit an institution at any time and measures risk of fraud and abuse by a provider s reporting of procedures and diagnosis codes on a claim 3

4 Coordinate and communicate study information Promote transparency in study documents Document a Process for billing in clinical trials 4 4

5 Billing for services that are already paid by the sponsor Billing for services promised free in the informed consent Billing for services that are for research-purposes only Billing for services that are part of a non-qualifying clinical trial Billing Medicare Advantage Plans (Part C) when claims should be directed to the Medicare Administrative Contractor 5 5

6 Information that must be coordinated to minimize compliance risks is traditionally in silos What is billable and not billable Who is enrolled in a research study Which services are required by the protocol Within academic medical setting, many different functions interact with research study and develop study documents that have important information for billing: University/Campus Schools of Medicine Medical Center Physician Offices CROs 6 6

7 Principal Investigator Clinical Research Coordinator IRB process Budget negotiators Clinical Trial Agreement negotiators Grant administration Information Technology Health Information Management Registration/Scheduling Medical center billing and coding Physician professional fee billing and coding Study fund managers Managed care contract negotiators.and others! 7

8 FMV and Contracts with all Referral Bases Charge Capture, Segregation, Research Pricing Billing Compliance Budget, Contract, Consent, Coverage Analysis Human Subject Protection Transparent Documents and Congruency Audit 8

9 Potential financial risk Regulatory problems Institutional Values lost Cultural priorities and fear of change Exposure 9

10 Payback, penalties or fines Audits from other federal agencies Accreditation status jeopardized Loss of Federal Grants Loss of Key Thought Leaders Bad Press and Public Relations 10

11 Develop database of approved research studies Identify status of research studies No enrollment Closed to enrollment, but subjects receiving services Open to enrollment and subjects receiving services Long-term follow-up only Prioritize which studies to develop MCAs Consider two parallel tracks: 1. All proposed studies get MCA for budgeting accurately 2. Begin active studies with those with subjects receiving services 11

12 Develop a database of subjects/patients Identify patients not in long-term follow-up Flag patient accounts for review against an MCA Begin reviewing patient accounts against MCA Delineate clear roles and responsibilities of all parties 12

13 Clinical research billing rules rely on multiple study documents to determine what is billable to patient or insurance Study document language should be in harmony, but documents are often developed for different reasons and by different individuals and units If the billing process is contemplated early, then there is a better chance for clear and consistent study documents Coverage Analysis is the way to achieve transparency and compliance with Medicare s clinical trial policy 13

14 Interpreting the ICF ICF interpreted for MCA from the perspective of the patient Plain meaning of the words used in the informed consent Promises made to research patients should be kept If lines could contradict each other, then tried to reconcile the lines 14

15 Potential Benefits: Therapeutic Intent In order to meet therapeutic intent criterion, ICF must state some theory of how the study services could help the patient ICF need not promise benefit but it should state a possible benefit If ICF states that patient will not benefit from participating in the research study, then ICF could be used to show lack of therapeutic intent 15

16 Added Costs Section Regulation: 45 CFR (b)(3): Any additional costs to the subject that may result from participation in the research If the added costs section of the informed consent form states that an item or service will not be charged to the patient, then the MCA identifies the service as not billable 16

17 Examples of language You or your health plan must provide payment for hospital, clinic, and other medical costs that are considered routine care for patients with your disease. The sponsor of the study will provide the study drugs at no cost to you. Medical testing done for the purposes of the study will also be provided to you at no charge. 17

18 Patients enrolled in a research study receive core services according to the protocol s schedule of events The protocol is a road map Up side: each study can follow a consistent tool Down side: billing errors replicate easily Study documents may not be written with billing in mind and can create systemic issues Example: A diagnostic test may be characterized in an investigator-initiated Protocol as being performed for research and regulator may consider that to mean data collection only and the service not billable 18

19 Most clinical trial billing rules in the United States are generally shaped by the Medicare Program s Clinical Trial Policy and Medicare s device trial coverage regulations UC Davis billing rules for clinical research are set according to Medicare standards While Medicare has complicated rules, there is logic to them and generally allows billing for medically necessary services as long as all subjects in a study billed the same way Medicare normally is billed 19

20 Medicare requires that it not be billed for a trial related service if any enrollee or enrollee s insurer would not be billed for the service Example: If a CXR at 6 weeks is not billed to commercial insurance patient, then it cannot be billed to Medicare Utilize Medicare clinical research billing rules as a baseline for budget negotiations and for billing Use pre authorization process for commercial and group health plans as additional way to put payors on notice 20

21 What is a Medicare Coverage Analysis? 21 21

22 Follows Medicare Coverage principles to comply with the National Coverage Decision and Clinical Trials Policy Acts as a way to manage, coordinate and communicate study information Acts as a translation tool to brings the world of a research study into the world of billing Acts as a way to communicate study information but it s not the end of the story as a Coverage Analysis is fluid Systematic review of research related documents to determine the Medicare billing status of both the study itself and the items and services provided to the research subjects that are outlined in the documents. 22

23 2012 Kelly Willenberg, Hypothetical MCA: Manage the information LLC Code Infusion 1 Infusion 2 2 weeks 12 weeks 24 weeks Comment Physical Exam EKG M M M Drug 123 J0123 S S Infusion M M Urinalysis NB NB Ultrasound ICF M M M M Patient Diary N/A NB NB NB NB M=Medicare S=Sponsor ICF=Free in Informed Consent NB=Not billable to Medicare 23

24 Is it a Qualifying Trial? The first step in the CA process is determining if a clinical trial qualifies for Medicare coverage Medicare has explicit language in their national clinical trial policy that lists the requirements for qualification Determining if the trial qualifies for Medicare coverage is the foundation for complying with the National Clinical Trial Policy and the first step towards billing compliance If answer is yes List the schedule of events in a Grid Perform Coverage Analysis Put appropriate codes and modifiers on bills being sent to government payors 24

25 A Clinical Trial Agreement (CTA) is a contract between the Study Sponsor and the Institution for the conduct of the research. CTAs list the types of support provided by the sponsor: Items and services that will be paid by the Sponsor Items and services that will be provided by the Sponsor Payment schedule Indemnity Payment for subject injury 25 25

26 Cause of most research billing non-compliance: Breakdown in coordination What are some historical things that might come into play? History of institution Culture Existing structure Size and availability of resources Scope of the research program and scalability of it Important information to coordinate What research studies are being conducted at a facility? Which patients are enrolled in a research study? Which services should be charged to payors and which charged to study account? 26

27 Ensure compliance with Federal, state, and local regulations by using the Coverage Analysis as a standard approach to all payers Develop the Coverage Analysis as a tool to ensure compliant claims processing and minimize patient billing errors Minimize denials and/or claims processing errors by including a marker to identify charges that require the V70.7 diagnosis, modifiers, or condition codes Identify the claims to be split before billing by flagging Medicare HMO (Advantage) patients who are enrolled in research studies Identify the charges to be submitted to the study sponsor in the detailed billing grid with charge codes 27

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29 Centers for Medicare & Medicaid Services, "Medicare Coverage ~ Clinical Trials" Questions and Answers, Medicare coverage of clinical trials National Comprehensive Cancer Network American College of Cardiology American College of Nuclear Medicine Medicare Claims Processing manual ch. 32, 68 and 69 National Guideline Clearinghouse American College of Radiology National Cancer Institute Lab Tests Online Clinical Trials. Gov American Academy of Professional Coders American Society of Clinical Oncology American Heart Association MedlinePlus Health RxList The Internet Drug Index 29

30 Kelly Willenberg