Clinical Research Billing Compliance

Transcription

1 Clinical Research Billing Compliance Julie Colasacco & Michael C. Roach Presented at Virginia Commonwealth University August 29, N Ravenswood Ave, Ste.200 Chicago, IL www. aegis- compliance. com 1

2 Overview Current Regulatory Environment Coverage Analysis Medicare Billing Rules Clinical Trial Agreements Protocol Design to Improve Billing & Budgets Informed Consent Language Your role in this process 2013 Aegis Compliance & Ethics Center, LLP 2

3 Current Research Regulatory Environment Cases of improper clinical trials billing Tenet Healthcare (Norris Cancer Ctr) Northwestern University Rush University Million Dollars Mayo Clinic Yale $0.0 $1.0 $2.0 $3.0 $4.0 $5.0 $6.0 $7.0 $8.0 3

4 Important Terms & Acronyms Clinical Research Billing CRB Medicare Clinical Trial Policy CTP Qualifying Clinical Trial QCT 4 4

5 Risks Associated With Non-Compliance CRB risks can be grouped: 1. Billing for services that are already paid by the sponsor (double billing) 2. Billing for services promised free in the informed consent 3. Billing for services that are for research-purposes only 4. Billing for services that are part of a non-qualifying clinical trial 5. Billing Medicare Advantage Plan when claim should be directed to Medicare Administrative Contractor ( MAC ) 5 5

6 Challenges Cause of most research billing non-compliance: Breakdown in coordination Important information to coordinate What research studies are being conducted at the facility? Which patients are enrolled in a research study? Which services should be charged to payors and which charged to study account? Sponsor, grant, internal account Informed consent form language Clinical trial agreement language Protocol language 6

7 Coordination Who impacts research billing? 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 A note on the medical record Section 69.3 of Ch. 32 also contains the following: The billing provider must include in the beneficiary's medical record the following information: trial name, sponsor, and sponsor-assigned protocol number. This information does not need to be submitted with the claim but must be provided if requested for medical review. 8

9 The importance of a Coverage Analysis (CA) for compliance 4147 N Ravenswood Ave, Ste.200 Chicago, IL www. aegis- compliance. com 9

10 What is a Coverage Analysis? 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 required by the study A tool to coordinate information for purposes of: Budgeting Billing Auditing 10

11 Physical Exam Hypothetical CA: a way to coordinate information Code Infusion 1 Infusion 2 EKG RC RC RC Drug 123 J0123 SB SB Infusion RC RC Urinalysis NB NB Ultrasound ICF 2 weeks 12 weeks 24 weeks Comment RC RC RC RC Patient Diary N/A NB NB NB NB RC=Routine Care SB=Sponsor Bill ICF=Free in Informed Consent NB=Not billable to Medicare 2013 Aegis Compliance & Ethics Center, LLP 11

12 An overview of Medicare rules for billing during clinical research studies 4147 N Ravenswood Ave, Ste.200 Chicago, IL www. aegis- compliance. com 12

13 True or False? We have billed for this service hundreds of times and the claim is always paid by Medicare, so it must be covered. False: You cannot assume that just because Medicare has been paying for a service that it is a covered service 13

14 True or False? Medicare pays for standard of care during research studies. False: Medicare pays for routine costs during qualifying clinical trials 14

15 True or False? My friend in California says this service is covered when she provides it, so it s covered for us, too. Maybe: Medicare Administrative Contractors ( MACs ) can issue local coverage determinations ( LCDs ) that limit coverage in their area. If your friend has a different MAC, you may not be able to bill a service that she can. Possible for your friend to have a different MAC even if she works at a facility down the street from you 15

16 True or False? You are making clinical decisions when you decide something is not billable to Medicare. False. Decisions about whether a service is covered is not a clinical decision. It is a decision based on an analysis of the billing rules and coverage determinations made by CMS and Medical Directors at MACs. 16

17 Medicare s CRB Framework Medicare requires a five-part process for clinical research services coverage: 1. Does the study qualify for coverage? 2. What items and services are routine costs? 3. Do Medicare rules allow coverage of specific routine costs within a research study? 4. What is paid for by the sponsor? 5. What is promised free in the informed consent? 17

18 The Hierarchy of Medicare Rules The Statute National CMS National Coverage Determinations ( NCDs ) Manuals (e.g., Medicare Benefit Policy Manual, Medicare Claims Processing Manual) Local - MACs Local Coverage Determinations ( LCDs ) Medical Director articles Medical Director rulings Reasonable & Necessary Rule Document medical necessity when no coverage rule 18

19 How the budget structure influences what can be billed to insurance 4147 N Ravenswood Ave, Ste.200 Chicago, IL www. aegis- compliance. com 19

20 Why is the CTA important for the research billing process? Services for which sponsor is obligated to pay for in the CTA cannot be billed to the subject or the subjects insurance If the CTA is not clear on what is being paid for by the sponsor, the document may be misinterpreted both by the sponsor and by regulators in the event of an audit The information in the CTA on what the sponsor is paying for must be communicated to the billing process Institutions may suffer unintended consequences based on what is written in the CTA 20

21 Non industry contracts The concepts in this presentation apply equally to contracts for funding support with non-industry sponsors Most CRB compliance risks can occur without respect to whether the sponsor is industry, government, or a private foundation Negotiators of government contracts should coordinate with the individuals who negotiate the budget and be cognizant of their impact on the CRB process Offices within organizations that deal with government contracts should be brought into the CRB process training 21

22 What and where is the study budget? The study budget for industry-sponsored studies is typically an appendix or exhibit to the CTA and serves as the compensation detail The study budget and the main body of the contract are part of the same document they will be interpreted together 22

23 Operational issues that could impact the CRB process Many clinical trial agreements have been negotiated in parts One person negotiates the main body Another person negotiates the budget /compensation Protocol is incorporated but may not be reviewed carefully by either person, particularly if there is no formal MCA process in place Fundamental principle of Clinical Trial Agreements Singularity: A CTA is one contract with many parts Interpreted as a single legal document 23

24 Bringing a CRB perspective early to CTA Best practice CRB processes analyze both the main body of the CTA and the study budget exhibit from a billing perspective Goal: Clarity in the final documents If sponsor is paying for all services, then the CTA and study budget should be clear and that should be reflected in a Medicare Coverage Analysis (MCA) or other communication tool to inform the CRB process If sponsor is only paying for some of the protocol services, then the study budget should be clear as to which services are being paid for so there is no confusion in developing the MCA Ambiguities in the CTA and study budget will usually be interpreted by insurers to their benefit (i.e., no billing) 24

25 Structure of Financial Provisions: Compensation Exhibit/ Study Budget There is no standard approach to the Compensation Exhibit each sponsor tends to have its own format Some structures utilized: Payments for research service at milestones Note: Is research service defined? Be clear which services are considered research services Spreadsheet with payments based on schedule of events Note: Best practice 25

26 Structure of Financial Provisions: Compensation Exhibit/ Study Budget Consider adopting a consistent approach for the compensation exhibits: the more detail on which services are being paid for, the better Be aware of conditional payment language The MCA can serve as a tool for budgeting and lends itself to be used as the compensation exhibit Negotiating Suggestion: Watch out for footnotes! Avoid footnotes in the study budget, if possible 26

27 Tips on protocol design for investigator-initiated studies to improve budgeting and billing 4147 N Ravenswood Ave, Ste.200 Chicago, IL www. aegis- compliance. com 2013 Aegis Compliance & Ethics Center, LLP 27

28 The design of the study impacts billing 3 Items to think about in protocols: 1. Loose use of the term research If the service is being used for research purposed and clinical care, then discuss the clinical care When a protocol only talks about the research aspects of a service, an auditor could ignore the clinical usefulness of the services 28

29 The design of the study impacts billing 3 Items to think about in protocols: 2. Stating a potential benefit If protocol or informed consent form states that the subject will receive no benefit from the study, then no services will be billable Describe in the protocol and the informed consent any potential benefit (though do not guarantee benefit) 29

30 The design of the study impacts billing 3 Items to think about in protocols: 3. What are the objectives in a Phase 1 study? Is it necessary in the study to state principal and secondary objectives of the study? Or can all objectives be stated without rank? Some Medicare Contractors and auditors have denied coverage to Phase 1 studies when measurement of therapeutic outcome is not a primary objective or a clearly articulated objective 30

31 How the language of the Informed Consent Form influences what can be billed to insurance 4147 N Ravenswood Ave, Ste.200 Chicago, IL www. aegis- compliance. com 2013 Aegis Compliance & Ethics Center, LLP 31

32 Role of informed consent form Interpreting the ICF ICF interpreted for MCA from the perspective of the subject Plain meaning of the words used in the informed consent Promises made to subject regarding what is free must be kept If two sentences in Costs section could reasonably be interpreted in a way that they contradict each other, then re-word 2013 Aegis Compliance & Ethics Center, LLP 32

33 Research Informed Consent: Context OHRP & FDA Rules: 45 CFR & 21 CFR 50.20: The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. Goal: Language in 6 th to 8 th grade reading level Government reviews and audits of ICF: Interpreted from the perspective of the subject The ICF means what it says: assumes plain meaning of the terms 2013 Aegis Compliance & Ethics Center, LLP 33

34 IFC and Added Costs Section Regulation: 45 CFR (b)(3) & 21 CFR 50.25(b)(3) require the ICF include, when appropriate, 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 provider cannot bill for that service Note: The regulation does not require that the ICF list the services that are or are not charged, rather it requires the ICF to list the additional costs the patient will incur as a result of participating in the study (many routine costs are not costs resulting from participation) 2013 Aegis Compliance & Ethics Center, LLP 34

35 Problematic Added Costs Language You or your insurer will have no costs for participating in this research study. (Subject/insurer may not be billed for any protocol-required items or services, nor for complications/injuries or other costs associated with participation) Your routine medical care will be billed in the usual way. However, you will not be charged for any [research] [study] visits or services. (Inconsistent terms within the same document) You will be responsible for the costs of any services you would have received if you did not enroll in this research study. However, you will not be billed for any lab services or imaging services. (Inconsistent terms within the same document) 2013 Aegis Compliance & Ethics Center, LLP 35

36 Added Costs Section Contemplating the CRB Process Language which keeps the ICF neutral : You will be responsible for the costs of services required by the research study that are routine to treat your condition. You will not be responsible for the costs of services that are required only because you are enrolled in the research study. Language which specifically identifies services that will not be billed (if IRB desires specifics) You will be responsible for costs for care you would have received if you were not enrolled in this research. However, you will not be responsible for the costs of the CT scan conducted at the start of each drug cycle Aegis Compliance & Ethics Center, LLP 36

37 Questions? 4147 N Ravenswood Ave, Ste.200 Chicago, IL www. aegis- compliance. com 37