1. Overview September 2014

2. Budget & Contract ICF Coverage Analysis ProtocolUB’s Sponsors Invoicing Physician office Payer Issues © 2014 Kelly Willenberg, LLC

3. Sponsor CRO Investigator(s) FDA Ancillary IRB/EC PFS HIM Registration © 2014 Kelly Willenberg, LLC Pharmacy Research Admin Research Admin

4. © 2014 Kelly Willenberg, LLC FCA Violations Double Dipping Payments from sponsors and from 3 rd party payers for same item/service Inducement Investigator incentives may entice stacking of patients in studies Kickback Residual research account balances 1 1 2 2 3 3 4 4

5. © 2014 Kelly Willenberg, LLC Physicians/Investigators Are conducting Clinical Trials independent of Hospitals Reasons: Independence Lack confidence in Hospital’s ability Control of grants/study funds Circumvent hospital bureaucracy Decrease paperwork conducting Clinical Trials independent of Hospitals Hospitals Research financial compliance programs may not be operationally effective and/or efficient Causes: Ownership & Accountability Policies and Procedures Centralization Resources Physicians trust lacking Management of grant/study funds research billing compliance Programs may not be operationally effective and/or efficient External Parties Are approaching the investigator directly Goals: The PI knows sooner Immediate results Decrease paperwork Decrease costs Maintain control Reduce accountability and scrutiny Circumvent the hospital approaching the investigator directly

6.  Investigators will use the IRB submission as the protocol ◦ Calendar of events “loose” which makes budgeting a challenge, coverage analysis impossible  Assume that everything in the protocol is conventional care or “standard of care” and therefore billable  Confusion about drug supplies ◦ In IIT trials the drugs are sometimes not billable and reimbursable  Collaborating with team to decide on budget © 2014 Kelly Willenberg, LLC

7.  Read the protocol and review the proposed budget sent by the sponsor  Determine if the trial is qualified under Medicare guidelines  Decide what are considered patient services that are standard of care and what are research patients services  Do a Coverage Analysis September 2014

8.  Perform Qualifying Clinical Trial (QCT) Analysis  Develop grid to match schedule of events  Identify items or services “hard-wired” free into protocol  Determine items and services that are routine costs  Determine if routine costs are covered by Medicare © 2014 Kelly Willenberg, LLC

9.  Check proposed contract to determine if offered budget covers items and services that are not billable  Negotiate contract/budget against the Coverage Analysis  Finalize necessary sections of informed consent  Finalize and lock grid once study approved to be used as translation tool for billing and reimbursement. © 2014 Kelly Willenberg, LLC

11.  Clinical Trials Policy – CMS Policy (July 2007) that provides guidance regarding Medicare beneficiaries participating in Clinical Trials and routine costs http://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/index.html http://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/index.html  Routine Costs: items and services that are provided to the patient even if s/he was NOT in a clinical trial, conventional care  Routine Costs are defined, specified and documented in the Trial documents prior to the beginning of the Trial: a thorough coverage analysis September 2014

12.  A Coverage Analysis will determine whether any procedures may be billed to Medicare (and by extension to other insurance companies)  This presentation does not cover MCA’s but demonstrates why doing an MCA important when completing a budget  This is the first step to doing a proper budget © 2014 Kelly Willenberg, LLC

13.  Is the study “qualifying” under the guidelines?  What are the “routine” costs?  Which of the above are covered by Medicare?  How is the costs worded in the contract and consent? © 2014 Kelly Willenberg, LLC

14. 14 Billing for services not rendered Billing for services that are already paid by the sponsor or promised free in the informed consent Billing for services that are for research-purposes only or are part of a non-qualifying clinical trial Billing Medicare for device trials without MAC approval letter in hand Bill Medicare Advantage Plans (Part C) when claims should be directed to the Medicare Administrative Contractor ©Kelly Willenberg, LLC 2014

15. 15 Billing for items or services not supported by required documentation A proper, signed order Adequate documentation of medical necessity for the item or service Documentation of study participation, as required Billing without proper codes, modifiers or NCT # Waiving/paying/reimbursing subject co-pay or deductible obligations ©Kelly Willenberg, LLC 2014

16. © 2013 Kelly Willenberg, LLC 16

17.  The 8-digit clinical trial number must be reported on all claims (Medicare beneficiaries, Traditional and Managed Care) associated with clinical trial participation National Clinical Trial (NCT) number NCT12345678 Also known as the Clinicaltrials.gov Identifier  Effective Date: Services on/after January 1, 2014 Voluntarily reported since January 2008  Claim types: Both hospital/technical and professional September 2014

18.  CMS will use this number to identify all items and services provided to Medicare beneficiaries (Traditional and Managed Care) during their participation in a Medicare qualifying clinical trial, study, or registry  Permits CMS to: Better track payments Ensure that the information gained from the research is used to inform coverage decisions Make certain that the research focuses on issues of importance to the Medicare population September 2014

19. Clinical Trials.gov NCT Number http://ClinicalTrials.gov http://ClinicalTrials.gov website NCT Number http://ClinicalTrials.gov

20.  ICD-9-CM Diagnosis Code V70.7 (Examination of a participant in a clinical trial); ICD-10 coming 2015  Revenue Code 0624 for FDA Investigational Devices, as applicable  Condition Code 30  Q0 and Q1 modifiers, as applicable (outpatient claims only)  NCT number  Report in UB-04 Form Locators 39-41 September 2014

21.  ICD-9-CM Diagnosis Code V70.7 (Examination of a participant in a clinical trial); ICD-10 coming in 2015  Revenue Code 0624 for FDA Investigational Devices, as applicable  Q0 and Q1 modifiers, as applicable (outpatient claims only)  NCT number  Report in CMS-1500 Field 19 September 2014

22. If some, but not all of the required elements (NCT #, ICD-9 code, modifiers, revenue codes, condition codes) are reported, the claim will be stopped and returned to the provider (RTP) Possible RTP statements: “Claim lacks information which is needed for adjudication …..” “Missing/incomplete/invalid Investigational Device Exemption number for FDA-approved clinical trial services” “Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable ….” September 2014

23. Kelly Willenberg, MBA, BSN, CHRC, CHC kelly@kellywillenberg.com www.kellywillenberg.com 864-473-7209 © 2014 Kelly Willenberg, LLC