Pamela Richtmyer MGH Research Compliance

Transcription

1 Pamela Richtmyer MGH Research Compliance 1

2 ICH E6 Financial References Remuneration and Reimbursement Research Billing Best Practices 2

3 ICH Guideline for Good Clinical Practice: Consolidated Guidance (E6) Section 4: Investigator 4.8: Informed Consent of Trial Subjects 4.9: Records and Reports Section 5: Sponsor 5.8: Compensation to Subjects and Investigators 5.9: Financing Section 6: Clinical Trial Protocol and Protocol Amendments 6.14: Financing and Insurance 3

4 Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following: (j) The compensation and/or treatment available to the subject in the event of trial-related injury. (k) The anticipated prorated payment, if any, to the subject for participating in the trial. (l) The anticipated expenses, if any, to the subject for participating in the trial. 4

5 4.9.6: The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution. 5

6 5.8.1 If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence The sponsor's policies and procedures should address the costs of treatment of trial subjects in the event of trial-related injuries in accordance with the applicable regulatory requirement(s) When trial subjects receive compensation, the method and manner of compensation should comply with applicable regulatory requirement(s). 6

7 The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution. 7

8 6.14 Financing and insurance if not addressed in a separate agreement. 8

9 Remuneration and Reimbursement 9

10 Partners policy definition: Cash or cash equivalents (e.g., checks, gift cards) provided to research subjects as compensation for their time and effort Also known as: compensation, stipend, payment Remuneration made by means other than Partners Accounts Payable check must be tracked IRS considers remuneration taxable income regardless of dollar amount Even $10 gift card is considered taxable 10

11 US citizens and permanent residents 1099 is issued when total payments in calendar year > $600 Must collect Social Security # or Individual Taxpayer ID # AND valid US address Nonresident Foreign Nationals No Green Card or formal Visa status Regardless of amount may be considered taxable Type of Visa matters Questions: contact Partners International Office or Tax Department 11

12 PHRC general guidance Compensation to minors Prorated compensation Parking Suggested monetary compensation for certain procedures Informed consent should provide details: Total amount of remuneration Prorated amount Cash or check Tell if SS#/Tax ID# and address required When to expect payment at time of visit or in mail Potential tax consequences 12

13 Partners policy definition: Item of nominal value given to subject (tote bag, water bottle, toy, etc) Maximum value of $100 Exceptions must be approved by IRB IRB determines value of item still qualifies as nominal and that exception is justifiable Example: glucose monitor subject used during study participation Not considered taxable 13

14 Study staff signing on behalf of the study participant Mail gift cards to study participants Study PI does not have Procurement card Study PI purchased gift cards with P-card but referenced a training grant Funding period ending on grant verbal commitment for grant renewal - wants to purchase more gift cards Expired gift cards 14

15 Prepaid cards Electronic payment system Functions like debit card Payments to participants added to card Multiple studies can contribute to same card for particular study participant Streamlines process for study teams, Accounting, and participants Pilot project started 5/25/2017 at MGH and BWH 15

16 Partners policy definition: payments to research subjects to cover out-of-pocket expenses Examples: Travel, meals, parking, taxi Receipts are required (originals with details) Not considered taxable since based on receipts Direct payment by institution for expense Easier for the subject and study team Investigator/fund manager retains receipts Meal vouchers Taxi vouchers Airfare Parking validation (stickers) 16

17 Informed consent should provide details: Cash or check Tell if SS# / Tax ID# and address required When to expect payment at time of visit or in mail Original receipt requirement Provide subject Information Sheet regarding Reimbursement (IRB approved) What is and is not covered Receipts required original with details How to submit Provide a log for patient to enter expenses Patient signature on form 17

18 Alcohol on meal receipts Receipts with no detail Meals for others on participant meal receipts PI decided to reimburse for travel but reimbursement not included in IRB application and consent Reimburse for mileage but air travel less expensive 18

19 Research Billing 19

20 Study participants should have good understanding of how study services will be charged (21 CFR 50.25and ICH E6: l) Informed consent should include: What will study pay for? What is considered research? What, if anything, will be billed to insurance/patient? Who should participants contact for billing issues? What study will not cover: co-pays, deductibles, or whatever insurance will not cover Informed consent is ongoing process 20

21 Medicare revised policy regarding coverage of patient care costs in clinical trials Medicare Clinical Trial Policy (effective 2000, revised 2007) Medicare covers routine costs of qualifying clinical trials Includes items and services that are otherwise available to Medicare beneficiaries MCA - Partners requirement since January 2008 (MGH, BWH, Spaulding, Faulkner) MCA determination required prior to IRB approval/activation 2 categories Qualifying Clinical Trial (QCT) Non-qualifying Clinical Trial 21

22 Qualifying Full MCA required 3 criteria mandatory Study must have therapeutic intent Enroll individuals with diagnosed disease Healthy individuals only as controls Evaluate item or service that Medicare covers Study-specific billing grid/calendar created PI notified of determination and receives copy of MCA billing grid Guides charge direction Template for Timeline in Epic Medicare covers: Usual and customary care, Detection/prevention/treatment of complications, Administration of investigational drug/device 22

23 Non-qualifying MCA billing grid/calendar not required PI receives notification of non-qualifying status Majority of studies Study pays for all patient care charges OR No patient care charges in study Usual and customary services provided outside of study covered as usual 23

24 Study Code created in Epic IRB approved protocol, open to enrollment, identified fund linked to protocol and set up properly Epic Study code Example: 2016p (non-oncology) Example: (Oncology) Enroll patients in correct study code Some studies have multiple funding sources so multiple study codes Link study-related activities to correct study code Orders, procedures, study medication, encounters/visits, inpatient admissions Must be done in advance of service or during inpatient admission Review charges on Research Billing Review (RBR)

25 Required to review within 7 days of posting in Epic Review charges 2-3 times/week Direct charges as appropriate: Study Related Bill to Study Study Related Bill to Insurance/Patient QCTs only Not study Related Bill to Insurance/Patient Mark as reviewed and accept Before marking as reviewed refresh screen to confirm charges are in correct bucket

26 Research Patient Care Billing Checklist Prior to study start up and revise during study as needed Monitor patient care charges Patient Care Log Maintain list of all potential charges for research related patient care services Track expected charges for each participant Charges posted to fund Work with PI and Grant Manager Study Milestone Tracker Clinical Trial Management Systems Partners OnCore, DFCI OnCore REDCap or department-specific system

27 Correction types: Transfer within Research Funds Transfer Insurance/Self Pay to Research Fund Transfer from Research Fund to Insurance/Self Pay Expected Charge Did Not Post to Fund Incorrect Patient on Fund Correct Patient and Fund but Incorrect Charge Confirm Research Rate Charged to Fund

28 Delinquent charge review Unlinked orders and misdirected charges Patients billed incorrectly Over 80% of research billing errors Insurance filing limits exceeded Lost revenue for institution/departments Patient Care Log not maintained - expected charges not tracked Patients billed incorrectly Patients sent to Collections Study fund closed prior to verifying all patient care charges on fund Submitting Patient Care Correction request for charges > 90 days old Sometimes charges cannot be billed to fund or insurance so charges directed to sundry fund 28

29 Contact International Patient Center if expect international patients to enroll Provide a copy of the informed consent and Medicare Coverage Analysis (if applicable) to the International Patient Center Coordinate with patient regarding payment and logistics International Patient Center receives many inquires regarding research studies 29

30 All this billing stuff is complicated and confusing! Who cares where the charges go? This is the job of billing groups, why do research teams have to do this? This is just busy work and I don t have time for this I have real clinical research work to do like enroll patients, schedule study visits, collect data, completed CRFs, etc. The charge is standard of care and going to be charged to insurance anyway so what difference does it make if I say it is research related or not?

31 Associating an encounter with a study and the Coordinator Research Billing Review are the first of many steps in the billing process How the charge is reviewed and routed dictates what happens downstream Billing groups do not know the specific details of your research protocol, informed consent, study budget, or agreement Accurate and compliant patient care billing is everyone s responsibility PI, research team, billing provider, billing staff, and institution Study participants get very upset if billed for services covered by the study Question study team competence and credibility Negative impact on continued participation

32 Fraud occurs in clinical trial billing when: Bill insurance for services that are: Already paid for by the sponsor Promised free in the informed consent Part of a non-qualifying clinical trial Inappropriately using research funds to pay for routine care Co-pays Deductibles

33 Audits and financial settlements 1993 HHS-OIG Investigation: most of the 130 hospitals investigated were improperly billing Medicare for implanting investigational devices 1999 GAO Report: Medicare was unknowingly being billed for routine costs in oncology clinical trials. GAO/HEHS Public Settlements University of Alabama settlement - $3.4 million 2005 Rush University Medical Center settlement - $1 million 2005 Weill Cornell Medical Center settlement - $4.3 million 2010 Tenet Healthcare System, Norris Cancer Center 1.9 million Damaged reputation/loss of public trust Negative impact on research participation

34 Informed consent discussion is ongoing discussion throughout study participation Remind about billable services Make use of tools to assist with tracking patient care charges and remuneration Contact International Patient Center if enrolling international patients Remain current with: Remuneration and Reimbursement check requests Link encounters in advance Check Upcoming Visits report at least once a week Careful review patient care charges at least 2-3 times per week Monitoring patient care charges on fund Coordinate with Grant Administrator Timely submission of Patient Care Correction requests 34

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