PREP Course #22: Research Billing Compliance Basics

Transcription

1 PREP Course #22: Research Billing Compliance Basics Presented by: Emmelyn Kim, Director The Office of Research Compliance & Danny Halfant, Manager, Financial Operations The Clinical Research Service 1

2 CME Disclosure Statement The North Shore LIJ Health System adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the North Shore-LIJ for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director, Kevin Tracey, has disclosed a commercial interest in Setpoint, Inc. as the cofounder, for stock and consulting support. He has resolved his conflicts by identifying a faculty member to conduct content review of this program who has no conflicts. Emmelyn and Danny have nothing to disclose. 2

3 Today s Objectives Identify requirements for proper billing Apply techniques to evaluate billing compliance 3

4 We Will Discuss the Following Federal and local regulations and policies as it relates to research billing Cost uniformity among study documents Preliminary analysis of charge direction and Medicare coverage analysis Proper billing procedures, fiscal monitoring, handling of errors and documentation requirements 4

5 Background Medicare National Coverage Decision (NCD) for Clinical Trials (CTs) covers: Routine costs of qualifying clinical trials Reasonable & necessary items and services used to diagnose and treat complications from participating in CTs Available through CMS = Centers for Medicare & Medicaid Services 5

6 The Past In 2005 Rush University Medical Center reported issues related to research billing for cancer clinical trials to DOJ, CMS, & OIG including: Services paid by sponsor also charged to 3 rd party payers The consent form indicated that items and services were free to subjects, but they were charged to 3 rd party payers Billed for services that did not meet routine costs definition They settled for $1M; 3 year agreement w/oig 6

7 A Look at the Current Environment OIG special agents making Medicare fraud arrests; pic.twitter.com/wixchk 7

8 Federal Requirements Center for Medicare and Medicaid Services (CMS) National Coverage Determinations (NCDs) Clinical Trials Policy Devices: Medicare Benefit Policy Manuals CMS Transmittals use of billing modifiers (Q1, Q0 for clinical research) 8

9 Other Federal Rules False Claims Act: Submitting false claims for payment to the government OIG & DOJ investigations/settlements Double-billing Payer of Last Resort Rule for charges incurred related to treatment of injury/ illness related to trial 9

10 Local Requirements Local Coverage Decisions (LCDs) Local Medicare Contractor NGS National Government Services Includes determinations by Medical Director Or find LCDs on Health System Policy on Research Billing 10

11 Coverage Analysis and Billing Plan Charge Capture, Segregation, Research Pricing Clinical Research Billing Budget, Contract, Consent Third-party Billing Subject Registration and Tracking Audit

12 Step 1: Determining Whether Your Trial is Qualifying As outlined by the Clinical Trials Policy, the trial must meet the following: 1. Evaluates an item or service that falls within the Medicare benefit category 2. Have therapeutic intent 3. Enroll patients with diagnosed disease AND 12

13 Step 1: Qualifying Trial (Cont d) Be one of following types of trials deemed to meet the 7 desirable characteristics: 1. Funded by NIH, CMS, AHRQ, DOD, VA or CDC 2. Supported by centers or cooperative groups funded by NIH (e.g. GOG, CALGB, COG, SWOG, etc.) 3. Conducted under an investigational new drug application (IND) reviewed by the FDA 4. IND exempt with exemption letter from FDA 13

14 Step 2: Perform a Coverage Analysis Review of research-related documents to determine whether Medicare can be billed for the items and services provided to research subjects Analyzes cost uniformity among study documents Creates supporting documentation of research vs. routine care determinations 14

15 What are the Benefits of Performing a Coverage Analysis? Provides research subjects with accurate information related to costs of the CT Determine true costs of the the CT, which you can use to negotiate with sponsors Provides protection from violation of false claims act and other regulations 15

16 About Devices Category A: Experimental/Investigational Category B: Nonexperimental/Investigational Coverage of investigational devices if: On master list of IDE devices Reasonable & necessary Cat B Dates of service within dates on master list No other policy that prohibits coverage 16

17 Coverage Determination Devices: requires pre-authorization from the local Medicare contractor National Government Services IDE Request Form Private Insurance: May need to obtain preauthorization prior to provision of services to ensure coverage 17

18 Step 3: Develop a Billing Grid Review study documents: protocol, consent Create a worksheet Schedule of Events Indicate clear charge direction for each procedure during each visit E.g. research vs. routine Creates transparency 18

19 Billing Grid Example Sponsor: Danny Halfant Research Lab Study Title: "The Effects of Drug # H-007 on Patients with Right Heart Catherizations" P.I.: Hearty Smith, MD S = Standard of Care / Routine Costs, Insurance or Patient Pays Campus: Feinstein Institute - Dr Smith's Lab - Room 3018 R = Research, Sponsor Pays Protocol Schedule of Events Visit Number Coverage Analysis Baseline Screening 1 Month Follow-Up 6 Month Follow-Up 9 Month Follow-Up 12 Month Follow-Up Description Day 0 Day 31 Day 181 Day 272 Day 365 Informed Consent R Inclusion/Exclusion Criteria R Medical History S Concomitant Medications Assessment S S S S S Physical Exam S S S S S Vital Signs S S S S S Patient Reimbusement (travel) R R R R R Procedures: Defibrillator Interrogation S S S S S EKG R R Echocardiogram S S S Cat Scan R R R MRI S S S Lab Tests: Complete Blood Count & Creatinine S S S S S #N/A 19

20 Routine Costs Items or services: Typically provided during conventional care Required solely for the provision of the investigational item or service, the clinically appropriate monitoring of the effects of the item/service or prevention of complications Needed for reasonable and necessary care arising from provision of an investigational item or service 20

21 Routine Costs Are Not Items or services: That are statutorily excluded or where there is a non-coverage decision Which are investigational Provided solely for data collection & analysis Provided by research sponsors at no cost to the subjects 21

22 Billing Procedures 3 Types of Billing: 1) Cost reimbursement bill sponsor for actual expenses charged to a fund: salaries, fringe benefits, supplies, purchased services, payments to pts., etc. 2) Per patient reimbursement sponsor will pay an agreed-upon amount for each pt. 3) Fixed price the sponsor and PI agree on a specific dollar amount for doing the study, regardless of how much it costs the institution 22

23 Health System Policy GR023: Research Billing Procedure for Outpatient Services, Inpatient Services and Ancillary Testing On Healthport under Policies 23

24 OUTPATIENT RESEARCH SUBJECT REGISTRATION Attachment A ATTN: Investigators/Research Coordinators: Attach this form to a prescription or requisition for services. A separate form must be completed for each service that is required by protocol and reimbursed by a grant or contract. A copy of this form should be maintained in the patient s medical record and in study regulatory documents. Outpatient Research Subject Registration Form ATTN: Registration/Patient Accounts: This patient is a participant on a research study. Research procedures reimbursed by a research grant or contract may not be billed to a subject and/or their insurance carrier. Reimbursement for research procedures and services listed must be invoiced to the plan code and PeopleSoft project number listed below. DO NOT bill a third party payer or patient for the following procedures or visits. If the procedure/visit is being billed via INVISION apply the registration to plan code F60 for NSUH Manhasset or plan code GNT for LIJ, SCH, ZHH and enter people-soft project number into the prior authorization AND policy number fields. If the procedure/visit is being billed via IDX apply the invoice to plan code RES for NSUH Manhasset or plan code GNT for LIJ, SCH, and ZHH and enter people-soft project number into the prior authorization field. Research Subject Information Patient Name Date of Birth / / Medical Record # Account # Gender (circle) Male Female Date subject signed consent / / Research Services are Requested (circle) YES* NO * Procedure is required by the protocol and is covered by a research grant or contract. Do not bill the following to a patient or third party payer. Date of Service Billing Information Procedure Plan Code (circle one) F60 (INVISION: NSUH Manhasset) GNT (LIJ/SCH/ZHH) RES (IDX: NSUH Manhasset) PeopleSoft Project # to be charged Requested by: Date of Request: / / (Print Name) Signature: Department: Division: Contact Name Name of Study: Name of PI: Form version: 04/07/05 Phone #: 24

25 INPATIENT RESEARCH SUBJECT REGISTRATION 12/12/06 Attn: Research Teams: Patient accounts and/or admitting must be notified as soon as the subject signs informed consent or becomes hospitalized after agreeing to be in a research study. A copy MUST be maintained in the patient s medical record and in study regulatory documents. Inpatient Research Subject Registration Form ATTN: Finance/Patient Accounts: Research participants must be transferred. Do NOT discharge and readmit. This patient is a participant on a research study. Reimbursement for research bed days, procedures and services listed must be invoiced to the plan code and PeopleSoft project number listed below. Do NOT bill a third party payer or patient for the following days, procedures or visits. Research Subject Information Patient Name Date of Birth / / Medical Record # Admit Date / / Account # Gender (circle) Male Female Date subject signed consent / / Research Bed Days are Requested (circle) YES 1 NO 1 Hospitalization is required by the protocol and covered by a research grant or contract. Do not bill the following to a patient or third party payer. Date Research Service Begins / / Date Research Service Ends / / Number of Days Requested* Research Services ONLY are Requested (circle) YES 2 NO 2 Hospitalization is NOT required by the protocol and the following services are covered by a research grant or contract. Do not bill the following to a patient or third party payer. Date of Service Procedure # of Units Billing Information Plan Code (circle) F10 (NSUH Manhasset) GNT (LIJ/SCH/ZHH) PeopleSoft Project # to be charged Requested by: Date: / / Name of Study: DEPARTMENTAL APPROVAL: Department Administrator or Designee Date: / / *An additional form must be completed if the patient requires a longer length of stay than approved by this form. For information or assistance contact the Office of Research Compliance at

26 Core Lab Special Purpose Form 10 NEVADA DRIVE, LAKE SUCCESS, NEW YORK (516) NEW FUND/GRANT ACCOUNT SET UP FORM Est. Mo. Vol.: Requested By: Start Account: New Date: Courier P/U Required: Yes No Automatic: Will Call: Dept. Number: PROTOCOL Name: PEOPLE SOFT PRODUCT / PROJECT FUND #: Business Unit: End Date: Telephone Number: ( ) Address: Fax Number: ( ) City: State: Zip Code: County: Administrator/Contact Person: Phone #: ( ) Fax #: ( ) Contact Shruti Kadakia at Core Lab Business Office Manager: Phone #: ( ) Fax #: ( ) Physicians: Name Dr#: Lic #: Name Dr#: Specialty: Lic #: UPIN #: Name Dr#: Specialty: Lic #: UPIN #: Name Dr#: Specialty: Lic #: UPIN #: Reports: 1 Copy 2 Copies 3 Copies Pre-Print Requisitions: Yes No Special Tests: Billing Type: Fund / Grant / Research Special Instructions (Test on the Protocol): (General Ledger Chargeback to Hospital) Requester s Signature: When completed please form to: skadak@nshs.edu (678) Please list any Specific request in the Special Instruction box. 26

27 Core Lab Billing Cover Letter Review information SPECIAL PURPOSE FUND Date: January 25, 2012 Client No.: 10215, 10220, 10260, Charge To: NSUH Special Purpose Fund Attention: 10 NEVADA DRIVE LAKE SUCCESS, NEW YORK (516) Dr Dan Smith The attached ancillary cost for all your studies has been charged to your appropriate hospital cost center reference below. If the cost center number charged is incorrect, please contact Danny Halfant at (516) Any questions regarding this invoice please contact Shruti Kadakia at (678) See details attached. Core Lab # Study Name Fund # Month Total HCV NOV & DEC NV19865B, 1986C NOV & DEC IRS VX NOV & DEC ENDO 1& NOV & DEC Protocol 524H NOV & DEC TOTAL: $ Cc: Danny Halfant 27

28 Dan Smith, MD Nov & Dec 2011 SAMPLE Bill Detail Review Information CLTN CLT NAME PATIENT NAME MEDREC DOS TESTNAME CPT RVU NV19865B, 1986C DAVIS, BETTY /16/11 Albumin, Serum NV19865B, 1986C DAVIS, BETTY /16/11 Alkaline Phosphatase, Ser NV19865B, 1986C DAVIS, BETTY /16/11 Aspartate Aminotransferas NV19865B, 1986C DAVIS, BETTY /16/11 Bilirubin Indirect NV19865B, 1986C DAVIS, BETTY /16/11 Bilirubin Total NV19865B, 1986C DAVIS, BETTY /16/11 Bilirubin, Direct NV19865B, 1986C DAVIS, BETTY /16/11 Blood Urea Nitrogen NV19865B, 1986C DAVIS, BETTY /16/11 Chloride Serum NV19865B, 1986C DAVIS, BETTY /16/11 Creatinine, Serum NV19865B, 1986C DAVIS, BETTY /16/11 Gamma Glutamyl Transferas NV19865B, 1986C DAVIS, BETTY /16/11 Potassium Serum NV19865B, 1986C DAVIS, BETTY /16/11 Protein Total Serum NV19865B, 1986C DAVIS, BETTY /16/11 SGPT NV19865B, 1986C DAVIS, BETTY /16/11 Sodium Serum NV19865B, 1986C DAVIS, BETTY /16/11 CBC/D NV19865B, 1986C DAVIS, BETTY /16/11 Hepatitis C RNA Quant Total IRS VX JAMES, JESSIE /01/11 GLU IRS VX JAMES, JESSIE /01/11 Alkaline Phosphatase, Ser IRS VX JAMES, JESSIE /01/11 Aspartate Aminotransferas IRS VX JAMES, JESSIE /01/11 Bilirubin Indirect IRS VX JAMES, JESSIE /01/11 Bilirubin Total IRS VX JAMES, JESSIE /01/11 Bilirubin, Direct IRS VX JAMES, JESSIE /01/11 Blood Urea Nitrogen IRS VX JAMES, JESSIE /01/11 Chloride Serum IRS VX JAMES, JESSIE /01/11 Creatinine, Serum IRS VX JAMES, JESSIE /01/11 Gamma Glutamyl Transferas IRS VX JAMES, JESSIE /01/11 Potassium Serum IRS VX JAMES, JESSIE /01/11 SGPT IRS VX JAMES, JESSIE /01/11 Sodium Serum IRS VX JAMES, JESSIE /01/11 CBC/D IRS VX JAMES, JESSIE /01/11 AFP IRS VX JAMES, JESSIE /01/11 Hepatitis C RNA Quant Total PROTOCOL 524H04 TAFT, WALLY /20/11 Albumin, Serum PROTOCOL 524H04 TAFT, WALLY /20/11 Alkaline Phosphatase, Ser PROTOCOL 524H04 TAFT, WALLY /20/11 Aspartate Aminotransferas PROTOCOL 524H04 TAFT, WALLY /20/11 Bilirubin Indirect PROTOCOL 524H04 TAFT, WALLY /20/11 Bilirubin Total PROTOCOL 524H04 TAFT, WALLY /20/11 Bilirubin, Direct PROTOCOL 524H04 TAFT, WALLY /20/11 Blood Urea Nitrogen PROTOCOL 524H04 TAFT, WALLY /20/11 Chloride Serum PROTOCOL 524H04 TAFT, WALLY /20/11 Creatinine, Serum PROTOCOL 524H04 TAFT, WALLY /20/11 Gamma Glutamyl Transferas PROTOCOL 524H04 TAFT, WALLY /20/11 Potassium Serum PROTOCOL 524H04 TAFT, WALLY /20/11 Protein Total Serum PROTOCOL 524H04 TAFT, WALLY /20/11 SGPT PROTOCOL 524H04 TAFT, WALLY /20/11 Sodium Serum PROTOCOL 524H04 TAFT, WALLY /20/11 CBC/D PROTOCOL 524H04 NITTY, FRANK /22/11 CBC/D PROTOCOL 524H04 NITTY, FRANK /22/11 Pregnancy Test, Urine PROTOCOL 524H04 NITTY, FRANK /22/11 COMPMETA PROTOCOL 524H04 NITTY, FRANK /19/11 Molis WAM Manual Differen PROTOCOL 524H04 NITTY, FRANK /19/11 Urine Microscopic-Add On Total Grand Total $ FIXED (OH) TOTAL 28

29 Step 4: Billing Procedures Process mapping working with registration staff/pt accounts, etc. at site Know who s going to contact who Inpatient vs. Outpatient Discuss process during kick-off meetings Meetings by request 29

30 Step 5: Fiscal Monitoring Access to EPM Peoplesoft reports Request Peoplesoft access form User Security form Include ALL personnel who need to look at reports Frequency of monitoring Monthly reports Review of charges to grants (F60, F10, GNT) Medicare Fee Schedule 30

31 Fiscal Monitoring (Cont d) Where do the checks go? GMO vs. BRANY GMO - deposits and charges overhead BRANY - review check payment letters -normally include details by pt. -may have to contact BRANY for explanations Clinical Research Service (CRS) is always available to review revenue & expenses Office of Research Compliance (ORC) will perform routine billing audits 31

32 Closeout Fund is ready to be closed out after all payments have been received & all applicable expenses charged Transfer of the final balance surplus or deficit transferred to Clinical Trial Investment Fund (separate fund for each department/division where closed funds are transferred to & expenses related to multiple trials are charged) 32

33 Handling Errors Core lab Shruti or Danny Review of the detail general ledger expenses may reveal errors Contact CRS Danny for explanations and processing of corrections Documentation needed copy of EPM report detail Reviewing erroneous patient bills should have been charged to grant Contact CRS ASAP for hospital bill or physician bill (PAANS) 33

34 Handling Errors (Cont d) Handling charging of physician s fees to the grants Note that sometimes there is no reading of a test (done by PI) and so there is no physician charge 34

35 Common Findings Based on ORC billing audits in the HS: Research subject registration forms not used at the time of service; pt. or their insurer were billed Information from forms not keyed in or keyed in incorrectly into billing system Charges from other studies posted to fund account No fiscal monitoring by research team 35

36 Questions? Contact us: Danny Halfant, Manager, Financial Operations Clinical Research Service (516) , Emmelyn Kim, Director Office of Research Compliance (516) , 36