1. PREPARED BY: SUZAN BRUCE, CPC CLINICAL TRIALS OFFICE, UC DAVIS 1 Clinical Research Billing & Coding

2. 2 Medicare National Clinical Trial Policy

3. Medicare Clinical Research Coverage 3  Clinical Trials must meet the requirements of Medicare National Clinical Trial Policy #310.1 to qualify for coverage of extra patient care services in a clinical trial  To determine if a clinical trial qualifies for coverage Research Physician/Staff perform an analysis of clinical trial services vs requirements of policy  Analysis is a two step process (Coverage Analysis)  Step 1 determines if clinical trial meets the requirements of policy  Step 2 is a listing of patient care services by CPT code and clinical trial modifiers

4. Medicare Coverage Analysis 4  Performed for all clinical research studies anticipating patient care billing  A clinical trial must meet certain criteria in NCD 310.1 to qualify for reimbursement  A coverage analysis is performed to determine if your trial meets these requirements  Coverage Analysis is a process performed by most institutions across the United States

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6. What is covered in a clinical trial? 6  Medicare:  As a general rule, covers “routine costs” during “qualifying clinical trials”  Routine costs=diagnosing, treatment, monitoring, investigational drug or device administration costs, complications  Medi-Cal:  Requires coverage of cancer clinical trials but mostly silent for non-cancer  Commercial Insurance:  State requirement to cover cancer clinical trials but for non-cancer it is a matter of contract and coverage policy

7. What does Medicare/Insurance or Study pay for? 7 Patient care purely research- paid by Financial sponsor/Study Medicare expands their coverage for routine costs to monitor, diagnose, treat patients during a clinical trial paid by Insurance/Medicare/Pt Acct Medicare /Commercial Insurance/Pt Acct covers services “standard of care” typically used to treat a patient

8. Items and services NOT billable to Medicare 8  The investigational item or service itself, unless otherwise covered outside of the clinical trial  Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan)  Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial

9. How to report clinical trial services on claim form 9  Extra services are needed to monitor, diagnose, treat patients in a clinical trial (e.g. labs, Xrays, surgery, infusions)  National clinical trial policy states coverage is allowed if requirements are met  Clinical trial services must be identified on a claim form  Services are reported on a claim using clinical trial modifiers (Q0(zero),Q1)  Modifiers needed to identify which services on a claim form are part of a clinical trial  Diagnosis code V70.7 is report in secondary position, condition or disease is primary

10. 10 Diagnosis Code V70.7  ICD-9 Code V70.7 = Examination of participant or control in clinical research  This diagnosis code is reported for all qualifying clinical trial claims that have any charges billed to a payer that are related to the patient’s participation in a clinical trial  This diagnosis code is applied the following charges:  Inpatient  Outpatient  Facility Fees  Professional Fees

11. Diagnosis Code V70.7 11  Diagnosis code V70.7 Examination for participant in clinical trial shall be reported as the secondary diagnosis (Medicare)  Diagnosis code ICD-10 = Z00.6 Encounter for examination for normal comparison and control in clinical research program

12. Modifier Q0/Q1 12  Q0: Investigational clinical service in a Research Study  Q1: Routine clinical service in a Research Study  Q0: Investigational clinical services are defined as those items and services that are being investigated as an objective within the study. Investigational clinical services may include items or services that are approved, unapproved, or otherwise covered (or not covered) under Medicare  Q1: Routine clinical services are defined as those items and services that are covered for Medicare beneficiaries outside of the clinical research study; are used for the direct patient management within the study; and, do not meet the definition of investigational clinical services. Routine clinical services may include items or services required solely for the provision of the investigational clinical services (e.g., administration of a chemotherapeutic agent); clinically appropriate monitoring, whether or not required by the investigational clinical service (e.g., blood tests to measure tumor markers); and items or services required for the prevention, diagnosis, or treatment of research related adverse events (e.g., blood levels of various parameters to measure kidney function)

13. Things to know: 13  The Q0/Q1 modifier are Medicare specific and should only be used for charges being submitted to Medicare  These modifiers apply to both facility and professional fees for outpatient charges and professional fees only for inpatient charges  If more than one modifier applies to a charge, modifiers affecting payment should always be first  Medicare may reject claims with the V70.7 diagnosis code if there are no charges with a Q0/Q1 modifier  Q = Qualified  Q modifiers indicate that the principal investigator (physician) attests that the clinical trial qualifies for coverage

14. EXAMPLES OF WHEN TO USE MODIFIERS, DX AND CONDITION CODES 14 The patient is in a dermatology research study where some charges are billed to Medicare and some are billed to a Big Pharma (financial sponsor). The Billing Grid indicates that the sponsor pays for a C-Spine and DEXA bone density scan every month because these X-rays are needed for research only. A CBC, Metabolic Panel and an office visit are considered routine standard of care services and would routinely be provided whether this patient was in a study or not. The encounter for the patient’s individual account is coded with V70.7 in the secondary position C-SPINE72020$8.00 DEXA77080$4.00Bill to Big PharmaNo Q modifier CBC85004$5.00Q1 modifier Metabolic Panel80053$19.50Q1 modifier ClinfeeLvl3Est99213$16.00 Bill to pt’s account Q1 modifier No Q modifierBill to Big Pharma Bill to pt’s account

15. The patient is in an investigational drug research study for cancer. An investigational drug is provided for free by the sponsor and all other drugs are billed to patient’s insurance (Medicare). All billable drugs are FDA approved and part of the investigation. “Q0” modifier identifies these billable drugs as part of the “objective” of the investigation Chemo Infusion 0-1 Hr96413$7.50Bill to pt’s accountQ1 modifier TemozolomideJ9328$7.00Bill to pt’s accountQ0 modifier IrinotecanJ9206$4.00Bill to pt’s accountQ0 modifier Bevacizumab IND#7921N/AProvided free by sponsor N/A Patient Visit99215$23.00Bill to pt’s accountQ1 modifier 15 The encounter for the patient’s individual account is coded with V70.7 in the secondary position and is reported on the hospital claim and professional claim

16. Take-away Points 16  Clinical Trial must meet requirements of National Medicare Clinical Trial Policy #310.1 to bill for extra coverage  A Coverage Analysis can be performed to mitigate billing errors and compliance risks  Clinical Trial diagnosis code V70.7 applies to inpatient, outpatient, facility and professional fees  V70.7 diagnosis code must be in the secondary position (Medicare)  Q0/Q1 modifiers apply to both facility and professional fees for outpatient charges and professional fees only for inpatient charges  Modifiers should be ordered with payment affecting modifiers first  The Q0/Q1 modifiers are Medicare specific and should not be used for other payers  ICD 10 diagnosis code Z00.6

17. 17 Compliance

18. Billing violations under the False Claims Act 18  Biggest risk violation of “False Claims Act” - Federal law prohibits knowingly making or causing a false claim to be submitted  False claim in clinical trial=billing insurance for items and services already paid by sponsor  U of Alabama $3.4 million, 2005  Rush University $1 million, 2005  Tenet Healthcare System, Norris Cancer Center $1.9 million, 2010

19. Why is clinical trial billing at risk for compliance errors? 19  National coverage policy expands reimbursement of the extra patient care services needed to monitor, treat, diagnose, and administer investigational drug or device  These services may not typically be covered by insurance – except when they are part of a clinical trial  Services identified on claim form with clinical trial modifier (Q1 or Q0) and V70.7 diagnosis code must be documented appropriately as part of a clinical trial  Coverage Analysis identifies billable services  Rules are complex- errors easily made during billing

20. Why is research billing compliance critical? 20  Coverage Analysis reduces the risk of audits and investigations by identifying clinical trial services billable to insurance or financial sponsor  Federal payers (including Medicare and Medicaid) are on the look out for billing irregularities and inaccuracies  CPT codes, diagnosis codes, modifiers, are tools to track irregularities  Double billing, over billing and irregular-billing practices have been the subject of numerous Office of Inspector General (OIG) and Department of Justice (DOJ) investigations

21. The 3 C’s of Research Billing Compliance 21  Coordination of study information across multiple study documents  Communication of relevant study information to the billing process  Cooperation among departments and offices that may not usually work together

22. Are there exclusions or limitations on coverage? 22  CMS Online NCD and LCD database  Medicare Benefits Policy Manual  NCCI edits

23. Resources Websites CMS overview on clinical trial policy http://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/inde x.html?redirect=/ClinicalTrialPolicies/ http://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/inde x.html?redirect=/ClinicalTrialPolicies/ Clinical Trial Policy http://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=1&ncdver=2&fromdb=true Medicare Noridian https://med.noridianmedicare.com/web/jeb QUESTIONS Suzan Bruce Suzan.bruce@ucdmc.ucdavis.edu 23