Coverage Analysis: The Cornerstone of Clinical Research Billing Presented by: Mary L. Veazie, CPA, MBA, CHC, CHRC Executive Director, Clinical

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1 Coverage Analysis: The Cornerstone of Clinical Research Billing Presented by: Mary L. Veazie, CPA, MBA, CHC, CHRC Executive Director, Clinical Research Finance The University of Texas MD Anderson Cancer Center

2 Objectives Define routine care & research care under the Medicare regulations Describe how a Medicare Coverage Analysis is developed Describe how the Medicare Coverage Analysis is incorporated into the clinical research billing process 2

3 Definitions & Purpose A Closer Look 3

4 Clinical Trial Type of clinical study Involves research using human volunteers (participants) intended to add medical knowledge There are different kinds of clinical trials, including those to study: Prevention options New treatments or new ways to use existing treatments New screening and diagnostic techniques Options for improving quality of life for people who have serious medical conditions 4

5 Coverage Analysis (CA) A billing grid listing all potential billable patient care items & services as defined by the protocol Includes: CPT codes, service codes & other billing code Technical Charges (Hospital) Professional Charges (Provider), if the provider is employed by the hospital or agreement to place the rates on the CA National coverage determination (NCD) / Local coverage determination (LCD) ClinicalTrials.gov number (NCT), if available Medicare research modifiers Research discounted rates, if applicable Designated funding source General protocol demographics Recommended for all clinical trials prior to enrolling participants 5

6 Cross functional & multi-purpose Sponsored Contracts Institutional Compliance Coverage Analysis Patient Access Coord Billing Informed Consent 6

7 Purpose of Coverage Analysis A reference document used to: Comply with billing requirements of the Center for Medicare/Medicaid (CMS) program Prospectively identify & categorize charges Springboard for clinical research billing Used for financial feasibility analysis Assist with clinical trial budget development & negotiations with the sponsor 7

8 Background & Regulations Who s Idea Was This Anyway? 8

9 Regulation Historical Look 06/07/2000 Medicare directed to pay for routine care and medical complications associated with participation in clinical trials 09/19/2000 Center for Medicare and Medicaid Services (CMS) responded with a Clinical Trial Policy (CTP) National Coverage Determination (NCD) 07/2006 CMS addressed several issues of 2000 CTP NCD 07/09/2007 CMS issued a final decision memorandum that preserves 2000 CTP but provided clarification that items that are covered outside trial are covered inside trial and added coverage trials under a NCD 9

10 Regulation On June 7, 2000, the President of the United States issued an executive memorandum directing the Secretary of Health and Human Services to "explicitly authorize [Medicare] payment for routine patient care costs...and costs due to medical complications associated with participation in clinical trials. 10

11 Regulation (cont.) In response to the Presidential order the Center for Medicare and Medicaid Services (CMS) issued the clinical trial policy national coverage determination (NCD) NCD Routine Costs in Clinical Trials (CMS Internet Only Manual (IOM) Publication , Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section Routine Costs in Clinical Trials ) Effective September 19, 2000 Revised July 9,

12 Regulation (cont.) Patient Protection and Affordable Care Act (PPACA) became law in March In 2014, new and non-grandfathered health plans will be required to cover clinical trials. Plans may not: Deny the individual participation in the clinical trial Deny, limit, or impose additional conditions on the coverage of routine patient costs for items & services furnished in connection with participation in the trial; and Discriminate against the individual based on their participation For this act, an individuals is eligible to participate in an approved clinical trial according to the trial protocol for cancer or life threatening disease and if referred by a participating health care provider 12

13 CMS Coverage & Reimbursement Requirements Routine / Research Cost for Clinical Trials 13

14 Clinical Trial Routine Cost Coverage CMS has specific rules that must be met to qualify for coverage of the Routine Costs associated with the trial Cannot bill for Routine Services if the trial fails to meet CMS criteria Some items/services never can qualify to bill to CMS Items that cannot be billed must be covered by the trial funding source such as the sponsor 14

15 NCD Routine Costs for Clinical Trials National Coverage Determination explains that specific requirements must be met in order to: Qualify for coverage Submit a claim properly and Receive reimbursement for claims submitted 15

16 Qualifying for Coverage Three (3) Mandatory Requirements: 1. Trial must: Evaluate an item or service within a benefit category and Not be statutorily excluded from coverage Example: What Meets this Criteria? Diagnostic tests, drugs, & biologics o Yes! Hearing aids, cosmetic surgery, dental exams o No! 16

17 Qualifying for Coverage 2. The Trial must: Not be designed exclusively to o Test toxicity or o Disease pathophysiology Have therapeutic intent Example: What Meets this Criteria? Phase 2 clinical trial testing FDA investigational new drug Yes! Prospective lab trial to test tumor signal pathways No! 17

18 Qualifying for Coverage 3. Trials of therapeutic interventions must: Enroll patients with diagnosed disease rather than healthy volunteers Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group Example: What Meets this Criteria? Phase 2, two-arm comparison trial testing use of endoscopy dye to detect colon polyps. Will enroll participants with known polyp hx scheduled for follow-up colonoscopy, and pts with no known colon hx scheduled for initial colon screening. Yes! Phase 1 study of the general population testing new cholesterol lowering medicine. Will enroll healthy volunteers ages No! 18

19 Qualifying for Coverage 3 Requirements Are Not Enough Trial Must ALSO meet 7 characteristics (synopsis) potentially improves health outcomes well-supported by scientific & medical information does not unjustifiably duplicate existing studies is appropriate to answer the research question sponsored by a credible organization in compliance with Federal regulations conducted with scientific integrity 19

20 Qualifying for Coverage Some trials will meet the 7 characteristics automatically if: Funded by NIH, CDC, AHRQ, CMS, DOD and VA; FDA IND & IRB Deem IND Exempt Drug Trials: or Supported by Centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA 20

21 Qualifying Clinical Trial If the trial: Meets all 3 mandatory criteria and The 7 desirable characteristics (synopsis) Then the trial is considered to be a Qualifying Clinical Trial Thereby meets the requirements for coverage of Routine Costs 21

22 Covered Services/Routine Costs What Does CMS consider to be Routine Costs? Routine costs of a qualifying clinical trial is defined as: Reasonable & necessary items and services used to diagnose and treat complications All other Medicare rules apply All items and services that are otherwise generally available to Medicare beneficiaries that are provided in either the experimental or the control arms of a clinical trial Items or services that are typically provided absent a clinical trial 22

23 Routine Costs (cont.) Items or services required solely for: The provision of the investigational item or service Covers the administration of an investigational product Clinically appropriate monitoring of the effects of the item or service, or Clinically appropriate monitoring for the prevention of complications Items or services needed for reasonable and necessary care for the diagnosis and/or treatment of complications. 23

24 Routine Care/Cost Decision Tree Would the participant receive the item or service if they were not enrolled in a clinical trial? Routine Care/Cost No Is the item or service required to provide a research item or service? Example: Administration of non-chemotherapeutic agent, or a medically necessary inpatient admission for an investigational surgery Yes Yes No Is the service rendered required for the monitoring of the effects of the investigational item or service? No Yes The item is covered and considered Routine Care/Cost Is the service rendered for the prevention of complications related to the investigational item or service? No Is the item or service medically necessary for the diagnosis or treatment of complications arising from the investigational service? Example: Participant in an arm of the study develops a complication requiring a medically necessary admission Yes Yes 24

25 CMS Defined Research Costs What does CMS consider to be Research? The investigational item or service itself Unless otherwise covered outside of the clinical trial Example: Some items or services are covered but are also part of the trial investigation Off-Label Use of approved drugs Provided these meet CMS criteria usage requirements 25

26 Research Costs Include Items and services provided solely to: Satisfy data collection and analysis needs Services not used in the direct clinical management of the patient Example: 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 If sponsor covers the cost of the service, CMS cannot be billed 26

27 Non-covered Items & Services Services which are statutorily prohibited are not covered under the CMS healthcare plan Example: Cosmetic Surgery Complication relating to the non-covered item & unrelated reasonable and necessary care are covered Will not cover the service itself 27

28 Local Regulations - Novitas Novitas works on behalf of Medicare to manage and process claims and implement state coverage rules called: Local Coverage Determinations (LCD) LCDs detail requirements necessary for reimbursement for certain services including Applicability, frequency, and exceptions Off-Label Drug Use in Clinical Trials Reimbursement requirements for IDE (investigational device exemptions) 28

29 Coverage Analysis Process Separation of Allowable Items and Services Congruency Checks 29

30 Separation of Allowable Items & Services Note all services that are sponsor has agreed to pay Identify remaining line items as administrative, routine clinical services or investigational clinical services (research) Consider all line items identified as administrative to be paid by the sponsor: Non-clinical, investigator salaries, protocol development, recruitment, data QA, statistical analyses, dissemination of findings and study management Clinical services provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient 30

31 Separation of Allowable Items & Services (cont ) Identify routine costs that are payable by the patient and/or third party payor (insurance) Sponsors may indicate in a clinical trial agreement or budget that some items and services are standard of care (SOC) SOC for research billing purposes is not a recognized term and does not always equate to a billing and reimburseable services based on CMS guidelines If a sponsor indicates an item or service is SOC and they are not paying for it, are the services billable and reimburseable? 31

32 Separation of Allowable Items & Services (cont ) Refer to CMS NCD and LCD polices for coverage Refer to investigator brochure and professional practice guidelines 32

33 Consistency of Study Documents Ensure consistency in all study documents: Clinical trial agreement Budget Protocol Schedule of events Informed consent Coverage analysis Consistency check should occur prior to executing the contract and enrolling participants on the study 33

34 Billing / Reimbursement for Qualifying Clinical Trial Services Coverage Analysis Utilization 34

35 CMS Billing Documentation Medicare Claims Processing Manual, Chapter 32, 69.6: Requirements for Billing Routine Costs of Clinical Trials (Rev. 1723, Issued: , Effective: , Implementation: ) (Notice first issued in Medicare Program Memorandum dated September 19, 2000.) Routine Costs Submitted by Practitioners/Suppliers Claims with dates of service before January 1, 2008: HCPCS modifier QV Diagnosis code V70.7 (Examination of participant in clinical trial) reported as the secondary diagnosis Claims with dates of service on or after January 1, 2008: HCPCS modifier Q1 (numeral 1 instead of the letter i) affixed to each service; and Diagnosis code V70.7 (Examination of participant in clinical trial) reported as the secondary diagnosis If the QV or Q1 modifier is billed and diagnosis code V70.7 is submitted by practitioners as a secondary rather than the primary diagnosis, do not consider the service as having been furnished to a diagnostic trial volunteer. Instead, process the service as a therapeutic clinical trial service. Effective for claims processed after September 28, 2009, with dates of service on or after January 1, 2008: Claims submitted with either the modifier QV or the modifier Q1 shall be returned as 35

36 CMS Billing Components Items to be include on the claim: Diagnosis Code called ICD-9 code Line items - list of services provided These are identified by a system of codes CPT codes: common procedural terminology Associated Technical (Hospital) & Professional (Physician) service fees, as applicable Billing and Research Modifiers, if applicable Some specific to research Others explain a modification of service provided ClinicalTrial.gov Number (CTN) 36

37 CMS Billing Components Mandatory reporting of an 8-digit Clinical Trial Number (CTN) on claims: Transmittal #2955 Issued 05/14/2014 Effective 01/01/2014 Implemented 01/06/2014 Full implementation beginning 01/01/2015 Required for all items/services provided in relation to participation in a clinical trial, clinical study or registry that may result from Coverage with Evidence Determinations, Medicare Clinical Trial policy, or a CMS approved investigational device exemption (IDE) study For IDE trials, IDE and CTN required 37

38 CMS Reimbursement Requirements Must use diagnosis code V70.7 (Examination of participant in clinical trial) No cost items (those provided free to the participant but required for billing reimbursement) must be coded as such e.g. administration of non-covered chemo This allows some items to be reflected as free of charge so associated services can be billed to CMS 38

39 CMS Reimbursement Requirements Medical record must be available, if requested and Must contain trial name, sponsor, and protocol number Must have applicable billing and research modifiers for each line item Must have separate line item detail of each service billed 39

40 Research Modifiers In 2008, CMS mandates 2 types of modifiers be applied to the claim NOTE Many other types of modifiers are used, these are the clinical trial specific ones. The 2 types are: Q1 represents routine costs for a clinical trial Q0 represents item or service that is the object of the investigation, and billable to CMS any investigational item on the claim, that is a covered service outside of a clinic trial setting 40

41 Coverage Analysis (CA) Impact In the absence of Clinical Trial Management System (CTMS) Create billing grid for each participant enrolled Follow participant activity IRB approved revisions to protocol Update CA to reflect changes as needed Available for stakeholders: Billing office Principal investigator/study team members Ancillary service providers Radiation Oncology, Pathology, Cardiology, Diagnostic Radiology, etc. Compliance office 41

42 Clinical Research Billing Responsibility Harmonization of all study documents Determine if the study is a qualifying trial for reimbursement of routine care costs by CMS Separation of allowable costs creation of coverage analysis Medical record documentation that services/procedures are related to the clinical trial V70.7: diagnosis code for research; examination of participant in clinical trial Q0 research modifier: investigational clinical service provided in a clinical research study Q1 research modifier: routine clinical service provided in a clinical research study that is an approved clinical research study 42

43 Closing Summary The Coverage Analysis: Created to meet Federal Law requirements Based on protocol procedure/calculated on per pt basis Categorization of charges based on CMS definitions and requirements Foundation of Clinical Research Billing 43

44 Case Study A coordinator reviews a protocol to determine standard of care versus research costs in developing a study budget. The sponsor has indicated what tests they will pay for in the budget and indicated the rest are standard of care. The coordinator develops the budget based on the sponsor s assessment of standard of care costs. Are there any additional items that the coordinator needs to consider or review? 44

45 Case Study A coordinator responsible for submitting CMS claims is reviewing the study budget for an NIH funded Phase 2 clinical study in which a chemotherapeutic agent is being investigated on patients with breast cancer. The sponsor indicated that they will pay for the chemotherapeutic agent, but not additional testing. The coordinator develops the budget based on the sponsor paying for all of the testing since the chemotherapy is not approved by the FDA. Are there any additional items that the coordinator needs to consider or review? 45

46 Poll Rank your understanding of how a Medicare Coverage Analysis is developed after attending this presentation (raise hands) Totally confused Much clearer than when I walked in the door Confident that I could utilize information to prepare a study budget 46

47 Questions Thank you 47

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