1. Billing Compliance Basics
Coverage Analysis 101
April 27, 2017

2. Why is research billing compliance important?
Need to follow local and federal laws related to patient billing
Do not want the patient to be charged for something that should be covered by the study sponsor
Serious consequences for non-compliance
Important that more than billers are involved in billing compliance

3. Risks of Poor Billing Compliance
Double billing
Billing the patient for an item promised free in the consent or an item promised free in the consent
Patient receiving incorrect bills
Can result from billable designations not being reviewed properly or information being entered incorrectly at the time of visit
Fraudulent billing

4. Consequences of Non-Compliant Billing
Fines, paybacks, and penalties
Increased government scrutiny
Cost associated with investigation and action plan
Loss of current or future federal grants
Bad publicity
Reputational harm
Unhappy patients

5. Internal Consequences of Poor Billing Compliance
Confusion from employees and departments
Frustrated employees/staff turnover
Patient Complaints
Delays in the overall process
Operational inefficiencies
Duplicated work
Treatment Delays

6. Impacts of Poor Billing Compliance
Audits, fines, paybacks, and investigations are a concern to sponsors
May make it more difficult to be selected for future studies
Cannot grow research department and can lose access to beneficial therapies
Bad PR
Patients may be less willing to enroll in a study when they hear about audits and improper billing at the institution
Impacts entire institution, not just the research department
Loss of Federal Funds
Inability to participate in federally funded studies and/or obtain to federal grants
Unhappy patients
The patient is already undergoing a stressful health situation and receiving bills and do not need added financial stress from receiving additional medical bills

7. Billing Compliance Activities That Should Occur Before the Study Opens . . .

8. Coverage Analysis/ Billing Grid
Items that Need to be Reviewed for Compliance Reasons Before the Study Opens
Coverage Analysis/ Billing Grid
Budget
Contract
Consent Form
CTMS Build
All must be consistent to establish billing compliance!

9. What is a coverage analysis?

10. Coverage Analysis: Overall Goal
Determine if the study sponsor or insurance will pay for each item or service required by the study.
Similar to a billing grid, but will include written justification

11. Reasons for a Coverage Analysis
Determines if Items/Services are Financial Responsibility of the Patient or Sponsor
Comprehensive Analysis of Clinical Trial Documents
Basis of Research Billing Compliance/ Audit Documentation
Budget Building Tool

12. Building a Coverage Analysis
Grid that shows each protocol required visit and activities at each visit
Includes analysis for why the patient should or should not be billed for each protocol required item or service
Ensures each item has a payor
Compliance and financial impacts
Study calendar

13. Important Billing Compliance Rules
Medicare
Clinical Trial Policy (NCD 310.1)
Benefit Policy Manual
Claims Processing Manual
Local Coverage Determinations
National Coverage Determinations
Institutional
Are there institutional billing policies and procedures?

14. Why are Medicare rules used for billing compliance?
Coverage information is publicly available
Significant compliance risks present if Medicare is improperly billed
Most institutions want to follow a standard set of rules/guidelines

15. Medicare: What do they cover?
Medicare Coverage:
Medicare defines items that are medically necessary as “reasonable and necessary to the overall diagnosis and treatment of the patient’s condition.”
Medicare generally does not cover services without a patient symptom or complaint

16. What does reasonable and necessary mean?
The item must be proper for the diagnosis and/or treatment of the patient’s condition
Used for the diagnosis, direct care, and treatment of the patient’s condition
Meet standards of medical practice
Are not used for the convenience of the patient, provider, or supplier

17. What if we are not enrolling Medicare patients in our study?
Medicare rules may still be cited for research billing consistency
A coverage analysis is still required to prevent double billing
Do not want patient to receive an incorrect bill!
Can use private payor rules, if available
Bring up peds

18. Medicare Rules: NCD 310.1 The Clinical Trial Policy

19. Medicare’s Clinical Trial Policy (NCD 310.1)
Starting Place for Coverage Analysis and Basis of Research Billing Compliance
States what will not be covered within a trial
States what will be covered within a trial
Defines how a trial qualifies for coverage

20. NCD Qualifying Status
All four of these conditions must be met to be considered a Qualifying Clinical Trial
The investigational item must fall under a Medicare Benefit Category
The trial must have therapeutic intent
The trial must enroll patients diagnosed with disease
The study must be deemed

21. Qualifying Status: Medicare Benefit Categories
The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare Benefit Category. A few examples are listed below:
Drugs and Biologicals
Inpatient Hospital Services
Medical Devices and Prosthetics
Durable Medical Equipment
Oral Anticancer Drugs
Oral Antiemetic Drugs

22. Qualifying Status: Therapeutic Intent and Diagnosed Disease
The trial must test efficacy and not just safety
Combined Phase 1/2 studies are a unique challenge
Diagnosed Disease
Trial must enroll patients with diagnosed disease, not just healthy volunteers
Study may have healthy control arm as long as there is a corresponding arm that is diagnosed with disease

23. NCD 310.1 Qualifying Status-Deemed
Trial meets the Seven Desirable Characteristics
The principle purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes
The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already common in clinical use
The trial does not duplicate existing studies
The trial design is appropriate to answer the research question being asked in the trial
The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully
The trial is in compliance with Federal regulations relating to the protection of human subjects
All aspects of the trial are conducted according to the appropriate standards of scientific integrity

24. Qualifying Status: Deemed Trials
Trials that are automatically deemed to meet the seven desirable characteristics are:
Funded by NIH, CDC, AHRQ, HCFA (CMS), DOD, and VA
Supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, HCFA, DOD, and VA
Conducted under an investigational new drug application (IND) reviewed by the FDA
Drug trials that are exempt from having an IND under 21 CFR (b)(1)

25. NCD 310.1: What is covered during a clinical trial?
Items provided absent a clinical trial (conventional care)
Items or services required for the provision of the investigational item or service (IV admin of an investigational drug)
Items and services that are reasonable and necessary care for the diagnosis and treatment of complications

26. NCD 310.1: What is not covered during a clinical trial?
The investigational item itself (unless covered absent a trial)
Items used only for data collection
Items or services provided by the sponsor free of charge
Items or services limited by other National or Local Coverage Determinations (NCDs/LCDs)

27. Use national guidelines
Review side effects in the consent form and warnings on the FDA label
Review the sponsor budget to see if the sponsor is paying for an item
Review the consent to see what is promised free to the patient
How does the coverage analysis team determine if something is billable under NCD 310.1?

28. Challenges for the Analyst Questions for the Study Team
Challenges and Possible Questions for the Study Team Related to NCD 310.1
Challenges for the Analyst
Questions for the Study Team
Guidelines and FDA warnings are not written for the clinical research setting
Guidelines often lack frequency recommendations
Cannot find guidelines
How often do you do this test for non-research patients?
Would this test be repeated after the patient is diagnosed?
Do you have any guidelines that you would recommend?

29. Why is this information so important?
No one wants the patient to be charged inappropriately!

30. Patient Billing in Device Trials
Medicare will cover “routine care” items for certain device types
Routine Care Items
Medicare Benefit Policy Manual Chapter 14
Item would be otherwise available to the beneficiary
May need Medicare approval to bill for routine care items
Device Status Required to Bill Routine Care Items
Category A or B IDE
PMA
510 (k)
Humanitarian Use Device
Hospital IRB Approved Non-Significant Risk

31. Determining What Can be Billed Under Medicare Benefit Policy Manual Chapter 14
Medicare Benefit Policy Manual Chapter 14 (not NCD 310.1)
Supports coverage for certain investigational devices and services incident to the device under conditions
National and local coverage determinations (and any other rules/regulations) still apply
May require Medicare Administrative Contractor Approval
Medicare coverage ceases if device loses FDA status

32. Types of Devices Potentially Covered By Medicare
Category B IDE
510(K)
PMA
Hospital IRB Approved
Humanitarian Use Devices

33. Investigational Device Exemption Studies (IDE)-Category A and Category B
Significant Risk Devices
Generally, implanted in the body
Only distributed through research studies
Require labeling, monitoring, and reporting
Study sponsor is responsible for FDA submission (could be PI in IIT)
Notes:
Medicare will cover routine costs associated with Category A and Category B devices
Medicare will cover the Category B device, but not the Category A device
Study needs to be submitted to Medicare and approved by Medicare prior to billing

34. Similar/Equivalent Legally Marketed Device Must Exit
510 (k) Cleared Devices
Similar/Equivalent Legally Marketed Device Must Exit
Must be at least as safe and effective as the legally marketed device
Medicare may cover the device and routine costs
Indications/limitat-ions for Medicare coverage may be found in NCDs/LCDs

35. Premarket Approval (PMA) Devices
Used for riskiest devices (Class III-support or sustain life)
Most stringent level of FDA device review
Must submit data from previous studies
Classification allows device to be marketed
Medicare may cover PMA devices-need to review NCDs/LCDs

36. Hospital IRB-Approved Devices (non-significant risk)
Non-significant risk devices that do not require FDA approval
Sponsor makes initial determination and then IRB confirms or rejects decision
Medicare contractors make coverage decision (use IDE criteria)

37. Humanitarian Device Exemptions
For devices that benefit patients with rare disease (less than 4,000 patients diagnosed per year)
Sponsor must submit to the FDA for HDE approved
FDA approved for a specific use
LCD L36238 – states HDE devices and procedures will be reviewed on an individual claim basis with the following information:
Details about the specific device and FDA HDE approval
Clinical indications for why the device was required along with documentation that the benefit outweighs the risk
A copy of the institutional IRB approval letter for each patient

38. Additional Medicare Rules (non-research)

39. National and Local Coverage Determinations
NCD
National Coverage Determination
Released by CMS
Apply nationwide and to US territories
LCD
Local Coverage Determination
Released by Medicare Contractors
Apply to contractor’s region only
Cannot contradict NCDs
Both standardize Medicare coverage for certain tests/procedures
Apply to Medicare Part A and Part B

40. General Information Found in NCDs/LCDs
Common NCD/LCD Sections
Benefit Category (lists the benefit category of the test/procedure)
Item/Service Description (provides general background information regarding the test/procedure)
Indications (describes specific situations when an item will be reimbursed for certain patient populations)
Limitations (describes specific situations when an item will not be reimbursed for certain patient populations)
ICD Code List (these can confirm if the study indication is covered)

41. Challenges with NCDs and LCDs
Not written for the clinical research setting
Coverage often dependent on the patient having signs and symptoms
Hard to know if every patient will experience certain signs/symptoms
Coverage may be limited after a patient has a normal test result

42. Medicare Benefit Policy Manual Chapter 15- Drug Coverage
Several Medicare rules for billing drugs
Off-label oncology
Off-label non-oncology
Oral oncology
Oral drugs in the outpatient setting

43. Rules for Off-Label Drug Coverage
May be billed if:
Use is supported in a compendium
Use is supported in a peer reviewed journal
Need documentation to bill!
The study team may be asked for documentation to support billing the medication
Documentation must be specific to the patient population

44. Coverage Analysis Sign-Offs What information is needed from the clinical team?

45. Considerations for CA Sign-Off
Goal is to be consistent with billing outside of research
Focus on the billing designation
Compliance concerns with changing billing designations after a patient enrolls

46. Considerations for CA Sign-Off
Would the test be ordered outside of the trial?
Example: CPK testing during chemotherapy
Under what circumstances would the test be ordered outside of the study?
All patients or only under certain circumstances
Is the test required by the protocol what would normally be used to monitor the item?

47. Considerations for CA Sign-Off
Items may be marked as a research cost even if normally billed to the patient when. . .
The sponsor is paying for the item
There are Medicare billing requirements that cannot be assumed for all patients before the time of care
The test is ordered at a greater frequency than standard practice

48. Billing Compliance After the Study Opens

49. After the Study Opens . . .
Having an approved CA on file does not equal billing compliance
Billers and financial/invoicing teams need to use the CA to ensure patients are billed correctly
The costs section of the consent needs to be clearly explained to the patient
Documentation may need to be provided to the billers and invoicing team

50. Using the CA
Billers –
Review the CA to see if any research items need to be removed from the claim
Make sure the NCT number and research identifiers are added to the claim for routine costs
Invoicing Team
Review the CA and budget to determine if any items need to be invoiced to the sponsor

51. Information Required from the Study Team
Standard of care windows
Some items are billable for patients if it falls within their standard of care imaging window. If the item falls outside the window (repeated for study enrollment purposes only), then it is research
Coordinator or physician will need to provide information about whether or not the item fell within the SOC window

52. Information Required from the Study Team
When certain administrative activities occur:
SAEs
Screen fail
IND safety reports
Sponsor pays for administrative work required for these activities (and others), but only pay after the site sends an invoice

53. Summary Several consequences for poor billing compliance
Billing compliance is driven by the coverage analysis
Coverage analysis is developed following Medicare rules and regulations
Goal is to be consistent with billing in and out of research
More than just billers are involved in a successful billing compliance process!

54. Discussion