1. PFS Clinical/Florida Hospital Coverage Analysis Workshop
April 27-28, 2017

2. Coverage Analysis Goal
To determine if the study sponsor or insurance will pay for each item or service required by the study. If insurance pays for an item or service, then justification for billing should be included.

3. Who/what does the CA impact?
Patient
Billers
Invoicers
Physician
Coordinator
Sponsor
Finance

4. What information should be included in a CA?
Qualifying trial analysis
NCT number
Basic study information
Grid
CPT/HCPCS codes
Justification for billing
Research modifiers
Talk about the basic study info. Bring up items like document version dates, consent costs section documentation, verifying that the consent benefits matches the objectives, documenting the reason why or why not the item is billable, etc.

5. CA Process Overview Qualifying Status/NCT
Build Grid-Include CPT/HCPCS Codes
Analyze Items/Services Included in the Grid
Add Appropriate Modifiers
Finalize Coverage Analysis

6. Drug Study Coverage Analysis

7. Qualification Process

8. Determining if the study qualifies
Non-Device Studies: NCD 310.1:
Must meet all four criteria below to qualify
Must fall under a Medicare Benefit Category
Trial must have therapeutic intent
Trial must enroll patients diagnosed with a disease
Trial must be deemed (have an IND, cooperative group, government funded, IND exempt)
** Please note: In order to bill items in a qualifying clinical trial, an NCT number is also required. **

9. Where do you find this information?
What is the investigational item? Benefit categories are listed at the top of NCD 310.1
Benefit Category:
Protocol objectives (look for efficacy, response rates, time to progression, not safety)
Therapeutic Intent:
Protocol inclusion criteria
Diagnosed Disease:
IND letter or IND number listed in first few pages of the protocol OR study sponsor
Deemed Status:

10. Example

11. Grid and CPT Codes Grid itself is critical – especially in the CTMS
Start with the protocol schedule of events, then look for additional items
May match to sponsor budget format in industry studies
CPT codes are an important factor
Help identify National and Local Coverage Determinations
Assist the billers
Show bundled items

12. Building the Grid Start with schedule of events
Transpose items and timepoints
Add CPT/HCPCS codes
Look for items/services not included in schedule of events

13. Grid Building Considerations
What does the protocol schedule of events look like compared against the sponsor budget? Do they match?
Sometimes it will be better to follow the budget format than the protocol format
Common example: Protocol calendar has one column for “all cycles” and sponsor budget has an individual column for each cycle through cycle 15
How will the grid look once it is entered into the CTMS?
Limited footnote functionality in the CTMS system – footnotes will be better placed in the comment box

14. Grid Building Considerations
Document page numbers - it will make it easier for the next user to find the item in the protocol or consent, especially when item is not in schedule of events
Double check that time points were entered correctly
Start with the schedule of events, but also read the protocol section for a better definition of the item
Example: Disease assessment (may be a simple staff time review or it may mean scans + a physical exam)
Verify central vs. local lab – reach out the sponsor if this is not clear because this has a major impact on patient billing

15. Analysis

16. Goal of Analysis
Form an argument and present evidence for why the item should or should not be billed to the patient at each time point

17. What items are referenced for coverage analysis arguments and evidence?
Sponsor Budget
Informed Consent
Protocol
NCD (non-devices)
Medicare Benefit Policy Manual Chapter 14 (devices)
Medicare Benefit Policy Manual
National Coverage Determinations
Local Coverage Determinations
Hospital/Department Standard Practices

18. Starting Place for Analysis- Drugs and Devices
Consent Form
and
Sponsor Budget
Does the consent form promise anything free?
If so, is this the true intent?
What is the sponsor paying for?
Document all items paid for by the sponsor

19. Why start with the budget and consent?
Prevent double billing!
Save time!
It takes a long time to analyze each item, no need to analyze items that are sponsor paid!
Identify language that requires editing early
Catch changes that need to be made before the study opens

20. Coverage Analysis Arguments
NCD (non-devices)
Medicare Benefit Policy Manual Chapter 14 (devices)
Reasonable and Necessary
NCDs/LCDs
Medicare Benefit Policy Manual (inpatient and drugs)
Research Related

21. General Considerations for Analysis
Consider the following when analyzing each protocol:
Trial phase
Patient’s disease
Disease stage
Open-label vs. blinded
When is the item required throughout the study?
Qualifying vs. non-qualifying trial
Inpatient vs. outpatient

22. General Considerations – Pediatrics
Many sites will develop a pediatric policy
Can use Medicare rules for consistency or may not use any Medicare rules
“Payor analysis” – is there one major payor? If so, what is their research coverage policy?
Try to find pediatric specific resources to cite
Work with physicians and study team to ensure items marked as routine care would be ordered outside of a study
Many sites follow the Medicare rules, but do not actually cite them. May make items billable that are clearly connected to the disease, but limited by a Medicare rule

23. Could you explain why the item is billable to an auditor?
Think about what the counter-argument is-if an item is billable, what would the argument be for making it research. Are there gaps in your argument? For example, did you address all of the study time points.

24. Forming The Strongest Arguments
Why, why, why???
Reason for performing item at each time point may be different
Screening, during therapy, follow-up
Citations=evidence
Use citations whenever possible
Keep it simple
Discuss that reason at one time point may be for the clinical management of the patient, but for research data purposes at another timepoint
Importance of tying back to a Medicare rule
Simple will help the next users of the document

25. Forming Arguments Based on Medicare’s Research Specific Rules

26. Routine Costs of a Clinical Trial According to NCD 310.1
Items provided absent a trial (conventional care)
Items required for the provision of the investigational item or service
Items that are reasonable and necessary for the diagnosis and treatment of complications of the investigational product

27. Defining NCD 310.1 Arguments

28. Items Typically Provided Absent a Study
Defined as “conventional care”
Determine conventional care by using national guidelines
NCCN, AHA, ACCF, journals
Guidelines should be specific to the patient’s underlying condition and disease stage

29. Finding Guidelines Finding guidelines is a challenge!
Scholar.google.com shows if full text article is available for free
Make sure guidelines match your study situation
May need to use multiple guidelines to complete analysis

30. Using the Guidelines

31. NCCN Guidelines - Oncology
Free resource (nccn.org)
Gold standard for oncology
Address pre-treatment and post-treatment
On treatment information is limited in most sets

32. Terminology for NCCN Guidelines
Pre-treatment=Workup
A set of tests and procedures performed prior to starting a new therapy or as part of disease staging/diagnosis. Workup may be different depending on the patient’s disease stage.
Post-Treatment=Follow-up/Surveillance
Tests and procedures done after the patient completes therapy to monitor their disease and for signs and symptoms of relapse.

33. Applying the Guidelines to the Protocol
Work-up and initial evaluation can be applied to the screening visit (pre-therapy)
Follow-up/surveillance may be applied to the post-therapy period
Watch carefully to see if follow-up appears before or after the guidelines for relapsed patients

34. Walkthrough NCCN Guidelines and Examples

35. NCCN Appropriate Use of Imaging Criteria
Provides information about when imaging is considered conventional care
Addresses the treatment period that is often missing in the guidelines
Walkthrough (

36. Non-Oncology Guidelines
Look for guidelines from credible organizations such as American College of Cardiology
National Guideline Clearing House is a good starting place:
American College of Radiology Appropriateness Criteria:

37. Walkthrough guideline.gov and ACR Websites

38. Citing Guidelines
Always list the full name of the article at least once in the analysis in order to reference later, if required
Save a PDF version – guidelines update all the time!
Include quotes whenever possible
State the item is “conventional care”
Always include page numbers (it will help if anyone needs to reference later)

39. NCD 310.1 –Provision of the Investigational Item
Medicare covers the cost of items required for the provision of the investigational item or service
IV Admin of Study Drug
SC Admin of Study Drug
IT or IM Admin of Study Drug
Hydration required for study drug
This is an item where it is common to reject sponsor payment because it is easier for the billers when the IV admin is billed to the patient

40. NCD 310.1- Side Effects One of the most common CA arguments used
NCD covers items used to monitor side effects of the study drug
Argument is frequently used to justify tests during the active treatment period of the study

41. Where to find side effects?
Consent Form
DailyMed (FDA Label)
Protocol
Investigator’s Brochure

42. Considerations for Justifying Based on Side Effects
Are the side effects reported from animal or human studies?
Is there a warning on the FDA label that includes recommendations for monitoring certain tests?
Is the test appropriate to monitor the side effect?
Are side effects strongest justification at screening and follow-up?
Can find side effects for everything, but what is the likelihood that it will occur? Consider the level and frequency of testing. Be careful about justifying tests during follow-up based on side effects

43. Using the FDA Labels
The FDA label often contains clinical testing recommendations
Sometimes, includes testing frequency recommendations that provide strong justification for billing the item

44. Walkthrough DailyMed Resource

45. Side Effect Based Analysis
Cite the resource where you found the side effect
Always cite the FDA label, if used
Example:
Doxorubicin is known to cause decreased blood counts (DailyMed). The FDA label states that blood counts should be monitored prior to each dose (DailyMed). Therefore, this item is used to detect, monitor, and treat potential side effects of the study drug on day one of each chemotherapy cycle.

46. Items Not Covered in a Clinical Trial According to NCD 310.1
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)

47. What are other Medicare rules that need to be incorporated into a coverage analysis?

48. Additional Medicare Rules to Incorporate
Compliance with non-research rules is critical!
Medicare Benefit Policy Manual Chapter 14 (devices)
Reasonable and Necessary
NCDs/LCDs
Medicare Benefit Policy Manual (inpatient and drugs)

49. General Medicare Coverage

50. What does Medicare cover?
“Items that are considered reasonable and necessary to the overall diagnosis and treatment of the patient’s condition”
Source:

51. How does Medicare define reasonable and necessary?
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
Source:

52. When to use the reasonable and necessary argument?
The item makes sense for the patient population, but is not included in the guidelines and is not a side effect
“Medical common sense”
Common examples: pre-operative labs, imaging during chemotherapy, labs during an inpatient stay
Challenge: The item is probably standard practice for the patient population, but a specific guideline cannot be found to cite. The physician should be verifying these items (along with everything else) when they sign off

53. A Note About Mixed Designations
Billable/Research
Common in complex studies
Have an impact on budgeter, billers, invoicers, the sponsor, and the study team
Discuss impact on the others. Discuss avoiding when making it billable/research dependent entirely on individual patient symptoms

54. Common Mixed Designation Situation
Item is billable if it falls within the patient’s SOC window at screening and research if it falls outside of the SOC window
Can the SOC window be defined?
If not, need to define how the study team will inform billers and invoicers whether the item fell within the SOC window for each patient
Used primarily for screening
Needs to be clearly defined in the CA and budget

55. NCDs and LCDs

56. What are NCDs and LCDs?
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

57. Reading and Interpreting NCDs/LCDs
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)

58. Searching for NCDs NCD Search Alphabetical List Organized by Specialty
Manual
LCD Search
LCDs
Active First Coast Service Options LCD List

59. Most Commonly Used NCDs
190.15: Blood Counts
190.20: Glucose
220.1: CT Scans
20.15: ECG
190.23: Lipid
220.2: MRI
: PET for Oncology
190.17: PT
190.16: PTT

60. Interpreting NCDs and LCDs
Coverage information is not always clear
Range of interpretations is possible for trickier NCDs/LCDs
May be able to work with billing/reimbursement departments to find out when certain tests/procedures were covered or denied outside of trials
Common place for policy development

61. Walkthrough NCD (PTT)

62. Example: NCD 190.23 Lipid Testing
“Routine screening and prophylactic testing for lipid disorder are not covered by Medicare. While lipid screening may be medically appropriate, Medicare by statute does not pay for it. Lipid testing in asymptomatic individuals is considered to be screening regardless of the presence of other risk factors such as family history, tobacco use, etc.”
Does any language stand out?

63. Example: NCD 190.23 Lipid Testing
“Routine screening and prophylactic testing for lipid disorder are not covered by Medicare. While lipid screening may be medically appropriate, Medicare by statute does not pay for it. Lipid testing in asymptomatic individuals is considered to be screening regardless of the presence of other risk factors such as family history, tobacco use, etc.”
Summary: testing in asymptomatic patients is not covered!
Screening= absent signs and symptoms, not necessarily the screening visit
Even if it is appropriate, it is still not covered

64. Analyzing Lipid Tests
Patients enrolled in the study have melanoma and will take pembrolizumab, which is known to cause hypercholesterolemia and hypertriglyceridemia. Is the lipid test billable prior to each pembrolizumab cycle?

65. Analyzing the Lipid Test
Lipid disorders are a side effect of the study medication, pembrolizumab. Therefore, the side effect argument from NCD could be used
BUT . . .
NCD limits testing in asymptotic individuals regardless of risk factors
Therefore, the lipid test should not be billed to the patient

66. NCD/LCD Analysis Strong support for billing an item
Useful when there are limited guidelines available
Challenge:
Not written for research
Dependent on signs and symptoms, but it is not known if every patient will develop the side effect . . .

67. NCD/LCD Analysis What is the challenge with this analysis?
NCD states a PTT test is covered only when patients experience signs or symptoms of bleeding or thrombosis. The study medication, ABC123, is known to cause blood clots (ICF, p. 14). Therefore, a PTT test is billable for patients who experience a blood clot.
NCD limits coverage for the PTT test absent signs or symptoms of bleeding and thrombosis. Therefore, this test is research related for asymptomatic patients.
Discuss impacts this analysis has on others once the study opens

68. Solution
Avoid making analysis dependent on individual patient symptoms
Make the PTT research
Saves the budgeter, biller, invoicer, and study team time
Removes compliance risk

69. Considerations for Modifiers and Claims

70. Modifiers and NCT Number
Modifiers, the NCT number and Z00.6 code are required on claims for qualifying clinical trials
Special Situations:
Inpatient studies
Non-qualifying studies

71. Q0: Q1: Research Q Modifiers
Used for the investigational item (even when the sponsor provides the drug)
Q0:
Used for routine costs in qualifying clinical trials
Q1:

72. NCT Number and Investigator Initiated Trials
If the trial qualifies, make sure the study is listed on clinicaltrials.gov
NCT will be required on the claim along with modifiers and Z00.6 code
Missing NCT number is a common issue for investigator initiated trials

73. Practice Study

74. Medicare Drug Coverage
Most IV medications used on-label (FDA approved for the indication) will be covered
Always double check for NCDs and LCDs, some drugs will have special conditions for coverage
Some medications will be covered off-label if they are considered medically accepted (compendium or peer reviewed journals)
NIH DailyMed is a great resource for FDA labels

75. NIH DailyMed Walkthrough www.dailymed.nlm.nih.gov/dailymed

76. Off-Label Drugs Medicare Benefit Policy Manual Chapter 15, Section 50
Medicare allows coverage for oncology and non-oncology off-label drugs
Support from compendium OR peer reviewed journal
May need to request supporting documentation from study team

77. Oral Medications Medicare Benefit Policy Manual Chapter 15, Section 50
Not covered in the outpatient setting
Challenge:
Protocol gives option between oral and IV medication
Chemotherapy pre-medications

78. Oral Medications
Will the patient obtain the medication at a commercial pharmacy?
If medication given in the clinic . . .
Check to see if PI has a preference for oral or IV
Can the pre-medications be built into the budget?
Does the department already have a process in place for oral medications?

79. Device Coverage Analysis

80. Medicare Benefit Policy Manual Chapter 14
Supports coverage for certain investigational devices and services incident to the device under conditions
Supports coverage for items a patient that would otherwise be available to the beneficiary (routine care)
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

81. “Qualifying Status” Devices
Medicare Benefit Policy Manual Chapter 14
IDE
FDA approved as an IDE for patient population
Listed on the Medicare IDE website
PMA and 510 (K)
FDA approved as a 510(k) for patient population
No Medicare approvals
Humanitarian Use Devices
FDA approve as a HDE for patient population
No Medicare approval
Hospital IRB-Approved
Investigator determines status, confirmed by IRB
Need Medicare approval letter to bill
FDA status is the key to qualifying a device study. Medicare approval only required for certain device types.

82. Non-qualifying device studies
Rare
Lack of FDA status OR Medicare approval is cause for concern
Check to see if there are any potentially billable items
Talk to the sponsor before proceeding with analysis
Will the IDE study be submitted to Medicare?
Did Medicare not approve the IDE study?
Talk about importance of stopping analysis until confirmation from the sponsor

83. Coverage for Routine Care Items
An item that would be otherwise available to the beneficiary
Does this sound familiar? How do you determine if an item is routine care?

84. How to determine when an item is routine care
Guidelines!

85. How to determine when an item is routine care
Guidelines!

86. Device Guidelines American Heart Association
American College of Cardiology
American Association of Neurology Nurses

87. Medicare Rules that Need to be Incorporated Into Device Studies
NCDs
LCDs
Medicare Benefit Policy Manual
Reasonable and Necessary
Standard Practices (not Medicare, but important to be consistent with non-research patients)

88. Coverage for Investigational Devices
Device Types Covered by Medicare
Category B IDE
510 (K) Devices
PMA Devices
Humanitarian Use Devices (HDE)
IRB Approved Non-Significant Risk Devices
Note: Category A IDE devices are not covered by Medicare, but routine care items will be covered

89. How to find out if the device is covered
Review the FDA letter (may need to request from sponsor)
Is the device category covered by Medicare?
Is the device being used “on-label”?
Is there Medicare approval for the study (IDE studies and hospital-IRB approved devices)?
If the answer is yes to all of the above, then the device can be billed to the patient (assuming it is not limited by a NCD or LCD).

90. Special Items to Look for in Device Studies
Coding
Many surgery codes are inclusive of other items (example: angiography, EKGs, etc)
It is important to make sure the sponsor does not cover the cost of items bundled with the procedure
NCDs and LCDs:
Many surgical procedures and diagnostic tests have LCDs and NCDs
Need to ensure the patient population and coverage information in the NCD/LCD matches the protocol

91. Practice Device Study

92. Special Topic – Coverage with Evidence Development
Allows coverage for items that have evidence of benefit, but Medicare has not determined if the item is reasonable and necessary
Supports coverage for new treatments and technologies
Special requirements

93. Coverage with Evidence Development Requirements
Clinical study participation
Item will only be covered within clinical studies
CMS publishes a list of studies, similar to the IDE search
Data may also need to be submitted to a registry
Check to make sure study location is on the registry

94. Coverage with Evidence Development
If the study is not on the list AND the Florida Hospital location is not on the registry, then the item cannot be billed to the patient
Extra step to the qualification process

95. Summary Qualification Do this before completing any subsequent steps!
Grid Build
Start with schedule of events, then review the remainder of protocol for hidden items
Analysis
Start with NCD or Medicare Benefit Policy Manual Chapter 14
Do not forget non-research Medicare rules!

96. Wrap-Up Questions? Amanda Miller
Training Manager, Clinical Research Administration
ext. 2263
Jess Melton
Manager, Clinical Research Administration
ext. 2281