Clinical Research Billing Analysis - FAQs

  1. What is a Clinical Trial Master Matrix (CTMM)?
  2. Why do I have to create a Clinical Trial Master Matrix?
  3. What are the benefits of creating a Clinical Trial Master Matrix?
  4. Why is a Billing Analysis necessary?
  5. What is a Coverage Analysis (CA)?
  6. Why do we perform a Coverage analysis if the Sponsor had already done one for the study?
  7. My study is a ‘qualifying trial’.   What does that mean?
  8. Why must I evaluate whether or not my study is “Medicare Qualifying”?
  9. Why use Medicare rules in determining coverage of costs? (My studies may never involve subjects within the Medicare population.)
  10. What are the qualifying criteria for a Medicare Qualifying Trial?
  11. What is meant by ‘Therapeutic Intent” in the context of a clinical trial?
  12. What is a routine cost?
  13. Which items/service would not be considered routine?
  14. What is a research cost?
  15. What are LCDs and NCDs?
  16. Do all Device Trials have to be submitted to CMS for a coverage determination?
  17. Why does my Device Trial have to be sent to WPS for a Medicare Coverage Determination?
  18. What is a MAC?
  19. To which MSC do we belong?
  20. What is the “turn-around time” for device trials sent to the WPS Medical Director for the coverage determination?
  21. Can I enroll study subjects that have insurance other than Medicare on my device trial before the MAC Medical Director notifies us of the coverage determination?
# Questions Answers
1.      What is a Clinical Trial Master Matrix (CTMM)? The Clinical Trial Master Matrix (CTMM) is an Excel spreadsheet workbook that records basic information about the clinical trial along with protocol specific scheduling of research related procedures/treatments and details how these procedures / treatments will be billed.   The CTMM was designed to function as a “stand alone” document that serves as a resource for authorized personnel who do not have immediate access to the contract, budget, and/or protocol.
2.      Why do I have to create a Clinical Trial Master Matrix?  The Clinical Trial Master Matrix (CTMM) has been required by policy and procedure since June of 2006.  The IRB will not release a study for enrollment until the CTMM has been completed and submitted to the Clinical Research Financial Compliance Specialist (CRFCS) and Institutional Review Board (IRB) for review. 
3.      What are the benefits of creating a Clinical Trial Master Matrix? Preparing the Automated Matrix Workbook offers many benefits, especially if completed early in the study initiation process. It provides the framework for the coverage analysis process, aids in budget preparation and negotiation with sponsor, in addition to providing transparency in charging/billing thereby promoting billing compliance.
4.      Why is a billing analysis necessary?   The billing analysis process was designed to document due diligence and provide transparency of clinical trial billing.  The Office of the Inspector General (OIG) work plans consistently include clinical research billing as a high priority in their compliance initiatives. From a business and research perspective, identifying conventional care vs. research costs is paramount when determining the responsibility for charge payment. 
5.      What is a Coverage Analysis (CA)?   The Coverage Analysis (CA), using the Clinical Trial Master Matrix (CTMM), verifies conventional “standard” care vs. research only costs to identify what can or cannot be billed to a third party payer (either private insurance or Medicare).  The process also compares the matrix, Informed Consent Document (ICD), and preliminary budget to ensure that all costs are covered, thereby assuring that the study budgets reflect the true cost of research.
6.      Why do we perform a Coverage analysis if the Sponsor had already done one for the study? Coverage is not standard across the United States and will differ depending upon the rulings of the Medical Directors of the various Medicare Administrative Contractors (MACs). The Sponsor has no idea which entities will be participating in any given trial.  If they perform a coverage analysis at all, they usually will meet the criteria and guidelines appropriate for their home state and MAC jurisdiction. The sponsor’s analysis may not satisfy the criteria identified by the Medical Director of our J-5 MAC, Wisconsin Physicians Service (WPS). We also have to comply with the policies and procedures of UNMC/TNMC/UNMC-Physicians and Nebraska state statutes and guidance.
7.      My study is a ‘qualifying trial’.  What does that mean? This means your trial may bill the routine costs to Medicare or other 3rd party insurance payers. Per National Coverage Decision (NCD) 310.1 Routine costs of clinical trials may be billed to Medicare if the study is a “Medicare Qualifying Trial”. If the study does not meet the qualifying criteria provided, no costs can be billed to insurance, not even routine costs. Notable exception: diagnosis and treatment of adverse events for all trials regardless of qualifying status.
8.      Why must I evaluate whether or not my study is “Medicare Qualifying”?       Without this evaluation, we might bill Medicare in error for items/services that are not eligible.  This would invoke the Office of the Inspector General’s  (OIG) “fraud and abuse” rulings and open our institutions/PIs to audits and investigations. 
9.      Why use Medicare rules in determining coverage of costs? (My studies may never involve subjects within the Medicare population.) Medicare is considered the ‘gold standard’ for comparison. National Coverage Decision (NCD) 310.1 provides guidelines, referencing Medicare, for determining the qualifying status and what may be covered. Many states have passed legislation that requires private payers to follow the Medicare rules.
10.    What are the qualifying criteria for a Medicare Qualifying Trial?

Mandatory criteria – must satisfy all 3 criteria

  1. The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category and is not statutorily excluded from coverage.
  2. The trial must have ‘therapeutic intent’ and is not designed to exclusively test toxicity or disease pathophysiology.
  3. Trials of therapeutic intervention must enroll patients with diagnosed disease rather than healthy volunteers. Notable exception: If protocol design calls for a proper control group healthy volunteers may be enrolled and covered for routine costs. 
AND ‘Deeming’ criteria(must satisfy at least 1 of the 4 possibilities)
  1. Trial is funded by NIH, CDC, AHRQ, CMS, DoD, or VA OR
  2. Trial is funded by a center or cooperative group funded by one of the government agencies listed above OR
  3. Trial is conducted under an Investigational New Drug application (IND) reviewed by the FDA OR
  4. Drug trial is exempt from having an IND under 21CFR 312.2(b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that time the trial must be reassessed for qualifying criteria in order to maintain Medicare Coverage of routine costs. (Applies to future status of the trial and will not be used to retroactively change the earlier ‘deemed’ status.)
11. What is meant by ‘Therapeutic Intent” in the context of a clinical trial? The Centers for Medicare & Medicaid Services (CMS) has not provided a specific definition for ‘Therapeutic Intent”. The official UNMC (IRB sanctioned) definition is: "To have therapeutic intent, the trial must, to some extent, assess the effect of the intervention on the patient outcome.  The trial must not be designed to exclusively test for toxicity or disease pathophysiology.” Basically we expect the patient to benefit, in some way, from participation in the clinical trial.
12. What is a routine cost?

Medicare defines routine costs as:

  1. Items or services that are typically provided when the patient is not on a clinical trial (e.g., conventional care, or standard of care services)
  2. Items or services required for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent)
  3. The clinically appropriate monitoring of the effects of the item or service, or the prevention of complications.
  4. Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service – in particular, for the diagnosis or treatment of complications.
13. Which items/service would not be considered routine?

Items/Service not considered to be routine costs are:

  1. The investigational item/service (whatever is being studied) unless the item/service is already covered outside a clinical trial
  2. Items/services provided solely for research purposes (e.g., data collection, tests performed more frequently than dictated by conventional standards, etc.)
  3. Items/services solely to determine eligibility
  4. Items/services provided/paid by the Sponsor
  5. Items/services promised free in the Informed Consent document (ICD
  6. Items/services not generally available:
    1. Items/services falling outside of a Medicare benefit category
    2. Items/services that are statutorily excluded (e.g., excluded by National Coverage Decisions (NCDs) or Local Coverage Decisions (LCDs)
14. What are Research Costs?

Patient care costs associated with the research trial. Examples of items and services that are specifically included as research costs are

  1. The investigational item or service, itself.
  2. 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)
  3. Items and services customarily provided by the research sponsor free of charge for any enrollee in the trial.
  4. Items and services provided solely to determine trial eligibility.
15. What are LCDs and NCDs?               

Coverage provided to Medicare beneficiaries is determined by a Centers for Medicare & Medicaid Services (CMS) process. There are two types of coverage assessments that may take place, those on a local level and those on a national level.

  • Local Coverage Decisions (LCDs) are confined to a specific geographic area.
  • National Coverage Decisions (NCDs) are made on a national level.
If LCDs and NCDs exist concurrently in regard to a particular coverage policy, the NCD takes precedence.
16. Do all device trials have to be submitted to CMS for a coverage determination? No, There are different classifications for device trials. It will depend upon the type of device trial you are proposing.  Types of device trials are:
  • Pre-Market Approval (PMA)
  • 510(k)
  • Investigation Device Exemption (IDE)
    • Category A – Experimental (class III devices)
    • Category B – Non-experimental and/or investigational devices  (class I or II or III where the underlying questions of safety and efficacy have been resolved, if the device type is equivalent to other devices that have obtained FDA approval)
17. Why does my Device Trial have to be sent to Wisconsin Physicians Service (WPS) for a Medicare Coverage Determination? Your trial has an Investigational Device Exemption (IDE).   The Medical Director for the Medicare Administrative Contractor (MAC) must review and approve the trial for Medicare coverage prior to subject enrollment. (Medicare Claims Processing Manual, Pub. 100-4 Ch.32, Sec.68.2 transmittal 951)  CMS determines Medicare device coverage based on which category the Food and Drug Administration (FDA) assigns the device. Devices are designated as either a Category A IDE or a Category B IDE.
18. What is a MAC? A MAC is a Medicare Administrative Contractor. CMS has awarded 19 MACs through a competitive bidding process during the initial implementation phase. These include 15 A/B MACs servicing the majority of all types of providers (both Part A and Part B), and four specialty MACs servicing durable medical equipment suppliers. The current home health and hospice providers will be consolidated into to existing jurisdictional divisions.
19. To which MAC jurisdiction do we belong? We belong to the jurisdiction - 5 (J-5) MAC and our contractor is Wisconsin Physicians Services (WPS). WPS has three Medical Directors that share the duties of the office.
20. What is the “turn-around time” for device trials sent to the Wisconsin Physicians Services (WPS) Medical Director for the coverage determination? The Wisconsin Physicians Services (WPS) Medical Director states that coverage determinations may take up to six weeks (45 working days).
21. Can I enroll study subjects that have insurance other than Medicare on my device trial before the Medicare Administrative Contractor (MAC) Medical Director notifies us of the coverage determination? NO. UNMC procedures dictate that no patient, regardless of insurer, will be enrolled on the trial until the letters from Medicare (Part A and Part B) have been received and distributed.  The IRB retains the stamped Informed Consent Document (ICD) for the trial until the coverage determination is received from the Wisconsin Physicians Services (WPS) Medical Director.  Rationale for this decision is that the Informed Consent Document (ICD) may change depending upon the determination.  Many third party payors, usually, will follow the rulings of Centers for Medicare & Medicaid Services (CMS) regarding payment for these trials.  In addition, CMS must update their computer system to reflect the ruling. Any claims received prior to the update will be summarily rejected.