Clinical Research Billing & Coverage Analysis Certification — Professional

Lesson material opens once you are enrolled. The full syllabus and every learning outcome are shown here so you can judge the coverage before you pay.

1. Module 1

   1

   1 lesson · 6 h

   1. Locked.Why research billing is a distinct discipline; the authority hierarchy6 h · Locked

      On completion you will be able to

      • On completion the candidate can:
      • 1.1 Explain to a non-specialist why an ordinary billing process produces wrong answers on research encounters.
      • 1.2 Classify a given obligation by its source — statute, regulation, national coverage determination, local coverage determination, manual instruction, transmittal, payer policy, institutional policy — and rank the sources.
      • 1.3 Distinguish the coverage, coding, payment and documentation questions and route each correctly.
      • 1.4 Locate the current version of a governing instrument and verify it is current before relying on it.
      • 1.5 State the False Claims Act knowledge standard and explain why competence, not good faith, is the operative protection.
      • 1.6 Identify the point at which a question belongs to counsel.

2. Module 2

   2

   1 lesson · 10 h

   1. Locked.The qualifying clinical trial determination10 h · Locked

      On completion you will be able to

      • On completion the candidate can:
      • 2.1 Apply the Medicare Clinical Trial Policy's stated requirements to a study's actual documents and reach a determination.
      • 2.2 Apply the deemed status categories and identify the documentary evidence each requires.
      • 2.3 Distinguish a deemed study from one requiring direct assessment.
      • 2.4 State the consequence of a negative determination.
      • 2.5 Document the determination so it can be reproduced years later.
      • 2.6 Re-determine on a triggering change.
      • 2.7 Identify a marginal case and escalate it.

3. Module 3

   3

   1 lesson · 12 h

   1. Locked.Routine costs and the three exclusions12 h · Locked

      On completion you will be able to

      • On completion the candidate can:
      • 3.1 Apply the routine costs definition to an item and reach a determination.
      • 3.2 Distinguish the three exclusions from one another and apply each on its own terms.
      • 3.3 Apply the "used in the direct clinical management of the patient" test.
      • 3.4 Determine the treatment of items required solely for the provision of the investigational item, and of items for monitoring effects and preventing complications.
      • 3.5 Determine the treatment of care for complications arising from the investigational item.
      • 3.6 Document each determination with its basis.

4. Module 4

   4

   1 lesson · 12 h

   1. Locked.The research-versus-standard-of-care determination12 h · Locked

      On completion you will be able to

      • On completion the candidate can:
      • 4.1 Establish a documented standard of care for a given clinical situation from citable sources, without forming a clinical opinion.
      • 4.2 Determine whether a protocol-required item is standard of care, and at what frequency.
      • 4.3 Handle protocol-driven over-frequency by splitting standard-of-care instances from excess instances.
      • 4.4 Determine the position of an item that is standard of care generally but not for this indication, or not medically necessary on these facts.
      • 4.5 Analyse screening and eligibility procedures, including overlap with diagnostic activity that would have occurred anyway.
      • 4.6 Recognise the limit of their own competence and route a genuinely clinical question to a clinician.

5. Module 5

   5

   1 lesson · 8 h

   1. Locked.Device trials, IDE categories, and coverage with evidence development8 h · Locked

      On completion you will be able to

      • On completion the candidate can:
      • 5.1 Determine whether a study involves a device under an investigational device exemption and identify its category.
      • 5.2 State the coverage consequence of each category, distinguishing the device itself from routine care items and services.
      • 5.3 Identify what must be in place before the first related claim and confirm it is.
      • 5.4 Recognise a coverage-with-evidence-development study and apply its conditions.
      • 5.5 Escalate a categorisation question rather than deciding it.

6. Module 6

   6

   1 lesson · 8 h

   1. Locked.The document set and the reconciled schedule of events8 h · Locked

      On completion you will be able to

      • On completion the candidate can:
      • 6.1 Assemble and verify the complete document set before beginning analysis.
      • 6.2 Identify what is unknowable when a given document is missing, and decline to proceed.
      • 6.3 Build a reconciled schedule of events for coverage purposes.
      • 6.4 Resolve and document discrepancies between protocol table, protocol body, ancillary manuals and consent document.
      • 6.5 Represent conditional, branching, unscheduled and optional-sub-study activity.

7. Module 7

   7

   1 lesson · 12 h

   1. Locked.Building the billing grid12 h · Locked

      On completion you will be able to

      • On completion the candidate can:
      • 7.1 Produce a complete billing grid assigning each item at each visit to third-party payer, sponsor, or neither, with a documented basis per line.
      • 7.2 Demonstrate that every line is assigned and no line is assigned twice.
      • 7.3 Produce the grid in a form downstream systems can consume.
      • 7.4 Version the grid and amend it on protocol amendment, including determining retrospective effect.
      • 7.5 Defend any line in the grid to an auditor from the record alone.

8. Module 8

   8

   1 lesson · 6 h

   1. Locked.Three-document reconciliation: grid, budget, consent6 h · Locked

      On completion you will be able to

      • On completion the candidate can:
      • 8.1 Reconcile the grid against the study budget and identify any payer-assigned line priced to the sponsor, and any unassigned line.
      • 8.2 Reconcile the grid against the informed consent cost and billing language and identify contradictions.
      • 8.3 Reconcile the grid against the clinical trial agreement, including its subject-injury provisions.
      • 8.4 Escalate a contradiction to the correct owner — study team, contracts, IRB, or compliance — rather than resolving it unilaterally.
      • 8.5 Sequence coverage analysis, budget and activation correctly.

9. Module 9

   9

   1 lesson · 8 h

   1. Locked.Claim execution I: identifying the research encounter and routing the charge8 h · Locked

      On completion you will be able to

      • On completion the candidate can:
      • 9.1 Design and verify a mechanism that identifies a research encounter at the point of service.
      • 9.2 Configure and verify charge routing consistent with the grid.
      • 9.3 Make and document an encounter-level research-versus-standard-of-care determination for unanticipated activity.
      • 9.4 Handle unscheduled visits, emergency presentations and off-study encounters.
      • 9.5 Test whether institutional systems are enforcing the grid or merely recording it.

10. Module 10

    10

    1 lesson · 8 h

    1. Locked.Claim execution II: claim identification requirements8 h · Locked

       On completion you will be able to

       • On completion the candidate can:
       • 10.1 Identify the modifier applicable to an investigational clinical service and the modifier applicable to a routine clinical service furnished in an approved clinical research study, and apply each correctly.
       • 10.2 Identify the condition code identifying a qualifying clinical trial and the claim type on which it belongs.
       • 10.3 Report the research diagnosis code correctly, including knowing that it may be either primary or secondary and is not required to be primary.
       • 10.4 Report the ClinicalTrials.gov identifier in the correct field for the claim type.
       • 10.5 Distinguish institutional from professional claim requirements for the same encounter.
       • 10.6 Detect and correct claims missing required research identification, and claims carrying it wrongly.
       • 10.7 Work with certified coding staff within the correct boundary.
       • 10.8 Verify any coding requirement against the current source before relying on it.

11. Module 11

    11

    1 lesson · 6 h

    1. Locked.Payers other than traditional Medicare6 h · Locked

       On completion you will be able to

       • On completion the candidate can:
       • 11.1 Determine a commercial plan's obligation under 42 U.S.C. 300gg-8 and identify when it does not apply.
       • 11.2 Determine a Medicaid programme's obligation using the Medicaid definition, not the Medicare one.
       • 11.3 Manage prior authorisation for research-associated services.
       • 11.4 Analyse a denial and respond correctly.
       • 11.5 Determine the position of a participant enrolled in a Medicare Advantage plan.
       • 11.6 Recognise and correct the unsupported assertion that sponsor payment creates Medicare Secondary Payer status.

12. Module 12

    12

    1 lesson · 4 h

    1. Locked.Monitoring, reconciliation, audit and enforcement exposure4 h · Locked

       On completion you will be able to

       • On completion the candidate can:
       • 12.1 Design a prospective control rather than relying on detection.
       • 12.2 Perform a post-billing review and quantify error.
       • 12.3 Reconcile sponsor invoices, payer claims and the grid for a study.
       • 12.4 Determine look-back scope for an identified systematic error.
       • 12.5 Recognise the point at which correction becomes a disclosure question and route it to compliance and counsel.
       • 12.6 Report research billing risk accurately to leadership.