FAQs

Billing analysis documents due diligence and provides 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. 

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.

Yes.  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, Nebraska Medicine, our clinical partners,  and Nebraska state statutes and guidance.

If your trial is a "Qualifying Trial" routine costs may be billed 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.

You must evaluate whether your study is qualifying so that Medicare is not billed 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. 

Mandatory Criteria

A trial must meet all three of the following:

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. 

Deeming Criteria

A trial must satisfy at least one of the four possibilities listed:

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.)

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.

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.

Items/Services 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)

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.

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.

• 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)

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.

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.