Frequently Asked Questions

A Coverage Analysis is a process of determining and documenting the funding source for the clinical trial's patient care costs commonly know as billable events. In other words, prior to clinical trial enrollment of subjects, the coverage analysis is created to identify which party (study sponsor, patient, third-party payer, etc.) should be billed for each patient item/service.

For qualifying clinical trials, Medicare covers items and services considered to be "routine costs." Routine costs in clinical trials include:

1. Items or services that are typically provided absent a clinical trial (e.g., conventional care);

2. Items or services required solely for the provision of the investigational item or services (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and

3. Items or services needed for reasonable and necessary care arising for the provision of an investigational item or service in particular, for the diagnosis.

All other Medicare rules apply.

Below are resources available. We will add to this list when new information becomes available.

- Medicare Clinical Trial Policy (National Coverage Determination 310.1) NCD - Routine Costs in Clinical Trials (310.1) (cms.gov)

- CMS MLN Matters SE0822 SE0822 (hhs.gov)

- Decision Memo for Clinical Trial Policy (CAG-00071R) NCA - Clinical Trial Policy (CAG-00071R) - Tracking Sheet (cms.gov)

An overpayment is a payment made by CMS to a provider that exceeds the amount due and payable according to existing laws and regulations. Identified overpayments are debts owed to the federal government. Laws and regulations require CMS recover overpayments. Below is a link to the MLN Overpayment Fact Sheet:

MLN006379 – Medicare Overpayments (cms.gov)

Our office does complete chart reviews and retrospective audits. Education will be provided and a focused audit to concentrate on areas which need improvement may be required to ensure billing compliance. 

During our ongoing professional billing audits, we may reveal some revenue opportunities that were missed and provide education to the providers and billing staff.