CMS Pub. 100-04, ch. 32, § 69.5

Instruct practitioners and institutional providers to enter clinical trial and non-clinical trial services on separate line

items when billing both types of services on the same claim. For services that require a Certificate of Medical

Necessity (CMN), continue to require CMNs. Items and services provided free-of-charge by research sponsors

generally may not be billed to be paid by Medicare, and providers are not required to submit the charge to Medicare.

If it is necessary for a provider to show the items and services that are provided free-of-charge in order to receive

payment for the covered routine costs (e.g. administration of a non-covered chemotherapeutic agent), providers are

instructed to submit such charges as non-covered at the time of entry, while also assuring that the beneficiary is not

held liable. This instruction applies to all hospitals including hospitals located in Maryland under the jurisdiction of

the Health Services Cost Review Commission (HSCRC).

For OPPS claims, providers must report a token charge for a ‘no cost’ item in the covered charge field along with the

applicable HCPCS modifier (i.e., modifier –FB) appended to the procedure code that reports the service provided to

furnish the ‘no cost’ item, in instances when claims processing edits require that certain devices be billed with their

associated procedures. For more information on billing ‘no cost’ items under the OPPS, refer to Chapter 4, §§20.6.9

and 61.3.1 of this manual.

NOTE: Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical

trial number on claims for items/services provided in clinical trials/studies/registries, or under CED.

Future updates will be issued in a Recurring Update Notification.