Clinical research items/services may be billed to the patient’s private third party payor if the item/service is not paid by the study sponsor or promised free to the patient in the informed consent, AND:
the study is a Phase 1-4 therapeutic cancer trial (see California Health and Safety Code Section 1370.6; Cal. Ins. Code § 10145.4), OR
the commercial payor has pre-authorized the item/service for coverage, as a research-related item/service, OR
the commercial payor’s coverage terms otherwise provide coverage for the item/service when provided related to research.
Not always. Unfunded patient care costs in an NIH-sponsored study do not qualify for coverage by Medicare simply because the study is sponsored by another government agency. Medicare rules still apply.
If unfunded patient care costs in an NIH-sponsored study are determined by the coverage analysis to not be billable to Medicare and other third party payors, the Principal Investigator must secure other appropriate sources of funding.
(See Medicare Clinical Trial Policy for detailed information: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&fromdb=true)
Clinical research items/services may be billed to Medicare, Medi-Cal, or other government payors if the item/service is not paid by the study sponsor, promised to be paid for other subjects in the study, or promised free to the patient in the informed consent, and it is either:
a “routine cost” of a Qualified Clinical Trial (See FAQ below), OR
it would have nevertheless been provided and covered as reasonable and necessary care to the patient for prevention, diagnosis, or treatment absent the clinical trial, OR
it is for diagnosis and treatment of complications or injuries arising from participation in the research, and care of such complications or injuries is not promised to be paid or paid by the study sponsor for other subjects in the study.
The following qualified clinical trial cost types are not billable to the study subject or insurance, and should be paid by the study sponsor or covered by other appropriate funding source:
Any item/service that is:
promised free in the informed consent
customarily provided by the research sponsor free of charge for any enrollee in the trial
The investigational item/service that is the objective of the clinical trial unless it is otherwise covered outside the study or by other CMS coverage determination.
Protocol activity/items/services that are not for the direct clinical safety and management of the subject at the time of the order (e.g., consent, inclusion/exclusion labs/imaging/services, research-only protocol activity, monthly CT scans for a condition usually requiring only a single scan).
No. Medicare and Private Payor rules and requirements for documentation, coverage, and billing DO apply to ALL clinical studies. The funding source or lack of an outside funding source (internally funded or unfunded) is not relevant. Therefore, it is important to perform itemized coverage analysis to identify which protocol services are billable and, when encountered using CareConnect, to enter timely, complete and accurate study, enrollment and encounter information.