Medical Research Billing Compliance has gathered useful information regarding insurance policies, Medicare, and clinical trials to aid in the billing process. Insurance providers' policies differ, and the resources below will help to ensure that all aspects of medical billing and collections are handled in accordance with the applicable policies and legislation.
The Connecticut state legislation regarding clinical trials includes information regarding hospitalization at out-of-network facilities, HMO and insurer requirements, and accountability of private insurers.
Insurance coverage policies vary from company to company.
Based on the Connecticut Legislation Public Act 11-172 certain individual health insurance companies require pre-authorization for coverage of routine care patient care costs for certain clinical trials. The individual carrier’s policies provide guidelines for obtaining pre-authorization.
For more information on Medicare coverage and the Clinical Trials Final National Coverage Decision NCD, please visit the U.S. Department of Health & Human Services CMS Medicare Coverage Database.
See Medicare Benefit Policy Manual Chapter 14 – Medical Devices for information on Medicare’s coverage of investigational devices and the related services.
The local Medicare contractor’s clinical trials policy may be found on the National Governmental Services website: www.ngsmedicare.com.
The Medicare Quick Reference Guide provides information directly from the U.S. Department of Health & Human Services CMS.
To view The Department of Health and Human Services Claims Processing Instructions, click here. These insturctions apple to carriers participating in Medicare qualifying clinical trials. For updated modifier and diagnosis billing requirements, click here.
TRICARE Coverage of Cancer Clinical Trials
The Department of Defense (DoD) has partnered with the National Cancer Institute (NCI) to offer Cancer Clinical Trials to eligible TRICARE beneficiaries. The Cancer Clinical Trials provide NCI-sponsored cancer prevention and treatment studies as a TRICARE-covered health care benefit.
TRICARE will cost share:
- All medical care and testing needed to determine eligibility for an NCI Cancer Clinical Trial; and,
- All medical care needed because of participation in an NCI study.