Clinical Trials

CMS has specific billing requirements for Clinical Trials. For clinical trials other than IDE A and B devices and Clinical Evidence Development, traditional Medicare A or B will pay primary, waiving any deductible. To ensure claims are processed correctly, it is extremely important that claims are billed according to CMS guidelines. Additional Electronic Billing requirements can be obtained in the Availity Companion Guide.

• All claims must be billed with V700.7 (ICD9) or Z00.6 (ICD10) in the first or second diagnosis position

• Each claim submitted must include the clinical trial number

• Outpatient claims must contain an appropriate modifier

• Q1 on each line to denote routine service

• Q0 on each line billed for investigational services

• Electronic claims billed for IDE A or B devices must have an LX in REF01, loop 2300 and Clinical Trial claims must have P4 in REF01, loop 2300

• Clinical Trial Claims (other than IDE and Clinical Evidence Development) must be submitted to traditional Medicare first, then submitted to the Medicare Advantage plan with the Medicare EOB

Well-Child Care

Well-child care refers to physician-provided preventive health care services for children. The well-child benefit applies to an insured dependent child under BlueOptions, BlueChoice or Traditional products.

Well-child services include:

• The first newborn examination in the hospital by a physician other than the delivering obstetrician or anesthesiologist

• Periodic examinations to monitor the normal growth and development of a child

• Specified immunizations (see chart)

• Specified laboratory tests (see chart)

Well-child services are not subject to a calendar-year deductible and are reimbursed at the contracted percentage of the allowed amount.

Note: Florida Blue HMO (Health Options, Inc.) product, uses the USPSTF guidelines for preventive care and the recommended childhood immunization schedule published and updated annually by the Centers for Disease Control and Prevention.