Insurance Policies

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.

Insurance Coverage

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.

Insurer Chart for Pre-Authorization  

CT Request for Coverage of Routine Costs Form

Individual Policy Information

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:

CMS letter to AAMC clarifying qualifying trials  14-May-2014

CMS Presentation Medicare Coverage in Clinical Studies 09-Feb-2015

Since September 19, 2000 the Department of Health and Human Services has had specific claims processing instructions for claims submitted for Medicare carriers associated with ‘qualifying’ studies, click here to review this information. For updated modifier requirements, click here. For updated diagnosis billing requirements, click here. For requirements to include the 8-digit Clinical Trial Number (the number assigned by the National Library of Medicine on the website) on claims, click here.

CMS’s Questions and Answers on Mandatory Reporting of National Clinical Trial # (updated 10/31/2014)

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.

Aetna’s coverage of routine patient care costs associated with a clinical trial follow the Centers for Medicare & Medicaid Services Policy with certain limitations for out-of-network care, utilization management rules, and precertification/registration/referral requirements.

Anthem follows federal and state laws, and the patients’ specific contract provision in determining eligibility for coverage.  The patient’s benefits, in effect on the day the services were rendered, are used to determine whether or not the costs are covered.

Changes to Anthem’s Clinical Trial Coverage effective 1/1/2014 under the Affordable Care Act

Cigna Healthcare determines coverage on a case-by-case basis for patients participating in Phase 3 and 4 trials.  Each trial needs to be evaluated for potential benefits and risks.

Changes to Cigna’s Clinical Trial Coverage effective 1/1/2014 under the Affordable Care Act.
Updated Cigna Clinical Trial Policy effective 1/1/2014.

Harvard Pilgrim Health Care reimburses services rendered during qualified clinical trials to the same extent those services are covered for members not enrolled in clinical trial and in accordance with state and federal mandates for coverage. A copy of their Clinical Trials Payment policy and Authorization policy is noted below.

Harvard Pilgrim Health Care Payment Policies for Clinical Trials dated June 2014

Harvard Pilgrim Health Care Authorization policy dated April 2014

HealthyCT may cover certain costs associated with clinical trials. Their policy indicates that the trial must be pre-authorized for the patient to receive their coverage benefits.

Certificate of Coverage benefits for HealthyCT dated 23-Jun-2014

State Medicaid programs may or may not cover costs associated with clinical trials. CT’s Medicaid program does not cover:

  • procedures or services of an unproven, educational, social, research, experimental, or cosmetic nature
  • any diagnostic, therapeutic, or treatment service considered in excess of those deemed medically necessary to treat the client’s condition
  • services not directly related to the client’s diagnosis, symptoms, or medical history
Oxford Health Plans coverage is dependent upon the patient’s plan of benefit or certificate of coverage.  Precertification with review by a Medical Director or their designee is required for all clinical trials.

United Healthcare Commercial Plans and United Healthcare Medicare Advantage Plans

Coverage decisions are based on the patients’ benefit documents.  For patients with United Healthcare Commercial Plans, coverage is based upon their employers’ contract and prior authorization is required. 

For Patients with United Healthcare Medicare Advantage Plans, coverage is based upon Medicare’s National Coverage Determinations, Local Coverage Determinations, and General Medicare Coverage Guidelines.  

Connecticut 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.