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 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.
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. Click here for policy www.aetna.com/cpb/medical/data/400_499/0466.html
Their policy indicates providers will not routinely be required to submit documentation about the trial to Aetna, but Aetna can, at any time, request such documentation.
Aetna's "Clinical Trial Q&A" can be found at https://www.aetna.com/health-reform-connection/questions-answers/clinical-trials.html
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.
Coverage of routine care costs and other clinical trial costs is determined based upon the patient's insurance plan. Most coverage in these plans follows the coverage outlined under the Affordable Care Act, but Administrative Services Only (ASO) plans that are grandfathered may opt out of clinical trial coverage completely.
The clinical trial provision of the Patient Protection and Affordable Care Act is summarized in this "Fact Sheet" Cigna Clinical Trial Fact Sheet
Updated Cigna Clinical Trial Policy effective 1/1/2014.
For patients with Connecticare Commercial Plans, coverage is based upon their individual plan or contract. Connecticare has indicated pre-authorization is required for clinical trial related services or procedures, as well as a copy of the patient consent form. Connecticare follows the Connecticut State requirement of requiring pre-authorization for coverage of routine costs associated with clinical trials. See pages 14 and 15 on the rider for a description of their coverage terms.
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.
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.
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
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.
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 clinicaltrials.gov website) on claims, click here.
CMS’s Questions and Answers on Mandatory Reporting of National Clinical Trial # (updated 10/31/2014)
Clarification of Medicare Payment for Routine Costs in a Clinical Trial MLN-SE0822 Medicare Clarification of Routine Costs Revised 07-Jan-2009
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.
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 the United Healthcare Clinical Trials Coverage Determination Guidelines, effective 10/1/2015, United Healthcare Clinical Trials CDG.006.05
Additional information from United Healthcare on coverage of costs associated with participation in a clinical trial and changes under the Affordable Care Act is available at https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Main%20Menu/Tools%20%26%20Resources/Policies%20and%20Protocols/Medicare%20Advantage%20Reimbursement%20Policies/R/RoutineCostsClinicalTrials_NCD310-1_02042013.pdf
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.
- United Healthcare Medicare Advantage Plan Reimbursement Policy for Routine Costs in Clinical Trials Current Approval Date 12/17/2014
- United Healthcare Medicare Advantage Plans Coverage Summary for Experimental Procedure and Items, Investigational Devices and Clinical Trials Last Review Date 9/15/2015
- United Healthcare Oxford Clinical Trials Policy effective 10/1/2015
- United Healthcare Oxford Experimental/Investigational Treatment Policy effective 12/1/2014
- United Healthcare Oxford Experimental/Investigational Treatment Policy for NJ Plans effective 12/1/2014