Health Care Reform

Clinical Trial Participants

For plan years beginning on or after January 1, 2014, with respect to individuals who participate in clinical trials, non-grandfathered health plans may not deny participation in a clinical trial, limit coverage for routine items and services typically covered for individuals who are not enrolled in clinical trials, or discriminate against individuals based on their participation in clinical trials. Plans do not have to pay for the investigational item, device, or service.  The Agencies stated that this provision is self-implementing, and they will not issue guidance in the near future. 

Note: The nondiscrimination rules applicable to clinical trial participants only apply to certain types of health plans, such as major medical insurance.  They do not apply to HIPAA excepted benefits, such as disability, cancer, hospital indemnity, or accident  insurance. Click here for more information about the types of benefits that are exempt from the Health Care Reform plan design mandates.

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Clinical Trial Hot Topics & FAQs

  • Provider Non-Discrimination
    For plan years beginning on and after January 1, 2014, Health Care Reform prohibits a non-grandfathered group health plan from discriminating against any health care provider who is acting within the scope of the provider’s license or certification under applicable state law. Health Care Reform does not require that a group health plan accept every willing provider into its network or other arrangement, and it does not prohibit a plan from varying reimbursement rates based on quality or performance measures.

    In the FAQs, the Agencies state that this section is “self-implementing”, and they do not expect to issue regulations in the near future. The Agencies indicated that until further guidance is issued, group health plans are required to implement this provision using a good faith, reasonable interpretation of the law. In making this good faith determination, a group health plan may use reasonable medical management techniques with respect to frequency, method, treatment or setting for an item or service, if the group health plan does not discriminate based on the provider’s license or certification and the provider is acting within its scope. For more information on provider non-discrimination, click here.

American Fidelity Assurance Company does not provide tax or legal advice.

ESB-837(0713)

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