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The Impact of the Affordable Care Act on Clinical Trials

Julie O’Brien, BSN, RN, MS
President, AliCare Medical Management

The Affordable Care Act (ACA) implemented dramatic changes to our health care system, expanding coverage to more Americans and creating a host of new mandates for health plans. In the wake of all the health insurance exchange publicity, limited public attention has been paid to a new key requirement for insurers and group health plans to cover costs related to clinical trials.

Clinical trials are performed to determine if new treatments and procedures, new drugs and combinations of drugs or new devices are clinically safe and effective and should be used as a standard of care for future patients. They can also help determine whether a new treatment works as well as or better than an existing treatment. That being said, participation in clinical trials is often considered when standard therapies have failed.

Clearly, clinical trials are a useful alternative to standard care. Their coverage under the ACA began when Section 2709 of the Public Health Service (PHS) Act was amended to mandate that as of January 1, 2014, non-grandfathered health plans (i.e. those that were not in place before March 23, 2010) cannot deny a qualified individual participation in an approved clinical trial or deny or limit the coverage of routine patient costs in connection with participation in the trial. Generally speaking, there are two types of costs associated with a clinical trial: patient care costs and research costs. The intent of PHS section 2709 is to cover the patient care costs incurred in clinical trials while excluding the research costs. Research costs, however, may be covered by a trial’s sponsor.

Unfortunately, sometimes a health plan may elect to not provide coverage related to a patient requesting a clinical trial. When that happens, a patient or a provider may file an appeal. The appeal must be submitted to the health plan that denied the coverage and should request they reconsider the denial and provide coverage for the requested treatment. The appeal should be based on the medical necessity of the clinical trial and why the physician feels a clinical trial is the best treatment option for the patient. If the internal appeal options are denied, the patient or their attending physician is permitted to file an external appeal based upon rights established both by federal and state law. In fact, the ACA expanded the rights for most individuals to file an external appeal outside of the health plan.

In the post-ACA world, case managers and care management programs are uniquely positioned to help coordinate with doctors, financial counselors, the clinical trial research team, health plan administrators, hospital staff, both network and non-network providers and others to make sure the right information is getting to the right person at the right time. Care management firms like AliCare Medical Management can use their utilization management, case management and external review expertise to steer patients toward the best care options, address questions regarding medical necessity and scope of benefits and act as an invaluable partner for anyone seeking guidance on their clinical trials coverage.

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