A hospital recently treated a Medicare Advantage (MA) Humana patient who underwent a transcatheter aortic valve replacement (TAVR). When the facility billed Humana, the claim was denied, with Humana indicating that the hospital should bill Medicare, as the patient was “enrolled in a clinical trial.” The problem was that the hospital was not participating in any TAVR clinical trials, nor was the patient enrolled in one at any other facility.

In this case, Humana seemed to be trying to avoid paying the claim (either intentionally or inadvertently) by confusing two concepts: coverage for clinical trials and coverage for evidence development. Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. If a clinical trial meets certain strict criteria, as specified by the Centers for Medicare & Medicaid Services (CMS) in National Coverage Determination (NCD) 30.1, Coverage for Routine Costs in Clinical Trials, or if it is funded by a federal agency such as the National Institutes of Health or the Agency for Healthcare Research and Quality, then Medicare or the MA plan covers the costs of routine services (but not the cost of the experiment device or service itself).

The cost of the investigational item or service is the responsibility of the investigator/sponsor of the trial. For example, if a new chemotherapy agent was being tested in a clinical trial, the trial sponsor would be responsible for the cost of the medication and monitoring, but Medicare or the MA plan would cover the cost of the remainder of the patient’s medical care, including treatment of other conditions that may also be present.

On the other hand, coverage with evidence development (CED) refers to services for which CMS has approved an NCD that includes, as a condition of payment, the development and capture of additional patient data to supplement standard claims data. As described by CMS, “the purpose of CED is to generate data on the utilization and impact of the item or service evaluated in the NCD so that Medicare can a) document the appropriateness of use of that item or service in Medicare beneficiaries under current coverage; b) consider future changes in coverage for the item or service; (or) c) generate clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding the item or service.” This process is undertaken when CMS reviews a new service for development of an NCD and sees evidence that the item or service is reasonable and necessary for the diagnosis or treatment of illness or injury – or to improve the functioning of a malformed body member, as required in Section 1862 of the Social Security Act (along with a determination that more data is needed to make a definitive coverage determination).

This additional data can be gathered in two ways: either through a clinical trial or through a clinical registry. Unlike a clinical trial, in which there is limited enrollment and strict eligibility as determined by the trial protocol, a registry allows a wide range of providers to provide the service as long as specific criteria are met and the provider participates in collecting and reporting the required data. In order for the registry to be considered appropriate for use in CED, it must be registered on www.ClinicalTrials.gov and be listed in the AHRQ Registry of Patient Registries (is a registry for registries the ultimate in bureaucracy, or what?)

To add to the confusion, the same service potentially could be provided as part of a clinical trial for one patient, under an NCD with CED for another patient, and under a standard NCD for a third patient. For example, a hospital may be studying the use of continuous positive airway pressure (CPAP) in stroke patients in a clinical trial, using CPAP for patients with a clinical diagnosis of sleep apnea but no formal sleep study under the NCD with CED, and applying the treatment in patients with sleep study-proven sleep apnea per NCD 240.4.

While most people have never heard of an NCD with CED, there are currently 18 services with such coverage, from stem cell transplant for myelodysplastic syndrome to transcatheter mitral valve repair. Interestingly, there is a CED for the use of transcutaneous electrical nerve stimulation (TENS) for chronic low back pain, but there is no clinical registry established to collect the necessary data, so TENS is currently not covered by Medicare.

So, what should a hospital do if it receives a “clinical trial” denial? First, it should check with the respective hospital department to see if it is participating in a clinical trial or submitting data to a clinical registry. Then it should check the CMS CED list and review the applicable criteria for coverage. If the insurer denied payment inappropriately, talk to them, point out the error, and demand payment. But if it appears that the service was provided without meeting the requirements, talk to your administrative staff and compliance officer immediately to investigate.

We all want to provide patients the best care, but we also must be cognizant of the payment rules, both established by CMS and the commercial insurers. No hospital can survive giving away expensive care. 

About the Author

Ronald Hirsch, MD, FACP, CHCQM is vice president of the Regulations and Education Group at Accretive Physician Advisory Services at Accretive Health. Dr. Hirsch’s career in medicine includes many clinical leadership roles at healthcare organizations ranging from acute care hospitals and home health agencies to long-term care facilities and group medical practices. In addition to serving as a medical director of case management and medical necessity reviewer throughout his career, Dr. Hirsch has delivered numerous peer lectures on case management best practices and is a published author on the topic. He is a member of the American Case Management Association and a Fellow of the American College of Physicians.

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