Study Highlights Insurance Payment Issues for Off-label Deep Brain Stimulation

Joana Fernandes, PhD avatar

by Joana Fernandes, PhD |

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insurance and off-label treatments

Patients who have had deep brain stimulation (DBS) to treat diseases that are not approved for the technique may not be reimbursed by an insurance company for the procedure’s costs, even though they were initially told the treatment was covered, according to a new study published in JAMA Neurology.

In the study, “The Problem Of Funding Off-Label Deep Brain Stimulation – Bait-And-Switch Tactics And The Need For Policy Reform,” the authors call for better policies to avoid the insurance “trap” that patients who have undergone DBS often get caught in.

DBS is a surgical procedure approved by the U.S. Food and Drug Administration (FDA) for patients with neurological diseases affecting movement, such as Parkinson’s, dystonia, and essential tremor, to treat their symptoms and help control their movements.

A medical device called a neurostimulator is implanted in the brain to deliver electrical stimulation to the areas that control movement, regulating nerve signals that cause tremors and other symptoms.

However, patients with other neurological and psychiatric diseases, such as Tourette’s syndrome or obsessive-compulsive disorder, may also be submitted to DBS under research-based or compassionate use guidelines, the so-called off-label DBS.

Despite the benefits of DBS, surgery and post-operative care are expensive. According to the authors, the surgical costs can run as high as $65,000 per patient, not to mention battery replacements for the neurostimulator, which can add $10,000 to $20,000 to the final cost in the first three years after surgery.

“These costs can be daunting because governmental and commercial insurance providers are reluctant to subsidize off-label therapies,” the authors wrote. “Coverage depends on preauthorization requests that require exhaustive documentation of a patient’s medical history and peer-to-peer review with an insurance provider’s medical director.”

However, even when all paperwork is settled and approved, third-party payers often refuse to reimburse the costs of off-label DBS, which, in many cases, comes after the patient underwent surgery.

The authors investigated this trend by reviewing claims data for all DBS procedures performed for 10 years (January 2005 to December 2014) at a movement disorder center from their university. They found that 74 DBS procedures (including implantation, implantable pulse generator or battery-replacement procedures) had been performed on 26 patients with diseases other than those approved for the treatment, such as Tourette’s syndrome, Alzheimer’s disease, and obsessive-compulsive disorder.

Research grants covered the costs of 23 of these surgeries. The remaining procedures required payment from third parties and, although all of them had been pre-approved, 33 were not reimbursed, largely due to a government insurance provider’s failure to pay.

The authors termed this pre-approval and then denial of expenses as a bait-and-switch tactic.

“Physicians (and patients) are baited to believe that coverage will be provided and then when the decision to subsidize switches and payment is denied, physicians must explain to patients and their families that coverage was refused and explain why,” they wrote.

“This financial uncertainty can impose additional stress on patients that can compromise therapeutic outcomes, and physicians may be obliged to draw on limited research funds to help patients cover expenses.”

Although the team only analyzed data from their center, they believe that as federal government insurance providers were among those who denied the reimburse of patients, these occurrences may represent a national trend.

The authors call for a change in the funding policies from the government to stop this problem. They suggested that, for example, insurance policies could support novel and investigational approaches in the treatment of small groups of patients so that off-label DBS procedures could also be covered.

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