Psychiatrists face challenges in creating Spravato practices

Addressing delivery challenges

After the FDA approval, Jacqueline Posada, MD, was tasked with helping a small psychiatry practice develop the framework to incorporate intranasal esketamine. Dr. Posada, a consultation-liaison psychiatry fellow at the Inova Fairfax Hospital-George Washington University program in Falls Church, Va., started by creating a comprehensive screening form for esketamine candidates, developing an informed-consent protocol, and researching storage guidelines for an outpatient practice.

Before the practice could move forward, however, Dr. Posada learned that building regulations for the office prohibited “medical procedures” from occurring in the space. While the 10-doctor practice is associated with George Washington University, Washington, it is located several blocks away in an office setting.

“It was pretty disappointing,” Dr. Posada said. “Our organization is looking for another spot that allows psychiatry to administer a medical procedure. There’s a lot of people who are in private practice who are in a type of office building that may restrict medical procedures. Depending on the type of space they are renting, they need to know what is allowed in their office building.”

Patient privacy is also a primary consideration when delivering the medication. Dr. Posada said she and her staff had contemplated conducting the 2-hour patient monitoring in a group setting, but that idea was quickly thwarted.

“Our plan was in 15- to 20-minute appointments, administer the esketamine, and have maybe 5-10 people monitored in a room with barriers between each chair,” she said. “We were advised by our privacy officer that that could hinder patient confidentiality and was not a viable option for administering the medication in our practice.”

Practices should also determine a long-term treatment plan for each patient receiving esketamine, Dr. Sanacora said, particularly in light of data suggesting that a substantial number of patients will relapse if treatment is stopped. A long-term treatment plan should be considered prior to, or at the same time that esketamine treatment is initiated.

Comanagement of patients by clinicians is another essential part of esketamine treatment, Dr. Sanacora added.

“It is going to be important for the community clinicians not directly offering the treatment to develop close and ongoing relationships with the clinicians and sites that are offering this treatment to optimize the care of their patients,” he said. “Conversely, it is going to be imperative that the esketamine providers develop effective and efficient methods of maintaining close communications with the referring clinicians.”

Reimbursement comes with upfront cost

As far as payment, Dr. Levine expects that the nasal spray will be widely reimbursed. Clinics must first purchase the medication and insurers will reimburse them later for the drug, a method commonly referred to as “buy and bill.” The upfront cost could be too expensive for some physicians.

“That’s not something psychiatrists are used to, storing a controlled substance on site, having the financial outlay of keeping inventory of an expensive drug, and waiting for reimbursement,” Dr. Levine said.

Practices can also bill an evaluation and management code for the treatment as well as for observation time. At this point, it appears insurers will not cover psychotherapy delivered at the same time, which is disappointing, he said.

Sanjay J. Mathew, MD, a psychiatry professor and vice chair for research at Baylor College of Medicine, Houston, said because many psychiatrists who specialize in psychopharmacology and who see treatment-resistant depression patients do not accept private insurance or Medicare/Medicaid, patient access to the drug may be limited.

“Given the REMS and the need for 2-hour monitoring following the treatment, I believe that primarily, specialized clinics and centers for ‘interventional psychiatry’ will be the early adopters,” he said. “The typical office-based psychiatrist who does not accept insurance, and does not have means to store and dispense a controlled substance or monitor patients, may not readily adopt this new approach.”