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The one—hour rule controversy

May 1, 2007
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Experts disagree on who should evaluate patients after they have been secluded or restrained

Late last year, the Centers for Medicare and Medicaid Services (CMS) issued final rules to prevent patient injuries and deaths from the improper use of seclusion and restraint techniques in healthcare facilities, as well as ban their use as a punitive measure.1 The final rules, effective since January 8, also strengthen staff training requirements. In promulgating the regulations, CMS Acting Administrator Leslie Norwalk said the agency will hold facilities responsible for the appropriate use of seclusion and restraint techniques.

The final rules are controversial, especially the “one-hour” rule, which requires a face-to-face patient evaluation by a physician or independent licensed practitioner within one hour of implementing seclusion and restraint practices. While the interim rules required a physician to conduct the evaluation, the final rules permit other staff members, such as nurses, to conduct the evaluation and issue restraint and seclusion orders, in accordance with hospital rules and state laws.

Mark Covall, executive director of the National Association of Psychiatric Health Systems (NAPHS), says his association always has supported the concept that a physician needs to be responsible for ordering seclusion and restraint practices, but he says there are practical advantages in allowing other staff members to perform the one-hour evaluations. For example, he says RNs usually are more available and more familiar with a specific patient's condition than physicians.

Robert Bernstein, executive director of the Bazelon Center for Mental Health Law, disagrees. He believes the interim rules issued in 1999, with their stricter interpretation of the one-hour rule, offered patients more protection. “In our view, hospitals should have a physician see a restrained patient within an hour,” he says. “Restraint or seclusion is our ‘code blue’. There are significant physical and psychological risks involved.”

Bernstein says CMS caved to industry complaints that requiring a physician to see a secluded or restrained patient within an hour was too burdensome. He believes it's important to have a physician involved to determine whether a medical condition is underlying the behavior that prompted the use of seclusion and restraint practices. He acknowledges that there could be situations in which having a physician readily available for an evaluation could be difficult, such as in a rural area in the middle of a snow storm, but he says that national policy should not be based on extraordinary exceptions.

At a time when mental health advocates have been working with the Substance Abuse and Mental Health Services Administration (SAMHSA) to further reduce the use of seclusion and restraint practices, the CMS final rules are a marked departure from the reforms taking place nationwide, Bernstein asserts. “Changes to this rule will detrimentally alter the progress made over recent years in reducing physical harm to people who need emergency psychiatric care,” he says.

Bernstein says the threats from using seclusion and restraint practices are real, citing a September 2006 report from the Department of Health and Human Services's Office of Inspector General, who found that hospitals were underreporting deaths related to seclusion and restraint use. For instance, of the 104 behavior management-related deaths documented between August 2, 1999, and December 31, 2004, 44 were not reported directly to CMS, and fewer than one-third of those directly reported to CMS were reported in a timely manner.2 The final rules note that HHS had received “anecdotal information” from advocacy groups, patients, and hospital staff about “patients being choked during takedowns even though staff had been trained in proper procedures, and patients suffering broken limbs and other injuries.”1

“I think that is an acknowledgment that [seclusion and restraint use] is dangerous and should be used for emergencies—and that it needs a doctor involved,” says Bernstein.

Yet some of the comments submitted on the interim rules argued that CMS was giving “too much credence to over-dramatized accounts” of seclusion and restraint use, particularly accounts of injuries and deaths.

Despite the controversy, Covall expects that most behavioral health facilities will have little difficulty complying with the final rules. Many of the provisions in the final rules haven't changed much since the interim rules were introduced eight years ago and, therefore, most behavioral health facilities are very familiar with them and already have instituted relevant protocols, he notes. And according to anecdotal information Covall has received from his members, seclusion and restraint use has been on the decline during the past ten years, perhaps on the scale of 50 to 80%, he suggests.

Covall concludes, “It was important for CMS to clearly focus on the issues involved in use of restraints and give us more clarity. There are many variations on the theme. A lot of specific situations can occur. And we want to make sure that patients remain safe in all of them.”

Michael Levin-Epstein is a freelance writer.