Despite HCFA regulations and pending changes to JCAHO standards, Congress responded to pressure by patient groups and others to legislate new seclusion and restraint standards for adults in hospitals and other inpatient facilities and youth in group homes and residential treatment centers receiving federal funds.

The language is part of an omnibus children’s health bill (HR 4365) passed by Congress last month, that among other things, reauthorizes the programs of the Substance Abuse and Mental Health Services Administration. President Clinton signed the bill into law on October 17.

The seclusion and restraint provisions are modeled closely on bills sponsored by Sen. Christopher Dodd (D-Conn.).

"APA opposed the legislation because we believed it was unnecessary in the wake of new rules developed by the Health Care Financing Administration [HCFA] and standards set by the Joint Commission on Accreditation of Healthcare Organizations [JCAHO]," said Nicholas Meyers, deputy director for federal relations in APA’s Division of Government Relations (DGR).

"Despite the opposition of APA, the AMA, and hospital organizations, including the National Association of Psychiatric Health Systems and the American Hospital Association, it became clear that Congress would yield to pressure from protection and advocacy groups and others and pass new seclusion and restraint standards in the waning days of the 106th Congress. At that point we had little choice but to change the Dodd bill to make it less onerous, and to ensure that it did not create new requirements on top of the HCFA and JCAHO standards."

The new law does not replace stronger federal protections such as the rule requiring a face-to-face evaluation within one hour or stronger state protections.

A coalition of patient groups and the protection and advocacy systems aggressively advocated for legislation sponsored by House Commerce Committee Democrats (H.R. 4867) as a substitute for the Dodd language. The House bill would have imposed draconian new restrictions on the use of seclusion and restraint. For example, that bill would have established a "must-fail" system requiring certification that less restrictive methods were tried before seclusion or restraint could be used. One version of the House bill would have required reporting of all deaths and serious injuries—including undefined psychological injuries—to protection and advocacy systems. APA and its allies succeeded in preventing the House bill from moving forward.

"In addition to blocking consideration of the extreme restrictions in HR 4867, we were also able to soften the Dodd language to exclude short-term interventions such as timeouts and physical escorts from the definitions of seclusion and restraint," Meyers said.

The new law sets two tiers of standards, one for hospitals and other "medical facilities," and another for nonmedical facilities for children and youth (for example, residential treatment centers and group homes).

According to DGR, the medical facility standards limit the use of seclusion and restraint to interventions required to protect the physical safety of the patient, staff, or others. Drugs could be considered restraints if they are used to control behavior or restrict freedom of movement and are not considered a standard treatment for the patient’s medical or psychiatric condition.

The second set of standards, applicable to nonmedical facilities serving children and youth, restricts the use of seclusion and restraint to emergency situations and only to ensure the immediate physical safety of the resident, a staff member, or others, according to Meyers.

Individuals applying seclusion or restraint must be certified by the state in core competencies defined in the legislation.

The legislation requires the Secretary of Health and Human Services to develop national guidelines and standards for staff training within six months of the law’s enactment. States must develop licensing rules for staff training and monitoring standards within one year after the federal standards are released, according to Meyers.

In the interim, facilities for youth must ensure that supervisory or senior staff trained in seclusion and restraint procedures conduct a face-to-face mental and physical evaluation of the child in seclusion or restraint within one hour of initiation. There must be continuous monitoring while the child is restrained. During seclusion, the continuous monitoring must be face to face, according to the legislation.

In related news, Rep. Saxby Chambliss (R-Ga.), chair of the House Budget Committee Task Force on Health, called on HCFA to suspend the controversial one-hour rule requiring a face-to-face evaluation of patients in restraints or seclusion until it completes an economic-impact analysis.

Chambliss’s action came in the wake of a finding by the Small Business Administration’s Office of Advocacy that HCFA violated the Regulatory Flexibility Act when it abruptly issued seclusion and restraint regulations last July. APA has complained strenuously that the rules went into effect 30 days after being issued, rather than allowing for the standard 60-day comment period. The SBA noted that "the affected industry did not have a meaningful opportunity to comment prior to the effective date of the regulation, and specifically faulted HCFA for failing to consider the impact of the regulation on small rural hospitals, and failing to contemplate less burdensome alternatives than the one-hour face-to-face requirement," said Meyers.

In September, a U.S. District Court judge ordered HCFA to conduct the required economic-impact analysis, but allowed the one-hour rule to stand. "APA will continue to work with Congress and our allies to mitigate the impact of the 1999 rule," said Meyers.