Centers for Medicare and Medicaid Services eases requirements in restraint, seclusion interim final rule

While the Centers for Medicare and Medicaid Services (CMS; formerly the Health Care Financing Administration) published an interim final rule on Jan. 22 establishing requirements for use of restraints and seclusion in some residential facilities that provide psychiatric services to children and youth under 21, an interim rule published in May makes changes, which were requested during the rule’s comment period.

The interim final rule had been scheduled to take effect March 23, but implementation was delayed until May 22 as a result of the Bush administration decision to reconsider many regulations proposed in the waning days of the Clinton administration.

The May 22 Federal Register notice for the interim final rule made significant changes in response to comments the agency received to the interim final rule it published in January.

The January publication established a definition of a "psychiatric residential treatment facility" that is not a hospital and may furnish covered Medicaid inpatient psychiatric services for individuals under 21. The May 22 document clarifies that the interim final rule applies only to facilities whose payment includes compensation for a resident’s room and board as well as a comprehensive package of services. It does not apply to other providers that receive Medicaid compensation on a service-by-service basis and do not receive Medicaid payment for an individual’s room and board.

The regulation says that under Medicaid conditions of participation for psychiatric residential treatment facilities providing inpatient psychiatric services to individuals under age 21, all resident children and youth now have the right to be free from restraint or seclusion as a means of coercion, discipline, convenience, or retaliation.

Specifically, restraint and seclusion may only be used to ensure safety of a resident or others during an emergency safety situation and must terminate when the emergency safety situation has ended. The least-restrictive emergency safety intervention likely to be effective must be used, and written standing orders or "as needed" orders are not allowed for either restraint or seclusion.

The initial publication had provided that use of restraint or seclusion could only be ordered by a board-certified psychiatrist or licensed physician with specialized training and experience in the diagnosis and treatment of mental disorders. However, the federal government changed that provision after hearing concerns that a nationwide shortage and unavailability of psychiatrists and registered nurses could make it impossible for a facility to comply with the requirement. The change in the May 22 document specifies that use of restraints or seclusion also can be ordered by other licensed practitioners whose state licensure allows them to write such orders.

If a resident’s treatment team physician is available, only he or she can order restraint or seclusion. Verbal orders must be followed up with a signed written form in the patient’s record. The physician or other licensed practitioner who issues the order must be available to staff for consultation, at least by phone, throughout the period of the emergency safety intervention.

If an emergency safety situation extends beyond the time limit included in the restraint or seclusion order, a licensed staff person must contact the licensed professional who issued the initial order for further instructions.

According to the revised interim final order, a physician or other licensed practitioner trained in the use of emergency safety intervention and permitted by the state and facility to evaluate a resident’s well-being must conduct such an evaluation immediately after a restraint is removed or a resident is removed from seclusion.

Finally, the revised interim final rule requires that facilities report the death of any resident to CMS.

Laurel Stine, director of federal relations for Bazelon Center for Mental Health Law in Washington, DC, tells State Health Watch that while her organization was pleased that the regulation was released by the administration, there is concern about broadening the types of staff who can order use of restraints or seclusion because they may not have sufficient clinical experience.

It will be important, she says, to see additional guidelines and other materials from CMS to get a better sense of how the regulation will be implemented and enforced. "We’re pleased that the regulation is out there with a relatively high level of protection, although we’re concerned about who can order restraints and seclusion. We look forward to getting more information from the agency."

Another patient advocacy group, the National Association of Protection and Advocacy Systems (NAPAS), also in Washington, DC, says changes to the regulation didn’t address concerns the group had raised when it first came out. Gary Gross, senior public policy counsel, tells SHW his group is "positive about the regulations in general because there have been disproportionate deaths among children and no oversight until now."

However, Joy Midman, executive director of the National Association of Psychiatric Treatment Centers for Children (NAPTCC) also in Washington, DC, says there has not been a disproportionate number of deaths among children and that several states already have exercised oversight, although there has not been federal oversight.

In comments submitted to CMS on March 22, a coalition of national disability groups chaired by NAPAS made very specific recommendations on definitions of restraints, including suggesting there be a distinction between restraint and a physical escort that is not resisted by a patient. CMS responded to that suggestion by clarifying that in its interim final rule, "personal restraint" does not including briefly holding, without undue force, a resident in order to calm him or her, or holding a resident’s hand to safely escort him or her from one area to another. The agency says it made that and other changes because it was concerned that reading the definition too broadly could prevent facilities from participating in the Medicaid program and result in needless displacement of Medicaid beneficiaries.

The coalition says it supported a provision prohibiting simultaneous use of restraint and seclusion, but urged a change to also prohibit use of mechanical restraints on children under 13. According to the coalition, children under 13 who present an emergency safety situation should be secluded, held, or subject to continuous in-the-room monitoring. "Children who are so seriously and acutely ill that they require further protection against hurting themselves or others even while in seclusion should be transferred to a psychiatric hospital."

Commenting from the perspective of treatment facility staff, NAPTCC had expressed concerns that the standards don’t recognize that residential treatment facilities are not part of the traditional medical model. Ms. Midman says that because there are differences in state licensing, there is no consistency throughout the country.

When the Child Health Act of 2000 was being written, she says, her group worked hard on the section relating to reporting requirements for various entities, hoping to achieve a balance and consistency and a recognition that the world has changed in terms of treatment models. She now is looking forward to the regulations that will be written to implement that act in hopes that they will be consistent with the interim final rule.

In March 20 comments on the January publication of the rule, NAPTCC expressed "great disappointment with its tone." The association said reference to media reports and other accounts of improper use of restraints "sets an adversarial tone and stage for a proscriptive and even punitive regulation. It ignores the tireless and thankless commitment of front-line providers who work with seriously disturbed children . . . as well as the reality that the reported abuses do not typify the majority of treatment programs or organizations."

NAPTCC also said that the rule was harder on residential treatment facilities than it was on hospitals, and pointed out the inconsistency in being applied only to those programs that are required by their states to maintain a contract with the state Medicaid agency for that distinct service, including residential room and board payments.

In specific comments, the group challenged the rule’s requirement that an emergency safety situation be unanticipated. Ms. Midman says staff in residential facilities continually monitor patient behavior and must be prepared to intervene to avert an unsafe situation regardless of whether the behavior was anticipated or unanticipated. She also had asked that the definition of personal restraint be changed to exclude therapeutic holds that, she says, are brief, calming, and effective in protecting a child from an impulsive or momentary outburst.

Of particular concern to NAPTCC were the requirements on who may order restraints. Requiring an order from a board-certified psychiatrist, she says, was "impractical, inefficient, and medically unnecessary. No less so [was] the requirement that a registered nurse obtain the doctor’s order by phone if the doctor [was] not present. Preventing a child from running into the street, biting, or throwing chairs requires the ability to act in emergency situations and prevent them from escalating. Physicians and/or nurses are not present on the playgrounds, in the schoolrooms, or on the buses, but rather the milieu and support staff are, who work with these children on a regular basis. This requirement would be less of an issue if brief holds were excluded from the definition of personal restraint."

The association had recommended that a facility be allowed to authorize qualified registered nurses or other qualified and trained staff members who are not licensed independent practitioners to initiate use of restraints or seclusion. Verbal or written orders would then be required as soon as possible from the physician or other licensed professional.

Other NAPTCC concerns dealt with the requirement for a face-to-face assessment within one hour, monitoring of a child in restraints or seclusion, notification of parents, post-intervention debriefings, facility reporting, and education and training.

While all sides on this issue talk about their desire for patient safety and facility accountability in a variety of circumstances, they seem far apart on the best way to meet their shared goals, and CMS may have a difficult time reaching an acceptable compromise.

[Contact Ms. Stine at (202) 467-5730, ext. 3, Mr. Gross at (202) 408-9514, and Ms. Midman at (202) 857-9735.]