Moving from Coercion to Collaboration in Mental Health Services

Legislative and Regulatory Overview

Nicholas Meyers

My expertise is in the field of politics and government relations. I am familiar with the political and substantive climate surrounding the development of national policy on seclusion and restraint, but I am not a clinician. In my own experience, most of the participants in the debate on seclusion and restraint, whether they are clinicians, patient or family advocates, legislators, or regulators, are genuinely interested in doing what is right for patients, even when there are fundamental disagreements between them about what that means. If this symposium provides a framework for a modulated discussion about the clinical knowledge base, it will be a big success.

Unfortunately, national efforts to define safe, effective, and appropriate use of seclusion and restraint in a psychiatric setting have taken place in the context of a heated and often poorly informed political process in which the emphasis has been on achieving expedient solutions to a volatile and difficult issue. I will focus on the development and implementation of national standards of seclusion and restraint. I will outline the American Psychiatric Association (APA) response to existing and proposed regulations and legislation and say where I think the debate is heading. I am going to confine my remarks to the period from the fall of 1998 to today.

I want to suggest first that although there continue to be heated debates on how to define safe and effective use of seclusion and restraint, there is much agreement between the various stakeholders. I think most stakeholders, and certainly the APA, would agree that:

The use of seclusion and restraint should be minimized.
Staff should be thoroughly trained in techniques for the safe use of force.
Restraints and seclusion should not be considered a routine event.
The use of restraint and seclusion should not be the first option, but rather should be used at the end of a continuum of options in which other less intrusive alternatives have been considered and discarded.
The facility should have a system of monitoring and reporting events in its seclusion and restraint, and particularly where there is a suboptimal outcome.

There is not a lot of debate about these points. Unfortunately, despite this broad framework of agreement, we’ve gotten hung up on fundamental disagreements over the extent to which Federal policy should specifically regulate the practice of medicine and limit the independent judgment of the clinician in the field. Therefore, key areas of disagreement continue to include:

how long patients can be restrained,
who should order seclusion and restraint,
how quickly patients should be assessed by a physician or other practitioner, and
what should be reported and to whom it should be reported when there is a suboptimal outcome.

These are difficult questions. The disagreements are exacerbated by the strongly held views of some stakeholders that any use of seclusion and restraint represents a complete treatment failure, that seclusion and restraint are always inherently violative and inevitably traumatic for the patient, and that all episodes of restraint should be treated as sentinel events under Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards, thus requiring external reporting to an independent third party for investigation and obliging the facility to a complex root-cause analysis. Unfortunately, the regulatory and legislative processes are very blunt instruments and are not well suited for measured and dispassionate discussion of clinical merits, particularly theories of appropriate care. As a consequence, more divergent views have tended to drive the debate; thus, the basic framework of agreement between stakeholders has been profoundly obscured by the key diff! erences. Having struggled with this issue for 2½ years, I am still not sure how we resolve the problem, and perhaps today’s symposium might move us in that direction.

In 1998, The Hartford Courant ran a series of disturbing articles detailing the untimely deaths, over a 10-year period, of some 142 individuals, many of them young adults and children receiving treatment in a variety of mental health settings. The Courant series detailed what appeared to be substandard treatment, particularly with respect to the use of restraint, which was alleged to be the cause of death in most of the cases. This treatment led to an immediate outcry for national standards governing the use of seclusion and restraint.

The National Alliance on Mental Illness (NAMI) amended its board policy to stipulate that:

Restraints should be used only with a physician’s order and only for emergency safety use.
Once orders were given, the physician involved should see the patient face to face within 30 minutes.
Orders could be written only for 1 hour.
Reassessment would be required for any subsequent restraint.
Every restraint use must be treated as a sentinel event, requiring the generation of a root-cause analysis.
After each use of restraint and seclusion, the patient should receive trauma counseling.

The APA’s Medical Director responded to the challenge by convening a panel of clinical experts charged with reviewing the literature on seclusion and restraint and developing a detailed statement of general principles on the use and interventions. The panel met in February 1999 and included representatives from geriatric, forensic, child, and adolescent psychiatry; those from APA and JCAHO; hospital administrators; and APA medical staff. The net result of that meeting was a resource guide on seclusion and restraint that encompassed 24 general principles, including the following:

Seclusion and restraint may be used when, in the clinical judgment of medical staff, less restrictive interventions are inadequate. They may be indicated to prevent harm to the patient or other persons including other patients, family members, and staff and to ensure a safe treatment environment.

The use of seclusion and restraint should be minimized to the extent that is consistent with safe and effective clinical needs of the individual patient.
Seclusion and restraint should require a physician’s order.
Staff should be thoroughly trained and have demonstrated competency in the application of safe and effective restraint techniques.
Patients should be removed from seclusion and restraint when, in the physician’s judgment, the patient no longer poses a danger to self or others, including staff.
Quality assurance measures should provide for appropriate involvement of family members and other parties provided that confidentiality and the clinical integrity of the treatment program are maintained.
Death or serious injury resulting from interventions involving seclusion and restraint should be subject to internal review, with external review by or subject to an accrediting organization with appropriate legal and confidentiality protections.

The comparison of APA’s and NAMI’s views clearly shows more agreement than disagreement. Both organizations agree that seclusion and restraint should be used as minimally as possible. Both organizations agree that the verbal order to seclude or restrain should be physician driven. Both organizations agree that seclusion and restraint should be terminated as soon as the patient is no longer a danger to self or others, and that properly trained staff in sufficient numbers are key elements in the safe and effective use of the interventions.

Unfortunately, we disagreed in several key respects, especially on whether every episode of restraint should be considered a sentinel event, requiring the generation of a root-cause analysis. Nor do we agree that there is clear clinical foundation for a national standard requiring a face-to-face assessment of patients within a prescribed period of time.

When we met with NAMI representatives during the development of these recommendations, we learned that the NAMI board position had already been adopted and could not be changed.

Although we agreed on 85 to 90 percent of the general principles, the key elements were already firmly established, which made it very difficult to engage in any kind of meaningful dialogue in which each side could inform the other and perhaps influence policy.

Starting in 1999, Federal legislators introduced legislation to amend Medicare and Medicaid statutes by establishing broad requirements governing permissible use of seclusion and restraint. The objective was to bar the improper use of involuntary seclusion and restraint for purposes of convenience, coercion, and punishment and to provide the limits for acceptable use.

Unfortunately, we found that the bills were wide of their mark in many respects. For example, all the legislation referenced the use of chemical restraints. We strenuously objected to the use of the term as pejorative and inaccurate. The Centers for Medicare and Medicaid Services (CMS) (formerly the Health Care Financing Administration) eventually got it right and substituted the concept of inappropriate use of a drug as a restraint.

One bill would allow restraint use only to protect the safety of the patient or other patients but not of such non-patients as staff in the facility. Other bills extracted the concept of sentinel events from JCAHO requirements, but without JCAHO’s definitions of sentinel events and particularly without distinguishing between the reportable and non-reportable sentinel events.

All the bills included problematic reporting requirements that would breach confidentiality, and we feared that it would make it less likely that facilities with a sentinel event would have a candid post-event discussion. Some bills would require reporting events involving undefined psychological injury. We saw this as an extremely open-ended definition that would lead to a circumstance in which any use of seclusion and restraint would be seen as injurious from a Federal perspective.

In 1999, CMS issued an interim final rule governing the use of seclusion and restraint. The rule was unveiled at an unprecedented Capitol Hill press conference featuring the wife of the Vice President, the CMS Administrator, and several senators and representatives. The rule’s focus on behavioral health in the use of seclusion and restraint was unprecedented and certainly unexpected. It sharply limited permitted use of seclusion and restraint. It required a face-to-face assessment of the patient within 1 hour, required consultation with the patient’s treating physician as soon as possible, limited the total effect of duration, required new face-to-face assessments before new orders could be written, and required ongoing education of staff.

The new rule introduced specific clinical standards of care, which were an inappropriate attempt to substitute proscriptive regulations for the independent clinical judgment of the physician. The rule was promulgated precipitously, going into force only 1 month after introduction, even before the customary comment period closed.

In the past 10 to 15 years, no other issue has generated more comment from APA members. CMS received approximately 50,000 comments on the rule, which is extraordinary.

CMS never issued a final rule, so we were left with an interim final rule, which made fundamental changes in clinical practice based on questionable conclusions. Hospital groups sued the Secretary of the Department of Health and Human Services (DHHS) to block enforcement on the grounds that CMS failed to adequately consider less burdensome and costly alternatives. The courts and the Small Business Administration ultimately held that CMS failed to develop an appropriate cost impact analysis.

Congress passed a seclusion and restraint provision as part of a bill (The Children’s Health Act of 2000) that reauthorized the Substance Abuse and Mental Health Services Administration. This bill established a two-tiered system of requirements for the use of seclusion and restraint: one for hospital facilities and a second for facilities that provide services to children and adolescents. The final language incorporated many of APA’s recommendations.

In early 2001, JCAHO substantially revised its own standards governing the use of seclusion and restraint, eliminating the one-hour face-to-face assessment requirements. However, CMS subsequently insisted that JCAHO must survey for compliance with the one-hour rule. This requirement represents a fundamental change in the relationship with CMS and JCAHO, in which CMS has imposed oversight content on JCAHO.

Finally, the Clinton administration issued a rule governing the use of seclusion and restraint in psychiatric residential treatment centers serving Medicaid patients under age 21. Publication of the rule occurred after the President left office. After a directive from the Bush White House delaying or deferring such last-minute hold-over rules, we joined with the American Medical Association to urge DHHS Secretary Thompson to withdraw and review the rule thoroughly.

This paper concludes a very cursory overview of the complicated seclusion and restraint legislative and regulatory process. I would like to summarize by saying that this is a complex issue that has been poorly handled by legislators and regulators from the beginning. Given the broad agreement between stakeholders outlined above, the Clinton administration would have been justified if it had said to all parties, “The number of reported deaths and serious injuries attributable to the use of seclusion and restraint is completely unacceptable. We want you to sit down together, review the literature, set aside your preconceived positions, and develop a set of standards that will continue to seek to eliminate death or serious injuries while working to dramatically lower the use of restraint or seclusion.” This sort of collaborative and negotiated rule-making process would have allowed for decision-making to be based on clinical standards of care and not on politics. Instead, we! have had a piecemeal approach to legislation and regulation that has resulted in overlapping, confusing, and conflicting developments in the past 3 years. This process has resulted in burdensome and contradictory requirements, which may reduce the quality of care and limit access to inpatient care, especially for seriously ill patients who have a history of violent behavior.

The political arena is the last place that we should resolve questions about clinical standards of care. The result is a hodgepodge of well-intended and not so well-intended standards that have reduced the role of the psychiatric physician, increased the cost of care, and potentially reduced access to care for some patients. This is hardly the result that I think we would have hoped to achieve at the outset of this debate.

Question: In the deliberations about the legislative process around physical restraints, did anyone review clinical practices in other jurisdictions? There are countries where physical restraint is not used much, and I wonder if that came up in the course of your deliberations.

Answer: The APA held a conference in 1999 in which we did a fairly thorough review of the literature, including international and State experiences, but the U.S. legislative process is really like a moving target. I started with the legislative and regulatory history to reflect the way things happen, usually in a precipitous and rather reactive pattern. This pattern is often due to the huge workload and to obvious political pressures on legislators. I think we would have done better in developing standards by having a recent review of literature, including looking at the experience of the State of Pennsylvania (see the State hospital perspective) as well as the experiences of other countries. Unfortunately, that didn’t happen. What we ended up with were standards that were promulgated on short notice and that really put stakeholders in the position of having to react to rather than helping to create. I made a lot of rounds on the Hill, and the reaction that I frequ! ently got was the following: “The case you make in terms of substance is persuasive, but this issue is just so politically awful, I don’t think there is anything we can do to help you.” This is not a good way to deal with clinical issues that may have profound consequences for patient care.

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