On July 2, 1999, the Health Care Financing Administration (HCFA) published an Interim Final Rule creating a new Patients' Rights Condition of Participation (COP) for hospitals participating in Medicare and Medicaid. This new COP outlines requirements that must be met by all participating hospitals, including psychiatric, short-term, rehabilitation, long-term, children's, and alcohol-drug hospitals.

General Overview

The new COP includes the following six new standards:

(1) Notice of Rights. A hospital must inform each patient or his or her representative of the patient's rights.

(2) Exercise of Rights. The patient or his or her representative has the right to participate in the development and implementation of his or her plan of care and to make informed decisions regarding his or her care. These rights include: (1) the right to formulate advance directives and have hospital staff and practitioners comply with those directives; and (2) the right to have a family member or representative of his or her choice and his or her own physician notified promptly of his or her admission to the hospital.

(3) Privacy and Safety. The patient has the right to personal privacy, to receive care in a safe setting, and to be free from all forms of abuse and harassment.

(4) Confidentiality of Patient Records. The patient has the right to the confidentiality of his or her clinical records and to access information contained in those clinical records in a reasonable time frame.

(5) Restraint for acute medical and surgical care. The patient has the right to be free from restraints of any form that are not medically necessary or are used as a means of coercion, discipline, convenience, or retaliation by staff.

(6) Seclusion and restraint for behavior management. The patient has the right to be free from seclusion and restraints of any form that are imposed as a means of coercion, discipline, convenience, or retaliation by staff.

The first four standards outlined in the Patients' Rights COP were first described in the Notice of Proposed Rulemaking published by HCFA in December, 1997. Since HCFA has solicited and received comments related to these standards, they are considered final and HCFA will not consider additional comments.

However, the fifth and sixth standards -- outlining rules for the use of seclusion and restraint -- were described only in the preamble, rather than the text, of the Notice of Proposed Rulemaking. Thus, although these standards will be considered "final" in the interim, HCFA has invited comment on these new standards and will publish a Final Rule, tentatively scheduled for December, 1999. These two standards are discussed in more detail below.

Standards Regarding the Use of Seclusion and Restraint

HCFA has developed separate rules governing the use of restraints in acute medical and surgical care and the use of restraints and seclusion for "behavior management." Because most instances of seclusion or restraint use in psychiatric facilities are likely to fall into the category of "behavior management," the following discussion will focus on that section.

Summary of the Rule

The Interim Final Rule provides that patients "have the right to be free from seclusion and restraints, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff." The Rule defines restraints to include physical and mechanical restraints and drugs "used to control behavior or to restrict the patient's freedom of movement" if that drug is not a standard treatment for the patient's medical or psychiatric condition.

The Rule also provides that:

• Seclusion or restraint can only be used in emergency situations if needed to ensure the physical safety of the patient.
• Only physicians or other licensed independent practitioners can order seclusion and restraint. If the treating physician is not the person who orders seclusion or restraint, he or she must be consulted as soon as possible.
• A physician or other licensed independent practitioner must see and evaluate the need for seclusion or restraint within one hour of the intervention.
• Written orders for seclusion or restraint are limited to four hours for adults; two hours for children ages 9 to 17; and one hour for children under 9.
• Orders may be renewed for up to a total of 24 hours.
• The ordering physician or licensed independent practitioner must see and assess the patient before issuing a new order.
• Seclusion and restraint may not be used simultaneously unless there is continual monitoring, either face-to-face monitoring or through the use of both video and audio equipment.

The Rule requires all staff who have direct patient contact to receive ongoing education and training in alternative methods for handling behavior and the safe use of seclusion and restraint. In addition, the Rule requires hospitals to report to HCFA any death that occurs while a patient is in seclusion or restraint, or that can reasonably be related to seclusion or restraint.

Issues for Discussion

Much of HCFA's Interim Final Rule supports the language and intent of NASMHPD's draft position statement on seclusion and restraint, which was approved by the NASMHPD Board of Directors on March 26, 1999 for presentation to the full NASMHPD membership for a vote at the Summer Commissioners' Meeting July 11-13. In particular, the Rule emphasizes that: (1) seclusion and restraint are emergency measures of last resort; (2) staff should be trained in alternative techniques as well as the safe use of seclusion and restraint; (3) patients in seclusion or restraint should be continually assessed and monitored; and (4) the interventions should be ended as soon as it is safe to do so.

Some of these issues may generate additional discussion as the full NASMHPD membership considers this important issue. In addition, HCFA's Interim Final Rule includes several provisions that are inconsistent with or are not considered in the draft NASMHPD position statement:

• Appropriateness of interventions. HCFA's Interim Final Rule provides:

  Seclusion or restraint can only be used in emergency situations if needed to ensure the patient's physical safety and less restrictive interventions have been determined to be ineffective. (emphasis added)

  This provision is inconsistent with the preamble to the Interim Final Rule, which notes that "in some emergency situations the use of restraint may be the least potentially harmful way to protect the individual's safety or that of others," and with another provision in the Interim Final Rule, which provides that restraint or seclusion can be used "to protect the patient or others from harm." (emphasis added) This provision is also inconsistent with the draft NASMHPD position statement, which provides:

  ... seclusion and restraint should be used only when there exists an immediate risk of danger to the individual or others and no other safe and effective intervention is possible. (emphasis added)

  NASMHPD believes that HCFA may not have intended to bar the use of seclusion and restraint when needed to protect the physical safety of people other than the patient. Based on conversations with family and consumer advocates, we are not aware of any organization that would object to amending the Rule to address this issue.

• Assessing "last resort." The Rule provides that restraints or seclusion can be used "only when less restrictive measures have been found to be ineffective ..." There is some concern that this language could be interpreted to mean that all other interventions must be tried before seclusion or restraint can be used, even in emergency safety situations. The NASMHPD draft position statement provides possible alternative language:

  Seclusion and restraint should be used only when there exists an immediate risk of danger to the individual or others and no other safe and effective intervention is possible. (emphasis added)

The Interim Final Rule does not include several issues addressed in the NASMHPD draft position statement, such as: (1) early identification and assessment of individuals who may be at risk of being secluded or restrained; (2) assessment of trauma histories; and (3) patient/staff debriefings following these interventions.

The full text of the Interim Final Rule is published, along with HCFA's analysis of comments received in the Notice of Proposed Rulemaking, in the July 2, 1999 Federal Register beginning on page 36070. Comments are due August 31, 1999.

If you have questions or need additional information, please call (703) 739-9333.

Robert W. Glover, Ph.D.
Executive Director

Jenifer Urff, J.D.
Director of Government Relations