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On June 25, Tipper Gore with Senator Joseph Lieberman (D-CT); Representatives John Dingell (D-MI), Pete Stark (D-CA), Diana DeGette (D-CO), and Rosa DeLauro (D-CT), and Administration officials in attendance announced a new Health Care Financing Administration (HCFA) regulation governing the use of restraints and seclusion in Medicare and Medicaid financed hospitals. The actual interim final rule appeared in the July 2, Vol. 64, No. 127 Federal Register.
Equally important as the hospital rule itself, Mrs. Gore’s press release also declared: "Mrs. Gore also announced that Secretary Shalala has committed to working to determine the feasibility of extending these same protections to residential care facilities for children and other providers participating in the Medicaid program by the end of the year." A major NAMI public policy objective has been the issuance of a HCFA-wide single national standard on restraint use, particularly as it covers residential treatment centers for children.
This is an interim final rule and comments are being accepted by HCFA up to August 31, 1999 (details follow).
The July 2 rules make significant improvements in how restraints are used in hospitals. But the rules fail to achieve the NAMI advocated standard contained in NAMI’s Omnibus Mental Illness Recovery Act initiative. NAMI’s standards are based on the actual Pennsylvania Office of Mental Health and Substance Abuse policies as implemented in the state’s nine state psychiatric hospitals.
The Good News
The preamble to the rules state: "The patient’s right to be free from restraint is paramount." Seclusion and restraint may only be used in emergency situations if needed to ensure the patient’s physical safety and when less restrictive alternatives have been determined ineffective. All patients have a right to be free from seclusion and restraints, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff.
HCFA acknowledges in the preamble that "various studies provide evidence that restraint is still being used when alternate solutions are available." This is a useful acknowledgment.
Further, restraints and seclusion must conform to a written plan of care, be implemented in the least restrictive manner possible, and be ended at the earliest possible time. And the use of restraints and seclusion are components of a larger set of patient’s rights including the patient’s right to participate in treatment planning and the right to formulate advance directives.
Acute Care vs Behavior Management
The HCFA rules regulate restraints in two categories of treatment - acute medical and surgical care, and behavior management. Restraints, but not seclusion, may be used in acute medical and surgical care while both seclusion and restraint may be used for behavior management. Examples of acute medical and surgical care restraint use include intravenous and feeding tube security and prevention of re-injury after surgery. Psychiatric treatment is considered for purposes of the HCFA rule to be behavior management, not acute medical care. Restraint is designed in behavior management for "unanticipated, severely aggressive, or destructive behavior."
The Bad News
NAMI’s public policy platform is based on the Pennsylvania nine state psychiatric hospital experience - only a physician may order a seclusion or restraint; registered nurses may seclude or restrain a patient in an emergency, but a verbal physician’s order must be immediately obtained, and the physician must personally assess the patient within 30 minutes; a new order must be written by the physician after a one hour order expires; the physician must reassess the patient in person each time an order is written; and seclusion and restraint orders may not exceed one hour. None of these standards are contained in the HCFA rules.
The HCFA rules are based on the Joint Commission of Accreditation of Healthcare Organizations (JCAHO) standards, with some further modifications to satisfy hospital interests.
Restraints and seclusion may be authorized by a physician or other licensed independent practitioner permitted by the state and hospital. As of February 1997, there were over 600,000 mental health professionals recognized by state law, regulation, or practice. So, HCFA’s rule is an improvement - aides can no longer authorize the use of restraints, but any licensed independent practitioner who is authorized to provide care and services without direction or supervision can authorize restraints and seclusion. The good news in this otherwise almost open-ended authorization process is that the treating physician must be consulted as soon as possible, if the restraint or seclusion is not ordered by the treating physician.
National legislation, endorsed by NAMI, S. 736, S. 750, and H.R. 1313, each would mandate a physician’s order for the use of restraint and seclusion.
It is also confusing that restraints are explicitly allowed for acute medical and surgical care but any licensed mental health professional can authorize restraints. One doubts how many social workers, for example, would or should authorize feeding tube security.
Further Bad News
Restraints and seclusion are allowed for four hours for adults, two hours for children and adolescents, ages 9 to 17, and one hour for patients under the age of 9 years. The original order may be renewed for up to 24 hours. After 24 hours, the authorization process by any licensed independent practitioner starts again.
Further, the rules allow seclusion and restraints to be used simultaneously, even for children under the age of 9 years. In such circumstances the patient must be continually monitored either face-to-face OR by video and audio equipment.
Though the rules say that the condition of the patient must be continually assessed, monitored and reevaluated, there are no timelines established. Existing JCAHO standards require that patients in restraint be checked for physical health and comfort every fifteen minutes. Pennsylvania requires that patients in restraints be kept under constant observation with the health status documented in the medical record. HCFA’s December 1997 preamble to proposed hospital rules would have required a physical check every 15 minutes and vital-sign readings every two hours. The July 2, 1999 rules have no timelines for monitoring.
Some Other Positives
All staff who have direct patient contact must have ongoing education and training in the proper and safe use of seclusion and restraint application and techniques, and alternative methods for handling behavior, symptoms and situations.
Any death related to restraint or seclusion must be reported to HCFA. The rules do not say what HCFA will do with the reports.
Other Missing Information
Pennsylvania requires debriefing of staff and debriefing of patients after release from restraint or seclusion, and the treatment plan must be updated after each restraint or seclusion incident. Neither JCAHO nor HCFA require such debriefing. NAMI advocates for such debriefing.
The HCFA rules require that restraints and seclusion must be in accordance with a written modification to the patient’s plan of care. But JCAHO requirements are more precise; JCAHO requires each episode of restraint and seclusion to be recorded in the patient’s medical record including clinical justification for use and measures taken to protect the rights, dignity, and well-being of the patient.
COMMENTS DUE TO HCFA BY AUGUST 31, 1999
Comments (an original and three copies) should be sent to the Health Care Financing Administration, Department of Health and Human Services, Attention: HCFA - 3018 - IFC - P. O. Box 7517, Baltimore, MD 21207-0517.
Information is available from Rachel Weinstein, R.N., HCFA - 410-786-6775.
SUGGESTED COMMENTS TO HCFA
1. Restraints and seclusion should only be authorized by physicians. Pending national legislation (S. 736, S. 750, and H.R. 1313) would require this.
2. Physicians should reauthorize restraints and seclusion on the hour, after a face-to-face examination.
3. Seclusion and restraint should not be used simultaneously.
4. Patients should be checked for physical health status and comfort every 15 minutes.
5. Hospitals should be required to have debriefing of both staff and patients following each incident of restraint and seclusion, and cited in the medical record.
6. HCFA should be encouraged to designate, in every state, a state-based entity which can actually investigate deaths and serious injuries related to restraints. Pending national legislation (S. 736, S. 750, and H.R. 1313) would require this.
7. Compliment HCFA for taking action in Medicare and Medicaid hospitals, reinforce the core of the regulation that restraints may only be used for emergency safety situations, and encourage HCFA to apply these standards to all other Medicaid funded facilities, particularly residential treatment centers for children.