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NAMI Members Need To Send Comments On HFCA Restraint Rules By August 31, 1999

Chris Marshall
For Immediate Release
11 Aug 99

On June 25, new regulations by the Health Care Financing Administration (HCFA) were announced that govern the use of restraints and seclusion in Medicare and Medicaid financed hospitals. The actual interim final rule which appeared in the July 2, Vol. 64. No. 127 Federal Register makes significant improvements in how restraints are used in hospitals. The rules state that 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. Further, 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. (For more detail see July 9, E-News Vol. 00-4, "HCFA Announces Restraints Rules")


At this time, hospitals are launching a campaign to oppose these HCFA regulations. It is essential that the NAMI membership nationwide send their comments to HCFA to reinforce the core of the regulation that restraints may only be used for emergency safety situations. Attached below is a copy of NAMI's comments. HCFA needs to hear from all NAMI members, and all members are strongly encouraged to send a similar letter to safeguard these important rights. NAMI has suggested ways that the rules can be strengthened.

Please send one original and three copies of your letter to the Health Care Financing Administration, Department of Health and Human Services, Attention: HCFA - 3018-IFC, P.O. Box 7517, Baltimore, MD 21207-0517. Comments must be received by August 31, 1999.


August 10, 1999

Health Care Financing Administration
Department of Health and Human Services
Attention: HCFA-3018-IFC
P.O. Box 7517
Baltimore, MD 21207-0517

Attn: File Code HCFA-3018-IFC

Dear Administrator:

NAMI, the National Alliance for the Mentally Ill, with a nationwide grassroots membership of 210,000 persons directly affected by severe mental illness- submits the following comments in reference to the interim final rule on the Conditions of Participation (42 CFR Part 482) for hospitals receiving Medicaid and Medicare payments, as published in the Federal Register on July 2, 1999.

We are generally pleased with the new rules establishing minimum patient rights and protections; however, we hold some strong concerns with regard to the standards for the use of restraint and seclusion for behavior management. We have developed these comments in collaboration with the Bazelon Center for Mental Health Law, the National Mental Health Association, and the National Association of Protection and Advocacy Systems. This NAMI letter is consistent with, but not identical to, the coalition comments which have been submitted to the rules docket. We have recommended specific changes to HCFA's standard to further safeguard these important rights.

Section 482.13 (f)(3)(ii): Order of a Physician or Other Licensed Independent Practitioner
Comment: NAMI recommends that restraints and seclusion only be authorized by a physician. This should occur within thirty minutes of initiation, following a face-to-face evaluation and such procedure should be repeated each hour until the emergency has passed. The HCFA rules would allow any one of over 600,000 mental health professionals to authorize the use of restraint and seclusion, undermining the purpose of the rule - to restrict the use of restraint and seclusion to emergency situations involving safety.

It is both reasonable and affordable to expect hospitals to have physicians available 24 hours a day for medical emergencies. In fact, the Hospital Conditions of Participation require there be a physician on call 24 hours a day and HCFA pays for emergency visits by physicians. It is therefore reasonable to require that only a physician authorize the use of procedures which can have serious and dangerous consequences for patients. We strongly believe that a physician must complete a face-to-face assessment of the patient on the hour after the initiation of the intervention. There are a number of factors that may lead to a patient displaying violent or agitated behavior, including inappropriate medication, which oftentimes can be corrected immediately.

The policy of the state of Pennsylvania, for its nine state psychiatric hospitals, is an example of a reasonable rule in this regard. It requires that any restraint or seclusion be authorized by a physician within 30 minutes of initiation, following a face-to-face evaluation, and that reauthorizations for continued use of restraints and seclusion be on the hour following a face-to-face evaluation. We strongly urge that HCFA require physicians to authorize any use of seclusion and restraint.

NAMI does recognize the unique situations of rural areas where such physician personnel may not always be available and medically underserved areas, as officially designated by the U.S. Public Health Service, where current practice and current reimbursement may be barriers to such physician on-the-hour and face-to-face requirements. We would be supportive of flexibility in implementing such a standard in such circumstances.

Section 482.13 (f)(3)(ii)(D): Time-limited Orders for Seclusion and Restraint

Comment: Time lines for the application and removal of restraints or seclusion should be narrowly and conservatively drawn. Under the rule, seclusion or a restraint can only be used in emergency situations to ensure the patient's physical safety. As soon as the emergency subsides, the restraint or seclusion should be discontinued, even if the time-limited order has not expired.

We believe that the initial order should be restricted to one hour for adults. For adolescents and children these time lines should be shorter (see separate section on children and adolescents).

During the period of seclusion or restraint, a clinically licensed registered nurse should check the patient's health status and comfort, every 15 minutes. The preamble to the December 1997 HCFA proposed rule suggested required checks of vital signs every 15 minutes. We encourage HCFA to incorporate that suggested standard in the final rule. The patient should also be permitted bathroom breaks and the opportunity to eat meals.

The date and time and duration of restraint or seclusion should be documented in the medical record.

Hospitals should be required to ensure that all physical contact that occurs during the use of seclusion and restraints takes into account factors such as gender, age, developmental issues, ethnicity, history of physical or sexual abuse, medical condition and physical disabilities.

Section 482.13 (f)(4)(i) and (f)(4)(ii): Restraint and Seclusion Simultaneously Comment: Restraint and seclusion should never be used simultaneously. We believe there is no justification for subjecting a patient to both restraint and seclusion at the same time other than for the convenience of staff, for discipline, coercion or retaliation. The interim rule fails to specify "continually monitored," which will be defined through interpretive guidance. In particular, we strenuously object to monitoring through video equipment for an individual who is in seclusion and restraint. Should this practice continue to be permitted, patients should be constantly monitored by staff who are in the room or right outside the seclusion room, but in direct visual sight. Once again, we believe the standard in the preamble to the earlier proposed rule (December 1997) sets adequate monitoring times of 15 minute intervals.

Request for Comments on Special Issues Related to Children and Adolescents

Comment: First, we urge HCFA to broaden the applicability of these standards so as to include residential treatment centers (RTCs) for children and other providers participating in the Medicaid program. Standards for children and adolescents should be more stringent than the seclusion and restraint standards for adults. Any facility holding itself out as a program for the treatment of psychiatric illness must be held to a national treatment standard. This specifically applies to both RTCs and those institutions for mental diseases (IMDs) which are 16 beds or under, and thus qualify for Medicaid reimbursement.

Rules for restraint and seclusion should be different for children than for adults, and different for children of different ages. Children are not little adults. They experience time differently, making the length of any restraint or seclusion dramatically more traumatic for a youngster. Physical control by adults can also be more frightening for a child. Children in seclusion should receive frequent, in-person monitoring and be released immediately when their behavior is under control.

Rules regarding seclusion should clarify the distinction between a seclusion (e.g., a child is locked up in a room) and a time out. Time outs should be defined, and permitted, as actions to require the child/adolescent to retire to an alternative setting, either in the room or in a separate, quiet room, but without restraining or locking the child up. Children in time out should be able to return to regular activities as soon as they calm down and are able to behave in a manner which is appropriate for the activity.

Therapeutic holds also need to be defined. As with mechanical restraints, such holds should be used only in emergency situations, for very limited periods of time and only by staff who are well trained in doing such holds without hurting or harming the child. Generally speaking, two adults should gently hold the child to prevent him/her from acting out physically, and should continually reassure the youngster and explain that they will end the hold as soon as the child can control him/herself. The rule should clarify that therapeutic holds should never involve a child being thrown to the floor and either sat or laid upon by adults.

Regulations should specify time limits for use of restraints and seclusion on children and adolescents. Seclusion should be approved for no more than 30-minute intervals, with a physician order required to extend this time if the child is still uncontrolled and in danger of hurting him/herself or others. Use of restraints should be similarly limited.

Section 482.13 (f)(7): Reporting of Deaths and Injuries
Comment: We have serious concerns regarding several aspects of the reporting process. The process should be modified to ensure that timely, accurate and detailed reporting is provided to both HCFA and Protection and Advocacy Systems (P&As) regarding a broader universe of deaths, as well as regarding all serious injuries, that may be related to restraint and seclusion.

Facilities should be required to report directly to P&As because of the P&As unique authority to address the misuse of restraint and seclusion. A fundamental mandate of the P&A System is to investigate reports of abuse and neglect in facilities that serve persons with disabilities. P&As have authority to access the records of individuals in these facilities and to monitor facility conditions relating to health and safety. They may initiate an investigation if there is evidence presented to them of abuse and neglect, and are authorized to pursue all appropriate remedies to ensure that the human and civil rights of persons with disabilities are protected.

Despite the P&A System's strong authority to access records, the System still needs to receive prompt and detailed reports of deaths and injuries to accomplish this goal. Currently, under Federal law, P&As are authorized to obtain facility records (including investigative reports and medical records) only under narrow circumstances. The primary prerequisites for such access to records are as follows: (1) the receipt by the P&A of a detailed and credible report regarding abuse or neglect (e.g., from an informant in a facility), or (2) the agency's finding of probable cause to suspect that one or more identifiable persons have been subject to abuse or neglect. 42 U.S.C. §§ 6042(a)(2)(I) and 10805(a)(4). Because facilities serving persons with disabilities have not been required to report deaths that may be related to the misuse of restraints, a large number of these deaths simply do not come to the attention of the P&A System, and may not be investigated.

A mandatory, detailed system of reporting to P&As would be effective in ensuring comprehensive investigations. Indeed, a parallel state reporting system, involving the New York Protection and Advocacy System, has worked with great success in New York State for 20 years. New York State law (New York State Mental Hygiene Law, Section 45.19) requires reporting to the P&A of all deaths and allegations of abuse with respect to mental health consumers, and authorizes the agency to investigate. With a similarly strong reporting requirement in these regulations, P&A Systems will be able to achieve similar results throughout the nation.

Reporting of a broader universe of deaths is necessary: We strongly recommend that hospitals be required to report all deaths of patients with either a psychiatric or psychological illness or with mental retardation. If such a standard is not possible, then, at a minimum, reporting should be provided regarding all such individuals who have died within a specified time frame (e.g., one week) after having been placed in restraints and/or seclusion. In addition, reports should be provided as well for those deaths, occurring after the end of this time frame, which reasonably may be assumed to be the result of restraint and seclusion.

We believe that it is critical for the reporting requirement to cover this broader universe of patient deaths so as to ensure that independent third parties - i.e., HCFA and P&As - can make unbiased determinations as to whether the deaths were indeed precipitated by the misuse of restraint and seclusion. Based on the P&A System's experience, health care providers too often dismiss restraint-related deaths as unfortunate isolated incidents and not as the manifestation of individual abuses or systemic failures.

The reporting requirements in the regulations will almost certainly have the unintended effect of excusing hospitals from revealing many deaths which truly were precipitated by the misuse of restraint and seclusion. It is quite clear that the requirement that hospitals report deaths of individuals which occur while actually in restraints or seclusion creates a large loophole. Many individuals placed in restraints and/or seclusion, and who sustain critical injuries as a result, actually die some time after their removal from restraints and seclusion. For instance, cases have been documented where individuals are provided unsuccessful life saving measures on site or are transferred to other specialized facilities for care - and expire hours, days or even weeks later. Examples of such cases are detailed in the Hartford Courant series on deadly restraint practices.

The additional reporting requirement contained in the regulations - covering those deaths which reasonably may be assumed to have resulted from restraint and seclusion - also will be ineffective in ensuring accurate reporting of deaths which were truly precipitated by the practice. It is simple enough for hospitals to rationalize a large array of deaths which were actually precipitated by restraint and seclusion as the result of a patient's underlying condition, or "due to natural causes." This especially may be true in the case of deaths related to asphyxiation or cardiac arrest. For instance, the Hartford Courant (in an October 11, 1998 article at p. A11) documented a case involving the death of a young man who suffered a severe asthma attack soon after fighting with another patient and being restrained. The death was ruled to be due to natural causes, even though the medical examiner found that the stress of the fight and restraint triggered the asthma attack. Similarly, the paper reported on the death of another young man, who was restrained and died afterwards when a seizure resulted in asphyxiation; the state medical examiner ruled this incident to be an accident.

If hospitals have unilateral discretion in making subjective determinations about the cause of death, as permitted by the regulations, investigating agencies will have little ability to question these determinations.

Once a P&A receives these reports, their trained investigators and legal staff can make a preliminary determination as to which deaths may be due to the misuse of restraint and/or seclusion. Thereafter, the P&A would determine whether an independent investigation is warranted. If a separate investigation is planned or ongoing, the P&A might review that process to determine if it is sufficiently thorough, and/or collaborate in the inquiry. Where appropriate, the P&A could take appropriate corrective actions to ensure that these abuses do not occur in the future. For example, through negotiation or litigation, if necessary, corrective actions could be imposed to reform facility practices or statewide policies, appropriate compensation for family members of the deceased can be obtained, and staff involved in the death can be subjected to termination and/or criminal prosecution.

None of these efforts can take place if a hospital, based on a subjective and possibly biased determination, is allowed to unilaterally withhold information on deaths which may or may not have been precipitated by restraint and/or seclusion.

Serious injuries must be reported as well. In addition to deaths, facilities should also report "sentinel events." These should be defined as: any unexpected occurrence involving a substantial impairment of the physical or psychological condition of a resident or patient, including any burn, laceration, or abrasion of the skin, fracture of any bone, substantial hematoma, injury to any internal organ, or any injury that occurs as a result of repeated harm to any bodily function or organ (including the skin).

This would ensure reporting of the most serious injuries which potentially may be related to restraint and seclusion.

Reports must be in writing and contain sufficient information, and be provided to HCFA and to the P&A within a specific time frame. At a minimum, the reports should provide the following information: (1) the identity of the deceased or injured party; (2) his or her age; (3) the identity of the individual's guardian, if he or she has one; (4) the identity of the individual's next of kin (in the case of a death); (5) the date of death or injury; (6) the individual's home address; (7) the medications the individual was taking and other medical services that were provided; (8) the cause and circumstances of the death or injury; (9) whether and by whom the death or injury is being investigated; and (10) the identity of the person making the report.

Further, the regulation should be revised to ensure that these reports are received by the regional office within four days of the incident involved (either the injury or death), and by the P&A within an additional three days. The seven-day time frame for providing these reports to P&As is consistent with the time frame contained in the House restraint bill, H.R. 1313, "Patient Freedom from Restraint Act of 1999." The regulations currently provide no time frame for making these reports. Consequently, hospitals are left entirely to their own discretion as to the timing of the reports. Thus, the hospital is free to make the reports within two days or two years. If the reporting is delayed beyond the recommended time frame, the ability of both HCFA and

P&As to effectively investigate would be compromised. For instance, staff involved in an incident may leave the jurisdiction, medical or documentary evidence could be lost or concealed, etc. Moreover, if the report is delayed, potentially deadly practices would continue without intervention by investigators.

Posting of Information on P&As
Comment: We urge HCFA to revise the regulations to require hospitals to post the name, address and telephone number of the local P&A, along with a brief description of the services provided by the agency. This information also should be provided directly to individual patients or their representatives or guardians. This may be accomplished by amending the regulations at section 482.13(a), which addresses the duty to provide a notification of patient rights.

As stated in the preamble, the notice requirement could be accomplished by posting the notice on the P&A along with existing information that must be provided to patients to fulfill civil rights requirements. This requirement would be consistent with HCFA's rules applicable to long-term care facilities, which require such facilities to post information on P&As and other advocacy groups. 42 C.F.R. § 483.10(b)(7)(iii). Patients in the hospitals covered by these regulations have just as much need to be informed about P&A services as do residents of long-term care facilities.

Section 482.13 (b)(3): Right to Formulate Advance Directives
Comment: We applaud you for referencing advance directives in the new rules. We believe the advance directive can serve as an important tool to help minimize the use of seclusion and restraint when a patient is in a psychiatric emergency and hope that the interpretive guidelines describing aspects particular to advance directives will also include a statement encouraging their use.

Debriefing Following Incidents
Comment: We believe that the use of restraints and seclusion is a treatment failure. As such, all alternatives should be attempted first (as required by the rule) and both staff and patients should clearly understand why such incidents occurred in order to improve treatment and avoid restraint use in the future. We recommend the current practice of the state of Pennsylvania, for its nine state psychiatric hospitals, be incorporated into the standard: that there be debriefing by staff, followed by debriefing with the individual, within 24 hours of each incident of restraint and seclusion.

We look forward to working with you to provide minimum protections to other health care facilities, such as Residential Treatment Centers. Thank you for the opportunity to provide comments.


E. Clarke Ross, D.P.A.
Deputy Executive Director for Public Policy


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