[Federal Register: December 8, 2006 (Volume 71, Number 236)] [Rules and Regulations] [Page 71377-71428] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr08de06-18] [[Page 71377]] ----------------------------------------------------------------------- Part IV Department of Health and Human Services ----------------------------------------------------------------------- Centers for Medicare & Medicaid Services ----------------------------------------------------------------------- 42 CFR Part 482 Medicare and Medicaid Programs; Hospital Conditions of Participation: Patients' Rights; Final Rule [[Page 71378]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 482 [CMS-3018-F] RIN 0938-AN30 Medicare and Medicaid Programs; Hospital Conditions of Participation: Patients' Rights AGENCY: Centers for Medicare & Medicaid Services (CMS), DHHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This final rule finalizes the Patients' Rights Condition of Participation (CoP) which is applicable to all Medicare- and Medicaid- participating hospitals and contains standards that ensure minimum protections of each patient's physical and emotional health and safety. It responds to comments on the following standards presented in the July 2, 1999 interim final rule: Notice of rights; exercise of rights; privacy and safety; confidentiality of patient records; restraint for acute medical and surgical care; and seclusion and restraints for behavior management. As a result of comments received, we have revised the standards regarding restraint and seclusion and set forth standards regarding staff training and death reporting. DATES: Effective Date: These regulations are effective on January 8, 2007. FOR FURTHER INFORMATION CONTACT: Patricia Chmielewski, RN, MS (410) 786-6899, Janice Graham, RN, MS (410) 786-8020, Monique Howard, OTR/L (410) 786-3869, Jeannie Miller, RN, MPH (410) 786-3164, Rachael Weinstein, RN, MPA (410) 786-6775. SUPPLEMENTARY INFORMATION: Table of Contents I. Background A. Overview B. Key Statutory Provisions C. Regulatory Background D. Requirements for Issuance of Regulations E. Restraint and Seclusion in Other Settings II. Provisions of the Proposed and Interim Final Rules Regarding Patients' Rights III. Comments on and Responses to the Provisions of the Interim Final Rule With Comment Period A. General Comments on the Requirements for Use of Restraint and Seclusion 1. Is There Cause for Concern? 2. The Difference Between Standards (e) and (f) 3. The Roles of CMS and JCAHO 4. Applicability of the Patients' Rights CoP 5. Debriefing After the Use of Restraint/Seclusion B. Comments Received on Specific Provisions 1. The Right to Be Free From Restraint (Sec. Sec. 482.13(e)(1) and (f)(1)) 2. Definition of ``Restraint'' and ``Physical Restraint'' (Sec. Sec. 482.13(e)(1) and (f)(1)) 3. Definition of a ``Drug Used as a Restraint'' (Sec. Sec. 482.13(e)(1) and (f)(1)) 4. Use of Restraints (Sec. Sec. 482.13(e)(2) and (e)(3)(i)) 5. Ordering of Restraint/Seclusion (Sec. Sec. 482.13(e)(3)(ii) and (f)(3)(ii)) a. Definition of Licensed Independent Practitioner (LIP) (Sec. Sec. 482.13(e)(3)(ii) and (f)(3)(ii)) b. Physician Only c. Elimination of Protocols d. Initiate versus Order 6. Prohibition on Standing and PRN Orders (Sec. Sec. 482.13(e)(3)(ii)(A) and (f)(3)(ii)(A)) 7. Consultation with the Treating Physician (Sec. Sec. 482.13(e)(3)(ii)(B) and (f)(3)(ii)(B)) 8. Written Modification of the Plan of Care (Sec. Sec. 482.13(e)(3)(iii) and (f)(3)(iii)) 9. Implementation of and Appropriate Use of Restraint/Seclusion (Sec. Sec. 482.13(e)(3)(iv), (e)(3)(v), (f)(3)(iv), and (f)(3)(v)) 10. Discontinuing the Use of Restraint/Seclusion (Sec. Sec. 482.13(e)(3)(vi) and(f)(3)(vi)) 11. Assessment, Monitoring, and Evaluation of the Restrained/ Secluded Patient (Sec. Sec. 482.13(e)(4) and (f)(5)) 12. Staff Training in the Use of Restraints/Seclusion (Sec. Sec. 482.13(e)(5) and (f)(6)) 13. Definition of Seclusion (Sec. 482.13(f)(1)) 14. Use of Restraint/Seclusion for Behavior Management (Sec. 482.13(f)(2)) 15. One Hour Rule (Sec. 482.13(f)(3)(ii)(C)) a. Comments Objecting to a Physician or LIP Seeing the Patient Within 1 Hour b. Comments Supporting Telephone Consultation with a Nurse Onsite Performing the Patient Assessment c. Comments Opposing Telephone Orders, Nurse Evaluation, and LIP Involvement d. Comments Stating that the 1-Hour Rule Did Not Address the Problem 16. Limits for Restraint/Seclusion Orders (Sec. 482.13(f)(3)(ii)(D)) 17. Simultaneous Use of Restraint and Seclusion (Sec. 482.13(f)(4)) 18. The Use of Video and Audio Monitoring 19. Reporting of Death(s) Related to Restraint/Seclusion (Sec. 482.13(f)(7)) IV. Provisions of the Final Rule V. Collection of Information Requirements VI. Regulatory Impact Analysis A. Overall Impact B. Anticipated Effects 1. Effects on Providers a. Section 482.13(e) Standard: Restraint or Seclusion b. Section 482.13(f) Standard: Restraint or Seclusion: Staff Training Requirements c. Section 482.13(g) Standard: Death Reporting Requirements 2. Effect on Beneficiaries 3. Effect on the Medicare and Medicaid Programs C. Alternatives Considered Regulations Text I. Background A. Overview This rule set forth final requirements for Patients' Rights in hospitals, provides strong patient protections, provides flexibility to providers, and is responsive to comments. This regulation focuses on patient safety and the protection of patients from abuse. These standards support and protect patients' rights in the hospital setting; specifically, the right to be free from the inappropriate use of restraint and seclusion with requirements that protect the patient when use of either intervention is necessary. It recognizes the legitimate use of restraint for acute medical and surgical care as a measure to prevent patient injury, as well as the use of restraint or seclusion to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. In addition, this rule finalizes, without modification, the standards for Notice of Rights, Exercise of Rights, Privacy and Safety, and Confidentiality of Patient Records. B. Key Statutory Provisions Sections 1861(e) (1) through (8) of the Social Security Act (the Act) define the term ``hospital'' and list the requirements that a hospital must meet to be eligible for Medicare participation. Section 1861(e)(9) of the Act specifies that a hospital must also meet such other requirements as the Secretary finds necessary in the interest of the health and safety of the hospital's patients. Under this authority, the Secretary has established in regulations at 42 CFR part 482 the requirements that a hospital must meet to participate in the Medicare program. Section 1905(a) of the Act provides that Medicaid payments may be applied to hospital services. Regulations at Sec. 440.10(a)(3)(iii) require hospitals to meet the Medicare CoPs to qualify for participation in Medicaid. The Children's Health Act of 2000 (CHA) (Pub. L. 106-310) was enacted October 17, 2000. Section 3207 of the CHA amended Title V of the Public Health Service Act (PHSA) by adding a new part H, which contains requirements relating to the rights of residents of certain facilities. Specifically, section 591 of the PHS Act, as added by the CHA (42 U.S.C. 290ii), establishes certain minimum requirements with regard to the use of restraint and seclusion in facilities that receive support in any form from any program supported in whole or in part [[Page 71379]] with funds appropriated to any Federal department or agency. In addition, Sections 592 and 593 of the PHS Act (42 U.S.C. 290ii and 290ii-3) establish minimum mandatory death reporting and staff training requirements. This final rule conforms to the requirements of the CHA. As implementing regulations are issued, a critical point for consideration is that Title V, part H of the PHS Act is not an isolated enactment, but part of a trend of legislation and regulations aimed at protecting and promoting resident, patient, and client rights. Part H, section 591(c) of the PHS Act states ``This part shall not be construed to affect or impede any Federal or State law or regulations that provide greater protections than this part regarding seclusion and restraint.'' The value of preserving existing law and regulations is recognized while extending protections to those facilities that are currently without the protection intended by the Congress. C. Regulatory Background In the December 19, 1997 Federal Register (62 FR 66726), we published a proposed rule entitled ``Medicare and Medicaid Programs; Hospital Conditions of Participation; Provider Agreements and Supplier Approval'' to revise the entire set of CoPs for hospitals found at 42 CFR part 482. This proposed rule included a CoP for patients' rights. In the July 2, 1999 Federal Register (64 FR 36070), we published the Patients' Rights CoP as an interim final rule with comment. This CoP was separated from the other proposed hospital CoPs in response to Congressional and public interest. Although we have modified some of the provisions to address public comments, these modifications do not lessen protections afforded patients who are restricted or secluded. We note that we have revised the regulation to expand training requirements and have added a requirement that the attending physician or other licensed independent practitioner (LIP) responsible for the care of the patient be consulted as soon as possible when the ``one hour'' evaluation of a patient in restraint or seclusion is conducted by a trained registered nurse (RN) or physician assistant (PA). D. Requirements for Issuance of Regulations Section 902 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and requires the Secretary, in consultation with the Director of the Office of Management and Budget, to establish and publish timelines for the publication of Medicare final regulations based on the previous publication of a Medicare proposed or interim final regulation. Section 902 of the MMA also states that the timelines for these regulations may vary but shall not exceed 3 years after publication of the preceding proposed or interim final regulation except under exceptional circumstances. In a notice published December 30, 2004 (69 FR 78442), we implemented section 902 of the Act by announcing that all outstanding interim final rules as of December 8, 2003 would be finalized by December 8, 2006 or expire. This final rule finalizes provisions set forth in the July 2, 1999 interim final rule with comment. In accordance with section 902 and our notice of 2004, this final rule is being published within 3 years of the date of enactment of the MMA, which was December 8, 2003, in order to finalize the 1999 interim final rule with comment. E. Restraint and Seclusion in Other Settings In the preamble of the July 2, 1999 interim final rule with comment period, we explained that we were considering the advisability of adopting a consistent restraint and seclusion standard that would apply not only to hospitals but to other kinds of health care entities with which CMS has provider agreements, including those that provide inpatient psychiatric services for individuals under 21 years of age (a program under Medicaid). We asked the public whether we should adopt the same standards that appeared in the July 2, 1999 interim final rule with comment period, or whether we should adopt more stringent standards. Consumer advocacy groups that commented on extending these requirements to other settings generally argued for more stringent expectations for the care of children, citing special hazards and concerns that arise when children and adolescents are restrained. Some commenters encouraged CMS to apply the restraints and seclusion standards of the interim final rule with comment period to all other Medicaid-funded facilities, particularly residential treatment centers for children and adolescents. Other commenters did not agree with this approach, arguing that the fields of mental health and developmental disabilities are very different and that similarities between the two should not be assumed. For example, some commenters stated that little research exists on the use of restraint/seclusion in mental health, but that in contrast, a considerable amount of research in the developmental disabilities field supports the effectiveness of restraint and seclusion for severe behavior problems. Thus, the field of developmental disabilities already has extensive guidelines, standards, and rules governing the use of restraint and seclusion. Some of those commenters who supported uniform restraint and seclusion standards across settings offered detailed suggestions for what those standards should require. For example, commenters suggested that the regulation forbid the use of mechanical restraints for children under a certain age (these commenters offered varying suggestions regarding the threshold age (17 and 21 years of age were two of these suggestions)), or permit therapeutic holding for periods no longer than 15 minutes. Some of the commenters expressed concern about proposing requirements that paralleled existing requirements for hospitals because of the differences in patient acuity and characteristics and treatment. We considered the comments we received in developing specific restraint and seclusion requirements for inpatient psychiatric services for individuals under 21 years of age. These requirements were published in an interim final rule with comment period entitled, ``Medicaid Program; Use of Restraint and Seclusion in Psychiatric Residential Treatment Facilities Providing Services to Individuals under Age 21'' in the January 22, 2001 Federal Register (66 FR 7148). In the May 22, 2001 Federal Register (66 FR 28110), we published an additional interim final rule with comment period to amend and further clarify the January 22, 2001 interim final rule with comment period. There was little comment on extending restraint and seclusion requirements to specific non-behavioral or non-psychiatric types of settings or providers, such as home health agencies, ambulatory surgical centers, or providers of x-ray services. While a few commenters gave blanket support to this idea, they did not supply a rationale for applying one set of standards versus another. Several commenters discussed their concern about extending the restraint and seclusion requirements to the nursing home setting and strongly disagreed with any adoption of the standards presented in the interim final rule with comment period in that setting. One nursing home industry association argued for consistency in terminology and philosophy, but recognized that the settings where beneficiaries receive services are diverse, as are the beneficiaries [[Page 71380]] themselves, and that adopting a blanket approach might not be practical or appropriate. After considering these comments and engaging in internal deliberations, we have decided that it would not be appropriate to adopt a detailed, technical approach that would create an identical standard for all of the providers with which CMS has agreements. Instead, the needs of specific treatment populations and settings should drive the types of standards developed. Therefore, we do not plan to adopt the hospital requirements verbatim for other provider types. However, we are concerned about beneficiaries receiving care in settings where no regulatory protections regarding the use of restraint or seclusion currently exist. The CHA provides statutory protection to patients at any facility receiving Federal funding. While it is impractical, in our view, to take the requirements for hospitals, nursing homes, or intermediate care facilities for the mentally retarded and adopt them as a whole in any other given setting, we can instead develop any new requirements with the same philosophical foundation that underlies the three existing sets of standards and requirements. This foundation encompasses the belief that the patient has the right to be free from unnecessary restraint or seclusion, that using a restraint for convenience, punishment, retaliation, or coercion is never acceptable, and that each patient should be treated with respect and dignity. These beliefs are true in every care setting and are legally enforceable in accordance with the CHA. As appropriate, we will develop regulations that support these concepts. However, given the variations in treatment populations and settings, the individual case setting will drive the type of standards developed which will vary as appropriate. II. Provisions of the Proposed and Interim Final Rules Regarding Patients' Rights The December 19, 1997 hospital CoP proposed rule included a patients' rights CoP that proposed to establish standards for the following: Notice of rights. Exercise of rights regarding care. Privacy and safety. Confidentiality of patient records. Seclusion and restraint. With the exception of the standard for seclusion and restraint, we received few comments in response to these proposed requirements. In the July 2, 1999 Federal Register, we published an interim final rule with comment period that separated the patients' rights CoP from the other hospital CoPs and introduced modifications to proposed standard (e) and added a new standard (f), governing the use of restraint and seclusion. Because we received few comments on the other provisions of the patients' rights section (standards a through d), these four provisions were not reopened for public comment in the July 2, 1999 interim final rule with comment period. In the 1997 proposed rule, standard (e) was entitled ``Seclusion and restraint,'' and covered the patient's right to be free of restraint or seclusion used as a means of coercion, convenience, or retaliation by staff. The proposed language set forth several basic ideas and expectations; namely, that restraint (including psychopharmacological drugs used as restraints) and seclusion must be used in accordance with the patient's plan of care; that restraints or seclusion may be used only as a last resort and in the least restrictive manner possible to protect the patient or others from harm; and that restraint or seclusion must be removed or ended at the earliest possible time. The interim final rule with comment period introduced two standards on restraint and seclusion--one governing the use of restraint in the provision of acute medical and surgical care and the other governing the use of seclusion and restraint for behavior management. The revised standard (e) included definitions that had not specifically appeared in the proposed rule and also included: (1) A prohibition on standing orders or orders on an as needed basis (that is, PRN) for restraint; (2) an emphasis on continual assessment and monitoring; and re- evaluation of the condition of the restrained patient; (3) a requirement that the hospital notify the patient's treating physician if he/she did not issue the restraint order personally; and (4) a training requirement for all staff with direct patient contact. Standard (f) offered definitions and provided more prescriptive requirements than the proposed or revised standard (e). The focus on behavior management in standard (f) was intended to apply in situations where the patient's aggressive or violent behavior creates an emergency situation that places his or her safety or that of others at risk. The more prescriptive elements, such as--(1) requiring a physician or licensed independent practitioner (LIP) to see and evaluate the need for restraint or seclusion within 1-hour of the initiation of the intervention; (2) the limitation on the length of orders and required re-evaluation; and (3) the requirement for continual face-to-face monitoring or continual monitoring using both video and audio equipment if restraint and seclusion are used simultaneously, were meant to be commensurate with the increased risk to patient health and safety when these interventions are used to address violent or aggressive patient behavior. In both standards (e) and (f) of the July 2, 1999 interim final rule with comment period, the phrase ``psychopharmacological drugs used as restraints'' was replaced with the phrase ``drug used as a restraint,'' in recognition of the idea that singling out one type of medication encourages the misperception that only one class of drugs is used to restrain patients. Concern for patient health and safety prompted us to make these requirements effective on August 2, 1999. However, given the changes to the proposed standard (e) and the addition of standard (f), we believed that the public should have an opportunity to comment on the revised restraint and seclusion provisions. For these reasons, we published the July 2, 1999 rule as an interim final rule with comment period. III. Comments on and Responses to the Provisions of the Interim Final With Comment Period We received approximately 4,200 timely comments on the interim final rule with comment period. Comments were received from hospitals, mental health treatment facilities, physicians, nurses, attorneys, professional associations, accrediting bodies, state agencies, national and State patient protection and advocacy groups, and members of the general public. Many commenters applauded the addition of the restraint and seclusion provisions in the Patients' Rights CoP, even if they disagreed with specific requirements or concepts. A summary of the comments received on these provisions (standards (e) and (f)) and our responses follows. We received comments on issues out of the scope of the interim final rule with comment period; these comments will not be addressed in this final rule. A. General Comments on the Requirements for the Use of Restraint and Seclusion Some commenters suggested that the 1-hour physician or LIP visit and assessment were not consistent with the goal of creating a government that works better and costs less. A few commenters stated that the rapid introduction of standards (e) and (f) was a ``knee-jerk [[Page 71381]] reaction'' to the lobbying of certain groups and the sensationalized media coverage of a limited number of cases. One commenter stated, ``It is time the legislature and administrative agencies stop reacting to sensational headlines and layering the health care system with costly and time consuming regulations to meet.'' Another commenter questioned the validity of the 1998 Hartford Courant series of articles (cited in the preamble to the interim final rule with comment period), asserting that the articles did not clearly determine that the use of restraint and seclusion were the proximate and sole cause of deaths in the cases cited. The same commenter asked in which setting these deaths occurred, stating that it makes no sense to regulate a hospital on this point if there is no evidence that restraint-related deaths are problematic in hospitals. Another commenter questioned the FDA's estimate of at least 100 deaths per year from improper use of restraints, specifically noting that he believes that these are not cases where restraint use was unmerited. Another commenter stated that while the abuse and deaths that have occurred are unfortunate, they do not represent an emergency situation meriting the actions that were taken by CMS. The commenter made the following statement: While 142 deaths in 10 years is unfortunate, the number pales when compared to the 3 million people hospitalized per year for adverse drug reactions and 150,000 deaths resulting from drugs taken properly as prescribed by the physician. A commenter stated that CMS has given too much credence to over- dramatized accounts of restraint and seclusion use. Many hospitals reported having no injuries or deaths associated with restraint or seclusion use. A number of physicians also noted that none of their patients have suffered serious injuries or died due to the use of restraints. One commenter stated that it was unfair to subject the industry as a whole to highly prescriptive requirements when the events that triggered such concern occurred in a handful of facilities. The commenter argued that only the hospitals where the deaths occurred should be governed by these rules. Another commenter suggested that in the situations where these deaths occurred, the practices used were out of compliance with the hospitals' own policies and procedures. Accordingly, the commenter stated that prescriptive regulations do not represent the gateway to reduced injuries and deaths, and that enforcement of existing requirements would be more effective. Still other commenters have suggested that even if death and injury are of concern, CMS has not yet hit upon the correct solution. To balance these comments, we mention those received from advocacy groups, patients, and hospital staff. Some of the anecdotal information provided was clearly disturbing, including accounts of patients being choked during takedowns even though staff had been trained in proper procedures, and patients suffering broken limbs or other injuries. Other commenters described situations where patients had been placed in restraints for extended periods of time (up to 10 consecutive hours) and staff did not take vital signs regularly, did not offer food, fluids, or use of the toilet at all, or offered them only once while the patient was restrained. Comments also related concerns about the over use and inappropriate use of restraint or seclusion. One commenter stated that a lawsuit was filed on behalf of a patient dually diagnosed with mental retardation and organic brain syndrome who was placed in restraints 48 times within a six month period. The commenter stated that in the six months after the lawsuit was settled, the patient had only been restrained twice. Many commenters applauded the regulatory action. Commenters stated that the action was long overdue and important for the safety of vulnerable populations most in need of protection from abuse of restraints and seclusion. Commenters see this rule as a major step forward in addressing issues surrounding the use of restraint and seclusion in inpatient facilities and support further movement toward the goals of ultimately eliminating the use of seclusion and restraint, and preserving patients' rights and dignity. In addition, many commenters stated that they would like to see even more stringent requirements for the use of restraint and seclusion for behavior management. 1. Is There Cause for Concern? Given the prevalence of restraint use, we believe that awareness and vigilance are justified. On October 11, 1998, the Hartford Courant reported that of the 142 deaths it confirmed, 59.6 percent occurred in the hospital setting (including psychiatric hospitals and psychiatric wards of general hospitals). The Courant further stated that 47.2 percent of the 142 deaths involved physical restraints or therapeutic holds, while 44.1 percent involved mechanical restraint, 3.1 percent involved a combination of the two, and the remaining 5.5 percent were seclusion-related. Although the Courant did not claim that restraint and seclusion use were the sole and proxmate cause of death in each case, we question the usefulness of this criterion in determining whether restraint and seclusion pose significant risk to health and safety. Obviously, when a patient's trachea is crushed during a takedown, restraint would constitute the ``sole and proximal'' cause of death. However, a case cited by one commenter illustrates how this characterization may fail to take into account the many times that restraint or seclusion can play a part in injury. The commenter reported that one young man died after suffering 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 both the stress of the fight and the restraint triggered the asthma attack. One cannot only consider whether restraint or seclusion is the sole cause of death when examining whether the use of restraint or seclusion poses a significant risk to the patient. One commenter questioned the statistical significance of 142 deaths over a 10-year period. This number may not reflect the actual number of such deaths that occur each year. In explaining how it conducted its investigation, the Courant noted, ``Throughout the reporting * * * it became clear that many deaths go unreported.'' To better determine the national annual death rate, the Courant hired statistician Roberta Glass, a research specialist for the Harvard Center of Risk Analysis at the Harvard School of Public Health. The Courant reported the following: Glass projected that the annual number of deaths could range as high as 150. ``Admittedly, the estimates are only rough approximations,'' Glass said. ``The data needed for precise estimation are not collected in a systematic way nationwide.'' On October 26, 1999, Associate Director Leslie Aronovitz of the U.S. Government Accountability Office provided testimony before the Senate Committee on Finance entitled, ``Extent of Risk from Improper Restraint or Seclusion is Unknown.'' Aronovitz testified to the following: Neither the federal government nor the states comprehensively track the use of restraint or seclusion or injuries related to them across all types of facilities that serve individuals with mental illness or mental retardation * * * Because reporting is so piecemeal, the exact number of deaths in which restraint or seclusion was a factor is not known. We contacted the P&As [[Page 71382]] [protection and advocacy agencies] for each state and the District of Columbia and asked them to identify people in treatment settings who died in fiscal year 1998 and for whom restraint or seclusion was a factor in their death. The P&As identified 24, but this number is likely to be an understatement, because many states do not require all or some of their facilities to report such incidents to P&As. The lack of systemic information collection is an important point. The Joint Commission on Accreditation for Healthcare Organizations (JCAHO), which accredits 80 percent of the hospitals that participate in Medicare and Medicaid, does not require hospitals to report ``sentinel events'' such as injuries or deaths related to restraint or seclusion use, but encourages voluntary reporting through its sentinel event program. JCAHO defines a sentinel event as ``an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.'' Even if each of the accredited hospitals scrupulously and voluntarily reports sentinel events, the 20 percent of Medicare- and Medicaid-participating hospitals that are non-accredited do not provide this information to JCAHO. Since reporting is voluntary rather than mandatory, accredited hospitals may choose not to inform JCAHO. Hospitals may fear that reported information might be used against them in court, which would provide a clear disincentive to consistent and voluntary reporting. Even if Glass' projection of up to 150 deaths per year is correct, some may question its statistical significance when compared with the number of deaths that result from other factors, such as medical errors. We believe that while deaths are a focal point, it is important not to discount patient injuries. If deaths are under-reported, injury data are even more elusive. Estimating the psychological and social impact of restraint or seclusion is more challenging still. We do not imply that most of the nation's providers recklessly seclude or restrain patients without regard to their emotional well-being. To the contrary, many who commented on this regulation stated that restraint or seclusion are measures of last resort and that they do not undertake these interventions unless absolutely necessary. However, even when a restraint or seclusion is needed, the patient may feel dehumanized, isolated, or depressed as a result. Physical impact, although arguably not simple to measure, is more easily monitored and reported than impact on the spirit. In summary, we suspect that patient deaths and injuries are underreported, and, even if all parties voluntarily report incidents involving restraint or seclusion or comply with State and local reporting requirements, there are gaps in the system that thwart conclusive calculation of the number of physical injuries and deaths associated with restraint and seclusion use. Given the prevalence of use, the potential for injury, death, or adverse psychological impact, we maintain our original position--that this area deserves regulatory attention to safeguard patient health and safety. 2. The Difference Between Standards (e) and (f) Comment: Many commenters stated that it is unclear which standard applies in any given situation. One commenter recommended that we delineate a clear, objective explanation of when application of the behavior management standard outside the psychiatric care setting is expected. One commenter objected to the creation of separate requirements for the care of psychiatric patients versus those receiving acute medical treatment, and asserted that all patients should be treated equally. However, most commenters agreed that different requirements should apply to restraints used for violent, aggressive patients as opposed to restraints used in the provision of medical care; some suggested that setting-specific requirements are more reasonable than behavior-specific ones. Response: Based on public comment regarding the lack of clarity between the application of standard (e) Restraint for acute medical and surgical care, and the application of standard (f) Restraint and seclusion for behavior management, we have revised and combined these requirements into a single standard in the final rule. This combined standard, entitled ``Restraint or seclusion,'' is subparagraph (e) under Sec. 482.12 Patients' Rights in the final rule. This combined standard (e) applies to all uses of restraint or seclusion regardless of the patient's location. Although we have modified some of the provisions to address public comments, these modifications do not lessen protections afforded patients who are restricted or secluded. We note that we have revised the regulation to expand training requirements, and have added a requirement that the attending physician or other licensed independent practitioner (LIP) responsible for the care of the patient be consulted as soon as possible when the one-hour restraint or seclusion evaluation of the violent or self-destructive patient is conducted by a trained registered nurse (RN) or physician assistant (PA). Comment: A few commenters noted the challenge of making a determination on the standard of care for a patient with multiple diagnoses and behaviors. Response: We agree that multiple diagnosis and behaviors can make determination on the standard of care a challenge. Therefore, even though several requirements were revised based on public comments, none of the current requirements in standards (e) and (f) have been deleted. All of the requirements contained in the current standard (e) are also contained in the current standard (f). These requirements, in their entirety, have been moved to the combined standard (e) in the final rule. All of the requirements contained in the current standard (f), have also been moved, in their entirety, to the combined standard (e) in the final rule. Comment: One commenter noted the difficulty in enforcing behavior- specific standards. However, another commenter supported writing the standards to focus on patient behavior or circumstances rather than on the setting. Some commenters requested clarification on what ``behavior management'' means. Response: For the purpose of clarity we have eliminated the term ``behavior management'' and are using more specific language. The management of violent or self-destructive behavior can occur as part of medical and surgical care as well as part of psychiatric care. The use of the language ``violent or self-destructive behavior'' is intended to clarify the application of these requirements across all patient populations. It is not intended to single out any particular patient population. Based on public comments, we have eliminated the language ``behavior management,'' and have used clearer, more descriptive language in the final rule. Specifically, we have revised the regulations text at 482.13(e) to provide that restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others, and must be discontinued at the earliest possible time. This combined standard clearly outlines the requirements any time restraint or seclusion is used, regardless of the patient's location. We do not support a setting-based approach because interventions and protections provided without considering the patient's behavior and symptoms may fail to adequately safeguard the health and safety of patients. In addition, this standard is not targeted only at patients on psychiatric units or those with behavioral/mental health care needs. The patient protections contained in this standard apply to all patients when [[Page 71383]] the use of restraint or seclusion becomes necessary. Although a patient's violent or self-destructive behavior may jeopardize the immediate physical safety of the patient, a staff member, or others more frequently in a psychiatric unit or in a psychiatric hospital, this behavior also appears in the acute medical/ surgical care settings, including emergency and critical care settings. Some examples follow. A patient may experience a severe medication reaction that causes him or her to become violent. A patient may be withdrawing from alcohol and having delirium tremors (DTs). The patient is agitated, combative, verbally abusive, and attempting to hit staff. Regardless of facility type, such emergencies generally pose a significant risk for patients and others. For the safety of the patient and others, the use of restraint or seclusion may be necessary to manage the patient's violent or self-destructive behavior that jeopardize the immediate physical safety of the patient, a staff member, or others when less restrictive interventions have been determined to be ineffective to protect the patient, staff, or others from harm. It is not targeted only at patients on psychiatric units or those with behavioral/mental health care needs. The patient protections contained in this standard apply to all patients when the use of restraint or seclusion becomes necessary. Comment: One commenter suggested adding language in Sec. 482.13(f)(2) to indicate that standard (f) applies when a restraint or seclusion is used, ``In an emergency situation to manage an unanticipated outburst of severely aggressive or destructive behavior that poses an imminent danger to the patient or others.'' Several commenters suggested changing the title of standard (f), examples include, ``Emergency behavior management'' and ``Seclusion/restraint for patients with primary behavioral health care needs.'' Response: The current standard (e) contains two requirements that are more stringent, if restraint or seclusion is used when a patient jeopardizes the immediate physical safety of the patient, a staff member, or others. They are: time limits on length of each order, and the 1-hour face-to-face evaluation. The intent of these more stringent requirements is to add additional patient protections when restraint or seclusion is used for behavior management. We do not intend for these two more stringent requirements to apply to all uses of restraint. We have added clarifying language in the final rule that these requirements apply when restraint or seclusion are used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. We have also specified that seclusion is only permitted to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. Since publication of the interim final rule with comment period, we have repeatedly responded to inquiries regarding the criteria for differentiating between emergency situations where the patient's behavior is violent or self-destructive and jeopardizes the immediate physical safety of the patient, a staff member, or others versus the non-emergency use of restraint. Most of the individuals to whom we spoke indicated that this distinction was clear and understandable. Clinicians are adept at identifying behavior and symptoms, and can readily recognize violent and self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. Asking them to act based on evaluation of the patient's behavior is no different than relying on the clinical judgment that they use daily in assessing the needs of each patient and taking actions to meet those individual needs. In the final rule, we adopted the restraint definition contained in the CHA. Because the requirements governing the use of restraint or seclusion have been combined in a single standard, we also have a single, consistent definition of restraint. A restraint is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; or a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition. The final rule also clarifies that a restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort). The devices and methods described above are typically used in medical/surgical care, and would not be considered restraints, and thus not subject to these requirements. The final, combined standard (e) applies to the use of restraint, the use of seclusion, as well as the simultaneous use of restraint and seclusion. To clarify this point, we have adopted use of the word ``or'' in the final, combined standard for restraint and seclusion. The use of ``or'' imports the ``and,'' whereas ``and'' standing alone requires that both happen. It is not our intent that the requirements in this standard only apply when both restraint and seclusion are used. Therefore, throughout the regulation text, we have deleted ``and'' and inserted ``or.'' The regulations apply to the use of restraint or seclusion. This means they also apply when both restraint and seclusion are used. 3. The Roles of CMS and JCAHO Comment: Regarding any provision that was not identical to JCAHO's policy, a host of commenters expressed concern that CMS's standards did not parallel or actually ran counter to JCAHO's. One commenter stated that these discrepancies would create an implementation burden for hospitals. A number of commenters expressed concern that CMS was straying from its stated intent of maintaining consistency between Federal and accreditation standards. Response: In the interim final rule with comment period (64 FR 36079), we stated, ``We believe it is appropriate to recognize JCAHO's work in this area [regarding the length of physician or LIP orders] and maintain consistency between Federal and accreditation standards when possible.'' We adopted JCAHO's standard for time limited orders because, upon examination, we found nothing to suggest that these timeframes have been found faulty or that any more appropriate ones have been scientifically determined. However, we did not intend to suggest that we planned to follow JCAHO's standards in all respects. Comment: One commenter suggested that the requirement that a physician or LIP see a patient who is restrained or secluded for behavior management within 1-hour is unnecessary because current practice provides good patient care. The commenter cited JCAHO's revision of its standards regarding restraints and seclusion and noted that the hospital agreed with JCAHO and implemented those standards. Further, the commenter reported that the hospital has an ongoing improvement process, which has significantly decreased the use of restraints and seclusion for its adult population. [[Page 71384]] To govern the use of restraint and seclusion for children, another commenter suggested an approach similar to JCAHO's. The commenter further suggested that national accreditation bodies could establish a certification and approval process for nonviolent intervention regimes. Additionally, the commenter suggested that accreditation surveys or regulatory reviews could include thorough individual and aggregate review of documentation of restraint and seclusion use. Response: The hospital CoPs are minimum health and safety standards that hospitals must meet to participate in the Medicare and Medicaid programs. The CoPs are intended to protect patient health and safety and to ensure that high quality care is provided to all patients. While we applaud JCAHO's progress in the areas of examining restraint and seclusion use, JCAHO accreditation is voluntary and not the only way hospitals participate in the Medicare and Medicaid programs. Twenty percent of the hospitals that participate in Medicare and Medicaid are non-accredited. Non-accredited hospitals are surveyed by State survey agencies to determine compliance with the CoPs. We have the responsibility to ensure that all Medicare- and Medicaid-participating hospitals have certain protections in place. Before July 2, 1999, the CoPs contained no requirements concerning Patients' Rights. Our minimum requirements need to exist in regulatory form in order to carry the weight of the law and be enforceable. This final rule informs the public and provider community of our minimum requirements for the protection of patient health and safety while providing a sound basis for legal action if we find that those requirements are not met. While quality improvement initiatives and other internal efforts to track restraints and seclusion use and eliminate inappropriate use are important, we do not believe that they serve as a substitute for stated minimum Federal requirements. Comment: One commenter stated, ``Let's leave the seclusion and restraint abusers to the civil courts and JCAHO, who are quite capable of creating over-regulations without help from CMS.'' Conversely, another commenter asserted, ``CMS bears a great deal of the blame for the deaths, injuries, and serious long-term psychological harm which those aforementioned patients and their families have endured because it did not amend its CoPs to assure such desirable outcomes. The JCAHO standards were available to CMS during those many years but it chose--for unexplainable and unacceptable reasons--to maintain the status- quo.'' Response: There were other such polarized responses to the interim final rule with comment period. However, many commenters acknowledged the appropriateness of regulation in this area even if they disagreed with individual provisions of the interim final rule with comment period. The Congress has charged us with creating standards that protect the nation's Medicare and Medicaid beneficiaries and ensure that these beneficiaries receive high quality care. Many commenters came forward with ideas about how the regulation could be changed and improved. Our task is to reconcile these ideas when feasible, and determine the best, most reasonable approach that promotes patient health and safety and yet does not create a disincentive for providers to serve those populations who most critically need their help. Comment: A commenter stated that CMS's interest in alerting the public to the potential dangers associated with the use of restraint and seclusion is ``faddish.'' Response: This commenter's statement stood in stark contrast to those of many of his contemporaries who wrote of their tireless efforts to avert the potential hazards associated with the use of restraint and seclusion, and of the seriousness with which they undertake such interventions. While accounts of efforts to minimize use of restraint and seclusion and assure patient safety were heartening, a few of the letters we received were disturbing in their conceptualization of a restraint or seclusion not only as wholly appropriate, but as a ``time- honored'' standard of care. To that argument, we reply that standards of care continually evolve. For example, at one time patient shackles were considered a standard intervention. Habit does not justify the continued use of an intervention when alternative methods that are safer or more effective are available. The numerous training programs that emphasize alternative techniques for handling violent or self- destructive behavior and symptoms demonstrate that clinicians recognize the risks inherent in the use of restraint and seclusion. Practitioners in the field of medicine are constantly searching for better ways to manage symptoms and conditions that have been traditionally treated through the use of restraint or seclusion or both. We fully support these efforts. 4. Applicability of the Patients' Rights CoP Comment: One commenter stated that the preamble should explain the application and effect of the new regulation on psychiatric hospitals. If the regulation applies to psychiatric hospitals, the commenter stated the requirements specified in standard (f) (among others) might not be appropriate. Response: In the summary of the interim final rule with comment period (64 FR 36070), we explained, ``The Patients'' Rights CoP, including the standard regarding seclusion and restraint, applies to all Medicare- and Medicaid-participating hospitals, that is, short- term, psychiatric, rehabilitation, long-term, children's, and alcohol- drug.'' This final rule, including its provisions concerning the use of restraint and seclusion, is explicitly intended to apply in the psychiatric hospital setting. We disagree with the opinion that the requirements in the current standard (e) might not be appropriate for the psychiatric hospital setting. While violent or self-destructive patient behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others occasionally occurs on an acute care unit in a hospital, it occurs more often on a psychiatric unit or in a psychiatric hospital. When a patient's behavior becomes violent or self-destructive, the immediate physical safety of the patient, a staff member, or others is at risk. In such an emergency situation, it is critical to ensure that staff is well trained in alternative interventions and techniques; to ensure the safety and well being of the patient and others; to manage the patient's behavior; and, to competently apply restraints or use seclusion. Additionally, the protections provided ensure that: the restrained or secluded patient is appropriately monitored and that the patient's condition is reassessed; the patient's medical and psychological conditions are evaluated; and, the intervention is ended as quickly as possible. Therefore, we believe that the protections in the current standard (f) that have been relocated to the combined standard (e) in the final rule are appropriate for the psychiatric care setting. Comment: One commenter suggested that we need to develop a separate category of patient rights for children that address their developmental needs rights and other basic needs. Response: The provisions contained in the Patients' Rights CoP apply universally to all hospital patients, [[Page 71385]] including children. Although there is no separate category for patient's rights on the basis of age, the regulations recognize differences. Timeframes on orders for the use of restraints or seclusion are different based on age. For example, for children and adolescents 9 to 17 years of age, orders for restraint or seclusion are limited to a maximum of 2 hours. When implementing these regulations, we expect hospitals to develop and implement an approach that meets the individualized needs of the patient populations that they serve. Comment: One commenter stated that since there are no attending physicians in religious non-medical facilities, amendments should be made to incorporate the provisions of section 1861(ss) of the Act. Response: Effective January 31, 2000, religious non-medical facilities are not governed by the hospital CoPs, but by their own requirements. The new requirements for religious non-medical facilities do not permit the use of restraint or involuntary seclusion (Sec. Sec. 403.730(c)(4) and (5)). (For additional information, see the November 30, 1999 and November 28, 2003 Federal Registers (64 FR 67028) and (68 FR 66710), respectively). 5. Debriefing After the Use of Restraint/Seclusion Comment: Many consumer advocates suggested creating a requirement for debriefing staff and patients following each incident of restraint or seclusion, and documenting the use of either procedure in the patient's record. The debriefing's purpose would be to--(1) develop an understanding of the factors that may have evoked the behaviors necessitating the use of restraint or seclusion; (2) give the patient time to verbalize his or her feelings and concerns; and (3) identify strategies to avoid future use of seclusion or restraint. Another commenter recommended that staff debriefing, followed by patient debriefing, occur within 24 hours of each incident of restraint or seclusion. One commenter noted that its hospital requires staff debriefing as part of an approach that has dramatically reduced its incidence of restraint and seclusion use. Another commenter argued that debriefing is unnecessary in many cases of restraint use. The commenter further stated that requiring debriefing after each use of restraint or seclusion would create unnecessary work. ``It is not uncommon for patients to require restraint or seclusion for multiple episodes of aggression in a 24-hour time period. The underlying rationale for debriefings, to avoid future uses of restraint or seclusion, can be handled by other means, including consultation with the physician or advance practice nurse who authorizes restraint use. There could be debriefings when incidents are critical in nature.'' Response: We agree that debriefing can be a useful, productive exercise that helps both the patient and staff understand what has happened and how such situations can be averted in the future. However, we see the argument made by the opposing commenter as valid. The use of restraint or seclusion is only permitted while the unsafe situation persists, and must be discontinued at the earliest possible time. A patient may have multiple uses of restraint or seclusion in a fairly short timeframe. Requiring that a debriefing occur after each use may be impractical or unnecessary. We believe that hospitals and clinicians will use debriefing as a component of the treatment plan designed to safely manage violent or self-destructive patient behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others as necessary. Therefore, we are not requiring debriefing. Comment: One commenter suggested that a multidisciplinary team should review each incident within 24 hours. Their review should be part of the hospital's quality assurance and peer review procedures. Response: We believe that hospitals will monitor restraint and seclusion use through their Quality Assessment Performance Improvement (QAPI) programs. Mandating that a multidisciplinary team review each incident within 24 hours would be unnecessarily burdensome. Therefore, we are not specifying that this must occur in this rule. B. Comments Received on Specific Provisions 1. The Right To Be Free From Restraint (Sec. Sec. 482.13(e)(1) and (f)(1)) We stated that 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. Section 482.13(f)(1) paralleled this requirement and stated that the patient has the right to be free from seclusion and restraints, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Comment: Many commenters agreed with this general statement and applauded our efforts to eliminate the inappropriate use of restraint. However, some commenters stated that the procedural requirements specified in the interim final rule for the appropriate use of restraint were too idealistic. Response: We appreciate the support expressed by many commenters. Regarding concerns about the practicality of the current requirements, we believe that some commenters have interpreted current standard to require face-to-face monitoring in every clinical situation. Our intent is that the restrained or secluded patient's condition be assessed and monitored by a physician, other licensed independent practitioner or trained staff at an interval determined by hospital policy. In this final rule, we have amended the regulatory language at Sec. 482.13(e)(10) to reflect this. Hospital policies should address the frequency of assessment and the assessment parameters (for example, vital signs, circulation checks, hydration needs, elimination needs, level of distress and agitation, mental status, cognitive functioning, skin integrity). Hospital policies should guide staff in how to determine an appropriate interval for assessment and monitoring based on the individual needs of the patient, the patient's condition, and the type of restraint used. It may be that a specific patient needs continual face-to-face monitoring; or that the patient's safety, comfort, and well-being are best assured by periodic checks. Continual face-to-face monitoring is only required when restraint and seclusion are used simultaneously to address violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. The hospital is responsible for providing the level of monitoring and frequency of reassessment that will ensure the patient's safety. In this final rule, we have also added language to clarify that a restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort). Comment: One commenter stated that he could not find legal authority for health professionals to restrain their patients, absent specific court orders. The commenter also noted that health professionals might be excused for restraining patients only if the purpose of restraint is to minimize an imminent risk of great bodily harm, and only [[Page 71386]] when the need for restraint is not provoked by the health professional. Response: We agree that consideration of the safety of the patient, staff, or others is the basis for applying a restraint. We have supported this approach in combined standard (e) by stating that all patients have the right to be free from physical or mental abuse, and corporal punishment, and have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, staff or others and must be discontinued at the earliest possible time. In the final rule, we have also stated that restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient or others from harm. Finally, we have stated that the type or technique of restraint or seclusion used must be the least restrictive intervention that will be effective to protect the patient or others from harm. Comment: Several commenters argued that few effective means of therapeutic intervention for significant behavioral problems exist, and that disallowing the use of restraint or seclusion might result in a denial of treatment for individuals with significant problems because of the limitation on what providers can do to address symptoms. These commenters argued that providers would be unwilling to jeopardize staff and others' safety or incur any liability associated with untreated behaviors. Some commenters suggested that this regulation would result in the increased use of other interventions, such as psychotropic medications, to address behavioral challenges. Some suggested that without the use of restraint or seclusion, patients would remain incapacitated by their problems. Several commenters said that CMS inappropriately excluded ``therapeutic'' uses of restraint, such as therapeutic holding and medications. Response: This final rule does not ban the use of restraint or seclusion. However, it does prohibit the use of restraint or seclusion that are imposed as a means of coercion, discipline, convenience, or retaliation by staff. This final rule also establishes parameters to assure patient safety when less restrictive interventions have been determined to be ineffective to protect the patient, staff, or others from harm. In the final rule, a restraint is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; or a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition. A restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort. The devices and methods listed here that would not be considered restraints, and thus not subject to these requirements, are typically used in medical surgical care. Although physical holding of a patient for the purpose of conducting routine physical exams or tests is not considered a restraint, all patients have the right to refuse treatment. This patient right is addressed at Sec. 482.13(b)(2). The use of therapeutic holds to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others would be considered a form of restraint and therefore, would be subject to the requirements contained in this final rule. If the definition of restraint is met, then that practice or device (whether it is therapeutic holding or a mechanical device) is considered a form of restraint and may be employed so long as all of the requirements for restraint use are met. In the interim final rule with comment period, the definition of ``drug used as a restraint'' specifically exempted medications that are used as a standard treatment for the patient's medical or psychiatric condition. Some commenters criticized this definition as being too broad and subjective. This regulation is not intended to interfere with the clinical treatment of patients who are suffering from serious mental illness and who need appropriate therapeutic doses of medications to improve their level of functioning so that they can more actively participate in their treatment. Similarly, the regulation is not intended to interfere with appropriate doses of sleeping medication prescribed for patients with insomnia or anti-anxiety medication prescribed to calm a patient who is anxious. Thus, those medications that are a standard treatment for a patient's condition are not subject to the requirements of this regulation. In this final rule, we have defined a drug used as a restraint as a drug or medication that is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition. We believe this revised definition more clearly supports the role of medications that facilitate the patient's participation in their care and maintenance of the patient's functional status. Comment: A commenter suggested that the word ``discipline'' should be replaced with ``punishment,'' since the two words are not the same in meaning and there are situations where patient discipline is necessary. Response: The distinction between the word ``discipline'' and ``punishment'' is a more relevant issue in the developmental disability/mental retardation setting, as opposed to the psychiatric and acute care settings. Therefore, we have retained the use of the word ``discipline.'' Comment: One commenter opined that this regulation provides the ``right to fall and break a hip'' or ``crack your head open.'' Another commenter who provides care to patients with dementia who ``need a vest restraint [commonly referred to as a Posey vest] at night to prevent them from falling out of bed, or getting up and falling in the bathroom,'' questioned whether allowing these patients to fall unnecessarily is more humane than restraining them. The commenter also stated that while some patients can be medicated and restrained briefly on an occasional basis, others--those with dementia or Alzheimers or both, for example, need some type of restraint most of the time on a permanent basis for their own safety. Response: The final regulation states that devices that protect the patient from falling out of bed are not restraints. However, when the clinician raises all four side rails in order to restrain a patient, (defined in this regulation as immobilizing or reducing the ability of a patient to move his or her arms, legs, body, or head freely) to ensure the immediate physical safety of the patient then the rule applies. Raising fewer than four side rails when the bed has more than two side rails, would not necessarily immobilize or reduce the ability of a patient to move as defined in this regulation. Practitioners and hospitals utilize a variety of measures to ensure patient safety. Use of a restraint is only one of the possible interventions. [[Page 71387]] Comprehensive assessment of the patient and the environment, in conjunction with individualized patient care planning, should be used to determine those interventions that will best ensure the patient's safety and well-being with the least risk. However, as part of clinician's decision-making, we would expect such an assessment to be conducted regardless of whether or not the intervention to ensure patient safety is considered a restraint under this regulation. Clinical decision making, which includes assessments, would govern the use of restrictions that are not covered by these requirements. Regarding the idea that some patients require permanent restraint, we contend that every patient is entitled to an individualized assessment and treatment that takes into account the patient's individual strengths, weaknesses, choices, needs, and concerns. For example, most adults sleep at home in their beds each night without being tied down or otherwise protected from falling out of bed. All use of restrictions, whether governed by these regulations or not, should be based on an individualized patient assessment and the use of all available innovative alternatives and approaches to address patient care needs. Again, we have not prohibited the use of restraints; but we do prohibit using restraints as a substitute for adequate staffing, monitoring, assessment, or investigation of the reasons behind patient behavior such as wandering or getting up in the night, which may be indicative of unmet patient care needs. When the use of restraints is necessary, the combined standard (e) applies. Comment: One commenter suggested adding the words, ``Or as a replacement for adequate levels of staff,'' to the statement that restraint may not be used as a means of coercion, discipline, convenience, or retaliation by staff. Response: The final regulation language states that all patients have the right to be free from restraint or seclusion, of any form, imposed for convenience. This language precludes using restraint or seclusion as a substitute for adequate staffing levels. Therefore, we have not accepted this comment. Comment: One commenter suggested removing the words, ``medically necessary,'' from (e)(1), arguing that physicians would not order treatments that were not medically necessary. Another commenter, however, described just such a case; namely, interventions undertaken at the voluntary request of the patient, such as a cognitively intact patient asking to have his or her bed's side rails put up. This commenter asked if a voluntary request would be exempted from meeting the regulatory requirements. Response: In the final rule, ``not medically necessary'' has been removed from the definition of restraint. Restraint may only be used to ensure the immediate physical safety of the patient, staff, or others. In addition, a restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort). Often with the best of intentions, a patient or the patient's family may ask for a restraint to be applied. For example, a concerned husband may ask that his frail elderly wife be tied into bed to prevent her from wandering. In both examples, the concern may be valid, and a responsive intervention may be appropriate. However, a patient or family member may be unfamiliar with the many innovative, less restrictive alternatives available to address a patient's needs. Such a request, like any other patient or family request for an intervention, should prompt a patient and situational assessment to determine whether an intervention is needed. If a need is confirmed, the practitioner must then determine the type of intervention that will meet the patient's needs with the least risk and most benefit to the patient. A request from a patient or family member for the application of a restraint which they would consider to be beneficial is not a sufficient basis for the use of a restraint intervention. Regardless of whether restraint use is voluntary or involuntary, if restraint (as defined by the regulation) is used, then the requirements of the regulation must be met. Finally, this rule would not preclude a patient, or a patient's family member from requesting that his or her side rail be raised. Comment: One commenter asked whether the rule requires adding the rights provided by standards (e) and (f) to the hospital's patients' rights policies and procedures and/or a written notification provided to the patient. The commenter argued that specifically stating these rights would require increased staff time, would be a risk management ``nightmare,'' and would require a patient/family member release form to be signed authorizing the use of a restraint, even when a restraint is medically necessary. Response: Standard (a), Notice of rights, requires patient notification of his or her rights. We are not convinced that notifying the patient of the right to be free from restraint or seclusion imposed as a means of coercion, discipline, convenience, or retaliation by staff, will take significantly more time than informing the patient of his or her other rights, particularly since the hospital retains extreme flexibility in how and when this notice is provided. We are also uncertain why informing the patient of his or her rights would present a risk management ``nightmare.'' Concerning the commenter's third point, the rule does not require that the patient or his or her representative sign release forms. A hospital may choose to introduce this policy; however, depending on the mechanism the hospital uses to provide this notification (for example, as a standard part of each admissions packet; in posted forms in the admissions office or emergency room area; bundled with existing required notices) such a step may be unnecessary. 2. Definition of ``Restraint'' and ``Physical Restraint'' (Sec. Sec. 482.13(e)(1) and (f)(1)) In the interim final rule with comment period, we stated that the term ``restraint'' includes either a physical restraint or a drug that is being used as a restraint. A physical restraint is any manual method or physical or mechanical device, material, or equipment attached or adjacent to the patient's body that he or she cannot easily remove that restricts freedom of movement or normal access to one's body. Comment: One commenter recommended uniform definitions of restraint and physical restraint across care settings to avoid confusion. Another commenter suggested defining restraint as, ``the forcible and involuntary deprivation of the liberty to move about.'' The same commenter recommended classifying restraints in three categories: least restrictive (manual restraint or holding); intermediate (seclusion, to be defined as ``restricting voluntary movement by locking a patient in a room. If an individual cannot leave the room at will, the room is considered locked, whether the door is actually locked or not''); and most restrictive and intrusive (mechanical restraints such as belts, cuffs, or soft ties). Several other commenters argued for similar categorization, with corresponding monitoring and ordering requirements [[Page 71388]] (that is, with consideration for the differences between interventions such as a four-point restraint and a restraint used for frail patients). One commenter argued that physical and mechanical restraints should be defined separately rather than lumped into one category. Response: We agree that a uniform definition of restraint across care settings is a good approach, adds clarity, and avoids confusion. In the final rule, we have combined the regulations governing the use of restraint or seclusion into a single standard, and have adopted a single, consistent restraint definition. This definition applies to all uses of restraint in all hospital care settings. A restraint is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; or a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition. The final rule also clarifies that a restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort). This definition renders unnecessary the otherwise impossible task of naming each device and practices that can inhibit a patient's movement. The concept of liberty of movement as proposed in this comment is incorporated in the final rule at the beginning of combined standard (e). All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to insure the immediate physical safety of the patient, staff, or others and must be discontinued at the earliest possible time. However, we did not break restraints into three classes or view seclusion as a subset of restraint. We believe that the categorization proposed by the commenter is somewhat arbitrary, particularly in light of the fact that several of the deaths reported by the Hartford Courant occurred during physical holds, which the commenter would have categorized as ``least restrictive.'' This fact makes us wary of suggesting, even implicitly, that physical holds are preferable to mechanical restraint. The deaths resulting from other traditional mechanical devices also persuade us of the hazards of using mechanical restraints. The type of restraint used is not the defining hazard-- other variables, such as lack of patient assessment in choosing the restraint, inappropriate application of the physical restraint mechanism or technique, or inadequate patient monitoring could render many interventions dangerous. Accordingly, given the unique circumstances presented by each patient, we believe that it would be inappropriate and would place patients at risk to arbitrarily suggest that one form of restraint is categorically preferable to another. Finally, we have streamlined and clarified monitoring requirements in combined standard (e). The final rule states that the condition of the patient who is restrained or secluded must be monitored by a physician, other licensed independent practitioner or trained staff at an interval determined by hospital policy. When restraint or seclusion is used to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen and evaluated face-to-face within one hour after the initiation of the intervention. This final rule provides flexibility for trained staff to determine the monitoring parameters necessary when a restraint or seclusion is used. The more stringent continual monitoring requirements have been retained only for patients who are simultaneously restrained and secluded for management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. Comment: Some commenters asked whether the following constitute restraint: therapeutic holding; comforting children through holding; escorting or touching for de-escalation; virtually any type of touching, like holding a patient's arm to prevent him from hitting the wall; basket holds; or touching to encourage the patient to lie still for a procedure. Many commenters argued that therapeutic holding is necessary, and that the regulation should allow individualized treatment. Response: Several commenters mentioned different types of holding, including therapeutic holding. For the purposes of this regulation, a staff member picking up, redirecting, or holding an infant, toddler, or preschool-aged child to comfort the patient is not considered restraint. If an intervention meets the regulatory definition of restraint, then that intervention constitutes a restraint and the standards for restraint use must be followed. A restraint is any method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. A restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort. The devices and methods listed here that would not be considered restraints, and thus not subject to these requirements, are typically used in medical surgical care. The regulation permits the physical holding of a patient for the purpose of conducting routine physical examinations or tests. However, patients do have the right to refuse treatment. See Sec. 482.13(b)(2). This includes the right to refuse physical examinations or tests. Holding a patient in a manner that restricts the patient's movement against his or her will would be considered a restraint. This includes therapeutic holds. Many deaths have involved these practices and may be just as restrictive and potentially dangerous as restraining methods that involve devices. However, the opportunity for individualized treatment of the patient is still available, since the regulation does not prohibit the use of any particular type of restraint. This regulation requires individualized patient assessment and use of the least restrictive intervention when restraint is needed to protect the patient, a staff member, or others from harm. Comment: Several commenters asked whether a side rail was a physical restraint. One commenter stated that ``the majority'' of hospitals require that side rails be raised for safety reasons, and that patients do not perceive this common safety practice as a restraint. This commenter also cited a need for side rails to be raised to protect patients who are confused or disoriented by narcotics or controlled substances. Another commenter wanted to know if crib rails are a restraint. Response: The final rule states that a restraint does not include methods that protect the patient from falling out of [[Page 71389]] bed. It is standard practice to raise the side rails when a patient is on a stretcher, recovering from anesthesia, sedated, experiencing involuntary movement, or on certain types of therapeutic beds to prevent the patient from falling out of the bed. However, the use of side rails to prevent a patient from exiting a hospital bed may pose risk to the patient's safety, particularly for the frail elderly who may be at risk for entrapment between the mattress and the bed frame. A disoriented patient may see the side rail as a barrier to be climbed over or may attempt to wriggle through split rails or to the end of the bed to exit the bed. As a result, this patient may have an increased risk for a fall or other injury by attempting to exit the bed with the side rails raised. The risk presented by side rail use should be weighed against the risk presented by the patient's behavior as ascertained through individualized assessment. Clinical judgment determines whether or not the use of siderails is governed by the rule. When the clinician raises all four siderails in order to restrain a patient, defined in this regulation as immobilizing or reducing the ability of a patient to move his or her arms, legs, body, or head freely to ensure the immediate physical safety of the patient, then the rule applies. Raising fewer than four siderails when the bed has more than two siderails, would not necessarily immobilize or reduce the ability of a patient to move as defined in the regulation. Regarding the question of whether crib rails are a restraint, placement in a crib with raised rails is an age-appropriate standard safety practice for every infant or toddler. Therefore, placement of an infant or toddler in the crib with raised rails would not be regarded as a restraint. Age or developmentally appropriate protective safety interventions, such as stroller safety belts, swing safety belts, high chair lap belts, raised crib rails, and crib covers, that a safety- conscious child care provider outside a health care setting would utilize to protect an infant, toddler, or preschool-aged child would not be considered restraint or seclusion for the purposes of these regulations. The use of these safety interventions should be addressed in hospital policies or procedures. Comment: Several commenters believed that mechanical restraints should never be used in the mental health treatment of children and adolescents. One commenter suggested banning both mechanical restraint and seclusion for patients who are 17 years of age or younger. Several commenters offered permutations of this suggestion, such as a ban on the use of mechanical restraint for patients under 17 years of age. Response: Situations exist where it may become necessary to restrain or seclude a child or adolescent to ensure the safety of the patient or others. Regardless of age, the selection of an intervention must be individualized for each patient. When a restraint is used to manage self-destructive or violent behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, a variety of factors, such as medical condition, disability, psychiatric condition, history of abuse, height, and weight, as well as age, must be assessed and evaluated to determine the least restrictive intervention that will effectively ensure the safety of the patient and others. In unique emergencies, a mechanical restraint may be necessary for a patient under 17 years of age. For example, if a 250-pound 16- year old male is physically attacking another patient, staff may have limited options to stop the attack. At times, the child's size may eliminate the ability to safely use a physical hold with the staff available. The child's medical condition (for example, asthma or a fractured limb) could also contraindicate the use of a physical hold. However, we recognize that children and adolescents, as well as adults, are vulnerable and at risk when restrained or secluded to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. Therefore, we have retained the time limits on each order for restraint or seclusion to manage aggressive destructive in combined standard (e). Orders are limited to 4 hours for adults 18 years of age or older; 2 hours for children and adolescents 9 to 17 years of age; and 1-hour for children under 9 years of age. The restraint or seclusion order may only be renewed in accordance with these limits for up to a total of 24 hours. Before writing a new order, a physician or licensed independent practitioner must see and assess the patient. Comment: Many commenters indicated that the restraint definition is too broad and includes items that are typically used in the provision of care, such as catheters, drainage tubes, plastic casts, and bandages, which can restrict freedom of movement. Several commenters asked whether adaptive or protective devices such as helmets, or devices that are used for postural support, meet the definition of restraint. One commenter asked whether CMS would permit the use of devices to assist with chronic conditions or for physically frail patients. One commenter asked that we address the use of restraint for dental, diagnostic, and surgical procedures. The commenter stated that devices used for medical immobilization are given an exemption by JCAHO. The commenter asked if CMS would create a mirroring exemption. Response: In response to comments, we have added language that limits the application of this definition. In the final rule, a restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort). The devices and methods listed here that would not be considered restraints, and thus not subject to these requirements, are typically used in medical surgical care. Adaptive devices or mechanical supports used to achieve proper body position, balance, or alignment to allow greater freedom of mobility than would be possible without the use of such a mechanical support is not considered a restraint. For example, some patients are unable to walk without the use of leg braces, or are unable to sit upright without neck, head or back braces. Such devices generally permit the patient to participate more fully in activities without the risk of physical harm. Comment: Several commenters suggested that devices used for security purposes should be exempt from the regulatory requirements. Another commenter argued that forensic hospitals or units should be exempted from the regulatory requirements because they compromise the hospital's ability to manage behavior. Response: The use of handcuffs or other restrictive devices applied by law enforcement officials who are not employees of the hospital for custody, detention, and public safety reasons are not governed by this rule. The law enforcement officers who maintain custody and direct supervision of their prisoner (the hospital's patient) are responsible for the use, application, and monitoring of these restrictive devices in accordance with Federal and State law. However, the hospital is still responsible for providing safe and appropriate care to the patient. Comment: One commenter argued for the need for ``programmatic'' use of restraint for mentally retarded patients [[Page 71390]] in a psychiatric or an acute care unit and stated that the interim final rule with comment period created a barrier to using a restraint as part of a treatment plan. Response: Our expectation is that restraint or seclusion will not be a standard response to a particular behavior or situation. The use of such interventions is a temporary measure that protects the safety of patients and others, but is not a long-term solution for handling problematic behavior. 3. Definition of ``Drug Used as a Restraint'' (Sec. Sec. 482.13(e)(1) and (f)(1)) We stated that a drug used as a restraint is a medication used to control behavior or restrict the patient's freedom of movement and is not a standard treatment for the patient's medical or psychiatric condition. Comment: Some commenters indicated that the definition of ``drug used as a restraint'' was too broad, subjective, and confusing. One commenter suggested that we adopt the definition of chemical restraint found in the long-term care interpretive guidelines--that is, ``A medication used for discipline or convenience that is not required to treat medical symptoms.'' Several commenters argued that the determination of what constitutes a ``standard treatment'' for certain medical or psychiatric conditions is too subjective. One commenter observed that physicians may legitimately order nonstandard treatments for their patients. Another commenter noted that problems present in mentally retarded patients do not correspond closely to any medical or psychiatric diagnosis and that the rule only discusses these two sorts of standard uses of medication. One commenter explained that in acute care, medications are changed based on the patient's medical condition and symptoms. This commenter also stated that this regulation creates a burden for the administrative staff that will have to distinguish a drug used as ongoing medical management from a drug that, at some point, has evolved into a restraint that is not part of standard treatment. Other commenters grappled with how to characterize the appropriate role of medications in a patient's care. For example, one commenter expressed alarm at the apparent ban on PRN orders for medications that might affect a patient's behavior or restrict a patient's movement. The commenter argued that medications for behavioral health patients are used precisely to affect behavior so that the patient can participate more fully in his or her care, treatment, and therapy. The commenter stated that they are administered in order to avoid the emergence or escalation of specific behaviors that might prompt the use of more restrictive physical restraints or seclusion. The commenter also stated behavioral health providers recognize that the use of the same drug may be therapeutic in one instance and not in another, and have indicated that a drug used as a restraint should not be applied when its use impedes a person's ability to participate in his or her care. Some commenters noted that drug therapy should be part of an effective treatment plan to manage behavior. There was little agreement among commenters as to how drugs used to restrain patients should be handled. While a few commenters agreed with the concept that a drug used as a restraint is not a standard treatment (one stating that ``prohibition is critical''), several recommended deleting any reference to a drug used as a restraint. One commenter argued that the use of medications is already closely scrutinized through pharmacy oversight and the physician ordering process. The requirements of the interim final rule with comment period add an unnecessary layer of oversight. Another commenter stated that the use of a drug as a restraint should appear in its own standard, as the use of a medication differs from physical interventions. The idea of a medication ``controlling'' behavior garnered considerable comments which included the following: All psychotropic medications control behavior to the extent that they reduce psychiatric symptoms; The idea of a medication controlling behavior is not as straightforward as it appears; No medication ``controls'' behavior. A better word would be ``directs,'' ``contains,'' or ``ameliorates;'' All drugs have effects as a restraint; and The phrase ``control behavior'' should be removed, and a drug used as a restraint should be defined as a drug used with the intent to restrain or restrict the patient's freedom of movement. One commenter asked for clarification regarding the classification of paralytic drugs, sedatives, and analgesics, and how they would be affected by the regulation. A commenter suggested that if a patient has consented to the use of a medication, it should not be classified as a drug used as a restraint. Another commenter argued that if a drug is used as a one- time dose to help aid in the plan of care but is not part of the care plan, it is not a drug used as a restraint. Many commenters characterized the use of a drug as possibly the least restrictive alternative to deal with violent or aggressive behavior, arguing that its use is more humane than allowing the patient to escalate and lose self-control. Response: Patients have a fundamental right to be free from restraints that are imposed for coercion, discipline, convenience, or retaliation by staff, including drugs that are used as restraints. In the interim final rule with comment period, the definition of ``drug used as a restraint'' was phrased so that medications that are used as part of a patient's standard medical or psychiatric treatment would not be subject to the requirements of standards (e) or (f). These regulations are not intended to interfere with the clinical treatment of patients who are suffering from serious mental illness and who need therapeutic doses of medication to improve their level of functioning so that they can more actively participate in their treatment. Similarly, these regulations are not intended to interfere with appropriate doses of sleeping medication prescribed for patients with insomnia, anti-anxiety medication prescribed to calm a patient who is anxious, or analgesics prescribed for pain management. This language was intended to provide flexibility and recognize the variations in patient conditions. A standard treatment for a medication used to address a patient's condition would include all of the following: The medication is used within the pharmaceutical parameters approved by the Food and Drug Administration (FDA) and the manufacturer for the indications it is manufactured and labeled to address, including listed dosage parameters. The use of the medication follows national practice standards established or recognized by the medical community and/or professional medical association or organization. The use of the medication to treat a specific patient s clinical condition is based on that patient's symptoms, overall clinical situation, and on the physician's or other LIP's knowledge of that patient's expected and actual response to the medication. An additional component of ``standard treatment'' for a medication is the expectation that the standard use of a medication to treat the patient's condition enables the patient to more effectively or appropriately function in the world around them than would be [[Page 71391]] possible without the use of the medication. If the overall effect of a medication is to reduce the patient's ability to effectively or appropriately interact with the world around the patient, then the medication is not being used as a standard treatment for the patient's condition. We believe that trained practitioners possess the skills and abilities necessary to identity when a drug or medication is being used as a standard treatment for the patient's condition and when it is not. Whether or not the use of a medication is voluntary, or even whether the drug is administered as a one time dose or PRN are not factors in determining if a drug is being used as a standard treatment. The use of PRN medications is only prohibited if the drug is being used as a restraint. The regulation supports existing State laws that provide more vigorous promotion of the patient's choice and rights. Of course, as with any use of restraint, staff must conduct a patient assessment to determine the need for other types of interventions before using a drug as a restraint. For example, a patient may be agitated due to pain, an adverse reaction to an existing medication, or other unmet care need or concern. There are situations where the use of a medication is clearly outside the standard for a patient or a situation, or a medication is not medically necessary but is used for patient discipline or staff convenience (neither of which is permitted by the regulation). In such situations, the patient has the right to be free from the use of a drug as a restraint. For example, a patient has Sundowner's Syndrome, a syndrome in which a patient's dementia becomes more apparent at the end of the day than the beginning of the day. The patient may become agitated, angry, or anxious at sundown. This may lead to wandering, pacing the floors, or other nervous behaviors. The unit's staff find the patient's behavior bothersome, and ask the physician to order a high dose of a sedative to ``knock out'' the patient and keep him in bed. The patient has no medical symptoms or condition that indicates that he needs a sedative. In this case, for this patient, the sedative is being used as a restraint for staff convenience. Such use is not permitted by the regulation. The regulation does not allow a drug to be used to restrain the patient for staff convenience, to coerce or discipline the patient, or as a method of retaliation. While the characterization of medications as more humane and less invasive was quite common in comments on the interim final rule with comment period, we put forth the caveat offered by one physician--that overuse of antipsychotic medications can result in severe, sometimes irreversible neurological side effects or Neuroleptic Malignant Syndrome, which is potentially fatal. Also increased psychotropic medication use may lead to excessive sedation and cognitive dulling that impairs the patient's ability to benefit from therapy. While medications can be a beneficial part of a carefully constructed, individualized treatment plan for the patient, medication use should be based on the assessed needs of the individual patient and the effects of medications on the patient should be carefully monitored. We agree with the many comments regarding the idea of a medication ``controlling'' behavior. To further clarify our intent and respond to public comments, we have revised the definition of ``drugs used as a restraint.'' In this final rule, a drug used as a restraint is now defined as ``a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.'' Comment: One commenter asked whether the time-limited orders and the assessment, documentation, and monitoring requirements of standards (e) and (f) apply to a drug used as a restraint. Response: Yes. If the use of the medication for the patient meets the definition of a drug used as a restraint, the requirements of combined standard (e) apply. Comment: One commenter asked that orders for PRN medications be deemed appropriate. Many commenters objected to the ban on PRN orders for drugs used as a restraint. Response: In the final rule, PRN orders for medications are not prohibited. The use of PRN orders is only prohibited for drugs or medications that are being used as restraints. We believe that ongoing assessment, monitoring, and re-evaluation by the ordering practitioner are even more critical when a patient is receiving treatment that is not standard, or is administered in amounts or at a frequency greater than recommended by the manufacturer or current standard of practice, for the patient's condition. Therefore, we are retaining this requirement. 4. Use of Restraints (Sec. Sec. 482.13(e)(2) and (e)(3)(i)) Section 482.13(e)(2) states that a restraint can only be used if needed to improve the patient's well-being and less restrictive interventions have been determined to be ineffective. Section 482.13(e)(3)(i) states that the use of a restraint must be selected only when other less restrictive measures have been judged to be ineffective to protect the patient or others from harm. These two provisions are redundant, and in the final rule we have collapsed them into one requirement. We will discuss them together, as the public comments tended to apply to both. Comment: One commenter believed that the regulation should include illustrations of less restrictive interventions and alternative methods for handling behavior, including a requirement that when there is a history of a particular less restrictive intervention being ineffective, other interventions must be tried. Response: Including such illustrations in the regulation is not feasible. Putting aside the fact that regulations generally provide requirements rather than best practice suggestions, each care situation consists of a unique combination of factors. What seems least restrictive for one patient may not be an appropriate option for another patient. The underpinning of this regulation is the concept that good patient care hinges on looking at the patient as an individual and assessing the patient's needs, strengths, weaknesses, and preferences. Such an approach relies on caregivers who are skilled in individualized assessment and in tailoring interventions to individual patient's needs after weighing factors such as the patient's condition, behaviors, and history. A list of progressive interventions that should be taken would undermine the emphasis on individualized care, and could discourage creativity in meeting patient needs. However, there are resources available. For example, the American Psychiatric Association (APA), American Psychiatric Nurses Association (APNA), and the National Association of Psychiatric Health Systems (NAPHS), with support from the American Hospital Association (AHA), have sponsored the publication of a document entitled, ``Learning from Each Other--Success Stories and Ideas for Reducing Restraint/Seclusion in Behavioral Health.'' This document, published in 2003, was developed through dialogue with the field and extensive input from behavioral healthcare providers throughout the country who have been working to reduce the use of restraint and seclusion, and to improve care within their facilities. To access this document and other useful resources, visit the web sites of the sponsoring organizations: [[Page 71392]] http://www.naphs.org; http://www.psych.org; http://www.apna.org; http:/ /http://www.aha.org. Comment: One commenter argued that it would be impossible to comply both with the Patients' Rights CoP standard (c), which protects patient safety and the patient's right to be free from all forms of harassment, and standard (f). The commenter included the following example, a manic or psychotic patient may be verbally abusive to another patient or destructive of that patient's property without actually being a physical threat to the other patient. The commenter stated that such behavior has often been handled by the use of seclusion until medication can relieve the patient's agitation and abusiveness. Response: Standard (c) provides that each patient has the right to receive care in a safe setting, and the right to be free from all forms of abuse or harassment. This standard clearly prohibits the behavior described by this commenter, and some type of intervention would be warranted. However, such behavior need not prompt the automatic use of restraint or seclusion. The training requirements in standard (f) of this final rule ensure that patients are attended to by staff that are trained and skilled in utilizing an array of techniques and skills for handling aggression. Depending on this situation, various interventions (other than restraint or seclusion) may address the patient's behavior and simultaneously promote the right of others to safety and freedom from harassment and abuse. Comment: One commenter suggested that seclusion and restraint should be used only when less restrictive interventions, such as time- outs and one-to-one staffing, are ineffective in preventing immediate injury of the patient or others. Several commenters asked whether less restrictive interventions actually had to be tried and shown to fail before a more restrictive intervention was used. A number of these commenters also questioned whether the patient or another person must be injured before more restrictive intervention may be undertaken. Response: Less restrictive interventions should be considered before resorting to the use of restraint or seclusion. However, it is not always appropriate for less restrictive alternatives to be attempted prior to the use of restraint or seclusion. For example, when a patient physically attacks another patient, immediate action is needed. When a patient's behavior presents an immediate and serious danger to the patient or others, immediate action is needed. While staff should be mindful of using the least intrusive intervention, it is critical that the intervention selected be effective in protecting the patient or others from harm. Therefore, we have retained the requirement that a restraint or seclusion can only be used when less restrictive interventions have been determined to be ineffective to protect the patient or others from harm. Comment: One commenter suggested adding, ``The patient has the right to be treated in a safe manner when special procedures are required for the patient's care.'' Response: While we agree that the patient has the right to be treated in a safe manner, we believe that this right exists regardless of whether or not the patient is undergoing a special procedure. Comment: One commenter suggested considering an issue raised by a New England Journal of Medicine article; specifically, that the regulation should state plainly that a competent patient may refuse the use of physical restraint in the patient's acute care or treatment. The commenter further suggested that an incompetent patient's representative should be able to exercise this right to refuse physical restraint on the patient's behalf. Similarly, another commenter stated that the regulation should consider the individual's right to make choices regarding their health care. The commenter further stated that after complete information is provided about the method, risks, and effects of these procedures, individuals and families should have the right to either reject their use or select them as part of an overall treatment regime. Response: The Patients' Rights CoP promotes the patient's right to be involved in and make decision about the patient's health care. Standard (b)(2) states that the patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient's rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary. In this context, the use of a restraint would be considered a ``treatment.'' Before the patient decides to request or refuse the use of restraint or seclusion, the patient must be informed of the risks associated with refusing the use of a restraint. While the hospital should work with the patient regarding preferences as much as possible, the hospital is not obligated to come up with a menu of alternative options because of the patient's refusal. The hospital may refuse to perform a procedure or render care if it believes that it is unable to safely and appropriately do so because of the patient's refusal to allow certain aspects of the prescribed treatment. In addition, if the patient's violent or self-destructive behavior jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient does not have the right to refuse the use of restraint or seclusion. In this situation, the use of restraint or seclusion is an emergency measure to protect the safety of the patient, staff, or others. If the patient or the patient's representative requests the use of restraint or seclusion, the attending practitioner would need to decide whether the intervention is appropriate. In conclusion, the restraint or seclusion requirements do not prevent the patient from making informed decisions or participating in the patient's healthcare. The rule establishes the patient's right to be free from inappropriate restraint or seclusion, and lays out basic protections in the event that these interventions are needed. Comment: One commenter questioned whether, because of the ``Patients'' Rights'' provisions regarding patient privacy and safety, a restrained patient must be restrained in a separate, private room, and not in the day room. Response: A hazard of restraining a patient is the damage that may be done to the patient's dignity. The patient may feel dehumanized or humiliated, which could be exacerbated by having peers witness the experience. Certainly, we would not expect that a patient put in four- point restraint would be placed in the midst of the day room in a psychiatric facility since this would be humiliating to the patient. The restrained patient should be afforded as much privacy as possible. Since an underlying therapeutic goal for any psychiatric patient is the development of a strong sense of self-worth and dignity, the hospital should take steps to protect the privacy of the restrained patient. However, an individual wearing mitts to prevent self-mutilating behaviors is also being restricted. These individuals may desire socialization and group activity notwithstanding these restraints that a patient in the midst of a psychiatric crisis would not. We provide these examples to stress that it is critical for the hospital to use an individualized approach that is in the best interest of the patient and promotes [[Page 71393]] the patient's health, safety, dignity, self-respect, and self-worth. Comment: Several commenters believed that the documentation of clinical justification for the use of seclusion and restraint, the alternative methods used, and the reasons for their ineffectiveness should be included in the patient's record. Another commenter was concerned that staff's time for direct patient care would be diverted into creating documentation if we require demonstration that less restrictive interventions were proven ineffective in cases that involve medical immobilization. Response: We agree with the commenters. In the final rule under combined standard (e), we have specified that when restraint or seclusion is used, the following must be documented in the patient s medical record: The 1-hour face-to-face medical and behavioral evaluation when restraint or seclusion is used to manage violent or self- destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others; A description of the patient's behavior and the intervention used; Alternatives or less restrictive interventions attempted (as applicable); The patient's condition or symptom(s) that warranted the use of the restraint or seclusion; and The patient's response to the intervention used, including the need for continued use of the intervention. We believe that such documentation is a usual and customary recordkeeping practice. This information will provide a valuable tool for charting the patient's course of treatment as well as examining trends of use. In response to comments, we have added language that limits the application of the restraint definition. In the final rule, a restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort). The devices and methods listed here, typically used in medical/surgical care, would not be considered restraints and, therefore, not subject to these requirements. We believe that this addresses the commenter's concern regarding the burden of documentation in such cases. Comment: Several commenters asked that the word ``determined'' be replaced with the word ``found.'' Response: We consulted the dictionary to determine whether there was some significant difference between these two words. We found none. When we combined the two requirements, we retained the word ``determined.'' Comment: One commenter suggested moving the sentence, ``A restraint can only be used if needed to improve the patient's well-being and less restrictive interventions have been determined ineffective,'' from paragraph (e)(2) to paragraph (e)(1). The commenter stated that this would place a greater emphasis on the fact that less restrictive measures must be demonstrated to be ineffective first. Response: Although we agree that the language in paragraph (e)(2) is an essential component of standard (e), we do not believe that it is necessary to relocate this language to paragraph (e)(1). We also note that we have revised the regulatory text in the final rule to state that ``a restraint can only be used when less restrictive interventions have been determined to be ineffective to protect the patient or others from harm.'' We deleted the language ``to enhance the patient's well- being'' for clarity. Comment: One commenter asked which individual(s) would be responsible for making the determination that a less restrictive intervention was ineffective, and suggested that we use the phrase ``clinically determined'' to indicate that this decision would be made by the nursing staff. Response: Since any trained clinical staff could make such decisions, we have decided not to specify further who should determine that a less restrictive intervention is ineffective for a particular patient. Comment: One commenter stated that positive reinforcement should be used prior to restraint or seclusion. Response: Combined standard (e) specifies that restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient or others from harm. The intent, as suggested by the commenter, is to encourage staff to use alternative, less restrictive methods, such as positive reinforcement, in the patient's treatment. 5. Ordering of Restraint/Seclusion (Sec. 482.13(e)(3)(ii) and (f)(3)(ii)) In this section, we stated that the use of a restraint must be in accordance with the order of a physician or other licensed independent practitioner (LIP) permitted by the State and hospital to order a restraint. Section 482.13(f)(3)(ii) reiterated this requirement when a restraint is used for behavior management, but added that the use of seclusion must also be in accordance with such an order. a. Definition of Licensed Independent Practitioner (LIP) (Sec. Sec. 482.13(e)(3)(ii) and (f)(3)(ii)) Comment: Many commenters stated that the definition of LIP was unclear and open to interpretation. These commenters were unsure of how delegated authority affected whether a practitioner was considered an LIP, of which ``independent'' practitioners qualify as LIPs, and of how the counter-signing of orders affected the determination of whether a practitioner is independent. Several independently licensed health professionals, such as nurse practitioners and physician assistants, applauded our inclusion of the LIP as recognition of highly trained individuals with strong patient assessment skills. These commenters stated that it was important to recognize the contribution of the multidisciplinary team in today's health care settings. Many commenters asked for an explanation of who would be considered an LIP. Some commenters wanted explicit recognition of registered nurses as LIPs; one commenter suggested replacing ``LIP'' with the term ``health care professional,'' so that registered nurses would clearly be included. Many licensed professionals such as physician assistants, nurse practitioners and advanced practice registered nurses were concerned that narrow interpretation of the term ``LIP'' might limit their ability to be fully involved in patient care. One organization stated that ``LIP'' is the most problematic language in JCAHO's standards and argued that use of this term might result in inappropriate limits on its constituents' scope of practice. This organization explained that the phrase is given wide and varied interpretations by both hospitals and JCAHO surveyors. Another concern expressed by commenters was that this regulation marked the first appearance of this term in the CoPs. Several commenters questioned how LIPs might be introduced in the remaining hospital CoPs. One commenter viewed the term ``LIP,'' with its requirement that the practitioner be able to independently order restraint or seclusion, as restricting existing practice. This [[Page 71394]] commenter argued that such a restriction should only occur after a finding that the existing practice has had an adverse effect on patient care or that limiting this authority to physicians would improve patient care. The commenter believed that neither the former nor the latter point have been demonstrated or proven. This commenter also noted that State law usually addresses when an LIP may order restraints. Response: The introduction of an alternative practitioner who could order interventions, assess patients, and renew orders was an attempt to accommodate existing State laws that acknowledge the role of non- physicians in patient care and treatment. We originally used the term ``LIP'' to describe these practitioners to be consistent with existing JCAHO standards. For the purposes of this rule, a LIP is any individual permitted by State law and hospital policy to order restraints and seclusion for patients independently, within the scope of the individual's license and consistent with the individually granted clinical privileges. This provision is not to be construed to limit the authority of a physician to delegate tasks to other qualified healthcare personnel, that is, physician assistants and advanced practice nurses, to the extent recognized under State law or a State's regulatory mechanism, and hospital policy. It is not our intent to interfere with State laws governing the role of physician assistants, advanced practice registered nurses, or other groups that in some States have been authorized to order restraint and seclusion or, more broadly, medical interventions or treatments. Each State faces the issue of how to best provide its citizens with access to needed health care services. The issue is complex, as some States have special considerations such as geographic barriers to care delivery, medically underserved areas, and special population needs, all of which would affect how a State resolves this issue. To disregard a State's decision about who is qualified to order medical treatments and interventions and render patient care would be unproductive and arbitrary. To clarify this, in combined standard (e), we have revised the standard to state that the use of a restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under Sec. 482.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law. b. Physician Only Comment: While some commenters supported deferring to the States' determination of which health professionals are allowed to order seclusion or restraint, one contingent opposed allowing anyone other than a physician to order restraint or seclusion, evaluate the patient, or renew an order for restraint or seclusion. This group pushed for the rule to override existing State laws that would allow these functions to be performed by anyone other than a physician. Several of these commenters stated that the clinical skills and qualifications of some licensed therapists are not necessarily indicative of an understanding and knowledge of the medical needs or risks of patients in seclusion or restraint. Without this understanding or knowledge, there continues to be risk to patients if other medical symptoms are overlooked. Some commenters cited national legislation pending at the time that would permit only a physician to order restraint/seclusion. Advocacy organizations charged that by permitting someone other than a physician to order restraint or seclusion, CMS would be allowing any 1 of over 600,000 mental health professionals to authorize the use of restraint and seclusion, effectively undermining the purpose of the rule. Many commenters reminded us that the motivation behind the promulgation of this rule is the increasing concern regarding injuries, deaths or harm associated with the use of restraint and seclusion. One commenter maintained that by significantly narrowing the categories of clinicians permitted to authorize the use, the risk of misuse or overuse of restraint and seclusion would be minimized. Several commenters cited the importance of physicians' clinical training, the fact that they are individually accountable, and the fact that they are distanced from the daily stress and conflicts that arise between non-physician staff members and patients. Other commenters asserted that it is reasonable to require that only a physician authorize the use of procedures that can have serious and dangerous consequences for patients. A number of factors may lead to a patient displaying violent or agitated behavior, including inappropriate medication, which often times can be corrected immediately. One national organization representing physicians also opposed the recognition of non-physicians as being able to order restraints and seclusion. Response: Some States have issues such as geographic barriers to care delivery, medically underserved areas, and special population needs. States have handled these difficult issues through a variety of mechanisms. If a State has decided that a group of practitioners may order medications or treatments exclusively, we defer to State laws. Physicians are individually accountable for the care of their patients. The physician has the discretion to delegate, or to withhold the delegation of, tasks or responsibilities as he or she deems appropriate. We believe that the physician is more than capable of making the determination regarding whether his or her direct oversight is necessary, or whether in some situations, as permitted by hospital policy, these functions can be performed by another practitioner. The continued physician accountability for actions taken under his or her license provides a direct incentive for taki