[Federal Register Volume 67, Number 191 (Wednesday, October 2, 2002)]
[Rules and Regulations]
[Pages 61805-61808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24857]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicaid & Medicare Services

42 CFR Part 482

[CMS-3018-N]
RIN 0938-AL15


Medicare and Medicaid Programs; Hospital Conditions of 
Participation: Clarification of the Regulatory Flexibility Analysis for 
Patients' Rights

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Interim final rule; clarification of regulatory flexibility 
analysis.

-----------------------------------------------------------------------

SUMMARY: On July 2, 1999, we published an interim final rule with 
comment period introducing a new Patients' Rights Condition of 
Participation (CoP) that hospitals must meet to be approved for, or to 
continue participation in, the Medicare and Medicaid programs. Several 
aspects of that interim final rule with comment period were challenged, 
including its regulatory flexibility analysis (RFA). As a result of 
this action, a Federal court, without enjoining continued enforcement 
of the rule, ordered the Secretary of the Department Health and Human 
Services (DHHS) to complete a compliant RFA to accompany the interim 
final rule with comment period. This document addresses the court's 
order.

FOR FURTHER INFORMATION CONTACT: Jeannie Miller, RN, (410) 786-3164.

SUPPLEMENTARY INFORMATION:

I. Background

A. General

    In the December 19, 1997 Federal Register (62 FR 66726), we 
published a proposed rule that detailed our plans to revise all of the 
hospital conditions of participation (CoPs), emphasizing lessening 
Federal regulations to eliminate unnecessary structural and process 
requirements, focus on outcomes of care, allow greater flexibility to 
hospitals and practitioners to meet quality standards, and place a 
stronger emphasis on quality assessment and performance improvement. 
The proposed rule introduced our intent to include a new Patients' 
Rights CoP for hospitals. We solicited comments and received strong 
support for the establishment of the new CoP from the public, mental 
health advocacy groups, the media, and the Congress.
    After the proposed rule was published, reports of injuries and 
deaths associated with the use of restraints and seclusion increased 
our concern about patient safety. State surveyors, patient advocacy 
groups, the media, and the public also brought complaints about 
hospital violations of patients' rights to our attention. These 
violations included denying or frustrating patients' access to care, 
denying patients' full involvement in their treatment, disregarding 
patients' advance directives, and denying patients access to their 
records. In the July 2, 1999 Federal Register (64 FR 36070), we 
published an interim final rule with comment period to address these 
concerns and assure patient safety. The rule set forth requirements 
supporting and protecting patients' rights in the hospital setting, 
specifically, the right to be free from the inappropriate use of 
seclusion and restraint, with requirements to protect the patient when 
use of either intervention is necessary.

B. Legal Challenge of the Interim Final With Comment Period

    The interim final rule with comment period was challenged in United 
States District Court for the District of Columbia by the National 
Association of Psychiatric Health Systems, the American Hospital 
Association, the Sheppard and Enoch Pratt Foundation, Incorporated, and 
Acadia Hospital. (See National Association of Psychiatric Health Sys. 
v. Shalala, 120 F.Supp.2d 33 (D.D.C. 2000).) Plaintiffs challenged one 
provision of the new CoP, the requirement that hospitals must provide 
for an in-person evaluation of a patient by a physician or other 
licensed independent practitioner (LIP) within 1 hour of initiating the 
use of restraint or placing the patient in seclusion to address the 
patients' violent or aggressive behavior. (See Sec.  
482.13(f)(3)(ii)(C).)
    On September 14, 2000, the Court ruled in favor of the Secretary 
with respect to the plaintiffs' challenge under the Administrative 
Procedures Act; however, the Court ruled against the Secretary with 
respect to the plaintiffs' claim that the rule failed to fulfill 
certain requirements of the Regulatory Flexibility Act (RFA). In its 
decision, the Court noted that the RFA requires--
    [sbull] A succinct statement of the need for and objectives of the 
rule;
    [sbull] A summary of and response to the significant issues raised 
by public comments to the RFA assessment in the notice of proposed 
rulemaking;
    [sbull] A description and estimate of the number of small entities 
to which the rule will be applied;
    [sbull] A description of the projected reporting and recordkeeping 
requirements of the rule, including an estimate of the effect that the 
recordkeeping requirements will have on small entities; and
    [sbull] A description of the efforts the agency has taken to 
minimize the significant economic impact of the rule on small 
businesses, including a discussion of the less restrictive alternatives 
considered and rejected.
    The Court, noting that the Secretary had not made a ``reasonable 
good faith effort to canvass major options and weigh their probable 
effects,'' concluded that the agency failed to satisfy the fifth 
element of the Regulatory Flexibility Act. The case was remanded to the 
Department of Health and Human Services for completion of a compliant 
RFA without enjoining continued enforcement of the requirements of the

[[Page 61806]]

interim final rule with comment period. Accordingly, we are publishing 
this notice to discuss the alternatives that we considered when 
developing the July 2, 1999 interim final rule with comment period.

II. Revised Regulatory Impact Analysis of the July 2, 1999 Rule

A. Introduction

    When we published the July 2, 1999 interim final rule with comment 
period, we lacked critical factual reports, studies, and data that 
would have aided in the development of specific cost or savings 
estimates. This factor continues to be an obstacle in providing cost 
estimates on the impact of some of the requirements.
    At the time of the publication of the July 2, 1999 interim final 
rule with comment period, at least 80 percent of the 6,116 inpatient 
hospitals that participate in the Medicare or Medicaid programs were 
subject to existing accreditation requirements pertaining to the use of 
restraints and seclusion. While the pre-1999 Joint Commission for the 
Accreditation of Healthcare Organizations (JCAHO) requirements did not 
contain all elements addressed by the interim final rule with comment 
period, many parallel standards were in place. There were two major 
differences between JCAHO's standards and our standards. The first is 
that JCAHO did not require the 1-hour face-to-face assessment but 
instead required a phone call to the LIP. The second is that JCAHO's 
monitoring requirements were more stringent than ours. It is worth 
noting that JACHO is enforcing all of our requirements, including the 
1-hour rule, when conducting accreditation surveys. Accredited 
hospitals operated in an atmosphere that emphasized the elimination of 
unnecessary restraint, monitoring use, and reporting sentinel events to 
the JCAHO. Therefore, we approximated that 4,893 facilities were 
already subject to restraint and seclusion requirements. The remaining 
1,223 facilities (non-profit, proprietary, and government-funded) would 
be subject to any existing state laws concerning the use of restraint 
and seclusion. Additionally, at least two States (New York and 
Pennsylvania) had established detailed regulations and policies 
regarding the use of restraint and seclusion in State-run and private 
facilities. Therefore, we concluded that the majority of hospitals were 
already affected by restraint and seclusion-related requirements, even 
if they were not equal in all points to the requirements specified in 
the interim final rule with comment period. Thus, although Medicare- 
and Medicaid-participating hospitals have diverse characteristics, many 
are accredited; and therefore, could be assumed to have been meeting 
pre-existing accreditation standards at the time the interim final rule 
with comment period was published.
    Furthermore, with the increasing amount of research and literature 
identifying the potential hazards associated with restraint use, some 
hospitals were already engaged in efforts to reduce the use of 
restraints. The variations among hospitals, the lack of data on the 
prevalence of restraint or seclusion use in hospitals, and the trend of 
restraint use reduction efforts created problems in the formulation of 
a specific estimate for the interim final rule with comment period. 
While these were obstacles to the formulation of an estimate for the 
interim final rule with comment period, we invite hospital feedback on 
these points so that we may use this information in formulation of the 
final rule and its impact estimate.

B. Anticipated Effects and Options Considered

1. Effects on Hospitals
a. Restraint and Seclusion (Sec.  482.13(e) and (f))
    Our regulations in Sec.  482.13(e) and (f) prohibit the use of 
restraint and seclusion for purposes of coercion, discipline, 
convenience or retaliation by staff. These regulations also establish 
procedures that apply when hospitals use restraint or seclusion.
    We considered developing one set of general requirements regulating 
restraint and seclusion use in all hospitals. However, based on public 
comments and recent concern regarding the risks associated with 
restraint and seclusion use for behavior management situations, we 
concluded that one set of requirements did not afford patients with 
adequate protections. Moreover, we believe that it is important to 
maintain consistency between Federal and accreditation standards. 
Therefore, we adopted an approach to restraints and seclusion similar 
to the existing standards that JCAHO created (for example, 
differentiating between situations when a restraint is being used to 
manage behavior and the concept of time limited orders). Accordingly, 
we made a distinction between restraint use in the provision of acute 
medical and postsurgical care (Sec.  482.13(e)) and restraint and 
seclusion use for the management of aggressive or violent behavior 
(Sec.  482.13(f)).
b. Training (Sec. Sec.  482.13(e)(5) and (f)(6))
    Section 482.13(e)(5) requires that staff with direct patient 
contact (that is, staff who may be involved either with the application 
of a restraint or the monitoring, assessment, or reevaluation of a 
restrained or secluded patient's condition) are provided with ongoing 
education and training in the proper and safe use of restraints. 
Section 482.13(f)(6) parallels these requirements and adds that staff 
involved in the application of a physical restraint or seclusion to 
manage aggressive or violent behavior must receive additional training 
in alternative methods for handling behavior, symptoms, and situations 
that have been traditionally treated using restraints or seclusion.
    When writing the interim final rule with comment period, we 
considered the burden of requiring training on the use of restraints 
and seclusion for all staff members with direct patient contact. We 
believed that some persons inaccurately construed the requirement to 
entail the training of dietary, administrative, housekeeping, and other 
types of staff who are not involved in the application or use of 
restraints or seclusion. (See Tag A797, Appendix A of the State 
Operations Manual, HCFA Pub. No. 7, page A196.)
    Most hospitals that participate in Medicare or Medicaid already 
have some type of training program; therefore, we believed that these 
requirements refine existing programs rather than mandate new ones. 
JCAHO's standards are applicable to accredited hospitals (currently 80 
percent of Medicare- and Medicaid-participating hospitals) and require 
a similar training program for staff involved with the application of 
restraints or seclusion. (See JCAHO's 2000 Comprehensive Accreditation 
Manual for Hospitals standard TX 7.1.1.3 (which indicates that staff 
orientation and education create a culture emphasizing prevention and 
appropriate use of restraint or seclusion as well as encouraging 
alternatives) and standard TX 7.1.3.1.4 (which requires that restraint 
or seclusion is only used correctly by competent, trained staff)).
    Lastly, we considered no training requirements; however, the 
Hartford Courant newspaper series indicated that training programs are 
a key ingredient in assuring a reduction in patient injuries and deaths 
associated with the use of restraints and seclusion. To omit this 
requirement in the interim final rule with comment period would have 
been to leave a critical gap in the strategy to improve patient care 
and assure patient safety.

[[Page 61807]]

c. Face-to-Face Monitoring (Sec.  482.13(f)(4))
    The hospital CoPs require continuous face-to-face monitoring of a 
patient who is simultaneously physically restrained and secluded to 
address violent or aggressive behavior. As an alternative, continuous 
monitoring may occur through the use of both video and audio equipment, 
with the monitoring occurring in close proximity to the patient to 
allow quick intervention when needed.
    We agree that this requirement may incur costs for hospitals, 
depending on their current practice. However, we believed that the 
training required by the July 2, 1999 interim final rule with comment 
period equipped staff with alternative methods for handling violent or 
aggressive patient behavior thereby reducing overall use of restraint 
or seclusion.
    We did not require that this monitoring be done by a registered 
nurse. It could be performed by a nursing assistant or other staff 
member who has completed the required training.
    We considered only requiring periodic monitoring when the two 
interventions are used simultaneously. However, we concluded that the 
instances meriting dual use of restraint or seclusion would be so rare 
and extreme that they would indicate a need for greater staff 
vigilance. Restraint and seclusion can actually increase the patient's 
agitation, and staff should be available to help the patient regain 
self control, thus ending one intervention or both as quickly as 
possible. Leaving a distressed patient alone for half an hour or 
longer, not understanding what is happening to him or her, does not 
facilitate the patient's recovery of his or her self-control. We 
concluded that uninterrupted monitoring assures that if the patient 
becomes more distressed by the intervention, staff can assist quickly.
d. One-Hour Evaluation (Sec.  482.13(f)(3)(ii)(C))
    The interim final rule with comment period requires face-to-face 
assessment, by a physician or other LIP within one hour of the 
initiation of the intervention, of a patient who has been restrained or 
secluded to manage his or her violent or aggressive behavior. We 
considered whether this requirement was impossible to fulfill because 
of the lack of available personnel, geographic barriers, and costs 
associated with this degree of coverage. We also considered whether a 
required onsite evaluation by a physician or LIP is too costly or 
without a demonstrable benefit in many cases.
    When the interim final rule with comment period was published in 
July 1999, we were not aware of any data regarding the appropriateness 
of the 1-hour timeframe and we solicited, but did not receive, comments 
providing data undercutting this requirement.
    In including the 1-hour provision, we considered that hospitals are 
required to have 24-hour physician coverage. Section 482.12(c)(3) 
requires that the governing body of the hospital must ensure that a 
doctor of medicine or osteopathy is on duty or on call at all times. 
The interim final with comment period did not change this requirement 
or require hiring of new staff or having a physician onsite at all 
times. When staff are trained in alternatives to restraint or 
seclusion, prevalence of use should decline so that restraint or 
seclusion is used only as a last resort. We understand that for certain 
patient populations, such as for those who have self mutilating 
behaviors, a requirement for recurring onsite visits to assess the use 
of a restraint that is part of the patient's treatment plan may not be 
needed or appropriate. We plan to address these uses in forthcoming 
interpretive guidelines. Additionally, we reiterate that uses of 
restraint that occur in conjunction with an acute care need do not 
trigger the need for evaluation of the patient by a physician or other 
LIP within one hour. These uses may include, for example, a patient who 
is attempting self-extubation or tearing at lines whose behavior cannot 
be handled through less restrictive means.
    In establishing this requirement, we considered onsite physician-
only assessment within half an hour, which is the policy in one State's 
mental health system. However, we believed that this timeframe would 
not be reasonable in rural or remote areas, and therefore; we did not 
impose this requirement.
    We also considered less prescriptive approaches. For example, we 
could have drafted regulations that remained silent on this point. 
However, various sources of information, including the press indicated 
that the patient is at high risk for injury when being restrained or 
secluded in an effort to manage his or her violent or aggressive 
behavior. (See ``Deadly Restraint: A Hartford Courant Investigative 
Report,'' with articles from October 11 through 15, 1998). Often 
patients are medically complex, with concomitant medical and 
psychiatric symptoms and conditions. When staff must resort to 
restraint or seclusion to protect the patient or others, it is 
essential to examine: (1) The immediate situation, that is whether the 
patient has been injured by the intervention; (2) the patient's 
reaction to the intervention; (3) the patient's overall medical and 
psychiatric condition; and (4) whether the behavior may stem from a 
condition that can be remedied quickly. Such a determination is a 
medical decision that requires the integration of many pieces of 
information, and therefore; merits a physician's or other LIP's 
attention.
    We also considered other options that may be perceived as less 
burdensome. We could have drafted regulations that remained silent on 
the timeframe for a physician's or other LIP's assessment of a 
restrained or secluded patient. This alternative may be feasible for 
the types or uses of restraint described in Sec.  482.13(e). In these 
types of situations, we left to the physician's or other LIP's 
discretion the decision of whether immediate, inperson assessment is 
required. In an instance when an armboard is applied to prevent 
accidental dislodging of an intravenous needle, arguably the 
application of the restraint does not represent a significant change in 
the patient's status, nor does the armboard pose a grave hazard to the 
patient's health or safety. In contrast, a patient's attempt to self-
extubate could warrant immediate physician attention, depending on the 
patient and whether this behavior represents a marked change in status. 
However, we believed that requiring an inperson assessment within 1 
hour for the variety of restraint uses under Sec.  482.13(e) was not 
feasible because of the wide range of circumstances covered by that 
standard.
    On the other hand, Sec.  482.13(f) is more focused. We considered 
whether immediate attention was necessary when restraint or seclusion 
was used to manage a patient's violent or aggressive behavior. We 
recognized that the types of behavior that warrant the patient's 
placement in seclusion or the application of restraint often create a 
situation in which both the patient and staff are at risk for injury. 
The patient who is resisting staff restraint in this situation is 
unlike the noncombative patient who had an armboard applied. This 
patient has transitioned from seemingly calm behavior into a state at 
which an extreme measure has been undertaken to protect him or her. As 
discussed in the preamble to the interim final rule with comment 
period, we concluded that quick, medical involvement is warranted to 
assure safety and to develop a plan to avert or diminish further 
conflict. We believed that the maximum timeframe of 1 hour

[[Page 61808]]

established by this rule is a reasonable one.
    We also considered permitting a staff member to perform a patient 
assessment through telephone consultation with a physician or other 
LIP. Given the complexity of the patient population, we did not select 
this option. Physicians and LIPs are extensively trained in assessment 
of symptoms and behaviors, in physical examination and formulation of 
diagnoses and resulting treatment strategies. Staff who are onsite may 
have widely disparate assessment skills. Some hospitals may staff 
patient care areas with licensed practical nurses or other available 
staff. We are not persuaded that these staff members have the physical 
and psychiatric assessment skills that correspond to the medical 
complexity of a patient in crisis. Accordingly, we opted not to permit 
patient assessment through telephone consultation.
2. Effect on Beneficiaries
    The implementation of the Patients' Rights CoP served to protect 
not only Medicare and Medicaid beneficiaries, but all patients 
receiving care in any of the 6,166 Medicare- and Medicaid-participating 
hospitals (that is, acute care, psychiatric, rehabilitation, long-term 
care, children's, and alcohol-drug) including small rural hospitals. 
Our goal is to safeguard against the mistreatment of all patients in 
these facilities including, but not limited to-- (1) Deaths due to 
inappropriate restraint or seclusion use; (2) violation of patients' 
privacy and confidentiality in various aspects of the healthcare 
delivery process; and (3) systematic frustration of the patients' 
efforts to acquire his or her medical records. Patients benefit from 
the hospitals' focus on patients' rights. Through these protections, 
patient care can be delivered in an atmosphere of respect for an 
individual patient's comfort, dignity, and privacy. The interim final 
rule with comment period emphasizes the importance of staff training, 
adequate monitoring and assessment, and prompt evaluation of restrained 
or secluded patients. As these factors, lack of training, evaluation, 
monitoring, and assessment were involved in the deaths reported by the 
media, we believed that implementation of the Patients' Rights CoP 
would lead to a reduction in the number of restraint- and seclusion-
related injuries and deaths in hospitals. The following chart 
represents the data that we have received from providers regarding 
deaths that may have been related to restraint or seclusion use:

------------------------------------------------------------------------
                                                              Number of
                            Year                                Deaths
------------------------------------------------------------------------
August 1999--December 1999 \1\.............................           14
2000.......................................................           34
2001.......................................................           22
January 2002-March 2002 \2\................................            5
    Total from August 1999-March 2002......................          75
------------------------------------------------------------------------
\1\ The interim final rule with comment period was published on July 2,
  1999 and effective on August 2, 1999. Therefore, no data on deaths
  related to restraint or seclusion use was submitted by providers
  before August 1999.
\2\ The latest data available is through March 2002.

3. Effects on the Medicare and Medicaid Programs
    We did not expect the implementation of the new Patients' Rights 
CoP to generate significant costs to the Medicare or Medicaid programs. 
We did not believe that there would be any additional costs to the 
survey and certification program as compliance with this new CoP either 
would be reviewed through a routine, nonaccredited hospital survey, a 
validation survey or as part of a complaint survey.

C. Conclusion

    The Patients' Rights CoP introduced new Federal requirements that 
in many instances reflected existing State, accreditation or 
professional standards. These new Federal requirements are set forth in 
six standards to ensure minimum protections of each patient's physical 
and emotional health and safety. These standards address the patients' 
right to--
    [sbull] Be notified of his or her rights;
    [sbull] Exercise his or her rights in regard to his or her care;
    [sbull] Privacy and safety;
    [sbull] Confidentiality of and access to his or her medical 
records;
    [sbull] Freedom from restraints used in the provision of acute 
medical and postsurgical care unless clinically necessary; and
    [sbull] Freedom from restraint and seclusion use to manage violent 
or aggressive behavior unless clinically necessary.
(Catalog of Federal Domestic Assistance Programs No. 93.773, Medicare--
Hospital Insurance and No. 93.778, Medical Assistance Program)

    Dated: September 24, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare and Medicaid Services.

    Dated: September 26, 2002.
Tommy G. Thompson,
Secretary of Health and Human Services.
[FR Doc. 02-24857 Filed 9-27-02; 9:51 am]
BILLING CODE 4120-01-P