Executive Summary

This report was prepared under contract #HHS-100-03-0025 between the U.S. Department of Health and Human Services (HHS), Office of Disability, Aging and Long-Term Care Policy (DALTCP) and RTI International. For additional information about this subject, you can visit the DALTCP home page at http://aspe.hhs.gov/_/office_specific/daltcp.cfm or contact the ASPE Project Officer, Gavin Kennedy, at HHS/ASPE/DALTCP, Room 424E, H.H. Humphrey Building, 200 Independence Avenue, S.W., Washington, D.C. 20201. His e-mail address is: Gavin.Kennedy@hhs.gov.

The opinions and views expressed in this report are those of the authors. They do not necessarily reflect the views of the Department of Health and Human Services, the contractor or any other funding organization.

BACKGROUND

Balancing the need to assure both autonomy and safety is a major challenge when providing long-term care services to older persons who reside in licensed group settings, because provider policies and state regulations intended to ensure safety can conflict with individuals' ability to make the choices they prefer. One approach proposed to achieve a balance is the use of a negotiated risk agreement (NRA), which was developed as a practical strategy to operationalize resident autonomy in this environment.

Processes and documents similar to NRAs exist in health care settings--for example informed consent--but the specific process and structure of NRAs are unique to assisted living (i.e., written documents that list):

• the behavior or resident preference of concern to the provider;
• the potential or actual risk;
• the resident preferences and potential provider accommodations or suggested alternatives to the behavior that reduce risk while meeting resident preferences;
• a negotiated resolution; and
• the resident's acknowledgement and acceptance of the potential negative consequences of his or her actions.

NRAs were conceived to help assisted living meet its goal of providing a residential alternative to institutional care that provides frail and cognitively impaired older persons an option that maximizes privacy, independence, choice, and the maintenance of a normal lifestyle--qualities that are generally lacking in institutional long-term care settings. Over the past decade, many assisted living providers have adopted NRAs, and several states have regulatory provisions regarding their use. However, their use is not without controversy.

PURPOSE OF THE STUDY

The use of NRAs is a new topic in a relatively new long-term care setting. This study is designed to inform state policy makers, assisted living providers, and key stakeholders about NRAs and issues related to their use. The study's major objectives are to:

• Describe states' statutory and regulatory provisions related to NRAs and analyze the policy objectives that NRAs are designed to meet.
• Analyze and better understand the debate surrounding NRAs.
• Gain an understanding of how assisted living providers, staff, and residents view and use NRAs.

METHODS

We used standard policy analysis and qualitative research techniques, including a review of the published and unpublished literature; a review of statutes, regulations, and case law for all 50 states and the District of Columbia; discussions with over 50 experts and key stakeholders in long-term care law, policy, and practice; and in-depth interviews with 46 staff and residents of seven assisted living facilities in three states--Florida, Oregon, and Wisconsin.

STATE REGULATIONS REGARDING NRAS

Forty-one states have regulations that govern residential care settings called assisted living. The majority of states have no provisions related to NRAs in either statute or administrative code, leaving their use to the discretion of providers unless they are prohibited under other state statutes. Fourteen states and the District of Columbia have NRA or closely related provisions related to managing risk (hereafter, the states). No state explicitly prohibits the use of NRAs, though several place restrictions on their use.

State regulations regarding NRAs and related concepts vary in their provisions and specificity, but all states view NRAs or a similar process as a means to support residents' choices that conflict with medical advice or facility norms while managing the risks associated with their choices. Most states link NRAs with service planning.

Wisconsin is the only state that requires all persons entering a specific type of assisted living--Residential Care Apartment Complexes--to have an NRA at admission. Of the 15 states with NRA provisions, four do not reference NRAs as a distinct document that is written or signed, instead referring to risk discussions as part of service planning or provisions for managing risk.

THE DEBATE SURROUNDING NRAS

Purpose of NRAs

Views about the purpose of NRAs are polarized. The 15 states that reference NRAs or similar processes in their assisted living regulations and the majority of proponents believe NRAs have several purposes, providing: (1) a tool for identifying and reducing risks, (2) a communication tool for discussing risks and setting expectations, and (3) a method to support residents' rights to make choices that entail risk. Some states and proponents also view NRAs as a method for assigning responsibility and limiting provider liability.

The strongest opponents tend to view NRAs as having a sole purpose--an attempt to avoid liability for negative outcomes resulting from negligence. Others recognize that "good" providers may use NRAs to identify and reduce risks, but fear that "bad" providers will use them to force residents to accept substandard care because they have no practical alternative or fear discharge to an institutional setting. Several argue that residents are in an unequal bargaining position due to frailty, lack of acceptable alternatives, and the difficulty with relocation.

Furthermore, opponents believe consumers should not be required to negotiate to exercise autonomy in assisted living because they already have the right to make the choices NRAs are designed to foster. Proponents counter that the rights of residents in licensed facilities are constrained and that providers worried about their potential liability for the negative outcomes of residents' choices often overtly curtail residents' autonomy or apply subtle coercion to restrict it.

Both proponents and opponents were divided regarding the ability to mitigate the potential negative consequences of NRAs through law and regulation. Opponents believe that prohibiting NRAs altogether rather than risking abuse best serves the public interest; proponents believe the public is best served by allowing NRAs and implementing regulatory protections. If a state allows or require NRAs, opponents also believe that regulatory protections are needed.

Liability Waivers

Liability waivers--specific or implied--are the main issue that polarizes views about NRAs. Some proponents claim that NRAs are not and never were intended to limit provider liability while others argue that they were always intended to create a balance within a regulated setting, allowing resident autonomy by providing an appropriate amount of liability protection for providers. Many argue that without limiting provider liability that could result from residents' risky choices, providers will continue to restrict residents' autonomy in favor of safety. Most proponents note, however, that blanket waivers of liability are never appropriate.

An interesting feature of the debate about NRAs and liability waivers is that few proponents or opponents believe that NRAs can effectively limit legal liability, whether or not they include a specific liability waiver. The legal status of an NRA as a contract has yet to be determined, yet virtually no one believes that broad liability waivers are enforceable or that specific liability waivers are enforceable if negligence resulted in harm to a resident or if providers violated express regulatory requirements.

NRAs and State Admission and Discharge Requirements

Several opponents believe that providers will use NRAs to allow residents to remain in a facility after their needs exceed regulatory discharge requirements--sidestepping regulations in an effort to maintain their census without increasing staffing. The consensus of legal experts was that NRAs or any private contracts, as a general rule, can not overrule regulations or law because deregulation by private contract is not enforceable. Nor can NRAs supplant a provider's fulfillment of a statutory duty.

Some states explicitly prohibit the use of NRAs to override state-mandated discharge requirements. Nonetheless, it appears that NRAs and similar agreements can be specifically included in regulations as a mechanism to allow residents to accept risks within parameters established by regulations or as a defined mechanism with which to override state discharge requirements under certain circumstances. In other words, residents do not have a right to use NRAs to enforce their choices in opposition to the state's (or, generally, the provider's) rules unless the state explicitly provides in law or regulation for NRAs to do so.

Limitations on the Use of NRAs

When asked about specific issues related to the use of NRAs--for example, what topics are appropriate, whether providers should determine residents' decision-making capacity through a formal assessment prior to executing an NRA, and whether third parties should be allowed to execute an NRA on a resident's behalf--there was a lack of consensus. Many said their position on these issues would depend on the circumstances. Some providers said that more guidance on such issues would be helpful.

In sum, stakeholders and experts disagree about the advantages and disadvantages of NRAs. The meaning of "risk" and views regarding the relative importance of protection and autonomy varies among the many disciplines involved in assisted living practice--providers, consumer advocates, regulators, nurses, social workers, attorneys, and insurers. Even among advocates, especially between traditional advocates for the elderly and advocates for persons with disabilities, views on the need for NRAs and implementation standards vary widely.

HOW ASSISTED LIVING PROVIDERS, STAFF, AND RESIDENTS VIEW AND USE NRAS

Most of the experts and stakeholders we interviewed had strong views about NRAs, but few had firsthand experience with them. The primary purpose of our site visits was to get a sense of how NRAs are actually used and the views of those directly involved.

• With the exception of Wisconsin, which mandates NRAs for all residents admitted to a specific type of assisted living (Residential Care Apartment Complexes), NRAs appear to be used infrequently and selectively, generally only when informal discussions have not resolved an issue that has arisen more than once.
• Staff view NRAs primarily as a complement to service planning and a useful method for addressing residents' behaviors or choices that they believe pose risks to their health and safety. In particular, they foster discussion about difficult issues that providers, residents, and families might otherwise avoid. All staff agreed that behaviors that place staff or other residents at risk are not appropriate for negotiation.
• While some staff believe that NRAs could provide some liability protection in the event of a lawsuit over a negative outcome, they do not view this potential protection as the sole or primary purpose of the NRA. All management and professional staff agreed that an explicit discussion with residents and families about risk and of measures that can be taken to reduce risk can reduce providers' liability exposure.
• In no case, with the information available to us, did we determine that NRAs were being used to pressure residents into accepting inadequate care, the primary concern of NRA opponents. None of the NRAs we reviewed supported the view that providers are using NRAs exclusively as a liability "dodge" to allow them to admit and keep residents beyond the facility's capacity to care for them--or for poor quality care. However, some standardized NRAs were overly broad and inappropriate for persons with cognitive impairment (e.g., one facility had a standard NRA form that included a statement that a resident accepts responsibility for risk of injury due to wandering).
• All residents believed strongly that they should be able to make lifestyle and personal decisions that may place them at risk. Several residents did not remember signing the agreement or the specific details of their agreements.
• No facility uses a formal method to determine decision-making capacity prior to executing an NRA. In most cases, staff assess this capacity through informal observations of memory loss and poor judgment. Many staff do not appear to be knowledgeable about the cognitive domains and other factors that affect decision-making capacity.
• Some facilities are allowing surrogates to sign NRAs without knowledge of their legal standing to accept risk on behalf of the resident.
• Some staff expressed frustration with the need to assure residents' autonomy based on two concerns: (1) fear that residents might get hurt when staff have a moral obligation to protect them, and (2) concern that staff are held responsible for all negative outcomes.
• Often, direct care staff did not have much familiarity with the concept of NRAs, know that an individual resident had an NRA, or, if they knew a resident had an NRA, they did not know what impact it had on service delivery or a resident's ability to assume risk.
• Some NRAs were used for issues other than specific risks. For example, to note a general risk factor like blindness or obesity, or as a behavior modification agreement, stating that unless a resident ceased a particular behavior, like smoking or disturbing the peace, they would be discharged from the facility.

CONCLUSIONS

Assisted living providers, policy makers, aging advocates, and long-term care experts have defined NRAs as a mechanism to enhance resident choice by providing a rigorous process designed to balance autonomy and risk for residents and providers in assisted living. While our sample is small and not representative, our findings suggest that NRAs can be a useful tool to help residents and providers achieve a balance between desires for autonomy and concerns about safety. At the same time, they suggest that the NRA concept is proving difficult to broadly and consistently operationalize.

• NRA processes and purposes are not well understood and appear to vary widely across states, providers, and even staff in the same facility. While this may not be surprising given that assisted living varies widely within and across states, it does raise significant concerns about standards for the process. As identified in this study, the appropriate use of NRAs requires at a minimum, guidance in their use, as well as education and training.
• NRAs are not being used uniformly to maximize resident autonomy by balancing specific risks and consumer preferences as supporters advocate. Few of the NRAs we reviewed adhered to a form, process, or guidelines appropriate for the practice concept or to the recommendations in the Assisted Living Federation of America's report on NRAs. While some NRAs fit advocates' concepts, others that we reviewed addressed appropriate issues but did not include a discussion of alternatives or a negotiation, instead presenting topics in an either/or framework. Some NRAs simply identified the risk, stated that the resident should not do what staff identified as risky, and then noted that the resident planned to continue and accepted the risk.
• The enforceability of liability waivers has not been tested in the courts but most experts do not believe that NRAs with such waivers provide any more liability protection than those without them. NRAs can be structured to address provider and consumer concerns without using formal or even an implicit liability waiver. Most experts agreed that the availability of a signed document recording formal discussions between the facility and resident regarding risky choices, staff attempts to reduce risk, and the residents' acknowledgment of their choice despite the risks could be comparable in protection to a formal waiver of liability in the event of a law suit. Given this, proponents would be advised to give less attention to liability waivers and more to assuring that providers follow recommended practices when executing NRAs. In particular, issues related to executing NRAs with individuals who may lack decision-making capacity should receive more attention.

Whether NRAs should be used or continued with residents who have cognitive impairment is unclear. If an individual includes the authority to enter into an NRA in a power of attorney or if a court has granted a guardian this power, legal concerns about the use of surrogates are lessened. In most states, guidelines regarding NRAs and surrogates are either completely lacking or do not adequately address this issue. Additional state guidance regarding appropriate and inappropriate use of surrogates would be helpful to providers and would afford protection to persons with cognitive impairment.

It may be possible to address certain risk topics found in our review of NRAs using a process that is more closely tied to service planning, particularly to address areas of risk that are typically dealt with in service plans, such as prescribed diets, medications, and use of bedrails. For example, to obtain the primary advantages of fostering communication and documenting discussions and choices, providers could use forms that address "specialized service planning issues" as well as forms that are treated as addendums to the service plan. This approach would have the advantage of being part of initial and ongoing service planning while avoiding the legal complexities of an NRA. However, an enhanced serving planning approach would not afford the benefits of negotiation and risk assumption that many proponents believe are the primary value of NRAs--both to enhance resident autonomy and protect providers from liability for the consequences of residents' choices.

While many advocates and opponents characterize the debate as absolute for or against NRAs, the debate is better characterized as an attempt to determine acceptable limits to choice and what process best achieves a balance between autonomy and safety. It seems likely that with increasing attention to the rights of persons with disabilities to exercise choice and assume risk in both long-term care settings and independent housing, strategies for enhancing older persons' autonomy will become increasingly important.

NRAs or similar processes show some promise in providing a practical approach to enhancing resident autonomy in a living environment where a regulatory emphasis on safety and concerns about liability are salient factors affecting provider behavior. However, if NRAs are the correct tool for striking a reasonable balance between safety and autonomy, states, consumer advocates, provider associations, and the legal community need to give more detailed attention to how their use should be operationalized so they can play a significant role and to prevent potential abuse. Stakeholders also need to examine what role NRAs' can or should play in providing a process for "reasonable accommodation" when state or provider proscribed admission and discharge limits conflict with residents' preferences.