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Surely the wizard will help us, Toto? Implementing the Patient Self-Determination Act.

Implementing the Patient Self-Determination Act

Hospitals, nursing homes, home health agencies, and HMOs recently reached the one-year mark in attempting to implement the Patient Self-Determination Act.[1] Considerably less time has passed since the Health Care Financing Administration (HCFA) published its belated "interim final rule" on the PSDA in March 1992.[2] Since the rule does little more than parrot the language of the act, its significance may be slight. However, the more provocative feature of HCFA's interim rule is the long preamble generated considerable reaction in four score or so written comments received by HCFA, predominantly from providers, but also from consumers, states and other analysts.

Looked at as a whole, providers' comments to the rule suggest a classic conundrum, evocative of the story of Dorothy and her conflicted companions who sought the great and powerful Oz. On the one hand, providers rightfully insist that flexibility is essential to promoting meaningful patient autonomy. After all, the heart, brains, and courage to make good health care decisions cannot be created by decree or by smoke and fire from on high. In short, the federal government should not tell providers what to do in matters of this sort. Yet, paradoxically, comments from providers repeatedly urge HCFA, the always suspect sage of statutory construction, to tell them exactly what to do. They beseech HCFA to be more specific--more specific about who must receive information about health care decisionmaking rights, when they must receive it, how and when to document advance directives, and how providers can or cannot follow their consciences in complying or not complying with patient directives. In short, give us a brain, a heart, and courage, and transport us to the simplicity and certainly of Kansas.

On none of these points was Congress very specific, and that was so by design. Congress essentially proclaimed, "Thou shalt inform, ask, and educate," and took the wilful leap of faith that providers and the public were best equipped with the brain, the heart, and the courage to navigate their way through this relatively new land of health decisions. Whether the leap of faith will prove beneficial still remains to be seen. Right now, it appears that providers and provider organizations need reminding, like Dorothy, that the power lies within.

In fairness, providers' jitters about the specifics of implementation are not so surprising when the mind-set of provider organizations is appreciated. Most providers do the best job they can, but they feel regularly horse-whipped by regulations that require ever-increasing administrative minutiae to achieve compliance. The following discussion reviews some key concerns expressed by providers and consumer advocacy groups regarding implementation of the PSDA, as reflected in their comments on the interim final fule submitted to HCFA. For brevity, concerns unique to health maintenance organizations or other managed care organizations are not covered.

Documenting Advance Directives: Beginning at the Beginning

The interim rule itself, like the statute, requires providers to begin at the logical beginning--by asking patients at admission if they have an advance directive. Providers must "document in the individual's medical record whether or not the individual has executed an advance directive."[3] HCFA expressly asked in the preamble to the rule for comments on acceptable methods for documenting advance directives.

The primary tension evident in the comments received arises over the advisability of requiring face-to-face dialogue with patients versus using written questionnaires in admission or preadmission materials to ascertain the existence of an advance directive. Consumer groups emphasize the importance of face-to-face dialogue, but provider groups fall almost equally on both sides of the fence. Direct dialogue is labor intensive, but it provides a better starting point--a better opportunity for ensuring understanding, accuracy, and referral when individuals or family members want additional information.

Oddly, HCFA suggested in its preamble to the rule that providers might also use community education programs to ascertain whether individuals have executed advance directives. Most commentators express serious doubts about the viability of such bulk processing, especially since community education programs may have little connection with admission procedures.

Successful documenting and tracking of advance directives is largely determined by the particular information system and record-keeping procedures used by individual providers. Consequently, providers are best suited to take the lead in documentation by experimenting with and developing "best practices" appropriate to their particular environment. Realistically, it is only if providers fail to take documentation seriously that HCFA is likely to step in with more specific, and less flexible, minutiae regarding doucmentation.

Another concern about documentation is access to the advance directive document itself. Must a copy go in the record? If the patient merely indicates that one exists, how much investigative effort must a provider exert to track down the actual document or ascertain its contents? Typically, providers prefer to place responsibility squarely on the patient to produce the document, although the comments of at least one provider suggest a "reasonable effort" standard for facilities. The rule as it presently reads only requires the provider to "document" the directive. It does not explicitly require providers to put a copy of the directive in the medical record, even if the individual hands a copy to the provider.

At a minimum, patients should be able to expect that providers will place in the medical record any copy furnished by the patient or patient's surrogate. Indeed, most state advance directive laws already require this.

Conscientious Objections: The Straw Man?

The PSDA expressly allows providers to refrain from implementing advance directives based on conscience if state law allows such objections. However, every adult patient must be given written information about the facility's policies, so that any potential conscience objections will be known ahead of time. The interim final rule adds additional language, requiring providers to give a "clear and precise statement of limitation" of services based on conscience.[4]

Exactly how much information must providers impart about their policies, especially if facility policy defers to individual medical staff? Providers and consumer advocates fall into distinctly different camps on this question. In general, providers argue that the "clear and precise" standard is unrealistic, because: (a) facilities cannot possibly track and convey to patients the particular views of individual staff or health care providers (it is the physician's obligation to impart such information to patients); and (b) many providers rely on quite general and flexible principles, so objections are seldom categorical. Instead they arise on a case-by-case basis.

Some consumer advocacy groups express a quite contrary view, arguing that the "clear and precise" standard does not go far enough. Conscience objections can too easily be raised as a straw man to avoid compliance with patient wishes. Therefore, some advocates argue that the elements of a clear and precise explanation need to be spelled out and should include an explanation of steps to be taken if the provider refuses to comply at the time a decision needs to be made. Without such an articulation of elements, the meaning of "clear and precise" resides only in the eye of the beholder.

The American Bar Association Commission on Legal Problems of the Elderly specifically suggests that provider policies: (1) clarify any differences between institution-wide conscience objections and those that may be raised by individual physicians; (2) explain the basis for any facility objection (for example, it might be based on various religious, moral, or professional grounds); (3) identify the state legal authority permitting such objection; (4) describe the range of medical conditions or procedures affected by conscience objections; and (5) describe what steps will be taken to transfer or otherwise accommodate individuals whose wishes are impeded by the institution's policy. This kind of guideline for articulation in no way restricts objections based on conscience. Rather, it helps ensure that the information received by patients will contain common, indentifiable key elements.

Community Education: Careful, I Rust Easily

No mandate in the PSDA is as malleable or outright vague as the requirement that providers educate the "community" on issues concerning advance directives. The iterim final rule sheds no additional light on who constitutes the "community" and how much education is enough. Providers are simply told to develop a written community education plan. Again, the opportunity is ripe for providers to take up the task with enthusiasm and creativity and to shape a strategy that makes sense in their particular environment.

Provider comments to the rule, however, suggest an uneasiness about going beyond facility walls and into the community. Most facilities already do some form of education for patients, residents, family councils, or visitors to the facility, although the "education" sometimes amounts to little more than distributing brochures. Education is more than just distribution of information. But many providers have urged HCFA to keep the community education mandate at this minimal level to ensure that their existing efforts will be enough to satisfy the PSDA requirement.

Lack of receptiveness to bending in new directions suggests a problem with rust in the institutional joints. The PSDA clearly envisions a new educational effort, although the details are wisely left to providers. One of the best ways to "grease the joints" is to provide examples of initiatives that are feasible and effective. However, to set even a minimal basis for self-comparison among providers, some basic data must be generated. Unfortunately, the interim rule fails to help generate the data needed. This could be corrected if HCFA required providers to articulate at a minimum: (1) their intended target audiences; (2) the frequency of their educational efforts; (3) the expected penetration of the target population to be attained by the educational efforts; and (4) the resources and activities used in the educational program.

Covered Patients: Who Gets the Ruby Slippers?

The PSDA disclosure and documentation rights apply to all "adult" patients admitted for inpatient care. Comments to the rule raise several questions about this, the most elementary being, Who is an adult? The legal age of majority differs among states, as do criteria for emancipation. Moreover, minors are sometimes treated as "adults" under state laws for purposes of consent to certain medical treatments, such as abortions, or treatment of sexually transmitted diseases, mental health counseling, drug abuse, HIV testing, and other procedures. The regulations do not address whether these minors must be treated as adults for PSDA purposes. However, the spirit of the act would seem to dictate that providers should err on the side of being over-rather than underinclusive.

The second concern involves the meaning and consequence of "incapacity." The preamble to the interim final rule advises that if the patient is incapacitated at admission, "the facility should give advance directive information to the patient's family or surrogate ... in accordance with state law." If the patient regains capacity, the facility must then repeat the process directly with the patient. Providers want assurances that they can use maximum discretion in determining incapacity, especially with respect to psychiatric patients who are not incapacitated in a legal sense but for whom PSDA disclosures may be clinically inappropriate. Consider, for example, patients who are potentially suicidal, self-destructive, or seriously depressed. Such discretion is certainly not inconsistent with the PSDA. As in other matters, it falls back onto state law, standards, and practices regarding incapacity.

From a broader perspective, the issue is really one of appropriateness rather than capacity, and it arises with other groups of patients as well. Should PSDA mandates apply to labor and delivery patients, to frequent readmissions (for example, patients in a course of chemotherapy), to patients entering inpatient rehabilitation programs, or to critical care patients? The federal law provides no exemptions for these groups, although some flexibility can be achieved by applying a more malleable notion of the tasks to be accomplished at admission. This is discussed further in the section below on non-discrimination.

Finally, many providers criticize as too onerous the follow-up obligation with respect to incapacitated patients who later regain their capacity. Providers--especially hospitals--argue that the burden of determining and then tracking patient capacity for an indeterminate period of time for the purpose of complying with the PSDA is unduly burdensome. They believe that the initial disclosure to family or surrogates ought to be sufficient for compliance. Consumer groups, on the other hand, generally support the obligation to follow up on these patients. However, one other permutation championed by a disability group and a few providers argues that the PSDA disclosure obligation runs only to the patient and, thus, facilities bear no obligation to inform families or other surrogates while the patient is incapacitated.

Consumer advocates highlight an additional concern about incapacitation. Anecdotal evidence indicates that some providers hold the mistaken belief that, under the PSDA, guardianship must be sought for those incapacitated patients who have no clearly authorized surrogate under state law. HCFA should unequivocally dispel this notion, for the PSDA does nothing to change the need or criteria for guardianship. Indeed, a basic goal of the act is precisely to keep these cases out of the court.

Nondiscrimination: Beware the Wicked Witch!

Several related issues almost always succeed in befuddling the PSDA's prohibition against discriminating on the basis of whether the patient has an advance directive. In its simplest terms, the mandate prohibits a provider from saying, "We will admit and treat you only if you execute (or only if you do not execute) an advance directive." Providers often infer from this that they cannot express any opinion about whether it is a good idea to have an advance directive. That is a different issue, on which the PSDA is not neutral. A central purpose of enacting the PSDA was, indeed, to promote the use of advance directives. Providers can express an affirmative opinion, consistent with state law. But when providers do promote the use of advance directives, another elusive principle sometimes gets trampled upon--personal choice. Two choices are important here: the choice to execute an advance directive and the choice of what one actually says in it.

Comments on the nondiscrimination requirement come primarily from consumer groups and health professions associations, and they touch upon both types of choice. As to the choice to execute a document, consumer comments highlight serious concerns about the potential coercion inherent in the act of giving out advance directive forms at the time of admission. This is an acutely stressful time when most of us are conditioned to sign the multitude of paperwork plopped in front of us, even though we are least able to reflect upon our options. Vulnerability is greater still for persons with less than adequate education, financial resources, or family support.

As a result, some consumer advocates urge that forms not be routinely provided or executed at the time of admission. Instead, facilities should consider a two-step process. Step one, provide very basic information at admission; and step two, provide follow-up with patients who express a desire for more information through a cadre of specially trained staff. At the second stage, providing forms and assisting with their completion may be appropriate.

The choice of what to say in an advance directive is the other important choice. While most persons use advance directives to clarify conditions under which treatment is not wanted, individuals are perfectly free to direct that they want all medically appropriate treatment possible. Some consumer groups feel that HCFA and some states downplayed this latter choice.

State Descriptions of Law: Yellow Brick Pathways

The PSDA requires every state to "develop a written description of the law of the State (whether statutory or as recognized by the courts of the State) concerning advance directives that would be distributed by providers or organizations under the requirements of [the act]."[5] Summaries of this sort were nonexistent in most states prior to the PSDA. So for the first time, all states now have some official articulation of the legal pathways available to individuals to make and to plan for health care decisions.

In its preamble to the interim rule, HCFA remarks that states have some flexibility in fulfilling this requirement, particularly with respect to requiring all providers to use the same description of the law or, alternatively, to allow them to incorporate general information from the state into the provider's own package of materials. HCFA also solicited suggestions for appropriate time limits for providers to incorporate any changes in the law into their materials.

The time limit question generated a multitude of suggestions ranging from ten days to six months from the enactment of new legislation, or from the effective date of legislation, or from the issuance of significant court decisions. Most commentators recognize a need to specify a two-step time limit: one for the state to revise its description of law, and one for providers to incorporate those changes.

The flexibility question prompted consumer fears about the potential for inconsistency and inaccuracy in provider materials, with the result that consumers will be ill served. One national consumer group argues not just for a single state description requirement, but also for specific standards governing state development, review, and approval of the official description of law. Other consumer groups take a middle ground, emphasizing that if a state chooses not to utilize a single state description, then it must have in place a process for reviewing and preapproving each provider's particular version of the materials. Providers' supplementing or repackaging a single state description should not present a problem, as long as the basic state text is incorporated without change. Provider comments generally prefer flexibility in the contents of materials at the facility level, but they also seek to place responsibility for producing and updating the state descriptions squarely on the states' shoulders.

Conclusion: Finding Our Way

The regulatory process seldom if ever generates enthusiasm or a sense of collaboration and exploration among those regulated. Too often it generates defensive attitudes and minimal, mechanistic compliance. Into this milieu comes the PSDA--a "heart" statute. It exhorts providers to do good, but does not exactly tell them how. If the comments to HCFA's published rule can be taken as evidence of the success or failure of implementation, then we might conclude that providers' hearts are suffering from an understandable but unfortunate lack of courage to promote patient autonomy and pursue good medical decisionmaking in a regulatory forest filled with a fearsome mix of lions and tigers and bears. How will they gain the courage? The means, I believe, are there somewhere in the story.

[Charles P. Sabatino is assistant director of the American Bar Association's Commission on Legal Problems of the Elderly.]

References

[1.] Omnibus Budget Reconciliation Act of 1990 ("OBRA 90"), P.L. 101-508, Sections 4206 and 4751 (Medicare and Medicaid, respectively), codified at 42 U.S.C. Sections 1395cc(a) (1) (Q), 1395 mm (c) (8), 1395cc (f), 1396a (a) (57), (58), 1396a(w). Originally introduced as S. 1766 by Senators Danforth (R-MO) and Moynihan (D-NY), and as H.R. 5067 by Congressman Sander Levin (D-MI).

[2.] 57 Federal Register 8194-8204 (6 March 1992)

[3.] 42 C.F.R. section 489.102(a) (2), in 57 F.R. 8203.

[4.] 42 C.F.R. section 489.102(c) (2), in 57 F.R. 8204.

[5.] OBRA 90, at section 4751(a) (1), codified at section 1396a(a) (58).
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Title Annotation:Giving Life to Patient Self-Determination; includes related article
Author:Sabatino, Charles P.
Publication:The Hastings Center Report
Date:Jan 1, 1993
Words:3184
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