NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Center for Substance Abuse Treatment. Detoxification From Alcohol and Other Drugs. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 1995. (Treatment Improvement Protocol (TIP) Series, No. 19.)
This publication is provided for historical reference only and the information may be out of date.
A host of legal and ethical issues affect the operation of alcohol and other drug (AOD) detoxification programs. Some have to do with consent to treat. For example, staff members often deal with patients who are inebriated or intoxicated. How can they obtain a consent to enter detoxification treatment from such individuals? Are there special consent issues when the patient is a minor?
The staff of detoxification programs are also concerned about the standards of treatment that will apply, especially as managed care becomes more commonplace. Will the staff be held liable for any decisions of a managed care entity that result in harm to a patient? If an insurance carrier decides it will not cover an additional day of detoxification treatment when the program believes an additional day is necessary, what should staff members do?
In some States, detoxification programs treat patients who have been brought in involuntarily by the police or committed to treatment by the court system. What are the legal responsibilities of staff in such cases? Prisons and jails sometimes maintain detoxification units. Do special standards apply to the professionals practicing in such facilities?
Other legal and ethical issues arise during the daily operation of detoxification programs. Some programs use medications, including scheduled drugs, to help ease the detoxification process. What laws should staff be aware of with regard to the use of these medications? How should staff handle drugs that patients bring into the program when they are admitted?
Finally, additional issues arise because of the Federal laws and regulations guaranteeing confidentiality of information about patients. How can a detoxification program and the diverse agencies responsible for the patient's welfare communicate without violating these rules? How should a program, for example, gather information from other (collateral) sources, such as relatives, employers, criminal justice agencies, schools, or medical personnel? May a program contact a parent of a minor patient without the minor's consent? May a program communicate with an employer who has referred a patient to treatment? What should a program do if a patient does not want to disclose his or her treatment to an insurance carrier? Are there special rules about sharing information with criminal justice agencies? If the patient is threatening harm to him- or herself or another, may the program call the authorities? How can programs handle intoxicated patients who decide not to enter detoxification and insist on driving home? May programs call the police if a patient becomes violent? Should they report suspected child abuse or neglect?
This chapter attempts to answer these and other questions. It is divided into five sections:
- An overview of consent to treatment, standards of care, and medication and drug control
- Federal laws and regulations protecting the patient's right to confidentiality
- Rules governing the use of consent forms
- Rules governing communication of patient information
- Exceptions to rules prohibiting disclosure of patient information.
The answers to many of the questions addressed in this chapter are governed by State rather than Federal laws, and the laws vary from State to State. Consequently, while this chapter offers general advice concerning management of a patient who is too intoxicated to give informed consent, program staff who are faced with this situation should consult with a local attorney who is familiar with this area and the related issue of confidentiality. In some States, the law is still developing. As an example, a program's duty to warn of a patient's threat to harm others is constantly changing as State courts consider current cases. Programs dealing with this and other issues need up-to-the-minute legal counsel.
Consent to Treatment, Standards of Care, and Medication and Drug Control
Consent to Treatment
Adults generally have the right to consent to or to refuse treatment -- a right that is grounded in State law, judicial decision, and the United States Constitution. The right to consent to or refuse treatment -- in other words, to make an informed choice --is normally based upon a process: The treatment provider presents the patient with a diagnosis, a prognosis, a description of available alternative treatments and their risks and benefits, and a prediction of the likely outcome if there is no treatment. This process requires that the patient have the ability, sometimes called "decisional capacity," to make an informed choice.
Intoxicated or Incapacitated Patients
Detoxification programs, perhaps more than any other kind of AOD abuse treatment program, deal with patients whose capacity to make rational decisions may be impaired. Persons who are intoxicated often demonstrate diminished mental capacity. Individuals who are incapacitated by AODs may be unconscious, or their judgment may be so impaired that they are incapable of making a rational decision about their basic needs, including their need for treatment. How can detoxification programs secure consent when the patient's decisional capacity is diminished?
Staff should assess each patient in order to determine whether he or she is able to give informed consent. If a patient is not able to do so because he or she is intoxicated or incapacitated by AOD use, the program should obtain consent as soon as the patient has regained his or her faculties. In the meantime, the program may obtain consent to treat from a relative or parent, if the patient is accompanied to the program. (In obtaining consent, the program must be aware of the Federal confidentiality laws, as described later in this chapter.) The validity of a third party's consent may depend on State law.
Minor Patients
Many States have passed laws permitting minors to consent to AOD abuse treatment without parental involvement. Program staff should become familiar with the laws in their State, by consulting either with their single State agency (SSA) or an attorney familiar with the law in this area. 2
In those States that require parental consent for treatment, programs must be aware that the Federal confidentiality regulations require them to obtain a minor's consent before they contact the minor's parent (42 C.F.R. '2.14). 3 Thus, if a minor seeks treatment but refuses to authorize the program to speak to his or her parent, the program may inform the minor that it cannot provide services unless he or she consents to have the program contact the parent.
The Federal regulations do contain one exception. A program director may communicate with a minor's parents without his or her consent provided that
- The program director believes that the minor, because of extreme youth or medical condition, does not have the capacity to decide rationally whether to consent to the notification; and
- The program director believes the disclosure is necessary to cope with a substantial threat to the life or well-being of the minor or someone else.
If these two conditions do not exist, the program must explain to the minor that, while he or she has the right to refuse to consent to any communication with a parent, the program can provide no services without such communication and parental consent, §2.14(d). Section 2.14(d) applies only to applicants for services. It does not apply to minors who are already patients; their consent to communicate with their parents is always required, as explained below.
Although programs in those States that permit minors to consent to treatment do not need to be concerned about whether they may provide services, they may still have to confront the fact that, in the absence of parental consent, it may be impossible to secure payment for these services. In States where parental consent is not required for treatment, the Federal regulations permit a program to withhold services if the minor will not authorize a disclosure that the program needs in order to obtain financial reimbursement for that minor's treatment. Such a practice, however, may abridge State or local law.
Standards of Care
Managed Care and Treatment Standards
The staff members of AOD detoxification programs expect the care they provide their patients to come under the scrutiny of licensing or accrediting agencies, peer review organizations, and patient advocacy groups. With the advent of managed care, treatment providers are finding themselves under the scrutiny of a fourth group: third-party payers, who are interested not only in quality of care but also in cost containment.
Oversight by a managed care entity may be most problematic in cases where that entity disagrees with the detoxification program's judgment that a patient needs another day in the program and informs the program that it will not pay for such care. One option is for staff to explain the problem to the patient and try to obtain his or her agreement to pay for the additional day of treatment. 4 In many cases, the patient will be unable to do so. A second option is to try to arrange to have the patient admitted to a publicly funded program. A third option is to discharge the patient.
From a legal standpoint, if public care is unavailable and the patient cannot pay, programs should probably continue to treat the patient. The law in this area is unsettled. If the program discharges a patient against the judgment of its staff and the patient's outcome is adversely affected, the patient can sue the program for malpractice. This is an unfortunate situation, even if the program wins or convinces the court to place responsibility where it belongs -- on the managed care entity. Programs should also be aware that it is possible to get third-party payers to change a negative decision. Should this need arise, consultation with an attorney who can help them advocate for the patient is helpful.
Involuntary Patients
In some States, detoxification programs handle patients who are brought in by the police or by relatives or who are "involuntarily committed" to treatment by the courts. (Involuntary commitment is also known as "protective custody" and "emergency commitment.") States that place the duty to accept involuntary patients on programs often grant them immunity from criminal and civil liability. Such immunity, however, does not protect a program against a malpractice claim.
Jail or prison inmates are another group of involuntary patients. Persons who are incarcerated are entitled to adequate medical care and can sue a provider for malpractice or negligence. 5 Thus, involuntary patients are entitled to care that generally meets professional standards. Professionals who manage programs in prisons or jails or whose programs accept involuntary patients should stay abreast of standards in this area that have been developed by professional organizations and government agencies.
Medication and Drug Control
Use of Medication During Detoxification
Programs often use medications, including some scheduled drugs, to help patients through the detoxification process. Program staff must be aware of Federal and State laws and regulations governing the dispensing, storage, and inventory of all medications. These laws and regulations often require that medications be dispensed by certain classes of professionals. Separate provisions often govern the storage, prescription, and dispensing of scheduled drugs. Programs may inquire about such regulations from their SSAs and State departments of health, the Federal Drug Enforcement Administration, or the Federal Food and Drug Administration.
Drugs Brought Into the Program by Patients
Patients sometimes enter AOD detoxification with drugs on their person or in their luggage. Staff may wish to search all newly admitted patients and the belongings they bring with them. The safest approach is to tell the patient at admission that this is a standard part of the process and that he or she must agree to the search in order to enter detoxification. The program also may incorporate this notice in its admission papers, thereby ensuring that the patient agrees to it in writing.
If a staff member finds drugs on a patient or in a patient's luggage, what should the program do? State regulations sometimes govern how a program may dispose of drugs. They may require, for example, that the drugs be flushed down the toilet, destroyed, or turned over to the police. 6 (The Federal confidentiality laws and regulations, however, prohibit programs from turning patients who are in possession of drugs over to the police.) If a program does destroy drugs brought into treatment by patients, it is advisable for staff members responsible for such destruction to carry it out under observation and maintain a record of the act, so that a patient cannot later make a false accusation about what occurred. State regulations also govern the methods for handling prescription and over-the-counter medications that patients bring into treatment. Programs should check with their SSA for further guidance about State mandates.
Drugs Brought Into the Program by Visitors
Although programs cannot turn patients with illegal drugs over to the police, no such restrictions apply to visitors who enter the program facility with drugs. As long as no disclosure is made about a patient, such persons may be reported to the police. A program that plans to search visitors for drugs must obtain their consent, although it may make visiting privileges contingent on consent to search. The use of force should be avoided, as a visitor could sue the program for battery or false imprisonment.
Federal Law Protecting Patient's Right to Confidentiality
Two Federal laws (42 U.S.C. ''290dd-2 (1992) and a set of Federal regulations (C.F.R. Part 2) guarantee the strict confidentiality of information about all persons receiving AOD abuse prevention and treatment services. 7 They are designed to protect privacy rights and thereby attract individuals into treatment. The regulations are more restrictive of communications than are those governing the doctor-patient relationship or the attorney-client privilege. Violating the regulations is punishable by a fine of up to $500 for a first offense or up to $5,000 for each subsequent offense ('2.4).
Although some persons may view the restrictions that Federal regulations place on communications as a hindrance, if not a barrier, to program goals, due foresight can eliminate most of the problems that arise from the regulations. Familiarity with the regulations will facilitate communication and minimize the incidence of confidentiality-related conflicts among program, patient, and outside agency.
Types of Programs Covered by the Regulations
Any program that specializes, in whole or in part, in providing detoxification, treatment, counseling and assessment, and referral services, or a combination thereof, for patients with alcohol or other drug problems must comply with the Federal confidentiality regulations, '2.12(e). It is the kind of services provided, not the label, that determines whether a program must comply with the Federal law. Calling itself a "prevention program" does not insulate a program that also offers treatment services from the need to comply with confidentiality regulations. Although the Federal regulations apply only to programs that receive Federal assistance, the word "assistance" is broadly interpreted and includes indirect forms of Federal aid such as tax-exempt status or State or local funding that is derived, in whole or in part, from the Federal Government.
Federal Confidentiality Laws
The Federal confidentiality laws and regulations protect any information about a patient if the patient has applied for or received any alcohol- or drug-abuse-related services -- including assessment, diagnosis, detoxification, counseling, group counseling, treatment, and referral for treatment -- from a covered program. The restrictions on disclosure apply to any information that would identify the patient as an AOD abuser, either directly or by implication. The rule applies from the moment the patient makes an appointment. It applies to patients who are civilly or involuntarily committed, minor patients, patients who are mandated into treatment by the criminal justice system, and former patients. Finally, the rule applies whether or not the person making the inquiry already has the information, has other ways of getting it, enjoys official status, is authorized by State law, or comes armed with a subpoena or search warrant. 8
Conditions Under Which Confidential Information May Be Shared
Information that is protected by the Federal confidentiality regulations may always be disclosed after the patient has signed a proper consent form. (As explained earlier in this chapter, if the patient is a minor, parental consent must also be obtained in some States.) The regulations also permit disclosure without the patient's consent in several situations, including communicating information to medical personnel during a medical emergency or reporting child abuse to the authorities.
The most commonly used exception to the general rule prohibiting disclosures is for a program to obtain the patient's consent. The regulations' requirements regarding consent are somewhat unusual and strict and must be carefully followed.
Rules Governing Informed Consent
Required Items
Disclosures are permissible if a patient has signed a valid consent form that has not expired or been revoked ('2.31). 9 According to this section, a proper consent form must be in writing and must contain each of the items that appear in Exhibit E-1.
A general medical release form, or any consent form that does not contain all of the elements listed above, is not acceptable. A sample consent form may be found in Exhibit E-2. The following required items merit further explanation:
- The purpose of the disclosure
- How much and what kind of information will be disclosed.
These two items are closely related. All disclosures, especially those made pursuant to a consent form, must be limited to information that is necessary to accomplish the need for or purpose of the disclosure, '2.13(a). It would be improper to disclose everything in a patient's file if the person making the request needed only one specific piece of information.
In completing a consent form, one must determine the purpose of or need for the communication of information. Once this has been identified, it is easier to determine how much and what kind of information will be disclosed and to restrict the disclosure to what is essential to accomplish the identified need or purpose. As an illustration, if a patient needs to have the fact that he or she has entered a detoxification program verified in order to be eligible for a benefit program, the purpose of the disclosure would be "to verify treatment status," and the amount and kind of information to be disclosed would be "enrollment in treatment." The disclosure would then be limited to a statement that "Jane Doe [the patient] is receiving counseling at XYZ Program."
- The patient's right to revoke consent
The patient may revoke consent at any time, and the consent form must include a statement to this effect. Revocation need not be in writing. If a program has made a disclosure prior to the revocation, the program has "acted in reliance" on the consent and is not required to try to retrieve the information it has already disclosed.
The regulations state that acting in reliance includes providing services in reliance on a consent form permitting disclosures to a third-party payer. Thus, a program may bill the third-party payer for past services to the patient even after consent has been revoked. A program may not, however, make any disclosure to the third-party payer in order to receive reimbursement for services provided after the patient has revoked consent '2.31(a)(8).
- Expiration of the consent form
The form must also contain a date, an event, or a condition on which it will expire, if not previously revoked. A consent must last "no longer than reasonably necessary to serve the purpose for which it is given," '2.31(a)(9). If the purpose of the disclosure is expected to be accomplished in 5 or 10 days, it is better to stipulate that amount of time rather than to request a longer period or have a uniform 60- or 90-day expiration date for all forms.
The consent form may specify an event or a condition for expiration, rather than a date. For example, if a patient has been placed on probation at work on the condition that he or she attend the detoxification program, the consent form should not expire until the expected time of completion of the probationary period. Alternatively, if a patient is being referred by the program to a specialist for a single appointment, the consent form should provide that it will expire after he or she has seen "Dr. X," unless the patient is expected to need ongoing consultation with the specialist.
- Signatures of minors and parental consent
In order for a program to release information about a minor, even to his or her parent or guardian, the minor must have signed a consent form. The program must obtain the parent's signature only if it was required by State law to obtain parental permission before providing treatment to the minor ('2.14). ("Parent" includes parent, guardian, or other person legally responsible for the minor.) In other words, if State law does not require the program to get parental consent in order to provide services to a minor, parental consent is not required to make disclosures, '2.14(b). If, by contrast, State law requires parental consent to provide services to minors, parental consent also is required to make any disclosures. The program must always obtain the minor's consent for disclosures; it cannot rely on the parent's signature alone. The single limited exception to this rule has been discussed in Section I.A.2 above.
Required Notice Against Redisclosing Information
Once the consent form has been properly completed, one formal requirement remains. Any disclosure made with written patient consent must be accompanied by a written statement that the information disclosed is protected by Federal law and that the recipient may not make any further disclosure unless permitted by the regulations ('2.32). This statement, not the consent form itself, should be delivered and explained to the recipient at the time of disclosure or earlier.
The prohibition on redisclosure is clear and strict. Those who receive the notice are prohibited from rereleasing information except as permitted by the regulations. A patient may, of course, sign a consent form authorizing such a redisclosure. A sample Notice of Prohibition appears in Exhibit E-3.
Decisions Concerning Disclosure
The fact that a patient has signed a proper consent form authorizing the release of information does not force a program to make the proposed disclosure, unless the program has also received a subpoena or court order, ''2.3(b); 2.61(a)(b). The only obligation the program has is to refuse to honor a consent that is expired, deficient, or otherwise known to be revoked, false, or invalid, '2.31(c).
In most cases, the decision whether or not to make a disclosure pursuant to a consent form is within the discretion of the program, unless State law requires or prohibits disclosure once consent is given. In general, it is best to follow this rule: disclose only what is necessary, for only as long as is necessary, in light of the purpose of the communication.
Rules Governing Communication of Information
Seeking Information From Collateral and Referral Sources
Making inquiries of parents, other relatives, health care providers, employers, schools, or criminal justice agencies might seem at first glance to pose no risk to a patient's right to confidentiality, particularly if the person or entity approached for information referred the patient to treatment. Nonetheless, it does.
When a program that screens, assesses, or treats a patient asks a relative or parent, a doctor, an employer, or a school to verify information it has obtained from the patient, it is making a "patient-identifying disclosure." Patient-identifying information is information that identifies someone as an AOD abuser. In other words, when program staff seek information from other sources, they are letting these sources know that the patient has asked for detoxification services. The Federal regulations generally prohibit this kind of disclosure, unless the patient consents.
How should a program go about making such requests? The easiest way is to get the patient's consent to contact the relative, doctor, employer, school, or health care facility. When filling out the consent form, staff should give thought to the "purpose of the disclosure" and "how much and what kind of information is to be disclosed." For example, if a program is assessing a patient for treatment and seeks records from a mental health provider, the purpose of the disclosure would be "to obtain mental health treatment records to complete the assessment." The "kind of information disclosed" would be limited to a statement that "Robert Roe (the patient) is being assessed by the XYZ Program." No other information about Robert Roe would be released. If the program not only seeks records but also wishes to discuss with the mental health provider the treatment he or she provided the patient, the purpose of the disclosure would be "to discuss mental health treatment provided to Robert Roe by the mental health program." If the program merely seeks information, the kind of information disclosed would, as in the example above, be limited to a statement that "Robert Roe is being assessed by the XYZ Program;" however, if the program needs to disclose information it has gained in its assessment of Robert Roe to the mental health provider in order to further the discussion or coordinate care, the kind of information disclosed would be "assessment information about Robert Roe."
A program that routinely seeks collateral information from many sources could consider asking the patient to sign a consent form that permits it to make a disclosure for purposes of seeking information from collateral sources to any one of a number of entities or persons listed on the consent form. Such a form must still include "the name or title of the individual or the name of the organization" for each collateral source the program may contact.
Even when information is disclosed over the telephone, program staff are required to notify the recipient of the information of the prohibition on redisclosure. Mention should be made of this restriction during the conversation; for example, the staff member could say, "I'll be sending you a written statement that the information I gave you about Mr. Roe may not be redisclosed."
Communications with employers may warrant special consideration. When a patient enters treatment voluntarily, program staff should maintain an open mind about whether communications with an employer would be beneficial to the patient. A patient who tells program staff that his or her employer will not be sympathetic about the decision to enter treatment may well have an accurate picture of the employer's attitude. Should staff insist on communicating with the employer, the patient may lose his or her job. If such communication takes place without the patient's consent, the program may be faced with a lawsuit.
Communications With Insurance Carriers
Programs must obtain a patient's written consent on the form required by the Federal regulations in order to communicate with any third-party payer who may be responsible for funding the patient's treatment. What should programs do in these circumstances?
The program clearly cannot make a disclosure to a third-party payer without the patient's consent. If the third-party payer is the patient's employer, the program would not only be violating the Federal regulations Some patients do not want their treatment reported to the insurer. Patients whose employers are self-insured may fear they will be fired, demoted, or disciplined, should their employer learn they have a substance abuse problem. 10 Patients whose treatment is covered by health insurance may fear they will lose their benefits and be unable to obtain other coverage once their current insurer discovers they have been treated for a substance abuse problem. 11 but also would be risking a lawsuit, should the patient be fired or disciplined. If the third-party payer is an insurance company, the program is taking similar risks: If the patient's insurance is canceled or he or she cannot obtain coverage elsewhere, the program may face a lawsuit.
If a patient does not want the insurance carrier to be notified and is unable to pay for treatment, the program may refer the patient to a publicly funded program, if one is available. 12 Programs should consult State law to learn whether they may refuse to admit a patient who is unable to pay and who will not consent to the necessary disclosures to his or her insurance carrier.
Insurance carriers, particularly managed care entities, are demanding more and more information about the patients covered by their policies and the treatment provided to those patients. Programs need to be sensitive about the amount and kind of information they disclose, because the insurer may use this information to deny benefits to the patient. For example, if, in response to a request from the insurer, the program releases the patient's entire chart, the insurer may learn from the intake notes that the patient's substance abuse problem included both alcohol and illegal drugs. The insurer may then deny benefits, arguing that since its policy does not cover treatment for abuse of drugs other than alcohol, it will not reimburse for treatment when abuse of both alcohol and drugs is involved. As a second example, the insurer may learn that the patient began drinking at age 11 and deny benefits for a "preexisting condition." Treatment notes may contain personal information about the patient's family life that is extraneous for insurance company review, the sole purpose of which is to determine whether treatment should be covered and, if so, what kind.
Communication Among Agencies
Communication With Other Care Providers
Detoxification programs sometimes need to maintain ongoing communication with the referral source or with other professionals providing services to patients. The best way to proceed is to get the patient's consent.
In wording the consent form, one should take care to permit the kinds of communications necessary. For example, if the program will need ongoing communication with a mental health provider, the "purpose of the disclosure" would be "coordination of care for Mildred Moe;" "how much and what kind of information to be disclosed" might be "treatment status, treatment issues, progress in treatment." If the program is treating a patient who is on probation at work and whose continued employment is contingent on treatment, the "purpose of disclosure" might be "to assist the patient to comply with employer's mandates" or "supply periodic reports about treatment;" "how much and what kind of information will be disclosed" might be "progress in treatment." The kinds of information that would be disclosed in the two examples are quite different. The program might well share detailed clinical information about a patient with a mental health provider, if it would assist in coordinating care. Disclosure to an employer, by contrast, would generally be limited to a brief statement about the patient's progress in treatment. Disclosure of clinical information to an employer generally would be inappropriate.
The program should also be careful in setting the expiration date or event on which expiration of the consent form is based. A consent form with a mental health provider might expire when treatment ends, while a form permitting disclosures to an employer might expire when the patient's probationary period at work ends.
Referral for Further Treatment
When a staff member of a detoxification program refers a patient to another treatment program and makes an appointment for the patient, he or she is making a disclosure covered by the Federal regulations -- a disclosure that the patient has sought or received detoxification services. A consent form is, therefore, required. If the detoxification program is part of a larger program to which the patient is being referred, a consent form may not be necessary under the Federal rules, since there is an exception for information disclosed to staff within the same program.
Transferring Patients to the Hospital
Detoxification programs, particularly those with limited medical resources, often must transfer patients to a hospital for intensive medical management and care. How should programs handle such transfers, since they involve a disclosure of patient-identifying information?
Programs may deal with this issue in two ways. First, they may ask all patients admitted to detoxification to sign a consent form permitting disclosure to the cooperating hospital, should hospitalization be required. Second, they may take advantage of a provision in the Federal regulations that permits a program to make disclosures in a "medical emergency" to medical personnel "who have a need for information about a patient for the purpose of treating a condition which poses an immediate threat to the health of any individual." The regulations define "medical emergency" as "a condition which poses an immediate threat to the health of any individual and which requires immediate medical intervention" ('2.51). If a patient's condition requires emergency treatment, the program may use this exception to communicate with medical personnel at a hospital. Whenever a disclosure is made to cope with a medical emergency, the program must document in the patient's records the name and affiliation of the recipient of the information, the name of the individual making the disclosure, the date and time of the disclosure, and the nature of the emergency.
Mandatory Reporting to Public Health Authorities
All States require that new cases of acquired immunodeficiency syndrome be reported to public health authorities, which submit this information to the Federal Centers for Disease Control and Prevention. In some cases, they also use it for other purposes. Some States also require the reporting of new cases of human immunodeficiency virus infection. States also require reporting of certain infectious diseases, such as tuberculosis and sexually transmitted diseases. The public health authority often uses reports of infectious diseases to engage in "contact tracing," that is, finding others to whom an infected person may have spread the disease.
The types of information that must be reported and for which diseases, who must report, and the purposes to which the information is put vary from State to State. Therefore, program directors must examine their State laws to discover (1) whether they or any member of their staff is a mandated reporter, (2) when reporting is required, (3) what information must be reported and whether it includes patient-identifying information, and (4) what will be done with the information reported. 13
If State law permits the use of a code rather than a patient's name, the program may make the report without the patient's consent, since no patient-identifying information is being revealed.
If patient-identifying information must be reported, there are a number of ways programs can comply with State mandatory reporting laws without violating the Federal confidentiality regulations. They include the following:
- Obtaining consent. The easiest way to comply with a State law that mandates reporting of patient-identifying information to a public health authority is to obtain the patient's consent. The information reported by the program may not be redisclosed by the public health authority unless the consent form is drafted to permit redisclosure.
- Reporting without making a patient-identifying disclosure. If the program is part of another health care facility (e.g., a general hospital or mental health program), it can include the patient's name in reports if it does so under the name of the parent agency, as long as no information is released that would link the patient with AOD abuse treatment.
- Using a Qualified Service Organization Agreement (QSOA). A detoxification program that is required to report patients' names to a public health department also may enter into a QSOA with a general medical care facility or a laboratory that conducts testing or other services for the program. The QSOA, which is explained in detail later in this chapter, permits the detoxification program to report the names of patients to the medical care facility or laboratory, which may then report the information, including patient names, to the public heath department. However, no information is provided that would link those names with AOD abuse treatment.
- Reporting under the audit and evaluation exception. One of the exceptions to the general rule prohibiting disclosure without patient consent permits programs, under certain conditions, to disclose information to auditors and evaluators ('2.53). This provision is discussed earlier in this chapter. The U.S. Department of Health and Human Services (DHHS) has written two opinion letters that approve the use of the audit and evaluation exception to report HIV-related information to public health authorities. 14 Read together, these two letters suggest that AOD programs may report patient-identifying information even if that information will be used by the public health department to conduct contact tracing, as long as the health department does not disclose the name of the patient to the "contacts" it approaches. The letters also suggest that the public health authorities could use the information to contact the infected patient directly.
As its name implies, '2.53 is intended to permit an outside entity, such as a peer review organization or an accounting firm, to examine or copy a program's records in order to determine whether it is operating in accordance with regulations. It was not intended to permit an outside entity to gain information to perform other tasks or accomplish other social ends. The legal validity of these two letters may, therefore, be considered debatable.
Telephone Calls to Patients
If someone telephones a patient at a detoxification program, the staff may not reveal that the patient is at the program unless the program has a written consent form signed by a patient to make a disclosure to that particular caller. Given this restriction, how should a program handle telephone calls to patients? There are at least four options:
- The program can obtain the patient's written consent to accept telephone calls from particular people and consult a list of these individuals' names when the patient receives a phone call.
- If the patient has not consented to receive calls from a particular person, the staff member can put the caller on hold and ask the patient if he or she wants to speak to the caller. If the patient wants to accept the call, the patient, not the staff member, is making the disclosure that he or she is at the detoxification program. If the patient does not want to speak to the caller, the staff member must tell the caller, "I'm sorry, but I can't tell you whether Tommy Toe is here." At no time may the program reveal, even indirectly, that the person being inquired after is a patient at the program.
- The program can uniformly take messages for patients, telling all callers, "I'm sorry, but I cannot tell you if Tommy is here, but if he is I will give him this message." Again, this leaves it up to the patient whether to make a disclosure about being in treatment.
- The program can set up a "patient phone" that is answered only by patients. Since only patients would answer the telephone and give the phone number to others if the number were unlisted, the program would be making no disclosures. The program should caution patients to act discreetly and thoughtfully when handling calls for others.
Patients Mandated Into Treatment by the Criminal Justice System
Detoxification programs treating patients who are required to enter and participate in treatment as part of a criminal justice sanction must follow the Federal confidentiality rules. In addition, some special rules apply when a patient is in treatment as an official condition of probation, sentence, dismissal of charges, release from detention, or other disposition of any criminal proceeding, and information is being disclosed to the mandating agency.
A consent form or court order is still required before any disclosure may be made about an offender who is mandated into assessment or treatment. However, the rules concerning the length of time that a consent remains valid are different, and a "criminal justice system consent" may not be revoked before its expiration event or date.
The regulations require that the following factors be considered in determining how long a criminal justice system consent will remain in effect:
- The anticipated duration of treatment
- The type of criminal proceeding in which the offender is involved
- The need for treatment information in dealing with the proceeding
- When the final disposition will occur
- Anything else the patient, program, or criminal justice agency believes is relevant.
These rules allow programs to continue to use a traditional expiration condition for a consent form that once was the only one allowed, namely, "when there is a substantial change in the patient's criminal justice system status." A substantial change in status occurs whenever the patient moves from one phase of the criminal justice system to the next. For example, if a patient is on probation or parole, a change in criminal justice status would occur when the probation or parole ended, either by successful completion or revocation. Thus, the program could provide treatment or periodic reports to the probation or parole officer monitoring the patient and could even testify at a revocation hearing if it so desired, since no change in criminal justice status would occur until after that hearing. This formula appears to work well.
Concerning revocability of the consent (i.e., the conditions under which the offender can take back his or her consent), the regulations provide that the form may state that consent may not be revoked until a specified date arrives or condition occurs. The regulations permit the criminal justice system consent form to be irrevocable, so that a patient who has agreed to enter treatment in lieu of prosecution or punishment cannot later prevent the court, probation department, or other agency from monitoring his or her progress. Although a criminal justice system consent may be made irrevocable for a specified period of time, its irrevocability must end no later than the final disposition of the criminal proceeding. Thereafter, the patient may freely revoke consent.
Several other considerations relating to criminal justice system referrals are important. First, any information received by one of the eligible criminal justice agencies from a treatment program may be used by that justice agency only in connection with its official duties with respect to that particular criminal proceeding. The information may not be used in other proceedings, for other purposes, or with respect to other individuals, '2.34(d). Second, whenever possible, the judge or referring agency should require that a proper criminal justice system consent form be signed by the patient at the time he or she is referred to the treatment program. If this is not possible, the treatment program should have the patient sign a criminal justice system consent form at his or her first appointment. With a properly signed criminal justice consent form, the detoxification program can communicate with the referring criminal justice agency, even if the patient appears for assessment or treatment only once. This avoids the problems that may arise if a patient mandated into treatment does not sign a proper consent form and leaves before the assessment or treatment has been completed.
If a program fails to have the patient sign a criminal justice system form and the patient fails to complete the assessment or treatment, the program has few options when faced with a request for information from the referring criminal justice agency. The program could attempt to locate the patient and ask him or her to sign a consent form. The patient is, however, unlikely to do so. It is uncertain whether a court can issue an order to authorize the program to release information about a referred patient who has left the program in this type of case, because the regulations allow a court to order disclosure of treatment information for the purpose of investigating or prosecuting a patient for a crime only when the crime was "extremely serious." A parole or probation violation generally will not meet that criterion.
Therefore, unless the judge, criminal justice agency, or program obtains consent at the beginning of the assessment or treatment process, the program may be prevented from providing any information to the referring criminal justice agency.
If a patient referred by a criminal justice agency never applies for or receives services from the program, that fact may be communicated to the referring agency without patient consent, '2.13(c)(2). As soon as a patient has made an appointment to visit the program, a signed consent form or a court order is needed for any disclosures.
Duty To Warn
Patient Threats
For most treatment professionals, the decision whether to report a patient's threat to commit a crime is a troubling one. Many professionals believe that they have an ethical, professional, or moral obligation to prevent a crime when they are in a position to do so, particularly if the crime is a serious one. Although these issues may not arise often, programs may face questions about their "duty to warn" someone of a patient's threatened suicide, a patient's threat to harm another, or a patient's insistence on driving while impaired.
There is a developing trend in the law to require therapists who have learned that a patient presents a "serious danger of violence to another" to take "reasonable steps" to protect an intended victim. This trend started with the case of Tarasoff v. Regents of the Univ. of Cal., 17 Cal.3d 425 (1976), in which the California Supreme Court held a psychologist liable for monetary damages because he failed to warn a potential victim his patient threatened to, and then did, kill. The court ruled that if a psychologist knows that a patient poses a serious risk of violence to a particular person, the psychologist has a duty "to warn the intended victim or others likely to apprise the victim of the danger, to notify the police, or to take whatever other steps are reasonably necessary under the circumstances."
While strictly speaking the Tarasoff ruling applies only in California, courts in a number of other States have followed it in finding therapists and others liable for damages when they failed to warn a potential victim of threats disclosed during therapy by their patients. Most of these cases are limited to situations where patients threaten a specific victim; they do not generally apply where a patient makes a threat without identifying the intended target. States that have enacted laws on the subject have similarly limited the duty to warn to situations in which the identity of the potential victim has been revealed.
Faced with a potential "duty to warn" question, program staff must answer two, or sometimes three, questions:
- Is there a legal duty to warn in this particular situation under State law?
- If there is no State legal requirement to warn an intended victim or the police, does the program believe a moral obligation to warn exists?
The first question may be answered only by an attorney familiar with the law in the State in which the program operates. If the answer is "no," it is advisable to discuss the second question with a knowledgeable lawyer as well.
- If the answer to questions 1 or 2 is "yes," can the program warn the potential victim or someone likely to be able to take action without violating the Federal confidentiality regulations?
There is an apparent conflict between the Federal confidentiality requirements and the duty to warn imposed by States that have adopted the principles of the Tarasoff case. Simply put, the Federal confidentiality law and regulations prohibit a program from making the type of disclosure that Tarasoff and similar cases require, 15 unless it can do so by using one of the regulation's narrow exceptions.
When a patient threatens harm to self or another, a program has four options:
- It can go to court and request a court order authorizing the disclosure. The program must take care that the court abides by the requirements of the Federal confidentiality regulations. 16
- The program can make a disclosure that does not identify as a patient the individual who threatens to commit the crime. This can be accomplished either by making an anonymous report or, for a program that is part of an entity whose sole focus is not AOD treatment, by making the report in the larger entity's name. For example, a counselor employed by a detoxification program that is part of a mental health facility could telephone the police or the potential target of an attack, identify herself as a "counselor at the Johnson City Mental Health Clinic," and explain the risk. This would convey the vital information without identifying the patient as an alcohol or drug abuser. Counselors at freestanding detoxification units may not give the name of the program.
- The program can make a report to "medical personnel" if the threat presents a "medical emergency" that poses an immediate threat to the health of any individual and "requires immediate medical intervention" (§2.51). For example, a program could notify a private physician about a suicidal patient so that medical intervention can be arranged.
- The program can obtain the patient's consent. This may be unlikely, unless the patient is suicidal.
If none of these options is practical, what should a program do? It is, after all, confronted with conflicting moral and legal obligations. If a program believes there is clear and imminent danger to a patient or another person, it is probably prudent to report the danger to the authorities or the threatened individual. This is especially true in States that already follow the Tarasoff rule. While each case presents different questions, it is doubtful that any prosecution (or successful civil lawsuit) under the confidentiality regulations would be brought against a program or counselor who warned about potential violence when he or she believed in good faith that there was real danger to a particular individual. On the other hand, a civil lawsuit for failure to warn might well result if a threat were actually carried out. In any event, the program should try to make the warning in a manner that does not identify the individual as an AOD abuser.
As in other areas where the law is developing, programs should find a lawyer familiar with State law who can provide advice on a case-by-case basis. "Duty to warn" issues also present an area in which staff training, as well as a staff review process, may be helpful.
Driving While Impaired
Suppose that an intoxicated patient arrives at a detoxification program but decides not to enter treatment. If the patient is not in condition to drive home, what should the program do? First, it can offer the patient a ride home or taxi fare for a ride home. Second, it can maintain a room where such a person can "sleep it off." (The program would be wise to obtain the person's consent to alert his or her family.) This strategy can also be used by detoxification programs that do not admit patients who are inebriated.
What if the patient refuses both offers and leaves the premises, intending to drive home? Does the program have a duty to call the police to prevent an accident? Does it risk a lawsuit if it fails to do so? This is a question of State law.
In most States, it is unlikely that the program would be liable, particularly if it had made an effort to stop the patient from driving. As noted above, in States that follow the Tarasoff doctrine, liability has generally been limited to those situations where a patient threatens to harm a specific person. Liability has generally not been imposed in situations where a patient poses a threat to the community in general.
Liability concerns aside, the program may nonetheless believe it is obligated to call the police if its attempts to prevent the patient from driving fail. In doing so, it must take care not to violate the patient's confidentiality. For example, the program can call the police and tell them that the driver of a 1991 tan Nissan with a license number "XYZ 123," who is heading downtown from the intersection of Maple and Third streets, is not in a condition to operate a vehicle. The program should ask the police to respond immediately. The program may not tell the police that the patient has a substance abuse problem. This means it may not tell the police that the patient is impaired by alcohol or drugs and cannot reveal the program's name, since to do so would tell the police that the patient has a substance abuse problem.
In order to get the patient's license number and a description of his or her car, it may be necessary to detain the patient. If it does so, the program should avoid using force, since the patient could sue the program for battery or false imprisonment.
Dealing With Police
Programs sometimes unknowingly admit patients who are sought by the police. If the police discover that someone they are seeking is at the program and come armed with an arrest warrant, what should the program do? How should programs handle search warrants? The answers to these questions are quite different.
Arrest Warrants
An arrest warrant gives police the authority to search the program facilities; however, the program is not authorized to help the police by pointing out the offender. 17 The unfortunate result is that the confidentiality of all patients in the program may be compromised when the police enter and search for a fugitive. There is no solution to this problem, unless the police secure a court order under '2.66, which would authorize the program to disclose the identity of the patient. If the program cannot convince the police to obtain a court order, it can try to convince the patient to surrender voluntarily. (Voluntary surrender by a patient is a disclosure by the patient, not the program.) It is usually in the patient's best interest to surrender voluntarily, since arrest is probably inevitable and cooperation may positively influence the prosecutor and judge when the question of bail arises. The risk is that the patient will attempt to escape, which might expose the program to a charge of assisting unlawful escape. To reduce this possibility, the program should work with the police so that law enforcement personnel have secured the area around the program.
Search Warrants
A search warrant does not authorize the program to permit the police to enter the premises. Even if signed by a judge, a search warrant is not the kind of "court order" that the Federal regulations require before the program can allow anyone to enter and see patients or patient records when patients have not consented. Law enforcement officials are unlikely to know about the restrictions of the Federal regulations, however, and they will probably believe that a search warrant permits them to enter and search the program. What should a program do?
Presented with a search warrant, program staff should show the officer a copy of the Federal regulations and explain their restrictions. Staff can suggest that the officer obtain a court order that will authorize the program to make the disclosure called for in the search warrant. No harm will ordinarily be caused by resultant delay (although the police may not agree with this view). The program should call its lawyer and let him or her talk with the police. Failing that, a program could try to call the prosecutor who has sent the police, explain the regulations, and point out that any evidence seized without the proper court order may be excluded at trial, since it will have been seized illegally.
If none of these steps works, the program must permit the police to enter. Refusal to obey a direct order of the police may be a crime, even if the police are wrong, and forcible resistance would be unwise. If the program has made a good faith effort to convince the law enforcement authorities to pursue the proper route, it is unlikely that it would be held liable for allowing entry when argument fails.
Conclusion
Programs should develop protocols for dealing with arrest and search warrants and have a copy of the Federal regulations available at all times to show law enforcement officials. Programs should establish a relationship with an attorney who can be called upon to help in these situations. Finally, programs should reach out to law enforcement agencies before a crisis arises and work with them to develop ways of dealing with these issues. If the regulations are explained when there is no emergency and there can be no suspicion that the program is hiding anyone or anything, and a protocol is established, unpleasant confrontations may be avoided.
Reporting Criminal Activity by Patients
What should a program do when, for example, a patient tells a counselor that she intends to get her children some new clothes by shoplifting -- a crime the counselor knows she has committed many times in the past? Does the program have a duty to tell the police? Does a program have a responsibility to call the police when a patient discloses to a counselor that he or she participated in a serious crime some time in the past? What can a program do when a patient commits a crime at the program or against an employee of the program? Each of these questions requires separate analysis.
Threatened Criminal Activity
A program generally does not have a duty to warn another person or the police about a patient's intended actions, unless the patient presents a serious danger of violence to an identifiable individual. In the example above, shoplifting rarely involves violence, and it is unlikely that the counselor will know which stores are to be victimized. Petty crimes like shoplifting are important issues, but they should be dealt with therapeutically. They are not something a program should necessarily report to the police.
Past Criminal Activity
Suppose that a patient admits during a counseling session that he killed someone during a robbery 3 months ago. Does the program have a responsibility to report that?
In a situation where a program thinks it might have to report a past crime, three questions must be answered:
- Is there a legal duty under State law to report the past criminal activity to the police? The answer to this question is generally no. In most States, there is no duty to report to the police a crime committed in the past. Even those States that continue to make failure to report a crime rarely prosecute violators of the law.
- Does State law permit a counselor to report the crime to law enforcement authorities if he or she wants to? Whether or not there is a legal obligation to report past crimes to the police, State law may protect conversations between counselors of detoxification programs and their patients and may exempt counselors from any requirement to report past criminal activity by patients. Such laws are designed to protect the special counselor-patient relationship. State laws vary widely on the protection they accord communications between patients and counselors. In some States, admissions of past crimes may be considered privileged, and counselors may be prohibited from reporting them; in others, admissions may not be privileged. Moreover, each State uniquely defines the kinds of relationships protected. Whether a communication about past criminal activity is privileged (and therefore cannot be reported) may depend on the counselor's profession and whether he or she is State-licensed or certified. Any program that is concerned about this issue should ask a local attorney for an opinion letter about whether there is a duty to report and whether any counselor-patient privilege exempts counselors from that duty.
- If State law requires a report, or if it permits one and the program decides to make a report, how can the program comply with the Federal confidentiality regulations and State law? Any program that decides to make a report to law enforcement authorities about a patient's prior criminal activity must do so without violating either the Federal confidentiality regulations or State laws. It may comply with the Federal regulations by following one of the first three methods described in the discussion of duty to warn, namely:
- It can make a report in a way that does not identify the individual as a patient in a detoxification program
- If the crime is sufficiently serious, it can obtain a court order permitting it to make a report
- If the patient is an offender who has been mandated into treatment by a criminal justice agency, the program can make a report to that agency, provided it has a criminal justice system consent form signed by the patient that is worded broadly enough to allow disclosure of this sort of information.
Because of the complicated nature of this issue, any program considering reporting a patient's admission of criminal activity should seek the advice of a lawyer familiar with local law as well as the Federal regulations.
Crimes on Program Premises or Against Program Personnel
When a patient has committed or threatens to commit a crime on program premises or against program personnel, the regulations are more straightforward. They permit the program to report the crime to a law enforcement agency or to seek its assistance. Without any special authorization, the program can disclose the circumstances of the incident, including the suspect's name, address, last known whereabouts, and status as a patient at the program, §2.12(c)(5).
Reporting Child Abuse and Neglect
All 50 States have statutes requiring reporting when there is reasonable cause to believe or suspect child abuse or neglect. While many State statutes are similar, each has different rules about what kinds of conditions must be reported, who must report and when, and how reports must be made.
Most States now require not only physicians but also educators and social service workers to report child abuse. Most States require an immediate oral report, and many have toll-free numbers to facilitate reporting. Half of the States require both oral and written reports. All States extend immunity from prosecution to persons reporting child abuse and neglect. Most States provide for penalties for failure to report.
Because of the variations in State laws, programs should consult these documents to ensure that their reporting practices are in compliance. Since many State statutes require that staff report instances of abuse to administrators, who are then required to make an official report, programs concerned about this issue should establish reporting protocols under which staff may bring incidents of suspected child abuse to the attention of program administrators, who must then shoulder the responsibility to make the mandated reports.
The Federal confidentiality regulations permit programs to comply with State laws that require the reporting of child abuse and neglect. This exception to the general rule prohibiting disclosure of any information about a patient, however, applies only to initial reports of child abuse or neglect. Unless the patient consents or the appropriate court issues a special court order, programs may not respond to followup requests for information, or even to subpoenas, even if the records are sought for use in civil or criminal proceedings resulting from the program's initial report.
Conducting Research
Research about and evaluation of the efficacy of different methods of detoxification are essential if advances in treatment are to be made. But can detoxification programs share patient-identifying information with researchers and program evaluators? The confidentiality regulations do permit programs to disclose patient-identifying information to researchers, auditors, and evaluators without patient consent, providing certain safeguards are met (§§2.52, 2.53).
Research
Detoxification programs may disclose patient-identifying information to persons conducting "scientific research" if the program director determines that the researcher (1) is qualified to conduct the research, (2) has a protocol under which patient-identifying information will be kept in accordance with the regulations' security provisions (see §2.16, as described below), and (3) has provided a written statement from a group of three or more independent individuals who have reviewed the protocol and determined that it protects patients' rights. Researchers are prohibited from identifying an individual patient in any report or from otherwise disclosing any patient identities, except back to the program. 18
Audit and Evaluation
Federal, State, and local government agencies that fund or are authorized to regulate a program, private entities that fund or provide third-party payments to a program, and peer review entities performing a utilization or quality control review may review patient records on the program premises in order to conduct an audit or evaluation. 19 Any person or entity that reviews patient records to perform an audit or conduct an evaluation must agree in writing that it will use the information only to carry out the audit or evaluation and that it will redisclose patient information only (1) back to the program, (2) in accordance with a court order to investigate or prosecute the program (§2.66), or (3) to a Government agency overseeing a Medicare or Medicaid audit or evaluation, §2.53(a), (c), (d). Any other person or entity that is determined by the program director to be qualified to conduct an audit or evaluation and that agrees in writing to abide by the restrictions on redisclosure also may review patient records.
Followup Research
Research that follows patients for any period of time after they leave treatment presents a special challenge under the Federal regulations. The detoxification program, researcher, or evaluator who seeks to contact former patients to gain information about how they are faring after leaving treatment must do so without disclosing to others any information about their connection to the detoxification program. If followup contact is attempted by telephone, the caller must make sure he or she is talking to the patient before identifying himself or herself or mentioning a connection to the detoxification program. For example, asking for "Willy Woe," when his wife or child has answered the phone, and announcing that one is calling from the "ABC Detoxification Program" (or the "Drug Research Corporation") violates the regulations. The program or research agency may form another entity, without a hint of detoxification (or drugs or alcohol) in its name (e.g., Health Research, Inc.) that can contact former patients without worrying about disclosing information simply by giving its name. When a representative of such an entity calls former patients, however, care must be taken that the patient is actually on the line before revealing any connection with the detoxification program.
If followup is done by mail, the return address should not disclose any information that could lead someone seeing the envelope to conclude that the addressee had been in treatment.
Five Other Exceptions to the General Confidentiality Rule 2.
Reference has been made to other exceptions the Federal confidentiality rules make to the general rule prohibiting disclosure. Presented below are five additional categories of exceptions to the general rule.
Communications That Do Not Disclose Patient-Identifying Information
The Federal regulations permit programs to disclose information about a patient if the program reveals no patient-identifying information. Thus, a program may disclose information about a patient if that information does not identify the patient as an AOD abuser or does not verify anyone else's identification of the patient as an AOD abuser.
A program may make a disclosure that does not identify a patient in two ways. First, it may report aggregate data that give an overview of the patients served in the program or some portion of its population. For example, a program could tell the newspaper that in the last 6 months it had 43 patients, 10 female and 33 male. Second, a program may communicate information about a patient in a way that does not reveal the patient's status as a drug or alcohol abuse patient, §2.12(a)(i). For example, a program that provides services to patients with other problems or illnesses as well as alcohol or drug addiction may disclose information about a particular patient as long as the fact that the patient has a substance abuse problem is not revealed. To cite a more specific example, a counselor from a program that is part of a general hospital could call the police about a threat a patient made, as long as he or she does not disclose that the patient has an alcohol or drug abuse problem or is a patient of the detoxification program.
Programs that provide only alcohol or drug services or that provide a full range of services but are identified by the general public as drug or alcohol programs cannot disclose information that identifies a patient under this exception, since letting someone know a counselor is calling from the "XYZ Detoxification Program" will automatically identify the patient as someone who got services from the program. However, a freestanding program may sometimes make "anonymous" disclosures, that is, disclosures that do not mention the name of the program or otherwise reveal the patient's status as an alcohol or drug abuser.
Court-Ordered Disclosures
A State or Federal court may issue an authorizing order that will permit a program to make a disclosure about a patient that would otherwise be forbidden. A court may issue one of these orders, however, only after it follows certain special procedures and makes particular determinations required by the regulations. A subpoena, search warrant, or arrest warrant, even when signed by a judge, is not sufficient, standing alone, to require, or even to permit, a program to disclose information 20 (§2.61).
Before a court can issue an authorizing order, the program and any patient whose records are sought must be given notice of the application for the order and some opportunity to make an oral or a written statement to the court. 21 Generally, the application and any court order must use fictitious names for any known patient. All court proceedings in connection with the application must remain confidential, unless the patient requests otherwise, §_2.64(a), (b), 2.65, 2.66.
Before issuing an authorizing order, the court must find that there is "good cause" for the disclosure. A court may find "good cause" only if it determines that the public interest and the need for disclosure outweigh any adverse effect that the disclosure will have on the patient, the doctor-patient or counselor-patient relationship, and the effectiveness of the program's treatment services. Before it may issue an order, the court also must find that other ways of obtaining the information are unavailable or would be ineffective, §2.64(d). 22 The judge may examine the records before making a decision, §2.64(c).
There are also limits on the scope of disclosure that a court may authorize, even when it finds good cause. The disclosure must be limited to information essential to fulfill the purpose of the order and restricted to those persons who need the information for that purpose. The court also should take any other steps that are necessary to protect the patient's confidentiality, including sealing court records from public scrutiny, §2.64(e).
The court may order disclosure of "confidential communications" by a patient to the program only if the disclosure is necessary to protect against a threat to life or of serious bodily injury or to investigate or prosecute an extremely serious crime (including child abuse), or is in connection with a proceeding at which the patient has already presented evidence concerning confidential communications (§2.63).
Medical Emergencies
A program may make disclosures to public or private medical personnel "who have a need for information about a patient for the purpose of treating a condition which poses an immediate threat to the health of any individual." The regulations define "medical emergency" as a situation that poses an immediate threat to health and requires immediate medical intervention (§2.51).
The medical emergency exception permits disclosure only to medical personnel. It cannot be used as the basis for a disclosure to the police or other nonmedical personnel, including parents. Under this exception, however, a program could notify a private physician about a suicidal patient so that medical intervention could be arranged. The physician, in turn, could notify a patient's parents or other relatives, as long as no mention were made of the patient's AOD problem. Whenever a disclosure is made to cope with a medical emergency, the program must document in the patient's records the name and affiliation of the recipient of the information, the name of the individual making the disclosure, the date and time of the disclosure, and the nature of the emergency.
Qualified Service Organization Agreements
If a program routinely needs to share certain information with an outside agency that provides services to the program, it can enter into a QSOA. A QSOA (Exhibit E-4) is a written agreement between a program and a person providing services to the program, in which that person (1) acknowledges that in receiving, storing, processing or otherwise dealing with any patient records from the program, he or she is fully bound by [the Federal confidentiality] regulations; and (2) promises that, if necessary, he or she will resist in judicial proceedings any efforts to obtain access to patient records except as permitted by these regulations, §§2.11, 2.12(c)(4).
A QSOA should be used only when an agency or official outside of the program, for example, a clinical laboratory or data-processing agency, is providing a service to the program itself. An example is when laboratory analysis or data processing is performed for the program by an outside agency. A QSOA is not a substitute for individual consent in other situations. Disclosures under a QSOA must be limited to information that is needed by others so that the program can function effectively. QSOAs may not be used between programs providing alcohol and drug services
Internal Program Communications
The Federal regulations permit some information to be disclosed to individuals within the same program:
The restrictions on disclosure in these regulations do not apply to communications of information between or among personnel having a need for the information in connection with their duties that arise out of the provision of diagnosis, treatment, or referral for treatment of alcohol or drug abuse if the communications are (i) within a program or (ii) between a program and an entity that has direct administrative control over that program, §2.12(c)(3).
In other words, staff (including full- or part-time employees and unpaid volunteers) who have access to patient records because they work for or administratively direct the program may consult among themselves or otherwise share information if their substance abuse work so requires.
Does this exception allow a detoxification program that is part of a larger entity, such as a hospital, to share confidential information with others that are not part of the detoxification unit? The answer to this question is quite complicated. In brief, there are circumstances under which the detoxification unit may share information with other units that are part of the greater entity to which it belongs. Before such an internal communication system is set up within a large institution, however, it is essential that an expert in the area be consulted.
Other Requirements
Patient Notice and Access to Records
The Federal confidentiality regulations require programs to notify patients of their right to confidentiality and to give them a written summary of the regulations' requirements. The notice and summary should be handed to patients when they enter the program or shortly thereafter, §2.22(a). The regulations contain a sample notice that may be used for this purpose.
Unless State law grants the right of patient access to records, programs have the right to decide when to permit patients to view or obtain copies of their records. The Federal regulations do not require programs to obtain written consent from patients before permitting them to see their own records.
Security of Records
The Federal regulations require programs to keep written records in a secure room, locked file cabinet, safe, or other similar container. The program should establish written procedures that regulate access to and use of patient records. The program director or a single staff person should be designated to process inquiries and requests for information (§2.16).
Conclusion
Administrators and staff members of AOD detoxification programs should become thoroughly familiar with the many legal issues affecting their work. Such knowledge can prevent costly mistakes. Because legal requirements often vary by State and change over time, it is also essential that programs find a reliable source to whom they may turn for up-to-date information, advice, and training.
Footnotes
1. This appendix was written for the panel by Margaret K. Brooks, Esq.
2. For a discussion of AOD abuse treatment of adolescents and informed consent, see Dubler, N.N. Legal and ethical issues in the treatment of substance-abusing adolescents. In: Guidelines for the Treatment of Alcohol- and Other Drug-Abusing Adolescents. Rockville, Maryland: Center for Substance Abuse Treatment, 1993: 47-57. Treatment Improvement Protocol (TIP) Series Number 4.
3. Citations throughout this chapter in the form "§2..." refer to specific sections of 42 Code of Federal Regulations (C.F.R.), Part 2, Implementing the Substance Abuse and Mental Health Services Administration (42 U.S.C. §290dd-2) (1987).
4. For a discussion of procedures that programs may use to collect patient fees, see Confidentiality: A Guide to the Federal Laws and Regulations. New York: The Legal Action Center, 1991.
5. In Simmons v. City of Philadelphia, 947 F.2d 1042 (3d Cir. 1991), the mother of a man who was intoxicated when arrested and committed suicide while incarcerated successfully sued the City for failing to maintain a protocol to deal with emotionally disturbed intoxicated inmates, who comprised the majority of persons committing suicide while in prison.
6. The DEA regulations permit "any person in possession of any controlled substance and desiring or required to dispose of such substance [to] request the Special Agent in Charge of the Administration in the area in which the person is located for authority and instructions to dispose of such substance," 21 C.F.R. §1307.21(a). The regulation sets forth how such a request should be made. Subsection 1307.21(d) specifically states that the regulation "shall not be construed as affecting or altering in any way the disposal of controlled substances through procedures provided in laws and regulations adopted by any State."
7. Only patients who have "applied for or received" services from a program are protected. If a patient has not personally sought help from the program or has not yet been evaluated or counseled by a program, the program is free to discuss the patient's drug or alcohol problems with others. The Federal regulations govern from the moment the patient applies for services or the program first conducts an evaluation or begins counseling.
8. Search and arrest warrants are discussed below. For an explanation about how to deal with subpoenas, see Confidentiality: A Guide to the Federal Law and Regulations. New York: The Legal Action Center, 1995.
9. No information that is obtained from a program (even if the patient consents) may, however, be used in a criminal investigation or prosecution of a patient, unless a court order has been issued under the special circumstances set forth in §2.65 (42 U.S.C. §§290dd-2; 42 C.F.R. §2.12[a],[d]).
10. Although Federal and, in some cases, State laws may prohibit the employer from firing employees or taking other action simply because they have entered treatment, discriminatory practices against recovering people continue.
11. Some States prohibit insurance companies from discriminating against individuals who have received substance abuse treatment; however, discriminatory practices continue. Insurance companies routinely share information about policy holders. Although the Federal regulations prohibit insurance companies from sharing information from a treatment program with other carriers, that prohibition is no guarantee that such redisclosure will not take place.
12. If a patient who has signed a consent form permitting the program to make disclosures to a third-party payer later revokes his or her consent, the program can bill the third-party payer for services provided before consent was revoked. A program cannot, however, make any disclosures to the third-party payer in order to receive reimbursement for services rendered after the patient revoked consent, §2.31(a)(8).
13. If the State's reporting law is intended only to gather information for research purposes, detoxification programs can include patients' names in their reports, if the public health department complies with §2.52 of the Federal regulations. That section permits release of patient-identifying information to researchers when (1) they are qualified to conduct the research, (2) they have a research protocol to protect patient-identifying information, and a group of three or more individuals independent of the research project have reviewed the protocol and found it adequate, and (3) they agree not to redisclose patients' names or identifying information except back to the program and not to identify any patient in a report. In most cases, a department of public health will easily satisfy the first requirement. The Federal Department of Health and Human Services has suggested in opinion letters that the second requirement may not apply when the research is intended to track the incidence and causation of diseases. Thus, if the State is gathering information only for research purposes, the program can probably make reports including patients' names, if the department agrees not to redisclose patients' names or identifying information except back to the program and not to identify any patient in a report.
14. See Letter to Oklahoma State Department of Health from the Legal Adviser to the U.S. Alcohol, Drug Abuse, and Mental Health Administration, dated September 2, 1988, and Letter to the New York State Department of Health from the Acting General Counsel to the U.S. DHHS, dated May 17, 1989.
15. The regulations make it clear that Federal law overrides any State law that conflicts with the regulations (§2.20). In the only case, as of this writing, that addresses this conflict between Federal and State law (Hasenie v. United States, 541 F. Supp. 999 [D. Md. 1982]), the court ruled that the Federal confidentiality law prohibited any report.
16. Federal confidentiality statutes and regulations strictly prohibit any investigation or prosecution of a patient based on information obtained from records unless the court order exception is used (42 U.S.C. §§290dd-2(2)(C) and 42 C.F.R. §2.12(d)(1).
17. If the patient is being sought because he or she has committed a crime on program premises or against program personnel, the program can point the patient out (see section IV.I.3).
18. Two statutes (42 U.S.C. §241[d] and 21 U.S.C. §872[c]), both of which cover research into drug use, permit the Secretary of DHHS and the U.S. Attorney General, respectively, to authorize researchers to withhold the names and identities of research subjects. The statutes both state that the researcher "may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding" to identify the subjects of research for which such authorization was obtained. Such authorization is commonly called a "certificate of confidentiality." Whether or not research investigators have obtained an authorization from the Attorney General or the Secretary of DHHS, however, they must comply with the prohibitions on redisclosure discussed in this section of the chapter if they have been given access to patients' records in a federally assisted treatment program.
19. These particular entities also may copy or remove records, but only if they agree in writing to maintain patient-identifying information in accordance with the regulations' security requirements (see §2.16), to destroy all patient-identifying information when the audit or evaluation is completed, and to redisclose patient information only (1) back to the program, (2) in accordance with a court order to investigate or prosecute the program (§266), or (3) to a government agency overseeing a Medicare or Medicaid audit or evaluation, §2.53(b).
20. For information on how to deal with subpoenas, see Confidentiality: A Guide to the Federal Laws and Regulations, New York: Legal Action Center, 1991.
21. If the information is being sought to investigate or prosecute a patient, only the program need be notified (§2.65). If the information is sought to investigate or prosecute the program, no prior notice is required (§2.66).
22. If the purpose of seeking the court order is to obtain authorization to disclose information in order to investigate or prosecute a patient for a crime, the court also must find that (1) the crime involved was extremely serious, such as an act causing or threatening to cause death or serious injury; (2) the records sought are likely to contain information of significance to the investigation or prosecution; (3) there is no other practical way to obtain the information; and (4) the public interest in disclosure outweighs any actual or potential harm to the patient, the doctor-patient relationship, and the ability of the program to provide services to other patients. When law enforcement personnel seek the order, the court also must find that the program had an opportunity to be represented by independent counsel. If the program is a government entity, it must be represented by independent counsel, §2.65(d).
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