Checklist for Monitoring Alcohol and Other 

Drug Confidentiality Compliance 

Technical Assistance Publication Series

18

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Treatment

Rockwall II, 5600 Fisher Lane

Rockville, MD 20857

Introduction of TAP 18: Checklist for Monitoring Alcohol and Other Drug Confidentiality Compliance

This publication is part of the Substance Abuse Prevention and Treatment Block Grant technical 

assistance program. All material appearing in this volume except quoted passages from copyrighted 

sources is in the public domain and may be reproduced or copied without permission from the Center 

for Substance Abuse Treatment (CSAT) or the authors. Citation of the source is appreciated.

This publication was prepared under contract number 270-93-0004 from the Substance Abuse and 

Mental Health Services Administration (SAMHSA). Gayle Saunders, of CSAT, served as the 

Government project officer. 

The opinions expressed herein are the views of the authors and do not necessarily reflect the official 

position of CSAT or any other part of the U.S. Department of Health and Human Services (DHHS). 

DHHS Publication No. (SMA) 96-3083 Printed 1996 

Foreword 

The Center for Substance Abuse Treatment (CSAT) of the Substance Abuse and Mental Health 

Services Administration (SAMHSA) is pleased to present this document, Number 18 in the Technical 

Assistance Publication (TAP) series. Alcohol and drug treatment and prevention program staff and 

management, as well as State agency officials often have questions about the disclosure of

information relating to alcohol and other drug (AOD) diagnosis and treatment. This TAP is designed to 

answer some of those questions. It provides an easy-to-use checklist that should enable both AOD 

programs and State and other government monitoring agencies to quickly determine whether a 

breach of patient confidentiality has occurred under the Federal law and regulations governing patient 

confidentiality. 

This TAP is one of several products developed by the Legal Action Center pursuant to a grant by CSAT

to provide information on improving methods of collaboration between AOD treatment and prevention 

programs and State public health providers. 

Appendix B in this document is a presentation on the emerging issue of managed care and its impact 

on the confidentiality of AOD records. This is another area of concern to AOD programs and State 

government agencies. It is also an area in which these agencies are having to interact with new health 

care entities such as health maintenance organizations (HMOs). 
Nothing in this publication should be construed as authorizing or permitting any person to perform an 

act that is not permitted under the regulations governing confidentiality of substance abuse patient 

records as cited throughout these materials, or by any other Federal or State laws. 

David J. Mactas 

Director

Center for Substance Abuse Treatment

Introduction 

The Federal alcohol and other drug (AOD) confidentiality law requires covered programs to strictly 

maintain the confidentiality of AOD patient records. The law (42 U.S.C. § 290dd-2) and its 

accompanying regulations (42 C.F.R. Part 2, referred to in this guide as "the regulations" came about 

through Congress' recognition that safeguards on privacy serve the important purpose of encouraging 

persons to seek AOD dependence care by preventing the disclosure of information related to their AOD 

diagnosis and treatment, which could stigmatize them in their communities. 

Although remarkably effective, the laws are also complex. Questions about which disclosures are and 

are not permissible sometimes confuse AOD treatment programs and the State agencies responsible 

for funding and evaluating them. This guideline is designed to alleviate some of that confusion. It 

provides an easy-to-use checklist that should enable the compliance personnel of both AOD programs 

and State and other government monitoring agencies to quickly determine whether complaints 

alleging a breach of patient confidentiality are justified under the Federal confidentiality law. 

Two important caveats apply. First, this checklist should only be consulted to determine 

whether a prior disclosure complied with the law. It should not be consulted to determine 

whether to make a disclosure in the first instance. For such decisions, programs and State agency 

staff should consult more detailed analyses of the Federal regulations, such as that contained in the 

Legal Action Center's book, Confidentiality: A Guide to the Federal Law and Regulations. Because the 

checklist is written in summary form (hence its easy-to-use style), sole reliance on it could result in 

inadvertent breaches of the regulations. 

The second caveat is that when using the checklist for its intended purpose–to evaluate whether prior 

communications complied with the law–compliance personnel should consult more detailed 

analyses in order to understand the nuances of the law. In short, the checklist provides a 

conceptual framework and the basic principles to guide compliance personnel. In complex cases, 

compliance personnel should consult a more comprehensive source. 

The best way to use the guide is as follows. In all instances, consult Sections I and II first. Begin with 

Section I to determine whether the regulations even apply to the alleged confidentiality violation. For 

example, was the alleged breach by a "program" and about a "patient" as those terms are defined in 

the regulations? Second, consult Section II to determine whether a "disclosure" of patient-identifying 

information was made. Only after concluding that the regulations apply (Section I) and that a 

disclosure of patient-identifying information was made (Section II), will one need to consult Sections 

III-V to determine whether the disclosure was authorized under the regulations. Sections III: A–I 

cover nearly all of the rules (sometimes called "exceptions") that authorize AOD programs to disclose 

patient-identifying information. Compliance personnel first should consult those rules that most likely 

apply. If a rule applies, one need not go further. The communication was legal under the regulations. 

If a rule does not apply, consult other rules to see if they apply. Section III does not cover absolutely 

every rule in the regulations. For example, it omits discussion of the rules about reporting vital 

statistics (§ 2.15(b)) and central registries for methadone and detoxification programs (§ 2.34). 

Compliance personnel should consult the regulations directly for any rules not covered by this 

checklist. Section IV discusses search and arrest warrants, which are related to the discussion in 

Section IV–I. The two sections should be read in tandem. Finally, Section V discusses the regulations 

as they apply to persons who are not formally part of an AOD program but who nevertheless are 
bound by the regulations because they received patient-identifying information from an AOD program 

in circumstances authorized by the regulations. 

Within each section and its subparts, there is a checklist that the user can follow to ascertain whether 

the disclosure complied with the law, followed by a summary of the rule. 

In using the guide, bear in mind that in addition to the Federal law, many States may have 

laws and regulations that govern the confidentiality of AOD information. Make sure that you 

are familiar with such State laws; this guide does not incorporate them. 

Most States also have laws governing the confidentiality of HIV-related information (HIV confidentiality 

is determined only by State law; there is no Federal HIV confidentiality law), as well as the 

confidentiality of mental health and medical records. This guide does not address those State laws. 

Thus, even if a disclosure complies with the Federal AOD confidentiality law, compliance personnel 

might also choose to determine whether the disclosure violates any State confidentiality laws (e.g., 

those pertaining to AOD, HIV, mental health, or medical records). 

For instances in which a State's confidentiality law (AOD or otherwise) is more restrictive than the 

Federal law, a program must follow the stricter State law. For example, if a program has disclosed a 

patient's HIV status after the patient has signed a consent form that is proper under the Federal AOD 

confidentiality law, compliance personnel must also determine whether the State imposes any 

additional requirements for disclosing HIV-related information (e.g., a special HIV consent form). 

For instances in which a State's confidentiality law or any other State law is less protective of 

confidentiality than the Federal law, however, the Federal law controls. For example, if a State law 

mandates a program to notify parents about certain conduct by minor patients, but the Federal 

regulations absolutely prohibit such disclosure, the program cannot make the disclosure; the Federal 

law controls. However, there is usually a way to disclose properly under the Federal law, for example, 

by obtaining patient consent or a court order that meets the Federal requirements. Accordingly, there 

is rarely an irreconcilable conflict with State law. 

In addition, under 45 C.F.R. Part 96.132(e), States that receive Federal block grant funding for AOD 

treatment services, are required to: 

have in effect a system to protect from inappropriate disclosure patient records maintained by 

the State in connection with an activity funded under the program involved or by any entity 

which is receiving amounts from the grant and such system shall be in compliance with all 

applicable State and Federal laws and regulations including 42 CFR part 2. This system shall 

include provisions for employee education on the confidentiality requirements and the fact that 

disciplinary action may occur upon inappropriate disclosures. This requirement cannot be 

waived. 

Checklist for Monitoring Alcohol and Other 

Drug Confidentiality Compliance 

I. DOES 42 C.F.R. PART 2 APPLY?

A. WAS THE ALLEGED DISCLOSURE MADE BY A "PROGRAM"?
Issue: Is the individual or entity that made the alleged disclosure a "program" covered by 42 

C.F.R. Part 2?

1. Does the individual or entity that allegedly made the disclosure receive Federal 

financial assistance in any one of the following ways:

direct Federal funding; Y__ N__

is operated by the Federal Government or by a State or local government that 

receives funds that could be (but are not necessarily) spent for the alcohol 

and other drug (AOD) program; Y__ N__ 

Federal block grants or other funds channeled through State or local 

government; Y__ N__

licensure, certification, or registration by the Federal Government, for 

example: Y__N__

–authorization to conduct methadone maintenance treatment; 

–certification for Medicare reimbursement; or 

–authorization to dispense a substance under the Controlled Substances Act for use in treating 

AOD abuse. 

exemption from Federal taxation? Y__ N__

If the answer to any of the questions is "yes," go to question 2. 

If the answer to all of the questions is "no," the individual or entity that allegedly made the 

disclosure is not a "program" as defined by the regualtions. Go to question 7 to determine 

whether the entity is otherwise bound by the regulations.

2. Was the alleged disclosure made by a general medical care facility or a unit of a 

general medical care facility? Y__ N__ 

If "yes," go to question 3.

If "no," go to question 6. 

3. Does the general medical care facility (or unit of such facility) that allegedly made 

the disclosure hold itself out as providing and actually provide AOD abuse diagnosis, 

treatment, counseling, or referral for treatment? Y__ N__ 

If "yes," go to question 8.

If "no," go to question 4.
4. Was the alleged disclosure made by a staff member of a general medical care facility 

whose primary function is the provision of AOD abuse diagnosis, counseling, 

treatment, or referral for treatment? Y__ N__ 

If "yes," go to question 5. 

If "no," the alleged disclosure was not made by a "program" as defined by the regulations. Go 

to question 7 to determine whether the regulations otherwise apply.

5. Is such staff member identified as having the primary function of providing AOD 

abuse diagnosis, counseling, treatment, or referral for treatment? Y__ N__ 

If "yes," go to question 8. 

If "no," the individual who made the alleged disclosure is not a "program" as defined by the 

regulations. Go to question 7 to determine whether the individual is otherwise bound by the 

regulations. 

6. Was the alleged disclosure made by an individual or entity that holds itself out as 

providing and does provide AOD abuse diagnosis, treatment, counseling, or referral 

for treatment? Y__N__ 

If "yes," go to question 8. 

If "no," the individual or entity that made the alleged disclosure is not a "program" as defined 

by the regulations. Go to question 7 to determine whether the regulations otherwise apply. 

7. Does State law, regulation, or licensing requirement bind the individual or entity to 

the standards of 42 C.F.R. Part 2? Y__ N__ 

If "yes," the individual or entity that allegedly made the disclosure should be considered a 

"program" bound by the regulations. Go to Section I.B. 

If "no," see Section V to determine whether the individual or entity that allegedly made the 

disclosure is otherwise bound by the regulations because it received patient-identifying 

information from an AOD program. 

8. Was the information that was allegedly disclosed maintained in connection with the 

Department of Veterans Affairs' provision of hospital care, nursing home care, 

domiciliary care and medical services under Title 38 of the U.S. Code? Y__ N__ 

If "yes," the regulations do not apply. Consult 38 U.S.C. 4132 and the regulations issued 

under that authority by the Secretary of Veterans Affairs. 

If "no," go to question 9.

9. Was the information that was allegedly disclosed obtained by any component of the 

Armed Forces during a period when the patient was subject to the Uniform Code of 

Military Justice? Y__ N__ 

If "yes," go to question 10. 

If "no," the individual or entity that made the alleged disclosure is a "program." Go to Section 

I.B. 

10. Was the alleged disclosure made within the Armed Forces or between the Armed 

Forces and those components of the Department of Veterans Affairs furnishing health 

care to veterans? Y__ N__
If "yes," stop here because the individual or entity that made the alleged disclosure is not a 

"program" under the regulations. The regulations do not apply.

If "no," the individual or entity that made the alleged disclosure is a "program." Go to Section 

I.B.

Summary of the Rule

The Federal regulations only apply to "programs" as defined under the law (§ 2.11). "programs" are 

organizations or individual practitioners who: 

a. receive Federal assistance—Such assistance exists when the program is directly 

funded by the Federal Government, is operated by the Federal Government or by a 

State or local government that receives Federal funds that could be (but are not 

necessarily) spent for the AOD program, is registered or certified by the Federal 

Government (e.g., certified for Medicare reimbursement), receives Federal block 

grant or other funds through a State or local government, is licensed directly by the 

Federal Government (e.g., to dispense methadone), or is exempted from taxes under 

the Federal Internal Revenue Code (i.e., is a not-for-profit tax-exempt corporation); 

and 

b. provide and hold themselves out as providing AOD diagnosis, counseling, 

treatment, or referral for treatment. The regulations apply to both free-standing 

programs and programs that are part of larger organizations, such as a detoxification 

unit within a general hospital, an AOD clinic within a county mental health 

department, an AOD unit within an employee assistance program or student 

assistance program, or an AOD program within a managed care program that 

provides direct medical services (§ 2.12(e)(1)). 

With respect to general medical care facilities, in addition to identified AOD units, the 

regulations apply to medical personnel or other staff whose primary function is the provision of 

AOD abuse diagnosis, counseling, treatment, or referral for treatment and who are identified 

as such (§ 2.11). The regulations do not apply, however, to hospital emergency room 

personnel unless their primary function is the provision of the AOD services listed in number 2 

above and the person is identified as providing such services or the emergency room has 

promoted itself to the community as a provider of such services (§ 2.12). 

The regulations apply to all program employees, volunteers, student interns, former staff, and 

executive, administrative, clinical, and support personnel. 

The regulations do not apply to information on AOD patients maintained in connection with 

various Department of Veterans Affairs programs or to information maintained by the Armed 

Forces if the disclosures are within the Armed Forces or between the Armed Forces and the 

Department of Veterans Affairs (§ 2.12(c)(1)-(2)). 

Some States have enacted laws or regulations that require certain AOD facilities to adhere to 

the requirements of the Federal regulations even if they are not otherwise bound by them. 

Moreover, some third parties (entities that are not AOD programs) may become bound by the 

regulations if they receive patient-identifying information from an AOD program. See Section V 

for a discussion of such third parties.

B. DOES THE COMPLAINT PERTAIN TO A "PATIENT"?

Issue:Is the person whose confidentiality allegedly was breached a "patient." whose records 

are confidential under 42 C.F.R. Part 2? 
1. Did the person whose confidentiality was allegedly breached ever apply for or receive 

from an AOD program any of the following: 

a diagnostic examination or interview?Y__N__

treatment or counseling? or Y__N__

referral for treatment? Y__ N__ 

If the answer to any of the questions is "yes," he or she is a "patient" protected by the 

regulations. Go to Section II. 

If the answer to all of the questions is no, then he or she is not a "patient." Stop here because 

the regulations do not apply.

Summary of the Rule

Even if the alleged disclosure was made by a "program," the regulations only apply if the person 

whose confidentiality allegedly was breached was a "patient." A "patient." is anyone who has applied 

for or received a diagnostic examination or interview, counseling, treatment, or referral for treatment 

for AOD abuse from a program (§ 2.11). 

Applicants for such AOD services are covered by the regulations even if they fail to show for an initial 

appointment that they arranged or, having been interviewed or diagnosed, elect not to follow up or 

enter treatment. 

The regulations protect current, former, and deceased patients. 

II.WAS THERE A "DISCLOSURE" OF PATIENT-IDENTIFYING INFORMATION?

Issue:Did the disclosure reveal "patient-identifying information?"

1. Did the person making the disclosure indicate that:

he or she was from an AOD abuse program? or Y__ N__

the person about whom the disclosure was made was an AOD abuser or had 

ever applied for or received diagnosis, treatment, counseling, or referral for 

treatment? Y__ N__ 

If the answer to both questions is "no," the program did not make a "disclosure" of patient 

identifying information. Stop here because there was no violation. 

If the answer to either question is "yes," go to question 2.

2. Did the person making the disclosure state the name of the patient or reveal other 

information from which the patient could be identified? Y__ N__ 
If "yes," there was a "disclosure" of patient-identifying information. Go to Section III to 

determine whether the disclosure was authorized. 

If "no," there was no "disclosure" of patient-identifying information. Stop here because there 

was no violation. 

Summary of the Rule

The Federal regulations generally prohibit programs from disclosing "patient-identifying information." 

"Patient-identifying information" means any information that identifies a patient as (i) having applied 

for or received AOD-related services (diagnosis, treatment, counseling, or referral for treatment), or 

(ii) being an AOD abuser (§ 2.11, 2.12). 

By prohibiting "disclosures," the regulations do not merely refer to explicit statements, such as that a 

specified person is a patient or is an AOD abuser. Rather, the term "disclosure" includes implicit 

disclosures, such as the following: 

allowing a receptionist to confirm that a particular person is a patient, even if the 

caller or visitor says that he or she is the patient's family member and knows the 

patient attends the program;

sending a patient a letter in an envelope that suggests that the addressee may be a 

patient;

faxing a letter revealing or suggesting patient status to the patient's workplace, on 

the program's stationary;

faxing any patient-identifying information about a patient to the wrong fax number; 

leaving a telephone message revealing or suggesting patient status with a patient's 

roommate or on a patient's answering machine where another person may hear the 

message; 

disclosing the patient's name and the fact that the patient attended a program to a 

bill collection agency, attorney, or a small claims court;

having a program counselor appear at a patient's workplace or home and revealing 

his or her relationship with the patient to someone else; 

disclosing descriptive or anecdotal material from which a patient's identity may be 

inferred (e.g., by referring to a patient as "the Mayor's daughter");

producing and identifying a patient when the police arrive at the program with an 

arrest warrant, but without a valid court order; and

permitting the police to have access to patient records, without first protesting, when 

the police arrive at the program with a search warrant, but without a valid court 

order. 

The general prohibition against disclosing "patient-identifying information" does not mean that 

programs may never disclose their patients' names. If a program can disclose a patient's 

name, address, or even telephone number without indicating that the person has ever applied 

for or received AOD-related diagnosis, treatment or counseling, the program may do so 
without violating the Federal regulations. Such disclosures are possible primarily when the 

program is part of a larger organization, such as a general hospital, and, therefore, can use 

the name of the hospital when making the disclosure. Similarly, if a program has a physician 

who also maintains a separate office, the physician could make a disclosure about a patient 

without identifying the patient's participation in an AOD program. (In doing so, however, 

providers must be mindful not to violate State laws regarding doctor– or therapist–patient 

privilege.)

Another way to avoid disclosing patient-identifying information is to make a disclosure 

anonymously. Thus, if a patient threatened to harm his or her spouse, and a court order, 

consent form or other authorization under the regulations could not be feasibly used, the 

program could make an anonymous telephone call to the spouse or even the police. The 

program could disclose the patient's name but not the fact that the patient is in an AOD 

program. Again, the program should be careful not to violate any State laws regarding 

confidential communications between therapists and patients.

III. IF THERE WAS A DISCLOSURE, WAS THERE PROPER AUTHORIZATION?

A.CONSENT FORMS

Issue: Was the disclosure authorized by a valid consent form? 

1. Did the consent form contain all the following nine required elements of 42 C.F.R. 

Part 2? 

patient's name? Y__ N__

name of the program making the disclosure? Y__ N__

recipient of the information? Y__ N__

purpose of the disclosure? Y__ N__

information to be released? Y__ N__ 

revocation clause? Y__ N__

If "no," was the patient mandated into the program by the criminal justice system as a 

condition of the disposition of the patient's criminal proceeding? Y__ N__ 

If "yes," the consent can be irrevocable for the duration of the patient's criminal justice status 

(unless a State statute provides for an automatic expiration). Mark "O.K." in the "yes" blank 

next to "revocation clause," above. If "no," the consent must state that it is revocable. If it 

does not so state, check "no" in the blank next to "revocation clause," above. 
expiration date or condition? Y__ N__

date the consent form is signed? Y__ N__ 

signature of the actual patient (as opposed to the patient's parent or legal 

representative)?

If "yes" (meaning that you marked "yes" or "O.K." next to all of the nine elements), go to 

question 1-a.

If "no," (meaning that at least one "no," was checked next to the nine elements, without a 

corresponding "O.K."), go to question 2. 

a. Is the patient a minor? Y__ N__

If "yes," go to question 8. 

If "no," go to question 11. 

2. Was any element missing from the consent form aside from the patient's signature? 

Y__ N__

If "yes," the consent form is not valid. Stop here or determine whether the disclosure was 

otherwise authorized. 

If "no," go to question 3.

3. Has the patient been adjudicated incompetent? Y__ N__

If "yes," go to question 3-a.

If "no," go to question 4.

a. Is the form signed by the patient's guardian or other person authorized under state 

law to act on the patient's behalf? Y__ N__

If "yes," go to question 11.

If "no," the consent form is not valid. Stop here or determine whether the disclosure was 

otherwise authorized.

4. Is the patient deceased? Y__ N__

If "yes," go to question 4-a.

If "no," go to question 5.

a. Is the form signed by the executor or administrator of the patient's estate or other 

personal representative appointed under State law or, if none, then the patient's 

spouse or, if none, then by any responsible member of the patient's family? Y__ N__ 

If "yes," go to question 11.
If "no," the consent form is not valid. Stop here or determine whether the disclosure was 

otherwise authorized. 

5. Is the patient is a minor? Y__ N__

If "yes," go to question 6.

If "no," the consent form is not valid. Stop here or determine whether the disclosure was 

otherwise authorized.

6. Was the disclosure made to the minor's parent, guardian, or other person authorized 

under State law to act on the minor's behalf? Y__ N__

If "yes," go to question 7.

If "no," the disclosure was not authorized under the consent rule. Stop here or determine 

whether the disclosure was otherwise authorized. 

7. Is the patient a minor who was applying for services (as opposed to receiving 

services), and the program director determined that the minor applicant:

(a) lacked capacity to make rational decision on whether to consent to the disclosure and

(b)that the applicant's situation posed a substantial threat to the life or physical well-being of 

the applicant or any other individual that could be reduced by communicating relevant facts to 

the minor's parent, guardian, or other person authorized under State law to act on the minor's 

behalf? Y__ N__

If "yes," the disclosure was authorized by the regulations because the minor's consent was not 

necessary. 

If "no," the disclosure was not authorized under the consent rule because other than the 

narrow exception covered in this question, minors must always sign consent forms. Stop here 

or determine whether the disclosure was otherwise authorized.

8. Does the State require parental consent for treatment? Y__ N__ 

If "yes," go to question 9.

If "no," the consent form need only be signed by the minor. The disclosure was authorized 

under the consent rule.

9. Was the disclosure made to the minor's parent, guardian, or other person authorized 

under State law to act on the minor's behalf? Y__ N__ 

If "yes," the disclosure was authorized under the consent rule.

If "no," go to question 10.

10. Did the consent form also contain the signature of the parent, guardian, or other

person authorized under State law to act on the minor's behalf? Y__ N__ 

If "yes," go to question 11.

If "no," the disclosure was not authorized under the consent rule. Stop here or determine 

whether the disclosure was otherwise authorized.

11. Does the person whose confidentiality was allegedly breached (or other signatories 

on the consent form) claim to have revoked his or her consent, either through an 

oral or written revocation? Y__ N__
If "yes," go to question 12.

If "no," go to question 15.

12. Was the patient mandated into treatment by the criminal justice system as a 

condition of the disposition of the patient's criminal proceeding? Y__ N__ 

If "yes," go to question 13.

If "no," go to question 14.

13. Does the consent form state that it is irrevocable for a specified period of time? Y__ 

N__ 

If "yes," any purported revocation was not valid. Go to question 15.

If "no," go to question 14.

14. Is there any written evidence of such revocation, for example, a notation to that 

effect on the consent form or elsewhere in the patient's record, or a letter written by 

the patient? Y__ N__

If "yes," and yet the disclosure was made, the disclosure did not fall under the "consent" rule. 

Stop here or determine whether the disclosure was otherwise authorized.

If "no," there should be further investigation to determine whether the patient in fact revoked 

his or her consent. If the investigation reveals that such revocation did occur, then the 

disclosure did not fall under the "consent" rule. Stop here or determine whether the disclosure 

was otherwise authorized. If the investigation reveals that there was no revocation, go to 

question 15.

15. Was any information on the consent form added or altered after the patient 

signed it? Y__ N__

If "yes," go to question 16.

If "no," go to question 17.

16. Did the patient initial or otherwise give written authorization for the additions or 

changes? Y__ N__

If "yes," go to question 17.

If "no," the consent form is not valid. Stop here or determine whether the disclosure was 

otherwise authorized.

17. Was the disclosure within the scope of the consent form? Y__ N__

If "yes," go to question 18.

If "no," the disclosure was not authorized by the consent rule. Stop here or determine whether 

the disclosure was otherwise authorized. 

18. Was the disclosure followed by a notice prohibiting redisclosure? Y__ N__

If "yes," the disclosure was authorized by the consent rule.

If "no," the disclosure was not authorized by the consent rule. Stop here or determine whether 

the disclosure was otherwise authorized.

Summary of the Rule 
Generally, a program may disclose any information about a patient if the patient authorizes the 

disclosure by signing a valid consent form ('§ 2.31, 2.33). A consent form under the Federal 

regulations is much more detailed than a general medical release. It must contain all of the following 

nine elements. If the form is missing even one of these elements, it is not valid: 

the name of the patient;

the name or general designation of the program making the disclosure;

the recipient of the information;

o Although the recipient should not be as general as an entire agency or 

department, it need not be as specific as the name of an individual. Instead, 

the consent form may describe the recipient's job title and/or job functions.

o It is permissible to list more than one recipient on a single consent form and 

to authorize disclosures between and among all the parties listed. When doing 

such multiple-party consents, however, it is important that the "information" 

and "purpose" and all other elements of the form (see below) be the same for 

all of the authorized disclosures.

the purpose of the disclosure;

The purpose should be narrowly described and should correspond with the information to be 

released. The purpose should never be as broad as "for all client care."

the information to be released; 

The information should be described as exactly and narrowly as possible in light of the 

purpose of the release. Releases for "any and all pertinent information" are not valid; 

that the patient understands that he or she may revoke the consent at any time—

orally or in writing—except to the extent that action has been taken in reliance on it; 

o A consent for a patient referred by the criminal justice system, however, may 

be made irrevocable for a period of time (§ 2.35). (But note that some State 

statutes and regulations provide for the automatic expiration of such consents 

after 60 or 90 days.)

o When a patient revokes a consent form, the program is advised to note the 

date of the revocation clearly on the consent form and to draw an X through 

the form. 

the date or condition upon which the consent expires, if it has not been revoked 

earlier; 

o Although the Federal regulations do not provide for any time limit on the 

validity of a consent form, some State laws provide for the automatic 

expiration of consents after a certain period of time.

the date the consent form is signed; and
the signature of the patient.

o If the patient has died, the executor or administrator of the estate, or if there 

is none, the spouse or, if none, then any responsible member of the patient's 

family may sign (§ 2.15(b)(2)). 

o No consent is needed to disclose information relating to the cause of death to 

such agencies as are empowered to collect vital statistics or inquire into 

causes of death (§ 2.15(b)(1)). 

o If the patient is an adjudicated incompetent, a guardian or other person 

authorized by State law to act on the patient's behalf may sign (§ 

2.15(a)(1)).

o If the patient is a minor, the patient generally must sign the consent form—

even if the disclosure is to the minor's parent. 

For example, if State law requires a program to obtain a parent's consent in order to 

treat a minor, the minor must sign a consent form authorizing the disclosure to the 

parent (§ 2.14(b)-(c)). The only exception is for minors who are applying for AOD 

services and yet lack the capacity to make a rational decision about whether to sign a 

consent form authorizing a disclosure that the program director determines is 

necessary to reduce a threat to the life or physical well-being of the applicant or 

anyone else (§ 2.14(d)).

In addition to the minor's signature, the parent's or other legal guardian's signature is 

only required if State law requires parental authorization for treating a minor. If the 

State permits the minor to be treated without the legal guardian's authorization, the 

minor's signature alone may authorize a disclosure (§ 2.14(b)-(c)).

o A client should never sign or be requested to sign a consent form before all of 

the blanks have been filled in.

o If any changes are made to a consent form after a client signs it, the client 

should initial the changes when they are made to indicate that the patient 

understands and agrees to the changes. 

Whenever a disclosure is made pursuant to a consent, it must be accompanied by a 

written notice prohibiting redisclosure (§ 2.32). The written statement, which can be in 

the form of a separate sheet of paper or a rubber stamp on the disclosed document, 

warns the recipient that the information disclosed is protected by Federal law and may 

not be redisclosed except with the patient's consent or under other authorization. The 

language in the warning must be identical to that set forth in § 2.32 of the regulations. 

The prohibition on redisclosure notice must be sent to the recipient even if the 

disclosure was made orally. 

Copies of all consent forms should be kept in the patient's file. 

B. INTERNAL COMMUNICATIONS

Issue: Was the disclosure an authorized internal communication? 

1. Was the disclosure made to someone: 
within the program? or Y__ N__

in an entity having direct administrative control over a program? Y__ N__

If the answer to either question is "yes," go to question 2. 

If the answer to both questions is "no," the disclosure did not fall within the internal 

communications rule. Stop here or determine whether the disclosure was otherwise 

authorized. 

2. Did the recipient need the information in connection with his or her duties arising out 

of the provision of AOD abuse diagnosis, counseling, treatment, or referral for 

treatment? Y__ N__

If "yes," the disclosure was authorized by the internal communications rule. (If the disclosure 

was made to an entity having direct administrative control over a program, see Section V to 

determine whether the administrative entity complied with the law.) 

If "no," the disclosure did not fall within the internal communications rule. Stop here or 

determine whether the disclosure was otherwise authorized.

Summary of the Rule 

Patient-identifying information may be disclosed within a program, or to an entity having direct 

administrative control over a program, if the recipient of the disclosure needs the information in 

connection with his or her duties arising out of the provision of AOD abuse diagnosis, counseling, 

treatment, or referral for treatment (§ 2.12(c)(3)). 

"Within the program" means within the organization or organizational unit that provides AOD-related 

services. Thus for entities that only provide AOD treatment in part, they may only share patientidentifying information within that part. For example, the staff of a detoxification unit within a hospital 

may share patient-identifying information with one another—and with hospital administrators with 

direct supervisory oversight for the program—where such sharing of information is needed to provide 

AOD-related services to the program's patients. The program may also share information, as 

necessary, with, for example, the hospital's recordkeeping or billing departments, because those 

administrative units are integral to the program's functioning. However, the program may not freely 

share patient-identifying information with other parts or units of the hospital (because they are not 

part of the "program" or an entity with direct administrative control over the program). Note, 

however, that such communications are possible with the patient's proper consent (see Section I.A). 

Anyone within or in direct administrative control of a program that receives patient-identifying 

information is bound by the confidentiality regulations and may not redisclose the information except 

as allowed by the regulations (§ 2.12(d)(2)(ii)).

C. QUALIFIED SERVICE ORGANIZATION AGREEMENTS

Issue: Was the disclosure made pursuant to a qualified service organization agreement (QSOA)?

1. Was the alleged disclosure made to an entity (individual or agency) that provides 

services to the program (a "service organization")? Y__ N__ 

If "yes," go to question 2. 

If "no," the disclosure did not fall within the QSOA rule. Stop here or determine whether the 

disclosure was otherwise authorized. 
2. Did the outside service organization have a written agreement with the program (a 

"QSOA")? Y__ N__ 

If "yes," go to question 3. 

If "no," the disclosure did not fall under the QSOA rule. Stop here or determine whether the 

disclosure was otherwise authorized. 

3. Did the QSOA state that in receiving patient-identifying information, the qualified 

service organization: 

became bound by the Federal confidentiality regulations? and Y__ N__ 

agreed to resist in judicial proceedings, if necessary, any unauthorized efforts 

to obtain access to patient records? Y__ N__ 

If the answer to both questions is "yes," go to question 4. 

If the answer to either question is "no," the QSOA was not valid. Stop here or determine 

whether the disclosure was otherwise authorized. 

4. Was the service organization that received the information also an AOD program? 

Y__ N__ 

If "yes," go to question 5. 

If "no," the program's disclosure was authorized by the QSOA rule. (See Section V to 

determine whether the qualified service organization redisclosed the information in violation of 

the regulations.) 

5. Did the service organization that is also an AOD program need the information to 

perform an AOD-related service? Y__ N__ 

If "yes," the QSOA was not proper, according to a legal opinion issued by the Department of 

Health and Human Services (DHHS). Stop here or determine whether the disclosure was 

otherwise authorized. 

If "no," the program's disclosure was authorized by the QSOA rule. (See Section V to 

determine whether the qualified service organization redisclosed the information in violation of 

the regulations.) 

Summary of the Rule 

Programs may disclose patient-identifying information to a "qualified service organization" without the 

patient's consent (§ 2.12(c)(4)). A "qualified service organization" is a person or agency that provides 

services to the program, such as data processing, dosage preparation, laboratory analyses, vocational 

counseling, or legal, medical, accounting, or other professional services that the program does not 

provide for itself. 

The department of health can also be a "service organization" if it provides health-related services to 

the program. Examples of such services include offering tests for HIV, tuberculosis, and sexually 

transmitted diseases; providing treatment for communicable diseases; or monitoring the patient's 

case to ensure that he or she is receiving treatment. Managed care companies can, in limited 

circumstances, also be "service organizations," provided they are providing a service, such as legal, 

medical, accounting, or laboratory services. For example, if individuals enrolled in a managed care 

program can receive AOD treatment from any certified AOD program, but must receive primary health 

care from the managed care provider's staff physicians, the managed care provider could be 

considered a "service organization"; it is rendering medical services. 
In order to receive patient-identifying information, the "service organization" must enter into a written 

agreement with the program in which it acknowledges that it is bound by the Federal confidentiality 

regulations, promises not to redisclose patient-identifying information to which it becomes privy, and 

promises to resist unauthorized efforts to gain access to any patient-identifying information in its 

possession (§ 2.11). 

Once the program and the outside agency have entered into this QSOA, the program may freely 

communicate information from patient records to the "qualified service organization," but only that 

information that is specified in the QSOA and that is needed by the organization to provide services to 

the program. 

Although AOD programs may enter into QSOAs with a variety of outside organizations, they are not 

permitted—according to a legal opinion of the DHHS—to enter into them with one another (unless the 

services offered by one of the programs does not pertain to AOD-related services) or with law 

enforcement agencies. 

A program is not required to inform its patients of the QSOAs to which it is a party. 

D.MEDICAL EMERGENCIES

Issue: Was the disclosure made properly in a medical emergency? 

1. Was the alleged disclosure made: 

in response to an immediate threat to the health of any individual? Y__ N__ 

because of the need for immediate medical intervention?Y__N__ 

to medical personnel? and Y__N__ 

to someone who needed the patient-identifying information to treat the medical 

emergency?Y__N__ 

If the answer to all of these questions is "yes," go to question 2. 

If the answer to any of these questions is "no," the disclosure did not fall under the medical 

emergency rule. Stop here or determine whether the disclosure was otherwise authorized. 

2. After making the disclosure, did the program document in the patient's record the 

name of the recipient and his or her affiliation with any health care facility, the name 

of the individual making the disclosure, the date and time of the disclosure, and the 

nature of the emergency? Y__ N__ 

If "yes," the disclosure was proper under the medical emergency rule. 

If "no," the disclosure did not fall under the medical emergency rule. Stop here or determine 

whether the disclosure was otherwise authorized. 

Summary of the Rule 

Even without consent, patient-identifying information may be disclosed to medical personnel in a 

medical emergency (§ 2.51). 
A medical emergency is a situation that poses an immediate threat to the health of any individual (it 

need not be the patient) and requires immediate medical intervention. Typical examples of a medical 

emergency include a suicide threat, a drug overdose, or a patient with active and infectious 

tuberculosis who is not taking his or her medications. 

This rule permits the program to release patient-identifying information to medical personnel who 

need the information to treat the medical condition. The program may not use the medical emergency 

rule to contact family members or the police. When releasing information pursuant to a medical 

emergency, programs must document the disclosure in the patient's record, setting forth the name of 

the recipient and his or her affiliation with any health care facility, the name of the individual making 

the disclosure, the date and time of the disclosure, and the nature of the emergency (§ 2.51(c)). 

E.CRIMES ON PROGRAM PREMISES OR AGAINST PROGRAM PERSONNEL 

Issue: Was the disclosure made in response to a crime on program premises or against program 

personnel? 

1. Was the disclosure made in response to a crime or threatened crime: 

on the program premises (against anyone)? Y__ N__

against program personnel (anywhere)? Y__ N__ 

If the answer to either question is "yes," go to question 2. 

If the answer to both questions is "no," the disclosure did not fall under the crime on program 

premises or against program personnel rule. Stop here or determine whether the disclosure 

was otherwise authorized. 

2. Was the disclosure limited to the circumstances of the incident, including the 

patient's name, address, last known whereabouts, and patient status? Y__ N__ 

If "yes," the disclosure was authorized by the rule. 

If "no," the disclosure did not fall within the rule. Stop here or determine whether the 

disclosure was otherwise authorized. 

Summary of the Rule 

The regulations permit a program to release patient-identifying information to the police if a patient 

commits or threatens to commit a crime either (i) on the premises (against anyone) or (ii) against 

program staff anywhere. 

When reporting such a crime, in addition to the particulars of the crime, the program may give the 

police the patient's name, address, and last known whereabouts. The program may not release to the 

police the names of other patients who were victims or witnesses to the crime without those patients' 

prior written consent. 

This rule does not authorize disclosure of a patient's confession to a past crime unless the crime was 

on the program premises or against program personnel. 

F. MANDATED REPORTS OF CHILD ABUSE OR NEGLECT 

Issue: Was the disclosure authorized by the child abuse reporting rule? 
1. Was the disclosure required under the state's child abuse and neglect reporting law? 

Y__ N__ 

If "yes," go to question 2. 

If "no," the disclosure did not fall under the child abuse reporting rule. Stop here or determine 

whether the disclosure was otherwise authorized.

2. Did the disclosure include only the initial report and/or a confirmation of that report? 

Y__ N__ 

If "yes," the disclosure was authorized by the child abuse reporting rule. 

If "no," the disclosure was broader than that permitted under the child abuse reporting rule 

and, therefore, not permitted. Stop here or determine whether the disclosure was otherwise 

authorized. 

Summary of the Rule 

In 1987, the regulations were amended to permit AOD programs to comply with State laws requiring 

people in certain positions or occupations to report cases of suspected child abuse or neglect. 

Accordingly, the regulations "do not apply to the reporting under State law of incidents of suspected 

child abuse and neglect to the appropriate State or local authorities" (§ 2.12(c)(6)). 

Under this rule, program staff may make reports to local child abuse hotlines and even confirm the 

reports in writing. However, the program's disclosures must stop there. The regulations continue "to 

apply to the original alcohol or drug abuse patient records maintained by the program including their 

disclosure and use for civil or criminal proceedings which may arise out of the report of suspected 

child abuse and neglect." This means that although a program may make State-mandated child abuse 

reports, patient files must be withheld from child protection agencies absent patient consent or a court 

order. 

G. RESEARCH

Issue: Was the disclosure authorized under the research rule? 

1. Was the disclosure made to someone doing research? Y__ N__ 

If "yes," go to question 2. 

If "no," the disclosure did not fall within the research rule. Stop here or determine whether the 

disclosure was otherwise authorized. 

2. Before the program made the disclosure, did the director determine: 

that the researcher was qualified? Y__ N__ 

that the researcher had a protocol under which the security of patient records 

was assured (per § 2.16)? and Y__ N__ 

that patient-identifying information would not be redisclosed? Y__ N__ 

If the answer to all of the above questions is "yes," go to question 3.
If the answer to any of the above questions is "no," the disclosure did not fall within the 

research rule. Stop here or determine whether the disclosure was otherwise authorized. 

3. Did the researcher provide a written statement that three or more independent 

evaluators had reviewed the research protocol and determined that:

the rights and welfare of the patients concerned would be adequately 

protected? and Y__ N__ 

the potential benefits of the research outweighed the risks to patient 

confidentiality? Y__ N__ 

If the answer to both of the above questions is "yes," the program's disclosure was authorized 

by the research rule. (See Section V to determine whether the researcher also complied with 

the law.) 

If the answer to either of the above questions is "no," the disclosure did not fall within the 

research rule. Stop here or determine whether the disclosure was otherwise authorized. 

Summary of the rule 

A program may allow a researcher to have access to its patients' records under the following 

circumstances: 

First, the program director must determine (i) that the researcher is qualified, (ii) that the researcher 

has a protocol under which the security of patient records is assured (per § 2.16), and (iii) that 

patient-identifying information will not be redisclosed. 

In addition, the researcher must provide a written statement that three or more independent 

evaluators have reviewed the research protocol and determined that the rights and welfare of the 

patients concerned will be adequately protected and that the potential benefits of the research 

outweigh the risks to patient confidentiality (§ 2.52(a)). 

If a researcher satisfies the above standard, the researcher may proceed but is barred from 

redisclosing patient-identifying information except back to the program itself. No report may identify 

any individual patient (§ 2.52(b)). 

H. AUDIT AND EVALUATION

Issue: Was the disclosure authorized under the audit and evaluation rule? 

1. Was the disclosure made to any of the following: a Government agency that funds or 

regulates the program? Y__ N__

a private person or agency that provides financial assistance or third-party 

payments to the program? Y__ N__

a peer-review organization that performs utilization or quality control 

review? or Y__ N__
a person that the program director determined to be "qualified" to conduct 

the audit or evaluation? Y__ N__ 

If the answer to any of the questions is "yes," go to question 2. 

If the answer to all of the questions is "no," the disclosure did not fall within the audit and 

evaluation rule. Stop here or determine whether the disclosure was otherwise authorized. 

2. Was the purpose of the disclosure to enable the oversight entity to conduct the audit 

or evaluation of the program? Y__ N__ 

If "yes," go to question 3. 

If "no," the disclosure did not fall within the audit and evaluation rule. Stop here or determine 

whether the disclosure was otherwise authorized. 

3. Did the auditor or evaluator agree in writing that it would redisclose patientidentifying information only: 

back to the program? or Y__ N__ 

to a Government agency that is overseeing a Medicare or Medicaid audit or 

evaluation? Y__ N__ 

If the answer to both questions is "yes," go to question 4. 

If the answer to either question is "no," the disclosure did not fall within the audit and 

evaluation rule. Stop here or determine whether the disclosure was otherwise authorized. 

4. Did the auditor or evaluator agree in writing to use the information only:

for the audit or evaluation? or Y__ N__ 

pursuant to a court order to investigate or prosecute the program (not a 

patient)? Y__ N__ 

If the answer to both questions is "yes," go to question 5. 

If the answer to either question is "no," the disclosure did not fall within the audit and 

evaluation rule. Stop here or determine whether the disclosure was otherwise authorized. 

5. Did the program copy for or give the auditor or evaluator any records containing 

patient-identifying information for the auditor or evaluator to remove from the 

program premises? Y__ N__ 

If "yes," go to question 6.
If "no," stop here because the program's disclosure to the auditor or evaluator was authorized 

by the audit and evaluation rule. 

6. Was the auditor or evaluator a: 

Government agency that funds or regulates the program? Y__ N__ 

private person or agency that provides financial assistance or third-party 

payments to the program? or Y__ N__ 

peer-review organization that performs utilization or quality control review? 

Y__ N__ 

If the answer to any of the above questions is "yes," go to question 7. 

If the answer to all of the above questions is "no" (i.e., the auditor or evaluator was merely 

someone whom the director determined was "qualified" to conduct an audit or evaluation), the 

program was not authorized, under the audit and evaluation exception, to permit the auditor 

or evaluator to copy or remove records. Stop here or determine whether the disclosure was 

otherwise authorized. 

7. Prior to copying or removing patient records, did the auditor or evaluator agree in 

writing to: 

maintain the patient-identifying information in accordance with the security 

requirements provided in § 2.16 of the regulations (or more stringent 

requirements)? Y__ N__ 

destroy all patient-identifying information upon completion of the audit or 

evaluation? and Y__ N__ 

comply with the limitations on disclosure and use specified in § 2.53(d)? 

(Section 2.53(d) provides that any person or organization that conducts an 

audit or evaluation must agree in writing that it will redisclose patientidentifying information only (i) back to the program or (ii) to a Government 

agency that is overseeing a Medicare or Medicaid audit or evaluation. Such 

person or organization must also agree in writing to use the information only 

for the audit or evaluation or pursuant to a court order to investigate or 

prosecute the program (not a patient).) Y__ N__ 

If the answer to all of the above questions is "yes," the program was authorized, under the 

audit and evaluation rule to permit the copying or removal of records. (See Section V to 

determine whether the auditor or evaluator complied with the regulations.) 

If the answer to any of the above questions is "no," the program was not authorized under the 

audit and evaluation rule to permit the copying or removal of records. You may determine 
whether the disclosure was authorized under another rule. In addition, see Section V to 

determine whether the auditor or evaluator complied with the regulations. 

Summary of the Rule 

Government agencies that fund or regulate a program, private persons that provide financial 

assistance or third-party payments to a program, peer-review organizations that perform utilization or 

quality control review, and persons whom the program director determines are "qualified" may have 

access to program records for audits or evaluations of the program (§ .53). Examples of such funding 

or oversight agencies include Government agencies that administer the Medicaid program and that 

contract with AOD programs, insurance and managed care companies, and State agencies that license 

and regulate AOD programs. 

Any person or organization that conducts an audit or evaluation must agree in writing that it will 

redisclose patient-identifying information only (i) back to the program, or (ii) to a Government agency 

that is overseeing a Medicare or Medicaid audit or evaluation. Such person or organization also must 

agree in writing to use the information only for the audit or evaluation or pursuant to a court order to 

investigate or prosecute the program (not a patient) (§ 2.53(c) and (d)). 

The agencies listed in the first paragraph above also may copy or remove records, but only if they 

agree in writing to (i) safeguard the confidentiality of patient-identifying information in accordance 

with the security requirements of § 2.16 of the regulations (or more stringent requirements), (ii) 

destroy all such information on completion of the audit or evaluation, (iii) redisclose patient-identifying 

information back to the program or to a Government agency that is overseeing a Medicaid or Medicare 

audit or evaluation, and (iv) not use the information except for purposes of the audit or evaluation or 

to investigate or prosecute criminal or other activities as authorized by a court order entered under § 

2.66 (§ 2.53(b)-(d)). Thus a State regulatory agency could not obtain patient records pursuant to an 

audit and then store them permanently on a computer database. 

Any other person or organization determined by the program director to be "qualified" and that 

pledges in writing to observe the restrictions on redisclosure and use that are specified two 

paragraphs above may also inspect patient records for audit or evaluation purpose without consent. 

Only the agencies listed in the first paragraph, however, may copy or remove records. 

I. COURT ORDERS 

Issue: Was the disclosure made in response to a valid court order? 

1. Did the program make the disclosure in response to an order that states it was 

issued under the Federal confidentiality regulations (42 C.F.R. Part 2) and was 

signed or issued by a court? Y__ N__ 

If "yes," go to question 2. 

If "no," the disclosure did not fall under the court order rule. (Recall that a subpoena, search 

warrant, or arrest warrant, in and of itself, is not a court order that meets the requirements of 

42 C.F.R. Part 2. For arrest or search warrants, proceed to Section IV to determine whether 

the program's response was proper.) Stop here or determine whether the disclosure was 

otherwise authorized. 

2. Did the program itself apply for the court order (as opposed to a third party who 

wanted the information from the program)? Y__ N__ 

If "yes," go to question 3. 

If "no," go to question 7. 
3. Did the program's application use a fictitious name for the patient? Y__ N__ 

If "yes," go to question 5. 

If "no," go to question 4. 

4. Did the patient sign a valid consent authorizing the use of his or her name in the 

application? Y__ N__ 

If "yes," go to question 5. 

If "no," the application for the court order was not authorized by the court order rule. Stop 

here or determine whether it was otherwise authorized by the regulations. 

5. Did the program give the patient adequate notice of the application for the court 

order as well as an opportunity to make a written response or to appear in person for 

the limited purpose of responding to the application? Y__ N__ 

If "yes," go to question 7. 

If "no," go to question 6. 

6. Was the disclosure sought for the purpose of investigating or prosecuting the patient 

for a crime? Y__ N__ 

If "yes," the program did not need to give the patient notice. Go to question 7. 

If "no," stop here because the failure to provide the notice renders the program's application 

improper under the regulations, or determine whether the disclosure was otherwise 

authorized. 

7. Did the program disclose only that information described in the court order? Y__ N__ 

If "yes," the disclosure was authorized by the court order rule. 

If "no," the program's disclosure was broader than that allowed under the "court order" rule 

and, therefore, not permitted. Stop here or determine whether the disclosure was otherwise 

authorized. 

Summary of the Rule

A Federal, State, or local court may authorize a program to make a disclosure of patient-identifying 

information. A court may issue such an order, however, only after following certain procedures and 

making certain determinations specified in the regulations (§ 2.63-2.67). A subpoena, search warrant, 

or arrest warrant, even when it is signed by a judge, is not sufficient, by itself, to require or even 

permit a program to make a disclosure (§ 2.61). 

For guidance on how to respond to search and arrest warrants, see Section IV. When faced with a 

subpoena, a program may contact the patient referenced in the subpoena and seek the patient's 

consent to release the subpoenaed information. Alternatively, a program may contact the party that 

issued the subpoena and attempt to persuade the party to seek a proper court order. If that fails, the 

program could move to quash the subpoena. 

With respect to court orders, the applicant for the court order must follow certain procedures, such as 

using a fictitious name, like John Doe, to refer to any patient (unless the patient has consented to the 

use of his or her real name). In addition, the applicant generally must give the program and the 

patient "adequate notice" of an opportunity to file a written response to the application or appear in 

person for the limited purpose of responding to the application (§ 2.64(a) and (b)). If the court order 

was requested in order to criminally investigate or prosecute a patient, however, the patient need not 
receive notice. (§ 2.65) Likewise, if the court order was requested in order to criminally prosecute or 

investigate the program, the program need not receive notice (§ 2.66). 

This checklist is limited to those requirements for which AOD programs can properly be held 

accountable (i.e., the program made no disclosure until and unless a court ordered it to do so under 

the Federal regulations, and the program only disclosed the information listed in the court order). (The 

AOD program and its lawyer also are responsible for properly filing a request for a court order if the 

program initiates the application.) AOD programs cannot be held accountable for procedural or 

substantive errors made by a court, prosecuting attorney, and so on. This is not to suggest, however, 

that the program should not take steps to ensure that a third party who seeks a court order has 

followed the proper procedures, such as providing proper notice and holding a hearing with respect to 

whether the disclosure should be made. Furthermore, the program and/or the patient concerned could 

file an appeal if the court issued the order improperly. 

IV. RESPONDING TO SEARCH AND ARREST WARRANTS

Issue: Did the AOD program respond appropriately to a search or arrest warrant? 

1. When law enforcement officials contacted the program, did the program attempt to 

persuade the officials to obtain a court order (as discussed in Section III.I)? Y__ N__ 

If "yes," go question 2. 

If "no," there may have been a violation of the regulations if the program provided patientidentifying information. 

2. If the law enforcement officials insisted on entry, did the program either: 

point out the patient sought in the arrest warrant? or Y__ N__ 

provide the records sought in the search warrant? Y__ N__ 

If the answer to either question is "yes," there may have been a violation of the regulations. 

If the answer to both questions is "no," there likely was no violation of the regulations. 

Summary of the Rule 

As discussed in Section III.I, neither a search warrant nor an arrest warrant, in and of itself, 

constitutes the type of court order authorized under the regulations. Consequently, programs may not 

disclose patient-identifying information in response to such warrants. 

On the other hand, the regulations do not require a program to forcibly resist a law enforcement 

officer who insists on entry. The DHHS has ruled that when faced with an arrest or search warrant 

without a valid court order, programs generally should: 

produce a copy of the regulations and explain that they cannot cooperate with law 

enforcement unless they obtain a court order; 

try to get time to notify a lawyer; 

ask to contact the prosecuting attorney or commanding officer so that the program 

can repeat its arguments; and 
try other appeals to reason. 

If all of the above fail, programs should not forcibly resist. They may permit the law enforcement 

officials to enter, but they should not point out the patient sought in the arrest warrant or the records 

sought in the search warrant. 

V. DISCLOSURES BY THIRD PARTIES 

Issue: Did a third party who received patient-identifying information from an AOD program redisclose 

it without authorization? 

Third-Party Payers 

1. Did a third-party payer (e.g., insurance company) redisclose patient-identifying 

information it received from a program?1 Y__ N__ 

If "yes," go to question 2. 

If "no," go to question 4. 

2. Did the third-party payer receive the patient-identifying information pursuant to the 

audit and evaluation rule? Y__ N__ 

If "yes," go to question 11. 

If "no," go to question 3. 

3. Was the redisclosure authorized by one of the rules discussed in Section III? Y__ 

N__ 

If "yes," the redisclosure was authorized by the regulations. 

If "no," stop here because the redisclosure was not authorized by the regulations.

Entities With Administrative Control Over Programs 

4. Did an entity with administrative control over a program redisclose patientidentifying information it received from the program (pursuant to the internal 

communications rule discussed in Section III.B)? Y__ N__ 

If "yes," go to question 5. 

If "no," go to question 6. 

5. Was the redisclosure authorized by one of the rules discussed in Section III? Y__ 

N__ 

If "yes," the redisclosure was authorized by the regulations. 

If "no," stop here because the redisclosure was not authorized by the regulations. 

Consent 

6. Did a third party redisclose patient-identifying information that it received from an

AOD program pursuant to a valid consent form (discussed in Section III.A)? Y__ N__ 

If "yes," go to question 7.
If "no," go to question 8. 

7. Did the third party receive a "notice prohibiting redisclosure" from the AOD program? 

Y__ N__ 

If "yes," the third party's redisclosure was not authorized by the consent rule. Stop here or 

consult the other parts of Section III to determine whether the disclosure was otherwise 

authorized. 

If "no," the redisclosure was authorized and the third party was not bound by the regulations 

unless the third party was also bound by a QSOA or the research or audit and evaluation rules. 

Go to question 8 to determine whether any of those rules apply.

QSOAs

8. Did a third party redisclose patient-identifying information that it received from an 

AOD program pursuant to a QSOA (discussed in Section III.C)? Y__ N__ 

If "yes," the redisclosure was not authorized by the QSOA rule. Stop here or consult the other 

parts of Section III to determine whether the disclosure was otherwise authorized. 

If "no," go to question 9.

Research

9. Did a third party redisclose patient-identifying information that it received from an 

AOD program under the "research" rule (discussed in Section III.G)? Y__ N__ 

If "yes," go to question 10. 

If "no," go to question 11.

10. Did the third-party researcher:

redisclose patient-identifying information to someone other than back to the 

program itself? Y__ N__ 

issue a report that identified any individual patient? Y__ N__ 

If the answer to either question is "yes," the third party's redisclosure was not authorized by 

the research rule (see Section III.G). Stop here or consult the other parts of Section III to 

determine whether the disclosure was otherwise authorized. 

If the answer to both questions is "no," stop here because the third-party researcher did not 

violate the regulations. 

Audit and Evaluation 

11. Did a third party redisclose patient-identifying information that it received from an 

AOD program pursuant to the audit and evaluation rule (discussed in Section III.H)? 

Y__ N__ 

If "yes," go to question 12. 

If "no," stop here because the regulations do not apply. 
12. Did the third-party auditor or evaluator comply with the written agreement (see 

Summary of the Rule for Section III.H to: 

redisclose patient-identifying information only (i) back to the program or (ii) 

to a Government agency overseeing a Medicare or Medicaid audit or 

evaluation? and Y__ N__

use the information only for the audit or evaluation or pursuant to a court 

order to investigate or prosecute the program? Y__ N__ 

If the answer to both questions is "yes," go to question 13. 

If the answer to either question is "no," the auditor or evaluator violated the regulations. 

13. Did the auditor or evaluator copy or remove patient records from the program? Y__ 

N__

If "yes," go to question 14.

If "no," stop here because the auditor or evaluator complied with the regulations.

14. Did the auditor or evaluator comply with the written agreement (see Summary of the 

Rule for Section III.4) to: 

maintain the patient-identifying information in accordance with the security 

requirements provided in § 2.16 of the regulations (or more stringent 

requirements)? Y__ N__ 

destroy all patient-identifying information on completion of the audit or 

evaluation? and Y__ N__ 

comply with the limitations on disclosure and use specified in § 2.53(d)? Y__ 

N__ 

If the answer to all of the questions is "yes," the auditor's or evaluator's copying or removal of 

records was authorized by the audit and evaluation rule. 

If the answer to any of the questions is "no," the auditor's or evaluator's copying or removal of 

records was not authorized by the audit and evaluation rule. Stop here or consult the other 

parts of Section III to determine whether the copying or removal of records was otherwise 

authorized.

Summary of the Rule 

As discussed in Sections III.A, C, G, and H, third parties who receive patient-identifying information 

from AOD programs pursuant to consent forms, QSOAs, or the research or audit and evaluation rules 

are generally prohibited from redisclosing it. This section will not repeat the details regarding 

redisclosure under these rules (see Summary of the Rule for Sections III.A, C, G, and H). 
In addition, the regulations require third-party payers who receive patient-identifying information from 

programs to comply with the regulations, regardless of whether they received a notice prohibiting 

redisclosure (§ 2.12(d)(2)(i)). 

Likewise, entities with direct administrative control over programs, which receive information from 

programs pursuant to the internal communications' exception (see Section III.B), must abide by the 

disclosure restrictions in the regulations (§ 2.12(d)(2)(ii). 

Note, however, that the prohibitions against redisclosing information obtained from an AOD program 

apply to the information actually received from the AOD program and not from the patient. For 

example, if a third party receives patient-identifying information from an AOD program, and the 

patient self-discloses the identical information to the third party, the third party can redisclose the 

information. This is because the third party is not redisclosing information it received pursuant to the 

consent form or QSOA, but rather, information it received from the patient. 

Appendix A—The Confidentiality Law (42 

U.S.C. § 290dd-2)

This statute, which Congress enacted in 1992, consolidates and replaces (without substantive change) 

the two separate but identical laws Congress originally enacted to govern the confidentiality of alcohol 

abuse patient records (previously codified as 42 U.S.C. § 290dd-3) and drug abuse patient records 

(previously codified as 42 U.S.C. § 290ee-3). (The text of those laws, now replaced by this 1992 

statute, is set out in § 2.1 of the confidentiality regulations that are reprinted in the following pages.) 

The term "substance abuse" in the current law refers to both alcohol and drug abuse. The regulations 

themselves were not revised as a result of Congress' 1992 consolidation but were revised slightly in 

1995. The revised regulations appear on page 30.

§ 290dd-2: Confidentiality of Records 

(a) Requirement

Records of the identity, diagnosis, prognosis, or treatment of any patient that are maintained in 

connection with the performance of any program or activity relating to substance abuse education, 

prevention, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly 

or indirectly assisted by any department or agency of the United States shall, except as provided in 

subsection (e) of this section, be confidential and be disclosed only for the purposes and under the 

circumstances expressly authorized under subsection (b) of this section. 

(b) Permitted disclosure

(1) Consent

The content of any record referred to in subsection (a) of this section may be disclosed in accordance 

with the prior written consent of the patient with respect to whom such record is maintained, but only 

to such extent, under such circumstances, and for such purposes as may be allowed under regulations 

prescribed pursuant to subsection (g) of this section. 

(2) Method for disclosure 

Whether or not the patient, with respect to whom any given record referred to in subsection (a) of this 

section is maintained, gives written consent, the content of such record may be disclosed as follows: 
(A) To medical personnel to the extent necessary to meet a bona fide medical emergency.

(B) To qualified personnel for the purpose of conducting scientific research, management 

audits, financial audits, or program evaluation, but such personnel may not identify, directly or 

indirectly, any individual patient in any report of such research, audit, or evaluation, or 

otherwise disclose patient identities in any manner. 

(C) If authorized by an appropriate order of a court of competent jurisdiction granted after 

application showing good cause therefor, including the need to avert a substantial risk of 

death or serious bodily harm. In assessing good cause the court shall weigh the public interest 

and the need for disclosure against the injury to the patient, to the physicianBpatient 

relationship, and to the treatment services. Upon the granting of such order, the court, in 

determining the extent to which any disclosure of all or any part of any record is necessary, 

shall impose appropriate safeguards against unauthorized disclosure. 

(c) Use of records in criminal proceedings

Except as authorized by a court order granted under subsection (b)(2)(C) of this section, no record 

referred to in subsection (a) of this section may be used to initiate or substantiate any criminal 

charges against a patient or to conduct any investigation of a patient. 

(d) Application 

The prohibitions of this section continue to apply to records concerning any individual who has been a 

patient, irrespective of whether or when such individual ceases to be a patient. 

(e) Nonapplicability 

The prohibitions of this section do not apply to any interchange of records—

(1) within the Armed Forces or within those components of the Department of Veterans Affairs 

furnishing health care to veterans; or 

(2) between such components and the Armed Forces.

The prohibitions of this section do not apply to the reporting under State law of incidents of suspected

child abuse and neglect to the appropriate State or local authorities. 

(f) Penalties

Any person who violates any provision of this section or any regulation issued pursuant to this section 

shall be fined in accordance with Title 18. 

(g) Regulations 

Except as provided in subsection (h) of this section, the Secretary shall prescribe regulations to carry 

out the purposes of this section. Such regulations may contain such definitions, and may provide for 

such safeguards and procedures, including procedures and criteria for the issuance and scope of 

orders under subsection (b)(2)(C) of this section, as in the judgment of the Secretary are necessary or 

proper to effectuate the purposes of this section, to prevent circumvention or evasion thereof, or to 

facilitate compliance therewith. 

(h) Application to Department of Veterans Affairs 

The Secretary of Veterans Affairs, acting through the Under Secretary for Health, shall, to the 

maximum feasible extent consistent with their responsibilities under Title 38, prescribe regulations 

making applicable the regulations prescribed by the Secretary of Health and Human Services under 

subsection (g) of this section to records maintained in connection with the provision of hospital care, 
nursing home care, domiciliary care, and medical services under such Title 38 to veterans suffering 

from substance abuse. In prescribing and implementing regulations pursuant to this subsection, the 

Secretary of Veterans Affairs shall, from time to time, consult with the Secretary of Health and Human 

Services in order to achieve the maximum possible coordination of the regulations, and the 

implementation thereof, which they each prescribe. 

1995 Revisions 

Federal Register, Vol. 60, No. 87, May 5, 1995 

In § 2.11, the definition of Program is revised to read as follows: 

§ 2.11 Definitions. 

* * * * *

Program means: 

(a) An individual or entity (other than a general medical care facility) who holds itself out as 

providing, and provides, alcohol or drug abuse diagnosis, treatment, or referral for treatment; 

or 

(b) An identified unit within a general medical facility which holds itself out as providing, and 

provides, alcohol or drug abuse diagnosis, treatment, or referral for treatment; or 

(c) Medical personnel or other staff in a general medical care facility whose primary function is 

the provision of alcohol or drug abuse diagnosis, treatment, or referral for treatment and who 

are identified as such providers. (See § 2.12(e)(1) for examples.) 

* * * * *

Section 2.12(e)(1) is amended by adding the following sentence at the end to read as follows: 

§ 2.12 Applicability. 

* * * * *

(e) * * * (1) * * * However, these regulations would not apply, for example, to emergency room 

personnel who refer a patient to the intensive care unit for an apparent overdose, unless the primary 

function of such personnel is the provision of alcohol or drug abuse diagnosis, treatment, or referral 

and they are identified as providing such services or the emergency room has promoted itself to the 

community as a provider of such services. 

Subpart A— Introduction 

[42 C.F.R. Subpart A, § 2.1B2.5, as of May 9, 1996] 

§ 2.1 Statutory authority for confidentiality of drug abuse patient records. 

The restrictions of these regulations upon the disclosure and use of drug abuse patient records were 

initially authorized by section 408 of the Drug Abuse Prevention, Treatment, and Rehabilitation Act (21 

U.S.C. 1175). That section as amended was transferred by Pub. L. 98-24 to section 527 of the Public 

Health Service Act which is codified at 42 U.S.C. 290ee-3. The amended statutory authority is set 

forth below: 

§ 290EE-3. CONFIDENTIALITY OF PATIENT RECORDS. 
(a) Disclosure authorization

Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in 

connection with the performance of any drug abuse prevention function conducted, regulated, or 

directly or indirectly assisted by any department or agency of the United States shall, except as 

provided in subsection (e) of this section, be confidential and be disclosed only for the purposes and 

under the circumstances expressly authorized under subsection (b) of this section. 

(b) Purposes and circumstances of disclosure affecting consenting patient and patient regardless of 

consent

(1) The content of any record referred to in subsection (a) of this section may be disclosed in 

accordance with the prior written consent of the patient with respect to whom such record is 

maintained, but only to such extent, under such circumstances, and for such purposes as may be 

allowed under regulations prescribed pursuant to subsection (g) of this section. 

(2) Whether or not the patient, with respect to whom any given record referred to in subsection (a) of 

this section is maintained, gives his written consent, the content of such record may be disclosed as 

follows: 

(A) To medical personnel to the extent necessary to meet a bona fide medical emergency. 

(B) To qualified personnel for the purpose of conducting scientific research, management audits,

financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any 

individual patient in any report of such research, audit, or evaluation, or otherwise disclose patient 

identities in any manner. 

(C) If authorized by an appropriate order of a court of competent jurisdiction granted after application 

showing good cause therefor. In assessing good cause the court shall weigh the public interest and the 

need for disclosure against the injury to the patient, to the physician–patient relationship, and to the 

treatment services. Upon the granting of such order, the court, in determining the extent to which any 

disclosure of all or any part of any record is necessary, shall impose appropriate safeguards against 

unauthorized disclosure. 

(c) Prohibition against use of record in making criminal charges or investigation of patient 

Except as authorized by a court order granted under subsection (b)(2)(C) of this section, no record 

referred to in subsection (a) of this section may be used to initiate or substantiate any criminal 

charges against a patient or to conduct any investigation of a patient. 

(d) Continuing prohibition against disclosure irrespective of status as patient

The prohibitions of this section continue to apply to records concerning any individual who has been a 

patient, irrespective of whether or when he ceases to be a patient. 

(e) Armed Forces and Veterans' Administration; interchange of records; report of suspected child 

abuse and neglect to State or local authorities

The prohibitions of this section do not apply to any interchange of records—

(1) within the Armed Forces or within those components of the Veterans' Administration furnishing 

health care to veterans, or 

(2) between such components and the Armed Forces. 
The prohibitions of this section do not apply to the reporting under State law of incidents of suspected 

child abuse and neglect to the appropriate State or local authorities. 

(f) Penalty for first and subsequent offenses 

Any person who violates any provision of this section or any regulation issued pursuant to this section 

shall be fined not more than $500 in the case of a first offense, and not more than $5,000 in the case 

of each subsequent offense. 

(g) Regulations; interagency consultations; definitions, safeguards, and procedures, including 

procedures and criteria for issuance and scope of orders 

Except as provided in subsection (h) of this section, the Secretary, after consultation with the 

Administrator of Veterans' Affairs and the heads of other Federal departments and agencies 

substantially affected thereby, shall prescribe regulations to carry out the purposes of this section. 

These regulations may contain such definitions, and may provide for such safeguards and procedures, 

including procedures and criteria for the issuance and scope of orders under subsection (b)(2)(C) of 

this section, as in the judgment of the Secretary are necessary or proper to effectuate the purposes of 

this section, to prevent circumvention or evasion thereof, or to facilitate compliance therewith. 

(Subsection (h) was superseded by section 111(c)(3) of Pub. L. 94-581. The responsibility of the 

Administrator of Veterans' Affairs to write regulations to provide for confidentiality of drug abuse 

patient records under Title 38 was moved from 21 U.S.C. 1175 to 38 U.S.C. 4134.) 

§ 2.2 Statutory authority for confidentiality of alcohol abuse patient records.

The restrictions of these regulations upon the disclosure and use of alcohol abuse patient records were 

initially authorized by section 333 of the Comprehensive Alcohol Abuse and Alcoholism Prevention, 

Treatment, and Rehabilitation Act of 1970 (42 U.S.C. 4582). The section as amended was transferred 

by Pub. L. 98-24 to section 523 of the Public Health Service Act which is codified at 42 U.S.C. 290dd3. The amended statutory authority is set forth below: 

§ 290DD-3.CONFIDENTIALITY OF PATIENT RECORDS. 

(a) Disclosure authorization 

Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in 

connection with the performance of any program or activity relating to alcoholism or alcohol abuse 

education, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly or 

indirectly assisted by any department or agency of the United States shall, except as provided in 

subsection (e) of this section, be confidential and be disclosed only for the purposes and under the 

circumstances expressly authorized under subsection (b) of this section. 

(b) Purposes and circumstances of disclosure affecting consenting patient and patient regardless of 

consent 

(1) The content of any record referred to in subsection (a) of this section may be disclosed in 

accordance with the prior written consent of the patient with respect to whom such record is 

maintained, but only to such extent, under such circumstances, and for such purposes as may be 

allowed under regulations prescribed pursuant to subsection (g) of this section. 

(2) Whether or not the patient, with respect to whom any given record referred to in subsection (a) of 

this section is maintained, gives his written consent, the content of such record may be disclosed as 

follows: 
(A) To medical personnel to the extent necessary to meet a bona fide medical emergency. 

(B) To qualified personnel for the purpose of conducting scientific research, management audits, 

financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any 

individual patient in any report of such research, audit, or evaluation, or otherwise disclose patient 

identities in any manner. 

(C) If authorized by an appropriate order of a court of competent jurisdiction granted after application 

showing good cause therefor. In assessing good cause the court shall weigh the public interest and the 

need for disclosure against the injury to the patient, to the physician–patient relationship, and to the 

treatment services. Upon the granting of such order, the court, in determining the extent to which any 

disclosure of all or any part of any record is necessary, shall impose appropriate safeguards against 

unauthorized disclosure. 

(c) Prohibition against use of record in making criminal charges or investigation of patient 

Except as authorized by a court order granted under subsection (b)(2)(C) of this section, no record 

referred to in subsection (a) of this section may be used to initiate or substantiate any criminal 

charges against a patient or to conduct any investigation of a patient. 

(d) Continuing prohibition against disclosure irrespective of status as patient 

The prohibitions of this section continue to apply to records concerning any individual who has been a 

patient, irrespective of whether or when he ceases to be a patient. 

(e) Armed Forces and Veterans' Administration; interchange of record of suspected child abuse and 

neglect to State or local authorities 

The prohibitions of this section do not apply to any interchange of records—

(1) within the Armed Forces or within those components of the Veterans' Administration furnishing 

health care to veterans, or 

(2) between such components and the Armed Forces. 

The prohibitions of this section do not apply to the reporting under State law of incidents of suspected 

child abuse and neglect to the appropriate State or local authorities. 

(f) Penalty for first and subsequent offenses 

Any person who violates any provision of this section or any regulation issued pursuant to this section 

shall be fined not more than $500 in the case of a first offense, and not more than $5,000 in the case 

of each subsequent offense. 

(g) Regulations of Secretary; definitions, safeguards, and procedures, including procedures and 

criteria for issuance and scope of orders 

Except as provided in subsection (h) of this section, the Secretary shall prescribe regulations to carry 

out the purposes of this section. These regulations may contain such definitions, and may provide for 

such safeguards and procedures, including procedures and criteria for the issuance and scope of 

orders under subsection(b)(2)(C) of this section, as in the judgment of the Secretary are necessary or 

proper to effectuate the purposes of this section, to prevent circumvention or evasion thereof, or to 

facilitate compliance therewith. 
(Subsection (h) was superseded by section 111(c)(4) of Pub. L. 94-581. The responsibility of the 

Administrator of Veterans' Affairs to write regulations to provide for confidentiality of alcohol abuse 

patient records under Title 38 was moved from 42 U.S.C. 4582 to 38 U.S.C. 4134.) 

§ 2.3Purpose and effect. 

(a) Purpose. Under the statutory provisions quoted in § § 2.1 and 2.2, these regulations impose 

restrictions upon the disclosure and use of alcohol and drug abuse patient records which are 

maintained in connection with the performance of any federally assisted alcohol and drug abuse 

program. The regulations specify: 

(1) Definitions, applicability, and general restrictions in Subpart B (definitions applicable to § 2.34 only 

appear in that section); 

(2) Disclosures which may be made with written patient consent and the form of the written consent 

in Subpart C; 

(3) Disclosures which may be made without written patient consent or an authorizing court order in 

Subpart D; and 

(4) Disclosures and uses of patient records which may be made with an authorizing court order and 

the procedures and criteria for the entry and scope of those orders in Subpart E. 

(b) Effect. (1) These regulations prohibit the disclosure and use of patient records unless certain 

circumstances exist. If any circumstances exists under which disclosure is permitted, that 

circumstance acts to remove the prohibition on disclosure but it does not compel disclosure. Thus, the 

regulations do not require disclosure under any circumstances. 

(2) These regulations are not intended to direct the manner in which substantive functions such as 

research, treatment, and evaluation are carried out. They are intended to insure that an alcohol or 

drug abuse patient in a federally assisted alcohol or drug abuse program is not made more vulnerable 

by reason of the availability of his or her patient record than an individual who has an alcohol or drug 

problem and who does not seek treatment. 

(3) Because there is a criminal penalty (a fine—see 42 U.S.C. 290ee-3(f), 42 U.S.C. 290dd-3(f) and 

42 C.F.R. § 2.4) for violating the regulations, they are to be construed strictly in favor of the potential 

violator in the same manner as a criminal statute (see M. Kraus & Brothers v. United States, 327 U.S. 

614, 621-22, 66 S. Ct. 705, 707-08 (1946)). 

§ 2.4 Criminal penalty for violation. 

Under 42 U.S.C. 290ee-3(f) and 42 U.S.C. 290dd-3(f), any person who violates any provision of those 

statutes or these regulations shall be fined not more than $500 in the case of a first offense, and not 

more than $5,000 in the case of each subsequent offense. 

§ 2.5 Reports of violations. 

(a) The report of any violation of these regulations may be directed to the United States Attorney for 

the judicial district in which the violation occurs.

(b) The report of any violation of these regulations by a methadone program may be directed to the 

Regional Offices of the Food and Drug Administration. 

Subpart B—General Provisions 
[42 C.F.R. Subpart B, § 2.11B2.67, as of May 9, 1996] 

§ 2.11 Definitions. 

For purposes of these regulations: Alcohol abuse means the use of an alcoholic beverage which 

impairs the physical, mental, emotional, or social well-being of the user. 

Drug abuse means the use of a psychoactive substance for other than medicinal purposes which 

impairs the physical, mental, emotional, or social well-being of the user. 

Diagnosis means any reference to an individual's alcohol or drug abuse or to a condition which is 

identified as having been caused by that abuse which is made for the purpose of treatment or referral 

for treatment. 

Disclose or disclosure means a communication of patient-identifying information, the affirmative 

verification of another person's communication of patient-identifying information, or the 

communication of any information from the record of a patient who has been identified. 

Informant means an individual: 

(a) Who is a patient or employee of a program or who becomes a patient or employee of a program at 

the request of a law enforcement agency or official: and 

(b) Who at the request of a law enforcement agency or official observes one or more patients or 

employees of the program for the purpose of reporting the information obtained to the law 

enforcement agency or official. 

Patient means any individual who has applied for or been given diagnosis or treatment for alcohol or 

drug abuse at a federally assisted program and includes any individual who, after arrest on a criminal 

charge, is identified as an alcohol or drug abuser in order to determine that individual's eligibility to 

participate in a program. 

Patient-identifying information means the name, address, social security number, fingerprints, 

photograph, or similar information by which the identity of a patient can be determined with 

reasonable accuracy and speed either directly or by reference to other publicly available information. 

The term does not include a number assigned to a patient by a program, if that number does not 

consist of, or contain numbers (such as a social security, or driver's license number) which could be 

used to identify a patient with reasonable accuracy and speed from sources external to the program. 

Person means an individual, partnership, corporation, Federal, State or local government agency, or 

any other legal entity. 

Program means: 

(a) An individual or entity (other than a general medical care facility) who holds itself out as providing, 

and provides, alcohol or drug abuse diagnosis, treatment or referral for treatment; or 

(b) An identified unit within a general medical facility which holds itself out as providing, and provides, 

alcohol or drug abuse diagnosis, treatment or referral for treatment; or 

(c) Medical personnel or other staff in a general medical care facility whose primary function is the 

provision of alcohol or drug abuse diagnosis, treatment or referral for treatment and who are identified 

as such providers. (See § 2.12(e)(1) for examples.) 

Program director means: 

(a) In the case of a program which is an individual, that individual: 

(b) In the case of a program which is an organization, the individual designated as director, managing 

director, or otherwise vested with authority to act as chief executive of the organization. 
Qualified service organization means a person which: 

(a) Provides services to a program, such as data processing, bill collecting, dosage preparation, 

laboratory analyses, or legal, medical, accounting, or other professional services, or services to 

prevent or treat child abuse or neglect, including training on nutrition and child care and individual and 

group therapy, and 

(b) Has entered into a written agreement with a program under which that person: 

(1) Acknowledges that in receiving, storing, processing or otherwise dealing with any patient records 

from the programs, it is fully bound by these regulations; and 

(2) If necessary, will resist in judicial proceedings any efforts to obtain access to patient records 

except as permitted by these regulations. 

Records means any information, whether recorded or not, relating to a patient received or acquired by 

a federally assisted alcohol or drug program. 

Third party payer means a person who pays, or agrees to pay, for diagnosis or treatment furnished to 

a patient on the basis of a contractual relationship with the patient or a member of his family or on the 

basis of the patient's eligibility for Federal, State, or local governmental benefits. 

Treatment means the management and care of a patient suffering from alcohol or drug abuse, a 

condition which is identified as having been caused by that abuse, or both, in order to reduce or 

eliminate the adverse effects upon the patient. 

Undercover agent means an officer of any Federal, State, or local law enforcement agency who enrolls 

in or becomes an employee of a program for the purpose of investigating a suspected violation of law 

or who pursues that purpose after enrolling or becoming employed for other purposes. 

[52 FR 21809, June 9, 1987, as amended at 60 FR 22297, May 5, 1995] 

* * * * *

DAILY C.F.R. (TM) Note 60 FR 22296, No. 87, May 5, 1995 

SUMMARY: The Department published a notice of proposed rulemaking in the Federal Register at 59 

FR 42561 (August 18, 1994) with corresponding corrections at 59 FR 45063 (August 31, 1994), which 

proposed a clarification to the "Confidentiality of Alcohol and Drug Abuse Patient Records" regulations 

codified at 42 C.F.R. part 2. Specifically, the Department proposed to clarify that, as to general 

medical care facilities, these regulations cover only specialized individuals or units in such facilities 

that hold themselves out as providing and provide alcohol or drug abuse diagnosis, treatment or 

referral for treatment and which are federally assisted, directly or indirectly. The Secretary has 

considered the comments received during the comment period, and is amending the regulations. 

EFFECTIVE DATE: June 5, 1995. 

* * * * *

§ 2.12 Applicability.

(a) General—(1) Restrictions on disclosure. The restrictions on disclosure in these regulations apply to 

any information, whether or not recorded, which: 

(i) Would identify a patient as an alcohol or drug abuser either directly, by reference to other publicly 

available information, or through verification of such an identification by another person; and 
(ii) Is drug abuse information obtained by a federally assisted drug abuse program after March 20, 

1972, or is alcohol abuse information obtained by a federally assisted alcohol abuse program after May 

13, 1974 (or if obtained before the pertinent date, is maintained by a federally assisted alcohol or 

drug abuse program after that date as part of an ongoing treatment episode which extends past that 

date) for the purpose of treating alcohol or drug abuse, making a diagnosis for that treatment, or 

making a referral for that treatment. 

(2) Restriction on use. The restriction on use of information to initiate or substantiate any criminal 

charges against a patient or to conduct any criminal investigation of a patient (42 U.S.C. 290ee-3(c), 

42 U.S.C. 290dd-3(c)) applies to any information, whether or not recorded which is drug abuse 

information obtained by a federally assisted drug abuse program after March 20, 1972, or is alcohol 

abuse information obtained by a federally assisted alcohol abuse program after May 13, 1974 (or if 

obtained before the pertinent date, is maintained by a federally assisted alcohol or drug abuse 

program after that date as part of an ongoing treatment episode which extends past that date), for 

the purpose of treating alcohol or drug abuse, making a diagnosis for the treatment, or making a 

referral for the treatment. 

(b) Federal assistance. An alcohol abuse or drug abuse program is considered to be federally assisted 

if: 

(1) It is conducted in whole or in part, whether directly or by contract or otherwise by any department 

or agency of the United States (but see paragraphs (c)(1) and (c)(2) of this section relating to the 

Veterans' Administration and the Armed Forces); 

(2) It is being carried out under a license, certification, registration, or other authorization granted by 

any department or agency of the United States including but not limited to: 

(i) Certification of provider status under the Medicare program; 

(ii) Authorization to conduct methadone maintenance treatment (see 21 C.F.R. 291.505); or 

(iii) Registration to dispense a substance under the Controlled Substances Act to the extent the 

controlled substance is used in the treatment of alcohol or drug abuse; 

(3) It is supported by funds provided by any department or agency of the United States by being: 

(i) A recipient of Federal financial assistance in any form, including financial assistance which does not 

directly pay for the alcohol or drug abuse diagnosis, treatment, or referral activities; or 

(ii) Conducted by a State or local government unit which, through general or special revenue sharing 

or other forms of assistance, receives Federal funds which could be (but are not necessarily) spent for 

the alcohol or drug abuse program; or 

(4) It is assisted by the Internal Revenue Service of the Department of the Treasury through the 

allowance of income tax deductions for contributions to the program or through the granting of tax 

exempt status to the program. 

(c) Exceptions—(1) Veterans' Administration. These regulations do not apply to information on alcohol 

and drug abuse patients maintained in connection with the Veterans' Administration provisions of 

hospital care, nursing home care, domiciliary care, and medical services under Title 38, United States 

Code. Those records are governed by 38 U.S.C. 4132 and regulations issued under that authority by 

the Administrator of Veterans' Affairs. 
(2) Armed Forces. These regulations apply to any information described in paragraph (a) of this 

section which was obtained by any component of the Armed Forces during a period when the patient 

was subject to the Uniform Code of Military Justice except: 

(i) Any interchange of that information within the Armed Forces; and 

(ii) Any interchange of that information between the Armed Forces and those components of the 

Veterans Administration furnishing health care to veterans. 

(3) Communication within a program or between a program and an entity having direct administrative

control over that 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 the program. 

(4) Qualified Service Organizations. The restrictions on disclosure in these regulations do not apply to 

communications between a program and a qualified service organization of information needed by the 

organization to provide services to the program. 

(5) Crimes on program premises or against program personnel. The restrictions on disclosure and use 

in these regulations do not apply to communications from program personnel to law enforcement 

officers which—

(i) Are directly related to a patient's commission of a crime on the premises of the program or against 

program personnel or to a threat to commit such a crime; and 

(ii) Are limited to the circumstances of the incident, including the patient status of the individual 

committing or threatening to commit the crime, that individual's name and address, and that 

individual's last known whereabouts. 

(6) Reports of suspected child abuse and neglect. The restrictions on disclosure and use in these 

regulations do not apply to the reporting under State law of incidents of suspected child abuse and 

neglect to the appropriate State or local authorities. However, the restrictions continue to apply to the 

original alcohol or drug abuse patient records maintained by the program including their disclosure 

and use for civil or criminal proceedings which may arise out of the report of suspected child abuse 

and neglect. 

(d) Applicability to recipients of information—(1) Restriction on use of information. The restriction on 

the use of any information subject to these regulations to initiate or substantiate any criminal charges 

against a patient or to conduct any criminal investigation of a patient applies to any person who 

obtains that information from a federally assisted alcohol or drug abuse program, regardless of the 

status of the person obtaining the information or of whether the information was obtained in 

accordance with these regulations. This restriction on use bars, among other things, the introduction 

of that information as evidence in a criminal proceeding and any other use of the information to 

investigate or prosecute a patient with respect to a suspected crime. Information obtained by 

undercover agents or informants (see § 2.17) or through patient access (see § 2.23) is subject to the 

restriction on use. 

(2) Restrictions on disclosures—Third party payers, administrative entities, and others. The 

restrictions on disclosure in these regulations apply to: 
(i) Third party payers with regard to records disclosed to them by federally assisted alcohol or drug 

abuse programs; 

(ii) Entities having direct administrative control over programs with regard to information 

communicated to them by the program under § 2.12(c)(3); and 

(iii) Persons who receive patient records directly from a federally assisted alcohol or drug abuse 

program and who are notified of the restrictions on redisclosure of the records in accordance with § 

2.32 of these regulations. 

(e) Explanation of applicability—(1) Coverage. These regulations cover any information (including 

information on referral and intake) about alcohol and drug abuse patients obtained by a program (as 

the terms "patient" and "program" are defined in § 2.11) if the program is federally assisted in any 

manner described in § 2.12(b). Coverage includes, but is not limited to, those treatment or 

rehabilitation programs, employee assistance programs, programs within general hospitals, schoolbased programs, and private practitioners who hold themselves out as providing, and provide alcohol 

or drug abuse diagnosis, treatment, or referral for treatment. However, these regulations would not 

apply, for example, to emergency room personnel who refer a patient to the intensive care unit for an 

apparent overdose, unless the primary function of such personnel is the provision of alcohol or drug 

abuse diagnosis, treatment or referral and they are identified as providing such services or the 

emergency room has promoted itself to the community as a provider of such services. 

(2) Federal assistance to program required. If a patient's alcohol or drug abuse diagnosis, treatment, 

or referral for treatment is not provided by a program which is federally conducted, regulated or 

supported in a manner which constitutes Federal assistance under § 2.12(b), that patient's record is 

not covered by these regulations. Thus, it is possible for an individual patient to benefit from Federal 

support and not be covered by the confidentiality regulations because the program in which the 

patient is enrolled is not federally assisted as defined in § 2.12(b). For example, if a Federal court 

placed an individual in a private for-profit program and made a payment to the program on behalf of 

that individual, that patient's record would not be covered by these regulations unless the program 

itself received Federal assistance as defined by § 2.12(b). 

(3) Information to which restrictions are applicable. Whether a restriction is on use or disclosure 

affects the type of information which may be available. The restrictions on disclosure apply to any 

information which would identify a patient as an alcohol or drug abuser. The restriction on use of 

information to bring criminal charges against a patient for a crime applies to any information obtained 

by the program for the purpose of diagnosis, treatment, or referral for treatment of alcohol or drug 

abuse. (Note that restrictions on use and disclosure apply to recipients of information under § 

2.12(d).) 

(4) How type of diagnosis affects coverage. These regulations cover any record of a diagnosis 

identifying a patient as an alcohol or drug abuser which is prepared in connection with the treatment 

or referral for treatment of alcohol or drug abuse. A diagnosis prepared for the purpose of treatment 

or referral for treatment but which is not so used is covered by these regulations. The following are 

not covered by these regulations: 

(i) Diagnosis which is made solely for the purpose of providing evidence for use by law enforcement 

authorities; or 

(ii) A diagnosis of drug overdose or alcohol intoxication which clearly shows that the individual 

involved is not an alcohol or drug abuser (e.g., involuntary ingestion of alcohol or drugs or reaction to 

a prescribed dosage of one or more drugs). 

[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987, as amended at 60 FR 22297, May 5, 1995] 

* * * * *
DAILY C.F.R. (TM) Note 

60 FR 22296, No. 87, May 5, 1995 

SUMMARY: The Department published a notice of proposed rulemaking in the Federal Register at 59 

FR 42561 (August 18, 1994) with corresponding corrections at 59 FR 45063 (August 31, 1994), which 

proposed a clarification to the "Confidentiality of Alcohol and Drug Abuse Patient Records" regulations 

codified at 42 C.F.R. part 2. Specifically, the Department proposed to clarify that, as to general 

medical care facilities, these regulations cover only specialized individuals or units in such facilities 

that hold themselves out as providing and provide alcohol or drug abuse diagnosis, treatment or 

referral for treatment and which are federally assisted, directly or indirectly. The Secretary has 

considered the comments received during the comment period, and is amending the regulations. 

EFFECTIVE DATE: June 5, 1995. 

* * * * *

§ 2.13 Confidentiality restrictions.

(a) General. The patient records to which these regulations apply may be disclosed or used only as 

permitted by these regulations and may not otherwise be disclosed or used in any civil, criminal, 

administrative, or legislative proceedings conducted by any Federal, State, or local authority. Any 

disclosure made under these regulations must be limited to that information which is necessary to 

carry out the purpose of the disclosure. 

(b) Unconditional compliance required. The restrictions on disclosure and use in these regulations 

apply whether the holder of the information believes that the person seeking the information already 

has it, has other means of obtaining it, is a law enforcement or other official, has obtained a 

subpoena, or asserts any other justification for a disclosure or use which is not permitted by these 

regulations. 

(c) Acknowledging the presence of patients: Responding to requests. (1) The presence of an identified 

patient in a facility or component of a facility which is publicly identified as a place where only alcohol 

or drug abuse diagnosis, treatment, or referral is provided may be acknowledged only if the patient's 

written consent is obtained in accordance with Subpart C of these regulations or if an authorizing court 

order is entered in accordance with Subpart E of these regulations. The regulations permit 

acknowledgement of the presence of an identified patient in a facility or part of a facility if the facility 

is not publicly identified as only an alcohol or drug abuse diagnosis, treatment or referral facility, and 

if the acknowledgement does not reveal that the patient is an alcohol or drug abuser. 

(2) Any answer to a request for a disclosure of patient records which is not permissible under these 

regulations must be made in a way that will not affirmatively reveal that an identified individual has 

been, or is being diagnosed or treated for alcohol or drug abuse. An inquiring party may be given a 

copy of these regulations and advised that they restrict the disclosure of alcohol or drug abuse patient 

records, but may not be told affirmatively that the regulations restrict the disclosure of the records of 

an identified patient. The regulations do not restrict a disclosure that an identified individual is not and 

never has been a patient. 

§ 2.14 Minor patients.

(a) Definition of minor. As used in these regulations the term "minor" means a person who has not 

attained the age of majority specified in the applicable State law, or if no age of majority is specified 

in the applicable State law, the age of 18 years. 
(b) State law not requiring parental consent to treatment. If a minor patient acting alone has the legal 

capacity under the applicable State law to apply for and obtain alcohol or drug abuse treatment, any 

written consent for disclosure authorized under Subpart C of these regulations may be given only by 

the minor patient. This restriction includes, but is not limited to, any disclosure of patient-identifying 

information to the parent or guardian of a minor patient for the purpose of obtaining financial 

reimbursement. These regulations do not prohibit a program from refusing to provide treatment until 

the minor patient consents to the disclosure necessary to obtain reimbursement, but refusal to provide 

treatment may be prohibited under a State or local law requiring the program to furnish the service 

irrespective of ability to pay. 

(c) State law requiring parental consent to treatment. (1) Where State law requires consent of a 

parent, guardian, or other person for a minor to obtain alcohol or drug abuse treatment, any written 

consent for disclosure authorized under Subpart C of these regulations must be given by both the 

minor and his or her parent, guardian, or other person authorized under State law to act in the 

minor's behalf. 

(2) Where State law requires parental consent to treatment the fact of a minor's application for 

treatment may be communicated to the minor's parent, guardian, or other person authorized under 

State law to act in the minor's behalf only if: 

(i) The minor has given written consent to the disclosure in accordance with Subpart C of these 

regulations or 

(ii) The minor lacks the capacity to make a rational choice regarding such consent as judged by the 

program director under paragraph (d) of this section. 

(d) Minor applicant for services lacks capacity for rational choice. Facts relevant to reducing a threat to 

the life or physical well being of the applicant or any other individual may be disclosed to the parent, 

guardian, or other person authorized under State law to act in the minor's behalf if the program 

director judges that: (1) A minor applicant for services lacks capacity because of extreme youth or 

mental or physical condition to make a rational decision on whether to consent to a disclosure under 

Subpart C of these regulations to his or her parent, guardian, or other person authorized under State 

law to act in the minor's behalf, and 

(2) The applicant's situation poses a substantial threat to the life or physical well being of the 

applicant or any other individual which may be reduced by communicating relevant facts to the 

minor's parent, guardian, or other person authorized under State law to act in the minor's behalf. 

§ 2.15 Incompetent and deceased patients. 

(a) Incompetent patients other than minors—(1) Adjudication of incompetence. In the case of a 

patient who has been adjudicated as lacking the capacity, for any reason other than insufficient age, 

to manage his or her own affairs, any consent which is required under these regulations may be given 

by the guardian or other person authorized under State law to act in the patient's behalf. 

(2) No adjudication of incompetency. For any period for which the program director determines that a 

patient, other than a minor or one who has been adjudicated incompetent, suffers from a medical 

condition that prevents knowing or effective action on his or her own behalf, the program director may 

exercise the right of the patient to consent to a disclosure under Subpart C of these regulations for the 

sole purpose of obtaining payment for services from a third party payer. 

(b) Deceased patients—(1) Vital statistics. These regulations do not restrict the disclosure of patientidentifying information relating to the cause of death of a patient under laws requiring the collection of 

death or other vital statistics or permitting inquiry into the cause of death. 
(2) Consent by personal representative. Any other disclosure of information identifying a deceased 

patient as an alcohol or drug abuser is subject to these regulations. If a written consent to the 

disclosure is required, that consent may be given by an executor, administrator, or other personal 

representative appointed under applicable State law. If there is no such appointment the consent may 

be given by the patient's spouse or, if none, by any responsible member of the patient's family. 

§ 2.16 Security for written records. 

(a) Written records which are subject to these regulations must be maintained in a secure room, 

locked file cabinet, safe or other similar container when not in use; and 

(b) Each program shall adopt in writing procedures which regulate and control access to and use of 

written records which are subject to these regulations. 

§ 2.17 Undercover agents and informants. 

(a) Restrictions on placement. Except as specifically authorized by a court order granted under § 2.67 

of these regulations, no program may knowingly employ, or enroll as a patient, any undercover agent 

or informant. 

(b) Restriction on use of information. No information obtained by an undercover agent or informant, 

whether or not that undercover agent or informant is placed in a program pursuant to an authorizing 

court order, may be used to criminally investigate or prosecute any patient. 

[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987] 

§ 2.18 Restrictions on the use of identification cards. 

No person may require any patient to carry on his or her person while away from the program 

premises any card or other object which would identify the patient as an alcohol or drug abuser. This 

section does not prohibit a person from requiring patients to use or carry cards or other identification 

objects on the premises of a program. 

§ 2.19 Disposition of records by discontinued programs. 

(a) General. If a program discontinues operations or is taken over or acquired by another program, it 

must purge patient-identifying information from its records or destroy the records unless—

(1) The patient who is the subject of the records gives written consent (meeting the requirements of § 

2.31) to a transfer of the records to the acquiring program or to any other program designated in the 

consent (the manner of obtaining this consent must minimize the likelihood of a disclosure of patientidentifying information to a third party); or 

(2) There is a legal requirement that the records be kept for a period specified by law which does not 

expire until after the discontinuation or acquisition of the program. 

(b) Procedure where retention period required by law. If paragraph (a)(2) of this section applies, the 

records must be: 

(1) Sealed in envelopes or other containers labeled as follows: "Records of [insert name of program] 

required to be maintained under [insert citation to statute, regulation, court order or other legal 

authority requiring that records be kept] until a date not later than [insert appropriate date]"; and 

(2) Held under the restrictions of these regulations by a responsible person who must, as soon as 

practicable after the end of the retention period specified on the label, destroy the records. 
§ 2.20 Relationship to State laws.

The statutes authorizing these regulations (42 U.S.C. 290ee-3 and 42 U.S.C. 290dd-3) do not 

preempt the field of law which they cover to the exclusion of all State laws in that field. If a disclosure 

permitted under these regulations is prohibited under State law, neither these regulations nor the 

authorizing statutes may be construed to authorize any violation of that State law. However, no State 

law may either authorize or compel any disclosure prohibited by these regulations. 

§ 2.21 Relationship to Federal statutes protecting research subjects against compulsory 

disclosure of their identity. 

(a) Research privilege description. There may be concurrent coverage of patient-identifying 

information by these regulations and by administrative action taken under: Section 303(a) of the 

Public Health Service Act (42 U.S.C. 242a(a) and the implementing regulations at 42 C.F.R. Part 2a); 

or section 502(c) of the Controlled Substances Act (21 U.S.C. 872(c) and the implementing 

regulations at 21 C.F.R. 1316.21). These "research privilege" statutes confer on the Secretary of 

Health and Human Services and on the Attorney General, respectively, the power to authorize 

researchers conducting certain types of research to withhold from all persons not connected with the 

research the names and other identifying information concerning individuals who are the subjects of 

the research. 

(b) Effect of concurrent coverage. These regulations restrict the disclosure and use of information 

about patients, while administrative action taken under the research privilege statutes and 

implementing regulations protects a person engaged in applicable research from being compelled to 

disclose any identifying characteristics of the individuals who are the subjects of that research. The 

issuance under Subpart E of these regulations of a court order authorizing a disclosure of information 

about a patient does not affect an exercise of authority under these research privilege statutes. 

However, the research privilege granted under 21 C.F.R. 291.505(g) to treatment programs using 

methadone for maintenance treatment does not protect from compulsory disclosure any information 

which is permitted to be disclosed under those regulations. Thus, if a court order entered in 

accordance with Subpart E of these regulations authorizes a methadone maintenance treatment 

program to disclose certain information about its patients, that program may not invoke the research 

privilege under 21 C.F.R. 291.505(g) as a defense to a subpoena for that information. 

§ 2.22 Notice to patients of Federal confidentiality requirements. 

(a) Notice required. At the time of admission or as soon thereafter as the patient is capable of rational 

communication. each program shall: 

(1) Communicate to the patient that Federal law and regulations protect the confidentiality of alcohol 

and drug abuse patient records; and 

(2) Give to the patient a summary in writing of the Federal law and regulations. 

(b) Required elements of written summary. The written summary of the Federal law and regulations 

must include: 

(1) A general description of the limited circumstances under which a program may acknowledge that 

an individual is present at a facility or disclose outside the program information identifying a patient as 

an alcohol or drug abuser. 

(2) A statement that violation of the Federal law and regulations by a program is a crime and that 

suspected violations may be reported to appropriate authorities in accordance with these regulations. 
(3) A statement that information related to a patient's commission of a crime on the premises of the 

program or against personnel of the program is not protected. 

(4) A statement that reports of suspected child abuse and neglect made under State law to 

appropriate State or local authorities are not protected. 

(5) A citation to the Federal law and regulations. 

(c) Program options. The program may devise its own notice or may use the sample notice in 

paragraph (d) to comply with the requirement to provide the patient with a summary in writing of the 

Federal law and regulations. In addition, the program may include in the written summary information 

concerning State law and any program policy not inconsistent with State and Federal law on the 

subject of confidentiality of alcohol and drug abuse patient records. 

(d) Sample notice. 

CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS 

The confidentiality of alcohol and drug abuse patient records maintained by this program is protected 

by Federal law and regulations. Generally, the program may not say to a person outside the program 

that a patient attends the program, or disclose any information identifying a patient as an alcohol or 

drug abuser Unless: 

(1) The patient consents in writing: 

(2) The disclosure is allowed by a court order; or 

(3) The disclosure is made to medical personnel in a medical emergency or to qualified personnel for 

research, audit, or program evaluation. 

Violation of the Federal law and regulations by a program is a crime. Suspected violations may be 

reported to appropriate authorities in accordance with Federal regulations. 

Federal law and regulations do not protect any information about a crime committed by a patient 

either at the program or against any person who works for the program or about any threat to commit 

such a crime. Federal laws and regulations do not protect any information about suspected child abuse 

or neglect from being reported under State law to appropriate State or local authorities. 

(See 42 U.S.C. 290dd-3 and 42 U.S.C. 290ee-3 for Federal laws and 42 C.F.R. Part 2 for Federal 

regulations.) 

(Approved by the Office of Management and Budget under Control No. 0930-0099) 

§ 2.23 Patient access and restrictions on use.

(a) Patient access not prohibited. These regulations do not prohibit a program from giving a patient 

access to his or her own records, including the opportunity to inspect and copy any records that the 

program maintains about the patient. The program is not required to obtain a patient's written 

consent or other authorization under these regulations in order to provide such access to the patient. 

(b) Restriction on use of information. Information obtained by patient access to his or her patient 

record is subject to the restriction on use of his information to initiate or substantiate any criminal 

charges against the patient or to conduct any criminal investigation of the patient as provided for 

under § 2.12(d)(1). 

Subpart C—Disclosures With Patient's Consent 
§ 2.31 Form of written consent. 

(a) Required elements. A written consent to a disclosure under these regulations must include: 

(1) The specific name or general designation of the program or person permitted to make the 

disclosure. 

(2) The name or title of the individual or the name of the organization to which disclosure is to be 

made. 

(3) The name of the patient. 

(4) The purpose of the disclosure. 

(5) How much and what kind of information is to be disclosed. 

(6) The signature of the patient and, when required for a patient who is a minor, the signature of a 

person authorized to give consent under § 2.14; or, when required for a patient who is incompetent or 

deceased, the signature of a person authorized to sign under § 2.15 in lieu of the patient. 

(7) The date on which the consent is signed. 

(8) A statement that the consent is subject to revocation at any time except to the extent that the 

program or person which is to make the disclosure has already acted in reliance on it. Acting in 

reliance includes the provision of treatment services in reliance on a valid consent to disclose 

information to a third party payer. 

(9) The date, event, or condition upon which the consent will expire if not revoked before. This date, 

event, or condition must insure that the consent will last no longer than reasonably necessary to serve 

the purpose for which it is given. 

(b) Sample consent form. The following form complies with paragraph (a) of this section, but other 

elements may be added. 

1. I (name of patient) o Request o Authorize: 

2. (name or general designation of program which is to make the disclosure) 

3. To disclose: (kind and amount of information to be disclosed) 

4. To: (name or title of the person or organization to which disclosure is to be made) 

5. For (purpose of the disclosure) 

6. Date (on which this consent is signed) 

7. Signature of patient 

8. Signature of parent or guardian (where required) 

9. Signature of person authorized to sign in lieu of the patient (where required) 

10. This consent is subject to revocation at any time except to the extent that the 

program which is to make the disclosure has already taken action in reliance on it. If 

not previously revoked, this consent will terminate upon: (specific date, event, or 

condition) 

(c) Expired, deficient, or false consent. A disclosure may not be made on the basis of a consent which: 

(1) Has expired: 

(2) On its face substantially fails to conform to any of the requirements set forth in paragraph (a) of 

this section; 

(3) Is known to have been revoked; or 
(4) Is known, or through a reasonable effort could be known, by the person holding the records to be 

materially false. 

(Approved by the Office of Management and Budget under control number 0930-0099) 

§ 2.32 Prohibition on redisclosure.

Notice to accompany disclosure. Each disclosure made with the patient's written consent must be 

accompanied by the following written statement: 

This information has been disclosed to you from records protected by Federal confidentiality rules (42 

C.F.R. Part 2). The Federal rules prohibit you from making any further disclosure of this information 

unless further disclosure is expressly permitted by the written consent of the person to whom it 

pertains or as otherwise permitted by 42 C.F.R. Part 2. A general authorization for the release of 

medical or other information is NOT sufficient for this purpose. The Federal rules restrict any use of 

the information to criminally investigate or prosecute any alcohol or drug abuse patient. 

[52 FR 21809, June 9, 1987; 52 FR 41997, Nov. 2, 1987] 

§ 2.33 Disclosures permitted with written consent. 

If a patient consents to a disclosure of his or her records under § 2.31, a program may disclose those 

records in accordance with that consent to any individual or organization named in the consent, 

except that disclosures to central registries and in connection with criminal justice referrals must meet 

the requirements of § § 2.34 and 2.35, respectively. 

§ 2.34 Disclosures to prevent multiple enrollments in detoxification and maintenance 

treatment programs. 

(a) Definitions. For purposes of this section: 

Central registry means an organization which obtains from two or more member programs patientidentifying information about individuals applying for maintenance treatment or detoxification 

treatment for the purpose of avoiding an individual's concurrent enrollment in more than one 

program. 

Detoxification treatment means the dispensing of a narcotic drug in decreasing doses to an individual 

in order to reduce or eliminate adverse physiological or psychological effects incident to withdrawal 

from the sustained use of a narcotic drug. 

Maintenance treatment means the dispensing of a narcotic drug in the treatment of an individual for 

dependence upon heroin or other morphine-like drugs. 

Member program means a detoxification treatment or maintenance treatment program which reports 

patient-identifying information to a central registry and which is in the same State as that central 

registry or is not more than 125 miles from any border of the State in which the central registry is 

located. 

(b) Restrictions on disclosure. A program may disclose patient records to a central registry or to any 

detoxification or maintenance treatment program not more than 200 miles away for the purpose of 

preventing the multiple enrollment of a patient only if: 

(1) The disclosure is made when: 

(i) The patient is accepted for treatment; 
(ii) The type or dosage of the drug is changed; or 

(iii) The treatment is interrupted, resumed or terminated. 

(2) The disclosure is limited to: 

(i) Patient-identifying information: 

(ii) Type and dosage of the drug; and 

(iii) Relevant dates. 

(3) The disclosure is made with the patient's written consent meeting the requirements of § 2.31, 

except that: 

(i) The consent must list the name and address of each central registry and each known detoxification 

or maintenance treatment program to which a disclosure will be made; and 

(ii) The consent may authorize a disclosure to any detoxification or maintenance treatment program 

established within 200 miles of the program after the consent is given without naming any such 

program. 

(c) Use of information limited to prevention of multiple enrollments. A central registry and any 

detoxification or maintenance treatment program to which information is disclosed to prevent multiple 

enrollments may not redisclose or use patient-identifying information for any purpose other than the 

prevention of multiple enrollments unless authorized by a court order under Subpart E of these 

regulations. 

(d) Permitted disclosure by a central registry to prevent a multiple enrollment. When a member 

program asks a central registry if an identified patient is enrolled in another member program and the 

registry determines that the patient is so enrolled, the registry may disclose—

(1) The name, address, and telephone number of the member program(s) in which the patient is 

already enrolled to the inquiring member program; and 

(2) The name, address, and telephone number of the inquiring member program to the member 

program(s) in which the patient is already enrolled. The member programs may communicate as 

necessary to verify that no error has been made and to prevent or eliminate any multiple enrollment. 

(e) Permitted disclosure by a detoxification or maintenance treatment program to prevent a multiple 

enrollment. A detoxification or maintenance treatment program which has received a disclosure under 

this section and has determined that the patient is already enrolled may communicate as necessary 

with the program making the disclosure to verify that no error has been made and to prevent or 

eliminate any multiple enrollment. 

§ 2.35 Disclosures to elements of the criminal justice system which have referred patients. 

(a) A program may disclose information about a patient to those persons within the criminal justice 

system which have made participation in the program a condition of the disposition of any criminal 

proceedings against the patient or of the patient's parole or other release from custody if: 

(1) The disclosure is made only to those individuals within the criminal justice system who have a 

need for the information in connection with their duty to monitor the patient's progress (e.g., a 

prosecuting attorney who is withholding charges against the patient, a court granting pretrial or 

posttrial release, probation or parole officers responsible for supervision of the patient); and 

(2) The patient has signed a written consent meeting the requirements of § 2.31 (except paragraph 

(a)(8) which is inconsistent with the revocation provisions of paragraph (c) of this section) and the 

requirements of paragraphs (b) and (c) of this section. 

(b) Duration of consent. The written consent must state the period during which it remains in effect. 

This period must be reasonable, taking into account: 

(1) The anticipated length of the treatment; 
(2) The type of criminal proceeding involved, the need for the information in connection with the final 

disposition of that proceeding, and when the final disposition will occur; and 

(3) Such other factors as the program, the patient, and the person(s) who will receive the disclosure 

consider pertinent. 

(c) Revocation of consent. The written consent must state that it is revocable upon the passage of a 

specified amount of time or the occurrence of a specified, ascertainable event. The time or occurrence 

upon which consent becomes revocable may be no later than the final disposition of the conditional 

release or other action in connection with which consent was given. 

(d) Restrictions on redisclosure and use. A person who receives patient information under this section 

may redisclose and use it only to carry out that person's official duties with regard to the patient's 

conditional release or other action in connection with which the consent was given. 

Subpart D—Disclosures Without Patient Consent 

§ 2.51 Medical emergencies. 

(a) General Rule. Under the procedures required by paragraph (c) of this section, patient-identifying 

information may be disclosed 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 

and which requires immediate medical intervention. 

(b) Special Rule. Patient-identifying information may be disclosed to medical personnel of the Food 

and Drug Administration (FDA) who assert a reason to believe that the health of any individual may be 

threatened by an error in the manufacture, labeling, or sale of a product under FDA jurisdiction, and 

that the information will be used for the exclusive purpose of notifying patients or their physicians of 

potential dangers. 

(c) Procedures. Immediately following disclosure, the program shall document the disclosure in the 

patient's records, setting forth in writing: 

(1) The name of the medical personnel to whom disclosure was made and their affiliation with any 

health care facility; 

(2) The name of the individual making the disclosure; 

(3) The date and time of the disclosure; and 

(4) The nature of the emergency (or error, if the report was to FDA). 

(Approved by the Office of Management and Budget under control number 0930-0099) 

§ 2.52 Research activities. 

(a) Patient-identifying information may be disclosed for the purpose of conducting scientific research if 

the program director makes a determination that the recipient of the patient-identifying information: 

(1) Is qualified to conduct the research; 

(2) Has a research protocol under which the patient-identifying information: 

(i) Will be maintained in accordance with the security requirements of § 2.16 of these regulations (or 

more stringent requirements); and 

(ii) Will not be redisclosed except as permitted under paragraph (b) of this section; and 
(3) Has provided a satisfactory written statement that a group of three or more individuals who are 

independent of the research project has reviewed the protocol and determined that: 

(i) The rights and welfare of patients will be adequately protected; and 

(ii) The risks in disclosing patient-identifying information are outweighed by the potential benefits of 

the research. 

(b) A person conducting research may disclose patient-identifying information obtained under 

paragraph (a) of this section only back to the program from which that information was obtained and 

may not identify any individual patient in any report of that research or otherwise disclose patient 

identities. 

[52 FR 21809, June 9, 1987, as amended at 52 FR 41997, Nov. 2, 1987] 

§ 2.53 Audit and evaluation activities. 

(a) Records not copied or removed. If patient records are not copied or removed, patient-identifying 

information may be disclosed in the course of a review of records on program premises to any person 

who agrees in writing to comply with the limitations on redisclosure and use in paragraph (d) of this 

section and who:

(1) Performs the audit or evaluation activity on behalf of: 

(i) Any Federal, State, or local governmental agency which provides financial assistance to the 

program or is authorized by law to regulate its activities; or 

(ii) Any private person which provides financial assistance to the program, which is a third party payer 

covering patients in the program, or which is a peer review organization performing a utilization or 

quality control review; or 

(2) Is determined by the program director to be qualified to conduct the audit or evaluation activities. 

(b) Copying or removal of records. Records containing patient-identifying information may be copied 

or removed from program premises by any person who: 

(1) Agrees in writing to: 

(i) Maintain the patient-identifying information in accordance with the security requirements provided 

in § 2.16 of these regulations (or more stringent requirements); 

(ii) Destroy all the patient-identifying information upon completion of the audit or evaluation; and 

(iii) Comply with the limitations on disclosure and use in paragraph (d) of this section; and 

(2) Performs the audit or evaluation activity on behalf of: 

(i) Any Federal, State, or local governmental agency which provides financial assistance to the 

program or is authorized by law to regulate its activities; or 

(ii) Any private person which provides financial assistance to the program, which is a third part payer 

covering patients in the program, or which is a peer review organization performing a utilization or 

quality control review. 

(c) Medicare or Medicaid audit or evaluation.

(1) For purposes of Medicare or Medicaid audit or evaluation under this section, audit or evaluation 

includes a civil or administrative investigation of the program by any Federal, State, or local agency 

responsible for oversight of the Medicare or Medicaid program and includes administrative 

enforcement, against the program by the agency, of any remedy authorized by law to be imposed as a 

result of the findings of the investigation. 

(2) Consistent with the definition of program in § 2.11, program includes an employee of, or provider 

of medical services under, the program when the employee or provider is the subject of a civil 

investigation or administrative remedy, as those terms are used in paragraph (c)(1) of this section. 
(3) If a disclosure to a person is authorized under this section for a Medicare or Medicaid audit or 

evaluation, including a civil investigation or administrative remedy, as those terms are used in 

paragraph (c)(1) of this section, then a peer review organization which obtains the information under 

paragraph (a) or (b) may disclose the information to that person but only for purposes of Medicare or 

Medicaid audit or evaluation. 

(4) The provisions of this paragraph do not authorize the agency, the program, or any other person to 

disclose or use patient-identifying information obtained during the audit or evaluation for any 

purposes other than those necessary to complete the Medicare or Medicaid audit or evaluation activity 

as specified in this paragraph. 

(d) Limitations on disclosure and use. Except as provided in paragraph (c) of this section, patientidentifying information disclosed under this section may be disclosed only back to the program from 

which it was obtained and used only to carry out an audit or evaluation purpose or to investigate or 

prosecute criminal or other activities, as authorized by a court order entered under § 2.66 of these 

regulations. 

Subpart E—Court Orders Authorizing Disclosure and Use 

§ 2.61 Legal effect of order. 

(a) Effect. An order of a court of competent jurisdiction entered under this subpart is a unique kind of 

court order. Its only purpose is to authorize a disclosure or use of patient information which would 

otherwise be prohibited by 42 U.S.C. 290ee-3, 42 U.S.C. 290dd-3 and these regulations. Such an 

order does not compel disclosure. A subpoena or a similar legal mandate must be issued in order to 

compel disclosure. This mandate may be entered at the same time as and accompany an authorizing 

court order entered under these regulations. 

(b) Examples. (1) A person holding records subject to these regulations receives a subpoena for those 

records: a response to the subpoena is not permitted under the regulations unless an authorizing 

court order is entered. The person may not disclose the records in response to the subpoena unless a 

court of competent jurisdiction enters an authorizing order under these regulations. 

(2) An authorizing court order is entered under these regulations, but the person authorized does not 

want to make the disclosure. If there is no subpoena or other compulsory process or a subpoena for 

the records has expired or been quashed, that person may refuse to make the disclosure. Upon the 

entry of a valid subpoena or other compulsory process the person authorized to disclose must 

disclose, unless there is a valid legal defense to the process other than the confidentiality restrictions 

of these regulations. 

[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987] 

§ 2.62 Order not applicable to records disclosed without consent to researchers, auditors 

and evaluators. 

A court order under these regulations may not authorize qualified personnel, who have received 

patient-identifying information without consent for the purpose of conducting research, audit or 

evaluation, to disclose that information or use it to conduct any criminal investigation or prosecution 

of a patient. However, a court order under § 2.66 may authorize disclosure and use of records to 

investigate or prosecute qualified personnel holding the records. 

§ 2.63 Confidential communications. 

(a) A court order under these regulations may authorize disclosure of confidential communications 

made by a patient to a program in the course of diagnosis, treatment, or referral for treatment only if: 
(1) The disclosure is necessary to protect against an existing threat to life or of serious bodily injury, 

including circumstances which constitute suspected child abuse and neglect and verbal threats against 

third parties; 

(2) The disclosure is necessary in connection with investigation or prosecution of an extremely serious 

crime, such as one which directly threatens loss of life or serious bodily injury, including homicide, 

rape, kidnapping, armed robbery, assault with a deadly weapon, or child abuse and neglect; or 

(3) The disclosure is in connection with litigation or an administrative proceeding in which the patient 

offers testimony or other evidence pertaining to the content of the confidential communications. 

§ 2.64 Procedures and criteria for orders authorizing disclosures for noncriminal purposes. 

(a) Application. An order authorizing the disclosure of patient records for purposes other than criminal 

investigation or prosecution may be applied for by any person having a legally recognized interest in 

the disclosure which is sought. The application may be filed separately or as part of a pending civil 

action in which it appears that the patient records are needed to provide evidence. An application 

must use a fictitious name, such as John Doe, to refer to any patient and may not contain or 

otherwise disclose any patient-identifying information unless the patient is the applicant or has given a 

written consent (meeting the requirements of these regulations) to disclosure or the court has ordered 

the record of the proceeding sealed from public scrutiny. 

(b) Notice. The patient and the person holding the records from whom disclosure is sought must be 

given: 

(1) Adequate notice in a manner which will not disclose patient-identifying information to other 

persons: and 

(2) An opportunity to file a written response to the application, or to appear in person, for the limited 

purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court 

order. 

(c) Review of evidence: Conduct of hearing. Any oral argument, review of evidence, or hearing on the 

application must be held in the judge's chambers or in some manner which ensures that patientidentifying information is not disclosed to anyone other than a party to the proceeding, the patient, or 

the person holding the record, unless the patient requests an open hearing in a manner which meets 

the written consent requirements of these regulations. The proceeding may include an examination by 

the judge of the patient records referred to in the application. 

(d) Criteria for entry of order. An order under this section may be entered only if the court determines 

that good cause exists. To make this determination the court must find that: 

(1) Other ways of obtaining the information are not available or would not be effective; and 

(2) The public interest and need for the disclosure outweigh the potential injury to the patient, the 

physician–patient relationship and the treatment services. 

(e) Content of order. An order authorizing a disclosure must: 

(1) Limit disclosure to those parts of the patient's record which are essential to fulfill the objective of 

the order. 

(2) Limit disclosure to those persons whose need for information is the basis for the order; and 
(3) Include such other measures as are necessary to limit disclosure for the protection of the patient, 

the physician–patient relationship and the treatment services; for example, sealing from public 

scrutiny the record of any proceeding for which disclosure of a patient's record has been ordered. 

§ 2.65 Procedures and criteria for orders authorizing disclosure and use of records to 

criminally investigate or prosecute patients. 

(a) Application. An order authorizing the disclosure or use of patient records to criminally investigate 

or prosecute a patient may be applied for by the person holding the records or by any person 

conducting investigative or prosecutorial activities with respect to the enforcement of criminal laws. 

The application may be filed separately, as part of an application for a subpoena or other compulsory 

process, or in a pending criminal action. An application must use a fictitious name such as John Doe, 

to refer to any patient and may not contain or otherwise disclose patient-identifying information 

unless the court has ordered the record of the proceeding sealed from public scrutiny. 

(b) Notice and hearing. Unless an order under § 2.66 is sought with an order under this section, the 

person holding the records must be given: 

(1) Adequate notice (in a manner which will not disclose patient-identifying information to third 

parties) of an application by a person performing a law enforcement function; 

(2) An opportunity to appear and be heard for the limited purpose of providing evidence on the 

statutory and regulatory criteria for the issuance of the court order; and 

(3) An opportunity to be represented by counsel independent of counsel for an applicant who is a 

person performing a law enforcement function. 

(c) Review of evidence: Conduct of hearings. Any oral argument, review of evidence, or hearing on the 

application shall be held in the judge's chambers or in some other manner which ensures that patientidentifying information is not disclosed to anyone other than a party to the proceedings, the patient, 

or the person holding the records. The proceeding may include an examination by the judge of the 

patient records referred to in the application. 

(d) Criteria. A court may authorize the disclosure and use of patient records for the purpose of 

conducting a criminal investigation or prosecution of a patient only if the court finds that all of the 

following criteria are met: 

(1) The crime involved is extremely serious, such as one which causes or directly threatens loss of life 

or serious bodily injury including homicide, rape, kidnapping, armed robbery, assault with a deadly 

weapon, and child abuse and neglect. 

(2) There is a reasonable likelihood that the records will disclose information of substantial value in 

the investigation or prosecution. 

(3) Other ways of obtaining the information are not available or would not be effective. 

(4) The potential injury to the patient, to the physician–patient relationship and to the ability of the 

program to provide services to other patients is outweighed by the public interest and the need for the 

disclosure. 

(5) If the applicant is a person performing a law enforcement function that: 

(i) The person holding the records has been afforded the opportunity to be represented by 

independent counsel; and 

(ii) Any person holding the records which is an entity within Federal, State, or local government has in 

fact been represented by counsel independent of the applicant. 
(e) Content of order. Any order authorizing a disclosure or use of patient records under this section 

must: 

(1) Limit disclosure and use to those parts of the patient's record which are essential to fulfill the 

objective of the order; 

(2) Limit disclosure to those law enforcement and prosecutorial officials who are responsible for, or are 

conducting, the investigation or prosecution, and limit their use of the records to investigation and 

prosecution of extremely serious crime or suspected crime specified in the application; and 

(3) Include such other measures as are necessary to limit disclosure and use to the fulfillment of only 

that public interest and need found by the court. 

[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987] 

§ 2.66 Procedures and criteria for orders authorizing disclosure and use of records to 

investigate or prosecute a program or the person holding the records. 

(a) Application. (1) An order authorizing the disclosure or use of patient records to criminally or 

administratively investigate or prosecute a program or the person holding the records (or employees 

or agents of that program or person) may be applied for by any administrative, regulatory, 

supervisory, investigative, law enforcement, or prosecutorial agency having jurisdiction over the 

program's or person's activities. 

(2) The application may be filed separately or as part of a pending civil or criminal action against a 

program or the person holding the records (or agents or employees of the program or person) in 

which it appears that the patient records are needed to provide material evidence. The application 

must use a fictitious name, such as John Doe, to refer to any patient and may not contain or 

otherwise disclose any patient-identifying information unless the court has ordered the record of the 

proceeding sealed from public scrutiny or the patient has given a written consent (meeting the 

requirements of § 2.31 of these regulations) to that disclosure. 

(b) Notice not required. An application under this section may, in the discretion of the court, be 

granted without notice. Although no express notice is required to the program, to the person holding 

the records, or to any patient whose records are to be disclosed, upon implementation of an order so 

granted any of the above persons must be afforded an opportunity to seek revocation or amendment 

of that order, limited to the presentation of evidence on the statutory and regulatory criteria for the 

issuance of the court order. 

(c) Requirements for order. An order under this section must be entered in accordance with, and 

comply with the requirements of, paragraphs (d) and (e) of § 2.64 of these regulations. 

(d) Limitations on disclosure and use of patient-identifying information: (1) An order entered under 

this section must require the deletion of patient-identifying information from any documents made 

available to the public. 

(2) No information obtained under this section may be used to conduct any investigation or 

prosecution of a patient, or be used as the basis for an application for an order under § 2.65 of these 

regulations. 

§ 2.67 Orders authorizing the use of undercover agents and informants to criminally 

investigate employees or agents of a program. 

(a) Application. A court order authorizing the placement of an undercover agent or informant in a 

program as an employee or patient may be applied for by any law enforcement or prosecutorial 
agency which has reason to believe that employees or agents of the program are engaged in criminal 

misconduct. 

(b) Notice. The program director must be given adequate notice of the application and an opportunity 

to appear and be heard (for the limited purpose of providing evidence on the statutory and regulatory 

criteria for the issuance of the court order), unless the application asserts a belief that: 

(1) The program director is involved in the criminal activities to be investigated by the undercover 

agent or informant; or 

(2) The program director will intentionally or unintentionally disclose the proposed placement of an 

undercover agent or informant to the employees or agents who are suspected of criminal activities. 

(c) Criteria. An order under this section may be entered only if the court determines that good cause 

exists. To make this determination the court must find: 

(1) There is reason to believe that an employee or agent of the program is engaged in criminal 

activity; 

(2) Other ways of obtaining evidence of this criminal activity are not available or would not be 

effective; and 

(3) The public interest and need for the placement of an undercover agent or informant in the 

program outweigh the potential injury to patients of the program, physicianBpatient relationships and 

the treatment services. 

(d) Content of order. An order authorizing the placement of an undercover agent or informant in a 

program must: 

(1) Specifically authorize the placement of an undercover agent or an informant; 

(2) Limit the total period of the placement to 6 months; 

(3) Prohibit the undercover agent or informant from disclosing any patient-identifying information 

obtained from the placement except as necessary to criminally investigate or prosecute employees or 

agents of the program; and 

(4) Include any other measures which are appropriate to limit any potential disruption of the program 

by the placement and any potential for a real or apparent breach of patient confidentiality; for 

example, sealing from public scrutiny the record of any proceeding for which disclosure of a patient's 

record has been ordered. 

(e) Limitation on use of information. No information obtained by an undercover agent or informant 

placed under this section may be used to criminally investigate or prosecute any patient or as the 

basis for an application for an order under § 2.65 of these regulations. 

Appendix B—Managed Care and Client 

Confidentiality 
As managed care plans proliferate across the country, alcohol and other drug (AOD) treatment 

providers and single State agencies have become increasingly concerned about the impact of these 

plans on client confidentiality. Managed care plans vary from State to State and from program to 

program, yet all require some communication between a client's AOD treatment provider and his or 

her managed care plan. 

Some managed care plans require client information from treatment programs to perform 

"gatekeeping" functions—preapproving treatment plans and monitoring admissions and lengths of 

stay. Other managed care programs, such as health maintenance organizations (HMOs) that provide 

primary health care and AOD treatment services either directly or through network providers, require 

information to coordinate care as well as to perform gate-keeping functions. 

Depending on the purpose of the communication and the role of the managed care provider, different 

issues relating to confidentiality arise. This appendix addresses the ways in which AOD treatment 

programs, under the Federal confidentiality law and regulations, may communicate with managed care 

providers while still protecting clients' confidentiality rights. Also discussed are the confidentiality 

issues that programs have to consider as they explore ways to restructure the delivery of AOD 

treatment in a managed care environment. This appendix provides answers for the eight most 

frequently asked questions about managed care and client confidentiality. 

1. What is the overall relationship between the Federal confidentiality law and 

regulations (42 U.S.C. Sec. 290dd-2; 42 C.F.R. Part 2) and managed care 

plans?

The Federal confidentiality law and regulations prohibit Federally assisted AOD programs from 

disclosing any records or other information about any patient except under certain specified 

conditions. Programs that are covered by the regulations are those that, in whole or in part, provide 

AOD diagnosis, treatment, or referral for treatment. Thus, programs that are covered by the 

regulations cannot disclose any "patient-identifying information" (i.e., any information that would 

identify a client as having an AOD problem or receiving AOD services) to managed care plans unless 

the specific conditions laid out in the regulations are met. 

With the advent of managed care, many health care providers that have not traditionally fallen under 

the Federal confidentiality regulations now meet the definition of a program that must follow the 

regulations. For example, some for-profit AOD treatment programs have only accepted payment from 

insurance companies or patients themselves. These programs do not receive Federal assistance of any 

kind, either directly or indirectly, and, unless required to do so by the State where they do business, 

have not had to follow the Federal regulations. Increasingly, however, many of these programs have 

joined managed care networks, such as HMOs, that do receive some Federal funding. Consequently, 

these treatment programs now indirectly receive Federal funds and must follow the regulations. 

Similarly, many managed care organizations, such as HMOs, that have not traditionally had to follow 

the regulations are now providing the type of service and receiving the type of Federal assistance that 

bring them under the regulations. Many of these plans, typically HMOs, are beginning to provide AOD 

treatment directly or are performing assessments and diagnoses and referring patients for treatment. 

In addition, because plans that have historically accepted only privately insured patients are, in 

growing numbers, becoming part of Medicaid managed care and received Federally assisted Medicaid 

payments, they are now receiving Federal assistance. Thus, they too have to follow the regulations 

whenever they make a disclosure that involves patient-identifying information. 

2. What exceptions to the confidentiality law and regulations apply when a 

treatment program wishes to communicate with a managed care entity?

Depending on the purpose of the disclosure and the relationship between the treatment program and 

the managed care entity, several options, or "exceptions," under the Federal confidentiality 

regulations may enable programs to disclose client information to managed care providers. These 
options include written consent, a qualified service organization agreement (QSOA), audit or 

evaluation, internal communications, and medical emergency. 

(a) Proper consent 

Treatment programs may make a disclosure to a managed care provider if the client signs a valid 

consent form. The consent form must comply with the requirements of § 2.31 of the Federal 

confidentiality regulations and must be accompanied by the notice prohibiting redisclosure that is 

required by § 2.32. 

To protect their clients' rights, programs are advised to consult with their clients' managed care 

providers whenever possible to ascertain how they intend to use the information. Despite the 

prohibition on redisclosure, managed care providers frequently redisclose to third parties (e.g., 

insurance companies, other health care providers, government agencies) information that identifies 

the client as having received AOD services. 

If the program learns that the managed care provider will be redisclosing information, then it may 

decide to draft the original consent form in such a way that permits the redisclosure by the managed 

care agent. This helps ensure that the client is truly making an informed decision about whether to 

consent to the disclosure. Programs also have the option of drafting a consent form that allows for 

three-way communication (e.g., a situation in which the treatment program, the managed care 

provider, and another health care provider need to discuss and coordinate the client's care), as long as 

the purpose for the disclosure and the nature of the information to be disclosed are the same. 

(b) Qualified service organization agreement 

A treatment program may enter into a QSOA with a managed care provider if the managed care 

provider renders the type of service that qualifies it as a "service organization." Under § 2.11 of the 

regulations, a "qualified service organization" (QSO) is a person or agency that provides services to 

the program, such as legal, medical, accounting, laboratory analyses, or other professional services. 

To become a QSO, an organization must agree in writing to (1) follow the Federal rules in handling the 

information it receives from the AOD program and (2) challenge in court any unauthorized attempt to 

obtain that information, as a covered AOD program must also do. Once the agreement is signed, the 

treatment program may freely communicate information from patient records to the QSO without 

patient consent—but only the information that is needed by the QSO in order to provide services to 

the program. 

Thus, if a managed care program provides a service that qualifies it as a service organization, as 

defined in § 2.11, and if it is willing to sign a QSOA, then the treatment program may give the 

managed care provider the information it needs to perform its services without the client's consent. It 

is therefore crucial to look at the type of service being provided by a managed care entity to 

determine whether it is, in fact, a QSO. The following examples, depicting the most frequent managed 

care functions, illustrate the point: 

A. The ABC insurance company, a third-party payer, uses a managed care provider to 

determine whether it should pay for treatment. The managed care provider requires 

specific information from the program in order to make its determinations. 

A treatment program cannot enter into a QSOA with a managed care provider in this 

situation. Reimbursement for treatment is not a "service" being provided to the 

treatment program within the above definition of a service organization. Thus, to 

make disclosures to a managed care company for the purpose of receiving 

authorization and reimbursement for treatment, a program has to obtain the 

patient's written consent, as discussed above. 
B. An HMO managed care provider requires all its members who need AOD treatment 

services to come to its facility to be assessed. If a member is assessed as needing 

treatment, then he or she will either be seen at the HMO or referred to an outside 

treatment provider, depending on the diagnosis. 

An HMO that conducts assessments for an AOD program is providing a service. However, the 

HMO cannot sign a QSOA with the program it is assisting if it is also a "program" that falls 

under the Federal confidentiality regulations. This is because the U.S. Department of Health 

and Human Services (DHHS), the agency empowered to interpret and enforce the Federal 

confidentiality law and regulations, has ruled that a program that falls under the Federal 

confidentiality regulations may not be considered a "service organization" except in limited 

circumstances. In 1978, DHHS issued an opinion letter stating that a QSOA could only be 

signed between two programs covered by the regulations if one program (the "service 

organization") was providing a service other than an AOD service (Legal Opinion No. 78-27, 

issued December 6, 1978, by the Office of the General Counsel, Public Health Division, DHHS). 

Thus, if this HMO is covered by the regulations (i.e., if it receives Federal assistance and it 

provides AOD diagnosis, treatment, or referral for treatment), then it cannot be considered a 

QSO because it is performing an AOD treatment service—that is, conducting assessments—for 

the treatment program. 

If the HMO does not fall under the regulations (i.e., if it receives no Federal assistance of any 

kind), then the outside treatment program and the HMO can enter into a QSOA. 

C. Individuals enrolled in the ABC managed care program can receive treatment from 

any certified AOD treatment programs but must be seen by the physicians in the 

managed care program's network for primary health care services. This might occur 

in three ways:

if the managed care provider has physicians on staff;

if the managed care provider has a preferred provider list of physicians and allows its 

patients to receive health care services from physicians on that list without the 

managed care provider's approval; or 

if the managed care provider has a contractual relationship with the physicians in its 

network, but patients cannot be seen by those physicians without a referral from the 

managed care plan.

Medical services are clearly the type of services that can qualify an organization as a QSO. In the first 

example, because the managed care provider is itself rendering medical services to treatment 

program clients, it can be considered a "service organization." Thus, a QSOA can be signed between 

the treatment program and the managed care provider for the provision of health care services to the 

treatment program's clients. The treatment program should make sure that the QSOA specifies the 

nature of the service to be provided by the managed care program, so it can limit how the managed 

care program can use client information.

In the second two examples, the managed care providers do not provide primary health care services 

directly; instead, they contract out for those services. Because treatment providers in the second 

example do not need to involve the managed care provider when referring clients for health care 

services, they have no need for a QSOA with the managed care provider. Instead, they can sign 

QSOAs with the treating health care providers. Should the health care providers need to give 

information to the managed care provider in order to get reimbursed for services rendered, under the 

terms of the QSOA, they cannot not reveal any information they received from the treatment 

providers that would identify referred clients as having AOD problems or receiving AOD services. 
In the third example, the managed care provider is providing a service to the treatment program, that 

is, referral for primary care services for its clients. Therefore, the treatment program can sign a QSOA 

with the managed care provider for the provision of referral services. Should the need exist, the 

treatment program can also sign QSOAs with the health care providers who are actually treating its 

clients. However, as in the second example, neither the managed care provider nor the physicians 

would be allowed to share AOD patient-identifying information received from the treatment programs 

with each other. Instead, they would have to use one of the three methods described in the preceding 

paragraph. 

(c) Internal communications 

In some circumstances, HMOs and other managed care providers directly provide AOD treatment, and 

thus the treatment program and the managed care provider are one entity. The Federal regulations do 

permit AOD records to be shared between program personnel or with "an entity that has direct 

administrative control over the program" if the communication occurs "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" (§ 2.12(c)(3)). 

Disclosures between an AOD unit and other parts of a managed care program are authorized without 

patient consent if those disclosures are necessary to provide the AOD services. These might include 

communications to the managed care provider's central-billing or record-keeping departments or 

laboratory. 

(d) Medical emergency 

In certain circumstances, disclosures may also be made by treatment providers to their clients' 

managed care providers to the extent necessary to meet a bona fide "medical emergency" affecting 

the patient or any other person (§ 2.51). The medical emergency exception authorizes a program to 

disclose patient-identifying information 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 and which requires immediate medical intervention" (§ 2.51(a)). 

Thus, if a managed care program provides direct health care services, it can clearly be seen as 

"medical personnel" and can receive information from a treatment program when a client's condition 

poses an immediate threat to his or her health or that of others and requires immediate medical 

intervention. 

The same is not true, however, if the managed care provider does not directly provide health care 

services but rather merely pays for the emergency care. If a managed care provider allows clients to 

receive emergency care at an emergency room but requires notification within a specified period of 

time, then the managed care provider is acting as a third-party payer and not a treatment provider 

and cannot receive information from a treatment program under the medical emergency exception. 

However, medical personnel who treat the client for the emergency can contact the managed care 

provider for the purpose of getting reimbursed for the services rendered, even if that communication 

reveals that the client has an AOD problem. The restrictions on disclosures under the Federal 

confidentiality regulations do not apply to medical personnel who receive information from treatment

programs for the purpose of treating a medical emergency (§ 2.12(d)(2)). 

(e)Audit and evaluation 

Federal, State, or local government agencies that provide financial assistance to a program and 

managed care providers that are third-party payers covering patients in the program may examine 

patient records for the purpose of performing an audit or evaluation of the program (§ 2.53). This 

"audit-and-evaluation" exception is a narrow one, designed only to permit financial and programmatic 

evaluation of a program's functions. 
If a managed care provider wishes to see patient records to preauthorize or pay for treatment, then it 

may not do so without obtaining the client's consent. Such a review is not for determining how the 

program is functioning financially or otherwise and thus does not fit within the audit-and-evaluation 

exception. 

Any managed care organization or agency that conducts an audit or evaluation must agree in writing 

that it will redisclose patient-identifying information only (1) back to the program, (2) pursuant to a 

court order to investigate or prosecute the program (not a patient), or (3) to a government agency 

that is overseeing a Medicare or Medicaid audit or evaluation (§ 2.53(c), (d)). 

3. In general, what kinds of records should AOD providers be willing to share 

with a managed care entity if the appropriate exceptions are in effect?

Managed care organizations request information for many different reasons. As noted above, managed 

care plans sometime require client information from treatment programs to perform "gatekeeping" 

functions—preapproving treatment plans and monitoring admissions and lengths of stay. At other 

times, managed care programs require information to coordinate care or to document that the 

patient's treatment is reimbursable. 

Managed care entities appear to be requesting ever greater amounts of information about clients both 

before they approve treatment and as treatment progresses. Some managed care plans ask to see 

clients' entire files, sometimes dating back years. Whenever information is shared with insurance 

carriers and managed care entities, significant dangers arise to patient privacy. Many managed care 

plans, especially those that are part of private insurance companies, routinely share information 

through vast computerized networks. 

For these reasons, AOD programs making disclosures to managed care entities should try to negotiate 

a more limited disclosure because the regulations limit even consented disclosures to only that 

information necessary to meet the intended purpose (§ 2.13(a)). Programs can often convince 

insurance companies to be satisfied with less information than they initially sought. 

For example, determinations of eligibility for third-party payments often can be made without 

extensive disclosure of the patient's clinical record. Restricting disclosure to reasonably necessary 

information means that the program should communicate only the minimum amount of information 

required to show that the patient has received treatment and that such treatment is reimbursable. If 

the managed care entity asks for more detail, then the treatment program should question the 

necessity of divulging further information and, if necessary, appeal the request for additional 

information within the plan or to the State insurance department. Some States now regulate the 

actions of managed care entities. Of course, if a managed care plan insists on additional 

documentation before approving admission or processing a claim, its action is in accordance with State 

law, and the patient consents, then the program may have little choice but to comply. 

4. If a client who is covered by a managed care payer is mandated into AOD 

treatment, must the managed care company pay for the service that is 

mandated? 

This is a complicated question. If an insurance company or a managed care plan provides coverage 

that includes reimbursement for AOD treatment that is "medically necessary," then its decision to 

reimburse should be based on whether the treatment being mandated meets that criterion and not on 

the referral source. If a managed care plan takes the position that any care mandated by court is not, 

by definition, medically necessary, then that decision most likely violates the terms and conditions of 

its contract with the member and should be appealed. 

Some managed care plans, however, will not explicitly state that they will not reimburse for mandated 

services but set up procedures that virtually ensure that result. For example, some managed care 

plans will not accept the assessment of intermediate sanctions programs or other assessors who are 
outside of the managed care network. Yet, at the same time, the managed care plan will not come to 

court or jail to perform its own assessments, creating a "Catch 22" in which offenders cannot be 

diverted or released unless they have a program to go to but cannot be assessed and treated unless 

they have been diverted or released. 

Practices such as these threaten to disrupt tremendously the criminal justice system and family courts 

because these systems increasingly rely on AOD treatment both to rehabilitate offenders and to 

reduce unnecessary reliance on incarceration. Barring State legislation or regulation that requires 

managed care plans to pay for court-mandated services, patients should be advised to appeal any 

denial of reimbursement for such services and, if unsuccessful, file complaints with their State health 

and/or insurance department. 

5. When clients are mandated into AOD, who/what determines which records 

are to be made available to the managed care provider? The mandating 

agency (i.e., court) or the AOD program? 

Courts mandating individuals into treatment generally will not have any interest in directing what 

records should be made available to managed care providers. Courts will often, however, have an 

interest in receiving periodic reports from the AOD program about the progress of the individual 

mandated into treatment. In such a situation, the program should get the client's consent to disclose 

the information requested to the court. This usually includes information about the client's prognosis, 

attendance or lack of attendance at treatment sessions, and his or her cooperation with the treatment 

program. 

If a managed care plan is reimbursing an AOD program for services rendered to clients mandated into 

treatment, then that managed care plan will have the same interest in obtaining information about 

those mandated clients as they have in nonmandated clients. As noted above, this may involve the 

managed care plan asking for more information than the program believes is necessary to accomplish 

the disclosure's purpose. The program should then question the necessity of making such an extensive 

disclosure and try to negotiate a more limited disclosure with the managed care company. This may 

include the initial evaluation and diagnosis; a summary of the treatment plan; the patient's 

attendance, progress, and compliance; and the discharge plan. 

6. What disclosures are permitted by the confidentiality law and regulations 

when an AOD program contacts a managed care company to certify the 

client's eligibility? 

If the managed care provider requires an AOD program to get preauthorization before providing 

treatment, the program must obtain the client's consent before contacting the managed care provider. 

The Federal confidentiality regulations define the term "patient" as "any individual who has applied for 

or been given diagnosis or treatment for alcohol or drug abuse" (§ 2.11). Thus, once the client applies 

to the program for services, he or she is protected by the Federal confidentiality law, and information 

that would identify the client as an alcohol or drug abuser cannot be divulged by the program without 

his or her consent. Because calling a managed care plan to ask whether John Smith has coverage for 

AOD treatment is a disclosure that John Smith has applied for such services, Mr. Smith's consent is 

required before the program can make the call. 

7. As AOD programs form networks to provide a range of services to clients of 

managed care entities, how do the components of the network share 

information? When and how do the networks share information with the 

managed care entity? 

As AOD programs explore ways to restructure the service of the services so that they can adapt to the 

managed care environment, many are beginning to form networks. These networks are being 
configured in different ways. Depending on how these networks are designed, different options under 

the Federal regulations will enable the components to share information. 

For example, some AOD programs are coming together and setting up whole new programs that offer 

a full range of treatment services. These programs are not maintaining their own unique identities but 

rather are merging and creating a new identity. The different components of this new program can 

discuss patient-identifying information with each other following the internal communications 

provisions set out in the Federal regulations and explained in question 2. 

Thus, if one component is responsible for the initial intake and referral to the appropriate service 

component, and if the different parts of the agency meet periodically to discuss a patient's progress 

and decide that a different approach may be warranted, and if this information is given to the billing 

department so that the program can get paid by the managed care plan, then all of these disclosures 

are permitted under the internal communications option described in the Federal regulations because 

the recipients in each case need the information to provide the AOD service. 

Other programs are forming more loosely connected networks. They are not giving up their own 

separate identities but rather are working together to develop the kind of comprehensive service 

package that is attractive to managed care entities. Because these are all separate programs, the 

internal communication option is not available to such a network. Nor can these programs sign QSOAs 

with each other, because, as noted above, two programs that are covered by the regulations cannot 

sign a QSOA for the purpose of providing an AOD service. 

Thus, the only option available to such a network is the use of consent forms. Rather than each 

program having to draft its own consent form before it can disclose information to the other network 

members, however, the regulations do allow for the signing of multiparty consent forms. The key to 

such a form is making sure that it authorizes each party listed on the form to disclose the information 

specified to all the other parties on the form. For example, a patient can sign a consent form that 

states "the following treatment programs are authorized to disclose to and communicate with one 

another" the following specified information "for the purpose of coordinating my care and providing my 

treatment." 

If the network is using a multiparty consent form, it must make sure that the same kind and amount 

of information will be shared, for the same common purpose, among all those authorized to receive 

and/or disclose that information. 

When and how the various types of networks can share information with the managed care entity is 

discussed in question 2. 

8. What are some of the other consumer rights that patients of AOD programs 

should know regarding managed care? 

Besides the confidentiality protections afforded to patients in AOD programs, some States have passed 

legislation regulating managed care practices and containing numerous consumer protections. 

Depending on the legislation, the following protections exist for patients regarding managed care: 

plans must use nationally recognized assessment criteria and must disclose the 

criteria, standards, procedures, and methods used in making determinations;

managed care plans are prohibited from offering incentives to their employees to 

increase the number of adverse determinations;

initial decisions and decisions on appeal must be made by reviewers who have an 

expertise in the field they are reviewing;
plans must make decisions within certain specified times;

plans must ensure timely telephone access to review agents and timely access to 

care;

plans must provide complete information about their health plan, including 

information about the package of benefits, choice of provider, and limits on service 

and out-of-pocket costs, including copayments; and 

plans must specify the process by which patients are notified of adverse 

determinations and the process by which patients can file grievances and appeal 

adverse determinations; in some States, patients have a right to an independent 

review.