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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   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TAP 18: Checklist for Monitoring Alcohol and Other Drug Confidentiality Compliance
Checklist for Monitoring Alcohol and Other Drug Confidentiality Compliance
Technical Assistance Publication Series
18
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESPublic Health ServiceSubstance
Abuse and Mental Health Services AdministrationCenter for Substance Abuse
Treatment
Rockwall II, 5600 Fisher LaneRockville, 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 DirectorCenter 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?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.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.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.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.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.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.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.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.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.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:
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
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?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?"
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.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; andpermitting 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 FORMSIssue: Was the disclosure authorized by a valid consent
form?
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.Is the patient a minor?  Y__ N__If "yes," go to question 8.  
If "no," go to question 11.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.Has the patient been adjudicated incompetent?  Y__ N__If "yes," go to question 3-a.If "no," go to question 4.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.Is the patient deceased?  Y__ N__If "yes," go to question 4-a.If "no," go to question 5.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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;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.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;  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.)
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;  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; andthe signature of the patient.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)).
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)).
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)).
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)).A client should never sign or be requested to sign a consent form before
all of the blanks have been filled in.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 COMMUNICATIONSIssue:Was the disclosure an authorized internal
communication?
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.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 patient-identifying
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 AGREEMENTSIssue: Was the disclosure made pursuant to a qualified service
organization agreement (QSOA)?
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.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.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.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.)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 EMERGENCIESIssue: Was the disclosure made properly in a medical
emergency?
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.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 PERSONNELIssue: Was the disclosure made in response to a crime on
program premises or against program personnel?
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.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 NEGLECTIssue: Was the disclosure authorized by the child abuse reporting rule?
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.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.  RESEARCHIssue: Was the disclosure authorized under the research
rule?
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.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.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 EVALUATIONIssue:Was the disclosure authorized under the audit and
evaluation rule?
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.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.Did the auditor or evaluator agree in writing that it would
redisclose patient-identifying 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.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.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.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.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
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 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 ORDERSIssue:  Was the disclosure made in response to a valid court
order?
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.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.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.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.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.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.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?
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 patient-identifying information.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; andtry 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
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.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.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
Did an entity with administrative control over a program
redisclose patient-identifying 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.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
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.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
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
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.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
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.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.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.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. 290dd-3. 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.
Recordsmeans 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, school-based 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
patient-identifying 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
patient-identifying 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.
I (name of patient)  o Request o
Authorize:
(name or general designation of program which is to make the disclosure)
To disclose: (kind and amount of information to be disclosed)
To: (name or title of the person or organization to which disclosure is to
be made)
For (purpose of the disclosure)
Date (on which this consent is signed)
Signature of patient
Signature of parent or guardian (where required)
Signature of person authorized to sign in lieu of the patient (where
required)
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 patient-identifying 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, patient-identifying 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 patient-identifying 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 patient-identifying
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.
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.
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:
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.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.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; orif 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)).
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.
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.
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.
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.
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.
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; andplans 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.Table of Contents Top of Page


					
					
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TAP 18: Checklist for Monitoring Alcohol and Other Drug Confidentiality Compliance
Checklist for Monitoring Alcohol and Other Drug Confidentiality Compliance
Technical Assistance Publication Series
18
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESPublic Health ServiceSubstance
Abuse and Mental Health Services AdministrationCenter for Substance Abuse
Treatment
Rockwall II, 5600 Fisher LaneRockville, 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 DirectorCenter 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?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.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.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.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.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.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.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.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.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.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:
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
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?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?"
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.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; andpermitting 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 FORMSIssue: Was the disclosure authorized by a valid consent
form?
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.Is the patient a minor?  Y__ N__If "yes," go to question 8.  
If "no," go to question 11.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.Has the patient been adjudicated incompetent?  Y__ N__If "yes," go to question 3-a.If "no," go to question 4.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.Is the patient deceased?  Y__ N__If "yes," go to question 4-a.If "no," go to question 5.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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;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.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;  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.)
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;  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; andthe signature of the patient.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)).
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)).
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)).
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)).A client should never sign or be requested to sign a consent form before
all of the blanks have been filled in.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 COMMUNICATIONSIssue:Was the disclosure an authorized internal
communication?
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.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 patient-identifying
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 AGREEMENTSIssue: Was the disclosure made pursuant to a qualified service
organization agreement (QSOA)?
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.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.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.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.)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 EMERGENCIESIssue: Was the disclosure made properly in a medical
emergency?
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.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 PERSONNELIssue: Was the disclosure made in response to a crime on
program premises or against program personnel?
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.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 NEGLECTIssue: Was the disclosure authorized by the child abuse reporting rule?
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.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.  RESEARCHIssue: Was the disclosure authorized under the research
rule?
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.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.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 EVALUATIONIssue:Was the disclosure authorized under the audit and
evaluation rule?
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.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.Did the auditor or evaluator agree in writing that it would
redisclose patient-identifying 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.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.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.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.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
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 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 ORDERSIssue:  Was the disclosure made in response to a valid court
order?
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.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.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.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.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.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.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?
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 patient-identifying information.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; andtry 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
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.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.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
Did an entity with administrative control over a program
redisclose patient-identifying 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.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
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.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
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
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.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
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.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.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.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. 290dd-3. 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.
Recordsmeans 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, school-based 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
patient-identifying 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
patient-identifying 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.
I (name of patient)  o Request o
Authorize:
(name or general designation of program which is to make the disclosure)
To disclose: (kind and amount of information to be disclosed)
To: (name or title of the person or organization to which disclosure is to
be made)
For (purpose of the disclosure)
Date (on which this consent is signed)
Signature of patient
Signature of parent or guardian (where required)
Signature of person authorized to sign in lieu of the patient (where
required)
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 patient-identifying 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, patient-identifying 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 patient-identifying 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 patient-identifying
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.
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.
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:
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.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.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; orif 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)).
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.
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.
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.
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.
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.
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; andplans 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.Table of Contents Top of Page


					
					
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TAP 18: Checklist for Monitoring Alcohol and Other Drug Confidentiality Compliance
Checklist for Monitoring Alcohol and Other Drug Confidentiality Compliance
Technical Assistance Publication Series
18
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESPublic Health ServiceSubstance
Abuse and Mental Health Services AdministrationCenter for Substance Abuse
Treatment
Rockwall II, 5600 Fisher LaneRockville, 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 DirectorCenter 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?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.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.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.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.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.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.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.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.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.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:
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
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?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?"
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.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; andpermitting 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 FORMSIssue: Was the disclosure authorized by a valid consent
form?
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.Is the patient a minor?  Y__ N__If "yes," go to question 8.  
If "no," go to question 11.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.Has the patient been adjudicated incompetent?  Y__ N__If "yes," go to question 3-a.If "no," go to question 4.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.Is the patient deceased?  Y__ N__If "yes," go to question 4-a.If "no," go to question 5.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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;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.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;  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.)
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;  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; andthe signature of the patient.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)).
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)).
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)).
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)).A client should never sign or be requested to sign a consent form before
all of the blanks have been filled in.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 COMMUNICATIONSIssue:Was the disclosure an authorized internal
communication?
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.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 patient-identifying
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 AGREEMENTSIssue: Was the disclosure made pursuant to a qualified service
organization agreement (QSOA)?
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.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.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.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.)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 EMERGENCIESIssue: Was the disclosure made properly in a medical
emergency?
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.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 PERSONNELIssue: Was the disclosure made in response to a crime on
program premises or against program personnel?
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.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 NEGLECTIssue: Was the disclosure authorized by the child abuse reporting rule?
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.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.  RESEARCHIssue: Was the disclosure authorized under the research
rule?
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.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.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 EVALUATIONIssue:Was the disclosure authorized under the audit and
evaluation rule?
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.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.Did the auditor or evaluator agree in writing that it would
redisclose patient-identifying 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.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.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.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.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
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 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 ORDERSIssue:  Was the disclosure made in response to a valid court
order?
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.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.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.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.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.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.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?
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 patient-identifying information.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; andtry 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
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.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.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
Did an entity with administrative control over a program
redisclose patient-identifying 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.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
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.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
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
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.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
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.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.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.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. 290dd-3. 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.
Recordsmeans 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, school-based 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
patient-identifying 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
patient-identifying 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.
I (name of patient)  o Request o
Authorize:
(name or general designation of program which is to make the disclosure)
To disclose: (kind and amount of information to be disclosed)
To: (name or title of the person or organization to which disclosure is to
be made)
For (purpose of the disclosure)
Date (on which this consent is signed)
Signature of patient
Signature of parent or guardian (where required)
Signature of person authorized to sign in lieu of the patient (where
required)
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 patient-identifying 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, patient-identifying 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 patient-identifying 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 patient-identifying
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.
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.
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:
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.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.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; orif 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)).
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.
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.
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.
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.
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.
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; andplans 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.Table of Contents Top of Page


					
					
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