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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 CFR 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' Administraton 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:
(1) 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 program. The restrictions on dis in these regulations communications
tween 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
(1) 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
(1) 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 pro
gram, 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:
(1) Third party payers with regard to records disclosed to them by federally assisted alcohol or drug abuse programs;
(11) Entities having direct administrative control over programs with regard to information communicated to them by the program under $2.12(C)(3); and
(iii) Persons who receive patient records directly from a federally assisted alcohol or drug abuse program and who are notified of the restrictions on redisclosure of the records in accordance with $2.32 of these regulations.
(e) Explanation of applicability (1) Coverage. These regulations cover any information (including information on referral and intake) about alcohol and drug abuse patients obtained by a program (as the terms “patient” and “program" are defined in $2.11) if the program is federally assisted in any manner described in $2.12(b). Coverage includes, but is not limited to, those treatment or rehabilitation programs, employee assistance programs, programs within general hospitals, schoolbased programs, and private practitioners who hold themselves out as providing, and provide alcohol or drug abuse diagnosis, treatment, or referral for treatment. However, these regulations would not apply, for example, to emergency room personnel who refer a patient to the intensive care unit for an apparent overdose, unless the primary function of such personnel is the provision of alcohol or drug abuse diagnosis, treatment or referral and they are
identified as providing such services or (ii) A diagnosis of drug overdose or the emergency room has promoted it- alcohol intoxication which clearly self to the community as a provider of shows that the individual involved is such services.
not an alcohol or drug abuser (e.g., in(2) Federal assistance to program re
voluntary ingestion of alcohol or drugs quired. If a patient's alcohol or drug
or reaction to a prescribed dosage of abuse diagnosis, treatment, or referral
ugs). for treatment is not provided by a pro- (52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, gram which is federally conducted, reg- 1987, as amended at 60 FR 22297, May 5, 1995) ulated or supported in a manner which constitutes Federal assistance under $ 2.13 Confidentiality restrictions. $2.12(b), that patient's record is not (a) General. The patient records to covered by these regulations. Thus, it which these regulations apply may be is possible for an individual patient to disclosed or used only as permitted by benefit from Federal support and not these regulations and may not otherbe covered by the confidentiality regu- wise be disclosed or used in any civil, lations because the program in which criminal, administrative, or legislative the patient is enrolled is not federally proceedings conducted by any Federal, assisted as defined in $2.12(b). For ex- State, or local authority. Any discloample, if a Federal court placed an in- sure made under these regulations dividual in a private for-profit program
must be limited to that information and made a payment to the program on
which is necessary to carry out the behalf of that individual, that patient's purpose of the disclosure. record would not be covered by these
(b) Unconditional compliance required. regulations unless the program itself
The restrictions on disclosure and use received Federal assistance as defined
in these regulations apply whether the by $2.12(b).
holder of the information believes that (3) Information to which restrictions are
the person seeking the information alapplicable. Whether a restriction is on
ready has it, has other means of obuse or disclosure affects the type of in
taining it, is a law enforcement or
other official, has obtained a subpoena, formation which may be available. The
or asserts any other justification for a restrictions on disclosure apply to any
disclosure or use which is not perinformation which would identify a pa
mitted by these regulations. tient as an alcohol or drug abuser. The
(c) Acknowledging the presence of parestriction on use of information to
tients: Responding to requests. (1) The bring criminal charges against a pa
presence of an identified patient in a tient for a crime applies to any information obtained by the program for
facility or component of a facility
which is publicly identified as a place the purpose of diagnosis, treatment, or
where only alcohol or drug abuse diagreferral for treatment of alcohol or
nosis, treatment, or referral is provided drug abuse. (Note that restrictions on
may be acknowledged only if the pause and disclosure apply to recipients
tient's written consent is obtained in of information under $2.12(d).)
accordance with subpart C of these reg(4) How type of diagnosis affects cov
ulations or if an authorizing court erage. These regulations cover any order is entered in accordance with record of a diagnosis identifying a pa- subpart E of these regulations. The tient as an alcohol or drug abuser
regulations permit acknowledgement which is prepared in connection with
of the presence of an identified patient the treatment or referral for treatment
in a facility or part of a facility if the of alcohol or drug abuse. A diagnosis facility is not publicy identified as prepared for the purpose of treatment only an alcohol or drug abuse diagor referral for treatment but which is nosis, treatment or referral facility, not so used is covered by these regula- and if the acknowledgement does not tions. The following are not covered by reveal that the patient is an alcohol or these regulations:
drug abuser. (i) Diagnosis which is made solely for (2) Any answer to a request for a disthe purpose of providing evidence for closure of patient records which is not use by law enforcement authorities; or permissible under these regulations
must be made in a way that will not af- nor's application for treatment may be firmatively reveal that an identified communicated to the minor's parent individual has been, or is being diag- guardian, or other person authorized nosed or treated for alcohol or drug under State law to act in the minor's abuse. An inquiring party may be given behalf only if: a copy of these regulations and advised (i) The minor has given written conthat they restrict the disclosure of al- sent to the disclosure in accordance cohol or drug abuse patient records, with subpart C of these regulations or but may not be told affirmatively that (11) The minor lacks the capacity to the regulations restrict the disclosure make a rational choice regarding such of the records of an identified patient. consent as judged by the program di. The regulations do not restrict a dis- rector under paragraph (d) of this secclosure that an identified individual is tion. not and never has been a patient.
(d) Minor applicant for services lacki
capacity for rational choice. Facts rel$ 2.14 Minor patients.
evant to reducing a threat to the life or (a) Definition of minor. As used in physical well being of the applicant or these regulations the term “minor" any other individual may be disclosed means a person who has not attained to the parent, guardian, or other perthe age of majority specified in the ap- son authorized under State law to act plicable State law, or if no age of ma
in the minor's behalf if the program dijority is specified in the applicable rector judges that: State law, the age of eighteen years. (1) A minor applicant for service
(b) State law not requiring parental lacks capacity because of extreme consent to treatment. If a minor patient youth or mental or physical condition acting alone has the legal capacity to make a rational decision on whether under the applicable State law to apply to consent to a disclosure under subfor and obtain alcohol or drug abuse part C of these regulations to his or her treatment, any written consent for dis- parent, guardian, or other person aoclosure authorized under subpart of thorized under State law to act in the these regulations may be given only by minor's behalf, and the minor patient. This restriction in- (2) The applicant's situation poses a cludes, but is not limited to, any dis- substantial threat to the life or phys closure of patient identifying informa- ical well being of the applicant or any tion to the parent or guardian of a other individual which may be reduced minor patient for the purpose of ob- by communicating relevant facts to taining financial reimbursement. the minor's parent, guardian, or other These regulations do not prohibit a person authorized under State law to program from refusing to provide act in the minor's behalf. treatment until the minor patient consents to the disclosure necessary to ob
82.16 Incompetent and deceased på
tients. tain reimbursement, but refusal to provide treatment may be prohibited (a) Incompetent patients other than m. under a State or local law requiring nors—1) Adjudication of incompetence the program to furnish the service irre- In the case of a patient who has been spective of ability to pay.
adjudicated as lacking the capacity, (c) State law requiring parental consent for any reason other than insufficient to treatment. (1) Where State law re- age, to manage his or her own affairs quires consent of a parent, guardian, or any consent which is required under other person for a minor to obtain al- these regulations may be given by the cohol or drug abuse treatment, any guardian or other person authorized written consent for disclosure author- under State law to act in the patient's ized under subpart C of these regula- behalf. tions must be given by both the minor (2) No adjudication of incompetency and his or her parent, guardian, or For any period for which the program other person authorized under State director determines that a patient law to act in the minor's behalf.
other than a minor or one who has beer (2) Where State law requires parental adjudicated incompetent, suffers from consent to treatment the fact of a mi- medical condition that preventi
c) knowing or effective action on his or 11 her own behalf, the program director a may exercise the right of the patient to i consent to a disclosure under subpart C
of these regulations for the sole pur2 pose of obtaining payment for services Bent from a third party payer.
(b) Deceased patients (1) Vital statistics. These regulations do not restrict is the disclosure of patient identifying inpro formation relating to the cause of di 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. er per 8 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.
for : of
cal.ch OD 017 re un
82.18 Restrictions on the use of identi
fication 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 discon.
tinued 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.
Olicanti ay be ant u
$ 2.17 Undercover agents and inform
ants. (a) Restrictions on placement. Except
as specifically authorized by a court who be order granted under 82.67 of these reguthe cop lations, no program may knowingly
employ, or enroll as a patient, any unTOWA dercover agent or informant.
(b) Restriction on use of information. giver! No information obtained by an under
cover agent or informant, whether or not that undercover agent or informant is placed in a program pursuant to
an authorizing court order, may be the prys used to criminally investigate or prosat & Poecute any patient. suffer! 152 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2,