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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.
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 82.34 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(1), 42 U.S.C. 290dd-3(f) and 42 CFR 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)).
Subpart B-General Provisions 82.11 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 indentifying 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
82.4 Criminal penalty for violation.
Under 42 U.S.C. 290ee-3(f) and 42 U.S.C. 290dd-3(1), any person who violates any provision of those statutes or
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.
(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 fac lity 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 analy
ses, or legal, medical, accounting, or other professional services, or services to prevent or treat child abuse or de glect, including training on nutrition and child care and individual and group therapy, and
(b) Has entered into a written agres ment with a program under which tha: person:
(1) Acknowledges that in receiving storing, processing or otherwise dealing with any patient records from the progams, it is fully bound by these reg. ulations; and
(2) If necessary, will resist in judicial proceedings any efforts to obtain access to patient records except as per. mitted by these regulations. Records
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 of 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 gov. ernmental 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 by 60 FR 22297, May 5, 1995)
such an identification by another per:son; and
(il) Is drug abuse information obbtained by a federally assisted drug in abuse program after March 20, 1972, or
is alcohol abuse information obtained z 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 15. 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:
(1) 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) Erceptions(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 that program. The restrictions on disclosure in these regulations do not apply to communications of information be
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
(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
(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 crimina proceeding and any other use of the in formation to investigate or prosecutes patient with respect to a suspected crime. Information obtained by under cover 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 adminis trative 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) Erplanation 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
dentified as providing such services or (11) A diagnosis of drug overdose or she 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
one or m drugs). jor treatment is not provided by a pro- (52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, zram 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 82.13 Confidentiality restrictions. 32.12(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 restrictions on disclosure apply to any
or asserts any other justification for a
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 obtained in of information under $2.12(d).)
accordance with subpart 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. (1) 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