Page images

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 ar but may not be told affirmatively that (ii) 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 diThe regulations do not restrict a dis- rector under paragraph (d) of this seo closure that an identified individual is tion. not and never has been a patient.

(d) Minor applicant for services lacks

capacity for rational choice. Facts rel $ 2.14 Minor patients.

evant to reducing a threat to the life of (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 services

(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 auclosure authorized under subpart C 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

§ 2.15 Incompetent and deceased på

tients. tain reimbursement, but refusal to provide treatment may be prohibited (a) Incompetent patients other than miunder 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 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 been (2) Where State law requires parental adjudicated incompetent, suffers from consent to treatment the fact of a mi- medical condition that prevents

[ocr errors]

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.

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.

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.

$ 2.17 Undercover agents and inform

ants. (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)

$ 2.20 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 disclose certain information about i these regulations nor the authorizing patients, that program may not invol statutes may be construed to authorize the research privilege under 21 CF any violation of that State law. How- 291.506(8) as a defense to a subpoena ft ever, no State law may either author- that information. ize or compel any disclosure prohibited by these regulations.

$ 2.22 Notice to patients of Federi

confidentiality requirements. 8 2.21 Relationship to Federal statutes (a) Notice required. At the time of ad protecting research subjects

mission or as soon threreafter as th against compulsory disclosure of their identity.

patient is capable of rational commo

nication, each program shall: (a) Research privilege description. (1) Communicate to the patient that There may be concurrent coverage of Federal law and regulations protect patient identifying information by the confidentiality of alcohol and drug these regulations and by administra- abuse patient records; and tive action taken under: Section 303(a) (2) Give to the patient a summary in of the Public Health Service Act (42 writing of the Federal law and regulsU.S.C. 242a(a) and the implementing tions. regulations at 42 CFR part 2a); or sec- (b) Required elements of written sur tion 502(c) of the Controlled Substances mary. The written summary of the FedAct (21 U.S.C. 872(C) and the imple- eral law and regulations must include: menting regulations at 21 CFR 1316.21). (1) A general description of the limThese "research privilege” statutes ited circumstances under which a pro confer on the Secretary of Health and gram may acknowledge that an indiHuman Services and on the Attorney vidual is present at a facility or dis General, respectively, the power to au- close outside the program information thorize researchers conducting certain identifying a patient as an alcohol or types of research to withhold from all drug abuser. persons not connected with the re- (2) A statement that violation of the search the names and other identifying Federal law and regulations by a proinformation concerning individuals gram is a crime and that suspected vio who are the subjects of the research. lations may be reported to appropriate

(b) Effect of concurrent coverage. These authorities in accordance with these regulations restrict the disclosure and regulations. use of information about patients, (3) A statement that information re while administrative action taken lated to a patient's commission of a under the research privilege statutes crime on the premises of the program and implementing regulations protects or against personnel of the program is a person engaged in applicable research not protected. from being compelled to disclose any (4) A statement that reports of susidentifying characteristics of the indi- pected child abuse and neglect made viduals who are the subjects of that re- under State law to appropriate State search. The issuance under subpart E or local authorities are not protected. of these regulations of a court order (5) A citation to the Federal law and authorizing a disclosure of information regulations. about a patient does not affect an exer- (c) Program options. The program may cise of authority under these research devise its own notice or may use the privilege statutes. However, the re- sample notice in paragraph (d) to comsearch privilage granted under 21 CFR ply with the requirement to provide 291.505(g) to treatment programs using the patient with a summary in writing methadone for maintenance treatment of the Federal law and regulations. In does not protect from compulsory dis- addition, the program may include in closure any imformation which is per- the written summary information conmitted to be disclosed under those reg- cerning State law and any program ulations. Thus, if a court order entered policy not inconsistent with State and in accordance with subpart E of these Federal law on the subject of confidenregulations authorizes a methadone tiality of alcohol and drug abuse pamaintenance treatment program to tient records.

Subpart C-Disclosures With

Patient's Consent

(d) Sample notice.

ABUSE PATIENT RECORDS The confidentiality of alcohol and drug buse patient records maintained by this rogram is protected by Federal law and reglations. Generally, the program may not ay to a person outside the program that a a tient attends the program, or disclose any aformation identifying a patient as an alcool or drug abuser Unless:

(1) The patient consents in writing:

(2) The disclosure is allowed by a court rder; or

(3) The disclosure is made to medical peronnel in a medical emergency or to qualiied personnel for research, audit, or proram evaluation.

Violation of the Federal law and regulacions by a program is a crime. Suspected vioations may be reported to appropriate auchorities in accordance with Federal regulacions.

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 CFR part 2 for Federal regulations.) (Approved by the Office of Management and Budget under control number 0930-0099)

$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.

8 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(2)(1).

1. I (name of patient) Request Authorize: 2. (name or general designation of program which is to make the disclosure)

3. To disclose: (kind and amount of information to be disclosed)

4. To: (name or title of the person or organization to which disclosure is to be made)

5. For (purpose of the disclosure)

6. Date (on which this consent is signed)

7. Signature of patient

8. Signature of parent or guardian (where required)

9. Signature of person authorized to sign in lieu of the patient (where required)

10. This consent is subject to revocation at any time except to the extent that the program which is to make the disclosure has already taken action in reliance on it. If not previously revoked, this consent will terminate upon: (specific date, event, or condition)

(c) Expired, deficient, or false consent. A disclosure may not be made on the basis of a consent which:

(1) Has expired:

(2) On its face substantially fails to conform to any of the requirements set forth in paragraph (a) of this section;

(3) Is known to have been revoked; or

(4) Is known, or through a reasonable effort could be known, by the person holding the records to be materially false. (Approved by the Office of Management and Budget under control number 0930-0099) $ 2.32 Prohibition on redisclosure.

Notice to accompany disclosure. Each disclosure made with the patient's written consent must be accompanied by the following written statement:

This information has been disclosed to you from records protected by Federal confidentiality rules (42 CFR 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 CFR 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)

central registries and in connect with criminal justice referrals m meet the requirements of $$ 2.34 a 2.35, respectively. 82.34 Disclosures to prevent multi

enrollments in detoxification a

maintenance treatment programs (a) Definitions. For purposes of th section:

Central registry means an organis tion which obtains from two or ma member progams patient identifyii information about individuals applyii for maintenance treatment or detox fication treatment for the purpose avoiding an individual's concurrent et rollment in more than one program.

Detoxification treatment means th dispensing of a narcotic drug in di creasing doses to an individual in orde to reduce or eliminate adverse physit logical or psychological effects inc dent to withdrawal from the sustaine use of a narcotic drug.

Maintenance treatment means the dis pensing of a narcotic drug in the treat ment of an individual for dependenci upon heroin or other morphine-liki drugs.

Member program means a detoxifica tion treatment or maintenance treat ment 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.

$ 2.33 Disclosures permitted with writ

ten 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

« PreviousContinue »