or existing codification. (2) The patient has signed a written consent meeting the requirements of 2.31 (except paragraph (a)(6) of this section which is inconsistent with the revocation provisions of paragraph (c) of this section) and the requirements of paragraphs (b) and (c) of this section. 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 substance use disorder diagnosis, treatment, or referral for treatment. 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 written consent (meeting the requirements of the regulations in this part) to disclosure or the court has ordered the record of the proceeding sealed from public scrutiny. eCFR :: 42 CFR Part 51 -- Requirements Applicable to the Protection and (ii) Subject to the HHS regulations regarding the protection of human subjects (45 CFR part 46), and provides documentation either that the researcher is in compliance with the requirements of 45 CFR part 46, including the requirements related to informed consent or a waiver of consent (45 CFR 46.111 and 46.116) or that the research qualifies . (c) Permitted disclosure by a central registry to prevent a multiple enrollment. The official, published CFR, is updated annually and available below under The restrictions on disclosure in the regulations in this part 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 patients with substance use disorders if the communications are: (ii) Between a part 2 program and an entity that has direct administrative control over the program. user convenience only and is not intended to alter agency intent 82 FR 6115, Jan. 18, 2017, unless otherwise noted. (d) Criteria. Such an order does not compel disclosure. Consent requirements. (b) Required elements of written summary. (ii) The consent may authorize a disclosure to any withdrawal management or maintenance treatment program established within 200 miles of the program, but does not need to individually name all programs. A central registry and any withdrawal management or maintenance treatment program to which information is disclosed to prevent multiple enrollments may not re-disclose or use patient identifying information for any purpose other than the prevention of multiple enrollments or to ensure appropriate coordinated care with a treating provider that is not a part 2 program unless authorized by a court order under subpart E of this part. (1) Restrictions on disclosure. Statement of Need. The regulations at 42 CFR part 2 ("Part 2") protect the confidentiality of substance use disorder (SUD) treatment records. (2) The regulations in this part are not intended to direct the manner in which substantive functions such as research, treatment, and evaluation are carried out. A written consent to a disclosure under the regulations in this part may be paper or electronic and must include: (1) The name of the patient . Disclosures with Patient Consent, including disclosures which require patient consent and the consent form requirements; (3) Subpart D of this part . Subpart DDisclosures Without Patient Consent, Subpart ECourt Orders Authorizing Disclosure and Use. This contact form is only for website help or website suggestions. For the purposes of the regulations in this part, this definition does not include tobacco or caffeine use. 290dd2(g), the regulations in this part impose restrictions upon the disclosure and use of substance use disorder patient records which are maintained in connection with the performance of any part 2 program. Treatment means the care of a patient suffering from a substance use disorder, a condition which is identified as having been caused by the substance use disorder, or both, in order to reduce or eliminate the adverse effects upon the patient. [82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43037, July 15, 2020]. result, it may not include the most recent changes applied to the CFR. (9) The date on which the consent is signed. (ii) Special instructions for entities that facilitate the exchange of health information and research institutions. 290ee-3 for federal laws and 42 CFR Part 2 for federal regulations.) 42 CFR Part2 Confidentiality - Indian Health Service (IHS) Title 42. (3) Other ways of obtaining the information are not available or would not be effective. 2.19 Disposition of records by discontinued programs. Part 2 Subpart C 2.31 Previous Next Top eCFR Content 2.31 Consent requirements. (5) If the applicant is a law enforcement agency or official, that: (i) The person holding the records has been afforded the opportunity to be represented by independent counsel; and. Upon request, patients who have consented to disclose their patient identifying information using a general designation pursuant to 2.31(a)(4)(ii)(B) must be provided a list of entities to which their information has been disclosed pursuant to the general designation. 2.66 Procedures and criteria for orders authorizing disclosure and use of records to investigate or prosecute a part 2 program or the person holding the records. citations and headings site when drafting amendatory language for Federal regulations: This document is available in the following developer friendly formats: Information and documentation can be found in our (2) The minor applicant's situation poses a substantial threat to the life or physical well-being of the minor applicant or any other individual which may be reduced by communicating relevant facts to the minor's parent, guardian, or other individual authorized under state law to act in the minor's behalf. You are using an unsupported browser. Please do not provide confidential (iii) Determine the need for adjustments to payment policies to enhance care or coverage for patients with SUD. These formal policies and procedures must address: (i) Transferring and removing such records; (ii) Destroying such records, including sanitizing the hard copy media associated with the paper printouts, to render the patient identifying information non-retrievable; (iii) Maintaining such records in a secure room, locked file cabinet, safe, or other similar container, or storage facility when not in use; (iv) Using and accessing workstations, secure rooms, locked file cabinets, safes, or other similar containers, and storage facilities that use or store such information; and. (2) Give to the patient a summary in writing of the federal law and regulations. (a) General rule. (3) Medical personnel or other staff in a general medical facility whose primary function is the provision of substance use disorder diagnosis, treatment, or referral for treatment and who are identified as such providers. (a) Notice required. We recommend you directly contact the agency associated with the content in question. (B) A general designation of an individual or entity participant(s) or class of participants that must be limited to a participant(s) who has a treating provider relationship with the patient whose information is being disclosed. (4) How type of diagnosis affects coverage. 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 the extremely serious crime or suspected crime specified in the application; and. It is not an official legal edition of the CFR. Yes. the hierarchy of the document. Criminal penalty for violation. (a) Restrictions on disclosure. [82 FR 6115, Jan. 18, 2017, as amended at 85 FR 43036, July 15, 2020]. eCFR :: 42 CFR 2.14 -- Minor patients. The central registry and non-member program treating prescriber may communicate as necessary to verify that no error has been made and to prevent or eliminate any multiple enrollments or improper prescribing. The name(s) of the individual(s) or the name(s) of the entity(-ies) to which a disclosure is to be made. (c) Review of evidence: Conduct of hearing. In accordance with 2.13(a), the disclosure must be limited to that information which is necessary to carry out the stated purpose. (b) Notice not required. (ii) Any interchange of that information between the Armed Forces and those components of the Department of Veterans Affairs furnishing health care to veterans. (iv) Any combination of a HIPAA covered entity or business associate, and/or subject to the HHS regulations regarding the protection of human subjects, and/or subject to the FDA regulations regarding the protection of human subjects; and has met the requirements of paragraph (a)(1)(i), (ii) (iii), and/or (iv) of this section, as applicable. result, it may not include the most recent changes applied to the CFR. The restrictions on disclosure and use in the regulations in this part apply whether or not the part 2 program or other lawful holder of the patient identifying information believes that the person seeking the information already has it, has other means of obtaining it, is a law enforcement agency or official or other government official, has obtained a subpoena, or asserts any other justification for a disclosure or use which is not permitted by the regulations in this part. Restrictions on the use of identification cards. 7332 and regulations issued under that authority by the Secretary of Veterans Affairs. Pressing enter in the search box user convenience only and is not intended to alter agency intent HealtheConnections uses the NYSDOH-approved model consent form and is, therefore, compliant with the 42 CFR Part 2 requirements. (3) Such other factors as the part 2 program, the patient, and the individual(s) within the criminal justice system who will receive the disclosure consider pertinent. The name(s) of the individual(s) or the name(s) of the entity(-ies) to which a disclosure is to be made. 290dd-2 and this part; (D) Must ensure that any audit or evaluation involving patient identifying information occurs in a confidential and controlled setting approved by the designated executive; (E) Must ensure that any communications or reports or other documents resulting from an audit or evaluation under this section do not allow for the direct or indirect identification (e.g., through the use of codes) of a patient as having or having had a substance use disorder; and. Thus, the regulations do not require disclosure under any circumstances. (b) Restriction on use of information. Search & Navigation The patient and the person holding the records from whom disclosure is sought must be provided: (1) Adequate notice in a manner which does not disclose patient identifying information to other persons; and. 2.65 Procedures and criteria for orders authorizing disclosure and use of records to criminally investigate or prosecute patients. (vi) As soon as practicable after the end of the required retention period specified on the label, the portable electronic device or the original and backup electronic media must be sanitized to render the patient identifying information non-retrievable consistent with the policies established under 2.16. A written consent to a disclosure under the regulations in this part may be paper or electronic and must include: (2) The specific name(s) or general designation(s) of the part 2 program(s), entity(ies), or individual(s) permitted to make the disclosure. Displaying title 42, up to date as of 6/29/2023. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. eCFR :: 42 CFR Part 2 Subpart D -- Disclosures Without Patient Consent Microsoft Edge, Google Chrome, Mozilla Firefox, or Safari. (c) Revocation of consent. (2) Armed Forces. This content is from the eCFR and may include recent changes applied to the CFR. 2.2 Purpose and effect. (e) Limitation on use of information. Electronic Code of Federal Regulations (e-CFR) Title 42Public Health; CHAPTER IPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES; SUBCHAPTER AGENERAL PROVISIONS; PART 2CONFIDENTIALITY OF SUBSTANCE USE DISORDER PATIENT RECORDS . (4) Include any other measures which are appropriate to limit any potential disruption of the part 2 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. Disclose means to communicate any information identifying a patient as being or having been diagnosed with a substance use disorder, having or having had a substance use disorder, or being or having been referred for treatment of a substance use disorder either directly, by reference to publicly available information, or through verification of such identification by another person. Records otherwise transmitted by a part 2 program to a non-part 2 provider retain their characteristic as records in the hands of the non-part 2 provider, but may be segregated by that provider. For purposes of the regulations in this part: Central registry means an organization which obtains from two or more member programs patient identifying information about individuals applying for withdrawal management or maintenance treatment for the purpose of avoiding an individual's concurrent enrollment in more than one treatment program. The patient has signed a written consent meeting the requirements of 2.31 (except paragraph (a)(6) . (ii) The minor lacks the capacity to make a rational choice regarding such consent as judged by the part 2 program director under paragraph (c) of this section. CCBHCs must comply with federal Substance Abuse Confidentiality Regulations (42 CFR Part 2), which govern the confidentiality, use, and disclosure of clinical records for care and treatment related to substance use disorders. Purpose and effect. (a) Required elements for written consent. (b) Expired, deficient, or false consent. [82 FR 6115, Jan. 18, 2017, as amended at 83 FR 251, Jan. 3, 2018]. (6) A statement that the consent is subject to revocation at any time except to the extent that the part 2 program or other lawful holder of patient identifying information that is permitted to make the disclosure has already acted in reliance on it. Learn more about the eCFR, its status, and the editorial process. eCFR :: 42 CFR 2.34 -- Disclosures to prevent multiple enrollments. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. 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. Electronic signatures are permitted to the extent that they are not prohibited by any applicable law. (e) Content of order. The act of recording information about a SUD and its treatment does not by itself render a medical record which is created by a non-part 2 treating provider subject to the restrictions of this part 2. (2) Meet a bona fide medical emergency in which a part 2 program is closed and unable to provide services or obtain the prior written consent of the patient, during a temporary state of emergency declared by a state or federal authority as the result of a natural or major disaster, until such time that the part 2 program resumes operations. The person may not disclose the records in response to the subpoena unless a court of competent jurisdiction enters an authorizing order under the regulations in this part. (3) An opportunity to be represented by counsel independent of counsel for an applicant who is a law enforcement agency or official. (2) There is a reasonable likelihood that the records will disclose information of substantial value in the investigation or prosecution. A part 2 program or other lawful holder must obtain patient consent to a disclosure of records to a prescription drug monitoring program under 2.31 prior to reporting of such information. If you work for a Federal agency, use this drafting Substance use disorder means a cluster of cognitive, behavioral, and physiological symptoms indicating that the individual continues using the substance despite significant substance-related problems such as impaired control, social impairment, risky use, and pharmacological tolerance and withdrawal. Patient identifying information means the name, address, social security number, fingerprints, photograph, or similar information by which the identity of a patient, as defined in this section, can be determined with reasonable accuracy either directly or by reference to other information. (1) Under this paragraph (d), patient requests: (ii) Are limited to disclosures made within the past two years; (2) Under this paragraph (d), the entity named on the consent form that discloses information pursuant to a patient's general designation (the entity that serves as an intermediary, as described in 2.31(a)(4)(ii)(B)) must: (i) Respond in 30 or fewer days of receipt of the written request; and. developer resources. (1) An individual or entity (other than a general medical facility) who holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment; or, (2) An identified unit within a general medical facility that holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment; or. Disclosures permitted with written consent. HIPAA and Part 2 | HHS.gov 42 CFR 2.31 - Consent requirements. | Electronic Code of Federal 12, 2007; 78 FR 40042, July 3, 2013] Using the eCFR Point-in-Time System. The restrictions on disclosure in the regulations in this part apply to: (A) Third-party payers with regard to records disclosed to them by part 2 programs or under 2.31(a)(4)(i)(A); (B) Entities having direct administrative control over part 2 programs with regard to information that is subject to the regulations in this part communicated to them by the part 2 program under paragraph (c)(3) of this section; and. Comments or questions about document content can not be answered by OFR staff. (2) The name, address, and telephone number of the inquiring member program to the member program(s) in which the patient is already enrolled. A written consent to a disclosure under the regulations in this part may be paper or electronic and must include: (1) The name of the patient. A part 2 program or other lawful holder is permitted to report any SUD medication prescribed or dispensed by the part 2 program to the applicable state prescription drug monitoring program if required by applicable state law. If patient records are not downloaded, copied or removed from the premises of a part 2 program or other lawful holder, or forwarded electronically to another electronic system or device, patient identifying information, as defined in 2.11, may be disclosed in the course of a review of records on the premises of a part 2 program or other lawful holder to any individual or entity who agrees in writing to comply with the limitations on re-disclosure and use in paragraph (f) of this section and who: (1) Performs the audit or evaluation on behalf of: (i) Any federal, state, or local governmental agency that provides financial assistance to a part 2 program or other lawful holder, or is authorized by law to regulate the activities of the part 2 program or other lawful holder; (ii) Any individual or entity which provides financial assistance to the part 2 program or other lawful holder, which is a third-party payer covering patients in the part 2 program, or which is a quality improvement organization performing a QIO review, or the contractors, subcontractors, or legal representatives of such individual, entity, or quality improvement organization. 2, 1998, as amended at 64 FR 56658, Oct. 20, 1999; 72 FR 10619, Mar. Statutory authority for confidentiality of substance use disorder patient records. This definition includes both current and former patients. Orders authorizing the use of undercover agents and informants to investigate employees or agents of a part 2 program in connection with a criminal matter. (2) The part 2 program director will intentionally or unintentionally disclose the proposed placement of an undercover agent or informant to the employees or agents of the program who are suspected of criminal activities. No person may require any patient to carry in their immediate possession while away from the part 2 program premises any card or other object which would identify the patient as having a substance use disorder. These regulations do not prohibit a part 2 program from giving a patient access to their own records, including the opportunity to inspect and copy any records that the part 2 program maintains about the patient. 2.36 Disclosures to prescription drug monitoring programs. Learn more. 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. (iii) The treatment is interrupted, resumed or terminated. PART 2 CONSENT What information about the recipient is required on consent forms? 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. (c) Program options. However, no state law may either authorize or compel any disclosure prohibited by the regulations in this part. The placement of an undercover agent or informant must end after 12 months, unless a new court order is issued to extend the period of placement; (3) Prohibit the undercover agent or informant from disclosing any patient identifying information obtained from the placement except as necessary to investigate or prosecute employees or agents of the part 2 program in connection with the suspected criminal activity; and.