NEW PRODUCT ANNOUNCEMENT 42 CFR Part 2 Training!

3Lions Publishing, Inc. announces a new series of 42 CFR Part 2 ("Part 2") training that addresses regulations associated with Part 2 Subparts A-E (i.e. full coverage of the regulations and HHS' attempt to harmonize Part 2 with HIPAA).  

 

The authorizing statute, Title 42, United States Code (U.S.C.) 290dd-2, protects the confidentiality of the records containing the identity, diagnosis, prognosis, or treatment of any patient that are maintained in connection with the performance of any federally assisted program or activity relating to substance abuse (now referred to as substance use disorder 'SUD') education, prevention, training, treatment, rehabilitation, or research.

Regulations in PART 2 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. 

 

In general, Part 2 Programs are prohibited from disclosing any information that would identify a person as having or having had a SUD unless that person provides written consent. Part 2 specifies a set of requirements for consent forms, including but not limited to the name of the patient, the names of individuals/entities that are permitted to disclose or receive patient identifying information, the amount and kind of the information being disclosed, and the purpose of the disclosure (see §2.31).

 

42 CFR Part 2 products can be purchased INDIVIDUALLY or as a Combo package of Parts A through E. 

1. Subparts A & B
2. Subparts C & D
3. Subpart E
4. COMBO Subparts A-E

 

A Deeper Dive into 42 CFR Part 2

  

Webinar Title: A Deeper Dive into 42 CFR Part 2 

 

Description: This webinar will review salient aspects of CFR 42 Part 2  2017 & 2018 HHS Rule Making with an emphasis on HIPAA harmonization (or lack thereof).

 

Date:  July 25, 2019

Time:  2:00 - 3:30 p.m. EST

Register here for the FREE July Webinar

 

Background of 42 CFR Part 2 with Commentary on Key Definitions

INTRODUCTION

Title 42 of CFR part 2 was first promulgated in 1975

during the Nixon Administration(40 FR 27802) and last substantively updated in 1987 (52 FR 21796). The authorizing statute, Title 42, United States Code (U.S.C.) 290dd-2, protects the confidentiality of the records containing the identity, diagnosis, prognosis, or treatment of any patient that are maintained in connection with the performance of any federally assisted program or activity relating to substance abuse (now referred to as substance use disorder 'SUD') education, prevention, training, treatment, rehabilitation, or research.

SAMSHA

The Substance Abuse and Mental Health Services Administration (SAMHSA) is the agency within the U.S. Department of Health and Human Services that leads public health efforts to advance the behavioral health of the nation. SAMHSA's mission is to reduce the impact of substance abuse and mental illness on America's communities.

SAMHSA Key Components Privacy Security Interoperability HIPAA Harmonization (sort of)

 

The National Survey on Drug Use Health (NSDUH) - Part of SAMSHA - also helps to identify the extent of substance use and mental illness among different sub-groups, estimate trends over time, and determine the need for treatment services. 

SAMSHA monitors use of illegal drugs, prescription drugs, alcohol, and tobacco as well as mental disorders, treatment, and co-occurring substance use and mental disorders. This data provides estimates of substance use and mental illness at the national, state, and sub-state levels.

Lack of harmonization with HIPAA clearly is a function of the separation of authoritative bodies as shown above for SAMHSA and OCR. Although these organizations are both associated with HHS, the regulations for which they provide guidance are separate and data collected is dissimilar.

For example, HIPAA regulations involve Protected Health Information which means individually identifiable health information:

(1) Except as provided in paragraph (2) of this definition, that is:

(i) Transmitted by electronic media;

(ii) Maintained in electronic media; or

(iii) Transmitted or maintained in any other form or medium.

(2) Protected health information excludes individually identifiable health information:

(i) In education records covered by the Family Educational Rights and Privacy Act, as amended, 20 U.S.C. 1232g;

(ii) In records described at 20 U.S.C. 1232g(a)(4)(B)(iv);

(iii) In employment records held by a covered entity in its role as employer; and

(iv) Regarding a person who has been deceased for more than 50 years.

SAMSHA data collection includes more than simply health information. The Center for Behavioral Health Statistics and Quality (CBHSQ) is the leading source of behavioral health data in the United States. Behavioral health data collected includes:

• Prevalence of mental illness and substance use disorders
• Behavioral health service provision and use
• Evaluation data

This data helps researchers, public health officials, and policymakers to understand and solve issues.

 

Individuals are identified for screening with a personal face-to-face interview or via Computer-Based questionnaires. Initial contact with residents of specific SDUs is made through a lead letter that gives a brief explanation of the nature of the interview and its methods.

However; like HIPAA, informed consent is obtained prior to interviews.

A minimum of four visits may be made at different times of day on different days of the week to complete the interview. More often than desired, potential respondents exercised their "right to refuse to participate." Refusals at the screening and interviewing level have historically been a problem for NSDUH (as is common with many other national-level household surveys). Again, another similarity with HIPAA rights for refusal.

Table 7.3 shows the national totals for ineligible and eligible cases, as broken down by population density and screening result code. As part of each NSDUH interview, field interviewers (FIs) were required to assess the respondent's level of cooperation, understanding, and privacy during the interview. One question asked whether respondents revealed to the FI answers entered during the audio computer-assisted self-interviewing (ACASI) section.

This excerpt of Table 7.11 shows the national totals for eligible and ineligible cases and lists results for each state broken down by population density and non-response rate.

REGULATIONS

Regulations under Part 2 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. Violations of these may be directed to the United States Attorney for the judicial district in which the violation occurs as well as to the Substance Abuse and Mental Health Services Administration (SAMHSA) office responsible for opioid treatment program oversight.

AUTHORIZED DISCLOSURE

Like HIPAA's Privacy Rule, Part 2 contains Disclosure rules. A court order under the regulations in Part 2 may authorize the disclosure of confidential communications

made by a patient to a part 2 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 allegedly committed by the patient, 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.

CONCLUSION

The Substance Abuse and Mental Health Services Administration (SAMHSA) is the agency within the U.S. Department of Health and Human Services (HHS) that leads public health efforts to advance the behavioral health of the nation and to improve the lives of individuals living with mental and substance use disorders, and their families.

Vision

To provide leadership and resources - programs, policies, information and data, funding, and personnel - advance mental and substance use disorder prevention, treatment, and recovery services in order to improve the individual, community, and public health.

Mission

To reduce the impact of substance misuse and mental illness on America's communities.