On March 21, 2017, Substance Abuse and Mental Health Services Administration’s (SAMHSA’s) Final Rule on 42 CFR Part 2 (“Part 2”) went into effect.  Designed to modernize Part 2, to facilitate information exchange within new health care models and to protect the privacy of individuals seeking and receiving treatment for substance use disorders, health centers and behavioral health care providers should carefully review the new requirements to assure they are in compliance.

For the first blog of our series on the Part 2 Final Rule, we answer the question, “Who Must Comply with the Part 2 Final Rule?”  Two types of organizations must comply with the Part 2 Final Rule.

A. Organizations that are “federally assisted” and that meet the definition of a Part 2 “program”

For Part 2 to apply, an organization must meet be “federally assisted” and must be a “program” as defined in the regulation.  Health centers and behavioral health organizations will want to walk through the following steps to determine whether Part 2 applies or whether it will apply to any service or scope expansions.

STEP ONE: To determine whether your organization meets the definition of “federally assisted,” answer each of the questions below:

1. Is the program conducted in whole or in part, either directly or by contract, by any department or agency of the United States?
2. Is the program 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:
   • Certification of provider status under the Medicare program?
   • Authorization to conduct methadone maintenance treatment?
   • Registration to dispense a substance under the Controlled Substances Act to the extent the controlled substance is used in the treatment of substance use disorders?
3. Is the program supported by funds provided by any department or agency of the United States by being:
   • A recipient of Federal financial assistance in any form (does not have to directly pay for the substance use disorder activities)?
   • Conducted by a state or local government unit which (through general or special revenue sharing) receives Federal funds which could be (but are not necessarily) spent for substance use disorder programming?
4. Is the program assisted by the Internal Revenue Service (IRS) through the allowance of income tax deductions for contributions to the program or through the granting of tax exempt status?

If you answered “yes” to any of the questions above, your organization meets the definition of “federally assisted” for purposes of Part 2.  Move to step two to determine whether your organization also meets the definition of a Part 2 “program.”

If your organization answered “no” to all of the questions above, your organization does not meet the definition of “federally assisted” for purposes of Part 2.  Your organization may still be required to comply with Part 2 if it is the “lawful holder of patient identifying Part 2 information.”

STEP TWO: To determine whether your organization meets the definition of a “program,” answer each of the questions below:

1. Does the organization (other than a general medical care facility) hold itself out as providing, and provides, substance use disorder diagnosis, treatment or referral for treatment?
2. Does an identified unit within a general medical facility hold itself out as providing and provide substance use disorder diagnosis, treatment, or referral for treatment?
3. Do any medical or other staff members in a general medical facility have as a primary function the provision of substance use disorder diagnosis, treatment or referral for treatment and are they identified as such providers?

The Final Rule does not define “general medical facilities;” however, a past guidance referenced in the comments to the Final Rule, SAMHSA stated that hospitals, trauma centers and federally qualified health centers are generally considered “general medical facilities.”  Part 2 is not intended to extend to the provision of substance use disorder treatment services as an incident to the provision of general health care.  “General medical facilities” must determine whether a department, program, team or individual staff members represent that they provide substance use diagnosis, treatment or referral.

If you answered “yes” to any of the questions in step two, your organization meets the definition of a “program” for purposes of Part 2 and your organization must comply with 42 CFR Part 2.

If you answered “no” to all of the questions in step two, your organization does not meet the definition of a “program” for purposes of Part 2.  Your organization may still be required to comply with Part 2 if it is the “lawful holder of patient identifying Part 2 information.”

B. Organizations that become the “lawful holder of patient identifying Part 2 information”

The Final Rule clarifies that Part 2 applies to individuals or entities who receive patient records from other lawful holders of patient identifying information.  A “lawful holder” of patient identifying Part 2 information is an individual or entity who has received such information as the result of a Part 2 compliant patient consent (along with a notice of prohibition on re-disclosure) or as a result of one of Part 2’s limited exceptions to the consent requirements.  Whether an organization is a “lawful holder” is a fact-specific determination; however, SAMHSA provided the following examples of “lawful holders:” a patient’s treating provider, a hospital emergency room, an insurance company, an individual or entity performing an audit or evaluation, or an individual or entity conducing scientific research.

Lawful holders of patient identifying Part 2 information are bound by the requirements of Part 2.  If, for example, an organization receives Part 2 information from a patient’s substance use treatment providers, it must comply with Part 2 for purposes of those records.

Organizations should keep in mind that Part 2 applies only to information that would identify, directly or indirectly, an individual as having been diagnosed, treated, or referred for treatment for a substance use disorder. Other health-related information, such as treatment for an unrelated health condition, may be re-disclosed, if permissible under the applicable law.