b.) Programs Subject to the Regulations
A substance abuse program is any of the following:
- An identified unit or program within a general medical facility that holds itself out as providing, and provides, substance abuse diagnosis, treatment, or referral for treatment;16
- Medical personnel or other staff in a general medical care facility whose primary function is the provision of substance abuse diagnosis, treatment, or referral for treatment and who are identified as such providers;17 and
-
An entity (other than a general medical facility) that holds itself out as providing, and provides, substance abuse diagnosis, treatment, or referral.18 This could include:
- Treatment or rehabilitation programs;
- Employee assistance programs;
- School-based programs; or
- Private practitioners.19
Even if a substance abuse program holds itself out as, and actually is, a provider of substance abuse services, the Part 2 regulations only apply to the following types of programs:
- Programs conducted in whole or in part (directly or by contract) by any United States department or agency;20
- Programs being carried out under a license, certification, registration, or other authorization granted by any US department or agency – this includes entities that are certified as Medicare providers, entities authorized to conduct methadone maintenance treatment, and entities registered with the Drug Enforcement Agency (DEA) to dispense a controlled substance used in the treatment of substance abuse (e.g., entities with a DEA number);21
- Programs supported by funds provided by any US department or agency as a recipient of federal financial assistance in any form;22
- Programs conducted by a state or local government unit that receives federal funds that could be (but are not necessarily) spent for the substance abuse program;23 or
- Programs allowed federal income tax deductions for contributions to the program or granted federal tax-exempt status by the IRS.24
In sum, only federally assisted programs that hold themselves out as providing (and actually provide) substance abuse diagnosis, treatment, or referral for such treatment are subject to Part 2.25 Given the broad definition of “federally assisted” (to include Medicare providers and entities with a DEA number), nearly all programs are considered federally assisted. The only programs and providers that would not fall under this definition are those that are for-profit and which only accept the privately insured or individuals who pay out of pocket for all treatment received.
Footnotes
- 16. 42 CFR § 2.11 at ¶ (b) of “Program.”
- 17. 42 CFR § 2.11 at ¶ (c) of “Program.”
- 18. 42 CFR § 2.11 at ¶ (a) of “Program.”
- 19. 42 CFR § 2.12(e)(1).
- 20. 42 CFR § 2.12(b)(1).
- 21. 42 CFR § 2.12(b)(2) (this includes certification of provider status under Medicare (b)(2)(i), authorization to conduct methadone maintenance treatment (b)(2)(ii), and registration to dispense a controlled substance under the Controlled Substances Act to the extent that the substance is being used in the treatment of alcohol or drug abuse (b)(2)(iii).
- 22. 42 CFR § 2.12(b)(3)(i) (including financial assistance that does not directly pay for the alcohol or drug abuse diagnosis, treatment, or referral activities).
- 23. 42 CFR § 2.12(b)(3)(ii).
- 24. 42 CFR § 2.12(b)(4).
- 25. 42 CFR § 2.12(e)(2).
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