Under 42 U.S.C. 290dd-2, federal law requires “records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to substance use disorder education, prevention, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly or indirectly assisted by any department or agency of the United States” to be maintained confidentially and disclosed only as provided under this law. Accordingly, such substance abuse treatment programs and related third-party payers and administration entities should be aware of the restrictions on disclosure and use of patient records relating to certain substance use disorders under this statute and 42 C.F.R. Part 2. Violations of this regulation may be subject to criminal penalty. Significantly, this regulation does not compel disclosure of such records even if they fall into permissible circumstances, but rather indicates circumstances in which these records may be disclosed. Patient consent and/or a court order authorizing disclosure of patient information otherwise prohibited by this regulation is necessary in order to provide this information in response to a subpoena or other legal requirement.
For purposes of this regulation, a “program” is an individual, entity, or identified unit within a general medical facility “who holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment.” Additionally, medical staff and other staff in a “general medical facility” may be considered a “program” if their “primary function is the provision of substance use disorder diagnosis, treatment, or referral for treatment and who are identified as such providers.” The restrictions on disclosure and use of substance abuse treatment program records also apply to individuals or entities who receive patient records or patient identifying information relating to substance use disorders. The regulation provides conditions that identify a substance abuse treatment program as “federally assisted” and, therefore, within the scope of the regulation’s restrictions on the disclosure and use of such records, with these conditions including, but not limited to, receipt of federal financial assistance, participation in the Medicare program, or maintenance of tax-exempt status.
The regulation outlines a number of exclusions to its restrictions on disclosure and use of substance abuse treatment program records, as well as a number of situations (largely related to provision of health care to the relevant patient, research needs, and program auditing and evaluation) where such disclosure may be made without the patient’s consent. However, the overarching prohibition on such disclosures and use of these records may raise barriers to inclusion of such records in discovery responses where no court order requires their provision.