|Applicability and Re-Disclosure
||Treatment records created by non-part 2 providers based on their own patient encounter(s) will not be covered by part 2, unless any SUD records previously received from a part 2 program are incorporated into such records. Segmentation or holding apart of any part 2 patient record previously received can be used to ensure that new records created by non-part 2 providers will not become subject to part 2.
||To facilitate coordination of care activities by non part-2 providers.
|Disposition of Records
||When an SUD patient sends an incidental message to the personal device of an employee of a part 2 program, the employee will be able to fulfill the part 2 requirement for "sanitizing" the device by deleting that message.
||To ensure that the personal devices of employees will not need to be confiscated or destroyed, in order to sanitize per part 2.
||An SUD patient may consent to disclosure of his part 2 treatment records to an entity (e.g., the Social Security Administration), without naming a specific person as the recipient for the disclosure.
||To allow patients to apply for benefits and resources more easily, for example, when using online applications that do not identify a specific person as the recipient for a disclosure of part 2 records.
|Disclosures Permitted w/ Written Consent
||Disclosures for the purpose of "payment and health care operations" are permitted with written consent, in connection with an illustrative list of 17 example activities.
||In order to resolve lingering confusion under part 2 about what activities count as "payment and health care operations," the list of examples will be moved into the reg text from the preamble.
|Disclosures to Central Registries and PDMPs
||Non-OTP (opioid treatment program) providers will become eligible to query a central registry, in order to determine whether their patients are already receiving opioid treatment through a member program.
OTPs will be permitted to enroll in a state prescription drug monitoring program (PDMP), and permitted to report data into the PDMP when prescribing or dispensing medications on Schedules II to V, consistent with applicable state law.
|The revised central registry and PDMP provisions will help to prevent duplicative enrollments in SUD care, duplicative prescriptions for SUD treatment, and adverse drug events related to SUD treatment.
||Declared emergencies resulting from natural disasters (e.g., hurricanes) that disrupt treatment facilities and services will meet the definition for a "bona fide medical emergency," for the purpose of disclosing SUD records without patient consent under part 2.
||To ensure clinically appropriate communications and access to SUD care, in the context of declared emergencies resulting from natural disasters.
||Disclosures for research under part 2 will be permitted by a HIPAA covered entity or business associate to individuals and organizations who are neither HIPAA covered entities, nor subject to the Common Rule (re: Research on Human Subjects).
||To facilitate appropriate disclosures for research, by streamlining overlapping requirements under part 2, the Privacy Rule and the Common Rule.
|Audit and Evaluation
||Part 2 will be revised to clarify that some specific situations fall within the scope of permitted disclosures for audits and/or program evaluation.
||To resolve current ambiguity under part 2 about what activities are covered by the audit and evaluation provision.
||The standard for court ordered disclosures of SUD records for the purpose of investigating "an extremely serious crime" will be revised, by dropping the phrase "allegedly committed by the patient."
||To correct an earlier technical error from the 2017 rule-making, in which this phrase was inadvertently added to regulatory text without notice or public comment.
|Undercover Agents and Informants
||Court-ordered placement of an undercover agent or informant within a part 2 program will be extended to a period of 12 months, and courts will be authorized to further extend the period of placement through a new court order.
||To address DOJ concerns that the current policy is overly restrictive to some ongoing investigations of part 2 programs.