Part 2 program definition

Editorial approval scope: The team checked current source fidelity, scope boundaries, dates, arithmetic, reader usefulness, practical workflow, and general-information limitations.

Current rule checkpoint

The HHS Part 2 final-rule fact sheet explains the 2024 regulatory changes and February 16, 2026 compliance date. The Federal Register final rule supplies the agency's adopted text and discussion. Program classification still depends on the live definitions and applicability provisions. Recheck older inventories when a general medical facility creates an SUD unit, changes how personnel are identified, adds referral services, changes public descriptions, or receives a new form of federal assistance.

General facilities require a more specific fit

42 CFR 2.11 distinguishes the outside person, identified unit, and identified personnel routes. 42 CFR 2.12 supplies federal assistance and other applicability rules. Map each service configuration separately.

Holding out and actual service both matter

Review websites, signage, contracts, directories, intake materials, referrals, staffing, schedules, clinical functions, billing, licenses, and organizational charts. Preserve dates and identify the legal entity, site, unit, and workforce group.

A mixed organization can contain different statuses

Separate primary care, mental health, SUD units, individual professionals, vendors, and affiliates. Apply role-based access and data lineage so Part 2 records remain governed when they cross systems or organizational boundaries.

Choose the correct program route

For a person or organization outside a general medical facility, the definition looks for both holding out as providing and actually providing SUD diagnosis, treatment, or referral. Within a general medical facility, analyze an identified unit that holds itself out and provides those services, or identified medical personnel whose primary function is providing them. State which route is being used instead of blending all three.

“Holding out” evidence can include websites, directories, signs, intake forms, contracts, referral materials, advertising, payer listings, and statements to the community. Service evidence can include staffing, schedules, clinical documentation, billing, referrals, and workflows. Date each source because public presentation and actual operations can diverge or change.

Map mixed settings precisely

A hospital, health system, group practice, school, telehealth organization, or multi-service clinic may contain functions with different Part 2 status. 42 CFR 2.12 explains that coverage can include programs within general hospitals, school-based programs, employee assistance programs, and private practitioners when the elements are met. It also gives an emergency-room example showing why an overdose referral alone does not necessarily establish program status.

Identify legal entity, facility, unit, workforce group, primary function, service, federal-assistance evidence, and effective dates. Do not label an entire enterprise based on one unit, or assume that moving records into a shared system changes their source classification.

Connect status to records and controls

After classifying the program, trace intake, referral, diagnosis, treatment, billing, messaging, portal, analytics, paper, vendor, and backup data created or received in connection with the covered activity. Apply access, consent, notice, disclosure, incident, legal-demand, retention, and transition controls to the correct records and recipients.

When a service closes or reorganizes, preserve the historical program map. Former patients and existing records do not lose their history because the current organizational chart looks different.

Assign review triggers

Refresh the analysis after acquisitions, new service lines, renamed units, staffing changes that alter primary function, site moves, website updates, referral changes, federal funding or authorization changes, and EHR migrations. Give privacy, compliance, clinical, legal, and operations owners a shared decision record rather than separate conflicting inventories.

Example

Ten facility configurations are assessed. Seven have complete holding-out, service, unit or personnel, and federal-assistance evidence; three use an organization-wide label. Completeness is 7 of 10.

Program-definition checklist

• select the outside-person, identified-unit, or identified-personnel route;
• document both public holding-out evidence and actual SUD service evidence where required;
• verify primary function for identified personnel in a general medical facility;
• pair program fit with current federal-assistance evidence;
• trace governed records across shared systems, vendors, and later copies; and
• retain dated decisions and recheck after material operational change.

This definition does not classify a particular provider, facility, or workforce group on its own. The exact entity, setting, function, presentation, federal assistance, dates, exceptions, and law control. Experienced Part 2 privacy and legal review remains necessary.

Document the final decision in a dated program map that separates legal entities, locations, identified units, identified personnel, public descriptions, actual services, federal-assistance routes, and record systems. Mark unresolved configurations and their interim controls. Give the map an accountable owner and review date, and connect it to onboarding, contracting, access, disclosure, incident, and acquisition workflows so classification affects real operations.