A recent Determination of Coverage provides that, under specific circumstances, the dispensing and prescribing of Naloxone to non-health center patients is protected by the Federal Tort Claims Act (FTCA) program.

On August 17, 2022, the Health Resources and Services Administration (HRSA) published a Determination of Coverage for Community-Based Prescription and Distribution of Naloxone to Individuals Who Are Not Health Center Patients (“Naloxone Determination of Coverage”). This determination provides for FTCA program protection for certain services provided to non-health center patients as provided for under 42 U.S.C. § (g) – (n). The immunity from suit provided by the FTCA program is limited, among other things, to services provided to health center patients as defined in the Federal Tort Claims Act Health Center Policy Manual. However, 42 U.S.C. § 233(g)(1)(B) and (C) provides the Secretary with the authority to determine specific situations in which care to non-health center patients is protected by the FTCA program.

Under the Naloxone Determination of Coverage, deemed health centers that prescribe and dispense naloxone as a service within their scope of project to individuals who are not health center patients can be protected by the FTCA program. The prescribing and dispensing can be at a health center site, off site locations and may be in-person and in the case of prescriptions, via telehealth. All clinical staff must be acting on behalf of the deemed entity and, as required by the FTCA program, acting within their scope of employment.

The Naloxone Determination of Coverage does not apply to dispensing or prescribing under agreements with other organizations. This appears to preclude agreements to dispense or prescribe naloxone to organizations such as police departments, emergency response organizations or fire departments. Naloxone must be prescribed or dispensed to an individual.

The Naloxone Determination of Coverage has expectations for record keeping. For each service (dispensing or prescribing naloxone) the health center should record the following.

1. The service provided;
2. The location where services were administered;
3. The name of the provider(s);
4. The date and time services were provided; and
5. The identity of the individual receiving the services.

In implementing a naloxone prescribing and dispensing program health centers must ensure that pharmacy services are within their scope of project and shown on Form 5A in Column I if the health center’s own clinical staff are providing this service. In addition, this activity must conform to the scope of employment for each clinician involved in the program. If the services will be provided off-site, the employment agreement should require the clinician to work in other locations, including off-site as needed and in addition to their normal duty station.

Finally, any naloxone prescribing and dispensing program must be in accordance with state and local laws and regulations.

If you have any questions, please contact Martin J. Bree at mbree@feldesman.com.