Demers & Associates

04/15/2026

A new 340B lawsuit could reshape the definition of a “patient.”

In AbbVie v. HRSA, AbbVie challenges HRSA’s patient definition as too broad and directly leading to "widespread 340B program abuse". This directly opposes the 2023 Genesis decision, where the court rejected HRSA’s interpretation as too narrow , setting the groundwork for revisiting some entities more restrictive use of patient defintion policies.

This sets up a high-stakes legal battle on a core statutory question: who qualifies as a 340B patient?

If successful, the case could introduce stricter eligibility standards, including tighter links between care and prescriptions, time-limited patient status, and increased manufacturer audits and documentation expectations.

The outcome may significantly impact 340B patient eligibility rules including referral-based prescribing.

Read the full article below for a detailed analysis of the case and its potential implications:

Put on your seatbelt. The 340B space is about to get even more interesting. The newly filed AbbVie lawsuit against HRSA presents the inverse legal argument advanced in Genesis HealthCare Inc.  Both cases center on the same statutory question, who qualifies as a patient under the 340B sta

03/24/2026

Introducing 340B Performance360°

Seamless Data. Smarter Decisions. Stronger Financial Performance. Watch the video below to learn about 304B Performance 360°: an integrated dashboard that allows you to monitor data across multiple administrators and pharmacy systems.

01/01/2021

Finally some clarification for covered entities in the battle over contract pharmacy use.

On Wednesday, the HHS Office of the General Counsel released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program (340B Program) on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities.

03/23/2020

TELEMEDICINE -
Did you know that telemedicine is eligible for 340B use if under the correct circumstances. Patient Definition must still be met by an eligible "service" even if it takes place at an unregistered location.

Many entities are facing new circumstances never seen before. Telemedicine or remote medicine may be front and center as a care protocol for your patients.

HRSA has also posted updated clarification on other policy related matters that could be impacted by COVID-19.

https://www.hrsa.gov/opa/COVID-19-resources

Here's is the current FAQ approved by HRSA on the Apexus website.

Question Is telemedicine an eligible service to qualify for 340B drug pricing in a covered entity?

Answer In the case of eligible hospitals, the clinic at which the covered entity provides healthcare services must be an integral part of the hospital, listed as reimbursable on its Medicare cost report. In the case of all other covered entities, the patients must be provided healthcare services by the covered entities that are within the scope of the grant or other statutory basis for eligibility. The entity is responsible for meeting the definition of a patient. For more information on the definition of a patient please see October 24, 1996 (Vol.61, No.207, pp. 55156-5158) Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility (Definition of Patient). ftp://ftp.hrsa.gov/bphc/pdf/opa/FR10241996.htm.

To be eligible, you would want to be able to show that the care is documented in the entity EMR, the service(s) is covered under your scope (pediatrics, geriatrics, ID, etc.), (or rolls up to an eligible an registered site on your recently filed MCR ), the provider is employed or contracted, and the CE is billing for the service as you would any service at a registered location. (This is not absolutely required, but makes it more clear).

It is suggested adding this to the definition of an eligible patient in your approved policies.

The same logic applies to "remote medicine" if providing approved services by eligible providers (and retaining records of care), at a site that is not otherwise eligible (nursing home, private home, etc).

HRSA is working to keep 340B Program participants and stakeholders updated on the latest information regarding the coronavirus disease 2019 (COVID-19). All COVID-19 information related to the 340B Program will appear on this page, and we will update resources as they become available.

05/28/2019

From May 7, 2019 HRSA Primary Health Care Digest

BPHC changes 340B Drug Pricing Program Requirements

HRSA Health Center Program Operational Site Visits no longer require an onsite review of 340B Drug Pricing Program requirements. HRSA uses other methods to ensure integrity, including working directly with health centers.

https://content.govdelivery.com/accounts/USHHSHRSA/bulletins/2436afa

05/28/2019

From May 7th BPHC Health Digest

HRSA Health Center Program Operational Site Visits no longer require an onsite review of 340B Drug Pricing Program requirements. HRSA uses other methods to ensure integrity, including working directly with health centers.

https://content.govdelivery.com/accounts/USHHSHRSA/bulletins/2436afa

https://content.govdelivery.com/accounts/USHHSHRSA/bulletins/2436afa

08/20/2018

HRSA expects all entities who have contact pharmacy relationships to have an annual external 340B audit or other mechanisms in place to ensure compliance. Check out our audit services.

Services & Specializations

08/08/2018

New estimates completed by Health Affairs find that changes to the 340B program would likely not affect overall drug spending but would only change the distribution of discounts to increase manufacture revenue and decrease recent Medicare savings estimates.

https://www.healthaffairs.org/do/10.1377/hblog20180807.985552/full/?utm_term=The+Size+Of+The+340B+Program+And+Its+Impact+On+Manufacturer+Revenues&utm_campaign=Health+Affairs+Today+Newsletter&utm_content=email&utm_source=Act-On_2018-08-08&utm_medium=email&cm_mmc=Act-On+Software-_-email-_-Impact+Of+The+340B+Program+On+Manufacturer+Revenues%3B+Health+Philanthropy+And+Social+Determinants+Of+Health%3B+Medicaid+Benefits+For+Addiction+Treatment+-_-The+Size+Of+The+340B+Program+And+Its+Impact+On+Manufacturer+Revenues

Health Affairs Blog Drugs And Medical Innovation Related Topics: Pharmaceuticals Clinics Markets Gene therapy Prescription drug costs Brand-name drugs Drug pricing Cost reduction Costs and spending Medicare Part B The Size of the 340B Program and Its Impact on Manufacturer Revenues Sean Dickson Alla...

07/11/2018

In July, OPA announced it will begin random review of registration documents for hospital registrations and/or contract pharmacies. If HRSA requests additional documentation and the entity can't produce it, the registration will be rejected.

The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau (HSB), Office of Pharmacy Affairs (OPA) is committed to maintaining the integrity of the 340B Drug Pricing Program (340B Program). HRSA continuously reviews and updates processes to improve program integrity, and woul...

10/18/2017

Remember to login to the new OPAIS system to create a user account for the Authorizing Official (AO) and Primary Contact (PC) before any changes to your database information can be made. Only the AO and PC can submit changes or registrations. If you have recertification coming up in the next few months, make sure you do this in plenty of time to review all database information and make changes at least a month before recertification starts.