Pharmacy Market BUZZ

Market News, Products, Services, and Trends

So You Want To Build A 340B Specialty Pharmacy. How Hard Can It Be?


Fair Warning: If you ever dismissively ask that question (above) of someone who’s led the planning and launch of a 340B hospital’s specialty pharmacy, and did it with no outside support, there’s a good chance you’ll get punched. Yes, it’s that difficult. 


Why is it so hard to build a 340B specialty pharmacy? 

(NOTE: We understand there’s no such thing as a “340B Pharmacy,” or a “340B Drug,” until a prescription actually qualifies. We’re using the terms simply to identify pharmacies where there is a concentration of 340B eligible drugs, and a focus on finding them.)

What makes a 340B specialty pharmacy so much harder to successfully (and profitably) operate than a 340B retail pharmacy is access. Specifically, access to 340B drugs and payers. And in order to get access to both, you need accreditation — which generally means dual accreditation: One from the Utilization Review Accreditation Commission (URAC), and one from the Accreditation Commission for Health Care (ACHC). Without accreditation, your 340B specialty pharmacy can't get In Network with many important payers. And earning accreditation is, to put it mildly, a beast.


340B specialty pharmacy accreditation: A VERY brief overview

ProxsysRx’s Specialty Pharmacy team has created a detailed punch-list of activities it manages — and personally undertakes — in shepherding 340B health systems through the process of earning specialty pharmacy accreditation. Below is only half of the process involved in the first of nine separate stages we undertake in earning a 340B health system specialty pharmacy accreditation. We call this stage “Business Support Services,” and here are six of the twelve steps we take:

  • Develop and implement a call center function. (This can be accomplished in different ways, according to the volume and desires of the facility).
  • Develop KPIs (Key Performance Indicators) and reporting metrics for appropriate stakeholders. These services may be performed virtually or in-person at the hospital’s facilities and/or clinics.
  • Provide call center services to manage prescription orders, refill requests, medication related questions, and other calls.
  • Evaluate the hospital’s PBM for available Specialty Pharmacy benefits.
  • Obtain prior authorizations under the hospital’s health insurance or other Specialty Pharmacy benefit plans.
  • Manage and apply financial assistance programs for the indigent and/or uninsured.


It goes without saying, every stage in the planning and accrediting process isn’t merely time-consuming. It’s complicated. It requires highly-specialized expertise; the kind of expertise that only comes from highly-specialized training, and hands-on experience. 


340B specialty pharmacy reporting protocols

In addition to implementing the strict protocols required, your 340B specialty pharmacy has to report all of its relevant caring, administration and patient data back to the manufacturers; data which confirm that you're actually handling their drugs, and your patients, correctly. 


Reaping the benefits of 340B specialty pharmacy compliance

The payoff to confirming your compliance with manufacturers’ protocols is twofold: 1) You’ll get reimbursed for the specialty drugs you’ve filled, and 2) Your pharmacy will get access to more specialty drugs from the manufacturers. 


Overcoming 340B manufacturer restrictions 

There’s another critical benefit to a 340B health system having its own on-campus specialty pharmacy: Overcoming restrictions many of the drug manufacturers have imposed on access to 340B reimbursement; most prominently, the restriction of reimbursement to only pharmacies within a 40-mile radius of your hospital campus. 


Partnering with manufacturers on specialty pharmacy drug research

A well-run specialty pharmacy enables your hospital to partner with drug manufacturers in their ongoing research. Many specialty drugs require ongoing usage and outcome data to support their efficacy claims to justify reimbursement. This is exactly the kind of data that successful specialty pharmacies can provide manufacturers in prescribing, dispensing and monitoring their 340B-eligible specialty drugs.


What to look for in a specialty pharmacy partner

There is an additional level of expertise that can cut the process (and the calendar time) of planning, accrediting and launching a 340B hospital’s specialty pharmacy virtually in half: Namely, accreditation by the very bodies that accredit your pharmacy. With their highly-coveted accreditations from URAC and ACHC, ProxsysRx’s specialty pharmacy team is authorized to grant accreditation for many of the benchmarks your 340B specialty pharmacy must meet.

The second critical quality your specialty pharmacy partner should offer is a willingness to share in the investment, and the financial risk, involved in building a 340B specialty pharmacy. ProxsysRx always offers its services At Risk: Which means we only get paid when our clients profit from our services, and we never earn more than the hospitals we serve. 

We’re currently contracted to build and manage 340B specialty pharmacies for five health systems. Moreover, our first specialty pharmacy opened its doors in June, 2024 — and within six months was generating a monthly net income of more than $1 million. Better still, our process enables the health systems we serve to get In Network for a number of 340B specialty drugs even before their specialty pharmacies are accredited — which helps provide much-needed cash-flow in funding them.


ProxsysRx is here to help, if you have questions. 

For more information on how to build and fund a successful specialty pharmacy, or for more information on any of the pharmacy-support services we offer, contact Howard Hall. C: 214.808.2700 | howard.hall@proxsysrx.com 


Today's Posts
Subscribe