The 30^th annual 340B Coalition Summer Conference in Washington, D.C. proved to be the biggest ever with more than 1,900 people attending. As a proud corporate sponsor of the event, Cloudmed took the temperature of the conference and found the repeated calls for advocacy, dealing with manufacturer limitations on discounts, and ongoing regulatory compliance concerns to be among the hot topics with attendees.

Call for providers to advocate for 340B program

With pharmaceutical manufacturers escalating public policy campaigns against the 340B Drug Pricing Program, potential policymaker shifts on The Hill, and a general lack of program awareness, the key message coming from the 340B Coalition Summer Conference was loud and clear – it’s time for stakeholders to educate about 340B and advocate for the program. From the keynote addresses by national healthcare policy leaders and 340B Health CEO Maureen Testoni to sessions focused on regulatory compliance and manufacturer restriction issues, the advocacy message reverberated as a clarion call to providers.

The word from Washington topped the conference

The conference was headlined by three keynote speakers with extensive public health policy credentials. They included Carole Johnson, Administrator of the Health Resources and Services Administration (HRSA), Dr. Emeka Egwim, Director of the Office of Pharmacy Affairs at HRSA, and former Surgeon General Jerome Adams, now a Professor, Presidential Fellow, and Executive Director of Health Equity Initiatives at Purdue University.

All three speakers had a common theme running through their presentations – the need for providers to educate and advocate by documenting and sharing their 340B program success stories. “We are fighting to deliver care to the vulnerable and the underserved and we’ve got to show those outcomes, show the value we’re delivering,” Adams told conference attendees.

Testoni noted in her remarks that interest in the 340B program has been growing as providers and manufacturers make their respective cases to the public and policymakers. Her organization, 340B Health, launched a public information campaign in July called ‘Protect Patients, Protect 340B’ with numerous associations co-sponsoring the effort. The goal of the campaign, Testoni says, is to educate policy decision makers about manufacturers’ restrictions on 340B pricing for contract pharmacies, how it impacts patient care, and why it has to stop. She urged providers to join the effort.

According to Administrator Johnson, HRSA’s 340B violation letters to manufacturers that impose conditions on 340B pricing and other policy actions “are rooted in ensuring the program is doing what it is intended to do and reaching the people it was intended to serve.” As if to underscore her message, this week another pharmaceutical company announced new limitations on 340B pricing through contract pharmacies.

Other important messages coming out of the keynotes included:

• HRSA efforts to secure regulatory authority have gone nowhere with lawmakers, so it will remain limited to providing guidance with scant enforcement and no rulemaking authority, restricting its ability to compel program compliance by manufacturers.
• 340B Health does not foresee any significant risk of change to patient definition used by the program; providers will still have to document ownership of care with a patient record and referral relationship with the providers writing prescriptions.
• Some key 340B champions on Capitol Hill will be leaving next year and it will take grassroots efforts to educate incoming lawmakers on the importance of the 340B program.

Manufacturer matters were high on the agenda

With 18 drug manufacturers now restricting 340B discounts to providers through their contract pharmacies, how to push back and deal with those restrictions was the subject of much discussion at the conference. One key takeaway was that providers must stay on top of what exclusions are coming and how they affect an organization’s 340B program. This will typically have a larger impact on hospitals than on Federally Qualified Health Centers (FQHC).

One of the biggest issues raised was how wholesalers are struggling to ensure workflows are in place to correctly apply exclusions. As a result, some providers are now checking their pricing files on a weekly or semiweekly basis to ensure exclusions are being granted correctly.

Demonstrating program value was in the spotlight

Administrator Johnson noted in her remarks that providers can do much more to help demonstrate the value that the 340B program delivers to their communities and patients. But she also admitted that right now there’s a lack of research to help make that case. That concern was echoed by Caroline Steinberg, Vice President of Research and Policy Analytics at 340B Health, who pointed to some arguably ingenuine charges that providers don’t funnel more 340B savings into charity care and that program savings aren’t reaching patients to illustrate the need for more study and reporting.

In that same session, Charles Stubbs, PharmD, MBA, 340B ACE, a 340B Pharmacist at Intermountain Health, stressed the importance of selecting a topic to research that could illustrate the problems drugmaker restrictions create and presented findings that showed just how difficult access to insulin for Intermountain patients became after their 340B discounts were limited to one pharmacy.

Compliance challenges and tech talk

While advocacy, education, and manufacturer actions garnered the lion’s share of attention at the conference, compliance challenges and technical issues were not far behind on the session agenda, with concerns aired about passing HRSA audits and the challenges EHR conversion can present to 340B program managers. Other sessions focused on the unique needs of different types of provider organization utilizing the program, and the various programs and community health services that depend on continued funding from the 340B program.

Although the future is always uncertain, healthcare policy leaders at the 340B Coalition Summer Conference gave providers both a glimpse of what may come from program opposition and the remedy to prevent it. With the 340B program facing ongoing resistance to key program elements from manufacturers, it is up to providers and their stakeholder partners to take action to ensure the program continues to fund quality care in their communities.

Learn more about maximizing 340B program value, staying compliant, and advocating for your program and patients in our 340B Insider webinar.