February 202016340B Coalition Winter Conference Promises Answers, But Uncertainty Still Lingers

- By Russ Barron, Pharmacy and 340B Information Systems Subject Matter Expert

On February 19th, the 340B Coalition wrapped up the 12th annual Winter Conference in San Diego. For many of the participants, the 3-day event was a welcome break from what has been a difficult winter back home. Other attendees were overheard wondering whether those participants brought with them the weather from back home.

Perhaps unanimous among conference-goers, however, was a feeling of cautious optimism. Being the first 340B Coalition major event since the release of several key changes to the program (including the Proposed Omnibus regulations), the conference agenda was packed with topics meant to ease the concerns of Covered Entities across the country.

Attendees heard from speakers with a variety of different backgrounds, from attorneys to compliance specialists to CFOs, and everything in between. These speakers did a fantastic job of highlighting some of the common concerns expressed by Covered Entities regarding recent regulatory changes:

Q: “Will the Omnibus guidance change the way my hospital qualifies contract pharmacy prescriptions?”

A: “As written, yes, the Omnibus guidance will have a dramatic, and possibly paradigm-shifting effect on your contract pharmacy program.”

Q: “How will the AMP Final Rule affect my reimbursement policies?”

A: “The AMP Rule will require your state to move to an AAC reimbursement model, and codify its policies regarding 340B Medicaid reimbursement by early 2017.”

Q: “I’ve heard there are major changes on the horizon for infusion centers – is that true?”

A: “Possibly. The current draft of the Omnibus regulations specifically states that patients receiving infusion services alone do not qualify as a patient for purposes of the 340B program.”

Q: “Is the Omnibus guidance likely to be finalized as it is currently written?”

A: “HRSA received over 1,000 comment submissions in response to the 340B Omnibus Guidance, many of which raised important legal and operational concerns relating to the proposed regulations. Based on these comments alone, there will likely be a number of changes in the final release.”

Q: “What type of changes will be coming to the 2017 HRSA audit process?”

A: “In addition to requiring regular, third-party audits of all contract pharmacies, the Proposed Guidance indicates that HRSA will be moving to a ‘notice and hearing process’ to allow Covered Entities to appeal the results of their audit.”

Additional Questions and Answers Outlining Changes to come:

““Will the Omnibus guidance change the way my hospital qualifies contract pharmacy prescriptions?” “As written, yes, the Omnibus guidance will have a dramatic, and possibly paradigm-shifting effect on your contract pharmacy program.”
““How will the AMP Final Rule affect my reimbursement policies?” “The AMP Rule will require your state to move to an AAC reimbursement model, and codify its policies regarding 340B Medicaid reimbursement by early 2017.”
“I’ve heard there are major changes on the horizon for infusion centers – is that true?” “Possibly. The current draft of the Omnibus regulations specifically states that patients receiving infusion services alone do not qualify as a patient for purposes of the 340B program.”
“Is the Omnibus guidance likely to be finalized as it is currently written?” “HRSA received over 1,000 comment submissions in response to the 340B Omnibus Guidance, many of which raised important legal and operational concerns relating to the proposed regulations. Based on these comments alone, there will likely be a number of changes in the final release.”
“What type of changes will be coming to the 2017 HRSA audit process?” “In addition to requiring regular, third-party audits of all contract pharmacies, the Proposed Guidance indicates that HRSA will be moving to a ‘notice and hearing process’ to allow Covered Entities to appeal the results of their audit.”

The ripple effects of the all the above questions, and more, reverberated through almost every session during the conference. Nearly every presentation included discussion regarding at least one portion of the numerous regulatory changes that occurred since the last 340B Coalition conference.

In spite of all this, however, many attendees were left with more questions than answers. A common theme from many presentations was the lack of any certainty surrounding upcoming legislative changes, and HRSA seems to share this uncertainty, as the agency has now indicated that the release of the final 340B Omnibus Guidance will likely be postponed until 2017.

Until then, Covered Entities can be sure that there will no shortage of other legislative impacts to occupy their time.

It should also be noted that with the end of the 12th annual 340B Winter Conference, the sun and warmth reappeared for a very San Diego-like end to the week. Perhaps an omen for things to come with 340B in 2016 and 2017; we certainly hope so!

About Alinea Pharmacy Enterprise Solutions:

The Alinea Group (“Alinea”) provides management consulting and audit services to the country’s leading healthcare organizations with a focus on pharmacy enterprise solutions. Alinea has worked in the pharmacy consulting space for the last 20 years, and more specifically, pioneered the Pharmacy Operational Enhancement (“POE”), 340B, Pharmacy Audit, and Specialty Pharmacy Service teams at Ernst & Young, LLP. We are trusted advisors who specialize in helping our clients overcome operational challenges, assess and mitigate regulatory risk, and engage innovative strategies to unlock new opportunities for growth. We provide independent professional services and are vendor agnostic. Our only goal is to be objective and help ensure our client’s success.

Pharmacy Enterprise Solutions:

  • Specialty Pharmacy Strategy and Implementation
  • 340B Audits, Implementation, and Advisory
  • Pharmacy Revenue Cycle
  • Pharmacy Cost Containment and Operational Improvement
  • Healthcare and Pharmacy Big Data Analytics

Team Background:

Alinea’s Pharmacy Enterprise Solutions team is a diverse and tenured group comprised of healthcare audit professionals, regulatory experts, clinicians, pharmacists, former hospital administrators, healthcare information systems experts, and data analysts to name a few. Prior to joining Alinea, Alinea professionals served as leaders at some of the nation’s most highly regarded hospital systems, pharmaceutical companies, supply chain distributors, managed care organizations, and management consulting / Big 4 audit firms.