Covered Entities and the 340B Program: Avoid Common Pitfalls of the Medicaid Exclusion File

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When a covered entity enrolls in the 340B program it must inform the Health Resources and Services Administration (HRSA) whether it will “carve in” and acquire 340B drugs for its Medicaid fee-for-service (FFS) eligible patients, or “carve out” and purchase drugs for its FFS patients outside the 340B program.

A covered entity choosing to carve in Medicaid FFS claims must provide the HRSA Office of Pharmacy Affairs (OPA) with the Medicaid Provider Number(s) (MPNs) or National Provider Identifier(s) (NPIs) it uses to bill FFS Medicaid (in any state) for 340B drugs. This information will appear on the 340B Medicaid Exclusion File (MEF), notifying states and manufacturers that drugs purchased under that MPN or NPI are not eligible for a Medicaid rebate. Covered entities are required to ensure that the information listed on the MEF is accurate.

Published quarterly on the OPA Information System (OPAIS), the MEF is the data source HRSA uses to assist

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Making the Case for Your 340B Program

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Are you telling your 340B story? This webinar will teach you how to track the key data points that demonstrate the value of your 340B program. You will learn how to calculate your overall savings, track patient benefits, and create an Impact Profile. You will also learn about the new reporting requirements being passed at the state and federal levels, and how to communicate with lawmakers about the impact of your 340B program.

Key Takeaways:

  • Learn how to track the key savings metrics that demonstrate the value of your 340B program.
  • Track Patient Benefits to show all the services your CE provides to them.
  • Create an Impact Profile that shows the value of your 340B program to your community.
  • Stay up-to-date on the latest reporting requirements for 340B programs.
  • Learn how to communicate with lawmakers about the impact of your 340B program.

Who Should Attend:

This webinar is for

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Look to Specialty Pharmacy to Address 340B Challenges

Graphic image illustrating the revenue per dose that can be generated by a specialty contract pharmacy and an entity-owned specialty pharmacy for a leading rheumatoid arthritis medication.

SPONSORED CONTENT

Today’s U.S. health systems face significant financial challenges. Many are still trying to recoup pandemic-related losses stemming from forced shutdowns, elective procedure postponements, and reduced outpatient visits. These factors have contributed to billions in lost revenue, leaving many of America’s health systems with negative operating margins.

As a result, health systems are desperate to find new ways to maximize cost savings and generate new revenue. Enhancing specialty pharmacy operations is increasingly being recognized as a primary way to achieve this objective in the short term.  A new infographic outlines how therapy expansion, increased specialty drug spending, access challenges, and growing patient need are currently converging to create a unique opportunity for health systems to realize sizable financial gains by evolving their approach to specialty pharmacy.

Manufacturer restrictions create barriers to 340B discounts

Hospital or health system covered entities (CEs) eligible for drug discounts through 340B potentially have

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Covered Entities’ and Manufacturers’ 340B Summit

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Demonstrate Compliance with 340B Drug Pricing Requirements, Implement Strategies for Successful Audits, and Provide Quality Care

Designed for both Covered Entities and Manufacturers, attend this event to explore the latest developments in 340B with regards to transparency, HRSA 340B audits and other federal oversight activities.  Attendees will examine the impact of recent policy changes, trends in pharmacy contracting and drug management practices, how to effectively leverage data analytics, and strategies to maintain compliance and ensure program integrity.

  • Tailor your conference experience through multi-track offerings for covered entities’ and manufacturers’
  • Analyze current 340B litigation and its impact on future market dynamics through multi-stakeholder perspectives   
  • Explore the latest developments in 340B contracting, transparency, HRSA 340B audits and compliance  
  • Network with senior executives focused on 340B including manufacturers, covered entities, and HRSA grantees
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Is Your Technology a Triple Threat That Boosts Your Mission?

SPONSORED CONTENT

When people consider technology’s role in adapting to pandemic-constrained life, many begrudgingly think about endless hours spent on videoconferences. Yet, pandemic-infused technological innovations also altered our lives in other ways, big and small. For instance, I’ll never go back to wearing “slacks” and wondering what my face looks like with just a mustache. On a much more serious note, millions of Americans lost their lives or fought severe health battles. Others switched careers, relocated, or reconsidered how they wanted to live. In each of these instances, technology, more often than not, played a critical role.

It’s no secret that the pandemic had a devastating effect on health care institutions and front-line workers. At Avita, our covered entity partners bravely faced the one-two punch of evolving patient needs paired with providers leaving the profession in droves. When combined with the ever-changing 340B environment, this means community health organizations must leverage

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Tips for Specialty Pharmacy Success

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The Origin and Evolution of Specialty Pharmacy

Commencing in the early 1970s, specialty pharmacy was originally intended for patients requiring unique therapies for various conditions. Initially this included mainly infusions for hemophilia, cancer, or malnutrition[i]. Most of these offerings came with high costs (many of which can now be offset by copay assistance programs), and special storage and/or shipping requirements[ii].

Specialty pharmacy has since expanded rapidly, and Merck’s launch of indinavir (Crixivan®) in 1996 marked a significant milestone. As the third approved protease inhibitor for HIV treatment, the launch followed a record setting fast-track FDA approval. The decision to dispense Crixivan® exclusively through Stadtlanders specialty pharmacy[iii] set the tone for the limited distribution networks that we see today.

Between 1970 and 2000, most specialty medications were covered as a medical expense. However, a shift occurred in the early 2000s, with specialty transitioning to the pharmacy benefit. Today,

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340B Outlook from Capitol Hill and the States

SPONSORED CONTENT

Location: Gaylord National Resort & Convention Center

Start your 340B Coalition Summer Conference with the latest developments in the 340B program. Verity Solutions will be hosting a panel discussion at the Gaylord Resort in National Harbor with some of the most respected long-term experts on the 340B program. Join us for an up-to-the-minute report on hot button topics related to the legislative, compliance, and regulatory aspects of the 340B program.

Among the topics to be covered:

  • Developments on the 340B contract pharmacy legal situation
  • Updates on 340B legislative efforts in Washington, D.C. and the states and potential impact
  • Discussion about alternative replenishment models
  • Latest on HRSA policies including off-site clinic enrollment

Space is limited and only open to 340B covered entities.

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