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340B Insight - Analyzing 340B News from the Courts to Pharma Manufacturer Actions

Analyzing 340B News from the Courts to Pharma Manufacturer Actions

08/17/20 • 18 min

340B Insight

In this episode we speak with Maureen Testoni, President and CEO for 340B Health, on new 340B policy developments in recent weeks that include a major court decision and drug manufacturer challenges to 340B contract pharmacies. Prior to the interview, we answer a member question on changes this year to the 340B hospital recertification process.

Some key takeaways from the conversation with Testoni include:

Court Decision Upholds CMS Medicare Part B Cuts: Since 2018, The Centers for Medicare & Medicaid Services (CMS) has cut payments by nearly 30% to many 340B hospitals. Testoni explains how the D.C. Circuit Court of Appeals for the District of Columbia has overturned a lower court decision and has ruled that the government has the authority to continue with the cuts. Testoni shared potential next steps in the case.

CMS Proposes Steeper Medicare Part B Cuts for 2021: Following the D.C. Circuit Court of Appeals decision to allow CMS Medicare Part B cuts to hospitals, Testoni analyzed how CMS’ proposed 2021 Medicare Outpatient Perspective Payment Systems rule could result in an even steeper cut for 340B hospitals. She explained how 340B Health plans to work with members to respond.

Recent Actions by Pharmaceutical Companies: Several drug companies are refusing or threatening to not provide 340B pricing on drugs that will be distributed at a contract pharmacy. Two of these companies are asking 340B covered entities for claims data to be shared with them. Testoni says that these actions violate the 340B statute and that requests for claims data create multiple challenges for covered entities. She also gives insight to what 340B hospitals should do when manufacturers ask for claims data or do not offer 340B pricing on medications purchased for distribution at a contract pharmacy.

Progress on Protecting 340B Hospitals During the Pandemic: For 340B hospitals whose program eligibility is determined by their DSH adjustment percentage, there is concern that changes in payor mix during the COVID-19 pandemic puts them at risk for losing program eligibility. Testoni provides updates on two new bills in Congress that have been introduced to address this problem.

Check out all of our episodes on the 340B Insight podcast website. You can also stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover in this podcast, email us at [email protected].

Episode Resources

  1. 340B Health Recertification Webinar
  2. U.S. Court of Appeals Decision on CMS Medicare Part B Cuts to 340B Hospitals
  3. CMS 2021 Proposed Outpatient Prospective Payment System Rule
  4. Bipartisan Bill Would Protect 340B Status During Emergency
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In this episode we speak with Maureen Testoni, President and CEO for 340B Health, on new 340B policy developments in recent weeks that include a major court decision and drug manufacturer challenges to 340B contract pharmacies. Prior to the interview, we answer a member question on changes this year to the 340B hospital recertification process.

Some key takeaways from the conversation with Testoni include:

Court Decision Upholds CMS Medicare Part B Cuts: Since 2018, The Centers for Medicare & Medicaid Services (CMS) has cut payments by nearly 30% to many 340B hospitals. Testoni explains how the D.C. Circuit Court of Appeals for the District of Columbia has overturned a lower court decision and has ruled that the government has the authority to continue with the cuts. Testoni shared potential next steps in the case.

CMS Proposes Steeper Medicare Part B Cuts for 2021: Following the D.C. Circuit Court of Appeals decision to allow CMS Medicare Part B cuts to hospitals, Testoni analyzed how CMS’ proposed 2021 Medicare Outpatient Perspective Payment Systems rule could result in an even steeper cut for 340B hospitals. She explained how 340B Health plans to work with members to respond.

Recent Actions by Pharmaceutical Companies: Several drug companies are refusing or threatening to not provide 340B pricing on drugs that will be distributed at a contract pharmacy. Two of these companies are asking 340B covered entities for claims data to be shared with them. Testoni says that these actions violate the 340B statute and that requests for claims data create multiple challenges for covered entities. She also gives insight to what 340B hospitals should do when manufacturers ask for claims data or do not offer 340B pricing on medications purchased for distribution at a contract pharmacy.

Progress on Protecting 340B Hospitals During the Pandemic: For 340B hospitals whose program eligibility is determined by their DSH adjustment percentage, there is concern that changes in payor mix during the COVID-19 pandemic puts them at risk for losing program eligibility. Testoni provides updates on two new bills in Congress that have been introduced to address this problem.

Check out all of our episodes on the 340B Insight podcast website. You can also stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover in this podcast, email us at [email protected].

Episode Resources

  1. 340B Health Recertification Webinar
  2. U.S. Court of Appeals Decision on CMS Medicare Part B Cuts to 340B Hospitals
  3. CMS 2021 Proposed Outpatient Prospective Payment System Rule
  4. Bipartisan Bill Would Protect 340B Status During Emergency

Previous Episode

undefined - Addressing Healthcare Disparities During the COVID-19 Pandemic

Addressing Healthcare Disparities During the COVID-19 Pandemic

In this episode, we spoke with Dr. Jewel Younge, Clinical Pharmacist at the University of Illinois Hospital & Health Sciences System (UI Health) and Clinical Assistant Professor at the University of Illinois Chicago College of Pharmacy. We invited Jewel on the podcast after she participated in a panel discussion on health care inequalities during the 340B Coalition Virtual Summer Conference in late July. At the start of the episode, we discussed several news updates including a new presidential executive order regarding the 340B program.

Some key takeaways from the conversation with Jewel Younge include:

Jewel’s Path to Pharmacy: Jewel took a nontraditional path to become a pharmacist. Originally the Chair of the Visual and Performing Arts Department at Olive-Harvey College, Jewel sought to expand her horizons by taking chemistry courses. After years of learning and training, she is now a practicing pharmacist and assistant professor at the University of Illinois Chicago College of Pharmacy.

COVID-19 Highlights Health Disparities in the US: Jewel shared data pointing to race and age disparities during the COVID-19 pandemic in Chicago. She notes that the Black and Latinx communities have experienced higher positivity rates and deaths, while deaths for people over the age of 60 are disproportionately high.

Busting Myths: Jewel emphasizes that communities that lack trust in health care systems are suffering from “COVID-19 myths.” For example, many are skeptical that the costs of seeking hospital care for medical conditions during the pandemic outweigh the benefits. She calls on health care professionals to improve outreach and build relationships with these communities.

340B’s Role in Addressing Health Disparities: UI Health provides more than $27 million per year in uncompensated care and has more than $19 million in 340B savings, which in turn is invested in pharmacy services, a medication assistance program, and other services that enhance patient care. Jewel said, “That's really what 340B is all about. Taking a small benefit and turning it into a massive reward for as many people as possible.”

Closing patient care gaps that perpetuate health care disparities in the U.S. will require input and action from safety-net providers. We are fortunate to have leaders such as Jewel who are leading the way toward progress.

Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover in this podcast, email us at [email protected].

Episode Resources:

  1. President Trump Signs Executive Order on 340B
  2. Statement on Congresswoman Doris Matsui and Congressman Chris Stewart on Bipartisan House Legislation to Protect 340B During COVID-19
  3. Report: The Role of Hospitals in Serving Medicaid and Low-Income Medicare Patients (and accompanying infographic)
  4. University of Illinois Hospital & Health Sciences System

Next Episode

undefined - 340B and Caring for People Experiencing Homelessness

340B and Caring for People Experiencing Homelessness

In this episode, we spoke with Nicole Shoquist, Chief Pharmacy Officer for JPS Health Network in Fort Worth, Texas. Nicole described the importance of 340B in meeting the needs of patients experiencing homelessness. Nicole describes JPS’s innovative response to care for these patients during the height of the pandemic that included telehealth and new ways to help patients receive their prescriptions. Prior to the interview, our news update segment provides an update on drug manufacturers refusing to offer 340B pricing when drugs are dispensed at community pharmacies.

340B Savings Stretch Scarce Resources: Prior to COVID-19, JPS Health Network offered primary and some specialty care for the homeless population in Fort Worth, including a mobile van, hepatitis C and HIV clinics, and nurse practitioners in shelters. Nicole emphasized the importance of 340B in making these service offerings possible.

Shelter-in-Place and the Homeless Community: When Fort Worth and Tarrant County issued stay-home orders, regional homeless shelters closed, leaving their residents without access to medical clinics or a place to receive prescriptions. The city then made its Civic Center available to several hundred residents without shelter, and JPS made health care services normally accessed at its clinics and a mobile van available at the Civic Center.

Meeting the Challenge with Innovation: In addition to expanding its care offerings to the Civic Center, JPS installed iPads and phones in private areas there so that residents could take advantage of telehealth offerings. In addition, JPS initiated prescription delivery to the Civic Center.

Maintaining 340B Compliance: JPS worked to ensure it remained complaint with 340B as it delivered care both to patients it had an existing relationship with as well as first-time patients. In some cases, prescriptions were not eligible for 340B due to program eligibility rules.

Best Practices and Silver Linings: The pandemic has led to JPS discovering new best practices for serving a community of underserved patients that can be hard to reach. JPS found that delivering patients their medications rather than asking patients to come to the pharmacy led to improved medication adherence rates and lower hemoglobin A1C and blood pressure levels. As a result, Nicole says many of these best practices are continuing even though the Civic Center shelter operations have closed.

Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover in this podcast, email us at [email protected].

Episode Resources

  1. 1,100 + Hospitals Letter to Secretary Alex Azar Urges HHS to Halt Attempts to Undermine the 340B Drug Pricing Program
  2. 7 Groups Representing Hospitals Letter to Secretary Alex Azar Asking to Enforce 340B Rules
  3. Drug Manufacturer Updates for Members
  4. Webinar: Medicare Part B Drug Payment Cuts to 340B Hospitals
  5. JPS Health Network

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