340B Insight

340B Health
  • 0,0 (0)
  • Medicin
  • Hver anden uge

340B Insight provides members and supporters of 340B Health with timely updates and discussions about the 340B drug pricing program. The podcast helps listeners stay current with and learn more about 340B to help them serve their patients and communities and remain compliant. We publish new episodes twice a month, with news reports and in-depth interviews with leading health care practitioners, policy and legal experts, public policymakers, and our expert staff.

  1. 2 dage siden

    How Courts Are Shaping the Future of 340B

    With scores of pending lawsuits involving drugmaker and covered entity challenges of how federal and state governments regulate 340B, the courts have become an important arena in the national 340B debate. 340B Health’s Vice President of Legal and Policy Amanda Nagrotsky unpacks some of the cases and what they might mean for 340B’s future. Courts Wrestle With Issues of Federal and State Authority Drug companies have filed about 80 lawsuits challenging state contract pharmacy protection laws. Nagrotsky says drugmakers are arguing these state laws conflict with federal oversight, but most courts so far have ruled that contract pharmacy protection laws fall within a state’s ability to regulate drug distribution and delivery. A recent decision from a federal judge in Mississippi was a major win for covered entities because it completely dismissed a drugmaker’s challenge to the state’s law rather than just ruling on whether to pause enforcement of the law.  AbbVie Challenges 340B Patient Definition Drugmaker AbbVie is suing the Health Resources & Services Administration (HRSA) directly, arguing that the definition of whom the agency considers a 340B-eligible patient is too broad. AbbVie’s own, narrower patient definition would require drug companies to discount far fewer drugs and thus would limit hospital access to 340B savings significantly. The government is asking the court to dismiss the lawsuit on procedural grounds, and 340B Health along with two member hospitals are asking the court to allow them to intervene as defendants and provide additional arguments for why it should throw out the case. Uncertainty Remains Despite GPO, Child Site Rulings Federal district court decisions found that HRSA failed to explain why it adopted a 2013 policy barring certain 340B hospitals’ use of group purchasing organizations (GPOs) to make initial purchases for their virtual inventory systems and a 1994 policy establishing registration prerequisites for new 340B hospital outpatient facilities. Although the government opted against appealing the ruling striking down the GPO policy, the underlying prohibition remains in effect, leaving hospitals in limbo as to how HRSA will interpret the law. The government has appealed the child site ruling, and a final decision on that case will have a major impact on how quickly hospitals can use 340B drugs at new child sites.

    19 min.

  2. 26. maj

    How To Calculate How the IRA Will Affect 340B in 2027

    Hospitals already have felt some of the effects of the Inflation Reduction Act on 340B savings, but with the IRA set to expand to more drugs in 2027, hospitals also are starting to project how it might affect their bottom lines next year. 340B Vice President of Pharmacy Services and Education Steven Miller joins us to explain how hospitals can be making those projections now. The IRA Will Expand to Another 15 Drugs Next year, an additional 15 drugs will be subject to Medicare price caps under Medicare Part D on top of the 10 drugs that saw caps this year. Steve says this will cut into 340B savings and overall margins even more — with some 340B discounts possibly dropping to their statutory minimums. These reductions also will translate to commercial and cash-pay dispenses, changing the overall financial outlook for hospitals. Hospitals Cannot Rely on Current 340B Savings Levels for 2027 Steve says the 2027 changes are key for future budgeting. If hospitals do not adjust how they are budgeting for 340B drugs subject to Medicare price caps, they are likely to be short on their budget projections. He strongly recommends 340B teams have important conversations with finance teams now about how the IRA will affect their hospital or health system next year. Hospitals Can Be Planning Now For the rest of 2026, Steve recommends hospitals monitor list pricing and 340B ceiling pricing regularly and to increase monitoring of purchases overall, given how drugmaker pricing behavior affects future 340B prices and savings. As the IRA continues to broaden over the next several years, including to Medicare Part B dispenses, he also recommends hospitals consider securing funding or support from other areas for any 340B-funded services that might see negative IRA impacts. Resources: Prepare Your Leadership for 340B Changes From 2027 Medicare Drug Price Caps

    22 min.

  3. 11. maj

    How To Navigate a Drug Company’s Good-Faith Inquiry

    Drug companies often initiate good-faith inquiries of covered entities (CEs) to learn more about certain purchase patterns or volumes, but how should hospitals navigate these requests? Bibi Wishart, director of pharmacy at Atrium Health, describes what she’s learned being on the receiving end of these inquiries. Why Do Good-Faith Inquiries Happen? Bibi says the recent rise in good-faith inquiries is tied in part to drug companies gaining access to more varied data sources and expressing a goal of ensuring the information they collect is in line with what they are expecting. She says a variety of different factors could trigger this type of inquiry, including new providers purchasing certain drugs, concerns about duplicate discounts, or confusion around whether a drug is being used in an inpatient or outpatient setting. Hospitals are very complicated, so responding to an inquiry often can be more about educating drug companies about how hospitals dispense drugs. How Should a Hospital Respond? If her hospital receives a communication from a drug company through its authorized official and primary contact, Bibi says she prefers to respond within one or two business days just to confirm she has received the inquiry. She says that while it may take several days or weeks to respond with the requested data, that initial response establishes a cooperative tone and ultimately might prevent escalation to a formal audit process. That also gives the 340B team time to pull in the correct departments and hospital data to provide a full response. Ways To Prevent the Need for Inquiries Due to the sheer complexity of dispensing drugs — including reconciling data feeds from third-party administrators, vendors, and electronic medical records — regular internal audits are one of the best ways to identify discrepancies before drugmakers launch inquiries about them. Bibi recommends using internal auditing to catch these issues and having clear procedures in place for how to resolve any potential errors.

    16 min.

  4. 13. apr.

    The Rebate Debate and Other “Fast and Furious” 340B Developments

    340B lately has had a news cycle that seems to change by the hour, and 340B Health President and CEO Maureen Testoni joins us to break down some of the biggest news happening in Washington, D.C., and in courthouses around the country. HRSA Seeks Feedback on Reviving Rebates  After courts halted the rebate pilot that was set to go into effect in January, Maureen notes that the Health Resources & Services Administration is seeking more information on a possible revival of its rebate plans. Hospitals are responding with their objections, as are lawmakers on Capitol Hill. Nearly 100 members of the House of Representatives wrote a letter to the committee in charge of funding HRSA urging it to block federal spending for any HRSA rebate model. Huge Rulings on the GPO Prohibition, Child Site Registration The past several months have seen big 340B rulings from federal courts. One decision vacated HRSA guidance that had blocked certain 340B hospitals’ use of GPOs for their initial drug inventory, finding that HRSA failed to properly explain the reasons for that restriction. The other decision found that HRSA similarly failed to explain a rationale for restricting 340B eligibility for child sites for up to 23 months after the sites come online. Maureen notes that HRSA could appeal the rulings or seek to issue new guidance. Federal Government Weighs in on State Contract Pharmacy Lawsuits For the first time, the federal government has filed briefs in support of drug companies in several lawsuits over state contract pharmacy protection laws. In these briefs, Maureen says the government effectively is telling judges it does not believe states have the right to protect contract pharmacy because federal 340B law preempts such actions. With the federal government weighing in on the matter and a recent split among appeals courts over the issue of preemption, it is possible this issue might be appealed at some point to the U.S. Supreme Court. Resources Use Our Letter Template Today To Oppose Development of a New 340B Rebate ProgramNearly 100 Members of Congress Urge Funding Block for 340B Rebate ModelPlease Help Advocate for Enforcement Actions Against Drugmakers’ In-House Claims Data DemandsFederal Court Vacates HRSA’s 2013 GPO Prohibition PolicyFederal Court Decides HRSA Child Site Eligibility Restrictions Are UnlawfulFederal Government Backs Drug Companies in Litigation Over State Contract Pharmacy LawsAppeals Court Blocks West Virginia 340B Contract Pharmacy Law, Creating Potential Split with Other Circuits340B Health Impact Profile Guidebook and Template

    23 min.

  5. 30. mar.

    How To Improve 340B Inventory Management

    One of the most important responsibilities hospitals have in maintaining 340B compliance is effective and accurate inventory management, but how do hospitals juggle data from multiple systems and minimize discrepancies? Christina Carrizales Cortez, associate director of 340B compliance for UI Health in Chicago, outlines some of the common inventory issues she encounters and explains how her team works to prevent and fix discrepancies. 340B Discrepancies Can Come From a Variety of Sources Christina says that because 340B compliance relies on monitoring and analyzing a multitude of data feeds, inventory discrepancies can come in multiple forms. A wholesaler might lack an electronic interface — meaning items must be manually entered and verified by the hospital team. Accounts might not have up-to-date inventory locations and addresses. Test claims, a practice by which pharmacies ascertain the cost to a patient of certain drugs, can lead to discrepancies if they do not end up dispensing those drugs. Understanding Systems Can Be Key to Reducing Discrepancies Christina says that the terminology and quirks of 340B can introduce confusion. One remedy, she says, is to explain 340B better so non-340B staff can understand it. Breaking down the basics of 340B and explaining its intricacies can go a long way in rooting out common pain points. Other Tips for Reducing Discrepancies Christina finds that comprehensive monthly reviews are an excellent way to find mismatches, as are instituting different checkpoints in the review process. Analyzing data points such as timestamps can reveal patterns for hospitals. Mapping out all vendors and routinely auditing split-billing software can help ensure better compliance as well. Resources Federal Court Decides HRSA Child Site Eligibility Restrictions Are Unlawful

    18 min.

  6. 9. mar.

    Lessons From a Pro in Advocating Effectively for 340B

    As state legislatures shape up to be the primary battlegrounds for 340B in 2026, Memorial Healthcare Associate Vice President of Advocacy and Government Relations Ben Frederick joins us to share what he’s learned about advocating for 340B. Early Involvement “Crucial” as Focus Shifts to States Ben notes that as states started becoming the primary venues for debating 340B legislation, lobbying efforts from both hospitals and pharmaceutical companies began increasing. This snowballed into deeper conversations — and misleading narratives — about the intent of 340B. Those conversations underscored the importance of hospitals lobbying early and frequently with key stakeholders to help set the record straight about 340B. 340B as Key to Hospital Resiliency For Ben, one of the biggest points he comes back to is the importance of the flexibility of 340B savings. With safety-net hospitals operating on thin margins, the ability to access 340B and the freedom to use savings where the community needs them most is essential not just for serving patients but in many cases for keeping the lights on in the first place. Know Your “Why” for Supporting 340B When illustrating the importance of 340B, Ben told us about his “why” for 340B: When his father received a terminal cancer diagnosis, it was 340B funding that enabled his local hospital to invest in the top-notch cancer treatments and palliative care he received. That is how his father was able to receive his treatments five minutes from home instead of 45 minutes away. Those resources afforded Ben’s family a “dignity of local access” that 340B can provide patients in hospitals nationwide. Resources HRSA Considering Broader 340B Rebate Model Than Withdrawn Pilot340B Health Impact Profile Guidebook and Template

    23 min.

  7. 23. feb.

    What Happens After a State Enacts Contract Pharmacy Protections?

    Some of the biggest recent policy developments for 340B hospitals are when states enact legislation to protect access to 340B pricing through contract pharmacies. Olivia Little, 340B director at Johnson County Hospital in Tecumseh, Neb., was closely involved with a coalition of providers that was able to get such a bill passed through the state’s legislature and signed into law by the governor. But she describes why getting the law enacted wasn’t the end of the story. A Wide Range of Responses Little says once her state’s contract pharmacy protection law went into effect, she began receiving notices about 340B pricing being restored from some drug companies. But not all drugmakers restored previous pricing levels right away in Nebraska — some took months, and some have not yet done so despite the law going into effect nearly a year ago. The wide range of ways in which companies responded to the new law created difficult choices for hospitals between risking a potential compliance issue or leaving some 340B savings on the table.  Having a Game Plan Little says her advice to other health systems in states with new contract pharmacy protections would be to have a plan in place for what happens when the law goes into effect. Implementing these protections can raise questions about issue such as backdating, inventory, and retesting claims for 340B status. The complex tracking of multiple drugmaker policies in response to the Nebraska law resulted in her needing to closely document communications with drug companies and their vendors. The Need To Be Persistent Little also stressed that getting pharmacy protections to pass through her state legislature and get to the governor’s desk took years of effort, advocacy, and redrafting to ensure success. Between media appearances and advocating in the statehouse and on social media, Little says this success ultimately came down to the core message: 340B is good for patients, hospitals, and communities. Resources: HRSA Gives Short Window for Stakeholder Input on Reviving 340B Rebate Model

    23 min.

  8. 9. feb.

    Answering More of Your Top 340B Questions

    For the third year in a row, we consulted 340B Health’s experts on our staff to answer our listeners’ most pressing 340B questions. As 2026 gets underway, we answer your questions about the CMS drug acquisition cost survey, what states are doing on 340B this year, and more. Some of the topics we cover: CMS Drug Acquisition Cost Survey Not Mandatory Earlier this year, the Center for Medicare & Medicaid Services (CMS) launched a new survey focusing on hospitals’ outpatient drug acquisition costs, which could lead to Medicare Part B payment cuts for 340B drugs. Some hospitals recently saw materials suggesting they are required to complete the survey. Amanda Nagrotsky, vice president of legal and policy for 340B Health, notes that a CMS rule states there are no penalties under the Medicare statute for hospitals that choose not to respond. 340B Health and other groups sent a joint letter asking for the language to be corrected, citing the confusion it has caused. State Legislatures Are Becoming Major Battlegrounds for 2026 Just over one month into 2026, statehouses are already shaping up to be one of the biggest venues to debate various aspects of the 340B. Two broad categories of bills are emerging: legislation protecting access to 340B pricing — including protections for contract pharmacy arrangements — and state-level reporting mandates. 340B Health Senior Vice President of Government Relations Tom O’Donnell says the proposed reporting mandates mirror other states’ recently enacted requirements, and he argues they can be misleading, burdensome, or modeled on frameworks promoted by large drug companies. Medicare Announces More Drug Price Caps for 2028 Medicare is phasing in maximum fair pricing – or MFP – for high-spending drugs over several years. CMS recently announced the next group of 15 drugs that will be subject to these types of price caps in 2028, adding to the 2026 and 2027 drug lists. Starting in 2028, these price caps will apply to both Medicare Part D and Part B drugs, including those purchased through Medicare Advantage. 340B Health Senior Manager of Pharmacy Services Gilda Yeboah says this means hospitals will see reduced 340B savings on certain drugs as Medicare prices move closer to existing 340B ceiling prices. Yeboah says the issue is complex and evolving, and 340B Health is working to share concerns about MFP implementation with federal agencies. Resources 340B Health and Allies Urge CMS Contractor To Correct Statement Suggesting Hospitals Must Respond to OPPS Drug Cost SurveyStates Introduce New 340B Legislation in 2026 SessionsMaine Federal Court Rejects Drug Company Challenge to State 340B Contract Pharmacy LawMedicare Expands List of Drugs Subject to Price Caps, Decreased 340B Savings Starting in 2028Manufacturer Notices to Covered EntitiesHRSA Releases 340B Purchase Data for 2024FY 2025 Manufacturer Audit Results

    14 min.
Se alle (140)

Trailer

Om

340B Insight provides members and supporters of 340B Health with timely updates and discussions about the 340B drug pricing program. The podcast helps listeners stay current with and learn more about 340B to help them serve their patients and communities and remain compliant. We publish new episodes twice a month, with news reports and in-depth interviews with leading health care practitioners, policy and legal experts, public policymakers, and our expert staff.

Oplysninger

  • Skaber
    340B Health
  • Aktive år
    2020 - 2026
  • Episoder
    140
  • Vurdering
    Ikke anstødeligt
  • Copyright
    ©2020-2025 340B Health
  • Websted for serie
    340B Insight

Måske vil du også synes om