340B Insight

340B Health
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340B Insight

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. 6 DAYS AGO

    Answering More of Your 340B Questions

    In what has become an annual tradition for the podcast, we consulted with 340B Health’s expert staff to answer our listeners’ most pressing 340B questions. As an uncertain and busy year starts for the world of 340B, we want to prepare you by covering your queries about the efforts by drug companies to impose 340B rebates, proposed federal and state legislation on 340B, how Inflation Reduction Act implementation will affect 340B, and more. 340B Rebate Lawsuits Heat Up So far, five drug companies have sued the Health Resources & Services Administration to challenge HRSA’s rejections of their backend rebate proposals. 340B Health Vice President of Legal and Policy Amanda Nagrotsky notes that a rebate model would harm 340B hospitals through delayed access to 340B savings and potentially denials of legitimate rebate claims based on drugmaker interpretations of 340B rules. We recorded this episode just before 340B Health filed a motion to intervene as a defendant in the Johnson & Johnson (J&J) rebate lawsuit against HRSA. Lawmakers Eye Ways To Protect or Cut 340B The new year means a new Congress and the start of new state legislative sessions. 340B Health Senior Vice President of Government Relations Tom O’Donnell notes that members of Congress have floated potential reductions in what the federal government pays for 340B drugs to help fund new spending priorities outside of health care, though it is unclear how seriously they are considering those options. 340B Health Vice President of Legal and Policy Greg Doggett reports that several states are considering new contract pharmacy or payment nondiscrimination protections for 340B hospitals, but others have introduced proposed new mandates for covered entities.  Price Caps Will Apply to More Medicare Drugs The list of drugs eligible for Medicare price caps will grow to 25 starting in 2027 under the Inflation Reduction Act, which will have implications for 340B savings on those drugs. 340B Health Research and Policy Analytics Manager Claudia Escue notes that popular weight loss and diabetes drugs like Ozempic and Wegovy have made the price cap list because of how much they cost Medicare. 340B Health is tracking how these price caps might lower 340B savings and have submitted letters to Medicare officials to represent other hospital concerns about the implementation of the IRA. Resources: 340B Health Files Motion To Intervene in J&J Rebate LawsuitOption To Cut Commercial Pay Rates for 340B Drugs Is on Draft Congressional Budget “Menu”Medicare Expands List of Drugs Subject to Price Caps, Decreased 340B Savings340B Coalition Winter Conference Registration

    17 min

  2. JAN 21

    What’s in the First State 340B Report in the Nation?

    A Minnesota requirement for covered entities to submit data on the costs they pay and the payments they receive for 340B drugs yielded its first annual report this past November. Today’s guest, Minnesota Hospital Association Director of State Government Relations Danny Ackert, tells us why the report’s findings don’t tell the whole story. The Context for the Dollars  The first Minnesota report concluded that covered entities received a net of $630 million in payments for 340B drugs in 2023 and paid $120 million to contract pharmacies and third-party administrators. But Ackert notes the figures do not account for what entities would have paid for drugs at non-340B prices, nor what pharmacy administrative costs they would have had if they did not have access to 340B. Where the Money Goes Ackert notes that the report does not spell out how hospitals in the state use their 340B savings to stretch resources and provide more care and support to patients. He notes that Minnesota hospitals spend about $15 billion a year providing care. They also face an annual shortfall of about $1.8 billion from Medicare and Medicaid underpayments, a figure that does not even account for charity care, bad debt, and other unreimbursed hospital spending. Some rural hospitals in the state rely on 340B savings just to stay open. What Other States Can Learn Although submitting data for the report and countering misconceptions about its findings have been challenging for Minnesota hospitals, Ackert also notes that it has given them an opportunity to educate policymakers about 340B. By learning more about the report and following the state’s example, hospitals in other states considering reporting mandates can put themselves in a position to explain to lawmakers why 340B is so vital. Resources: Minnesota 340B Covered Entity ReportEpisode 89: How New 340B Reporting Requirements Are Affecting Hospitals (February 2024)340B Medicare Hospital Pay Cuts Floated as an Option for Congress

    25 min

  3. 12/16/2024

    The Fight Over Rebates Heats Up

    Earlier this year, the Health Resources & Services Administration took a strong stance against drug giant Johnson & Johnson’s plan for a proposed 340B rebate model, but the fight over rebates is far from over. 340B Health President and CEO Maureen Testoni joins us to discuss how the company is taking the issue to federal court and how they are not the only drugmaker doing so. J&J Sues HRSA Over Rebates J&J is arguing in court that HRSA lacks the authority to block a 340B rebate model. Such a model would allow individual drug companies effectively to impose their own rules on 340B drug purchases. These rules would curtail the number of drugs a company would offer a 340B discount on and reduce the number of patients that would be deemed 340B-eligible. Other Drugmakers Pushing Rebates Bristol Myers Squibb and Eli Lilly also sued HRSA, claiming the agency does not have the authority to stop a rebate model. Sanofi has not yet filed suit but is saying it will impose its rebate scheme in early January. The Sanofi model raises significant concerns not just because of the imminent effective date but because it would impose far more stringent restrictions on 340B eligibility than HRSA ever has. State Contract Pharmacy Laws Rack Up More Wins In another 340B issue before the federal courts, state contract pharmacy protections continue obtaining key litigation wins. Several district courts and one appeals court have upheld state laws designed to protect covered entity access to 340B pricing through community and specialty contract pharmacies. Resources: Brief Your Leadership on Drugmaker Rebate SchemesThe Wall Street Journal: “The Economic Imperative of Protecting 340B”Register for the 340B Coalition Winter Conference

    21 min

  4. 11/25/2024

    What Does the GOP Trifecta Mean for 340B?

    What Does the GOP Trifecta Mean for 340B? In January, Republicans will achieve what’s known as a governing trifecta – taking control of the executive branch combined with GOP majorities in both the U.S. House and Senate. How will this new dynamic affect the 340B world? We discuss what is ahead with McDermott+ vice presidents Rodney Whitlock, a former Republican legislative staffer, and Debbie Curtis, a former Democratic legislative staffer. Capitol Hill Shakeups and New Faces Several 340B champions are set to leave Congress through retirement or new appointments, including Reps. Elise Stefanik and Abigail Spanberger as well as Sens. Debbie Stabenow and Ben Cardin. But this provides an opportunity to speak to newly elected lawmakers to express the value of 340B and what it means for their constituents. Preparing for 340B Oversight The new Congress could bring oversight hearings and other opportunities for 340B critics to speak out. Although 340B has faced and surmounted challenges before, this will require getting back to core advocacy efforts designed to protect the program. Trump’s Second Term How the second Trump administration will fill key roles and the decisions they make on health policy issues could impact 340B. The implementation of Inflation Reduction Act drug pricing provisions also will affect 340B and could lead to discussions about additional changes to the program. Resources: Create or Update Your 340B Impact ProfileRead Our Analysis of J&J’s Legal Arguments for 340B RebatesLilly, Kalderos Press Federal Court for Ability To Impose Rebates

    23 min

  5. 11/11/2024

    How 340B Funds an Innovative Program for Cancer Survivors

    The focus of attention on cancer care most often goes to the curative treatments required to put cancer into remission, but what do cancer survivors need after that point to fully recover and lead their best possible lives? We discuss that question and how 340B can help answer it with guests Sarah Loschiavo and Ellen Morris-White, two nurse practitioners with UConn Health based in Farmington, Conn. Survivorship Care at a Crucial Time UConn Health’s Cancer Survivorship Program is led by advanced practice registered nurses who provide comprehensive care and support to cancer patients starting three to six months after their curative cancer treatments are complete. With the help of 340B funding, the multidisciplinary program is broad in scope, including referrals to meet cancer survivors’ physical, psychosocial, spiritual, and financial needs. The goal is to keep patients on the road to recovery and to continue screening for any cancer recurrence or secondary cancers that could occur. 340B Is Key To Covering Costs  UConn Health covers the costs of its survivorship care, and low-income patients can receive additional financial assistance for their ongoing cancer therapies through this program. 340B funding is essential to making that happen. Over time, the program is expected to decrease health care costs by avoiding hospital readmissions and cancer recurrences.  Building Out Best Practices Evidence on survivorship care models is lacking, but UConn Health has worked on research that could provide some best practices for other institutions. Although there is no one-size-fits-all approach for hospitals, they can use elements of the nurse practitioner-led, interdisciplinary model to meet cancer patients’ needs months and even years after curative treatment.  Resources:  UConn Health Cancer Survivorship ProgramDesigning, Implementing, and Evaluating an Interprofessional Survivorship Model of Care in an Academic Cancer Center

    21 min

  6. 10/28/2024

    How 340B Is All About Health Equity

    The 340B drug pricing program is crucial for safety-net hospitals and other providers that care for patients in need, especially those whom traditionally have been underserved by the broader health system. We speak with Dr. Tony Jackson, assistant vice president for pharmacy services at Scripps Health in San Diego, for his views on why 340B is “all about health equity.” 340B Helps Serve the Underserved Jackson stresses the variety of services and support that 340B funding enables at Scripps Health. Because of 340B, Scripps can serve large populations of patients in the area who are homeless, lack health coverage, and are dealing with higher rates of chronic illness and disease. It does so in part through partnerships with community health centers and other community groups on outreach to those populations.  Restrictions to 340B Threaten Patient Care 340B savings help support vital Scripps services that include emergency department care, access to specialists, discharge and maintenance medications, and community health benefits such as disease screenings. Jackson notes that drug company restrictions on access to those savings threaten such services and risk creating health care deserts in the area. Representation and Advocacy Matter Jackson is part of the Association of Black Health-System Pharmacists (ABHP), which works to increase Black representation in the pharmacy field with the goal of improving underserved patients’ trust in pharmacists and access to needed care. He notes how ABHP leaders have advocated for 340B with the understanding of how important it is to the pursuit of health care equity. Resources 340B Health Equity Report 2023Black Pharmacists Stand as Advocates in Support of 340B Access to CareSenate Letter to HHS on Rebates

    23 min

  7. 10/15/2024

    How Hospitals Won This Round in the 340B Rebate Fight

    Within the past few weeks, drugmaker Johnson & Johnson went head-to-head with 340B hospitals and the federal government over the company’s plan to stop paying upfront 340B discounts on two of its top-selling drugs. 340B Health Senior Counsel Amanda Nagrotsky joins us to explain how that conflict played out. HRSA Warns Johnson & Johnson of Strong Punitive Actions In letters to J&J, the Health Resources & Services Administration (HRSA) warned the drugmaker that replacing 340B rebates with discounts only would be allowed if approved by the Health and Human Services (HHS) secretary. HRSA gave the company until the end of September to announce that it was going to walk away from its plan or face both civil monetary penalties and the termination of its pharmaceutical pricing agreement (PPA). Nagrotsky said the threat to end the PPA was unprecedented, noting that it would cause the company to lose access to Medicaid and Medicare Part B coverage for all its drugs. Johnson & Johnson Backs Down Under Pressure J&J announced at the end of September that it would walk back its plan to implement rebates in mid-October, bowing to pressure from federal health officials and a bipartisan group of nearly 200 members of Congress who opposed the J&J strategy. The company maintained that it disagreed with HRSA’s reasoning and noted that it was reserving all legal rights with respect to rebates. That stance indicates the company is likely to continue its push to implement rebates. The Battle Against Rebates Continues Despite the win for hospitals on the J&J rebate scheme, efforts from the drug industry to change the 340B discount structure continue. Drug industry consultant Kalderos is part of ongoing litigation in a federal court in Washington, D.C., over the right to impose rebates. HRSA’s references to the concept of HHS approval of rebate proposals also leaves open the door for companies to seek federal consent for such a model. Resources 340B Hospitals Prevail on J&J Rebate Plans, But Fight Is Not OverBipartisan U.S House Letter to HHS, Sept. 27 HRSA Letter to Johnson & Johnson, Sept. 27J&J Response to HRSA, Sept. 30

    18 min

  8. 09/30/2024

    The Latest on 340B Rebates

    A renewed push by a drugmaker to fundamentally transform 340B has the potential to cause major problems for 340B hospitals if allowed to take effect. 340B Health President and CEO Maureen Testoni joins us to explain the controversial 340B rebate issue and to cover some of the other recent developments in the 340B world.   A Plan To Replace Upfront Discounts With Rebates   For years, drugmakers have been pushing unsuccessfully for approval to turn 340B from an upfront discount program into a back-end rebate program. But recently, Johnson & Johnson announced it would unilaterally proceed with plans to stop selling two of its drugs at the discounted price for certain hospitals. Maureen explains the reaction of the government, hospitals, and others and outlines the potential next steps in the advocacy against such a harmful change.   More Legislative Action on Capitol Hill   Recently, Sen. Peter Welch of Vermont introduced legislation to make access to 340B through contract pharmacies a very clear part of statute and to prohibit manufacturers from imposing conditions on 340B pricing. It is one of several 340B bills pending on Capitol Hill, which also include a potential Medicaid payment reporting requirement for 340B hospitals. Maureen notes that although Congress does not have much time left to legislate this year, it is possible 340B will be part of the action during a lame-duck session after the elections.   Court Action Continues on State 340B Laws   Although two federal appeals courts recently ruled that the 340B statute does not categorically prohibit drugmaker conditions on 340B pricing, several states have moved to impose their own such prohibitions. Drug companies are suing to block these laws, but so far courts have denied these attempts. Maureen notes that 340B Health and other organizations continue to file friend of the court briefs in support of these state laws.   Resources 1. HRSA Threatens Johnson & Johnson With Sanctions Over Rebate Plans 2. HRSA Letter to J&J

    22 min
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About

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.

Information

  • Creator
    340B Health
  • Years Active
    2020 - 2025
  • Episodes
    111
  • Rating
    Clean
  • Copyright
    ©2020-2023 340B Health
  • Show Website
    340B Insight

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