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

1. Use Our Letter Template Today To Oppose Development of a New 340B Rebate Program
2. Nearly 100 Members of Congress Urge Funding Block for 340B Rebate Model
3. Please Help Advocate for Enforcement Actions Against Drugmakers’ In-House Claims Data Demands
4. Federal Court Vacates HRSA’s 2013 GPO Prohibition Policy
5. Federal Court Decides HRSA Child Site Eligibility Restrictions Are Unlawful
6. Federal Government Backs Drug Companies in Litigation Over State Contract Pharmacy Laws
7. Appeals Court Blocks West Virginia 340B Contract Pharmacy Law, Creating Potential Split with Other Circuits
8. 340B Health Impact Profile Guidebook and Template

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

1. Federal Court Decides HRSA Child Site Eligibility Restrictions Are Unlawful

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

1. HRSA Considering Broader 340B Rebate Model Than Withdrawn Pilot
2. 340B Health Impact Profile Guidebook and Template

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:

1. HRSA Gives Short Window for Stakeholder Input on Reviving 340B Rebate Model

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

1. 340B Health and Allies Urge CMS Contractor To Correct Statement Suggesting Hospitals Must Respond to OPPS Drug Cost Survey
2. States Introduce New 340B Legislation in 2026 Sessions
3. Maine Federal Court Rejects Drug Company Challenge to State 340B Contract Pharmacy Law
4. Medicare Expands List of Drugs Subject to Price Caps, Decreased 340B Savings Starting in 2028
5. Manufacturer Notices to Covered Entities
6. HRSA Releases 340B Purchase Data for 2024
7. FY 2025 Manufacturer Audit Results

HRSA Pauses Rebate Implementation After Court Ruling

In late December, a federal court in Maine issued a ruling that temporarily blocks the Health Resources & Services Administration (HRSA) from moving forward with the 340B rebate pilot. HRSA then announced it was pausing the pilot and instructed drug companies to continue providing 340B pricing through the traditional upfront discount model. Nagrotsky says the judge found that hospitals had demonstrated a high likelihood of irreversible harm if rebates went forward.

Government Appeals, Then Reconsiders

Immediately after the ruling, HRSA unsuccessfully argued to the Maine court and an appeals court that the agency still should be able to implement the 340B rebate pilot program while it appealed the initial ruling. After the courts denied that request, the government agreed to voluntarily dismiss its appeal and said it would reconsider its rebate program approvals. Nagrotsky stresses that it is unclear what this means. It could mean the government might overhaul or scrap the rebate program, or it might issue revised approval notices to better explain the rebates’ purpose and address concerns of potential harm to 340B hospitals.

Medicare Maximum Fair Price Provisions Still Take Effect

Despite the legal questions surrounding the 340B rebate pilot program, new Medicare maximum fair price (MFP) provisions did take effect at the beginning of January for the drugs that would have been subject to the rebates. Nagrotsky says that while 340B still can be used for these drugs, covered entities are not entitled to MFP refunds from drug companies in those scenarios. She recommends hospitals closely track expected MFP rebates to identify any missing refunds for claims that did not use 340B drugs.

Resources

1. Dismissal of Appeal Sets Stage for HRSA Reconsideration of 340B Rebates

Rebates Take Shape

Swartz says 2025 will go down as the year that a rebate model shifted from a hypothetical approach pushed by drugmakers into a fully developed model with implementation criteria. The Health Resources & Services Administration (HRSA) approved plans for 340B rebate models set to take effect in January for nine of 10 drugs subject to the 2026 Medicare maximum fair prices. Rebates for the remaining drug on that list will kick in April 1. Swartz discusses how hospitals should prepare for this pilot program, which is set to upend decades of established 340B operations and impose intense financial and logistical burdens on safety-net hospitals nationwide.

Medicaid, IRA Changes Set To Impact 340B Hospitals

This year also saw massive changes to Medicaid funding as well as Medicare pay changes under the implementation of the Inflation Reduction Act (IRA). Swartz says these developments are projected to shrink safety-net hospital margins even further. Renewed congressional focus is putting 340B in a high-profile spot, with potentially significant implications for the program and hospitals in the coming months.

2026 Tips for Hospitals

Swartz says she’s identified two areas as more of a focus for HRSA audits this year: expanded scrutiny of offsite and on-site trial balances and the ways covered entities list shipping addresses. To prepare for possible shakeups in 2026, she recommends that covered entities begin and maintain cross-functional planning across departments and closely monitor denials, delays, and other costs from new rebate programs in addition to monitoring wholesale acquisition cost (WAC) changes and contract pharmacy developments.

Resources

1. 340B Health Year-in-Review Webinar: 2025 Highlights and What’s on the Horizon

Seven States Enact New Reporting Laws

This year, Colorado, Hawaii, Idaho, Indiana, Ohio, Rhode Island, and Vermont have added new 340B reporting laws, increasing the list of states with such mandates to 10. O’Donnell says the first reporting requirements that Minnesota enacted in 2023 have influenced newer requirements in the other states. He notes hospitals’ continuing concerns about the burdens and possible repercussions of focusing on several specific types of reporting data, including breakdowns by payer type and most frequently used drugs.

Hybrid Bills Combine Protections With Reporting Mandates

Five states that passed new 340B laws in 2025 did so with a twist. Colorado, Hawaii, Maine, Rhode Island, and Vermont passed combination bills with both contract pharmacy protections with new reporting mandates. O’Donnell says he’s also concerned that statehouses are shoehorning in amendments to original statutes to ramp up concerning reporting requirements.

Model Legislation Could Mean More Debate in 2026

While Minnesota has served as a reference for reporting mandates for other states, model legislation from the American Legislative Exchange Council (ALEC) has created more opportunities for state legislators to push proposals that would limit or scrutinize 340B. O’Donnell says this reflects part of the latest efforts from drugmakers to take their 340B priorities to sympathetic lawmakers at the state level, and it underscores the importance of informing and supporting hospitals on how to push back against these bills.

Resources:

1. HRSA Approves Novartis’s 340B Rebate Pilot Proposal
2. State Policy & Advocacy Communications Resource Center

Since launching in May 2020, 340B Insight has released more than 125 episodes featuring conversations with hospital and health system leaders, policy experts, and operations specialists from across the country. Their insights have helped listeners stay informed on the latest developments in 340B and bring practical lessons back to their own organizations.

As we plan the next phase of the podcast, we want to hear directly from our listeners. The brief survey asks what draws you to the show, the topics and guests you’ve found most valuable, and what you’d like us to explore in future episodes. Your input will help ensure the podcast continues to reflect the needs and interests of the 340B community.

The survey takes only a few minutes to complete. You may submit your responses anonymously, or you can share your contact information to be entered into a drawing for a $100 gift card. Take the survey by visiting 340bpodcast.org/survey. Thank you for listening and sharing your thoughts!

How Clinical Pharmacists Can Be a “Value Multiplier”

Embedding clinical pharmacists in their specialty pharmacies improves operations in myriad ways. These pharmacists can take the burden off other providers by meeting with patients to go over their drug regimens, coordinating care, and running split-fill programs to reduce waste. At St. Luke’s, the approach has improved patient adherence to medications and reduced the time between the specialty prescription and the patient having the medication in hand to less than 48 hours – far quicker than the industry standard.

340B Savings Are Key to the Investment

Weber says cost savings from 340B are critical in calculating how they embed resources into specialty pharmacy, noting that improving adherence and retention can increase 340B savings exponentially. These savings then can enable health systems such as St. Luke’s to reinvest in their internal specialty pharmacies, provide more patient cost assistance and unreimbursed care, and ultimately shield themselves from headwinds such as drugmaker contract pharmacy restrictions.

Embedding Pharmacists Depends on Hospital-Specific Factors

For hospitals considering following the lead of St. Luke’s Health System, Weber said a variety of factors such as patient volume, payer mix, and drug spend can call for a variety of service models and investment strategies. Harnessing data such as heat maps showing where patients are and which clinics they visit can inform how best to embed pharmacists and ultimately improve specialty pharmacy care for patients.

Resources:

1. Drugmakers Release 340B Rebate Pilot Program Descriptions
2. HRSA 340B Rebate Model Pilot Program
3. Beacon Rebate Model Resources

Questions Remain About January’s 340B Rebate Pilot 

After the Health Resources & Services Administration (HRSA) released 340B rebate pilot program guidance over the summer, all nine manufacturers of the 10 drugs subject to Medicare price caps applied to HRSA to implement rebates for the drugs starting in January. Testoni says we expect to find out which plans are approved in early November, as drugmakers need to give eight weeks of notice so covered entities can prepare for the change. Testoni says questions remain about the rebate pilot, but information that the drugmakers’ rebate vendor has released so far provides enough detail for hospitals to start preparing for both rebates and price caps.

Potential Medicare Cuts Expected To Target 340B Hospitals

Earlier this year, the Trump administration released an executive order directing the Centers for Medicare & Medicaid Services (CMS) to survey hospitals on drug acquisition costs with the goal of using the results to set payment rates for Medicare Part B drugs starting in 2027. Testoni says she is concerned the proposed survey will lead to CMS targeting only 340B drugs for cuts that could bring payment rates down to actual acquisition costs, which would be a steeper cut than what the agency imposed during the first Trump administration.

States Keep Moving on Contract Pharmacy Protections, 340B Mandates

Nearly 20 states have contract pharmacy protection laws in place and a small number of drugmakers have sued to block all these statutes. But Testoni says so far, courts have denied those requests and the laws have stayed in effect despite significant opposition advocacy by drugmakers. An increasing number of states also have enacted laws requiring 340B hospitals to report substantial data on their 340B costs and savings, and some are looking to limit how hospitals can use those savings.

Resources:

1. Senate Hearing Features Both Bipartisan Support for 340B and Calls for Reforms
2. Read Our Comments on CBO’s 340B Growth Report
3. Review Our 340B Rebate Pilot and IRA Resources
4. Beacon Shares New Details on 340B Rebate Pilot Implementation

Improved Drug Affordability and Patient Education

When a prescription goes through IU Health’s comprehensive medication review clinic, pharmacists and other staff will prioritize finding financial assistance for eligible individuals and teaching patients important information about taking their medications. Krekeler says clinic staff will look for discounts for all medications a patient is on and see what a patient’s insurance will cover, if there are copays, and if prior authorization is needed. Staff then will connect patients to coupon cards, manufacturer assistance programs, or 340B-funded assistance through IU Health.

Demonstrated Results

In the two years since the clinic launched, Krekeler says its success has prompted IU Health to reinvest more 340B dollars to expand its reach. Patients with heart failure and diabetes who have gone through the clinic have seen significant improvements in their key health metrics. The clinic helps patients better maintain their health and stay out of the hospital.

Understanding 340B Is Vital for Such Programs

Krekeler says IU Health was able to launch its clinic after adapting a similar initiative that UC Davis had implemented. The key to getting the IU Health clinic off the ground was obtaining buy-in from executives who understood 340B and finance and were able to see the long-term benefit in investing 340B dollars in this area.

The Barriers to Cancer Screening

WVU Medicine identified that some of the biggest social determinants of health for its West Virginia patients were relatively unique to the areas it serves. The rural state has significant travel barriers, small population areas, and high poverty rates, a combination that leaves thousands of patients without easy access to a source of primary care.

Mobile Screenings Look for Breast, Lung Cancers

Today, WVU Medicine operates two types of mobile cancer projects: Bonnie’s Bus and LUCAS. The former launched in 2009 and is a mobile mammography unit named after a patient who died because she had limited access to breast cancer screenings. Her family donated funding to the hospital to support this effort. More than a decade later, WVU Medicine introduced the mobile lung screening program LUCAS. That initiative provides low-dose CT scans to patients meeting the screening guideline using a nearly 70,000-pound tractor trailer.

340B Is Key To Sustaining Mobile Screening Efforts

Famoso says WVU Medicine funds its mobile cancer screening programs through grants and donations, but that is not enough to cover the full cost. That is where 340B savings can help cover the operating loss, which was almost $400,000 last year. Without those 340B savings, the health system’s financial situation would not allow investments in mission-focused programs such as Bonnie’s Bus and LUCAS.

Resources

1. Lung Cancer Screening on Wheels
2. HRSA Reviewing Rebate Pilot Proposals and Comments
3. Second Federal Appeals Court Upholds State Contract Pharmacy Law

Setting a Baseline of 340B Knowledge

UNC Health utilizes a two-pronged strategy to 340B education for its team: didactic and interactive approaches. The didactic approach involves creating three online, standardized learning modules to educate those who are new to 340B or who interact with it indirectly as well as those who are more involved in day-to-day 340B operations. The interactive approach involves an educational and decision-making structure designed to adapt to new 340B developments in real time. 

Compliance Meetings Facilitate Discussion

UNC Health uses entity-level and system-level oversight committees to discuss key 340B compliance issues and relevant metrics. Shah says these meetings offer ways to inform senior leadership about key 340B changes and keep other stakeholders, such as hospital compliance and legal credentialing professionals, in the loop.

340B Education Is Best When Nimble

As hospitals evaluate their 340B education efforts, Shah says it’s important they explore existing resources but also work with stakeholders to discuss what would best serve them when learning about 340B. Hospitals also can change existing governance structures to incorporate 340B discussions. Shah says the ability to stay nimble and be able to quickly identify and assemble key players in the 340B space is key to keeping teams informed amid times of change.

Resources

1. Read Our Appeals Court Brief Opposing 340B Rebate Schemes

Why recertification is “exceptionally important”

Swartz says annual recertification is not just important, it’s also one of the central tenets of 340B compliance. All hospital types except critical access hospitals need to make sure they’re meeting the minimum disproportionate share percentage threshold. Hospitals also need to affirm that they are non-profit facilities and that all their registered parent and child sites continue to have reimbursable outpatient costs and charges on their Medicare cost reports.

The cost of losing eligibility is high

Failure to recertify 340B eligibility in a timely manner can lock hospitals out of their access to 340B pricing for a year or more. That could deprive a hospital of crucial resources to provide the care and support its patients need.

Tips for a smooth recertification

Swartz says a key to making the process go smoothly is to start early and make sure hospital officials have the necessary worksheets and other documentation before the recertification process begins. Authorized officials and primary contacts should be on the lookout for returned tasks from HRSA and other messages to ensure their recertification process is complete. Taking screenshots of each step of the process also can help identify and fix discrepancies that might arise.

Resources

1. Annual Hospital Recertification Began August 11
2. 340B Health Webinars
3. HRSA Announces 340B Rebate Pilot Program for up to 10 Drugs in 2026 
4. 340B Health Responds To HRSA 340B Rebate Pilot Program

LAI clinics offer comprehensive services

SSM Health’s three LAI clinics offer injections for patients with conditions such as bipolar disorder, schizophrenia, and alcohol and opioid use disorders that might last as long as three to six months. Clinic visits also give the patients access to a full team of pharmacists, psychiatrists, nurses, therapists, and others to help them navigate treatment and stay healthy.

340B funds are key to patient access

Because behavioral health is often a subsidized service, 340B savings are crucial to the operations of the clinics. They also enable SSM Health to offer financial assistance to patients living up to 400% of the poverty level so they can afford the treatments they need to stay on the road to recovery.

Cuts to 340B would be detrimental to patients

Schmitt says losing access to 340B pricing could mean a 60-70% price increase in the cost of LAI drugs, which would threaten the viability of the clinics and the financial assistance that many patients rely on to access their treatments. She says these clinics are a great example of how 340B is about much more than just price discounts; it provides resources for health systems to meet unique community health needs and serve patients where they are.

Resources

1. Federal Legislation Would Ban Harmful Drug Company Restrictions on 340B

The Good and Bad News for Covered Entities

The good news, Desai says, is that there is potential for the 340B ceiling prices to go down for certain medications. This is because the MFP will become the new “best” price in the formula for calculating 340B prices. However, because the law will cap reimbursement rates to MFP when Medicare patients receive those drugs, 340B hospitals will see their 340B savings amounts go down for those dispenses.

Updated Calculator Can Help Hospitals Gauge Potential Impact

340B Health recently updated its calculator for hospitals to use to estimate the effects of MFP pricing based on the newest data. This new calculator allows users to project what the potential impact from the IRA could be on a hospital, including if drugmakers decide to lower their list prices significantly to avoid IRA inflation penalties. This drop in prices of Medicare drugs could result in 340B hospitals seeing higher ceiling prices and reduced savings.

Reduced Savings Could Impact Patient Care

Desai says Medicare price caps, combined with other financial pressures on hospitals, could mean some rough times ahead for hospitals that care for a large proportion of low-income patients. She encourages 340B teams to share their results from the IRA calculator with their senior leadership and with 340B Health as the hospital community prepares for the impact of these caps.

Resources

1. Use Our IRA Calculator and Share How Your 340B Savings Will Change
2. Read Our Analysis: Second Federal Court Affirms HRSA's Authority Over 340B Rebates

Following rules for 340B purchases

Disproportionate share (DSH) hospitals, children’s hospitals, and cancer hospitals are subject to a group purchasing organization (GPO) prohibition that bars them from buying covered outpatient drugs on GPO accounts. That requires maintaining a purchasing system that involves buying drugs at wholesale acquisition cost (WAC) for neutral inventory and then replenishing at 340B, WAC, or GPO pricing depending on how the drug is used.

How the cycle can break down

Purchasing drugs outside of the outlined processes could cause violations of the GPO prohibition or other 340B rules, which could lead to sanctions that might include losing eligibility for 340B. That is why health systems such as MetroHealth use staff education, regular auditing, and other safeguards to ensure they are purchasing and replenishing drugs on the correct accounts.

Investments in the strategy

Campitelli recommends 340B hospital teams bring their senior leadership on board to invest in auditing and other resources to ensure a strong purchasing strategy. Such investments will help avoid potential rule violations while ensuring that hospitals are not walking away from 340B savings to which they are entitled.

Resources

1. 340B Health Appeals Rebate Ruling; Federal Court Agrees to Fast-Track Drugmaker Appeals

Court deals a blow to drugmakers

D.C. district court judge Dabney Friedrich ruled on May 15 that manufacturers cannot unilaterally implement rebate models for 340B, agreeing with the Health Resources & Services Administration (HRSA) that the agency effectively has preapproval authority over rebates. In her decision, the judge cited early results from a 340B Health survey finding that shifting 340B to a rebate model would divert significant hospital resources from patient care. Drugmakers have already appealed the ruling.

Some bright spots for drugmakers in this decision

Although the decision largely went against pharmaceutical companies, the judge ruled that the 340B statute does not categorically prohibit rebates, leaving the door open for government approvals of rebates. The judge also agreed with drugmakers’ assertions that HRSA should consider how rebate models could improve 340B compliance and how requiring the sharing of data through rebates could aid in drug company audits of covered entities.

Will HRSA stop all rebates from proceeding?

Despite this decision, the legal fight over rebates isn’t over yet. The judge found that, for three of the manufacturers in these cases, HRSA has yet to issue final decisions with respect to their proposed rebate models. In the case of Sanofi, the judge found that HRSA failed to adequately explain the legal basis for rejecting the drugmaker’s rebate model, and she directed the agency to reconsider its decision and explain whether and how it would violate the 340B statute. HRSA sent rebate guidance to the White House for approval earlier this month, though as of recording this episode it was not known what that guidance would say.

Resources

1. Read Our Analysis of the First Federal Court Decision on Rebates
2. 340B Health Continues Court Fight Against Rebates

Hospital readmissions down, patient convenience up

Renown Health’s 340B-funded program offers medication to patients who are being discharged from the hospital, either through bedside delivery, pneumatic tube, or a unique discharge lounge. The effort began as a pilot for Medicaid patients in 2016, and it demonstrated patients in the program were 25% less likely to be readmitted to the hospital once discharged. These health improvements plus the added convenience of medication access for patients convinced the system to expand the program.

340B pricing to patients who cannot pay

Porath says Renown Health refers patients who cannot afford discharge medications to its social services team, which can authorize providing the drugs to those patients at the 340B-discounted rate. The team also will work with patients to see if they qualify for coverage such as Medicaid or other programs to reduce their out-of-pocket costs. Porath said Renown’s meds-to-beds program provides drugs free of charge to about 30 patients per month.

The keys to success

Renown Health’s meds-to-beds program has been a success, with more than 80% of eligible patients participating as of the end of 2024. The hospital expanded the services to all patients and started operating it 24/7 in April 2024. Porath said the keys to success include regular reporting to stakeholders and innovations to handle a large volume of patients discharging at once. Such changes allow all parties to stay in the loop with the development of the program and to celebrate successes as they occur.

Resources

1. Read Our Analysis of the First Federal Court Decision on Rebates
2. Second Federal Judge Allows 340B Health, Member Hospitals To Intervene in Rebate Lawsuit

Rebates Get Their Day in Court

340B Health, two member hospitals, and the government met drug companies in court in late April to challenge drugmaker attempts to replace 340B discounts with rebates. Testoni says the judge cited potentially devastating consequences to hospitals if rebates proceeded but also had probing questions for the government on how it is working to address drugmaker compliance concerns. The Dept. of Health and Human Services is set to release guidance by early June on the rebate issue, and the court’s decision could come out soon.

The White House Proposes 340B Big Oversight Shift 

A leaked copy of the Trump administration’s latest budget proposal includes a plan to move the Office of Pharmacy Affairs (OPA) from the Health Resources & Services Administration to the Centers for Medicare & Medicaid Services. Testoni says the oversight shift is concerning because of a stark difference between the purpose of 340B and the operations of Medicare and Medicaid. CMS also imposed years of Medicare payment cuts to 340B hospitals that the U.S. Supreme Court eventually overturned.

340B Protections, Mandates Take Center Stage

States continue enacting laws to protect hospital access to 340B pricing, but they also are moving forward with reporting mandates and proposals to define how hospitals should use their savings. Testoni said reporting and use-of-savings mandates lead to misdirected views on the purpose of 340B, which goes far beyond direct patient care and cost assistance. On Capitol Hill, a report from a long-running investigation of 340B recently came out, contributing to the debate over possible new restrictions.

Resources

1. Federal Government Signals Upcoming Guidance on 340B Rebate Models Amid Legal Challenges
2. Brief Your Leaders on White House Plans for Major 340B Changes
3. Nebraska Is 12th State To Enact Contract Pharmacy Protections
4. Indiana Becomes Fifth State To Mandate 340B Reports From Hospitals
5. Key Senator Concludes 340B Investigation, Calls for Major Reforms
6. New 340B Health Research
7. 340B Impact Profiles

How is a 340B child site onboarded?

Moss says the first big step to identifying potential sites is to work with a hospital’s finance, revenue, pharmacy, and legal departments to evaluate a site. The team looks at Medicare cost reports and trial balances to ensure they are eligible for 340B. As part of the process, they also use electronic medical record and retail data to identify potential clinic areas based on their patient volumes.

A 340B child site is registered. Now what?

The work is not over once a child site has been registered in 340B. UH has a program it calls the “340B Concierge Program,” which aims to provide comprehensive, ongoing support and guidance to a given child site. The program offers additional education and information in such areas as procurement processes, the appropriate ways to handle drug transfers, and miscellaneous licensing issues.

Onboarding requires relationships and a close eye on compliance

Moss says that hospitals onboarding a child site should establish and maintain close ties with the site to prevent issues with 340B compliance. This can involve being the first line for any pharmacy issues the site staff might be having, holding frank conversations with clinic management when necessary, and inviting staff to observe mock audits so they can learn more about what goes into maintaining 340B compliance.

Resources:

1. Trump Executive Order Could Revive Medicare 340B Cuts

Compliance protects 340B access

Being prepared for HRSA audits serves a crucial function that ultimately benefits the patients whom hospitals serve, Lacknauth explains. Maintaining the integrity of 340B means protecting access to 340B savings that hospitals can invest in crucial care for community members that need it. 

Continuous audit readiness

Lacknauth discusses how Broward Health maintains audit readiness by conducting internal audits, bringing in external consultants, and identifying areas of opportunity for improvement. A robust system of internal reviews means that when HRSA comes knocking, Broward Health is already prepared. This was evident after a recent audit of one of the system’s hospitals that resulted in zero recommendations for improvement.

Organization, resources, transparency are key

Preparing for audits requires a health system to invest time and resources, but Lacknauth stresses that these investments pay off. Engaging a comprehensive team from various departments in the audit readiness process allows for a health system to have the appropriate level of responsiveness and transparency during a HRSA audit.

Resources:

1. Nebraska Is 12th State To Enact Contract Pharmacy Protections
2. Idaho Becomes Fourth State To Mandate 340B Reports From Hospitals

AI, automation, and how they can support 340B

Chupka distinguishes that AI is like a machine learning and making decisions depending on what it is taught. Automation, although similar to AI, does not make decisions. Both can systematize processes and with the help of guardrails, enable pharmacists to dedicate more time to patient care. 

Opportunities and considerations 

The novelty of AI promises an opportunity for 340B teams that can consider and correct its potential pitfalls. Chupka explains that as with any emerging technology, it is best to start slowly, teach the algorithm, and consistently check in to ensure accuracy and ethical considerations. This approach can limit errors and inspire confidence as time goes on. 

What entities can learn from Dartmouth Health? 

The Dartmouth Health team has explored how AI can help with budgeting, modeling, and auditing, always double-checking work to avoid errors. Because a fully staffed team is required for this, Chupka reassures that AI has not affected staffing. If anything, Chupka says AI is a tool to assist in compliance. 

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 podcast@340bhealth.org. 

Resources:

1. 340B Health, Member Hospitals Ask Court To Throw Out Drugmaker Rebate Lawsuits)

Clinical pharmacies are a bridge between providers and patients

Riggle says clinical pharmacy teams serve as drug experts that can help teach patients about potential side effects and how to take their medications properly. But these teams also can take the lead on supporting other providers on refills, prior authorizations, financial assistance, and more. That allows the other providers to focus less on those processes and more on providing medical care to the patients. 

In-house pharmacies can improve patient care and generate revenue

Using an in-house clinical pharmacy has benefits for both patients and the hospital. Riggle notes that keeping prescriptions and pharmacy support in-house can enable hospitals to keep better track of patients’ health and identify if there are issues or questions with certain medications. At the same time, it generates revenue and 340B savings that support even more hospital services and improve patient health outcomes even more.

Ramping up clinical pharmacy services and overcoming barriers can take time

Riggle says expanding clinical pharmacy initiatives at UC Davis Health has come with some challenges. It took years to roll out a refill program for all the providers who needed that support, and achieving success with a prior authorization program involved an evaluation of workflows to improve efficiency. But he noted that hospital pharmacists can present a value proposition to their leaders for how investing in 340B-supported clinical pharmacy services can be worth it to improve care quality and provider satisfaction.

Resources

1. Federal Judge Allows 340B Health, Member Hospitals To Intervene in Rebate Lawsuits

Carrying and Compliance Costs

Each drugmaker’s push to impose rebates would incur new drug purchasing and compliance expenses for covered entities. Bristol-Myers Squibb’s rebate policy alone would cost Genesis HealthCare System an additional $400,000 per month in drug spend if it applied to all BMS drugs. If 340B rebate models became the norm for all drugmakers, Carr estimates Genesis would pay an additional $5.2 million per month in upfront costs. Those figures do not include additional hundreds of thousands of dollars in annual staffing expenses to process rebate claims and challenge denials.

Effects on Patient Care and Support

Imposing 340B rebates could force Genesis HealthCare System to scale back or discontinue its patient assistance program, according to Carr. But 340B savings do not just go towards direct patient help with drug costs at the hospital. The financial impact of rebates also could affect other community programs and free services, such as patient transportation, meds-to-beds, health screenings, and a paramedicine program.

Advice for Other Hospitals

Carr says every covered entity that has not already done so should begin reviewing drugmaker rebate policies and working with their 340B third-party administrators to estimate potential costs. She says this involves entities asking bigger questions: Would rebate policies require additional 340B staffing? Does senior leadership understand the potential impact of these changes? What 340B-funded programs might be at risk?

Resources:

1. 340B Health Seeks To Intervene in All Drugmaker Rebate Lawsuits
2. Declaration of Shona Carr in Support of Motion To Intervene

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:

1. 340B Health Files Motion To Intervene in J&J Rebate Lawsuit
2. Option To Cut Commercial Pay Rates for 340B Drugs Is on Draft Congressional Budget “Menu”
3. Medicare Expands List of Drugs Subject to Price Caps, Decreased 340B Savings
4. 340B Coalition Winter Conference Registration 

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:

1. Minnesota 340B Covered Entity Report
2. Episode 89: How New 340B Reporting Requirements Are Affecting Hospitals (February 2024)
3. 340B Medicare Hospital Pay Cuts Floated as an Option for Congress

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:

1. Brief Your Leadership on Drugmaker Rebate Schemes
2. The Wall Street Journal: “The Economic Imperative of Protecting 340B”
3. Register for the 340B Coalition Winter Conference

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:

1. Create or Update Your 340B Impact Profile
2. Read Our Analysis of J&J’s Legal Arguments for 340B Rebates
3. Lilly, Kalderos Press Federal Court for Ability To Impose Rebates

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: 

1. UConn Health Cancer Survivorship Program
2. Designing, Implementing, and Evaluating an Interprofessional Survivorship Model of Care in an Academic Cancer Center

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

1. 340B Health Equity Report 2023
2. Black Pharmacists Stand as Advocates in Support of 340B Access to Care
3. Senate Letter to HHS on Rebates

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

1. 340B Hospitals Prevail on J&J Rebate Plans, But Fight Is Not Over
2. Bipartisan U.S House Letter to HHS, Sept. 27 
3. HRSA Letter to Johnson & Johnson, Sept. 27
4. J&J Response to HRSA, Sept. 30

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 

How the program works

Orth says his system’s direct savings program is built into the system that prescribes medication electronically from its clinics and its hospitals’ electronic medical records system. When the prescriptions that generate from those visits are sent to a system pharmacy, 340B eligibility codes are attached that allows the pharmacy to know that they are eligible to receive the drugs at the 340B-discounted price plus a dispensing fee.

Underinsured patients also benefit

Orth says University Health describes its direct savings model as an uninsured program because that describes the key patient population that benefits from receiving the 340B price. But that assistance also is available for underinsured patients who otherwise would be expected to pay more in prescription drug copays than the 340B price. 

Drugmaker restrictions are a barrier

Orth says this program is the difference between patients receiving a needed medication and going without one, which prevents hospital readmissions and emergency department visits. But he also notes that drug company restrictions limiting 340B pricing to a single contract pharmacy are negatively affecting the program, ultimately adding another barrier for access to care. 

Resources:

1. 340B Health Urges HRSA To Block J&J Plan To Replace 340B Discounts With Rebates
2. J&J Implements 340B Rebate Model Despite HRSA Opposition
3. 340B Health Equity Report 2023

Steven Miller, the vice president of pharmacy services for 340B Health, describes what is at stake when it comes to hospitals completing recertification every year. Failure to do so could take a hospital months to correct and cost it millions of dollars – resources that the hospital could be using towards services for patients who need help the most.

The key players

Miller says the hospital’s authorizing official (AO) and primary contact (PC) are two of the most important figures for recertification. These individuals will be key to verifying and submitting information to the government during the process, and there are important rules governing their roles and responsibilities.

Preparing for recertification

Miller says hospitals should have their “ducks in a row” and be ready to undergo recertification as soon as the period begins. This involves having the necessary staff involved, having required documentation on hand, and being prepared to respond quickly to any inquiries from the Health Resources & Services Administration (HRSA).

Hospital best practices

Miller has tips for hospitals that want to navigate the recertification process efficiently and accurately. This includes advice on ensuring all the information in the HRSA Office of Pharmacy Affairs Information System is correct, fixing any discrepancies that could lead to future audit findings, and documenting needed changes to make sure they take effect.

Resources:

1. 340B Health Registration and Recertification Resource
2. 340B Health Webinar Archive
3. 340B Health Equity Report 2023

What Can a 340B “Bot” Do?

Gibson’s team uses artificial intelligence to improve its 340B internal auditing processes. What they call “the bot” can streamline the process by pulling data from the health system’s electronic medical records system and automating the administrative tasks required to set up an audit. The bot also can make the process more effective by increasing the number of audited claims and flagging potential problem areas. She noted this makes the team more prepared for the data they must collect for external 340B audits as well.

Lessons Learned During Implementation

Gibson said installing the bot for 340B use was a very “trial and error” approach, though the team was able to make quick changes to fix any issues they encountered. She said one of the biggest growing pains of the AI-based system was the time needed to make the tool operational. She also notes the bot may be clunkier than a product they would have purchased through an outside vendor because it is designed to allow the team to customize and modify as needed.

Opening Eyes to the Benefits of Automation

Gibson said this new tool has led to her team re-evaluating other 340B processes that they can automate, even if that does not involve AI. WVU also is considering potential bots that will look specifically at Medicaid claims and help conduct retail audits. She urged health systems to consider the concept of automation more broadly than AI, bots, and machine learning, as collaborating with other departments that can share automation skills could help improve overall 340B processes.

Relationships — Ryan says the relationships 340B advocates formed with other hospitals, lawmakers, and public policy staff contributed to their successes at the state level. The first time to discuss 340B with these individuals cannot be when a bill is going up for consideration, much less when stakeholders are on defense and trying to explain the importance of 340B in the wake of legislation that would harm covered entities.

Messaging — Ryan explains how the messaging that resonated in the states during the 340B contract pharmacy debate focused on how big pharma is trying to take money away from not-for-profit hospitals and drive it to out-of-state shareholders. By emphasizing the variety of patient programs and support that are possible because of 340B without making it a referendum on the federal program at large, that case mostly sells itself.

Grassroots — Ryan notes that there are roughly 18,000 members of his health system across Louisiana and Mississippi. These are physicians, nurses, pharmacy techs, and other health care professionals with representatives that they can contact. Knowing when to deploy these grassroots supporters to make phone calls and send emails is important, because that can get attention and results when timed well.

Resources:

1. Missouri Becomes Eighth State To Enact Contract Pharmacy Protections

More states ban drug company restrictions on 340B contract pharmacies

Following the lead of Arkansas and Louisiana, five additional states have enacted contract pharmacy protection laws so far this year. Some states enacted standalone contract pharmacy laws, while others paired these laws with PBM non-discrimination bills. Another bill is with the governor in Missouri after passing the state legislature.

Court battles continue despite early wins for state 340B laws

The pharmaceutical industry continues to fight state 340B protection laws in federal courts, with most challenges focusing on whether federal 340B law preempts such state laws. So far, none of those lawsuits have succeeded, with one federal district court and one federal appeals court rejecting the preemption arguments.

More states consider requiring 340B hospital savings data

Last year, Maine, Minnesota, and Washington enacted 340B reporting laws at the state level. And while no additional reporting packages have passed out of state legislatures so far this year, several considered doing so, and Minnesota added even more requirements for hospitals. These reporting requirements add burdens to covered entities and raise concerns about how states will use this information in the future.

Resources:

1. Mississippi Court Rejects Drug Industry Calls To Block Contract Pharmacy Protections
2. 340B Health State Policy and Advocacy Resource Center

A second federal appeals court rules for drug companies

In May, the D.C. Circuit Court of Appeals ruled that the 340B statute does not categorically prohibit drug manufacturers from imposing their own conditions on 340B. However, the court did note that manufacturers cannot impose a condition that effectively prevents a covered entity from purchasing a particular drug at the 340B price. This raises the importance of entities demonstrating situations in which they are cut off from all 340B access to a drug. Another appeals court based in Chicago has yet to issue a decision in its 340B contract pharmacy case.

More states ban 340B restrictions as the industry increases state lobbying efforts 

So far this year, Kansas, Maryland, Minnesota, Mississippi, and West Virginia have joined Arkansas and Louisiana in enacting laws to prohibit contract pharmacy restrictions on covered entities. But the pharmaceutical industry has become much more active in opposing ongoing legislative efforts in other states. A “dark money” group also has been running ads opposing these state bills by accusing covered entities of laundering taxpayer money to subsidize care for undocumented immigrants.

New pharma-backed bill in Congress would slash 340B hospital eligibility

U.S. House lawmakers recently introduced a bill known as the 340B ACCESS Act. The legislation is backed by the Pharmaceutical Research & Manufacturers of America (PhRMA) and the National Association of Community Health Centers (NACHC). It would impose significant restrictions on 340B hospital eligibility and access to savings, including by restricting 340B usage for insured patients and tying participation in the 340B program directly to levels of charity care.

Resources:

1.      Statement on New Federal Legislation To Restrict 340B Hospital Eligibility

2.      Statement on D.C. Circuit Appeals Court Decision on Drug Companies’ 340B Restrictions

3.      Report: 340B Hospitals Prescribe Medicare Part D Drugs to Greater Shares of Historically Underserved Patients

4.      House Energy and Commerce Oversight and Investigations Subcommittee Hearing on 340B June 4

How the ADR is intended to work

Jason notes that the ADR will use a panel of government officials to arbitrate certain types of disputes between covered entities and manufacturers. This process can allow covered entities to bring complaints against manufacturers for overcharging, and it can allow manufacturers to bring complaints against previously audited covered entities relating to allegations of diversion or duplicate discounts. The panel collects evidence from both sides and issues a binding decision in the dispute.

The pros and cons of the final rule

Jason says there are aspects of the final rule that are favorable to covered entities and some areas they might find lacking. The panels will be able to hear a wider range of complaints against drug companies, will have lower barriers to entry, and will avoid potential conflicts of interest in choosing their members. But they also will be able to take up to a year to issue decisions, will not be required to publish their findings, and will be able to hear certain controversial cases about alleged duplicate discounts.

Having offensive and defensive strategies

Jason recommends that covered entities be prepared for navigating the ADR process as both the filer of a complaint and as the subject of a complaint. Both parties must engage in good-faith efforts to resolve the dispute and drugmakers cannot file a complaint against a covered entity without conducting an approved audit first, so an ADR complaint should not come as a surprise to either party. Entities should consult legal counsel before making decisions related to any dispute.

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 podcast@340bhealth.org.

Resources:

1. Final Administrative Dispute Resolution (ADR) Rule Adopts Several 340B Health Recommendations
2. Report: 340B Hospitals Prescribe Medicare Part D Drugs to Greater Shares of Historically Underserved Patients

Improving student health on campus

Since the end of 2022, Comanche County Medical Center has been operating a school campus-based program that pairs onsite diagnostic equipment with telehealth visits to keep students and staff healthy without requiring families to miss school and work. The program has decreased absenteeism and enabled faster recoveries for the patients it serves.

Putting community care on wheels

Comanche County Medical Center has a fully equipped mobile van clinic that it can deploy wherever the community needs care. By bringing the clinic to food drives, sporting events, and areas affected by wildfires, the center has been able to provide many more residents with preventive services, medications, and other vital care that they otherwise would not have accessed.

Expanding the reach through pharmacy partners

The community pharmacies that Comanche County Medical Center partners with, combined with prescription delivery services, has greatly expanded the numbers of patients whom the center can connect to needed prescription drugs. But drugmaker restrictions on contract pharmacies has had substantial negative impacts on that access and has affected the center’s plans for health services growth.

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 podcast@340bhealth.org.

Resources:

1. Court-Backed Arkansas Contract Pharmacy Law Prompts Enforcement Action, More Drugmaker Retreats

340B optimization strategies
 
One way that Novant Health optimized its 340B program was through a multidisciplinary team that includes data analysts and auditors. Matt says that while this team prioritizes compliance above all else, it also can focus on technology and data to increase 340B efficiency and to find opportunities to increase patient access to the drugs and care they need.
 
How 340B optimization helps patients

Novant Health was able to use their 340B optimization team to find cases in which patients receive a prescription from the hospital but use a non-contracted pharmacy to fill their medication. The team found out where this was occurring and used the information to expand their contract pharmacy footprint and better meet patients’ needs where they are.

The complexity of optimizing

Matt says health systems can encounter numerous systemic challenges in pursuing 340B optimization, including navigating individuals’ choice, rising drug costs for patients, and complex reimbursement issues. Still, Novant’s optimization efforts are paying off for patients by measurably improving their health outcomes and connecting them to more affordable drugs and care.

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 podcast@340bhealth.org.

Resources:

1. Mississippi Bans Drugmakers’ Contract Pharmacy Restrictions
2. HRSA Issues Final Rule on Changes to Administrative Dispute Resolution (ADR) Process

Federal bills could help covered entities but also limit 340B’s scope

One new bill introduced in the House of Representatives would restore access for covered entities to 340B pricing through their community and specialty pharmacies, as well as protecting access to discounted pricing at in-house pharmacies. The bill would tackle drug company restrictions that have been in place for nearly four years by authorizing the government to impose civil monetary penalties for drug companies that cut off this access.

But another draft bill under discussion in the U.S. Senate could have more mixed effects on covered entities. The Senate legislation would address the community and specialty pharmacy dispute, but it also could include additional provisions that would limit hospital eligibility for 340B and the types of patients that could receive 340B drugs. 340B Health was among the many stakeholder groups that submitted comments on the Senate bill discussion draft.

Major ruling by federal court is a big win for 340B advocates

The U.S. Court of Appeals for the Eighth Circuit recently ruled in favor of an Arkansas law that protects covered entity access to 340B discounts through specialty and community pharmacies. The pharmaceutical industry had sued to try to block the law in Arkansas as well as a similar law that Louisiana recently enacted. The decision will apply to any additional states within the Eighth Circuit jurisdiction that might enact their own 340B protections. Other federal appeals courts hearing drug industry challenges also will take note of this decision when considering those lawsuits.

West Virginia becomes the third state to protect 340B pharmacy access

The West Virginia governor recently signed into law a new 340B law that closely resembles the statute on the books in Louisiana. 340B hospitals in the state had worked closely with state lawmakers to advocate for the measure and drive it toward enactment. More than 20 states are considering such legislation during their current legislative sessions, so the number of states with 340B pharmacy access laws on the books could grow before the end of the year.

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 podcast@340bhealth.org.

Resources

1. House Bill Would End Drugmakers’ 340B Contract Pharmacy Restrictions
2. Learn How Stakeholders Weighed in on Draft Senate 340B Bill
3. Federal Appeals Court Upholds Arkansas Contract Pharmacy Law
4. West Virginia Bans Drugmakers’ Contract Pharmacy Restrictions

Compliance factors can vary state by state

Melissa notes that it is important for covered entities to think through the duplicate discount compliance requirements in their home state, especially if their health system treats many patients from across state borders. A border state, a community that attracts tourists, or a college town are examples of areas in which providers can face different requirements depending on Medicaid rules for the states where those patients reside.

Ensuring compliance can be complex

Ensuring duplicate discount compliance can be complex, especially if a provider has multiple child sites. How does a health system establish a carve-in or carve-out list? Melissa explains that some entities can have manual workflows that involve individuals reviewing Medicaid dispenses, understanding EHRs, and using spreadsheet skills to keep drug purchases compliant. But given the complexity that UNC Health faced under this method, the health system took a different approach.

Workflow automation can increase reliability and instill trust

UNC Health decided to use an automated workflow approach to streamline manual duplicate discount prevention tasks. The team is rolling out the automation to other locations after finding that it improved accuracy and confidence in the process. Melissa notes that each health system will need to determine whether such an automated process makes sense for them.

Check out all 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 podcast@340bhealth.org.

Resources:

1. New Federal Legislation Would End Drug Company Restrictions on 340B
2. Matsui Introduces Legislation To Protect 340B Drug Pricing Program
3. Federal Appeals Court Upholds Arkansas Contract Pharmacy Law

How new hospital child sites gain 340B eligibility

Chuck explains that 340B child sites are outpatient departments that are not on the main hospital campus but are fully integrated with the hospital parent site. To start using 340B drugs at a new child site, the location must appear on a filed Medicare cost report with associated costs and charges and then be registered with the HRSA Office of Pharmacy Affairs Information System (OPAIS).

What changed during the pandemic

Prior to the COVID-19 pandemic, the process to start using 340B drugs at a new child site could involve up to nearly two years. Chuck notes that during the pandemic, HRSA indicated that child sites that had not yet been registered could begin using 340B drugs right away if they were for eligible patients. Hospitals believed that shift in policy would be permanent.

Where things stand now

The COVID-era child site eligibility changes did not last. In October 2023, HRSA ended what it called a temporary flexibility, citing the termination of the public health emergency in May 2023. Although HRSA granted a grace period for hospitals to come into compliance, that did not provide protections for planned child sites that had not yet been using 340B drugs. Chuck explains how this affected one of Intermountain’s planned sites, and he shares advice for hospitals that are in similar situations.

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 podcast@340bhealth.org.

Resources:

1. HRSA Announces Policy Restricting Use of 340B at New Child Sites After Transition Period

How a hospital can prepare for a 340B audit

Auditors typically will ask to schedule a pre-site visit call and will provide a data request list for the information the auditor is seeking. Mark says it is important to provide this information in a timely, accurate and concise way, and to make sure you inform key stakeholders at your organization so you can get the subject matter experts involved. He also recommends doing test runs of the audit ahead of time.

What a hospital should expect on the day of an audit

On the day of an audit, the auditor will trace a sample to see how a 340B drug goes from drugmaker to pharmacy to patient. The auditor will assess whether the hospital is following its 340B policies and procedures to make sure the drug went to an eligible patient and does not involve a duplicate discount. Mark says the process can be very stressful but that it also provides an opportunity to reframe the audit to showcase the great work of your hospital.

What hospitals should do if they receive audit findings

If HRSA issues a finding, the hospital must draft and implement a corrective action plan. Mark recommends bringing in legal counsel and 340B consultants to review this document. After HRSA approves the CAP, the hospital will demonstrate to the agency that it is in place to ensure compliance going forward.

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 podcast@340bhealth.org.

Resources:

1. HRSA 340B Program Integrity Website

What Minnesota’s reporting law requires

Danny explains that Minnesota’s new reporting law requires 10 aggregated categories of information that hospitals and other covered entities must submit starting this April. Individual hospitals’ reports will not be made public, but an aggregated report due in November will be made available to the state legislature and the public.

Adjusting to an unprecedented system

Minnesota’s new 340B requirements mandate an entirely new reporting system that the 340B program has not been trained to. These new requirements will affect 340B operations for small and large hospitals alike. 

Advocacy advice for hospitals in other states

Danny urges covered entities in other states that might be considering reporting to be speaking up on 340B now. He says talking about 340B can seem complicated because it involves pharmacy benefits, discounts and acquisitions, costs, savings, and more, but it is important for legislators to be educated on how it works.

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 podcast@340bhealth.org.

Resources

1. Senate 340B Bipartisan Working Group Discussion Draft
2. Statement on Senate 340B Bipartisan Working Group Discussion Draft
3. Senators Developing 340B Bill Seek More Feedback on Contract Pharmacy, Patient Definition, Child Sites

Patient Definition After the Genesis Decision 

One listener wonders how the recent Genesis court decision might affect 340B patient definition issues. We discuss the implications, the status of HRSA’s 1996 patient definition guidelines, and expectations for covered entities in the wake of this decision. 

Federal and State 340B Action

In response to listeners’ question, we discuss how 340B might come up on Capitol Hill and in state legislatures this year. After a busy first half of the 118th Congress for 340B, we discuss how the election year may influence issues on Capitol Hill and how lawmakers in numerous statehouses are already considering changes to 340B in their states. 

Timing of Repayments for Medicare Cuts

Listeners inquire about upcoming Medicare Part B repayments, an increase in manufacturer overcharges for 340B drugs, last year’s HRSA 340B audit findings, and the expected effects of the government’s Medicare drug price-setting program under the Inflation Reduction Act. 

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 podcast@340bhealth.org.

Resources

1. HRSA Stresses Federal Court Decision on Patient Definition Only Applies to Genesis FQHC 
2. Implications of Genesis Decision on 340B Patient Definition Webinar
3. State Policy and Advocacy Resource Center 
4. Analysis of the Medicare 340B Pay Cut Remedy
5. HRSA Program Integrity Website
6. Inflation Reduction Act: Assessing Financial and Operational Challenges Webinar 

The 340B drug pricing program can produce significant savings that hospitals can invest in more equitable care for underserved patients. What are some of the best ways for hospitals to use their savings in the pursuit of greater health equity? We sit down with Danielle McPherson, the executive director of managed care contracting and operations with Mercy Health, to discuss how one Mercy hospital uses 340B savings to close health care gaps in the St. Louis area. Danielle provides practical advice for how other hospitals can take their own integrated, collaborative, and formalized approaches to 340B and health equity.

Investing in preventive and primary care

Mercy Hospital St. Louis invests significant 340B funding into primary and preventive care for patients who face barriers to accessing that care. These include maternal and child care for underserved patients, a clinic partnership in one of the lowest-income areas in the North City of St. Louis, and a mobile mammography van for patients who lack transportation. 

Improving substance use disorder and behavioral health treatment

Mercy Hospital St. Louis found that significant portions of their patient population suffer from behavioral health problems and substance use disorders regardless of their insurance status. In response, the hospital invested more than a million dollars into an emergency department-based screening and therapy initiative and a health network partnership to support patients with the most complex needs.

Helping patients with their drug costs

Mercy Hospital St. Louis found too many patients face health inequities because of the high costs of prescription drugs to treat their chronic diseases. The hospital uses millions in 340B savings to offset drug costs through infusion centers and specialty pharmacies as well as through a partnership with Dispensary of Hope to provide free drugs to patients.

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 podcast@340bhealth.org.

Resources

1. Report: 340B Hospitals Advancing Health Equity
2. Takeda Becomes 29th Drugmaker To Impose Restrictions on Use of Contract Pharmacies
3. House Approves 340B Medicaid Spread Reporting Requirement
4. HRSA Manufacturer Notices to Covered Entities

Landmark Federal Court Ruling on Patient Definition

In November, a federal court in South Carolina ruled against the Health Resources & Services Administration for an unpublished interpretation of 340B patient definition guidelines the agency had been using in audits of covered entities. Maureen explains the implications of this ruling, which could extend far beyond the long-running dispute between HRSA and community health center Genesis Healthcare.

HRSA Notice Officially Limits Use of 340B in New Hospital Clinics

HRSA also released a new notice in October clarifying that new hospital clinics cannot use 340B until they appear on a filed Medicare cost report and are registered – a process that could take up to nearly two years. Maureen describes a transition period for certain hospitals to come into compliance with the policy, continued advocacy for changes to the restrictions, and a new hospital lawsuit over the issue.

Repayments Coming for 340B Medicare Payment Cuts

Hospitals affected by unlawful Medicare payment cuts from 2018-2022 are set to receive direct lump-sum payments by early 2024 under a final rule the Centers for Medicare & Medicaid Services issued in November. Maureen goes over the repayments and discusses lingering concerns about how CMS is implementing the plan.

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 podcast@340bhealth.org.

Resources

1. Federal Court Issues Decision Against HRSA Limitation on “Patient”
2. HRSA Facing Hospital Lawsuit Over Child Site Eligibility Policy
3. Read 340B Health’s Analysis of the Medicare 340B Pay Cut Remedy
4. West Virginia Journal: A Health Care Policy We Can All Support
5. Zanesville Times Recorder: Drug Pricing Program Is Critical for Patient Care
6. Los Angeles Sentinel: Black Pharmacists Stand as Advocates in Support of 340B Access to Care
7. The Washington Informer: Holy Cross Health, Maryland, Laser-Focused on Achieving Health Equity Through 340B Drug Discounts

In this episode, Bowling discusses her clinical and leadership experience, her 340B advocacy and communications work, and her advice for getting hospital and health system leaders engaged on 340B. 

Connecting 340B to Patients

Bowling has spent decades working in health care since starting her career as an emergency department nurse in a small rural hospital in West Virginia’s Wyoming County. Now that she is a regional and national 340B leader, she has a keen understanding of how 340B connects to the patient care mission. She explains how to use that knowledge to engage with the C-suite on these issues.

Promoting 340B Advocacy Efforts

As a government relations professional, Bowling knows how crucial it is to advocate for 340B with state and federal lawmakers. She describes how to make and maintain connections with policymakers who play a major role in determining 340B’s future.

Telling the 340B Story

Bowling urges hospitals to communicate about how they use 340B to help patients in need, including through opinion pieces, media briefings, and community events. She recently wrote an op-ed for West Virginia’s The State Journal on the benefits of 340B and the harm caused by attempts to limit these benefits.

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 podcast@340bhealth.org.

Resources

1. Federal Court Rules HRSA Is Unlawfully Restricting Patients Who Qualify for 340B
2. Read Our Full Analysis of the Medicare 340B Pay Cut Remedy
3. HRSA Announces Policy Restricting Use of 340B at New Child Sites After Transition Period
4. West Virginia State Journal: A Health Care Policy We Can All Support

340B Nondiscrimination Laws

Amanda shares with us the importance of protecting 340B from discriminatory practices by pharmacy benefit managers (PBMs) and other payers when it comes to reimbursing providers for 340B drugs. More than half of the states have enacted such laws, including California, whose law will affect many providers and patients. 

Protecting Access to Contract Pharmacies 

Amanda discusses two states that have implemented laws against drugmaker restrictions on drugs dispensed at community and specialty pharmacies. Arkansas enacted its law in 2021 and Louisiana did so earlier this year, leading some drugmakers to suspend their restrictive policies in both states. However, the pharmaceutical industry is challenging these laws in federal courts, where the legal process can take years to play out. 

Hospital Reporting and Looking Ahead to 2024

Amanda explains an increased interest in 340B hospital reporting requirements, with states such as Maine and Minnesota enacting new laws and Connecticut, Indiana, and Virginia considering legislation. As hospitals and their government relations team prepare for the 2024 session, she explains how 340B Health is monitoring legislation and supporting our members in their advocacy efforts. 

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 podcast@340bhealth.org.

Resources

1. 340B Health Analyzes Potential Implications of Unprecedented Provisions in BMS Contract Pharmacy Policy Update
2. HRSA Issues Findings for a Fourth Drugmaker Audit in FY 2023

Mitigating Drug Shortages

Inventory optimizing helps ensure organizations meet their resource demands. Jake discusses minimizing repetitions within an organization’s entities by centralizing supply ordering to a single location. For Froedtert, this means purchasing bulk drugs to one large warehouse and then redistributing among hospitals.

Contract Compliance

Froedtert’s 60,000 square foot drug distribution warehouse is centrally located in Milwaukee. There, Jake works alongside Froedtert’s contract manager, a set up that simplifies in-person communication regarding the complex factors of compliance, negotiation, and management. The process boosts speed, efficiency, and clarity among the team.

Patient Care

Jake and Froedtert consider centralized distribution models essential for improving patient care. While Jake’s model may not suit every health system, he believes organizations can adapt distribution methods to their unique needs, simplifying vendor, client, and inventory management for better efficiency and improved patient care.

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 podcast@340BHealth.org.

State Legislation

Testoni notes how states such as Arkansas and Louisiana are leading the way on expanding protections for 340B, leading to changes in drugmaker behavior and lawsuits in federal courts.

Federal Legislation

The House and Senate have been considering legislative language that would negatively impact. 340B. Testoni notes how lawmakers have backed away from some of the more harmful provisions but that advocates are remaining vigilant.

Federal Regulation

Testoni outlines a plan from the administration to pay back 340B hospitals for unlawful Medicare payment cuts. Advocates have submitted comments in favor of the repayment plan but in opposition to a related proposal to claw back other Medicare hospital funds.

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 podcast@340bhealth.org. 

Before the interview, we give an update on the projected effects on the 340B program of the first 10 Medicare Part D drugs subject to caps starting in 2026 under the Inflation Reduction Act and the negative effects of the Stop Drug Shortages Act if it is passed into law as currently drafted. 

Types of Crosswalks

Anja speaks to the different kinds of data crosswalks involving national drug codes, charge description masters, and electronic medical records, that are involved with mapping data from department to department. She stresses the importance of maintaining good contacts with hospital facilities management to stay aware of departmental changes. 

Interdepartmental Support

Experts on each of these crosswalks within hospitals must be able to rely on each other to further their understanding of each portion of the data. Anja talks about the significance of mapping data correctly for potential federal audits and expounds on the different players who should become involved in the process.

340B Is Not Just Pharmacy

Anja speaks about the importance of ensuring that all hospital members understand how they should engage with the 340B program within their roles. She also gives advice on where hospitals can turn if they need help from outside sources on setting up crosswalks. 

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 podcast@340bhealth.org. 

Resources

1. Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026
2. House Drug Shortage Bill Would Provide Windfall to Drugmakers While Harming 340B Hospitals
3. 340B Coalition Winter 2024 Conference Call for Speakers

Uncovering the Effects of the Inflation Reduction Act. The IRA will result in unique changes to 340B hospitals and health systems. Meetali discusses how the changes will roll out, how the drug pricing component might affect 340B savings, and how hospitals can prepare for the changes.

Examining the Decrease in Medicare Reimbursements for 340B Hospitals. The IRA introduces a new maximum fair price (MFP) set by Medicare for select drugs. Meetali explains how this will create a smaller margin between the 340B price and the Medicare reimbursement amount, how that difference might affect a hospital's bottom line, and how administrators can project how that will affect their hospitals.

Modeling the Impact of the IRA. How can organizations respond to the changes the IRA might bring? Meetali explains how hospitals can simulate the real-world effects of the IRA on their operations through modeling and how this can better place them to make informed decisions about how to navigate these effects.

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 podcast@340bhealth.org.

Resources

Merck Relaxes Contract Pharmacy Restrictions in Two States

HHS Issues First Findings for Drugmaker Audit in FY 2023

How the Recertification Process Works

Steve explains the step-by-step process for covered entities to confirm and validate the accuracy of their information and ensure they are still eligible for 340B. 

Eligibility Criteria for Hospitals

Steve discusses the criteria covered entities must meet to qualify for recertification and how they can ensure their official information reflects that eligibility.

Recertification Best Practices and Resources

Steve shares his best practices for recertification, including common error hospitals must avoid, and explains how 340B Health can help member hospitals during this process.

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 podcast@340bhealth.org.

Resources

1. 340B Health Responds to Senate Request for Information on 340B
2. 340B Health RFI Response
3. 340B Health Member Webinar Archive

Starting a Career in Health Care 

Cindy shares valuable lessons for aspiring pharmacy professionals gleaned from decades of experience from her early interest in pharmacy during high school to her current role at Riverside. She advises how such professionals can invest in training and professional development to gain competency in 340B. 

Managing a 340B Program

Cindy shares best practices for how to manage a 340B program effectively by maximizing its value while maintaining compliance, and she stresses the importance of establishing key connections that are both internal and external. 

Advocating for 340B and Pharmacy Issues 

Cindy shares how she made time in her career for participation in advocacy, explains why this activity is critical, and gives practical steps for how 340B professionals can start contributing to such efforts. 

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 podcast@340bhealth.org.

Resources

1. Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022 Proposed Rule
2. Statement on CMS Proposed Remedy for Unlawful 340B Medicare Payment Cuts

Challenges for Hospitals in Managing Specialty Drug Costs
Managing costs in a hospital setting, particularly specialty drug costs, is challenging. Tim shares how hospital administrators can address various factors to keep costs in check and ensure smooth operation.

Role of 340B Discounts in the Specialty Drug Market
Tim highlights the value of the 340B discounts and how they can support hospitals while also highlighting how limited distribution drug networks and the influence of PBMs can further complicate cost management.

Continued Growth of Biosimilars
Tim discusses the biosimilar market, where it stands in the specialty pharmacy landscape, and how we can expect it to grow in the coming years. 

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 podcast@340bhealth.org.

Resources

1. Astellas is Company No. 24 to Impose Contract Pharmacy Restrictions
2. 340B Health Contract Pharmacy Resources

Drug Company Restrictions on Contract Pharmacies
Maureen shares her concerns about the increasing restrictions, their effects on hospital access to 340B discounts, and expected court decisions regarding manufacturers setting these limits.

340B Legislation in Congress and the States
Maureen provides insights into some critical legislation that affects 340B providers, including federal and state legislation to require data reporting from 340B hospitals.

HRSA Policy Changes
The end of the COVID-19 public health emergency created uncertainty about the Health Resources & Services Administration (HRSA) policy on the use of 340B in new hospital child sites. Maureen explains how hospitals are seeking clarity on the issue and how they should proceed in the meantime. 

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 podcast@340bhealth.org.

Before the interview, we give an update on two problematic bills approved by the House Energy and Commerce Committee that would have adverse effects on 340B hospitals if they were to become law.

Pharmacy Supply Chain's Growing Prominence
The pandemic spotlighted supply chain management and its influence on health care delivery and patient care. Ashley emphasizes how hospital pharmacy leaders can ensure the efficient management of their supply chains and the timely provision of patient care by staying informed and actively engaged with industry developments.

Hospital Access to Medications
Supply chain challenges often are exacerbated by factors such as global manufacturing problems and staffing shortages. Ashley gives strategies that leaders can adopt to overcome these obstacles and ensure patients have access to medication.

Leveraging Data and Analytics
Ashley explains how pharmacy leaders can optimize their budgets and prepare for potential disruptions more effectively by adopting a data-driven approach to managing the pharmacy supply chain. 

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 podcast@340bhealth.org.

Resources

Joint Statement from National Hospital and Pharmacist Associations on Harmful House 340B Legislation
House Committee Approves Problematic 340B Reporting Legislation

340B Coalition Summer Conference Registration

Before the interview, we give an update on a drug company placing additional restrictions on its 340B pricing and recap a recent 340B advocacy event on Capitol Hill.

The Impact of Drug Company Restrictions

The restriction of 340B discounts has had a substantial financial impact on Sanford Health. Jesse shares how these restrictions have made it more difficult for Sanford to obtain 340B savings and use them to provide care to its patients.

Making the Decision to Submit Claims Data

Responding to companies whose policies require submitting patient claims data requires critical decision-making by hospitals. Jesse explains what is involved in submitting the data, how to decide if submitting is a viable option, and what steps hospital 340B teams need to take to prepare their data submissions.

What Happens After Claims Are Submitted?

Jesse explains how quickly discounts might be restored after submitting the claims, how consistently drug companies are keeping the 340B pricing in place, and the challenges hospitals face when dealing with discrepancies between claims. 

Resources

1. 340B Health Contract Pharmacy Infographic
2. Bayer Is Latest Company to Tighten 340B Restrictions
3. 340B Health Hill Day Features Advocacy for Introducing Contract Pharmacy Bill
4. 340B Coalition Summer Conference 2023 Registration

The Data Behind the Report

Caroline discusses the primary data sources for the report, including data from the federal government and survey results from 340B Health members. 

Tip of the Iceberg 

The report breaks down the amount of savings stripped from the health care safety net in 2021 from the five companies restricting 340B discounts for all of that year. Caroline uses this information to project the billions of dollars in annual lost 340B savings from the contract pharmacy restrictions. She also describes the patterns she found in the types of drugs that drugmakers are restricting. 

The Toll on Patient Care

340B hospital survey data in the report uncovers how lost 340B savings from drug company restrictions affects patients’ access to services and their ability to obtain discounts on medications through contract pharmacies. Caroline discusses results from the survey that shed light on how drug company demands for patient claims data are diverting resources from patient care. She also shares individual stories from the report of harm to patient care. 

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 would like us to cover in this podcast, email us at podcast@340bhealth.org.

Resources 

1. 340B Health, AHA, Arkansas Hospital Association Urge Federal Appeals Court to Uphold State Law Protecting 340B Community Pharmacies
2. 340B Health Spring 2023 Report on Contract Pharmacy Restrictions 
3. 340B Health Spring 2023 Contract Pharmacy Report Infographic
    
4. 340B Coalition Summer Conference 2023 Registration  

Causes of Maternal Health Disparities 

Fatimah shares data demonstrating disparities in maternal health outcomes and discusses the role that social determinants of health play in health disparities. 

The Saint Peter's Approach to Maternal Health
Saint Peter's University Hospital created a birth center that has adopted a midwifery model of care. Fatimah discusses how the birth center incorporates doulas into patient care and how it approaches high-risk pregnancies. She also notes that the birth center cares for all patients no matter their health insurance status.

340B’s Role in Maternal Health
Saint Peter's has used its 340B savings to provide maternal health services and expand its family health center. The hospital’s plans for continuing to support maternal health include creating a food pantry for mothers and families who are experiencing food insecurity.  

Check out all 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 would like us to cover in this podcast, email us at podcast@340bhealth.org.

Resources 

1. 340B Health Statement on the Protect 340B Act to Ban Discriminatory Payment Policies 
2. Novartis Is Latest in String Of Companies Tightening 340B Restrictions 
3. 340B Health Contract Pharmacy Dispute Resources for Members 
4. National Minority Health Month 

Economic Challenges

Many hospital CEOs face economic challenges in their organization. Matt shares the value that 340B leaders provide to help hospitals have the resources they need to meet their patient care mission. 

How to Engage Hospital CEOs in 340B Operations and Advocacy 

Matt provides best practices for how 340B professionals can best educate the CEO about 340B to help the CEO strategize how to use 340B savings to grow and sustain services for patients in need. He also discusses why 340B hospital CEOs should become engaged in program advocacy. 

Connecting 340B Professionals to the C-suite 

Matt describes how he and his leadership team support 340B program leadership and established an organizational structure for communication with the health system’s 340B program leader. He also shares advice for 340B professionals who are interested in a health system C-suite career path. 

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 would like us to cover in this podcast, email us at podcast@340bhealth.org.

Resources 

1. 340B Health March 2023 Report on Drug Company 340B Contract Pharmacy Restrictions 
2. Joint Statement from National Hospital and Pharmacist Associations on PhRMA-led Proposal to Restrict 340B Eligibility
3. Matt Perry Op-ed about 340B Providing Stability for Hospitals Amid the COVID-19 Pandemic 

The Benefits of Internal Audits 

Internal audits help 340B covered entities stay in compliance. Tristan outlines the internal audit process her health system uses and how this supports the overall compliance effort. She also explains how the internal audit process has changed over time. 

What HRSA Expects from Internal Audits

Tristan discusses what HRSA expects hospitals to share about their 340B internal audits. 

Staying Organized During Internal Audits 

Tristan shares her approach to accomplishing a successful internal audit, including which materials her hospital gathers for the process. 

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 podcast@340bhealth.org.

Resources 

1. 340B Health Statement on PhRMA Proposal to Reduce Safety-Net Hospital Participation in 340B
2. Rep. Doris Matsui Statement on Proposal to Change 340B Program 
3. PhRMA Unveils More Details About Proposed 340B Hospital Eligibility Cuts 
4. 340B Coalition Winter Conference  

Why You Need to Pay Attention to State Health Policy  

Abby discusses the power states have to regulate health care. 

Advocating for a 340B Non-Discrimination Law 

Abby details the steps her hospital and other provider organizations took to help state legislators understand the need to stop payer and pharmacy benefit manager (PBM) payment discrimination against 340B providers. She also explains the work advocates sometimes need to do to ensure laws are enforced. 

Joining 340B State Advocacy Efforts 

Abby shares how 340B professionals can join advocacy efforts in their states and how advocacy differs between the state and federal levels. 

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 would like us to cover in this podcast, email us at podcast@340bhealth.org.

Resources 

1. Statement on New Johnson & Johnson Restrictions on 340B Access 
2. Contract Pharmacy Dispute Resources for 340B Health Members
3. 340B Coalition Winter Conference 

IT's Intersection With 340B Operations

Bob discusses the different types of IT systems providing data that are important for closely monitoring your 340B program, including electronic health records, automated dispensing cabinets, and IV workflow software. He emphasizes the importance of the 340B team members becoming experts on 340B data. 

EHR Conversions

Bob explains how EHR system conversions affect 340B operations and compliance. He walks through the steps his team took before and during one of its conversions and points out the potential pitfalls to avoid.  

Strategies for Managing NDCs 

An EHR conversion means 340B professionals need to be aware of potential NDC challenges that go along with it. Bob shares some questions 340B professionals should ask about charging and administration practices when planning for a change in EHR systems. 

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 would like us to cover in this podcast, email us at podcast@340bhealth.org.

Resources 

1. List of Drugmaker 340B Restrictions Grows in Wake of Court Decision 
2. 340B Insight Episode 67: Maureen Testoni’s Outlook for 340B in 2023
3. 340B Coalition 2023 Winter Conference 

*Editor’s note: We spoke with Maureen prior to Bayer and EMD Serono announcing they will restrict 340B discounts. When these restrictions start in March, at least 21 companies will be limiting 340B discounts, with 14 of these companies conditioning 340B pricing on providers sharing contract pharmacy claims data.* 

U.S. Appeals Court Decision on 340B Contract Pharmacies

Litigation continues on drug companies imposing restrictions on 340B pricing to hospitals and other providers when drugs are dispensed through community and specialty pharmacy partners. Maureen discusses a recent U.S. federal appeals court decision and the next steps in the litigation process. She also explains the trends in the drugmakers’ restrictions.  

2023 Advocacy Landscape for 340B 

Two recent national newspaper stories portrayed 340B in a negative light, but they did not include a complete picture about how 340B works. Maureen discusses what the increased media attention means for 340B advocacy this year and what hospitals should do to advocate for the program. She also shares an overview of 340B legislative activity at the state level.  

Medicare Payment Issues for 340B Hospitals

Maureen shares what she will be watching for during the implementation of a new Medicare drug price-setting law. She also explains the status of repayments to 340B hospitals for unlawful Medicare cuts. 

340B Administrative Dispute Resolution (ADR) Process

HHS has proposed revisions to the ADR process for resolving disputes between covered entities and drug manufacturers over 340B pricing. Maureen examines how these revisions will clarify the process and further changes that 340B hospitals are requesting.

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 would like us to cover in this podcast, email us at podcast@340bhealth.org.

Resources 

1. Statement on Third Circuit Appeals Court Decision on Drugmakers’ 340B Restrictions
2. Statement on Bayer and EMD Serono Restricting 340B Discounts Through Community-based Pharmacies 
3. 340B Health Comment Letter to HRSA on Proposed Changes to the 340B Administrative Dispute Resolution 
4. 340B Coalition Winter Conference 2023