Episodios
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What Does the GOP Trifecta Mean for 340B?
In January, Republicans will achieve what’s known as a governing trifecta – taking control of the executive branch combined with GOP majorities in both the U.S. House and Senate. How will this new dynamic affect the 340B world? We discuss what is ahead with McDermott+ vice presidents Rodney Whitlock, a former Republican legislative staffer, and Debbie Curtis, a former Democratic legislative staffer.
Capitol Hill Shakeups and New Faces
Several 340B champions are set to leave Congress through retirement or new appointments, including Reps. Elise Stefanik and Abigail Spanberger as well as Sens. Debbie Stabenow and Ben Cardin. But this provides an opportunity to speak to newly elected lawmakers to express the value of 340B and what it means for their constituents.
Preparing for 340B Oversight
The new Congress could bring oversight hearings and other opportunities for 340B critics to speak out. Although 340B has faced and surmounted challenges before, this will require getting back to core advocacy efforts designed to protect the program.
Trump’s Second Term
How the second Trump administration will fill key roles and the decisions they make on health policy issues could impact 340B. The implementation of Inflation Reduction Act drug pricing provisions also will affect 340B and could lead to discussions about additional changes to the program.
Resources:
Create or Update Your 340B Impact ProfileRead Our Analysis of J&J’s Legal Arguments for 340B RebatesLilly, Kalderos Press Federal Court for Ability To Impose Rebates -
The focus of attention on cancer care most often goes to the curative treatments required to put cancer into remission, but what do cancer survivors need after that point to fully recover and lead their best possible lives? We discuss that question and how 340B can help answer it with guests Sarah Loschiavo and Ellen Morris-White, two nurse practitioners with UConn Health based in Farmington, Conn.
Survivorship Care at a Crucial Time
UConn Health’s Cancer Survivorship Program is led by advanced practice registered nurses who provide comprehensive care and support to cancer patients starting three to six months after their curative cancer treatments are complete. With the help of 340B funding, the multidisciplinary program is broad in scope, including referrals to meet cancer survivors’ physical, psychosocial, spiritual, and financial needs. The goal is to keep patients on the road to recovery and to continue screening for any cancer recurrence or secondary cancers that could occur.
340B Is Key To Covering Costs
UConn Health covers the costs of its survivorship care, and low-income patients can receive additional financial assistance for their ongoing cancer therapies through this program. 340B funding is essential to making that happen. Over time, the program is expected to decrease health care costs by avoiding hospital readmissions and cancer recurrences.
Building Out Best Practices
Evidence on survivorship care models is lacking, but UConn Health has worked on research that could provide some best practices for other institutions. Although there is no one-size-fits-all approach for hospitals, they can use elements of the nurse practitioner-led, interdisciplinary model to meet cancer patients’ needs months and even years after curative treatment.
Resources:
UConn Health Cancer Survivorship ProgramDesigning, Implementing, and Evaluating an Interprofessional Survivorship Model of Care in an Academic Cancer Center -
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The 340B drug pricing program is crucial for safety-net hospitals and other providers that care for patients in need, especially those whom traditionally have been underserved by the broader health system. We speak with Dr. Tony Jackson, assistant vice president for pharmacy services at Scripps Health in San Diego, for his views on why 340B is “all about health equity.”
340B Helps Serve the Underserved
Jackson stresses the variety of services and support that 340B funding enables at Scripps Health. Because of 340B, Scripps can serve large populations of patients in the area who are homeless, lack health coverage, and are dealing with higher rates of chronic illness and disease. It does so in part through partnerships with community health centers and other community groups on outreach to those populations.
Restrictions to 340B Threaten Patient Care
340B savings help support vital Scripps services that include emergency department care, access to specialists, discharge and maintenance medications, and community health benefits such as disease screenings. Jackson notes that drug company restrictions on access to those savings threaten such services and risk creating health care deserts in the area.
Representation and Advocacy Matter
Jackson is part of the Association of Black Health-System Pharmacists (ABHP), which works to increase Black representation in the pharmacy field with the goal of improving underserved patients’ trust in pharmacists and access to needed care. He notes how ABHP leaders have advocated for 340B with the understanding of how important it is to the pursuit of health care equity.
Resources
340B Health Equity Report 2023Black Pharmacists Stand as Advocates in Support of 340B Access to CareSenate Letter to HHS on Rebates -
Within the past few weeks, drugmaker Johnson & Johnson went head-to-head with 340B hospitals and the federal government over the company’s plan to stop paying upfront 340B discounts on two of its top-selling drugs. 340B Health Senior Counsel Amanda Nagrotsky joins us to explain how that conflict played out.
HRSA Warns Johnson & Johnson of Strong Punitive Actions
In letters to J&J, the Health Resources & Services Administration (HRSA) warned the drugmaker that replacing 340B rebates with discounts only would be allowed if approved by the Health and Human Services (HHS) secretary. HRSA gave the company until the end of September to announce that it was going to walk away from its plan or face both civil monetary penalties and the termination of its pharmaceutical pricing agreement (PPA). Nagrotsky said the threat to end the PPA was unprecedented, noting that it would cause the company to lose access to Medicaid and Medicare Part B coverage for all its drugs.
Johnson & Johnson Backs Down Under Pressure
J&J announced at the end of September that it would walk back its plan to implement rebates in mid-October, bowing to pressure from federal health officials and a bipartisan group of nearly 200 members of Congress who opposed the J&J strategy. The company maintained that it disagreed with HRSA’s reasoning and noted that it was reserving all legal rights with respect to rebates. That stance indicates the company is likely to continue its push to implement rebates.
The Battle Against Rebates Continues
Despite the win for hospitals on the J&J rebate scheme, efforts from the drug industry to change the 340B discount structure continue. Drug industry consultant Kalderos is part of ongoing litigation in a federal court in Washington, D.C., over the right to impose rebates. HRSA’s references to the concept of HHS approval of rebate proposals also leaves open the door for companies to seek federal consent for such a model.
Resources
340B Hospitals Prevail on J&J Rebate Plans, But Fight Is Not OverBipartisan U.S House Letter to HHS, Sept. 27 HRSA Letter to Johnson & Johnson, Sept. 27J&J Response to HRSA, Sept. 30 -
A renewed push by a drugmaker to fundamentally transform 340B has the potential to cause major problems for 340B hospitals if allowed to take effect. 340B Health President and CEO Maureen Testoni joins us to explain the controversial 340B rebate issue and to cover some of the other recent developments in the 340B world.
A Plan To Replace Upfront Discounts With Rebates
For years, drugmakers have been pushing unsuccessfully for approval to turn 340B from an upfront discount program into a back-end rebate program. But recently, Johnson & Johnson announced it would unilaterally proceed with plans to stop selling two of its drugs at the discounted price for certain hospitals. Maureen explains the reaction of the government, hospitals, and others and outlines the potential next steps in the advocacy against such a harmful change.
More Legislative Action on Capitol Hill
Recently, Sen. Peter Welch of Vermont introduced legislation to make access to 340B through contract pharmacies a very clear part of statute and to prohibit manufacturers from imposing conditions on 340B pricing. It is one of several 340B bills pending on Capitol Hill, which also include a potential Medicaid payment reporting requirement for 340B hospitals. Maureen notes that although Congress does not have much time left to legislate this year, it is possible 340B will be part of the action during a lame-duck session after the elections.
Court Action Continues on State 340B Laws
Although two federal appeals courts recently ruled that the 340B statute does not categorically prohibit drugmaker conditions on 340B pricing, several states have moved to impose their own such prohibitions. Drug companies are suing to block these laws, but so far courts have denied these attempts. Maureen notes that 340B Health and other organizations continue to file friend of the court briefs in support of these state laws.
Resources
1. HRSA Threatens Johnson & Johnson With Sanctions Over Rebate Plans
2. HRSA Letter to J&J
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The 340B drug pricing program is designed to give hospitals the flexibility to use their savings toward the types of patient care and support that their communities need the most. How does that work for hospitals that decide to use their access to 340B to provide the discounts directly to patients who cannot afford their drugs? Paul Orth, 340B program manager at University Health Kansas City Truman Medical Center, sits down with us to discuss how his health system’s direct drug savings program is helping both uninsured and underinsured patients.
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:
340B Health Urges HRSA To Block J&J Plan To Replace 340B Discounts With RebatesJ&J Implements 340B Rebate Model Despite HRSA Opposition340B Health Equity Report 2023 -
This marks the time of year when 340B hospitals complete the recertification process to maintain their eligibility for 340B. But why is this recertification needed, and what do hospitals need to know before undergoing recertification?
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:
340B Health Registration and Recertification Resource340B Health Webinar Archive340B Health Equity Report 2023 -
Artificial intelligence is a hot topic in 2024. Discussions about AI in health care continue to grow, including about the potential for such technology to improve care and save lives. What role might AI play in the 340B world? We speak with WVU Medicine Enterprise 340B Program Coordinator Elizabeth Gibson to learn how one health system is exploring this potential.
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.
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We have released several episodes in recent months in which we have discussed federal and state legislative efforts on 340B. But what does it take to get 340B protections through a state legislature and to the governor’s desk? In this episode, we speak with Ryan Cross, vice president of governmental affairs with Franciscan Missionaries of Our Lady Health System, based in Baton Rouge, La. This system operates 10 hospitals in Louisiana and Mississippi. Both states recently enacted contract pharmacy protection laws. Ryan says there were three factors involved with getting these state protections over the legislative finish line:
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:
Missouri Becomes Eighth State To Enact Contract Pharmacy Protections -
While significant 340B actions have happened at the federal level, state legislatures also have made big moves in the world of 340B so far this year. We are joined by Amanda Sellers Smith, 340B Health’s legal counsel, to explain more.
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:
Mississippi Court Rejects Drug Industry Calls To Block Contract Pharmacy Protections340B Health State Policy and Advocacy Resource Center -
The world of 340B has seen significant developments on the state and national levels in recent months. A second federal appeals court decision on 340B contract pharmacies came down in recent weeks, a new bill in Congress threatens to impose significant restrictions on hospital participation in 340B program, and more states move to protect covered entities from drugmaker restrictions. To understand these new developments, 340B Health President and CEO Maureen Testoni joins us to explain more.
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
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The finalized 340B administrative dispute resolution (ADR) rule is set to go into effect on June 18 and will create a process to settle certain disputes between covered entities and drug manufacturers. But what should covered entities know about this process before it launches? Jason Reddish, a 340B expert with the Powers Pyles Sutter & Verville health care practice group, joins us to discuss.
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 [email protected].
Resources:
Final Administrative Dispute Resolution (ADR) Rule Adopts Several 340B Health RecommendationsReport: 340B Hospitals Prescribe Medicare Part D Drugs to Greater Shares of Historically Underserved Patients -
Hospitals throughout the U.S. use their 340B savings in innovative ways to care for their patients in need. In some cases, they can take that care outside the walls of the hospital to meet patients where they learn, live, and play. We speak with Heather Armstrong with Comanche County Medical Center in central Texas to tell us how her health system invests 340B savings into innovative approaches to community care.
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 [email protected].
Resources:
Court-Backed Arkansas Contract Pharmacy Law Prompts Enforcement Action, More Drugmaker Retreats -
340B savings can help hospitals and other covered entities better serve patients and improve their health outcomes. But how can these entities make the best use of 340B funds for their institutions? We sat down with Matt Webber, director of pharmacy business at Novant Health based in North Carolina, to learn more.
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 patientsNovant 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 [email protected].
Resources:
Mississippi Bans Drugmakers’ Contract Pharmacy RestrictionsHRSA Issues Final Rule on Changes to Administrative Dispute Resolution (ADR) Process -
The 340B community has seen major activity on several fronts since the start of 2024 – the introduction of new legislation on Capitol Hill, movement on legislation in the states, and key developments in the courts. 340B Health President and CEO Maureen Testoni returns to the show to help us make sense of these developments and how they might affect stakeholders.
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 [email protected].
Resources
House Bill Would End Drugmakers’ 340B Contract Pharmacy RestrictionsLearn How Stakeholders Weighed in on Draft Senate 340B BillFederal Appeals Court Upholds Arkansas Contract Pharmacy LawWest Virginia Bans Drugmakers’ Contract Pharmacy Restrictions -
One of the most important elements of 340B compliance is preventing duplicate discounts. Ensuring there are no duplicate discounts is high on the list of compliance concerns for covered entities, and it is one of the major items that 340B auditors look for. But how do these entities ensure they stay compliant? On this episode, we speak to Melissa Bruce, an ACE-certified compliance analyst for the 340B Programs Team at UNC Health in North Carolina, to learn more.
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 [email protected].
Resources:
New Federal Legislation Would End Drug Company Restrictions on 340BMatsui Introduces Legislation To Protect 340B Drug Pricing ProgramFederal Appeals Court Upholds Arkansas Contract Pharmacy Law -
340B hospitals can register certain outpatient locations with the Health Resources & Services Administration (HRSA) as 340B child sites, which allows them to use 340B drugs. HRSA recently announced some changes to how it had been determining this eligibility during the COVID-19 public health emergency. How have these changes affected 340B hospitals, particularly those that had planned new child sites under the previous policy? For the answers to this question and more, we spoke to Chuck Stubbs, a 340B pharmacist with Intermountain Health based in Salt Lake City.
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 [email protected].
Resources:
HRSA Announces Policy Restricting Use of 340B at New Child Sites After Transition Period -
The Health Resources & Services Administration audits 200 covered entities each year for compliance with 340B rules. We speak with Mark Capuano, senior director of the corporate pharmacy 340B program at New York City Health and Hospitals, about what hospitals should expect when they find out they will be going through a 340B audit.
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 [email protected].
Resources:
HRSA 340B Program Integrity Website -
340B sits at an intersection where federal programs and state agencies come together. Maine, Minnesota, and Washington recently enacted new laws requiring hospitals to report 340B information to the states each year. What should health systems know about these new requirements? We speak with Danny Ackert, the director of state government relations at the Minnesota Hospital Association, to learn more about what these requirements look like in his state and what hospitals might expect in other states considering such reporting.
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 [email protected].
Resources
Senate 340B Bipartisan Working Group Discussion DraftStatement on Senate 340B Bipartisan Working Group Discussion DraftSenators Developing 340B Bill Seek More Feedback on Contract Pharmacy, Patient Definition, Child Sites -
We are returning to a popular episode format we aired early last year, when we consulted with 340B Health’s expert staff to answer your most pertinent 340B questions. As we start another busy year for 340B, we help you prepare for the action by answering your questions about the Genesis court decision, 340B activity in state legislatures, Medicare Part B repayments, and more.
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 [email protected].
Resources
HRSA Stresses Federal Court Decision on Patient Definition Only Applies to Genesis FQHC Implications of Genesis Decision on 340B Patient Definition WebinarState Policy and Advocacy Resource Center Analysis of the Medicare 340B Pay Cut RemedyHRSA Program Integrity WebsiteInflation Reduction Act: Assessing Financial and Operational Challenges Webinar - Mostrar más
