Latest news with #340B
Business Wire
10-07-2025
- Business
- Business Wire
Many 340B Disproportionate Share Hospitals Fail to Reinvest in Patient Care
WASHINGTON--(BUSINESS WIRE)--A new analysis of 340B hospital data found that the number of Disproportionate Share Hospitals (DSHs) participating in the 340B Drug Pricing Program 1 has surged more than sixfold, rising 565% from 2004 to 2023, with little evidence of commensurate growth in benefit to vulnerable populations. Yet, following 340B enrollment, DSHs' financial investments, including stocks, bonds and other financial instruments, soared. 'Most 340B disproportionate share hospitals have morphed into corporate profit machines, putting Wall Street-style growth ahead of patient care. Many hospitals that joined the program in 2016 and 2017 boosted their financial portfolios – while slashing the amount of free and discounted care they provided. This isn't just a betrayal of the program's purpose – but a betrayal of public trust,' said Mike Kapsa, Board Member, CARH. In theory, DSH participation in the 340B program should enhance care for vulnerable patients. But the data tell a different story: 340B DSHs are reducing their commitment to uncompensated care, all while growing financial reserves and investments. The study found DSHs that joined 340B between 2016 and 2017 reduced their spending on free or reduced cost care by 22%, on average, while increasing financial investments by 89% in the five years following enrollment. 'We continue to see growth in 340B drug sales and questions around hospital use of these funds,' said Amanda Forys, Managing Partner, Magnolia Market Access. 'This study supports the same narrative – disproportionate share hospitals are not directing 340B revenue toward patient care. Policies that promote appropriate use of 340B funds are needed to make sure vulnerable patients benefit from these steep drug discounts.' The analysis and report were completed by Magnolia Market Access, made possible through support from CARH. To access the full analysis, visit HERE and learn more about how non-profit DSHs are misusing 340B revenue and the importance of program oversight to ensure vulnerable patients benefit, not corporate interests. About Magnolia Market Access: Magnolia Market Access provides tailored strategies and insights to pharmaceutical companies, device manufacturers, and trade associations to meet their market access, HEOR, and healthcare policy needs. Our experts provide 360-degree perspectives and analysis of our in-house and client-specific clinical and real-world data to shape policy, communicate value, secure reimbursement, and drive patient access. For more information, visit About CARH: Community Action for Responsible Hospitals (CARH) is a non-profit organization of patient-focused stakeholders including labor unions, faith leaders, healthcare providers, consumer advocates, and public interest groups. For more information, visit 1 Established in 1992 under the Public Health Service Act, the 340B Drug Pricing Program is a federal program that provides discounts on outpatient prescription drugs to 'covered entities,' such as qualifying hospitals and clinics that treat a high number of low-income and uninsured individuals.
Business Wire
02-07-2025
- Business
- Business Wire
IntegriChain Deepens Pricing and 340B Advisory Services with Recognized Industry Expert
PHILADELPHIA--(BUSINESS WIRE)--IntegriChain, the leading provider of revenue optimization technology and insights for the pharmaceutical industry, today announced the hiring of Clay Willis. Willis brings IntegriChain more than a decade of experience in pharmaceutical consulting and advisory, predominantly around 340B, contracting, pricing, and market access issues. 'The ever-changing regulatory and pricing landscape poses a tremendous challenge to our customers, and nothing is more troublesome than managing the dynamics of the 340B program,' said Bill Roth, Senior Vice President and Managing Partner, Consulting & Advisory of IntegriChain. 'Clay brings decades of industry-proven leadership around these complex issues and will help IntegriChain to deliver even deeper insights as well as decision and operational support.' 'I am excited to join the IntegriChain Advisory team at this pivotal moment,' said Willis. 'Our enhanced Consulting and Advisory services, coupled with IntegriChain's data, technology, and outsourcing capabilities, make IntegriChain ideally suited to address today's drug commercialization challenges. I look forward to helping IntegriChain's customers optimize their revenue and mitigate risk in the complex and dynamic world of 340B, IRA, and other government programs.' About Clay Willis Clay will be responsible for expansion of IntegriChain's Government Pricing and Gross to Net Advisory practice, helping companies understand and navigate the dynamic life sciences and healthcare landscape, especially in the areas of 340B Drug Pricing Program ('340B') and impacts to manufacturers from the Inflation Reduction Act of 2022 ('IRA'). Clay's specific expertise is based on a detailed understanding of government programs (Medicaid, Medicare, VA/FSS, 340B) strategy, operations, compliance, and overall channel management. He has knowledge in Government Pricing calculation, gross-to-net optimization, forecasting, and 340B strategies, operations, and self-help related solutions. Most recently, Clay was a Director in Berkeley Research Group's Health Analytics practice where he assisted companies in 340B strategy and operational related matters including helping manufacturers implement 340B Center of Excellence governance and operating models. Previously, Clay held senior-level advisory roles at Deloitte and Huron Consulting where he provided operational, financial, compliance, and strategy related support to small, mid-size, and large pharmaceutical manufacturers. He is a frequent speaker at industry events and is a recognized expert on Government Programs (Medicaid, Medicare, 340B, and VA/FSS) and regulatory dynamics. About IntegriChain IntegriChain is the leading provider of revenue optimization technology and insights for the Pharma industry. The company's unique combination of data management, enterprise applications, consulting, and outsourcing helps manufacturers achieve better financial results by connecting commercial execution to net revenue. IntegriChain is backed by Nordic Capital, a leading sector-specialized private equity investor with a broad portfolio in Healthcare and Technology. IntegriChain is headquartered in Philadelphia, PA, with offices in Ambler, PA, and Pune, India. For more information, visit or follow on LinkedIn.
Yahoo
10-06-2025
- Business
- Yahoo
Drug maker sues over new North Dakota pharmaceutical law
A pharmacy manager retrieves a bottle of antibiotics. (Photo by) North Dakota is being sued over a new law that requires drug manufacturers to sell more of their medications at a discount. House Bill 1473, signed by Gov. Kelly Armstrong in April, primarily affects drug companies participating in a federal program called 340B. A drug manufacturer has filed suit over the policy in North Dakota federal court, claiming it is unconstitutional and will hurt its profits. The state denies the company's claims. The 340B program was created by Congress in 1992 to improve health care access in low-income communities. It requires participating drug companies to offer discounted products to qualifying hospitals and other medical facilities. Drug companies must take part in 340B in order to participate in federal Medicaid and Medicare programs. In legislative hearings, proponents of the bill called 340B a critical program for rural North Dakota, subsidizing medication for patients and allowing hospitals to provide a wider range of services. 'This is a lifeblood to rural facilities across the state,' Rep. Jon Nelson, a Rugby Republican and bill sponsor, said during a February committee meeting. North Dakota this year became one of a handful of states to pass a law limiting drug manufacturers' freedom to decide where and how they sell 340B drugs. House Bill 1473 makes it a class B misdemeanor for companies to adopt policies that 'deny, restrict, prohibit, or otherwise interfere' with pharmacies' ability to obtain and dispense products to patients on behalf of 340B hospitals. In testimony on the proposal, hospital representatives complained that drug companies were cutting off access to medications subsidized through 340B, namely by refusing to sell the drugs to more than one pharmacy hospitals work with. In an April complaint filed against North Dakota, drug company AbbVie argued that Congress intended for manufacturers to be able to set additional requirements for 340B hospitals to access their products — so long as the medications are offered at the reduced costs mandated by the program. The company alleges that pharmacies and hospitals are taking advantage of the 340B program by selling the discounted medications at full price. Barring drug manufacturers from placing additional parameters on these sales will only harm the low-income patients the program is intended to benefit, AbbVie wrote in its complaint. In testimony in favor of House Bill 1473, hospital and pharmacy representatives said that the real reason drug companies are reluctant to sell discounted drugs to more pharmacies is because they want to sell their medication at list price at as many places as possible. AbbVie also alleges that North Dakota is trying to use a state law to change a federal program, which they say is a violation of the U.S. Constitution's Supremacy Clause. Any changes to how 340B operates must be approved by Congress, the company argues. They claim that federal law makes the U.S. Department of Health and Human Services the sole agency in charge of enforcing 340B compliance, leaving no room for state policies like House Bill 1473. The company further argues that the law is an illegal attempt to regulate business in other states. Since some North Dakota hospitals have agreements with pharmacies across state lines, House Bill 1473 could affect transactions between out-of-state drug companies and pharmacies — which AbbVie says is unconstitutional. According to the company, the law also violates rights protected under the Fifth Amendment by forcing it to sell its property to a private party. Companies found in violation of the new law, which takes effect Aug. 1, could face 30 days in jail, a maximum fine of $1,500, or both. The North Dakota Board of Pharmacy can also impose civil penalties on violators, according to testimony on the bill. AbbVie has asked a federal judge to declare House Bill 1473 unconstitutional and to order that North Dakota cannot enforce it. SUBSCRIBE: GET THE MORNING HEADLINES DELIVERED TO YOUR INBOX Courts across the country have ruled differently on this issue. The D.C. Circuit Court of Appeals and Third Circuit Court of Appeals have both ruled the 340B program does not prevent drug companies from imposing additional requirements on hospitals and pharmacies, the drug manufacturer noted in court filings. However, the Eighth Circuit in 2024 upheld an Arkansas law similar to House Bill 1473. The Arkansas law makes it illegal for drug companies to prevent hospitals from using pharmacies to get 340B drugs into the hands of patients. The Eighth Circuit includes North Dakota, South Dakota, Minnesota, Iowa, Missouri, Kansas, Nebraska and Arkansas. SUPPORT: YOU MAKE OUR WORK POSSIBLE
Yahoo
06-06-2025
- Business
- Yahoo
AstraZeneca sues Utah attorney general over new drug pricing law
AstraZeneca, a major pharmaceutical company, has sued Utah's Attorney General Derek Brown over a recently passed state law allowing for lower pricing in pharmacies. The lawsuit concerns how SB69, passed during the 2025 state legislative session, deals with Section 340B of the federal Public Health Service Act. The suit was filed in May in the U.S. District Court of the District of Utah. The lawsuit argues that SB69 violates federal law by expanding the 340B drug discount program to unlimited pharmacies. The 340B drug discount program is designed to provide pricing benefits to specific eligible health care entities. It requires pharmaceutical manufacturers to offer products at steeply discounted rates for a specific list of entities. 'Because such price controls can disincentivize innovation and destabilize markets, Congress carefully crafted Section 340B and limited participation in the program to fifteen — and only fifteen — types of covered entities," per the lawsuit. It also points out that for-profit pharmacy chains, such as CVS and Walgreens, were not included in the list of covered entities. AstraZeneca's suit seeks for an order declaring that SB69 violates federal law and is unconstitutional. It also seeks to stop Brown and Utah Insurance Commissioner Jon Pike from enforcing SB69 against AstraZeneca in any manner. The Utah Attorney General's Office said Friday it had no comment on the lawsuit. SB69, which was sponsored by Sen. Evan Vickers, R-Cedar City, defines terms related to the 340B drug discount program and prohibits pharmaceutical manufacturers from setting certain restrictions. Under the law, manufacturers cannot prohibit or restrict pharmacies from contracting with 340B entities. They also cannot deny these 340B entities access to specific drugs. 'Apparently dissatisfied with the scope of federal law, the State of Utah has enacted a statute seeking to achieve under state law precisely the same result that federal courts have resoundingly rejected,' per the suit. 'The state law requires pharmaceutical manufacturers to offer 340B-discounted pricing for sales at an unlimited number of contract pharmacies.' The suit says that SB69 extends Section 340B price caps beyond the scope of the federal program, requiring manufacturers to make discounted drugs available for sale at any and all pharmacies 'authorized by a 340B entity to receive the drug.' It alleges that the law extends the discounts to new categories of transactions that are not covered by the program, thus conflicting with federal law requirements. The suit argues that the law conflicts with federal law, specifically court rulings that 'make clear that the federal 340B statute does not obligate manufacturers to deliver discounted drugs to unlimited contract pharmacies." According to the suit, SB69 also violates federal patent law, which 'prohibits states from regulating the price of patented goods.' 'It requires manufacturers like AstraZeneca to offer steeply discounted prices for the sale of their patented drugs, thereby extending federal price caps to an additional category of patented drug sales (contract pharmacy sales) that federal courts have held fall outside of the 340B program. It also argues that SB69 violates the Contracts Clause of the U.S. Constitution and the Constitution's takings clause.
Yahoo
06-06-2025
- Business
- Yahoo
Pharmaceutical company AstraZeneca sues to stop Utah law expanding access to discounted drugs
Sen. Evan Vickers, R-Cedar City, is pictured on the first day of the legislative session at the Capitol in Salt Lake City on Tuesday, Jan. 16, 2024. (Photo by Spenser Heaps for Utah News Dispatch) Pharmaceutical giant AstraZeneca is suing Utah's attorney general and insurance commissioner over a law passed during the legislative session aimed at stopping drug manufacturers from limiting where hospitals and clinics can buy discounted medication. Filed in May in federal court in the District of Utah, the company accuses the law of being unconstitutional and in conflict with prior court rulings. Sponsored by Sen. Evan Vickers, R-Cedar City, SB69 deals with the federal 340B program, a decadesold provision in the Public Health Service Act that aims to supply hospitals and health clinics with drugs at a discounted price. The program requires drug manufacturers to provide discounts on certain outpatient drugs for entities covered under the program, like hospitals, clinics, or Native American tribes. According to the American Hospital Association, hospitals can pass savings from the 340B program along to patients by offering health care to uninsured patients, providing free vaccinations, or expanding mental and community health programs. SUBSCRIBE: GET THE MORNING HEADLINES DELIVERED TO YOUR INBOX But Vickers, who owns and operates a pharmacy in Cedar City, said the program is not popular among drug manufacturers, who have tried to limit where the entities covered under 340B can obtain the discounted drugs. Speaking on the Senate floor earlier this year, Vickers said manufacturers have been enforcing a 'one pharmacy rule,' where certain drugs can only be obtained from certain pharmacies. 'From their perspective it's expanded more than they would like, so they've tried to limit the access of drugs,' Vickers said. 'Essentially, you could have a patient being able to get a product at a discounted price in one town but not the other.' SB69, which passed in March during the final week of the legislative session, tries to prevent this. The bill is relatively simple at just 53 lines, and states that drug manufacturers cannot restrict pharmacies from contracting with entities covered under the 340B program. It also restricts manufacturers from preventing the delivery of a 340B drug to any location authorized to receive it. 'I don't stand here professing that the manufacturers are happy with this, I will tell you they're not,' said Vickers earlier this year, telling his Senate colleagues that states that have passed similar legislation have been targeted by lawsuits. 'But what we're looking at is providing access to medication at a discounted price.' Vickers was right. AstraZeneca, the global pharmaceutical company that generated more than $54 billion in revenue in 2024, is now suing Utah Attorney General Derek Brown and Utah Insurance Commissioner Jon Pike to stop the enforcement of SB69. The Utah Attorney General's Office did not provide comment on the active litigation. In the complaint, attorneys for AstraZeneca point to prior court rulings that supersede Utah's law. 'Apparently dissatisfied with the scope of federal law, the State of Utah has enacted a statute seeking to achieve under state law precisely the same result that federal courts have resoundingly rejected,' the complaint reads, accusing SB69 of requiring 'discounted pricing for sales at an unlimited number of contract pharmacies.' According to AstraZeneca, the requirement in SB69 goes beyond the original intent of the 340B program, putting state law at odds with federal law and violating the Supremacy Clause of the U.S. Constitution. Plus, the lawsuit alleges, SB69 violates the Contracts Clause of the Constitution because it interferes with agreements between drug manufacturers and the U.S. Department of Health and Human Services, as well as the Constitution's Takings Clause, which protects private property from being seized for public use, since SB69 requires AstraZeneca to transfer its private property (prescription drugs) to entities covered under 340B. SUPPORT: YOU MAKE OUR WORK POSSIBLE
