Latest news with #PublicHealthServiceAct
Time of India
a day ago
- Health
- Time of India
US Senate confirms Trump nominee Susan Monarez as CDC director
Washington: The U.S. Senate voted on Tuesday night 51-47 along party lines to confirm President Donald Trump's nominee, Susan Monarez , as director of the Centers for Disease Control and Prevention, charged with leading the response to threats against public health. Monarez, a career public health official who served as acting director of the CDC until her nomination, will report to Secretary of Health and Human Services Robert F. Kennedy Jr. , who has long questioned the safety of vaccines, contrary to scientific evidence, including suggesting a link between them and autism. The first CDC director to require Senate confirmation following amendments to the Public Health Service Act, Monarez sought to distance herself somewhat from some of Kennedy's views during her confirmation hearing last month, while also praising his leadership on multiple occasions. She told a Senate committee last month that she had not seen evidence linking vaccines and autism, and promised to prioritize vaccine availability if confirmed. Monarez, the first CDC director without a medical degree since 1953, holds a PhD from the University of Wisconsin-Madison. Her research focused on developing technologies to diagnose, treat and prevent infectious diseases. She is the Trump administration's second nominee for the role. In March, the president withdrew his nomination of former Republican congressman and vaccine critic Dave Weldon, a Kennedy ally, just hours before his scheduled confirmation hearing. The United States is facing a growing measles outbreak, with confirmed cases this month reaching the highest level since the disease was declared eliminated from the country in 2000. Monarez is expected to lead the response to the outbreak, and play a critical role in tackling the spread of bird flu. Monarez will lead a diminished agency, with the White House seeking to cut the CDC's budget by almost $3.6 billion, leaving it with a $4 billion budget, and Kennedy enacting a layoff plan that cut 2,400 employees, though some 700 were rehired. Kennedy has also made major decisions on vaccines in the absence of a CDC director. It is unclear if he will continue to do so. He fired all members of the CDC's vaccine expert panel, which recommends how vaccines are used and by whom, last month, and replaced them with hand-picked advisers including anti-vaccine activists. Kennedy also announced in May that the U.S. would stop recommending routine COVID vaccinations for pregnant women and healthy children, bypassing the CDC's traditional process.
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.
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
Yahoo
21-05-2025
- Health
- Yahoo
Dixon council inks agreement with OSF Saint Katharine that allows enrollment in drug discount program
May 20—DIXON — The Dixon City Council on Monday, May 19, approved an agreement with OSF HealthCare marking its commitment to providing care to low-income and uninsured patients. The memorandum of understanding is basically a formality because OSF Saint Katharine Medical Center, a non-profit and a Catholic health system, as part of its policy already provides care to all individuals regardless of their ability to pay. It's really intended to fulfill a prerequisite for the hospital to participate in a federal assistance program that provides drug discounts to hospitals and clinics that qualify, Dixon Mayor Glen Hughes said. The 340B Drug Discount Program, authorized under Section 340B of the Public Health Service Act, provides significant discounts on outpatient drugs for certain safety-net health care providers, primarily those that serve a higher number of low-income and uninsured patients, according to the Health Resources and Services Administration website. In Lee County, the median household income is about $68,459 a year compared to about $80,306 a year across Illinois. About 11.7% of people in Lee County are living in poverty, which is nearly equal to the estimated 11.6% statewide, according to the U.S. Census 2023 American Community Survey 5-Year Estimates data. That data also estimates that 3.6% of people in Lee County do not have health care coverage, which is less than the estimated 6.2% for all of Illinois. The agreement "does not create any substantive legal requirements on the part of the city," City Attorney Rob LeSage told the council, adding that the agreement doesn't impose any cost or liability requirements on the city. "We're just making that statement that we have an understanding with them and that we're supporting the fact that they are providing services to an above-average lower-income or Medicaid clientele," Hughes said. OSF Saint Katharine is "effectively doing these things already, and by memorializing this in this standard form of wave the magic wand, and now they are eligible to receive pharmaceuticals at a lower cost," LeSage said. "This agreement marks a significant milestone in our continuing efforts to improve healthcare access and affordability for the communities we serve," OSF Saint Katharine President Jackie Kernan said. "By participating in this program, we can extend our resources, making sure that our patients receive the medications they need at a lower cost. We thank the city of Dixon for their partnership and shared vision in making this initiative possible."
