Latest news with #MedicareDrugPriceNegotiationProgram
Epoch Times
09-08-2025
- Business
- Epoch Times
These Drug Prices Won't Soon Go Down—Here's Why
Pharmaceutical companies can continue to charge the federal government—and Medicare beneficiaries—full price for a handful of drugs that might have seen price reductions as soon as next year. That's because Congress changed the law to outright exempt or delay consideration of more than 300 medications for the Medicare Drug Price Negotiation Program.
The Hill
07-08-2025
- Business
- The Hill
Two more cases challenging Medicare negotiation rejected in federal courts
Federal judges in Texas and Connecticut on Thursday ruled against arguments challenging the constitutionality of the Medicare Drug Price Negotiation Program, delivering two more blows to the pharmaceutical industry this week after an appeals court upheld the dismissal of a similar case. In Connecticut, the U.S. Second Circuit Court of Appeals upheld a decision granted by U.S. District Judge Michael P. Shea last year against pharmaceutical company Boehringer Ingelheim. The company's diabetes medication Jardiance was among the first 10 drugs chosen for Medicare negotiations and two more of its products were chosen for the following round of negotiations. In his 2024 ruling, Shea found that Boehringer Ingelheim could not demonstrate irreparable harm as a result of Medicare negotiations and also agreed with the federal government that the program did not violate laws such as the Medicare Act or the Administrative Procedures Act. Boehringer Ingelheim had also argued Medicare negotiations violated its First and Fifth Amendment rights. In its ruling on Thursday, the Second District Court of Appeals concurred with Shea's ruling, finding that the company's claims of unconstitutionality were not proven in their argument. 'Participation in the Negotiation Program is voluntary and thus does not entail an unlawful deprivation of rights,' the judgment stated. 'The program does not impose unconstitutional conditions on Boehringer's ability to participate in Medicare and Medicaid because the program is designed to promote the legitimate government purpose of controlling Medicare spending and does not regulate the company's conduct in the private market.' The Hill has reached out to Boehringer Ingelheim for comment. In Texas, Senior U.S. District Judge David Alan Ezra dismissed the lawsuit brought forward by the trade group PhRMA with prejudice, closing the case. As in Connecticut and other cases challenging Medicare negotiations, Ezra noted that drugmaker participation in Medicare is entirely voluntary. Ezra stated that because of the voluntary participation, drugmakers do not have a protected interest to sell drugs to Medicare at their preferred 'fair market value.' He similarly found that the plaintiffs had failed to demonstrate that they will suffer irreparable harm due to negotiating drug prices and was unconvinced of claims that the program violated the plaintiffs' Fifth and Eighth Amendment rights. 'In sum, Plaintiffs cannot demonstrate that the Program deprives them of a protected interest and therefore their Due Process Clause claim fails as a matter of law,' wrote Ezra, granting the federal government's request for summary judgment. The Hill has requested comment from PhRMA. These decisions come just one day after a federal judge upheld a ruling to dismiss a similar challenge to Medicare negotiations brought forward by the U.S. Chamber of Commerce. The courts found that several of the plaintiffs attached to the case lacked standing to sue. Merith Basey, executive director of the advocacy group Patients For Affordable Drugs, lauded the rulings in a statement Thursday. 'Once again, a drug company brought its high-priced lawyers to lay out its arguments against Medicare negotiation, and once again they have lost. This ruling against Boehringer Ingelheim marks the fifth consecutive legal victory for patients who have long awaited relief from Big Pharma's monopoly control over drug prices,' said Basey. 'It's truly US v Big Pharma. Patients For Affordable Drugs stands firm in our commitment to defending the hard-won Medicare negotiation program against Big Pharma's relentless attempts to undermine it at the expense of patients,' she added.
The Hill
06-08-2025
- Business
- The Hill
Appeals court upholds dismissal of US Chamber challenge to Medicare negotiation
The U.S. Sixth Circuit Court of Appeals on Wednesday upheld a lower court's ruling to dismiss a challenge to the Medicare Drug Price Negotiation Program brought by the U.S. Chamber of Commerce, finding once again that the parties involved did not have standing to sue. Almost exactly one year ago, a federal judge dismissed the Chamber's lawsuit challenging the Medicare negotiation program established through the Inflation Reduction Act. The judge found that the other plaintiffs included in the suit — the Dayton Area Chamber of Commerce, the Ohio Chamber of Commerce and the Michigan Chamber of Commerce — lacked standing to sue on behalf of their members, though it said the U.S. Chamber had standing on its own if it filed a new suit in a new venue. The appeals court largely agreed with the district court's ruling while also clarifying some points that were made. While the court agreed that the Dayton Area Chamber of Commerce's interests are not relevant to the case, it made clear that national organizations are not the only entities that can sue over federal laws that can impact U.S. states and regions. The district court last year had also found that the pharmaceutical companies AbbVie and its subsidiary Pharmacyclics had no direct connections to the business climate of Dayton, Ohio for the chamber to sue on its behalf. But the appeals court clarified that businesses often have interests in places where they aren't headquartered, so a lack of such geographic ties should not be considered 'fatal' to establishing standing. In this case, however, the lack of headquarters combined with a 'lack of any direct connection between the Dayton Chamber's purpose' was enough to disprove associational standing for both entities. Finding again that the Dayton Chamber and the Ohio Chamber lacked standing to sue, the appeals court found that the district court 'did not err' in its initial ruling. 'And because Plaintiffs did not identify an appropriate venue outside of Ohio that the case could be transferred to if the Dayton Chamber and the Ohio Chamber lacked standing, the district court did not abuse its discretion in dismissing this case for lack of proper venue,' the appeals court found. Having lost at the appellate court level, the U.S. Chamber could choose to appeal the case to the Supreme Court. The Hill has reached out to the U.S. Chamber for comment. The advocacy group Patients For Affordable Drugs (P4AD) applauded the ruling. 'This decision marks the 10th court ruling in favor of patients and against the pharmaceutical industry's desperate legal attacks on the overwhelmingly popular Medicare Negotiation Program, which in January will deliver lower prices to more than 9 million patients across the nation,' P4AD Executive Director Merith Basey said in a statement. 'Pharma is spending millions in an attempt to protect its full monopoly pricing power at the expense of patients, but the courts keep rejecting the industry's arguments,' Basey added. 'By upholding the lower court's decision, the U.S. Court of Appeals is siding with American patients who deserve a much better deal against an industry that continues to try to hold them hostage.'
Associated Press
13-06-2025
- Business
- Associated Press
ASCP and NCPA Announce Joint Recommendations to Manufacturers to Effectuate Medicare's Maximum Fair Price (MFP)
ALEXANDRIA, VA / ACCESS Newswire / June 13, 2025 / The American Society of Consultant Pharmacists (ASCP) and the National Community Pharmacists Association (NCPA) have announced joint recommendations to pharmaceutical manufacturers aimed at helping to support pharmacies facing material cash flow concerns under Medicare's Drug Price Negotiation Program (MDPNP). The two organizations, both of which represent pharmacists committed to high-quality care for all patients including Medicare beneficiaries, expressed concerns about the impact of the MFP, which is part of the Medicare Drug Price Negotiation Program (MDPNP). This was included in the Inflation Reduction Act of 2022 and enables Medicare to directly negotiate the prices of certain single-source medications without generic or biosimilar competition. CMS selected 10 drugs for an initial round of negotiations in 2023. These included medications for diabetes, heart failure, and peripheral artery disease. These negotiated prices, the highest that a Medicare Part D beneficiary or plan sponsor will have to pay for targeted medications, are slated to go into effect on January 1, 2026. While ASCP and NCPA fully support ensuring fair medication prices for Medicare beneficiaries, an analysis conducted for NCPA found that under MFP, pharmacies may face manufacturer refund payment delays of more than 21 days, beyond the 14-day Medicare prompt pay standard. At the same time, pharmacies could lose nearly $11,000 in weekly cash flow and $43,000 annually. Over 93% of independent pharmacies surveyed by NCPA state they may not be able to stock some medications targeted for price reductions because of cash flow and reimbursement below cost; and most LTC pharmacies anticipate closures, staff layoffs, service reductions, and medications shortages stemming from the MDPNP. Pharmacists at greatest risk for these negative impacts include sole proprietors in rural and urban areas, pharmacies that heavily rely on prescription revenue, and long-term care pharmacies. To address these concerns, ASCP and NCPA made several key recommendations to manufacturers, including the following: 'Most independent pharmacies and long-term care pharmacies care for populations that are heavily dependent on Medicare. It's critical that they are compensated in a fair and timely manner. Otherwise, they will face massive cash-flow problems and not be able to provide prescription services to their Medicare patients. A recent NCPA survey found that 93 percent of independent pharmacists would consider opting out of the program unless those concerns are addressed. That would be a disaster for Medicare beneficiaries and the program itself,' said Doug Hoey, NCPA's CEO. 'The IRA presents unprecedented threats to long-term care pharmacy as well as new opportunities to build a constructive, transactional relationship between pharmacists and manufacturers,' said Chad Worz. 'In developing and presenting these recommendations, we are hoping to send a fair and equitable framework that rekindles the historical partnership between pharmaceutical manufacturers and pharmacies. This, first and foremost, benefits patients while also protecting the sustainability of pharmacies and innovators. We look forward to continuing our constructive conversations with impacted manufacturers.' ASCP and NCPA urge manufacturers to incorporate these recommendations into their MFP effectuation plans by September 1, 2025, ensuring pharmacies remain viable and patients retain access to essential medications. About ASCP: The American Society of Consultant Pharmacists (ASCP) is the only international professional society devoted to optimal medication management and improved health outcomes for all older persons. ASCP's members manage and improve drug therapy and improve the quality of life of geriatric patients and other individuals residing in a variety of environments, including nursing facilities, sub-acute care and assisted living facilities, psychiatric hospitals, hospice programs, and home and community-based care. About NCPA: Founded in 1898, the National Community Pharmacists Association is the voice for the community pharmacist, representing over 18,900 pharmacies that employ more than 205,000 individuals nationwide. Community pharmacies are rooted in the communities where they are located and are among America's most accessible health care providers. Contact Information Melissa Blacketer Senior Director of Communications [email protected] 703-739.1311 SOURCE: ASCP press release
The Hill
01-06-2025
- Health
- The Hill
With his new prescription drug order, Trump fixes what Biden broke
Americans have been clamoring for sensible prescription drug reform for years. With the stroke of his pen, President Donald Trump answered that call. His executive order aims to bring down drug prices while 'once again putting Americans first.' Luckily, it specifically addresses one of the serious flaws in the Biden administration's Medicare Drug Price Negotiation Program — an oversight that has discouraged investment in affordable, widely used medications. This reform could deliver major savings to patients — without undermining the innovation that drives medical breakthroughs. Now it's up to Congress to finish the job. The reform in question addresses a flaw in the Medicare price-setting scheme put in place by the 2022 Inflation Reduction Act. That law gave the secretary of Health and Human Services sweeping new authority to impose price controls on certain drugs covered by Medicare. But it also drew an arbitrary line between different types of medicines by giving biologics, which are made from living organisms,13 years before price-setting kicks in, while small-molecule drugs, like pills and capsules, get just nine. That four-year gap makes no clinical or economic sense. Many of the most important drugs in history, from aspirin to statins to HIV treatments, are small-molecule medicines. Yet innovators are now steering investment away from them. According to a recent study, investment in small-molecule drugs has already dropped by 68 percent. And compared to pre-IRA levels, new small-molecule cancer drug development programs fell over 40 percent last year. President Trump's order calls for correcting this imbalance. The Republican-backed EPIC Act offers the clearest solution, aligning the treatment of small-molecule drugs with biologics by extending the price-setting window to 13 years. My hope is that this legislation will pass quickly with bipartisan support. Passing EPIC would protect innovation, preserve patient access and deliver on the president's promise to fix what the last administration got wrong. The order also directs the secretary of Labor to write new transparency rules to address some of the other significant issues affecting drug access and prices. That's a big win for patients and a critical step toward restoring fairness to the system and decreasing out-of-pocket costs for Americans. In addition to these transparency reforms, the order acknowledges the critical role of intellectual property rights in bringing new drugs to patients — and promises to optimize those protections in ways that improve access and lower drug costs. Patents and other intellectual property protections play a central role in pushing medical science forward. The previous administration's efforts to undermine these essential tools posed a direct threat to the foundations of America's innovation-driven economy. President Trump's unequivocal stance on this issue should come as welcome news to the nation's inventors and entrepreneurs — including those in the biotech sector. Equally encouraging is the executive order's treatment of the 340B Prescription Drug Program. The program was originally designed to help safety-net providers offer affordable medications to low-income patients. Yet today, less than 40 percent of hospitals that use the program are in underserved areas. During my time in Congress, I took up this issue — championing reforms to promote transparency, increase accountability and require participating hospitals to report patient's benefits. Now, emboldened by the White House, lawmakers should do the same. Altogether, this order is a blueprint for drug pricing reform that's patient-focused, pro-innovation and rooted in real-world solutions. Now, Congress can do its part, beginning with passing the EPIC Act. If they do, American patients could finally get the kind of affordable, innovative and equitable prescription drug sector they've long demanded. Larry Bucshon, MD, a cardiothoracic surgeon, served as the U.S. representative for Indiana's 8th District from 2011 to 2025.
