Latest news with #MedicareDrugPriceNegotiationProgram

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.


CBS News
12-05-2025
- Business
- CBS News
Trump ordering that the U.S. to pay only the price other nations do for some drugs
President Trump on Monday called on drugmakers to lower their prices within the next month to be closer to those charged in other high-income countries, threatening to subject them to steep caps on how much they can earn from Medicare if they fail to do so. "Starting today, the United States will no longer subsidize the healthcare of foreign countries, which is what we were doing, we're subsidizing others' healthcare, in countries where they pay a small fraction of what, for the same drug, that what we pay," the president told reporters Monday at the White House. Mr. Trump told reporters that "some prescription drug and pharmaceutical drug prices will be reduced almost immediately by 50% to 80% to 90%," and "big pharma will either abide by this principle voluntarily or we'll use the power of the federal government to ensure that we are paying the same price of other countries." The president said his move marks an expansion of the "most favored nation" idea from his first term, when the Centers for Medicare and Medicaid Services set steep price caps tied to the prices charged in other developed countries for how much it would pay for some prescription drugs. "It's called most favored nation," Mr. Trump said. "We are going to pay the lowest price there is in the world. We will get, whoever is paying the lowest price, that's the price that we're going to get." At the time, that proposal applied only to drugs given by providers in hospitals and clinics through Medicare Part B — not the broader swath of prescriptions that seniors fill at drug store pharmacies. Medicare said it would only pay hospitals and doctors for a price based on the lowest amount paid among developed countries. A report by the Trump administration during its first term found that the U.S. spends twice as much as some other countries on covering those drugs. Medicare Part B drug spending topped $33 billion in 2021. That idea was blocked by the courts during Mr. Trump's first term, after the administration shortcutted "rulemaking" steps to try to rush to implement the proposal in its final days. The Biden administration later formally abandoned the proposal and sought instead to curb drug costs through the Medicare Drug Price Negotiation Program created by Congress. Under the new version of Mr. Trump's "most favored nation" proposal, the White House says it will seek to develop new rules to revive the price caps in Medicare, in addition to a new "mechanism" to allow Americans to buy drugs directly from manufacturers at this price. Drug manufacturers that "fail to offer most-favored-nation pricing" voluntarily will have the prices imposed on them through new rules, which the White House says it is directing the Department of Health and Human Services to propose. Over the next month, CMS Administrator Dr. Mehmet Oz said the administration is planning to approach "pharmaceutical companies to talk specifically about what we want the most favored nation price to be, based on the best data we have." "We're looking forward to a thoughtful interaction with these corporate leaders, many of whom we've spoken to and in quite will agree, the system is not right the way it is," Oz said. It's not yet clear which drugs will be included in the president's push, although he mentioned the "fat shot drug" as potentially one of them. A CMS spokesperson was not able to immediately respond to a request for comment, asked about how the agency was determining which drugmakers to approach and what the pricing would be. White House officials said ahead of the announcement that they were looking for price reductions in drug costs across both federal and private health insurance, not just Medicare. No specific class of drugs is being targeted, they said, but they are planning to focus on drugs with the biggest disparity between U.S. and foreign prices. Americans pay significantly more than citizens of other countries do for many of the same pharmaceutical drugs. Experts have blamed it on a range of factors, including a complex web of insurers, middlemen and providers that underpin the U.S. healthcare system, unlike other countries, which set prices through government-run healthcare systems. The drug industry has opposed "most favored nation" pricing as a "deeply flawed proposal," calling it "importing socialized medicine" and claiming it could upend small and mid-size biotech companies in the U.S. "Applying other countries' antiquated approach to how they value – and pay – for medicines will stall investment across America's biotech companies, risk access to vital treatments and cures for millions of American patients, and lead to fewer American jobs," John F. Crowley, president of the Biotechnology Innovation Organization, said in a statement Monday. The pharmaceutical industry argued that Mr. Trump's 2020 attempt would give foreign governments the "upper hand" in deciding the value of medicines in the U.S. The industry has long argued that forcing lower prices will hurt profits, and ultimately affect innovation and its efforts to develop new medicines. and contributed to this report.
Yahoo
02-05-2025
- Health
- Yahoo
Opinion: An unfair penalty on life-saving pills
There are times when government interventions create unanticipated negative consequences. Such is the case with what has become known as the 'pill penalty' that resulted from the Biden administration's Inflation Reduction Act (IRA). The IRA imposed a system of price controls on certain medications commonly used by millions of American seniors through Medicare Part D through the Medicare Drug Price Negotiation Program. This program is hardly negotiation, but rather a set of targeted price controls. Congress, in legislating a price control scheme, created a disruptive division between types of drugs. The details are complicated, but the result is different treatment for two major types of drugs that has created growing market distortions and disparities. Most common prescriptions come in pill or capsule form. Generally, pills are less costly and easier for patients to take. That means they are more likely to be used consistently, a key factor in managing chronic diseases like diabetes. Medicines in pill or capsule form are called 'small molecule' drugs. 'Large molecule' drugs, or 'biologics,' often cost more. Many are administered by health workers in a clinical setting through infusions, or patients can self-administer injections. All these forms of administration are far less convenient for patients to take. Also, these drugs are often indicated for rare diseases or those that are more difficult to treat. The problem is that Congress subjected small molecule drugs to price controls four years sooner than large molecule drugs. That inequality is known as the 'pill penalty' and has led to a disparity in investment for research and development between the two drug classes. The pill penalty is already having a profound effect throughout the biomedical industry, including here in Utah. Investment in pill-form, 'small molecule' research and development (R&D) has dropped as much as 70%, as investment dollars shift to the more profitable 'large molecule' sector, or 'biologics.' Since the passage of the IRA, dozens of research projects on the pill side have been scuttled as capital naturally migrates over to more profitable products. Not only will fewer 'small molecule' medicines be produced because of ill-conceived government action, those that exist now may not ever be fully developed. Over half of small molecule drugs that have been approved in decades past have later been cleared by the FDA for additional uses, such as treating other maladies or for pediatric use. Post-approval research is key for developing new uses and/or improving formulations. Without further research and testing, those additional benefits will be lost. The good news is that Congress can help reverse these unforeseen negative consequences with a proposed bill that recently won the support of the White House. In an executive order, President Trump has called upon Congress to fix the pill penalty. It is vital to codify the proposed changes with congressional action. The Ensuring Pathways to Innovative Cures (EPIC) Act is now moving through Congress, hopefully on a bipartisan basis. The EPIC Act will do away with the pill penalty and put both small and large molecule medicines back on a level playing field. The fix is easy enough — others can debate the wisdom of government price controls, but if we must have them, it only makes sense to treat small and large molecule drugs equally. That will fix the bias against typically lower cost pill-form medicines and restore investment dollars to their development. We at Bio-Utah are grateful to Sen. John Curtis for becoming a co-sponsor of the EPIC Act. We also invite other members of Utah's federal delegation to join Sen. Curtis in supporting the EPIC Act, including as co-sponsors if possible. The problems that emerged from the IRA have created unintended harms for the pharmaceutical industry. The EPIC Act is a great way to resolve one of those harms.


Associated Press
17-04-2025
- Health
- Associated Press
NASP Applauds President Trump for Efforts to Reduce Drug Pricing and Address Necessary PBM Reforms
Washington, DC, April 17, 2025 (GLOBE NEWSWIRE) -- President Trump issued an Executive Order titled Lowering Drug Prices by Once Again Putting Americans First on Tuesday, April 15. The Executive Order called for the Administration and Congress to continue efforts from the first Trump Administration to reduce prescription drug costs. Included in the Executive Order is a plan to address the Medicare Drug Price Negotiation Program, including improvements in the transparency of the program and reducing negative impacts to the pharmaceutical industry. The Executive Order also calls for a review of the role of Pharmacy Benefit Managers (PBMs). 'NASP is appreciative of President Trump's continued effort to reduce the drug costs of American seniors. NASP encourages the Trump Administration to ensure that implementation of the Drug Price Negotiation Program does not cause harm to specialty pharmacies who serve some of the sickest Americans.' NASP President and CEO Sheila Arquette, RPh stated. 'Specifically, we encourage the Trump Administration to ensure that specialty pharmacies are not left holding the bag as they seek to support patients. Pharmacies must be paid in a timely manner for drugs they dispense through the drug price negotiation program, and must not be reimbursed below the cost to dispense.' 'NASP appreciates the White House's want to address the anticompetitive practices of some PBMs. For far too long, specialty pharmacies have faced practices by some PBMs that make it impossible for specialty pharmacies to participate in networks, eliminating patient access to the specialty pharmacy of their choice. We have long been advocating for the passage of federal legislation to address these concerns. We call on the Trump Administration to ensure reform occurs through executive action, regulation or via legislation this year. 'NASP wants to also emphasize the importance of the 340B program in supporting low-income medication access for those with specialty conditions and funding chronic disease management programs. We caution against any reforms that would negatively impact the program, participating pharmacies and the patients served.' ### NASP represents all specialty pharmacy industry stakeholders. Specialty pharmacies serve communities of patients who have complex health conditions like cancer, rheumatoid arthritis, multiple sclerosis, cystic fibrosis, hemophilia, organ transplantation and rare diseases. Specialty pharmacies are accredited by an independent, third party nationally recognized accreditation organization ensuring consistent quality of extensive drug management and clinical patient care services. Sheila M. Arquette, RPh National Association of Specialty Pharmacy (NASP) (703) 842-0122 [email protected]