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Medicare Enrolled will see Lower Costs on Select Drugs in 2026

Published in Blackstone Valley Call & Times on December 2, 2025

With Medicare Open Enrollment ending next week, the Centers for Medicare & Medicaid Services (CMS) has announced that last year’s Medicare negotiations produced a net savings of 44%—about $12 billion—on 15 widely used prescription drugs that treat cancer and other serious chronic conditions.

The new Maximum Fair Prices (MFPs) for these 15 drugs will take effect on January 1, 2027. Combined with the 10 drugs already negotiated—whose MFPs take effect January 1, 2026—a total of 25 drugs will have negotiated lower prices. These medications, used to treat conditions such as cancer, diabetes, asthma, and cardiovascular and neurological disorders, represent some of the highest Medicare Part D spending.

The Beginning of Drug Price Negotiations

Three years ago, after President Biden signed the Inflation Reduction Act (IRA) in August 2022, CMS began developing the process for Medicare’s first-ever drug price negotiations. On March 15, 2023, the federal agency issued its initial program guidance and received more than 7,500 public comments from consumer groups, patient advocates, drug manufacturers, and pharmacies. Revised guidance followed on June 30, 2023.

On August 29, 2023, CMS released the first list of 10 high-cost drugs selected for negotiation—marking the first time in Medicare’s history that it could negotiate directly with pharmaceutical companies.

Pharmaceutical industry groups and several companies attempted to block the law in court. In response, 70 organizations and 150,000 petition signers urged Merck, Bristol Myers Squibb, Janssen Pharmaceuticals, Astellas Pharma US, the Pharmaceutical Research and Manufacturers of America (PhRMA), and the U.S. Chamber of Commerce to drop their lawsuits. Multiple organizations also filed amicus briefs supporting the law.

Three years in process, and with courts ultimately allowing the program to proceed, that first round of 10 drugs with negotiated prices will take effect in 2026.

CMS Drug Negotiations Added 15 Drugs

On January 17th, CMS announced it had selected 15 additional drugs for the second cycle of negotiations under Medicare Part D and on November 25th, it was announced that agreements had been reached on all of them. These medications are among the most costly and most commonly used by Medicare beneficiaries, treating conditions such as cancer, diabetes, and asthma. The new round of negotiations is expected to save Medicare billions and strengthen the program’s long-term sustainability.

“This year’s results stand in stark contrast to last year’s,” said CMS Administrator Mehmet Oz, MD, in announcing the second cycle of negotiations.  “Using the same process with a bolder direction, we have achieved substantially better outcomes for taxpayers and seniors in the Medicare Part D program — not the modest or even counterproductive ‘deals’ we saw before.”

“Whether through the Inflation Reduction Act or President Trump’s Most Favored Nation policy, this is what serious, fair, and disciplined negotiation looks like,” adds CMS Deputy Administrator and Medicare Director Chris Klomp. “I’m deeply proud of our team, who execute exceptionally well to bring affordability to the country in everything we do.”

Between January 1 and December 31, 2024, approximately 5.3 million Medicare Part D enrollees used one or more of these 15 drugs. Total gross Part D spending for them was $42.5 billion, representing about 15% of all Part D drug costs.

Anthony Wright, executive director of Families USA, praised the newly released negotiated prices, stating that they show what is possible when “policymakers put patients before corporate profits.” Wright emphasized that these reductions build on the work of establishing the Drug Price Negotiation Program, which aims to provide financial relief to older adults and people with disabilities.

Wright noted that the first and second rounds of negotiated drugs together account for about one-third of Medicare Part D spending, with price reductions ranging from 38% to 85%. In 2027, beneficiaries using these drugs are projected to save $685 million in out-of-pocket costs. He added that the savings support both individual beneficiaries and the long-term sustainability of the Medicare program.

Despite pharmaceutical companies’ continued attempts to limit the program—through lawsuits and legislative provisions such as those in H.R. 1—Wright said the negotiation program remains “the most effective tool currently available to lower drug prices.”

“The Medicare Negotiation Program changed the trajectory of drug pricing in the United States, helping to reduce Big Pharma’s monopoly pricing power, which dictated prices to Americans on Medicare for two decades,” said Merith Basey, executive director of Patients for Affordable Drugs in a statement. “This second round of negotiations — now under President Trump — marks another major milestone, delivering continued savings for patients and taxpayers,” he said.

“The lower negotiated prices are more than numbers on a page. For patients who’ve been forced to work multiple jobs, cut pills in half, or choose between filling a prescription and buying groceries, these lower prices will bring long-overdue relief, flexibility, and stability,” added Basey.

“The requirement that Medicare negotiate lower prices for prescription drugs continues to pay dividends for older Americans and taxpayers,” adds Richard Fiesta, executive director of the Alliance for Retired Americans. “The announcement of lower drug prices for 15 high-priced drugs is a win for more than 5 million seniors who take these drugs to treat asthma, diabetes, lung disease and other serious conditions, and will soon pay less for their medications,” he says.

“The 4.4 million members of the Alliance are pleased that the Trump Administration has followed the law, negotiated these prices, and defended this law in court,” Fiesta says, calling on Congress to increase the number of drugs subject to price negotiations.

While the White House along with aging groups praise the impact of IRA’s Medicare drug negotiation provisions, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued a statement calling it “flawed.”

“Whether it is the IRA or MFN, government price setting for medicines is the wrong policy for America. Price setting does nothing to rein in PBMs who decide which medicines are covered and what patients pay. In fact, many patients are facing additional coverage barriers and paying more out-of-pocket for medicines because of the IRA, warns Alex Schriver, Senior Vice President of Public Affairs.

“These flawed policies also threaten future medical innovation by siphoning $300 billion from biopharmaceutical research, undermining the American economy and our ability to compete globally,” states Schriver, noting that PhRMA members are stepping up to make medicines more affordable by enabling direct purchase at lower prices and investing in U.S. manufacturing and infrastructure.

Lower Drug Cost Legislation Introduced

Congressman John B. Larson (D-CT), a senior member of the House Ways and Means Committee, praised the latest CMS announcement, estimating that both negotiation rounds will save older Americans more than $2 billion per year in out-of-pocket costs. Larson noted that families and seniors continue to struggle with rising prices, especially for prescription drugs.  The lawmaker pushed to enable Medicare to negotiate drug prices to lower drug costs by the enactment of IRA.

Last week, House Democrats introduced the Lower Drug Costs for American Families Act, aimed at closing loopholes in H.R. 1 and further reducing prescription drug prices. The bill (H.R. 6166), introduced November 20 by Ranking Members Frank Pallone Jr. (Energy and Commerce), Richard Neal (Ways and Means), and Bobby Scott (Education and Workforce), has been referred to all three committees.

Key provisions of the bill would:

  • Extend Medicare’s price negotiation authority to all Americans with private insurance—covering more than 164 million people with employer-sponsored plans and over 24 million enrolled in Affordable Care Act plans
  • Apply inflation-based rebate protections to private insurance markets, potentially saving $40 billion over 10 years
  • Increase the number of negotiated drugs from 20 to 50 per year
  • Extend the $2,000 annual out-of-pocket prescription drug cap to privately insured patients
  • Cap insulin costs at $35 per month for those with private insurance
  • Close the orphan-drug loophole that allows companies to avoid negotiation
  • Require consideration of international drug prices to ensure Americans do not pay three to five times more than patients in other countries

Continue the Momentum

According to CMS, the agency will announce the specifics on 15 drugs for the third round of Medicare price negotiations by February 1, 2026. This new round will include drugs paid under Medicare Part B for the first time and will begin with negotiated prices effective January 1, 2028. CMS has already released final guidance for the program and will also use this process to select drugs for renegotiation in previous cycles. IRA also establishes an ongoing process where more drugs will be selected for negotiation in subsequent years.

A Dec. 2024 AARP survey found that almost 3 in 5 adults age 50 and older expressed concern about their ability to afford prescriptions over the near future.  Respondents included both Medicare beneficiaries and younger persons. About 96 percent of the respondents call on the government to do more to lower pharmaceutical prices.

AARP noted that this survey was taken right before a new $2,000 cap on out-of-pocket drug expenses took effect in 2025.

With the announcement of lower drug costs that result from Medicare’s round 2 drug negotiations, there is an  opportunity to build on this momentum for real change. Lawmakers can legislate to put the public’s health above profit by giving consumers more power to negotiate, making competition stronger, and keeping patients from having to pay too much out of pocket.

It is now time for Congress to act.

Federal Court denies attempt to stop Medicare drug negotiation program

Published in RINewsToday on November 6, 2023

Over two months ago, as supporters of President Biden’s Inflation Reduction Act (IRA) celebrated the one-year anniversary of the passage of the historic legislation, the U.S. Chamber of Commerce, Pharmaceutical Research and Manufacturers of America (PhRMA), along with drugmakers filed multiple lawsuits to block the IRA’s drug price negotiation provisions.  The drug price negotiation program, created by IRA, allows Medicare to use its bargaining power to negotiate the prices of ten prescription drugs for the first time.

The multiple-filed legal suits came weeks before Sept. 1 when the for Centers Medicare & Medicaid Services (CMS) was scheduled to publish a list of the first 10 drugs that would be subjected to negotiations.  These lawsuits argued that the federal price negotiation program was unconstitutional because it violated the First and Fifth Amendments of the U.S. Constitution, as well as the separation of powers clause, by giving the U.S. Department of Health and Human Services (HHS) discretion over a maximum fair price for any given drug selected for negotiation.  These lawsuits also charge that CMS price controls would force drug makers to pull back on developing new drugs, jeopardizing medical breakthroughs for individuals with life-threatening and chronic illnesses. 

Among the nine lawsuits scheduled to go to trial, one was a motion filed on July 12, 2023 by the Chamber and several of its affiliates in Ohio. This motion requested the court to issue a preliminary injunction to halt the Medicare drug negotiation program from implementation. The ruling came before the Oct. 1, 2023 deadline requiring drugmakers whose pharmaceuticals were selected for negotiations to either sign agreements to participate or to face stiff penalties.  

The U.S. Department of Justice opposed the Chamber’s motion, filing a motion to dismiss its case.  On Sept. 15, 2023, the court held oral arguments giving the  Chamber and the DOJ an opportunity to present their legal arguments in greater detail.  

Overcoming a Major Legal Hurdle 

On Friday, September 29, 2023, U.S. District Judge Michael J. Newman for Southern District of Ohio, denied the Chambers request to block implementation of the newly established Medicare drug price negotiation program before the drug price negotiation talks began.  The ruling called on the Chamber to file an amended complaint by Oct. 13, 2023. DOJ would then have until Oct. 27, 2023 to renew its motion to dismiss.

According to Spencer Kimball of CNBC, legal experts say the pharmaceutical industry hopes to see conflicting rules from lawsuits filed in other federal appellate courts to bring this issue to the Supreme Court for final resolution. 

The Willimantic, Connecticut-based Center for Medicare Advocacy (CMA), a nonprofit group pushing for comprehensive Medicare coverage, health equity and quality of health care for seniors and people with disabilities, is encouraged by Judge Newman’s ruling, which assessed the drug manufacturer’s claims “to be weak in the face of clearly established laws.”

According to CMA, the 28-page court order found that the Chamber and other plaintiffs had demonstrated neither likelihood of success on the merits, nor irreparable harm, which are required for a preliminary injunction.  CMS noted that this case cited “clear” law that “participation in Medicare, no matter how vital it may be to a business model, is a completely voluntary choice.” The court also found that the price established by negotiations cannot be considered ‘confiscatory,’ as the Chamber charges or “a violation of due process, because drug manufacturers can opt out of Medicare entirely.”

Newman’s ruling noted that drugmakers are not compelled to sell drugs at the prices established by the Medicare program and that any economic harm, when the negotiated drug prices take effect in 2026, was too speculative to warrant immediate relief, reported CMS.  However, the court did deny the government’s motion to dismiss the lawsuit entirely, saying that more information on whether the plaintiffs have standing to sue would be beneficial and therefore the judge is allowing for limited discovery to clarify issues related to legal standing, after which the government may renew its motion to dismiss, noted the Medicare advocacy group.

With this ruling, Medicare may move forward with its implementation of its drug negotiation program as this case and others continue to proceed. 

Giving their two cents…

At press time, the Chamber did not respond to a request for comment about the court’s ruling.  But health care and aging advocacy groups issued statements expressing their thoughts about the impact of Newman’s ruling. 

“This is the first major blow to Big Pharma in its legal battles to block the drug price negotiation provisions under the Inflation Reduction Act, says Peter Maybarduk, Public Citizen’s director of the Access to Medicines program.

“The Chamber’s lawsuit lacks merit; the court made the right decision not to grant the injunction, which would have caused needless patient suffering and treatment rationing, notes Maybarduk, calling on drugmakers “to drop their lawsuits and drop their prices.”

“Now, drug companies should agree to participate in the negotiation program in good faith. The program is an important first step in ending the exorbitant prices charged to Medicare enrollees,” adds Maybarduk.

Frederick Isasi, Executive Director of Families USA, happily noted that the Medicare drug negotiation program continues, calling the ruling “a big win for seniors and their ability to purchase life-saving medications. The ability to afford medication is a matter of life and death for millions of older adults. That’s why we are fighting this David and Goliath battle – people deserve to pay a fair price for their drugs and Medicare price negotiation is a critical piece of this puzzle. And let’s not forget each drug subject to fair price negotiation is an old drug that millions of people need and doesn’t have competition,” he notes.

“It never ceases to amaze us that – on one hand – Big Pharma can cry poverty by saying that drug negotiations will hurt their bottom line, while recent earnings reports show they are raking in money hand over fist.  We are glad Judge Michael J. Newman, a Trump appointee in Ohio’s Southern District, saw through this hypocrisy by affirming the Biden administration’s power to begin negotiating the prices of 10 medications with drugmakers,” says Dan Adcock, Director of Government Relations and Policy, of the Washington, DC-based National Committee to Preserve Social Security and Medicare. (NCPSSM).

According to NCPSSM, Drug makers made a whopping $493 billion in revenue from ten drugs that are now subject to price negotiations between CMS and the manufacturer, which have accounted for more than $170 billion in gross Medicare spending, according to a report from the nonprofit, Protect Our Care.

“The court’s decision to allow Medicare drug price negotiations to move forward is welcome news, says William Alvarado Rivera, Senior Vice President for Litigation at AARP Foundation. “Pausing Medicare negotiations would have risked billions of dollars in savings for taxpayers – and countless lives. It is unconscionable that Americans face such high prescription drug costs that many people skip taking medication altogether or must ration it,” he said.

“We’re prepared to fight for as long as necessary to ensure big drug companies can’t charge excessive prices at the expense of patients’ health, says Rivera, noting that the new Medicare negotiation law would bring financial and medical relief to millions of older Americans and their families, and put drugs that treat life-threatening and chronic conditions, from cancer to heart disease, within their reach. Rivera says, “It must not be derailed.” 

Congress has put the breaks to the spiraling costs of pharmaceuticals by giving Medicare the authority to negotiate the price of popular drugs with drug makers.  America’s seniors will continue to suffer financial  hardships and many might even lose their lives by not choosing not to take their costly medications if courts rule in favor of drug companies.  Time will tell.   

U.S. Judge Michael J. Newman ruling denying the U.S. Chamber of Commerce’s request for a preliminary injunction, go to https://www.bloomberglaw.com/public/desktop/document/DaytonAreaChamberofCommerceetalvBecerraetalDocketNo323cv00156SDOh/5?doc_id=X3U600KOGG69QHQBPEU24OS1JMO

A listing of drugmaker revenues of the first ten negotiated drugs, go to https://www.protectourcare.org/by-the-numbers-the-ten-costly-drugs-that-are-now-eligible-to-have-lower-prices-negotiated-by-medicare/

Medicare to negotiate select drug prices with Big Pharma, lists first 10 drugs

Published in RINewsToday on September 4, 2023

While critics are attempting to go through the courts to put the brakes on allowing Medicare to negotiate and set drug prices, last week, the Biden administration announced its list of 10 drugs that will be subject to price negotiations mandated by the Inflation Reduction Act (IRA).  

Earlier this month, more than 70 groups and a petition signed by 150,000 individuals called on Merck & Co., Bristol Myers Squibb Company, Janssen Pharmaceuticals, Astellas Pharma US, Pharmaceutical Research and Manufacturers of America (PhRMA) and the U.S. Chamber of Commerce, to drop their lawsuits to block the drug price negotiation provisions from taking place, and several organizations filed an amicus brief in support of the Biden administration’s historic law. 

With President Biden signing the IRA into law in Aug. 2022, the Centers for Medicare and Medicaid Services (CMS) began hammering out the regulations by issuing on March 15, 2023 its initial guidance for its Medicare Drug Price Negotiation Program. At that time, CMS had received over 7,500 comments on its initial guidance from consumer and patient groups, drug companies and pharmacies.  On June 30, 2023, the federal agency released its revised guidance detailing the requirements and parameters for the program. With the publishing of the listing of 10 drugs on August 29, 2023, for the first time, Medicare is now able to move forward in negotiating prices directly with drug companies, with the goal of lowering prices on some of the costliest prescription drugs. 

According to CMS, the selected 10 drugs accounted for $50.5 billion in total Part D gross covered prescription drug costs, or about 20%, of total Part D gross covered prescription drug costs between June 1, 2022, and May 31, 2023, which is the time period used to determine which drugs were eligible for negotiation. The negotiations with participating drug companies begin now until 2024, and any negotiated prices will become effective beginning in 2026. Medicare beneficiaries taking the 10 drugs covered under Part D selected for negotiation paid a total of $3.4 billion in out-of-pocket costs in 2022 for these drugs.

It’s a Long Wait…Lower Prices to Take Effect Jan. 2026

CMS will publish any agreed-upon negotiated prices for the selected drugs by September 1, 2024; those prices will come into effect starting January 1, 2026. In future years, CMS will select for negotiation up to 15 more drugs covered under Part D for 2027, up to 15 more drugs for 2028 (including drugs covered under Part B and Part D), and up to 20 more drugs for each year after that, as outlined in the IRA.  CMS will provide opportunities for public comment at patient-focused listening sessions in Fall 2023.

“For far too long, pharmaceutical companies have made record profits while American families were saddled with record prices and unable to afford life-saving prescription drugs,” says Secretary Xavier Becerra, of the U.S. Department of Health and Human Services (HHS). “Although drug companies are attempting to block Medicare from being able to negotiate for better drug prices, we will not be deterred,” she pledges. 

With the announcement of the first drugs selected for Medicare drug price negotiation, CMS Administrator Chiquita Brooks-LaSure noted it marked a significant and historic moment for the Medicare program. ”Our goal with these negotiations is to improve access to some of the costliest drugs for millions of people with Medicare while driving competition and innovation,” she said.

Adds Meena Seshamani, MD, PhD, CMS’s Deputy Administrator and Director of the Center for Medicare, “Promoting transparency and engagement continue to be at the core of how we are implementing the new drug law and the Medicare Drug Price Negotiation Program, and that is why we set out a process for the first round of negotiation that engages the public throughout.” 

“No one should have to choose between paying for lifesaving medication and other basic necessities, like food and housing,” says Rep. Seth Magaziner, representing Rhode Island’s Congressional District 2.  Nearly 191,000 Rhode Islanders are enrolled in Medicare Part D and could be eligible for cost savings that results from CMS’s negotiating with drug makers, he says, noting that.  Rhode Island seniors paid an average of $6,022 in out-of-pocket costs per year for one of the drugs selected for Medicare Price Negotiations.  These drugs are used to treat some of the most common diseases like diabetes, heart disease, arthritis, blood clots, and cancers.   

But PhRMA and U.S. Chamber of Commerce express strong concerns over imposing government price controls on the price of medications.  

CMS’s release of 10 drugs selected for negotiation “is the result of a rushed process focused on short-term political gain rather than what is best for patients,” says PhRMA) President and CEO Stephen J. Ubl. “Many of the medicines selected for price setting already have significant rebates and discounts due to the robust private market negotiation that occurs in the Part D program today,” he claims.

“Giving a single government agency the power to arbitrarily set the price of medicines with little accountability, oversight or input from patients and their doctors will have significant negative consequences long after this administration is gone,” warns Ubl.

Furthermore, “insurance companies and their Pharmacy Benefit Managers may further restrict access to medicines through increased utilization management, higher copays and more restrictive formularies, notes Ubl.

USCoC also expresses strong concerns over HHS’s move to impose government price controls on medications. While USCoC is supportive of affordable medications, it warns that an implementing government price controls scheme is both “counterproductive and will restrict access to critical medicines, delay treatment for patients, and jeopardize the search for new lifesaving cures,” says Executive Vice President and Chief Policy Officer Neil Bradley. 

“In its rush to implement the IRA’s price control scheme, the Biden administration failed to examine the likely negative side effects of the policy, charges Bradley.

Celebrating a Sweet Victory

“The negotiated drugs list is a watershed moment for medicine affordability. Drug corporations pretend this is a catastrophe, but I would rather see that money in seniors’ pockets than Big Pharma’s,”  says Peter Maybarduk, director of the Access to Medicines program at Public Citizen

“Drug corporations, in crude arrogance, are suing to limit price negotiations under the IRA. But the list shows instead how important it is to expand those negotiation powers. Several monopolized drugs that are expensive for Medicare today are exempted from price negotiation, and will remain expensive,” predicts Maybarduk, explaining that for a many-years long grace period after a drug first comes to market. “During those years, drug makers will exploit patent monopolies with minimal checks on profiteering. That profiteering period is even longer for biologics, which comprise some of the most exorbitantly priced drugs,” he says. 

“This is an historic day in the effort to lower prescription drug prices for seniors.  The Biden administration has released the names of the 10 life-saving drugs that will be subject — for the first time ever — to price negotiation between Medicare and Big Pharma,” stated Max Richtman, President and CEO, National Committee to Preserve Social Security and Medicare.

According to Richtman, the Inflation Reduction Act provides for this reform, in addition to a $2,000 out-of-pocket cap for patients’ Medicare Part D drug costs and penalties for drug-makers who hike prices above the rate of inflation. Medicare price negotiation alone is expected to save seniors and taxpayers billions of dollars in drug costs over next the decade.

“This is a sea change in the government’s ability to lower prescription drug prices for older Americans, who all too often are compelled to ration medications or forgo filling prescriptions because of soaring costs. NCPSSM has fought for Medicare to be empowered to negotiate prices for some twenty years now,” adds Richtman., noting that the next step is to enlarge the number and type of medications subject to negotiation, to deliver maximum relief to seniors on fixed incomes.   

“Allowing Medicare to negotiate prices for these first 10 drugs will finally bring much needed access and relief to American families, particularly older adults. We cannot overstate how monumental this law is for older Americans’ financial stability and overall health, said AARP Executive Vice President and Chief Advocacy and Engagement Officer Nancy LeaMond. 

“The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore. AARP will keep fighting to protect Medicare negotiation from any efforts to undo or weaken it, so all older Americans can afford their lifesaving medicines,” Says LeaMond.

And Alex Lawson, Executive Director of Social Security Works, says CMS’s listing of 10 drugs are among the most outrageously priced drugs on the market, calling these drugs, “Pharma’s prized cash cows.”

“This is just the beginning,” says Lawson, predicting that within a decade, Medicare will have the power to negotiate lower prices on well over 100 drugs. “That’s a huge win for seniors and people with disabilities,” she adds, noting that it is the biggest legislative defeat Big Pharma has ever suffered – and it won’t be the last.

Final Note…

Vincent Marzullo, who serves on the Board of the Senior Agenda Coalition of RI as well as a member of Congressman Magaziner’s Senior Advisory Committee, says that despite CMS’s  announcement of the 10 drugs to be negotiated, consumers won’t realize a penny in savings until January 2026, 28 months from now. “Unfortunately, urgency seems not to be a feature of the Inflation Reduction Act at least when we will get lower priced prescriptions,” he says.

View a fact sheet from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) at: https://aspe.hhs.gov/sites/default/files/documents/705b9c384d493e442a1d4004905cf8ae/ASPE-IRA-Drug-Negotiation-Fact-Sheet.pdf.

More information on the Medicare Drug Price Negotiation Program is available at https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation.