Former President Donald Trump on Aug. 30

Former President Donald Trump has boasted in recent months about “Right To Try,” a law he signed in 2018. It’s aimed at boosting terminally ill patients’ access to potentially lifesaving medications not yet approved by the Food and Drug Administration.

“We have things to fight off diseases that will not be approved for another five or six years that people that are very sick, terminally ill, should be able to use. But there was no mechanism for doing it,” Trump , speaking in Washington, D.C., to supporters of the conservative parental rights advocacy group Moms for Liberty.

He also said that because of Right To Try, “we have saved thousands and thousands of lives.”

Trump similarly praised the program during an in Pennsylvania, in a with a conservative commentator, and during his Republican National Convention : “Right To Try is a big deal,” Trump said then.

Medical experts who’ve studied the experimental treatment program, however, say there’s no evidence to support Trump’s claims. These experts say Right To Try weakened regulations intended to protect patients.

What Is Right To Try?

The , aka Right To Try, passed Congress on a bipartisan basis and was signed into law in 2018. It sought to streamline the process for getting potentially lifesaving drugs that weren’t yet FDA-approved to terminally ill patients. The speed matters; industry groups say it takes on average for a new medicine to reach pharmacy shelves.

However, a similar FDA program, the pipeline, sometimes called “compassionate use,” has existed , and became law in 1987.

And that is the root of many criticisms of Right To Try.

“Right To Try is basically ‘expanded access light,’” said Alison Bateman-House, a medical ethicist who researches access to investigational medical products at New York University’s Grossman School of Medicine.

Right To Try caters to fewer patients than expanded access and offers them fewer treatments, Bateman-House said.

Easing Access or Erasing Safeguards?

Patients must meet specific, but different, criteria to qualify for either experimental medication program.

To qualify for expanded use, patients must have a “serious or immediately life-threatening disease or condition” for which there is no “comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition,” according to . Clinical trials must be infeasible for the patients, and the use of these drugs must not interfere with any in-progress studies. Also, the potential benefits must justify the risks, according to the prescribing physicians.

Then, after identifying a treatment, the patient’s doctor must receive approval from its manufacturer, the FDA, and the institutional review board overseeing the medication’s clinical trials.

The FDA said these steps exist so the agency can “fairly weigh the risks and benefits” of the medication and protect the patient’s safety. The agency also collects data about the drugs’ clinical impact on the patient and any adverse effects to inform the wider approval process for the drug.

Right To Try sought to hasten this approval process. Under the new program, for instance, a doctor must merely identify an experimental medication and receive authorization to use it from the manufacturer. In most cases, the FDA has no authority to approve or deny the application, and there’s no review board process to navigate.

But, because of the Right To Try program’s definitions, fewer patients and fewer medicines qualify.

Under Right To Try, patients must have a “life-threatening” disease or condition, not just “serious,” as with expanded access. Experimental medications are available only after they’ve completed Phase 1 clinical trials; treatments accessed through the expanded access program can be administered during a Phase 1 study.

Right To Try, which includes liability protections for manufacturers and prescribing physicians, also weakens requirements that govern how doctors disclose experimental medications’ risks to patients, leaving informed consent undefined. And it prevents the FDA from using information about how patients tolerate the drugs to “delay or adversely affect the review or approval of such drug(s),” unless top officials justify the benefit to public health in writing.

Supporters say Right To Try is an example of successful deregulation and claim that its more efficient approval process saved lives. But critics see this as a key reason for concern, because it “opens up the opportunity of exploiting desperate patients,” said Holly Fernandez Lynch, a bioethicist who studies pharmaceutical policy at the University of Pennsylvania’s Perelman School of Medicine.

Government data shows regulatory agencies weren’t the main hurdle patients faced when seeking experimental drugs. The FDA almost always approved expanded access applications, and quickly by government standards.

According to a 2018 FDA report on the expanded access program, the FDA authorized 99% of the roughly 9,000 requests it received in the previous five years, approving emergency requests for experimental medications in less than one day on average. More shows that approval trend has continued, even as the number of applications has grown each year.

In rare cases in which the FDA didn’t automatically approve requests, regulators often didn’t deny them, but recommended tweaks to the requested dosage to address safety and effectiveness concerns.

Right To Try by the Numbers

The FDA does not share detailed information about the number of doses provided or patients treated under Right To Try. Instead, it posts only an showing how many drugs have been approved under the program. The agency says that since Right To Try began in 2018 it has approved 16 treatments: 12 from 2018 to 2022 and four last year.

The FDA declined to provide additional information about the number of Right To Try requests or approvals.

Although the 16 medications approved through Right To Try were possibly provided to more than one patient each, experts said it’s extremely unlikely thousands of patients were involved, as Trump said.

Trump’s claim represents an “egregious overestimate of the number of people who are using Right To Try,” said Fernandez Lynch, noting she believes the real numbers are “very, very low.”

The Trump campaign did not respond to multiple inquiries about the source of the former president’s statistics. Karoline Leavitt, the campaign’s national press secretary, told Â鶹ŮÓÅ Health News that in a second term “President Trump will of course remain open to other pathways to expand ‘Right to Try’ to save more American lives.”

It remains unclear how Trump might expand the program, though the conservative Goldwater Institute is advocating for “,” which it claims will let patients receive individualized therapeutics.

Experts noted such drugs are already accessible through the expanded access program.

Meanwhile, evidence shows that the high price of experimental treatments, which are sometimes available through certain drug company programs but not typically covered by insurance, is a greater hurdle to patients than regulatory guardrails are.

“I don’t think that people are having a problem with the FDA blocking access to individualized therapeutics,” Bateman-House said. “I think the problem is that individualized therapeutics are incredibly expensive, and there’s only a very small number of researchers in the country who know how to make them.”

Our Ruling

Trump has claimed throughout the campaign that his Right To Try program is novel and has saved thousands of lives. But a similar program has existed for decades, and there is no evidence Right To Try has had anywhere close to the impact Trump said it has had.

Neither the Trump campaign nor Right To Try advocates provided evidence to back claims of widespread benefit. And government data shows only 16 medications have been approved under the program in its first six years, with no accounting of how many patients used those medications or their clinical outcomes.

Moreover, public health experts have said Right To Try weakens patient protections and fails to address the true barriers to experimental medications.

We rate Trump’s claim False.

our sources:

Congressional Research Service, “,” March 16, 2021

Food and Drug Administration, “,” Feb. 28, 2024

Food and Drug Administration, “,” May 2, 2024

Food and Drug Administration, “,” May 2018

Food and Drug Administration, “,” November 2022

Food and Drug Administration, “,” accessed Sept. 29, 2024

Food and Drug Administration, “,” Jan. 23, 2023

Food and Drug Administration, “,” June 6, 2024

Goldwater Institute, “,” accessed Sept. 29, 2024

Goldwater Institute, “,” accessed Sept. 29, 2024

Goldwater Institute, “,” Oct. 5, 2014

Goldwater Institute, “” accessed Sept. 29, 2024

Los Angeles Times, , June 14, 2019

Phone interview with Alison Bateman-House, assistant professor at New York University’s Grossman School of Medicine, Sept. 24, 2024

Phone interview with Holly Fernandez Lynch, associate professor of medical ethics and law at the University of Pennsylvania Perelman School of Medicine, Sept. 17, 2024

PhRMA, “,” accessed Sept. 29, 2024

Roll Call, “,” Aug. 17, 2024

The Singju Post, “,” Aug. 31, 2024

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Vice President Kamala Harris at the ABC News presidential debate, Sept. 10

Since Vice President Kamala Harris entered the presidential race, she and former President Donald Trump have sparred over their approaches to lowering prescription drug costs. Harris has described this as an important campaign promise that Trump made but didn’t deliver on.

“Donald Trump said he was going to allow Medicare to negotiate drug prices,” Harris said during the on Sept. 10 in Philadelphia. “He never did. We did.”

She that Trump’s promise to pursue such negotiations “never happened” during his administration.

During the 2016 presidential campaign, Trump , if elected, to take steps to allow the government to negotiate drug prices. He never enacted such a policy in office. The Trump administration pursued smaller, temporary programs aimed at lowering drug costs.

However, experts say the effect of Trump’s moves fell far short of the expected effect of the Medicare drug price negotiation program included in President Joe Biden’s Inflation Reduction Act and of what Trump promised.

Medicare Drug Price Negotiation Policy, Explained

The Inflation Reduction Act — a sweeping climate and health care law Biden signed in August 2022 — included a measure authorizing the Centers for Medicare & Medicaid Services to negotiate Medicare prescription drug prices directly with pharmaceutical companies.

“The idea behind drug price negotiation is that Medicare can use its buying power to get a better price than what is currently being negotiated for these drugs,” according to Juliette Cubanski, deputy director of the Program on Medicare Policy at Â鶹ŮÓÅ, a health information nonprofit that includes Â鶹ŮÓÅ Health News.

Medicare covers more than 67 million Americans, giving it enormous potential influence over prices for U.S. drugs and medical services.

In August, CMS announced it had secured significant discounts on the list prices of 10 drugs because of its negotiations. Those discounts ranged from a 38% reduction for blood cancer medication Imbruvica on the low end to a 79% cut for diabetes drug Januvia on the high side. (List prices and the prices Medicare drug plans pay can differ.)

The new prices are expected to save Medicare $6 billion in the first year, with Medicare beneficiaries set to save an additional $1.5 billion in out-of-pocket costs, according to the White House.

Those new prices aren’t set to take effect until 2026 — though Biden and Harris have highlighted other aspects of the law that are bringing down drug costs sooner, such as a $35-a-month out-of-pocket price cap on insulin for Medicare enrollees and a $2,000 yearly out-of-pocket spending cap for Part D drugs effective in January. The Part D program covers most generic and brand-name outpatient prescription drugs.

CMS will start negotiating prices for the next group of drugs — 15 a year for the next two years — in early 2025, and those talks will continue annually at least through the end of the decade.

Trump’s Promises Versus His Actions

As a presidential candidate in 2016, Donald Trump pledged to pursue prescription drug price negotiation programs — and sometimes overstated such a policy’s power to cut prices.

During and that year, Trump suggested allowing the government to negotiate drug prices directly with manufacturers would save $300 billion a year, a claim a then.

“The problem is, we don’t negotiate,” Trump said during an in Charleston, South Carolina, on Feb. 17, 2016. “We’re the largest drug buyer in the world. We don’t negotiate.” He went on to say: “If we negotiated the price of drugs, Joe, we’d save $300 billion a year.”

Similarly, at a Feb. 24, 2016, rally in Virginia Beach, Virginia, Trump reiterated his interest in making this change. “If you bid them out we’ll save $300 billion … and we don’t even do it. We’re going to do it.” The pharmaceutical industry would push back, he said, but he added: “Trust me I can do it.”

In office, however, Trump backed away from those promises, rejecting spearheaded by then-House Speaker Nancy Pelosi (D-Calif.) to authorize such negotiations. The Democratic-led House ultimately passed that legislation, though the Republican-led Senate didn’t consider it.

“Pelosi and her Do Nothing Democrats drug pricing bill doesn’t do the trick,” , the social platform then known as Twitter.

Trump pursued smaller initiatives that sought to lower drug costs. One such program, the “” model, tried to cap the cost of some Part B medications — those administered in a doctor’s office or hospital outpatient setting — at the lowest price paid in certain peer nations with a per capita GDP of at least 60% that of the United States.

“Medicare is the largest purchaser of drugs anywhere in the world by far,” Trump said in announcing the program. “We’re finally going to use that incredible power to achieve a fairer and lower price for everyone.”

The Trump campaign didn’t respond to an inquiry about prescription drug price negotiations or the most favored nation model.

The program would have started in January 2021 and lasted seven years. the government would save more than $85 billion on Part B spending. But some of those savings came from assumptions that Medicare beneficiaries would lose access to some Part B medications under the model, with some manufacturers unlikely to sell products at the lower, foreign prices.

Trump’s program never took effect. Amid lawsuits from several drug companies and industry groups, a federal judge stayed the plan in December 2020. The Biden administration scrapped it in 2022.

Even if the most favored nation model had been enacted, experts say it wouldn’t have come close to saving Americans or the government as much money as the IRA’s drug price negotiation provisions. A of Trump’s proposal estimated that 7% of the 60 million Medicare beneficiaries in 2018 would have benefited.

More importantly, the most favored nation model did not authorize the government to negotiate prescription drug prices with manufacturers — the policy Trump promised to implement.

What Comes Next?

A shows 85% of Americans, including more than three-quarters of Republicans, favor allowing Medicare to negotiate prices with drug companies.

And lowering drug costs continues to be a key issue for both campaigns, with Trump and Harris sparring over everything from the price of insulin to the impact of the Inflation Reduction Act on Medicare spending.

“I’ll lower the cost of insulin and prescription drugs for everyone with your support, not only our seniors,” Harris told supporters at an Aug. 16 campaign event in Raleigh, North Carolina, promising to extend the IRA’s price caps.

A Trump campaign spokesperson, meanwhile, previously told Â鶹ŮÓÅ Health News that the former president “will do everything possible to lower drug costs for Americans when he’s back in the White House, just like he accomplished in his first term.” She provided no specifics.

Trump, however, has also repeatedly promised to repeal parts of the Inflation Reduction Act — though he has never specifically mentioned the drug price negotiation provision — and to rescind unspent money. Congressional Republicans have about their intentions to roll back the drug price negotiation provision.

Even without legislative changes, the next president will have the opportunity to steer Medicare’s prescription drug price negotiation process.

“An administration that wants to be more lenient on drug companies might be more lax in the negotiations process,” said Tricia Neuman, a senior vice president at Â鶹ŮÓÅ and the executive director of its Program on Medicare Policy. “Or the administration could perhaps be tougher than the Biden administration.”

Our Ruling

As a presidential candidate in 2016, Donald Trump promised to let the government negotiate prescription drug prices directly with pharmaceutical companies. As president, however, he instead tried to tie some U.S. drug prices to their costs in other countries. Drugmakers and industry groups sued, challenging the move, and courts blocked it.

Harris, therefore, is correct that Trump never was able to open Medicare up to drug negotiations despite his sweeping campaign promises.

We rate Harris’ claim True.

Our Sources:

ABC News, “,” Sept. 10, 2024

Axios, “,” Sept. 17, 2024

Centers for Medicare & Medicaid Services, “,” Nov. 18, 2020

CNN, “,” Aug. 30, 2024

Congress.gov, “,” accessed Sept. 17, 2024

Factbase, “,” Feb. 17, 2016

Factbase, “,” Feb. 19, 2016

Federal Register, “,” Nov. 27, 2020

Â鶹ŮÓÅ, “” Feb. 11, 2021

Â鶹ŮÓÅ, “,” Sept. 13, 2024

Â鶹ŮÓÅ, “,” Aug. 27, 2020

Â鶹ŮÓÅ Health News, “5 Things To Know About the New Drug Pricing Negotiations,” Aug. 30, 2023

Â鶹ŮÓÅ Health News, “Harris Did Not Vote To ‘Cut Medicare,’ Despite Trump’s Claim,” Aug. 20, 2024

Â鶹ŮÓÅ Health News, “Trump Is Wrong in Claiming Full Credit for Lowering Insulin Prices,” July 18, 2024

Phone interview with Tricia Neuman, a senior vice president at Â鶹ŮÓÅ and the executive director of its Program on Medicare Policy, Sept. 13, 2024

Reuters, “,” Dec. 23, 2020

The Washington Post, “,” Feb. 18, 2016

The White House, “” July 24, 2020

The White House, “,” Aug. 16, 2024

X, then known as Twitter, “,” Nov. 22, 2019

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— Former President Donald Trump at a July 24 campaign rally in Charlotte, North Carolina

Former President Donald Trump claimed at a recent campaign rally that more than 300,000 Americans are dying each year from the synthetic opioid drug fentanyl, and that the number of fentanyl overdoses was the “lowest” during his administration and has skyrocketed since.

“We’re losing 300,000 people a year to fentanyl that comes through our border,” Trump told his supporters at a July 24 campaign rally in Charlotte, North Carolina. “We had it down to the lowest number and now it’s worse than it’s ever been,” he said.

Trump’s figures appear to have no basis in fact. Government statistics show the per year is hovering around 100,000 to 110,000, with opioid-related deaths at about 81,000. That’s enough that the government opioid-related overdoses an “epidemic,” but nowhere close to the number Trump cited.

Moreover, though the number of opioid deaths has risen since Trump left office, it’s incorrect to claim they were the “lowest” while he was president.

Numbers Are High, but Nowhere Near Trump’s Claim

Trump campaign national press secretary Karoline Leavitt wouldn’t comment specifically on the source for Trump’s statistics. She instead sent Â鶹ŮÓÅ Health News an about the opioid crisis under the heading: “DRUGS ARE POURING OVER HARRIS’ OPEN BORDER INTO OUR COMMUNITIES.”

One such bullet noted that there were “112,000 fatal drug overdoses” last year and linked to a story reporting that fact — directly rebutting Trump’s own claim of 300,000 fentanyl deaths. Additionally, the number NPR reported is an overall figure, not for fentanyl-related deaths only.

estimated that there were 107,543 total drug overdose deaths in 2023, with an estimated 74,702 of those involving fentanyl. Those figures were in line with what experts on the topic told Â鶹ŮÓÅ Health News.

“The number of actual deaths is probably significantly higher,” said Andrew Kolodny, medical director for the Opioid Policy Research Collaborative at Brandeis University, noting that many such overdose deaths go uncounted by government researchers.

“But I don’t know where one would get that number of 300,000,” Kolodny added.

Trump’s claim that fentanyl deaths were the “lowest” during his administration and are now worse than ever is also off the mark.

Overdose deaths — specifically those from synthetic opioids such as fentanyl — started climbing steadily in the 1990s. When Trump took office in January 2017, the number of overdose deaths related to synthetic opioids was about 21,000. By January 2021, when he left the White House, that tally was nearing 60,000, data from the Centers for Disease Control and Prevention’s shows. Deaths involving synthetic opioids continued to increase after Trump left office.

“There’s some truth to saying that there are more Americans dying [of opioids] than ever before,” Kolodny said. “But again, if you were to look at trends during the Trump administration, deaths just pretty much kept getting worse.”

In the last year, though, statistics show that overdose numbers have plateaued or fallen slightly, though it’s too soon to say whether that trend will hold.

Given that Trump’s claims about fentanyl came when discussing the southern border “invasion,” it’s worth noting that, , the vast majority of fentanyl caught being smuggled into the country illegally comes via legal ports of entry. Moreover, of people convicted of fentanyl drug trafficking in 2022 were U.S. citizens, an analysis by the Cato Institute, a libertarian think tank, showed. That year, U.S. citizens received 12 times as many fentanyl trafficking convictions as did immigrants who were in the U.S. without authorization, the analysis showed.

Our Ruling

Trump said, “We’re losing 300,000 people a year to fentanyl that comes through our border. We had it down to the lowest number and now it’s worse than it’s ever been.”

Annual U.S. fentanyl deaths have increased since he left office, but Trump’s claim about 300,000 deaths has no basis in fact and is contradicted by figures his press secretary shared.

Trump is wrong to assert that overdoses were the lowest when he was president. Moreover, Trump continues to link fentanyl trafficking to illegal immigration — a claim statistics do not support.

We rate Trump’s claim Pants on Fire!

Our Sources

Cato Institute, “,” Aug. 23, 2023.

Centers for Disease Control and Prevention, “,” May 15, 2024.

C-SPAN, , July 24, 2024.

Department of Homeland Security, , Dec. 22, 2023.

Email exchange with Karoline Leavitt, national press secretary for Donald J. Trump for President, July 29, 2024.

National Vital Statistics System, Centers for Disease Control and Prevention, , July 7, 2024.

NPR, “,” Dec. 28, 2023.

Phone interview with Andrew Kolodny, medical director for the Opioid Policy Research Collaborative at Brandeis University, July 31, 2024.

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— Former President Donald Trump at a July 24 campaign rally in Charlotte, North Carolina.

During a in Charlotte, North Carolina, former President Donald Trump claimed that Vice President Kamala Harris was responsible for passing legislation in the U.S. Senate to cut Medicare spending by nearly $300 billion.

“As vice president, Kamala Harris cast the tie-breaking vote to cut, as you know, Medicare by $273 billion,” Trump told rally attendees. “She cast a vote to cut Medicare.”

Trump gave no further explanation for which vote he was referring to or how he arrived at that figure. A campaign spokesperson told Â鶹ŮÓÅ Health News in an email that Trump was referring to a statistic from a by Tomas Philipson, a University of Chicago economist and a former Trump administration official.

Philipson’s op-ed argued that the Inflation Reduction Act — a sweeping climate and health care measure passed in 2022 for which Harris cast the — would harm Medicare patients by driving up costs. His article cited a showing that the measure’s health care provisions would reduce the federal deficit by $237 billion over 10 years. “(M)ost of that reduction comes from the program spending less on prescription drugs,” Philipson wrote.

But the government’s spending less on Medicare programs would not amount to the kind of “cut” to Medicare benefits Trump implied, experts told Â鶹ŮÓÅ Health News. Several provisions in the law pertaining to prescription drug pricing are widely seen by health policy experts as beneficial to both consumers and the government. Individual patients are expected to spend less out-of-pocket on their prescription drugs, while the government will reduce Medicare spending without any impact to services offered.

We dug into the facts surrounding Trump’s claim and the law’s effect on Medicare. It resurfaces a long-running debate over Medicare savings versus cuts and the question of whether lowered spending automatically leads to a reduction in benefits for Medicare enrollees.

Following the Numbers

The Inflation Reduction Act’s many provisions include some intended to lower prescription drug costs for older Americans and others receiving Medicare insurance coverage. 

The law caps the cost of insulin at $35 per month for most Medicare beneficiaries, establishes out-of-pocket spending limits for Part D drug coverage, and institutes penalties for drug companies that raise prices faster than the inflation rate. The law also authorizes Medicare officials, for the first time, to negotiate drug pricing directly with pharmaceutical manufacturers. 

“The idea behind drug price negotiation is that Medicare can use its buying power to get a better price than what is currently being negotiated for these drugs,” said Juliette Cubanski, deputy director of the program on Medicare policy at Â鶹ŮÓÅ, a health information nonprofit that includes Â鶹ŮÓÅ Health News.

According to an , the nonpartisan federal agency that calculates the financial impact of new legislation, the Inflation Reduction Act’s health care measures will have a mixed effect on spending. Some steps, such as the cap on beneficiaries’ out-of-pocket prescription drug spending, will likely cost the government more. But others, including the drug price negotiations, are projected to save the government money. All told, the Inflation Reduction Act’s health care measures are expected to save taxpayers $237 billion over 10 years.

On the numbers, Trump said the law would “cut Medicare” by $273 billion; he likely meant $237 billion.

Despite the government being expected to spend less overall, beneficiaries’ services would not necessarily be cut, as Trump claimed. In fact, most Medicare recipients would likely see their costs decrease, too, while keeping the same level of benefits.

“There are big shifts in who’s paying for what,” said Andrew Mulcahy, a senior health economist who researches prescription drug markets at the Rand Corp., a nonpartisan think tank. “But that doesn’t mean they’re getting any less. If anything, they’ll have better access to drugs.”

Cubanski, echoing Mulcahy, said: “When you’re reducing Medicare spending, that’s not the same thing as a cut to Medicare or cutting Medicare benefits. If you buy eggs every week and now you’re getting them cheaper, you’re still getting the eggs, you’re just getting them for a lower price.”

A year ago, the Centers for Medicare & Medicaid Services named the on which it will focus, though the exact savings from the drug pricing negotiations process will be known only when the government and drug manufacturers reach agreements. The new pricing for this first batch of medications is set to take effect in 2026.

Whether the government can negotiate meaningfully lower costs versus current prices is unclear, especially since pharmacy benefit managers, or PBMs — middlemen in the negotiations among drug companies, insurers and pharmacies — are tasked with doing that.

“I think for many of the drugs selected in the first year, my expectation is that the government won’t be able to do much better than the PBMs,” Mulcahy told Â鶹ŮÓÅ Health News. 

The Medicare drug pricing program could have negative side effects. Philipson, for example, argued in his op-ed that the negotiations will “deter companies from developing new medicines” and threaten older Americans’ access to doctors, as manufacturers and hospitals would likely be reimbursed less for their drugs and services.

Cubanski brushed off such concerns.

“The drug industry certainly has a vested interest, you know, in raising alarm bells,” she said. “I think it’s just still too early to talk about ‘the sky is falling’ with regard to pharmaceutical innovation. Time will tell, but it certainly is the case right now that the law includes a lot of provisions that will be very helpful for Medicare beneficiaries.”

On Aug. 15, CMS of its negotiation over the first round of drugs. The new prices represent discounts ranging from 38% to 79% of the original costs. White House officials said the negotiations will lead to $6 billion in savings for Medicare the first year, while Medicare recipients are expected to save an additional $1.5 billion in out-of-pocket costs.

Our Ruling

Trump’s statement is wrong both on the hard numbers and his interpretation of what they mean.

The analysis Trump cited, per his campaign, said the Inflation Reduction Act’s health care provisions would lower the deficit by $237 billion — not $273 billion, as the former president claimed. Moreover, whatever the exact number is, multiple experts pushed back against the notion that the savings equated to a “cut” to Medicare, as Trump claimed.

We rate Trump’s claim False.

Our Sources

Centers for Medicare & Medicaid Services, , June 2023.

Centers for Medicare & Medicaid Services, .

, August 2023.

The Wall Street Journal, “,’” July 9, 2024.

Congressional Budget Office, , Sept. 7, 2022.

Congressional Budget Office, , February 2023.

C-SPAN, “,” July 24, 2024.

Email exchange with Karoline Leavitt, national press secretary for Donald J. Trump for President, July 29, 2024.

Â鶹ŮÓÅ Health News, “Trump Is Wrong in Claiming Full Credit for Lowering Insulin Prices,” July 18, 2024.

Phone interview with Andrew Mulcahy, senior health economist at Rand Corp., July 26, 2024.

Phone interview with Juliette Cubanski, deputy director of the program on Medicare policy at Â鶹ŮÓÅ, July 29, 2024.

United States Senate, Roll Call Vote 117th Congress-2nd Session, Aug. 7, 2022.

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Former President Donald Trump in a , June 8

Former President Donald Trump has repeatedly claimed that he — and not President Joe Biden — deserves credit for lowering older Americans’ prescription drug prices, specifically for insulin.

In a on Truth Social, the former president’s social platform, Trump wrote: “Low INSULIN PRICING was gotten for millions of Americans by me, and the Trump Administration, not by Crooked Joe Biden. He had NOTHING to do with it.”

Trump again claimed sole credit for lowering insulin prices during the June 27 presidential debate in Atlanta. After Biden touted the $35 monthly out-of-pocket cap for Medicare patients mandated by the Inflation Reduction Act, : “I’m the one that got the insulin down for the seniors. I took care of the seniors.”

It’s not just the former president making such claims. Fox News anchor and former Arkansas Gov. , a Republican, both have said the Biden administration is wrong to take credit for lowering insulin costs.

Because drug prices and Medicare will likely be issues in the presidential campaign, we dug into the facts surrounding those claims.

The Trump Administration’s Program

Trump is correct that his administration enacted a program to lower insulin costs for some patients on Medicare.

In July 2020, Trump signed an establishing the “,” a temporary, voluntary program run by the Centers for Medicare & Medicaid Services that let some Medicare Part D prescription drug plans cap monthly out-of-pocket insulin copay costs at $35 or less. It covered at least one insulin product of each dosage and type.

The program began Jan. 1, 2021, and ran through Dec. 31, 2023. In 2022, the Trump-era program included a total of 2,159 Medicare drug plans, and that more than 800,000 Medicare beneficiaries who use insulin could have benefited from it that year.

The Department of Health and Human Services that more than 1.5 million Medicare beneficiaries paid more than $35 a month for insulin in 2020, before Trump’s program took effect. An , a nonpartisan think tank, showed the program reduced participants’ out-of-pocket insulin costs by $198 to $441 per year on average, depending on their Medicare plan.

The Inflation Reduction Act Provisions

The Inflation Reduction Act, which Congress passed and Biden signed into law in August 2022, included an insulin provision that went further than Trump’s voluntary initiative.

The act did cap out-of-pocket costs of insulin for Medicare patients at $35 per month. But whereas the Trump program applied only to certain Medicare Part D plans, the act mandated that all Medicare drug programs cap out-of-pocket insulin costs — including those in what’s known as Medicare Part B, which pays for medical equipment such as insulin pumps. The act’s insulin provisions took effect Jan. 1, 2023, for Part D plans and July 1 of that year for Part B.

The act also mandated that the out-of-pocket price cap apply to all insulin products a given Medicare plan covers, not just a subset.

Taken together, those provisions mean a far greater number of Medicare beneficiaries stand to benefit from the act’s insulin provisions — including people receiving insulin via a pump, who were left out of the Trump-era program.

CMS estimates that more than 3.3 million Medicare beneficiaries use one or more of the common forms of insulin. Although some of those people were likely already paying less than $35 per month for their medications, the Inflation Reduction Act benefited far more than the 800,000 patients affected by Trump’s program.

“It’s likely a larger population than under the Trump administration’s model,” said Juliette Cubanski, deputy director of the Program on Medicare Policy at Â鶹ŮÓÅ, a health information nonprofit that includes Â鶹ŮÓÅ Health News.

“The Trump administration did establish this voluntary model, and one perhaps could view that as some precedent for what we saw in the Inflation Reduction Act,” Cubanski added. “But I think it’s inaccurate to state that President Biden had nothing to do with enabling millions of Americans to benefit from lower insulin copayments.”

Preliminary research shows the Inflation Reduction Act’s insulin provisions had a greater average financial benefit than those in Trump’s program. Insulin-using older Americans were estimated to save an annual average of $501 per person, .

The Inflation Reduction Act has also had an impact beyond Medicare. After the law passed, some pharmaceutical companies — including , , , and — self-imposed price caps for all insured insulin users, not just Medicare patients. During his 2023 State of the Union address, Biden proposed to all insulin patients, and he’s made that point a staple of his campaign appearances.

“I’m determined to make that apply to every American, not just seniors, in the second term,” he said at a campaign event in May in Philadelphia.

The Stakes for the 2024 Election

Beyond insulin products, the Inflation Reduction Act caps total out-of-pocket prescription costs at $2,000 annually for people with Medicare drug plans starting in 2025, down from $3,300 this year for most Medicare beneficiaries.

But every congressional Republican opposed the Inflation Reduction Act, including its insulin savings provisions, in 2022, and the law is vulnerable to repeal should Trump take the White House. Trump has repeatedly criticized the law and called for overturning some of its provisions. He has not specified how he would address its health measures.

In an email exchange with Â鶹ŮÓÅ Health News, Trump campaign spokesperson Karoline Leavitt highlighted drug savings programs the former president instituted during his term in office, but repeatedly declined to extrapolate on, or defend, Trump’s claim that Biden deserves no credit for lowering insulin costs.

Asked whether Trump intended to maintain the Inflation Reduction Act’s insulin provisions should he win a second term in office, Leavitt wrote, “President Trump will do everything possible to lower drug costs for Americans when he’s back in the White House, just like he accomplished in his first term.”

Our Ruling

Trump can claim some credit for lowering insulin costs for seniors, as his administration advanced a voluntary program to do so.

But his claim that Biden had “NOTHING to do with it” is patently false. The Inflation Reduction Act, which Biden signed into law, imposed a mandatory Medicare insulin price cap that applied across the program, benefiting a significantly larger number of insulin users — including people not enrolled in Medicare. 

We rate Trump’s claim False.

Sources:

Civica Rx, “,” March 3, 2022

Centers for Medicare & Medicaid Services, “,” accessed July 2, 2024

CMS, “,” May 26, 2020

CNN, “,” June 28, 2024

Eli Lilly and Co., “,” March 1, 2023

Email exchange with Karoline Leavitt, Donald J. Trump 2024 campaign national press secretary, July 1, 2024

Facebook.com, , June 10, 2024

Federal Registrar, “,” July 24, 2020

Department on Health and Human Services, “,” Jan. 24, 2023

Â鶹ŮÓÅ, “,” April 20, 2023

Novo Nordisk, “,” March 14, 2023

Phone interview with Juliette Cubanski, deputy director of Â鶹ŮÓÅ’s Program on Medicare Policy, June 16, 2024

Rand Corp., “,” May 2023

Republican Study Committee, “,” March 20, 2024

Sanofi, “.,” June 1, 2023

Stat, “,” June 13, 2024

The White House, “,” March 2, 2023

The White House, “,” May 29, 2024

The White House, “,” Feb. 7, 2023

Truthsocial.com, , June 8, 2024

X.com, , June 3, 2024

Â鶹ŮÓÅ Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at Â鶹ŮÓÅ—an independent source of health policy research, polling, and journalism. Learn more about .

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President Joe Biden in a campaign advertisement, May 8

President Joe Biden’s reelection campaign wants voters to contrast his record on health care policy with his predecessor’s. In May, Biden’s campaign began airing a monthlong, $14 million ad campaign targeting swing-state voters and minority groups with spots on TV, digital, and radio.

In the ad, titled “,” Biden assails former President Donald Trump for his past promises to overturn the Affordable Care Act, also known as Obamacare. Biden also warns of the potential effect if Trump is returned to office and again pursues repeal.

“That would mean over a hundred million Americans will lose protections for preexisting conditions,” Biden said in the ad.

Less than six months from Election Day, Trump narrowly leading Biden in a head-to-head race in most swing states. And voters trust Trump to better handle issues such as inflation, crime, and the economy by significant margins.

An of about 2,200 adults, released in early May, shows the only major policy issues on which Biden received higher marks than Trump were health care and abortion access. It’s no surprise, then, that the campaign is making to Biden’s pitch to voters.

As such, we dug into the facts surrounding Biden’s claim.

Preexisting Condition Calculations

The idea that 100 million Americans are living with one or more preexisting conditions is not new. It was the subject of a back-and-forth between then-candidate Biden and then-President Trump during their previous race, in 2020. After Biden cited that statistic in a , Trump responded, “There aren’t a hundred million people with preexisting conditions.”

A Â鶹ŮÓÅ Health News/PolitiFact HealthCheck at the time rated Biden’s claim to be “mostly true,” finding a fairly large range of estimates — from 54 million to 135 million — of the number of Americans with preexisting conditions. Estimates on the lower end tend to consider “preexisting conditions” to be more severe chronic conditions such as cancer or cystic fibrosis. Estimates at the spectrum’s higher end include people with more common health problems such as asthma and obesity, and behavioral health disorders such as substance use disorder or depression.

Biden’s May ad focuses on how many people would be vulnerable if protections for people with preexisting conditions were lost. This is a matter of some debate. To understand it, we need to break down the protections put in place by the ACA, and those that exist separately.

Before and After

Before the ACA’s preexisting condition protections took effect in 2014, insurers in — people buying coverage for themselves or their families — could charge higher premiums to people with particular conditions, restrict coverage of specific procedures or medications, set annual and lifetime coverage limits on benefits, or deny people coverage.

“There were a number of practices used by insurance companies to essentially protect themselves from the costs associated with people who have preexisting conditions,” said , a co-director of the Center on Health Insurance Reforms at Georgetown University and an expert on the health insurance marketplace.

Insurers providing coverage to large employers could impose long waiting periods before employees’ benefits kicked in. And though employer-sponsored plans couldn’t discriminate against individual employees based on their health conditions, small-group plans for businesses with fewer than 50 employees could raise costs across the board if large numbers of employees in a given company had such conditions. That could prompt some employers to stop offering coverage.

“The insurer would say, ‘Well, because you have three people with cancer, we are going to raise your premium dramatically,’ and therefore make it hard for the small employer to continue to offer coverage to its workers because the coverage is simply unaffordable,” recalled , a research professor at Georgetown University’s McCourt School of Public Policy who researches public health insurance markets.

As a result, many people with preexisting conditions experienced what some researchers dubbed “.” People felt trapped in their jobs because they feared they wouldn’t be able to get health insurance anywhere else.

Some basic preexisting condition protections exist independent of the ACA. The 1996 , for example, restricted how insurers could limit coverage and mandated that employer-sponsored group plans can’t refuse to cover someone because of a health condition. Medicare and Medicaid similarly can’t deny coverage based on health background, though age and income-based eligibility requirements mean many Americans don’t qualify for that coverage.

Once the ACA’s preexisting condition protections kicked in, plans sold on the individual market had to provide a comprehensive package of benefits to all purchasers, no matter their health status.

Still, some conservatives say Biden’s claim overstates how many people are affected by Obamacare protections.

Even if you consider the broadest definition of the number of Americans living with such conditions, “there is zero way you could justify that 100 million people would lose coverage” without ACA protections, said , who was a Trump administration health policy adviser and is now a senior research fellow with the Paragon Health Institute and a senior fellow at the Manhattan Institute for Policy Research, a conservative think tank.

Joseph Antos, a senior fellow at the American Enterprise Institute, a conservative think tank, called the ad’s preexisting conditions claim “the usual bluster.” To reach 100 million people affected, he said, “you have to assume that a large number of people would lose coverage.” And that’s unlikely to happen, he said.

That’s because most people — about 55% of Americans, according to the most recent — receive health insurance through their employers. As such, they’re protected by the Health Insurance Portability and Accountability Act rules, and their plans likely wouldn’t change, at least in the short term, if the ACA went away.

Antos said major insurance companies, which have operated under the ACA for more than a decade, would likely maintain the status quo even without such protections. “The negative publicity would be amazing,” he said.

People who lose their jobs, he said, would be vulnerable.

But Corlette argued that losing ACA protections could lead to Americans being priced out of their plans, as health insurers again begin medical underwriting in the individual market.

Park predicted that many businesses could also gradually find themselves priced out of their policies.

“For those firms with older, less healthy workers than other small employers, they would see their premiums rise,” he told Â鶹ŮÓÅ Health News.

Moreover, Park said, anytime people lost work or switched jobs, they’d risk losing their insurance, reverting to the old days of job lock.

“In any given year, the number [of people affected] will be much smaller than the 100 million, but all of those 100 million would be at risk of being discriminated against because of their preexisting condition,” Park said.

Our Ruling

We previously ruled Biden’s claim that 100 million Americans have preexisting conditions as in the ballpark, and nothing suggests that’s changed. Depending on the definition, the number could be smaller, but it also could be even greater and is likely to have increased since 2014.

Though Biden’s claim about the number of people who would be affected if those protections went away seems accurate, it is unclear how a return to the pre-ACA situation would manifest.

On the campaign trail this year, Trump has promised — as he did many times in the past — to with something better. But he’s never produced a replacement plan. Biden’s claim shouldn’t be judged based on his lack of specificity.

We rate Biden’s claim Mostly True.

our sources

ABC News/Ipsos Poll, “,” May 5, 2024

Avalere, “,” Oct. 23, 2018

Biden-Harris 2024 campaign email, “NEW AD: Biden-Harris 2024 Launches ‘Terminate’ Slamming Trump for Attacks on Health Care,” May 8, 2024

Center for American Progress, “,” Oct. 2, 2019

Census Bureau, “,” September 2023

CNN, “,” Oct. 22, 2018

Department of Health and Human Services, “,” Jan. 5, 2017

Department of Health and Human Services, “,” accessed May 15, 2024

Email exchanges with Biden-Harris 2024 campaign official, May 13-15, 2024

Email exchange with Karoline Leavitt, Trump 2024 campaign national press secretary, May 13, 2024

Â鶹ŮÓÅ, “,” May 15, 2024

Â鶹ŮÓÅ, “,” Feb. 6, 2024

Â鶹ŮÓÅ Health News, “Drowning in a ‘High-Risk Insurance Pool’ — At $18,000 a Year,” Feb. 27, 2017

Â鶹ŮÓÅ Health News and PolitiFact, “Biden’s in the Ballpark on How Many People Have Preexisting Conditions,” Oct. 1, 2020

The New York Times, “,” May 13, 2024

Phone interview and email exchanges with , a senior fellow at the Manhattan Institute and the director of the Private Health Reform Initiative at the Paragon Health Institute, May 14-15, 2024

Phone interview with , a research professor at Georgetown University’s McCourt School of Public Policy, May 22, 2024

Phone interview with , a co-director of the Center on Health Insurance Reforms at Georgetown University, May 14, 2024

Truthsocial.com, , Nov. 25, 2023

The Wall Street Journal, “,” Sept. 23, 2017

Work, Aging and Retirement, “,” Feb. 19, 2016

YouTube.com/@CSPAN, “,” Sept. 29, 2020

YouTube.com/@JoeBiden, “” campaign advertisement, May 10, 2024

Phone interview with Joseph Antos, a senior fellow at the American Enterprise Institute, June 5, 2024

Health Affairs, , Sept. 11, 2020

Â鶹ŮÓÅ, , Dec. 12, 2016

PolitiFact, “,” June 3, 2024

Â鶹ŮÓÅ Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at Â鶹ŮÓÅ—an independent source of health policy research, polling, and journalism. Learn more about .

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This story can be republished for free (details).