DENVER — On a bustling street corner one recent afternoon outside the offices of the Harm Reduction Action Center, employees of the education and advocacy nonprofit handed out free naloxone kits to passersby.

Distributing the opioid reversal medication is essential to the center’s work to reduce fatal overdoses in the community. But how long the group can continue doing so is in question. The center depends on Colorado’s Opioid Antagonist Bulk Purchase Fund, also known as the Naloxone Bulk Purchase Fund, which now lacks a recurring source of money — despite hundreds of millions of dollars in national opioid lawsuit settlement cash flowing into the state.

“Our concern is that we won’t have access to naloxone and that means that more people will die of a very preventable overdose,” said Lisa Raville, executive director of the center.

The bulk fund was created in 2019 to provide free naloxone to organizations like the Harm Reduction Action Center. The fund’s annual budget grew from just over $300,000 in fiscal year 2019 to more than $8.5 million in fiscal 2022, according to legislative reports by the state’s Overdose Prevention Unit.

The fund has boosted the availability of the medication throughout Colorado, which passed a law in 2013 that gives legal immunity to medical providers who prescribe the drug and to any person who administers it to someone suffering an overdose. The fund currently provides more than $550,000 worth of naloxone kits to various entities each month.

Despite the increased availability of naloxone, fatal opioid overdoses continued to rise. In 2023, 1,292 people in Colorado died of an opioid overdose, according to data from the Colorado Department of Public Health and Environment. That was 132 more people than the year before.

And now, one of the fund’s major money sources, the American Rescue Plan passed by Congress in response to the covid-19 pandemic, is set to expire next year. As of September, the Colorado fund had $8.6 million left, according to Vanessa Bernal, a spokesperson for the state health department.

The fund got a boost in September when the state’s Behavioral Health Administration provided it with $3 million from a one-time Substance Use Prevention, Treatment, and Recovery Services Block Grant and nearly $850,000 through a State Opioid Response Grant. Colorado Attorney General Phil Weiser said his office will “ensure that the necessary budget remains in place for the next year.”

The amount of that funding and where it will come from has yet to be determined, and long-term solutions are still being weighed, as well. One option to shore up the fund beyond the next year is to use Colorado’s share of settlement funds from the national opioid lawsuits, said Mary Sylla, former director of overdose prevention policy and strategy at the National Harm Reduction Coalition.

“It’s just completely ironic that something that addresses the opioid overdose crisis is underfunded at the very same time that these settlement funds are flowing,” Sylla said. “There couldn’t be a better use for them.”

As of July, Colorado had received and distributed more than $110 million in opioid settlement money to regions, local governments, state entities, and infrastructure projects, according to the Colorado attorney general’s office, and the total is expected to reach more than $750 million by 2038.

However, more than half of the settlement money Colorado has received thus far has already been disbursed to its 19 Regional Opioid Abatement Councils, which have created their own plans to distribute money to programs such as substance abuse treatment centers, public education campaigns, and training for emergency providers.

For example, Denver’s council, which has received more than $18 million since 2022, has disbursed money to organizations in two- and three-year contracts, the majority not including the purchase of naloxone.

“We thought we could all continue to get [naloxone] from the state health department and the Naloxone Bulk Purchase Fund,” Raville said.

The Denver council is working on a plan for the coming years, expected to come out in mid-2025, and is considering the bulk fund’s dwindling money, said Marie Curran, program coordinator for Denver’s opioid abatement funds.

Lawrence Pacheco, a spokesperson for the attorney general’s office, which manages 10% of the state’s opioid settlement dollars, said the office “is working on options to ensure that this lifesaving medication can continue to be part of the state’s effort to abate the opioid crisis.” Those options have not yet been made public.

California, where Sylla works, has used settlement money for a distribution program that’s similar to Colorado’s. In Washington and Kentucky, as part of the states’ settlements with Teva Pharmaceuticals, tens of thousands of free naloxone kits will be available to residents. Each state uses its opioid settlement funds differently, and while many provide naloxone to residents in some manner, including via vending machines, there is no central tracking of naloxone distribution programs.

Over the past five years, Colorado’s fund has distributed more than half a million doses of the opioid reversal drug to hundreds of organizations and schools across the state. Last year, the Harm Reduction Action Center received 7,284 doses from the fund, which Raville estimates helped save more than 4,500 lives.

Unless additional money is found, the bulk fund runs the risk of having to further limit distribution, leaving the hundreds of organizations that rely on it with little or no access to free naloxone. While the medication became available over the counter nationally last fall, the $45 price tag per two-dose package means it can remain out of reach for some who need it most.

In May, the state announced a plan for prioritizing which groups get the medication from the bulk fund with four categories, from “essential” to “low need,” based on how frequently an entity directly encounters people who are most at risk of experiencing or witnessing an overdose. The Harm Reduction Action Center has been classified in the “essential” category. School districts, as well as colleges and universities, are in the next-highest category.

Another organization, The Naloxone Project, said it was misclassified by not being put at the highest priority level. As a result, it said, it received just 1,200 naloxone doses from the fund this year, instead of the 6,000 it requested.

“We would argue that we would fall under ‘essential’ because many of our programs are public-facing and consistently provide naloxone for people who use drugs and who are at the highest risk of experiencing overdose,” said Rachael Duncan, associate director of The Naloxone Project.

The group, which has chapters in 12 states, provides nasal and injectable forms of naloxone to more than 90% of Colorado’s hospitals, to give to patients before they are discharged from the emergency department or from labor and delivery units. More than half of the 12,000 naloxone kits the project has distributed to Colorado medical entities have come from the bulk fund.

Another organization, UCHealth’s Center for Dependency, Addiction and Rehabilitation, known as CeDAR, which offers residential, outpatient, and telehealth treatment, is no longer eligible to receive free naloxone, because its patients typically are insured or can pay out-of-pocket.

Karli Yarnell, a CeDAR physician assistant, said that even when someone can pay for it, that doesn’t mean they can get to a pharmacy to pick up the medicine.

And Duncan is concerned about what the loss of doses will mean for organizations like The Naloxone Project and CeDAR.

“What I fear will happen is a scarcity mindset of organizations competing for funding,” Duncan said. “But I also worry about places that are used to getting it so reliably running out.”

The Host

As part of a media blitz aimed at women voters, Vice President Kamala Harris this week rolled out a plan for Medicare to provide in-home long-term care services. It’s popular, particularly for families struggling to care for both young children and older relatives, but its enormous expense has prevented similar plans from being implemented for decades.

Meanwhile, President Joe Biden called out former President Donald Trump by name for having “led the onslaught of lies” about the federal efforts to help people affected by hurricanes Helene and Milton. Even some Republican officials say the misinformation about hurricane relief efforts is threatening public health.

This week’s panelists are Julie Rovner of KFF Health News, Shefali Luthra of The 19th, Jessie Hellmann of CQ Roll Call, and Joanne Kenen of the Johns Hopkins schools of public health and nursing and Politico.

Among the takeaways from this week’s episode:

• Vice President Kamala Harris’ plan to expand Medicare to cover more long-term care is popular but not new, and in the past has proved prohibitively expensive.
• Former President Donald Trump has abandoned support for a drug price policy he pursued during his first term. The idea, which would lower drug prices in the U.S. to their levels in other industrialized countries, is vehemently opposed by the drug industry, raising the question of whether Trump is softening his hard line on the issue.
• Abortion continues to be the biggest health policy issue of 2024, as Republican candidates — in what seems to be a replay of 2022 — try to distance themselves from their support of abortion bans and other limits. Voters continue to favor reproductive rights, which creates a brand problem for the GOP. Trump’s going back and forth on his abortion positions is an exception to the tack other candidates have taken.
• The Supreme Court returned from its summer break and immediately declined to hear two abortion-related cases. One case pits Texas’ near-total abortion ban against a federal law that requires emergency abortions to be performed in certain cases. The other challenges a ruling earlier this year from the Alabama Supreme Court finding that embryos frozen for in vitro fertilization have the same legal rights as born humans.
• The 2024 KFF annual employer health benefits survey, released this week, showed a roughly 7% increase in premiums, with average family premiums now topping $25,000 per year. And that’s with most employers not covering two popular but expensive medical interventions: GLP-1 drugs for weight loss and IVF.

Also this week, excerpts from a KFF lunch with “Shark Tank” panelist and generic drug discounter Mark Cuban, who has been consulting with the Harris campaign about health care issues.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week they think you should read, too:

Julie Rovner: KFF Health News’ “A Boy’s Bicycling Death Haunts a Black Neighborhood. 35 Years Later, There’s Still No Sidewalk,” by Renuka Rayasam and Fred Clasen-Kelly.

Shefali Luthra: The 19th’s “Arizona’s Ballot Measure Could Shift the Narrative on Latinas and Abortion,” by Mel Leonor Barclay.

Jessie Hellmann: The Assembly’s “Helene Left Some NC Elder-Care Homes Without Power,” by Carli Brosseau.

Joanne Kenen: The New York Times’ “Her Face Was Unrecognizable After an Explosion. A Placenta Restored It,” by Kate Morgan.

Also mentioned on this week’s podcast:

To hear all our podcasts, click here.

And subscribe to KFF Health News’ “What the Health?” on Spotify, Apple Podcasts, Pocket Casts, or wherever you listen to podcasts.

Most employers have little idea what the pharmacy benefit managers they hire do with the money they exchange for the medications used by their employees, according to a KFF survey released Wednesday morning.

In KFF’s latest employer health benefits survey, company officials were asked how much of the rebates collected from drugmakers by pharmacy benefit managers, or PBMs, is returned to them. In recent years, the pharmaceutical industry has tried to deflect criticism of high drug prices by saying much of that income is siphoned off by the PBMs, companies that manage patients’ drug benefits on behalf of employers and health plans.

PBM leaders say they save companies and patients billions of dollars annually by obtaining rebates from drugmakers that they pass along to employers. Drugmakers, meanwhile, say they raise their list prices so high in order to afford the rebates that PBMs demand in exchange for placing the drugs on formularies that make them available to patients.

Leaders of the three largest PBMs — CVS Caremark, Optum RX and Express Scripts — all testified in Congress in July that 95% to 98% of the rebates they collect from drugmakers flow to employers.

For KFF’s survey of 2,142 randomly selected companies, officials from those with 500 or more employees were asked how much of the rebates negotiated by PBMs returned to the company as savings. About 19% said they received most of the rebates, 27% said some, and 16% said little. Thirty-seven percent of the respondents didn’t know.

While a larger percentage of officials from the largest companies said they got most or some of the rebates, the answers — and their contrast with the testimony of PBM leaders — reflect the confusion or ignorance of employers about what their drug benefit managers do, said survey leader Gary Claxton, a senior vice president at KFF, a health information nonprofit that includes KFF Health News.

“I don’t think they can ever know all the ways the money moves around because there are so many layers, between the wholesalers and the pharmacies and the manufacturers,” he said.

Critics say big PBMs — which are parts of conglomerates that include pharmacies, providers, and insurers — may conceal the size of their rebates by conducting negotiations through corporate-controlled rebate aggregators, or group purchasers, mostly based overseas in tax havens, that siphon off a percentage of the cash before it goes on the PBMs’ books.

PBMs also make money by encouraging or requiring patients to use affiliated specialty pharmacies, by skimping on payments to other pharmacies, and by collecting extra cash from drug companies through the federal 340B drug pricing program, which is aimed at lowering drug costs for low-income patients, said Antonio Ciaccia, CEO of 46brooklyn Research.

The KFF survey indicates how little employers understand the PBMs and their pricing policies. “Employers are generally frustrated by the lack of transparency into all the prices out there,” Claxton said. “They can’t actually know what’s true.”

Billionaire Mark Cuban started a company to undercut the PBMs by selling pharmaceuticals with transparent pricing policies. He tells Fortune 500 executives he meets, “You’re getting ripped off, you’re losing money because it’s not your core competency to understand how your PBM and health insurance contracts work,” Cuban told KFF Health News in an interview Tuesday.

Ciaccia, who has conducted PBM investigations for several states, said employers are not equipped to understand the behavior of the PBMs and often are surprised at how unregulated the PBM business is.

“You’d assume that employers want to pay less, that they would want to pay more attention,” he said. “But what I’ve learned is they are often underequipped, underresourced, and oftentimes not understanding the severity of the lack of oversight and accountability.”

Employers may assume the PBMs are acting in their best interest, but they don’t have a legal obligation to do so.

Prices can be all over the map, even those charged by the same PBM, Ciaccia said. In a Medicaid study he recently conducted, a PBM was billing employers anywhere from $2,000 to $8,000 for a month’s worth of imatinib, a cancer drug that can be bought as a generic for as little as $30.

PBM contracts often guarantee discounts of certain percentage points for generics and brand-name drugs. But the contracts then contain five pages of exclusions, and “no employer will know what they mean,” Ciaccia said. “That person doesn’t have enough information to have an informed opinion.”

The KFF survey found that companies’ annual premiums for coverage of individual employees had increased from an average of $7,739 in 2021 to $8,951 this year, and $22,221 to $25,572 for families. Among employers’ greatest concerns was how to cover increasingly popular weight loss drugs that list at $2,000 a month or more.

Only 18% of respondents said their companies covered drugs such as Wegovy for weight loss. The largest group of employers offering such coverage — 28% — was those with 5,000 or more employees.

Californians in November will weigh in on a ballot initiative to increase scrutiny over the use of health-care dollars — particularly money from a federal drug discount program — meant to support patient care largely for low-income or indigent people. The revenue is sometimes used to address housing instability and homelessness among vulnerable patient populations.

Voters are being asked whether California should increase accountability in the 340B drug discount program, which provides money for community clinics, safety net hospitals and other nonprofit health-care providers.

The program requires pharmaceutical companies to give drug discounts to these clinics and nonprofit entities, which can bank revenue by charging higher reimbursement rates.

Advocates pushing the measure, Proposition 34, say some entities are using the drug discount program as a slush fund, plowing money into housing and homelessness initiatives that don’t meet basic patient safety standards. Researchers and advocates have called for greater oversight.

“There are 340B entities that are misusing these public dollars,” said Nathan Click, a spokesperson for the pro-Proposition 34 campaign. “The whole point of this program is to use this money to get more low-income people health-care services.”

The initiative wouldn’t bar 340B providers from using health-care funds for housing or homelessness programs. Instead, it targets providers that spend more than $100 million on purposes other than direct patient care over 10 years. It would mandate that 98 percentof 340B revenues go to direct patient care. It also targets 340B providers with health insurer contracts and pharmacy licenses and those serving low-income Medicaid or Medicare patients that have been dinged with at least 500 high-severity housing violations for substandard or unsafe conditions.

That has placed a bull’s eye on the Los Angeles-based AIDS Healthcare Foundation, a nonprofit that provides direct patient care via clinics and pharmacies in California and other states, including Illinois, Texas and New York. It also owns housing for low-income and homeless people.

A Los Angeles Times investigation found that many residents of AIDS Healthcare Foundation properties are living in deplorable, unhealthy conditions.

Michael Weinstein, the foundation’s president, disputes those claims and argues that Proposition 34 proponents, including real estate interests, are going after him for another ballot initiative that seeks to implement rent control in more communities across California.

“It’s a revenge initiative,” Weinstein said, arguing that the deep-pocketed California Apartment Association is targeting his foundation — and its health and housing operations — because it has backed ballot measures pushing rent control across California. “This is a two-pronged attack against us to defeat rent control.”

Weinstein is locked in a feud with the apartment association, the chief sponsor of the initiative, which has contributed handsomely to pass Proposition 34. Opponents argue that the initiative is “a wolf in sheep’s clothing.”

Weinstein acknowledged to KFF Health News that his nonprofit uses money from 340B drug discounts to support its housing initiatives but argued they are helping treat and house some of the most vulnerable people, who would otherwise be homeless.

The apartment association declined several requests for comment. But Proposition 34 backers say they aren’t going after rent control — or Weinstein and his nonprofit.

Supporters argue that “rising health care costs are squeezing millions of Californians” and say that the initiative would “give California patients and taxpayers much needed relief, and lowers state drug costs, while saving California taxpayers billions.”

If the initiative passes and 340B providers do not spend 98 percent of the revenue on direct patient care, they could lose their license to practice health care and their nonprofit status.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact [email protected].

It’s that time of year again: In most states, the Affordable Care Act’s annual open enrollment season for health plans begins Nov. 1 and lasts through Jan. 15.

Current enrollees who do not update their information or select an alternative will be automatically reenrolled in their current plan or, if that plan is no longer available, into a plan with similar coverage.

Last year marked a record enrollment of about 21 million people. This time around, consumers will find a few things have changed.

Don’t Fall for Advertising Scams

While some health plans offer small-dollar gift cards or other incentives to encourage participation in wellness efforts, they would not offer cash cards worth thousands of dollars a month to help with groceries, gas, or rent. Even so, social media and online sites are rife with such promises.

Such ads are among the avenues allegedly used by unscrupulous brokers who enroll or switch plans without the express permission of consumers, according to a lawsuit filed in Florida.

Also, be cautious about the websites you use to search for coverage.

Type “Obamacare” or “cheap health insurance” into a search engine and often what pops up first are sponsored private sector websites unaffiliated with the official state or federal government marketplaces for ACA coverage.

While they may try to look official, they are not. Many such sites offer various options, including non-ACA coverage with limited benefits, a “secret shopper” study found in 2023. Such non-ACA coverage would not qualify for federal subsidies to help consumers pay premiums.

The fine print on some websites says that consumers who provide personal information automatically consent to be contacted by sales agents via phone calls, emails, text messages, or automated systems with prerecorded messages.

When exploring plans, always start with the official federal marketplace’s website, healthcare.gov.

Even if you don’t live in one of the 29 states served by the federal marketplace, its website provides the link to your official enrollment site when you select your state, or the District of Columbia, from a drop-down list. The federal and state marketplaces also have call centers and other ways to get enrollment assistance. The “find local help” link on healthcare.gov, for example, gives consumers a choice of finding assisters or sales agents near them.

Is It Real Insurance?

Another concern: Regulators are seeing an increase in complaints from consumers about offers of health coverage requiring consumers to join a limited liability corporation, or otherwise attest they are working for a specific company. Indeed, at least two states — Maryland and Maine — have issued warnings, saying that instead of comprehensive ACA coverage, these are often non-ACA products, amounting to a hodgepodge of discount cards, for example, or limited-indemnity plans. This type of plan pays a flat-dollar amount — say, $50 for a doctor visit or $1,000 for a hospital stay — and is meant to buttress more comprehensive coverage, not replace it.

“Unlike major medical plans, some of these self-funded plans only cover preventive services such as a yearly check-up or annual health screening,” the warning from the Maine Bureau of Insurance says.

Premiums Might Be Higher … and Other New Things

Some insurers will lower premium rates for 2025, but many others are increasing them.

Although final numbers are still being crunched, experts estimate a median increase of 7% for premiums, according to an analysis by KFF, a health information nonprofit that includes KFF Health News. Most people who buy ACA coverage are eligible for a subsidy to help with the premiums, which is likely to offset much of the increase, although the higher cost means the government will be paying out more for those subsidies.

Rising health costs — including for hospital care and the new class of weight loss drugs — are contributing to the increase.

Some other changes this open season:

• People often referred to as “Dreamers” because they qualified for the Deferred Action for Childhood Arrivals — a federal program offering some protection to those brought to the country as children without proper immigration documentation — can now enroll in ACA coverage and are eligible for subsidies.
• Short-term plans, which are technically not ACA coverage and not subject to its benefit rules and preexisting benefit protections, can be issued for, at most, only four months of coverage, based on a Biden administration action that took effect with plans starting Sept. 1. It walks back a Trump administration rule that loosened requirements to allow insurers to offer coverage that ranged up to 364 days, and allowed insurers the option of renewing the policies for up to two additional years. Existing plans and those issued before Sept. 1 don’t fall under the new rules. But consumers who relied on the longer periods need to check their plans’ details and consider enrolling in an ACA plan instead to avoid a situation in which their short-term plan expires early or midyear, potentially leaving them unable to get coverage elsewhere for the remainder of the year.

The Sign-Up Process Might Take Longer, Too

Federal regulators this year wrestled with a growing number of complaints — 200,000 in the first six months alone — from consumers who were being enrolled into or switched from ACA plans without their express permission by agents seeking to gain commissions.

To thwart such efforts, they put new rules in place.

What does that mean for most consumers? If you are working with a new agent — one who wasn’t already listed on your ACA plan — you will likely need to get on a three-way call with the federal marketplace to confirm that you are, indeed, authorizing that agent to make changes to your policy for the coming year. Plan on this taking additional time. No one knows how busy the call lines will get during open enrollment.

You don’t need to use a broker to enroll. But sorting through the dozens of options on the marketplace is challenging, so most people do seek assistance. Consumers need to weigh not only the monthly premium cost, but also variations in deductibles and copayments for such things as doctor visits, hospitalization, and drugs.

Shop Around

Experts say another consideration when choosing a plan is to check whether its network includes the doctors and hospitals you typically see, as well as whether its formulary covers your prescription medications, and how much it charges for them.

To help with making comparisons, rules kicked in two years ago requiring insurers to include some “standardized plans” as options, which must all have the same deductibles, and costs for such things as doctor visits, emergency room care, and other consumer cost sharing.

Even so, many people have dozens of options available, which can be daunting.

But one piece of advice remains constant: Whether you are enrolling for the first time or have an existing plan, it’s always worth it to shop around. Even if you don’t change plans, you can make sure the one you have is still your best option.

In most states, consumers must enroll by Dec. 15 to get coverage that begins Jan. 1. Heads up in Idaho, where open enrollment starts earlier — Oct. 15 — but also ends sooner, closing on Dec. 15. In California, New Jersey, New York, Rhode Island, and the District of Columbia, residents can enroll through Jan. 31.

“Donald Trump said he was going to allow Medicare to negotiate drug prices. He never did. We did.”

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 ABC News debate on Sept. 10 in Philadelphia. “He never did. We did.”

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

During the 2016 presidential campaign, Trump repeatedly promised, 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 KFF, a health information nonprofit that includes KFF 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 multiple campaign rallies and media interviews that year, Trump suggested allowing the government to negotiate drug prices directly with manufacturers would save $300 billion a year, a claim a fact-checker said was “absurd” then.

“The problem is, we don’t negotiate,” Trump said during an MSNBC town hall 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 a bill 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,” Trump wrote on X, the social platform then known as Twitter.

Trump pursued smaller initiatives that sought to lower drug costs. One such program, the “most favored nation” 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. CMS officials estimated 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 contemporaneous analysis 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 recent KFF poll 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 KFF 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 spoken publicly 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 KFF 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, “READ: Harris-Trump Presidential Debate Transcript,” Sept. 10, 2024

Axios, “Hill GOP Sets Sights on Scrapping Drug Price Talks,” Sept. 17, 2024

Centers for Medicare & Medicaid Services, “Trump Administration Announces Prescription Drug Payment Model To Put American Patients First,” Nov. 18, 2020

CNN, “READ: Harris and Walz’s Exclusive Joint Interview With CNN,” Aug. 30, 2024

Congress.gov, “H.R.3 – Elijah E. Cummings Lower Drug Costs Now Act,” accessed Sept. 17, 2024

Factbase, “Donald Trump Attends an MSNBC Town Hall in Charleston, South Carolina,” Feb. 17, 2016

Factbase, “Donald Trump in Pawleys Island, SC,” Feb. 19, 2016

Federal Register, “42 CFR Part 513,” Nov. 27, 2020

KFF, “A Status Report on Prescription Drug Policies and Proposals at the Start of the Biden Administration,” Feb. 11, 2021

KFF, “KFF Health Tracking Poll September 2024: Support for Reducing Prescription Drug Prices Remains High, Even As Awareness of IRA Provisions Lags,” Sept. 13, 2024

KFF, “Most People Are Unlikely To See Drug Cost Savings From President Trump’s ‘Most Favored Nation’ Proposal,” Aug. 27, 2020

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

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

KFF 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 KFF and the executive director of its Program on Medicare Policy, Sept. 13, 2024

Reuters, “Federal Judge Blocks Trump Administration Drug Pricing Rule,” Dec. 23, 2020

The Washington Post, “Trump’s Truly Absurd Claim He Would Save $300 Billion a Year on Prescription Drugs,” Feb. 18, 2016

The White House, “Remarks by President Trump at Signing of Executive Orders on Lowering Drug Prices” July 24, 2020

The White House, “Remarks by Vice President Harris at a Campaign Event in Raleigh, NC,” Aug. 16, 2024

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

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

Clarifying the FDA’s Role and Authority Over Direct-to-Consumer Drug Ads

While several inaccuracies in the recent opinion piece about direct-to-consumer prescription drug advertisements by KFF Health News’ Elisabeth Rosenthal have been corrected in response to FDA’s direct requests, in this letter the FDA seeks to provide additional information about the agency’s oversight to readers and correct any misimpressions that may remain (“Perspective: With TV Drug Ads, What You See Is Not Necessarily What You Get,” Sept. 9). The FDA is strongly committed to protecting public health by ensuring prescription drug promotion by or on behalf of a drug manufacturer, distributor, or packer is truthful, balanced, and accurately communicated.

Federal law has long required prescription drug advertisements to present a true statement regarding the side effects, contraindications, and effectiveness associated with the advertised prescription drug (with information relating to major side effects and contraindications referred to as the “major statement” in TV or radio ads). This requirement has been in place for many decades and helps to ensure a truthful and non-misleading presentation of information about the prescription drug, as well as a balanced presentation of safety and efficacy information.

In 2023, the FDA issued a final rule establishing five standards to help ensure that the major statement in ads for human prescription drugs in TV/radio format is presented to consumers in a clear, conspicuous, and neutral manner. The aforementioned article suggests it is unclear how to determine whether an advertisement complies with this rule. However, the rule and the FDA’s plain language guidance pointedly outline specific criteria for each standard in order for the ad to be considered compliant. The FDA believes these standards will help consumers better understand the advertised drug’s side effects, so they are better informed when they participate in health care decision-making. Companies have until Nov. 20, 2024, to bring ads into compliance.

Additionally, the article does not discuss one of the agency’s crucial post-marketing surveillance tools for prescription drug ads. Federal law generally does not require companies to submit promotional communications prior to use, but companies are required to submit ads at the time of initial dissemination. These submissions, in addition to other tools like the Bad Ad program, greatly aid the FDA’s surveillance of promotional activities.

The FDA takes seriously its responsibility to monitor prescription drug ads and to ensure they are compliant with FDA’s applicable laws and regulations. We will continue to monitor and take appropriate action if prescription drug advertisements are found to contain false or misleading information.

— Catherine Gray, director of the FDA’s Office of Prescription Drug Promotion, Washington, D.C.

Jerry Berger, formerly the director of media relations at a Harvard Medical School teaching hospital, shared the article on the social platform X:

And then there’s the matter of how much all that’s spent on these ads affect the pricingWith TV Drug Ads, What You See Is Not Necessarily What You Get https://t.co/HGxkg949UA via @kffhealthnews

— jerrymberger (@jerrymberger) September 9, 2024

— Jerry Berger, Boston

How to Raise the Cybersecurity Bar

I just finished reading the article “Cyberattacks Plague the Health Industry. Critics Call Feds’ Response Feeble and Fractured” (Sept. 19), and while it is on point in terms of the inadequacy of the federal cybersecurity management, I think it should have gone deeper into outlining other creative options to raise the cybersecurity bar among all health care providers. Similar to the adoption of electronic health records, provider cyber-preparedness needs an economic infusion of technology and resources; a “Meaningful Use”-like program if you will (but, hopefully, better defined and implemented!). The federal government also needs to take a more active role in applying “offensive resources” to neutralize threats when they arise and before they expand across the health care ecosystem.

— Robert Swaskoski, vice president of enterprise risk management for Heritage Valley Health System, Sewickley, Pennsylvania

An employee benefits specialist outside Atlanta chimed in on social media:

“Responsibility for the nation’s #healthcare #cybersecurity is shared by three offices within two different agencies.” Maybe that’s part of the problem? Ya think? https://t.co/PF8Sa2F5Ou

— Catherine Collingwood Estes (@collingwest) September 19, 2024

— Catherine Collingwood Estes, Duluth, Georgia

In June 2019, Lija Greenseid handed Minnesota Gov. Tim Walz an empty vial of insulin that her 13-year-old daughter had painted gold.

Greenseid’s daughter has Type 1 diabetes, which means she requires daily injections of manufactured insulin to stay alive. The price of a single vial of insulin rose by about 1,200% between 1996 and 2018, and the gold vial was a reminder, Greenseid said, that this lifesaving pharmaceutical shouldn’t be as expensive as precious metal.

“What I heard is that that gold vial remained on his desk at the governor’s office, and he brought it up throughout that summer and fall when he was trying to talk to legislators to get them moving,” Greenseid said.

Ten months later, in April 2020, Walz signed the Alec Smith Insulin Affordability Act. The law was named after the 26-year-old Minnesotan whose 2017 death from rationing insulin became a catalyst for the patient advocates who turned the high cost of insulin in the U.S. into a national political priority.

Now it’s an issue in the presidential campaign. Both former President Donald Trump and Vice President Kamala Harris and her running mate, Walz, have sought to appeal to the nation’s 8.4 million insulin users and their families by touting policies that make insulin cheaper for some patients.

But advocates for diabetes patients fret that neither presidential candidate would go as far as Walz’s Minnesota law, which helps patients even if they are uninsured, despite the law being under legal attack by the drug industry.

The landscape on insulin pricing has already changed significantly in the past five years. One month after Walz signed the Minnesota law, the Trump administration announced a voluntary program for Medicare prescription drug plans to cap copayments for some insulin products at $35. Two years later, President Joe Biden signed a law requiring all Medicare drug plans to cap copayments for insulin at $35 a month.

Now, amid the current presidential campaign, Harris has proposed extending that $35 cap on insulin copayments to Americans with commercial health insurance.

The Trump campaign’s national press secretary, Karoline Leavitt, touted his efforts on prescription drug prices when he was in the White House, including approval of a pathway for prescription drugs to be imported from Canada as well as the voluntary $35 insulin Medicare copayment cap. But she did not offer new insulin-specific initiatives for his possible second stint as president.

“President Trump will finish what he started in his first term,” Leavitt wrote in a statement.

Copayment caps, which have been enacted by 25 states, are popular policies because they provide an immediate financial benefit that many patients see at the pharmacy, according to University of Southern California economist Neeraj Sood. They’re also relatively easy to implement.

But copayment caps don’t address the high list price of insulin itself, so uninsured patients don’t benefit from such rules. About 1 in 12 Americans lacked health insurance last year.

That’s what makes Minnesota’s insulin safety net different. The system has two parts: an emergency program that allows individuals to get a one-time, 30-day supply of insulin for $35, and a continuing need program that provides insulin to eligible patients for a year at no more than $50 for a 90-day supply.

By contrast, list prices for a 30-day supply of insulin can easily top $215, depending on the insulin.

The bill that created Minnesota’s program was bipartisan out of necessity. Republicans controlled the state Senate at the time, while the Minnesota Democratic-Farmer-Labor Party held the House and governor’s office.

Nicole Smith-Holt, whose son the bill was named after, watched in tears as it finally passed the state legislature in 2020.

“I was happy. I was relieved,” Smith-Holt said. “I was sad that it took Alec dying to get to the point where people could walk into the pharmacy and pick up their prescription for an affordable price.”

But because Minnesota’s program requires insulin manufacturers to provide the insulin, it has prompted a backlash from manufacturers. Pharmaceutical industry lobbying group PhRMA filed a lawsuit in 2020 to block the Minnesota law, arguing it violates the “takings clause” of the U.S. Constitution, which says private property can’t be taken for public use “without just compensation.”

That suit is ongoing, yet the state program is up and running and by the end of 2023 it had been used over 1,500 times.

PhRMA spokesperson Reid Porter said his group is committed to helping patients afford medicines. Insulin makers voluntarily dropped list prices last year and now offer patient assistance programs for affording the drugs. And the CEO of insulin maker Eli Lilly first proposed the voluntary Medicare copay cap Trump announced in 2020.

Porter said insulin costs have been driven up by insurance companies and pharmacy benefit managers, also known as PBMs — the middlemen between insurance plans or employers and drug manufacturers — when they pocket the discounts from the list price of drugs that they negotiate with manufacturers.

“Minnesota’s insulin program does not solve this problem and is unconstitutional,” Porter said. “This is not how the system should work, and why it’s critical that policymakers should prioritize reforming the PBM system, a solution that puts patient health over politics.”

In 2021, Sood co-authored a study that found that, despite insulin list prices rising between 2014 and 2018, income received by drugmakers decreased while increasing for intermediaries like PBMs and pharmacies.

In September, the Federal Trade Commission announced a lawsuit against the nation’s three biggest PBMs, alleging they created a system that inflated insulin prices. The companies denied the claims.

Jing Luo, a physician at the University of Pittsburgh, said that regardless of who wins in November he doesn’t expect existing insulin policies like Medicare’s popular copay cap to be rolled back, due in part to the advocacy of people like Smith-Holt and Greenseid.

“They’ve been really effective at tying high insulin prices with really bad, morally repugnant outcomes,” Luo said.

The key in Minnesota was including real stories, Greenseid said.

“We had enough real people who reached out and had conversations and helped to show politicians the extent of the problem,” Greenseid said, “and they listened.”

The Host

Congress has left Washington for the campaign trail, but after the Nov. 5 general election lawmakers will have to complete work on the annual spending bills for the fiscal year that starts Oct. 1. While the GOP had hoped to push spending decisions into 2025, Democrats forced a short-term spending patch that’s set to expire before Christmas.

Meanwhile, on the campaign trail, abortion continues to be among the hottest issues. Democrats are pressing their advantage with women voters while Republicans struggle — with apparently mixed effects — to neutralize it.

This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of Politico and the Johns Hopkins schools of nursing and public health, Alice Miranda Ollstein of Politico, and Lauren Weber of The Washington Post.

Among the takeaways from this week’s episode:

• When Congress returns after the election, there’s a chance lawmakers could then make progress on government spending and more consensus health priorities, like expanding telehealth access. After all, after the midterm elections in 2022, Congress passed federal patient protections against surprise medical billing.
• As Election Day approaches, Democrats are banging the drum on health care — which polls show is a winning issue for the party with voters. This week, Democrats made a last push to extend Affordable Care Act subsidies expanded during the pandemic — an issue that will likely drag into next year in the face of Republican opposition.
• The outcry over the first reported deaths tied to state abortion bans seems to be resonating on the campaign trail. With some states offering the chance to weigh in on abortion access via ballot measures, advocates are telling voters: These tragedies are examples of what happens when you leave abortion access to the states.
• And Sen. Bernie Sanders of Vermont summoned the chief executive of Novo Nordisk before the health committee he chairs this week to demand accountability for high drug prices. Despite centering on a campaign issue, the hearing — like other examples of pharmaceutical executives being thrust into the congressional hot seat — yielded no concessions.

Plus, for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: KFF Health News’ “Across North Carolina, Medical Debt Exacts a Heavy Toll,” by Ames Alexander, The Charlotte Observer, and Noam N. Levey.

Lauren Weber: Stat’s “How the Next President Should Reform Medicare,” by Paul Ginsburg and Steve Lieberman. 

Joanne Kenen: The Atlantic’s “The Woo-Woo Caucus Meets,” by Elaine Godfrey. 

Alice Miranda Ollstein: Stat’s “How Special Olympics Kickstarted the Push for Better Disability Data,” by Timmy Broderick.

Also mentioned on this week’s podcast:

To hear all our podcasts, click here.

And subscribe to KFF Health News’ “What the Health?” on Spotify, Apple Podcasts, Pocket Casts, or wherever you listen to podcasts.

Former president Donald Trump and Vice President Kamala Harris are both eager to take on high drug prices, leaving pharmaceutical companies on the defensive as they spend millions of dollars this election season.

When Harris was California’s attorney general, she joined cases that resulted in almost $7.2 billion (about $22 per person in the United States) in fines for drug companies. In that role, she was an aggressive regulator of the drug industry. In her current position, she cast the tiebreaking Senate vote in 2022 for legislation that allows Medicare to negotiate drug prices for its more than 60 million beneficiaries.

As president, Trump also was willing to challenge GOP orthodoxy by taking action to combat high drug costs. His administration sought to lower the prices Medicare pays for drugs through a proposal that the PwC Health Research Institute estimated would cost five drugmakers as much as $500 million a year. What was known as the “most favored nation” interim final rule was blocked because of legal challenges and rescinded by the Biden administration.

In addition, Trump issued a rule setting up a path to import drugs from Canada and other countries, with Florida this year becoming the first state to get federal approval to do so.

If elected, the Harris-Walz ticket appears more likely to be successful on drug pricing than Trump, whose policies were more disjointed, said Sergio Jose Gutierrez, a political strategist who has worked primarily with Democrats.

“His efforts were largely fragmented and faced resistance from both the industry and lawmakers,” Gutierrez said.For example, he said Trump promoted the executive order on international prices to tie certain Medicare drug costs to their prices overseas. But the final rule spurred four industry lawsuits and never went into effect.

The Biden administration successfully implemented a strategy of negotiating prices for top-selling Medicare drugs, even as lawsuits have been filed to stop the program.

Another shift in the pharmaceutical industry is emerging in its political contributions. An industry that gave three or four times as much to GOP candidates as to Democrats in the 1990s and early 2000s is now hedging its bets. So far in the 2024 cycle, drug companies have given $4.89 million to Democrats and $4.35 million to Republicans, according to OpenSecrets, a nonpartisan research group.

Harris has received $518,571 from the industry, and Trump has received $204,748.

Catherine Hill, a spokeswoman for Pharmaceutical Research and Manufacturers of America, or PhRMA, said the industry trade group looks forward to collaborating with any future presidential administration.

She criticized the Biden administration’s plan for Medicare price negotiation and Trump’s plan to align U.S. prices with those in foreign countries. Last month, the Biden administration announced new, reduced prices for 10 drugs in the program following negotiations between the federal government and drugmakers. The lower costs take effect in 2026.

“Previous price controls adopted by the Biden administration threaten to stifle that innovation,” Hill said. “Undermining intellectual property protections and borrowing other countries’ price controls will further undercut innovation and threaten patients’ access to medicine.”

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