Linda Hennis was checking her Medicare statement in January when she noticed something strange: It said a company she had never heard of had been paid about $12,000 for sending her 2,000 urinary catheters.

But she had never needed or received catheters.

Ms. Hennis, a retired nurse who lives in a Chicago suburb, noted that the company selling the plastic tubes was called Pretty in Pink Boutique and was based in Texas. “There's been a mistake here,” Mrs. Hennis remembered thinking.

She is one of more than 450,000 Medicare beneficiaries billed for urinary catheters in 2023, up from about 50,000 in previous years, according to a new report from the National Association of Accountable Care Organizations, an advocacy group that represents hundreds of health care organizations. systems throughout the country. The report used a federal database of Medicare claims available to researchers.

The massive increase in catheter billing included $2 billion billed by seven major suppliers, according to that analysis, potentially accounting for nearly a fifth of all Medicare spending on medical supplies by 2023. Doctors, insurance departments and health care groups near The country said the spike in claims for never-delivered catheters indicated a far-reaching Medicare scam.

“We think it's outrageous,” said Clif Gaus, executive director of the group that conducted the analysis.

Dara Corrigan, who heads Medicare's Center for Program Integrity, declined to say whether the agency was investigating the catheter bills. When the federal government suspects fraud, it sometimes holds payments in an escrow account while it reviews the claims. But she does not want to say whether this also happened for the catheter payments.

“We do all of this behind the scenes to ensure the integrity of the investigation,” Ms. Corrigan said, speaking generally about the agency's process. She described Medicare billing scams as “one of these problems that is always present and always frustrating.”

Pretty in Pink Boutique, which billed Medicare at least $267 million for catheters between October 2022 and December 2023, could not be reached by phone.

Medicare billing scams can have far-reaching consequences. Even if patients don't pay the bills themselves, increased spending by the government insurance program could increase the premiums paid by enrollees in the future.

Catheters and other medical supplies are often targeted by billing systems. Last April, the federal government released prosecution against 18 defendants who submitted bills for non-existent coronavirus testing and other pandemic-related services. And in 2019, the Justice Department said it did split up an international fraud ring involving more than $1 billion in counterfeit invoices for back and knee braces.

Medical supply companies are easy to set up and the bar for proving medical necessity is relatively low. The companies “don't need much to show why grandma needs a urinary catheter,” said Eva Gunasekera, who previously led a health care fraud investigation at the Justice Department.

Patients and doctors who have been reporting mysterious claims about catheters to Medicare for months say they are frustrated by a lack of communication from the government about whether billions of dollars have been lost in ongoing billing scams.

One of the advocacy group's members, Dr. Bob Rauner, leads a large network of physicians in Nebraska. In an interview, he said his patients had collectively billed nearly $2 million for phantom catheters in 2023. (He tracks such expenses because his organization gets bonus payments from Medicare when patients have good health outcomes with low overall medical expenses.)

“I just know it's all fraud because our doctor didn't order it and our patient never got it,” said Dr. Rauner, who filed a complaint with the Federal Department of Health's Office of Inspector General in mid-December .

The vast majority of the suspicious claims identified by the new analysis came from seven companies, many of which have shared executives, according to public documents and the advocacy group's report. Only one of the companies had a working phone number and a request for comment was not returned. The remaining numbers were closed, went to different companies or in one case went to a previous owner.

Pretty in Pink Boutique is registered with Medicare to a home address in El Paso. The phone number goes to an auto body shop called West Texas Body and Paint, where an employee answering a reporter's call said the store gets calls “all day, every day” from Medicare participants concerned about fraudulent bills.

Pamela Ludwig runs an unrelated business in Nashville called Pretty in Pink Boutique. She has had so many catheter complaints that she… added a page on her website and explained that her company was not part of a scam.

“There are people calling me, swearing and shouting,” Ms Ludwig said. “They feel violated.”

She filed a complaint with Medicare in September, she said, but the barrage of calls hasn't stopped. In November, her husband heard from a New York City banker who said several men had come to his office asking if they wanted to open an account for Pretty in Pink Boutique. “He asked if we had sold our business recently,” Ms. Ludwig said.

The issue came onto the Oklahoma Insurance Department's radar in July as it investigated fraudulent Medicare claims for Covid-19 test kits. Officials also noted a surprisingly high number of claims for catheters.

“When we asked seniors, they told us they had never used urinary catheters and didn't know why these claims were happening,” said Ray Walker, chief of the department's Medicare division. Since then, he estimates that at least 70 Medicare beneficiaries have filed complaints about catheter claims, including one just this week.

In Illinois, Travis Trumitch said he reported four cases of possible catheter fraud to the federal Department of Health's inspector general after his group, the Illinois Senior Medicare Patrol, fielded more than a dozen calls from Medicare beneficiaries. The group is part of a national network that warns older adults about federal health insurance scams.

It is unclear how the catheter companies obtained the Medicare accounts of so many people, but Mr. Trumitch said some people told him they had previously received phone calls asking them for their Medicare identification number. Others said they had not received any calls but suspected their names had been obtained through data breaches.

Suzanne Gustafson, 76, filed a complaint with Medicare last month after noticing a suspicious payment of about $4,000 to a New York company. She also saw a similar charge on her husband's account. And when she posted on Facebook, wanting to raise awareness, another friend reached out and said she had been hit with a similar charge.

Ms. Gustafson speculated that the company could have obtained her Medicare information from a data breach at a hospital she had gone to in Louisville, Kentucky. This wasn't Ms. Gustafson's first encounter with suspicious Medicare billers: Last year, she said, she was incorrectly billed for coronavirus tests she never ordered or received.

Ms. Hennis said she does not know how her information reached the Pretty in Pink Boutique. When she reported the improper billing to Medicare, she said, she was told someone had created a second Medicare account in her name and billed the catheters to the new account.

“I hate the idea of ​​anyone ripping off Medicare,” she said. “Many of us rely on it. It's just ethically wrong.”

It's the best news that few people seem to know: Prescription drug costs have fallen for more than a million seniors this year — in many cases by thousands of dollars.

The lower costs are the result of the Inflation Reduction Act, or IRA, which was signed into law by President Biden in 2022 and is best known for investing more than $370 billion in climate and energy programs. The changes to Medicare, which will help people enrolled in the prescription drug coverage plans known as Part D, are significant. Still one recent research by the non-profit organization KFF found that most Americans were unaware of it.

The changes started last year with a $35 monthly cap on the cost of insulin for diabetes patients and free vaccines. This year, a $3,300 annual copayment goes into effect because people covered by Part D will no longer have to pay 5 percent of the cost of brand-name drugs once they reach that spending level. Another provision punishes pharmaceutical companies for price increases that exceed the rate of general inflation. And the IRA expands eligibility for financial assistance to include Part D costs for low-income seniors.

The law also authorized Medicare to negotiate prices for expensive drugs with pharmaceutical companies for the first time. The first negotiations will concern ten medicines, including the blood thinners Eliquis and Xarelto and the diabetes medicines Jardiance and Januvia. The effect of these talks is uncertain, and they have already led to lawsuits by drug makers.

The stronger vaccine coverage eliminates cost sharing for all the many vaccines covered by Part D. Vaccines for Covid-19, the flu and some other conditions are covered under Part B (which covers outpatient care). Some withdrawals previously had high out-of-pocket costs. For example, patients paid an average of $77 in 2021 for the vaccine that prevents shingles. federal data.

In 2025, there will be two more important changes: a beneficiary's total out-of-pocket expenses will be capped at $2,000, and people will be able to spread their own costs year-round by setting up a monthly payment plan with their Part D insurance companies.

The new out-of-pocket cost caps will save thousands of dollars for those taking expensive medications for conditions such as cancer and multiple sclerosis. In many cases, Medicare beneficiaries have paid tens of thousands of dollars for their medications. In 2020, 1.4 million People who did not receive low-income subsidies had annual out-of-pocket costs of $2,000 or more, according to KFF, which focuses on health policy.

“The prescription drug reforms in this law mark the most substantive changes to the Medicare D program since the introduction of the prescription drug benefit in 2006,” said Tricia Neuman, senior vice president of KFF.

But even among people eligible for Medicare (65 years or older), awareness of these changes is low. The KFF survey found that only 25 percent were aware of annual out-of-pocket cost caps. And only 8 percent were aware of the penalties for price increases that exceed inflation.

“Someone who is taking a very expensive drug will probably be very grateful that their costs go down this year,” said Dr. Neuman. “But really, no one understands why they pay what they pay for drugs, so it's no surprise that people don't know these improvements have gone into effect or don't attribute it to the Inflation Reduction Act.”

I pay almost $17,000 in a year

David Mitchell is among those who will benefit from the changes. In November 2010 he was diagnosed with multiple myeloma, an incurable cancer, but one that can be treated with very expensive drugs. Mr. Mitchell was 60 when he was diagnosed and ran a communications company he co-founded in Washington, D.C. His company's health insurance covered the medications he needed, although his out-of-pocket costs escalated sharply over the years.

After an initial round of treatment, Mr. Mitchell went into remission and then began a maintenance regimen of more than five years, including expensive cancer drugs. Mr. Mitchell knew the healthcare industry well; his communications company worked with numerous industry clients and also ran public health campaigns. And, he said, he was growing increasingly angry because most patient organizations involved in the drug price debate were accepting funding from drug and medical device companies, creating conflicts of interest.

As he learned more about the way drugs are priced, Mr. Mitchell became convinced of the need for a patient advocacy group. “One morning in the summer of 2016, I woke up and had an epiphany: If no one else is going to do this, maybe you should try it,” he said. He quit his business that year and started Patients for affordable medicines, a national organization funded solely by individuals and foundations. The organization urged the passage of the IRA

When he retired at age 66, Mr. Mitchell enrolled in Medicare. Then he started to experience the problem of the expensive drugs in the program. In addition to his cancer, he is also being treated for atrial fibrillation. Some of the medications he takes fall under Part B because they are administered in a health care setting. Others are covered by Part D, and last year he paid $16,916 for all his medications. Most of that amount was for just one of his current cancer drugs, Pomalyst.

This year is different because of the new out-of-pocket cap. “I filled my first prescription and it cost $3,308, and I'm done for the year now,” he said.

Some patients may be just beginning to understand the cap's importance, said Frederic Riccardi, president of the Medicare Rights Center, an advocacy and consumer group. “They may have faced high costs in January, but we have clients with chronic conditions who are taking very expensive prescription drugs and realizing significant savings,” he said. “During fall registration last year, we helped one person take a life-saving medication that will save more than $15,000 this year.”

The stronger out-of-pocket protections come at a time when other Medicare costs are rising. The standard Part B premium rose 5.9 percent this year to $174.70, and the deductible rose $14 to $240.

Part D premiums are also increasing. KFF estimated that Medicare recipients who enrolled in a standalone Part D plan and did not switch providers this year experienced an average 21 percent premium increase, to $48 per month. (Medicare Advantage enrollees are not affected, as most do not pay a separate premium for drug coverage.)

The increase is partly due to the higher plan costs expected by insurers under the enhanced protections for patients in the IRA. But the stronger insurance protections benefit everyone who participates in Part D, Dr. argued. Neuman. “The whole point of insurance is to protect people with the highest costs, and that could be any of us tomorrow,” she said.

Help for low-income seniors

Another important change expands access to federal subsidies that help low-income seniors with their Part D premiums, deductibles and cost sharing by raising income limits. The subsidy, called Extra Help, amounts to: worth approximately $5,300 per year for people who sign up for it, according to the Social Security Administration, which administers the program.

This year, annual income must be less than $22,590 for an individual, or $30,660 for a married couple; assets must be less than $17,220 for an individual, or $34,360 for a married couple.

The program is a key feature of Part D. In 2020, 13.1 million Medicare beneficiaries received full or partial Extra Help benefits, representing 28 percent of all enrollees that year. according to KFF.

This year, the expanded benefit was automatically extended to nearly 300,000 low-income people on Medicare, but Medicare estimates another three million people could benefit from the expansion. The program is national and the application is available online.

Another important source of assistance is the Medicare Savings Programs, which help low-income people pay Part B premiums and some other costs. The programs are available nationwide and administered by state Medicaid agencies, but they are often underutilized because few know about them and because they have complex applications. Some states have expanded eligibility.

Federal funding helps community organizations like the State Health Insurance Assistance Program to conduct outreach and enroll eligible beneficiaries. But that funding requires periodic renewal and was excluded from the current federal spending resolution, which expires in early March.

The under-enrollment problem largely stems from a lack of awareness, said Mr. Riccardi of the Medicare Rights Center. “We need consistent education about these programs, especially for people new to Medicare.”

The leading contenders for the 2024 presidential election have accused each other in recent weeks of endangering Social Security and Medicare, key entitlement programs for seniors.

The future of the programs has been fodder for endless political debate – and disruption – because of the long-term financial challenges they face.

Social Security’s main trust fund is currently projected be exhausted by 2033, meaning the program would then only be able to pay about three-quarters of the total planned benefits. For its part, Medicare is at risk of not having enough money to fully pay hospitals in 2031.

President Biden, former President Donald J. Trump, Nikki Haley, the former governor of South Carolina, and Governor Ron DeSantis of Florida are among the candidates targeting these vulnerabilities, often by referencing each other’s past positions.

Here’s a fact check.

WHAT WAS SAID

“Trump in 2020: we are cutting social security and healthcare”
– Biden campaign in a Social media post from December including a clip of Mr Trump

This is misleading. The Biden campaign has repeatedly claimed that scaling back the programs is one of Mr. Trump’s policies. But while Mr. Trump has suggested in the past that he might pursue entitlement cuts, he has repeatedly pledged during his campaign to protect the programs.

In this case, the Biden campaign shared a short clip of Mr. Trump during the campaign a Fox News town hall in March 2020 and ignored his clarification at the time.

The clip shows a Fox News host, Martha MacCallum, telling Trump, “If you don’t cut back on rights, you’re never really going to pay off the debt.”

“Oh, we’re going to have cuts, but we’re also going to have growth like you’ve never had before,” Mr. Trump responded.

The Trump administration immediately walked back his comments, saying he was referring to deficit reduction. “I will protect your Social Security and Medicare, just as I have done for the past three years,” Mr. Trump said wrote in a message one day later.

During his time in office, Trump has proposed some cuts to Medicare — though experts said the cost savings would not significantly affected benefits – and to social security programs for people with disabilities. They are not established by Congress.

Like other candidates, including Mr. Biden, Mr. Trump has shifted his positions over time. In a book from 2000 Mr. Trump suggestedfor people under 40, raising the age for receiving full social security benefits to 70. said it was open on the idea of ​​privatizing the program, even though he didn’t like the concept. He no longer promotes these positions.

The former president became president last January said in a video that “under no circumstances should Republicans vote to cut even a cent from Medicare or Social Security.” But he has not outlined a clear plan to keep the programs solvent. The Trump campaign did not respond to a request for comment.

Mr. Trump proposed last month that the government could prevent any changes to social security by expanding drilling in the United States, but experts say this is not feasible.

“Spending current oil and gas lease revenues on Social Security would cover less than 4 percent of the deficit, and it would be impossible to fix Social Security even if all federal land was opened for drilling operations,” According to the Committee for a Responsible Federal Budget.

WHAT WAS SAID

“And unlike Ron DeSantimonious, we will always protect Social Security and Medicare for our wonderful seniors. He wanted to destroy Social Security and Medicare.”
– Mr. Trump at a campaign rally in mid-December

This is misleading. While in Congress, Mr. DeSantis supported budget frameworks that proposed raising the full retirement age for Social Security to 70 but leaving the early retirement age the same. As a presidential candidate, he has said he would not cut Social Security benefits for seniors, but has sometimes expressed openness to changes for young people, without specifying what they are.

Currently employees are eligible for their full benefits at their full retirement age, which ranges from 66 to 67 depending on year of birth. But recipients can qualify for reduced benefits as early as age 62.

As a Florida congressman, Mr. DeSantis did just that vote for Republican budget proposals – which in themselves would not have changed the law – that supported gradually raising the full retirement age for social security to 70 years. The proposals did not call for a change to the early retirement age.

The proposals too called for changes to Medicare, including by eventually raising the retirement age from 65 to 67 or 70, and by transitioning the program to ‘premium support’, in which the government would offer payments for seniors to purchase various health care plans.

Mr. DeSantis has not made clear his plans for Medicare as he runs for president, but he has often rejected the idea of ​​changing Social Security. “As Republicans, we’re not going to mess with Social Security, I think that’s pretty clear,” he says said in March.

That said, he has indicated he is open to adapting the program for youth. In a Interview in July on Fox News, Mr. DeSantis said: “Talking about making changes for people in their 30s or 40s so that the program is viable, you know, that’s a whole different thing, and that’s something that I think needs discussions will be. on.”

The DeSantis campaign did not respond to a request for comment.

WHAT WAS SAID

“Nikki Haley, she has claimed that the retirement age is way, way, way too low. That’s what she said. So you have a lot of people who have worked hard all their lives. Life expectancy is declining in this country. It’s tragic, but it’s true. So if you look at those demographic trends and say you would ramp it up so people can’t get benefits. I mean, I don’t know why she says that.’
– Mr. DeSantis last month on CNN

This needs context. Life expectancy in the United States fell during the coronavirus pandemic, but is slowly rising again. And Ms. Haley has only called for changes to Social Security for younger people — similar to what Mr. DeSantis himself has entertained.

“The way we deal with it is we don’t touch anyone’s pension or anyone who has been promised an appointment, but we go to people, like my children in their 20s, when they come into the system, and we say, ‘The rules have changed,” Ms. Haley said in an interview in August with Bloomberg. “We are changing the retirement age to reflect life expectancy.”

Ms. Haley did not specify what the new retirement age should be. “What we do know is that 65 is way too low, and we need to increase that,” she said when pressed. “We have to do it according to life expectancy.”

Ms. Haley also called for determining benefit adjustments based on inflation, instead of the current cost-of-living calculation, and limiting benefits for the wealthy.

As for Medicare, Ms. Haley has proposed expanding it Medicare Benefitwhere private companies provide plans and are paid by the government to cover the beneficiary.

But before 2023, the government was projected to spend $27 billion more on Medicare Advantage plans than if these enrollees were in traditional Medicare. Experts note that expanding Medicare Advantage while achieving overall savings would require structural changes that would be politically challenging to implement.

“It would require a change in payment policy, which would likely be met with fierce opposition,” said Tricia Neuman, a senior vice president at the nonprofit KFF and executive director of the program on Medicare Policy.

Curious about the accuracy of a claim? Email factcheck@nytimes.com.

As he challenges President Biden on the long term, Rep. Dean Phillips says he’s had an epiphany about America’s health care policy.

Gone is his long-standing skepticism about the implementation of a single-payer national health care system. Now Mr. Phillips, a moderate Democrat from Minnesota, is embracing the “Medicare for All” proposal, which was championed in two presidential campaigns by Senator Bernie Sanders — whose former top aide is now advising Mr. Phillips’ campaign.

Mr. Phillips said in an interview on Tuesday that he would join as a cosponsor of a House proposal that would expand Medicare by creating a national health insurance program available to all Americans, a shift that comes seven weeks into a presidential campaign that has took place. have not yet shown significant progress in public opinion polls.

“I was a good example of someone who was convinced by propaganda that it was a nonsensical left-wing idea,” Mr. Phillips said. “It’s not. It really isn’t. And that, I think, is part of my migration, if you will, a migration of understanding and due diligence and intellectual curiosity and, most importantly, listening to people..”

Embracing the House bill is a low-stakes maneuver. Now that Republicans are in control of the House, it is unlikely that it will be voted on. Even when Representative Nancy Pelosi of California was speaker, Democrats never voted on Medicare for All proposals championed by their progressive caucus — largely because President Biden did not support such a move, and centrist Democrats believed it was also a bridge. far.

Mr. Phillips — who spoke in the interview by videoconference, from an onscreen profile that identified him as “Generic Democrat” in a sly nod to the top performer in the polls — argued that his recent evolution on health care was not an attempt to outflank Mr. Phillips. Biden from the left.

Instead, he said, he has become convinced that expanding Medicare, the government-run insurance program for the elderly, to all Americans would ultimately save the federal government money and attract support not just from progressives but also from conservatives – including backers. from former President Donald J. Trump.

“This is absolutely not a Hail Mary,” Mr Phillips said. “It’s not an olive branch to progressives. Do you know what it really is? It is an invitation to Trumpers.”

Biden’s campaign spokesman, Kevin Munoz, declined to comment on Mr. Phillips.

Mr. Phillips, a businessman who became wealthy and helped run his family spirits distilling empire and later helped build a gelato giant, is the former chairman of Allina Health, one of Minnesota’s largest health care systems. He said his beliefs began to change about a decade ago, when his daughter Pia, then 13, was diagnosed with Hodgkin’s lymphoma, and he “saw the divide between the haves and the have-nots.”

In July 2020, as a first-term congressman, he embraced a “public state option” that would allow Americans to purchase Medicaid. More recently, he said, he has consulted with Rep. Pramila Jayapal of Washington, the chair of the Congressional Progressive Caucus, who is a House Medicare’s lead sponsor for all billssupported by more than half of Democrats in the House of Representatives.

Mr. Biden has shifted the Democratic conversation on health care away from the idea of ​​a single-payer plan, focusing instead on narrower issues such as lowering drug costs and improving maternal health.

“This is not a serious proposal as it stands,” Leslie Dach, chairman of the health care group Protect Our Care and a former Obama administration official, said of Mr. Phillips’ move. “We live in an age where it takes all our energy to protect what we have from Republicans in Congress.”

Mr. Phillips has not gained much traction. A poll last month from CNN and the University of New Hampshire found that he had support from about 10 percent of likely Democratic primary voters in New Hampshire, the only state where he has a campaign apparatus. Mr. Biden’s name will not appear on the ballot there, but the same CNN poll found that 65 percent of voters said they would write in his name.

Mr. Phillips said he hoped to do well in New Hampshire before moving to Michigan, where Mr. Biden’s approval ratings have taken a hit in recent polls from black and Arab-American voters who have rejected his support for Israel in its war against Hamas.

But Mr. Phillips offered little clarity between himself and Mr. Biden on that conflict, which has left Democratic voters fiercely divided. The congressman said he would not call for an immediate ceasefire and that he does not consider Israel “an apartheid state,” as many on the left claim.

Still, Mr. Phillips claimed that Democrats were so disenchanted with Mr. Biden that if given another option, they would accept it.

“The good news is that 66 percent of the country doesn’t hate me yet,” Phillips said, criticizing the president’s dismal approval ratings. “America has already made up its mind about President Biden and Vice President Harris.”

The pharmaceutical industry, which suffered an embarrassing defeat last year when President Biden signed a bill authorizing Medicare to negotiate the price of some prescription drugs, is now waging a broad assault on the measure — just as negotiations are about to begin.

The bill, the Inflation Reduction Act, is a signature legislative achievement for Mr Biden, who boasted that he took on the drug industry and won. Medicare is the federal health insurance program for the elderly and disabled; the provisions that allow it to negotiate prices are expected to save the government an estimated $98.5 billion more than a decade while lowering insurance premiums and out-of-pocket costs for many older Americans.

On Tuesday, Johnson & Johnson became the latest drugmaker to take the Biden administration to federal court in an attempt to halt its drug pricing program. Three other pharmaceutical companies — Merck, Bristol Myers Squibb And Astellas Pharma – have filed their own lawsuits, as have the the industry’s most important trading group and the American Chamber of Commerce.

The lawsuits make similar and overlapping claims that the drug pricing provisions are unconstitutional. They are scattered in federal courts across the country — a tactic that experts say gives the industry a better chance of securing conflicting rulings that will accelerate legal challenges to a business-friendly Supreme Court.

The legal push comes just weeks before the Centers for Medicare & Medicaid Services releases a long-awaited list of the first 10 drugs to be negotiated. The list will be out on September 1; the makers of the selected drugs have until October 1 to announce whether they will participate in the negotiations – or face heavy financial penalties if they fail to do so. The lower prices will not take effect until 2026.

Earlier this month, the chamber asked a federal judge in Ohio to issue an injunction that would block all negotiations while the case is heard.

Lawrence O. Gostin, a public health law expert at Georgetown University, said the Supreme Court could be sympathetic to some of the industry’s arguments. In particular, he pointed to a claim by drug companies that by requiring them to negotiate or pay a fine, the law violates the Fifth Amendment’s prohibition against taking private property for public use without just compensation.

“The Supreme Court is openly hostile to any alleged violation of the Fifth Amendment,” Mr. Gostin said, adding, “I wouldn’t be at all surprised if these cases go to the Supreme Court and have them strike it down.”

For Mr. Biden and his fellow Democrats, that would be a painful blow. The president and Democrats have long campaigned to lower drug prices and plan to make it a central theme of their 2024 campaigns. White House press secretary Karine Jean-Pierre said in a statement that Mr. Biden was confident the administration would win in court.

“For decades, the pharma lobby has blocked efforts to get Medicare to negotiate lower drug costs,” she said. “President Biden is proud to be the first president to defeat them.”

Republicans oppose the drug pricing provisions, which they view as a form of government price control. But the politics of the issue are treacherous to them. Because so many Americans are concerned about high drug prices, it’s hard for Republicans to defend the industry, said Joel White, a Republican strategist with expertise in health policy.

Instead, Republicans are focusing on another drug industry priority: scrutinizing the practices of pharmacy administrators, who negotiate prices with drug companies on behalf of health plans. The drug companies say that the pharmacy benefit administrators contribute to the high cost of prescription drugs by taking a middleman.

For drugmakers, the stakes of the legal challenges extend beyond their dealings with Medicare, their largest customer. The industry fears that Medicare will effectively set the bar for all payers, and that once the government’s lower prices are made public, pharmacy benefit administrators negotiating on behalf of the privately insured will have more clout to demand bigger discounts.

Along with its legal campaign, the pharmaceutical industry is on a PR offensive. The industry group that filed one of the lawsuits, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, is running ads aimed at pharmacy fee administrators and industry executives are publicly claiming that drug pricing provisions will lead to fewer cures. The implication is clear: lower prices will put a dent in revenue, which will discourage companies from developing certain drugs.

“You can’t take hundreds of billions of dollars out of the pharmaceutical industry and expect it to have a real impact on the industry’s ability to develop new treatments and treatments for patients,” said Robert Zirkelbach, an executive vice president at PhRMA. He quoted an analysis funded by the drugmaker Gilead Sciences that claimed the industry would lose $455 billion over seven years if companies negotiated with Medicare.

An investigation released last month which was funded by the Biotechnology Innovation Organization, another trade group, warned that the pricing policies would discourage innovation, resulting in as many as 139 fewer drug approvals over the next 10 years.

But that assessment is at odds with an analysis by the Congressional Budget Office, which estimated the law would result in just one fewer drug approval in a decade and about 13 fewer drugs over the next 30 years.

In addition, many new drugs offer “no clinically meaningful advantage over existing drugs,” said Ameet Sarpatwari, an expert in pharmaceutical policy at Harvard Medical School. The Inflation Reduction Act, he said, could encourage companies to focus more on breakthrough therapies, rather than so-called me-too drugs, because the law requires the government to consider the clinical benefit of drugs when determining the price Medicare will pay for them.

Until now, Medicare has been explicitly barred from directly negotiating prices with drugmakers — a condition the industry demanded in exchange for supporting the creation of Part D, the Medicare prescription drug program, signed into law 20 years ago by President George W. Bush.

Under the Inflation Reduction Act, the government will select an initial set of 10 drugs for price negotiations based on how much the Part D program spends on them. More drugs will be added in the coming years.

Experts expect the initial drug list of commonly prescribed drugs such as the blood thinners Eliquis and Xarelto; anticancer drugs such as Imbruvica and Xtandi; Symbicort, which treats asthma and chronic obstructive disorder; and Enbrel, for rheumatoid arthritis and other autoimmune diseases.

Medicare already pays discounted prices for those drugs. In 2021, the most recent year for which data is available, Medicare spent about $4,000 per patient on Eliquis and Xarelto, which at the time had sticker prices of $6,000 per year. The lower price reflects rebates obtained from drug makers by pharmacy benefit administrators negotiating on behalf of the private companies contracted with the government to administer Part D plans.

But those negotiations are opaque and only modestly reduce Medicare spending. The rationale behind the drug pricing provisions of the Inflation Reduction Act is that because Medicare covers so many people, it can use its clout to get even bigger discounts.

The United States spends more on drugs per person than peer countries, in part because other countries proactively monitor drug pricing. Surveys show that many Americans are refraining from taking their medications because they cannot afford them.

Experts say the Medicare negotiation program is likely to translate into direct savings for seniors, initially in the form of lower premiums enabled by lower drug spending. And when lower prices take effect in 2028 for drugs administered at clinics and hospitals under another Medicare program, known as Part B, that could mean lower out-of-pocket costs for seniors covered by traditional Medicare who don’t have supplemental insurance.

Supporters of the Inflation Reduction Act say the negotiations will not only save money for the government and patients, but also bring much-needed transparency to the complicated process of setting drug prices. If a company refuses to negotiate, it must either pay a hefty excise tax or withdraw all its drugs from both Medicare and Medicaid.

“This is not a ‘negotiation,'” Merck said in his complaint. “It amounts to extortion.”

Taken together, the lawsuits represent a variety of constitutional arguments. In addition to claiming that the government violates the Fifth Amendment by improperly taking property, they include claims that the law violates the First Amendment by forcing drug companies to agree in writing to negotiate a “fair price.” Another argument is that the excise tax amounts to an excessive fine prohibited by the Eighth Amendment.

“If the government can impose price controls on pharmaceutical companies in this way,” said Jennifer Dickey, deputy lead attorney in the chamber’s legal division, “the same thing could happen to every sector of our economy.”

Biden administration officials say there is nothing mandated by law. They argue that the companies are free not to negotiate and that they can issue press releases or make other public statements disagreeing with the negotiated price. And they note that the government routinely negotiates the purchase of other products and that the Department of Veterans Affairs already negotiates drug prices with drug companies.

“For me, Medicare does what it’s supposed to do,” says Mr. Gostin, the Georgetown professor. “It’s a huge buyer of a product, and it’s basically using that clout, that bargaining power, to get the best price.”

The pharmaceutical industry “throws the sink at the government,” he added. “They look for what sticks, and their arguments are aimed directly at the Supreme Court.”

People with private Medicare coverage may not get the mental health care they need because they can’t find a psychiatrist within their plan’s network, according to a new study.

More than half of the counties the researchers studied did not have a single psychiatrist participating in a Medicare Advantage plan, the counterpart of traditional Medicare in the private sector. about 30 million people, just over half of all federal program participants are enrolled in these private plans.

The researchers found in a paper published Wednesday in the journal Health Affairs that of plans reviewed, nearly two-thirds were narrow, with less than a quarter of available psychiatrists in a plan’s network. The networks offered under an Obamacare plan or Medicaid-administered care were not as restrictive, covering about 40 percent of available psychiatrists, according to the study.

The more limited “networks present a frustrating additional barrier in mental health care even when, on paper, there are enough providers in a geographic region,” the researchers wrote.

The pandemic helped expose a widespread need for mental health care among older Americans, many of whom struggle with loneliness, the loss of a loved one or their own deteriorating health. While about one in four people who enroll in Medicare have a mental health condition such as depression, anxiety or schizophrenia, an estimated half or fewer receive treatment, according to a recent survey. analysis of mental health care by the Commonwealth Fund, a non-profit organization.

“We need systems so people can easily find and pay for the care they need,” said Gretchen Jacobson, vice president of Medicare at Commonwealth. “It’s not clear that humans are capable of that.”

The difficulty of finding a psychiatrist is not unique to Medicare Advantage policyholders, in part because of increased demand. The scarcity of psychiatrists, particularly those willing to accept insurance, makes it difficult for plans to find providers. Many psychiatrists have also chosen not to see patients under traditional Medicare, according to one recent report.

“Part of what’s going on is we have this big problem of a shortage of psychiatrists and mental health providers,” said Beth McGinty, chief of the division of health policy and economics at Weill Cornell Medicine and the author of the Commonwealth report. “It’s gotten worse here.”

Because going out-of-network is expensive, many people will delay or skip treatment, said Dr. Jane M. Zhu, one of the study’s authors and a family physician at Oregon Health and Science University. She said her own patients often struggled to find help.

“I referred them, but they just couldn’t access mental health providers,” said Dr. Zhu. One of her patients called more than a dozen providers before getting an appointment, she said.

Insurers say their goal is to offer a wide variety of mental health services. “Everyone deserves access to effective, affordable and equitable mental health care,” Kristine Grow, a spokeswoman for AHIP, a trade group that represents the insurers, said in an email.

But Ms. Grow criticized the Health Affairs study for not comparing the plans to traditional Medicare and for not examining other types of mental health services available to patients that would be provided by other clinicians or through telehealth. “Essentially, this study uses a very narrow definition of mental health clinician to prove a pre-existing thesis about Medicare Advantage,” she said.

More broadly, regulators and legislators have raised concerns that people in private Medicare plans may not be getting the services they are entitled to under the federal program. Critics have long complained about inadequate access to mental health care.

Senator Ron Wyden, the Oregon Democrat who heads the Senate Finance Committee, stood his ground a hearing in May about so-called “ghost networks” of mental health providers, in which many of the clinicians listed in Medicare Advantage plans do not, in fact, accept patients. His staff conducted a secret customer survey and were only able to get an appointment 18 percent of the time.

The Health Affairs study may have exaggerated the availability of psychiatrists because it only looked at which providers were in the plan’s directory, said Dr. Zhu. “It probably paints a rosier picture,” she said.

Doctors may not be willing to participate in Medicare Advantage plans because of the low payments paid by the insurers, coupled with all the required paperwork, said Dr. Robert Trestman, chairman of the board on healthcare systems and funding for the American Psychiatric Association and testified at the Senate hearing. “Many of the challenges and frustrations are highlighted in the Medicare Advantage plans,” he said.

Some insurers pay psychiatrists less under their Medicare Advantage plans than traditional Medicare pays for the same services, the researchers said. The plans may also provide an incentive to contract with a smaller group of doctors to have more control over costs and the care provided, the researchers said.

The pharmaceutical company Merck sued the federal government on Tuesday over legislation that would allow Medicare to negotiate prices directly with drug manufacturers for the first time.

Merck’s lawsuit, filed in federal court in Washington, is the drug industry’s most significant move to date to fight back against a substantial health policy change set to take effect in 2026. a provision of the Inflation Reduction Act, which defines it as a way to lower drug prices.

Only a few drugs will be negotiated with Medicare and only after they have been on the market for years without competition. But in public remarks, pharmaceutical executives have portrayed the Medicare negotiation program as a serious threat to new cures. Several said yes judge again their drug development plans.

In the Merck lawsuit, the company’s lawyers argue that the Medicare bargaining program is unconstitutional. They argue that the program would force Merck to provide its products at prices set by the government, in violation of a Fifth Amendment clause that prohibits the government from using private property for public use without just compensation. They also allege that the program would violate Merck’s First Amendment rights by forcing the company to sign an agreement that it did not agree to after negotiations were completed.

According to the federal government’s guidance on its plans to implement the program, the process will allow drugmakers to first make a counteroffer on pricing and later reject Medicare’s final offer and walk away without a deal if they’re not satisfied are subject to a tax.

In September, the government plans to announce the first 10 drugs to be negotiated in 2026. A common Merck drug for diabetes known as Januvia is probably on that list.

The program could also affect Merck’s long-term plans for its golden goose, popular cancer drug Keytruda. It could be one of the first products targeted when negotiations begin in 2028 on drugs administered in a healthcare setting.

The current version of Keytruda, administered as an IV, will face competition for the first time that same year, so sales are expected to decline whether or not the program is targeted. But Merck had expected to generate significant revenue from a new formulation of Keytruda it is developing that is more easily administered subcutaneously. This can also be negotiated as part of the government’s plans for the programme.

Merck said in a statement Tuesday that the law “unlawfully detracts from our core purpose of engaging in innovative research that saves and improves lives.” Last year, the company posted a profit of $14.5 billion.