Doctors in London say they have apparently eradicated HIV from a patient’s body. It’s only the second time this has been accomplished, despite many attempts over more than a decade.

While some commentators are calling this a “cure” for HIV, the scientists who performed the experiment say it’s too soon to say that. Instead, they say the patient is in remission.

Both cases involved a risky procedure called a stem-cell transplant (otherwise known as a bone marrow transplant). The first recipient, Timothy Brown, gained fame as the so-called Berlin patient after transplants in 2007 and 2008 rid him of HIV. He remains free of HIV today.

That result raised hopes that HIV could be eradicated through a medical procedure and cure people of HIV infection. Yet Brown’s case remained the lone success since then. Other attempts had failed.

Now, researchers at University College London report in a paper being published Tuesday in Nature that they have apparently eliminated HIV in a second person.

That man had been diagnosed with HIV in 2003. Then, in 2012 the unidentified patient was diagnosed with a cancer, Hodgkin lymphoma. After standard treatments failed, they gave the patient a stem-cell transplant — essentially killing off his old immune system and giving him a new one.

The doctors selected a donor who had two copies of a particular mutation in the CCR5 gene that prevents HIV from infecting T-cells, a part of the immune system where the virus takes hold and does its damage. As a result, the man ended up with an immune system that was naturally resistant to HIV.

Sixteen months after the man’s transplant, doctors found no sign of HIV in his body. They decided to stop treating him with antiviral drugs after he volunteered to stop taking them. It has now been more than 18 months and the infection hasn’t reappeared, the scientists say.

Ravindra Gupta and his colleagues write, “it is premature to conclude that this patient has been cured,” but they are hopeful that will prove to be the case.

“This is a highly significant study,” Aine McKnight, a professor of viral pathology at Queen Mary University of London, said in a statement. “After a ten year gap it provides important confirmation that the ‘Berlin patient’ was not simply an anomaly.”

But McKnight cautioned that this won’t necessarily lead to a treatment for anyone with HIV. For one thing, the rare mutation in this case, a variant of a receptor called CCR5, only blocks one variety of HIV. A second, less common form of HIV could still cause infection despite a transplant like this.

This receptor was recently in the news after Chinese scientist He Jiankui claimed he had edited the genes of embryos to include a protective version of CCR5. This experiment raised an ethical furor.

AIDS researchers have known about this CCR5 mutation for years and have tried to think of ways to exploit it as a treatment for HIV.

“Although it is not a viable large-scale strategy for a cure, it does represent a critical moment in the search for an HIV cure,” Anton Pozniak, president of the International AIDS Society, said in a statement. “These new findings reaffirm our belief that there exists a proof of concept that HIV is curable.”

Stem-cell transplants are expensive and risky, because they involve wiping out a patient’s immune system with powerful drugs or radiation and then reconstituting it.

The benefits of this treatment outweigh the risk for cancer patients, which is where it is most commonly used. But HIV drugs have become so effective that many people carrying this infection have a normal lifespan if they take these medications for a lifetime.

The scientists note in their study that the treatment for the second patient was less harsh than the one used for the Berlin patient, raising the possibility that they could develop a less risky procedure for stem-cell transplants for HIV-positive patients.

They say this procedure could be useful now for those rare people with HIV who have also been diagnosed with cancer and are in need of a stem-cell transplant to reconstitute their immune systems. Those patients could benefit if they can find a donor with the rare mutation in CCR5 that protects them from HIV reinfection.

You can contact NPR Science Correspondent Richard Harris at rharris@npr.org.

Let’s block ads! (Why?)

A bipartisan group of Texas lawmakers announced plans this week to address surprise medical bills in a way they believe would ease the burden on patients in the state.

During a news conference Thursday, state Sen. Kelly Hancock, a Republican from suburban Fort Worth, announced he had filed a bill in the Texas Legislature aimed at preventing medical providers from, among other things, balance billing patients — charging patients the difference between what the health care provider and the medical insurer think a medical service or procedure is worth. State Rep. Trey Martinez Fischer, a Democrat from San Antonio, is filing a similar bill in the House.

If passed, the legislation would force medical providers and health insurers to mediate payment disputes before they send bills to patients. Hancock said the point of SB 1264 is to take “the burden off of patients.”

“[It] takes it off of their plates completely,” Hancock said.

He highlighted the case of Drew Calver, a public school teacher in Austin whose six-figure hospital bill after a heart attack was featured in a “Bill of the Month” investigation last summer by NPR, Kaiser Health News and KUT, NPR’s member station in Austin. Hancock noted Calver’s bill was reduced after the media attention but said it shouldn’t take such attention for a patient to get a reasonable bill.

Under this legislation, both sides of the payment dispute would settle their issues through an existing balance bill mediation program. The Texas Department of Insurance program has been successful in lowering medical bills across the state.

The legislation would beef up the program, which addresses surprise balance bills greater than $500 from all emergency providers — including free-standing emergency departments and all out-of-network providers working at a network facility.

“This is designed to apply in situations where patients don’t have any choice which facility they go to or which physician is involved in their care,” Hancock said.

Historically, the Insurance Department’s mediation program had many loopholes, and few consumers qualified for help. It was expanded in 2017, though, and more patients have been filing complaints.

For example, in 2014, the department was asked to mediate 686 medical bills. During the 2018 fiscal year, it received 4,445 bills.

Hancock said the program, so far, has saved Texas patients $30 million.

Still, consumer advocates argue, the system works only when patients know mediation is an option.

Stacey Pogue, a senior policy analyst with the Center for Public Policy Priorities, said patients don’t always know help is available, or they find the process intimidating.

“The instructions for how to do it are on your medical bill and your explanation of benefits — the most indecipherable documents you are going to get,” she told KUT earlier this year.

She and others have argued Texas should adopt a program similar to those in other states like New York, California and Florida, whose systems are more consumer-friendly.

Martinez Fischer said it’s time Texas officials stepped in to help patients who are caught in the middle of disputes between medical providers and health insurers. “It has been an industry issue for a few years, I grant you that — the health plans and the providers fighting over their business interests,” he said. “And I respect that. But 10 years later, it is a consumer issue.”

Among other things, Hancock’s bill would allow people with federally regulated, self-funded health plans to opt into the state’s mediation program. According to Hancock, those plans make up about 40 percent of Texas’ insurance market, but those consumers are currently not able to take part in the program.

Hancock said this should provide relief to consumers while federal lawmakers weigh their own efforts to address surprise medical bills.

“Texas will send a loud and clear signal to D.C. that similar consumer protections need to be passed at the federal level,” Hancock said. “Until then, Texas … [is] committed to doing something about it.”

U.S. Rep. Lloyd Doggett, a Democrat who represents Austin in Congress, said he is encouraged by Texas’ efforts but called federal protections “essential.”

“Only approval in Congress of legislation like my End Surprise Billing Act can both protect those who work for large employers with self-funded, federally regulated ERISA plans and assure that patients across America are not forced to pay the price for conflicts between insurers and health care providers,” Doggett said in a written statement.

This story is part of NPR’s reporting partnership with KUT and Kaiser Health News, an editorially independent news service of the Kaiser Family Foundation. You can follow Ashley Lopez on Twitter: @AshLopezRadio

Let’s block ads! (Why?)

State attorneys general and women’s health advocates who are hoping to block in court new Trump administration rules for Title X, the federal family planning program, face one major obstacle: The Supreme Court upheld very similar rules in 1991.

Those rules were summarily canceled after a change in administrations. But the court is arguably more conservative than it was 28 years ago.

Still, those who oppose the Trump administration’s rules say that the ground has shifted. They expect to succeed in court this time, they say — pointing to protections enacted in the 2010 Affordable Care Act and changes made by Congress in the mid-1990s in bills that fund Title X.

“I don’t file a lawsuit unless I’m confident we will prevail,” Washington state Attorney General Bob Ferguson said at a news conference Monday, as he announced his plans to sue the Trump administration over the changes to the program. “We’ve filed 17 cases against this administration,” Ferguson said. “We have not lost a case yet.”

The new rules for Title X, posted Friday by the Department of Health and Human Services, are aimed primarily at evicting Planned Parenthood from the program — a longtime goal of abortion opponents. Currently no Title X money can be used for abortions. But conservative groups argue that since many Planned Parenthood affiliates receiving Title X support also provide abortions, the federal family planning money could be improperly commingled with funds used for the procedure.

Planned Parenthood affiliates serve about 40 percent of the program’s 4 million patients.

Specifically, Trump’s rules would forbid family planning providers in almost all cases from referring pregnant patients for abortion. It also would rescind previous regulations that require providers to give women with unintended pregnancies “nondirective” counseling about all their options. “Nondirective” counseling has meant that providers can neither encourage nor deter women from any specific action. Women’s health advocates, including Planned Parenthood, argue that changing that provision, as the Trump administration wants to, would hamper physicians and other providers from giving women unbiased advice, which they say is a violation of medical ethics.

The new regulations also would require any providers that also perform abortions to make those facilities physically and financially separate from their clinics that receive federal funds.

Planned Parenthood has not specifically announced that it will sue, but Dr. Leana Wen, the organization’s president, was clear last week in a call with reporters that “Planned Parenthood cannot participate in a program that would force our providers to compromise their ethics.”

And several other lawsuits are being lined up in anticipation of the rules’ formal publication in the Federal Register, expected next week.

The American Civil Liberties Union announced it will sue on behalf of the National Family Planning & Reproductive Health Association, which represents publicly funded family planning providers and administrators, as well as the Cedar River Clinics in Washington state. The Center for Reproductive Rights has said it will sue on behalf of family planning providers in Maine.

Several other state officials have said that they will sue, including officials in New York, Oregon and California.

Proponents of the administration’s move point to the 1991 Supreme Court case Rust v. Sullivan as proof that the rules are constitutional. In a 5-4 decision, the court said that very similar regulations issued by the Reagan administration in 1988 were an acceptable exercise of executive authority and did not violate the underlying law or the U.S. Constitution.

Although the rules were upheld, subsequent legal action meant they were in effect only for a month before again being blocked and then rescinded by President Bill Clinton in 1993.

Alliance Defending Freedom, a law firm that opposes abortion, released a statement regarding Trump’s new Title X rules that said, in part: “The Protect Life Rule, which the U.S. Supreme Court has upheld, will prevent organizations like the nation’s largest abortion business, Planned Parenthood, from funding their abortion activities through the Title X program.”

Opponents of the new rules, however, insist that the situation has changed in the years since that Supreme Court decision. For one thing, argued several members of Congress in a letter to HHS earlier this month, the department may have violated the federal Administrative Procedure Act that governs the crafting of regulations.

For example, the letter said, HHS “declined to deem the Title X rule economically significant — completely disregarding the considerable health-related costs the rule would impose — and failed to conduct a comprehensive regulatory impact analysis.”

And while the top court is more conservative than it was in 1991, “there are two new developments,” Washington Assistant Attorney General Jeff Sprung told reporters; “two statutes passed by Congress, that impose new requirements.”

One of those statutes involves language added to the spending bill that funded HHS in 1995 and was renewed in subsequent years. It restates the ban on using family planning funds for abortion, but also stipulates that “all pregnancy counseling be nondirective.”

In 2010, the Affordable Care Act added to that, with language that, among other things, bars HHS from issuing any regulation that “interferes with communications regarding a full range of treatment options between the patient and the provider” or that “restricts the ability of health care providers to provide full disclosure of all relevant information to patients making health care decisions.”

Leah Litman, an assistant professor of law at the University of California, Irvine, said the now more conservative Supreme Court might not necessarily accept those arguments, as well as others likely to be raised.

But there is no question, she said, that “the underlying scope of [the Title X program] has changed” since 1991.

Julie Rovner is chief Washington correspondent for Kaiser Health News, a nonprofit news service, which is an editorially independent program of the Kaiser Family Foundation and not affiliated with Kaiser Permanente.

Let’s block ads! (Why?)

Surgeons are known for their busy schedules — so busy that they don’t just book surgeries back to back. Sometimes they’ll double-book, so one operation overlaps the next. A lead surgeon will perform the key elements, then move to the next room — leaving other, often junior surgeons, to open the procedure and finish it up.

A large study published Tuesday in JAMA suggests that this practice of overlapping surgeries is safe for most patients, with those undergoing overlapping surgeries faring the same as those who are the sole object of their surgeon’s attention.

But the study also identified a subset of vulnerable patients who might be bad candidates; the practice of double-booking the lead surgeon’s time seemed to put these patients at significantly higher risk of post-op complications, such as infections, pneumonia, heart attack or death.

Researchers say Tuesday’s study by a multidisciplinary research team from several universities is the most comprehensive analysis of the practice to date, delving into the outcomes of more than 60,000 knee, hip, spine, brain or heart surgeries among patients ages 18 to 90 at eight medical centers. The study compared the outcomes of procedures done in isolation with those that were scheduled to overlap by an hour or more.

Dr. Anupam Jena, a physician and health economist on the faculty of Harvard Medical School and senior author of the study, says his research team found overlapping surgeries to be “generally safe.” Overlapping surgeries were not significantly associated with difference in rates of death or post-op complications.

These findings, says Jena, are in line with all but one of several such studies conducted since 2015, when an investigative team at the Boston Globe first turned searing attention on Harvard’s Massachusetts General Hospital. There, at one of the nation’s premier teaching hospitals, reporters highlighted a practice that at that point was little-studied and not widely discussed outside hospitals. In extreme cases, the surgeries were essentially concurrent, with the multi-tasking lead surgeon moving back and forth between ORs.

Within a year, the Senate Finance Committee jumped in with a report detailing lawmakers’ safety concerns about little-studied practice. And the American College of Surgeons updated its guidelines, adding that juggling “critical” parts of a surgery was “inappropriate.”

However, the less extreme practice of letting the beginning and end of surgeries overlap is still viewed by hospitals as an efficient means of deploying the skillful hands of their top surgeons. Mass General, which has continued the practice, is in the company of teaching hospitals nationwide. Overlapping surgeries in this way “offers greater and more timely access to certain surgical specialties,” Mass General says in an FAQ on the topic, “many of them high-demand, high-volume elective procedures.”

Jena says this is the first study to show that certain types of patients might particularly be at risk.

“This is the only [study] that breaks out and finds in certain high-risk groups, we might have worse outcomes”— namely, in older patients, those with pre-existing medical conditions, and those undergoing coronary artery bypass graft surgery, where blood flow is restored to the heart.

When the researchers homed in on these high-risk patients, they found slightly higher mortality rates among the patients who had undergone overlapping surgeries and were older or had underlying medical conditions — 5.8 percent compared with 4.7 percent for patients who had the lead surgeon’s full attention.

The scientists found a similar discrepancy in complication rates — 29.2 percent of high-risk patients experienced post-surgical complications when subject to overlapping surgery, compared to 27 percent of patients whose procedure was done in isolation. (The “complications” recorded in the study ranged from minor infections at the surgical site to heart attack or stroke.)

This discrepancy, says Jena, “could occur because a surgeon is separating their mental effort between two cases or [from] literally being [in] two places at once. Those kinds of problems would have a measurable effect on high-risk patients.”

The study also found that surgeries booked to overlap lasted a half-hour longer, on average, than those done in isolation.

Dr. Robert Harbaugh, former president of the American Association of Neurological Surgeons and current chair of the department of neurosurgery at Penn State’s Milton S. Hershey Medical Center, was not involved in the study, but says he was not surprised to see the findings show a “modest but real” risk posed to high-risk patients.

“In my practice, if I know someone is a very high-risk patient, you’re much less likely to (schedule) that patient for an overlapping surgery,” says Harbaugh. Surgical patients who have multiple underlying conditions, such as diabetes or hypertension, he says, require his full attention.

This study, he says, supports his sense that there is “a specific group of patients that probably has to be monitored more closely.”

However, Harbaugh says, overlapping surgeries are crucial “to make the operating room run more efficiently.” Surgeons are fully booked two or three months in advance in his department at Penn State, he says. Allowing four surgeries a day lets patients be treated that much sooner — as well as providing “the next generation of surgeons” much-needed training time.

The leading surgeon is always scrubbed-in for the “dangerous part of the surgery,” Harbaugh notes, and only leaves the patient with residents who are “competent to open or close a case.”

“If you’re finishing an operation and you tell your resident, ‘you can you go ahead and close the incision,’ they’re more than competent enough to do that,” he says. “Then you leave, go to another room where a [surgical] fellow has started a case. That’s an efficient use of time.” Harbaugh estimates 15 percent of the surgeries done by doctors in his department overlap.

Harbaugh also notes that his surgical department at Penn State requires surgeons to explain to patients when they sign the consent form that that they will be stepping out for parts of the surgery. But he doubts that policy of transparency is universal, he says.

Jena says there is “little information about what patients know” when it comes to the practice of overlapping surgeries. A 2017 study found few people had ever heard of the practice.

He says he and the study’s lead author, Dr. Eric Sun, an anesthesiologist and assistant professor at Stanford University, “both would agree that doctors should be telling patients about this practice.” Jena recommends patients ask, ahead of the operation, if their surgeon will be dividing their time.

If they don’t like the answer, Jena says, “At any point, the patient could say, “I don’t want care provided to me.”

Diana Zuckerman, a policy analyst and president of the National Center for Health Research, is doubtful many such conversations are likely to occur. “Most patients wouldn’t know to ask,” she says.

“The good news is, for an an individual patient, they shouldn’t worry,” Zuckerman says, pointing to the fact that the study found no significant increase in post-op problems or deaths overall.

However, she says, questions linger over whether patients should be informed about a surgeon’s other commitments, even if the risks of complications are low.

“I think it’s safe to say if patients were told, nobody would like it,” Zuckerman says. “Nobody wants to feel like the doctor is going in and out their surgery.

Let’s block ads! (Why?)

Carol Marley wants everyone to know what a life-threatening cancer diagnosis looks like in America today.

Yes, it’s the chemotherapy that leaves you weak and unable to walk across the room. Yes, it’s the litany of tests and treatments – the CT scans and MRIs and biopsies and endoscopies and surgeries and blood draws and radiation and doctor visits. Yes, it’s envisioning your funeral, which torments you day and night.

But none of these is her most gnawing, ever present concern.

That would be the convoluted medical bills that fill multiple binders, depleted savings accounts that destroy early retirement plans and so, so many phone calls with insurers and medical providers.

“I have faith in God that my cancer is not going to kill me,” says Marley, who lives in Round Rock, Texas. “I have a harder time believing that this is gonna get straightened out and isn’t gonna harm us financially. That’s the leap of faith that I’m struggling with.”

Coping with the financial fallout of cancer is exhausting — and nerve-wracking. But the worst part, Marley says, is that it’s unexpected.

When she was diagnosed with adenocarcinoma of the pancreas head in July, she didn’t anticipate so many bills, or so many billing mistakes. After all, she is a hospital nurse with good private insurance that has allowed her access to high-quality doctors and hospitals.

Randall Marley, a computer systems engineer, says he frequently comes home from work to find his wife feeling unwell and frustrated about having spent a precious day of her recovery making phone calls to understand and dispute medical bills. One recent night she was in tears and “emotionally at a breaking point,” he says. “The hardest part of this is seeing the toll it’s taken on my wife.”

Stress-inducing bills accumulate

More than 42 percent of the 9.5 million people diagnosed with cancer from 2000 to 2012 drained their life’s assets within two years, according to a study published last year in the American Journal of Medicine. Cancer patients are 2.65 times more likely to file for bankruptcy than those without cancer, and bankruptcy puts them at a higher risk for early death, according to research.

But those statistics don’t convey the daily misery of a patient with a life-threatening disease trying to navigate the convoluted financial demands of the U.S. health care system while simultaneously facing a roller coaster of treatment and healing.

Stephanie Wheeler, a professor at the University of North Carolina at Chapel Hill, said the number of bills coming from different providers can be overwhelming.

“It’s oftentimes multiple different bills that are rolling in over a period of several months and sometimes years,” says Wheeler, who has conducted survey research with metastatic cancer patients. “As those bills start to accumulate, it can be very stress inducing.”

Given that many patients can’t work during treatment, these bills may force even relatively well-to-do cancer patients to take out second mortgages, spend college savings or worry about leaving debt behind for their families, Wheeler says.

Carol Marley is a slight woman who dotes on her two dogs and is involved in her church. Her 88-year-old father, who has dementia, had moved in a few years earlier. She and her husband, Randall, pride themselves on living frugally. They pay their credit card off every month and don’t have car payments.

Carol and her daughter, June Marley, who is a second-year college student, have health insurance through Carol’s employer, Ascension Health, a large faith-based health care system with facilities across the nation. Carol’s husband has separate insurance through his job.

They were hoping to retire early, buy an RV and drive around the country. Instead, they see their meticulous plans disappearing, even if Carol recovers.

Their high-deductible insurance policy meant they had to spend $6,000 before their insurance started covering her treatment expenses. They hit their annual out-of-pocket maximum of $10,000 well before the year was over.

But Carol says she was prepared for that. “What I didn’t anticipate is the knock-down, drag-out fight that I would have to engage in to get people to see there were errors and address it.”

Since she’s unable to work, the family lost her nursing salary.

“Money is not coming in, and it’s going out by the thousands,” she says.

From nurse to patient

Carol had treated cancer patients before. She had seen them come in with unexplained aches and leave with devastating diagnoses. Now it was her turn.

Though she didn’t recognize it at the time, her symptoms were textbook. Fatigue. Back pain. Weight loss. In July, doctors told her she had pancreatic cancer.

Her first thought was that she was going to die. One nurse friend asked if she had her affairs in order. That’s because pancreatic cancer is usually discovered too late. Just 9 percent of patients are alive five years after diagnosis, compared with 90 percent of breast cancer patients.

Carol knew she was lucky. Hers hadn’t spread. She might be able to undergo surgery. But first, four months of chemotherapy and five weeks of radiation.

The chemotherapy — seven or eight rounds, she can’t quite remember — drained her. “I couldn’t put words together in my head,” she says. She had muscle spasms and developed fevers that landed her in the emergency room.

As she became weaker, Carol realized she could no longer care for her father at home. On a recent morning in early January, she sat down with a nurse from a memory-care facility where a space had become available. Holding back tears, Carol told the nurse she knew this day would come. “I didn’t think it would be so soon, and I didn’t know under these circumstances.”

Different insurers lead to different bills

Later that same day, Carol’s energy was up. She adjusted the colorful scarf on her head, turned on her computer and pulled out a pen. Some days she spends hours trying to clarify and fix medical bills. “But I don’t do that frequently because it is so fruitless and it is stressful,” she said.

Often, she is just trying to figure out what different bills mean. “Even as a nurse, I feel like it’s impossible to understand,” she said. “I can’t make heads or tails of it.”

Sometimes there are errors.

Part of the problem, she contends, is that one insurance company covers visits with Ascension providers and hospitals and another company covers pharmacy claims, specialty drugs and providers outside Ascension’s network. Some of the bills, including a $1,400 one from an ER visit — were sent to the wrong insurer, she says.

Carol cites other issues. An $18,400 chemotherapy bill was submitted with missing information and then denied because it arrived late. An $870 MRI bill was denied because the provider said there was no pre-authorization.

“It’s not any one individual. It’s not any one system or provider,” she says. “The whole system is messed up. … There’s no recourse for me except to just keep making phone calls.”

On this particular afternoon, Carol has a long list of calls to make. One to figure out why she couldn’t access her insurance claims online. Another to a medical provider that urged her to pay $380, even though it acknowledged that it owed her about $80 of that total.

Someone who answers the phone suggests again that Carol pay the entire amount. “Once it’s posted to your account and it goes through, we would send you a check,” the woman says.

Carol shakes her head. “I’m sure y’all are fine people over there, but I’m not trusting a refund to come,” she responds, reflecting on her experience as a consumer of cancer care. “The problem is, they want their money and they are going to get it one way or the other.”

As for her hospital bills, Ascension declined to comment, citing protected health information. But spokesman Nick Ragone said, “The matter at issue was favorably resolved.”

He didn’t say which issue was resolved.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation and is not affiliated with Kaiser Permanente.

Let’s block ads! (Why?)

The leaders of seven drug industry giants were forced to defend their industry’s prices and business practices on Capitol Hill on Tuesday, as lawmakers criticized them for failing to put patients before profits.

“Prescription drugs did not become outrageously expensive by accident,” said Sen. Ron Wyden, D-Ore. “Drug prices are astronomically high because that’s where pharmaceutical companies and their investors want them.”

The pharmaceutical company leaders, testifying at a hearing of the Senate Finance Committee, acknowledged that their prices are high for many patients, but they deflected blame onto the insurance industry, government and middlemen known as pharmacy benefit managers.

They each acknowledged briefly that they have some role to play in helping lower drug prices. But they defended their industry by touting their multibillion-dollar investments in research and development and praising advances in treatments for cancer, hepatitis C, schizophrenia and autoimmune diseases.

“Last year, Janssen invested $8.4 billion globally in research and development, making Janssen one of the top research and development investors in any industry anywhere in the world,” said Jennifer Taubert, worldwide chairman of pharmaceuticals for Johnson & Johnson, which owns Janssen.

The drug industry leaders also pointed out that the list prices they set for drugs are not what they are actually paid by insurance companies or pharmacy benefit managers, the middlemen that negotiate discounts and rebates on behalf of employers or insurers, which include companies like CVS Caremark and Express Scripts.

“We want these rebates, which lower net prices, to benefit patients,” said Olivier Brandicourt, CEO of Sanofi, which makes Lantus, one of the highest priced brands of insulin, whose list price has risen from $244 to $431 since 2013, according to the committee.

“Unfortunately, under the current system, savings from rebates are not consistently passed through to patients in the form of lower deductibles, co-payments or coinsurance amounts,” Brandicourt said in testimony prepared for the hearing.

According to investment research firm SSR Health, the net price of Lantus has declined 28 percent over the last two years because of those discounts and rebates.

“Addressing list prices alone will not be sufficient for solving the problem of patients’ out-of-pocket costs,” Brandicourt said.

But the Senators had little patience for those arguments.

“For a patient taking a drug that has no competition, the list price becomes very important,” said Sen. Chuck Grassley, R-Iowa, the committee’s chairman. “I’ve heard about people skipping doses of their prescription drugs to make them last until the next paycheck.”

Wyden piled on.

“I think you and others in the industry are stonewalling on the key issue, which is actually lowering list prices,” he said. “Lowering those list prices is the easiest way for consumers to pay less at the pharmacy counter.”

Many patients have to pay the full price for a prescription drug until they meet their deductible, and others have payments that are calculated as a percentage of the list price. So higher list prices often translate to higher costs at the pharmacy counter, even when pharmacy benefit managers and insurers have negotiated discounts.

Several of the drug company leaders said they support a Trump administration proposal to change the current system in which drug prices are set using secret rebates negotiated by pharmacy benefit managers.

The change would make those rebates illegal and force pharmacy benefit managers to instead negotiate discounts upfront so that people will get the discounts at the pharmacy counter even if they haven’t yet met their deductible.

Several of the CEOs, under pressure from Grassley, said they would lower their list prices if that proposal is finalized and the rule applied to both government and commercial prescription drug plans.

“It is our very clear intention that we will not keep a single dollar from these rebates. We will try to move every single penny to the patients,” said Albert Bourla, CEO of Pfizer.

Taubert of Johnson & Johnson said the company’s final price would depend on whether additional fees were imposed by pharmacy benefit managers.

However, they said they don’t want to see the government negotiating drug prices directly through Medicare, a proposal that has been brought forward by Democrats and was originally embraced by President Trump.

“The government should not directly control the price of medicines either through federal government price controls or worse, outsourcing prices to other countries,” Brandicourt said.

Even as the companies protest that the high list prices of their products don’t reflect what they actually make on those products, drugmakers have consistently enjoyed some of the highest profit margins of any industry.

Pharmaceutical manufacturers’ profit margins have exceeded 26 percent for the last three years and 22 percent for the past 10 years, according to a presentation by CVS Health that cited Macrotrends.net as its source.

The company executives were not supportive of another Trump proposal to tie the price that Medicare pays for drugs to the prices paid in other developed countries.

“We need an American solution to this American challenge,” said Taubert of Johnson & Johnson’s Janssen unit.

Wyden grilled Richard Gonzalez, CEO of AbbVie, about why his company’s drugs cost on average 40 percent less in Germany and France than in the United States. (AbbVie makes the drug Humira, which generates about $18 billion in revenue for the company each year.)

“You’ve got a double standard,” Wyden said. “You’re willing to sit by and hose the American consumer and give the breaks to people overseas.”

Gonzalez acknowledged that the company makes a profit in those countries, even with the lower prices, but warned of dire consequence if U.S. prices fell to those levels.

“If a market the size of the U.S. were to collapse to the lower end of that pricing model, I can just tell you that AbbVie would not be able to invest in the level of R & D that it invests in today,” Gonzalez said.

In response to a question from Grassley, all the CEOs said they consider the risk of negative public opinion when they decide on their list prices. The Trump administration has proposed requiring companies to include their drugs’ list prices in all their direct-to-consumer advertising, a plan the companies have resisted.

They also said they consider the reaction of federal officials to their price announcements.

“The federal government is a very key aspect of our deliberations,” said Pascal Soriot of AstraZeneca, an answer echoed by all seven industry leaders.

Let’s block ads! (Why?)

Laura Lucero Y Ruiz De Gutierrez has a heart condition and fibromyalgia and is at high risk of developing diabetes. She has health insurance through her husband’s job. But between the $800 monthly premium for the couple’s coverage and the $2,100 deductible she has to pay down before insurance starts picking up the tab, she doesn’t feel she can afford to go to the doctor when she needs to.

She hopes that this may soon change. Identical bills proposed in recent weeks in the New Mexico House and Senate would make Gutierrez eligible to buy into a public health plan modeled on the Medicaid program, with funding support from the state of New Mexico. She could receive state-funded assistance via the program that would save her hundreds of dollars a month on premiums.

“Medicare for all” – often described as a national, single-payer health system built on the Medicare model — has become a rallying cry for some progressive Democrats. Meanwhile, New Mexico is one of several states looking at offering consumers a different type of government-sponsored plan to provide a health care option that’s more affordable than current options.

These states’ proposals are often referred to as “Medicaid buy-in” plans because, typically, they would offer benefits similar to what is available through Medicaid, the state-federal health plan for people who have low incomes.

The proposals under consideration vary from state to state. Variables include eligibility criteria, how they might be funded and whether they would be offered on the Affordable Care Act’s insurance exchange.

And depending on how they structure their plan, states may have to get approval from the federal government to move ahead.

States that are interested in a buy-in plan typically are considering taking advantage of the Medicaid program’s provider networks and reimbursement rates. Those payment rates generally are lower than for Medicare and for commercial plans.

That may help keep costs down, though in some states it also means the network of doctors would likely not be as large as that found with Medicare or some commercial plans.

“Medicare-for-all is not going to happen legislatively in the next couple years,” says Heather Howard, who directs Princeton University’s State Health and Value Strategies program and is working closely with some of the states. “In the meantime, states are saying, ‘What about “Medicaid-for-more”?’ “

In New Mexico, the buy-in plan would be similar to the state’s Medicaid program. It would be offered outside the exchange and would not require federal approval to implement. The state would provide financial assistance to help people with lower incomes buy into it.

A report commissioned by New Mexico projected that up to 16,000 people would enroll in a program like the one originally proposed in the state’s bills and that their premiums would be 15 to 28 percent lower than plans sold on the individual market.

New Mexico Gov. Michelle Lujan Grisham favors a Medicaid buy-in option. She doesn’t have a position on the current bill, but she is following it closely, says Nora Sackett, the governor’s deputy press secretary.

In addition to the governor’s and lawmakers’ interest, other stakeholders have been deeply involved, increasing the odds of success, Howard says.

Lawmakers in Colorado, Oregon, Washington and Minnesota are among others exploring similar options, says Howard. Nevada lawmakers passed a bill last year that would have set up a Medicaid buy-in plan, but the Republican governor vetoed it.

“The proposals take on different flavors depending on the state” and what officials are trying to accomplish, she says, whether it’s increasing the number of people with insurance, making coverage more affordable or helping states avoid having “bare” counties where no marketplace plans are offered.

New Mexico’s bill would target individuals who aren’t eligible for Medicaid or Medicare and those who can’t get the Affordable Care Act’s premium subsidies because their incomes are above 400 percent of the federal poverty level (about $50,000 for one person or $103,000 for a family of four). The plan would also be available to state residents whose immigration status in the U.S. is undocumented.

And the measure would help people like Gutierrez who are vulnerable to the ACA’s so-called family glitch. Her husband’s $100 monthly premium for single coverage through his employer plan is considered affordable under the law because it costs less than 9.86 percent of their family’s income of about $46,000 a year. That makes her ineligible for premium subsidies on the exchange, even though the $800 premium for the two of them through her husband’s employer plan far exceeds that affordability percentage. Their three children already have Medicaid coverage.

“Right now, I pay to have the health care, but I can’t afford to use it,” says Gutierrez.

The bill would provide financial assistance from the state, with premiums and cost sharing for people whose incomes are less than 200 percent of the federal poverty level, or $60,340 for a family of five. The new coverage would take effect by January 2021.

Gutierrez, whose family lives in Albuquerque, would be eligible for financial assistance to help her buy into the Medicaid-like plan, while her husband stays on his employer plan. Because their $46,000 annual income is just above 150 percent of the federal poverty level, her monthly premium would likely be about $160 per month for a comprehensive plan with a $150 deductible, according to estimates by Manatt Health, which did the original state analyses of buy-in options that were published before the bills were introduced in January.

New Mexico has high levels of poverty, and 40 percent of New Mexico residents are already enrolled in the state’s Medicaid program, compared with about 23 percent nationwide.

“It’s the cornerstone” of our health care system, says Colin Baillio, director of policy and communication at Health Action New Mexico, an advocacy group. The legislation would use “those levers that Medicaid has to provide comprehensive coverage and a comprehensive provider network.”

The bills were passed by two legislative committees this month, with instructions for further study to examine expanding the buy-in plan to more groups. They now move to two other legislative committees for consideration, Baillio says.

And though hospitals and other health care providers would be reimbursed at Medicaid rates — typically lower than those for commercial plans — to the extent that people who are uninsured enroll in the new plan, some providers say they stand to gain financially.

“We’re obviously very supportive of anything that expands coverage,” says Jeff Dye, president of the New Mexico Hospital Association. “It’s the issue of getting some payment versus no payment for services rendered.”

If the Medicaid buy-in bill passes, Blanca and her husband, Hugo, could have health insurance for the first time since they moved to New Mexico 14 years ago. The couple and their oldest son, now 18, are undocumented immigrants from Mexico. (NPR is not using their last names, to protect the family’s privacy.) Their two younger children, who were born in the United States, are enrolled in Medicaid.

Hugo works as a plumber, and Blanca is studying early childhood development at a community college near their home in Albuquerque. Because they are unauthorized immigrants, they’re not permitted to buy health insurance on the ACA exchanges, even if they’re willing to pay the full price.

So like many people without insurance, they wait until they’re really sick before seeking help. When Blanca developed pneumonia a few years ago, the waiting lists for an appointment at community clinics that would see her without insurance were long. Finally, when she could no longer breathe comfortably, she went to the emergency department.

“It would bring us peace of mind not having to worry about our health care situation,” Blanca says through an interpreter.

Providing health care for residents who lack proper immigration status is “an underlying issue with many states that are considering a Medicaid buy-in,” said Chiquita Brooks-LaSure, managing director at Manatt Health, who co-authored the reports evaluating Medicaid buy-in options for New Mexico.

The New Mexico bill also would provide some relief for Leah Steimel’s family. Neither she nor her husband has employer-sponsored coverage, and with a family income of about $100,000, they don’t qualify for tax credits that would reduce their ACA premiums. They now pay more than $1,900 per month for a silver-level plan with a $10,000 deductible to cover themselves and two of their kids (the third is older than 26).

Buying into a Medicaid-like plan would be tempting, says Steimel, who works as a community health consultant with some of the groups advocating for the buy-in. Sure, she says, she does wonder if the Medicaid plan would be as easy to use as a regular commercial plan and if it would give the family access to as many providers.

“But being able to pay into something that would reduce by even a third what I’m paying now — I’d love that,” she says.

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation and is not affiliated with Kaiser Permanente. Michelle Andrews is on Twitter: @mandrews110.

Let’s block ads! (Why?)