Republicans Now Control Obamacare. Will Your Coverage Change?

Though they failed to mobilize Congress to repeal the Affordable Care Act last month, Paul Ryan (R-Wis.) (right), Kevin McCarthy (R-Calif.) and the White House could still undercut the insurance exchanges, reduce Medicaid benefits and let states limit coverage of birth control or prenatal visits.

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The Affordable Care Act’s worst enemies are now in charge of the vast range of health coverage the law created. They’re also discussing changes that could affect a wider net of employment-based policies and Medicare coverage for seniors.

Although Republicans failed last month in their first attempt to repeal and replace the ACA, President Donald Trump vows the effort will continue.And even if Congress does nothing, Trump has suggested he might sit by and “let Obamacare explode.”

Health insurance for the 20 million who benefited from the ACA’s expanded coverage is especially at risk. But they’re not the only ones potentially affected. Here’s how what’s going on in Washington might touch you.

A 3-year-old lawsuit threatens many health plans

A suit by the Republican-led House challenges some of the subsidies that support private plans sold to individuals and families through the ACA’s online insurance marketplaces (also called exchanges). The lawsuit has already gained one court victory. By many accounts, it would wreck the market if successful, leaving up to 12 million people without coverage.

“It’s the single-biggest problem facing the exchanges,” said Rachel Sachs, a health law professor at Washington University in St. Louis. “That would make insurers not only exit tomorrow but also not want to offer plans in 2018.”

The litigation involves lesser-known ACA subsidies that reduce out-of-pocket costs such as co-payments and deductibles for lower-income consumers. These are different from the law’s income-linked tax credits, which help pay for premiums.

Filed in 2014, when Barack Obama was president, the lawsuit could backfire by politically harming the Republicans now in charge. House leaders requested and were granted a delay of the litigation for now, and said they won’t drop the lawsuit but will continue the subsidies while it gets considered. The administration has not said how it plans to handle the lawsuit.

Policy confusion undermines coverage

Even if Congress doesn’t repeal the ACA, the continuing battle is making insurance companies think twice about offering marketplace policies for next year. The less clarity insurance carriers have about subsidies and whether the administration will promote 2018 enrollment, the likelier they are to bail or jack up premiums on the policies they offer, to cover themselves.

Preserving the subsidies, which limit out-of-pocket costs for lower-income consumers, “is essential,” said Kevin Lewis, CEO of Community Health Options, a nonprofit Maine insurer.

“Markets don’t like uncertainty,” Lewis said. “The ‘sword of Damocles’ hanging over our collective heads is unsettling, to say the least.”

Democrats say Republicans are sabotaging Obamacare

Shortly after taking power, Trump officials yanked advertising designed to maximize enrollment in marketplace plans just before a Jan. 31 deadline. It was partly restored after an outcry.

Then the administration said it would scrap an Obama-era plan of rejecting tax returns from individuals who decline to say whether they had health insurance. Scrapping that plan weakens the requirement that everyone have health coverage.

Trump aide Kellyanne Conway suggested in January the administration might entirely stop enforcing that requirement — it’s the part of the law most hated by many Republicans. If officials persist with that message, health plans might attract even fewer of the young and healthy members whose insurance premiums are needed to support the ill. That would cause more hikes in premiums and exits by insurers.

“More mischief can be done,” said Dr. Peter Kongstvedt, a health industry consultant and senior faculty member at George Mason University. “It is absolutely possible that some markets will end up with no carriers unless a combination of state and federal government act to preserve the market” with taxpayer money.

Trump officials will move to roll back ACA coverage even if Congress doesn’t repeal

Tom Price, secretary of the Department of Health and Human Services, has signaled his intent to reverse parts of the ACA through regulation even if Congress doesn’t repeal the law.

For example, Price couldn’t unilaterally eliminate coverage for birth control or maternity care, both of which many Republicans object to on moral grounds or because of cost. But birth control might no longer be free as a preventive benefit. Maybe the administration would let states limit the number of prenatal visits in maternity coverage. Perhapsmore employers could gain religious exemption from providing birth control.

Medicaid coverage for people with low incomes could shrink

Obamacare’s coverage expansion included government Medicaid coverage for folks with lower incomes. Thirty-one states and the District of Columbia expanded Medicaid to most adults who have incomes below about $16,000 for singles and $28,000 for a family of three (although eligibility varies).

Republicans want to reduce the growth of Medicaid spending and give more control over the program to states. Discussions about a Medicaid overhaul have focused on replacing ACA provisions with less-generous federal grants to states.

But even if the ACA survives, it’s likely the administration will give states more say in who gets Medicaid coverage and how much. Many Republicans favor having work requirements for Medicaid recipients and raising out-of-pocket payments for patients.

Under the failed House replacement bill, the American Health Care Act, 9 million people in those states would have lost Medicaid coverage in 2020, according to estimates from the nonpartisan Congressional Budget Office.

At the same time, however, Republican support for the ACA’s Medicaid expansion is growing, which might mean overall cutbacks would be less severe or Medicaid coverage could increase among the 19 states that didn’t expand the program under the ACA.

Some Republicans want to overhaul Medicare for seniors

House Speaker Paul Ryan wants to restrain Medicare growth by giving members fixed, “premium support” payments to buy plans; he’d also like to raise the age of eligibility for Medicare. Both those ideas could lead to less coverage or greater out-of-pocket expense.

But those proposals weren’t part of the Republicans’ replacement bill. Changing Medicare likely would trigger loud objections from AARP and other powerful lobbies. And Trump doesn’t seem inclined to back a change.

“I don’t think … Trump wants to meddle with Medicare or Social Security,” White House chief of staff Reince Priebus told the press in January.

Job-based coverage could become less generous

Although ditching Obamacare would end the requirement for large employers to offer health insurance, most companies would keep their plans as a way to attract workers, analysts say.

But that coverage could become less generous. The ACA limits the annual out-of-pocket costs for members of employer-based plans, and also prohibits caps on annual and lifetime benefits. The ACA also prohibits waiting periods for covering a new worker’s preexisting illness.

Any replacement law signed by Trump might not include those protections.

Kaiser Health News, is an editorially independent part of the Kaiser Family Foundation. You can follow Jay Hancock on Twitter: @jayhancock1.

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A Baby With 3 Genetic Parents Seems Healthy, But Questions Remain

Mitochondrial diseases can be passed from mothers to their children in DNA.

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Last fall, the New York-based reproductive endocrinologist John Zhang made headlines when he reported the birth of the world’s first “three-parent” baby — a healthy boy carrying the blended DNA of the birth mother, her husband and an unrelated female donor.

The technique, called mitochondrial replacement therapy, allowed the 36-year-old mother to bypass a defect in her own genome that had led, twice before, to children born with Leigh syndrome, a devastating neurological disorder that typically culminates in death before age 3.

While heralded in many circles as a breakthrough, the news triggered numerous ethical and scientific questions, many of which remained unanswered at the time. Last week, Zhang and his colleagues at the New Hope Fertility Center provided some answers — and raised yet more concerns.

John Zhang of the New Hope Fertility Clinic in Manhattan performed the procedure that used DNA from three people to create a baby boy.

Courtesy of the New Hope Fertility Clinic

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Courtesy of the New Hope Fertility Clinic

Their new report, published in the journal Reproductive BioMedicine Online, describes both the technique and the participants in greater detail, something that fellow researchers had demanded in order to properly scrutinize Zhang’s methodology.

But in publishing the new material, the journal editors themselves also noted that Zhang’s report still contains “weaknesses and limitations in a number of areas,” including lingering questions about informed consent, the full risks of mitochondrial replacement therapy and the long-term health of the child.

“Although we were able to encourage the authors to include more details of their work in the submission,” journal editor and clinical embryologist Mina Alikani noted in an accompanying editorial co-written with her colleagues, “some uncertainties concerning methodologies and results still remain.”

In a statement provided by the New Hope facility, Zhang conceded that more work needs to be done. “There is always concern about any new procedure and innovation implemented on humans,” Zhang said. “We agree that there are still a lot of unknowns about this technique and will make every effort to monitor the boy’s ongoing progress and test for any adverse outcomes.”

A key weakness in Zhang’s work, according to critics, is that the procedure is not approved in the United States, which forced the team to undertake the procedure in Mexico. “This particular experiment is being done almost entirely outside the normal regulatory structure,” says bioethicist and pediatrician Jeffrey Botkin of the University of Utah, who participated in an Institute of Medicine committee last year that issued a call for more animal research on mitochondrial replacement therapy.

Without proper oversight, Botkin says, vital questions about the technique, as well as the impact of such experiments on resulting embryos, remain difficult to answer.

As it stands, Congress last year prohibited the Food and Drug Administration from considering applications for research in this area, but in December the U.K.’s Human Fertilization and Embryology Authority agreed to let clinics apply to try the procedure on a case-by-case basis. In March, it granted a license to carry out the first procedure to Doug Turnbull, director of the Wellcome Trust Center for Mitochondrial Research at Newcastle University.

“We’re going to look to those in Britain,” Botkin says, “to do careful trials and help us better understand how this technique works.”

In broadest terms, Zhang and his colleagues lifted the nucleus out of the egg of the original mother, leaving behind most — though not all — of her defective mitochondria, which would have led to the almost certain development of Leigh syndrome in the fetus. They then placed that nucleus inside a healthy donor woman’s egg, whose own nucleus had been removed. The result was a hybrid egg with the original mother’s nuclear genes and the donor mother’s cytoplasm and mitochondria. The hybrid egg was fertilized by the father’s sperm and implanted in the birth mother.

The technique could potentially prevent a wide range of mitochondrial diseases, ranging from hereditary blindness to progressive muscle wasting.

A key problem, however, is that not all of the defective mitochondria can be eliminated. The boy, Zhang reports in the new paper, currently carries between 2.36 and 9.23 percent of potentially defective DNA, according to sampling of his urine, hair follicles and circumcised foreskin.

“That’s not surprising,” says Doug Wallace, head of the Center for Mitochondrial and Epigenomic Medicine at the Children’s Hospital of Philadelphia, who was not involved in the study. “As far as I know, very few cases have been found where there is absolutely no carryover of mitochondria from the donor nucleus.”

Even at a 9 percent load of defective DNA, Wallace said, most people with Leigh Syndrome will appear normal. He added that while it is unlikely, levels could be higher in the boy’s other tissues, such as the brain or heart.

Zhang and his team report that physical examination of the boy has included detailed neurological investigation at regular waypoints, including at two weeks, four weeks, two months, three months and four months. All have proved normal, Zhang said, and the boy is still under close monitoring with “a long-term follow-up plan.”

Just what such a long-term plan might look like, however, is uncertain — particularly given that the parents have publicly said that they do not plan to have the boy regularly tested throughout his life to monitor levels of the errant DNA. University of California molecular biologist Patrick O’Farrell, who was not involved in the Zhang study, suggested that this was worrying, given that there could a rising load of mutations as the boy ages.

In this case, a total five eggs underwent the transfer and were fertilized, Zhang and his team reported. The embryo that was ultimately implanted carried about a 5 percent load of the defective DNA, but the researchers did not examine how much defective DNA was carried over in the embryos that were not used.

The remaining fertilized eggs are still available, says Zhang, but he has not tested them to see how much defective DNA each contains. Should the parents decide they’d like to have another baby, Zhang said he would test the others.

Still, without readily accessible data on the transfer of defective DNA in all of the fertilized eggs, O’Farrell argues that important insights are being overlooked. A three-parent baby, he said, offers the rare chance to study the “segregation and transmission of mitochondrial genomes.”

In a telephone interview, Zhang emphasized that analyses are ongoing. “This is new ground, so there are many questions to ask and more studies to come,” Zhang said. “With new tests in new studies, we will continue to learn more.”

For all of the lingering questions, Zhang’s groundbreaking research has sparked a flurry of similar research elsewhere. The editors of the journal carrying his new report credit Zhang with helping to nudge “cautious use” of mitochondrial replacement therapy in the U.K. Meanwhile, the fertility specialist Valery Zukin has used the three-parent technique in the Ukraine to help two infertile women who suffer from a syndrome known as embryo arrest, where their fertilized eggs stop growing before they can be implanted in the uterus.

Both women gave birth to apparently healthy babies this year.

Such news will surely be welcomed by desperate parents looking for new ways to conceive, but experts like O’Farrell continue to worry that the procedure is being deployed too quickly, and with too many question unanswered.

“I feel like extending this work into infertility cases is dangerous,” O’Farrell says. “For every gene that compromises fertility, we need to know whether it also is going to affect later aspects of development.

“If you only rescue fertility,” he adds, “the other defects that gene might cause will still be there.”

Jill Neimark is an award-winning science journalist and an author of adult and children’s books. Her most recent book is The Hugging Tree: A Story About Resilience.

A version of this articleoriginally appeared at Undark, a digital science magazine published by the Knight Science Journalism Fellowship Program at MIT.

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FDA Approves Marketing Of Consumer Genetic Tests For Some Conditions

23andMe is now allowed to market tests that assess genetic risks for 10 health conditions, including Parkinson’s and late-onset Alzheimer’s diseases.

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The U.S. Food and Drug Administration approved 23andMe’s personal genetic test for some diseases on Thursday, including Alzheimer’s, Parkinson’s and celiac diseases.

The tests assess genetic risk for the conditions but don’t diagnose them, the FDA says. The agency urges consumers to use their results to “help to make decisions about lifestyle choices or to inform discussions with a health care professional,” according to a press release about the decision.

Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, wrote, “it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.” Other known factors that can play into the development of disease include diet, environment and tobacco use.

The FDA has previously scolded the company for marketing the personal genetic testing kits without the agency’s consent. In 2013, the agency told 23andMe to stop selling its personal genome kits in the United States until they gained FDA approval by proving they were accurate.

The company agreed to work with the FDA, as we reported, and a recent FDA review of peer-reviewed studies found more consistent links between certain gene variants and 10 diseases, the FDA says.

As a result, the FDA is now allowing 23andMe to market tests that assess genetic risks for the following 10 diseases or conditions:

The company’s $199 Health and Ancestry test is available directly to consumers, without seeing a physician or genetic counselor. Consumers’ DNA is extracted from a saliva sample. After mailing in their sample, people can see their results online.

“This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” said Anne Wojcicki, the CEO and co-founder of 23andMe, in a company press release.

Sharon Terry, the CEO of the Genetic Alliance, a nonprofit organization that advocates for health care for people with genetic disorders, likens it to another consumer test. “Women learn they are pregnant using a test directly marketed to them and buy it off the shelf in a drugstore,” she told NPR. “In 10 years we will marvel that this is an ‘advance’ at all. Imagine pregnancy tests being only available through a doctor!”

Robert Green, a professor of medicine at Harvard Medical School, says people should be able to access genetic information in whatever way is best for them. “Some people really want this [genetic] information on their own, and others want it through their physician,” he said. “Both those channels are legitimate. People should just be aware that this information is complicated.”

But some are stillconcerned about whether the genes in question actually correspond to a higher risk of disease reliably enough to warrant direct-to-consumer marketing and testing, as opposed to genetic testing with the guidance of a professional.

Somehealth professionals worry that consumers will “take the results and run,” as Mary Freivogel put it. Freivogel, a certified genetic counselor and the president of the National Society of Genetic Counselors, added that genetics are just “one piece to the story when it comes to developing a disease.”

Freivogel said speaking with a genetic counselor before getting tested for disease is important. “Direct-to-consumer testing takes away a pre-test conversation,” she said, where counselors can help patients think about questions like: “What do you want to know? What are you going to do with this information? Is it something you’re prepared to know, or is it going to just make you anxious?”

And it isn’t clear what consumers should do with their newly calculated disease risk, especially for conditions like Alzheimer’s for which there isn’t a cure or even a course of action to prevent the disease.

What’s more, having the genes is not the same as having the diseases the genes are associated with. A person may have genes that are associated with Alzheimer’s, for example, but that doesn’t mean he or she will ever get the disease. Conversely, some people develop Alzheimer’s without the identified risk genes.

The Alzheimer’s Association does not recommend routine genetic testing for the disease in the general population because it can’t “productively guide medical treatment.”

A genetic test result for Alzheimer’s is “not going to provide useful information even if you’re at an increased risk,” said Keith Fargo, director of scientific programs at the Alzheimer’s Association. “It’s not like there’s a drug you can take right now [to prevent the disease] or a lifestyle change you can make that you shouldn’t make anyway,” such as exercising and eating right to keep your brain healthy.

John Lehr, the CEO of the Parkinson’s Foundation, says personal genetic tests can help identify risk for Parkinson’s disease. But, he wrote in a statement following the FDA’s announcement, the foundation recommends “that people who are interested in testing first seek guidance from their doctors and from genetic counselors to understand what the process may mean for them and their families.”

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Fentanyl Adds A New Terror For People Abusing Opioids

Allyson and Eddie, clients at the AAC Needle Exchange and Overdose Prevention Program in Cambridge, Mass., say they carry naloxone and try to never use drugs alone to reduce the risk of overdosing.

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Robin Lubbock for WBUR

There’s a clear culprit in the rising drug overdose death count in Massachusetts, but it’s not heroin. It’s the synthetic opioid fentanyl.

Seventy-five percent of the state’s men and women who died after an unintentional overdose last year had fentanyl in their system, up from 57 percent in 2015. It’s a pattern cities and towns are seeing across the state and across the country, particularly in New England and the Rust Belt states.

Fentanyl may be especially lethal because it’s strong, it’s mixed with other drugs in varying amounts unknown to the user, and it can trigger an overdose within seconds. “It happens so fast, like instantly, as soon as you do the shot,” says Allyson, a 37-year-old woman who started using heroin in her late teens.

“In the past, it [an overdose] was something that you saw happening, like, you could see the person start to slow down, their color would start to turn blue, and then they would go out, within 10 minutes or so,” Allyson says. With fentanyl, there’s no progression. “Now it’s instant,” she says.

Allyson leans back in a chair at the AAC Needle Exchange in Cambridge, Mass., and tugs the hood of her gray sweatshirt down to her eyes. We’ve agreed not to use her full name or the full names of any people in this story who buy illegal drugs, so as not to harm their future job prospects.

Allyson is a regular client at the needle exchange, where manager Meghan Hynes urges everyone to carry naloxone, the drug that reverses an overdose. Hynes uses her own kit every few weeks.

“Recently we had a guy leave the bathroom and all the color just drained from his face, like immediately, and he just turned blue,” Hynes says, describing what’s become a typical fentanyl overdose. “I’ve never seen anyone turn blue that fast. He was completely blue and he just fell down and was out — not breathing.”

Hynes bent over the man turning blue to pump his heart, but she couldn’t. He was hit with “wooden chest,” a side effect of fentanyl that may be increasing the death toll.

“Your chest seizes up. You literally have paralysis and that’s obviously really dangerous, because if someone needs CPR, you can’t do it,” Hynes says. “And in this situation it spread, so he had lockjaw and his mouth was only open a tiny, tiny bit. And so I could hardly even do rescue breathing for him.”

Breathing for overdose patients is critical because brain cells can die after just five minutes without oxygen. Hynes revived the man on the floor. Because of the increasing overdoses she sees with fentanyl in the mix, she urges clients to stick to a dealer they know, and use with a buddy.

Many drug users also inject a small amount before they give themselves the full shot.

“But it’s really hard to tell these days, even if you do a tester shot,” Allyson says, because the grains of fentanyl that could kill you aren’t mixed uniformly in a bag. That’s a lesson she learned one death-defying night a few months ago.

Allyson, who is homeless, spent the night in a tent with a friend. She woke up and used the last of a bag from the day before to get herself going.

“And I actually said to my friend, I said, ‘Wow, I can’t believe I only saved myself this much.’ It was a very small amount, like a third of what I did the night before,” Allyson says, shaking her head. “I overdosed on it.”

The friend had enough naloxone in the tent, which was far from a road or hospital, to bring Allyson back from the dead.

Fentanyl is an opioid 50 times more powerful than heroin. There’s a legal, Food and Drug Administration-approved version. But labs in China are churning out cheap versions of fentanyl that dealers are selling on the streets mixed with fillers, heroin or other drugs.

Buyers have no idea how much fentanyl they are getting or how much risk they are taking with every injection. So, these days, drug users who frequent this needle exchange assume there’s fentanyl in every bag they buy.

“Most of us know that that’s what we’re getting,” says Sean, who started using heroin more than 20 years ago. “And if you don’t believe it, you’re living in a fairy tale world.”

There’s no reliable way for drug users to test the contents of bags bought on the street. Eddie relies on taste.

“It’s slightly bitter, but it’s mainly sweet if it’s fentanyl. If it’s heroin, you can tell right away because it’s got a bitter taste and it’s a long-lasting aftertaste,” Eddie says. “I will not put anything in my arm before I taste it.”

Eddie and Allyson say they try to avoid fentanyl. But when their last dose of drugs starts to wear off, they’ll take anything to avoid withdrawal, which they describe as the flu on steroids with fever, vomiting, diarrhea and high anxiety.

“It literally feels like your skin is crawling off. You’re sweating profusely,” Allyson says. “Your nose is running, your eyes are running. And that’s all you can focus on. You can’t think.”

Some drug users seek fentanyl because it’s a more immediate rush and intense high. But Allyson doesn’t like it. She says a fentanyl high fades much more quickly than heroin’s, which means she has to find more money to buy more drugs and inject more often, which leads to more risk.

When fentanyl fades, she and Eddie say, they are more likely to take other drugs. “You’re getting a fast rush but it doesn’t last, so people are mixing,” Allyson says.

At 37, Allyson is having experiences most Americans don’t face until much later in life. “As of two days ago, 30 people that I know have passed away. Basically my entire generation is gone in one year,” Allyson says. “It’s the fentanyl, definitely the fentanyl.”

Older drug users who have been through other epidemics say this moment with fentanyl is the worst they’ve seen. A man named Shug twists a towel in his hands.

“Addicts are dying, like, every day. It’s crazy, man,” Shug says, his eyes filling with tears. “Nobody seems to give a damn.”

Shug is grateful for the needle exchange, which hasn’t lost anyone to an overdose. But on the streets outside, the death toll keeps rising.

This story is part of a reporting partnership with NPR, WBUR and Kaiser Health News.

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Tom Murphy was a healthy rugby player diagnosed with ALS in his 50s. …. With his doctor’s help he signs up for an experimental treatment with a drug called dexpramipexole, or “Dex.” At first, he’s very hopeful, and it seems to be helping him, but they run the tests and figure out that it actually doesn’t work. In fact none of the ALS drugs work. I focus on Tom Murphy because he’s a victim of the system here — of these failures.

What happened in the case of ALS was there were at least a dozen drugs that had been tried in a handful of small studies — way too small — of animals. And they all seemed to have some sort of promise — some of them went into very large clinical trials. We spent tens of millions of dollars developing these drugs, and they all failed. There’s a group in Cambridge Massachusetts — the ALS Therapy Development Institute — that went back and reviewed all these studies and realized all the initial studies were wrong. They used very few mice. They weren’t thinking enough about the different genetics of the mice. And a lot of other problems. …. This therapy institute came away thinking none of these drug candidates were really realistic.

On the ways the scientific enterprise in Charles Darwin’s time was very different

Darwin was very interesting. It took him decades to come up with his theory of evolution and he was not in a hurry — he was studying barnacles, he was studying birds, all sorts of things. He felt no pressure to publish until somebody came up with a similar idea, and he decided, ‘hmmm … maybe I do want to be first. …” But we’re not in that world anymore. Things are very competitive, very fast-paced. So the competitive world of biomedicine is shaping this problem of evidence that can’t be replicated a lot.

On why the delight that’s long been an intrinsic part of science can disappear over time — and why that’s bad

I think a lot of people go into science out of a sense of wonder. But … as time goes on people feel the career pressures, and they realize it isn’t just about exploring and having big ideas. They have to have research that helps them progress toward their first job, toward tenure, then the next grant, and so on. Those pressures are different from just, sort of, exploring and understanding fundamental biology…. And the less you’re focussing on delight, the less maybe you’re aiming at the truth and the more you are, inadvertently, often aiming at other goals — career goals, financial goals and so on. This may give you a fruitful life as an individual, but may produce less value to us as a society.

On how the public should respond when they hear of a big biomedical advance

I think it is good to question it. Every time you hear something like this, just remember, it’s all contingent — here is one study, and it may not stand the test of time. I think that’s healthy. … When scientists read the scientific literature, they realize, “Oh, probably half of this is wrong.” It’s just, not knowing which half — that’s the vexing part.

On the risk that pointing out flaws in science will make people question its value

It’s always uncomfortable to point out problems, but it’s also essential. I mean, we are taxpayers — we are citizens, and we support this enterprise and we expect to reap its rewards. If it’s not operating at full steam … and not doing everything right, it’s worth pointing that out and saying, “No. Think about this. Let’s make it better.” Many prominent scientists agree with me and are concerned about this — and are thinking hard about how to make things better, from the top of NIH on down. There are solutions, and I talk about them in my book.

On why the Trump administration’s proposed cuts to NIH funding wouldn’t make things better

It’s a very appealing idea, obviously, to say, “Oh, well, let’s just identify the waste and root it out.” But that’s not the way science works. … If you cut the budget of the National Institutes of Health, you’re going to shrink that already very small pool of money even smaller, and you’re going to increase the competitive pressures. You’re going to increase all these perverse incentives that put us in this position to begin with. So I think that would actually be devastating to biomedical research.

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Pulse Check: Can The GOP Health Care Bill Be Saved?

Vice President Mike Pence is leading talks with House Republicans for the Trump administration to try and revive the failed health care bill.

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Timothy D. Easley/AP

President Trump may have said he is ready to move on, but the House Freedom Caucus can’t let health care go.

The same firebrand conservatives who helped derail the GOP’s long-awaited legislation to repeal and replace key parts of the Affordable Care Act are now trying to breathe new life into the bill with a long shot effort to bring it back for a vote in May.

Or at least keep it on life support through the two-week April recess when they’ll otherwise have to explain the bill’s derailment back home. “We’re on the eve of going home and spending two weeks with our constituents… and they know they’re going to get questions about this,” said Rep. Steve Womack, R-Ark. “And for the people who were ‘no’ they’ll have justification to deal with.”

Womack, who was a ‘yes’ on the GOP’s American Health Care Act, said despite encouraging talk from some corners of the House, a revival was not in sight.

“I did not get the message from our conference this morning that we’re nearing the finish on health care,” he said. “It’s obvious those negotiations continue to take place — and there might be some movement in some areas that give leadership some hope we can get closer to the finish line — but I’m not suggesting at all that we are right there and this thing could change on a dime.”

The thirty-some members of the conservative House Freedom Caucus, led by Rep. Mark Meadows, R-N.C., are in active talks with the administration — in the wake of a skirmish between some of the group’s members and Trump over the failure of the health care bill. Those talks are being led by Vice President Mike Pence, who spent Monday and Tuesday in the U.S. Capitol huddling with different factions of House Republicans.

According to lawmakers and aides briefed on the negotiations, conservatives are talking with the White House about tweaking AHCA to allow states to seek waivers from Obamacare’s requirements on “essential health benefits,” or basic health care services all insurance plans must offer, as well as restrictions on “community ratings,” or how much insurers can charge for premiums based on age and gender.

Originally, conservatives wanted to repeal those aspects of the law entirely to allow for health plans with lower premiums. Now there are talks about keeping them in place but allowing states to appeal to the Department of Health and Human Services to waive them on a state-by-state basis.

It’s far less than conservatives had hoped for in negotiations. “It perhaps is as much of a repeal as we can get done,” conceded Meadows, according to the Associated Press. “That’s the calculation we have to make.”

The talks have not so far publicly brought on board any of the moderate Republicans who already opposed rolling back essential health benefits, or who worry that doing so would raise costs on people with preexisting conditions. The talks also ignore the fact that many of the GOP’s ‘no’ votes were based on the legislation’s sweeping changes to how Medicaid is funded, and the current negotiations don’t address those concerns at all.

It’s also unclear that including the updated proposal into the bill would even secure the votes of enough House Freedom Caucus members to pass it. Rep. Mo Brooks, R-Ala., is still a ‘no,’ and said his colleagues should not expect the conservative faction to vote as a bloc.

“For some reason, some in the media think that we vote lock step with each other. That is categorically not the case. If you were to think of us more as an intellectual conservative think tank with a backbone, that’s what we are,” Brooks told reporters.

House Speaker Paul Ryan, R-Wis., spoke cautiously of the effort, describing talks as in “the conceptual stage” and that any action before the April recess was highly unlikely. “We want to make sure that when we go, we have the votes to pass this bill,” he said.

White House spokesman Sean Spicer was similarly cautious. “I’m not going to raise expectations, but I think that there are more and more people coming to the table with more and more ideas about how to grow that vote.”

The House is operating under a tight timeline. Republicans on all sides of this debate agree that May is a make-or-break deadline for the bill because of budgetary constraints. The health care bill is moving under a process protected by this year’s budget resolution. Once Congress begins moving on next year’s resolution, the budget protections for their health care bill expire.

Even if the House can muscle up the votes to revive the bill next month, it still must clear the Senate, which is expected to make significant changes to the House bill, and then the House would have to pass it again.

Politically, most Republicans say they do not want to drag out the health care debate longer than they have to if it’s clear it can’t pass. The only thing worse than failing once to deliver on a central campaign promise, is failing twice.

“Let me just tell you what we can’t do — we can’t try again and fail,” Womack said. “So there will not be a try-again effort unless it is certain that we have the votes to pass it.”

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Are Proposed Health Care Changes Still Alive?

The White House and a group of House Republicans say they are trying to reach a deal to revive their failed health care bill, but there’s little optimism for success this time around.

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Taking Shortcuts In Drug Testing Can Put Patients At Risk

Using surrogate endpoints can speed up testing of new drugs, but doesn’t always find out if they actually help patients.

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We all want breakthroughs in medicine. I’ve never met someone who doesn’t.

Even with all the progress we have seen in medicine, millions of people suffer, or have family members who suffer, from diseases that are making their lives worse or threatening their lives. Time means something different to these people. They do not have the luxury of waiting patiently while researchers test new drugs.

There is growing interest in reducing the evidence required to approve new drugs and to more rapidly deliver new therapies to patients. The sentiment behind speeding approval is a good one – no one wants to delay the availability of drugs that are beneficial and safe – but can lead to shortcuts in evidence generation that can also come with risk.

One such shortcut is to study the effect of the drug on some outcome other than what happens to patients. The idea is that the intermediary marker, or what is called a surrogate outcome, can be obtained faster and be used in place of a patient outcome that would require more people to be studied over a longer period of time.

For example, a study might focus on tumor shrinkage rather than survival. Or a study could evaluate cholesterol levels instead of heart attacks. By using these intermediate markers, the Food and Drug Administration can approve a drug for one use, cholesterol lowering, with the presumption that it reliably predicts an outcome patients care about, helping them avoid heart attacks.

The problem is that the effect of a drug on a single marker of risk like cholesterol, or even a group of markers, may not ultimately translate into whether that drug produces a benefit for a given patient. When you actually do the study that measures patient outcomes, the results can – and have – surprised us.

A legendary example is torceptrapib, which increased good cholesterol and decreased bad cholesterol. Pfizer invested heavily on this medication, and had the foresight to do a study that measured patient outcomes. For reasons that are still unclear, they found that despite its effect on cholesterol, the drug increased the risk of death. Fortunately, the drug had not yet come to market, which likely saved millions of patients from taking a drug that would have increased their risk.

Other examples abound. We have seen cancer drugs approved on the basis of surrogate outcomes fail to improve overall mortality. We have seen that drugs approved for diabetes on the basis of reducing blood glucose to almost normal levels did not lower overall risk of heart attacks. We have seen that other cholesterol drugs like niacin and fenofibrate, blockbuster drugs whose big sales were based on how they affected lipid values, failed to improve patient survival or lower their risk of heart disease.

We puzzle over why these disappointments happen. But it seems that drug effects in people are complex and hard to predict based on intermediary measures. Most drugs cause numerous changes at the same time, and we can only know the overall effect by focusing on patient outcomes.

Last month we published a study of two decades of experience with intermediate markers of risk, or surrogates, in cardiovascular trials. We identified 157 studies published in prestigious medical journals in which the surrogate outcomes indicated the drug or intervention was favorable. Only a quarter of these studies ever had a major follow-up study using patient outcomes. Of those, almost half reversed the initial conclusion.

Robert Califf, a former FDA cCommissioner, stated in an accompanying editorial that “one must question the simplistic approach to reducing standards for evidence across the board advocated by some — particularly when the FDA’s existing accelerated approval programs show that it is possible to create working pathways for streamlined drug development while maintaining standards that ensure ample empirical evidence.”

There are no shortcuts to knowing how a drug might affect what happens to people. A recent FDA report identified 22 case studies where early, small clinical studies found drugs in development to have beneficial effects, but later, larger more definitive studies found no evidence of benefit and, in some cases, evidence of harm.

The solution to speeding breakthroughs in medicine is not to take shortcuts in evidence generation, but to leverage emerging methods and networks that can potentially generate robust clinical evidence faster, cheaper and better. In a digital age, we can push for better evidence without sacrificing much time.

One example is the Patient-Centered Research Foundation that is leveraging relationships with patients and health systems, as well as the digital transformation in health data to innovate knowledge generation. With new approaches, even for outcomes that occur years or decades later, we can be poised to collect data that are accumulating over time at much lower cost and more efficiently than was previously possible.

Before any drug is approved, regulators must always take into consideration the available options and the threat of the condition. And if at times approval is made on less than strong evidence, then we need to acknowledge its weakness and commit to acquiring more. And we also need to ensure that each person who receives any drug approved under those circumstances is aware of our collective uncertainty of the drug’s risks and benefits and monitored closely.

In the end, shortcuts will generally not serve us best. They may be necessary at times, but the knowledge that the evidence is not strong should push us to redouble our efforts to create the means to rapidly generate the evidence we need and the public deserves.

Harlan Krumholz is a cardiologist and the Harold H. Hines Jr. Professor of Medicine at Yale School of Medicine. He directs the Yale-New Haven Hospital Center for Outcomes Research and Evaluation and is a co-director of the Robert Wood Johnson Foundation Clinical Scholars Program. Joseph Ross is a primary care physician and an associate professor of medicine and public health at Yale School of Medicine.

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Trump Team Urges Skimpier Health Plans To Lure More People To Buy Insurance

The Trump administration proposed a new rule permits insurers to raise the deductibles and copays of new policies sold on the exchanges.

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Would opening the door to cheaper, skimpier marketplace plans with higher deductibles and copays attract consumers and insurers to the exchanges next year? That’s what the Trump administration is betting on.

In February, the administration proposed a rule that would take a bit of the shine off bronze, silver, gold and platinum exchange plans by allowing them to provide less generous coverage while keeping the same metal level designation.

But consumer advocates and insurance experts say the proposal, which is subject to finalization later this year, fails on two fronts. It doesn’t address key concerns among insurers about plan design, and it might push consumers away from the exchanges because it could increase their out-of-pocket costs and reduce the amount they receive in tax credits for their health plan’s premiums.

The proposal is one of several rule changes the administration put forward to help stabilize the insurance marketplaces while Republicans work to repeal and replace the Affordable Care Act.

Repeal is at least temporarily off the table, after the failure of the Republicans’ replacement bill in late March. But insurers remain skittish about participating in the insurance marketplaces given the continuing uncertainty and mixed signals from the administration and Congress about how they will oversee the ACA.

By lowering the minimum coverage requirements — called a plan’s “actuarial value” — the proposed rule would let insurers offer plans with higher consumer out-of-pocket costs than are currently allowed. Right now, for example, if you buy a silver plan, the most popular choice, the plan must be designed to pay 70 percent of covered medical costs for an average consumer, while you pay the other 30 percent through your deductible, copays and coinsurance.

Since it’s difficult to design a plan that covers exactly 70 percent of medical costs, insurers have some wiggle room. Plans with actuarial values between 68 and 72 percent are considered silver plans.

The new rule would lower the floor by 2 percentage points, allowing insurers to offer silver plans that cover just 66 percent of medical costs. It would do the same for other metal level plans as well, allowing bronze plans with actuarial values as low as 56 percent instead of the 60 percent standard, gold plans at 76 rather than 80, and platinum plans at 86 rather than 90. (The allowed upper limits wouldn’t change.)

How does this affect consumers? For one thing, the premium would likely be lower for plans that offer less generous coverage. But the tradeoff would probably be higher deductibles, copays and coinsurance.

Since all plans must cover the 10 essential health benefits mandated by the ACA, insurers have few options apart from cost-sharing adjustments to alter a plan’s coverage to be more or less generous.

Maybe that seems like a decent deal if you’re a healthy person who doesn’t need much care, but some consumer advocates aren’t so sure.

“Young adults really care about overall cost sharing and not just premiums,” said Erin Hemlin, director of training and consumer education at Young Invincibles, an advocacy group for this demographic.

According to the group’s analysis of 2017 exchange enrollment, 75 percent of 18- to 34-year-olds bought silver plans while just 20 percent bought bronze plans. Cheaper premiums might not be a lure for this group, which is highly sought after by insurers because young people tend to be healthy.

Reducing the minimum actuarial value could also shrink the amount of the subsidies that help people buy insurance, consumer advocatessay. Marketplace customers with incomes up to 400 percent of the federal poverty limit (about $48,000 for one person) might qualify for tax credits to use toward the premium.

But the amount of the tax credit would be based in part on the cost of the premium of the second lowest-priced silver plan in the customer’s geographic area. If insurers offer some plans with actuarial values of 66 percent, it’s likely one of them will become the “benchmark” on which tax credits are based. Since the premium for that plan would generally be lower than that of a more generous policy, consumers’ tax credits would be smaller too.

“People have to spend more in premiums to get the same coverage because their tax credit is less,” said Aviva Aron-Dine, a senior fellow at the Center on Budget and Policy Priorities, who co-authored an analysis of the impact of the proposed change. Alternatively, they could pay the same premium as before for a plan with a higher deductible and other out-of-pocket costs, she said.

Switching from a plan with a 68 percent actuarial value to one at 66 could increase the per-person deductible by $550, according to the CBPP analysis, or to more than $1,000, according to estimates by Families USA.

The proposed rule change isn’t going to help make marketplace participation more attractive to insurers either, said Robert Laszewski, a health policy consultant and longtime critic of the Affordable Care Act.

The proposed actuarial value changes are just “rounding at the edges,” Laszewski said. Insurers are hampered in critical ways by other requirements in the law that limit the types of plans they can offer, he said, citing maximum out-of-pocket spending limits for consumers (currently $7,150 for an individual plan and $14,300 for a family plan), maximum deductibles (the same as the spending limits), and being prohibited from offering plans with even lower actuarial values.

“The biggest obstacles to creating far more flexible plans — and particularly appealing to younger, healthier people — are in the statute that the administration can’t change,” Laszewski said.

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Follow Michelle Andrews on Twitter: @mandrews110.

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With Obamacare Here to Stay, Some States Revive Medicaid Expansion

Kansas Gov. Sam Brownback opposes legislative efforts to expand the state’s Medicaid program.

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Kansas state Sen. Barbara Bollier is a Republican who has been fighting for years to get her colleague to agree to expand Medicaid.

For years she pushed against what she described as a “Tea Party-ish” Senate and a governor who wouldn’t consider the issue. In return for her efforts, she was stripped of her committee assignments and sidelined.

But in last November’s election, the makeup of the Kansas legislature moved decidedly to the center. And last week, the state’s House and Senate both agreed to expand eligibility for Medicaid, the government health program for the poor, to about 150,000 more Kansans.

“This has been a long time and a hard road,” Bollier said in an interview shortly after the vote.

The vote had reverberations back in Washington, D.C., because it came just days after Republicans in the U.S. House of Representatives failed in their effort to repeal the Affordable Care Act, also known as Obamacare. That failure breathed new life into efforts in the states expand Medicaid as the law allows.

In all, 31 states and the District of Columbia have expanded Medicaid after the Affordable Care Act passed in 2010. The majority acted so that the expansion went into effect in 2014. A handful of states, including Louisiana and Montana, that first rejected the expansion have since embraced it.

But those efforts face the same political and ideological fights that have plagued health care policy in Washington,

You could hear the echoes in Wichita last week.

State Sen. Ty Masterson, a Republican, urged his colleagues to reject expanding Medicaid because it was part of the Affordable Care Act. He likened the federal health law to a broken amusement park ride.

“We’re standing at an amusement park ride that’s closed. It’s broken. And we’re saying we want to go ahead and get on the ride,” Masterson said. “There is a reason there is nobody in line behind us. Sign’s up: ‘Out of Order.’ I don’t want to be first in that line. I want to get out of that line.”

But Bollier says the Affordable Care Act is here to stay, and that makes taking federal money to expand health care to the poor, which has overwhelming support in the public, a no-brainer.

“I’ve never had anything like that in the legislature,” she said. “It was just overwhelming support. Not just support; begging, pleading, ‘Please, we desperately need this in place.’ “

Bollier is a doctor, the daughter of a doctor and a nurse. She says getting health care to the working poor shouldn’t be a partisan issue.

“I have yet to meet a patient who comes in and says, ‘I’m a Republican,’ or ‘I’m Democrat, so mete out my care accordingly,’ ” she said.

The law allows states to offer Medicaid coverage to people with incomes up to 138 percent of the federal poverty level, or about $16,400 for a single adult. It also extended eligibility to “able-bodied” adults with no children for the first time.

But Kansas Gov. Sam Brownback didn’t see it that way. On Thursday, he vetoed the bill.

“It fails to serve the truly vulnerable before the able-bodied, lacks work requirements to help able-bodied Kansans escape poverty, and burdens the state budget with unrestrainable entitlement costs,” he said in a statement. Brownback said he also opposed it because it allowed government money to go the what he called “the abortion industry.”

Bollier calls the governor’s’ arguments “disingenuous.”

“He keeps claiming we just can’t afford this,” she says. “You afford what you choose. Where you place your money is a reflection of your value system.”

Now Bollier and other proponents are working furiously to change just two of their colleagues’ minds in hopes of overriding that veto — perhaps as soon as Monday.

About 1,200 miles due east from the fight in Wichita is Richmond, Va.

When it comes to Medicaid expansion, the two capital cities are mirror images.

Virginia Gov. Terry McAuliffe is a Democrat pushing his Republican legislature to expand Medicaid.

“I have had more excuses out of our Republican general assembly, none of them correct,” McAuliffe tells Shots. “The most recent argument was this was going to be repealed. Well, now it’s not. It’s not going away.”

McAuliffe says about 400,000 Virginians could be eligible for Medicaid under an expansion. And the Federal government would send $2.4 billion a year to the state to cover the costs.

But the legislature in Richmond isn’t buying it.

In a statement, Virginia’s Republicans said they’re still against the proposal.

“The House Republican majority remains strongly opposed to implementing ObamaCare’s Medicaid expansion in Virginia,” the statement said. “Virginia can barely afford our current program, much less an expansion. Every dollar spent on Medicaid is one less that can be spent on education, transportation or public safety.”

McAuliffe says the barrier is political. Among Virginia Republicans, the specter of U.S. House Majority Leader Eric Cantor unexpectedly losing his primary battle two years ago looms large.

“My legislature is terrified of the Tea Party,” McAuliffe says. “That’s the only reason they’re not voting for it. Because they’re afraid they’ll get taken out in the primary, plain and simple.”

So in Virginia, expanding Medicaid remains a long shot.

But up north, in Augusta, Maine, lawmakers have handed the question to the people after that state’s governor vetoed measures passed by the legislature five different times.

Tom Saviello is that state’s representative for Franklin County, a poor rural district where many people have no health care coverage.

Expanding Medicaid would make people healthier, bring in federal money and help the local hospital that’s struggling to care for all the people who can’t pay, he says.

“To me it was a no-brainer, absolutely a no-brainer,” says Saviello, a Republican, in an interview.

He sponsored bills to expand Medicaid in the past that were vetoed by Republican Gov. Paul LePage. Then on Election Day, a citizens group collected enough signatures — 67,000 — in a single day to put the question to a referendum. Saviello says he withdrew his latest bill in order to let the public decide.

“Because we have the citizens’ petition, we’re putting it in the citizens’ hands,” he says.

Polls show that 60 percent of Mainers want to expand Medicaid, Saviello says.

So come November, he predicts: “It’s going to happen. It’s coming.”

James McLean from member station KCUR in Kansas City, Mo., contributed to this report.

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