The tobacco tax initiative has become the most expensive ballot measure race in Montana history, drawing $17 million in opposition funding from tobacco companies in a state with fewer than 200,000 smokers.
Montana legislators expanded Medicaid by a very close vote in 2015. They passed the measure with an expiration date: It would sunset in 2019, and all who went onto the rolls would lose coverage unless lawmakers voted to reapprove it.
Fearing legislators might not renew funding for Medicaid's expanded rolls, Montana's hospitals and health advocacy groups came up with a ballot measure to keep it going — and to pay for it with a tobacco tax hike.
If ballot initiative I-185 passes Tuesday, it will mean an additional $2-per-pack tax on cigarettes and levy a tax on e-cigarettes, which are currently not taxed in Montana.
The tobacco tax initiative has become the most expensive ballot measure race in Montana history — drawing more than $17 million in opposition funding from tobacco companies alone — in a state with fewer than 200,000 smokers.
Amanda Cahill works for the American Heart Association and is a spokeswoman for Healthy Montana, the coalition backing the measure. She said coalition members knew big tobacco would fight back.
"We poked the bear, that's for sure," Cahill said. "And it's not because we were all around the table saying, 'Hey, we want to have a huge fight and go through trauma the next several months.' It's because it's the right thing to do."
Most of the $17 million has come from cigarette maker Altria. According to records from the National Institute on Money in Politics, that's more money than Altria has spent on any state proposition nationwide since the center started keeping track in 2004.
Meanwhile, backers of I-185 have spent close to $8 million on the initiative, with most of the money coming from the Montana Hospital Association.
"What we want to do is — No. 1 — stop Big Tobacco's hold on Montana," Cahill said. Also, she continued, it's imperative that the nearly 100,000 people in Montana who have gotten Medicaid under the expansion will be able to keep their health care.
Cahill said I-185 will allocate plenty of money to cover the expansion, though some lawmakers say the state can't afford the expansion even with higher taxes.
Nancy Ballance, a Republican representative in the Montana state Legislature, opposes the measure.
"In general I am not in favor of what we like to refer to as 'sin taxes,' " Ballance said. "Those are taxes that someone determines should be [levied] so that you change people's behavior."
Ballance also isn't in favor of ballot initiatives that, she said, try to go around what she sees as core functions of the Legislature: deciding how much revenue the state needs, for example, or where it should come from, or how it should be spent.
"An initiative like this for a very large policy with a very large price tag — the Legislature is responsible for studying that," Ballance said. "And they do so over a long period of time, to understand what all the consequences are — intended and otherwise."
Most citizens, she said, don't have the time or expertise to develop that sort of in-depth understanding of a complicated issue.
Montana's initiative to keep Medicaid's expansion going would be a "double whammy" for tobacco companies, said Ben Miller, the chief strategy officer for the nonprofit Well Being Trust.
"People who are covered are more likely to not smoke than people who are uninsured," said Miller, who has studied tobacco tax policies for years. He notes research showing that people with lower incomes are more likely than those with higher incomes to smoke; and if they're uninsured, they're less likely to quit.
Federal law requires Medicaid to offer beneficiaries access to medical help to quit smoking.
Plus, Miller added, every time cigarette taxes go up — thereby increasing the price per pack — that typically leads to a decrease in the number of people smoking.
And that, he said, works against a tobacco company's business model, "which is, 'you need to smoke so we can make money.' "
Ballance agrees that tobacco companies likely see ballot initiatives like I-185 as threats to their core business. But, she said, "for anybody who wants to continue smoking, or is significantly addicted, the cost is not going to prohibit them from smoking."
MODESTO, Calif. — Betsy Foster and Doug Dillon are devotees of Josh Harder. The Democratic upstart is attempting to topple Republican incumbent Jeff Denham in this conflicted, semi-rural district that is home to conservative agricultural interests, a growing Latino population and liberal San Francisco Bay Area refugees.
To Foster's and Dillon's delight, Harder supports a "Medicare-for-all" health care system that would cover all Americans.
Foster, a 54-year-old campaign volunteer from Berkeley, believes Medicare-for-all is similar to what's offered in Canada, where the government provides health insurance to everybody.
Dillon, a 57-year-old almond farmer from Modesto, says Foster's description sounds like a single-payer system.
"It all means many different things to many different people," Foster said from behind a volunteer table inside the warehouse Harder uses as his campaign headquarters. "It's all so complicated."
Across the country, catchphrases such as "Medicare-for-all," "single-payer," "public option" and "universal health care" are sweeping state and federal political races as Democrats tap into voter anger about GOP efforts to kill the Affordable Care Act and erode protections for people with preexisting conditions.
Republicans, including President Donald Trump, describe such proposals as "socialist" schemes that will cost taxpayers too much. They say their party is committed to providing affordable and accessible health insurance, which includes coverage for preexisting conditions, but with less government involvement.
Voters have become casualties as candidates toss around these catchphrases — sometimes vaguely and inaccurately. The sound bites often come across as "quick answers without a lot of detail," said Gerard Anderson, a professor of public health at the Johns Hopkins University Bloomberg School Public Health.
"It's quite understandable people don't understand the terms," Anderson added.
For example, U.S. Sen. Bernie Sanders (I-Vt.) advocates a single-payer national health care program that he calls Medicare-for-all, an idea that caught fire during his 2016 presidential bid.
But Sanders' labels are misleading, health experts agree, because Medicare isn't actually a single-payer system. Medicare allows private insurance companies to manage care in the program, which means the government is not the only payer of claims.
What Sanders wants is a federally run program charged with providing health coverage to everyone. Private insurance companies wouldn't participate.
In other words: single-payer, with the federal government at the helm.
Absent federal action, Democratic gubernatorial candidates Gavin Newsom in California, Jay Gonzales in Massachusetts and Andrew Gillum in Florida are pushing for state-run single-payer.
To complicate matters, some Democrats are simply calling for universal coverage, a vague philosophical idea subject to interpretation. Universal health care could mean a single-payer system, Medicare-for-all or building upon what exists today — a combination of public and private programs in which everyone has access to health care.
Others call for a "public option," a government plan open to everyone, including Democratic House candidates Antonio Delgado in New York and Cindy Axne in Iowa. Delgado wants the public option to be Medicare, but Axne proposes Medicare or Medicaid.
Are you confused yet?
Sacramento-area voter Sarah Grace, who describes herself as politically independent, said the dialogue is over her head.
"I was a health care professional for so long, and I don't even know," said Grace, 42, who worked as a paramedic for 16 years and now owns a holistic healing business. "That's telling."
In fact, most voters approached for this article declined to be interviewed, saying they didn't understand the issue. "I just don't know enough," Paul Her of Sacramento said candidly.
"You get all this conflicting information," said Her, 32, a medical instrument technician who was touring the state Capitol with two uncles visiting from Thailand. "Half the time, I'm just confused."
The confusion is all the more striking in a state where the expansion of coverage has dominated the political debate on and off for more than a decade. Although the issue clearly resonates with voters, the details of what might be done about it remain fuzzy.
A late-October poll by the Public Policy Institute of California shows the majority of Californians, nearly 60 percent, believe it is the responsibility of the federal government to make sure all Americans have health coverage. Other state and national surveys reveal that health care is one of the top concerns on voters' minds this midterm election.
Democrats have seized on the issue, pounding GOP incumbents for voting last year to repeal the Affordable Care Act and attempting to water down protections for people with preexisting medical conditions in the process. A Texas lawsuit brought by 18 Republican state attorneys general and two GOP governors could decimate protections for preexisting conditions under the ACA — or kill the law itself.
Republicans say the current health care system is broken, and they have criticized the rising premiums that have hit many Americans under the ACA.
Whether the Democratic focus on health care translates into votes remains to be seen in the party's drive to flip 23 seats to gain control of the House.
The Denham-Harder race is one of the most watched in the country, rated too close to call by most political analysts. Harder has aired blistering ads against Denham for his vote last year against the ACA, and he sought to distinguish himself from the incumbent by calling for Medicare-for-all — an issue he hopes will play well in a district where an estimated 146,000 people would lose coverage if the 2010 health law is overturned.
Yet Harder is not clinging to the Medicare-for-all label and said Democrats may need to talk more broadly about getting everyone health care coverage.
"I think there's a spectrum of options that we can talk about," Harder said. "I think the reality is we've got to keep all options open as we're thinking towards what the next 50 years of American health care should look like."
To some voters, what politicians call their plans is irrelevant. They just want reasonably priced coverage for everyone.
Sitting with his newspaper on the porch of a local coffee shop in Modesto, John Byron said he wants private health insurance companies out of the picture.
The 73-year-old retired grandfather said he has seen too many families struggle with their medical bills and believes a government-run system is the only way.
"I think it's the most effective and affordable," he said.
Linda Wahler of Santa Cruz, who drove to this Central Valley city to knock on doors for the Harder campaign, also thinks the government should play a larger role in providing coverage.
But unlike Byron, Wahler, 68, wants politicians to minimize confusion by better defining their health care pitches.
"I think we could use some more education in what it all means," she said.
Hospitals often avoid the glitches by turning the software off and switching to paper charts. But that's less than ideal since hospitals have evolved to become increasingly reliant on electronic systems.
Modern technology has helped medical professionals do robot-assisted surgeries and sequence whole genomes, but hospital software still can't handle daylight saving time.
One of the most popular electronic health records software systems used by hospitals, Epic Systems, can delete records or require cumbersome workarounds when clocks are set back for an hour, prompting many hospitals to opt for paper records for part of the night shift.
And it happens every year.
"It's mind-boggling," said Dr. Mark Friedberg, a senior physician policy researcher at RAND, adding that in 2018, "we expect electronics to handle something as simple as a time change. "Nobody is surprised by daylight savings time. They have years to prep. Only, surprise, it hasn't been fixed."
Dr. Steven Stack, a past president of the American Medical Association, called the glitches "perplexing" and "unacceptable," considering that hospitals spend millions of dollars on these systems, and Apple and Google seem to have dealt with seasonal time changes long ago. Epic was founded in 1979, but some hospitals have used these electronic systems longer than others.
Carol Hawthorne-Johnson, an ICU nurse in California, said her hospital doesn't shut down the Epic system during the fall time change. But she's come to expect that the vitals she enters into the system from 1 a.m. to 2 a.m. will be deleted when the clock falls back to 1 a.m. One hour's worth of electronic record-keeping "is gone," she said.
Hospital staff have learned to deal with it by taking extra chart notes by hand, but it's still a burden, she said, especially if vitals change, or a patient needs something like a blood transfusion.
Although hospitals often avoid the software glitches by turning the software off and switching to paper charts, it's far from ideal because hospitals have evolved to become increasingly reliant on electronic systems, said Stack, an emergency physician in Kentucky.
"When [electronic medical records] work, it's wonderful," he said, but when the system is turned off, doctors can't use it to access patient records or order tests. Whiteboards are a thing of the past, and some staff members aren't as comfortable with paper records because they've relied on electronic records their entire careers.
"It's an hour where you're flying sort of blind," Friedberg said.
The one-hour pause slows everything down, which can cause patients to spend more time in emergency department waiting rooms, prompting some to go home before seeing a health care provider. That's dangerous, Stack said.
Not all hospitals turn Epic off, however. At Johns Hopkins Hospital, providers who need to check patients periodically through the night use a workaround. They enter vitals at 1 a.m. and then when the clock falls back an hour later and they have to enter new vitals, they list them at 1:01 a.m. They leave a note that it's an hour later, not a minute later. That's how the Cleveland Clinic does it, too.
"I don't disagree with the sentiment that we would like health IT systems to be much more sophisticated," said Dr. Peter Greene, Johns Hopkins chief medical information officer. But there are plenty of other problems he'd like to see fixed first. "This particular aspect is not one that has caused us a lot of trouble."
Other electronic medical records systems may require similar workarounds, said Jennifer Carpenter, vice president of IT clinical systems at University Hospitals in Cleveland, which uses several electronic medical records systems. Cerner, another major electronic medical records company, was unavailable for comment, but many hospitals plan for Cerner to be down during the time change, too.
When asked to comment on the glitches and workarounds, Epic spokeswoman Meghan Roh provided the following statement:
"Daylight savings time is inherently nuanced for healthcare organizations, which is why we work closely with customers to provide guidance on how to most effectively use their system to care for their patients during this time period. We're constantly making improvements and looking for opportunities to enhance the system."
But Friedberg pointed out that hospitals are locked into their electronic medical record systems because they've invested so much money in them. And it would cost even more to convert and transfer the records into a new system. As a result, there's little incentive for software companies to improve their products, he said.
"I shudder to think … what does it do with leap years?" Friedberg wondered.
Voters this year have told pollsters in no uncertain terms that health care is important to them. In particular, maintaining insurance protections for preexisting conditions is the top issue to many.
But the results of the midterm elections are likely to have a major impact on a broad array of other health issues that touch every single American. And how those issues are addressed will depend in large part on which party controls the U.S. House and Senate, governors' mansions and state legislatures around the country.
All politics is local, and no single race is likely to determine national or even state action. But some key contests can provide something of a barometer of what's likely to happen — or not happen — over the next two years.
For example, keep an eye on Kansas. The razor-tight race for governor could determine whether the state expands Medicaid to all people with low incomes, as allowed under the Affordable Care Act. The legislature in that deep red state passed a bill to accept expansion in 2017, but it could not override the veto of then-Gov. Sam Brownback. Of the candidates running for governor in 2018, Democrat Laura Kelly supports expansion, while Republican Kris Kobach does not.
Here are three big health issues that could be dramatically affected by Tuesday's vote.
1. The Affordable Care Act
Protections for preexisting conditions are only a small part of the ACA. The law also made big changes to Medicare and Medicaid, employer-provided health plans and the generic drug approval process, among other things.
Republicans ran hard on promises to get rid of the law in every election since it passed in 2010. But when the GOP finally got control of the House, the Senate and the White House in 2017, Republicans found they could not reach agreement on how to "repeal and replace" the law.
This year has Democrats on the attack over the votes Republicans took on various proposals to remake the health law. Probably the most endangered Democrat in the Senate, Heidi Heitkamp of North Dakota, has hammered her Republican opponent, U.S. Rep. Kevin Cramer, over his votes in the House for the unsuccessful repeal-and-replace bills. Cramer said that despite his votes he supports protections for preexisting conditions, but he has not said what he would do or get behind that could have that effect.
Polls suggest Cramer has a healthy lead in that race, but if Heitkamp pulled off a surprise win, health care might well get some of the credit.
And in New Jersey, Rep. Tom MacArthur, the moderate Republican who wrote the language that got the GOP health bill passed in the House in 2017, is in a heated race with Democrat Andy Kim, who has never held elective office. The overriding issue in that race, too, is health care.
It is not just congressional action that has Republicans playing defense on the ACA. In February, 18 GOP attorneys general and two GOP governors filed a lawsuit seeking a judgment that the law is now unconstitutional because Congress in the 2017 tax bill repealed the penalty for not having insurance. Two of those attorneys general — Missouri's Josh Hawley and West Virginia's Patrick Morrisey — are running for the Senate. Both states overwhelmingly supported President Donald Trump in 2016.
The attorneys general are running against Democratic incumbents — Claire McCaskill of Missouri and Joe Manchin of West Virginia. And both Republicans are being hotly criticized by their opponents for their participation in the lawsuit.
Although Manchin appears to have taken a lead, the Hawley-McCaskill race is rated a toss-up by political analysts.
But in the end the fate of the ACA depends less on an individual race than on which party winds up in control of Congress.
"If Democrats take the House … then any attempt at repeal-and-replace will be kaput," said John McDonough, a former Democratic Senate aide who helped write the ACA and now teaches at the Harvard School of Public Health.
Conservative health care strategist Chris Jacobs, who worked for Republicans on Capitol Hill, said a new repeal-and-replace effort might not happen even if Republicans are successful Tuesday.
"Republicans, if they maintain the majority in the House, will have a margin of a half dozen seats — if they are lucky," he said. That likely would not allow the party to push through another controversial effort to change the law. Currently there are 42 more Republicans than Democrats in the House. Even so, the GOP barely got its health bill passed out of the House in 2017.
And political strategists say that, when the dust clears after voting, the numbers in the Senate may not be much different so change could be hard there too. Republicans, even with a small majority last year, could not pass a repeal bill there.
2. Medicaid expansion
The Supreme Court in 2012 made optional the ACA's expansion of Medicaid to cover all low-income Americans up to 138 percent of the poverty line ($16,753 for an individual in 2018). Most states have now expanded, particularly since the federal government is paying the vast majority of the cost: 94 percent in 2018, gradually dropping to 90 percent in 2020.
Still, 17 states, all with GOP governors or state legislatures (or both), have yet to expand Medicaid.
McDonough is confident that's about to change. "I'm wondering if we're on the cusp of a Medicaid wave," he said.
Four states — Nebraska, Idaho, Utah and Montana — have Medicaid expansion questions on their ballots. All but Montana have yet to expand the program. Montana's question would eliminate the 2019 sunset date included in its expansion in 2016. But it will be interesting to watch results because the measure has run into big-pocketed opposition: the tobacco industry. The initiative would increase taxes on cigarettes and other tobacco products to fund the state's increased Medicaid costs.
In Idaho, the ballot measure is being embraced by a number of Republican leaders. GOP Gov. Butch Otter, who is retiring after three terms, endorsed it Tuesday.
But the issue is in play in other states, too. Several non-expansion states have close or closer-than-expected races for governor where the Democrat has made Medicaid expansion a priority.
In Florida, one of the largest states not to have expanded expanded Medicaid, the Republican candidate for governor, former U.S. Rep. Ron DeSantis, opposes expansion. His Democratic opponent, Tallahassee Mayor Andrew Gillum, supports it.
However, the legislatures in both states have opposed the expansion, and it's not clear if they would be swayed by arguments from a new governor.
3. Medicare
Until recently, Republicans have remained relatively quiet about efforts to change the popular Medicare program for seniors and people with disabilities.
Their new talking point is that proposals to expand the program — such as the often touted "Medicare-for-all," which an increasing number of Democrats are embracing — could threaten the existing program.
"Medicare is at significant risk of being cut if Democrats take over the House," Rep. Greg Gianforte (R-Mont.) told the Lee Montana Newspapers. "Medicare-for-all is Medicare for none. It will gut Medicare, end the VA as we know it, and force Montana seniors to the back of the line."
Gianforte's Democratic opponent, Kathleen Williams, is proposing another idea popular with Democrats: allowing people age 55 and over to "buy into" Medicare coverage. That race, too, is very tight.
Meanwhile, back in Washington, congressional Republicans are more concerned with how Medicare and other large government social programs are threatening the budget.
"Sooner or later we are going to run out of other people's money," said Chris Jacobs.
Senate Majority Leader Mitch McConnell suggested in an Oct. 16 interview with Bloomberg News that entitlement programs like Medicare are "the real driver of the debt by any objective standard," but that bipartisan cooperation will be needed to address that problem
Republican Jacobs and Democrat McDonough think that's unlikely any time soon.
"Why would Democrats give that up as an issue heading into 2020?" asked McDonough, especially because Republicans in recent years have been proposing deep cuts to the Medicare program.
Agreed Jacobs, "Trump may not want that to be the centerpiece of a re-election campaign."
Companies sometimes promote new products, but withhold the detailed findings until much later. The consequences for both consumers and the health system are vast.
At the end of September, Amarin Corp. teased some early findings for Vascepa, its preventive medicine for people at risk of heart disease. The claim was astounding: a 25 percent relative risk reduction for deaths related to heart attacks, strokes and other conditions. Headlines proclaimed a potential game changer in treating cardiovascular disease. And company shares quickly soared, from $3 a share to about $20.
Vascepa is Amarin's only product. The company wants to turn its pill made of purified fish oil into a cash cow, allowing it to staff up both in the United States and abroad so it can sell doctors and millions of consumers on its medical benefits. Although the product has been on the market for more than five years, its first TV ad campaign rolled out this summer in anticipation of the study findings.
Except there is one problem. The particulars of the scientific study on which this claim was based remain a mystery.
Amarin's preliminary announcement came via a news release on Sept. 24. The company plans to release detailed findings in November at the national American Heart Association conference. Then early next year, it plans to seek Food and Drug Administration approval to use the drug as a preventive for a range of heart conditions, beyond its current role targeting high triglyceride levels.
In the interim, a battle is brewing among physicians, cardiovascular experts and pharma watchers who say Vascepa brings to the foreground troubling trends in the marketing and advertising of new drugs. Companies sometimes promote new products, but withhold the detailed findings until much later. The consequences for both consumers and the health system are vast.
"Until all the data is available for review by the public and medical community, it's really premature to see some of the cheerleading that's being done," said Dr. Eric Strong, a hospitalist and clinical assistant professor at Stanford School of Medicine. "It's harder to change people's minds once you have these rosy pictures."
John Thero, Amarin's CEO, argued that the imminent release of the drug's complete picture should alleviate those concerns.
In unveiling topline findings in a news release, he said, the company's playbook doesn't diverge from that of other pharmaceutical makers, and provides a necessary level of disclosure for shareholders.
But it's the specifics in the data — for instance, which patients benefited, by how much, their absolute risk reduction and which precise conditions saw improvement — that illustrate whether a product is cost-effective, said medical and drug experts.
That's especially true in the case of Vascepa, whose manufacturer is working hard to convince people the product is clinically superior to ordinary fish oil supplements. Fish oil, which can retail for a few dollars a bottle, has long been promoted as a preventive for heart disease. But the substance has never held up in clinical trials as a way to systematically lower disease risk, said experts.
That's where Amarin's product is superior, Thero said.
The manufacturer has tried to limit competition by seeking to block other fish oil products —arguing to the U.S. International Trade Commission that omega-3 supplements aren't equivalents, and calling on the FDA to block a chemical component of fish oil, known as EPA and marketed by a number of supplement companies, from being sold as a dietary supplement. Amarin hasn't yet prevailed.
Preston Mason, a biologist who consults for Amarin and has advocated on its behalf, argued that ordinary fish oil supplements carry risks because they are not regulated or approved by the FDA, which does oversee prescription drugs like Vascepa.
How Vascepa performs against regular fish oil remains unknown. Amarin's trial compared the drug against a placebo, not over-the-counter supplements.
Vascepa itself isn't new. It was approved in 2012 as a remedy for extremely high triglyceride levels, which can put patients at risk for pancreatic problems. But reducing that fat hadn't been conclusively tied to, say, lowering the risk of heart attacks, or other major cardiac problems.
That link, ostensibly, is what Amarin is trying now to assert. And there's plenty of money to be made if it succeeds.
As of last December, Vascepa retailed for about $280 for a month-long supply, a list price increase of 43 percent over five years, though the company says its net sale price has stayed the same. (That difference would come if Amarin increased the size of rebates, or discounts it provides, commensurate with price hikes.)
Now, citing the drug's potentially increased value, Amarin has declined to say whether it will change the price again — though Thero said he sees greater profit potential if the company increases sales volume rather than price.
This gets at the crux of this debate. If a company makes available the technical details of a product, but only after hyping the findings, and if the details undercut some of that buzz — is it too late?
Dr. Khurram Nasir, a Yale cardiologist, acknowledged that it's unclear how effective Vascepa really is, but maintained those ambiguities will be cleared up soon enough.
"As the findings reveal themselves, there will be a lot of discussion around cost effectiveness, and whether this is worth the spend," Nasir said.
Mason, the Amarin scientist, said FDA scrutiny can also alleviate concerns about overhype.
But others worry the perception of Vascepa's effectiveness is now set.
"People are weighing in with really strong language, without enough information," said Dr. Lisa Schwartz, who co-directs the Dartmouth Institute's Center for Medicine and Media and studies effective scientific communication.
That has both clinical and financial consequences, she added. Doctors are more likely to prescribe a product that's been heavily promoted, even if subsequent discussion indicates the drug isn't as powerful as initially implied. And manufacturers can cash in, whether through increased company stock market value or by charging higher list prices.
For Vascepa, the central question is which specific heart conditions saw risk reduction, she and others said. In its news release, Amarin noted a "composite outcome" — that is, the 25 percent relative improvement encompassed all conditions for which the researchers tested.
"People are saying, Wow, it reduced heart attack, stroke and blah, blah, blah — when it may just reduce the least important one," said Dr. Steven Woloshin, Schwartz's research partner.
Another issue: The Vascepa trial focused on a specific population — patients with high triglyceride levels plus elevated risk of cardiovascular disease or diabetes who were already taking a daily statin. That means any proof of benefit is limited to that group.
Woloshin and Schwartz both suggested that nuance could get lost in translation. "It is this much narrower, high-risk population," Schwartz said.
Woloshin added, "The fear is [the message] would generalize to anyone with high triglycerides."
This concern is amplified by a 2016 court settlement in which the FDA permitted Amarin to market Vascepa to audiences for whom it hasn't been specifically approved — so long as the company doesn't say anything untrue about the drug.
Thero said Amarin's marketing of Vascepa has stayed, and will remain, consistent with what is factual and relevant.
"We are proceeding consistently with what the FDA has guided," he said.
But, some experts said, the 2016 settlement could unlock the door to wider marketing of Vascepa's off-label use, implying the pill benefits more people than it actually does.
"They'll take pains to show how different this is from everything out there … and its results in these populations," said Dr. Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School, who studies the pharmaceutical industry. "What they can't do is say it will be beneficial to these other populations. But they can hint at that."
Despite federal rules requiring plans to keep up-to-date directories, consumers may lack access to clear information about which health plans have 'narrow networks' of providers or which hospitals and doctors are in or out of an insurer's network.
As a breast cancer survivor, Donna Catanuchi said she knows she can't go without health insurance. But her monthly premium of $855 was too high to afford.
"It was my biggest expense and killing me," said Catanuchi, 58, of Mullica Hill, N.J.
A "navigator" who helps people find coverage through the Affordable Care Act found a solution. But it required Catanuchi, who works part time cleaning offices, to switch to a less comprehensive plan, change doctors, drive farther to her appointments and pay $110 a visit out-of-pocket — or about three times what she was paying for her follow-up cancer care.
She now pays $40 a month for coverage, after she qualified for a substantial government subsidy.
Catanuchi's switch to a more affordable but restrictive plan reflects a broad trend in insurance plan design over the past few years. The cheaper plans offer far narrower networks of doctors and hospitals and less coverage of out-of-network care. But many consumers are overwhelmed or unaware of the trade-offs they entail, insurance commissioners and policy experts say.
With enrollment for ACA health plans beginning Nov. 1, they worry that consumers too often lack access to clear information about which health plans have "narrow networks" of medical providers or which hospitals and doctors are in or out of an insurer's network, despite federal rules requiring plans to keep up-to-date directories.
"It's very frustrating for consumers," said Betsy Imholz, who represents the advocacy group Consumers Union at the National Association of Insurance Commissioners. "Health plan provider directories are often inaccurate, and doctors are dropping in and out all the time."
These more restrictive plans expose people to larger out-of-pocket costs, less access to out-of-network specialists and hospitals, and "surprise" medical bills from unforeseen out-of-network care.
More than 14 million people buy health insurance on the individual market — largely through the ACA exchanges, and they will be shopping anew this coming month.
Both have more restrictive networks and offer less out-of-network coverage compared with preferred provider organizations (PPOs), which represented 21 percent of health plans offered through the ACA exchanges in 2018, according to Avalere, a health research firm in Washington, D.C.
PPOs typically provide easier access to out-of-network specialists and facilities, and partial — sometimes even generous — payment for such services.
Measured another way, the number of ACA plans offering any out-of-network coverage declined to 29 percent in 2018 from 58 percent in 2015, according to a recent analysis by the Robert Wood Johnson Foundation.
For example, in California, HMO and EPO enrollment through Covered California, the state's exchange, grew from 46 percent in 2016 to 70 percent in 2018, officials there said. Over the same period, PPO enrollment declined from 54 percent to 30 percent.
In contrast, PPOs have long been and remain the dominant type of health plan offered by employers nationwide. Forty-nine percent of the 152 million people and their dependents who were covered through work in 2018 were enrolled in a PPO-type plan. Only 16 percent were in HMOs, according to the Kaiser Family Foundation's annual survey of employment-based health insurance.
The good news for people buying health insurance on their own is that the trend toward narrow networks appears to be slowing.
"When premiums shot up over the past few years, insurers shifted to more restrictive plans with smaller provider networks to try and lower costs and premiums," said Chris Sloan, a director at Avalere. "With premium increases slowing, at least for now, that could stabilize."
Some research supports this prediction. Daniel Polsky, a health economist at the University of Pennsylvania, found that the number of ACA plans nationwide with narrow physician networks declined from 25 percent in 2016 to 21 percent in 2017.
Polsky is completing an analysis of 2018 plans and expects the percent of narrow network plans to remain "relatively constant" for this year and into 2019.
"Fewer insurers are exiting the marketplace, and there's less churn in the plans being offered," said Polsky. "That's good news for consumers."
Insurers may still be contracting with fewer hospitals, however, to constrain costs in that expensive arena of care, according to a report by the consulting firm McKinsey & Co. It found that 53 percent of plans had narrow hospital networks in 2017, up from 48 percent in 2014.
"Narrow networks are a trade-off," said Paul Ginsburg, a health care economist at the Brookings Institution. "They can be successful when done well. At a time when we need to find ways to control rising health care costs, narrow networks are one legitimate strategy."
Ginsburg also notes that there's no evidence to date that the quality of care is any less in narrow versus broader networks, or that people are being denied access to needed care.
Mike Kreidler, Washington state's insurance commissioner, said ACA insurers in that state "are figuring out they can't get away with provider networks that are inadequate to meet people's needs."
"People have voted with their feet, moving to more affordable choices like HMOs but they won't tolerate draconian restrictions," Kreidler said.
The state is stepping in, too. In December 2017, Kreidler fined one insurer — Coordinated Care — $1.5 million for failing to maintain an adequate network of doctors. The state suspended $1 million of the fine if the insurer had no further violations. In March 2018, the plan was docked another $100,000 for similar gaps, especially a paucity of specialists in immunology, dermatology and rheumatology. The $900,000 in potential fines continues to hang over the company's head.
Pennsylvania Insurance Commissioner Jessica Altman said she expects residents buying insurance in the individual marketplace for 2019 to have a wider choice of providers in their networks.
"We think and hope insurers are gradually building more stable networks of providers," said Altman.
New State Laws
Bad publicity and recent state laws are pushing insurers to modify their practices and shore up their networks.
About 20 states now have laws restricting surprise bills or balance billing, or which mandate mediation over disputed medical bills, especially those stemming from emergency care.
Even more have rules on maintaining accurate, up-to-date provider directories.
The problem is the laws vary widely in the degree to which they "truly protect consumers," said Claire McAndrew, a health policy analyst at Families USA, a consumer advocacy group in Washington, D.C. "It's a patchwork system with some strong consumer protections and a lot of weaker ones."
"Some states don't have the resources to enforce rules in this area," said Justin Giovannelli, a researcher at the Center on Health Insurance Reforms at Georgetown University. "That takes us backward in assuring consumers get coverage that meets their needs."
Like many Republican candidates struggling to explain how they could support protections for preexisting conditions while also supporting changes that would gut them, Rep. Tom MacArthur has offered vague but persistent promises to shield Americans with medical conditions.
EDGEWATER PARK, N.J. — Not long ago many voters knew little about Tom MacArthur. A low-key moderate Republican congressman in a district that twice went for Barack Obama, he burnished his reputation as the guy who worked with Democrats to help rebuild in the years after Hurricane Sandy.
Now, as he wages a bitter fight for re-election to a seat he won by 20 percentage points just two years ago, even some of his supporters have turned virulently against him. The reason? His new reputation as the turncoat whose legislation almost repealed the Affordable Care Act.
Like many Republican candidates struggling to explain how they could support protections for preexisting conditions while also supporting changes that would gut them, MacArthur has offered vague but persistent promises to shield Americans with medical conditions.
But he also wrote the Republican legislation that would have allowed states to charge those Americans higher premiums or limit what services are covered, gaining enough support for the repeal bill to clear the House last year.
As such, MacArthur's candidacy has become a kind of Rorschach test for Republicans' repeated attempts to repeal and otherwise undermine the Affordable Care Act — and how much candidates in swing districts will pay for those efforts.
If this New Jersey district is any indication, it could be a lot.
Sue Coleman, 64, split her ballot in 2016, voting for MacArthur and Hillary Clinton. "I thought he was a moderate, so I voted for him," she said. Today, she feels so angry that she arrived at a recent political event at the 45th Street Pub here wearing an unruly wig, a full beard and mustache paired with a dark suit and blood-red tie — imitating one of the congressman's top aides who has become a familiar gatekeeper as she and others have personally lobbied MacArthur. The crowd laughed and cheered.
Earlier that day, dozens of people, most of them women, gathered in a strip mall parking lot before scattering to knock on doors on behalf of MacArthur's Democratic challenger, Andy Kim. MacArthur "didn't listen to the people," said Nancy Keegan, 57, of Delran Township, N.J., as she stood with her sisters.
Some of the volunteers couldn't help but point out that the high school across the street was where MacArthur held a nearly five-hour town hall last year that made national headlines for the irate crowd of constituents and protesters who shouted down explanations of his attempts to resuscitate the repeal effort. MacArthur has made fewer, and more limited, public appearances since then.
In a sign of the race's power to help Democrats reclaim the House, members of Planned Parenthood, NARAL and Rep. Katherine Clark (D-Mass.) were on hand to energize the sweatshirt- and sneaker-clad crowd. While it has been about a year and a half since MacArthur bolstered the Republican repeal effort, the anger hasn't faded. Said Susan Harper, 64, also of Delran Township and Keegan's sister: "I don't think that's going away."
MacArthur, 58, a wealthy insurance executive who has received hundreds of thousands of dollars in corporate contributions and invested millions of his own in his campaigns, is locked in "a true toss-up" this year, said David Wasserman, an editor at the Cook Political Report. Kim, 36, — a former Obama administration national security official — had raised $750,000 more than MacArthur had by the end of September.
Trump won MacArthur's 3rd Congressional District — which spans the state from the suburbs outside Philadelphia to the tourist destinations and retirement communities of the Jersey Shore — by about 6 points. In spring 2017, as House Republicans bickered over how to repeal the health care reform law, MacArthur — then a leader of the chamber's moderate Republican caucus — brokered a deal with far-right members. It would have allowed states to circumvent some of the law's protections for people with medical conditions, if they set up high-risk insurance pools to help cover those patients.
Through that compromise, known as the MacArthur Amendment, the bill passed the House without any Democratic support. It later stalled in the Senate.
Less than a week later, appearing at that town hall in his district's Democratic stronghold, MacArthur spoke of losing his 11-year-old daughter, Grace, to a rare neurological condition, a painful story he had rarely discussed in public.
The death of MacArthur's daughter "is the very reason his constituents do not understand his actions," said Maura Collinsgru, the health care program director at New Jersey Citizen Action, a liberal watchdog group. "How could you, having had that experience, justify your votes?"
Democrats across the country have been hitting their Republican opponents hard on the issue in light of the repeal effort and a legal effort by many Republican state attorneys general to end protections for preexisting conditions. Republicans are fighting back with promises but few plans to match. During a recent forum on a local TV station, MacArthur said: "I fought to protect preexisting conditions, and I've always supported that."
The MacArthur campaign did not respond to multiple requests for an interview.
Kim, who has never held elected office, started considering whether to run when MacArthur's compromise was released, he said. But he was convinced after doctors warned him and his wife that their unborn son was dangerously underweight.
"I told my wife that if we could get through this, and if our baby is born and he is stable, I want to do what I can to hold my representative accountable for what he did," he said. Today, Kim said, his son is doing fine.
Kim has framed himself as the anti-MacArthur, vowing to hold in-person town halls once a month and reject corporate contributions.
Further complicating MacArthur's re-election prospects is his vote for the Republican tax bill, which the nonpartisan Tax Policy Center said would be most damaging for New Jersey, where it estimated 10.2 percent of households would see their federal taxes increase this year. He was the only New Jersey lawmaker to support it.
Mike DuHaime, a strategist who advised former Republican Gov. Chris Christie on his 2009 campaign, said Kim is benefiting from the "historical and partisan headwinds" facing Republican incumbents in blue states like New Jersey.
"Anyone who thinks Tom MacArthur doesn't care about those with preexisting conditions is grossly mistaken and completely unaware of the type of person he is," he wrote in an email. "He was trying to forge progress, and when you do that, you will be criticized."
But in a time of such intense political loyalties, it is unclear whether MacArthur's role in trying to repeal the Affordable Care Act would be damaging enough to oust him.
"It seems to me in this election people have chosen their tribal corners and issues have less potency overall," said Tom Moran, the editorial page editor and political columnist at the state's largest newspaper, the Star-Ledger.
"But if there is one issue that penetrates," he added, "it's health care."
The U.S. is grappling with a doctor shortage that’s expected to grow to as many as 120,000 physicians by 2030. Foreign-born doctors are vital to the national healthcare delivery system.
ATLANTA — Dr. Alluri Raju, a native of India, vividly remembers how his ethnicity prompted concern and discrimination in the southwest Georgia town of Richland. Doctors there hesitated to grant the family practitioner and general surgeon privileges to the local hospital when he arrived in 1981.
"I guess they wanted to cut me off so that I wouldn't be a competitor," he recalled.
Yet, in the 37 years Raju has been practicing in Richland, more than 20 doctors have come and gone and he's the only physician left — not just in Richland, but in all of Stewart County and neighboring Webster County, an area roughly half the size of Rhode Island with a population of more than 8,000.
"Today, I'm it," he said. And his patients, he said, treat him with respect — and not as a foreigner.
Stories like Raju's are the common thread for many immigrant doctors in the United States.
The American Medical Association said that, as of last year, 18 percent of practicing physicians and medical residents in the U.S. in patient care were born in other countries. Georgia's percentage of foreign-born doctors is similar, at 17 percent.
Yet President Donald Trump's focus on securing U.S. borders and restricting immigration — and the bitter arguments between the national political parties on the issue during midterm campaigns — have sown concerns about opportunities for foreign-born doctors.
Many of these doctors, like Raju, work in rural areas that are desperate to attract medical professionals. Yet those areas are often reliable supporters of Trump and his strict immigration policies. A recent national poll found that immigration is the top concern for Republican voters.
Some health care experts say Trump's tough stance could make it harder for rural areas such as Richland to relieve critical physician shortages.
Georgia's Republican lawmakers have considered legislation in recent years that opponents say would have restricted the rights of some immigrants. And Republican candidates for governor here campaigned in the primary this year on cracking down on illegal immigrants, though advocates for that position say bias is not the motivation, but rather the need for border security.
Raju's patients say they don't see any problem in seeking care from an immigrant. Raju has been treating Willie Hawkins, a retired road worker, for 30 years, as well as his mother and his sister.
Sometimes, Hawkins said with a smile, he has to ask the nurse what the doctor just said.
"You know, he talks a little funny," said Hawkins, 66. "But who cares?"
Maybe when Raju first came here to practice, people were a bit skeptical, Hawkins recalled. Many had never met someone from India before, he said. "But today it just doesn't matter," he said.
Foreign-born doctors are vital to the national health system. The U.S. is grappling with a doctor shortage that's expected to grow to as many as 120,000 physicians by 2030, according to the Association of American Medical Colleges.
Even now, primary care doctors are relatively scarce in certain areas of the country. Georgia has a few counties without any doctors at all, and many counties lack a pediatrician or an OB-GYN.
These immigrants help fill some of the gaps, especially in primary care, said Dr. William Salazar of Augusta University's Medical College of Georgia, who came to the U.S. from Colombia. And rural Georgia has a higher percentage of immigrant doctors than do urban areas, said Jimmy Lewis of HomeTown Health, an association of rural hospitals mostly in Georgia.
"Foreign-born doctors go to places no one wants to go," said Dr. Gulshan Harjee, a Tanzanian-born physician who co-founded the Clarkston Community Health Center, a free clinic serving mainly immigrants and refugees in metro Atlanta.
Patients' Bias
Several foreign-born doctors here recalled awkward interactions with patients, occasionally experiencing bias.
"When they think you're different, they think you're not as smart, and think they won't understand what you're saying," said Salazar. "You develop skills to overcome that.''
But patients overall are getting used to people from other countries, he added.
Saeed Raees, a pharmacist originally from Pakistan who co-founded the Clarkston clinic, said that "you'll run into a small minority who don't want to be seen by a foreign-born doctor or a Muslim doctor."
Physicians from predominantly Muslim countries face increased pressure after the Trump administration tightened its visa and immigration policies. Several doctors said that their visa applications take longer than before or are on hold, and re-entry into the U.S. after traveling was difficult.
Nearly half of Muslim physicians in the U.S. felt more scrutiny at work compared with their peers, and many said they experienced discrimination in the workplace, according to a study by Dr. Aasim Padela at the University of Chicago. Nearly a tenth of the physicians surveyed reported that patients had refused their care because they were Muslim.
There is also acceptance.
Dr. Buthena Nagi, a native of Libya, is employed as a hospitalist at Navicent Health in Macon. Nagi, 40, completed her residency at Morehouse School of Medicine in Atlanta in 2015. But to stay in the country she has to meet immigration criteria.
Most foreign physicians complete their residency in the U.S., typically on a student visa. To remain beyond that, U.S. immigration law requires them to practice in a medically underserved area for at least three years. Afterward, they can apply for a green card and, eventually, American citizenship.
Nagi wears a hijab — a traditional head covering for many Muslim women — with her scrubs, and sometimes patients and colleagues ask her about it.
"I then explain that this is part of my religion," she said. "And once the dialogue kicks in, the fear dies down, and people seem to understand that I'm not an alien from outer space."
In metro Atlanta's highly diverse DeKalb County, about 75 percent of the patients at the free Clarkston health center are immigrants, refugees or migrant workers. Up to 30 languages are spoken there. Co-founder Harjee said she speaks "only six."
Sameera Vadsariya, 37, said through an interpreter that she loves the services there. She was born in India and is here on a visa. She has no health insurance, so the free services are worth the long wait for treatment.
Most of the volunteer doctors at the Clarkston clinic are foreign-born, said Harjee. "This is a passion for them. They want to give back.''
Opportunity Lost
Belsy Garcia Manrique also wants to play a role.
At age 7, she left her home in Zacapa, Guatemala, and headed north through Mexico with her mother and sister. It was a two-week odyssey — a combination of walking and driving — up to the southern tip of Texas. Her father, Felix, who had come to the U.S. two years earlier seeking political asylum, met them and drove the family to his home in Georgia.
For many years, she dreamed of being a doctor, hoping to treat Spanish-speaking patients in the parts of northwest Georgia where she was raised.
U.S. immigration policy, however, blocked her path to medical school. She was not a legal resident. Most states, including Georgia, prevented undocumented immigrant children like Garcia Manrique from qualifying for in-state tuition at public universities.
But Garcia Manrique caught a break when President Barack Obama issued an executive order six years ago that created the Deferred Action for Childhood Arrivals program. DACA offered more than 800,000 undocumented immigrants brought to the U.S. by their parents a chance to stay without fear of deportation.
From 2012 to 2016, medical schools from California to Massachusetts accepted roughly 100 DACA students, whose families hailed from Mexico, Pakistan, Venezuela and other countries. Garcia Manrique applied to nearly 40 schools. The Stritch School of Medicine at Loyola University Chicago, the first medical school to accept DACA students, was the only one that offered her admission.
Shortly after taking office in 2017, Trump rescinded DACA, a move that has become the subject of ongoing legal and political battles. If the law stands, Garcia Manrique will be allowed to stay in the U.S. But if it's overturned, she and DACA medical trainees won't be allowed to renew their work permits.
Garcia Manrique is finishing medical school and applying for a residency program to train in family medicine. Only two Georgia medical programs — at Emory University and Morehouse College — said they would consider a DACA recipient. She applied to both.
Of her 50 applications, Garcia Manrique received interview offers from nearly a dozen programs, including ones in Illinois, California and Washington. She hasn't heard from the ones in Georgia.
And these days she isn't sure if the Georgia she knew, and the Georgia she loved, is a place where she'd feel welcome.
"After a certain time of being looked down upon, being told 'no,' going the extra mile to get the same benefits, you get tired of that," Garcia Manrique said. "I've seen many immigrants who have talent in the South move out. Why not be somewhere where you're wanted?"
The administration says it's looking to assist those left behind by the ACA. The efforts are dramatically reshaping the individual insurance market to one that looks more as it did before the 2010 law.
In the span of less than 12 hours last week, the Trump administration took two seemingly contradictory actions that could have profound effects on the insurance marketplaces set up by the Affordable Care Act.
First, officials issued guidance Monday morning that could weaken the exchanges set up for people who buy their own insurance. The new approach makes it easier for states to get around some ACA requirements, including allowing the use of federal subsidies for skimpier plans that can reject people with preexisting conditions.
Yet, the other move — a proposed rule unveiled Monday evening — could bolster ACA marketplaces by sending millions of people with job-based coverage there, armed with tax-free money from their employers to buy individual plans.
Both efforts play into the parallel narratives dominating the bitter political debate over the ACA.
The administration, frustrated that Congress did not repeal the law, say some critics and policy experts, is working to undermine it by weakening the marketplaces and the law's consumer protections. Those efforts make it easier for insurers to offer skimpier policies that bypass the law's rules, such as its ban on annual or lifetime limits or its protections for people with preexisting conditions. Congress also zeroed out the tax penalty for not having coverage, effective next year. Combined, the moves could reduce enrollment in ACA plans, potentially driving up premiums for those who remain.
The administration and Republicans in Congress say they are looking to assist those left behind by the ACA — people who don't get subsidies to help them buy coverage and are desperate for less expensive options — even if that means purchasing less robust coverage.
"These are people who were buying insurance before [the law] and then the rules changed and they could not buy it because they could not afford it," said Joe Antos, a resident scholar at the conservative American Enterprise Institute. "They have been slowly dropping out of insurance coverage altogether."
The efforts are dramatically reshaping the ACA and the individual insurance market to one that looks more as it did before the 2010 law, when regulation, coverage and consumer protections varied widely across the country.
"Some states will do everything they can to keep individual markets strong and stable. Others won't," said Sabrina Corlette, research professor at the Center on Health Insurance Reforms at Georgetown University.
So what expectations should consumers have? Here are three key takeaways:
Protections for preexisting health problems are uncertain.
Polls show that keeping the ACA's guarantees on coverage for people with medical problems is a top concern for Americans, and Democrats have made their defense of the health law a key part of their midterm election campaigns.
Republicans have gotten that message and even those who voted to repeal the ACA or joined a lawsuit by 20 red states to overturn it now say they want to protect people with preexisting conditions. Still, GOP lawmakers have not introduced any plan that would be as protective as the current law.
In August, the administration released a rule allowing expanded use of short-term plans, which are less expensive than ACA policies. To get those lower prices, most of these plans do not cover prescription drugs, maternity care, mental health or substance abuse treatments.
The move is unlikely to benefit people with health problems, as short-term plans can reject people with preexisting conditions or decline to cover care for those medical problems.
Under the rule, insurers can sell them starting in 2019 for up to a year's duration, with an option to renew for up to three years, reversing an Obama-era directive that limited them to 90 days.
Administration officials estimate such plans could draw 600,000 new enrollees next year, and others have estimated the numbers could be far higher. The concern is if many healthy people in 2019 switch out of the ACA market and choose short-term plans, premiums will rise for those who remain, including those with preexisting conditions or make the ACA market less attractive for insurers.
Where you live matters more.
One of the biggest changes ushered in with the ACA was a standard set of rules across all states.
Before the law took effect, consumers buying their own coverage saw tremendous variation in what was offered and what protections they had, depending on the state where they lived.
Most states, for example, allowed insurers to reject people with medical conditions. A few states required insurers to charge similar premiums across the board, but most allowed wide variations based on age, gender or health. Some skimpy plans didn't cover prescription drugs, chemotherapy or other medical services.
By standardizing the rules and benefits, the ACA barred insurers from rejecting applicants with medical conditions or charging them more. Women and men get the same premium rates and insurers could charge older people no more than three times what they charged younger ones.
Under the new guidance issued this week giving states more flexibility on what is offered, consumers could again see a wide variation on coverage, premium rules and even subsidy eligibility.
"It shifts pressure to state politicians," said Caroline Pearson, a senior fellow at NORC, a nonpartisan research institution at the University of Chicago. That could play into the calculus of whether a state will seek to make broad changes to help people who cannot afford ACA plans, even if the trade-off affects people with medical conditions.
"You risk making some worse off by threatening those markets," said Pearson. "That is always going to be hard."
Millions more will join the "buy-your-own" ranks.
The proposed rule released Tuesday allows employers to fund tax-free accounts — called health reimbursement arrangements (HRAs) — that workers can use to buy their own coverage on the ACA marketplaces.
The administration estimates about 10 million people would do so by 2028 — a substantial boost for those exchanges, which policymakers say never hit the enrollment numbers needed to attract enough insurers and hold prices down.
John Barkett, senior director of policy affairs at Willis Towers Watson, a benefits consulting firm, said he expects employers to "seriously consider" the new market. The infusion of workers will improve options by attracting more insurers, he added.
"These people coming in will be employer-sponsored, they'll have steady jobs," Barkett noted, and will likely stick with coverage longer than those typically in the individual market.
Currently more than 14 million people buy their own insurance, with about 10 million of those using federal or state ACA marketplaces. The others buy private plans through brokers.
The proposed rule won't be finalized for months, but it could result in new options by 2020.
If these workers seeking coverage are generally healthy, the infusion could slow premium increases in the overall ACA marketplace because it would improve the risk pool for insurers.
But, if employers with mainly higher-cost or older workers opt to move to the marketplaces, it could help drive up premiums.
In an odd twist, the administration notes in the proposed rule that the ACA has provisions that could protect the marketplace from that type of adverse selection, which can drive up prices. But most of the protective factors cited by the rule have been weakened, removed or expired, such as the tax penalty for being uninsured and the federal subsidies for insurers to cover lower deductibles for certain low-income consumers.
Benefits consultants and policy experts are skeptical about how many companies will move to the HRA plan, given the tight labor market. Continued uncertainty about the fate of the ACA marketplace may keep them reluctant to send workers out on their own, they say.
Health benefits are a big factor in attracting and retaining workers, said Chris Condeluci, a Washington attorney who previously worked for Sen. Chuck Grassley (R-Iowa) and served as counsel to the Senate Finance Committee during the drafting of the ACA.
"Most employers believe their group health plan will provide better health coverage than an individual market plan," he said.
Proposition 8 would wipe out DaVita's earnings in California, according to recent investment firm reports. Passing the initiative 'would be so devastating,' to the tune of $450 million a year, that DaVita 'would likely walk away from the state altogether.'
It's been a year of playing defense for DaVita Inc., one of the country's largest dialysis providers.
A federal jury in Colorado this summer awarded $383.5 million to the families of three of its dialysis patients in wrongful death lawsuits. Then this month, the Denver-based company announced it would pay $270 million to settle a whistleblower's allegation that one of its subsidiaries cheated the government on Medicare payments.
But its biggest financial threat is a ballot initiative in California that one Wall Street firm says could cost DaVita $450 million a year in business if the measure succeeds.
Despite these recent hits, the company continues to rake in profits and receive favorable ratings from stock analysts. Its shares are trading at about $65 a share, only about 19 percent below a 52-week high set in January. That's largely because DaVita controls about one-third of a growing market, health experts say.
"They don't really have many rivals, and they perform a necessary, lifesaving service," said Leemore Dafny, a professor of business administration at Harvard Business School. "If you're producing something people want to buy and you're the only one making it, people are going to buy it."
Patients with chronic kidney failure often need dialysis to filter the impurities from their blood when their kidneys can no longer do that job.
And as Americans live longer and get heavier, more people become diagnosed with kidney disease and possibly need dialysis. In 2015, 124,114 new patients received dialysis, up from 94,702 in 2000, a 31 percent increase, according to the U.S. Renal Data System.
DaVita is one of the largest dialysis providers in the country, operating more than 2,500 clinics nationwide. In California, the company operates 292 clinics, half of all chronic dialysis clinics in the state.
Its parent company, DaVita Inc., reported $10.9 billion in revenue last year and $1.8 billion in profits, almost all of which came from its dialysis business.
This year, company officials project the dialysis group will bring in $1.5 billion to $1.6 billion in profits. It's a big turnaround for a corporation that could barely make payroll in 1999, when it was under review by the Securities and Exchange Commission for questionable accounting practices. Its success has largely been credited to CEO Kent Thiry, a colorful personality who has dressed up as a Musketeer and ridden a horse into corporate meetings to rally workers.
Now those big profits — generated from treating sick patients — has put a target on the company's back, as well as that of its biggest competitor, Fresenius Kidney Care.
The Service Employees International Union succeeded this year in placing Proposition 8 on California's Nov. 6 ballot, which would limit dialysis center commercial revenues to 115 percent of patient care costs. The ballot fight pits a well-funded industry against labor and the California Democratic Party.
DaVita declined to make anyone available for this article, but in a statement said Proposition 8 "will limit patients' access to life-saving dialysis treatments, jeopardizing their care."
Last year, roughly two-thirds of DaVita's dialysis revenue came from government-based programs, such as Medicare and Medicaid. But that isn't enough to cover its costs, according to the company's 2017 annual report, which states that DaVita loses money on each Medicare treatment it provides. (Medicare covers dialysis for people 65 and older, and for younger patients after private insurance has provided coverage for 30 months.)
Instead, DaVita generates profits from commercial health plans, which it acknowledges pay "significantly higher" rates than government programs. The ballot measure targets those higher rates, which Dafny describes as "their bread and butter."
The prospect of the measure passing led DaVita to delay or cancel plans to open new clinics in California despite growing patient demand, Javier Rodriguez, chief executive officer of DaVita Kidney Care, told investors on a call in May, according to the online equity research website Seeking Alpha.
A few months later, Rodriguez declined to provide a dollar amount when asked how the initiative would impact the company. Rather, he warned investors that it would become "unsustainable" for the industry to treat the estimated 66,000 dialysis patients in California, should the measure succeed.
Wall Street analysts agree that Proposition 8 would wipe out DaVita's earnings in California, according to recent reports issued by investment firms J.P. Morgan and Baird. Passing the initiative "would be so devastating," to the tune of $450 million a year, that DaVita "would likely walk away from the state altogether," according to a March Baird report.
DaVita has poured $66.6 million into the opposition campaign as of Oct. 25, and rival Fresenius has contributed $33.6 million. That dwarfs $17.3 million in union contributions in support of the measure, according to campaign records filed with California's secretary of state office.
Both Wall Street firms conclude that Proposition 8 is likely to fail, citing the industry's massive spending and the union's record of failure at the polls on other issues.
The company's legal troubles don't worry stock analysts, either; Baird's October report on DaVita's financial performance dedicates just two sentences to them. It notes that DaVita "is subject to numerous ongoing government investigations and inquiries, similar to most large-scale, high-profile Medicare providers."
There are no specific references to the Colorado jury award this summer, which the company is appealing, over the death of three patients who died of cardiac arrest after treatment at DaVita clinics. Nor was there concern about this month's $270 million settlement over Medicare billing.
That's because those incidents are seen by investors as the cost of doing business — one-time hits that don't affect a company's earnings power in the future, said Matthew Gillmor, a senior research analyst at Baird.
"Almost all companies I follow, at some point, have had to pay a fine to the government," Gillmor said.
Thiry, DaVita's CEO, acknowledged that settlements, which aren't good public relations, are a reality for large corporations, when The Denver Post asked him last year about the company's previous legal battles.
"If, in a trial, you are found to be wrong on even a small part of the case, it could mean that you are excluded from Medicare, which typically would mean bankruptcy for your company," Thiry said. "So, you are essentially forced to settle."