More than 500 former patients and families have filed claims against a Detroit-area doctor convicted of poisoning patients with chemotherapy and other drugs.
Victims of "Dr. Death" had until this week to submit receipts for unnecessary chemotherapy, medical bills for liver damage and funeral expenses for their loved ones. By an initial count on Tuesday, 517 former patients and their families had filed claims against Farid Fata, the Detroit-area cancer doctor convicted of raking in over $17 million by poisoning patients with chemotherapy and other drugs they did not need.
Fata was branded by prosecutors as "the most egregious fraudster" in U.S. history for scamming Medicare and private insurers by giving at least 553 patients, some of whom did not have cancer, thousands of doses of unnecessary and expensive drugs. Now he insists he did nothing wrong. Breaking his silence in a jailhouse interview, Fata said victims claiming he killed loved ones or ruined their lives are misguided and that those who died were "going to die anyhow because of the nature of the diseases."
Fata, nicknamed "Dr. Death" by his victims, is serving a 45-year sentence in a federal prison in South Carolina after pleading guilty to 13 counts of health care fraud, one count of conspiracy to pay or receive kickbacks and two counts of money laundering. He ran one of Michigan's largest private cancer practices, with a network of clinics outside of Detroit, from 2005 to 2013.
The 51-year-old prisoner told Kaiser Health News he plans to speak in court at a Jan. 17 restitution hearing and declare his innocence. Fata said his guilty plea in 2014 came under duress, and he is preparing to seek freedom through a habeas corpus petition, by which a judge would determine if his detention is lawful.
"I am now fighting for my innocence," he said.
Meanwhile, an electronic records company hired by the Department of Justice is sorting through former patients' claims for a share of a $11.9 million fund created from assets seized from Fata's bank accounts, his home and medical practice. The process marks the final chapter in a gut-wrenching federal prosecution that brought scores of victims to tell harrowing tales on the stand, in written testimony and on national TV. The federal charges, prompted by a whistleblower, not only ended his career but also made him a global poster child for medical horrors.
To be eligible for restitution, patients treated by Fata from 2005 through 2013 had to submit claims postmarked by Tuesday. The number may grow as more stream in by mail, said Gina Balaya, spokeswoman for the Eastern Michigan U.S. attorney's office. The restitution fund won't pay for victims' pain and emotional trauma, but it covers out-of-pocket medical costs, including treatment repairing damage Fata inflicted, as well as funeral expenses for patients who died. The U.S. attorney's office has no firm count of how many patients died from Fata's mistreatment; court documents allege only that he put patients at risk of death, not that he killed anyone.
Among those seeking repayment is Teddy Howard, 56, a former financial analyst who said Fata destroyed his life. Fata diagnosed him with a rare blood disorder and gave him 44 chemotherapy treatments. After Fata's arrest in 2013, Howard was appalled to learn that he never had cancer in the first place.
The arrest came too late, Howard said: 18 months of chemotherapy had already wrecked his liver and teeth. Howard had a liver transplant and plans to undergo surgery to replace all of this teeth. He said he filed a restitution claim for about $100,000 in medical bills.
Howard said that sum doesn't come close to repairing Fata's damages. After Howard began chemotherapy, he lost his job and his house outside Detroit. Now unemployed, he lives on disability income and takes daily medication so that his body doesn't reject his new liver.
"I went from being healthy and put on chemo to the condition I'm in now — post-liver transplant and fighting for my life," Howard said.
Other claims came from grieving family members such as Sydney Zaremba, whose 87-year-old mother Helene died under Fata's care in 2011. Zaremba said her mother had non-Hodgkin lymphoma and declined swiftly under Fata's treatments; prosecutors concluded Fata overtreated her at the end of her life.
"He killed my mom," Zaremba said. "She had a very treatable disease. By the time he got done with her, she was taking 16 meds."
Zaremba is seeking reimbursement for a portion of $15,000 in funeral expenses, but "there's no amount of money that can replace what we lost."
Ellen Piligian is seeking restitution on behalf of her father, John, who had stage 4 cancer and died in 2012. She said Fata acted as a fearmonger, insisting her father continue to take powerful and toxic chemotherapy drugs.
"My dad could have had much better life quality those last couple of years," she said.
Piligian said she has been through "voicemail hell" trying to track down proof of payment from health insurers — a factor that has made it difficult for other victims to file claims. She filed a claim for $6,000 for medications and funeral expenses.
Another 43 victims have had success filing civil suits against Fata and are sharing an $8 million settlement. But they are fighting off liens from insurance companies seeking repayment for treatments the patients didn't need.
Patty Hester, a former Fata patient, said the liens may prevent her from seeing a penny of her settlement payment, which is less than $100,000.
Hester, 62, said she suffers from rotting teeth, high blood pressure and organ damage. She said Fata diagnosed her with myelodysplastic syndrome, also known as preleukemia, and told her she was dying. She endured two and a half years of iron and intravenous immunoglobulin treatments, and gave away her possessions — even her wedding ring. Then she got a letter from federal prosecutors saying her treatments had been unnecessary.
Hester has requested repayment for over $800 in dental bills, but she said the restitution isn't enough. The government is paying for remedial treatment only until Sept. 6, 2016, but her medical problems continue.
Fata, meanwhile, said these patients' medical problems are not his fault. He said he treated his patients appropriately, but when the federal government alleged he was mistreating them, it "created doubts in their mind."
Fata, who earned a medical degree in his native Lebanon, believes federal prosecutors targeted him for political reasons. He said he pleaded guilty to protect his family, and he couldn't afford to mount a robust defense because the government had seized his assets.
Fata, the son of Christian missionaries, said he is working with a group of born-again Christians who plan to publish a book entitled, "Convicted out of thin air: The true story of Dr. Farid Fata."
Geraldine Smith Parkin, whose husband Tim was one of Fata's patients, said she is shocked by Fata's innocence claim.
"Just to hear that he still will not say, 'I'm guilty'" extends the suffering for everyone involved, she said. "It seems like we're being victimized over and over and over."
Former patients like Howard, meanwhile, said Fata has destroyed their faith in the medical system.
"I will never trust another doctor again as long as I live," Howard said. "I trusted this doctor with my life and he failed me."
For 2017, Blue Shield is raising its exchange rates by nearly 20 percent, on average. At a board meeting Thursday, Covered California officials are expected to share details on the current open enrollment and hear from experts about the exchange's long-term future.
The chief executive of Blue Shield of California, the largest insurer on the state-run marketplace, says he's committed to selling coverage there even as Republicans pursue a repeal of the federal health law.
In an interview this week with California Healthline, Paul Markovich also criticized President-elect Donald Trump's support for the sale of insurance plans across state lines in order to boost competition and consumer choice.
"It will push health plans to find the regulatory body or state with the fewest number of regulations," Markovich said. "It's a race to the lowest common denominator and least rich benefits. That is what we want to avoid, and I don't think it will do much to increase competition. I find it perplexing."
Blue Shield covers nearly 30 percent of enrollees in the Covered California exchange market. Industry giants Anthem Inc. and Kaiser Permanente are close behind.
Nationally, as a Republican Congress looks to dismantle key parts of the Affordable Care Act, some policymakers and consumer advocates are concerned that an increasing number of insurers will leave the government-run exchanges.
Markovich said he expects the San Francisco-based insurer to lose money on its exchange business this year after posting profits in 2014 and 2015. But he said the insurer isn't looking to pull out.
"There are always risks and concerns moving from one policy framework to another, but I think an effective transition is workable. We wouldn't be running for the hills," Markovich said. "We intend to keep offering individual coverage and keep trying to make it work under whatever regulatory or legislative umbrella we are under."
For 2017, Blue Shield is raising its exchange rates by nearly 20 percent, on average.
At a board meeting Thursday, Covered California officials are expected to share details on the current open enrollment and hear from experts about the exchange's long-term future.
California has the largest state-run marketplace, with about 1.4 million enrollees. It has served 2.5 million residents since enrollment began in 2014. Nearly 90 percent of exchange customers receive federal premium subsidies.
Kaiser Permanente's chief executive, Bernard Tyson, expressed optimism that key elements of the health law, such as premium assistance and Medicaid expansion, may be salvaged after Trump and Republican lawmakers look at their alternatives for coverage expansion.
"Clearly, President-elect Trump and his administration are not up close to what the Affordable Care Act really is and what it really means," Tyson said in an interview. "I believe when they get under the hood of the ACA, I think we may start to see and hear different conversations."
Tyson warned about giving up on the historic gains in insurance coverage that have occurred under the health law. If people lose coverage and the rate of the uninsured increases, hospitals and physicians face the prospect of more uncompensated care and declining health for many patients.
Kaiser Permanente is somewhat unique as both a major insurer and a health system running hospitals and physician offices.
"I don't get to walk away from this if government is not providing coverage to them anymore," Tyson said. "They are still part of our community and we have to figure it out."
Some health care groups have endorsed Trump's proposal for more cross-border insurance plans, saying it would curb the insurers' market power in some states. On his presidential transition website, Trump touted it as a way to "maximize choice and create a dynamic market for health insurance."
Under the Affordable Care Act, companies are already allowed to sell across state lines if there's an agreement among the states involved. The health plans, however, must still meet the minimum coverage requirements of the federal law. No states have pursued that option, and health insurers haven't shown much interest.
But some Republicans are looking to scrap those minimum federal requirements and hand more flexibility to the states.
California's health insurance market for individuals and employers is more competitive than many states, with major players including HMO giant Kaiser Permanente and two Blue Cross Blue Shield carriers.
Consumer advocates in California have slammed the idea of selling insurance across state lines and echoed the criticism from Blue Shield. They said out-of-state insurers would be able to skirt the state's consumer protections on access to timely care, adequacy of provider networks and the right to appeal an insurer's denial of care.
Republicans who have voted for years to repeal the law now have their chance to enact a replacement. Medicare and Medicaid might also see major changes under a GOP-controlled White House and Congress.
MARY AGNES CAREY: Hi. I'm Mary Agnes Carey of Kaiser Health News. Along with our partners at The Lancet. I'd like to welcome you to an analysis of what the 2016 election results mean for health care.
Starting in January, Republicans will control the White House and both chambers of Congress. After promising to repeal and replace the Affordable Care Act, president-elect Donald Trump has said he'd now like to keep some elements of the law.
Republicans who have voted for years to repeal the law now have their chance to enact a replacement. Medicare and Medicaid might also see major changes under a GOP-controlled White House and Congress.
Joining me here at the Kaiser Health News studios in Washington are Julie Rovner, a KHN senior correspondent, and Margot Sanger-Katz, a domestic correspondent at The New York Times, where she covers health care for The Upshot.
Joining us from The Lancet's editorial offices in London is Richard Lane, the medical journal's web editor.
Thanks to everyone for joining me. Appreciate it.
Cross talk: Lovely to be here, thank you.
MARY AGNES CAREY: Julie I want to start with you. Can you talk a little bit about what Donald Trump's presidency and Republican control of Congress mean for ACA repeal? Both of them say that repeal is a top priority but how would they actually go about it? And would Senate Republicans really go along with all of this?
JULIE ROVNER: This is the classic case of the dog who catches the car. Then they go 'Now what do we do with it?' The Republicans have been voting to repeal all or parts of the law pretty much since it passed. And now they've discovered, low and behold, some parts of the law are actually kind of popular. So if they're actually going to repeal it they're actually going to have to have something to replace it with. For all these repeal votes, they don't really have a set program to replace it with. On the campaign trail, Donald Trump only really described it as "something terrific." They're basically backed into a corner. They have to do it. They have to repeal the law and they have to figure out what they're going to replace it with and that's what's going to play out over the next year.
MARY AGNES CAREY: Margot, how do you see this shaking out?
MARGOT SANGER-KATZ: I think it's extremely hard to predict. I don't have a good sense of whether there's a lot of consensus among Republicans about what they want to do. There's sort of a whole menu of different things they could do. They could just repeal the law and say we'll fix it later, but that has a lot of political risk because then you end up with a lot of disruption, with lots of people potentially losing their insurance, with insurance companies deciding they don't want to provide insurance in this uncertain environment. And then they sort of own the political fallout in the way that the Democrats in the last few years have really owned the challenges of the ACA's problems.
They could come together and say we're going to repeal the Affordable Care Act and we have a new program that we're going to replace it with, but, you know, it's not so easy to develop these health reform proposals as we learned the last time around. And it's not clear that all Republicans are necessarily going to agree on one plan. They have majorities in both houses of Congress but they don't have a really big majority in the Senate. They really just have enough if all but one vote they can squeak something through. The sort of second option is could they come together with some really detailed proposal and do it all at once. And then I think there's sort of a third option that Donald Trump alluded to on Friday, which is maybe we don't repeal and replace it, we just amend the affordable Care Act. Maybe they could take a couple of particularly unpopular provisions or make a couple of changes that they've really wanted to do for a long time and try to keep most of what's there and make these little tweaks and be able to say, 'Ok, we've done the thing that we've told our voters we would do by changing the law.'
JULIE ROVNER: It's worth remembering that everybody thinks the Affordable Care Act started when President Obama was inaugurated. Actually the Affordable Care Act started about a year and a half before that. The committees in Congress were laying the groundwork, they were talking with stakeholders, with industry people. There were all these negotiations. There was a white paper that the chairman of the Senate Finance Committee put out, what was it, a day or two after the election. So all of the groundwork had been laid and it still took Congress a year and a half to get the Affordable Care Act through. So if Republicans think they can repeal and replace this in 100 days, I think that's highly unlikely.
MARY AGNES CAREY: In my memory, the Library of Congress, the big summit on health care. Julie may have covered that as well. Yeah, this has definitely been kicking around for a while.
Richard Lane, I want to go to you. What do people outside of the U.S. think of the election results, and from your perspective at The Lancet, what do you think all this means for the future of the ACA?
RICHARD LANE: Yeah, that's one great question. We're still very much in shock, actually, as I'm sure a lot of America is too because the result obviously wasn't predicted and we weren't expecting it. So we're getting over the shock of last Tuesday and it's hard to believe it's only just about a week ago. But also, there's a sense that 'Well, what does it mean?' And I guess there's a certain sense of bewilderment because what we're hearing coming from President-elect Trump, as you've already alluded to, seems to be already changing quite quickly. I mean, he clearly said some very strong, contentious thing when he was on the campaign trail, but we're getting the sense that as he said, maybe he's reconsidering or maybe that meeting with Barack Obama last Thursday is already having a bit of an effect. In terms of health policy, I mean, yes, we're very concerned at The Lancet because of course broadly speaking, we very much supported the progressive agenda under the Barack Obama — or two Barack Obama administrations. We also know from you guys and from other sources how difficult the Affordable Care Act — what a difficult life it had it terms of implantation, not just from when the websites all crashed when they tried to launch the insurance markets, but the problems with the costs, the lack of people entering the insurance markets which has meant that some insurers have pulled or prices have gone through the roof.
So we certainly are clear that the Affordable Care Act, which clearly had very good progressive intentions, has been implemented pretty badly and we're obviously very concerned about that. But we're sort of getting the impression that what Trump might be saying now is what Hillary Clinton might have been saying if she'd become President, which is 'Yeah, I know the Affordable Care Act is having problems, but my God, I'm going to fix it.' I'm pretty sure Hillary Clinton was saying, 'I'm going to fix the Affordable Care Act,' wasn't she? So it would seem that we're almost as a philosophical point of view, almost there's a bit of convergence going on.
JULIE ROVNER: That's an excellent point and I've been thinking of it myself. In some ways, if they actually want to fix what's wrong with the Affordable Care Act, they're more likely to do it with a Republican President and a Republican Congress rather than a Democratic President and a Republican Congress where clearly, they never would have gone along with it. Now they feel some sense of ownership of what they're going to do. And I've actually been saying for a while that I think they can end up sort of accidentally backing into fixing it because they may not be able to think of anything else to do instead.
RICHARD LANE: Yes, we wonder that too — whether there might actually be a bit of a policy vacuum being created as a result of the shock election results and whether, potentially, that could be, ironically or paradoxically, provide an opportunity for better progress in health care. And one thing we're particularly aware of here, as I'm sure you're aware, that from The Lancet's perspective, we believe that health is a human right, not an employment privilege or benefit. And I know it's more than just an employment benefit in the United States, you have your Medicare and Medcaid programs, obviously, but in terms of the principle of trying to prevent individual people, particularly people on low incomes from having catastrophic health expenses. I'm sure Donald Trump and the Republican party — the last thing they're going to want once they get into power is that suddenly people who were beginning to be reached by the Affordable Care Act, suddenly for whatever reason not having insurance coverage, or if you're going to have people who have lost their jobs which has resulted in those Rust [Belt] state people voting for Trump last week in the election, suddenly finding themselves even more crippled because there isn't a plan in place, that could really backfire, surely on Trump and his new team.
MARGOT SANGER-KATZ: In some ways this reflects real division inside the Republican party. You know, Donald Trump — and we've been talking about this throughout the entire election — is sort of not the standard-bearer for the party. He is an idiosyncratic candidate who is more of a populist who had throughout the campaign expressed sort of more support for social welfare programs, including the health care programs and, you know, it's sort of hard to know how he and the Republicans in Congress who, in general, have been much less enthusiastic about providing health insurance to low-income Americans will reach some kind of compromise. Trump has said repeatedly throughout the campaign that he was very concerned about health care access for the poor, that he thought it was important that there was a safety net. He said, you know, people shouldn't be dying in the streets. That one time he said, 'Even if I lose the election for having this position, it will have been worth it because I think it's important.' But we do see in some of the kind of more formal campaign documents that they put out, and most recently on their transition website, that the kinds of policies that they're describing in print are rather different than the things that he says on the campaign trail and seem much more in line with what Republicans in Congress are interested in, which is a sort of more stripped-down, more free market kind of program that probably provides a little bit less of a safety net. So I think this is going to be one of the most interesting things to watch is: how does Trump and other members of his party find some common ground?
JULIE ROVNER: You know we've talked so much about the divisions in the Democratic Party between the single payer wing, the people who want Medicare for all, and the Affordable Care Act wing, if you will, who sort of want to try to keep this more … a little bit less heavy-government. You have sort of the same thing in the Republican Party. You have, well, I guess what used to be called moderate Republicans who want social programs and believe in health care programs but don't necessarily want the government fully involved in health care and then there are the market-based people who want no government in health care. The problem is at this point in time, as we've been discussing, you have 20 million people who are getting insurance through this law. It's not theoretical anymore. It's not just an argument about, 'What role should the government play in health care?' Because if you just turned a switch and made it go away, you would have 20 million people who would be very angry.
MARY AGNES CAREY: Well there's a lot of political peril in that too, right? I mean I don't want to talk about elections, but the midterms are only about 22 months away. Do you really want to get, Republicans I think do not want to get blamed for leaving upwards of 20 million or more high and dry without coverage.
JULIE ROVNER: Many of them in Republican states.
MARGOT SANGER-KATZ: The politics are very tricky though because if you look at the surveys of Republican voters, wanting to repeal the Affordable Care Act is probably the most unifying issue across the waterfront of policy issues. Republican voters in general really do not like the Affordable Care Act. I don't know that they're kind of in the weeds of, 'what is the Affordable Care Act and what's not, what does repeal really mean?' But I think that they expect their elected representatives to do something about this. On the other hand, I do think that any kind of repeal of the Affordable Care Act, even one that has sort of a great consensus replacement package, is going to create some disruption, is going to mean that there are many millions of people who either lose health insurance or have to change their health insurance arrangements. And we saw with the implementation of the Affordable Care Act that even a very small minority of Americans being disrupted by these policy changes can really make a lot of noise and can make a lot of political trouble.
MARY AGNES CAREY: So let's go to a little bit to the mechanics, kind of the ground game, Julie, how this will happen. We know the Republicans don't have 60 votes — that's what you need in the Senate to stop a filibuster. So they have to use something called "budget reconciliation," where with 51 votes you can make some changes. Take us through what sort of changes might happen, and what are the things in the law that will remain, that they can't touch through this process?
JULIE ROVNER: There are a number of opportunities actually. President Trump once he's sworn in could do a lot on his own to undermine the law.
MARY AGNES CAREY: So, that's the executive orders?
JULIE ROVNER: That's the executive orders. And you know the essential benefits actually, as someone pointed out, those are regulations. I mean, they're in the law but what they are is a regulation. He could order that changed. He could drop this very contentious lawsuit and basically get rid of the cost sharing subsidies that help people under two and a half times poverty pay their deductibles and copayments. By law, the insurers would have to continue to provide that, but the government couldn't pay them back, that would kind of blow a hole in the exchanges. The general, obviously we don't know what's going to happen, but there's sort of a general working consensus that he's probably not going to do things that would seriously undermine the insurers who are offering coverage because if they're really going to delay this, if they're going to repeal it and say 'but it's going to go away on a date certain' giving them time to come up with a replace, you don't really want to blow up the insurance coverage that people have now. So assuming that he's not going to do that then they move on to the idea of using this budget process called reconciliation where you don't, where you are not subject to a filibuster in the Senate. But not everything can be done. They can't repeal the entire law through budget reconciliation, they can only repeal things that have an immediate impact on the federal budget — either adding or subtracting. So a lot of the insurance regulations that affect the private market are not subject to being repealed under budget reconciliation. So they could basically, what they could do is undermine the law to the point where it wouldn't work. But in order to replace it they're going to have to have 60 votes.
MARY AGNES CAREY: Margot, you wrote about this today in the Times, about if some parts are repealed and some remain. Sort of take us through your story and some of the impacts of some of these things coming in and out of the law.
MARGOT SANGER-KATZ: So we saw Mr. Trump last week say that there are some parts of the Affordable Care Act that he really likes and he wisely picked the things that are the most popular among Americans because they are the things that make the law feel fair. And the main thing that he talked about is that the law prevents insurance companies from shutting out people who have preexisting health conditions. So, you know, if you have asthma, if you have had cancer in the past, if you've had even allergies, before the Affordable Care Act, if you went to an insurance company and said, "Sell me insurance," they could say, "No, we don't want to give insurance to someone who had allergies, we'd rather give health insurance to someone who had a completely clean bill of health."
And so the law said, no, you have to offer insurance to everyone. But then it included all these other provisions that were designed to make sure that the market wouldn't just become a market for really sick people. It created a lot of incentives for healthier people to also buy health insurance because if you have a health insurance market where sick people can get coverage when they need it, those people have a really big incentive to sign up. And healthy people have a really big incentive to just wait until they get sick and then they can buy insurance. And so what you end up with is a very, very expensive insurance pool. Insurance is not affordable for anyone, and it's especially not affordable for those sort of good Samaritan healthy people that are like trying to be responsible and get in early.
So, you know, if you take away all of the kind of unpleasant parts of the Affordable Care Act that help bring healthy people into the market, then this sort of market-based structure where you can't have discrimination doesn't work very well. And you know, I don't know that Donald Trump has really thought about the kind of nuts and bolts of how it works, but, you know, that is definitely something that's going to have to be thought about.
And if we go through this budget process that Julie described, the budget process can get rid of some of those incentives because they're financial. It can say, we're going to stop giving people money to help them pay for their insurance premiums and we're going to stop fining people who fail to buy insurance. But it would be much harder for them to use this process to take away those rules that allow everyone to buy insurance who wants it. And so you could really see a very dysfunctional market resulting from that mixture of policies.
I think it's just a reminder that, you know, the Affordable Care Act as it's written has a lot of problems and flaws, but the Democrats who wrote it did think pretty carefully about how you kind of layered a bunch of policies together to try to create the most stability. And any replacement that's going to have to come next is going to have to wrestle with some of those same questions.
We can't just have the most popular, the most wonderful parts and none of the parts that are unpleasant. Surely, if we could have done that, that's what would have been done the first time.
JULIE ROVNER: It's worth pointing out that Mitt Romney had the same position in 2012, that this is sort of — part of the Republican position on health care is that we're going to try to keep the things that are popular and find out, you know, and find ways to fix the parts that are unpopular. Except that they haven't actually been able to do that yet.
MARY AGNES CAREY: Well, will Republicans make peace with the individual mandate? I mean they've criticized — they were for it before, historically.
JULIE ROVNER: It's a Republican idea.
MARY AGNES CAREY: It's a Republican idea, right, and it's been criticized as part of the Affordable Care Act, but as Margot points out, it's one of those essential things you need to balance the risk pool. So how do they, how do they make their way on this?
JULIE ROVNER: That's one of the things that they're going to have to fight about. I suspect they won't make peace with the individual mandate. But the problem with that is that you have, then, if you don't require people to have insurance, then your choices are, blow up the market, as Margot was talking about because only sick people will have insurance — or put sick people in a separate pool, which they call high-risk pools, which has been done before and which hasn't worked. Because they're incredibly expensive, and what we ended up with were high-risk pools that ran out of money.
Florida's high-risk pool was closed I think since 1991. I mean, it was just, they only had a limited amount of money, and even when people could get in, they often weren't covered for the thing that got them in. So if you had cancer and you couldn't get insurance and you got into the high-risk pool, it wouldn't cover your cancer.
So there have been all kinds of problems with high-risk pools. They could end up being as expensive, if not more expensive, than the subsidies that are being given out now.
So I don't think they're going to like the individual mandate, but you know, a lot of people have thought for a long time about ways to keep the insurance market working without it and I haven't seen one yet.
MARGOT SANGER-KATZ: Well, one idea that I've heard discussed, it's sort of like a weaker version of the individual mandate. So it doesn't force you to buy insurance but it basically says, as long as you have health insurance and continue to renew your policy — so if you buy health insurance one year, and then you buy it another year, maybe you change jobs, you have to change plans, but as long as you continue to be insured, then if you get sick, the insurance company in the future can't say, "I don't want you as a customer."
But if you go uninsured for some period of time — if you decide, I'm healthy or I don't have the extra money this year, and you just take a break from having insurance — then when you come back in, you will be shut out. And so that's another way of creating sort of a financial incentive for people to keep insurance all the time.
You know, that obviously will close a lot more people out of the insurance market then the current system, but I think it will be a way to create some incentive for people to have insurance even when they're healthy.
JULIE ROVNER: And that actually has had — that has been the law in the employer market since 1996. It was only the individual market — the HIPAA law actually says … people think of it as privacy, but it actually stands for "health insurance portability," that if you have — if you go from insurer to insurer and you don't have a break in coverage, you can not only continue to be covered without preexisting condition exclusions but that you can also get into the individual market at the end. But that did not take into account people who were self-employed and buying their own insurance. Which is what the ACA did.
RICHARD LANE: Well then I was just curious, and thank you for the detail, I was really just expressing a concern from afar — and I realize, of course, outside of America we think differently over here in Europe — but we are very, very concerned and interested in your health policy situation. But if you got away from the individual mandate, which I realize is a real possibility, are we seriously expecting that people will — particularly people who are feeling the pinch financially — are going to voluntarily go and get themselves insured when they're feeling healthy? The obvious concern is that it's just going to reverse some of the progress that has been made in getting people covered. Surely we're going to end up with a lot of people uninsured if that individual mandate disappears. Because people just think, "I'm healthy. And by the way I'm not very well off, I can't afford to buy insurance."
MARGOT SANGER-KATZ: Well one of the things that we see now with the Affordable Care Act is that I don't think that the mandate has turned out to be as powerful an incentive as people thought it would. What it looks like is that instead the federal subsidies that help people buy insurance — so, if you're kind of low- or middle-income you can get some federal dollars that will make your insurance premium cheaper for you and represent a smaller percentage of your income — it seems like that's mostly where the incentive is. And you know if you think about it, it makes sense. Most people want to have health insurance. They don't want to be exposed to these big risks of either having a huge financial hit or just not being able to access care if they or someone in their family gets sick. So you know I think that one of the things we're learning is that if you make insurance affordable for people, a lot of them are going to want to buy it. And there are some people on the margin, clearly, who that little bit of a kind of punishment of "if you don't buy you're going to have pay a fine" that creates an incentive too. But it is the structure where there are positive and negative incentives that are part of the Affordable Care Act and if you start to take those away then I think it is much less clear who will continue to buy insurance.
JULIE ROVNER: And plus, we talk so much about these young, healthy people who think that they are invulnerable and that they don't want to buy insurance. Well, all their parents want them to buy insurance. I hear from a lot of those parents: it's really like, "I wish my kid had good, comprehensive but not too-expensive policy that I can buy for said kid." I mean there is a lot of that. So I think Margot is right: the individual mandate has not been as strong as, certainly, the insurers wish that it had been. But I think if they could come up with a way of making insurance less expensive, more power to them.
MARGOT SANGER-KATZ: And I think that's the argument that Republicans tend to make. That they say that the real problem is not that we haven't forced people to buy insurance effectively enough. It's that we haven't made insurance affordable enough that everyone wants to come into the system. So I think that's something that we can look forward to in their policies are ideas that are designed to make insurance cheaper. I don't think that's so easy, because the reason why health insurance is so expensive in the United States is not because the insurance companies have to cover a lot of benefits, although they do. And it's not because they're greedy and they're hoarding a lot of profits, because they're not. It's really because the underlying cost of health care in the United States is just so expensive. We pay a lot of money to doctors and hospitals and drug companies. And we give people a lot of very intensive, high-tech treatments. So that means that it is just expensive to provide health insurance
MARY AGNES CAREY: Sure. But what else will Congress be focusing on next year? The ACA obviously is going to take a lot of steam. Are we going to hear about rising drug prices? We heard about those on the campaign. There are some other must-pass bills that Congress has to do.
JULIE ROVNER: That's right, there are a number of things that actually Congress has to do next year regardless, because there are laws that expire. One of them, there are user fees that the drug industry and the medical device industry pay for extra people at the Food and Drug Administration so that they can speed up the approval of new drugs and devices. That comes up for renewal next year. That could be a vehicle if they want to do something on drug prices. Although I don't think that's as likely as people might've been thinking because I think they're going to take up too much of the bandwidth with the Affordable Care Act. The Children's Health Insurance Program, which was supposed to sort of fade away under the Affordable Care Act, hasn't, for a variety of reasons. But when they renewed that two years ago, it was only for two years so that has to be dealt with, whether or not that is going to be continued.
MARY AGNES CAREY: It traditionally has had bipartisan support.
JULIE ROVNER: Right, that was created with bipartisan support, it has had bipartisan support. It will be interesting to see what a Republican president, a Republican Congress thinks of that. It's covered more than 8 million kids. It's a very popular program and the states like it. And then, going back to the Affordable Care Act, there were a number of not very popular taxes that got delayed, again though only for two years so they will have to decide again things like the tax on medical device makers, things that actually pay for the Affordable Care Act. And this very controversial tax on very generous health plans, the so-called Cadillac tax. They have to decide whether or not that's going to happen. … It was delayed to 2020, but employers would need a long lead time to adjust if that's going to happen.
MARGOT SANGER-KATZ: We've seen there's quite a lot of interest among Republican in Congress in doing some reform of the FDA (Food and Drug Administration), which reviews and approves drugs and devices. They passed some legislation last year, and I think it's reasonable to think that some version of that will come back.
MARY AGNES CAREY: Richard Lane, I'm going to send the last question to you. Obviously, there are some very important health care issues that might get the short-end of the stick next year on Capitol Hill: health care inequities, global health, the health impacts of climate change. What do you think happens if Congress doesn't engage on these issues?
RICHARD LANE: Well, I think this is probably as big an issue for The Lancet as the domestic issues are that we've just been discussing now and the future of the Affordable Care Act. Because one major concern and one great unknown is — we've already had a bit of movement, as we've just discussed — about the Affordable Care Act, possibly, we'll see. But when it comes to the broader issues — the international arena — global health leadership, this is something very close to Lancet's heart, obviously, and this is something again that we would have been quite optimistic if Hillary Clinton had prevailed given her role in the international health arena already. So the big question mark for us is what does this mean for not just USA as a donor for global health initiatives, through agencies obviously like US AID, CDC and other programs and NGOs that America is involved in. But what is going to happen to that money? And don't forget just in the last session when Barack Obama … just a year or so ago when he was battling to get increased funding through because of Zika, look at the difficulties Barack Obama had there even getting funding. He didn't get the funding that was initially asked for. That was when he had the influence to do that. So there are some real concerns. Again, we don't know the answers yet, but on the global arena — not just to do with foreign policy — but more broadly too and how that will impact on global health. That is a concern to us.
Climate change you just mentioned. I mean, I don't know if Donald Trump has watered down his view on this in the past 48 hours, but the last time I saw his views on climate change he thought it was a conspiracy invented by China. I mean, it would be laughable, if it wasn't so serious. I mean there's scientific evidence of the effects of climate change are just so well-known. And are inextricably linked with health or based in a complex manner. Sure, there are huge question marks that remain and understandably I can see why initially President-elect Trump is focusing on the domestic issues because America has genuine concerns about those. But at the same time, and this is where again where I suppose one could be optimistic, you could argue there could be the potential to influence the policy in this area. So that's something that we'll be looking at very closely. I suspect it's not going to be a priority come Jan. 20.
MARY AGNES CAREY: Well, you've given us all lots to talk about in the coming year. I'd like to thank Julie Rovner of Kaiser Health News, Margot Sanger-Katz of The New York Times and Richard Lane of The Lancet. Thank you all.
Unlike rotating teams of nurses and surgical techs, reps are a consistent presence, often functioning as uber-assistants to surgeons with whom they cultivate close relationships and upon whom their six-figure salaries depend.
They are a little-known presence in many operating rooms, offering technical expertise to surgeons installing new knees, implanting cardiac defibrillators or performing delicate spine surgery.
Often called device reps — or by the more cumbersome and less transparent moniker "health-care industry representatives" — these salespeople are employed by the companies that make medical devices: Stryker, Johnson & Johnson and Medtronic, to name a few. Their presence in the OR, particularly common in orthopedics and neurosurgery, is part of the equipment packages that hospitals typically buy.
Many "people who don't work in health care don't realize that industry reps are sometimes in the OR," said Josephine Wergin, a risk management analyst for the ECRI Institute, a Pennsylvania nonprofit that conducts research on medical subjects for the health care industry. "A lot of times they are the real experts on their products."
Unlike rotating teams of nurses and surgical techs, reps are a consistent presence, experts say, often functioning as uber-assistants to surgeons with whom they cultivate close relationships and upon whom their six-figure salaries depend.
Although they don't scrub in, reps are expected to be intimately familiar with the equipment they sell, making sure it is at the ready for the surgeon and poised to answer technical questions.
Who's The Expert?
But how much influence do reps wield, how necessary and costly are their services and does their presence in the OR, which may not be disclosed to patients, raise ethical questions about informed consent? A string of court cases has raised questions about their involvement in surgeries that went awry, dating back to the late 1970s when a New York sales manager who had not graduated from high school tried for three hours to fix a prosthetic hip while a surgeon allegedly left the OR.
Despite their role, device reps have received little scrutiny, in sharp contrast to drug salespeople, whose role has been the subject of considerable research.
"There's so little public awareness of this," said Adriane Fugh-Berman, an associate professor of pharmacology at the Georgetown University School of Medicine and director of PharmedOut, a project that focuses on prescribing and drug-marketing practices. Fugh-Berman is the coauthor of a recent study that raises questions about whether surgeons rely too heavily on reps for technical expertise and assistance, to the potential detriment of patients.
But the cost of medical devices, an industry with about $150 billion in annual U.S. sales, combined with concerns about conflicts of interest by doctors who must report industry payments as part of the Affordable Care Act, has resulted in increased scrutiny, as hospitals from Savannah to Stanford seek to standardize and circumscribe the activities of device salespeople.
Several high-profile lawsuits have played a role, among them a 2006 Ohio case in which a surgeon and a rep were ordered to pay a patient $1.75 million after botched brain surgery. The salesperson had wrongly assured the surgeon that a bone cement was suitable for sealing a hole in the patient's skull. In 2003, Endovascular Technologies pleaded guilty to 10 felonies in federal court and paid more than $92 million in criminal and civil penalties for covering up problems including 12 deaths associated with an abdominal device. Doctors had been removing the device using a technique devised by reps that had never been approved by the Food and Drug Administration.
Some hospitals, most notably Loma Linda University Medical Center in California, have largely eliminated reps in orthopedics, buying implants directly from the manufacturer at a substantial discount and training surgical technicians to take their place in the OR. Loma Linda's chief of orthopedics said the hospital has saved about $1 million annually, a savings of about 50 percent on the cost of the devices, without affecting outcomes.
"I think there is a role" for reps, said Lisa McGiffert, director of the Consumer Reports Safe Patient Project. But, she added, when it comes to choosing the best device — such as a prosthetic knee — "can the patient trust that they're getting the expertise of the doctor or the influence of the rep?"
The presence of device reps in the OR, she added, also raises questions about the adequacy of consent, if patients are not explicitly informed of their presence.
Learning On The Fly
ECRI recently repeated its recommendation that hospitals obtain explicit written consent from patients if reps are to be present and warned surgeons against learning "how to use … devices on the fly."
How often that happens is unclear, because what happens in the OR tends to stay in the OR. A small 2014 study suggests that reps' over-involvement is not uncommon.
A survey conducted by researchers at New York's Albany Medical College found that 88 percent of 43 device reps said they had provided verbal instructions to a doctor during surgery, while 37 percent had participated in a surgery in which they felt their involvement was excessive, often because the surgeon lacked sufficient expertise. Twenty-one percent said they had direct physical contact with hospital staff or a patient during an operation, which could violate hospital policy as well as state law.
Terry Chang, associate general counsel of AdvaMed, a device industry trade association, points to its code of ethics as well as newly revised guidelines issued by the American College of Surgeons, which state that reps are to refrain from medical decision-making and participating in surgery.
But Chang says that reps, who have witnessed dozens if not hundreds of the same procedures, provide an essential benefit for doctors and patients. They "are only present at the behest of the physician and only as a trainer," and they provide "a live interactive resource."
Their value, Chang said, lies in their expertise, which can make surgery faster and more efficient. "For a lot of institutions, it's a bandwidth issue," he said, echoing a finding in Fugh-Berman's study that some surgeons prefer working with reps because they are more knowledgeable than hospital staff.
Gerald Williams, a Philadelphia joint replacement specialist who is president of the 18,000-member American Academy of Orthopaedic Surgeons, agrees. "Even if a surgeon is extremely familiar" with a device, "there are different teams scrubbing in" who typically have less familiarity with the procedure and the surgeon's process than a rep with whom a surgeon regularly works.
"Their presence is dictated by the complexity of the surgery," he said. "They are probably there close to 100 percent in complicated cases such as spine surgery and joint implants."
Williams said he doesn't tell his patients that a rep will be in the room, adding, "I don't tell them there's a circulating nurse, either. My patients look at me as being the captain of the ship. I think if I told them about a rep, they would all be supportive of it."
While salespeople have been in operating rooms for decades, their participation mushroomed beginning in the late 1990s with the proliferation of total joint replacement operations, said Linda Groah, the longtime executive director of AORN, the Association of periOperative Registered Nurses.
These days, "there's much more control of the reps," she said. "They just don't come through willy-nilly.'"
But Jeffrey Bedard's 2014 study about their role in the OR makes it clear that in some cases, there may be a chasm between guidelines and actual practice.
Bedard, who conducted his research as a graduate student in medical ethics, said it was prompted by his experience as an orthopedic device rep in the late 1990s. He subsequently became a drug salesman and now works in the pharmaceutical industry.
Bedard vividly remembers participating in one case involving a patient in her mid-40s. The surgeon, with whom he had not previously worked, refused all preoperative training, including watching a video, on a new $10,000 hip replacement system. "He said, 'You're going to be there, right?'" Bedard remembers being asked.
"To say that the case was a train wreck would be an understatement," Bedard recalls. The surgeon repeatedly cursed at him and at the circulating nurse, who continually monitors the patient and is responsible for ensuring that the proper equipment is available, as he struggled to perform the procedure. "I had to hold up the illustrated surgical technique and talk him through the case step by step," Bedard remembered. "I was absolutely beside myself."
Bedard recalled that when he called his supervisor to report what had happened, "my boss said: 'You just made $1,000 for three hours' worth of work. What are you complaining about?'"
Judging by the responses to his anonymous survey, which found that 37 percent of reps said they believed they had been excessively involved in an operation and 40 percent had attended a surgery in which they questioned the surgeon's competence, Bedard said little appears to have changed. "As a rep," he said, "you're paid to sell, to grow your business."
Two years ago, Gary Botimer, a joint replacement specialist who is chief of orthopedics at Loma Linda, undertook a radical experiment: He got rid of reps in joint replacement cases. Botimer negotiated a steep discount on the price of artificial joints bought in bulk from a well-known American manufacturer and sent hospital surgical techs to the technical training given to device salespeople.
"It took me two years to convince the administration" to do this, recalled Botimer, who said that one surgeon, who had significant financial ties to a manufacturer, quit. "I took a lot of bullets."
"What we basically did is to take the skill set of the reps and replace it with our own employees, who don't have a conflict of interest," Botimer said. "It's very easy to train your own people. We have found that the techs are better than the reps."
The 'Rep-Less Model'
To lay the groundwork, Botimer said he and other surgeons reviewed the literature to select the best implants as the hospital's standard. After the program was launched in 2014, Botimer said, he and his staff tracked the outcomes of all 500 joint replacement cases for one year to see if the "rep-less model" was equivalent. No difference in outcomes was detected, he said, but the hospital saved $1 million each year. (While standard implants are used in about 90 percent of cases, Loma Linda surgeons are free to use other devices if they believe doing so is in the patient's best interest.)
The program has been so successful that it is being extended to other orthopedic surgeries, such as trauma and spine operations, he said. Botimer added that he is fielding inquiries from other hospital systems contemplating a similar move.
"This is a big change in the culture, and no one makes that change easily," he said. "You have operating [room] personnel who've only known one way of doing things, doctors who are afraid to try it and administrators worried that docs would turn on them. We've spent a couple of years proving to everybody that their worst fears didn't happen."
Using patient information including mental health history, drug use, and insurance status, paramedics determine next steps: hospital, psych facility, or outpatient care.
For Kelly Kjelstrom, plugging the gaps in mental health care can mean something as simple as a late-night taco and a friendly chat.
Kjelstrom, 45, is a community paramedic in Modesto, California. Part of his job is to help psychiatric patients in need of care avoid winding up in the emergency room, where they can get "boarded" for days, until they are released or a bed frees up at an inpatient facility.
Here's how the concept of community paramedics works. When the local 911 system comes upon a patient with a potential mental health crisis, these specially trained paramedics are dispatched to the scene. They've learned to identify problems, intervene and de-escalate the situation.
After a physical assessment, paramedics like Kjelstrom talk to the patient — to figure out what, precisely, the issue is, asking also about issues like a patient's mental health history, drug use and insurance status. They use that information, along with details about resources available, to figure out the next steps for the patient — maybe it is a hospital or a psych facility, or maybe it is outpatient care.
Increasingly, these paramedics also become involved in follow-up. Kjelstrom estimates that, on visits, he spends twice as long with patients as he used to. He builds relationships with them. While out on duty, if he runs across a familiar face, he stops and checks in. Like over a night-time snack.
"One of the patients we see on a regular basis," Kjelstrom said. "I buy him a taco, no big deal, and I remind him to take his meds."
That simple interaction, he said, can keep someone out of the ER, and on the path to better health.
The Modesto pilot program launched a year ago. Similar projects are also underway in North Carolina, Minnesota, Texas, Colorado and Georgia. Other states, such as Washington and Nevada, have shown interest.
"Emergency departments are bursting at the seams," said Kevin Mackey, medical director of the Mountain Valley EMS agency, who launched the Modesto initiative, which has now been operating for a year. "This is at least a partial answer to giving people care in the right place at the right time."
Those efforts come as the issue of mental illness, which affects about 1 in 4 adults, continues to be a national concern and cases like October's police shooting of a woman with schizophrenia in New York spark conversation about ways to better reach these patients.
"If we could coordinate care — if we have the right medications and the right coordinating approach to these patients, we can avoid shooting people," Mackey added.
Jurisdictions are beginning to see the benefits.
In Wake County, North Carolina, for instance, a third of mental health-related 911 calls are now sent to specialized psychiatric facilities, said Michael Bachman, deputy director at the county's Office of Medical Affairs. That's about 350 patients a year who would otherwise have gone to the emergency department.
But patients can only be connected with the treatment they need if there are doctors or treatment sites available. Often, they aren't.
In addition, no one has been able to track whether these patients stay healthier, Bachman acknowledged.
And that's in part because of another issue. Paramedics can only redirect patients from the ER if there's somewhere else to take them and if they'll get proper follow-up care after. Far too often, experts said, that isn't the case.
"This works," Bachman said. "But the thing that has to improve is there has to be more access to places for patients to go."
In Modesto, Kjelstrom will see patients who would most benefit from a short stay in a dedicated mental health facility. But he'll often run up against the issue that the local centers just don't have enough beds to take patients in need. That limits how effective he can really be, he said.
Mackey said he estimates 30 percent of the time that patients needed to go to an inpatient facility, there wasn't a bed available. It's a similar story elsewhere. For Atlanta-based Grady Health System, which launched a paramedic program in 2012, finding available bed-space remains "a pretty big challenge," said Michael Colman, the system's vice president of EMS operations.
And then there's follow up.
"If we're talking about using community paramedics — or social workers, or some other community organization — to connect people with behavioral health care services, [these kinds of barriers] are an issue," said Kate Blackman, senior policy specialist for the health program at the National Council of State Legislatures.
Even so, experts said, it's a promising first step.
The Affordable Care Act transformed the medical system, expanding coverage to millions, injecting billions in tax revenue, changing insurance rules and launching ambitious experiments in quality and efficiency.
Less of that might disappear under President-elect Donald Trump's pledge to "repeal and replace Obamacare" than many believe, say policy analysts. Republicans promising change might not quickly admit it, but in some respects Obamacare's replacement may look something like the original.
"It gets into a questions of semantics," said Mark Rouck, an insurance analyst for Fitch Ratings. "Are they really repealing the act if they replace it with new legislation that has some of the same characteristics?"
Problems that helped give rise to the health law — rising costs, an aging population, mediocre medical results — haven't gone away. The ACA pushed insurers, hospitals and employers to launch their own reimbursement reforms, which are largely unaffected by who runs Washington.
Even fierce health-law opponents may pause at the political risk of taking benefits from millions who gained coverage since its implementation. Subsidies for the middle class to buy insurance may remain — even if they're not the Obamacare tax credits applied through online marketplaces, said Joseph Antos, a health economist at the American Enterprise Institute.
"The idea that they're just going to wipe that money away is pretty unlikely," he said. "They don't want to be in a position of saying they're just kicking millions of people out in the street."
Others disagree.
"I think they go away," said Ana Gupte, a health care analyst for Leerink Partners. "The subsidies … are at risk" along with the ACA's requirement that everybody have health coverage, she said.
Topping the list of ACA provisions likely to survive under Trump is the requirement that employers cover workers' children up to the age of 26, analysts said. The measure is widely popular and not especially expensive.
A health law crafted by Republicans might also retain the ACA's protections for people with preexisting illness seeking coverage, said Glenn Melnick, a health economist at the University of Southern California.
That could include relaxing the ACA's limit on how much insurers can charge and allowing them to adjust premiums based on an individual's health, he said. However, that might put the price of insurance out of reach for many.
The health law's payment reforms might also survive in some form. The ACA prompted hundreds of experiments to control costs by rewarding doctors for efficiency and fixing payments for episodes of care or treating entire populations.
"Part of what I would expect to hear from [the new administration] is we want more value out of the entire system," said Daniel Steingart, a hospital analyst at Moody's Investors Service. "All of that jibes pretty closely" with ACA payment experiments by the Department of Health and Human Services, he said. "I can foresee a scenario where they gradually expand all those programs."
Republicans have criticized HHS's innovation lab, which presides over accountable care organizations and many other payment tests. But they may find it more appealing under their own supervision, said Rodney Whitlock, a strategist and former top Republican health advisor in the Senate.
"You can really want to curtail it — until maybe you're in charge," he said. "Then maybe you would like it."
In any case private insurance companies, employers and hospitals are likely to continue their own payment reforms, analysts said.
"Private industry is really taking that and running with it," said Gupte. To be sure, health policy and financing are likely to look substantially different in a Trump administration, experts said.
The ACA's biggest coverage expansion came through the Medicaid program for the poor and disabled, which added more than 15 million people. Trump has suggested giving states fixed federal grants for Medicaid, which could lead to a substantial reduction in coverage or benefits.
Even partial cuts in Medicaid funding and subsidies for private plans would hurt hospitals, which have benefited from the health law's revenue infusion.
"If you're running a health system and you now have more insured people through a Medicaid expansion or exchange customers — if even a portion of those go away, that might be your [profit] margin for the year," said Benjamin Isgur, who heads the Health Research Institute at PwC, a consultancy.
On the other hand, hospitals and insurers represent a powerful lobby seeking to maintain something that looks like the status quo.
"There's a bigger role [hospitals] can play, a much more cost-effective role we can play if we have a long-term strategy" as part of a consistent health reform program, said Bill Ryan, a spokesman for the Einstein Healthcare Network, a Philadelphia-based hospital system. "And stopping and starting seems to be a crazy way to do this."
Other aspects of health care will probably stay the same in the near future no matter what Congress does, analysts said.
Health costs continue to grow faster than the economy's ability to pay for them. Partly as a result, high deductibles — what patients pay before insurance kicks in — have become widespread in employer and individual plans alike. Neither have much to do with the health law, said Don Berwick, who was acting Medicare administrator early in the Obama administration.
Republicans "managed to make the public think Obamacare was causing all the trouble. That is absolutely wrong," he said. "They could repeal it tomorrow and still have a broken delivery system and costs would continue to go up."
Now Republicans face the same challenge, said Mark McClellan, who ran Medicare in the George W. Bush administration.
"It'll be a different path, but the urgency of finding ways to transform health care — to give care that's more personalized in prevention and less costly and more accessible, especially to people of limited means — the pressure to do that is not going to go away," he said. "It's going to increase."
Reducing the number of people in Medicaid while ensuring that only the most needy remain eligible will be a goal for Trump and the new Congress, but there are obstacles to the Republicans' plans.
Millions of low-income Americans on Medicaid could lose their health coverage if President-elect Donald Trump and a Republican-controlled Congress follow through on GOP proposals to cut spending in the state-federal insurance program.
The biggest risk for Medicaid beneficiaries comes from pledges by Trump and other Republicans to repeal the Affordable Care Act, which provided federal funding to states to expand Medicaid eligibility starting in 2014. Thirty-one states and Washington, D.C. did so, adding 15.7 million people to the program, according to the government. About 73 million are now enrolled in Medicaid — about half are children.
Reducing the number of people in Medicaid while ensuring that only the most needy — such as children and pregnant women — remain eligible will be a goal for Trump and the new Congress, said Brian Blase, senior research fellow at the conservative Mercatus Center at George Mason University in Virginia.
"If we do not have fewer people in Medicaid in four years, then we have not reformed health policy in a good direction," he said.
But there are obstacles to the Republicans' plans. Medicaid, one of President Lyndon Johnson's "Great Society" domestic programs that was created in 1965, is the nation's main health insurance program for low-income people.
Overhauling it is politically difficult because of the potential harm to recipients as well as the financial consequences to states, hospitals, doctors and other health providers, who might not get paid for their services if patients don't have coverage. Total Medicaid spending was $532 billion in fiscal 2015, with about 62 percent funded by the federal government.
One major change endorsed by both Trump and House Speaker Paul Ryan (R-Wis.) would transform Medicaid from an entitlement program into a block grant program.
Here's the difference. In an entitlement program, coverage is guaranteed for everyone who's eligible. The federal government's commitment to help states cover costs is open-ended. The states' obligation is to cover certain groups of people and to provide specific benefits. Children and pregnant women who meet specific income criteria must be covered, for example.
That formula would change if federal funds flow to states through block grants. States would have more flexibility to run their Medicaid programs as they wish — including cutting benefits and eligibility. And proponents say it would allow the federal government to spend less on Medicaid and make states responsible for covering costs beyond their federal allotments.
Turning Medicaid into a block grant program has been discussed for more than 25 years, but the idea has always met resistance from some states, health providers, health care advocates and Democrats. Even with a Republican majority in Congress and Trump in the White House, the plan would still face an uphill legislative battle.
The federal government rarely shifts power to the states and not all states want to be at increased financial risk for the program.
"Medicaid block grants face a very uncertain future," said Joel Cantor, director of the Center for State Health Policy at Rutgers University in New Jersey.
Another option to redefine Medicaid funding, similar to a block grant, is known as a per capita cap. States would be given a set amount of money per enrollee, which would increase each year but critics fear likely not keep up with rising health expenses. That method would help states better deal with growing enrollment because funding would rise, too.
Even without help from Congress, Trump's administration could change Medicaid using the executive branch's power to approve states' requests for waivers from federal rules. That could allow Trump to approve changes proposed by Republican governors that the Obama administration has rejected, including work requirements for Medicaid enrollees and monthly premiums and other cost-sharing.
Trump could also end some waivers that expanded Medicaid and sent billions in new federal funding to some states that transformed care.
Any congressional changes to Medicaid next year would likely include negotiations about the Children's Health Insurance Program, another federal-state program that provides coverage to youngsters whose families are slightly over the Medicaid eligibility. The program expires if not reauthorized by Sept. 30, 2017. According to the Kaiser Family Foundation, about 8 million children get coverage through CHIP, which has had Republican and Democratic support.
After Trump is in office, he may find it's harder than he realized to repeal Obamacare and tinker with Medicaid because cutting off coverage for millions of people could bring plenty of political fallout, said Joan Alker, executive director of the Center for Children and Families at Georgetown University.
Republican Gov. Matt Bevin of Kentucky took a similar tack last year, she observed, running against Obamacare and vowing in his campaign to eliminate the expansion. He has since proposed major changes to Medicaid, but he has not yet moved to kill the expansion.
Still, Alker said Trump's win puts the block grant idea front and center in January. And an agreement to do it could give states flexibility to make cuts in federally required benefits, such as health screenings for infants and children.
"I would be very concerned about what could happen," Alker said.
Health policy experts don't expect Republicans to immediately kick millions of people off their insurance policies. Instead, they predict lawmakers may repeal parts of the law and allow for some transition period for consumers while a replacement plan is put together.
California has a lot to lose if President-elect Donald Trump and the Republican-led Congress fulfill their campaign pledge to repeal Obamacare.
The Golden State fully embraced the Affordable Care Act by expanding Medicaid coverage for the poor and creating its own health insurance exchange for about 1.4 million enrollees. Supporters held California up as proof the health law could work as intended.
But now President Barack Obama's signature law is in serious jeopardy and California officials are left wondering what Republicans in Washington may put in its place.
"There is no doubt that Obamacare is dead," said Robert Laszewski, a health care consultant and expert on the California insurance market. "The only question is just exactly how Republicans will get rid of it."
Health policy experts don't expect Republicans to immediately kick millions of people off their insurance policies. Instead, they predict lawmakers may repeal parts of the law and allow for some transition period for consumers while a replacement plan is put together.
Still, the personal and financial impact for the state could be jarring. The number of uninsured Californians would more than double to 7.5 million people if the Affordable Care Act was repealed, according to a recent study by the Urban Institute.
Researchers also said California stands to lose an estimated $15 billion annually in federal funding for Medicaid expansion and insurance subsidies — more than any other state. That loss of federal money would make it difficult for California to pursue health reform on its own.
State Sen. Ed Hernandez, (D-West Covina), chairman of the Senate Health Committee, said it's difficult to predict what the next iteration of the Affordable Care Act may look like.
"Will there be federal subsidies? Will the state legislature pay for subsidies to ensure Californians have coverage? Those are open questions," Hernandez said. "I will do everything I can to make sure California continues to take the lead on this issue."
California Insurance Commissioner Dave Jones said the state doesn't have the money to maintain Medi-Cal expansion or insurance subsidies on its own.
"With repeal, there is not some soft landing. There is not any capacity on the part of states to backfill what these cuts will do," Jones said. "I am very frustrated that the progress that has been made reducing the uninsured by half in this state and the nation will be undone. I am horror struck at all the Americans who will be without health insurance."
Congress already has voted to eliminate funding for Medicaid expansion and premium tax credits to dismantle two key pillars of the health law. Obama vetoed that legislation earlier this year, but Trump made the repeal of Obamacare a centerpiece of his campaign.
If repeal goes through, state leaders and consumer advocates may look to the ballot box, asking voters to fund expanded health coverage through higher taxes or fees. In Tuesday's election, Californians backed the extension of a hospital fee to help pay for Medi-Cal, the state's Medicaid program.
State officials could aim even higher and try for a government-funded single-payer health system at the state level. But that's expensive, disruptive to the current system and a tough sell to the public. Colorado voters soundly rejected a state single-payer initiative during Tuesday's election.
Some Republican lawmakers in California would applaud a reversal on Medi-Cal expansion. They have argued that state and federal spending increases on the program are unsustainable.
The state's Medi-Cal program now covers about a third of all Californians. The health law's Medicaid expansion has added about 3.5 million Californians to the program since January 2014 and total enrollment stands at more than 13 million.
Molina Healthcare, a Long Beach-based insurer, is a major player in Medicaid managed care nationwide and also covers about 600,000 people through exchanges in California and eight other states. The company's chief executive, Dr. J. Mario Molina, said he thinks Covered California and other exchanges will become a smaller part of health reform under a Republican plan and coverage expansion will shift more to Medicaid.
Molina said Republicans in Congress could grant governors more flexibility on Medicaid benefits to keep costs down while maintaining guaranteed access to coverage regardless of preexisting conditions, a popular provision of the health law.
"Republicans have the benefit of looking back at the experiment of Obamacare and seeing what worked and what didn't work," Molina said in an interview. "I think the Republicans will negotiate a deal where Medicaid gets expanded with more state control and exchanges will play a different role. The most cost effective way to do coverage expansion is through Medicaid."
Consumer advocates acknowledged the financial challenges posed by repeal but also encouraged Californians to keep signing up for coverage in the meantime.
"Californians should continue to enroll in Covered California this open enrollment season, in Medi-Cal, and all the benefits they are still entitled to–and then fight like hell to keep them," said Anthony Wright, executive director of Health Access California, a consumer advocacy group.
But some Covered California policyholders expressed concern about what a Trump administration might mean for their coverage.
"I worry it will be gone, and I don't know what I will do for insurance," said Jane Henning Childress, 61, who lives in Calaveras County.
Taking into account her federal subsidy, she said she pays about $135 a month for her exchange plan. Earlier this year, she used it to help cover surgery for an ovarian cyst. "It sure helped me out," she said.
Even before the election, some major health insurers were pulling out of the exchange market nationally and premiums shot up 22 percent, on average, for state and federal exchanges for 2017.
In the Covered California exchange, the average rate increase was 13.2 percent for next year. That's higher than the 4 percent average rate increases that California negotiated its first two years. Open enrollment started Nov. 1.
Health insurers in California and nationwide face plenty of uncertainty as well from the election outcome. Some analysts said more insurers may exit state marketplaces rather than wait for them to unravel and risk getting stuck with too many expensive patients.
Four big insurers, led by Anthem Inc. and Blue Shield of California, account for about 90 percent of Covered California's enrollment.
"The unthinkable has happened," said Ana Gupte, a senior health care research analyst at Leerink Research. "With a Republican sweep of the White House, Senate and the House, we are looking ahead to a 2017 filled with much change and uncertainty in the health care markets."
Republicans could use fast-track budget authority to make some major changes to the ACA, although that could take some time. In the short term, however, Trump could use executive power to make some major changes on his own.
Throughout the campaign, President-Elect Donald Trump’s entire health message consisted of promising to repeal the Affordable Care Act.
That remains difficult with Democrats still commanding enough power in the Senate to block the 60 votes needed for a full repeal. Republicans could use fast-track budget authority to make some major changes to the law, although that could take some time. In the short term, however, Trump could use executive power to make some major changes on his own.
Beyond the health law, Trump also could push for some Republican perennials, such as giving states block grants to handle Medicaid, allowing insurers to sell across state lines and establishing a ;federal high-risk insurance pool for people who are ill and unable to get private insurance.
But those options, too, would likely meet Democratic resistance, and it’s unclear where health will land on what could be a jam-packed White House agenda.
Still, there are several health issues the next Congress and the new administration will be required to address in 2017, if only because some key laws are set to expire.
And those could provide a vehicle for other sorts of health changes that might not be able to clear political or procedural hurdles on their own.
Here are some of the major health issues that are certain to come up in 2017:
The Affordable Care Act
If the GOP could not repeal the law and Trump were to turn to Congress to address some of the issues associated with it, it’s not clear if the executive and legislative branches could work together to respond to rising insurance premiums, declining insurance company participation or other unintended impacts of the health law. Nonetheless, some aspects of the law are unavoidable next year. For example, Congress in 2015 temporarily suspended or delayed three controversial taxes that were created to help pay for the law.
One of those taxes, a fee levied on health insurers, is suspended for 2017, while a 2.3 percent tax on medical devices was suspended for 2016 and 2017. Both industries lobbied heavily for the changes — arguing that the taxes boosted the prices of their products — and would like to permanently kill the taxes.
Also on hold is the most controversial health law tax of all, the so-called “Cadillac Tax” that levies a 40 percent penalty on very generous health insurance plans. The idea is to prevent consumers who pay little out of pocket because of their coverage from overusing health care services and driving up overall health costs.
The tax was technically put off from 2018 to 2020, but experts say pressure will begin to mount next year for reconsideration because employers will need a long lead time if they are to change benefits to avoid paying it. While economists are virtually unanimous in their support for the tax on high-end health plans, business and labor both strongly oppose it.
Children’s Health Insurance Program
The Children’s Health Insurance Program, a federal-state partnership that Hillary Clinton helped set up in negotiations with Congress during her husband’s administration, is up again for renewal in 2017. CHIP covers more than 8 million children from low- and moderate-income households and has made a huge dent in the number of uninsured children. According to the Census Bureau, nearly 95 percent of children had insurance coverage in 2015.
When the federal health law passed in 2010, many policymakers thought CHIP would quietly go away because most of the families whose children are eligible for the program became eligible for tax credits to help them purchase plans for the entire family in the health law’s marketplaces. But it turned out that CHIP in most states remained more popular because it provided better benefits at lower costs than did plans through the ACA.
In 2015, Congress compromised between those arguing to extend CHIP and those who wanted to end it, by renewing it for only two years. That ends Oct. 1, 2017. In practice, if Congress wants to extend CHIP, it needs to act early in 2017 because many states have fiscal years that begin in July and need lead time to plan their budgets.
Prescription Drug And Medical Device User Fees
Also expiring in 2017 is the authority for the Food and Drug Administration to collect “user fees” from makers of prescription drugs and medical devices.
The Prescription Drug User Fee Act, known as PDUFA (pronounced pah-doof-uh), was originally passed in 1990 in an effort to speed the review of new drug applications by enabling the agency to use the extra money to hire more personnel. The user fees were later expanded to speed the review of medical devices (2002), generic copies of brand-name drugs (2012) and generic biologic medicines (2012).
PDUFA gets reviewed and renewed every five years, and its “must-pass” status makes it a magnet for other changes to drug policy. For example, in 2012 the renewal also created a program aimed at addressing critical shortages of some prescription drugs. Earlier renewals also included separate programs that gave pharmaceutical firms incentives to study the effect of drugs in children.
Some policy-watchers think this year the bill could serve as a vehicle for provisions to help bring down drug prices, although it is not clear how well many of the ideas currently being floated would work.
“I think [Congress] will talk a lot about it and do very little,” said Robert Reischauer of the Urban Institute, who called the drug price issue “incredibly complex.”
Medicare’s Independent Payment Advisory Board
One more issue that might come up is a controversial cost-saving provision of the federal health law called the Independent Payment Advisory Board, or IPAB. The board is supposed to make recommendations for reducing Medicare spending if the program’s costs rise significantly faster than overall inflation. Congress can override those recommendations, but only with a two-thirds vote in each of the House and Senate.
So far the trigger hasn’t been reached. That’s lucky because the board has turned out to be so unpopular with both Democratic and Republican lawmakers, who say it will lead to rationing, that no one has even been appointed to serve.
The lack of an actual board, however, does not mean that nothing will happen if the requirement for Medicare savings is triggered. In that case, the responsibility for recommending savings will fall to the secretary of Health and Human Services. Medicare’s trustees predicted in their 2016 report that the targets will be exceeded for the first time in 2017.
That would likely touch off a furious round of legislating that could, in turn, lead to other Medicare changes.
The fungus, called Candida auris, has been detected in a total of 13 hospital patients since May 2013. A CDC report provides details on the first seven cases, which were reported in New York, Illinois, Maryland, and New Jersey.
A deadly new drug-resistant fungus has been linked to the deaths of four hospital patients in the U.S., according to a report released Friday from the Centers for Disease Control and Prevention.
The fungus, called Candida auris, preys on the sickest patients and can spread in hospitals. Although doctors have been concerned about the spread of antibiotic-resistant bugs for many years, this fungus is relatively new on the world scene. It was first identified in Japan in 2009 and has since spread around the globe, emerging in South America, the Middle East, Africa and Europe, according to the CDC.
The CDC first identified the fungus as a potential threat in 2013, based on a possible case in the U.S., and has been on the lookout for the fungus since June. In its new report, the CDC said the fungus has been detected in a total of 13 patients since May 2013; the agency provided details on the first seven cases, which were reported in New York, Illinois, Maryland and New Jersey.
All of the patients had serious underlying medical conditions, including cancer, and had been hospitalized an average of 18 days when they tested positive for the fungus. Two patients had been treated in the same health care facility and had nearly identical fungal strains. Doctors can't say for sure if the patients died from the fungus or their underlying health problems.
But health officials say the nation's hospitals need to be on alert.
"We need to act now to better understand, contain and stop the spread of this drug-resistant fungus," said Thomas Frieden, director of the CDC. "This is an emerging threat, and we need to protect vulnerable patients and others."
Identifying the fungus is difficult and requires special laboratory methods because it's so similar to other bugs. Most of the samples in the new report were initially misidentified as other fungal species, the CDC said.
Treating the fungus is even harder; 71 percent of the fungal samples were resistant to current drugs. Samples of the fungus in other countries have been resistant to all three major classes of antifungal drugs.
Hospitalized patients are at especially high risk from the fungus because many have had antibiotics, which can kill off healthy bacteria that help protect us from disease, said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston.
"It's a warning or wake-up against the indiscriminate use of antibiotics, especially in hospital settings," Hotez said.
Hospitals have been testing for the fungus more frequently due to outbreaks in Asia and the United Kingdom, said Amesh Adalja, senior associate at the UPMC Center for Health Security in Baltimore.
In earlier outbreaks, the fungus has killed 59 percent of patients, including 68 percent of patients whose infection spread to the bloodstream, said Adalja, who published a brief report on the infection Friday. Previous patients have had a median age of 54, Adalja said. The most common underlying medical problem was diabetes, and half of the patients had undergone surgery within 90 days. Nearly 80 percent of patients had a catheter placed in a major vein in the chest and 61 percent had a urinary catheter.
"Candida auris is a major threat that carries a high mortality," Adalja said. "Candida fungal species are ubiquitous. … As we learn more about this species, it will be essential to understand how it spreads in health care facilities and what the best infection control and treatment strategies are."
Although it's unclear exactly how the patients were infected, the CDC said that the fungus strains were related to ones found in South Asia and South America. None of the patients had traveled to those regions, however, and likely caught the infections here in the U.S.
The fungus apparently "arrived in the United States only in the past few years," said Tom Chiller, chief of the CDC's mycotic diseases branch. "We're working hard with partners to better understand this fungus and how it spreads so we can improve infection control recommendations and help protect people."
Hospitals should thoroughly clean rooms where patients with the fungus have stayed, the CDC said.