Gerald Chinchar isn't quite at the end of life, but the end is not far away. The 77-year-old fell twice last year, shattering his hip and femur, and now gets around his San Diego home in a wheelchair. His medications fill a dresser drawer, and congestive heart failure puts him at high risk of emergency room visits and long hospital stays.
Chinchar, a Navy veteran who loves TV Westerns, said that's the last thing he wants. He still likes to go watch his grandchildren's sporting events and play blackjack at the casino. "If they told me I had six months to live or go to the hospital and last two years, I'd say leave me home," Chinchar said. "That ain't no trade for me."
Most aging people would choose to stay home in their last years of life. But for many, it doesn't work out: They go in and out of hospitals, getting treated for flare-ups of various chronic illnesses. It's a massive problem that costs the health care system billions of dollars and has galvanized health providers, hospital administrators and policymakers to search for solutions.
Sharp HealthCare, the San Diego health system where Chinchar receives care, has devised a way to fulfill his wishes and reduce costs at the same time. It's a pre-hospice program called Transitions, designed to give elderly patients the care they want at home and keep them out of the hospital.
Social workers and nurses from Sharp regularly visit patients in their homes to explain what they can expect in their final years, help them make end-of-life plans and teach them how to better manage their diseases. Physicians track their health and scrap unnecessary medications. Unlike hospice care, patients don't need to have a prognosis of six months or less, and they can continue getting curative treatment for their illnesses, not just for symptoms.
Before the Transitions program started, the only option for many patients in a health crisis was to call 911 and be rushed to the emergency room. Now, they have round-the-clock access to nurses, one phone call away.
"Transitions is for just that point where people are starting to realize they can see the end of the road," said San Diego physician Dan Hoefer, one of the creators of the program. "We are trying to help them through that process so it's not filled with chaos."
The importance of programs like Transitions is likely to grow in coming years as 10,000 baby boomers — many with multiple chronic diseases — turn 65 every day. Transitions was among the first of its kind, but several such programs, formally known as home-based palliative care, have since opened around the country. They are part of a broader push to improve people's health and reduce spending through better coordination of care and more treatment outside hospital walls.
But a huge barrier stands in the way of pre-hospice programs: There is no clear way to pay for them. Health providers typically get paid for office visits and procedures, and hospitals still get reimbursed for patients in their beds. The services provided by home-based palliative care don't fit that model.
In recent years, however, pressure has mounted to continue moving away from traditional payment systems. The Affordable Care Act has established new rules and pilot programs that reward the quality rather than the quantity of care. The health reform law, for example, set up "accountable care organizations" networks of doctors and hospitals that share responsibility for providing care to patients. They also share the savings when they rein in unnecessary spending by keeping people healthier. Those changes are helping to make home-based palliative care a more viable option.
In San Diego, Sharp's palliative care program has a strong incentive to reduce the cost of caring for its patients, who are all in Medicare managed care. The nonprofit health organization receives a fixed amount of money per member each month, so it can pocket what it doesn't spend on hospital stays and other costly medical interventions.
'Something That Works'
Palliative care focuses on relieving patients' stress, pain and other symptoms as their health declines, and it helps them maintain their quality of life. It's for people with serious illnesses, such as cancer, dementia and heart failure. The idea is for patients to get palliative care and then move into hospice care, but they don't always make that transition.
The 2014 report "Dying in America," by the Institute of Medicine, recommended that all people with serious advanced illness have access to palliative care. Many hospitals now have palliative care programs, delivered by teams of social workers, chaplains, doctors and nurses, for patients who aren't yet ready for hospice. But until recently, few such efforts had opened beyond the confines of hospitals.
Kaiser Permanente set out to address this gap. Nearly 20 years ago, it created a home-based palliative care program, testing it in California and later in Hawaii and Colorado. Two studies by Kaiser and others found that participants were far more likely to be satisfied with their care and more likely to die at home than those not in the program. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)
One of the studies, published in 2007, found that 36 percent of people receiving palliative care at home were hospitalized in their final months, compared with 59 percent of those getting standard care. The overall cost of care for those who participated in the program was a third less than for those who didn't.
But Enguidanos knew that Kaiser Permanente was unlike most health organizations. It was responsible for both insuring and treating its patients, so it had a clear financial motivation to improve care and control costs. Enguidanos said she talked to medical providers around the nation about this type of palliative care, but the concept didn't take off at the time. Providers kept asking the same question: How do you pay for it without charging patients or insurers?
"I liken it to paddling out too soon for the wave," she said. "We were out there too soon. … But we didn't have the right environment, the right incentive."
A Bold Idea
Dan Hoefer's medical office is in the city of El Cajon, which sits in a valley in eastern San Diego County. Hoefer, a former hospice and home health medical director and nursing home doctor, has spent years treating elderly patients. He learned an important lesson when seeing patients in his office: Despite the medical care they received, "they were far more likely to be admitted to the hospital than make it back to see me."
When his patients were hospitalized, many would decline quickly. Even if their immediate symptoms were treated successfully, they would sometimes leave the hospital less able to take care of themselves. They would get infections or suffer from delirium. Some would fall.
His patients were like cars with 300,000 miles on them, he said. They had a lot of broken parts. "You can't just fix one thing and think you have solved the problem," he said.
And trying to do so can be very costly. About a quarter of all Medicare spending for beneficiaries 65 or older is to treat people in their last year of life, according to a report by the Kaiser Family Foundation. (Kaiser Health News, which produces California Healthline, is an editorially independent program of the foundation.)
Hoefer's colleague, Suzi Johnson, a nurse and administrator in Sharp's hospice program, saw the opposite side of the equation. Patients admitted into hospice care would make surprising turnarounds once they started getting medical and social support at home and stopped going to the hospital. Some lived longer than doctors had expected.
In 2005, the pair hatched and honed a bold idea: What if they could design a home-based program for patients before they were eligible for hospice?
Thus, Transitions was born. They modeled their new program in part on the Kaiser experiment, then set out to persuade doctors, medical directors and financial officers to try it. But they met resistance from physicians and hospital administrators who were used to getting paid for seeing patients.
"We were doing something that was really revolutionary, that really went against the culture of health care at the time," Johnson said. "We were inspired by the broken system and the opportunity we saw to fix something."
Despite the concerns, Sharp's foundation board gave the pair a $180,000 grant to test out Transitions. And in 2007, they started with heart failure patients and later expanded the program to those with advanced cancer, dementia, chronic obstructive pulmonary disease and other progressive illnesses. They started to win over some doctors who appreciated having additional eyes on their patients, but they still encountered "some skepticism about whether it was really going to do any good for our patients," said Jeremy Hogan, a neurologist with Sharp. "It wasn't really clear to the group … what the purpose of providing a service like this was."
Nevertheless, Hogan referred some of his dementia patients to the program and quickly realized that the extra support for them and their families meant fewer panicked calls and emergency room trips.
Hoefer said doctors started realizing home-based care made sense for these patients — many of whom were too frail to get to a doctor's office regularly. "At this point in the patient's life, we should be bringing health care to the patient, not the other way around," he said.
Across the country, more doctors, hospitals and insurers are starting to see the value of home-based palliative care and are figuring out how to pay for it, said Kathleen Kerr, a health care consultant who researches palliative care.
"It is picking up steam," she said. "You know you are going to take better care of this population, and you are absolutely going to have lower health care costs."
Providers are motivated in part by a growing body of research. A study published in January showed that in the last three months of life, medical care for patients in a home-based palliative care program cost $12,000 less than for patients who were getting more typical treatment. Patients in the program also were more likely to go into hospice and to die at home, according to the study.
Two studies of Transitions in 2013 and 2016 reaffirmed that such programs save money. The second study, led by outside evaluators, showed it saved more than $4,200 per month on cancer patients and nearly $3,500 on those with heart failure.
The biggest differences occurred in the final two months of life, said one of the researchers, Brian Cassel, who is palliative care research director at the Virginia Commonwealth University School of Medicine in Richmond.
One reason for the success of these programs is that the teams really get to know patients, their hopes and aspirations, said Christine Ritchie, a professor at UC San Francisco's medical school. "There is nothing like being in someone's home, on their turf, to really understand what their life is like," she said.
A Home Visit
Nurse Sheri Juan and social worker Mike Velasco, who both work for Sharp, walked up a wooden ramp to the Chinchars' front door one recent January morning. Juan rolled a small suitcase behind her containing a blood pressure cuff, a stethoscope, books, a laptop computer and a printer.
Mary Jo Chinchar was already familiar with Transitions because her mother had been in the program before entering hospice and dying in 2015 at the age of 101. Late last year, Gerald Chinchar's doctor recommended he enroll in it, explaining that his health was in a "tenuous position."
Chinchar, who has nine grandchildren and four great-grandchildren, likes to tell stories about his time in the Navy, about traveling the country for jobs and living in San Francisco as a young man.
He has had breathing problems much of his life, suffering from asthma and chronic obstructive pulmonary disease — ailments he partly attributes to the four decades he spent painting and sandblasting fuel tanks for work. Chinchar also has diabetes, a disease that led to his mother's death. He recently learned he had heart failure.
"I never knew I had any heart trouble," he said. "That was the only good thing I had going for me."
Now he's trying to figure out how to keep it from getting worse: How much should he drink? What is he supposed to eat?
That's where Juan comes in. Her job is to make sure the Chinchars understand Gerald's disease so he doesn't have a flare-up that could send him to the emergency room. She sat beside the couple in their living room, its bookshelves filled with titles on gardening and baseball. A basket of cough drops and a globe sat on a side table.
Any pain today? Juan asked. How is your breathing? Are you more fatigued than before? Is your weight the same? He replied that he had gained a few pounds recently but knew that was because he'd eaten too much bacon.
Posted on the couple's refrigerator was a notice advising them to call the nurse if Gerald had problems breathing, increased swelling or new chest pain.
Juan checked his blood pressure and examined his feet and legs for signs of more swelling. She looked through his medications and told him which ones the doctor wanted him to stop taking. "What we like to do as a palliative care program is streamline your medication list," she said. "They may be doing more harm than good."
Mary Jo Chinchar said she appreciates the visits, especially the advice about what Gerald should eat and drink. Her husband doesn't always listen to her, she said. "It's better to come from somebody else."
A Nearly Impossible Decision
On a rainy January day, doctors, nurses and social workers gathered in a small conference room for their bimonthly meeting to discuss patient cases. Information about the patients — their hospitalizations, medications, diagnoses — was projected on the wall. Their task: to decide if new patients were appropriate for Transitions and if current patients should remain there.
It's nearly impossible to predict how long someone will live. It's an inexact algorithm based on the severity of their disease, depression, appetite, social support and other factors. Nevertheless, the team tries to do just that, and they may recommend hospice for patients expected to live less than six months.
That was the case with an 87-year-old woman suffering from Alzheimer's disease. She had fallen many times, slept about 16 hours a day and no longer had much of an appetite. Those were all signs that the woman may be close to death, so she was referred to hospice.
Patients typically stay in Transitions about seven or eight months, but some last as long as two years before they stabilize and are discharged from the program. Others go directly to hospice, and still others die while they are still in Transitions.
The group turned its attention to an 89-year-old woman with dementia, who believed she was still a young Navy wife. She suffered from depression and kidney disease, and had been hospitalized twice last year.
"She's a perfect patient for Transitions," Hoefer told the team, adding that she could benefit from extra help. Another good candidate, Hoefer said later, was El Cajon resident Evelyn Matzen, who is 94 and has dementia. She had started to lose weight and was having more difficulty caring for herself. They took her in because "we were worried that it was going to start what I call the revolving door of hospitalization," Hoefer said.
About eight months after she joined the program, Matzen sat in Hoefer's office as he checked her labs and listened to her chest. Her body was starting to slow down, but she was still doing well, he told her. "Whatever you are doing is working."
Bill Matzen, who accompanied his mom to the appointment, said she had started to stabilize since going onto Transitions. "She is on less medication, she is in better condition, physically, mentally, the whole nine yards," he said.
Hoefer explained that frail elderly patients have fewer reserves to tolerate medical treatment and especially hospitalization. Bill Matzen said his mother leaned that the hard way after a recent fall. Though the Transitions nurse had come to see her, the Matzens decided to go to the hospital because they were still concerned about a bruise on her head. While she was in the hospital, Evelyn Matzen started hallucinating and grew agitated.
Being in the hospital "kicks her back a notch or two," her son said. "It takes her longer to recover than if she had been in a home environment."
A Changed Climate
Outpatient palliative care programs are cropping up in various forms. Some new ones are run by insurers, others by health systems or hospice organizations. Others are for-profit, including Aspire Health, which was started by former senator Bill Frist in 2013.
Sutter Health operates a project called Advanced Illness Management to help patients manage symptoms and medications and plan for the future. The University of Southern California and Blue Shield of California recently received a $5 million grant to provide and study outpatient care.
"The climate has changed for palliative care," said Enguidanos, the lead investigator on the USC-Blue Shield project.
Ritchie said she expects even more home-based programs in the years to come, especially if palliative care providers work alongside primary care doctors. "My expectation is that much of what is being done in the hospital won't need to be done in the hospital anymore and it can be done in people's homes," she said.
Challenges remain, however. In addition to questions about reimbursement, not enough trained providers are available. And some doctors are unfamiliar with the approach, and patients may be reluctant, especially those who haven't clearly been told they have a terminal diagnosis.
Now, some palliative care providers and researchers worry about the impact of President Donald Trump's plans to repeal the Affordable Care Act and revamp Medicare.
"It would be horrible," Kerr said. "Before, we had an inkling that this was helping a lot of folks. Now we know it is really helping."
Gerald Chinchar, who grew up in Connecticut, said he never expected to live into old age. His father, a heavy drinker, died of cirrhosis of the liver at 47. In his family, Chinchar said, "you're an old-timer if you make 60."
Chinchar said he gave up drinking and is trying to eat less of his favorite foods — steak sandwiches and fish and chips. He just turned 77, a milestone he credits partly to the pre-hospice program.
"If I make 80, I figured I did pretty good," he said. "And if I make 80, I'll shoot for 85."
A last-minute attempt by conservative Republicans to dump standards for health benefits in plans sold to individuals would probably lower the average consumer's upfront insurance costs, such as premiums and deductibles, said experts on both sides of the debate to repeal and replace the Affordable Care Act.
But, they add, it will likely also induce insurers to offer much skimpier plans, potentially excluding the gravely ill, and putting consumers at greater financial risk if they need care.
For example, a woman who had elected not to have maternity coverage could face financial ruin from an unintended pregnancy. A healthy young man who didn't buy drug coverage could be bankrupted if diagnosed with cancer requiring expensive prescription medicine. Someone needing emergency treatment at a non-network hospital might not be covered.
What might be desirable for business would leave patients vulnerable.
"What you don't want if you're an insurer is only sick people buying whatever product you have," said Christopher Koller, president of the Milbank Memorial Fund and a former Rhode Island insurance commissioner. "So the way to get healthy people is to offer cheaper products designed for the healthy people."
Such a change could give carriers wide room to do that by eliminating or shrinking "essential health benefits" including hospitalization, prescription drugs, mental health treatment and lab services from plan requirements — especially if state regulators don't step in to fill the void, analysts said.
As part of the push by House GOP leaders to gain more support for their plan, they amended the bill Thursday to allow states to decide, starting next year, what if any benefits insurers must provide on the individual market, rather than requiring health plans to include the law's essential health benefits, according to House Ways and Means Chairman Kevin Brady (R-Texas).
The Affordable Care Act requires companies selling coverage to individuals and families through online marketplaces to offer 10 essential benefits, which also include maternity, wellness and preventive services — plus emergency room treatment at all hospitals. Small-group plans offered by many small employers also must carry such benefits.
Conservative House Republicans want to exclude the rule from any replacement, arguing it drives up cost and stifles consumer choice.
On Thursday, President Donald Trump agreed after meeting with members of the conservative Freedom Caucus to leave it out of the measure under consideration, said White House Press Secretary Sean Spicer. "Part of the reason that premiums have spiked out of control is because under Obamacare, there were these mandated services that had to be included," Spicer told reporters.
Pushed by Trump, House Republican leaders agreed late Thursday to a Friday vote on the bill but were still trying to line up support. "Tomorrow we will show the American people that we will repeal and replace this broken law because it's collapsing and it's failing families," said House Speaker Paul Ryan (R-Wis.). "And tomorrow we're proceeding." When asked if he had the votes, Ryan didn't answer and walked briskly away from the press corps.
But axing essential benefits could bring back the pre-ACA days when insurers avoided expensive patients by excluding services they needed, said Gary Claxton, a vice president and insurance expert at the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)
"They're not going to offer benefits that attract people with chronic illness if they can help it,"said Claxton, whose collection of old insurance policies shows what the market looked like before.
One Aetna plan didn't cover most mental health or addiction services — important to moderate Republicans as well as Democrats concerned about fighting the opioid crisis. Another Aetna plan didn't cover any mental health treatment. A HealthNet plan didn't cover outpatient rehabilitative services.
The House replacement bill could make individual coverage for the chronically ill even more scarce than a few years ago because it retains an ACA rule that forces plans to accept members with preexisting illness, analysts said.
Before President Barack Obama's health overhaul, insurers could reject sick applicants or charge them higher premiums.
Lacking that ability under a Republican law but newly able to shrink benefits, insurers might be more tempted than ever to avoid covering expensive conditions. That way the sickest consumers wouldn't even bother to apply.
"You could see even worse holes in the insurance package" than before the ACA, said Sabrina Corlette, a research professor at the Center on Health Insurance Reforms at Georgetown University. "If we're going into a world where a carrier is going to have to accept all comers and they can't charge them based on their health status, the benefit design becomes a much bigger deal" in how insurers keep the sick out of their plans, she said.
Michael Cannon, an analyst at the libertarian Cato Institute and a longtime Obamacare opponent, also believes dumping essential benefits while forcing insurers to accept all applicants at one "community" price would weaken coverage for chronically ill people.
"Getting rid of the essential health benefits in a community-rated market would cause coverage for the sick to get even worse than it is under current law," he said. Republicans "are shooting themselves in the foot if they the offer this proposal."
Cannon favors full repeal of the ACA, allowing insurers to charge higher premiums for more expensive patients and helping consumers pay for plans with tax-favored health savings accounts.
In an absence of federal requirements for benefits, existing state standards would become more important. Some states might move to upgrade required benefits in line with the ACA rules but others probably won't, according to analysts.
"You're going to have a lot of insurers in states trying to understand what existing laws they have in place," Koller said. "It's going to be really critical to see how quickly the states react. There are going to be some states that will not."
Mary Agnes Carey and Phil Galewitz contributed to this story.
With prescription drug prices soaring and President Donald Trump vowing to take action, an old idea is gaining fresh traction: allowing Americans to buy medicines from foreign pharmacies at far lower prices. A new bill in Congress to allow the practice would modify previous safety standards and remove a barrier that proved insurmountable in past attempts to enable progress.
Congress came close to allowing importation through the Medicare Modernization Act in 2003, but added one firm precondition that has prove a nonstarter. The secretary of Health and Human Services had to guarantee that imported medications posed no additional risk to public safety and would save money.
"That is a fairly absolute standard and a high bar to cross," said Elizabeth Jungman, director of public health at the Pew Charitable Trusts. Such an exacting standard — guaranteeing that no imported prescriptions posed a threat — has kept any secretary of HHS from condoning it.
In an open letter to Congress, four former commissioners of the Food and Drug Administration argue consumer drug importation remains too risky to permit. "It could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard, or counterfeit drugs," they said in the letter distributed to media organizations. It was signed by Robert Califf, Margaret Hamburg, Mark McClellan and Andrew von Eschenbach, who headed the FDA at various times between 2002 through 2016.
The recent proposal, from Sen. Bernie Sanders (I-Vt.) and such Democrats as Cory Booker from New Jersey and Bob Casey from Pennsylvania, drops that requirement. Instead, it sets up a regulatory system where Canadian pharmacies who purchase their supply from manufacturers inspected by the Food and Drug Administration would be licensed to sell to customers across the border. The bill allows not only individuals but drug wholesalers and pharmacies to buy from Canada.
After two years, HHS could allow importation from other countries that meet standards comparable to those of the U.S.
(Another bill in Congress, proposed in January by John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.) focuses solely on allowing individuals to purchase from such pharmacies.)
Trump has promised that "pricing for the American people will come way down." Last week, he had a high-profile meeting at the White House with Elijah Cummings, Peter Welch (D-Vt.) and the head of Johns Hopkins Hospital, Redonda Miller, to discuss allowing Medicare to negotiate prices on outpatient medicines. Cummings told reporters later that Trump said he supports Medicare price negotiation as well as the Sanders bill.
PhRMA, the drug industry's trade group, has denounced Sanders' proposal as it has others that enabled imports in the past.
"The bill lacks sufficient safety controls [and] would exacerbate threats to public health from counterfeit, adulterated or diverted medicines, and increase the burden on law enforcement to prevent unregulated medicines and other dangerous products from harming consumers," said PhRMA spokeswoman Nicole Longo.
Surveys indicate that up to 8 percent of Americans have bought medicines outside the U.S. even though the practice is technically illegal and imported pills are subject to confiscation.
Around 45 million Americans — 18 percent of the adult population — said last year they did not fill a prescription due to cost, according to an analysis of data from the Commonwealth Fund by Gabriel Levitt, president of PharmacyChecker.com, whose company helps Americans buy medications online by vetting overseas pharmacies and comparing prices for different drugs. Data compiled by the company comparing prices offered in Canada to those in New York, shows drugs are frequently three times or more as costly in the U.S. as over the border.
For example, a simple Proventil asthma inhaler costs $73.19 in the U.S. vs. $21.66 in Canada. Crestor, the cholesterol-lowering drug, is $6.82 per pill in the U.S. but $2.58 in Canada. Abilify, a psychiatric medicine, is $29.88 vs. $7.58, according to pharmacychecker.com.
Many previous bills to allow importation or to allow Medicare to negotiate prices for its beneficiaries have failed in the face of $1.9 billion in congressional lobbying by the pharmaceutical industry since 2003, according to Open Secrets. But Americans may be reaching a tipping point of intolerance. In polling just before the election by the Kaiser Family Foundation, 77 percent of Americans called drug prices "unreasonable" and well over half favored a variety of proposals to address them.
To address safety concerns, the Sanders bill institutes several new strategies. Canadian pharmacies that want to be registered to sell to Americans would have to pay a fee to pay for additional FDA monitoring. A General Accountability Office study would be required within 18 months of the final rule to address outcomes related to importation processes, drug safety, consumer savings and regulatory expenses.
Allowing people to legally import medications wouldn't totally solve the problem of high prescription drugs, advocates say, but would be a step in the right direction. Said Levitt: "The best way for Americans to afford their meds is to enact polices here to bring the prices down here."
KHN's coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
Proposed changes could potentially saddle people on Medicaid with unaffordable medical bills, shortchange providers, and raise costs throughout the healthcare system.
An under-the-radar provision in the Republican proposal to replace the Affordable Care Act would require the millions of Medicaid enrollees who signed up under the Obamacare expansion to renew their coverage every six months — twice as often as under current law.
That change would inevitably push many people out of coverage, at least temporarily, experts say, and help GOP leaders phase out Medicaid expansion — a key goal of the pending legislation.
"That's designed to move people off those rolls as soon as possible," said Ken Jacobs, chairman of the University of California, Berkeley, Center for Labor Research and Education.
The proposal to cut renewal time in half is among other changes that seem only procedural but could have a profound effect on Medicaid enrollees' health, pocketbooks and ability to get — and keep — coverage.
Another proposal would eliminate the ability of new Medicaid enrollees to request retroactive coverage for up to three months before the month they apply, which they can do under the current law — assuming they were eligible during that previous period.
Health care experts and advocates fear that could potentially saddle people on Medicaid with unaffordable medical bills, shortchange providers and raise costs throughout the health care system.
"These are changes to fundamental pieces of the Medicaid program," said Cathy Senderling-McDonald, deputy executive director of the County Welfare Directors Association of California in Sacramento, which represents human services directors from the state's 58 counties.
"They could result in people delaying their health care or having to pay out-of-pocket and not having any hope for reimbursement at all," she said.
But Michael Cannon, director of Health Policy Studies at the libertarian Cato Institute, said some of these changes would prevent fraud and keep ineligible people from obtaining benefits, thus saving taxpayer money.
"It's so hard to eliminate fraud in Medicaid, because someone always benefits from it," he said. "They don't want to give that up."
The expansion of Medicaid — the federal-state health care program for people with low incomes, known as Medi-Cal in California — would be phased out under the Republicans' plan starting in 2020.
The expansion, adopted by 31 states and the District of Columbia, added more than 11 million people to the rolls, including about 3.7 million in Medi-Cal. The federal government picks up a much higher proportion of the cost for this population than for traditional Medicaid enrollees.
In the GOP plan, people already covered under the expansion would continue to be funded by the federal government after Jan. 1, 2020, but if states opted to sign up new enrollees under the expansion criteria after that date, they wouldn't receive the more generous federal funding for them.
And those who remained in the program after 2020 but later lost eligibility would not draw the more generous federal funding for expansion enrollees if they became eligible again and re-enrolled at a later date.
In California, the potential loss of federal dollars caused by the rollback of the expansion would be massive. The state Legislative Analyst's Office estimated last month that the Golden State is slated to receive more than $17 billion from the federal government for the Medi-Cal expansion in 2017-18.
"We're talking about a big shift in costs to the state of California and potentially a major loss in coverage," said UC Berkeley's Jacobs.
The GOP legislation, which is scheduled for a vote on the House floor on Thursday, would impose the new renewal requirement on expansion enrollees starting Oct. 1.
"They're saying to states that do the expansion, 'We'll cover people who are continuously in the program, but we'll make it really hard for people to be continuously in the program,'" Jacobs said.
Wolf Faulkins, a resident of Mariposa, Calif., who enrolled in Medi-Cal in 2014 as a result of the expansion, said the proposed rule change regarding renewal would add one more layer to Medi-Cal's already considerable bureaucratic requirements, none of them logical or simple.
"If I were more of a senior citizen than I am now, I would be overwhelmed" by it, Faulkins, 61, said. "I would not be a happy camper." But he would complete the extra paperwork, he added, because his Medi-Cal coverage keeps him alive: Among other things, he has a heart condition and high blood pressure as well as knee and hand ailments.
Senderling-McDonald said the new paperwork will lead some enrollees to drop out for two reasons: Either they're no longer eligible, or they're eligible but the new bureaucratic hurdle stops them.
Faulkins agreed. Even though he would jump through the necessary hoops to keep his coverage, some others probably wouldn't, he guessed. "There are people who are just going to say, 'It's important, but it's too overwhelming. There's no one to advocate for me. There's no one to help me figure this out, " he said. "People are just going to get frustrated and say no."
The new renewal time frame has a precedent in California, which adopted a semiannual reporting requirement in 2003 for some enrollees that lasted about a decade. Though it was less cumbersome than the regular annual renewals, it nonetheless resulted in people dropping from the rolls, Senderling-McDonald said.
But the Cato Institute's Cannon believes six-month renewals are reasonable. "The savings from removing ineligible people would justify the paperwork involved," he said.
The paperwork imposed by these changes could be the least of the headaches for Medicaid beneficiaries.
Retroactive benefits, for example, are extremely valuable for new Medicaid enrollees who face medical bills during a gap in coverage, and losing them could cause financial pain.
"If they have had health expenses, like having to pay for a prescription out-of-pocket or a doctor's visit, or a woman goes into labor uninsured, they can say to the county, 'I had medical bills. Can you see if I was eligible during that time?'" said Senderling-McDonald.
Pregnant women are among the most frequent beneficiaries because they often don't know that they're pregnant right away, she added.
The GOP bill would end this, and would allow coverage to begin only the month in which enrollees apply. This provision would affect all Medicaid applicants and, like the change in renewal time, would begin Oct. 1.
Some experts believe the proposed change would increase medical debt for consumers hit with massive bills, and for providers who ultimately won't get paid for their services.
The three-month retroactive rule is "a big deal for hospitals as well as people, because it keeps them from being saddled with medical debt," said Judith Solomon, vice president for health policy at the Center on Budget and Policy Priorities in Washington, D.C.
Senderling-McDonald warned that as more consumers racked up medical debt, the cost of it would shift to other people. "If someone has to declare bankruptcy when they are hit with bills they can't pay, everybody else takes the hit for it," she said. "They're going to raise insurance rates or costs of care for everybody. People who have coverage through employers or the private market could see their rates go up."
Cannon agreed that providers will get hit with more unpaid bills, but said that this provision would save the federal government money. "States have taxing authority and can fund these benefits themselves if they want to," he said. "If they don't, that should tell us something — that they don't value these benefits that much."
New England's bucolic countryside looks much the same on either side of the Connecticut River separating Vermont from New Hampshire.
But Medicaid beneficiaries are far better off in Vermont.
Vermont generously funds its Medicaid program. It provides better benefits, such as dental care, and pays doctors more than New Hampshire's program does. That brings more doctors into the program, giving enrollees more access to care.
New Hampshire has twice Vermont's population, but Vermont spends almost as much on Medicaid and covers more enrollees. Under the complicated formulas that set federal funding, Vermont's substantial investment helps it capture nearly as much aid from the government as New Hampshire gets.
States' policies differ about who or what to cover in Medicaid, and those decisions have led to historical variances in how much federal money they receive. House Republicans' effort to shrink federal Medicaid spending would lock in the differences in a way that favors those already spending high amounts per enrollee.
"Republicans are finding out why changing Medicaid is so hard and why the easiest thing to do is to do nothing given the substantial variation in federal spending across states," said John Holahan, a health policy expert with the nonpartisan Urban Institute.
Here's why.
Medicaid, the national health program for low-income people that covers about 1 in 5 Americans, is 60 percent funded by the federal government and 40 percent by states. Total spending in 2015 was about $532 billion, according to the latest official data.
Federal funding is open-ended, which means the government guarantees states it will pay a fixed rate of their Medicaid expenses as spending rises.
Those matching rates are tied to average personal incomes and favor the lowest-income states. Mississippi has the highest Federal Matching Assistance Percentage—76—while 14 wealthy states, including New York and California, get the minimum 50 percent from the federal government.
But state Medicaid spending varies significantly, too, and that influences how much federal money each receives to fund its program. State policies about how generous benefits should be and how much to pay doctors and hospitals account for those differences.
GOP leaders want to give states a set amount of money each year based on the number of Medicaid enrollees they had in 2016, a formula known as per-capita caps.
A per-capita system would benefit high-spending states already receiving relatively rich allotments from the government, the Urban Institute said in a paper last September.
According to its estimates, if the system were in effect this year, Vermont would receive $6,067 per enrollee—one of the highest allotments in the country—while New Hampshire would get the least, just $3,084 per enrollee.
Per-capita caps would limit the government's Medicaid spending because it would no longer be on the hook to help cover states' rising costs. But caps also would shift costs and financial risks to the states and could force them to cut benefits or eligibility to manage their budgets.
"It would present a huge problem," said Adam Fox, a spokesman for the Colorado Consumer Health Initiative, an advocacy group.
Under the GOP bill, federal Medicaid funding to states would be adjusted annually based on a state's enrollment and medical inflation. But that would not be enough to keep up with rising Medicaid spending per enrollee, which would force states to put up more of their money or scale back the program, the nonpartisan Congressional Budget Office saidMarch 13.
Other analyses of the GOP plan have reached the same conclusion.
Since 1999, however, the average annual growth rate in Medicaid spending per enrollee has risen more slowly than medical inflation, according to MACPAC, the Medicaid and CHIP Payment and Access Commission, which advises Congress.
Republicans argue that overhauling federal Medicaid spending as they propose would hold down federal costs while giving states more leeway to run their programs as they see fit. "This incentive would help encourage efficiencies and accountability with taxpayer funds," House Speaker Paul Ryan wrote last June in his white paper, A Better Way.
Rep. Greg Walden (R-Ore.), chairman of the powerful House Energy and Commerce Committee, which has oversight of health care matters, sounded a similar note at a press conference in Washington, D.C., when the GOP plan was announced. "I think it's really important to empower states and to put Medicaid on a budget," he said.
But Fox argued the opposite would happen under a per-capita system — instead of gaining more control over their Medicaid programs, states would not be able to meet their needs because they'd have fewer dollars to decide how to spend, he said.
Bill Hammond, director of health policy for the nonpartisan Empire Center for Public Policy in New York, said House leaders' decision to tie future Medicaid funding to medical inflation could help mute concerns that funding wouldn't keep up with rising costs, but would not address the fairness issue of giving some states higher per-capita amounts than others.
"If a low-spending state decides it wants to spend more money on paying hospitals and doctors or adding more benefits, they would have a harder time doing that without breaking the federal cap," he said.
Medicaid advocates in New Hampshire are worried because their state has few alternatives to make up for a loss in federal funding. New Hampshire lacks an income or sales tax.
"There is a tremendous amount of fear among families here as Republicans try to dismantle the ACA," said Martha-Jean Madison, co-director of New Hampshire Family Voices.
WASHINGTON — For the first time, research shows that a pricey new medication called Repatha not only dramatically lowers LDL cholesterol, the "bad cholesterol," it also reduces patients' risk of dying or being hospitalized.
Repatha, a man-made antibody also known as evolocumab, cut the combined risk of heart attack, stroke and cardiovascular-related death in patients with heart disease by 20 percent, a finding that could lead more people to take the drug, according to a study presented Friday at a meeting of the American College of Cardiology.
Some doctors hailed the results as major progress against heart disease. In an editorial in The New England Journal of Medicine, Dr. Robin Dullaart, a researcher at the University of Groningen in the Netherlands, called it a landmark study.
Others said they expected more from the $14,000-a-year drug. It was approved in 2015 without evidence that it prevents heart attacks, simply because its cholesterol reductions were so dramatic and promising.
Doctors often recommend that people keep their LDL levels under 100 milligrams per deciliter, and that people at very high risk reduce their LDL under 70.
In the new study, patients with heart disease who combined Repatha with a statin, the most commonly used cholesterol medication, decreased their LDL from 92 milligrams per deciliter to 30. Doctors have rarely seen cholesterol levels that low. Many doctors wondered if such low levels would be dangerous, causing memory problems or dementia due to a lack of cholesterol, said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, who was not involved in the new research but has led clinical trials of PCSK9 inhibitors in the past.
Insurers have been reluctant to cover Repatha because of its price and uncertain benefits.
Insurance plans initially reject about 75% of all requests for Repatha, although they eventually approve half, said Dr. Joshua Ofman, senior vice president of global value and access at Amgen, the drug's manufacturer. Doctors make an average of five requests before getting the medication approved.
In an unusual move aimed at increasing coverage, Amgen on Friday offered a special deal to insurance companies: If they loosen restrictions on coverage, Amgen will refund the medication cost should patients have a heart attack or stroke while taking it.
Although about 5% of patients in the clinical trial had a heart attack or stroke, rates of those problems could be two to three times higher in the real world, where patients are often older and sicker than those in clinical trials, Ofman said.
The refunds would go to insurance companies, not patients, Ofman said. He said insurance companies would have to decide for themselves if they want to refund patients' out-of-pocket expenses.
The offer isn't completely unprecedented. Geisinger Health System offers refunds to members who are dissatisfied with their care.
Some health care experts weren't impressed by Amgen's offer.
The offer is "a fig leaf covering a massive price," said Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York.
Insurance companies would lose money on the offer, Bach predicted, because they would have to pay to treat dozens of patients to prevent one heart attack or stroke.
The new study, which followed 27,000 patients for two years, found no safety risks.
While doctors said they were relieved that Repatha is safe, doctors such as David Rind said they had hoped the study would show that the injectable medication reduces heart attacks and other serious complications by 30 percent or more, given its success in early studies.
"This [result] is probably a little less than we had been hoping for," said Rind, chief medical officer at the Boston-based Institute for Clinical and Economic Review, which evaluates drugs' cost effectiveness. Rind also was not involved in the study.
The study's author, Dr. Marc Sabatine, said the "compelling reductions" in heart attacks, strokes and death suggest doctors should treat cholesterol much more aggressively, aiming to lower LDL levels as much as possible. His study focused on patients with underlying heart disease, most of whom had already had a heart attack.
The standard treatment for cholesterol, other than diet and exercise, is a generic statin, which costs $250 a year. Statins can cut LDL levels by up to half and reduce heart attack risk by 25 percent, Nissen said.
Some doctors are less impressed with the new study, which was funded by Amgen.
In the study, also published in The New England Journal of Medicine, 5.9 percent of patients who combined Repatha with a statin had a heart attack, stroke or died, compared with 7.4 percent of patients who took a statin plus a placebo.
"It's a small reduction for a super expensive drug," said Dr. John Mandrola, a cardiologist at Baptist Health in Louisville, Ky., and chief cardiology correspondent for Medscape, who wasn't involved in the study.
Yet Repatha's high cost could burden the U.S. health system, said Dr. Steve Miller, senior vice president and chief medical officer at Express Scripts, a pharmacy benefit manager. A similar drug to Repatha, called Praluent, costs about as much. Doctors don't know whether Praluent would also prevent heart attacks, Rind said.
Repatha and Praluent, which belong to a class called PCSK9 inhibitors, are especially expensive because they would be taken for such a long time. Unlike an antibiotic, which patients take for a few days or weeks, those prescribed Repatha would take it for the rest of their lives.
Given its price, doctors aren't likely to give Repatha to everyone with high cholesterol, said cardiologist Cam Patterson, chief operating officer at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, who wasn't involved in the study.
About 11 million Americans could be eligible for Repatha, according to Amgen. Repatha was approved for people with an inherited condition that causes high LDL levels or who have underlying heart disease but haven't been able to adequately lower their LDL with statins alone. About 70 million Americans have high cholesterol and 25 million take statins, Nissen said.
Repatha could be an important drug for some high-risk patients, in spite of the cost, he said.
"It would be hard for me to look a patient in the eye, if they've had a couple of heart attacks and is scared to death, and say it's not worth you taking this medication," Nissen said.
KHN's coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
Requiring a "community health needs assessment" was part of a package of rules included in the ACA to ensure that nonprofit hospitals justify the tax exemption they receive.
For the past six years, Mardi Chadwick has run a violence prevention program at Boston's Brigham and Women's Hospital. The program's goal is to address broader, community-based health issues and social problems that make people ill or prone to repeated injury from gunshots, stabbings or environmental causes.
In Chadwick's view, this endeavor — almost from its inception — made a big difference in nearby neighborhoods. But its profile in the eyes of hospital administrators got a boost from an Affordable Care Act provision that required nonprofit hospitals to conduct triennial assessments of local health needs and devise strategies, updated yearly, to address them. Falling short would trigger a financial penalty.
"Everyone, all of a sudden, cares about the social determinants of health," she said. "Our expertise is being brought in. … We have a bigger seat at the table."
But will programs like this one continue to get such attention? As the GOP-controlled Congress works to scrap Obamacare, the answer is uncertain.
Requiring this "community health needs assessment" was part of a broader package of rules included in the health law to ensure that nonprofit hospitals justify the tax exemption they receive. Another directive was that these facilities establish public, written policies about financial assistance available for medically necessary and emergency care and that they comply with limits on what patients who qualify for the aid can be charged.
These requirements add to the ongoing controversy about whether all nonprofit hospitals do enough to deserve a tax break. People on one side of the issue view the assessment rule, for instance, as an undue, unfunded burden while others say it doesn't do enough. So far, though, the community health assessment requirement hasn't exactly been a hot topic in the repeal-and-replace debate and was not addressed by the House Republicans' health plan unveiled March 6.
Sen. Chuck Grassley (R-Iowa), who has long urged that more scrutiny be applied to nonprofit hospitals' tax status, championed the provision. His spokeswoman said he will continue to advocate that it remains in effect in whatever new health policy plans emerge. Regardless, the financial uncertainty of any overhaul of the health law could undermine some hospitals' efforts.
The decades-old nonprofit tax status, granted by the Internal Revenue Service to institutions that meet the "community benefit" standard, spares hospitals from paying federal taxes and is collectively worth billions of dollars. Nonprofit hospitals have generally cited the uncompensated or "charity" care they provide, as well as initiatives they undertake to promote public health, as sufficient proof that they earn their tax exemption. But for-profit hospitals, which do pay taxes, cry foul, saying they make similar contributions.
The new requirements overall were meant to hold nonprofits to a higher standard — and penalize those that didn't deliver. Under the law, hospitals that fail to complete the assessment and implementation strategy face a $50,000 fine — which can seem small next to their overall operating budgets. But down the line, the penalties can accumulate and ultimately could jeopardize their valuable tax exemption.
Meanwhile, federal data show that as recently as 2011 nonprofit hospitals targeted less than 10 percent of their operating expenses to benefit the community — this includes charity care, unreimbursed costs from Medicaid and other government programs and medical research and education. Less than 1 percent went to community health improvement services like Chadwick's.
Advocates hoped the health law would change this. The idea was to push nonprofit hospitals to invest more in public health initiatives that do not directly earn them money — giving such programs more value on the balance sheet. But it's hard to gauge whether that's happened.
"You can find hospitals that have done this. But … are we seeing a real shift in the hospital community? Or are these a few hospitals that are outliers?" said Gary Young, director of the Center for Health Policy and Healthcare Research at Northeastern University. "We've asked them to make a sea change in how they're doing things. And that can't happen overnight."
Part of the problem, analysts say, is that the underlying idea — reaching into the community to help people navigate the social and economic factors that can influence health — goes beyond what hospitals have traditionally viewed as their mission. Despite the potential for long-term payoff, administrators tend to focus on the immediate questions: How many beds are full? What medical services are being provided? How are they doing with their operating budget?
"It's a new world out there in terms of the hospital not being the center of the universe," said Lawrence Massa, president of the Minnesota Hospital Association, the state's hospital trade group, which has been tracking hospital response to the health assessment requirement.
Initially, they found the money nonprofit hospitals put toward "community needs" went up after the assessment requirement: from about $355 million in 2011 to $459 million in 2013, according to an analysis by the association. (The needs assessment requirement took effect in between, for the tax year starting after March 2012.) But the increase leveled off in 2014 — the most recent year for which data are available.
Massa's conclusion: Caring for the health of people before they come into the hospital is unfamiliar territory. Not everyone took naturally to it. "We saw some communities that embraced this, and did a nice job. … In other communities, there's been friction between public health and the acute setting — and lack of understanding."
With continued time and sustained emphasis, that could have changed, said Sara Rosenbaum, a professor of health law and policy at George Washington University.
But now? Even if the community benefit requirements remain intact, she and others fear this accountability effort could take a hit. Repeal of the health care law is likely to create fresh financial challenges for hospitals. For instance, although the House GOP's American Health Care Act would restore some of the uncompensated-care funding cuts hospitals absorbed under the ACA, the coverage changes proposed in Republicans' plan could mean tens of millions more uninsured people.
That scenario, policy experts and trade groups say, would increase the amount of free care nonprofit hospitals provide, creating new budget pressures that could lead them to tamp down on efforts to promote community health work.
"We could be right back in a situation where there is a fair amount of charity care, and that could become a large component of how hospitals are justifying their nonprofit status," said Ken Fawcett, a physician who runs a community health worker initiative at Spectrum Health in Grand Rapids, Mich.
Meanwhile, the health assessment's impact has been evident at Boston-based Massachusetts General Hospital. There, administrators used it to devise an intervention strategy around drug abuse — partnering, for instance, with local schools and community organizations, and hiring former addicts to help patients navigate recovery.
"There's no question the Affordable Care Act required us to bump up our game," said Joan Quinlan, its vice president for community health. If people lose coverage, she added, hospitals will increasingly argue that's enough reason for a tax break. It could stifle efforts to promote more substantial community benefit.
"If the ranks of the uninsured or underinsured grow, then charity care will increase. And the ability to do some of these more creative downstream efforts will be hampered," she said. "There might be heightened awareness. But if there aren't resources to address them, it's going to be hard."
Scott Gottlieb's career has included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.
President Donald Trump's pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor and board member. Scott Gottlieb, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.
"It seems like the main question is, 'Which Gottlieb are we going to get?'" said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.
Here's a look at Gottlieb's career, by the numbers:
188 Companies
New Enterprise Associates, the venture capital firm where Gottlieb is a partner, is currently or has been invested in 188 health care companies.
8 Boards Of Directors
Gottlieb serves or served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.
8 Drug And Device Companies
Eight pharmaceutical companies disclosed payments to Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco and London.
9 Recusals
In a memo, Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA's deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche and Sanofi-Aventis.
The recusals generated some headlines during the avian flu scare because Gottlieb had to recuse himself from some of the planning efforts around vaccines.
7 Years
Starting in 1997, Gottlieb spent seven years as a staff writer for BMJ, the British Medical Journal. BMJ is one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.
Gottlieb also spent the past seven years as an adviser to drugmaker GlaxoSmithKline's product investment board, according to his LinkedIn page.
33 Years Old
Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier, but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.
"He has done a lot of thinking about how FDA should be managed — his operational sophistication is going to be a great asset," said former FDA attorney Coleen Klasmeier, who worked with Gottlieb and co-authored articles with him. "He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives."
18 Times Before Congress
Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.
"Most people watching at the FDA would breathe a sigh of relief," Dr. Joshua Sharfstein, who served as the FDA's principal deputy commissioner until 2011, said of Gottlieb's impending nomination. He added that Gottlieb is "not someone who has expressed antagonism to the core principles of the agency."
36,000 Twitter Followers
More than 36,000 people follow Gottlieb on Twitter, though he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.
72 Percent
Almost three-fourths of the 53 drug companies surveyed by Mizuho said they'd prefer Gottlieb to head the FDA.
$414,000
Pharmaceutical companies paid Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel and meals.
That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco. Only one other doctor received more money toward promoting the drug.
The drug's price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.
Nearly $30,000
Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.
Gottlieb contributed the most money toward Republican Sen. Ben Sasse of Nebraska, spending $2,600 in the primary and $2,600 again in the general election in 2013. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was "dividing" the nation, in his view.
"But have you noticed how Mr. Trump uses the word 'Reign' — like he thinks he's running for King?" Sasse asked in the post.
Programs to circumvent litigation by offering prompt disclosure, apology and compensation for mistakes as an alternative to malpractice suits are becoming more popular.
When Donna Helen Crisp, a 59-year-old nursing professor, entered a North Carolina teaching hospital for a routine hysterectomy in 2007, she expected to come home the next day.
Instead, Crisp spent weeks in a coma and underwent five surgeries to correct a near-fatal cascade of medical errors that left her with permanent injuries. Desperate for an explanation, Crisp, who is also a lawyer, said she repeatedly encountered a white wall of silence: The hospital and her surgeon refused to say little more than "things didn't go well." Crisp spent years piecing together what happened. "I decided I was going to find out even if it takes the rest of my life," she said.
Jack Gentry said he "went into the hospital a patient and came out a victim." In 2013, the retired Baltimore police officer suffered a catastrophic spinal cord injury during disk replacement surgery at MedStar Union Memorial Hospital that left him a quadriplegic.
But unlike Crisp, Gentry and his wife, a nurse, were immediately told what had gone wrong by his surgeon, who apologized for the error. The hospital covered Gentry's rehabilitation and other major expenses and paid an undisclosed amount in compensation, all without litigation.
"When hospitals mess up, they need to do the right thing," Gentry said. "MedStar did."
For patients and their families killed or maimed by medical errors, Crisp's experience — in which doctors clam up and hospitals deny wrongdoing and aggressively defend their care — remains standard operating procedure in most institutions.
But spurred by concerns about the "deny and defend" model — including its cost, lack of transparency and the perpetuation of errors — programs to circumvent litigation by offering prompt disclosure, apology and compensation for mistakes as an alternative to malpractice suits are becoming more popular. Researchers at Johns Hopkins University in Baltimore recently estimated that medical mistakes kill 251,000 Americans annually, which would make them the third-leading cause of death. Traditionally, the only way for patients to find out what went wrong has been to sue.
A blueprint for the approach used in Gentry's case is being promoted by the federal Agency for Healthcare Research and Quality. Called CANDOR, an acronym for Communication and Optimal Resolution, the approach is modeled on a long-standing program pioneered at the University of Michigan. It was tested in 14 hospitals around the country, including MedStar's Washington Hospital Center and Georgetown University Hospital.
Although they differ, these programs — which typically feature prompt investigation of errors whose findings are shared with the victims, as well as an apology and compensation for injuries — are operating at the University of Illinois at Chicago, Stanford and eight hospitals and outpatient groups in Massachusetts. Despite fears that the new approach would encourage lawsuits, the opposite has proved true. In Michigan, the number of lawsuits was cut nearly in half, and the hospital system saved about $2 million in litigation costs in the first year after the new model was adopted in 2001.
"The whole point of this isn't to drop malpractice costs, it's to drive patient safety," said Richard Boothman, the University of Michigan Health System's executive director of clinical safety and chief risk officer, who launched the program after a career defending doctors and hospitals. "We need to hard-wire as quickly as possible the lessons of these cases."
In most hospitals, Boothman said, patient safety experts do not routinely talk to risk managers who handle malpractice claims. As a result, valuable information about preventing errors is lost.
In The Dark
Most patients never learn they are victims of a medical error. A landmark 1991 Harvard study found that only 2 percent of people harmed by errors file a lawsuit. Those who do face daunting odds: Patients lose 80 percent of malpractice cases. Huge litigation costs, combined with laws that have reduced damage awards in many states, have left many unable to find an attorneybecause plaintiffs' lawyers are paid on contingency. Malpractice cases typically take three or more years to resolve. In the interim, many injured people struggle to pay for care.
Litigation "is a tortuous process for patients and health care workers," said Beth Daley Ullem, who spent five years seeking answers about the 2003 death of her newborn son from a Chicago hospital that denied any wrongdoing.
"We later learned that this had happened to a family before us and another seven months after," said Daley Ullem, a former McKinsey & Co. consultant whose ruptured uterus went untreated for an hour. She said she received a $4 million settlement before trial, which she offered to give back to the hospital to fund safety improvements. The hospital refused.
Disclosure efforts also face stiff resistance from doctors, insurers and lawyers, including defense attorneys for whom speedier resolution means fewer billable hours.
Despite laws in most states that prevent apologies from being used against doctors in lawsuits, many worry that it will make patients more likely to file suit, said Thomas Gallagher, a University of Washington professor of medicine who has written extensively about disclosure. A recent study found that 77 percent of 300 primary-care doctors would not fully disclose a delayed breast cancer diagnosis to a patient.
Doug Wojcieszak — who founded an Illinois-based disclosure advocacy group called "Sorry Works!" — said one Iowa doctor told him that if he started apologizing when things went wrong, "he'd be doing nothing else all day long."
Insurers are also leery, said Brian Atchinson, president of Physician Insurers Association of America, the trade association for liability insurers, which was involved in the development of CANDOR. "Some states are more conducive to this than others," he said. "But there are those who don't believe the benefits outweigh the risks."
Lawyer Joanne Doroshow, director of the Center for Justice & Democracy at New York Law School, expressed worry that disclosure programs may take advantage of vulnerable patients who are not represented by a lawyer. "The hospitals are in control of it, and it's still in their interest to try and limit compensation to patients," she said.
Jeffrey Catalano, a Massachusetts plaintiffs' lawyer who is president of the state bar and a participant in that state's disclosure program, says that patients should be represented early in the process. "I think if there's a good attorney present, there's no way a client is going to be shortchanged," he said. "Good attorneys know this: Medical malpractice cases are hard to take to trial. If a client can get $1 now rather than risking getting nothing [at trial] for the prospect of $1.50 later, it may be better to take the $1 now."
Doing The Right Thing
The country's first disclosure program began 30 years ago with a doctor's desire to do the right thing.
Pulmonologist Steve Kraman, newly named as chief of staff for what is now the Lexington Veterans Affairs Medical Center in Kentucky, said he faced a problem in 1987: how to handle the death of a middle-aged woman caused by an "undeniable error," a massive overdose of potassium.
"If we had said nothing, [the family] never would have known a thing," said Kraman, who was also the hospital's risk manager. "We never would have gotten sued. But I just didn't feel that was right." So he suggested to the hospital's lawyer that they come clean to the patient's two adult daughters, from whom she was estranged.
"I sat down and told them exactly what happened, that we were responsible for it, that they should hire a lawyer and we were going to negotiate a payment," he recalled. Two months later, the family was paid $250,000.
From then on, Kraman said, all cases involving errors were handled similarly. "We paid out for things that nobody could have sued for in their wildest dreams," said Kraman, who is now a professor at the University of Kentucky. Some patients declined the cash, he said, because they feared it would "ruin their relationship with the doctor." Kraman said he refused to pay a dime in cases where no injury could be proved. "That just alienates doctors and nurses who feel like you're throwing them under the bus."
Kraman said he had several advantages: Doctors were employed and insured by the VA system. Payments, which averaged $16,000, were made from the U.S. Treasury, not the hospital coffers. And the program had the support of the hospital's director and lawyer as well as the U.S. attorney for Kentucky.
"This has to be done from the top down" or it won't work, Kraman said. "The message has to be 'This is how we do business.'"
When Boothman arrived at the University of Michigan in 2001 — after two decades defending doctors, including an orthopedic surgeon who had been sued 21 times — he decided to try a similar approach. That included encouraging staff to report errors and bad outcomes; reports jumped from 2,400 a year to more than 34,000.
"You have to normalize honesty," Boothman said, "to create a culture of continuous improvement." Applying the lessons gleaned from those errors, he said, has helped make care safer.
"Litigating a case for three years and telling everybody, 'Don't talk about it and don't change anything,' is immoral and counterproductive," he added. "I don't serve my organization well by defending care we shouldn't be defending."
"Today we're often at the bedside as soon as things happen," he said. Patients and their families are interviewed as part of the hospital's investigation of the facts, something that does not happen in traditional litigation.
Like Kraman, Boothman said he worries that some hospitals are using disclosure to cherry-pick small or unwinnable cases, not as a standard approach.
A Test Case
Orthopedic surgeon P. Justin Tortolani remembers with sickening clarity the moment he realized that a device he was installing had gone too far, penetrating Jack Gentry's spine. The 60-year-old retired police officer, who once had hiked the entire Appalachian Trail, was instantly paralyzed from the neck down.
"You can't really believe it's happening," said Tortolani, Union Memorial's director of spine surgery. Summoning his years of training, the surgeon formulated a plan and steeled himself to tell Teresa Gentry what had happened. It was the first of many conversations about the accident that he would have with the family.
"We didn't want to go through litigation, we didn't need to go through litigation," said Larry Smith, MedStar's vice president for risk management. MedStar uses CANDOR in about a dozen cases with substantial damages annually.
MedStar executives "told me what had happened, why it happened, that it was directly or indirectly their fault and that whatever I needed I should ask for," Gentry recalled. MedStar paid for five months of inpatient rehab — Gentry's insurance would have covered only two weeks — modifications to the couple's home, a $45,000 wheelchair and a new wheelchair-accessible van. It provided a case manager, a home-care nurse and $15,000 for incidental medical expenses.
"Because of the nature of Jack's injury, we would have had to mortgage everything to pay for his care" otherwise, Teresa Gentry said.
Early on, Gentry said, his older brother, a Baltimore malpractice lawyer, expressed bafflement at MedStar's approach. "He said as long as we were getting what we needed, to just go with it," Gentry recalled.
At the end of two years, the case was settled with a confidential payment negotiated by lawyers for the couple, MedStar and the device manufacturer.
"I felt like it would take care of Jack for the rest of his life," said Teresa Gentry, adding that the couple had been prepared to file a lawsuit if an agreement could not be reached. "Did I get enough to pay for everybody's pain and suffering and trauma? No."
"I was very skeptical in the beginning of this whole process," she recalled, but she said she believes it has worked well, as does her husband.
Tortolani said he feels "remorse, guilt and sorrow for Jack and his family. This shakes you to your core," he said. MedStar officials have been "unbelievably supportive," Tortolani said, and he remains deeply grateful to the Gentrys. "My relationship with Jack has never been stronger."
Donna Helen Crisp says she thinks she would have been less traumatized had the North Carolina hospital and her surgeon not stonewalled her. "I would have been deeply depressed that I had such a bad experience, but I could have moved on with my life," said Crisp, who has written a book about her experience entitled "Anatomy of Medical Errors: the Patient in Room 2." Being denied the truth left her with "no way to put it into perspective."
The Congressional Budget Office is out with its estimate of what effects the Republican health bill, "The American Health Care Act," would have on the nation's health care system and how much it would cost the federal government. The GOP plan is designed to partially repeal and replace the Affordable Care Act passed during the Obama administration.
Here are some of the CBO highlights:
• $337 billion reduction in the deficit. That's CBO's estimate over the next decade, taking into account both decreased government spending in the form of less help to individuals to purchase insurance and lower payments to states for the Medicaid program. It also includes decreased revenue from the repeal of the taxes imposed by the ACA to pay for the new benefits.
• 24 million more people without insurance in a decade. The federal budget experts estimate that people will lose insurance and that the drop will kick in quickly. In 2018, they say 14 million more people would join the ranks of the uninsured. It would reach the 24 million by 2026, when "an estimated 52 million people would be uninsured, compared with 28 million who would lack insurance that year under current law."
• 15 to 20 percent increase in 2018 premiums, but relief would follow. Monthly costs for insurance would go up at first, due to the elimination of the requirement for most people to have insurance or else pay a tax penalty. After 2018, CBO estimates that average premiums would actually drop by 10 percent by 2026 compared to current law. That is because the lower prices for younger people would encourage more to sign up. By contrast, the law would "substantially [raise] premiums for older people."
• $880 billion drop in federal Medicaid spending over the decade. That comes primarily by imposing, for the first time, a cap on federal contributions to the program for those with low incomes.
• 14 million fewer Medicaid enrollees by 2026. That's 17 percent fewer than projected under current law. The projection includes people who are currently eligible and would lose coverage, as well as people who might have become eligible if more states, as expected, expanded coverage under the ACA. CBO projects that is unlikely to happen now.
• 95 percent of people who are getting Medicaid through the health law's expansion would lose that enhanced federal funding. The CBO estimates that only 5 percent of enrollees in the expansion program would remain eligible for the higher federal payments by 2024, since the bill would phase out those payments to states as patients cycle in and out of eligibility.
• 15 percent of Planned Parenthood clinic patients would "lose access to care." These patients generally live in areas without other sources of medical care for low-income people. The Republican bill would cut out Medicaid funding for Planned Parenthood for a year.