Three senior executives at scope maker Olympus Corp., which is under federal investigation for its role in superbug outbreaks, repeatedly invoked their Fifth Amendment right against self-incrimination when questioned recently about internal company emails.
The Tokyo executives declined to answer questions about the correspondence during two days of depositions Nov. 30 and Dec. 1 in a civil case against Olympus, according to lawyers representing a Seattle hospital and a patient's widow.
The company emails, first reported byKaiser Health News and the Los Angeles Times, are key evidence in several pending civil suits against Olympus and could be relevant to the ongoing federal probe.
They show that Susumu Nishina, one of the three executives deposed, told the company's U.S. managers in February 2013 not to issue a broad warning to American hospitals despite reports of scope-related infections in Dutch, French and U.S. hospitals.
At least 35 patients in American hospitals have died since 2013 after developing infections tied to tainted Olympus duodenoscopes — flexible, lighted tubes used to peer deep inside the body. More than 25 patients and families, including the Seattle-area widow, have sued Olympus for wrongful death, negligence or fraud.
Legal experts said it's not uncommon for corporate executives to exercise their constitutional right against self-incrimination in civil lawsuits when separate criminal charges are possible. While not indicative of guilt, that legal move does indicate concern about what prosecutors could do with any testimony, the experts said.
"There is a real danger you end up saying something an aggressive prosecutor would seize on," said Patrick Cotter, a former federal prosecutor and white-collar criminal defense attorney at law firm Greensfelder, Hemker & Gale in Chicago. He isn't involved in the Olympus cases.
In addition to Nishina, the company's chief manager for market quality administration at the Tokyo headquarters, the other two executives who were questioned were Hisao Yabe and Hiroki Moriyama, court records show. Yabe appears to be the highest ranking official among the three, serving as an executive officer in charge of the medical manufacturing improvement division, according to the company's website.
Moriyama is a key figure in the company's regulatory affairs and quality assurance unit. He's listed on several company patents for endoscopes. And he was the manufacturer's contact on numerous injury reports filed with U.S. regulators about scope-related infections.
Nishina fielded numerous emails containing questions from Olympus executives in the U.S. and helped shape their response to infections at American hospitals. Yabe and Moriyama were included on some of those emails, court documents show.
The three executives were recently deposed at the U.S. Embassy in Tokyo by lawyers representing Virginia Mason Medical Center in Seattle and Theresa Bigler. Her 57-year-old husband, Richard, died in 2013 after he was infected by a contaminated Olympus scope, according to the family's lawsuit in King County Superior Court in Washington. Bigler is suing Olympus for wrongful death and seeking damages.
The separate federal investigation into Olympus surfaced in March 2015, when the company said it received a subpoena from investigators that "seeks information relating to duodenoscopes that Olympus manufactures and sells."
In a Feb. 6, 2013 response to a question from a U.S. Olympus executive about whether American hospitals should be warned, Nishina replied it is "not need[ed] to communicate to all the users actively," because a company assessment of the risk to patients found it to be "acceptable."
A year later, in March 2016, Paul Fishman, the U.S. Attorney for the District of New Jersey, said the scope-related investigation was continuing. The focus of the probe was not specified, and a spokesman for the U.S. attorney's office declined to comment further for this story.
The emails could figure in both the civil case and federal investigation because they show that a month after Olympus alerted European customers in January 2013 that a scope it manufactured could become contaminated it decided not to broadly warn U.S. customers.
Nishina said, however, that a U.S. executive could respond to inquiries from a customer. Nishina, Yabe and Moriyama didn't respond to requests for comment sent through their lawyers.
Olympus said it doesn't comment on pending litigation. Previously, the company has said that patient safety is a top priority and it's working with the proper authorities to address any scope-related issues. The company recalled its duodenoscopes in January and did repairs over several months to reduce the risk of infection.
Duodenoscopes are threaded down a person's throat to diagnose and treat digestive tract problems such as gallstones, cancers and bile duct blockages. The tip of the snake-like device has proven difficult to clean even when following the manufacturer's instructions, and antibiotic-resistant bacteria known as superbugs can spread from one patient to another.
Although infections have been tied to scopes made by other companies, Olympus dominates the market and its scopes remain in wide use.
In California, Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center in Los Angeles, as well as Huntington Memorial Hospital in Pasadena, have reported infections linked to Olympus scopes.
In a court filing in the Washington state case, Olympus "denies it is liable to plaintiff in any manner" and said the alleged injuries to Richard Bigler "may have been the result of unforeseeable circumstances and reasons beyond the control" of the company.
Olympus said the hospital involved, Virginia Mason Medical Center, failed to follow the instructions for cleaning the scopes.
At Virginia Mason, 39 people became infected from contaminated Olympus scopes and 18 of them died. The hospital said the patients who died had other underlying illnesses.
Rando Wick, an attorney representing the hospital, said it was disappointing that Olympus executives refused to answer questions, but he said it lends support for Virginia Mason's case.
"Olympus in Japan knew of the dangers of the duodenoscopes not being able to be adequately disinfected even when Olympus guidelines are followed," Wick said. "Yet they failed to notify health-care providers in the U.S. of this problem."
John Gagliardi, a Seattle attorney representing the Bigler family, agreed it was a significant development. "You only take the Fifth if you think you could be in real trouble," he said.
Next month, the attorneys said they are scheduled to depose Olympus executives in the U.S. They include Laura Storms, vice president of regulatory and clinical affairs at the company's U.S. headquarters in Center Valley, Pa., and Donny Shapiro, a director of regulatory affairs in San Jose, Calif.
After receiving the reply from Nishina, Storms wrote to Shapiro: "Donny, [Olympus Japan] has determined that a global communication is not required."
Republicans in Congress are so eager to repeal the federal health law that some have vowed to get a bill to President-elect Donald Trump's desk on the day he takes the oath of office.
"We will move right after the first of the year on an Obamacare repeal resolution," Senate Majority Leader Mitch McConnell, R-Ky., told reporters at a news conference Monday.
But could lawmakers introduce, pass and get a repeal measure to the new president in the 17 days between Jan. 3, when they convene, and Inauguration Day, Jan. 20?
Not likely, say budget experts.
"No way. I just don't think it's possible," said G. William Hoagland, senior vice president at the Bipartisan Policy Center, a Washington-based think tank, and a 20-year Republican staff veteran of the Senate Budget Committee.
Others think it could be done, but probably won't be. "Mechanically they can get it done," said Ed Lorenzen, senior adviser to the nonpartisan Committee for a Responsible Federal Budget. "The bigger question is can they decide what should be in the package."
Republicans and the incoming Trump administration have been careful not to talk about exactly what they plan to do to the Affordable Care Act beyond repealing virtually all of its coverage expansions and the taxes that help fund them. But they seem to be coalescing around a strategy of "repeal and delay," in which they would pass a bill to kill many of the major provisions of law by a certain date, then set to work on crafting and passing a replacement before that date arrives.
It would be quicker for Congress to simply repeal the health law outright. But Republicans can't do that, because they would need 60 votes in the Senate to fend off Democrats' delaying tactics, and they will only have 52 GOP members. So instead they will be limited to using a special budget strategy that will let them pass their bill with 51 votes.
That so-called "budget reconciliation" measure does not let lawmakers repeal the entire law — only the parts that directly impact federal spending. That has been widely discussed. There has been less focus on how long the process takes.
No one in Congress can simply introduce a budget reconciliation bill. The word "reconciliation" refers to the process by which congressional committees that control permanent spending programs such as Medicare and Medicaid, as well as tax policy, take action to "reconcile" that spending with the terms of the annual budget resolution.
That means the first action must be to pass a budget resolution, which Congress failed to do last year. That is the "resolution" McConnell was referring to.
The budget resolution, which is essentially a planning document for spending and taxes for the coming fiscal year, does not go to the president for a signature. But, like a regular bill, it does have to be passed by both the House and Senate in the same form. And while the budget resolution also may not be filibustered in the Senate, lawmakers have up to 50 hours to debate it, and unlimited time to vote on proposed amendments, which in practice can take up to another full day.
Once that measure is agreed to by the full House and Senate, the action moves back to congressional committees. The budget resolution often includes "reconciliation instructions" to committees. Those instructions order proposed legislative changes to the programs the committees oversee to meet the terms of the budget. That triggers the reconciliation bill that goes to the president.
In the normal course of events, those changes take from several weeks to several months to accomplish. Legislative changes need to be written, voted on by the committee and reported back to the House or Senate budget committees, which then forward them to the House or Senate floor for votes. Again, Senate debate is limited to 20 hours with unlimited additional voting on amendments. House and Senate negotiators then hammer out a compromise, pass it again in the full House and Senate and then send it to the president.
The last budget reconciliation bill, considered a dry-run by Republicans for the coming year, was launched by the budget resolution at the end of April 2015. The resulting reconciliation bill was sent to President Barack Obama (who vetoed it) on Jan. 26, 2016.
Clearly, if Republicans were to simply recycle their 2015 bill, the process could be dramatically shortened. That bill called for repeal of funding for the Medicaid expansion, as well as for jettisoning premium and other subsidies that help individuals afford private coverage, along with the taxes to pay for those benefits, as of Dec. 31, 2017.
Budget expert Stan Collender, executive vice president of the communications firm Qorvis MSLGROUP, a Washington communications and consulting firm, said predictions of getting the reconciliation bill to the president by Inauguration Day are ambitious. "It would be unprecedented to do it that quickly," said Collender, who has worked for the both the House and Senate budget committees. "But just because it hasn't worked that expeditiously before, doesn't mean they can't do it."
While Jan. 20 might not be feasible, "I think they could do it by the end of January," said Lorenzen. He noted that while some Republicans in the Senate have been expressing doubts about repealing the law without having a replacement in hand and others in the House object to leaving current policies in place for as long as three years, "no one want to be the skunk that stops repeal."
But others think that even with a model bill in hand, the process will be harder — and take longer — than many Republicans are saying.
With last year's bill, "that repeal legislation, they knew they weren't shooting with real bullets," said Hoagland of the Bipartisan Policy Center. "They knew it was going to be vetoed."
Already health analysts and health provider groups are warning that repealing major pieces of the law without immediately replacing them could cause a virtual collapse of the individual insurance market that currently covers around 20 million people.
That could — and should — slow things down, said Chris Jennings, a health consultant who worked in both the Bill Clinton and Obama White Houses.
"Few people have ever been wrong projecting that Congress takes a little bit longer" than some predictions, he said. "I think this health debate is of such consequence that will likely be the case for this as well."
Prospective Health and Human Services Secretary Tom Price, currently the chairman of the House Budget Committee, brings a distinctive to-do list to the agency. And, if confirmed by the Senate, he will have tremendous independent power to get things done.
While he will report to the president, heads of major agencies like HHS — with a budget of more than $1 trillion for the current fiscal year — can interpret laws in different ways than their predecessors, and rewrite regulations and guidance, which is how many important policies are actually carried out.
"Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run," said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.
Price, a Georgia physician who opposes the Affordable Care Act, abortion and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress.
Some advocates are excited by that possibility. "With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change," said Robert Moffit, a senior fellow at the conservative Heritage Foundation, in a statement.
Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said: "I don't know if I want to brainstorm bad ideas for him to do."
Here are five actions the new HHS secretary might take, according to advocates on both sides, that would disrupt health policies currently in force:
As secretary, Price would have two main options. He could expand the "accommodation" that already exempts some houses of worship from the requirement to any employer with a religious objection. Or, because the specific inclusion of birth control came via a regulation rather than the law itself, he could simply eliminate no-copay birth control coverage from the benefits insurance plans must offer. (This assumes continuing existence of the health law, at least for the short term.)
Medicare payment changes: The health law created an agency within Medicare, called the Center for Medicare and Medicaid Innovation, that was tasked with exploring new ways to pay doctors and hospitals that would reduce costs while maintaining quality. The HHS secretary has the authority to doctors and hospitals to participate in the experiments and new payment models. Some have proved unpopular with physician and hospital groups, in particular the idea of paying providers so-called bundled payments for packages of care, rather than allowing them to bill item-by-item; one such package covers hip and knee replacements, from the time of surgery through post-surgical rehabilitation. Price, as a former orthopedic surgeon himself, would likely act to scale back, delay or cancel that project, since he "has been a critic in the past," said Dan Mendelson, CEO of Avalere Health, a Washington-based consulting firm.
Planned Parenthood funding: Republicans have been agitating to separate Planned Parenthood from its federal funding literally for decades. Congress would have to change Medicaid law to permanently defund the women's health group, which also performs abortions (with non-federal funds) at many of its sites. But an HHS secretary has many tools at his disposal to make life miserable for the organization.
For example, during the Reagan and George H.W. Bush administrations, rules were put in place, and eventually upheld by the Supreme Court, that would have banned staff in federally funded family planning clinics from counseling or referring for abortion women with unintended pregnancies. The subsequent Clinton administration repealed the rules, but they could make a comeback under the new secretary's leadership.
Price could also throw the weight of the department into the current investigations into Planned Parenthood's ties to firms allegedly selling fetal tissue for profit.
Tobacco regulation: After years of discord, Congress finally agreed to give the Food and Drug Administration (limited) authority to regulate tobacco products in 2009. "The core authority is statutory," said Matt Myers of the Campaign for Tobacco-Free Kids, who advocated for the law. That means Congress would have to act to eliminate many of its changes. But a secretary who opposes the law (Price voted against it at the time) could weaken enforcement, says Myers. Or he could rewrite and water down some rules, including recent ones affecting cigars and e-cigarettes.
"The secretary has very broad discretionary authority not to vigorously enforce or implement the statute in an aggressive manner," Myers said.
Conscience protections: At the very end of the George W. Bush administration, HHS issued rules intended to clarify that health care professionals did not have to participate in performing abortions, sterilizations or other procedures that violated a "religious belief or moral conviction."
Opponents of the rules complained, however, that they were so vague and sweeping that they could apply not just to opponents of abortion, but also to those who don't want to provide birth control to unmarried women, or HIV treatment to homosexuals.
The Obama administration revised the rules dramatically, much to the continuing consternation of conservatives. They are among the few health-related items included on the president-elect's website, which says "The Administration will act to protect individual conscience in health care." Many expect the rules to be reinstituted in their original form.
Tom Price has tried to block efforts by Medicare to scale back payments for expensive chemotherapy and to limit large payments for hip and knee replacements. There isn't consensus in the medical community about his appointment.
In picking Tom Price to be secretary of Health and Human Services, Donald Trump has chosen an orthopedic surgeon who in his congressional career, has loyally promoted the interests of the medical profession —its freedom and importantly, its financial interests.
A conservative representing Georgia's 6th District, Price sponsored a 2015 bill that would restrict efforts to reduce doctor payments for medical services. He cosponsored another 2011 bill that would have limited reports used by hospitals and regulators to perform background checks used to screen doctors before hiring them.
A fierce critic of Obamacare, Price has tried to block efforts by Medicare to scale back payments for expensive chemotherapy and to limit large payments for hip and knee replacements. He also has taken the lead in trying to impose federal controls on medical malpractice suits.
Most of Price's proposals stalled in Congress, but he now stands a better chance of implementing his ideas with a powerful cabinet position and a Republican-controlled White House and Congress.
"Instead of having a secretary for the people, you have a secretary for the medical profession," said Max Mehlman, a law professor at Case Western University, who specializes in medical malpractice and reviewed Price's proposal.
The American Medical Association, the doctors' professional group whose members are among Price's top campaign supporters, says he brings a unique perspective to the job of HHS secretary, a role traditionally filled by foundation executives, career politicians, social scientists, lawyers and public health experts.
The most recent physician to hold the position was Dr. Louis Sullivan who served under George H.W. Bush and was the founding president of Morehouse School of Medicine, as well as an expert on health care in minority populations.
"As a lawmaker, Dr. Price has had the valuable ability to see how legislation and regulation would affect patients and their physicians," Dr. Patrice Harris, chair of the AMA board of trustees, said in a statement to Kaiser Health News.
Price, who founded a large orthopedic practice in suburban Atlanta, did not respond to interview requests. He came to Congress with strong backing from medical interests, including the AMA and trade groups representing orthopedic doctors, dentists and anesthesiologists, according to campaign finance data compiled by the nonprofit, nonpartisan Center for Responsive Politics.
But there isn't consensus in the medical community about his appointment. Within days, more than 4,800 physicians from a wide array of backgrounds signed a petition protesting his appointment.
"Dr. Price's proposed policies threaten to harm our most vulnerable patients and limit their access to health care," wrote the group, citing his stance on Medicaid. "Dr. Price purports to care about efficiency, while opposing innovations by the Centers for Medicare & Medicaid to improve value and eliminate waste in health care."
Price describes himself as the "go-to Republican on quality health care policy," according to his website. He mobilized GOP opposition to the Affordable Care Act and proposed alternate plans, the most recent in May 2015, called the Empowering Patients First Act.
In a recent interview with Radio America, Price said increases in insurance premiums and deductibles show the failures of Obamacare.
"We opposed the plan because it doesn't work for people, it doesn't work for patients," Price said.
Price's alternative includes health care saving accounts to help individuals pay for health insurance, a concept now embraced by the Trump team.
But the bill also includes fine print calling for "lawsuit abuse reforms" that would allow the HHS secretary to give states money to create tribunals to review malpractice claims. The process would make it more difficult for patients to prove medical error, setting the standard at "gross negligence."
Chip Wagar, a New Orleans malpractice lawyer who advises a patient advocacy group, said Price's proposal, if implemented, would mean that "checks and balances that have been in place, which are already friendly to the medical profession, would be even further tilted away from patient and victims' rights."
The AMA did not support Price's 2015 bill, although it has supported specialized health courts.
In 2011, Price cosponsored a bill that would limit reports to the National Practitioner Data Bank, a confidential repository of information, such as malpractice judgments and hospital discipline, about doctors and other health professionals. The information is used by health licensing boards and hospitals making hiring decisions.
The bill, which died in committee with 15 GOP co-sponsors, would have allowed physicians to contest reports to the data bank by hospitals that deny doctors' access to their facilities due to questionable performance.
Dr. Michael Carome, director of Public Citizen's Health Research Group, a consumer advocacy group, said the proposal would have made it more difficult for hospitals to adequately oversee physicians.
"Dr. Price is a physician who is just obviously responding to pressure from colleagues in the medical field who'd like to be exempt from being held accountable," said Carome, who also reviewed Price's malpractice proposal.
Price has also criticized some Obama administration efforts to cut health costs, citing too much government interference. His Obamacare replacement bill would bar states from limiting doctors' charges for medical services.
Price opposed a Medicare proposal intended to rein in spending for medications doctors administer to patients, such as intravenous chemotherapy drugs. Medicare officials have said spending on such drugs went from $3 billion in 2007 to $8 billion in 2015.
The change, which has not been approved, would have eliminated incentives for doctors and hospitals that earn higher payments by prescribing more expensive drugs.
Price cosponsored a bill in March to block final implementation of the proposal, saying it would harm vulnerable patients by limiting their access to care.
Price had the first signature on a letter backed by more than 200 Congress members, saying the proposal would force some doctors — particularly those in small practices — to lose money. "The impact on patients will be sweeping and affect seniors across the country," the letter says.
The nonpartisan Congressional Budget Office estimated that Price's proposal to ax drug pricing limits would cost taxpayers $395 million from 2016 to 2026.
Price sought to delay implementation of another plan to pay doctors a flat rate for joint replacement surgery, eliminating situations where Medicare covers the added costs of patient infections or prolonged physical therapy.
Tom Miller, a resident fellow with the American Enterprise Institute, a conservative think tank, said Price's opposition to cost-cutting proposals arises from a free market philosophy that less government intervention is better.
"Many of those objections are to how the cost cutting are being done — a brute-force, top-down bureaucratic approach," he said. "His opposition is to government control of more aspects of health care — that's the driving force. It's a shared point of view if you're a Republican conservative doctor."
Even some critics of Price's proposals are hopeful his experience will prompt him to tackle cost-cutting and improve patient-care quality as HHS secretary.
"He has been a loyal Republican and a champion of conservative causes that I don't support," said William Sage, a University of Texas at Austin law professor who has studied medical malpractice and health care costs. "Far more important is that as someone with deep inside knowledge of health care he understands how overpriced health care delivery is and how disorganized and often ineffective it is."
Among Republican ideas to transform the health care system is a proposal to allow health insurers to sell their policies across state lines.
President-elect Donald Trump and Rep. Tom Price, the Georgia congressman picked by Trump to lead the Department of Health and Human Services, have backed the proposal. They and other advocates see it as a way to boost competition. The interstate sales idea is part of a general GOP blueprint to replace the 2010 Affordable Care Act, often called Obamacare.
In Georgia, the interstate sale of health insurance has already had a five-year tryout.
The state legislature in 2011 passed a bill letting insurers sell any policies in Georgia that they offer in other states. The legislation was hailed by supporters and business groups as a way to skirt the state's required benefit coverages — such as screenings for cervical, prostate and colorectal cancer, along with mammograms — and thus lower the sticker price of insurance.
The law is still in effect. But since it was passed, no health insurer has taken advantage of it.
And since January, an obscure provision of the ACA has been in effect, letting individual states agree among themselves to allow sales by one another's health insurance companies. Although several states have passed laws to move toward such a compact, none has made any deals to sell across state lines, insurance experts and regulators told The Hill in October.
Each state has its own set of health insurance regulations, though large employers that self-insure (those that use their own funds to cover employees' health expenses) are exempt from these state rules.
Currently, the idea of eliminating barriers to interstate sales is drawing some opposition from state insurance regulators and insurance industry officials, The Wall Street Journal reported last week. "That sounds like a silver bullet to solve a major problem, and there are no silver bullets," said Louisiana Insurance Commissioner Jim Donelon. "There are no simple answers."
Some Democrats have voiced concern about the erosion of state consumer protections.
Graham Thompson, executive director of the Georgia Association of Health Plans, an industry group, said Wednesday that the GOP proposals aimed at helping health insurers are "a positive change in tune'' after industry losses suffered under the Affordable Care Act.
A federal law allowing interstate sales across the country "could be different'' from the more limited Georgia experience, Thompson said. "We'll have to see the details."
He said that one obstacle to insurers selling out-of-state policies in Georgia is that "all health care is local — and all health care costs are local." So insurers would still have to strike contracts with local hospitals and other medical providers, Thompson noted.
Bill Custer, a health insurance expert at Georgia State University, said a handful of other states have passed interstate insurance laws similar to Georgia's, but the effect has been the same.
State insurance regulators told the Journal that in states requiring locally licensed insurers to offer extensive coverage, healthy people might abandon those companies to buy bare-bones policies from out of state. That, in turn, would leave local plans insuring mostly people with health problems, who need broader, more expensive coverage. As the locally registered insurance companies absorb the financial hit, the state might feel pressure to relax standards to give them a break.
But the proposals pushed by Price and House Speaker Paul Ryan (R-Wis.) would still require a minimum set of essential benefits at the federal level in order to qualify for tax credits, said Custer of Georgia State. So the effect of interstate insurance could be minimal, he said.
"It's unlikely to have a large effect on competition in any market,'' he said.
An industry trade group, America's Health Insurance Plans, said in a statement to Georgia Health News on Wednesday that "our first interest is in providing consumers with competition and choice, which empowers them to better health and financial stability. We want to work with lawmakers to bring our experience and lessons learned to the table, and we want to cooperate and collaborate to find solutions that work for consumers.''
Cindy Zeldin, executive director of consumer group Georgians for a Healthy Future, said interstate sales "would erode rights and protections for health care consumers, complicate their efforts to find in-network providers, and do little to nothing to improve affordability.''
More than 500,000 Georgians are at risk of losing their coverage if the ACA is repealed without an adequate replacement, she said. "Buying a health insurance plan from Texas or Idaho isn't going to solve the problem, and would leave consumers in Georgia with little recourse if they were treated unfairly by an insurance company based in another state or in cases of fraud."
Prompted by a state law that took effect this year, a coalition of emergency and social service providers is working to create an electronic registry that will be accessible to first responders and medical providers.
CONCORD, Calif. — Mary De Freze, who has heart problems, chronic lung disease and a history of falling, knows she may not have too many years left. And she's clear about what she wants — and doesn't want — at the end of her life.
"I don't want to be in a lot of pain and I don't want to be kept alive by machines," said De Freze, 81.
After a recent fall landed De Freze in Stonebrook Healthcare Center with cracked ribs and a bruised spleen, the staff there helped her put those wishes on paper.
The document they used, Physician Orders for Life-Sustaining Treatment, or POLST, gives patients a choice of how much medical care they want in an emergency.
Prompted by a state law that took effect this year, a coalition of emergency and social service providers is working to create an electronic registry for POLST forms so they will be available to first responders and medical providers when they are needed. The group is starting with a three-year pilot project in San Diego and Contra Costa counties that could serve as a model for a single, statewide registry. Paper-based POLST forms are used across the nation, but electronic registries exist only in a few states, including Oregon, New York and West Virginia.
Many adults have advance directives, which are legal documents that designate a surrogate decision-maker and list patients' health care preferences. POLST forms go further, creating a set of medical orders that are signed by the provider and the patient or a legally recognized decision-maker. Unlike advance directives, they are specifically designed for people who are already seriously ill or near the end of life.
Research shows that POLST forms help ensure patients' end-of-life wishes are followed. But that only happens if doctors and other emergency providers can get them quickly. In California, the POLST form is a paper document and might not be at hand when patients need it. In many situations — a heart attack, a stroke or severe dementia — patients may not be able to communicate. And doctors may not be able to reach their families right away.
Without information on what patients want, there is an increased chance their wishes won't be followed.
"If you take the time to fill out a POLST form, you want your health care wishes to be known and respected," said Kate O'Malley, a senior program officer at the California Health Care Foundation, which is funding the pilot project in California. (California Healthline is an editorially independent service of the California Health Care Foundation.)
A POLST registry "would be a big plus for being able to give people the care they want and not give them the care they don't want," said Jeffrey Klingman, a neurologist at Kaiser Permanente in the East Bay.
"I don't want to do things to people they don't want done," he said. "On the other hand, I don't want to delay treatment while I wait to figure out what they want done."
Oregon was the first state to use POLST forms in 1991. California has been using them for nearly 20 years. Filling out the forms is voluntary, but once they are completed and signed, they must be followed, and providers have immunity from criminal prosecution or civil liability when they do so in good faith. The forms are printed on bright pink paper and include decisions such as whether a patient should be resuscitated, admitted to the intensive care unit or have a feeding tube inserted.
Tony Chicotel, a staff attorney at California Advocates for Nursing Home Reform in San Francisco, said patients should document their wishes in advance but that there are some downsides to doing so only with POLST forms. They are not nearly as thorough as advance directives and don't allow you to designate a decision-maker, he noted. "The most comprehensive health care planning you can do is to name an agent."
In addition, Chicotel said many nursing home residents are being urged to complete POLST forms even if they aren't seriously ill or at the end of life. He said if an electronic registry is created, it should also include advance health care directives.
California's electronic registry would be a secure, cloud-based portal for medical providers to submit and view POLST forms, regardless of whether the patient was at home, in the hospital or at a nursing home.
An electronic registry is a "no-brainer," said Judy Thomas, CEO of the Coalition for Compassionate Care of California, which coordinates the state's POLST program. But implementation will be much harder because it will require the cooperation of state agencies, doctors, emergency personnel, and private and public health systems. Success will also depend in part on hospitals' willingness to share records.
"We are not asking all health systems to share all information," said Allen Namath, co-founder of Vynca, the technology vendor for the project. "But the value in these forms is being able to share them."
Patients who go through the trouble of documenting their medical preferences shouldn't have to worry about getting the wrong care, he said. "It is not a cardiology problem. It is not a cancer problem. Helping improve our end-of-life care … applies to everybody."
San Diego County already has a health information exchange that allows hospitals and health systems to share some data. But Contra Costa County is further behind.
"It's going to be challenging," said Donald Waters, executive director of the Alameda-Contra Costa Medical Association, which is helping lead the pilot project.
But Waters said it's worth the effort to overcome the hurdles because having documents uploaded means paramedics and others will know in an instant if patients want to be resuscitated or just kept comfortable.
Situations arise every day in which being able to access POLST forms electronically could improve end-of-life care, said Tom Sugarman, an emergency physician at Sutter Delta Medical Center in Antioch, Calif.
"If you come [to the hospital] in full cardiac arrest … we only have one or two minutes to make a decision," said Sugarman, who educates doctors about POLST. "All physicians are going to err on the side of preserving life."
Sometimes, however, a patient may prefer comfort care, Sugarman said. A POLST form — if it is available — means families don't have to make decisions during an emergency, he said. "The worst time to have that conversation is during a crisis."
At Chaparral House, a nursing home in Berkeley, the POLST forms are in the residents' folders at the nursing station. The forms go with patients to the hospital, but sometimes there is still a disconnect. Administrator KJ Page recalls one resident getting a feeding tube when he didn't want one and another who almost underwent bypass surgery against his wishes.
Audrey de Jesus, 83, arrived at Chaparral House just a few months ago. She uses a wheelchair and an oxygen tank. Beside her bed sits a Bible and a book of Psalms.
De Jesus has seven children and said the form tells them exactly what she wants — comfort-focused treatment — so there aren't any questions in an emergency. "I want pain control and the least suffering for my family," she said.
Stonebrook Healthcare Center Social Services Director Shirley Jackson said filling out POLST forms is part of the admission process. "It's almost like a driver's license for the end of your life," she said. "It's important."
Having the form available electronically would make it much easier for everyone. "If, God forbid, you have to send somebody out in an emergency, especially if they are unresponsive, it's right there in the chart," she said.
De Freze, a former certified nursing assistant, said she plans to put her pink form on her refrigerator when she leaves Stonebrook. She knows she could have an emergency and may not be able to tell doctors or paramedics what she wants.
"You can't communicate if you are in excruciating pain," she said.
Approximately three-quarters of health care and hospital systems ask for "point-of-service collections," estimates a Healthcare Financial Management Association executive.
Tai Boxley needs a hysterectomy. The 34-year-old single mother has uterine prolapse, a condition that occurs when the muscles and ligaments supporting the uterus weaken, causing severe pain, bleeding and urine leakage.
Boxley and her 13-year-old son have health insurance through her job as an administrative assistant in Tulsa, Okla. But the plan has a deductible of $5,000 apiece, and Boxley's doctor said he won't do the surgery until she prepays her share of the cost. His office estimates that will be as much as $2,500. Boxley is worried that the hospital may demand its cut as well before the surgery can be performed.
"I'm so angry," Boxley said. "If I need medical care I should be able to get it without having to afford it up front."
At many doctors' offices and hospitals, a routine part of doing business these days is estimating patients' out-of-pocket payments and trying to collect it up front. Eyeing retailers' practice of keeping credit card information on file, "there's certainly been a movement by health care providers to store some of this information and be able to access it with patients' permission," said Mark Rukavina, a principal at Community Health Advisors in Chestnut Hill, Mass., who works with hospitals on addressing financial barriers to care.
But there's a big difference between handing over a credit card to cover a $20 copayment versus suddenly being confronted with a $2,000 charge to cover a deductible, an amount that might take months to pay off or exceed a patient's credit limit. Doctors may refuse to dispense needed care before the payment is made, even as patient health hangs in the balance.
The strategy leaves patients financially vulnerable too. Once a charge is on a patient's credit card, they may have trouble contesting a medical bill. Likewise, a service placed on a credit card represents a consumer's commitment that the charge was justified, so nonpayment is more likely to harm a credit score.
Approximately three-quarters of health care and hospital systems ask for payment at the time services are provided, a practice known as "point-of-service collections," estimated Richard Gundling, a senior vice president at the Healthcare Financial Management Association, an industry group. He could not say how many were doing so for higher priced services or for patients with high-deductible plans, situations that would likely result in out-of-pocket outlays of hundreds or thousands of dollars.
"For providers, there's more risk with these higher deductibles, because the chance of being able to collect it later diminishes," Gundling said.
But the practice leaves many patients resentful.
After arriving by ambulance at the emergency department, Susan Bradshaw lay on a gurney in her hospital gown with a surgical bonnet on her head, waiting to be wheeled into surgery to remove her appendix at a hospital near her home in Maitland, Fla. A woman in street clothes approached her. Identifying herself as the surgeon's office manager she demanded that Bradshaw make her $1,400 insurance payment before the surgery could proceed.
"I said, 'You have got to be kidding. I don't even have a comb,'" Bradshaw, a 68-year-old exhibit designer, told the woman on that night eight years ago. "I don't have a credit card on me."
The woman crossed her arms and Bradshaw remembers her saying, "You have to figure it out."
As providers aim to maximize their collections, many contract with companies that help doctors and hospitals secure payments up front, often providing scripts that prompt staff to talk with patients about their payment obligations and discuss payment scenarios as well as software that can estimate what a patient will owe.
But as hospitals and doctors push for point-of-service payments to reduce bad debt from patients with increasingly high deductibles, the risk is that patients will delay care and end up in the emergency room, Rukavina said. "Patients are essentially paying for their procedures up front," he said. "It may not be a significant amount compared to their salary, but they don't necessarily have it available at the time of service."
The higher their deductible, the less likely patients are to pay what they owe, according to an analysis of 400,000 claims by the Advisory Board, a health care research and consulting firm. While more than two-thirds of patients with a deductible of less than $1,000 were likely to pay at least some portion of what they owe, just 36 percent of those with deductibles of more than $5,000 did so, the analysis found.
Fifty-one percent of workers with insurance through their employer had a deductible of at least $1,000 for single coverage this year, according to the Kaiser Family Foundation's annual survey of employer health insurance. (KHN is an editorially independent program of the foundation.)
Boxley pays $110 a month for her family plan. She could not afford the premiums on plans with lower deductibles that her employer offered. She plans to talk with the doctor and hospital about setting up a payment plan so she can get the surgery in January.
"I'll make payments," Boxley said, although she acknowledged what she could pay monthly would be small. If that doesn't pan out, she figures she'll have to use student loan money she got for graduate school to cover what she owes.
Still, experts say that trying to pin patients down for payment in more acute settings, such as the emergency department, may cross a line.
Under the federal Emergency Medical Treatment and Labor Act (EMTALA), a patient who has a health emergency has to be stabilized and treated before any hospital personnel can discuss payment with them. If it's not an emergency, however, those discussions can occur before treatment, said Dr. Vidor Friedman, an emergency physician who is the secretary-treasurer of American College of Emergency Physicians' board of directors.
Bradshaw finally got her appendix removed by calling a friend, who read his MasterCard number over the phone. The surgery was uneventful and Bradshaw was home within 24 hours.
"It's a very murky, unclear situation," Friedman said of Bradshaw's experience, noting that a case might be made that her condition wasn't life threatening. "At the very least it's poor form, and goes against the intent if not the actual wording of EMTALA."
A sprawling health bill expected to pass the Senate and become law before the end of the year is a grab bag for industries that spent plenty of money lobbying to make sure it happened that way.
Here are some of the winners and losers in the 21st Century Cures Act:
Winners
Pharmaceutical and Medical Device Companies. The bill will likely save drug and device companies billions of dollars bringing products to market by giving the Food and Drug Administration new authority and tools to demand fewer studies from those companies and speed up approvals.
The changes represent a massive lobbying effort by 58 pharmaceutical companies, 24 device companies and 26 "biotech products and research" companies, according to a Kaiser Health News analysis of lobbying data compiled by the Center for Responsive Politics. The groups reported more than $192 million in lobbying expenses on the Cures Act and other legislative priorities, the analysis shows.
Medical schools, hospitals and physicians. The bill provides $4.8 billion over 10 years in additional funding to National Institutes of Health, the federal government's main biomedical research organization. (The funds are not guaranteed, however, and will be subject to annual appropriations.)
The money could help researchers at universities and medical centers get hundreds of millions more dollars in research grants, most of it toward research on cancer, neurobiology and genetic medicine.
The bill attracted lobbying activity from more than 60 schools, 36 hospitals and several dozen groups representing physician organizations. They reported spending more than $120 million in disclosures that included Cures Act lobbying.
Mental health and substance abuse advocates. The bill provides $1 billion in state grants over two years to address opioid abuse and addiction. While most of that money goes to treatment facilities, some will fund research.
The bill also boosts funding for mental health research and treatment, with hundreds of millions of dollars authorized for dozens of existing and new programs.
Mental health, psychology and psychiatry groups spent $1.8 million on lobbying disclosures that included the Cures bill as an issue.
Patient groups. Specialty disease and patient advocacy groups supported the legislation and lobbied vigorously. Many of these groups get a portion of their funding from drug and device companies. The bill includes more patient input in the drug development and approval process, and the bill is a boost to the clout of such groups.
More than two dozen patient groups lobbied the bill, and reported spending $6.4 million in disclosures that named the bill as one of their issues.
Health information technology and software companies. The bill pushes federal agencies and health providers nationwide to use electronic health records systems and to collect data to enhance research and treatment. Although it doesn't specifically fund the effort, IT and data management companies could gain millions of dollars in new business.
More than a dozen computer, software and telecom companies reported Cures Act lobbying. The groups' total lobbying spending was $35 million on Cures as well as other legislation.
Losers
Preventive medicine. The bill cuts $3.5 billion — about 30 percent — from the Prevention and Public Health Fund established under Obamacare to promote prevention of Alzheimer's disease, hospital acquired infections, chronic illnesses and other ailments.
Consumer and patient safety groups. Groups like Public Citizen and the National Center for Health Research either fought the law outright or sought substantial changes. Although they won on some points, these groups still say Cures opens the door for unsafe drug and device approvals and doesn't address rising drug costs.
Hair growth patients. The bill says federal Medicaid will no longer help pay for drugs that help patients restore hair. The National Alopecia Areata Foundation spent $40,000 on lobbying disclosures this cycle that included Cures.
The FDA. The bill gives the FDA an additional $500 million through 2026 and more hiring power, but critics say it isn't enough to cover the additional workload under the bill. The agency also got something it opposed: renewal of a controversial voucher program that awards companies that approve drugs for rare pediatric diseases.
The Obama administration has agreed that the increasing supply of fentanyl on the street is a major challenge and said agencies are doing a lot. But reducing the supply is complicated.
The latest chart of overdose deaths in Massachusetts shows a climbing blue line labeled "fentanyl." Pick a spot on that line in mid-August and picture a big, affable 40-year-old man named Joe Salemi. He died at his mom's home in working-class Everett, Mass., after almost 25 years of heroin use.
Salemi had overdosed before. His brother Anthony Salemi said he was pretty sure, at the time, that something besides heroin killed Joe. The medical examiner later confirmed it.
"I knew, deep in my mind, it was going to be the stuff that everyone's talking about now — fentanyl," Anthony said. "Because I never thought straight heroin would kill him."
Anthony Salemi was familiar with fentanyl. He'd been prescribed the powerful painkiller after surgery in 2006. Anthony had warned his younger brother about reports that dealers were adding an illicit version of the drug to heroin, sometimes promising a more intense high. Fentanyl is more than 50 times more potent than heroin, according the Centers for Disease Control and Prevention.
But people like Joe rarely know for sure if there is fentanyl in the tiny plastic bags of illegal powder they buy — or how much. Just a few grains of pure fentanyl, doctors say, is enough to kill most users. In Massachusetts, 75 percent of the people who overdosed this year tested positive for the drug.
"It just seems like the dealers and the drugs are ravaging the whole country," said Anthony Salemi. "The supply just keeps coming in, no matter how many cops you put at the border, it just keeps coming in. This is scary."
The Obama administration agreed that the increasing supply of fentanyl on the street is a major challenge and said agencies are doing a lot. But reducing the supply is complicated.
Fentanyl is a synthetic opioid, constructed with lab chemicals — unlike heroin or morphine, which start with the opium sap of a poppy plant. Drug enforcement agents said clandestine labs across China are the main source of the illegally sold fentanyl.
Producers then ship the drug to Mexico, where drug cartels mix it into heroin or press it into blue, pink or white tablets that look like prescription pills for anxiety or pain. The powder or pills are delivered to dealers, or directly to users, via the internet or darknet, an online area used for illegal purchases.
"Synthetic drugs are a real winner because they are easy to make, and they're cheap to produce," said Kara McDonald, director of policy, planning and coordination at the international narcotics and law enforcement bureau of the U.S. Department of State.
"They're not dependent on a season or the weather like a plant-based drug," McDonald said. "And with the distribution system — through mail order — they can be delivered directly to the door in some cases. Like a pizza."
The profit margin is huge, said Drug Enforcement Administration spokesperson Russ Baer. He said it costs from $3,000 to $4,000 to produce a kilo — 2.2 pounds — of fentanyl. The fentanyl is then cut with cheap fillers to make pills, or mixed into bags and fraudulently sold as pure heroin.
"Drug traffickers involved in the wholesale distribution of those products can yield close to $1.5 million off that one kilogram," said Baer.
The DEA has six agents who operate out of Beijing and work closely with China's Ministry of Public Security, Baer said. Chinese officials established controls on 116 new chemicals last year, including 19 that have much the same molecular structure as fentanyl. Baer said that helped reduce the supply of some of these designer analogs of the drug. (Though each analog drug has a slightly different chemical structure from fentanyl, they work much the same way in the body.)
And in September, the DEA moved to declare another fentanyl analog called U-47700 illegal. But the producers always seem to be one step ahead of enforcement agencies, Baer said.
"Once we control a substance, whether here in the U.S. or in China, for example," he said, "the drug manufacturers simply change a molecule, tweak a molecule, in an attempt to circumvent the law."
Keeping up with the inventive chemists sounds nearly impossible.
"We're identifying one to two new synthetic substances every week," Baer said.
The international control system is only able to detect, process and outlaw about 10 new psychoactive substances a year, McDonald said. "It doesn't take a mathematician to identify that we have a real challenge here."
If a drug compound is similar to fentanyl, or if it produces the same physiological effect, the DEA can file trafficking charges here in the U.S. But these variations are not illegal in many countries. McDonald said the State Department is working, through the United Nations and with individual nations, to make sure police everywhere can identify new drugs and prosecute dealers.
To get in front of production, the State Department and a group of U.S. senators asked the United Nations in October to add to the list of tightly controlled substances two key ingredients used to make fentanyl. A decision is expected next year.
McDonald and Baer at the DEA said slowing demand for illicit uses of fentanyl and other opioids has become an urgent priority. The office of the U.S. Surgeon General last week also issued a report on the growing problem of substance abuse and the need for more widespread implementation of well-recognized, evidence-based treatment programs to address the problem.
In an interview with NPR's Steve Inskeep on Morning Edition, Surgeon General Vivek Murthy called addiction "a chronic disease of the brain."
"We need to treat it with the same urgency and compassion that we do any other illness," Murthy told Inskeep.
But some lawmakers, physicians and families who've lost loved ones say the Obama administration has done too little too late to tackle the epidemic.
U.S. Sen. Ed Markey, a Democrat from Massachusetts, said it's time to make the illegal production and trafficking of fentanyl the top policy issue in relations with China and Mexico.
"Many more people are going to die from this than [from] any threat from nuclear weapons or any devastation that's caused by an imbalance in trade," Markey said.
Baer said trying to stop the supply of opioids is part of the solution, but so is tackling demand by addressing addiction as a disease.
"The community needs to embrace these folks, create treatment opportunity," Baer said. "We need to educate the public. It's the No. 1 priority and it represents a public health crisis that all of us must work together to try to resolve."
The CDC offers a sobering perspective. While about 78 Americans will die today after an overdose, another 580 will try heroin — or what they think is heroin — for the first time.
This story is part of a partnership that includes WBUR, NPR and Kaiser Health News.
What do those things have to do with the repeal of the Affordable Care Act?
Economists and policymakers think the U.S. may be overpaying for such services, which helps drive up health care expenses for everyone. And the health law has a program that includes testing new ways to pay for care — including in those three areas — that might result in better quality and lower costs.
But with the ACA up for potential repeal, what happens to that testing now? One of the emerging questions is whether Congress will save all or part of that effort, known as the Center for Medicare & Medicaid Innovation.
Republican lawmakers have complained — along with some in the health care industry — that the law under the Obama administration gave too much authority to the head of the Department of Health and Human Services to create and expand projects. Now, however, that very same authority may look appealing as Republicans head the department and may want to use the center to test their own ideas, including those that would revamp Medicare or Medicaid.
"You can dislike that authority, until you have the opportunity to use the authority," said Rodney Whitlock, a vice president at ML Strategies, a government consulting firm in Washington, D.C., and former Republican staff member of the Senate Finance Committee.
As they debate and discuss ways to repeal the Affordable Care Act, lawmakers will weigh the innovation center, funded through the health law with $10 billion for 2011 to 2019, and another $10 billion for each subsequent decade. The Congressional Budget Office estimates the center would increase federal spending initially, but ultimately result in lower costs and save up to $34 billion over the next 10 years.
Congressional Republicans have not yet hinted whether they will keep, modify or kill the program but they generally support the cost-saving goal of the center and many observers think they will want to preserve it.
"If health care providers can do a better job of delivering patient care … at the same or lower costs, that's the kind of flexibility the system needs more of," said Mark McClellan, a professor of health policy at Duke University who headed Medicare for two years under the George W. Bush administration.
One group that generally supports the broad cost-saving goal of the center, nonetheless warned that Congress should place limits on it. Otherwise, "there is nothing preventing [the center] from testing a model … that includes all Medicare and/or Medicaid beneficiaries in the U.S," the Healthcare Leaders for Accountable Innovation in Medicare said in a white paper. "In effect [the center] could test a model that completely restructures the Medicare or Medicaid program."
Billions of dollars have already been spent by the center, testing a variety of ideas, from ways to improve care for at-home dialysis to ways to foster more collaboration between doctors and hospitals to efforts to reduce unnecessary hospital visits by chronically ill Medicare patients. Many of the efforts look at ways to move from Medicare's traditional fee-for-service payment system — that economists and policymakers say drive up costs — and instead set up reimbursement that rewards coordinated care. Few of the projects have been in place long enough for the center to determine if they truly save money and improve care.
Even if the center were eliminated, many experts say these types of payment reforms will continue because of private sector interest.
"Pay-for-value is going to be a guiding principle going forward irrespective of who is in power," said Dan Mendelson, president and CEO of the consulting firm Avalere Health. "It would surprise me to see wholesale U-turn from that policy."
To date, most of the programs funded by the innovation center are voluntary, but controversy has arisen over several recent initiatives that require participation by doctors or hospitals.
What may happen is that there will be fewer of these mandatory efforts. This year, one such project got underway, testing a method of "bundling" payments for joint replacements at 800 hospitals in 67 metro areas. For their Medicare patients, the project requires a single bundled payment to cover the cost of these procedures, including in-patient and post-operative care, instead of separate payments for each doctor, hospital or nursing home visit. A similar mandatory project for certain kinds of cardiac care has also been proposed.
In the end, the center's future will be determined by whether the Republican majority believes it is one of the best ways to slow rising medical costs, said Christopher Condeluci, principal at CC Law & Policy in Washington, D.C., and the former tax and benefits counsel to the Senate Finance Committee.
"If the answer is yes, they will keep it and it might go to new heights," Condeluci said.
But economist Joe Antos, a resident scholar at the American Enterprise Institute, does not think the new administration — or many members of Congress — will push to use the center's authority to create broad, mandatory nationwide experiments with Medicare.
"I can't imagine a Trump administration saying we want the bureaucrats to decide on the health care your grandmother is going to get," said Antos. "Anything that is that much of a marquee issue absolutely has to go through Congress."