Medicare is contemplating whether it will help pay for knee replacement surgeries outside the hospital, either in free-standing surgery centers or outpatient facilities.

Hospitals And Surgery Centers Play Tug-Of-War Over America's Ailing Knees

KFF Health News, December 21, 2016

Medicare is contemplating whether it will help pay for knee replacement surgeries outside the hospital, either in free-standing surgery centers or outpatient facilities.

This article first appeared December 21, 2016 on Kaiser Health News.

By Christina Jewett

Five years ago, Dr. Ira Kirschenbaum, an orthopedic surgeon in the Bronx who replaces more than 200 knees each year, would have considered it crazy to send a patient home the same day as a knee replacement operation.

And yet there he was this year, as the patient, home after a few hours. A physician friend pierced his skin at 8 a.m. at a Seattle-area surgery center. By lunch, Kirschenbaum was resting at his friend's home, with no pain and a new knee.

"I'm amazed at how well I'm doing," Kirschenbaum, 59, said recently in a phone interview, nine weeks after the operation.

What felt to Kirschenbaum like a bold experiment may soon become far more standard. Medicare, which spends several billions of dollars a year on knee replacements for its beneficiaries — generally Americans 65 and over — is contemplating whether it will help pay for knee replacement surgeries outside the hospital, either in free-standing surgery centers or outpatient facilities.

The issue is sowing deep discord in the medical world, and the debate is as much about money as medicine. Some physicians are concerned that moving the surgeries out of hospitals will land vulnerable patients in the emergency room with uncontrolled pain, blood clots or other complications.

But proponents of the change say it can give patients more choice and potentially better care, as well as save Medicare hundreds of millions of dollars. Already, an "overwhelming majority" of commenters said they want to allow the surgeries out of hospitals, according to recent rule-making documents.

The final decision, which could come within a year, would also act as a test of sorts for Donald Trump and his new administration. They will weigh whether to limit government controls, as Trump has often suggested, or to bend to pressure from hospitals and doctors, many of whom oppose the change.

"I think the question will come down to two things," said David Muhlestein, senior director for research at Leavitt Partners, a leading health consulting firm. "It's the balance of trying to reduce regulations and let the market function — and the competing interest of vested parties."

Demand for total knee replacements is growing — 660,000 are performed each year in the United States. That number is likely to jump to two million annually by 2030, making this complex and expensive operation one of surgery's biggest potential growth markets.

Even if the policy change is made, Medicare would still pay for patients to get traditional inpatient surgery. But with the agency also paying for the bulk of outpatient procedures, there would be a huge shift in money — out of hospitals and into surgery centers. Medicare could save hundreds of millions of dollars if it no longer needed to pay for multiple-day stays at the hospital. Investors at the outpatient centers could profit greatly, as could some surgeons, because doctors often have an ownership stake in the outpatient centers where they operate.

Whether the shift is beneficial for patients remains an open question. Medicare patients tend to spend nearly three days in a hospital, data shows. Forty percent of Medicare patients also spend time in a rehabilitation facility for further recovery. The data, which reflects knee replacement operations from 2014, suggests that Medicare patients are taking advantage of the post-operation support at hospitals and aftercare centers. Given that, it is unclear the percentage of eligible patients who would choose outpatient care.

But improvements in surgery — from new medicines to control bleeding to better pain management techniques — mean that, for some patients, the days of close medical supervision are no longer necessary.

Kirschenbaum, who is in favor of the change, acknowledged that outpatient surgery would be the right move for only a small subset of his Medicare patients — perhaps 10 to 15 percent — who have good caretaking at home and few chronic health issues. But it would not be for the people who are frail, live alone or in a dwelling with stairs, he said. The decision about whether an outpatient surgery should be done instead of an inpatient one tends to be made by the physician and patient.

"We want to make sure patients — when they go home, they're safe, no question," said Kirschenbaum, the chairman of orthopedics at Bronx-Lebanon Hospital Center and a founder of SwiftPath, a company that offers technical support to outpatient joint replacement centers.

Perhaps of equal concern to patients are the financial consequences, because even though less care is given, outpatient procedures require higher out-of-pocket costs for patients. Medicare covers inpatient procedures 100 percent, with no patient copayment. Outpatient procedures, though, require patients to contribute a 20 percent copayment, which would easily add up to thousands of dollars in the case of knee surgery.

The battle lines over outpatient knee replacements began forming in 2012, when Medicare first considered removing the surgeries from its "inpatient only" list of invasive and complicated medical procedures. Many orthopedic doctors and hospitals rose up in protest, calling the proposal "ludicrous" and "dangerous" and prompting Medicare to abandon the idea.

Dr. Charles Moon, who has performed knee replacement surgeries at Cedars-Sinai Medical Center in Los Angeles, fired off a letter at the time saying that knee replacement patients stayed at his hospital for 2.5 days on average, and that that was "considered borderline safe" given the need to monitor patients' response to clot-busting medications.

Other objectors cited research showing that patients who received knee replacements as outpatients were twice as likely to die shortly afterward, and that even one-day-stay hospital patients were twice as likely to need a follow-up surgery, compared with those who remained inpatients longer.

"While we realize this can be good for some patients, it's not for all patients and all locations," said Dr. Thomas C. Barber, the chairman for the American Academy of Orthopaedic Surgeons' advocacy council.

Yet the proposal has gained renewed momentum, backed aggressively by some surgeons and surgery center investors who say that their accumulating experience justifies the change. In recent months, Medicare has signaled a strong interest in outpatient knee replacements, noting the potential for "overall improved outcomes" as well as the potential savings for the government program.

The final decision is made by Medicare officials in the annual course of proposing changes, seeking public input and announcing a final rule. If Medicare does decide to make a change, it would probably not be put into effect until a year or so later.

In an interview, Thomas Wilson, the chief executive of the for-profit Monterey Peninsula Surgery Centers, an outpatient clinic, said his doctors have replaced knees of hundreds of adults — 59 years old on average, but up to 82 — with low complication rates and sky-high satisfaction rates. He said advances in surgical technique, anesthetics and patient education make it possible.

Presented with such evidence, a panel that recommends hospital outpatient payment policies to Medicare officials unanimously recommended in August that Medicare remove the procedure from the "inpatient only" payment list.

Wilson said that as a first step, doctors should use strict criteria for choosing which patients are good candidates, like a low to moderate body mass index and a healthy heart and lungs.

Patients who meet the criteria are teamed with a friend or family member who works as a coach. The patient and coach attend an educational session before the operation, and the coach is also there to help after.

The patient is typically discharged after 23 hours in the outpatient center, and a home health service or private nurse follows up. Patients also go on to physical therapy.

"Our mix is like our regular mix of patients," said Wilson, whose center advertises a knee replacement surgery for $17,030. "It's not what we call unicorns, not 49-year-old marathon runners. These are average folks who need to have a knee or hip replaced and they're generally not sick."

But Barber and others worry that moving the procedure outside the hospital could become a norm or an expectation, even though some patients, especially those with complicating conditions like diabetes and heart disease, need the added support of a hospital team. Patient safety could be compromised, they warned.

Kirschenbaum said undergoing surgery has changed the way he approaches patients. Now he can roll up his pant leg, show a scar and tell them: "You can do this, too."

In the operating room, "with a knife in my hand, nothing has changed," he said. "But what has changed is how we treat them before and after. The education, support and being available — it's very important."

In Colorado, A Low-Price Drug Cocktail Will Tamp Down Cost Of Death With Dignity

In Colorado, A Low-Price Drug Cocktail Will Tamp Down Cost Of Death With Dignity

KFF Health News, December 20, 2016

Many health insurance plans pay for aid-in-dying drugs, but some don't, and the medications aren't covered by federal programs such as Medicare or Catholic-run health care systems. That can create a barrier for terminally ill patients who want to use the law.

This article first appeared December 1, 2016 on Kaiser Health News.

By JoNel Aleccia

As Colorado's aid-in-dying law takes effect this month, proponents say they'll make sure terminally-ill patients have access to a new, affordable drug concoction that will avoid the $3,000 cost of a common lethal sedative that has skyrocketed in price.

Officials with Compassion & Choices, an advocacy group, are reaching out to pharmacies statewide to confirm that they'll stock components of a lethal four-drug cocktail to substitute for secobarbital, known as Seconal, the pricey sleeping pill most often prescribed to induce death.

It's the second time in a year that right-to-die advocates have come up with a substitute for Seconal after Canadian drugmaker Valeant Pharmaceuticals International Inc. acquired the medication in February 2015 — and abruptly doubled the $1,500 retail price.

"We were looking for something more affordable and available," said Kat West, an attorney and policy expert with Compassion & Choices.

The new law, which was passed by a two-thirds majority, was signed into law on Dec. 16 by Gov. John Hickenlooper. Colorado joins five other states — Oregon, Washington, Vermont, Montana and California — in which terminally ill patients, usually those expected to live six months or less, can choose to take doctor-prescribed drugs to end their lives. In Oregon, at least 991 patients have died after taking drugs prescribed since the law took effect in 1997. In Washington state, at least 917 have died under terms of the law enacted in 2009.

Access to the medications can depend, in part, on cost. Many health insurance plans pay for aid-in-dying drugs, advocates said, but some don't, and the medications aren't covered by federal programs such as Medicare or Catholic-run health care systems. Medicaid programs for the poor and disabled in Oregon and California will pay, but not those in Washington state, Vermont or Montana. In Colorado, it's still unclear.

That can create a barrier for terminally ill patients who want to use the law, said Beth Glennon, a client-support coordinator for End of Life Washington, an advocacy group.

"The cost does affect people's decisions," Glennon said.

As of March, the latest data available, a bottle of 100 capsules of 100-milligram Seconal had a retail price of $3,082, according to data from Truven Health Analytics. Ten grams is a lethal dose.

When Oregon's law began, the cost was about $150, recalled Dr. David Grube, national medical director for Compassion & Choices and a family doctor who has practiced in the state for nearly 40 years. He calls the price hikes "an almost-evil practice of greed."

"I think it's the black side of capitalism," he said. "It really breaks my heart."

Valeant officials didn't respond to requests for comment, but in March firm officials issued a statement saying that secobarbital is approved only for treating short-term insomnia, epilepsy and for use in pre-operative anesthesia.

"If it is being prescribed for off-label uses, it is not something for which the product is manufactured or intended," the statement said.

To fight the high prices, doctors in Washington state experimented last year with a cheaper mixture that included three drugs — phenobarbital, chloral hydrate and morphine sulfate. The components are widely available and cost about $500 for a lethal dose. But the combination turned out to be too harsh, said Dr. Robert Wood, a volunteer medical adviser for End of Life Washington.

"The chloral hydrate mixture was too caustic for some folks and our volunteers didn't like using it," because some patients became distressed, Wood said.

Most doses of lethal medication are bitter, often requiring patients to take anti-nausea drugs. But the new mixture was not only bitter but also caused a burning sensation in the mouths of some patients, said Glennon. "There was some profound burning," she said. "We didn't like working with it. As a volunteer, you want to reassure people. We're about a peaceful, dignified death."

Wood and his colleagues came up with a new option this summer, a four-drug mixture that includes diazepam, digoxin, morphine and propranolol, known as DDMP. It costs between $300 and $600.

The mixture, which puts patients to sleep and then halts their heartbeat and breathing, has been used 38 times so far, Wood said.

"It is no more difficult than Seconal to ingest and it seems to work quite well," he added.

The mixture has been used "a fair amount" in California, where an aid-in-dying law took effect in June, said Grube. It's not yet known how many terminally-ill patients have died under that state's law, but dozens have requested prescriptions, officials said.

Valeant was widely criticized for raising the price of secobarbital, a popular sedative in the 1960s and 1970s that lost its patent status in the early 1990s. It has been used for aid-in-dying patients since Oregon passed the first U.S. law in 1997, which was modeled on similar action in the Netherlands, where secobarbital was the drug of choice.

Another sedative, pentobarbital, was also frequently used, but supplies in the U.S. became expensive and scarce after European drugmakers objected to its use as an execution drug in death penalty cases.

Doctors and pharmacists are not obligated to participate in aid-in-dying treatment under existing laws, including the Colorado action. In a recent poll, about 40 percent of more than 600 doctors surveyed said they would be willing to prescribe lethal medication, 42 percent said they wouldn't and 18 percent weren't sure, noted Dr. Cory Carroll, a solo practice family physician in Fort Collins, Colo., who endorsed the measure.

"The docs that are in opposition have a right to their beliefs, but they don't have the right to control others," Carroll said in a recent press conference.

West of Compassion & Choices anticipates that Colorado's law will be used immediately, as similar laws in other states have been.

"We're already getting calls from terminally ill people in Colorado who want to access this law," she said. "I fully expect people to begin requesting prescriptions."

Upstarts are seizing on growing evidence that many reusable instruments cannot be cleaned reliably.

The Throwaway Scope: A Way To Ditch Superbugs?

KFF Health News, December 19, 2016

Upstarts are seizing on growing evidence that many reusable instruments cannot be cleaned reliably.

This article first appeared December 15, 2016 on Kaiser Health News.

By Chad Terhune

In response to a series of superbug outbreaks around the country, some doctors and hospitals are trying out disposable scopes to combat the spread of antibiotic-resistant bacteria.

U.S. regulators recently approved two new colonoscopes designed to be used just once and thrown away. They will sell for $250 or less apiece — compared to roughly $40,000 or more for a conventional scope that lasts several years but must be disinfected after each use. Other companies are promoting such devices — flexible, lighted tubes used to peer deep inside the body — for use in the lungs and kidneys.

The new scopes are coming primarily from smaller companies looking to challenge a handful of dominant device makers. The upstarts are seizing on growing evidence that many reusable instruments cannot be cleaned reliably, even when manufacturer's instructions are followed.

"If you can tell patients we have a disposable device so there's really no chance of infection, that has to be very appealing," said Chris Lavanchy, engineering director at the ECRI Institute, a nonprofit organization that tests medical devices. "This could allay public fears."

Scopes include a wide array of devices used on millions of patients annually. As they snake through a patient's throat, intestines and other cavities, they pick up mucus, blood and thousands of microbes. But the delicate devices can't be sterilized like a scalpel because intense heat would destroy crucial components.

Instead, the scopes are brushed and washed with disinfectants in preparation for the next patient. Despite those efforts, contamination can persist and drug-resistant bacteria can result in patient infections that are difficult or even impossible to treat.

The threat has led to safety alerts from the Food and Drug Administration and a recent U.S. Senate investigation into repeated failures by manufacturers and hospitals to report outbreaks.

Overall, as many as 350 patients at 41 medical facilities worldwide were exposed to or infected by contaminated gastrointestinal scopes from 2010 to 2015, according to the FDA. And at least 35 patients at U.S. hospitals have died since 2013 after developing infections tied to tainted scopes, according to hospitals and public health officials.

For now, just a handful of medical centers are experimenting with the disposable colonoscopes. Some doctors remain skeptical about whether a cheaper scope will provide the high-quality images and versatility they need to diagnose and treat patients effectively. Many doctors count on the sophisticated cameras on existing scopes as well as multiple channels inside the device to accommodate surgical instruments.

Dr. Simon Lo, a nationally known gastroenterologist at Cedars-Sinai Medical Center in Los Angeles, said he shares those concerns. Nonetheless, he said he's eager to try the disposable colonoscope from German device maker Invendo Medical in the coming months. The scope secured clearance from the U.S. Food and Drug Administration in August.

"I'm not totally sold this will be comparable to the [conventional] scopes other companies have spent decades perfecting. It's almost too good to be true with it being so cheap," Lo said. "But this is a fantastic possibility and at least gives us an alternative to the current scopes."

Physician groups such as the American Society for Gastrointestinal Endoscopy maintain that the overall risk of infection is very low from these reusable devices. They say the benefits of screenings and many other procedures far outweigh any potential danger.

But some doctors say a simpler, single-use scope could be sufficient for many routine examinations. It could also be preferred for immunosuppressed patients who are more susceptible to infection and for patients who have already tested positive for antibiotic-resistant bacteria and would be likely to spread it.

"For those patients, it would be great to use this and throw it away," Lo said.

His hospital, Cedars-Sinai, reported four infections last year from contaminated duodenoscopes, which are inserted down a patient's throat and used to treat problems in the digestive tract such as cancers and blockages in the bile duct.

Colonoscopes, which look at the inner lining of the large intestine, haven't been linked to the recent outbreaks, but concerns about cleaning and the spread of bacteria apply to all types of reusable scopes. Last year, the FDA warned about the risk to patients posed by bronchoscopes, used to examine problems in the airway and lungs.

In one study, researchers found that more than 75 percent of colonoscopes and gastroscopes were still contaminated after cleaning and disinfection in accordance with manufacturer guidelines.

Hospitals have experimented with a wide variety of new safety measures over the past two years. Some facilities started testing scopes for contamination after cleaning and holding them in quarantine for 48 hours to check them again for bacterial growth.

Those steps added layers to what was already a labor-intensive process. It costs about $75 or more to clean a scope each time.

"There is a lot of time and money tied up in that," said John Cifarelli, chief commercial officer for Invendo. "The best solution is a device that doesn't have to be cleaned."

The leading scope makers haven't shown much interest thus far in single-use devices, which could affect their longstanding dominance in the business.

Olympus Corp., which controls 85 percent of the U.S. market for gastrointestinal scopes, didn't respond to a request for comment. The Tokyo-based company, linked to numerous infections in the U.S. and Europe, conducted a voluntary recall of its duodenoscopes this year and made repairs designed to reduce the contamination risk.

In a statement, another big manufacturer, Fujifilm, said it "has no plans at this time to market single-use disposable scopes, and cannot speak to the benefits or risks associated with such products."

Israeli company GI-View received FDA clearance in August for its single-use colonoscope, called Aer-O-Scope, priced at about $200. The company's chief executive, Tal Simchony, acknowledges that his smaller company faces an uphill battle against the industry giants. But he said he's optimistic it can address the "ick" factor some patients feel with a reusable scope.

Other companies see opportunity, too. Boston Scientific, a bigger device maker, promotes a disposable ureteroscope to aid in treatment of kidney stones and other procedures. Ambu A/S, based in Denmark, has sold a single-use bronchoscope for about $300 in the U.S. for the past few years.

In Europe, two biomedical engineers are raising money to build a prototype and manufacture what could become a full line of disposable endoscopes. Francisco Soriano, one of the engineers in Barcelona, said he learned the business from repairing scopes with his father, who was a longtime Olympus technician.

"We must reinvent the endoscope as we know it," Soriano said. "Our vision is to eliminate cross-infection completely."

Grilled About Deadly Superbug Outbreaks, Execs At Scope Maker Olympus Take Fifth

Grilled About Deadly Superbug Outbreaks, Execs At Scope Maker Olympus Take Fifth

KFF Health News, December 19, 2016

The three executives of Olympus Corp. were deposed at the U.S. Embassy in Tokyo by lawyers representing Virginia Mason Medical Center in Seattle.

This article first appeared December 19, 2016 on Kaiser Health News.

By Chad Terhune

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.

Olympus official in Japan says a U.S. safety alert is not needed in February 2013 (p. 43)

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."

Olympus executive asks whether U.S. hospitals should be warned in January 2013

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 and the incoming Trump administration seem to be coalescing around a strategy of "repeal and delay."

GOP's Timetable For Getting Repeal To Trump May Be Ambitious

KFF Health News, December 14, 2016

Republicans and the incoming Trump administration seem to be coalescing around a strategy of "repeal and delay."

This article first appeared December 14, 2016 on Kaiser Health News.

By Julie Rovner

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."

5 Quick Ways A New HHS Secretary Could Change The Course Of Health Policy

5 Quick Ways A New HHS Secretary Could Change The Course Of Health Policy

KFF Health News, December 12, 2016

Here are five actions the new HHS secretary might take, according to advocates on both sides, that would disrupt health policies currently in force.

This article first appeared December 9, 2016 on Kaiser Health News.

By Julie Rovner

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:

Birth control coverage: Under the ACA, most insurance plans must provide women with any form of contraception approved by the Food and Drug Administration at no additional cost. This has been particularly controversial in regards to religious employers who object to artificial contraception, leading to alterations in the rules, and resulting in a two separate Supreme Court rulings, one about private firms' rights to make religious objections, and one about nonprofit religious hospitals and schools.

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.

Price Poised To Protect Doctors' Interests At HHS

Price Poised To Protect Doctors' Interests At HHS

KFF Health News, December 12, 2016

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.

This article first appeared December 12, 2016 on Kaiser Health News.

By Christina Jewett and Marisa Taylor

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."

Interstate Health Insurance Sales Has a Tryout in GA But No Takers

KFF Health News, December 9, 2016

In Georgia, the interstate sale of health insurance has already had a five-year tryout. No health insurer has taken advantage of it.

This article first appeared December 8, 2016 on Kaiser Health News.

By Andy Miller, Georgia Health News

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.

CA Tests Database For End-Of-Life Wishes

KFF Health News, December 7, 2016

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.

This article first appeared December 7, 2016 on Kaiser Health News.

By Anna Gorman

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.

Doctors And Hospitals Say 'Show Me The Money' Before Treating Patients

KFF Health News, December 6, 2016

Approximately three-quarters of health care and hospital systems ask for "point-of-service collections," estimates a Healthcare Financial Management Association executive.

This article first appeared December 6, 2016 on Kaiser Health News.

By Michelle Andrews

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."

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