KFF Health News

KFF Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

No Cash, No Heart. Transplant Centers Require Proof Of Payment.

KFF Health News, December 5, 2018

More than 114,000 people are waiting for organs in the U.S. and fewer than 35,000 organs were transplanted last year. Transplant centers want to make sure donated organs aren't wasted.

This article first appeared December 05, 2018 on Kaiser Health News.

By JoNel Aleccia

When Patrick Mannion heard about the Michigan woman denied a heart transplant because she couldn't afford the anti-rejection drugs, he knew what she was up against.

On social media posts of a letter that went viral last month, Hedda Martin, 60, of Grand Rapids, was informed that she was not a candidate for a heart transplant because of her finances. It recommended "a fundraising effort of $10,000."

Two years ago, Mannion, of Oxford, Conn., learned he needed a double-lung transplant after contracting idiopathic pulmonary fibrosis, a progressive, fatal disease. From the start, hospital officials told him to set aside $30,000 in a separate bank account to cover the costs.

Mannion, 59, who received his new lungs in May 2017, reflected: "Here you are, you need a heart — that's a tough road for any person," he said. "And then for that person to have to be a fundraiser?"

Martin's case sparked outrage over a transplant system that links access to a lifesaving treatment to finances. But requiring proof of payment for organ transplants and post-operative care is common, transplant experts say.

"It happens every day," said Arthur Caplan, a bioethicist at the New York University Langone Medical Center. "You get what I call a 'wallet biopsy.'"

Virtually all of the nation's more than 250 transplant centers, which refer patients to a single national registry, require patients to verify how they will cover bills that can total $400,000 for a kidney transplant or $1.3 million for a heart, plus monthly costs that average $2,500 for anti-rejection drugs that must be taken for life, Caplan said. Coverage for the drugs is more scattershot than for the operation itself, even though transplanted organs will not last without the medicine.

For Martin, the social media attention helped. Within days, she had raised more than $30,000 through a GoFundMe account, and officials at Spectrum Health confirmed she was added to the transplant waiting list.

In a statement, officials there defended their position, saying that financial resources, along with physical health and social well-being, are among crucial factors to consider.

"The ability to pay for post-transplant care and life-long immunosuppression medications is essential to increase the likelihood of a successful transplant and longevity of the transplant recipient," officials wrote.

In the most pragmatic light, that makes sense. More than 114,000 people are waiting for organs in the U.S. and fewer than 35,000 organs were transplanted last year, according to the United Network for Organ Sharing, or UNOS. Transplant centers want to make sure donated organs aren't wasted.

Kaiser Health News Graph

Courtesy of Kaiser Health News

"If you're receiving a lifesaving organ, you have to be able to afford it," said Kelly Green, executive director of HelpHopeLive, the Pennsylvania organization that has helped Mannion.

His friends and family have rallied, flocking to fundraisers that ranged from hair salon cut-a-thons to golf tournaments, raising nearly $115,000 so far for transplant-related care.

Allowing financial factors to determine who gets a spot on the waiting list strikes many as unfair, Caplan said.

"It may be a source of anger, because when we're looking for organs, we don't like to think that they go to the rich," he said. "In reality, it's largely true."

Nearly half of the patients waiting for organs in the U.S. have private health insurance, UNOS data show. The rest are largely covered by the government, including Medicaid, the federal program for the disabled and poor, and Medicare.

Medicare also covers kidney transplants for all patients with end-stage renal disease. But, there's a catch. While the cost of a kidney transplant is covered for people younger than 65, the program halts payment for anti-rejection drugs after 36 months. That leaves many patients facing sudden bills, said Tonya Saffer, vice president of health policy for the National Kidney Foundation.

Legislation that would extend Medicare coverage for those drugs has been stalled for years.

For Alex Reed, 28, of Pittsburgh, who received a kidney transplant three years ago, coverage for the dozen medications he takes ended Nov. 30. His mother, Bobbie Reed, 62, has been scrambling for a solution.

"We can't pick up those costs," said Reed, whose family runs an independent insurance firm. "It would be at least $3,000 or $4,000 a month."

Prices for the drugs, which include powerful medications that prevent the body from rejecting the organs, have been falling in recent years as more generic versions have come to market, Saffer said.

But "the cost can still be hard on the budget," she added.

It's been a struggle for decades to get transplants and associated expenses covered by insurance, said Dr. Maryl Johnson, a heart failure and transplant cardiologist at the University of Wisconsin School of Medicine and Public Health.

"It's unusual that there's 100 percent coverage for everything," said Johnson, a leader in the field for 30 years.

GoFundMe efforts have become a popular way for sick people to raise money. About a third of the campaigns on the site target medical needs, the company said.

But when patients need to raise money, they should use fundraising organizations specifically aimed at those costs, transplant experts say, including HelpHopeLive, the National Foundation for Transplants and the American Transplant Foundation.

There's no guarantee funds generated through such general sites such as GoFundMe will be used for the intended purpose. In addition, the money likely will be regarded as taxable income that could jeopardize other resources, said Michelle Gilchrist, president and chief executive for the National Foundation for Transplants.

Her group, which helps about 4,000 patients a year, has raised $82 million for transplant costs since 1983, she said. Such efforts usually involve a huge public-relations push. Still, 20 percent of the patients who turn to NFT each year fail to raise the needed funds, Gilchrist said.

In those cases, the patients don't get the organs they need. "My concern is that health care should be accessible for everyone," she said, adding: "Ten thousand dollars is a lot to someone who doesn't have it."

Every transplant center in the U.S. has a team of social workers and financial coordinators who help patients negotiate the gaps in their care. Lara Tushla, a licensed clinical social worker with the Rush University transplant program in Chicago, monitors about 2,000 transplant patients. She urges potential patients to think realistically about the costs they'll face.

"The pharmacy will not hand over a bag full of pills without a bag full of money," she said. "They will not bill you. They want the copays before they give you the medication."

Government Investigation Finds Flaws In the FDA's Orphan Drug Program

KFF Health News, December 3, 2018

A third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020, leading many to wonder whether the Orphan Drug Act may have overcorrected.

This article first appeared November 30, 2018 on Kaiser Health News.

By Sarah Jane Tribble and Sydney Lupkin

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday.

The Government Accountability Office, which spent more than a year investigating the FDA's orphan drug program, said "challenges continue" in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

The GAO uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended "executive action" to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

In response to GAO's probe, the FDA issued a statement saying it agreed with the report recommendations regarding documentation and that the agency is "streamlining our processes." The agency declined requests for interviews. In a comment included with the report, Matthew Bassett, assistant secretary for legislation at the Department of Health and Human Services, said HHS agreed with GAO's recommendations.

John Dicken, director of the GAO's health care team, said the focus of the report is "ensuring that the intent of the law is being met."

The FDA's rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren't expected to be profitable. The law provides fee waivers, tax incentives for research and seven years of marketing exclusivity for any drug the FDA approves as an "orphan."

The incentives, though, have proven to be more powerful and highly coveted than expected, said Avik Roy, president of the Foundation for Research on Equal Opportunity, a conservative think tank.

Many people are "starting to wonder whether or not the Orphan Drug Act over-corrected for the problem," Roy said, noting that a third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020.

GAO analysts examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA's reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat their disease.

In nearly 60 percent of the cases, the FDA reviewers did not capture regulatory history information, including "adverse actions" from other regulatory agencies. The FDA uses experienced reviewers, Dicken noted, who may already know the history of certain submitted drugs and not see the need to document it.

And 15 percent of the time FDA reviewers failed to independently verify patient estimates provided by the drugmaker.

Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information.

"It is tempting to think that perhaps those approvals were sort of granted routinely without sufficient scrutiny," said Bernard Munos, senior fellow at FasterCures and the Milken Institute.

By contrast, early Orphan Drug Act advocate Abbey Meyers said she was not concerned about the lack of population estimates because many rare diseases lack population studies that show how common a disease is.

Rather, Meyers said, she's "disappointed that there is no government-funded agency that is willing to finance" such research.

The GAO investigation began after Scott Gottlieb, who took over as FDA commissioner in May 2017, announced a "modernization" of the rare-disease program.

Critics have long complained that drugmakers game the FDA's approval process for orphan drugs. In January 2017, the KHN investigation, which was co-published and aired by NPR, revealed that many orphan drugs aren't entirely new and don't always start as treatments for rare diseases.

The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people.

KHN's investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions.

In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives.

Genentech's Avastin, a cancer treatment approved for mass-market use in 2004, won three more orphan-designated approvals this year for the treatment of three rare forms of cancer. It now has 11 approved orphan uses in all, and exclusive protections that keep generics at bay won't run out until 2025.

Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter in March 2017 asking the GAO to investigate the program and find out whether Congress' original intent for it was still being followed.

"Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options," Hatch said in a statement Friday. "I hope that my colleagues will utilize this [GAO] report as they work to strengthen the accomplishments of the Orphan Drug Act and encourage developers to continue their investment in this patient population." The GAO report also mentioned concerns about prices, noting that "the ability to command high prices" was one reason the rare-disease market was growing so rapidly.

The average cost per patient for an orphan drug was $147,308 in 2017 compared with $30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the United States. Celgene's chemotherapy drug Revlimid was the top-selling orphan with $5.4 billion in sales and $184,011 in revenue per patient.

"We have accepted culturally that it's OK for a company to charge high prices for [orphan] drugs," said Roy. "The end result is that a lot of these orphan drugs are $10 billion drugs, even though they are for rare diseases."

From 2008 to 2017, more than half of the drugs granted orphan status were for cancer or blood disorders, according to the GAO report. And nearly two-thirds of drugs approved in the program were given expedited review processes, such as accelerated approval or fast-track designation.

Prior to announcing Gottlieb's modernization plan, the FDA had a backlog of 138 drug applications for orphan status that had been waiting more than 120 days. The backlog was cleared in August 2017 after staff from across the agency stepped in to help.

Medicare Cuts Payments To Nursing Homes Whose Patients Keep Ending Up In Hospital

KFF Health News, December 3, 2018

Hospitalizations of nursing home residents, while decreasing in recent years, remain a problem, with nearly 11% of patients in 2016 being sent to hospitals for conditions that might have been averted with better medical oversight.

This article first appeared December 03, 2018 on Kaiser Health News.

By Jordan Rau

The federal government has taken a new step to reduce avoidable hospital readmissions of nursing home patients by lowering a year's worth of payments to nearly 11,000 nursing homes. It gave bonuses to nearly 4,000 others.

These financial incentives, determined by each home's readmission rates, significantly expand Medicare's effort to pay medical providers based on the quality of care instead of just the number or condition of their patients. Until now, Medicare limited these kinds of incentives mostly to hospitals, which have gotten used to facing financial repercussions if too many of their patients are readmitted, suffer infections or other injuries, or die.

"To some nursing homes, it could mean a significant amount of money," said Thomas Martin, director of post-acute care analytics at CarePort Health, which works for both hospitals and nursing homes. "A lot are operating on very small margins."

The new Medicare program is altering a year's worth of payments to 14,959 skilled nursing facilities based on how often their residents ended up back in hospitals within 30 days of leaving. Hospitalizations of nursing home residents, while decreasing in recent years, remain a problem, with nearly 11 percent of patients in 2016 being sent to hospitals for conditions that might have been averted with better medical oversight.

These bonuses and penalties are also intended to discourage nursing homes from discharging patients too quickly — something that is financially tempting as Medicare fully covers only the first 20 days of a stay and generally stops paying anything after 100 days.

Over this fiscal year, which began Oct. 1 and goes through the end of September 2019, the best-performing homes will receive 1.6 percent more for each Medicare patient than they would have otherwise. The worst-performing homes will lose nearly 2 percent of each payment. The others will fall in between. (You can see the scores for individual nursing facilities here.)

For-profit nursing homes, which make up two-thirds of the nation's facilities, face deeper cuts on average than do nonprofit and government-owned homes, a Kaiser Health News analysis of the data found.

In Arkansas, Louisiana and Mississippi, 85 percent of homes will lose money, the analysis found. More than half in Alaska, Hawaii and Washington state will get bonuses.

Overall, 10,976 nursing homes will be penalized, 3,983 will get bonuses, and the remainder will not experience any change in payment, the KHN analysis found.

Medicare is lowering payments to 12 of the 15 nursing homes run by Otterbein SeniorLife, an Ohio faith-based nonprofit. Pamela Richmond, Otterbein's chief strategy officer, said most of its readmissions occurred with patients after they went home, not while they were in the facilities. Otterbein anticipates losing $99,000 over the year.

"We're super disappointed," Richmond said about the penalties. She said Otterbein is starting to follow up with former patients or the home health agencies that send nurses and aides to their houses to care for them. If there are signs of trouble, Otterbein will try to arrange care or bring patients back to the nursing home if necessary.

"This really puts the emphasis on us to go out and coordinate better care after they leave," Richmond said.

Congress created the Skilled Nursing Facility Value-Based Purchasing Program incentives in the 2014 Protecting Access to Medicare Act. In assigning bonuses and penalties, Medicare judged each facility's performances in two ways: how its hospitalization rates in calendar year 2017 compared with other facilities and how much those rates changed from calendar year 2015.

Facilities received scores of 0 to 100 for their performances and 0 to 90 for their improvements, and the higher of the two scores was used to determine their overall score. Facilities were then ranked highest to lowest.

Medicare is not measuring readmission rates of patients who are insured through private Medicare Advantage plans, even though in some regions the majority of Medicare beneficiaries rely on those to afford their care.

Through the incentives, Medicare will redistribute $316 million from poorer-performing to better-performing nursing homes. Medicare expects it will keep another $211 million that it would have otherwise paid to nursing homes if the program did not exist.

The new payments augment other pressures nursing homes face from Medicare and state Medicaid programs to lower readmissions to hospitals.

"Skilled facilities have been working toward this and knew it was coming," said Nicole Fallon, vice president of health policy and integrated services at LeadingAge, an association of nonprofit providers of aging services.

The American Health Care Association, a trade group of nursing homes, said in a statement that it had supported the program and was gratified to see that more than a quarter of facilities received bonuses.

While most researchers believe that readmissions can be reduced, some consumer advocates fear that nursing homes will be reluctant to admit very infirm residents or to re-hospitalize patients even when they need medical care.

"It may end up causing great pain to residents who actually need to be hospitalized," said Patricia McGinnis, executive director of California Advocates for Nursing Home Reform, which is based in San Francisco.

Fallon said Medicare eventually may penalize homes that have done all they can to prevent return trips to the hospital. But because of the program's design by Congress, Medicare still will need to punish large numbers of homes.

"There's always going to be winners and losers, even if you make good progress," Fallon said. "At what point have we achieved all we can achieve?"

Meanwhile, Medicare is looking to expand financial incentives to other kinds of providers. Since 2016, it has been testing quality bonuses and penalties for home health agencies in nine states. Richmond, the nursing home executive, applauded that kind of expansion.

'There's a whole bunch of people in this chain" of institutions caring for patients at different stages, she said, "and we all need to be working in a common direction."

Is Trump Pushing Health Insurance Innovation Or An ACA Rollback?

KFF Health News, November 30, 2018

Coupled with other ongoing efforts by the Trump administration to gut Obamacare, policy experts predict the ideas would further foster a parallel market of cheaper, less robust coverage that could draw younger or healthier consumers, but drive up premiums for those who remain in ACA market plans.

This article first appeared November 29, 2018 on Kaiser Health News.

By Julie Appleby

On his first day in office, as part of his mission to dismantle the Affordable Care Act, President Donald Trump signed an order promising to give states flexibility "to create a more free and open healthcare market."

The administration on Thursday released an official set of examples to help states flex these powers.

It is intended to roll back key elements of Obama-era requirements, which were designed to promote enrollment in ACA plans that cover a broad range of medical needs and meet uniform national standards.

Seema Verma, the Centers for Medicare & Medicaid Services administrator, said those strict rules were seen by many as burdensome, and "virtually impossible" for states to meet.

Instead, the Trump administration wants states to innovate in ways that could produce more lower-cost options, even if those alternatives do not provide the same level of financial or medical coverage as an ACA plan.

"I'm confident states will come up with ideas that will work better," said Verma.

Still, coupled with other ongoing efforts by the Trump administration to gut Obamacare, policy experts predict the ideas would further foster a parallel market of cheaper, less robust coverage that could draw younger or healthier consumers, but drive up premiums for those who remain in ACA market plans.

"Invariably, the coverage is going to be more expensive for people who really need comprehensive coverage," said Timothy Jost, a retired Washington and Lee University law professor who follows the ACA closely.

One of the biggest changes signaled by the administration involves allowing states to revamp how federal subsidies are used. Currently, they are strictly targeted to lower-income Americans and are seen as key to bolstering enrollment in marketplace plans.

The Trump guidance would give states wider latitude to expand or narrow the income range eligible for subsidies, target them toward younger people or allow them to be used for less costly but skimpier types of insurance.

This would "potentially upend the subsidy structure," said Sabrina Corlette, research professor at Georgetown University's Health Policy Institute.

Another example would, for the first time, make federal subsidy money available to people who get job-based insurance, countering Obama-era rules that generally prohibited that. It would let states use federal dollars to fund accounts consumers could use to buy insurance or pay other health costs, such as deductibles or copayments. Employers or consumers could also add additional funds to these accounts.

Still, managing those accounts would be a large administrative expense for a state to oversee, said Corlette. "I don't understand why a state would want to set it up," she added.

Supporters say the examples unveiled Thursday would give consumers more control over how they choose to spend their health care dollars and the types of coverage they want to buy. They say it might also improve the markets, which are seeing declining enrollment as premiums rise.

"If states can provide larger subsidies to younger individuals to attract them to enroll, that will improve the market overall," said Christopher Condeluci, a Washington, D.C., attorney who specializes in employee benefits and has served as the tax and benefits counsel to the U.S. Senate Finance Committee.

However, if many states follow the administration's lead, critics say, it would bring back the days when insurance rules varied widely state by state. Consumers could end up buying skimpier plans that leave them vulnerable to high, unexpected medical bills.

While not prescriptive, the examples are designed to encourage states to innovate and apply for permission to offer more choices for consumers, so long as the proposals don't cost taxpayers more and don't reduce access to ACA plans, said Verma.

State proposals would still have to be affordable, comprehensive and not raise the federal deficit, she said. And CMS would pay particular attention to potential effects on low-income Americans, she added.

Reshaping The Individual Market

The administration's examples focus on states' health marketplaces, where insurance plans are designed for individuals who don't get job-based coverage and small businesses. An estimated 14 million people buy their own coverage through those markets or through brokers.

Premiums in those markets have risen substantially since the law took effect in 2014, for a variety of reasons, including lower-than-expected enrollment by healthy people and actions taken by Congress and the Trump administration that removed the tax penalty for failing to have coverage, eliminated some payments to insurers and loosened restrictions on alternative types of insurance plans.

The administration's examples add a new twist to a provision of the ACA, which gave states the option of seeking a federal waiver to develop alternative marketplace proposals.

To get one under Obamacare rules, however, states have to meet four "guardrails" established in 2015. These require states to ensure their proposals would provide equally comprehensive and affordable coverage, not result in fewer people enrolling or increased costs for taxpayers.

The examples, tapped by the administration as "waiver concepts," build on the Trump administration guidance issued in late October to loosen those guardrails. That guidance, effective in 2020, says states have to provide access to affordable and comprehensive coverage, but will not be held to a strict tally of how many people actually enroll. So long as a state could show that equal numbers of people were buying some kind of coverage — either comprehensive ACA plans or less expensive but skimpier plans — it could pass the test.

That October announcement, and Thursday's concepts, drew immediate criticism from ACA supporters, who said it encourages the use of subsidies to buy short-term plans, which aren't as comprehensive as ACA coverage and can bar people with preexisting conditions.

Congressional Democrats sent a letter to top administration officials saying the process by which the changes are being made — meaning they are not following a formal rule-making process — are illegal.

"We believe this sub-regulatory guidance exceeds the Secretaries' statutory authority," wrote Ways & Means ranking member Richard Neal (D-Mass.) and Energy and Commerce ranking member Frank Pallone Jr. (D-N.J.). "It appears to be part of the Administration's ideologically motivated efforts to sabotage the ACA."

The Brookings Institution and other experts have raised similar questions and predicted a legal challenge.

"As soon as any state proceeds to go somewhere with this, there will be legal challenges," said Jost, the law professor.

Verma pushed back against this warning, noting that the Obama administration also issued its guardrails as guidance, not a formal rule.

And, just as when the administration released its earlier guidance in October, Verma anticipated that critics would say the ideas would adversely affect people with preexisting medical conditions.

Those critics argue that anything that draws younger and healthier people out of the market will drive up costs for those who remain in ACA plans, including those with medical conditions who might be barred from buying an alternative policy, such as a short-term plan.

But Verma said that "nothing in this guidance would take away protections from people with preexisting conditions."

Sales Reps May Be Wearing Out Their Welcome In The Operating Room

KFF Health News, November 30, 2018

Critics of the practice say that device reps attend surgeries to strengthen their relationships with particular surgeons and thereby persuade them to choose one brand of artificial hip joint or stent or pacemaker over a competitor's.

This article first appeared November 30, 2018 on Kaiser Health News.

By Blake Farmer, Nashville Public Radio

In the operating room, surgical masks and matching scrubs can make it hard to tell who's who — at least for outsiders.

Patients getting wheeled in might not realize that salespeople working on commission are frequently present and sometimes even advise the clinical team during surgery.

Who are these salespeople, and why are they there?

The answer to the first question is pretty easy. These sales reps typically work for medical device companies, such as Stryker, Medtronic or DePuy Synthes. Many surgeries, especially orthopedic trauma and cardiac procedures, require insertion of artificial joints or other hardware manufactured by these companies.

But as to why they're present in the operating room, the answer depends on whom you ask.

Critics of the practice say that device reps attend surgeries to strengthen their relationships with particular surgeons and thereby persuade them to choose one brand of artificial hip joint or stent or pacemaker over a competitor's.

The device reps say they observe surgeries because they are experts on particular devices and their accompanying toolkits, which often include hundreds of wrenches, screws and other hardware to aid in installation.

Sometimes, the device reps have observed more surgeries with a particular device than any one surgeon. That depth of experience can be helpful, the reps say, especially with the newest device model or upgrade.

"I can't keep my socks together through the dryer. You can imagine trying to get 100 pans or 300 pans of instruments all set up correctly," said Dr. Michael Christie of Nashville, an orthopedic surgeon who specializes in new hips.

Device reps have been attending surgeries for years, but that practice is coming under new scrutiny. As baby boomers age, there has been exponential growth in device-dependent procedures like total joint replacements. In addition, insurers are starting to crack down on health care costs, telling hospitals that they'll pay only a fixed price, known as a "bundled payment," for certain surgical procedures, such as hip or knee replacements.

That approach has forced hospitals to take a hard look at the price tags of the devices and the salespeople who are pushing the latest models. Hospitals are "starting to figure out what these reps make for a living. They feel like they're making too much money, and I think that's why they want them out," said Brent Ford, a former sales rep who now works for Nashville-based HealthTrust, a firm that handles contracting and purchasing of supplies like hip implants for more than 1,600 U.S. hospitals.

Medical device reps are more often business majors than biology buffs, but they train for the job as if they might have to conduct surgery themselves. At an educational center in Colorado, future reps learn how to saw off a hip bone and implant an artificial hip.

Their corporate training frequently involves cadavers, which helps reps develop the steel stomach required for the unsettling sights and sounds of an orthopedic operating room — like a surgeon loudly hammering a spike into a bone.

"Before we're allowed to sell our products to surgeons, we have to know the anatomy of the body, go through tests of why physicians use these types of products and how we can assist in surgery," says Chris Stewart, a former rep for Stryker, one of the largest device manufacturers.

Stewart now works for Ortho Sales Partners, a company that helps device manufacturers navigate relationships with hospitals.

Keeping those relationships strong is crucial, because hospitals don't have to allow reps into their operating rooms. But if reps are allowed, there are rules: Reps can't touch the patient or anything that's sterile.

Big companies like Stryker have developed detailed policies for their own reps about how to behave in the operating room. And some hospitals, like hospital chain HCA's flagship medical center in Nashville, have instituted even stricter rules — selling is banned in the OR and reps are only allowed to provide support for surgical cases.

But Stewart maintains reps still can be useful. Some help surgical assistants find a particular tiny component among the trays of ancillary tools. Some reps even deliver the tool trays to the hospital themselves, prior to the surgery. They want the procedure to run as smoothly as possible so that a busy surgeon will become a steady customer.

"Obviously, there's a patient on the table being operated on, so that's where the sense of urgency is," Stewart said. "You have to become an expert in understanding how to be efficient with helping everyone in the OR making sure your implants are being utilized correctly."

Keeping Up With Technology

It has become difficult for hospital staffs to keep pace with constant design changes for artificial joints or spinal rod systems, Stewart said.

The speed of innovation concerns some researchers, including Dr. Adriane Fugh-Berman, a Georgetown University medical doctor who studies the relationships between industry and physicians.

"What we need are skilled helpers in the operating room who are not making money off of the choices of the surgeons," she said.

Fugh-Berman said she has come to believe that reps should be banned from operating rooms. Her biggest concern is safety, including the occasional violations of sterile protocol. As part of her research, she anonymously interviewed reps who said they're instructed to always push the latest, most expensive products, even when the old version is more proven.

"The newest device is not necessarily the best device," she said. "In fact, it may be the worst device."

Cost Concerns

Yet safety issues are not what has worn out the welcome for some reps — it's their potential influence on surgical costs. Their precise impact remains hard for hospitals to quantify, but hospital executives now have a new incentive to push back on the role of the rep because insurance reimbursement formulas have changed.

For example, in 2016 the government-run Medicare program began changing how it pays hospitals for a joint replacement — from a traditional billing-for-costs model to a fixed-dollar amount for each surgery. It's a cost-control move, because joint replacement has become one of the most common reasons for inpatient hospitalization for Medicare patients.

Increasingly, hospitals are feeling the squeeze of these new payment caps.

"They're looking at costs and saying, 'I want to understand everything that drives cost in my OR,'" said Doug Jones, a former rep with DePuy who now works for HealthTrust to control surgical spending. "I think they're becoming more aware that that rep is in there and saying, 'Is there a cost associated with it?'"

HealthTrust hasn't been telling administrators to kick out sales reps. But it has been suggesting hospitals reassess their role. The company, which is a subsidiary of for-profit hospital chain HCA, has studied particular devices, like pedicle screws, often used in spine procedures. They cost anywhere from $50 to $100 to manufacture, but a hospital might pay a thousand dollars apiece to keep them in stock. One basic spine procedure can involve several screws and rods, with the sales rep standing to make a 10 percent to 25 percent commission on the equipment used, according to HealthTrust's market research.

And in many places, upselling occurs in the room, said HealthTrust's Ford. He recalled seeing reps encouraging a surgeon preparing for a procedure to use a fancier device that wasn't on the hospital's discounted list.

Other HealthTrust clients are starting pilot projects on running operating rooms without company-sponsored reps and buying equipment directly from smaller firms, which often have devices that are nearly identical to the brand names.

But getting rid of the rep may have hidden costs, too.

Surgeon-Rep Relationships

Joint replacements have become so routine that an experienced surgical team can nearly operate in silence. When the surgeon says "neck" and reaches out his hand, an assistant places the piece in his hand without a moment's delay.

The array of tools and components are often in the right place because a device rep made sure of it. Logistics is a big part of the job — delivering trays of instruments in the pre-dawn hours to be sterilized by the hospital, the "non-glorious side of being a rep," Ford said.

The logistical role has essentially been filled by the manufacturers instead of hospitals in recent decades. And now surgeons may trust their reps more than anyone else in the room. They're often the first call he or she makes when scheduling a case, to make sure the device will be ready to go.

"If that widget isn't there the next day when I'm doing a case and I need the widget, we're kind of at an impasse," said Christie, the Nashville-based joint replacement surgeon.

Many experienced surgeons, like Christie, also have financial ties to manufacturers, collecting substantial royalties for helping design new implants. As of 2013, these payments are now disclosed publicly. Christie, for example, was paid $123,000 by DePuy in 2017.

An industry trade group spokesman defends the close relationship as a way to improve their products and provide hands-on training to surgeons. "Those are two areas where it's key to maintain a close, collaborative relationship, with the appropriate ethical limitations," said Dr. Terry Chang, associate general counsel for AdvaMed.

Filling A Personnel Gap

The overall result is that many clinicians are happy to have reps in the room.

"You say 'sales rep,'" said Marley Duff, an operating room manager at TriStar Centennial Medical Center. "I look at them more being somebody that's expertly trained in their field to provide support for the implants that they happen to sell."

Reps can be especially helpful when a failing artificial joint needs to be removed and replaced, Duff said.

Hospitals are reluctant to remove reps, for fear of irritating surgeons, who typically don't work directly for a particular hospital and could move their cases to another institution. Those hospitals experimenting with going "rep-less" have done so quietly and have had to hire additional staff to pick up the slack.

One of the first in the country to try, Loma Linda University Health in Loma Linda, Calif., boasted in 2015 of reducing costs for total knee and hip replacements by more than 50 percent by going rep-less.

But a hospital spokeswoman now says that the medical center has abandoned the effort, though she refused to discuss why.

Short On Federal Funding, Obamacare Enrollment Navigators Switch Tactics

KFF Health News, November 30, 2018

Nationwide, navigator groups are scrambling to make up for the loss of federal funding to ensure they can help people make sense of their health insurance options.

This article first appeared November 30, 2018 on Kaiser Health News.

By Phil Galewitz

Enrollment is down sharply on the federal health insurance marketplace this fall, and the consumer assistance groups that help with sign-ups think they know why.

They don't have the staff to help as many customers as before because the Trump administration slashed funding. The federal government is spending $10 million this year on navigators who help individuals enroll in coverage. The government spent $36 million in 2017 and $63 million in 2016.

"We don't have the people to provide the enrollment assistance nor to do the outreach and marketing to let people know what's happening," said Jodi Ray at the University of South Florida, who has overseen Florida's largest navigator program since 2014.

Ray's program received $1.2 million in federal funding this year, down from $5 million a year ago. Florida leads the nation in enrollment in the Affordable Care Act marketplace plans.

With less money, Ray can afford to pay only 59 navigators across the state this year, down from 152 a year ago. With fewer navigators, much of the group's counseling is done by phone instead of in person. That complicates their job, she said, because it is much easier to talk with and show marketplace customers in person when looking at dozens of health plans with different costs and benefits.

Open enrollment in the Obamacare plans began Nov. 1 and will run until Dec. 15 for the 39 states covered by the federal exchange, healthcare.gov. The other exchanges — run by states — typically extend until the end of December or into January.

Obamacare plans are for people without workplace or government coverage.

Nationwide, navigator groups are scrambling to make up for the loss of federal funding to ensure they can help people make sense of their health insurance options.

In South Carolina, the Palmetto Project has transformed into the state's first nonprofit insurance agency. Several of its former federally funded navigators are now licensed insurance agents. In their new role, they get paid a commission on their sales and don't have to follow Trump administration rules that encourage navigators to talk to customers about short-term plans with limited benefits. The agents can also help customers enroll in Medicaid, Medicare and off-exchange plans.
The Community Council of Greater Dallas, which was funded last year to help with enrollment in 56 counties, has raised money from private donors to continue serving seven counties around Dallas. But it has 25 fewer navigators, so consumers seeking help must wait three days on average, compared with less than a day last year. Across Texas, 211 of 254 counties have no federally paid navigators.
In Wisconsin, the organization Covering Wisconsin has raised millions of dollars from cities, counties and local United Way chapters, as well as the state Medicaid agency, to make up for the federal cuts. Even still, it will be able to provide in-person assistance in only eight counties around Milwaukee and Madison. Twenty other counties are served by telephone.
The Kansas Association for the Medically Underserved is relying totally on volunteers to help consumers with in-person and telephone assistance. In the past year, the association was able to use government funding to pay about 20 navigators.

Nationally, nearly 800 counties served by the federal marketplace will not have any federally funded navigators this fall — up from 127 counties in 2016, according to the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.)

Federal officials said they were not providing funds for navigators in Iowa, Montana or New Hampshire because no organizations applied in those states.

Nearly 12 million people across the country — including nearly 9 million on the federal exchange — enrolled in Obamacare plans for 2018.

At the halfway point in the six-week enrollment period, 2.4 million people chose a plan for the 2019 coverage year on healthcare.gov, the federal health insurance exchange, according to data released Wednesday by the federal Centers for Medicare & Medicaid Services. That compares with nearly 2.8 million consumers who selected their coverage through the exchange during the first 25 days last year.

Among states with the largest enrollment drops: Pennsylvania (down 25 percent from last year), Missouri (down 25 percent) and Ohio (down 20 percent).

The annual enrollment tally is being closely followed in part because 2019 marks the first year since the marketplace plans began in 2014 that Americans won't be fined for failing to have coverage.

But consumer experts think the lack of navigator funding could end up having a bigger impact on enrollment. Caroline Gómez-Tom, navigator program manager of Covering Wisconsin, said the end of the so-called individual mandate penalty has been a "non-issue" among people seeking coverage.

"Some folks mention it, but at the end of the day they still walk away with health coverage," she said. "The ability to have coverage at affordable prices outweighs the penalty being gone because people still see health care insurance as important to have."

Consumers generally have a greater choice of plans for 2019 as more companies enter the individual market and existing plans expand service areas. Plus, premiums are dropping in some areas, and where they are rising the rate of increase is among the lowest in several years.

Katrina McGivern, director of policy and public affairs for the Kansas Association for the Medically Underserved, said people in rural areas of the state will have the most difficulty getting help as a result of funding cuts.

After five years of experience, she said, she is hopeful that people are figuring out how to do it on their own. Still, she added, there are always "people who need assistance to get through it."

Chronically Ill, Traumatically Billed: The $123,000 Medicine For MS

KFF Health News, November 28, 2018

Even in a world of soaring drug prices, multiple sclerosis medicines stand out. Over two decades, costs for MS medicines rose five to seven times faster than those for prescription drugs generally.

This article first appeared November 28, 2018 on Kaiser Health News.

By Jay Hancock

Shereese Hickson's multiple sclerosis was flaring again. Spasms in her legs and other symptoms were getting worse.

She could still walk and take care of her son six years after doctors diagnosed the disease, which attacks the central nervous system. Earlier symptoms such as slurred speech and vision problems had resolved with treatment, but others lingered: she was tired and sometimes still fell.

This summer, a doctor switched her to Ocrevus, a drug approved in 2017 that delayed progression of the disease in clinical trials better than an older medicine did.

Genentech, a South San Francisco-based subsidiary of Swiss pharma giant Roche, makes Ocrevus. It is one of several drugs for multiple sclerosis delivered intravenously in a hospital or clinic. Such medicines have become increasingly expensive as a group, priced in many cases at well over $80,000 a year. Hospitals delivering the drugs often take a cut by upcharging the drug or adding hefty fees for the infusion clinic.

Hickson received her first two Ocrevus infusions as an outpatient two weeks apart in July and August. And then the bill came.

Patient: Shereese Hickson, 39, single mother who worked as a health aide and trained as a medical coder, living in Girard, Ohio. Because her MS has left her too disabled to work, she is now on Medicare; she also has Medicaid for backup.

Total Bill: $123,019 for two Ocrevus infusions taken as an outpatient. CareSource, Hickson's Medicare managed-care plan, paid a discounted $28,960. Hickson got a bill for about $3,620, the balance calculated as her share by the hospital after the insurance reimbursement.

Medical Service: Two Ocrevus infusions, each requiring several hours at the hospital.

Service Provider: Cleveland Clinic, a nonprofit, academic medical center in Ohio.

What Gives: Hickson researched Ocrevus online after her doctor prescribed the new medicine. "I've seen people's testimonies about how great it is," on YouTube, she said. "But I don't think they really go into what it's like receiving the bill."

That was particularly shocking because, covered by government insurance for her disability, she'd never received a bill for MS medicine before.

"I have a 9-year-old son and my income is $770 a month," said Hickson. "How am I supposed to support him and then you guys are asking me for $3,000?"

Even in a world of soaring drug prices, multiple sclerosis medicines stand out. Over two decades ending in 2013, costs for MS medicines rose at annual rates five to seven times higher than those for prescription drugs generally, found a study by researchers at Oregon Health & Science University.

"There was no competition on price that was occurring," said Daniel Hartung, the OHSU and Oregon State University professor who led the study. "It appeared to be the opposite. As newer drugs were brought to market, it promoted increased escalation in drug prices."

With Ocrevus, Genentech did come up with a price that was slightly less than for rival drugs, but only after MS medicines were already extremely expensive. The drug launched last year at an annual list price of $65,000, about 25 percent lower than that of other MS drugs, Hartung said. MS drugs cost about $10,000 per year in the 1990s and about $30,000 a decade ago.

"We set the price of Ocrevus to reduce price as a barrier to treatment," said Genentech spokeswoman Amanda Fallon.

It was also probably a response to bad publicity about expensive MS drugs, Hartung said. "Now companies are very aware at least of the optics of releasing drugs at higher and higher prices," he said.

Patients starting Ocrevus get two initial infusions of 300 milligrams each and then 600 mg twice a year. Cleveland Clinic charged $117,089 for Hickson's first two doses of Ocrevus — more than three times what hospitals typically pay for the drug, said John Hennessy, chief business development officer at WellRithms, a firm that analyzes medical bills for self-insured employers.

As is typical of government programs such as Medicare, the $28,960 reimbursement ultimately collected by the Cleveland Clinic was far less — but still substantial.

"We kind of got ourselves in a pickle here," he said. "We're more excited about the discount than we are about the actual price."

Hickson's nearly $3,620 bill represented the portion that Medicare patients often are expected to pay themselves.

Last year, the Institute for Clinical and Economic Review, an independent nonprofit that evaluates medical treatments, completed a detailed study on MS medicines. It found that Ocrevus was one of three or four medicines that were most effective in reducing MS relapses and preventing MS from getting worse. But it also found that patient benefits from MS drugs "come at a high relative cost" to society.

At the same time, deciding which MS drug — there are about a dozen — would best suit patients is something of a shot in the dark: The science showing the comparative effectiveness of MS drugs is not as strong as it could be, researchers say.

"In general, there's a real lack of head-to-head studies for many of these drugs," said Hartung. The FDA has no required comparison standard for MS drugs, an agency spokeswoman said. Sometimes they're rated against placebos. With everyone able to charge a high price, the companies have little incentive to see which works better and which worse.

Resolution: After Hickson questioned the charges over the phone, the billing office told her to apply to the hospital for financial assistance. Hickson had to print a form, provide proof of her disabled status, mail it and wait.

Hospital officials told her in October she qualified for assistance based on her income through a state program funded by hospital contributions and federal money. Cleveland Clinic wiped out the $3,620 balance.

"I'm grateful that they approved me for that, but not everybody's situation is like that," she said. She was worried enough about being billed again for her next Ocrevus infusion that she considered switching back to her old medicine. But her doctor wants her to give it more time to gauge its effects.

The Takeaway: Always ask about charity care or financial assistance programs. Hospitals have different policies and wide discretion about how to apply them, but often do not even tell patients such programs exist.

Because health care costs are so high, you may be eligible even if you have a decent salary. Cleveland Clinic gives free care to everybody below a certain income, said spokeswoman Heather Phillips. But it wasn't until Hickson called that the hospital agreed to erase the charge.

While there are multiple new drugs to treat serious chronic conditions, they have often not been tested against one another. Moreover, your doctor may have no idea about their relative prices. He or she should. For newer drugs, all options may well be very expensive.

Keep in mind that drugs which must be infused often come with facility fees and infusion charges, which can leave patients with hefty copayments for outpatient treatment. Ask about oral medicines or those you can self-inject at home.

One Twin's Difficult Birth Puts A Project Designed To Reduce C-Sections To The Test

KFF Health News, November 27, 2018

To avoid unnecessary C-sections when what to do isn't clear, this hospital has changed the way labor and delivery is handled from start to finish.

This article first appeared November 27, 2018 on Kaiser Health News.

By Martha Bebinger, WBUR

The tiny hand and forearm slipped out too early. Babies are not delivered shoulder first. Dr. Terri Marino, an obstetrician in the Boston area who specializes in high-risk deliveries, tucked it back inside the boy's mother.

'He was trying to shake my hand and I was like, 'I'm not having this — put your hand back in there,'' Marino would say later, after all 5 pounds, 1 ounce of the baby lay wailing under a heating lamp.

This is the story of how that baby, Bryce McDougall, tested the best efforts of more than a dozen medical staffers at South Shore Hospital in Weymouth, Mass., that day last summer.

Bryce's birth also put to the test a new method of reducing cesarean sections developed at Dr. Atul Gawande's Ariadne Labs, a 'joint center for health systems innovation' at Brigham and Women's Hospital and the Harvard T.H. Chan School of Public Health in Boston.

The story starts before Bryce's birth, on the last day of August at about 9:30 in the morning.

Melisa McDougall has just checked into South Shore, after a routine ultrasound. She's in her 36th week, pregnant with twin boys. The doctors have warned Melisa that her placenta won't hold out much longer. She's propped up in bed, blond hair pulled into a neat bun, makeup still fresh, ordering a sandwich, when her regular obstetrician arrives.

'How are you?' asks Dr. Ruth Levesque, sweeping into the room and clapping her hands. 'You're going to have some babies today! Are you excited?'

The first of the twins — Brady — is head-down, ready for a normal vaginal delivery. But brother Bryce is horizontal at the top of Melisa's uterus.

That's one reason Melisa is a candidate for a C-section. Babies do not come out sideways. And there's another reason most doctors would not consider a vaginal delivery in Melisa's case, Levesque says. Four years ago, she delivered the twins' sister by cesarean.

'[Melisa] has a scar on her uterus,' Levesque explains, 'so there's a risk of uterine rupture — very rare, but there's always a possibility.'

And that possibility may be greater for Melisa because she's 37 and having twins. But the McDougalls hope to have vaginal deliveries for both boys.

'I just feel like it's better for the kids — better for the babies,' Melisa says.

How The 'Team Birth Project' Came To Be

Avoiding C-sections is also better for many moms. With cesareans, there's a longer recovery period, a greater risk of infection and an association with injury and death. And most C-sections are not medically necessary, said Dr. Neel Shah, who directs the Delivery Decisions Initiative at Ariadne Labs.

'We're fairly confident that, when you look nationally, the plurality — if not the majority — of C-sections are probably avoidable,' said Shah.

Those avoidable C-sections are the focus of the Team Birth Project, designed by Shah with input from roughly 50 doctors, nurses, midwives, doulas, public health specialists and consumer advocates who focus on childbirth. South Shore Hospital is one of the pilot sites for the project.

In describing the collaboration, Shah begins with an acknowledgement: Childbirth is complicated. You've got two patients — the mother and the baby — and an ad hoc, often shifting team that at a minimum includes the mom, a nurse and a doctor.

'So you've got three people who have to come together and become a very high-performing team in a really short period of time, for one of the most important moments in a person's life,' Shah said.

And this team has to perform at its best during an unpredictable event: labor.

Shah says doctors and nurses generally agree about three things: when a mom is in active labor; when a mom can definitely try for a vaginal delivery; and when she must have a C-section.

'And then there's this huge gray zone,' Shah said. 'And actually, everything about the Team Birth Project is about solving for the gray.'

To avoid unnecessary C-sections when what to do isn't clear, this hospital, in conjunction with Ariadne, has changed the way labor and delivery is handled from start to finish.

First, women aren't admitted until they are in active labor. Secondly, the mom's preferences — such as whether she'd like an epidural or not, whether she wants to have 'skin-to-skin contact' with the baby immediately after birth — help guide the members of the labor team. The team members map the delivery plan — including mom's preferences and the medical team's guidance — on a whiteboard, like the one in Melisa's room.

For the births of Bryce and Brady McDougall, the white erasable planning board gets a lot of use.

Under 'Team,' Levesque and registered nurse Patty Newbitt write their names. Melisa and Shaun McDougall are also listed as equal partners. The names of other family members or nurses may be added and erased as labor progresses. Shah's idea is that this team will 'huddle' regularly throughout the labor to discuss the evolving birth plan.

The birth plan itself is divided into three separate elements on the board: Maternal (the mom), Fetal (the baby) and Progress (in terms of how the labor is progressing). A mom with high blood pressure, for instance, may need special attention — and that would be noted on the board — but she could still have a normal labor and vaginal delivery.

Good Communication Throughout Labor And Delivery Is Key

Dr. Kimberly Dever, who chairs the OB-GYN department at South Shore, highlights a section of the whiteboard called 'Next Assessment.'

That category is included on the board, Dever said, 'because one of the things I often heard from patients is that they didn't know what was going to happen next. Now they know.'

Asking the mom — and the couple — about their preferences for the delivery is crucial, too, Levesque said.

'It forces us to stop and to think about everything with the patient,' she explained. 'It makes us verbalize our thought process, which I think is good.'

Shaun McDougall walks across the room to get a closer look at the whiteboard.

'Honestly, it seems like common sense,' he says. 'I would always think the nurses would have something like this, but to have it out where mom and dad can see it — I think it's pretty cool.'

With Melisa McDougall's plan in place, everyone settles in, to wait. About four hours later, Melisa isn't yet feeling contractions. Levesque breaks the water sac around Brady.

'Looks nice and clear,' Levesque reports. 'Hey bud, come on and hang out with us,' she says to the baby.

'So, you're going to keep leaking fluid until you leak babies,' the doctor explains to Melisa. 'Whenever you start getting uncomfortable, we'll get you an epidural at that point.'

Levesque moves to the board and adds updates: Melisa is 4 centimeters dilated; her waters broke at 13:26; the next assessment will be after she gets an epidural.

The medical team insisted ahead of time that Melisa agree to be numbed from the waist down if she wants to deliver Bryce — the second twin — vaginally. Melisa agreed. The obstetricians may need to rotate the baby in her uterus, find a foot and pull Bryce out, causing pain most women would not tolerate.

One of those doctors — Marino — peeks into the room and waves.

'Just came to say hi,' says Marino, who has more experience than most obstetricians in delivering babies positioned like Bryce. Along with Levesque, Marino has been seeing Melisa regularly through office visits.

Shaun McDougall asks the physicians if they'll pose for a picture with his wife.

'Can we make funny faces?' asks Levesque.

'I want you to,' says Shaun. 'You guys are like her favorite people on the planet.'

As the hours tick by, there's a shift change, and registered nurse Barbara Fatemi joins the McDougall team. She checks Melisa's pain level regularly to determine when she's ready for the epidural.

Melisa says she isn't feeling much, but adds that she has a high tolerance for pain. Shaun tells Fatemi he sees the strain on his wife's face. Fatemi acts on Shaun's assessment, and calls an anesthesiologist to prepare the epidural, something Shaun later says reinforces his feeling that they're a team.

Levesque soon arrives for the promised 'next assessment.' Melisa is now 10 centimeters dilated and ready to deliver — but she must hold on until nurses can get her into an operating room.

The OR will be the right place if the second baby, Bryce, doesn't shift his position, and the doctor needs to do a last-minute cesarean.

'I'll see you in a few minutes. No pushing without me, OK?' Levesque says over her shoulder as she heads to the OR to prep.

'I'll try,' Melisa says, weakly. In a minute, nurses are rolling her down the hall, following Levesque.

Almost five years ago, two women who were wheeled into this hospital's operating rooms during childbirth died after undergoing C-sections. Though state investigators found no evidence of substandard care, Dever, the head of obstetrics, said the hospital scrutinized everything.

'When you have something like that happen, that expedites your efforts,' she said. 'Exponentially.'

Now, Dever said, she sees an opportunity, through the Team Birth Project, to model changes that could help women far and wide.

'I would love women everywhere to be able to come in and have a safe birth and healthy baby,' she said. 'That's why I'm doing it.'

'They Did Not Flinch'

Dever is about to see her pilot study of the Team Birth Project pushed to new limits by little Bryce McDougall. First, though, Melisa must deliver Bryce's twin brother, Brady. Even his birth, the one that was expected to be easier, is more difficult than anticipated.

Bent nearly in half, her face beet red, Melisa strains for five pushes. She throws up, then gets back to laboring. And suddenly, there he is.

'Oh my goodness Brady, oh Brady,' wails Shaun. He follows a nurse holding his son over to a warmer.

Marino takes Shaun's place next to Levesque, who has reached inside Melisa to get the next twin. Levesque's mission is to grab Bryce's feet and guide him out. But everything feels like fingers, not toes.

'That's a hand,' she murmurs. 'That's a hand, too.'

Marino rolls an ultrasound across Melisa's belly, hoping the scan will show a foot. But Bryce's feet are out of sight and out of reach.

Marino has had more experience than most obstetricians with transverse babies and this procedure, known as a breech extraction; she asks to try. She reaches into Melisa's uterus while Levesque moves to Melisa's right side and uses her forearm to shift Bryce and push him down. Dever has come into the room, and takes over the ultrasound. At least six doctors and nurses encircle Melisa, whose face is taut. Shaun frowns.

'Babe, you OK?' he asks.

Melisa nods. Bryce's heart rate is steady. But there's still no sign of a foot. One little hand slips out and Marino nudges it back in.

'Open the table,' says Marino, her voice strained.

It's open and ready, her colleagues say, referring to the array of sterile surgical instruments that Marino may soon need, to begin a C-section.

For 36 seconds, this room with more than a dozen adults grows oddly quiet. Everyone is watching Marino twist her arm this way and that, determined to find Bryce's feet. Levesque leans hard into Melisa's belly. Shaun bites his lip. Then Marino yanks at something — and her gloved hand emerges, clenching baby Bryce by his two teeny legs.

'Oh babe, here he comes, here he comes — Woo!' squeals Shaun.

Shaun is overcome with emotion again. Melisa manages an exhausted giggle. Baby Bryce keeps everyone waiting a few more seconds and then howls.

Levesque tends to Melisa, and Marino comes around to congratulate the new mom.

'He was fighting you, huh?' Melisa says, and laughs.

'I think I found at least five hands,' says Levesque.

Outside the OR, Levesque and Marino look relieved and elated. Both agree that most doctors would have delivered Bryce by C-section. But at South Shore, the McDougalls found a hospital that has challenged itself to perform fewer C-sections, and a doctor with experience in these unusual deliveries — one who knew and respected the parents' preference.

'They specifically wanted to have a vaginal delivery of both babies,' Marino says — and that was on her mind during the difficult moments.

Bryce was fine, says Marino, so the deciding factor for her was that Shaun and Melisa did not panic.

'They did not flinch — they were like, 'Keep going,'' Marino recalls. 'Sometimes the patient will say 'stop,' and then you have to stop.'

The babies' father says he came close to requesting that, in the very last minute before Bryce was born.

'That part with the arm — it was pretty aggressive,' Shaun says.

But in that moment, he adds, the feeling that he and Melisa were part of the team made a difference.

'It made us more comfortable,' Shaun says, and that comfort translated to trust. 'We trusted the decisions they were making.'

Melisa says she's grateful for the vaginal delivery.

'I did not want to have a natural birth and a C-section,' she says. 'That would be a brutal recovery.'

Instead, 30 minutes after Bryce's birth, Melisa is nursing Brady and talking with family members on FaceTime.

Next Assessment For The Team Birth Project

South Shore began using the Team Birth approach in April. Three other hospitals are also pilot sites: Saint Francis in Tulsa, Okla.; EvergreenHealth in Kirkland, Wash.; and Overlake in Redmond, Wash. The test period runs for two years. In the first four months at South Shore, the hospital's primary, low-risk C-section rate dropped from 31 percent to 27 percent — about four fewer C-sections each month.

Experts who contributed to the development of the Team Birth Project are eager to see whether other hospitals can lower their rates of C-section and keep them down.

'Once you get past the early adopters, how do you demonstrate the benefits for others that aren't willing to change?' asked Gene Declercq, a professor of community health sciences at Boston University School of Public Health.

Declercq noted that a few insurers are beginning to force that question, refusing to include in their networks hospitals that have high C-section rates, or high rates of other unnecessary, if not harmful, care.

The federal government has set a target rate for hospitals: No more than 23.9 percent of first-time, low-risk mothers should be delivered by C-section. The U.S. average in 2016 was 25.7 percent.

The target was put in place because research has shown that if a woman's first delivery is a C-section, her subsequent deliveries are highly likely to be C-sections, too — raising her (and her baby's) risk for complications and even death.

Declercq said the project's focus on communication in the labor and delivery room makes sense because many physicians decide when to perform a cesarean based on clinical habit or the culture of their hospital.

'If you can impact that decision-making process, you can perhaps change the culture that might lead to unnecessary cesareans,' said Declercq.

Overshadowed By Opioids, Meth Is Back And Hospitalizations Surge

KFF Health News, November 26, 2018

As opioids become harder to get, police said, more people have turned to meth, which is inexpensive and readily available. Hospitalizations and deaths have surged.

This article first appeared November 26, 2018 on Kaiser Health News.

By Anna Gorman

The number of people hospitalized because of amphetamine use is skyrocketing in the United States, but the resurgence of the drug largely has been overshadowed by the nation's intense focus on opioids.

Amphetamine-related hospitalizations jumped by about 245 percent from 2008 to 2015, according to a recent study in the Journal of the American Medical Association. That dwarfs the rise in hospitalizations from other drugs, such as opioids, which were up by about 46 percent. The most significant increases were in Western states.

The surge in hospitalizations and deaths due to amphetamines "is just totally off the radar," said Jane Maxwell, an addiction researcher. "Nobody is paying attention."

Doctors see evidence of the drug's comeback in emergency departments, where patients arrive agitated, paranoid and aggressive. Paramedics and police officers see it on the streets, where suspects' heart rates are so high that they need to be taken to the hospital for medical clearance before being booked into jail. And medical examiners see it in the morgue, where in a few states, such as Texas and Colorado, overdoses from meth have surpassed those from the opioid heroin.

Amphetamines are stimulant drugs, which are both legally prescribed to treat attention deficit hyperactivity disorder and produced illegally into methamphetamine. Most of the hospitalizations in the study are believed to be due to methamphetamine use.

Commonly known as crystal meth, methamphetamine was popular in the 1990s before laws made it more difficult to access the pseudoephedrine, a common cold medicine, needed to produce it. In recent years, law enforcement officials said, there are fewer domestic meth labs and more meth is smuggled in from south of the border.

As opioids become harder to get, police said, more people have turned to meth, which is inexpensive and readily available.

Lupita Ruiz, 25, started using methamphetamine in her late teens but said she has been clean for about two years. When she was using, she said, her heart beat fast, she would stay up all night and she would forget to eat.

Ruiz, who lives in Spokane, Wash., said she was taken to the hospital twice after having mental breakdowns related to methamphetamine use, including a monthlong stay in the psychiatric ward in 2016. One time, Ruiz said, she yelled at and kicked police officers after they responded to a call to her apartment. Another time, she started walking on the freeway but doesn't remember why.

"It just made me go crazy," she said. "I was all messed up in my head."

The federal government estimates that more than 10,000 people died of meth-related drug overdoses last year. Deaths from meth overdose generally result from multiple organ failure or heart attacks and strokes, caused by extraordinary pulse rates and skyrocketing blood pressure.

In California, the number of amphetamine-related overdose deaths rose by 127 percent from 456 in 2008 to 1,036 in 2013. At the same time, the number of opioid-related overdose deaths rose by 8.4 percent from 1,784 to 1,934, according to the most recent data from the state Department of Public Health.

"It taxes your first responders, your emergency rooms, your coroners," said Robert Pennal, a retired supervisor with the California Department of Justice. "It's an incredible burden on the health system."

Costs also are rising. The JAMA study, based on hospital discharge data, found that the cost of amphetamine-related hospitalizations had jumped from $436 million in 2003 to nearly $2.2 billion by 2015. Medicaid was the primary payer.

"There is not a day that goes by that I don't see someone acutely intoxicated on methamphetamine," said Dr. Tarak Trivedi, an emergency room physician in Los Angeles and Santa Clara counties. "It's a huge problem, and it is 100 percent spilling over into the emergency room."

Trivedi said many psychiatric patients are also meth users. Some act so dangerously that they require sedation or restraints. He also sees people who have been using the drug for a long time and are dealing with the downstream consequences.

In the short term, the drug can cause a rapid heart rate and dangerously high blood pressure. In the long term, it can cause anxiety, dental problems and weight loss.

"You see people as young as their 30s with congestive heart failure as if they were in their 70s," he said.

Jon Lopey, the sheriff-coroner of Siskiyou County in rural Northern California, said his officers frequently encounter meth users who are prone to violence and in the midst of what appear to be psychotic episodes. Many are emaciated and have missing teeth, dilated pupils and a tendency to pick at their skin because of a sensation of something beneath it.

"Meth is very, very destructive," said Lopey, who also sits on the executive board of the California Peace Officers Association. "It is just so debilitating the way it ruins lives and health."

Nationwide, amphetamine-related hospitalizations were primarily due to mental health or cardiovascular complications of the drug use, the JAMA study found. About half of the amphetamine hospitalizations also involved at least one other drug.

Because there has been so much attention on opioids, "we have not been properly keeping tabs on other substance use trends as robustly as we should," said study author Dr. Tyler Winkelman, a physician at Hennepin Healthcare in Minneapolis.

Sometimes doctors have trouble distinguishing symptoms of methamphetamine intoxication and underlying mental health conditions, said Dr. Erik Anderson, an emergency room physician at Highland Hospital in Oakland, Calif. Patients also may be homeless and using other drugs alongside the methamphetamine.

Unlike opioid addiction, meth addiction cannot be treated with medication. Rather, people addicted to the drug rely on counseling through outpatient and residential treatment centers.

The opioid epidemic, which resulted in about 49,000 overdose deaths last year, recently prompted bipartisan federal legislation to improve access to recovery, expand coverage to treatment and combat drugs coming across the border.

There hasn't been a similar recent legislative focus on methamphetamine or other drugs. And there simply aren't enough resources devoted to amphetamine addiction to reduce the hospitalizations and deaths, said Maxwell, a researcher at the Addiction Research Institute at the University of Texas at Austin. The number of residential treatment facilities, for example, has continued to decline, she said.

"We have really undercut treatment for methamphetamine," Maxwell said. "Meth has been completely overshadowed by opioids."

In Health Insurance Wastelands, Rosier Options Crop Up For 2019

KFF Health News, November 26, 2018

When Republicans failed to kill the health law last year, they inadvertently may have made it stronger. Insurers banked hefty profits this year, and new companies are moving in.

This article first appeared November 23, 2018 on Kaiser Health News.

By Jordan Rau

In recent years, places such as Memphis and Phoenix had withered into health insurance wastelands as insurers fled and premiums skyrocketed in the insurance marketplaces set up by the Affordable Care Act. But today, as in many parts of the country, these two cities are experiencing something unprecedented: Premiums are sinking and choices are sprouting.

In the newly competitive market in Memphis, the cheapest midlevel "silver" plan for next year will cost $498 a month for a 40-year-old, a 17 percent decrease. Four insurers are selling policies in Phoenix, which then-presidential candidate Donald Trump highlighted in 2016 as proof of "the madness of Obamacare" as all but one insurer left the region.

Janice Johnson, a 63-year-old retiree in Arizona's Maricopa County, which includes Phoenix, said her premium for a high-deductible bronze plan will be $207 instead of $270 because she is switching carriers.

"When you're on a fixed income, that makes a difference," said Johnson, who receives a government subsidy to help cover her premium. "I'll know more than a year from now if I'm going to stick with this company, but I'm going to give them a chance, and I'm pretty excited by that."

Across all 50 states, premiums for the average "benchmark" silver plan, which the government uses to set subsidies, are dropping nearly 1 percent. And more than half of the counties that use the federal healthcare.gov exchange are experiencing an average 10 percent price decrease for their cheapest plan.

In most places, the declines are not enough to erase the price hikes that have accrued since the creation in 2014 of the health care exchanges for people who don't get insurance through an employer or the government.

Instead, experts said, next year's price cuts help to correct the huge increases that jittery insurers set for 2018 plans to protect themselves from anticipated Republican assaults on the markets. Although Congress came up one vote shy of repealing the law, Trump and Republicans in Congress did strip away structural underpinnings that pushed customers to buy plans and helped insurers pay for some of their low-income customers' copayments and deductibles. Insurers responded with 32 percent average increases.

"Insurers overshot last year," said Chris Sloan, a director at Avalere, a health care consulting company in Washington, D.C. "We are nowhere close to erasing that increase. This is still a really expensive market with poor benefits when it comes to deductibles and cost."

For 2019, the average benchmark silver premium will be 75 percent higher than it was in 2014, according to data from the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

When Republicans failed to kill the health law last year, they inadvertently may have made it stronger. Insurers banked hefty profits this year, and new companies are moving in.

All these factors were especially influential in Tennessee, where the average benchmark premium is dropping 26 percent, according to a government analysis. That is more than in any other state.

In 2018, 78 of 95 Tennessee counties had just one insurer. That monopoly allowed the insurer to set the prices of its plans without fear of competition, said David Anderson, a researcher at the Duke-Margolis Center for Health Policy in Durham, N.C. "They were massively overpriced," he said.

But for the coming year, 49 Tennessee counties will have more than one insurer, with a few — like Shelby County, where Memphis is located — having four companies competing. There, Cigna dropped the price of its lowest-cost silver plan by 15 percent. Nonetheless, it was underbid by Ambetter of Tennessee, which is owned by the managed-care insurer Centene Corp.

"We're finally at the point where the market is stabilized," said Bobby Huffaker, the CEO of American Exchange, an insurance brokerage firm based in Tennessee. "From the beginning, every underwriter, and the people who were the architects, they knew it would take several years for the market to mature."

Still, the cheapest Memphis silver premium is nearly three times what it was in 2014, the first year of the marketplaces. A family of four with 40-year-old parents will be paying $19,119 for all of next year unless they qualify for a government subsidy.

"The unsubsidized are leaving," said Sabrina Corlette, a professor at Georgetown University's Health Policy Institute. "They are finding these premiums unaffordable."

The landscape in Phoenix is greatly improved from when Trump visited after the federal government announced a 116 percent premium increase for 2017, as the number of insurers dropped from eight to one.

But now, three new insurers are entering Maricopa County. Ambetter, the only insurer this year, dropped its lowest price for a silver plan for next year by 12 percent and still offers the cheapest such plan.

Ambetter's plan is still 114 percent above the least expensive silver plan in the first year of the exchanges. And none of the insurers are offering as broad and flexible a choice of doctors and hospitals as consumers had back then, said Michael Malasnik, a local broker.

Since the start of the exchanges, he said, insurers have "raised their rates by multiples, and they've figured out you have to be a very narrow network."

Each plan for 2019 contains trade-offs. He said only Bright Health's plan includes Phoenix Children's Hospital. Ambetter's plan includes the most popular hospital and doctor groups, but they are not as conveniently located for people living in the southeastern corner of the county, making other insurers' plans appealing.

"Geography is the name of the game this year," Malasnik said.

Theresa Flood, a preschool teacher who lives outside Phoenix, said none of the plans she considered accepted her doctors, who include a specialist for her spine problems — she has had four surgeries — and a neurologist who monitors a cyst and benign tumor in her brain.

"I have to establish care with a whole new spine doctor and establish care with a whole new neurologist if I want to follow up on these things," Flood, 59, said. "You're going from established care to who in the heck am I going to see?"

The plan she chose would have been too expensive except that she and her husband, John, a pastor, qualified for a $1,263-a-month subsidy that will drop the cost to $207 a month. That bronze plan from Ambetter carries a $6,550-per-person deductible, so she expects she'll still have to pay for her doctors on her own unless she needs extensive medical attention.

"It's gone from being able to have a plan that you could sort of afford and got some benefit from, to putting up with what you can afford and hoping nothing happens that you actually have to use your insurance," she said. "At this point, I'll take what I can get."

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More than 114,000 people are waiting for organs in the U.S. and fewer than 35,000 organs were transplanted last year. Transplant centers want to make sure donated organs aren't wasted.

A third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020, leading many to wonder whether the Orphan Drug Act may have overcorrected.

Hospitalizations of nursing home residents, while decreasing in recent years, remain a problem, with nearly 11% of patients in 2016 being sent to hospitals for conditions that might have been averted with better medical oversight.

Coupled with other ongoing efforts by the Trump administration to gut Obamacare, policy experts predict the ideas would further foster a parallel market of cheaper, less robust coverage that could draw younger or healthier consumers, but drive up premiums for those who remain in ACA market plans.

Reshaping The Individual Market

Critics of the practice say that device reps attend surgeries to strengthen their relationships with particular surgeons and thereby persuade them to choose one brand of artificial hip joint or stent or pacemaker over a competitor's.

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Nationwide, navigator groups are scrambling to make up for the loss of federal funding to ensure they can help people make sense of their health insurance options.

Even in a world of soaring drug prices, multiple sclerosis medicines stand out. Over two decades, costs for MS medicines rose five to seven times faster than those for prescription drugs generally.

To avoid unnecessary C-sections when what to do isn't clear, this hospital has changed the way labor and delivery is handled from start to finish.

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As opioids become harder to get, police said, more people have turned to meth, which is inexpensive and readily available. Hospitalizations and deaths have surged.

When Republicans failed to kill the health law last year, they inadvertently may have made it stronger. Insurers banked hefty profits this year, and new companies are moving in.

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