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Updated: 21 hours 8 min ago

‘We’re Fighting For Our Lives’: Patients Protest Sky-High Insulin Prices

December 12, 2018

Angela Lautner knew her thirst was unusual, even for someone directing airplanes, outside in the Memphis summer heat.

“We had coolers of Gatorade and water for people to always have access to,” Lautner recalled of her job as a ground services agent. “But the amount of thirst that I felt was just incredible.”

She had no appetite and she lost an unusual amount of weight. Then after a trip to the emergency room, Lautner, who was 22, was diagnosed with Type 1 diabetes. The diagnosis was life-changing.

To start, it meant that for the rest of her life she would require insulin injections every day to stay alive. Unlike Type 2 diabetes, which can sometimes be controlled by diet, people with Type 1 diabetes need daily insulin injections to regulate their blood sugar.

Lautner’s diagnosis also meant she was no longer allowed to become a commercial airline pilot in the U.S. — a lifelong dream that she was training for in flight school at the time.

“I cried harder over losing my dream to fly than I did at the diagnosis of Type 1 diabetes,” Lautner said.

But after 18 years living with diabetes, Lautner now says the hardest thing about the diagnosis is accessing insulin — the expensive drug she needs to keep her alive. She has had to borrow money from her parents to pay for insurance; she has spent hours on the phone with drug companies; she has switched brands of insulin to save costs; and she even moved to a new state, Kentucky, with a more generous Medicaid plan.

Last year, Lautner noticed other people with Type 1 diabetes tweeting similar stories under the hashtag #Insulin4All. She read the stories of Shane Patrick Boyle and Alec Raeshawn Smith, two men who died because they could not afford their insulin. It was an epiphany.

“I thought, ‘My goodness, there’s more people than me. I’m not the only one out here,’ ” she said.

Since then, Lautner has joined a group of consumer activists, people who need insulin to live and are angry about the sky-high prices. They are putting pressure on the three main companies that make insulin: Sanofi of France, Novo Nordisk of Denmark and Eli Lilly and Co. in the U.S.

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Taking On The Drugmakers

The cost of insulin nearly tripled from 2002 to 2013 and has doubled again since then. The list price is over $300 for a single vial of medicine, and most people with Type 1 diabetes need multiple vials every month to live. That cost is typically lower with insurance or with discount programs. Still, for some people the price is unmanageable.

There’s been some action by lawmakers on the issue. In October, Minnesota’s attorney general sued insulin manufacturers alleging price gouging, and a bipartisan caucus in the U.S. Congress issued a report in November urging action to bring insulin prices down.

But prices are still going up, so consumer activists like Lautner are taking things into their own hands.

Nonprofit group T1International, which advocates for Type 1 diabetes around the world, with a particular focus on insulin prices, has started holding rallies outside the Indianapolis headquarters of pharmaceutical giant Eli Lilly and Co.

Lautner joined more than 70 people who came together to demonstrate there in September. They were asking for three things: transparency about how much it costs to make a vial of insulin and how much profit comes from each vial, and a commitment from the company to lower the list price of insulin.

Protesters hailed from at least 12 states, mainly Ohio, Illinois, Indiana and Kentucky, but also from as far away as New York. Lautner, who now lives outside Cincinnati, rented a school bus with a dozen others to make the 112-mile trip.

“Insulin is kind of the face of the drug pricing crisis in America,” said Elizabeth Pfiester, founder of T1International who has Type 1 diabetes herself. “We literally die without it,” she said. “We’re fighting for our lives.”

This was the third time the group had protested at Eli Lilly headquarters. Last fall, when the group held its first protest there, Pfiester said, it was “the first time where people living with Type 1 were able to physically stand and show that people are angry enough to come out.”

Eli Lilly declined a request for an interview, but in statement a spokesperson said, “We understand why people are making their voices heard.”

Protesting is one arm of their advocacy efforts; the group is also lobbying at the state and national level, and conducting online awareness-raising campaigns under the hashtag #Insulin4All.

Advocacy At The State Level

Last spring, the fight got even more personal for Angela Lautner. She got a letter from her insurance company saying they were no longer going to pay for the insulin she was taking. They wanted to switch her to a different brand.

Most people with Type 1 diabetes use two types of insulin: short-acting insulin to counteract the carbohydrates consumed with meals, and long-acting insulin to keep blood sugar stable throughout the day.

Lautner has found that the long-lasting insulin brand Lantus works best with her body; it keeps her blood sugars low, but not so low that she becomes dangerously hypoglycemic, risking death. But her insurer was dropping its coverage of Lantus in favor of a different long-lasting insulin, Basaglar.

“The problem that I immediately saw was that [Basaglar] had not worked for my body,” Lautner said. “So I go into my doctor’s office with this letter and I’m like, ‘What am I going to do?'”

Lautner’s doctor connected her to Sanofi’s drug discount program, where she was able to get a month’s supply of Lantus for a couple of hundred dollars. So she decided to pay for the insulin herself.

“I’m fortunate enough to have an emergency fund,” Lautner said.

But she knows others aren’t so lucky.

This year, Lautner organized her own group of diabetes activists in Kentucky, Ohio and Indiana, called KOI Insulin4All. They’ve met with legislators in all three states about establishing emergency insulin prescription refills and about making the cost of insulin more transparent.

There are similar groups starting up in Oklahoma, Pennsylvania, Minnesota and Illinois. In November, activists protested outside the Cambridge, Mass., office of Sanofi. All of them are pushing for the same thing — to make the voices of people with diabetes heard.

This story is part of a reporting partnership with NPR.

One Implant, Two Prices. It Depends On Who’s Paying.

December 11, 2018

Kim Daniels didn’t have to pay a penny for her double mastectomy or the reconstructive surgery she had after treatment for breast cancer in June 2018. Her health insurance, PennCare, administered through Independence Blue Cross in Pennsylvania, fully covered both procedures.

Knowing that, cost wasn’t an issue for Daniels when selecting the type of breast implants. She asked her plastic surgeon at the Hospital of the University of Pennsylvania, “If I were your wife, what would you [choose]?” He went with Mentor MemoryGel implants.

According to Daniels’ hospital bill, those implants came with a price tag of $3,500 apiece, or $7,000 total.

Such a high charge for the exact same item would have been unthinkable if the procedure was cosmetic breast augmentation, which is generally not covered by health insurance. When patients pick up the tab, cosmetic surgery packages for breast augmentation cost about the same — $7,000 — but that includes the doctor’s fee, implants, operating room time and anesthesia.

The radical difference in price demonstrates in stark numerical terms how costs often depend on who is paying the bill.

Dr. Anupam Jena, a health economist at Harvard Medical School, said it’s precisely because cosmetic patients pay out-of-pocket that their costs for implants are far lower than what hospitals charge reconstructive patients.

“Cosmetic surgery providers have to compete with each other,” he said, and “one of the big ways they’re going to compete is to compete on price.”

“Whatever the cost is for the implant, they can’t up-charge too much, or a patient will just go somewhere else.”

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Dr. Alex Sobel, a cosmetic surgeon and president of the American Board of Cosmetic Surgery, said the price he charges cosmetic patients for breast implants is pretty close to the price he pays for the implants from the manufacturer. High-end implants like Daniels’ would be priced at a maximum of $3,000 for a set, he added, if Daniels had been undergoing cosmetic breast augmentation surgery.

Sobel operates a cosmetic surgery practice in Bellevue, Wash., which is in the region of the U.S. with the highest cost range for cosmetic breast surgeries. He said he usually pays around $250 to $700 per implant for saline and $700 to $1,000 per implant for silicone. The most expensive form — stable silicone or “gummy bear” implants — are usually priced around $1,350 each.

Similarly, Dr. Brent Rosen, a cosmetic surgeon with a practice in a northern suburb of Philadelphia, said the silicone implants he buys range from $1,500 to $2,000 per individual implant.

For the entire cosmetic breast augmentation procedure with silicone implants Rosen charges $6,500. That’s $500 less than the charge for just Daniels’ silicone implants at the nearby Hospital of the University of Pennsylvania.

Jena, the Harvard health economist, said the reason behind many of these price markups is that hospitals are like any other business trying to make a profit. They can ask more from a company like an insurer than they can from an individual.

“Why does Apple charge $1,000 for an iPhone? It doesn’t cost that much to make an iPhone. It’s so they can extract surplus money. Same goes for hospitals,” said Jena.

Breast implants are just one example of how medical devices are significantly marked up by hospitals.

A 2017 study published in JAMA found that for knee and hip implants, insurance companies were paying double what the hospitals paid when they purchased the implants from manufacturers.

It is hard to define a reasonable manufacturing cost or wholesale price for a medical-grade bag of silicone. Mentor Worldwide and Allergan, the two biggest manufacturers of breast implants in the U.S., declined to share their products’ wholesale costs or their price negotiation practices with providers. Manufacturers regard their pricing as a trade secret.

Hospitals typically obtain medical devices through health care group purchasing organizations, which are supposed to negotiate with manufacturers to get lower costs for items. Bigger hospitals or providers that offer to use more of a certain product often get steep discounts over wholesale.

In 2016, Medicare, which has huge leverage in negotiations, paid $516.59 for a “silicone or equivalent breast prosthesis.”

So, the hospital markup for patients who pay for the procedure or are commercially insured is even more extraordinary.

A Penn Medicine spokesperson told KHN in an email that they were unable to comment on specific patient cases, but that the hospital receives a single “case rate” or bundled payment for all breast reconstruction surgeries and that reimbursement is not related to the type of breast implant chosen.

Of course, when dealing with powerful insurance companies, hospitals don’t get paid the full asking price conveyed on their bills. The price is often merely the starting point for negotiations with insurers.

“Hospitals are absolutely marking up the prices for medical devices,” said Jeffrey McCullough, a health policy professor at the University of Michigan. But, he added, “you can almost guarantee the list price you see on a hospital bill is not what the hospital is getting paid by insurance companies,” which bargain for discounts.

Even so, not all patients have health insurance coverage as comprehensive as Kim Daniels’. In such cases, all or part of the hospital’s high charge for breast implants could be billed directly to patients.

“If you don’t have an insurance company bargaining on your behalf, the default is to charge the patient,” McCullough said.

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation.

More Than Half Of California Nursing Homes Balk At Stricter Staffing Rules

December 07, 2018

More than half of California’s nursing homes are asking to be exempted from new state regulations that would require them to spend more time directly caring for their patients.

The state’s new staffing requirements for nursing homes, quietly passed in last year’s budget bill, seem universally unpopular. Patient advocates say the new regulations don’t go far enough and that residents remain at risk in poorly staffed homes. Nursing home operators say they can’t hire enough staff to comply.

Under the new rules, which took effect in July but haven’t yet been enforced, skilled nursing facilities must provide at least 3.5 hours of direct care per resident per day, up from 3.2 hours of care previously. That care can range from inserting a feeding tube to changing an adult diaper or helping residents with eating and bathing.

The California Department of Public Health, which oversees nursing homes, is expected to announce in late January which — if any — facilities it will exempt from the new regulations. But some patient advocates don’t like the nursing homes’ balking.

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“We’re appalled by the waiver system. It’s sending the worst possible message to California nursing homes that it’s OK to staff at levels that endanger residents,” said Mike Connors of California Advocates for Nursing Home Reform, a consumer advocacy group.

(Check to see which California nursing homes have applied for workforce shortage waivers here and here.)

Researchers have strongly linked more nursing staff with better care, with some experts recommending from 3.8 to 4.1 hours of care per patient per day as a bare minimum for quality nursing home care. Having enough staff helps prevent falls, pressure sores and other problems that can land fragile seniors in the hospital.

A recent Kaiser Health News investigation found that for years nursing homes nationwide overstated staffing to the federal government. Now, nursing homes are required to report actual payroll records to remain eligible for Medicare and Medicaid payments.

During the first three months of 2018, 58 percent of California’s skilled nursing facilities averaged at least 3.5 hours of patient care a day, according to a Kaiser Health News analysis of payroll records submitted to the federal government. That rose to 76 percent when including nursing homes where administrators also were counted.

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California is one of only a few states that set their own minimum requirements for nursing home staffing. Most states abide by federal government standards requiring skilled nursing facilities that receive money from Medicare or Medicaid to have enough staff to meet residents’ needs, said Robyn Grant, director of public policy and advocacy for National Consumer Voice for Quality Long-Term Care, an advocacy group.

Illinois requires nursing homes to provide a minimum of 3.8 hours of care per patient a day and the District of Columbia requires 4.1 hours, Grant said. Maine and Oklahoma take a different approach, establishing staff-to-patient ratios, rather than hours of care, for nursing homes.

Nursing home officials and their lobbyists say it’s tough to find qualified nurses and assistants in California’s robust economy, and they bemoan what they describe as inadequate reimbursement from Medicare and Medicaid. They also have criticized a provision of the new requirements that 2.4 of the 3.5 hours of patient care must be provided by a certified nursing assistant, rather than another nursing professional.

Nursing homes need flexibility because “not every patient is the same, not every diagnosis is the same,” said Matt Robinson, legislative affairs director for the California Association of Health Facilities, an industry group. “We’re not opposed to more staff. But we want quality staff. We want to make sure there’s a sustainable workforce to meet that mandate, otherwise it’s just an empty mandate.”

Robinson said facilities are applying for waivers on a “good-faith basis.” If waiver requests aren’t granted, he said, nursing homes may reduce their beds or even shut down.

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In Los Angeles, the 300-bed Kei-Ai Los Angeles Healthcare Center has applied for an exemption citing a “workforce shortage.” But Cynthia Sakaki Sirlin, whose 86-year-old father, a veteran of the Korean War, lives there says, “I think it’s wrong.”

“I don’t know why they’re doing this. They need more nursing staff to improve patient care, not less, the research shows that. So why are they asking for a waiver? Why is the state allowing them? That just rewards owners who are not willing to staff the homes,” Sakaki Sirlin said.

Sakaki Sirlin, a nurse practitioner and a representative of Kei-Ai’s family council, said that since the formerly nonprofit nursing home was purchased by a real estate developer in 2016, she has noticed more staff turnover. She worries that her father, a wheelchair user who can’t feed himself, won’t get the care he needs. Representatives from Kei-Ai did not respond to a request for comment.

There are nearly 100,000 certified nursing assistants in California, according to federal labor data. Patient advocates say many CNAs choose not to work for nursing homes because of the comparatively low pay and tough workload.

“If they paid them better, they’d have plenty of staff,” even in remote parts of California, said Suzi Fregeau, long-term care program manager in Humboldt and Del Norte counties. The mean hourly wage for certified nursing assistants in California was $16.13 in 2017, according to federal labor data.

Some of the California homes seeking exemptions have been repeatedly cited by the state’s Department of Public Health for inadequate staffing that led to patient harm. Among them are homes owned by Shlomo Rechnitz, who reportedly controls 1 in 14 nursing home beds in California. He has faced numerous federal and state probes of understaffing and quality problems at his homes.

The CEO of one of Rechnitz’s nursing home management companies said in a written statement that several homes submitted “patient needs” waiver requests on their own with data provided by the company. “All of these facilities prioritize the needs of their patients above all else and these facilities have a stellar history of complying with applicable staffing requirements,” said David Silver, CEO of Rockport Administrative Services LLC.

“What we’re seeing is that the facilities that already are understaffed — the facilities for which we do get complaints — are the ones asking for waivers,” said Joe Rodrigues, the state’s long-term care ombudsman. “We’re not supportive of those requests.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

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

December 05, 2018

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.”

Patrick Mannion received a double-lung transplant in May 2017 after being diagnosed with idiopathic pulmonary fibrosis, a progressive, life-threatening lung disease. Through a transplant fundraising organization, HelpHopeLive, he has raised nearly $115,000, twice the original goal to help pay expenses that insurance didn’t cover, including copays for costly anti-rejection drugs. (Courtesy of Patrick Mannion)

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.

(Story continues below.)

“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.

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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.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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

December 03, 2018

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.

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“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.

(Story continues below.)

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.

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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.”

KHN data editor Elizabeth Lucas contributed to this report.

KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.

Feds Order More Weekend Inspections Of Nursing Homes To Catch Understaffing

November 30, 2018

The federal government announced plans Friday to crack down on nursing homes with abnormally low weekend staffing by requiring more surprise inspections be done on Saturdays and Sundays.

The federal Centers for Medicare & Medicaid Services said it will identify nursing homes for which payroll records indicate low weekend staffing or that they operate without a registered nurse. Medicare will instruct state inspectors to focus on those potential violations during visits.

“Since nurse staffing is directly related to the quality of care that residents experience, CMS is very concerned about the risk to resident health and safety that these situations may present,” the agency said in a notification to state inspection offices.

The directive comes after a Kaiser Health News analysis found there are 11 percent fewer nurses providing direct care on weekends on average, and 8 percent fewer aides.

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Residents and their families frequently complain the residents have trouble getting basic help — such as assistance going to the bathroom — on weekends. One nursing home resident in upstate New York compared his facility to a weekend “ghost town” because of the paucity of workers.

Richard Mollot, executive director of the Long Term Care Community Coalition, an advocacy group in Manhattan, welcomed the new edict but said it was only necessary because state inspectors have not been properly enforcing the rules already on the books.

“The basic problem is the states don’t take this seriously,” Mollot said. “How many studies do we have to have, year after year, decade after decade, saying it all comes down to staffing, and there are very few citations for inadequate staffing and virtually all of them are identified as not causing any resident harm?”

CMS said it will identify potential violators by analyzing payroll records that nursing homes are now required to submit. Those records, which became public this year, showed lower staffing than what facilities had previously told inspectors during their visits, according to the KHN analysis.

“CMS takes very seriously our responsibility to protect the safety and quality of care for our beneficiaries,” CMS Administrator Seema Verma said in a statement.

The nursing home industry criticized the heightened scrutiny.

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“Unfortunately, today’s action by CMS will enforce policies that makes it even more difficult to meet regulatory requirements and hire staff,” said Dr. David Gifford, senior vice president of quality and regulatory affairs at the American Health Care Association, an industry trade group, in a written statement. “Rather than taking proactive steps to address the national workforce shortage long-term care facilities are facing, CMS seems to be focusing on a punitive approach that will penalize providers and make it harder to hire staff to meet the shared goal of increasing staffing.”

Currently, a tenth of inspections must occur during “off hours,” which can be either a weekend, or during a weekday before 8 a.m. or after 6 p.m. But for facilities that Medicare identifies as having lower weekend staffing, half of those off-hour inspections—or 5 percent of the total — must be performed on Saturdays or Sundays.

Medicare requires nursing homes to have a registered nurse on site for at least eight hours every day, but according to the payroll records, a quarter of nursing homes reported no registered nurses available at least one day during a three-month period. Since July, Medicare’s Nursing Home Compare website for consumers has highlighted homes that lack sufficient registered nurses and lowered their star ratings. Nursing Home Compare has downgraded ratings for 1,402 of 15,600 facilities for gaps in registered nurse staffing, records show.

The new directive instructs inspectors to more thoroughly evaluate staffing at facilities Medicare flags. The edict does not mean a flurry of sudden inspections. Instead, Medicare wants heightened focus on those nursing homes when inspectors come for their standard reviews, which take place roughly once a year for most facilities.

But what may appear to be staffing scarcities in payroll records may instead be clerical problems in which nurse hours are not properly recorded, say some nursing home officials.

Katie Smith Sloan, president of LeadingAge, an association of nonprofit providers of aging services, said in a statement that some homes are still struggling to adapt to the new data collection rules.

“We’ve been voicing our concerns to CMS and will continue to do so,” she said.

KHN’s coverage of these topics is supported by John A. Hartford Foundation and The SCAN Foundation

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

November 30, 2018

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.

This investigation examines the booming orphan drug business and how drugmakers have rushed into the marketplace with hundreds of drugs for rare diseases, helping patients while landing lucrative federal incentives and monopoly control for every drug that gets approved.

In This Series: Get All Stories

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.

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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.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Look-Up: Medicare’s Bonuses And Penalties For Nursing Homes Near You

November 30, 2018

Click here to download KHN’s full data set.

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

November 30, 2018

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.

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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.

This story is part of a partnership that includes WPLN, NPR and Kaiser Health News.

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

November 27, 2018

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.

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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.

Melisa McDougall hears comforting words from her nurse at South Shore Hospital in Weymouth, Mass. Part of the focus of the Team Birth Project is on facilitating communication among parents, nurses and doctors.(Jesse Costa/WBUR)

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.

The whiteboard in Melisa McDougall’s hospital room details the birth plan, including her preferences and the medical team’s guidance.(Jesse Costa/WBUR)

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.

This story is part of a reporting partnership with WBUR, NPR and Kaiser Health News.

KHN’s coverage of these topics is supported by Heising-Simons Foundation and The David and Lucile Packard Foundation

Playing On Fear And Fun, Hospitals Follow Pharma In Direct-To-Consumer Advertising

November 19, 2018

The scene is shadowy, and the background music foreboding. On the TV screen, a stream of beleaguered humans stand in an unending line.

“If you’re waiting patiently for a liver transplant, it could cost you your life,” warns the narrator.

One man pulls another out of the queue, signaling an escape. Both smile.

Is this a dystopian video game? Gritty drama? Neither. It is a commercial for the living-donor liver transplant center at the University of Pittsburgh Medical Center, an academic hospital embroiled in a high-profile battle with the region’s dominant health plan and now making a play to a national audience.

Hospitals are using TV spots like this one to attract lucrative patients into their hospitals as health care costs and industry competition escalate. Some institutions use them to build national and international brands on niche but high-priced health services. They’re often procedures involving expensive technology that benefit only a sliver of the population. But they could lure wealthy patients seeking high-end care and can also give hospitals some leverage with insurers.

“Hospitals are competing, just like any other business,” said Mark Fratrik, an economist at BIA Advisory Services, a media consulting firm.

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UPMC’s ad has been airing nationally this year during cable news shows. Advertising research company iSpot.tv estimates the campaign’s cost at more than $3 million since it first aired in early September. The commercial is aimed at the estimated 14,000 people on the United States liver transplant list, hospital officials said.

But some analysts worry that these hospital advertisements are incomplete or misleading.

“We have choices about where we seek medical care,” said Dr. Yael Schenker, an associate professor of medicine at the University of Pittsburgh, who has researched hospital advertising but was not involved with the liver transplant ad. “We want to spend our money wisely, and need information about the quality and cost of health care services. Health care advertising — which purports to offer that information and fill that need for consumers — really doesn’t.”

Last year, hospitals nationwide spent more than $450 million on advertising overall, according to figures from Kantar Media, a firm that monitors ad spending. That comes on the heels of a surge between 2011 and 2015, during which time hospitals and health systems upped their ad spending by 41 percent, according to figures published by Advertising Age, which tracks marketing trends. By 2015, hospital ad spending accounted for close to a quarter of all health care-related advertising, according to the Advertising Age report.

The UPMC ad is just one flavor. New York City’s Hospital for Special Surgery, an orthopedic hospital, launched its own national campaign this year — a minute-long spot featuring jaunty electronic music and people of all ages dancing, jogging and doing yoga and gymnastics. “How you move,” the text asserts, “is why we’re here.”

John Englehart, the hospital’s chief marketing officer, said the campaign is meant to introduce potential patients to HSS from around the country, but he said it should be viewed with other informational materials, such as independent rankings. He wouldn’t comment on how much the hospital has spent on its ad, though iSpot places its value at about $325,000.

A nationally broadcast ad for Yale New Haven Hospital, in Connecticut, shows a cancer survivor at a bicycle race telling viewers the hospital “did give me my life back.” That spot had a far shorter campaign life, and iSpot estimates its value around $11,000. The hospital did not provide comment, despite multiple requests.

Screengrab from the Hospital for Special Surgery commercial(iSpot.tv screengrab)

Screengrab from the Yale New Haven Hospital commercial(iSpot.tv screengrab)

Until now, hospital-to-patient marketing has stayed out of the spotlight, as politicians are focused on high drug costs and warn they will crack down on advertising by the pharmaceutical industry. (Pharma ads make up the bulk of paid health care marketing, though hospitals constitute the majority of health care spending.)

Unlike prescription drugs, whose commercials require special approval from the federal Food and Drug Administration, ads for hospitals and health systems are regulated by the Federal Trade Commission, which oversees the marketing of consumer goods.

Or as Schenker put it, “We’re treating them the same way we treat ads for cars and cereal.” But when it comes to health care versus other commodities, “it’s not as easy to figure out if we’ve made a good choice,” she said.

Direct marketing from hospitals and health care centers is by no means a new phenomenon. Billboards and TV ads for spinal surgery and cancer treatments date back years.

But “there’s more money in hospitals’ coffers these days to [market services] more. And why not?” said Robert Berenson, a health care expert at the Urban Institute, a think tank in Washington, D.C.

An ad like UPMC’s highlighting its live-donor liver transplant program signals prestige.

It caters to patients from around the country and even abroad who are often wealthier, or out-of-network, or covered by higher-paying private insurance, noted Paul Ginsburg, a health economist at the University of Southern California. All are more profitable audiences. (UPMC said it has provided live transplants to patients of all stripes, including those covered by Medicaid, which insures low-income people and pays hospitals less.)

Gerard Anderson, a Johns Hopkins health policy professor and expert on health care pricing, said the ad also can communicate to local consumers that, if they sign up with UPMC — as opposed to a competing hospital — they’re more likely to get better care.

“You’re differentiating yourself from everyone else by saying, ‘I can do this very sophisticated thing that no one else can do. Therefore, sign up with me,’” Anderson said.

Or as Berenson put it: “There are not that many people with liver transplants. There’s some halo effect. They’re trying to get people to recognize the name and go for other services.”

But there is no evidence to suggest that excelling in one particular, complex procedure tracks with providing good care overall.

UPMC casts its campaign as an outreach effort meant to inform people who need liver transplants of a potentially lifesaving option. It is not meant to imply anything further, hospital representatives said. “This is truly an awareness educational campaign,” said Dean Walters, UPMC’s chief marketing officer. He said 14,000 people in the United States need a liver transplant, and that number grows every year. “This is about making sure consumers are aware of this option.”

Walters would not disclose how much UPMC has spent on this particular campaign, though he acknowledged the hospital has made a “financial commitment” to promoting this service. According to Kantar, the marketing firm, UPMC spent more than $4 million on advertising in the first six months of 2018.

Englehart said HSS’ ad is meant to dispel any illusion that the hospital is catering to wealthy patients only — though he also said their campaign is meant to enhance HSS’ reputation both nationally and internationally.

Many health economists suggested the payoff can extend well beyond tapping into the market of potential American or foreign patients. A campaign like this one helps hospitals gain negotiating power in their ongoing struggle with insurers over reimbursement rates.

A hospital that successfully brands itself as excellent or prestigious — even in one procedure or specialty — can leverage that identity when bargaining with insurers.

“They want Hospital A in their network even more, which means Hospital A can extract more from insurers — mainly in the form of higher prices,” said Martin Gaynor, a health care economist at Carnegie Mellon University and former head of the FTC’s Bureau of Economics.

An Underused Strategy For Surge In STDs: Treat Patients’ Partners Without A Doctor Visit

November 13, 2018

If patients return to Dr. Crystal Bowe soon after taking medication for a sexually transmitted infection, she usually knows the reason: Their partners have re-infected them.

“While you tell people not to have sex until both folks are treated, they just don’t wait,” she said. “So they are passing the infection back and forth.”

That’s when Bowe, who practices on both sides of the North and South Carolina border, does something doctors are often reluctant to do: She prescribes the partners antibiotics without meeting them.

Federal health officials have recommended this practice, known as expedited partner therapy, for chlamydia and gonorrhea since 2006. It allows doctors to prescribe medication to their patients’ partners without examining them. The idea is to prevent the kind of reinfections described by Bowe — and stop the transmission of STDs to others.

However, many physicians aren’t taking the federal government’s advice because of entrenched ethical and legal concerns.

“Health care providers have a long tradition of being hesitant to prescribe to people they haven’t seen,” said Edward Hook, professor at the University of Alabama’s medical school in Birmingham. “There is a certain skepticism.”

A nationwide surge of sexually transmitted diseases in recent years, however, has created a sense of urgency for doctors to embrace the practice. STD rates have hit an all-time high, according to the Centers for Diseases Control and Prevention. In 2017, the rate of reported gonorrhea cases increased nearly 19 percent from a year earlier to 555,608. The rate of chlamydia cases rose almost 7 percent to 1.7 million.

“STDs are everywhere,” said Dr. Cornelius Jamison, a lecturer at the University of Michigan Medical School. “We have to figure out how to … prevent the spread of these infections. And it’s necessary to be able to treat multiple people at once.”

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A majority of states allow expedited partner therapy. Two states — South Carolina and Kentucky — prohibit it, and six others plus Puerto Rico lack clear guidance for physicians.

A 2014 study showed that patients were as much as 29 percent less likely to be re-infected when their physicians prescribed medication to their partners. The study also showed that partners who got those prescriptions were more likely to take the drugs than ones who were simply referred to a doctor.

Yet only about half of providers reported ever having prescribed drugs to the partners of patients with chlamydia, and only 10 percent said they always did so, according to a different study. Chlamydia rates were higher in states with no law explicitly allowing partner prescriptions, research published earlier this year showed.

Because of increasing antibiotic resistance to gonorrhea, the CDC no longer recommends oral antibiotics alone for the infection. But if patients’ partners can’t go in for the recommended treatment, which includes an injection, the CDC said that oral antibiotics by themselves are better than no treatment at all.

“Increasing resistance plus increasing disease rates is a recipe for disaster,” said David Harvey, executive director of the National Coalition of STD Directors. The partner treatment is important for “combating the rising rates of gonorrhea in the U.S. before it’s too late.”

The CDC recommendations are primarily for heterosexual partners because there is less data on the effectiveness of partner treatment in men who sleep with men, and because of concern about HIV risk.

Bowe said that even though she writes STD prescriptions for her patients’ partners, she still worries about possible drug allergies or side effects.

“I don’t know their medical conditions,” she said. “I may contribute to a problem down the road that I’m going to be held liable for.”

Physician Crystal Bowe, who practices in North and South Carolina, said she occasionally writes prescriptions for her patients’ partners but worries about possible drug allergies or side effects. “I don’t know their medical conditions,” she says. “I may contribute to a problem down the road that I’m going to be held liable for.” (Courtesy of Crystal Bowe)

In many cases, doctors and patients simply do not know about partner therapy. Ulysses Rico, who lives in Coachella, Calif., said he contracted gonorrhea several years ago and was treated by his doctor. He didn’t know at the time that he could have requested medicine for his girlfriend. She was reluctant to go to her doctor and instead got the required antibiotics through a friend who worked at a hospital.

“It would have been so much easier to handle the situation for both of us at the [same] moment,” Rico said.

Several medical associations support partner treatment. But they acknowledge the ethical issues, saying it should be used only if the partners are unable or unwilling to come in for care.

Federal officials are trying to raise awareness of the practice by training doctors and other medical professionals, said Laura Bachmann, chief medical officer of the CDC’s office of STD prevention. The agency posts a map with details about the practice in each state.

Over the past several years, advocates have won battles state-by-state to get partner treatment approved, but implementation is challenging and varies widely, said Harvey, whose National Coalition of STD Directors is a member organization that works to eliminate sexually transmitted diseases.

The fact that some states don’t allow it, or haven’t set clear guidelines for physicians, also creates confusion — and disparities across state lines.

The Planned Parenthood affiliate that serves Indiana and Kentucky sees this firsthand, said clinical services director Emilie Theis. In Indiana, providers can legally write prescriptions for their patients’ partners, but they are prohibited from doing so in Kentucky, even though the clinics are only a short drive apart, she noted. A similar dynamic is at play along the South Carolina-North Carolina border, where Bowe practices.

California started allowing partner treatment for chlamydia in 2001 and for gonorrhea in 2007. The state gives medication to certain safety-net clinics, a program it expanded three years ago. However, “it has been an incredibly difficult sell” because many medical providers think “it’s a little bit outside of the traditional practice of medicine,” said Heidi Bauer, chief of the STD control branch of California’s public health department.

At APLA Health, which runs several health clinics in the Los Angeles area, nurse practitioner Karla Taborga occasionally gives antibiotics to patients for their partners. But she tries to get the partners into the clinic first, because she worries they might also be at risk for other sexually transmitted infections.

“If we are just treating for chlamydia, we could be missing gonorrhea, syphilis or, God forbid, HIV,” Taborga said. But if prescribing the drugs without seeing the patients is the only way to treat them, she said, “it’s better than nothing.”

Edith Torres, a Los Angeles resident, said she pressured her then-husband to go to the doctor after he gave her chlamydia several years ago: She refused to have sex with him until he did. Torres said she wanted him to hear directly from the doctor about the risks of STDs and how they are transmitted.

If he had taken the medication without a doctor visit, he wouldn’t have learned those things, she said. “I was scared, and I didn’t want to get it again.”

KHN's coverage in California is supported in part by Blue Shield of California Foundation.

Fish Oil And Vitamin D Pills No Guard Against Cancer Or Serious Heart Trouble

November 10, 2018

A widely anticipated study has concluded that neither vitamin D nor fish oil supplements prevent cancer or serious heart-related problems in healthy older people, according to research presented Saturday at the American Heart Association Scientific Sessions. Researchers defined serious heart problems as the combined rate of heart attacks, stroke and heart-related deaths.

Although hundreds of studies of these supplements have been published over the years, the new clinical trial — a federally funded project involving nearly 26,000 people — is the strongest and most definitive examination yet, said Dr. Clifford Rosen, a senior scientist at the Maine Medical Center Research Institute who was not involved in the research.

Doctors have been keenly interested in learning the supplements’ true value, given their tremendous popularity with patients. A 2017 study found that 26 percent of Americans age 60 and older take vitamin D supplements, while 22 percent take pills containing omega-3 fatty acids, a key ingredient in fish oil.

The new study also suggests there’s no reason for people to undergo routine blood tests for vitamin D, said Rosen, who co-wrote an accompanying editorial. (Both were published in the New England Journal of Medicine.). That’s because the study found that patients’ vitamin D levels made no difference in their risk of cancer or serious heart issues, Rosen said. Even people who began the study with clear vitamin D deficiency got no benefit from taking the supplements, which provided 2,000 international units a day. This amount is equal to one or two of the vitamin D pills typically sold in stores.

A recent Kaiser Health News story reported that vitamin D testing has become a huge business for commercial labs — and an enormous expense for taxpayers. Doctors ordered more than 10 million vitamin D tests for Medicare patients in 2016 — an increase of 547 percent since 2007 — at a cost of $365 million.

“It’s time to stop it,” said Rosen of vitamin D testing. “There’s no justification.”

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Dr. JoAnn Manson, the study’s lead author, agrees that her results don’t support screening healthy people for vitamin D deficiency.

But she doesn’t see her study as entirely negative.

Manson notes that her team found no serious side effects from taking either fish oil or vitamin D supplements.

“If you’re already taking fish oil or vitamin D, our results would not provide a clear reason to stop,” Manson said.

Manson notes that a deeper look into the data suggested possible benefits.

When researchers singled out heart attacks — rather than the rate of all serious heart problems combined — they saw that fish oil appeared to reduce heart attacks by 28 percent, Manson said. As for vitamin D, it appeared to reduce cancer deaths — although not cancer diagnoses — by 25 percent.

But slicing the data into smaller segments — with fewer patients in each group — can produce unreliable results, said Dr. Barnett Kramer, director of the cancer prevention division at the National Cancer Institute. The links between fish oil and heart attacks — and vitamin D and cancer death — could be due to chance, Kramer said.

Experts agree that vitamin D is important for bone health. Researchers didn’t report on its effect on bones in these papers, however. Instead, they looked at areas where vitamin D’s benefits haven’t been definitely proven, such as cancer and heart disease. Although preliminary studies have suggested vitamin D can prevent heart disease and cancer, more rigorous studies have disputed those findings.

Manson and her colleagues plan to publish data on the supplements’ effects on other areas of health in coming months, including diabetes, memory and mental functioning, autoimmune disease, respiratory infections and depression.

Consumers who want to reduce their risk of cancer and heart disease can follow other proven strategies.

“People should continue to focus on known factors to reduce cancer and heart disease: Eat right, exercise, don’t smoke, control high blood pressure, take a statin if you are high risk,” said Dr. Alex Krist, a professor of family medicine and population health at Virginia Commonwealth University.

Measure To Cap Dialysis Profits Pummeled After Record Spending By Industry

November 08, 2018

Record-breaking spending by the dialysis industry helped doom a controversial California ballot measure to cap its profits.

The industry, led by DaVita and Fresenius Medical Care, spent nearly $111 million to defeat Proposition 8, which voters trounced, 62 to 38 percent, and appeared to approve in just two of 58 counties. The measure also faced strong opposition from medical organizations, including doctor and hospital associations, which argued it would limit access to dialysis treatment and thus endanger patients.

The opposition presented a powerful message that “if you can’t get dialysis, you will die,” said Gerald Kominski, a senior fellow at the UCLA Center for Health Policy Research. “If you didn’t know that, the commercials made it clear.”

Despite arguments about the outsize profits of dialysis companies, Kominski said the “Yes on 8” case wasn’t as clear. The measure, sponsored by the Service Employees International Union-United Healthcare Workers West, sought to cap dialysis clinic profits at 115 percent of the costs of patient care. Revenues above that amount would have been rebated primarily to insurance companies. Medicare and other government programs, which pay significantly lower prices for dialysis, wouldn’t have received rebates.

The union raised nearly $18 million — a large sum for most initiatives but about 16 percent of what the opposition mustered.

The proposition also was poorly written and difficult for voters to understand, said Erin Trish, associate director of health policy at the USC Schaeffer Center for Health Policy and Economics. Trish said she wasn’t surprised by the landslide defeat given the widespread ads against the initiative about the potential harms to patients. “The message came through loud and clear,”  she said.

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Trish said health care industry groups genuinely viewed Proposition 8 as a poor initiative — but they also didn’t want to see rate regulation. “This is not what most of these associations want to open the door to,” Trish said.

Generally speaking, said Jessica Levinson, a professor at Loyola Law School, voters’ default on initiatives is “no.” In addition, money spent against an initiative is usually more effective than money spent for it. Levinson said people weren’t 100 percent sure what they were voting on with Proposition 8. All of those factors made passage “an uphill battle,” she said.

Kathy Fairbanks, a spokeswoman for the opposition, credited the electorate for properly sorting out the facts. “Voters did their homework and saw who lined up on both sides,” Fairbanks said. “All the leaders of the medical community were against Proposition 8 because of the negative impact it would have had on patients and access to dialysis.”

Proponents of the measure argued that highly profitable dialysis companies don’t invest enough in patient care and that they need to hire more staff and improve clinic safety. Opponents said passage would have forced clinics to cut their hours or close altogether, resulting in more emergency room visits by dialysis patients.

SEIU-UHW said the opponents tried to “scare and mislead” voters. It vowed to continue targeting profitable dialysis companies with another measure on the 2020 ballot, as well as through legislation.

“We exposed problems within the dialysis industry and we put a spotlight on a sector that has operated in the shadow for far too long,” said Sean Wherley, spokesman for the “Yes” campaign. “But we are not finished yet. … The need is still there to hold this industry accountable.

He added that the union is proud to have put a spotlight on “the inflated charges that drive up health care costs for all California.”

Critics say that SEIU-UHW, which represents more than 95,000 workers in California, uses state and local ballot initiatives as a way to pressure legislators and gain bargaining power. They’ve sponsored measures on such topics as hospital and clinic funding, access to affordable insurance and training for in-home caregivers.

The union maintains its goal is simply to improve health care.

Two other Bay Area initiatives sponsored by SEIU, aiming to limit hospital pricing, also were defeated Tuesday, indicating that the ballot box may not be the best place to address concerns about costs in the health care industry.

“This is too complicated to do by ballot proposition,” Trish said.

Dialysis patients participated heavily in both the pro and con sides of the initiative, appearing in dramatic television ads and presenting their personal stories on social media.

Lili Hernandez, 27, who began treatment four years ago, showed up to her appointments at a DaVita clinic in Hollywood with “Yes on Prop. 8” placards even as  the clinic posted “No” signage, she said.

Hernandez supported the initiative because she believes the corporations should be held accountable, she said. “They take advantage of how much money they can charge, but don’t give the best service,” she said. “Too many people are at risk of infection and neglect.”

She woke up Wednesday feeling defeated. “I was awake last night, checked results online, had my cry and went to sleep,” she said, adding that she thinks people were confused about the initiative and believed the “false ads.”

Meanwhile, DeWayne Cox, a dialysis patient from Los Angeles, expressed relief. “This means that voters got the message, they understood,” he said.

Cox, 56, said he comes from a union family and believes in unions, but this was a “terrible” move by SEIU because it could lead to cutbacks in services. “Not only was this scary for me, but they made me angry,” he said. “If their motive was truly to help patients, they would have written a better, more precise measure.”

The measure became the most expensive race in California this year. Industry giants DaVita and Fresenius Medical Care, which operate nearly three-quarters of the chronic dialysis clinics in California, were responsible for more than 90 percent of the contributions in opposition to the measure

The California Medical Association, the California Hospital Association and the California chapter of the American College of Emergency Physicians all opposed Proposition 8. “Our concern was the impact on patient care,” said hospital association spokeswoman Jan Emerson-Shea. “If dialysis clinics were forced to close and patients needed care, we are the only place within the health care system that is open 24/7.”

Municipal ballot initiatives sponsored by SEIU-UHW targeted Stanford Health Care in Livermore and Palo Alto by attempting to cap prices at 115 percent of the “reasonable” cost of care. Under the initiatives, hospitals and other medical providers would have been required to pay back any charges above the cap each year to private commercial insurers. The initiatives failed dramatically, losing 77 to 23 percent in Palo Alto and in Livermore, 82 to 17 percent.

Voters did approve three statewide health care initiatives Tuesday, however:

  • Proposition 2 won 61 to 39 percent, allowing the state to issue $2 billion in bonds for housing for homeless people in need of mental health services. Bond money will be distributed to counties and repaid with proceeds from the Mental Health Services Act, which levies a 1 percent tax on personal incomes of $1 million and above.
  • Proposition 4, which won by the same margin, allows the state to distribute $1.5 billion in bonds to help the state’s 13 children’s hospitals’ pay for construction and equipment. It was the third time in 14 years that voters had agreed to subsidize the hospitals.
  • Proposition 11, passing with  59 percent of the vote, requires private ambulance employees to remain on call during their breaks — just as firefighters, policemen and other public emergency workers do.

Samantha Young and Harriet Rowan contributed to this report.

KHN’s coverage of these topics is supported by California Health Care Foundation and Blue Shield of California Foundation

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Like Clockwork: How Daylight Saving Time Stumps Hospital Record Keeping

November 03, 2018

Modern technology has helped medical professionals do robot-assisted surgeries and sequence whole genomes, but hospital software still can’t handle daylight saving time.

One of the most popular electronic health records software systems used by hospitals, Epic Systems, can delete records or require cumbersome workarounds when clocks are set back for an hour, prompting many hospitals to opt for paper records for part of the night shift.

And it happens every year.

“It’s mind-boggling,” said Dr. Mark Friedberg, a senior physician policy researcher at RAND, adding that in 2018, “we expect electronics to handle something as simple as a time change. “Nobody is surprised by daylight savings time. They have years to prep. Only, surprise, it hasn’t been fixed.”

Dr. Steven Stack, a past president of the American Medical Association, called the glitches “perplexing” and “unacceptable,” considering that hospitals spend millions of dollars on these systems, and Apple and Google seem to have dealt with seasonal time changes long ago. Epic was founded in 1979, but some hospitals have used these electronic systems longer than others.

Carol Hawthorne-Johnson, an ICU nurse in California, said her hospital doesn’t shut down the Epic system during the fall time change. But she’s come to expect that the vitals she enters into the system from 1 a.m. to 2 a.m. will be deleted when the clock falls back to 1 a.m. One hour’s worth of electronic record-keeping “is gone,” she said.

Hospital staff have learned to deal with it by taking extra chart notes by hand, but it’s still a burden, she said, especially if vitals change, or a patient needs something like a blood transfusion.

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Although hospitals often avoid the software glitches by turning the software off and switching to paper charts, it’s far from ideal because hospitals have evolved to become increasingly reliant on electronic systems, said Stack, an emergency physician in Kentucky.

“When [electronic medical records] work, it’s wonderful,” he said, but when the system is turned off, doctors can’t use it to access patient records or order tests. Whiteboards are a thing of the past, and some staff members aren’t as comfortable with paper records because they’ve relied on electronic records their entire careers.

“It’s an hour where you’re flying sort of blind,” Friedberg said.

The one-hour pause slows everything down, which can cause patients to spend more time in emergency department waiting rooms, prompting some to go home before seeing a health care provider. That’s dangerous, Stack said.

Not all hospitals turn Epic off, however. At Johns Hopkins Hospital, providers who need to check patients periodically through the night use a workaround. They enter vitals at 1 a.m. and then when the clock falls back an hour later and they have to enter new vitals, they list them at 1:01 a.m. They leave a note that it’s an hour later, not a minute later. That’s how the Cleveland Clinic does it, too.

“I don’t disagree with the sentiment that we would like health IT systems to be much more sophisticated,” said Dr. Peter Greene, Johns Hopkins chief medical information officer. But there are plenty of other problems he’d like to see fixed first. “This particular aspect is not one that has caused us a lot of trouble.”

Other electronic medical records systems may require similar workarounds, said Jennifer Carpenter, vice president of IT clinical systems at University Hospitals in Cleveland, which uses several electronic medical records systems. Cerner, another major electronic medical records company, was unavailable for comment, but many hospitals plan for Cerner to be down during the time change, too.

When asked to comment on the glitches and workarounds, Epic spokeswoman Meghan Roh provided the following statement:

“Daylight savings time is inherently nuanced for healthcare organizations, which is why we work closely with customers to provide guidance on how to most effectively use their system to care for their patients during this time period. We’re constantly making improvements and looking for opportunities to enhance the system.”

But Friedberg pointed out that hospitals are locked into their electronic medical record systems because they’ve invested so much money in them. And it would cost even more to convert and transfer the records into a new system. As a result, there’s little incentive for software companies to improve their products, he said.

“I shudder to think … what does it do with leap years?” Friedberg wondered.

Heart Drug Spotlights Troubling Trends In Drug Marketing

November 02, 2018

At the end of September, Amarin Corp. teased some early findings for Vascepa, its preventive medicine for people at risk of heart disease. The claim was astounding: a 25 percent relative risk reduction for deaths related to heart attacks, strokes and other conditions. Headlines proclaimed a potential game changer in treating cardiovascular disease. And company shares quickly soared, from $3 a share to about $20.

Vascepa is Amarin’s only product. The company wants to turn its pill made of purified fish oil into a cash cow, allowing it to staff up both in the United States and abroad so it can sell doctors and millions of consumers on its medical benefits. Although the product has been on the market for more than five years, its first TV ad campaign rolled out this summer in anticipation of the study findings.

Except there is one problem. The particulars of the scientific study on which this claim was based remain a mystery.

Amarin’s preliminary announcement came via a news release on Sept. 24. The company plans to release detailed findings in November at the national American Heart Association conference. Then early next year, it plans to seek Food and Drug Administration approval to use the drug as a preventive for a range of heart conditions, beyond its current role targeting high triglyceride levels.

In the interim, a battle is brewing among physicians, cardiovascular experts and pharma watchers who say Vascepa brings to the foreground troubling trends in the marketing and advertising of new drugs. Companies sometimes promote new products, but withhold the detailed findings until much later. The consequences for both consumers and the health system are vast.

“Until all the data is available for review by the public and medical community, it’s really premature to see some of the cheerleading that’s being done,” said Dr. Eric Strong, a hospitalist and clinical assistant professor at Stanford School of Medicine. “It’s harder to change people’s minds once you have these rosy pictures.”

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John Thero, Amarin’s CEO, argued that the imminent release of the drug’s complete picture should alleviate those concerns.

In unveiling topline findings in a news release, he said, the company’s playbook doesn’t diverge from that of other pharmaceutical makers, and provides a necessary level of disclosure for shareholders.

But it’s the specifics in the data — for instance, which patients benefited, by how much, their absolute risk reduction and which precise conditions saw improvement — that illustrate whether a product is cost-effective, said medical and drug experts.

That’s especially true in the case of Vascepa, whose manufacturer is working hard to convince people the product is clinically superior to ordinary fish oil supplements. Fish oil, which can retail for a few dollars a bottle, has long been promoted as a preventive for heart disease. But the substance has never held up in clinical trials as a way to systematically lower disease risk, said experts.

That’s where Amarin’s product is superior, Thero said.

The manufacturer has tried to limit competition by seeking to block other fish oil products —arguing to the U.S. International Trade Commission that omega-3 supplements aren’t equivalents, and calling on the FDA to block a chemical component of fish oil, known as EPA and marketed by a number of supplement companies, from being sold as a dietary supplement. Amarin hasn’t yet prevailed.

Preston Mason, a biologist who consults for Amarin and has advocated on its behalf, argued that ordinary fish oil supplements carry risks because they are not regulated or approved by the FDA, which does oversee prescription drugs like Vascepa.

How Vascepa performs against regular fish oil remains unknown. Amarin’s trial compared the drug against a placebo, not over-the-counter supplements.

Vascepa itself isn’t new. It was approved in 2012 as a remedy for extremely high triglyceride levels, which can put patients at risk for pancreatic problems. But reducing that fat hadn’t been conclusively tied to, say, lowering the risk of heart attacks, or other major cardiac problems.

That link, ostensibly, is what Amarin is trying now to assert. And there’s plenty of money to be made if it succeeds.

As of last December, Vascepa retailed for about $280 for a month-long supply, a list price increase of 43 percent over five years, though the company says its net sale price has stayed the same. (That difference would come if Amarin increased the size of rebates, or discounts it provides, commensurate with price hikes.)

Now, citing the drug’s potentially increased value, Amarin has declined to say whether it will change the price again — though Thero said he sees greater profit potential if the company increases sales volume rather than price.

This gets at the crux of this debate. If a company makes available the technical details of a product, but only after hyping the findings, and if the details undercut some of that buzz — is it too late?

Dr. Khurram Nasir, a Yale cardiologist, acknowledged that it’s unclear how effective Vascepa really is, but maintained those ambiguities will be cleared up soon enough.

“As the findings reveal themselves, there will be a lot of discussion around cost effectiveness, and whether this is worth the spend,” Nasir said.

Mason, the Amarin scientist, said FDA scrutiny can also alleviate concerns about overhype.

But others worry the perception of Vascepa’s effectiveness is now set.

“People are weighing in with really strong language, without enough information,” said Dr. Lisa Schwartz, who co-directs the Dartmouth Institute’s Center for Medicine and Media and studies effective scientific communication.

That has both clinical and financial consequences, she added. Doctors are more likely to prescribe a product that’s been heavily promoted, even if subsequent discussion indicates the drug isn’t as powerful as initially implied. And manufacturers can cash in, whether through increased company stock market value or by charging higher list prices.

For Vascepa, the central question is which specific heart conditions saw risk reduction, she and others said. In its news release, Amarin noted a “composite outcome” — that is, the 25 percent relative improvement encompassed all conditions for which the researchers tested.

“People are saying, Wow, it reduced heart attack, stroke and blah, blah, blah — when it may just reduce the least important one,” said Dr. Steven Woloshin, Schwartz’s research partner.

Another issue: The Vascepa trial focused on a specific population — patients with high triglyceride levels plus elevated risk of cardiovascular disease or diabetes who were already taking a daily statin. That means any proof of benefit is limited to that group.

Woloshin and Schwartz both suggested that nuance could get lost in translation. “It is this much narrower, high-risk population,” Schwartz said.

Woloshin added, “The fear is [the message] would generalize to anyone with high triglycerides.”

This concern is amplified by a 2016 court settlement in which the FDA permitted Amarin to market Vascepa to audiences for whom it hasn’t been specifically approved — so long as the company doesn’t say anything untrue about the drug.

Thero said Amarin’s marketing of Vascepa has stayed, and will remain, consistent with what is factual and relevant.

“We are proceeding consistently with what the FDA has guided,” he said.

But, some experts said, the 2016 settlement could unlock the door to wider marketing of Vascepa’s off-label use, implying the pill benefits more people than it actually does.

“They’ll take pains to show how different this is from everything out there … and its results in these populations,” said Dr. Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School, who studies the pharmaceutical industry. “What they can’t do is say it will be beneficial to these other populations. But they can hint at that.”

Dialysis Giant DaVita Defends Itself In Court And At The Polls

October 29, 2018

It’s been a year of playing defense for DaVita Inc., one of the country’s largest dialysis providers.

A federal jury in Colorado this summer awarded $383.5 million to the families of three of its dialysis patients in wrongful death lawsuits. Then this month, the Denver-based company announced it would pay $270 million  to settle a whistleblower’s allegation that one of its subsidiaries cheated the government on Medicare payments.

But its biggest financial threat is a ballot initiative in California that one Wall Street firm says could cost DaVita $450 million a year in business if the measure succeeds.

Despite these recent hits, the company continues to rake in profits and receive favorable ratings from stock analysts. Its shares are trading at about $65 a share, only about 19 percent below a 52-week high set in January. That’s largely because DaVita controls about one-third of a growing market, health experts say.

“They don’t really have many rivals, and they perform a necessary, lifesaving service,” said Leemore Dafny, a professor of business administration at Harvard Business School. “If you’re producing something people want to buy and you’re the only one making it, people are going to buy it.”

Patients with chronic kidney failure often need dialysis to filter the impurities from their blood when their kidneys can no longer do that job.

And as Americans live longer and get heavier, more people become diagnosed with kidney disease and possibly need dialysis. In 2015, 124,114 new patients received dialysis, up from 94,702 in 2000, a 31 percent increase, according to the U.S. Renal Data System.

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DaVita is one of the largest dialysis providers in the country, operating more than 2,500 clinics nationwide. In California, the company operates 292 clinics, half of all chronic dialysis clinics in the state.

Its parent company, DaVita Inc., reported $10.9 billion in revenue last year and $1.8 billion in profits, almost all of which came from its dialysis business.

This year, company officials project the dialysis group will bring in $1.5 billion to $1.6 billion in profits. It’s a big turnaround for a corporation that could barely make payroll in 1999, when it was under review by the Securities and Exchange Commission for questionable accounting practices. Its success has largely been credited to CEO Kent Thiry, a colorful personality who has dressed up as a Musketeer and ridden a horse into corporate meetings to rally workers.

Now those big profits — generated from treating sick patients — has put a target on the company’s back, as well as that of its biggest competitor, Fresenius Kidney Care.

The Service Employees International Union succeeded this year in placing Proposition 8 on California’s Nov. 6 ballot, which would limit dialysis center commercial revenues to 115 percent of patient care costs. The ballot fight pits a well-funded industry against labor and the California Democratic Party.

DaVita declined to make anyone available for this article, but in a statement said Proposition 8 “will limit patients’ access to life-saving dialysis treatments, jeopardizing their care.”

Last year, roughly two-thirds of DaVita’s dialysis revenue came from government-based programs, such as Medicare and Medicaid. But that isn’t enough to cover its costs, according to the company’s 2017 annual report, which states that DaVita loses money on each Medicare treatment it provides. (Medicare covers dialysis for people 65 and older, and for younger patients after private insurance has provided coverage for 30 months.)

Instead, DaVita generates profits from commercial health plans, which it acknowledges pay “significantly higher” rates than government programs. The ballot measure targets those higher rates, which Dafny describes as “their bread and butter.”

The prospect of the measure passing led DaVita to delay or cancel plans to open new clinics in California despite growing patient demand, Javier Rodriguez, chief executive officer of DaVita Kidney Care, told investors on a call in May, according to the online equity research website Seeking Alpha.

A few months later, Rodriguez declined to provide a dollar amount when asked how the initiative would impact the company. Rather, he warned investors that it would become “unsustainable” for the industry to treat the estimated 66,000 dialysis patients in California, should the measure succeed.

Wall Street analysts agree that Proposition 8 would wipe out DaVita’s earnings in California, according to recent reports issued by investment firms J.P. Morgan and Baird. Passing the initiative “would be so devastating,” to the tune of $450 million a year, that DaVita “would likely walk away from the state altogether,” according to a March Baird report.

DaVita has poured $66.6 million into the opposition campaign as of Oct. 25, and rival Fresenius has contributed $33.6 million. That dwarfs $17.3 million in union contributions in support of the measure, according to campaign records filed with California’s secretary of state office.

Both Wall Street firms conclude that Proposition 8 is likely to fail, citing the industry’s massive spending and the union’s record of failure at the polls on other issues.

The company’s legal troubles don’t worry stock analysts, either; Baird’s October report on DaVita’s financial performance dedicates just two sentences to them. It notes that DaVita “is subject to numerous ongoing government investigations and inquiries, similar to most large-scale, high-profile Medicare providers.”

There are no specific references to the Colorado jury award this summer, which the company is appealing, over the death of three patients who died of cardiac arrest after treatment at DaVita clinics. Nor was there concern about this month’s $270 million settlement over Medicare billing.

That’s because those incidents are seen by investors as the cost of doing business — one-time hits that don’t affect a company’s earnings power in the future, said Matthew Gillmor, a senior research analyst at Baird.

“Almost all companies I follow, at some point, have had to pay a fine to the government,” Gillmor said.

Thiry, DaVita’s CEO, acknowledged that settlements, which aren’t good public relations, are a reality for large corporations, when The Denver Post asked him last year about the company’s previous legal battles.

“If, in a trial, you are found to be wrong on even a small part of the case, it could mean that you are excluded from Medicare, which typically would mean bankruptcy for your company,” Thiry said. “So, you are essentially forced to settle.”

Harriet Rowan of California Healthline contributed to this report.

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

In California, Novel Initiatives Test Cities’ Power — And Will — To Tame Health Costs

October 29, 2018

At a time of mounting national anger about rising health care prices, the country’s largest union of health workers has sponsored ballot measures in two San Francisco Bay Area cities that would limit how much hospitals and doctors can charge for patient care.

The twin measures in Palo Alto and Livermore, sponsored by the Service Employees International Union-United Healthcare Workers West, take aim primarily at Stanford Health Care, which operates Stanford Hospital and Clinics, the facility with the third-highest profits in the country from patient care services, according to a 2016 study.

The union also is sponsoring Proposition 8, a statewide measure that would impose a cap on profits for dialysis clinics. Together, the state and local measures seek to draw on public outrage over sky-high medical prices. And, for municipalities, they amount to a novel and untested effort to rein in those prices through the ballot box.

“I’ve been in this field almost 50 years, and I’ve never seen a local government regulating hospital prices,” said Paul Ginsburg, director of public policy at the Schaeffer Center for Health Policy & Economics at the University of Southern California. A number of states set hospital rates in the 1970s, and two states, Maryland and West Virginia, do so today, he said.

Opponents question the legal authority of cities to regulate health care pricing, and they predict a flood of litigation against the measures if they pass. The city councils of both cities oppose the proposals, arguing that local officials with no expertise in health care costs would be required to create a new bureaucracy to regulate them.

Stanford Health Care officials say the measures could undermine quality. “It would threaten [the system’s] ability to provide top-quality health care to patients from Palo Alto and across the region,” according to a September statement from the system.

Ginsburg expressed skepticism. “Of course, you could cut rates too much and harm hospitals financially,” he said. “But if done with intelligence, you could accomplish some price reduction without harming quality.”

For the union, the ballot measures could help it gain leverage in future bargaining or organizing efforts with Stanford and other hospitals. Stanford Health Care operates the largest hospital system in both cities where the price cap proposal is on the ballot. Stanford has opened, has acquired or is building health care centers with clinics and specialty services in Emeryville, Pleasanton and Redwood City — Bay Area cities where the SEIU-UHW tried but failed to place similar price-control measures on local ballots.

But union officials say their motive is simply to rein in prices. “Stanford Health is nonprofit. They don’t pay property taxes or incomes taxes,” said Sean Wherley, an SEIU-UHW spokesman. “Taxpayers are subsidizing their operations and getting wrung out by over-the-top prices.”

Stanford and other health systems have been on a buying spree in recent years acquiring hospitals and physician practices, and this concentration of ownership has stifled market competition and further boosted prices for insurers and patients.

The Palo Alto and Livermore initiatives, which also affect other medical systems in the cities, would cap prices charged by hospitals and other health care providers at 115 percent of “the reasonable cost of direct patient care.”

And there, some experts say, lies the rub.

“What is a seemingly simple idea — limiting prices to 115 percent of ‘costs’ — is neither simple in execution, nor concept,” said Benedic Ippolito, a research fellow at the American Enterprise Institute who studies health care financing. “What costs are acceptable? How will we stop providers from increasing costs as much as possible” to compensate for the cap?

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Under the initiatives, hospitals and other medical providers would be obliged to pay back any charges above the cap each year to private commercial — but not government — insurers, and to patients who pay for their own care. They would also owe the cities a fine equal to 5 percent of the excess charges. Fines collected by the cities could be used to pay for enforcing the laws.

Stanford estimates that Proposition F, the Palo Alto measure, would reduce the health system’s budget by 25 percent, forcing it to make cutbacks and possibly end essential services, said David Entwistle, the health system’s president and chief executive officer.

Livermore would need to spend $1.9 million a year on the staff required to implement Measure U — its version of the proposal — and would likely incur another $750,000 to $1 million in legal and startup costs, according to an analysis conducted for the city by Henry Zaretsky, a health economist who has worked for the state and the California Hospital Association.

Patients in the wealthy region expect high-quality services but also can be savvy consumers and passionate voters. It is an open question whether the measures would pass.

Industry consolidation is far more pronounced in Northern California than in Southern California, according to a recent study from the University of California-Berkeley. As a result, inpatient hospital prices in the north were 70 percent higher and outpatient costs as much as 55 percent higher than in the south. The price disparities, even within the Northern California region, can be dramatic.

For instance, independent doctors in the Bay Area are reimbursed, on average, a median $2,408.45 for a routine vaginal delivery, which includes prenatal and postnatal visits, according to a 2017 Kaiser Health News analysis of claims data from Amino, a health cost transparency company. That compares with $5,238.13 for the same bundle of services for Stanford physicians (and $8,049.84 for doctors employed by the University of California-San Francisco).

The higher cost of medical care also pushes up insurance premiums for patients. Health plans purchased on the state insurance exchange were 35 percent higher in Northern California than in Southern California, the 2018 UC Berkeley study showed.

Earlier this year, California Attorney General Xavier Becerra took aim at medical industry consolidation and the high prices associated with it. He sued Sutter Health, one of the nation’s largest health systems, saying it was systematically overcharging patients and illegally driving out competition in Northern California.

To C. Duane Dauner, a former president and CEO of the California Hospital Association, the ballot proposals are “a power play by SEIU-UHW to put pressure on Stanford Health Care.” The union wants Stanford “to be neutral when they try to organize employees in Redwood City, Emeryville, Pleasanton and Livermore,” said Dauner, who heads the campaign committee opposing both measures.

Larry Tramutola, a veteran campaign consultant who is not involved on either side, agrees.

“I don’t think it has anything to do with controlling health care prices,” said Tramutola, who recently managed successful local initiatives to tax sodas and ban menthol cigarettes. “It’s about bargaining. Win or lose on this, other hospitals in other places will take notice and realize that SEIU is a formidable foe.”

Protect Our Local Hospitals and Health Care, the campaign committee opposing the measures, has raised $4.2 million so far this year. The union’s political action committee has spent $1.5 million in support of the initiatives.

California Healthline senior correspondent Barbara Feder Ostrov contributed to this report.

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

In Days Of Data Galore, Patients Have Trouble Getting Own Medical Records

October 25, 2018
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Medical records can be hard for patients to get, even in this digital information age. But they shouldn’t be: Federal law guarantees that people have a right to see and obtain a copy of their medical records.

New evidence of barriers to exercising this right comes from a study of 83 leading hospitals by researchers at Yale University. Late last year, researchers collected forms that patients use to request records from each hospital. Then, researchers called the hospitals and asked how to get records, the cost of doing so, how long it would take, the format in which information would be sent and whether the entire record would be available.

Researchers didn’t disclose they were conducting an academic study; instead, they posed as a relative asking questions on behalf of a grandmother who needed her records before seeking a second opinion. Family members make such requests on behalf of older relatives every day.

Hospitals’ answers were inconsistent: In many cases, the information on forms didn’t match what researchers were told on the phone. Sometimes their answers violated federal or state legal requirements.

Notably, only 53 percent of hospitals’ forms indicated patients could get their complete records. This right was acknowledged in all the phone calls. Forty-three percent of hospital forms didn’t disclose the estimated cost of obtaining records, as required. In phone calls, all but one hospital disclosed costs, but 59 percent cited a higher-than-government-recommended fee for electronic records.

“The unfortunate truth is that the system doesn’t give patients reliable or consistent responses. And some people who work in medical records departments appear to be ignorant of the law and the rights that patients have,” said Dr. Harlan Krumholz, co-author of the study and professor of medicine, epidemiology and public health at the Yale University School of Medicine.

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Under a groundbreaking law, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), patients have a right to get some or all of their medical records upon request. (Psychotherapy notes can be excluded.) Hospitals, medical clinics, physician practices, pharmacies and health insurers are required to make this information available within 30 days (sometimes a 30-day extension can be granted), at a reasonable cost and in the format that patients request (for instance, paper copy, fax, electronic copy or CD), if possible.

Research suggests that reviewing medical records can be beneficial. People are more likely to follow treatment recommendations, remember what happened at medical visits and feel engaged in their care when they have access to this information, studies indicate. Use Our Content This story can be republished for free (details).
But HIPAA requirements are often misunderstood. Jacqueline O’Doherty, a geriatric care manager with Health Care Connect LLC of Califon, N.J., encountered this last month when she tried to see records for an 80-year-old client who was being transferred from a hospital to a nearby rehabilitation facility after suffering acute respiratory distress.

Although the older woman had signed a form appointing O’Doherty as a “designated representative” — a status that should have allowed O’Doherty access to her clients’ records — a hospital nurse refused to let O’Doherty check the client’s lab results, medication list and discharge summary. It was only when an infectious-disease doctor intervened, citing the need for continuity of care, that O’Doherty was able to review her client’s records.

“It really depends on the institution, what they will and won’t let you do,” O’Doherty said.

After receiving a large volume of complaints about records’ cost and accessibility, the Office for Civil Rights of the U.S. Department of Health and Human Services, issued new guidelines in January 2016. For electronic records, the guidelines prohibit per-page charges and recommend a maximum cost of $6.50 for consumers. They also clarify patients’ right to have records sent to third parties, including family members or professionals advocating on their behalf.

Despite these protections, the forms used to request records aren’t standardized and can be confusing. Often it’s not clear what is being offered. “As a person who works in the health care system, even I had trouble understanding the forms and what I could request based on the options listed,” said Carolyn Lye, a medical and law student at Yale who did much of the legwork for the new study.

Problems may be even more common at physician practices, which often don’t have medical records departments. When GetMyHealthData, a campaign to expand access to digital health information, asked consumers about their experience, people described poorly informed or unhelpful staff, high fees, long waits and frustrating bureaucratic processes, among other barriers.

“People are being told ‘No I can’t give this to you’” because office staff, nurses and doctors “don’t know what they can or cannot do,” said Pamela Lane, vice president of policy and government relations for the American Health Information Management Association.

Electronic patient portals don’t solve the problem yet: Most contain limited information and don’t currently include a way for patients to request records such as the notes physicians take during patient visits. “We’re slowly moving in that direction, but we’re not there yet,” said Catherine DesRoches, executive director of OpenNotes, an organization devoted to making doctors’ and nurses’ notes more readily available to patients.

The government is making improved electronic access to medical records a priority through its new MyHealthEData Initiative, announced earlier this year. Full details of the initiative are not yet available. But Seema Verma, administrator of the Centers for Medicare & Medicaid Services, has repeatedly called for people with Medicare coverage to have better access to their records. In an unusual move, she spoke out on Twitter about the Yale study, calling its findings “not acceptable.”

What can people do if they encounter problems like those documented by the Yale researchers?

If your hospital or doctor’s office declines to make your records available, print out materials about your rights and use them to advocate on your behalf. “Tell staff, ‘I’m entitled to a copy of my records: This is my legal right, as explained here,’” Lane said.

A good resource is a model medical records release form created by the American Health Information Management Association last year, which people can copy and bring with them to help make their case, Lane said. A summary of your right to share medical information with family, friends or other authorized third parties can be found here.

To familiarize yourself with your overall rights, see this “Guide to Getting & Using Your Health Records” published by the government’s Office of the National Coordinator for Health Information Technology. And take a look at the “Get Your Data” section of the GetMyHealthData website, which includes a clear summary of your rights, how to request your medical records, and troubleshooting suggestions if you encounter obstacles. A helpful two-page summary is available here.

KHN’s coverage of these topics is supported by John A. Hartford Foundation and The SCAN Foundation

Primary Care Doctors ‘Not Doing Enough’ To Curb STDs

October 22, 2018

Julie Lopez, 21, has been tested regularly for sexually transmitted diseases since she was a teenager. But when Lopez first asked her primary care doctor about screening, he reacted with surprise, she said.

“He said people don’t usually ask. But I did,” said Lopez, a college student in Pasadena, Calif. “It’s really important.”

Lopez usually goes to Planned Parenthood instead for the tests because “they ask the questions that need to be asked,” she said.

As rates of sexually transmitted infections steadily rise nationwide, public health officials and experts say primary care doctors need to step up screening and treatment.

“We know that doctors are not doing enough screening for STDs,” said David Harvey, executive director at the National Coalition of STD Directors. The failure to screen routinely “is leading to an explosion in STD rates,” he said, adding that cutbacks in funding and a lack of patient awareness about the risks make it worse.

The federal government’s Centers for Disease Control and Prevention has set guidelines for annual screening for sexually active individuals. Among them: women under 25 should be tested for gonorrhea and chlamydia, and men who have sex with men should get tested for syphilis, chlamydia and gonorrhea.

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However, testing does not always happen as recommended. For example, only about half of sexually active women ages 16 to 24 with private health plans or Medicaid were screened for chlamydia in 2015. The rate was slightly better in California.

Nationally, reported cases of chlamydia, gonorrhea and syphilis are at an all-time high, CDC data show. In one year, from 2016 to 2017, nationwide rates of chlamydia rose by 7 percent, gonorrhea by 19 percent and syphilis by 11 percent.

Rates of congenital syphilis, which passes from mother to baby during pregnancy or delivery, increased by 44 percent during that time. Nearly one-third of the congenital syphilis cases are from California. The state also saw a record number of STDs last year: more than 300,000 cases of gonorrhea, chlamydia and early syphilis among adults.

Because sexually transmitted infections are often asymptomatic, screening is essential. Untreated STDs can lead to serious health problems, such as chronic pain, infertility or even death.

“Providers and primary care providers play a crucial role in combating these rising STD rates,” said Dr. Laura Bachmann, chief medical officer for the CDC division of STD prevention. “If providers don’t ask the questions and don’t apply the screening recommendations, the majority of STDs will be missed.”

State governments don’t have enough money to combat the rising number of cases, in part because federal STD funding for them has remained stagnant, Harvey said. Last year, he said, $152.3 million in federal funding was appropriated for prevention, the same as eight years earlier.

Experts cite several reasons primary care physicians don’t routinely diagnose and treat STDs. They may worry that they won’t be compensated for providing STD services, or they may not be familiar with the most up-to-date recommendations about testing and treatment. For example, the CDC in 2015 updated the medications it recommends to treat gonorrhea.

Perhaps most commonly, many family physicians are reluctant to discuss sexual health with their patients. One study showed that one-third of adolescents had annual visits that didn’t include any discussion about sexuality.

“We’re in this situation with health care providers and patients — each waiting for the other to start [the conversation],” said Dr. Edward Hook, professor at the University of Alabama-Birmingham School of Medicine. “Doctors worry if they ask patients about their sexual history that it will somehow be offensive to them.”

Dr. Michael Munger, president of the American Academy of Family Physicians, said he remembers that his conversations around sexual health were uncomfortable at first. “There are a lot of challenging conversations you can have with patients,” he said. “But this is important. If we don’t do it, who will?”

Rob Nolan gets tested for sexually transmitted diseases every six months so he always knows his status. But he says he feels more comfortable doing so at the Los Angeles LGBT Center rather than during visits with his regular doctor. “There is a sense of shame when you are telling your doctor you might have contracted something,” he says. (Courtesy of Rob Nolan)

Rob Nolan, a writer from Los Angeles, said he gets tested every six months, but he prefers to do so at the Los Angeles LGBT Center rather than during visits with his regular doctor, who rarely asks about sexual health.

Nolan, who said he has had experience with STDs, considers the clinic’s staff to be more knowledgeable about sexual health than those at a regular doctor’s office. “They just seem specialized in it,” he said. “And there is zero shame when you are in the clinic.”

Physicians also may have other, more immediate health issues to address during the short time they have with patients. Taking a sexual history and talking about sexual health falls to the bottom of many doctors’ priorities, said Dr. Leo Moore, acting medical director of the division of HIV and STD programs for the Los Angeles County Department of Public Health.

Julia Brewer, a nurse practitioner at Northeast Community Clinic in Hawthorne, Calif., said she screens for STDs as a regular part of women’s health exams. But she said her colleagues frequently refer cases to her rather than having the conversations themselves. “The family providers are overwhelmed with diabetes and high blood pressure,” she said. Sexual health, she said, can end up being an “afterthought.”

The L.A. County public health department, which identified STDs as a key priority for the next five years, recently sent representatives to doctors’ offices to teach providers how to address sexually transmitted infections. They distributed information detailing screening recommendations, sample sexual history questions and treatment guidelines.

The Los Angeles County Medical Association also plans to get the word out to doctors through social media and other efforts. “It’s an epidemic and we have to treat it that way,” said CEO Gustavo Friederichsen. “Doctors have to feel a sense of urgency.”

Dr. Heidi Bauer, who heads the California Department of Public Health’s STD control branch, said the state also is trying to educate doctors so they will screen more routinely. The department provides both in-person and online training for doctors to learn about STDs, and publishes downloadable information with current guidelines.

At the same time, Bauer urged the federal government to make its screening recommendations more comprehensive. Outside of pregnancy, for example, there are no recommendations for routine syphilis screening for women. “We are seeing this huge re-emergence of syphilis,” she said. “We haven’t been testing and syphilis is very challenging to diagnose.”

The CDC plans to review the recommendations in the next year, Bachmann said.

KHN's coverage in California is supported in part by Blue Shield of California Foundation.

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