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100 Days of Action on the President’s American Patients First Blueprint

HHS Gov News - 4 hours 22 min ago

“The President’s blueprint for lower drug prices is working, drug prices are coming down, and American patients are going to see the savings in their pocketbook.” — Secretary Alex Azar  

Tomorrow, August 21, marks 100 days since the release of President Trump’s American Patients First Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. In this short period of time, an unprecedented number of actions have been taken toward structurally rebuilding this entire segment of the economy to lead to enduring lower prices that are sustainable, support innovation, and put American patients first.

Below is the introduction to a new report on the 100 days of action from Dan Best, Senior Advisor to the Secretary for Drug Pricing Reform: 

“For years, American patients have suffered under a drug-pricing system that provides generous incentives for innovation, while too often failing to deliver important medications at an affordable cost. The flaws in America’s drug markets have been a topic of discussion in healthcare policy circles for years, but no comprehensive approach to reform has ever been undertaken.

“On May 11, President Trump and Health and Human Services (HHS) Secretary Alex Azar released the American Patients First blueprint, a comprehensive plan to bring down prescription drug prices and out-of-pocket costs.

“The extensive number of proposals in the blueprint reflect the scale of the task: restructuring and reforming a fundamentally flawed drug-pricing system that governs a more than $400 billion sector of our economy. Reforms of significant parts of the healthcare market on a similar scale, such as Medicare Part D, have generally taken several years to implement, and several years after that to effect changes across the entire drug market.

“In the 100 days since May 11, HHS has taken dozens of actions on the four strategies contemplated in the blueprint: increased competition, better negotiation, incentives for lower list prices, and reducing out-of-pocket costs. Together, these actions have helped bring into focus a vision for a more competitive pharmaceutical marketplace. Pharmaceutical manufacturers, pharmacy benefit managers, and other actors in the market have indicated that they recognize the scale of disruption this would involve.

“At the time of the release of the blueprint, few observers believed that, within months, drug manufacturers would begin to change their annual ritual of significant price hikes. Yet that is what happened in the months following.

“Within these first 100 days, 15 drug companies have reduced list prices, rolled back planned price increases, or committed to price freezes for the rest of 2018. Cutting list prices and rolling back proposed increases in particular are an unprecedented recognition of the fundamental changes going on in drug markets.”

To read the full report, please visit: https://www.hhs.gov/sites/default/files/ReportOn100DaysofAction_AmericanPatientsFirstBlueprint.pdf

And to read a fact sheet on 100 days of results from the blueprint, please visit: https://www.hhs.gov/sites/default/files/100DaysofResults_AmericanPatientsFirstBlueprint.pdf

Biorhythms And Birth Control: FDA Stirs Debate By Approving ‘Natural’ App

Kaiser Health News:Insurance - 6 hours 46 min ago

The Food and Drug Administration took a “big tent” approach earlier this month when it approved two new forms of birth control that prevent pregnancy in very different ways.

Women’s health advocates applauded the availability of a new vaginal ring that could be used for up to a year. But some questioned the approval of a mobile phone app that helps women avoid pregnancy by tracking their body temperature and menstrual cycle, a type of contraception called “fertility awareness.”

Critics pointed to reports that three dozen women in Sweden got pregnant despite monitoring their cycle with the app. They also fear that the FDA approval of the app may encourage patients to think that fertility awareness methods, which include a range of practices to track ovulation, and avoid unprotected sex during that time, are just as good at preventing pregnancy as some highly effective types of birth control, like the intrauterine device, or IUD. While “natural” methods can be successful, they generally require close daily attention.

There’s still room for improvement in contraceptive use by women and men. Nearly half of the 6.1 million pregnancies in the United States — 45 percent — in 2011 were unplanned, according to a study published in the New England Journal of Medicine. That figure is lower than the 51 percent rate in 2008, but is higher than the rate in many other industrialized countries.

The FDA has approved nearly two dozen contraceptive methods, including the pill, the patch, IUDs and hormonal implants and shots, among others. Insurance is required to cover all FDA-approved methods without charging women anything out-of-pocket.

The new vaginal ring, Annovera, releases hormones that prevent ovulation and must be removed after three weeks for seven days, then reinserted. It can be used for a year. The device will not be on the market until at least late 2019, and the price hasn’t been released by the manufacturer.

The Natural Cycles app instructs women to take their temperature at the same time every morning when they awake and record it in the app. They also track information about their menstrual cycle. When a slight temperature increase indicates they are ovulating, the app signals that women should avoid unprotected sex. It costs about $80 per year.

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Both of the new methods require more attention on the part of the user than say, an IUD, which once inserted can be ignored and is designed to prevent pregnancy for five to 10 years, depending on the brand.

Still, some women’s health experts worry that the FDA stamp of approval may be misinterpreted by some women.

“People will interpret this to mean that the FDA approves this and thinks it’s a good method,” said Dr. Christopher Zahn, vice president of practice activities for the American College of Obstetricians and Gynecologists.

“That’s why counseling is so important,” he said, noting that doctors should discuss all forms of birth control with women, and the conversation should include the efficacy of different methods.

But Dr. Gillian Dean, senior director of medical services at Planned Parenthood Federation of America, welcomes the approval of both new methods.

“More options are always better,” she said. “It isn’t one size fits all, and more options increases the likelihood that women will find a method that works for their needs.”

The right contraceptive depends on a woman’s goals, Dean said, including her reproductive plans, what her menstrual cycle is like, the number of partners she has and how important it is for her not to get pregnant. She said most women who visit Planned Parenthood clinics ask for and receive birth control pills, but an increasing number are asking for long-acting reversible methods of contraception, such as IUDs and hormonal implants.

The IUD and hormonal implants have a “failure rate” of less than 1 percent, making them among the most effective ways of preventing pregnancy (on par with permanent sterilization). Birth control pills, the patch and the vaginal ring have effectiveness rates of about 91 percent, according to the federal Centers for Disease Control and Prevention.

Fertility awareness methods, on the other hand, have a failure rate of about 24 percent, according to the CDC. But that figure is widely misunderstood, said Chelsea Polis, a senior research scientist at the Guttmacher Institute, a sexual and reproductive health research and advocacy organization.

Polis co-authored an analysis of studies of fertility awareness-based contraceptive methods that was published in August in the journal Obstetrics and Gynecology.

The 24 percent figure, she said, primarily reflects the expected failure rate for women who used the rhythm method, a calendar-based approach to calculating when ovulation occurs, rather than newer biometric methods that track body temperature, cervical mucous or urinary hormones. Some of those methods may be more effective, she said.

Based on a review of published studies, Polis and colleagues reported that the Natural Cycles app had a 9.8 percent unintended pregnancy rate. The FDA announcement, which includes the results of an additional study, noted a 6.5 percent rate.

Polis said her research indicates that about 3 percent of women who use contraception practice fertility awareness-based methods, either alone or with other types of birth control, and their numbers are growing.

“I think [the app approval] is largely a positive step forward,” Polis said. “I’m relieved that the FDA has a regulatory pathway to evaluate these uses and claims.”

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

The Man Who Sold America On Vitamin D — And Profited In The Process

Kaiser Health News:Marketplace - August 20, 2018

Dr. Michael Holick’s enthusiasm for vitamin D can be fairly described as extreme.

The Boston University endocrinologist, who perhaps more than anyone else is responsible for creating a billion-dollar vitamin D sales and testing juggernaut, elevates his own levels of the stuff with supplements and fortified milk. When he bikes outdoors, he won’t put sunscreen on his limbs. He has written book-length odes to vitamin D, and has warned in multiple scholarly articles about a “vitamin D deficiency pandemic” that explains disease and suboptimal health across the world.

His fixation is so intense that it extends to the dinosaurs. What if the real problem with that asteroid 65 million years ago wasn’t a lack of food, but the weak bones that follow a lack of sunlight? “I sometimes wonder,” Holick has written, “did the dinosaurs die of rickets and osteomalacia?”

Holick’s role in drafting national vitamin D guidelines, and the embrace of his message by mainstream doctors and wellness gurus alike, have helped push supplement sales to $936 million in 2017. That’s a ninefold increase over the previous decade. Lab tests for vitamin D deficiency have spiked, too: Doctors ordered more than 10 million for Medicare patients in 2016, up 547 percent since 2007, at a cost of $365 million.

But few of the Americans swept up in the vitamin D craze are likely aware that the industry has sent a lot of money Holick’s way. A Kaiser Health News investigation found that he has used his prominent position in the medical community to promote practices that financially benefit corporations that have given him hundreds of thousands of dollars — including drugmakers, the indoor-tanning industry and one of the country’s largest commercial labs.

In an interview, Holick acknowledged he has worked as a consultant to Quest Diagnostics, which performs vitamin D tests, since 1979. Holick, 72, said that industry funding “doesn’t influence me in terms of talking about the health benefits of vitamin D.”

There is no question that the hormone is important. Without enough of it, bones can become thin, brittle and misshapen, causing a condition called rickets in children and osteomalacia in adults. The issue is how much vitamin D is healthy, and what level constitutes deficiency.

Holick’s crucial role in shaping that debate occurred in 2011. Late the previous year, the prestigious National Academy of Medicine (then known as the Institute of Medicine), a group of independent scientific experts, issued a comprehensive, 1,132-page report on vitamin D deficiency. It concluded that the vast majority of Americans get plenty of the hormone through diet and sunlight, and advised doctors to test only patients at high risk of vitamin D-related disorders, such as osteoporosis.

A few months later, in June 2011, Holick oversaw the publication of a report that took a starkly different view. The paper, in the peer-reviewed Journal of Clinical Endocrinology & Metabolism, was on behalf of the Endocrine Society, the field’s foremost professional group, whose guidelines are widely used by hospitals, physicians and commercial labs nationwide, including Quest. The society adopted Holick’s position that “vitamin D deficiency is very common in all age groups” and advocated a huge expansion of vitamin D testing, targeting more than half the United States population, including those who are black, Hispanic or obese — groups that tend to have lower vitamin D levels than others.

The recommendations were a financial windfall for the vitamin D industry. By advocating such widespread testing, the Endocrine Society directed more business to Quest and other commercial labs. Vitamin D tests are now the fifth-most-common lab test covered by Medicare.

The guidelines benefited the vitamin D industry in another important way. Unlike the National Academy, which concluded that patients have sufficient vitamin D when their blood levels are at or above 20 nanograms per milliliter, the Endocrine Society said vitamin D levels need to be much higher — at least 30 nanograms per milliliter. Many commercial labs, including Quest and LabCorp, adopted the higher standard.

Yet there’s no evidence that people with the higher level are any healthier than those with the lower level, said Dr. Clifford Rosen, a senior scientist at the Maine Medical Center Research Institute and co-author of the National Academy report. Using the Endocrine Society’s higher standard creates the appearance of an epidemic, he said, because it labels 80 percent of Americans as having inadequate vitamin D.

“We see people being tested all the time and being treated based on a lot of wishful thinking, that you can take a supplement to be healthier,” Rosen said.

Patients with low vitamin D levels are often prescribed supplements and instructed to get checked again in a few months, said Dr. Alex Krist, a family physician and vice chairman of the U.S. Preventive Services Task Force, an expert panel that issues health advice. Many physicians then repeat the test once a year. For labs, “it’s in their financial interest” to label patients with low vitamin D levels, Krist said.

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In a 2010 book, “The Vitamin D Solution,” Holick gave readers tips to encourage them to get their blood tested. For readers worried about potential out-of-pocket costs for vitamin D tests — they range from $40 to $225 — Holick listed the precise reimbursement codes that doctors should use when requesting insurance coverage. “If they use the wrong coding when submitting the claim to the insurance company, they won’t get reimbursed and you will wind up having to pay for the test,” Holick wrote.

Holick acknowledged financial ties with Quest and other companies in the financial disclosure statement published with the Endocrine Society guidelines. In an interview, he said that working for Quest for four decades — he is currently paid $1,000 a month — hasn’t affected his medical advice. “I don’t get any additional money if they sell one test or 1 billion,” Holick said.

A Quest spokeswoman, Wendy Bost, said the company seeks the advice of a number of expert consultants. “We feel strongly that being able to work with the top experts in the field, whether it’s vitamin D or another area, translates to better quality and better information, both for our patients and physicians,” Bost said.

Since 2011, Holick’s advocacy has been embraced by the wellness-industrial complex. Gwyneth Paltrow’s website, Goop, cites his writing. Dr. Mehmet Oz has described vitamin D as “the No. 1 thing you need more of,” telling his audience that it can help them avoid heart disease, depression, weight gain, memory loss and cancer. And Oprah Winfrey’s website tells readers that “knowing your vitamin D levels might save your life.” Mainstream doctors have pushed the hormone, including Dr. Walter Willett, a widely respected professor at Harvard Medical School.

Today, seven years after the dueling academic findings, the leaders of the National Academy report are struggling to be heard above the clamor for more sunshine pills.

“There isn’t a ‘pandemic,’” A. Catharine Ross, a professor at Penn State and chair of the committee that wrote the report, said in an interview. “There isn’t a widespread problem.”

Ties To Drugmakers And Tanning Salons

In “The Vitamin D Solution,” Holick describes his promotion of vitamin D as a lonely crusade. “Drug companies can sell fear,” he writes, “but they can’t sell sunlight, so there’s no promotion of the sun’s health benefits.”

Yet Holick also has extensive financial ties to the pharmaceutical industry. He received nearly $163,000 from 2013 to 2017 from pharmaceutical companies, according to Medicare’s Open Payments database, which tracks payments from drug and device manufacturers. The companies paying him included Sanofi-Aventis, which markets vitamin D supplements; Shire, which makes drugs for hormonal disorders that are given with vitamin D; Amgen, which makes an osteoporosis treatment; and Roche Diagnostics and Quidel Corp., which both make vitamin D tests.

The database includes only payments made since 2013, but Holick’s record of being compensated by drug companies started before that. In his 2010 book, he describes visiting South Africa to give “talks for a pharmaceutical company,” whose president and chief executive were in the audience.

Holick’s ties to the tanning industry also have drawn scrutiny. Although Holick said he doesn’t advocate tanning, he has described tanning beds as a “recommended source” of vitamin D “when used in moderation.”

Holick has acknowledged accepting research money from the UV Foundation — a nonprofit arm of the now-defunct Indoor Tanning Association — which gave $150,000 to Boston University from 2004 to 2006, earmarked for Holick’s research. The International Agency for Research on Cancer classified tanning beds as carcinogenic in 2009.

In 2004, the tanning-industry associations led Dr. Barbara Gilchrest, who then was head of Boston University’s dermatology department, to ask Holick to resign from the department. He did so, but remains a professor at the medical school’s department of endocrinology, diabetes and nutrition and weight management.

In “The Vitamin D Solution,” Holick wrote that he was “forced” to give up his position due to his “stalwart support of sensible sun exposure.” He added, “Shame on me for challenging one of the dogmas of dermatology.”

Although Holick’s website lists him as a member of the American Academy of Dermatology, an academy spokeswoman, Amanda Jacobs, said he was not a current member.

Dr. Christopher McCartney, chairman of the Endocrine Society’s clinical guidelines subcommittee, said the society has put in place stricter policies on conflict of interest since its vitamin D guidelines were released. The society’s current policies would not allow the chairman of the guideline-writing committee to have financial conflicts.

A Miracle Pill Loses Its Luster

Enthusiasm for vitamin D among medical experts has dimmed in recent years, as rigorous clinical trials have failed to confirm the benefits suggested by early, preliminary studies. A string of trials found no evidence that vitamin D reduces the risk of cancer, heart disease or falls in the elderly. And most scientists say there isn’t enough evidence to know if vitamin D can prevent chronic diseases that aren’t related to bones.

Although the amount of vitamin D in a typical daily supplement is generally considered safe, it is possible to take too much. In 2015, an article in the American Journal of Medicine linked blood levels as low as 50 nanograms per milliliter with an increased risk of death.

Some researchers say vitamin D may never have been the miracle pill that it appeared to be. Sick people who stay indoors tend to have low vitamin D levels; their poor health is likely the cause of their low vitamin D levels, not the other way around, said Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women’s Hospital in Boston. Only really rigorous studies, which randomly assign some patients to take vitamin D and others to take placebos, can provide definitive answers about vitamin D and health. Manson is leading one such study, involving 26,000 adults, expected to be published in November.

A number of insurers and health experts have begun to view widespread vitamin D testing as unnecessary and expensive. In 2014, the U.S. Preventive Services Task Force said there wasn’t enough evidence to recommend for or against routine vitamin D screening. In April, the task force explicitly recommended that older adults outside of nursing homes avoid taking vitamin D supplements to prevent falls.

In 2015, Excellus BlueCross BlueShield published an analysis highlighting the overuse of vitamin D tests. In 2014, the insurer spent $33 million on 641,000 vitamin D tests. “That’s an astronomical amount of money,” said Dr. Richard Lockwood, Excellus’ vice president and chief medical officer for utilization management. More than 40 percent of Excellus patients tested had no medical reason to be screened.

In spite of Excellus’ efforts to rein in the tests, vitamin D usage has remained high, Lockwood said. “It’s very hard to change habits,” he said, adding: “The medical community is not much different than the rest of the world, and we get into fads.”

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

Babies Dependent On Opioids Need Touch, Not Tech

Kaiser Health News:Marketplace - August 20, 2018

Dr. Jodi Jackson has worked for years to address infant mortality in Kansas. Often, that means she treats newborns in a high-tech neonatal intensive care unit with sophisticated equipment whirring and beeping. And that is exactly the wrong place for an infant like Lili.

Lili’s mother, Victoria, used heroin for the first two-thirds of her pregnancy and hated herself for it.

“When you are in withdrawal, you feel your baby that’s in withdrawal too,” said Victoria, recalling sensations during her pregnancy. (Kaiser Health News is using her first name only because she has used illegal drugs.) “You feel your baby uncomfortable inside of you, and you know that. And then you use and then the baby’s not [uncomfortable], and that’s a really awful, vulgar thought, but it’s true. That’s how it is. It’s terrible.”

Though Victoria went into recovery before giving birth, Lili was born dependent on the methadone Victoria took to treat her opioid addiction. Treatment for infants like Lili has evolved, Jackson said.

“What happened 10, 15 years ago, is [drug-dependent] babies were immediately removed from the mom, and they were put in an ICU warmer with bright lights with nobody holding them,” said Jackson, who is a neonatologist at Children’s Mercy Hospital in Kansas City, Mo. “Of course, they are going to be upset about that! And so the risk of withdrawal is much higher.”

Jackson now leads a statewide effort to get hospitals in Kansas to use the science-based treatment methods for neonatal abstinence syndrome, as the condition is formally known. The symptoms include high-pitched screams, clenched muscles and trouble sleeping. The treatment involves keeping mothers and their infants together in the hospital, making sure babies are held and comforted, and providing opioids as needed in decreasing quantities to ease the baby’s symptoms until she can be weaned off of them.

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It’s estimated that around 2 percent of infants are now born drug-dependent. In areas gripped by the opioid crisis, the rate is even higher.

The low-tech, high-touch treatment approach that Lili received in the first weeks of her life is one that health experts encourage hospitals everywhere to adopt as they grapple with increasing numbers of infants born with drug dependencies.

In many parts of the state, Jackson said, she’s starting from scratch.

“Many hospitals have no standard of practice. No standard approach,” Jackson said.

But improving outcomes for opioid-dependent babies will probably take more than just educating hospital staff.

Dr. Elisha Wachman, who is a neonatalogist at Boston Medical Center and teaches pediatrics at Boston University, said that providing this kind of care is a big adjustment for many hospitals.

“It really depends on the capacity of the hospital and where they house the babies for monitoring,” Wachman said. “Some of them don’t have room for the mothers to stay with the babies.”

Compounding the problem, the matter of exactly what are the “best practices” is far from settled.

For example, new research suggests that methadone may be a better recovery drug for newborns than morphine, which Wachman said is most often used, even though doctors are still unsure about morphine’s long-term effects.

“There are very few high-quality clinical trials that have been done in this population of infants,” Wachman said. “If you can imagine, this is an incredibly difficult population to study. To do a randomized, controlled trial, for instance, of opiates and neonates is incredibly challenging.”

Jackson acknowledged the challenges, but she said establishing consistent practices based on what doctors do know is an important first step toward getting answers.

Victoria used heroin during her pregnancy with her fourth child, Lili. Victoria says she could feel Lili’s distress in utero when she experienced withdrawal symptoms. Now 16 months old, Lili is doing well and her mother has been in recovery for 18 months. (Alex Smith/KCUR)

Victoria said she did everything she could to help newborn Lili get healthy in the hospital, with no idea whether they’d be together in the long term.

“I was trying not to be connected with her, because, I thought, they’re probably going to take her,” Victoria said. “I haven’t been clean that long. So I was trying to not, like, be in love with her. But I was so in love with her.” Lili is her fourth child.

Victoria has continued to show state officials that she is committed to staying off drugs. She has been allowed to raise Lili at Amethyst Place, a recovery home in Kansas City.

Lili is now a 16-month-old girl who shares her mother’s blond hair, bright eyes and big smile. Despite her difficult start in life, the toddler is in good health, and her mom has been drug-free for a more than a year and a half.

This story is part of a partnership that includes KCURNPR and Kaiser Health News.

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

Hospitals Battle For Control Over Fast-Growing Heart-Valve Procedure

Kaiser Health News:Marketplace - August 17, 2018

BALTIMORE — When Medicare in 2011 agreed to pay for a revolutionary procedure to replace leaky heart valves by snaking a synthetic replacement up through blood vessels, the goal was to offer relief to the tens of thousands of patients too frail to endure open-heart surgery, the gold standard.

To help ensure good results, federal officials limited Medicare payment only to hospitals that serve large numbers of cardiac patients.

The strategy worked. In the past seven years, more than 135,000 mostly elderly patients have undergone transcatheter aortic valve replacement, known as TAVR. And TAVR’s in-hospital mortality rate has dropped by two-thirds, to 1.5 percent.

Now, in a campaign motivated by a muddy mix of health care and business, smaller hospitals and the medical device industry are arguing that the technique should be more widely deployed. They note only about half of the nearly 1,100 hospitals offering surgical valve replacement can do TAVR. And they say current limitations discriminate against minorities and people in rural areas, forcing patients to undergo a riskier and significantly more invasive treatment — or miss getting a new valve altogether.

Hospitals that already have a TAVR franchise are fighting to stifle new competitors, saying programs that don’t do enough procedures would not provide high-quality care.

At stake is the care of thousands of patients. Half of the more than 250,000 Americans estimated each year to develop severe aortic valve stenosis — narrowing of the valve that regulates the flow of blood from the heart to the largest artery of the body — die within two years. Getting an artificial heart valve lowers that death rate to as low as 17 percent, studies show.

Also at stake is the $45,000 Medicare pays hospitals for each TAVR case — excluding the doctor’s fee. While hospitals typically make only a small profit on the procedure — partly because the device costs more than $30,000 — they benefit because each TAVR patient typically needs other cardiac services and tests that can boost the hospital’s bottom line.

In addition, offering TAVR carries a cachet that helps recruit and retain top specialists, who bring in more patients.

At a Medicare advisory committee hearing in Baltimore on July 25, both sides of the debate emphasized how they were seeking to help patients. But the economics of TAVR was ever-present given the horde of medical device and hospital officials and industry analysts in the audience.

The committee split on the issue, although a majority of members backed the continued use of volume requirements. The Centers for Medicare & Medicaid Services is expected to decide later this year whether to change its patient volume minimum for TAVR.

Dr. Jason Felger, a heart surgeon who wants his community hospital in San Angelo, Texas, to offer the procedure, said behind the fight over TAVR is protecting profit and revenue. He refers patients to hospitals more than three hours away for the procedure or, if they aren’t willing to travel, they risk their lives to undergo the conventional operation.

Hospitals that offer TAVR, he said, aren’t willing to give up the referrals they now rely on from other hospitals.

“It’s all about the money,” he said.

Improving A Hospital’s Reputation

Unlike open-heart surgery, in which the chest is cracked open to remove the unhealthy valve, TAVR involves threading a catheter tipped with a replacement valve through a blood vessel to the heart. Doctors then implant the new valve. The old valve remains but is pushed aside, and the new one takes over its work.

With this less invasive valve procedure, people can get out of the hospital within two or three days and get back to daily activities much sooner than with open-heart surgery, which typically has a six-week recovery time.

TAVR has been approved by the Food and Drug Administration for people who cannot have open-heart surgery or for whom it would be risky. These include the elderly and frail and people with complications such as kidney and lung disease. But TAVR use has expanded among younger, and less sick, patients in recent years. Within the next year, the FDA is likely to approve the procedure for all patients needing a new aortic valve, industry analysts say.

TAVR does carry risks, including stroke. Patients may also need a pacemaker after the procedure to regulate heart rhythm.

TAVR involves threading a catheter tipped with a replacement valve through a blood vessel to the heart. Doctors then implant the new valve.(Courtesy of Edwards Lifesciences Corp.)

The large majority of patients getting TAVR are 65 and over. The importance of Medicare’s blessing goes beyond its payments, since private insurers typically follow Medicare standards. Physicians seeking to expand use of TAVR point out that Medicare has no volume requirements for other major cardiac procedures.

The two largest TAVR medical device companies are divided on the issue. Edwards Lifesciences Corp. of Irvine, Calif., supports eliminating the minimum-patient requirements, while Minneapolis-based Medtronic favors keeping the status quo. The Advanced Medical Technology Association, or AdvaMed, an industry trade group, also supports the change.

About 50,000 patients are expected to have TAVR this year, and those numbers are forecast to double by 2020, according to American College of Cardiology and other major heart groups.

When Michael Vigil, 50, needed TAVR in May, he drove more than three hours from his home in eastern Wyoming to a hospital in Denver. Before the procedure, the oil-drilling contractor was constantly tired and out of breath — even after mundane chores at home. Vigil’s aortic valve had been damaged from radiation treatments for non-Hodgkin lymphoma decades before.

Vigil was sent home a day after the TAVR procedure. He was back at work the following week.

He said he felt more energized almost immediately after having the procedure.

“It’s worked so well, my wife wishes they dialed it back a little,” Vigil said.

Donnette Smith, president of the patient advocacy group Mended Hearts, said many patients don’t have good access to the procedure.

“Patients do not know of this option unless they walk through the right door of the right hospital,” said Smith of Huntsville, Ala. She had heart valve surgery in 1988.

Mended Hearts receives funding from device makers.

‘Experience Matters’

To gain Medicare approval for TAVR programs, hospitals have to perform annually 50 open-heart valve repairs, 400 angioplasties and 1,000 cardiac catheterizations — a procedure in which medical teams use skills similar to those needed for TAVR.

Doctors at larger hospitals say procedure volume is a good predictor for success. The American College of Cardiology and the Society of Thoracic Surgeons recommend hospitals be able to do at least 50 TAVRs each year within two years of startup. More than three-quarters of the 582 hospitals authorized by Medicare for TAVR meet that standard.

“Whether it’s playing the violin or performing heart surgery, experience matters,” said Dr. Thoralf Sundt, chief of cardiac surgery at Massachusetts General Hospital.

Dr. Ashish Pershad, an interventional cardiologist who performs TAVR at Banner Medical Center in Phoenix, agreed that there are access issues. But he said it’s not because of a lack of programs. Rather, he said, surgeons too often don’t refer patients for it because they make more money from doing the open-heart surgical valve replacement.

“Patients are missing out on this procedure because they are not being referred, and primary care doctors lack knowledge about it,” he said.

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Expanding Treatment Options

Doctors seeking a Medicare rule to widen access say there is little evidence hospitals that perform more TAVRs have lower mortality rates. As long as they can show low mortality and complications, they believe their hospitals should be able to offer the service.

“Our intention is not to lower the quality of outcomes by expanding to ‘low volume’ centers; but to provide excellent care to a larger population of patients,” Felger and his colleagues at Shannon Medical Center in San Angelo, Texas, wrote to the CMS advisory group.

Last year, Felger said, he sent a dozen patients to hospitals in Austin or Dallas for TAVR, while eight other patients opted for the open-heart surgery.

“I have patients tell me they would rather have the surgical procedure at their local hospital than traveling to another city,” he said. “They tell me ‘Let’s do this; if I die, I die.’”

KHN’s coverage of these topics is supported by John A. Hartford Foundation and Gordon and Betty Moore Foundation

Purdue Pharma’s Sales Pitch Downplayed Risks Of Opioid Addiction

Kaiser Health News:Marketplace - August 17, 2018

Two decades ago, Purdue Pharma produced thousands of brochures and videos that urged patients with chronic pain to ask their physicians for opioids such as OxyContin, arguing that concerns over addiction and other dangers from the drugs were overblown, company records reveal.

Kaiser Health News earlier this year posted a cache of Purdue marketing documents that show how the pharmaceutical company sought to boost sales of the prescription painkiller, starting in the mid-1990s.

Purdue turned the records over to the Florida attorney general’s office in 2002 during its investigation of the company. Additional Purdue documents from the Florida investigation detail how the company targeted patients and allayed addiction worries.

“Fear should not stand in the way of relief of your pain,” a pivotal marketing brochure said.

How America Got Hooked On A Deadly Drug

An inside look at how Purdue Pharma pushed OxyContin despite risks of addiction and fatalities.

Read More

Purdue said it handed out thousands of copies of the brochure, which emphasized consumer power in treating pain, as well as a videotape. “The single most important thing for you to remember is that you are the authority on your pain. Nobody else feels it for you so nobody else can describe how much it hurts, or when it feels better,” the pamphlet states.

More than 1,500 pending civil lawsuits, filed mostly by state and local governments, allege that deceptive marketing claims helped fuel a national epidemic of opioid addiction and thousands of overdose deaths.

This week, the New York attorney general’s office filed another suit that accuses Purdue of operating a “public nuisance” in it sales tactics and marketing of opioids. Like many others, the suit demands compensation for addiction treatment costs and other problems. Purdue and other drugmakers have denied all allegations.

President Donald Trump said Thursday he wants the federal government to sue drugmakers in response to the addiction epidemic.

The Purdue brochure from the late 1990s spurred recent criticism from drug safety experts. Dr. G. Caleb Alexander, a physician at the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health, said the sales pitch was “simply not true” and called it “a smoking gun.”

“We have learned the hard way that many patients develop opioid [addiction] when using these medicines as prescribed,” he said.

Alexander said other drugmakers also appealed to patients hoping to influence their doctors — a tactic that was relatively new in the late 1990s. But Alexander said he was “shocked” to hear that Purdue did so with OxyContin, given the risks posed by long-term use of the morphine-like narcotic.

“These drugs [opioids] are in a class of their own when it comes to the harms that they have caused,” Alexander said.

The internal Purdue documents, dating from 1996 to 2002, show that the company began marketing OxyContin to doctors in late 1995 for treating moderate to severe cancer pain. With modest sales of $49.4 million in 1996, Purdue posted a loss of $452,000 on the drug. In 1997, sales reached $146.5 million for a pretax profit of $16.5 million, the company records show.

In 1998, as Purdue hawked OxyContin for conditions such as arthritis and back pain, it decided to “increase communications” with patients, company records show.

The goal: “convince patients and their families to actively pursue effective pain treatment. The importance of the patient assessing their own pain and communicating the status to the health care giver will be stressed.”

Purdue’s six-page pamphlet for patients, provided to the Florida attorney general, was titled “OxyContin: A Guide to Your New Pain Medicine.” “Your health care team is there to help, but they need your help, too,” the pamphlet says. It says OxyContin is for treating “pain like yours that is moderate to severe and lasting for more than a few days.”

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To patients or family members worried about addiction, Purdue’s pamphlet said: “Drug addiction means using a drug to get ‘high’ rather than to relieve pain. You are taking opioid pain medication for medical purposes. The medical purposes are clear and the effects are beneficial, not harmful.”

Asked to comment this week, Purdue spokesman Robert Josephson said the company “discontinued the use of this piece many years ago.”

Dr. Michael Barnett, a physician and assistant professor at the Harvard T.H. Chan School of Public Health, said that some of Purdue’s early marketing claims may have seemed reasonable to many doctors 20 years ago.

But he faulted the medical profession for not demanding scientific evidence that opioids were in fact safe and prudent for widespread use.

“I think a lot of physicians are coming to the realization that a lot of what we were taught about pain management was pure conjecture,” he said. “I feel foolish for believing it.”

In hindsight, he said, Purdue’s sales tactics seem “almost a satire of an unscrupulous corporation that really has no interest in understanding the implications and complications of people using their drugs.”

Dr. Art Van Zee, a physician in southwestern Virginia who was among the first to recognize the ravages of OxyContin misuse, said that some people who became addicted were drug abusers.

But he added: “There clearly are people that I’ve taken care of who took it as directed orally and became opioid-addicted.”

Purdue also paid a New York City production company to shoot a videotape called “From One Pain Patient to Another,” featuring testimonials by seven patients from the Raleigh, N.C., area under the care of pain doctor Alan Spanos. Filming took place at the patients’ homes, places of work and other area locations on July 17, 1997, according to the documents.

Purdue did not pay the patients, though Spanos received $3,400 as a “physician spokesman” on that video and another, the company records state. Contacted recently by phone, Spanos would not comment. In the documents, Purdue said that the patients “participated willingly, wishing to speak out regarding the importance to them of being able to receive effective therapy for their chronic pain.”

Between January 1998 and June 2001, Purdue distributed 16,000 copies of the video to doctors, who showed them to selected patients.

Facebook Live: The Marketing Plan That Fueled An Addiction Epidemic

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The video did not mention OxyContin directly, but the Food and Drug Administration did balk at a claim in the video that fewer than 1 percent of people taking opioids became addicted. The FDA said that claim was not substantiated, according to a December 2003 General Accountability Office audit.

Purdue destroyed remaining copies of the video in July 2001, including 4,434 Spanish-language versions, according to the company records.

By then, annual OxyContin sales had topped $1 billion as Purdue pushed to “attach an emotional aspect to non-cancer pain so physicians treat it more seriously and aggressively,” according to the company’s marketing reports.

Asked about the video, Purdue spokesman Josephson said the drugmaker has not made that claim — regarding 1 percent addiction — “in more than 15 years.”

Purdue submitted the marketing records to the Florida attorney general’s office during its investigation of the company. The state settled the case in 2002 when Purdue agreed to pay $2 million to help set up an electronic prescription-tracking program.

Florida officials released the records to two Florida newspapers in 2003 after Purdue lost a court battle to keep them confidential. KHN posted some of those documents earlier this year for readers to review on its website.

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

HHS Secretary Azar Meets with Specialty and Patient Groups Regarding Drug Pricing

HHS Gov News - August 17, 2018

On Wednesday, Secretary Alex Azar met with representatives of specialty-physician and patient groups to discuss the Trump Administration’s efforts to offer new tools for Medicare Advantage plans to negotiate lower drug prices for patients.

The groups included the American Academy of Ophthalmology, the American Cancer Society’s Cancer Action Network, the American College of Rheumatology, the American Society of Clinical Oncologists, and Patients for Affordable Drugs. Secretary Azar was joined by Centers for Medicare & Medicaid Services Principal Deputy Administrator Demetrios Kouzoukas, Senior Advisor for Drug Pricing Reform Dan Best, and Advisor to the Secretary John O’Brien.

Both Secretary Azar and the organizational representatives expressed appreciation for the opportunity to share their views with each other on the recent announcement that Medicare Advantage plans will be able to use step therapy or prior authorization to negotiate lower drug prices for patients. Most of the groups with representatives in attendance have expressed concerns about the new policy.

Representatives offered their individual views on the new policy, included concerns about the complexity and challenges their organizations’ members have faced in prescribing drugs for patients covered by plans that use prior authorization or step therapy. A number of individuals also expressed their support for the administration’s attention to the issue of prescription drug pricing.

Secretary Azar emphasized the department’s interest in innovations and solutions that can address the high price of prescription drugs, and individual attendees offered a number of ideas, including noting their support for concepts put forth in President Trump’s American Patients First blueprint. He also shared his openness to solutions that may alleviate the burden that could be imposed on physicians by the new negotiation tools.

Read the President’s American Patients First blueprint.

Podcast: KHN’s ‘What The Health?’ See You In Court!

Julie Rovner

Kaiser Health News

@jrovner

Read Julie's Stories Kimberly Leonard

Washington Examiner

@leonardkl

Read Kimberly's Stories Alice Ollstein

Talking Points Memo

@AliceOllstein

Read Alice's Stories Margot Sanger-Katz

The New York Times

@sangerkatz

Read Margot's Stories

A federal district court judge in Texas has set Sept. 10 as the date for oral arguments in a case filed by Republican state attorneys general and governors from 20 states. Their lawsuit charges that the Affordable Care Act should be found unconstitutional following Congress’ elimination of the tax penalty for failing to have insurance. That date is less than two months before the critical midterm election that will determine which party controls Congress.

Meanwhile, a group of cities whose leaders support the health law have also filed suit. They charge that President Donald Trump has violated his constitutional duty to “take care” to “faithfully execute” laws passed by Congress in relation to the ACA. They say the damage done to the law by the Trump administration has raised health costs in their jurisdictions.

Also in court this week were Medicaid recipients from Arkansas, who say the state’s new work requirements for healthy people getting such coverage threatens their health care.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Alice Ollstein of Talking Points Memo, Margot Sanger-Katz of The New York Times and Kimberly Leonard of the Washington Examiner.

Among the takeaways from this week’s podcast:

  • The timing of the arguments in the attorneys general’s ACA case — and the possibility of a quick decision — could remind midterm voters that the GOP is still vowing to get rid of the law. On the other hand, some Republicans are hoping that the case will help fire up the base, which in the past has responded well to the party’s criticisms of the law.
  • The attorneys general in Missouri and West Virginia are among those bringing the suit — and they are also challenging incumbent Senate Democrats. Their political futures could be closely tied to the suit.
  • As Arkansas’ work requirements move to a court case, the state announced that thousands of people are in danger of losing coverage because they did not report their work hours online, as required.
  • Despite the administration’s strong opposition to the ACA, officials are divided over whether to allow states to accept only a partial expansion of Medicaid under the law. That would save money for the states — who shoulder part of the cost of Medicaid — but likely would cost the federal government more because many people who ordinarily would qualify for Medicaid would instead move to the health insurance marketplace and get federal subsidies.
  • Hospitals are watching with concern the Democratic debate over setting up a national, single-payer health system. Savings that the Democrats expect from such a move would likely have to come from hospitals’ and doctors’ revenues.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too:

Julie Rovner: The Washington Examiner’s “Hospitals Present a Major Roadblock to Medicare for All Act,” by Kimberly Leonard

Also, Rovner mentioned a 2009 story: The New Yorker’s “Getting There From Here” by Atul Gawande

Margot Sanger-Katz: Kaiser Family Foundation’s “An Analysis Of Out-Of-Network Claims In Large Employer Health Plans,” by Gary Claxton, Matthew Rae, Cynthia Cox and Larry Levitt

Alice Ollstein: STAT News’ “Tapered To Zero: In Radical Move, Oregon’s Medicaid Program Weighs Cutting Off Chronic Pain Patients From Opioids,” by Lev Facher

Kimberly Leonard: Pew Stateline’s “For Addicted Women, the Year After Childbirth Is The Deadliest,” by Christine Vestal

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Energy-Hog Hospitals: When They Start Thinking Green, They See Green

Kaiser Health News:Marketplace - August 16, 2018

Hospitals are energy hogs.

With their 24/7 lighting, heating and water needs, they use up to five times more energy than a fancy hotel.

Executives at some systems view their facilities like hotel managers, adding amenities, upscale new lobbies and larger parking garages in an effort to attract patients and increase revenue. But some hospitals are revamping with a different goal in mind: becoming more energy-efficient, which can also boost the bottom line.

“We’re saving $1 [million] to $3 million a year in hard cash,” said Jeff Thompson, the former CEO of Gundersen Health System in La Crosse, Wis., the first hospital system in the U.S. to produce more energy than it consumed back in 2014. As an added benefit, he said, “we’re polluting a lot less.”

The health care sector — one of the nation’s largest industries — is responsible for nearly 10 percent of all greenhouse gas emissions — hundreds of millions of tons worth of carbon each year. Hospitals make up more than one-third of those emissions, according to a paper by researchers at Northeastern University and Yale.

Increasingly, though, health systems are paying attention:

  • Gundersen Health System in Wisconsin employs wind, wood chips, landfill-produced methane gas — and even cow manure — to generate power, reporting more than a 95 percent drop in its emissions of carbon monoxide, particulate matter and mercury from 2008 to 2016.
  • Boston Medical Center analyzed its hospital for duplicative and underused space, then downsized while increasing patient capacity. Among other changes, it now has a gas-fired 2-megawatt cogeneration plant that traps and reuses heat, saving money and emissions, while supplying 41 percent of the hospital’s needs and acting as a backup for essential services if the municipal power grid goes out.
  • Theda Clark Medical Center in Wisconsin is saving nearly $800,000 a year — 30 percent of its energy costs — after making changes that included retrofitting lights, insulating pipes, taking the lights out of vending machines and turning off air exchangers in parts of its building after hours.
  • Kaiser Permanente aims to be “carbon-neutral” by 2020, mainly by incorporating solar energy at up to 100 of its hospitals and other facilities. One already in use — at its Richmond (Calif.) Medical Center — is credited with reducing electric bills by about $140,000 a year. (Kaiser Health News is not affiliated with Kaiser Permanente.)
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While the environmental benefits are important, “what I’ve seen over the years is cost reductions are the prime motivator,” said Patrick Kallerman, research manager at the Bay Area Council Economic Institute, which released a report this spring outlining ways the hospital industry can help states such as California reach environmental goals by becoming more efficient.

Some of its recommendations are simple: replacing old lighting and windows. Others are more complex: powering down heating and cooling in areas not being used and updating ventilation standards first set back in Florence Nightingale’s day. Such tight standards “might not be necessary,” Kallerman said. Loosening them could help save money and energy.

When Bob Biggio was hired in 2011 to oversee Boston Medical Center’s facilities, hospital leaders were about to launch a broad redesign. Yet the hospital was also facing serious financial struggles. He put the move on hold while analyzing how the hospital was using its existing space, looking for unused or duplicative areas.

“My first impression with data I had gathered was our campus was about 400,000 square feet bigger than it needed to be, said Biggio. “A square foot you never have to build is most efficient of all.”

The new design is smaller but more efficient, handling 20 percent higher patient volume and eliminating the need for ambulance transportation between far-flung areas of the campus. It also cut power consumption by 42 percent from a 2011 baseline.

While the hospital sunk a lot of money into the renovation, the center was able to sell off some of its land to help offset the costs, leading to about a five-year return on investment, Biggio said.

“We are a safety-net hospital with a large Medicaid population,” he said. “So this is the last place people expect to see the type of investments and progress we’ve made.”

But how to sell that in the C-suite?

The environmental argument wasn’t how Thompson convinced executives at Gundersen.

“At no point did I mention climate change or polar bears,” said Thompson.

Instead, he focused on the organization’s mission to improve health — and the potential cost savings.

“There are multiple examples — at Gundersen and other places — where, if we’re thoughtful, we can improve the local economy, lower the cost of health care and decrease the pollution that is making people sick,” he said.

But hospitals’ energy efficiency efforts vary, with only about 10 percent attempting changes as dramatic as those done at Gundersen, estimated Alex Thorpe, a hospital energy expert at Optum Advisory Services, a consulting firm owned by UnitedHealth Group.

“About 50 percent are in the middle,” he added, perhaps because these investments are weighed against other capital needs.

“If you have a well-known doctor that wants a new cutting-edge piece of equipment, then it can be hard to make the business case [for investing in alternative energy],” said Thorpe.

Of the more than 5,000 hospitals in the country, about 1,100 are members of Practice Greenhealth, a nonprofit that promotes environmental stewardship. Fewer than 300 hospitals qualify as Energy Star facilities, an Environmental Protection Agency program that recognizes buildings that rank in the top quartile for energy conservation among their peers.

Greenhealth estimates its members average about a million dollars a year in savings, but it all depends what steps they take.

There are modest savings from such things as reducing the heating and air conditioning in operating rooms during hours they are not in use, with median annual cost savings of $45,398, a report from the group notes. Other energy reduction efforts net another median $53,599 in annual savings, while swapping older lighting for new LED bulbs in operating rooms saves another $3,329.

Individually, those savings are not even rounding errors in most hospitals’ total expenses, which are measured in the millions of dollars.

Still, within facility expenses, energy use accounts for 51 percent of spending, so even modest cuts are “significant,” said Kara Brooks, sustainability program manager for the American Society for Healthcare Engineering.

Ultimately, that may affect what hospitals charge insurers and patients.

“If hospitals can lower peak demand through energy efficiency efforts, that will directly impact their pricing,” said Thorpe.

HHS awards $125 million to support community health center quality improvement

HHS Gov News - August 15, 2018

Today, the U.S. Department of Health and Human Services (HHS) announced $125 million in Quality Improvement grant awards to 1,352 community health centers across all U.S. states, territories and the District of Columbia. Funded by the Health Resources and Services Administration (HRSA), health centers will use these funds to continue to improve quality, efficiency, and the effectiveness of healthcare delivery in the communities they serve. This announcement comes during National Health Center Week, the annual celebration that highlights the critical role community health centers play in providing high-quality, affordable, primary healthcare.

“Community health centers provide coordinated, comprehensive, and patient-centered care to millions of Americans,” said HHS Deputy Secretary Eric Hargan. “They have a track record of delivering quality care at significantly lower cost, and are vital partners in our movement toward a health system that delivers quality, affordable, value-based health care for all Americans.”

HRSA’s Quality Improvement grant awards promote continued community health center improvements in the following categories: Expanding access to comprehensive care, improving care quality and outcomes, increasing comprehensive care delivery in a cost-effective way, addressing health disparities, advancing the use of health information technology, and delivering patient-centered care.

Community health centers that exceed national clinical quality benchmarks, like Healthy People 2020 goals, receive special designation as National Quality Leaders. The top 30 percent of community health centers that achieve the best overall clinical performance receive designation as Health Center Quality Leaders.

“Quality, value-based care is a priority of the U.S. Department of Health and Human Services and HRSA-funded health centers serve as leaders in quality healthcare in the U.S.,” said HRSA Administrator George Sigounas, MS, Ph.D. “Nearly all HRSA-funded health centers demonstrated improvement in one or more clinical quality measures from the year prior, and these funds will support health centers’ work to improve the quality of care they deliver every day in their communities around the country.”

HRSA also released new data compiled from health centers through its Uniform Data System (UDS) reporting, providing an update on health centers’ provision of primary healthcare services. In 2017, more than 27 million people (approximately 1 in 12 U.S. residents) relied on a HRSA-supported health center for affordable, accessible primary healthcare including:

  • One in nine children 17 years or younger;
  • One in five rural residents;
  • One in three people living in poverty; and
  • More than 355,000 U.S. veterans.

For more than 50 years, health centers have delivered affordable, accessible, quality, and cost-effective primary healthcare services to patients. Today, nearly 1,400 health centers operate more than 11,000 service delivery sites nationwide.

For a list of FY 2018 Quality Improvement Awards recipients, visit: https://bphc.hrsa.gov/programopportunities/fundingopportunities/qualityimprovement/index.html

To learn more about HRSA’s Health Center Program, visit: http://bphc.hrsa.gov/about.

To locate a HRSA-funded health center, visit: http://findahealthcenter.hrsa.gov.

Financial Ties That Bind: Studies Often Fall Short On Conflict-Of-Interest Disclosures

Kaiser Health News:Marketplace - August 15, 2018

Papers in medical journals go through rigorous peer review and meticulous data analysis.

Yet many of these articles are missing a key piece of information: the financial ties of the authors.

Nearly two-thirds of the 100 physicians who rake in the most money from 10 device manufacturers failed to disclose a conflict of interest in their academic writing in 2016, according to a study published Wednesday in JAMA Surgery.

The omission can have real-life impact for patients when their doctors rely on such research to make medical decisions, potentially without knowing the authors’ potential conflicts of interest.

“The issue is anytime there’s a new technology, people get really excited about it,” said lead researcher Dr. Mehraneh Jafari. “Whoever is reading the data on it needs to have the most information.”

The study sought to “assess the credibility and accuracy” of conflict-of-interest statements — also known as COIs — in such journal articles, wrote the researchers.

They did this by sampling 10 large surgical and medical device manufacturers. This list includes Medtronic, Stryker Corp., Intuitive Surgical, Covidien, Edwards Lifesciences Corp., Ethicon, Olympus Corp., W.L. Gore & Associates, LifeCell Corp. and Baxter Healthcare.

The researchers also pinpointed the 10 physicians who received the highest compensation from each company. They then searched for articles published by these physicians between Jan. 1 and Dec. 31, 2016, and reviewed the full text of each article for COI disclosure.

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According to their findings, those 10 companies paid more than $12 million in 2015 to the 100 doctors included in the study. The median payment to these physicians was $95,993.

Jafari, a surgeon at the University of California-Irvine, said the disclosures aren’t necessarily omitted in bad faith, but standards for disclosure vary from one conference or publication to another.

“It’s not necessarily because surgeons are trying to hide conflicts of interest, but because the system is broken,” she added. “People don’t understand what the rules are and there’s no one clearing it up.”

It’s a problem because even the appearance of conflict can cast doubt on research, she said.

“We work very hard on our research, it’s difficult to conduct, we’re proud of what we do, and the papers we write might change patient outcomes for the better,” Jafari said. “We don’t want there to be the appearance of bias.”

The researchers concluded that the only way to make sure doctors are upfront about all potential conflicts is to have a universal process for full disclosure for every financial relationship in every paper.

A separate commentary letter by Dr. Greg Sacks and Dr. Joe Hines in the same issue of JAMA Surgery suggested, though, that the study might have used too high a standard to determine conflicts of interest. For instance, it cited the case of one doctor who disclosed the relationship he had with one device maker he was writing about, but not another one because he didn’t think it was a conflict.

Still, it reiterated the need to revise current disclosure procedures: “Given the enormous sums of money invested by industry into physician relationships, enforcing accurate disclosure … is a critical step to ensuring the integrity and reputation of our fields.”

The financial ties between medical device manufacturers and providers go well beyond academic research and ivory towers.

As many as 94 percent of doctors, according to research published in the New England Journal of Medicine, report getting some kind of benefit from the industry. These benefits can range from a fancy dinner or cocktail party with a sales representative to new equipment for students to use in the classroom to payments for being consultants.

With the passage of the Physician Payments Sunshine Act, which became law as part of the Affordable Care Act, medical product manufacturers are required to report to the Centers for Medicare & Medicaid Services payments made to physicians and teaching hospitals, among other things.

These payments are tracked in a federal database, which researchers used for this study. The database also offers patients a way to see their physicians’ financial relationships with these companies.

“I think the better and more information that patients and the public have, the better information they can have for their own care and what providers they turn to,” said Matt Wetzel, vice president and assistant general counsel for AdvaMed, the trade association of medical device manufacturers.

And the financial support is often a good thing, Jafari said.

The industry money that goes into the academic end of medicine comes out in the form of better training, better product development and better-prepared surgeons, she added.

Wetzel agreed. “The partnership is really a benefit to patients at the end of the day, but having that context around that relationship is important.”

Listen: Why Young Doctors Appear To Be Embracing Single-Payer

Kaiser Health News:Marketplace - August 15, 2018

Kaiser Health News correspondent Shefali Luthra talks with Susan Rinkunas, news editor for Tonic, about how a new generation of doctors within the American Medical Association hope to change the organization’s long-held opposition to such ideas as universal health care or single-payer systems. Luthra notes that some of the demographic and political shifts taking place within the profession mirror changes in the population at large.

You can read Luthra’s recent Kaiser Health News story on the topic here.

States Leverage Federal Funds To Help Insurers Lower Premiums

[UPDATED at 3:45 p.m. ET]

When Tracy Deis decided in 2016 to transition from a full-time job to part-time contract work, the loss of her employer’s health insurance was not a major worry because she knew she could get coverage through the marketplace set up by the Affordable Care Act.

But price was a big concern.

“The ACA made it possible to make the switch in my life,” said Deis, 48, who lives in Minneapolis. But she quickly added, “I was really worried about the cost.”

Her anxiety was understandable. In Minnesota, the average cost of insurance in the state-run exchange soared 57 percent in 2017, after a 40 percent rise in 2016.

Tracy Deis of Minneapolis was worried about the cost of an ACA marketplace plan. But Minnesota’s effort to help insurers cover some patients’ high bills is curbing premiums. (Courtesy of Carmen Carda)

Amid a public outcry, the legislature last year took several steps to stabilize its individual insurance marketplace.

Among those moves, lawmakers launched a “reinsurance” program. The program helps pay the costs insurers incur for people with high medical bills. In turn, the companies — knowing that these “outlier” expenses will be covered — can lower premiums. Alaska had launched a similar program in 2016.

The Alaska and Minnesota models have now become touchstones for other states eager to prevent startling premium increases in the individual insurance marketplace.

Critically, much of the money comes from the federal government. A provision in the ACA allows states to experiment with their marketplaces as long as they honor ACA requirements and don’t cost the federal government more money. (Federal reinsurance funding for high-cost patients reduces premium subsidies, which are fully paid by the federal government.)

Notably, even as the Trump administration has blocked other provisions of the ACA and pushed Congress to repeal the law, it has encouraged states to establish reinsurance programs and seek federal funding.

In Alaska, lawmakers used only state funds to cut an anticipated 43 percent premium increase to 7 percent in 2017. As the program continued in 2018 with $58 million in federal funds, the lone insurer in the state, Premera Blue Cross Blue Shield, lowered premiums by an average 22.4 percent. And on Aug. 2, Premera announced it had asked the state if it could reduce premiums by an average 3.9 percent in 2019.

Alaska’s program, unlike other states’, covers all the costs for people with 33 high-cost conditions. In 2017, about half of all expenses for enrollees in the exchange were for people with one or more of those conditions.

“We have unique issues here,” said Jim Grazko, president of Premera Blue Cross Blue Shield of Alaska. “Without the reinsurance program, things would be untenable in the individual market.”

The federal Department of Health and Human Services approved Minnesota’s waiver request for a 2018 reinsurance program, with $131 million in funding. The program covers medical bills between $50,000 and $250,000 for marketplace customers.

It worked. Premium rates declined by 13 percent in 2018 compared with 2017 and are projected to drop again in 2019 by 5 to 8 percent, according to Eileen Smith, a spokeswoman for the Minnesota Council of Health Plans.

That was good news for Deis. Her monthly premium this year is $317, down from $355 in 2017. She’s in a plan that includes the doctors she wanted and is happy with her coverage, although it has a deductible of $7,050.

“I wouldn’t mind if my premiums came down again for 2019,” she said. “Every little bit helps.”

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Pushing Premiums Down

Oregon also launched a federally approved reinsurance program in 2018. And last month, the Trump administration notified Wisconsin and Maine that their requests for reinsurance program funding had been approved.

Four other states — Idaho, Louisiana, Maryland and New Jersey — are seeking federal approval for reinsurance programs enacted this year. All hope to have plans in place for 2019.

Eric Cioppa, Maine’s insurance commissioner, estimates his state’s reinsurance program will reduce premiums in 2019 by an average 9 percent compared to what they would have been without the program.

“Reinsurance is possibly the best proven mechanism to restrain premium increases and keep health insurance affordable,” said Trish Riley, executive director of the National Academy for State Health Policy in Portland, Maine. “The biggest plus is that it’s a tool with support across the political spectrum.”

That includes some deep conservatives, such as Wisconsin Gov. Scott Walker, a Republican and longtime critic of Obamacare. He strongly supports the reinsurance program and touts it on the campaign trail as he seeks a third term.

Wisconsin’s program establishes a $200 million fund — $166 million of it federal money — to pay about 50 percent of the costs for individuals with medical expenses between $50,000 and $200,000.

The state’s insurance department estimates the program will yield premiums in 2019 that will be 11 percent lower on average than they would have been without reinsurance. Premiums rose 44 percent in 2018, leading 25,000 people to drop coverage.

Amy Brooks, who buys insurance on the health law’s marketplace and underwent brain surgery this year, said she supports Wisconsin’s plan to use reinsurance to help hold down premium costs. “Anything that keeps the costs down is a huge help because I could need this coverage for some time.” (Courtesy of Amy Brooks)

For Amy Brooks, of Madison, Wis., the initiative is especially timely. Brooks, 48, who pays $150 a month for subsidized coverage in an ACA plan because her job didn’t come with insurance, was diagnosed in April with a benign brain tumor that required surgery.

She lost her job after the diagnosis and said having insurance coverage “takes a gigantic weight off my shoulder. I would have gone bankrupt. … Anything that keeps the costs down is a huge help because I could need this coverage for some time.”

No Panacea

Insurance analysts say that state-based reinsurance programs are a potent mechanism to lower premiums, but not a panacea.

The programs don’t address underlying medical costs, for example. And if money for the programs is not sustained — or increased — over time, reinsurance can yield a one-time decline in premiums over a year or two.

“Reinsurance programs can meaningfully reduce premiums,” said Matthew Fiedler, a health policy researcher at the Brookings Institution in Washington, D.C. But, he said, other steps would also be needed to offset the effects of changes recently implemented by the administration.

The every-state-for-itself approach also frustrates insurers and consumer advocates.

“A sustained federal approach would be much preferable and what we’d like to see,” said Kris Haltmeyer, vice president for legislative and regulatory policy at the Blue Cross Blue Shield Association, which represents 36 Blues plans nationwide.

After Republicans in Congress failed to repeal and replace the ACA in 2017, Sens. Patty Murray (D-Wash.) and Lamar Alexander (R-Tenn.) launched a bipartisan effort to stabilize the ACA marketplaces. A prominent part of their plan was a $30 billion reinsurance pool — $10 billion a year.

The effort failed in March amid discord over an unrelated abortion measure in the bill.

Voters To Settle Dispute Over Ambulance Employee Break Times

Kaiser Health News:Marketplace - August 15, 2018

If private-ambulance workers take a break from work, even for 10 minutes, it can mean the difference between life and death.

So, they routinely accept emergency calls during their meal and rest breaks — just as firefighters, policemen and other public emergency workers do.

But labor laws guarantee most California workers uninterrupted breaks, and multiple lawsuits are challenging whether private ambulance companies have the right to interrupt their employees’ breaks.

In November, voters will resolve the issue. Proposition 11 — a measure backed and funded by American Medical Response (AMR), California’s largest private ambulance company — would require private-ambulance employees to remain on call during their breaks.

“If a dispatcher calls and the closest ambulance is only a few blocks away, they’ll be reachable and ready to respond,” said Marie Brichetto, spokeswoman for the campaign advocating the ballot measure. “In times of emergency, seconds will make a difference.”

Proposition 11 also would require private ambulance companies to provide their employees with mental health coverage and training to respond to natural disasters, mass shootings and other emergencies.

The ballot measure would apply to the state’s estimated 17,000 private ambulance employees, including dispatchers, emergency medical technicians (EMTs) and paramedics, who answer about three-quarters of the state’s emergency calls, according to a report by the state Legislative Analyst’s Office. The initiative doesn’t affect public ambulance workers because the labor codes governing rest and meal breaks apply only to private-sector workers.

Opponents of the measure, including a California lawmaker who works part time as an EMT, call it a “misleading” effort by the industry to save money on staffing — and get out of potentially bank-breaking lawsuits.

The initiative isn’t about public safety, but rather “trying to extract machine-level work from human beings,” said Mike Diaz, an AMR employee in Antelope Valley and president of the International Association of EMTs and Paramedics Local 77.

For AMR, “the most efficient ambulance crew is one that is on a call for every hour of your 24-hour shift,” he said. “We’re not machines. We need rest.”

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The initiative grew out of a 2016 state Supreme Court ruling in Augustus v. ABM Security, which found that a California security company had failed to meet its legal obligation to provide breaks because its workers had to remain on call.

Given the similarities between the private security and ambulance industries, the case is likely to be applied to private EMTs and paramedics, the analyst’s report concluded.

AMR is already facing at least two lawsuits from employees who say they were denied breaks.

If the ambulance companies lose in court, they can no longer assume their employees are available during their breaks and would have to increase staffing — which could cost the industry around $100 million a year, the report said.

Proposition 11 is the industry’s effort to avoid that. The ballot measure also includes a provision that would effectively nullify the pending lawsuits.

So far, AMR is the only donor on either side of the measure. The company has poured about $3.6 million into a committee to support the measure, and the committee has used about $3 million of that, mostly to get the measure on the ballot. AMR declined to comment for this article and referred inquiries to Brichetto, the Proposition 11 campaign spokeswoman.

Some ambulance companies have offered muted support for the measure, while others have remained silent.

Edward Guzman, CEO and general manager of the nonprofit Sierra Ambulance Company in eastern Madera County, said he supports Proposition 11. But he acknowledged there are some private companies that overwork their employees.

“Some of the urban providers … were running their people into the ground and not providing adequate rest or breaks,” he said. “There are players that will continue to do that because they don’t want to add extra units into the mix.”

This summer, Sierra added an additional ambulance and paramedics to its daytime rotation to respond to higher demand, and employees have a strong collective bargaining agreement that protects them from overwork or abuse, Guzman said.

Still, he fears that his smaller company could get slammed with lawsuits if Proposition 11 doesn’t pass. The measure protects Sierra “from unnecessary and expensive litigation,” he said.

County officials across the state cannot take political positions, but some worry that if the measure fails and lawsuits against the companies succeed, the cost of hiring more ambulance workers could be passed on to them. Some counties hire private ambulance companies to supplement local fire departments and public ambulances.

“Somebody’s gonna have to pay for that,” said Cathy Chidester, director of Emergency Medical Services for Los Angeles County. “That [cost is] going to go back to the general public.”

Opposition to the ballot measure is largely unorganized but includes some unionized emergency response workers and lawyers representing the plaintiffs who are suing AMR. They argue that the proposition won’t change how private-ambulance employees operate, because their first instinct is to help people in distress.

“If I see something happen in front of me while I’m having my meal or rest break, I’m gonna respond. That’s our duty. That’s our calling,” said state Assemblyman Freddie Rodriguez (D-Pomona), who works part time as an EMT. “We’re not gonna sit there and watch somebody die just because we’re eating.”

Rodriguez and other opponents say the Proposition 11 campaign’s emphasis on public safety masks its true intentions: to maximize private companies’ profit margins.

“It’s a little misleading,” Diaz said.

EMT and paramedic workloads vary greatly depending on the county and employers. Diaz, who works in the Antelope Valley region of Los Angeles County, said his area is chronically understaffed. But Dandy Mendoza and Esther Nungaray, who work for American Ambulance in Fresno County, said they take an average of six to seven calls during a 12-hour shift — a number they consider reasonable.

“I don’t really have a strong opinion because I really like my job. I show up to take care of people,” Mendoza said. “I try to stay out of politics.”

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

Feds Urge States To Encourage Cheaper Plans Off The Exchanges

For those who make too much money to qualify for health insurance subsidies on the individual market, there may be no Goldilocks moment when shopping for a plan. No choice is just right.

A policy with an affordable premium may come with a deductible that’s too high. If the copayments for physician visits are reasonable, the plan may not include their preferred doctors.

These consumers need better options, and in early August federal officials offered a strategy to help bring down costs for them.

The guidance is from the Centers for Medicare & Medicaid Services, which oversees the insurance marketplaces set up by the Affordable Care Act. CMS is encouraging states to allow the sale of plans outside of those exchanges that don’t incorporate a surcharge insurers started tacking on last year.

Many insurers added the premium surcharges last fall to plans sold on the individual market. It was a response to the Trump administration’s announcement that it would no longer pay the companies for the “cost-sharing reduction” subsidies required under the health law. The subsidies help cover deductibles and other out-of-pocket costs for lower-income consumers who buy marketplace plans.

Insurers typically added the cost to silver-level plans because those are the type of plans that consumers have to buy in order to receive the cost-sharing subsidies. “Silver loading,” as it’s called, added an estimated 10 percent to the cost of those plans, according to the Congressional Budget Office.

People who qualified for federal premium subsidies — those with incomes up to 400 percent of the federal poverty level (about $48,000 for one person or $100,000 for a family of four) — were shielded from the surcharge because their subsidies increased to cover the cost.

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But people with higher incomes faced higher premiums. The new guidance is geared to help them.

“It encourages states to encourage silver loading only on the exchange,” said Aviva Aron-Dine, vice president for health policy at the Center on Budget and Policy Priorities.

But some analysts say they’re unsure if the new federal policy will make a difference since states have already implemented similar strategies.

Many states moved last fall to limit silver loading to plans sold on the exchanges, while allowing or, in the case of California, requiring, very similar plans to be sold off the exchanges without the extra premium charge.

Yet CMS’ endorsement of the strategy removes doubts states may have had, said David Anderson, a research associate at Duke University’s Margolis Center for Health Policy who has tracked the issue.

Eighty-three percent of people who bought a plan during the open-enrollment period for 2018 qualified for premium tax credits. The average monthly premium per subsidized enrollee was $639; after accounting for premium tax credits, however, enrollees owed just $89 on average. That amount was 16 percent lower than the monthly premium the year before.

For people who don’t qualify for premium tax credits, the picture is very different. The average monthly premium for 2018 was $522. That total was 28 percent higher than the previous year’s total of $407, according to an analysis by the Center on Budget and Policy Priorities of CMS enrollment data.

In general, federal rules require that insurers charge the same rates for identical qualified health plans that are sold on and off the exchanges. The CMS guidance suggests that the unloaded plans could be tweaked slightly in terms of cost sharing or other variables so that they are not identical to those on the marketplaces.

Tracing what type of coverage is purchased off the exchange is difficult because there is no centralized source. Consumers can buy plans directly from insurers, or they may use a broker or an online web portal. According to one such portal, eHealth, 28 percent of unsubsidized consumers on its site bought silver plans in 2018, while 42 percent bought bronze plans, whose coverage is less generous than silver plans and typically have lower premiums. Conversely, on the exchanges nearly two-thirds of people bought silver plans in 2018 while 29 percent bought bronze plans, according to federal data.

If fewer insurers add the CSR load to silver plans sold off the exchange, those plans may be more affordable next year than they were in 2018, said Cynthia Cox, director of health reform and private insurance at the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

“This makes silver plans an option for [unsubsidized] people who wanted to buy a silver plan but might have been pushed off onto a bronze plan,” she said.

Consumers who want to consider off-exchange plans have to find them first. Some experts suggest checking with insurers that are selling on the marketplace in an area, because it’s possible that they’ll also be selling plans off the exchange.

But that’s not a given. A health insurance broker can help people find and evaluate plans sold off the exchange. But experts urge consumers to stay on their toes and make sure they understand whether the plans they’re considering provide comprehensive coverage.

Starting in October, insurers can offer short-term plans with limited benefits that last up to a year.

“Differentiating between the two may not be easy, and the off-exchange unsubsidized market is the target market for short-term plans,” said Anderson.

Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.

‘No One Is Ever Really Ready’: Aid-In-Dying Patient Chooses His Last Day

Kaiser Health News:States - August 14, 2018

In the end, it wasn’t easy for Aaron McQ to decide when to die.

The 50-year-old Seattle man — a former world traveler, triathlete and cyclist — learned he had leukemia five years ago, followed by an even grimmer diagnosis in 2016: a rare form of amyotrophic lateral sclerosis, or ALS.

An interior and urban designer who legally changed his given name, McQ had been in pain and physical decline for years. Then the disease threatened to shut down his ability to swallow and breathe.

“It’s like waking up every morning in quicksand,” McQ said. “It’s terrifying.”

Last fall, McQ decided to use Washington state’s 2009 Death With Dignity law to end his suffering. The practice, approved in seven states and the District of Columbia, allows people with a projected six months or less to live to obtain lethal drugs to end their lives.

Although the option was legal, actually carrying it out was difficult for McQ, who agreed to discuss his deliberations with Kaiser Health News. He said he hoped to shed light on an often secretive and misunderstood practice.

“How does anyone get their head around dying?” he said, sitting in a wheelchair in his Seattle apartment in late January.

Aaron McQ speaks during an interview in his Seattle apartment in January. “No one is ever really ready to die,” McQ said. “There will always be a reason not to.”(Dan DeLong for KHN)

More than 3,000 people in the U.S. have chosen such deaths since Oregon’s law was enacted in 1997, according to state reports. Even as similar statutes have expanded to more venues — including, this year, Hawaii — it has remained controversial.

California’s End of Life Option Act, which took effect in 2016, was suspended for three weeks this spring after a court challenge, leaving hundreds of dying patients briefly in limbo.

Supporters say the practice gives patients control over their own fate in the face of a terminal illness. Detractors — including religious groups, disability rights advocates and some doctors — argue that such laws could put pressure on vulnerable people and that proper palliative care can ease end-of-life suffering.

Thin and wan, with silver hair and piercing blue eyes, McQ still could have passed for the photographer’s model he once was. But McQ’s legs shook involuntarily beneath his dark jeans and his voice was hoarse with pain during a three-hour effort to tell his story.

Last November, doctors told McQ he had six months or less to live. The choice, he said, became not death over a healthy life, but a “certain outcome” now over a prolonged, painful — and “unknowable” — end.

“I’m not wanting to die,” he said. “I’m very much alive, yet I’m suffering. And I would rather have it not be a surprise.”

In late December, a friend picked up a prescription for 100 tablets of the powerful sedative secobarbital. For weeks, the bottle holding the lethal dose sat on a shelf in his kitchen.

“I was not relaxed or confident until I had it in my cupboard,” McQ said.

At the time, he intended to take the drug in late February. Or maybe mid-March. He had wanted to get past Christmas, so he didn’t ruin anyone’s holiday. Then his sister and her family came for a visit. Then there was a friend’s birthday and another friend’s wedding.

“No one is ever really ready to die,” McQ said. “There will always be a reason not to.”

In late December, a friend picked up Aaron McQ’s prescription for 100 tablets of the powerful sedative secobarbital. For weeks, the bottle holding the lethal dose sat on a shelf in his kitchen.(Dan DeLong for KHN)

Many people who opt for medical aid-in-dying are so sick that they take the drugs as soon as they can, impatiently enduring state-mandated waiting periods to obtain the prescriptions

Data from Oregon show that the median time from first request to death is 48 days, or about seven weeks. But it has ranged from two weeks to more than 2.7 years, records show.

Neurodegenerative diseases like ALS are particularly difficult, said Dr. Lonny Shavelson, a Berkeley, Calif., physician who has supervised nearly 90 aid-in-dying deaths in that state and advised more than 600 patients since 2016.

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“It’s a very complicated decision week to week,” he said. “How do you decide? When do you decide? We don’t let them make that decision alone.”

Philosophically, McQ had been a supporter of aid-in-dying for years. He was the final caregiver for his grandmother, Milly, who he said begged for death to end pain at the end of her life.

By late spring, McQ’s own struggle was worse, said Karen Robinson, McQ’s health care proxy and friend of two decades. He was admitted to home hospice care, but continued to decline. When a nurse recommended that McQ transfer to a hospice facility to control his growing pain, he decided he’d rather die at home.

Aaron McQ and his friend Karen Robinson go boating on Seattle’s Portage Bay in 2013, before he fell ill with leukemia and a rare form of ALS, or amyotrophic lateral sclerosis.(Courtesy of Karen Robinson)

“There was part of him that was hoping there were some other alternative,” Robinson said.

McQ considered several dates — and then changed his mind, partly because of the pressure that such a choice imposed.

“I don’t want to talk about it because I don’t want to feel like, now you gotta,” he said.

Along with the pain, the risk of losing the physical ability to administer the medication himself, a legal requirement, was growing.

“I talked with him about losing his window of opportunity,” said Gretchen DeRoche, a volunteer with the group End of Life Washington, who said she has supervised hundreds of aid-in-dying deaths.

Finally, McQ chose the day: April 10. Robinson came over early in the afternoon, as she had often done, to drink coffee and talk — but not about his impending death.

“There was a part of him that didn’t want it to be like this is the day,” she said.

DeRoche arrived exactly at 5:30 p.m., per McQ’s instructions. At 6 p.m., McQ took anti-nausea medication. Because the lethal drugs are so bitter, there is some chance patients won’t keep them down.

Four close friends gathered, along with Robinson. They sorted through McQ’s CDs, trying to find appropriate music.

“He put on Marianne Faithfull. She’s amazing, but, it was too much,” Robinson said. “Then he put on James Taylor for, like, 15 seconds. It was ‘You’ve Got a Friend.’ I vetoed that. I said, ‘Aaron, you cannot do that if you want us to hold it together.’”

DeRoche went into a bedroom to open the 100 capsules of 100-milligram secobarbital, one at a time, a tedious process. Then she mixed the drug with coconut water and some vodka.

Just then, McQ started to cry, DeRoche said. “I think he was just kind of mourning the loss of the life he had expected to live.”

After that, he said he was ready. McQ asked everyone but DeRoche to leave the room. She told him he could still change his mind.

“I said, as I do to everyone: ‘If you take this medication, you’re going to go to sleep and you are not going to wake up,’” she recalled.

McQ drank half the drug mixture, paused and drank water. Then he swallowed the rest.

His friends returned, but remained silent.

“They just all gathered around him, each one touching him,” DeRoche said.

Very quickly, just before 7:30 p.m., it was over.

“It was just like one fluid motion,” DeRoche said. “He drank the medication, he went to sleep and he died in six minutes. I think we were all a little surprised he was gone that fast.”

The friends stayed until a funeral home worker arrived.

“Once we got him into the vehicle, she asked, ‘What kind of music does he like?’” Robinson recalled. “It was just such a sweet, human thing for her to say. He was driving away, listening to jazz.”

McQ’s friends gathered June 30 in Seattle for a “happy memories celebration” of his life, Robinson said. She and a few others kayaked out into Lake Washington and left McQ’s ashes in the water, along with rose petals.

In the months since her friend’s death, Robinson has reflected on McQ’s decision to die. It was probably what he expected, she said, but not anything that he desired.

“It’s really tough to be alive and then not be alive because of your choice,” she said.

“If he had his wish, he would have died in his sleep.” 

Medicaid Officials Target Home Health Aides’ Union Dues

Kaiser Health News:States - August 13, 2018

Medicaid home care aides — hourly workers who help the elderly and disabled with daily tasks like eating, getting dressed and bathing — are emerging as the latest target in the ongoing power struggle between conservatives and organized labor.

About half a million of these workers belong to the Service Employees International Union, a public-sector union that represents almost 1.9 million workers in the United States and Canada. The union is an influential donor to liberal politicians and boasted strong ties to the Obama administration.

A proposed rule from the federal Centers for Medicare & Medicaid Services would prohibit home health aides paid directly by Medicaid from having their union dues automatically deducted from their paychecks, though it doesn’t name the fees explicitly.

Blocking these direct Medicaid payments means the workers — especially those who don’t work in a single, centralized office, or don’t have a credit card or a bank account — are far less likely to pay dues, diminishing the union’s potential influence.

CMS’ language affects only “individual providers” — that is, those who aren’t employed by the private, for-profit agencies that dominate this industry. Individual providers, who are technically state employees, are far more likely to be unionized.

The directive, which would overturn an Obama administration policy put in place to ease the collection of union dues and pay for other fees, such as health benefits, could take effect by the end of this year. A month-long comment period, ending Monday, has attracted more than 3,300 responses.

“This is just another way to make life more difficult for public-sector unions,” said Jake Rosenfeld, an associate professor of sociology at Washington University in St. Louis, who studies unions and their influence.

The proposed rule comes on the heels of June’s landmark Supreme Court ruling, in which a 5-4 majority held that public-sector workers don’t have to pay unions for the cost of collective bargaining, calling it a violation of their free speech.

That decision expanded on the Supreme Court’s 2014 ruling in Harris v. Quinn, in which the high court found that home care workers must explicitly state their desire to be in a union before the organization can collect dues. But because these workers are not attached to a single office or meeting point, organizing them into a collective unit poses a distinct challenge; collecting membership dues, even more so.

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As union membership has waned in other sectors, organized labor has doubled down on home care, lobbying liberal governors to declare thousands of workers as state employees, rendering them eligible to organize and engage in collective bargaining.

The median annual salary for home health aides in 2017 was $23,100, with about 67 percent turnover in 2017. The federal Bureau for Labor Statistics projects that demand for home care will increase by as much as 41 percent from 2016 to 2026, as more Americans age.

Both SEIU and the National Employment Law Project, an advocacy group, said that, if the rule takes effect, they expect to file a lawsuit seeking to reverse the decision. And a spokesperson for California Attorney General Xavier Becerra, who has frequently clashed with the White House, said the state will “take any action necessary” to blunt its impact.

In states where home care workers are unionized, the group can have the state withhold membership fees from their paycheck and transfer them directly to the union. Workers must actively choose to join the union.

In California, where most home care workers don’t work for private agencies, about 250,000 belong to the state SEIU chapter.

“They’ll effectively lose their voice on the job and their ability to advocate,” said Laphonza Butler, president of SEIU Local 2015, the California branch of the union.

Beyond California, home care aides have unionized in states including Connecticut, Massachusetts, Minnesota, Illinois, Oregon, Vermont and Washington.

The government is arguing that federal law does not allow states to divert Medicaid dollars to pay for a home care worker’s other benefits, such as health care or job training.

“The law provides that Medicaid providers must be paid directly and cannot have part of their payments diverted to third parties outside of a few very specific exceptions,” said Tim Hill, acting director for CMS’ Center for Medicaid and CHIP Services, in a statement.

Supporters of the rule, such as the National Federation of Independent Businesses, argue it stops powerful unions from using taxpayer dollars to pad their lobbying budget.

But it’s a controversial take. Critics said CMS’ argument inappropriately casts workers’ paychecks as government property, instead of as their own money. And they said it leaves vulnerable workers — arguably, the backbone of elderly care — unable to fend for themselves.

“When a state pays a worker, and the worker pays the union, it’s the worker’s money going into the union,” said Benjamin Sachs, a professor at Harvard Law School who studies labor law. “CMS doesn’t have the authority to decide.”

Some conservatives suggested that limiting union membership is less about home care policy and more about curtailing a powerful liberal lobbying force.

“There have been steps taken in underlying law and practice to provide extra favors to public sector unions. They are as much political bodies as they are representatives,” argued Thomas Miller, a resident fellow at the conservative American Enterprise Institute.

But labor advocates warned the consequences could be steep, and not just for home care workers.

Surveys from the National Employment Law Project suggest that unionized home care workers stay in their jobs longer when represented by unions, partially because they can negotiate better pay and benefits. Higher pay also makes the job more appealing, especially as need grows.

That, many experts argued, means patients also benefit.

“We can be putting more money into making these good quality jobs. The shortages and turnover we are facing —it is not rocket science what is causing that,” said Caitlin Connolly, who runs the National Employment Law Project’s campaign to increase home care wages. “If we made these quality jobs, we would be able to ensure that people had access to quality care.”

Readout of Secretary Azar’s ALEC Speech and Louisiana Healthcare Leaders Roundtable

HHS Gov News - August 10, 2018

On Thursday, Health and Human Services Secretary Alex Azar delivered remarks at the 45th American Legislative Exchange Council Annual Meeting in New Orleans, Louisiana. His remarks focused on the Trump Administration’s commitment to working with and challenging states to improve healthcare. Here is a key excerpt from his speech:

“From administering Medicaid programs to providing mental health services, retiree healthcare, and public health programs, states have a major role to play in running America’s healthcare system. But we don’t just want you administering our system as it stands today. This administration believes states should play a vital role in driving American healthcare forward.”

To read the full remarks, please visit: https://www.hhs.gov/about/leadership/secretary/speeches/2018-speeches/remarks-on-state-healthcare-innovation.html.

Later in the day, Secretary Azar and Adam Boehler, Director of the Center for Medicare & Medicaid Innovation and Senior Advisor for Value-Based Transformation and Innovation, visited the “O Bar” at Ochsner Medical Center to learn about their work to integrate technology into patients’ care.

They also held a roundtable discussion with Louisiana healthcare leaders to discuss one of the priorities that Secretary Azar has identified for HHS: transforming America’s healthcare system into one that pays for value.

At the roundtable, Secretary Azar and Mr. Boehler outlined their vision for this transformation, focusing on four areas:

  • Maximizing the promise of health IT, including through promoting interoperability and patient control of data.
  • Boosting transparency around price and quality.
  • Pioneering bold new models in Medicare and Medicaid.
  • Removing government burdens and barriers, especially those impeding care coordination.

At the roundtable, healthcare leaders discussed the challenges and successes they have had working with the federal government on daily basis. Other topics discussed by individual leaders included: President Trump’s American Patients First drug pricing blueprint, including HHS’s announcement this week of new tools for Medicare plans to negotiate with drug companies; the possibilities presented by telemedicine; the important role played by federally qualified health centers; innovations to help patients access their own healthcare data; and the future of Accountable Care Organizations.

Secretary Azar and Mr. Boehler stressed the department’s commitment to reforming regulations that could be impeding value-based, coordinated care, and President Trump’s commitment to ensuring all Americans have access to better healthcare at a lower cost.

Trump Administration Sinks Teeth Into Paring Down Drug Prices, On 5 Key Points

Kaiser Health News:Marketplace - August 10, 2018

Three months after President Donald Trump announced his blueprint to bring down drug prices, administration officials have begun putting some teeth behind the rhetoric.

Many details have yet to be announced. But experts who pay close attention to federal drug policy and Medicare rules say the administration is preparing to incrementally roll out a multipronged plan that tasks the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration with promoting competition, attacking the complicated drug rebate system and introducing tactics to lower what the government pays for drugs.

Mark McClellan, director of the Duke-Margolis Center for Health Policy in Durham, N.C., and a former CMS administrator, said that although none of the initial steps has “fundamentally transformed drug prices,” there is “a lot going on inside the administration.”

Two HHS officials who are rolling out the plan, Dan Best and John O’Brien, described their efforts to Kaiser Health News not as a public relations strategy but a push to reform the system.

“This administration is trying to go after root causes” of high drug prices, said Wells Fargo analyst David Maris.

But others are not so optimistic.

Ameet Sarpatwari, an instructor in medicine at Harvard Medical School in Boston, said policies the administration has rolled out thus far “alone will not translate into meaningful cost savings for most Americans.”

Broadly, the strategy falls under a handful of steps:

1. Attacking The Rebates

Health and Human Services Secretary Alex Azar has said Americans “do not have a real market for prescription drugs” because drug middlemen and insurers get a wide range of hidden rebates from drugmakers, but those savings may not be passed on to consumers or Medicare. In July, the administration submitted a proposed rule that could change the way rebates are handled.

Details of the proposal have not been made public. But O’Brien, a deputy assistant secretary at HHS, explained during a recent conference on federal drug spending sponsored by the Pew Charitable Trust: “You don’t have to use market power to get rebates, you can use market power to obtain discounts, to actually lower the price of the drug on the front end.”

Umer Raffat, an investment analyst with EverCore ISI, said “it’s not clear [that drug prices are going down]” but the “rebate structure is changing.”

2. Bringing More Negotiation To Medicare

This week, CMS Administrator Seema Verma announced that Medicare Advantage insurers can use a step-therapy approach to negotiate better prices for Part B drugs — those administered in hospitals and doctors’ offices. These private plans will be allowed to require patients to first select the least expensive drug before stepping up to more costly drugs if the original medications aren’t working.

The administration is also looking at ways to introduce more competition into Part B drug purchasing. That idea was mentioned deep inside the annual Medicare outpatient payment rule released last month.

Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes in New York, pointed to the possible introduction of a competitive purchasing program in which a firm negotiates with drugmakers to buy their drugs and then sells them to the doctors and hospitals that will administer the medications. Bach said that helps ensure that hospitals and doctors can’t make more money by prescribing more expensive drugs.

Currently, Medicare pays the average sales price plus 6 percent to doctors or hospitals when they purchase drugs, a pricing mechanism that can benefit the providers if the drug costs go up. If there were a third party buying the drugs, it would “have a huge effect,” Bach said.

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3. Paying For Value

Trump’s blueprint calls for CMS to encourage “value-based care” to lower drug prices, shifting from paying a set fee for drugs to basing payments on how well the patient does on them.

Louisiana’s Medicaid program could show the way. The state is working with CMS to explore a subscription-based model to pay for hepatitis C medicines. Louisiana would pay a fixed price to a drug manufacturer that would then get unlimited access to treat patients enrolled in Louisiana’s Medicaid program or in prison.

The program would move “from a big payment upfront to paying less over time based on actual outcomes,” said McClellan, who also serves on the boards of health care giant Johnson & Johnson and insurer Cigna.

CMS also approved a Medicaid waiver from Oklahoma in June. Medicaid programs are allowed to negotiate drug prices. Oklahoma’s plan would expand that to negotiate additional prescription price reductions based on value-based purchasing agreements.

Still, CMS’ recent rejection of a related Massachusetts proposal makes it difficult to believe negotiating drug prices will really happen, said Sara Rosenbaum, a professor of health law and policy at George Washington University.

That proposal would have allowed Massachusetts’ Medicaid program to choose drugs based on cost and how well the medicines work.

“They have been very good and quite careful with their [Medicaid] program and so why not let them try this?” Rosenbaum said.

4. Tackling Foreign Drug Costs

Pharmaceutical makers often sell their drugs at substantially lower prices in many foreign countries than they do in the United States. Trump emphasized in May that “it’s time to end the global freeloading once and for all,” saying U.S. consumers were paying part of the cost of the medicines that patients in other countries use.

He directed U.S. Trade Representative Robert Lighthizer to address the situation. Lighthizer’s office declined to comment.

When Sen. Todd Young (R-Ind.) asked during a Senate health committee hearing in June whether trade agreements with other countries should be used to “level the playing field,” Azar’s response was swift: “We absolutely believe we should be using our trade agreements to get them to pay more even as we have our job to pay less.”

Avalere Health President Matt Brow, who has been involved in talks with the administration, said it’s clear the focus on overseas pricing isn’t going away and the administration is “talking a lot about how to get the president what he wants.”

5. Increasing Competition

FDA Commissioner Scott Gottlieb has become the Trump administration’s lead proponent for increasing competition among drugmakers.

Competition resonates with Americans “because people see it every day in their experience in Costco and other places,” said Rena Conti, an assistant professor at the University of Chicago.

Gottlieb has announced plans to bolster the use of generic drugs and an “action plan” to encourage the development of biosimilars, which are copycat versions of expensive biologic drugs made from living organisms.

And to combat anti-competitive behavior in the market, Gottlieb said the FDA has passed along information to the Federal Trade Commission and hinted at potential action to come: “I think we’ve handed them some pretty good facts.”

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

Clinicians Who Learn Of A Patient’s Opioid Death Modestly Cut Back On Prescriptions

Kaiser Health News:Marketplace - August 10, 2018

Physicians and other medical providers modestly reduced the volume of opioids they prescribed after being told one of their patients had died of an overdose, according to research published Thursday.

“You can hear a lot of statistics about the crisis,” said Jason Doctor, lead author of the study, published Thursday in the journal Science. “But it always feels like it is happening elsewhere if you are not aware of any deaths in your own practice.”

The research included more than 800 clinicians — doctors, nurse practitioners, physician assistants and dentists — comparing those who received a letter from the medical examiner about a patient’s death and those who didn’t. The ones who knew about the overdose death cut the overall volume of opioids they prescribed by almost 10 percent over three months, while those who didn’t know prescribed roughly the same amount as before.

The study shows that awareness and education can change prescribing behavior, said Doctor, lead author and associate professor at University of Southern California’s Price School of Public Policy. The modest size of the reduction among those who were notified of a death suggests “that clinicians exercised greater caution with opioids rather than abandoning use,” according to the study.

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The providers in the study who were informed about patients’ deaths were also 7 percent less likely to start new patients on opioids.

The letter did not blame providers for the deaths but showed that authorities were paying attention, according to the study.

“We were providing them with important information and also giving them a way to make things better by changing prescribing,” Doctor said. “Anyone who got the letter could continue to prescribe as much as they wanted, but we found that they didn’t. They became more judicious prescribers.”

Over 19,000 people died from prescription opioids in 2016, roughly double the number 14 years earlier, according to the National Institute on Drug Abuse. Most of that increase occurred from 2002 to 2011, and the numbers have been relatively stable since then, according to the NIDA.

Meanwhile, prescriptions of opioids are declining, and health officials are seeking ways to accelerate the trend.

The study did not measure whether the letters from the medical examiner or the changes in prescribing patterns had any effect on patient deaths.

Across the country, physicians have been accused of overprescribing opioids and have even faced charges related to patient overdose deaths. In an effort to better track prescribing patterns, states have started prescription drug monitoring databases.

The CDC recommends that providers avoid opioids if possible, but if they are necessary, they should start with the lowest effective dose.

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

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