Trump Administration Moves To Make Health Care Costs More Transparent

Shopping around for the best deal on a medical X-ray or a new knee? The Trump administration has a plan for that.

On Monday, it proposed new rules that would provide consumers far more detail about the actual prices hospitals charge insurers. It comes amid growing calls from consumer advocates, who argue transparency can help tackle rising health care costs. But the plan also has the potential to overwhelm patients with data.

Under the proposal, hospitals would be required to post the prices they negotiate with every insurer for just about every service, drug and supply they provide to patients, starting Jan. 1.

The move follows an executive order issued by the president in June. It immediately drew sharp opposition from hospitals and insurers, who made it clear they plan to fight the proposal — all the way to court if necessary.

Final rules might differ from the proposal — and the courts will be asked to weigh in. But the move could help lift the secrecy that has long surrounded what patients, employers and insurers pay for medical services.

“As deductibles rise, patients have the right to know the price of health care services so they can shop around for the best deal,” said Seema Verma, administrator of the Centers for Medicare & Medicaid Services, who announced the proposal Monday.

The proposal, however, raises at least three questions:

Will Consumers Use It?

Some consumers will take advantage of price information, although maybe not many, said experts who have studied patient behavior.

The amounts would be different from what currently exists on websites run by some insurers, hospitals and private businesses because they would be actual negotiated prices, not area averages, estimates or hospital-set “charges,” which are usually far higher than the negotiated rates.

Even so, “a lot of things can get in way of patients using the data,” said Lovisa Gustafsson, assistant vice president at the Commonwealth Fund.

There may be only one hospital in town, for example, or patients might be reluctant to switch if they have a relationship with a specific hospital. Incentives to shop might be hampered, too, if a patient’s share of the cost of a procedure or test is small. Finally, only a portion of medical care is “shoppable,” meaning patients have time to look around and compare prices before they undergo the procedure or receive the treatment.

Still, when price data is available, some patients — particularly those with high deductibles that haven’t been met — will shop and choose a lower-priced provider, said Gustafsson.

Experts point to consumer behavior in New Hampshire, which posts price information by insurer online. Only a small percentage took advantage of the online look-up tool, but those who did saved money, according to a recent study by Zach Brown, an assistant professor of economics at the University of Michigan.

Still, the new dataset proposed by the Trump administration might simply overwhelm many consumers.

Although the proposal requires the information be presented so it can be searched online, the amount of data will be huge.

Start with the fact that each hospital has tens of thousands of charges, from room fees to suture costs to the price of each tablet of aspirin. Then multiply that by the number of insurers that contract with each hospital and the amount of data could be staggering.

Patients would need to know what tests, procedures, supplies and even drugs they might need for a given hospitalization, then add them up. For every hospital they are considering.

To help consumers, the proposal would also require hospitals to provide information on 300 “shoppable services” — say knee replacement — and include the price of all the related services that go with it rather than expect patients to somehow try to add them up a la carte.

Will It Lower Prices?

The short answer is maybe. But no one knows for sure.

“We’ve never had price transparency, so there is no evidence to point to exactly what it would do,” said Gustafsson.

In retail, having price information from shopping websites like Amazon has helped drive prices down. But when the Danish government required concrete manufacturers to disclose negotiated prices, they went up, according to a study trotted out by skeptics of the price transparency approach.

But is health care like retail or cement?

On one hand, having actual price information can give self-insured employers and health insurers a stronger hand in negotiations, so they can demand better deals from hospitals. But it could also spur some hospitals to raise their prices if they think competitors are getting a better deal from insurers.

Business professor George Nation, who studies hospital pricing at Lehigh University, lands on the side of the argument that more price information can lower prices, especially if employers and insurers use it to demand steeper discounts.

“This money is coming out of employers’ pockets,” he said. “They’re going to say, why, if Hospital B can do this for $300, why are you charging me $600? Justify your charge.”

While that won’t work in areas with a strong hospital monopoly, it’s a start, he said.

“You can’t have price competition without knowing the price. And that’s where we have been living.”

Will It Become Law?

Again, the answer is maybe.

The proposal could be modified after the administration reviews public comments, due Sept. 27.

After it’s finalized, there may well be a legal battle.

Hospitals and insurers didn’t wait to take the first shots.

Shortly after the proposed rule was released late Monday, their trade organizations released sharply critical statements. They’ve long opposed efforts to reveal their negotiated prices, which they say are trade secrets.

The Trump plan will backfire, said America’s Health Insurance Plans: “Posting privately negotiated rates will make it harder to bargain for lower rates, creating a floor — not a ceiling — for the prices that hospitals would be willing to accept.”

We’ll see you in court, was the not too thinly veiled threat that came from the American Hospital Association, which said the proposal “misses the mark, exceeds the administration’s legal authority and should be abandoned.”

But Medicare administrator Verma was unfazed. When asked by reporters about the potential for a legal battle over the proposal, she said, “We’re not afraid of that.”

Still, on the legal front, it could get complex.

Currently, the administration is backing a lawsuit from 18 red states that are seeking to have the entire Affordable Care Act overturned, including, presumably, any authority it gives the administration to require hospitals to post prices.

Again, Verma was not worried: “If there are any changes to the ACA, we would work with Congress to keep what’s working and get rid of what’s not,” she said at the press conference.

Nation said the attention the proposal is getting from industry backs his contention that there might be something to it.

“The strength of the opposition is indication this may work to lower prices,” he said.

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Trump firms up plan to import medicines; pharma companies resist

(Reuters) – The Trump administration took a step Wednesday toward allowing importation of medicines from Canada, an action the president has advocated as a way to bring cheaper prescription drugs to Americans, but the pharmaceutical industry was quick to resist the move.

FILE PHOTO: Pharmaceutical tablets and capsules are arranged in the shape of a U.S. dollar sign on a table. August 20, 2014. REUTERS/Srdjan Zivulovic/File Photo

The U.S. Department of Health and Human Services (HHS) said it and the Food and Drug Administration will propose a rule that will allow it to authorize states and other groups to pursue pilot projects related to importing drugs from Canada.

The agency also said it would allow drugmakers to bring drugs that they sell more cheaply in foreign countries into the United States for sale here, an option the companies are unlikely to embrace.

Capital Alpha analyst Rob Smith, in a research note, questioned why manufacturers would voluntarily lower prices in the United States to match those in Canadian or any other foreign country.

The announcement comes as President Donald Trump aims to address the world’s highest drug prices ahead of the 2020 elections and after several high-profile policy failures.

Reuters has previously reported that the administration is considering broadening its plans to link the cost of some drugs for the government Medicare program to an international pricing index.

Trump also supports bipartisan drug pricing legislation designed to force pharmaceutical companies to give discounts when drug prices rise more than inflation.

Another piece of bipartisan legislation aimed at prices of drugs developed using federal research funds was introduced on Wednesday by Republican Senator Rick Scott and Senator Chris Van Hollen, a Democrat.

The importation idea still needs to be proposed and then finalized by Health and Human Services. The largest U.S. pharmaceutical and biotech companies said they opposed the idea of importation through their lobbyists PhRMA and BIO.

“There is no way to guarantee the safety of drugs that come into the country,” PhRMA Chief Executive Officer Stephen Ubl said.

Drug industry shares were slightly higher, with the NYSE Arca Pharmaceutical Index .DRG up 0.13 percent versus a broader flat market.

STILL FAR AWAY

HHS Secretary Alex Azar said he has had prior discussion with Canada about importation and that it would be up to the states, pharmacies and distributors, who are expected to pursue the importation through trial models, to navigate the issues.

“There are hurdles of course, but the hurdles now are known. They are being laid out and they are surmountable,” Azar told reporters on a conference call.

The Canadian health minister’s office said in a statement that it will work to understand the implications for Canadians and to ensure it does not negatively affect supply or cost.

Earlier this month, Health Canada said the U.S. market is too large to rely on Canadian imports as a solution to the high cost of drugs.

Any implementation is still far away given the technical steps of rule making and that the proposals will face challenges, Evercore ISI analysts Ross Muken and Michael Newshel said in a research note. For instance, they said, while Democrats like importation, most Republicans in Congress oppose it.

Senate Democrats reacted with caution to the Trump administration moves toward allowing importation of medicines from Canada. “We have to look at the details of this plan to see if it amounts to much,” said Senate Democratic leader Chuck Schumer.

The first part of the proposal would allow states, wholesalers or pharmacists to submit plans for pilot projects for Canadian drugs if their raw materials are manufactured in the same plant as the U.S. version. It would exclude biologics, infused drugs, injected drugs and inhaled drugs for surgery.

The Trump Administration has had setbacks in efforts to bring down drug prices. Its plan to make drugmakers disclose list prices in TV ads had to be scrapped after the companies won a legal challenge, and it abandoned efforts to force pharmacy benefit managers to pass discounts onto Medicare recipients.

Reporting by Manas Mishra in Bengaluru, Michael Erman in New York, Allison Martell in Toronto, Kelsey Johnson in Ottawa and Susan Cornwell in Washington; Writing by Caroline Humer; Editing by Steve Orlofsky and Bill Berkrot

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U.S. nurses may not be ready for nuclear emergencies

(Reuters Health) – U.S. nurses may not receive adequate training in how to care for patients during a nuclear event or radiation emergency, a nationwide survey of nursing schools suggests.

More than three-fourths of nursing school administrators and faculty who participated said their curriculum included no training or less than one hour of training on nuclear emergency preparedness, researchers report in the journal Disaster Medicine and Public Health Preparedness.

“We’re looking at how to make sure the American health care system is robust and optimized for a disaster event, which includes making sure the workforce has the knowledge, skills and abilities to understand how to respond,” said lead author Tener Veenema of the Johns Hopkins School of Nursing in Baltimore, Maryland.

Public health emergency preparedness programs have grown since the nuclear power plant accident in Fukushima, Japan, in 2011, and disastrous hurricanes such as Irma, Harvey and Maria in 2017, Veenema’s team writes.

About 3 million people in the U.S. live within 10 miles of a nuclear power plant, the authors note, which puts them directly within the path for exposure should an accident occur.

“Nurses have learned how to respond to natural disasters, terrorist attacks involving mass casualties and large-scale infectious disease outbreaks,” Veenema told Reuters Health in a phone interview. “Each event requires different knowledge and skills, and the same is true for nuclear and radiation events.”

In May 2018, the study team sent surveys to 3,301 nursing school administrators and faculty whose schools belonged to the American Association of Colleges of Nursing or the Organization for Associate Degree Nursing Schools and Programs.

The questionnaires asked about the preparedness content included in nursing programs, radiation response plans and the perception of risk around these events. Based on ZIP codes, the study team also analyzed respondents’ proximity to nuclear power plants, nuclear waste and nuclear research facilities. They focused primarily on the “ingestion” emergency planning zone around each nuclear power plant, which the U.S. Nuclear Regulatory Commission designates as about 50 miles from the reactor site.

Of the 679 individuals who responded to the survey, 75% said their nursing curriculum taught zero or less than an hour of radiation and nuclear emergency preparedness content. The primary reasons given were: inadequate time in the curriculum; the topic isn’t mandated to be taught; there were no qualified faculty in the program to teach it; and no perceived risk of this type of event in the area.

One in three respondents said the topic wasn’t relevant to their school or there was no perceived risk in their area. Based on ZIP code, however, researchers calculated that 295 of the respondents were located within an emergency planning zone, and about half didn’t realize they were within 50 miles of a nuclear power plant.

“This is a patient safety and quality issue,” Veenema said. “If nurses, or any sector of the healthcare workforce, don’t understand proper responses strategies, triage, decontamination, and personal protective equipment, they can’t help others and they can’t keep themselves safe.”

Radiation or nuclear content curricula would need to be developed by experts, made available to schools for free and be a required part of the curriculum, respondents said.

Veenema, who was a nurse scholar-in-residence at the National Academy of Medicine in Washington, D.C., at the time of the survey, is part of a group now holding national workshops at the Academy to train nurses.

About 13% of schools reported having a radiation or nuclear emergency management operations plan, and 6% had tested their plans or run drills.

“The only way to mitigate a poor response to a disaster is to simulate it and train ahead of time,” said Laura Livingston, director of Texas A&M Health Science Center’s Clinical Learning Resource Center in Bryan, Texas. Livingston, who wasn’t involved in the study, has coordinated the center’s Disaster Day, which mimics emergencies such as explosions, hurricanes and wildfires and how nursing students should respond.

“The challenge with a radiological disaster is preventing further exposure and reducing the radiation spread from person to person,” Livingston said in a phone interview. “Nurses don’t learn much about this, so having some exposure to it during a simulated training could be helpful.”

SOURCE: bit.ly/2SUZNPH Disaster Medicine and Public Health Preparedness, online June 13, 2019.

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In The Battle Of The Fitness Trackers, The Most Steps Might Not Win

When Sonia Anderson got her first Fitbit step tracker, her poor pooch, Bronx, had no idea of all the steps that were coming.

The device — which counts every step Anderson takes and displays those steps on an app — was a Christmas gift from her daughters two years ago.

At the time, Bronx, a Yorkshire terrier, was younger and could still manage the additional walks up and down the trails along the sprawling apartment complex in Alexandria, Va., where Anderson lives. Anderson was on a mission to clock 10,000 steps a day.

More recently, as Bronx hit age 13, the dog started coming to dead stops during these long treks, as if to ask: What’s going on here?

Sonia Anderson and Landy Sorensen often walk together on Friday mornings while volunteering at a local food bank. The friends track each other’s progress on their cellphone apps and compete to see who logs the most steps.(Bruce Horovitz/KHN)

Like many other folks 50 and older, the 63-year-old Anderson has been commandeered by the step-tracker craze that began about a decade ago, and her dog is an unwilling victim.

Anderson has bought into the $26 billion global step tracker industry and matches her daily count with her Fitbit-wearing friend, Landy Sorensen, 43. The two women have become inseparable Fitbit fanatics and competitors at the Arlington Food Assistance Center, where they amass additional steps every Friday morning while volunteering in the food bank. Now, they diligently count each other’s steps on their cellphone apps in real time — and compete to record just one more step than the other.

“My Fitbit made me a friend I’d have never had,” Anderson said.

It might also help her live longer, according to a recent Harvard University study published in the Journal of the American Medical Association. The study concluded that among older women, as few as 4,400 steps per day helped to lower mortality rates.

With more steps per day, mortality rates decreased before leveling off at 7,500 steps, the study found.

In other words, the magic marketing number of 10,000 daily steps embraced by so many wearers of these devices — from Fitbits to Garmins to Samsungs to Apple Watches — may be about 2,500 steps more than necessary.

Truth be told, even the woman behind the study — who concedes that she, too, is enamored of her step tracker — can’t say how many steps are the right number for each walker.

“No one size fits all,” said I-Min Lee, an associate epidemiologist at Brigham and Women’s Hospital in Boston and a professor at Harvard Medical School.

But no matter how many steps you take, merely wearing and using a fitness tracker — particularly for older women, older men and other people who tend to be somewhat inactive — “can be beneficial not only to your health but to your quality of life,” Lee said.

Of course, some folks go over the top with their trackers — and proudly post their more unusual stats on social media sites such as Reddit. Like the vegan fitness buff who posted a video about logging 50,000 steps a day for five days. And the warehouse stocker who said that he slogged 20,000 steps a day on the job. And there’s also the guy who credits his Fitbit for helping him slim his 40-inch waist to a svelte 34 inches.

Clocking miles is even popular with workers who are on the clock. C-SPAN network, for instance, ran a month-long walking challenge sponsored by its health insurance plan, Cigna. The step competition among C-SPAN departments, which ended July 3, totaled 22,862,341 steps walked by 74 participants from 12 teams, spokesman Howard Mortman said. That’s an average 9,966 steps per day per person. More specifically, he said, that’s a total 1,028,805 calories burned — and 294 pounds lost. (For the record, the cable network’s digital media team won.)

For Anderson and Sorensen, fitness tracking has created a special bond — and a way to keep close tabs on each other. Like the day when Sorensen noticed that Anderson had suddenly doubled her step output. She immediately texted her and discovered that Anderson was on a European vacation and that her sightseeing had doubled her daily count. Another time, when Anderson noticed that Sorensen had barely logged 2,000 steps, she sent a concerned text asking: “Are you OK?”

“I thought it was so sweet of her to check in on me,” said Sorensen, who said the problem was actually a battery issue. “This is the kind of connection I wouldn’t otherwise have.”

Sorensen averages about 15,000 steps daily — roughly between 5 and 7 miles — and often tucks her early-generation Fitbit into a specially designed gold bracelet, so folks can’t even see she’s wearing one. When she wears this bracelet to formal affairs, no one suspects she’s tracking her footwork, she said.

Sonia Anderson, 53, checks her Fitbit. A recent Harvard University study published in the Journal of the American Medical Association concluded that, among older women, as few as 4,400 steps per day helped to lower mortality rates.(Scott Suchman for KHN)

Recently, Yorkshire terrier Bronx, who is 13, has started coming to dead stops during long walks. Anderson now carries him most of the way.(Scott Suchman for KHN)

Harvard’s Lee said she first got interested in wearable devices five years ago during a workplace program that promoted healthy lifestyles for doctors. Lee received a free device — whose familiar brand name she prefers not to publicize — and was asked to form a team of walkers. Lee, 59, is hesitant to discuss her step count because she believes the sheer act of regularly exercising is far more important than the sum total of steps. But, after some cajoling, she said she averages about 15,000 steps per day.

Studies show that 150 minutes of moderate activity, such as walking, can lower the risk of heart disease and stroke, improve sleep, help reduce weight gain and improve bone health.

Perhaps no one knows that better than Tom Holland.

He’s an exercise physiologist and sports nutritionist who has regularly appeared on “Good Morning America” as a fitness coach.

He also has worked as a personal trainer with thousands of clients — many of whom use step trackers. He’s a huge fan of fitness trackers because they get people moving.

“The fitness tracker is the first step to getting people off the couch,” he said. At the same time, he is put off by the much-ballyhooed 10,000-step daily goal, which he said is arbitrary.

“We need real numbers to shoot for,” he said. Holland, who recently turned 50, prefers recommending smaller amounts of exercise — not big feats such as 10,000 steps. “I’m a big believer in excessive moderation. Don’t do a lot a little bit — do a little bit a lot.”

Unless, of course, it involves himself.

Like the 70,000, or so, steps he clocked in a recent 50-kilometer trail run. Because Holland also is a triathlete, he not only uses a Fitbit from time to time but also sometimes slaps on “smart” sunglasses or T-shirts or shorts that track fitness data. Most often, however, he wears a Garmin fitness tracker that measures his steps, his sleeping habits and his heart rate.

“I’m not an addict,” he said jokingly, “but if you see me passed out on the side of the road, check my tracker, please.”

As for Anderson’s little dog, Bronx, he sometimes gets extra incentive to go on those walks. Occasionally, Anderson brings along her daughter’s English bulldog, Winston, whose namesake is the British statesman Winston Churchill. Perhaps, in a cosmic nod to future step trackers of all kinds, it was Churchill who said it best: “I never worry about action, but only inaction.”

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Inspector Paints A Rosy Picture Of Migrant Detention Centers — In Contrast To Audits

JEFFERSON, Md. — For the past year, the tiny Maryland company employed by the federal government to inspect U.S. immigration detention centers has painted a rosy picture of life in captivity.

In dozens of reports filed in the past 12 months, inspectors with the 11-person Nakamoto Group described detainees who had “no substantive complaints” and facilities where the atmosphere is “calm with no obvious indicators of high stress.”

“None of the detainees expressed any concerns about their treatment or safety,” Nakamoto employees wrote in a typical March 2019 report, following inspection of the Rio Grande Detention Center in Laredo, Texas, a border city overwhelmed by recent waves of Central American migrants seeking asylum.

“Detainees were satisfied with all conditions of their confinement.”

Nakamoto’s bland assessments — some of which date back more than a decade — stand in stark contrast to recent findings by the Department of Homeland Security’s inspector general, state auditors and outside watchdog groups, which have documented lax medical and mental health care and inappropriate use of solitary confinement at multiple U.S. Immigration and Customs Enforcement agency facilities.

A review by Kaiser Health News of thousands of pages of inspection reports from 2007 to 2012, and 2017 to 2019 — made available through litigation and new federal reporting requirements — reveals disturbing patterns about the company’s audits, including a general willingness to accept the accounts of the facilities that the company is paid to scrutinize, and to discount detainees’ complaints.

The findings show that Nakamoto has rarely reported bad news about conditions at the for-profit and government-run facilities it audits. Violations in the quality of medical care and safety of detainees are infrequent and cursory, according to a review of federal records and court documents.

For example, a surprise May 2018 inspection by government investigators at the Adelanto ICE Processing Facility in California’s Mojave Desert “revealed significant health and safety risks,” “improper and overly restrictive segregation” and “inadequate detainee medical care,” according to the Homeland Security agency’s inspector general.

A separate 2019 investigation by Disability Rights California, a nonprofit group with legal authority to monitor detention centers in California, highlighted people with serious mental illness being doused with pepper spray and multiple unreported suicide attempts.

Yet Nakamoto drew a very different conclusion in its 2018 report on Adelanto: While it noted hundreds of grievances from detainees and 83 physical assaults during the inspection period — more than one-third of which resulted in injuries that required medical referrals — its report concluded that “without exception, detainees stated that they felt safe at this facility.”

A June report by the inspector general found “unsafe and unhealthy conditions” at three other detention centers as well. All four had been given passing grades by Nakamoto.

Several current and former Adelanto detainees interviewed said delays in medical care were frequent and fear was pervasive inside the remote facility. Among the concerns, they said, was the sense that guards would indiscriminately send detainees to solitary confinement, known as “the Hole,” for the slightest infraction.

“It didn’t matter if you were good or if you were bad, you were always going to be put in the Hole,” said Lillian, 49, a former human rights professor from Caracas, Venezuela, who asked not to be identified by her last name for fear of reprisal. She was held at Adelanto from November 2017 until she was granted asylum in May 2018.

Other detainees said delays in medical care were so common at Adelanto that many people stopped filing requests. “You put in a medical request, and it can take days or weeks or even months for them to process it and give you the treatment you need,” said Mario, 32, who crossed into the U.S. with his parents when he was 5 and was held at Adelanto for six months in 2018.

Facing deportation for a 2017 misdemeanor, Mario is now out on bond and volunteering with an immigrant rights group in Ontario, Calif. He also asked not to be identified by his last name, for fear it would affect his deportation case.

The Nakamoto Group was established in 2003 by Jennifer Nakamoto, then in her 30s and a former employee at the National Institute on Drug Abuse. She remains the company’s president and sole owner. The George W. Bush administration first hired the company to audit immigration detention facilities, and its contracts were extended under President Barack Obama.

For at least the past two years, the Nakamoto Group — registered to Jennifer Nakamoto’s spacious home in the rolling farmland of western Maryland — has been the sole contractor responsible for inspecting nearly 100 federal immigration detention centers and county jails that house tens of thousands of noncitizens awaiting deportation hearings or decisions on pleas for asylum.

Since 2007, ICE has awarded the company more than $55 million in government contracts to ensure conditions meet federal detention standards. Its current contract could fetch another $16 million.

Nakamoto continues as the sole contracted inspector at ICE facilities even though John Kelly, Homeland Security’s former acting inspector general, issued a blistering analysis of its performance last year.

“Nakamoto’s inspection practices are not consistently thorough, its inspections do not fully examine actual conditions or identify all compliance deficiencies,” he wrote.

Kelly’s report noted that ICE employees told federal investigators that Nakamoto’s inspections are “useless” and “very, very, very difficult to fail.”

Mark Saunders, executive vice president for the Nakamoto Group, declined to discuss the company’s performance in detail. In an interview, he said only that he refuted the accusations in the inspector general’s report, and that the company “is the only impartial party.” He would not comment further.

ICE officials did not respond to specific requests for comment about Nakamoto’s contract.

A ‘Rubber Stamp’?

Questions about Nakamoto’s oversight come as the federal government struggles to process an unprecedented influx of migrants fleeing poverty and violence in Central America.

With the detainee population surging to 53,000 people this year, immigrant rights organizations contend that ICE is under pressure to keep facilities open at any cost — and that the agency has insulated itself from reproach by hiring inspectors who act as allies for the private prison companies that now house the majority of U.S. detainees.

(The children’s migrant detention centers that have been the topic of recent news reports and congressional visits are run by the U.S. Customs and Border Protection agency and subject to a different oversight process.)

“Nakamoto has this incentive to not be as critical as they could be” to maintain its lucrative government contract, said Aaron Fischer, an attorney with Disability Rights California.

Eunice Cho, a staff attorney at the ACLU of Washington, called Nakamoto inspections a “rubber stamp.”

You put in a medical request, and it can take days or weeks or even months for them to process it and give you the treatment you need.

Mario, who was held at Adelanto in 2018

Concerns over conditions in detention facilities stretch back decades and led to a change in policy during the Obama administration. A 2010 law barred facilities that failed two consecutive inspections from being paid.

The change was meant to weed out poorly managed programs. Instead, in subsequent years, inspectors have been less likely to fail facilities. Private inspectors failed nearly three dozen facilities from 2007 to 2009, and at least 14 facilities received poor reviews two years in a row.

But from 2010 to 2012, only one facility — the Freeborn County Adult Detention Center in Minnesota — failed an inspection. Since May 2018, only one facility appears to have failed.

The Adelanto facility failed an inspection in 2011 conducted by a different private contractor, MGT of America — only to have ICE overturn the finding. The following year, ICE hired Nakamoto to audit Adelanto and, despite the death of a 58-year-old detainee, the facility passed. Federal authorities who later investigated concluded Adelanto had committed “egregious errors,” including failing to provide timely medical care, and could have prevented the death.

Nakamoto announces inspections in advance and relies on the facilities’ records to track grievances, assaults and other measures. Some inspection reports go into detailed descriptions of trivial mishaps: tepid chicken patties or improperly inventoried tools and kitchen chemicals. But its inspectors are frequently derisive of more serious complaints, dismissing medical and safety concerns.

In a January inspection of the Otero County Processing Center, a 1,000-bed detention facility in Chaparral, N.M., Nakamoto inspectors noted and wrote off complaints about lukewarm showers (“water temperatures were checked and were within the parameters”) and requests for food items from detainees (“they were all from countries that partake in non-traditional foods that are most likely not approved for consumption in the United States”).

They concluded that, “without exception, detainees stated that they felt safe at the facility,” which is operated by the Management and Training Corp.

In fact, asylum-seekers at Otero had voiced grave concerns about conditions and long waits in detention, going so far as to stage nearly 100 hunger strikes last year.

While Nakamoto inspectors noted the hunger strikes, they accepted the facility’s explanation that they were being staged by “certain nationalities” who “apparently believe that they should be catered to at a higher rate of service than other detainees.”

A Death In Detention

Similarly, in dozens of audits at different facilities, Nakamoto inspectors methodically refuted complaints about medical care based largely on records that immigration attorneys say are often inaccurate or incomplete.

A detainee held in Versailles, Mo., for instance, told a Nakamoto inspector in February that he needed glasses. Nakamoto accepted the facility’s determination that he did not and suggested instead that a lack of natural light might be contributing to his poor vision.

At Webb County Detention Center in Laredo, Texas, a woman said she waited 15 days and made two requests to see a doctor. Again, Nakamoto accepted the facility’s determination: “The detainee was seen and treated in a timely manner.”

Cho, the ACLU attorney who is suing ICE, alleging detainee mistreatment, said, “There is a culture of not buying what detainees credibly have to say.”

When Kamyar Samimi, an Iranian national with permanent residency status, died in custody in December 2017, the divergence between Nakamoto’s assessment and that of federal investigators was striking.

Samimi, 64, had been arrested at his Denver home on Nov. 17, 2017, based on a 2005 drug conviction. Two weeks later, while detained at the ICE facility in Aurora, Colo., he vomited blood, stopped breathing and died 17 minutes after arriving at a nearby medical center.

In an inspection several months after Samimi’s death, Nakamoto inspectors reported he had been complaining of depression and withdrawal from methadone, a prescription drug he took daily to treat a long-dormant addiction. He had been placed on suicide watch, the company said, but no concerns about his medical treatment were found.

In its inquiry into the death, ICE’s Office of Professional Responsibility found that staff had failed to fully administer his medication and to seek emergency treatment in a timely manner.

When Sen. Elizabeth Warren of Massachusetts wrote Jennifer Nakamoto last November to express “deep concern” about the company’s work, Nakamoto said the inspector general didn’t understand the complexities of people held in prison-like centers.

In her written response, Nakamoto mockingly referred to government inspectors in quotation marks and questioned their qualifications. She described herself as “a hard-working minority woman, who took a risk 15 years ago in forming a small business to try to make my way in this great country.” She maintained her people are experts in their field and “staunch advocates of detainee rights.”

“Our work ethic is second to none,” she wrote. “We do not report inaccurately nor do we misrepresent information in our reports.”

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Second Ebola case detected in eastern Congo’s main city

FILE PHOTO: A man washes his hands after Ebola screening upon entering the General Hospital in Goma, Democratic Republic of Congo, July 15, 2019. REUTERS/Olivia Acland/File Photo

GOMA, Democratic Republic of Congo (Reuters) – A second case of Ebola was detected on Tuesday in the eastern Congolese city of Goma, a local health official said, increasing concern the virus could establish a foothold in the densely populated area close to the Rwandan border.

Goma’s first Ebola case was detected in mid-July, prompting the World Health Organization (WHO) to warn that the spread of the disease could accelerate. The epidemic has killed more than 1,700 people since it was declared almost a year ago, becoming the second-worst outbreak on record.

The latest person with the disease started developing symptoms on July 22, after arriving from a mining area outside the city, the health official quoted the head of Congo’s Ebola response team, Jean-Jacques Muyembe, as saying in an official statement.

Health officials believe the patient, a man, is not connected to the first case in Goma.

“The response teams continue to work to decontaminate the home of the case and the high-risk contacts of the case have been identified and will be vaccinated from tomorrow,” Muyembe said.

He said, unlike the first case, the latest patient will be able to receive appropriate treatment in Goma as a facility has been opened in the city, which is more than 350 kilometers (220 miles) south of where the outbreak was first detected.

Goma has been preparing for Ebola to arrive in the city for a year, setting up hand-washing stations and making sure moto-taxi drivers do not share helmets.

Reporting by Fiston Mahamba; Writing by Alessandra Prentice; Editing by Alison Williams and Frances Kerry

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Exclusive: Two powerful Canadian provinces argued against federal drug price crackdown

TORONTO/MONTREAL (Reuters) – Canada’s two most populous provinces, Ontario and Quebec, have privately expressed concerns with a federal government plan to slash the price of patented drugs, arguing that such regulatory changes could hurt investment in life sciences.

FILE PHOTO: A pharmacist counts prescription drugs at the at the CentreTown Pharmacy in Ottawa, Ontario, Canada, June 12, 2019. REUTERS/Chris Wattie/File Photo

The Canadian government has said it plans to soon publish a final version of new regulations aimed at cutting patented drug prices that are among the highest in the world. Announced in 2017, the changes were expected to take effect in January, but the government delayed them to review feedback.

With an election set for October, time is running out.

The previously unreported opposition from two provinces that are home to more than 60% of Canada’s population, seen in letters obtained by Reuters, shows the political risk of taking on the pharmaceutical industry and overhauling the nation’s drug-pricing system, a complex process that involves many governments and organizations.

Other provinces, including British Columbia, support the plan, and the federal government said it “remains committed to improving the access and affordability of prescription drugs”.

Quebec, in its April letter, said it favored negotiating lower drug prices but feared the plan to require drug companies to disclose discounts could make that more difficult.

“There is a fear that drugmakers would be more reluctant to offer discounts to the provincial and territorial governments in the event where they would need to share this information,” it wrote.

The federal regulations would give new powers to the Patented Medicine Prices Review Board, a national agency that sets maximum prices. Draft rules would change the countries it compares Canadian prices to, dropping the United States where they are highest, and would let the agency consider the cost-effectiveness of new medicines.

The draft drew criticism from global drugmakers here, including Johnson & Johnson (JNJ.N), Merck & Co (MRK.N) and Amgen Inc (AMGN.O), and intense lobbying from industry and patient groups which fear the changes could delay drug development.

The letter from Ontario’s Conservative government, led by right-wing populist Doug Ford, echoed a key industry talking point on the proposal.

“While we share the federal government’s objective to provide Canadians with affordable medicines, we are concerned that the regulations, as proposed, could result in delayed access to innovative medicine and longer wait times for patients,” reads the letter, sent in February.

LOBBYING

An Ernst & Young study commissioned by pharmaceutical lobby group Innovative Medicines Canada argued that new drugs tend to be launched later in some countries with strict price controls than in the United States or Canada.

“Lobbying played no role in the government’s decision to send this letter, which was intended to encourage the federal government to continue consultations,” said Ontario’s health ministry in an emailed statement.

Many countries with lower prices have more pharmaceutical industry investment, and access to drugs that is as good or better than Canada, the federal government said in its statement.

“There is no direct relationship between high drug prices, access to medicines, and investment in pharmaceutical research and development,” it said.

Asked about the letter, Alexandre Lahaie, press aide for Quebec Health Minister Danielle McCann, said the government’s priority was getting Quebecers access to the best medications and therapies.

Quebec elected the center-right Coalition Avenir Quebec last October.

Both provinces will be crucial to Liberal Prime Minister Justin Trudeau’s re-election campaign; the rival Conservative Party of Canada tends to be strongest in western Canada.

Ontario’s letter said the life sciences employ about 83,000 people and contribute C$38.5 billion ($29.2 billion) to the province’s gross domestic product. Quebec noted it was aiming to lure C$4 billion in private life sciences investment by 2022.

Other provinces were more positive. Manitoba said it was “supportive” of the PMPRB’s work, and Saskatchewan said it “generally supports the changes.”

Alberta said in a statement it “supports the goal of reducing drug costs so that savings can be reinvested in frontline services and patient care.”

“These reforms are foundational to increasing patient access and we strongly encourage the Federal Government to implement them in the best interest of all Canadians,” British Columbia’s Ministry of Health said in a statement.

BC’s health minister said the ministry had written to the federal government in February to say it “strongly supports the modernization of the PMPRB.”

Editing by Bernadette Baum

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‘Digital twins’ of individual patients may help find best medication to each patient

Advanced computer models of diseases can be used to improve diagnosis and treatment. The goal is to develop the models to “digital twins” of individual patients. Those twins may help to computationally identify and try the best medication, before actually treating a patient. The models are the result of an international study, published in the open access journal Genome Medicine.

One of the greatest problems in medical care is that medication is ineffective in 40-70% of patients with common diseases. One important reason is that diseases are seldom caused by a single, easily treatable “fault”. Instead, most diseases depend on altered interactions between thousands of genes in many different cell types. Another reason is that those interactions may differ between patients with the same diagnosis. There is a wide gap between this complexity and modern health care. An international research team aimed to bridge this gap by constructing computational disease models of the altered gene interactions across many cell types.

Our aim is to develop those models into ‘digital twins’ of individual patients’ diseases in order to tailor medication to each patient. Ideally, each twin will be computationally matched with and treated with thousands of drugs, before actually selecting the best drug to treat the patient.”

Dr Mikael Benson, Professor, Linköping University, Sweden

Benson led the study.

The researchers started by developing methods to construct digital twins, using a mouse model of human rheumatoid arthritis. They used a technique, single-cell RNA sequencing, to determine all gene activity in each of thousands of individual cells from the sick mouse joints. In order to construct computer models of all the data, the researchers used network analyses. “Networks can be used to describe and analyse most complex systems”, says Dr Benson. “A simple example is a soccer team, in which the players are connected into a network based on their passes. The player that exchanges passes with most other players may be most important”. Similar principles were applied to construct the mouse “twins”, as well as to identify the most important cell type. That cell type was computationally matched with thousands of drugs. Finally, the researchers showed that the “best” drug could be used to treat and cure the sick mice.

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The study also demonstrated that it may be possible to use the computer models to diagnose disease in humans. The researchers focused on the same cell type that was used for drug identification. This cell type, T cells, plays an important role in the immune defence, and serves as a fingerprint of the whole digital twin. The researchers analyzed T cells from patients with thirteen diseases, including autoimmune diseases, cardiovascular diseases and various types of cancer. The diagnostic fingerprints could be used not only to distinguish patients from healthy people, but also to distinguish most of the diseases from each other.

“Since T cells function as a sort of spy satellite, which is continuously surveying the body to discover and combat disease as early as possible, it may be possible to use this cell type for the early diagnosis of many different diseases”, says Mikael Benson.

Source:

Linköping University

Journal reference:

Gawel, D. et al. (2019) A validated single-cell-based strategy to identify diagnostic and therapeutic targets in complex diseases. Genome Medicine. doi.org/10.1186/s13073-019-0657-3

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Combination therapy could be a promising treatment for late-stage acute lymphoblastic leukemia

Acute lymphoblastic leukemia accounts for one in five adult leukemias, and is the most common pediatric cancer in the United States. While new immune therapies have helped improve survival rates, some patients are unresponsive to existing treatment regimens. In addition, drug-related toxicities and drug resistance are rampant for these patients, spurring an urgent need for new therapy options.

Researchers from Case Western Reserve University School of Medicine have developed a new combination treatment regimen that enhances the immune system’s ability to kill leukemias that do not respond to standard treatments. The regimen includes a therapeutic antibody designed to draw natural killer immune cells to cancer cells. The antibody attached specifically to acute lymphoblastic cancer cells as early as 30 minutes after treatment, and remained attached for two days, serving as a flag to attract natural killer immune cells. The researchers were able to maximize the antibody’s efficacy by adding a second, anti-tumor molecule to the regimen.

Results published in Cancer Immunology Research describe how the antibody attaches to a specific protein on the surface of acute lymphoblastic leukemia cells (B-cell Activating Factor, or BAFF-R). Once the antibody attaches to a cancer cell, natural killer cells also attach to the antibody and this antibody acts like a bridge connecting cancer cells to natural killer cells, where it quickly gets to work destroying the cancer cell. The antibody connects with natural killer cells through a second protein commonly found on their surfaces (CD16).

The researchers, Reshmi Parameswaran, PhD, assistant professor in the Department of Medicine and MD/PhD student in her lab and the Department of Pathology, Yorleny Vicioso, created a new acute lymphoblastic leukemia mouse model for the study. They used mouse models with growing, drug-resistant cancer cells collected from human patients. Then, they tested treatments over the course of disease progression–starting with the antibody alone.

If we started to treat mice with the antibody early during disease development, leukemia was almost eradicated by this treatment method; however, if treatment was administered late when the tumor had grown and established its own microenvironment, the antibody alone was less effective.”

Reshmi Parameswaran, PhD, member of the Case Comprehensive Cancer Center and a St. Baldrick’s Scholar

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As cancer cells grow, they secrete molecules that disrupt and confuse the body’s natural immune responses. The area around an established tumor–its surrounding “microenvironment”–can contain myriad molecules that inhibit immune cells. Parameswaran’s team found unusually high levels of an inhibitory molecule called TGF-beta in the bloodstreams of the mice. Closer inspection revealed that the cancer cells were secreting TGF-beta directly, which accumulated over time in their microenvironments as a defense against natural killer cells. TGF-beta in the microenvironment inhibit the ability of natural killer cells to kill cancer cells by more than half.

“There was a clear negative effect of the tumor microenvironment on natural killer cell killing capacity,” Parameswaran said. “So, we added a TGF-beta receptor inhibitor to our antibody treatment regimen.”

Using their mouse disease model, the researchers showed that the combination of these two treatments enhanced killing of acute lymphoblastic leukemia cells–even if the disease was advanced. Antibody and TGF-beta receptor inhibitor treatment increased natural killer cell activity against cancer cells by up to 35 percent. The researchers confirmed the combination’s efficacy in mice injected with acute lymphoblastic leukemia cells from four different patients.

The combination treatment could represent a promising new regimen for late-stage acute lymphoblastic leukemia, particularly benefitting adults who are unresponsive to existing options. Data from the new study suggest the antibody, which that attaches to BAFF-R on cancer cells, could be more effective in older patients.

“We looked at BAFF-R expression in a small group of 16 patients and all of them expressed this receptor. It’s promising as a therapeutic avenue for late-stage disease” Parameswaran said. Data from larger patient sets will help us draw a definitive conclusion.”

The custom BAFF-R antibody is currently being tested as a therapy to treat autoimmune diseases and rheumatoid arthritis in two clinical trials. The TGF-beta inhibitor was recently tested in a first-in-human clinical trial for treatment for advanced-stage solid tumors. The new mouse model study provides critical preclinical data to support combining the two treatment in human trials, Parameswaran said.

Source:

Case Western Reserve University

Journal reference:

Vicioso, Y. et al. (2019) Combination therapy for treating advanced drug-resistant acute lymphoblastic leukemia. Cancer Immunology Research. doi.org/10.1158/2326-6066.CIR-19-0058.

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Creator Of Brain Exam That Trump Aced Demands New Training For Testers

Last year, Dr. Ronny Jackson, then the White House physician, gave Donald Trump a standard test to detect early signs of dementia — and said the president had scored a perfect 30. “There is no indication whatsoever that he has any cognitive issues,” Jackson said at the time in front of TV cameras.

Trump’s team embraced the result, with Donald Jr. boasting on Twitter: “More #winning.” The publicity sparked a wave of interest in the screening tool. Much was written about what the test showed — or didn’t — about the president’s mental acuity. A media outlet even posted its questions online, suggesting readers could measure whether they were “fit to be U.S. president.”

Dr. Ziad Nasreddine, the creator of that test, the Montreal Cognitive Assessment, went with it. Within weeks, the Lebanese-Canadian neurologist and his colleagues were working on “mini-MoCA,” an online exam for anyone to take who was worried about his own cognitive decline. Nasreddine said at the time that he might charge the masses $1 or $2 per test.

Now Nasreddine has changed course. He says growing worries about the validity of test results — and possible liability for errors — have pressed him to require those who administer the test to pay for mandatory certification to make sure the results are accurate.

Further examination of the results called into question even perfect scores.

“I’ve seen so much variability, which might make us reconsider some of the decisions made based on the MoCA score,” said Nasreddine, who has reviewed hundreds of exams administered to patients in recent years.

Training and certification have been voluntary for years. But starting Sept. 1, most clinicians who administer the MoCA will be required to complete a one-hour, $125 online course, said Nasreddine, who holds the copyright to the test.

Nasreddine, director of the MoCA Clinic and Institute in Quebec, Canada, wouldn’t speculate about whether Trump’s test was accurate. Officials with the White House and the Navy, where Jackson is a rear admiral, did not respond to questions about the issue. Jackson did not reply to an email seeking comment.

The move to require certification — and particularly to charge for it — sparked outrage among geriatricians like Dr. Eric Widera of the University of California-San Francisco. He accused Nasreddine of creating a “pay to play” scenario that profits from a growing need and the test’s ubiquitous use.

“It raises huge red flags,” Widera said. “This is a growing issue, the monetization of tools that we promoted as the standard.”

It’s a controversial change for an exam that is used by doctors and other health professionals in nearly 200 countries to screen people for potential problems with memory and thinking.

In the U.S., the MoCA is a go-to tool used in about 8,000 visits each year to the 31 Alzheimer’s Disease Research Centers funded by the National Institute on Aging. The 30-question test assesses various cognitive domains through exercises that include drawing a cube, drawing a clock with hands set at a specific time, naming certain animals, memorizing a series of words and calculating numbers in a certain way.

Until now, the MoCA screen has been free for clinicians, making it a cheap, easy way to tell if someone should proceed to the more detailed evaluations used to make an actual diagnosis of dementia.

After Sept. 1, 2020 — a year after the training requirement begins — access to the test will be restricted to certified users, Nasreddine said. Only medical students, residents and fellows, and neuropsychologists will be exempt. Two-year recertification is optional and will be offered at half the original cost. Group rates will be available for institutions and government bodies to make the training affordable.

Still, Widera said he worries that requiring MoCA certification will deter nonspecialists from testing for early signs of dementia.

Studies estimate that somewhere between about 500,000 and 1 million Americans age 65 or older will develop Alzheimer’s disease this year.

Nasreddine said he has seen testing errors after reviewing hundreds of MoCA exams given by doctors and others who didn’t properly follow a four-page list of directions.

A MoCA score of 26 or higher is generally considered normal, while a score of 18 to 25 can indicate mild cognitive impairment, and 10 to 17 can indicate moderate impairment. A score of less than 10 indicates severe impairment.

On some tests, scores varied by as much as 5 points in the same patient over a few weeks, Nasreddine said.

“That is a lot of points out of 30,” he said. “If it’s within the same month, it’s not because the disease changed that quickly.”

Widera and others acknowledged that errors can occur in administering and interpreting the MoCA or any tool.

“There may be operator error,” he said. “That’s true for everything we do in medicine. Nobody licenses us every two years to use a stethoscope.”

Nasreddine said he and his team have been threatened with lawsuits — though it appears no cases have been filed — by people who said they were harmed by the results of tests given by health professionals who lack specialized dementia training.

“One man, they stripped him of his legal rights, put him in the nursing home — all … because he scored 15 or 20 on the MoCA test,” said Nasreddine, who in addition to running a memory clinic is an assistant clinical professor at McGill University and the University of Sherbrooke in Canada.

A nurse who had been having mild attention problems lost her job “because the psychiatrist who ran the test on her was not trained and didn’t do it well,” Nasreddine said, adding: “They’re blaming us.”

Regular users of the MoCA likened the controversy over the exam to the recent fate of another cognitive screening tool, the Mini-Mental State Examination.

That test, known as the MMSE, was used widely for 30 years before its authors began enforcing copyright protection and then granted an exclusive license to a third-party firm. A licensed version of the MMSE is now sold for $89 for a package of 50 tests.

The parallel upset experts like Dr. Louise Aronson, a UCSF professor of geriatrics and author of the best-selling book “Elderhood: Redefining Aging, Transforming Medicine, Reimagining Life.”

“First we gave up the #MMSE and now we will renounce the #MOCA,” Aronson tweeted on June 28. “Lessons in putting profit ahead of patients and #healthcare. Disappointing is the most polite word I can think of.”

Nasreddine said he has received many emails from MoCA users happy with the mandatory certification, adding that “the purpose of the training is to make the test more reliable and valid.”

Related Topics

Aging Health Industry Public Health

Dementia

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