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HHS Secretary Azar Statement on Drop in 2020 Medicare Drug Premiums

HHS Gov News - July 31, 2019

Today, HHS Secretary Alex Azar issued the following statement regarding the Trump Administration’s announcement that the average basic premium for Medicare Part D prescription drug plans is projected to drop in 2020, the third straight year to see a decrease:

“President Trump has listened to what American patients and seniors want, and he has promised to protect what works and fix what’s broken in American healthcare. Medicare Part D plans continue to be extremely popular, and the President is delivering improvements to Part D, offering plans more ways to provide low-cost options and delivering patients more transparency on drug prices. With premiums in Part D now projected to decline for 2020, President Trump is delivering on his promise to protect seniors and put patients in control.”

Read the press release from the Centers for Medicare & Medicaid Services.

In A Messy Democratic Presidential Debate, Facts About ‘Medicare For All’ Get Tossed About

Here we go again.

It’s been a month since Democratic presidential hopefuls last took to the debate stage, but Tuesday night in Detroit 10 candidates again faced off for the first of this two-night event.

Health policy issues were a hot topic.

The matchup between Sens. Elizabeth Warren of Massachusetts and Bernie Sanders of Vermont was considered the marquee event, with other candidates — including Minnesota Sen. Amy Klobuchar; Mayor Pete Buttigieg of South Bend, Ind.; author Marianne Williamson; Ohio Rep. Tim Ryan; and former Texas Rep. Beto O’Rourke — hoping to use the evening to stand out from the rest of the primary field.

Health care offered each candidate a potent opportunity. Former Maryland Rep. John Delaney argued that “Medicare for All” would “get Trump reelected.” Gov. Steve Bullock of Montana spoke to the plight of the teacher “working a second job to afford her insulin.” And former Colorado Gov. John Hickenlooper, who opposes Medicare for All, spoke of how he had expanded health care — a claim we rated mostly true earlier this year when he talked about steps he had taken toward achieving universal coverage.

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But even as the candidates put their markers down on the ideological spectrum, not all of their claims fully stood up to scrutiny.

We fact-checked some of those remarks.

SANDERS: “Right now, we have a dysfunctional health care system. Eighty-seven million uninsured or underinsured, 500,000 Americans every year going bankrupt because of medical bills, 30,000 people dying while the health care industry makes tens of billions of dollars in profit.”

That’s a lot of numbers for a Tuesday night, and as confidently as Sanders stated them, they rely on complicated data and, arguably, fuzzy math.

In claiming there are 87 million uninsured or underinsured Americans, he is citing 2018 data released by the Commonwealth Fund. Compared with the 27.4 million uninsured in 2017, according to the Kaiser Family Foundation, this includes those with insurance who nonetheless experienced high medical costs relative to their household income.

It is not clear how Sanders calculated the number of medical bankruptcies every year. He may be referring to a study released in February that found an estimated 530,000 families file for bankruptcy each year due to medical bills. However, typically, many factors play into filing for bankruptcy, making it difficult to pin on medical costs alone.

And though he did not complete the thought, this is not the first time Sanders has claimed that 30,000 people die every year because of the high cost of health care. When he tweeted that claim last month, we rated it half true because it appears to rely on weak math.

Former Maryland congressman John Delaney also reiterated a point he used in the first round of Democratic primary debates.

DELANEY: “It’s been well documented that if all the bills were paid at Medicare rate, which is specifically — I think it’s in section 1200 of their bill — then many hospitals in this country would close. I’ve been going around rural America and I ask rural hospital administrators one question: ‘If all your bills were paid at the Medicare rate last year, what would happen?’ And they all look at me and say, ‘We would close.’”

Delaney made this argument to attack Sanders’ Medicare for All plan, which he referred to as “bad” policy in his opening statement. He made this claim about rural hospitals during last month’s debates, too. We rated it false.

It is undeniable that Medicare pays hospitals a fraction of what private, employer-based insurance pays them. A RAND Health study released earlier this year found private insurers in 2017 paid hospitals 241% of the prices Medicare paid, on average.

But the experts we spoke with after the last debate said the effects on hospitals would be more nuanced: While some may take a hit under a Medicare for All system, other hospitals may do better. And it is unclear how much hospitals would be paid under Sanders’ plan; that section — it’s actually Section 611 — basically says the federal government would decide later how to pay providers.

And O’Rourke took on a public health concern.

O’ROURKE: “The Centers for Disease Control [is] prevented from actually studying [gun violence] in the first place.”

This is an outdated Democratic talking point. The reality is more complicated.

For two decades, spending bills included something called the Dickey amendment that said “none of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control.”

That language remains, but in 2018, lawmakers added, in a separate report, the words “the Secretary of Health and Human Services has stated the CDC has the authority to conduct research on the causes of gun violence.”

Even the original Dickey rule did not totally forbid research.

For a short while at least, the CDC continued to fund studies into the links between firearms and injuries, proof to some people that the Dickey amendment and research could coexist.

But after 1999, gun research plummeted. David Hemenway, director of Harvard’s Injury Control Research Center, told PolitiFact last year that politics, not the law, drove the CDC’s agenda.

“The CDC always had some flexibility, but it wasn’t going to fund firearms research since it knew it would, as had happened previously, get hauled before Congress and threatened with reduced funding if any research it sponsored suggested that having more firearms was not good for public health,” Hemenway said.

— PolitiFact’s Jon Greenberg contributed to this story.

In A Messy Democratic Presidential Debate, Facts About Medicare For All Get Tossed About

Here we go again.

It’s been a month since Democratic presidential hopefuls last took to the debate stage, but Tuesday night in Detroit  10 candidates again faced off for the first of this two-night event.

Health policy issues were a hot topic.

The match up between Sens. Elizabeth Warren of Massachusetts  and Bernie Sanders of Vermont was considered the marquis event, with other candidates — including Minnesota Sen. Amy Klobuchar; Mayor Pete Buttigieg of South Bend, Ind.; author Marianne Williamson; Ohio Rep. Tim Ryan; and former Texas Rep. Beto O’Rourke — hoping to use the evening to stand out from the rest of the primary field.

Health care offered each candidates a potent opportunity. Former Maryland Rep. John Delaney argued that Medicare for All would “get Trump reelected.” Gov. Steve Bullock of Montana spoke to the plight of the teacher “working a second job to afford her insulin.” And former Colorado Gov. John Hickenlooper, who opposes Medicare for All, spoke of how he expanded health care — a claim we rated mostly true earlier this year when he spoke about steps he took toward achieving universal coverage.

Don't Miss A Story

Subscribe to KHN’s free Weekly Edition newsletter.

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But even as the candidates put their markers down on the ideological spectrum, not all of their claims fully stood up to scrutiny.

We fact-checked some of those remarks.

SANDERS: “Right now, we have a dysfunctional health care system. Eighty-seven million uninsured or under-insured, 500,000 Americans every year going bankrupt because of medical bills, 30,000 people dying while the health care industry makes tens of billions of dollars in profit.”

That’s a lot of numbers for a Tuesday night, and as confidently as Sanders stated them, they rely on complicated data and, arguably, fuzzy math.

In claiming there are 87 million Americans who are uninsured or underinsured, he is citing 2018 data released by the Commonwealth Fund. Compared to the 27.4 million uninsured in 2017, according to the Kaiser Family Foundation, this includes those with insurance who nonetheless experienced high medical costs compared to their household income.

It is not clear how Sanders calculated the number of medical bankruptcies every year. He may be referring to a study released in February that found an estimated 530,000 families file for bankruptcy each year due to medical bills. However, typically there are many factors that play into filing for bankruptcy, making it difficult to pin on medical costs alone.

And though he did not complete the thought, this is not the first time that Sanders has claimed that 30,000 people die every year because of the high cost of health care. When he tweeted that claim last month, we rated it half true because it appears to rely on weak math.

Former Maryland congressman John Delaney also reiterated a point he used in the first round of Democratic primary debates.

Delaney: “It’s been well documented that if all the bills were paid at Medicare rate, which is specifically — I think it’s in section 1,200 of their bill — then many hospitals in this country would close. I’ve been going around rural America and I ask rural hospital administrators one question: ‘If all your bills were paid at the Medicare rate last year, what would happen?’ And they all look at me and say, ‘We would close.’”

Delaney made this argument to attack Sanders’ Medicare for All plan, which he referred to as “bad” policy in his opening statement. He made this claim about rural hospitals during last month’s debates, too. We rated it False.

It is undeniable that Medicare pays hospitals a fraction of what private, employer-based insurance pays them. A RAND Health study released earlier this year found private insurers in 2017 paid hospitals 241 percent of the prices Medicare paid, on average.

But the experts we spoke with after the last debate said the effects on hospitals would be more nuanced: While some may take a hit under a Medicare for All system, other hospitals may do better. And it is unclear how much hospitals would be paid under Sanders’ plan; that section — it’s actually Section 611 — basically says the federal government would decide later how to pay providers.

And O’Rourke took on a public health concern.

O’Rourke: “The Centers for Disease Control (is) prevented from actually studying (gun violence) in the first place.”

This is an outdated Democratic talking point. The reality is more complicated.

For two decades, spending bills included something called the Dickey Amendment that said, “none of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control.”

That language remains, but in 2018, lawmakers added, in a separate report, the words “the Secretary of Health and Human Services has stated the CDC has the authority to conduct research on the causes of gun violence.”

Even the original Dickey rule did not totally forbid research.

For a short while at least, the CDC continued to fund studies into the links between firearms and injuries, proof to some people that the Dickey amendment and research could co-exist.

But after 1999, gun research plummeted. David Hemenway, director of Harvard’s Injury Control Research Center, told PolitiFact last year that the politics, not the law, drove the CDC’s agenda.

“The CDC always had some flexibility, but it wasn’t going to fund firearms research since it knew it would, as had happened previously, get hauled before Congress and threatened with reduced funding if any research it sponsored suggested that having more firearms was not good for public health,” Hemenway said.

— PolitiFact’s Jon Greenberg contributed to this story.

‘If You Like Your Plan, You Can Keep It.’ Biden’s Invokes Obama’s Troubled Claim.

Joe Biden invoked a risky — and familiar — phrase to sell his health care plan. At an AARP event in Iowa, Biden told voters he would create a government insurance plan to compete with private ones called a public option. It would give consumers, Biden said, another choice.

“If you like your employer-based plan, you can keep it,” Biden said July 15. “If you have private insurance, you can keep it.”

It was a time warp moment that whipped us back to 2013.

“If you like your health care plan, you can keep it,” was President Barack Obama’s go-to pitch point as he stumped for the Affordable Care Act. By our count, Obama said some version of that line 37 times without any caveats or conditions.

For millions of people buying coverage on their own — about 8% of the market — it proved wrong.

The claim earned Obama PolitiFact’s 2013 Lie of the Year.

“Everyone knew that [Obamacare] was meant to make certain types of coverage go away,” said former Republican congressional staffer Rodney Whitlock. “He kept saying it, even when the whole goal was to push people out of bad plans, junk insurance, and into plans that met a minimum coverage standard.”

Today, with the law already in place, the removal of existing plans isn’t baked into Biden’s proposal. Whitlock and other analysts say that technically, Biden can fairly say that he’s not out to cancel anyone’s insurance.

His main idea is to set up a government-run insurance program where people would pay premiums to get covered. The public plan would go head-to-head with private carriers and, if consumers preferred it, they could buy in.

Biden would make premiums more affordable with larger subsidies than the current law. On top of that, for states that have expanded Medicaid to any adult just a bit above the federal poverty line, they would have the option to put those people into the public plan, so long as the state continued to pay Washington what it does today.

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Beware The Pitfalls In Health Care

History has shown that health care promises are tough to keep. The industry has many players, each angling for advantage. People who have spent years watching how it works say Biden’s reassuring words could crumble, as employers, employees and states adjust to the new ground rules.

Biden’s proposal wouldn’t necessarily force insurers to cancel plans, said Melinda Buntin, health policy chair at Vanderbilt University School of Medicine. But don’t expect the companies that buy insurance to sit still.

“Employers — especially small businesses with lower-income workers — might choose to drop coverage if their employees would qualify for the public plan with more generous subsidies,” Buntin said.

What employers choose to do highlights a widespread feature of insurance in America. Employers decide what plans to offer their workers and, in many cases, the option is to take it or leave it. The worker’s personal preference can be irrelevant. Or, anyone who takes a new job likely moves into a new insurance plan. That would be just as true under Biden’s plan as it is today.

Sources

AARP, AARP Presidential Candidate Forum: Health Care, High Drug Prices Among Top Issues, July 15, 2019.

Biden for President, Health Care, July 15, 2019.

SHRM, ACA’s Affordability Threshold Rises in 2019, May 30, 2018.

PolitiFact, Lie of the Year: ‘If you like your health care plan, you can keep it,’ Dec. 12, 2013.

Gallup, Most Americans Still Rate Their Healthcare Quite Positively, Dec. 7, 2018.

Niskanen Center, What’s wrong With Employer Sponsored Health Insurance, Nov. 6, 2018.

Interview with Rodney Whitlock, vice president, McDermott+Consulting, July 16, 2019.

Email exchange with Sherry Glied, New York University, July 16, 2019.

Email exchange with Melinda Buntin, chair, Department of Health Policy, Vanderbilt University School of Medicine, July 16, 2019.

Email exchange with Thomas Miller, resident fellow, American Enterprise Institute, July 16, 2019.

Email exchange with Jonathan Oberlander, chair, Department of Social Medicine, University of North Carolina at Chapel Hill, July 16, 2019.

Email exchange with Allison Hoffman, professor of health care law, University of Pennsylvania Law School, July 16, 2019.

How any of this plays out hinges on the details of Biden’s public option, and those remain unclear. New York University’s Sherry Glied said a very generous plan could entice many workers to ditch their employer-based insurance, leaving companies with too few people to attract affordable bids from insurance companies. Glied, though, is generally optimistic that the rules would still make employer plans a cheaper deal for employees.

“The plan retains most of the benefits of employer coverage, so people would probably stick with it, and the presence of a public option paying Medicare-like rates would likely lower payment rates all around,” she said.

One clear difference between Obama’s and Biden’s use of the line is politics.

In 2009, the fear was that the government would take over the entire insurance market. Obama deployed the line “to reassure already insured Americans,” University of North Carolina-Chapel Hill health policy professor Jonathan Oberlander said.

Biden’s focus today is on his Democratic rivals.

“It is aimed partly as a critique of ‘Medicare for All’ and those Democratic presidential candidates who have endorsed Medicare for All,” Oberlander said.

That would include Bernie Sanders, Elizabeth Warren and Kamala Harris. Medicare for All would essentially ban all private insurance.

Penn Law professor Allison Hoffman credits Biden with trying to help those who slip through the cracks, because they can’t get on Medicaid or would need deeper subsidies to buy private insurance. That incremental approach might define the plan’s limits, she said.

“It might be a very effective gap filler that would not force anyone off their current coverage, but also might not motivate very many to switch to the public option,” Hoffman said.

Hoffman also noted that, while Biden spoke specifically about people keeping their private insurance, the possible impact on people covered by Medicaid expansion under Obamacare are quite different. He gives states the option to shift that group from expanded Medicaid into the public option plan.

Where that happened, those people would see their current plans disappear.

Thomas Miller at the market-oriented American Enterprise Institute takes a more negative view of Biden’s reassuring words about existing coverage. Miller cautioned that there are many ways Biden’s plan could go awry, particularly if the government throws more weight behind the public option, at the expense of private ones.

“How long you can keep your present plan is a matter of how long it can, under its current terms, remain affordable, or how long before it threatens to outcompete the public option,” Miller said. “You can have your plan until it’s not allowed to be around anymore.”

Democrats Favor Building On ACA Over ‘Medicare For All’

Most Democrats and Democratic-leaning independents would prefer to expand the Affordable Care Act rather than replace it with a “Medicare for All” plan, according to a new tracking poll from the Kaiser Family Foundation.

The poll, released Tuesday, also examines opinions on a generic government-run “public option” health plan that would be available to all Americans and compete with private insurance. About two-thirds of the public said they support a public option, though more than 6 in 10 Republicans oppose it. (Kaiser Health News is an editorially independent program of the Kaiser Family Foundation.)

But the findings noted those opinions are far from set in stone. When told a public option would help drive down prices by increasing competition in the insurance market, support rose as high as 75%. When told it would lead to too much government involvement in health care, though, support fell to about 40%.

KFF’s findings may give pause to Democratic presidential candidates preparing for the second round of primary debates, scheduled for Tuesday and Wednesday evenings on CNN.

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Asked to choose between building on the ACA and replacing it with a national Medicare for All plan, 55% of Democrats and Democratic-leaning independents said they would expand the existing law. By comparison, 39% said they would prefer replacing the law with Medicare for All.

Respondents also voiced strong support for employer-based insurance, a reality likely to complicate efforts to replace the existing system. More than three-quarters have a favorable opinion of employer-based insurance, with an overwhelming majority of those covered by such plans rating their coverage as “good” or “excellent.”

Nearly all respondents covered by Medicare rated their coverage as “good” or “excellent.”

Primary season is when most candidates trot out the proposals that appeal to their party’s more ideologically driven voters, who are kicking the tires on a slate of potential nominees. Support for Medicare for All has become a litmus test for many progressive voters as they contemplate their more than two dozen candidates.

But as the primary season wanes, the remaining candidates traditionally shift toward more incremental proposals, hoping to attract the moderate voters they may need to win the presidency.

The new KFF poll shows the public’s support for the idea of Medicare for All has dipped to about 51%, from 56% in April.

In recent years, Medicare for All saw the peak of its favorability in March 2018, when about 59% of the public said they favored a system in which all Americans would get their insurance from one government plan.

While the newest numbers show support shifting among both Republicans and Democrats, the share of Democrats who said they “strongly favor” a Medicare for All plan has dropped to 42%, from 54% in April.

Medicare for All’s slip in popularity has come as Democratic presidential candidates have shared the details of their plans and Republicans have tested out campaign messages about creeping “socialism” in the health care system, suggesting an uphill battle toward making such a plan a reality.

About 83% of Democrats and Democratic-leaning independents said it is “very important” for the candidates to discuss health care during this week’s debates, with half saying they would prefer the candidates focus on the differences among themselves rather than with Trump.

The poll also found strong support for some of the ACA’s key provisions, including among Republicans, as a challenge led by GOP state officials and endorsed by the Trump administration winds through the federal court system.

For example, more than 7 in 10 respondents said it is “very important” to prevent insurers from denying coverage to those with preexisting conditions, while 64% said it is “very important” to prevent them from charging sick people higher premiums than they charge healthy people.

Conducted July 18-23, the KFF poll surveyed 1,196 adults by landline and cellphone, in English and Spanish. The margin of error is plus or minus 3 percentage points.

Secretary Azar Statement on Proposed Rule for Hospital Price Transparency

HHS Gov News - July 30, 2019

Health and Human Services Secretary Alex Azar issued the following statement on the Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) proposed rule:

“President Trump has laid out a clear vision for healthcare: a patient-centered system that puts you in control and provides the affordability you need, the options and control you want, and the quality you deserve. Providing patients with clear, accessible information about the price of their care is a vital piece of delivering on that vision, and it’s what the President’s executive order on transparency called for earlier this summer.” said HHS Secretary Alex Azar. “Under this proposal, hospitals will finally have to make their real, negotiated prices known to patients, enabling patients to shop among providers. Healthcare leaders across the political spectrum have been talking about the need for real transparency for years. This proposal is now the most significant step any President has ever taken to deliver transparency and put patients in control of their care.”

Read the full press release

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.

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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.”

New Protocol For HIV Prevention Drug Reduces The Number Of Pills Required

Health officials and AIDS advocates in San Francisco hope to expand the use of an effective HIV prevention drug with a new approach that requires fewer pills than the standard once-a-day regimen.

San Francisco’s public health department and the San Francisco AIDS Foundation have long promoted what is known as preexposure prophylaxis, or PrEP, for those at high risk of contracting HIV. With regular PrEP, the daily pill is taken indefinitely. But both organizations now endorse a strategy that requires taking just four pills timed to a specific sexual encounter — two within two to 24 hours before sex and one on each of the two following days.

They believe this approach will make PrEP more palatable to people who are ambivalent about the medication because of the cost, fear of potential side effects, mistrust of pharmaceutical companies or a general dislike of taking drugs.

The new strategy, called “2-1-1” or “on-demand” PrEP, is becoming popular overseas but has gotten little traction in the United States thus far. It has been proven effective only among men who have sex with men and is currently not recommended for women.

Proponents say the approach can work well for men whose encounters are intermittent and predictable: people in long-distance relationships who know when they will be with their partners, for example, or individuals who occasionally go out to pursue sexual activity.

The approach is not suitable for those who cannot plan for sex at least two hours in advance.

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“There are people who really object to taking a pill every day if they’re not having sex that frequently,” said Dr. Oliver Bacon, a deputy director and physician at the San Francisco Department of Public Health. The on-demand approach, he added, “extends PrEP to people who actually need it based on the sex they’re having but wouldn’t take a daily pill.”

Since the Food and Drug Administration approved daily PrEP use for HIV prevention in 2012, more than 200,000 people in the U.S., most of them men who have sex with men, have taken the drug. But more than a million people are at risk for HIV infection and could benefit from the treatment, according to the Centers for Disease Control and Prevention.

The list price of the PrEP drug, sold by Gilead Sciences under the brand name Truvada, is $1,758 per month when taken daily — though patients generally do not pay that much out of their own pockets.

Insurers typically cover much or most of the cost, but many have been shifting the financial burden onto patients in recent years. Help may be on the way, however.

Following a recommendation by the U.S. Preventive Services Task Force that doctors offer PrEP to at-risk patients, most health plans will be required to cover the drug starting in 2021 — though not the clinical and lab services that accompany its use.

And Gilead agreed earlier this year to donate enough Truvada to cover 200,000 patients annually for up to 11 years, though critics argue that cutting the price would be a more effective way to increase access.

Gilead declined to comment on the on-demand approach for using the drug.

Don Kirchman, a self-employed building developer in San Francisco who is on Medicare, started the on-demand regimen last year after discussing it with his doctor. He had previously taken Truvada daily, but then experienced heart trouble and a related drop in sexual interest and activity.

The new approach meets his current needs, because he prefers not to take unnecessary medication and is concerned about his out-of-pocket drug costs, he said. “There are times when I don’t feel like I’m in a sex cycle or I have a health issue that I’m concentrating on, so I’m not putting my attentions towards dating or hooking up,” Kirchman said.

In San Francisco, the health department issued an HIV update in February for local providers, suggesting they “consider” on-demand PrEP for men who were “ambivalent” about taking a pill every day. The department’s City Clinic began offering the option as a second-best choice for those reluctant to adopt the standard PrEP method.

In March, the San Francisco AIDS Foundation began formally enrolling men for on-demand PrEP at its Strut clinic in the city’s Castro district. In contrast to the health department, the foundation has presented on-demand and daily strategies as equal options. In the first two months, about a fifth of those who got PrEP at the clinic chose to take it on demand.

Since 2015, research in Europe has found on-demand PrEP to be effective at preventing HIV. Advocacy groups and health agencies in France, Netherlands, Australia and elsewhere have promoted it. The World Health Organization endorsed the approach this week during an international AIDS conference in Mexico City.

So far, neither the CDC nor the FDA has endorsed the on-demand approach. But Bacon, of the San Francisco public health department, said the city’s experience is being closely watched and he has fielded questions about the initiative from health officials in New York, Seattle and elsewhere.

A big challenge public health officials face with PrEP is that its adoption has been much slower among men of color than among whites. African Americans and Latinos are more likely to have undiagnosed or untreated HIV, so boosting awareness and use of PrEP is viewed as a key strategy for preventing infections.

Chicago physician John Schneider said the African-American gay and bisexual men he sees at a South Side clinic tend to distrust the health care establishment, including drug companies, because of a legacy of medical discrimination. “Patients don’t like taking a lot of pharmaceutical products,” he said.

Though Schneider generally recommends the standard once-a-day PrEP regimen, he said he sometimes suggests the on-demand approach for patients whose sexual behavior is compatible with it, if they struggle with taking a pill every day.

Some people who want PrEP but prefer to minimize their consumption of it have adopted a different non-daily strategy: a four-day-a-week approach known in the United Kingdom as the “T’s and S’s,” in which pills are taken on Tuesdays, Thursdays, Saturdays and Sundays.

Earlier PrEP research found that four pills a week conferred a high level of protection.

Timothy Price, an HIV prevention coordinator at the Northeast Indiana Positive Resource Connection, a Fort Wayne HIV/AIDS services organization, said he had relied on the T’s and S’s to limit his consumption of Truvada after a dispute with his insurance company involving prescription refills.

Price, a 56-year-old gay man, said he understood the science and knew he could safely reduce his intake to make his pills last longer. “I had a long period of time when they refused to fill it, so I decided after that I needed to build up some kind of cushion,” he said.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Doctor Alexa Will See You Now: Is Amazon Primed To Come To Your Rescue?

Now that it’s upending the way you play music, cook, shop, hear the news and check the weather, the friendly voice emanating from your Amazon Alexa-enabled smart speaker is poised to wriggle its way into all things health care.

Amazon has big ambitions for its devices. It thinks Alexa, the virtual assistant inside them, could help doctors diagnose mental illness, autism, concussions and Parkinson’s disease. It even hopes Alexa will detect when you’re having a heart attack.

At present, Alexa can perform a handful of health care-related tasks: “She” can track blood glucose levels, describe symptoms, access post-surgical care instructions, monitor home prescription deliveries and make same-day appointments at the nearest urgent care center.

Amazon has partnered with numerous health care companies, including several in California, to let consumers and employees use Alexa for health care purposes. Workers at Cigna Corp. can manage their health improvement goals and earn wellness incentives with Alexa. And Alexa helps people who use Omron Healthcare’s blood pressure monitor, HeartGuide, track their readings.

But a flood of new opportunities are emerging since Alexa won permission to use protected patient health records controlled under the U.S. privacy law known as the Health Insurance Portability and Accountability Act (HIPAA).

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Before, Alexa had been limited to providing generic responses about medical conditions. Now that it can transmit private patient information, Amazon has extended its Alexa Skills Kit, the software development tools used to add functions. Soon, the virtual assistant will be able to send and receive individualized patient records, allowing health care companies to create services for consumers to use at home.

Amazon’s efforts in this domain are important because, with its 100 million smart devices in use worldwide, it could radically change the way consumers get health information and even treatment — and not just tech-savvy consumers. Analysts expect 55% of U.S. households will have smart speakers by 2022.

Some of Alexa’s new skills depend on a little-understood feature of the devices: They listen to every sound around them. They have to in order to be ready to respond to a request, like “Alexa, how many tablespoons in a half-pint?” or “Put carrots on the shopping list.”

University of Washington researchers recently published a study in which they taught Alexa and two other devices — an iPhone 5s and a Samsung Galaxy S4 — to listen for so-called agonal breathing, the distinct gasping sounds that are an early warning sign in about half of all cardiac arrests. These devices correctly identified agonal breathing in 97% of instances, while registering a false positive only 0.2% of the time.

Earlier research had shown that a machine learning system could recognize cardiac arrest during 911 emergency calls more accurately and far faster than human dispatchers could.

Amazon, which declined to comment for this article, holds a patent on an acoustic technology that recognizes and could act on significant audio interruptions. Combined with patented technology from the University of Washington that differentiates coughs and sneezes from other background noises, for example, Alexa could discern when someone is ill and suggest solutions.

Because Amazon also holds patents on monitoring blood flow and heart rate through an Alexa-enabled camera, Alexa could send vitals to a doctor’s office before you head to your appointment and continue to monitor your condition after you get home.

“It opens possibilities to deliver care at a distance,” said Dr. Sandhya Pruthi, lead investigator for several breast cancer prevention trials at the Mayo Clinic, which has been on the front lines of using voice assistants in health care. “Think about people living in small towns who aren’t always getting access to care and knowing when to get health care,” she said. “Could this be an opportunity, if someone had symptoms, to say, ‘It’s time for this to get checked out’?”

A growing number of clinics, hospitals, home health care providers and insurers have begun experimenting with products using Alexa:

  • Livongo, a Mountain View, Calif.-based startup focused on managing chronic diseases, sells an Alexa-connected blood glucose monitor that can help diabetes patients track their condition.
  • Home health care provider Libertana Home Health, based in Sherman Oaks, Calif., created an Alexa skill that lets elderly or frail residents connect with caregivers, set up reminders about medications, report their weight and blood pressure, and schedule appointments.
  • Cedars-Sinai Medical Center in Los Angeles put Amazon devices loaded with a plug-in called Aiva into more than 100 rooms to connect patients with staff and to provide hands-free television controls. Unlike a static call button, the voice-controlled device can tell nurses why a patient needs help and can then tell the patient the status of their request.
  • Boston Children’s Hospital, which offered the first Alexa health care software with an educational tool called Kids MD, now uses Alexa to share post-surgical recovery data between a patient’s home and the hospital.

Many medical technology companies are tantalized by the possibilities offered by Alexa and similar technologies for an aging population. A wearable device could transmit information about falls or an uneven gait. Alexa could potentially combat loneliness. It is learning how to make conversation.

“Alexa can couple a practical interaction around health care with an interaction that can engage the patient, even delight the patient,” said elder care advocate Laurie Orlov.

It and other voice assistants might also help bring some relief to doctors and other medical practitioners who commonly complain that entering medical information into electronic health records is too time-consuming and detracts from effective interactions with patients.

This technology could work in the background to take notes on doctor-patient meetings, even suggesting possible treatments. Several startup companies are working on such applications.

One such company is Suki, based in Redwood City, Calif., which bills itself as “Alexa for doctors.” Its artificial intelligence software listens in on interactions between doctors and patients to write up medical notes automatically.

Amazon devices will need to excel at conversational artificial intelligence, capable of relating an earlier phrase to a subsequent one, if it is to remain dominant in homes.

In a 2018 interview on Amazon’s corporate blog, Rohit Prasad, a company vice president who is head scientist for Amazon Alexa, described Alexa’s anticipated evolution using “federated learning” that lets algorithms make themselves smarter by incorporating input from a wide variety of sources.

“With these advances, we will see Alexa become more contextually aware in how she recognizes, understands and responds to requests from users,” Prasad said.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

They May Owe Nothing — Half-Million-Dollar Dialysis Bill Canceled

Fresenius, one of the two largest dialysis providers in the U.S., has agreed to waive a $524,600.17 bill for a man who received 14 weeks of dialysis at a clinic in Montana.

Kaiser Health News, NPR and CBS This Morning told Sovereign Valentine’s story this week, as part of the “Bill of the Month” series, a crowdsourced investigation that seeks to understand the exorbitant health care bills faced by ordinary Americans.

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On Thursday, a representative from Fresenius told Sovereign’s wife, Dr. Jessica Valentine, that the company would waive their unpaid bill. Instead, they will be treated as in-network patients, and Fresenius will seek to negotiate with their insurer a rate higher than what the insurer has already paid. The Valentines are responsible only for their $5,000 deductible, which Sovereign, who goes by “Sov,” has already hit for the year. That leaves them with $0 left to pay on their in-network deductible.

“It’s a huge relief,” Sov said. “It allows me to put more energy back into just taking care of my health and not having stress hormones raging.” Sov said he hopes his experience will shed light on the problem of balance billing and help other patients in similar situations.

A 50-year-old personal trainer, Sov was diagnosed with kidney failure in January and sent for dialysis at a Fresenius clinic 70 miles from his home in rural Plains, Mont. A few days later, Sov and Jessica learned that the clinic was out-of-network and that they would be required to pay whatever their insurer didn’t cover.

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The Valentines initially could not find an in-network option, and Sov needed dialysis three times a week to survive. After he underwent 14 weeks of dialysis with Fresenius, the couple received a bill for $540,841.90. Their insurer, Allegiance, paid $16,241.73, about twice what Medicare would have paid. Fresenius billed the couple the unpaid balance of $524,600.17 — an amount that is more than the typical cost of a kidney transplant.

Fresenius charged the Valentines $13,867.74 per dialysis session, or about 59 times the $235 Medicare pays for a dialysis session.

Fresenius spokesman Brad Puffer said that the Valentines should always have been treated as in-network patients because their insurer, Allegiance, is a subsidiary of Cigna, which has a contract with the dialysis company. Under this contract, Fresenius would have been paid a higher rate than what Allegiance paid. The Valentines, he said, were caught in the middle of a contract dispute between the companies.

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“In the future, we pledge to better identify situations where we believe the insurer has incorrectly classified one of our facilities as being out of network,” Puffer said in a statement. “This will allow us to address the matter directly with the insurer in the first instance, without them placing the patient in the middle.”

Allegiance declined to comment for this story. Jessica Valentine questioned whether they may owe an out-of-network deductible and is waiting to hear what her insurer says about that.

Like her husband, Jessica is relieved that their bill seems to be resolved but worried that other people with bills like theirs might not be so lucky. She’s also grateful for all the attention their story has garnered. Montana Sen. Jon Tester’s office and their hospital’s insurance broker both offered to advocate for them. “And a nephrologist from Pennsylvania called me at work and expressed outrage and said she forwarded on our story to the medical director of Fresenius on our behalf,” Jessica wrote in an email.

Now that his bill has been resolved, Sov said he’ll be focusing on the next step in battling his kidney disease: a transplant. “I can just save my energy for that,” he said.

Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Robotic Surgical Tool, Not Medical Evidence, Drives Free Hernia Screenings

Some hospitals are trying a curious new tactic to attract patients: free hernia screenings.

One Illinois hospital raffled off tickets for a smart speaker to entice people to get their abdomens checked by a surgeon, while an Indiana hospital offered a chance to win dinner at a chophouse.

Announcements for screening events in Colorado and Maryland warned about “life-threatening” complications that could arise if hernias are left untreated. And hospitals in Georgia and California included a chance to “test-drive” a surgical robot.

Hospitals say such screenings provide valuable education about treatment options for the common medical condition, in which part of the intestine protrudes through a weak spot in the abdominal wall.

But no research has been done on hernia screenings, and some experts worry that these outreach efforts — some of which showcase da Vinci robotic surgery devices made by Intuitive Surgical based in Sunnyvale, Calif. — could lead people to get potentially harmful operations they don’t need.

“My question is: Why are we doing this?” said University of Michigan Medical School associate professor Dr. Dana Telem, the director of Michigan Medicine’s Comprehensive Hernia Program. “Even with the best intent, it makes me worry about the unintended consequences down the line.”

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A Common Condition

An estimated 1.6 million groin hernias are diagnosed and 500,000 are surgically repaired annually in the U.S., according to the Centers for Disease Control and Prevention. Some 27% of men and 3% of women are expected to have a groin hernia — the most common type — during their lifetimes.

Hernias can cause pain and abnormal bulges, and many patients eventually opt to get them fixed with surgery. Surgery can also prevent a rare but serious condition called strangulation, in which a hernia can entrap the intestine and cut off blood flow, requiring emergency surgery.

However, complications from hernia surgery are common. While any surgery carries risks, such as infection, groin hernia repairs leave as many as 12% of patients with chronic pain that can be debilitating, according to a 2016 study.

There’s also good evidence that people who have few symptoms can safely opt for watchful waiting rather than go under the knife, according to a 2018 article in JAMA. But such cautionary information is often missing in hospital screening announcements.

In fact, experts, including the American College of Surgeons, say there’s no data to back the use of such hernia screenings.

“A screening for hernia? That makes no sense to me,” said Dr. Michael Rosen, director of the Cleveland Clinic’s Hernia Center and medical director of the Americas Hernia Society Quality Collaborative, a consortium that tracks treatment outcomes. “Obviously, it’s just there to drive people to the operating room.”

Promoting Robotic Surgery

Some hospitals say warnings about the risks of letting hernias go untreated are appropriate, and these events educate the public, quell fears about robotic surgery and serve people who otherwise can’t or won’t see a doctor. Several hospitals said their doctors inform patients about all treatment options, not just robotic surgery.

“Unfortunately, you can get people in the door for their own protection with the word ‘free,’” said Victoria Montei, system director of surgical services at Midland-based MidMichigan Health system, which has hosted two hernia screening events that attracted 52 people and detected 33 hernias. “For a lot of people, a $20, $50, $100 copay [to see a doctor] can be a lot. They put it off.”

Some hospitals also use hernia screening to show off their flashy da Vinci surgical robots, often claiming that the robots’ 3D imaging and precision movements lead to reduced pain, fewer complications and faster recovery times.

Northeast Georgia Health System in Gainesville recently took one of its four da Vinci devices out of commission for three days to demo it at a hernia screening and other community events. Seeing the da Vinci up close “helps explain to the patient the value of it,” said Health System spokeswoman Kristin Grace.

Yet some hospitals seem to be rethinking their strategies. Dr. Sari Nabulsi, the chief medical officer of Medical Center Hospital in Odessa, Texas, which hosted a hernia screening event in 2018, said via email that the hospital “does not promote screening for hernia as there is no clinical value to such tests.” Its 2018 event was for “awareness” and the hospital “does not anticipate repeating the event in 2019,” he added.

Ben Drew, a spokesman for Walnut Creek, Calif.,-based John Muir Health, which advertised a robot test drive as part of a hernia screening event, said in an email that the robot was “not the focus of the assessment or the information provided to patients” and its announcement “could have been worded more clearly.”

Unclear Outcomes

The robot has been marketed as a way for surgeons to add minimally invasive surgery to their toolkits. Most hernias are repaired by open surgery, which uses large cuts. Conventional laparoscopic surgery, which uses smaller cuts, is technically challenging to learn for hernia repair, Rosen said.

But experts say there’s no firm evidence that robotic surgery provides better outcomes for hernia repair.

In fact, robotic surgery has sometimes been adopted ahead of evidence that it offers a benefit. Claims haven’t panned out for hysterectomies, and the Food and Drug Administration has issued a safety notice about the use of robots in cancer surgeries.

A screening for hernia? That makes no sense to me. Obviously, it’s just there to drive people to the operating room.

Dr. Michael Rosen, director of the Cleveland Clinic’s Hernia Center

Results of a pilot randomized clinical trial to compare robotic hernia repair with conventional laparoscopic surgery are expected to be published this fall, said Rosen, who is leading the study.

The trial will compare the two approaches on patient-reported pain, cost, ergonomics for surgeons and long-term recurrence rates. Still, larger studies will be needed to guide clinical practice, leaving answers years away, said Rosen.

Nevertheless, da Vinci’s manufacturer, Intuitive Surgical, has been pressing ahead with efforts to promote its use for hernia repair. In an email, Intuitive confirmed it has provided demo robots and “educational information” for hernia screenings at the request of surgeons and hospitals.

The company said the information it provides for screening events includes “descriptions of surgical and non-surgical options for hernia repair, including associated risks and benefits,” and it expects that “a large portion of hernia repairs will continue to be performed via different surgical modalities.” In other words, the way they’ve traditionally been done.

Intuitive’s 2018 annual report identified hernia repair as a “significant” growth opportunity, with general surgeries, including hernia repair, becoming the largest category of U.S. procedures in 2018. The company reported net income of $1.1 billion in 2018, up from $671 million in 2017.

The Economics Of Robotic Surgery

General surgery is a mainstay of community hospitals, which have recently begun to invest in robotic systems as a way to market themselves as “up on the latest technology,” said Diane Robertson, director of health technology assessment at ECRI Institute, a nonprofit that studies safety and cost-effectiveness of medical interventions.

But ECRI wrote an advisory warning that hospitals’ rapid adoption of robotic systems has outpaced the development of training and credentialing standards for the surgeons who use them.

Hospitals may not be thinking about whether it’s best for the patient or the most cost-effective option, Robertson added. For hernia repairs, she said, “There’s a huge question about why you would need to do them robotically.”

Each da Vinci costs an average of $1.5 million, plus hundreds of thousands of dollars annually to maintain and equip, according to Intuitive’s annual report.

Intuitive advertises in a video on its website that the robotic systems help hospitals woo surgeons and win market share. The website says robotic programs can help hospitals become “more efficient and cost effective.”

But robotic surgeries cost hospitals more to provide and often are reimbursed by insurers at the same rate as for conventional laparoscopy, according to some experts. A review of 510 hernia repairs at the University of Virginia found that the median hospital cost of a robotic hernia repair was $7,162, versus $4,527 for laparoscopic procedures and $4,264 for open surgeries.

Though individual patients may not necessarily pay more for a robotic surgery, Robertson said, the technology contributes to higher overall health care spending and may divert resources from other priorities. In addition, taxpayer-funded Medicare may end up reimbursing hospitals indirectly for robotic surgeries.

For at least one hospital, robotic surgery didn’t pay off.

Fifty-bed Massena Memorial Hospital in upstate New York ended its robotic services in June to help slash an operating deficit, according to chief financial officer Patrick Facteau.

The da Vinci didn’t increase the hospital’s surgical volume despite a marketing push that included free monthly hernia screenings, Facteau said.

“Part of the sales pitch is, you will get more surgeries and reduce costs,” he said. “We didn’t really see that.”

Nor, he said, did the da Vinci improve the hospital’s surgical quality measures or reduce lengths of stay. Most hernia procedures are already done on an outpatient basis.

The hospital — in the 12,000-person town of Massena, just south of the St. Lawrence River — was paying about $500,000 a year to lease a da Vinci and cover maintenance and instruments, he said.

Unlike most hospitals, which have bought their systems, Massena had the flexibility to ditch its lease. “Once you purchase it, getting out of it is not so easy,” Facteau said.

HHS Awards Nearly $42 Million to Expand Health Information Technology In Health Centers Nationwide

HHS Gov News - July 25, 2019

Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA) awarded almost $42 million in funding to 49 Health Center Controlled Networks (HCCNs). These awards will enable the HCCNs to support 1,183 federally-funded health centers across all 50 states, the District of Columbia and Puerto Rico to expand the use of health information technology (health IT). Empowering patients and promoting data sharing through health IT is an element of President Trump’s vision for a healthcare system that delivers better value and better health for American patients.

“Health centers play a crucial role in providing their communities with access to high quality, affordable healthcare,” said HHS Secretary Alex Azar. “Investing in more advanced health IT will help put patients at the center and unleash the power of data, helping us get better value from the care delivered by health centers and delivering on President Trump’s vision for healthcare.”

"Improvements in information technology will enhance the patient and provider experience as health centers continue to deliver high quality primary care in underserved communities across the nation,” said HRSA Administrator Dr. George Sigounas. "President Trump is determined to support and improve the ability of health centers to work together and deliver value-based care.”

HCCNs are groups of health centers collaborating to improve operational and clinical practices by making technology easier for providers and patients to use, increasing the security of patient information and using data to improve patient care.

Health centers’ participation in this program is growing; between 2016 and 2019 participation increased from 70% to 86% of HRSA-funded health centers.

To see a list of awardees, visit: https://bphc.hrsa.gov/program-opportunities/funding-opportunities/hccn/awards/

To learn more about HCCNs, visit: https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/hccn.html

GOP Senators Distance Themselves From Grassley And Trump’s Efforts To Cut Drug Prices

Kaiser Health News:Medicaid - July 25, 2019

The fight between policymakers intent on lowering prescription drug prices and the drugmakers who keep raising them intensified Thursday, as a slew of Republican senators threatened to side with manufacturers against legislation supported by their own committee chairman and president.

After months of closed-door meetings and high-profile hearings, the Senate Finance Committee voted 19-9 to advance legislation introduced by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) to rein in drug costs in the Medicare and Medicaid programs.

But even some Republicans who supported it warned they may not back the sweeping package of proposals in a full Senate vote. They object in particular to a provision that would cap drug prices paid by Medicare based on the rate of inflation.

Other obstacles have piled up. Wyden announced that Democrats, who provided most of the bill’s support in committee, would not allow a Senate vote without the Republicans agreeing to hold votes on cementing insurance protections for people with preexisting conditions. Democrats have complained for months that GOP efforts to kill the Affordable Care Act will leave people with these medical problems without any recourse to get affordable health care. Democrats also want to empower federal health officials to negotiate drug prices.

Here are the three major problems revealed in Thursday’s hearing.

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Many Senate Republicans disagree with President Donald Trump about how to lower drug prices.

Some of Trump’s efforts to reduce Americans’ drug costs took a beating Thursday. They were criticized — by members of his own party — for putting too much power in the hands of government.

Despite urging from White House and federal health officials to support the legislation, 13 of the committee’s 15 Republicans voted to remove its controversial proposal to prevent drug prices from rising faster than inflation under Medicare. Their attempt failed, barely.

Medicaid already uses this strategy, requiring drugmakers to pay the government a rebate if the prices it pays outpace inflation, and Medicaid tends to pay lower prices on drugs than Medicare. The HHS inspector general has said Medicare could collect billions of dollars from the drug industry if it did the same. But many Republicans strongly oppose any government interference in private markets or price setting.

Sen. Patrick Toomey (R-Pa.), who introduced the amendment to remove the proposal, said it wasn’t necessary because seniors would be protected from paying too much by another proposal in the bill to cap out-of-pocket expenses.

“It’s my view that we should not use this sledgehammer of a universal price control, imported from Medicaid, to deal with that relatively narrow problem and to disrupt a program that’s working very well,” Toomey said, mentioning Medicare’s popularity.

Grassley said the inflation caps would help relieve taxpayers from covering Medicare’s skyrocketing drug costs.

And having played a key role in 2003 creating Medicare’s prescription drug program, called Medicare Part D, he took issue with the idea that his latest bill would harm the program: “I wrote it, so you ought to know that I want to protect it,” Grassley said.

Most of the Republicans also backed an amendment to block a proposal being considered by the Trump administration to tie drug prices here to those paid in other developed nations, which narrowly failed. While Grassley said he, too, opposes the administration’s proposal, he did not want the issue to hold up his own bill and so voted against the amendment.

Grassley also said he is not comfortable with empowering federal health officials to negotiate drug prices, as Wyden said he would like to see considered. But Grassley noted that the issue isn’t going away: Trump campaigned on the idea, which White House officials have been discussing with House Democratic leaders as part of a plan expected to be released in September.

But that may not be enough, Grassley suggested: “I don’t think that you’re going to get 60 votes in the United States Senate.” 

Critics in Congress are using some of the same misleading arguments as drugmakers.

Smelling trouble, pharmaceutical executives met with Trump at the White House on Wednesday evening to voice their opposition to the Grassley-Wyden bill.

In a statement after their meeting, PhRMA, the industry’s lobbying group, called it “the wrong approach to lowering drug prices” and said it “imposes harmful price controls in Medicare Part D.”

PhRMA claimed the bill would “siphon more than $150 billion from researching and developing new medicines.” (Experts say most innovation now happens at academic institutions, not pharmaceutical companies.) It said the Medicare Payment Advisory Commission, a panel that advises Congress, had found “it will only benefit 2% of Medicare patients starting in 2022.” (A Bloomberg Law reporter said a commission official told her it had not analyzed the bill.) The lobbying group asserted the bill would “result in money going to the federal treasury instead of seniors.” (The money collected by the new rebates would go into the Supplemental Medical Insurance trust fund, which pays for health services for Medicare beneficiaries.)

The flaws in PhRMA’s claims did not stop critics from echoing some of them. Sen. Robert Menendez (D-N.J.), whose state is home to several drugmakers, said the bill’s savings should go to patients and not into “some fund” where patients would not see it. (He nonetheless voted to advance the bill.)

And Republicans decried the bill’s “price controls” — even as Grassley and Wyden explained that the inflation caps would do nothing to the list prices set by drugmakers, only slow price increases once they were on the market.

In one exchange, Sen. John Cornyn (R-Texas) questioned Phillip Swagel, the director of the Congressional Budget Office, about who would pay more under the legislation’s inflation caps. “If you cut the subsidy,” he said, referring to what the government pays drugmakers, “doesn’t somebody else’s cost have to go up?”

“In this case, the out-of-pocket spending would go down. The premiums would go down. The federal spending would go down,” Swagel replied. “The drug manufacturer, they would see lower price increases than they might have seen without this provision.”

“So they would have to eat that cost?” Cornyn asked.

“We would see them, as you put it, eating some of that cost, and they might change their overall pricing as well,” Swagel said.

Saying there was “sufficient uncertainty” about how the caps would work, Cornyn then asked to be added as a co-sponsor of the amendment opposing that change. 

Democrats, who unanimously voted to advance the bill, may still kill it.

Wyden opened with an unusual declaration as he discussed the legislation he and Grassley had spent months crafting: If Republican leaders do not allow votes on amendments that would protect preexisting conditions and empower federal health officials to negotiate drug prices, Democrats will oppose moving forward on it.

In short, he threatened his own bill.

“We’re certainly not going to sit quietly by while protections for preexisting conditions are wiped out,” Wyden said. “We’re not going to sit by while opportunities for seniors to use their bargaining power in Medicare are frittered away.”

Democrats slammed Republicans during the 2018 midterm election for not doing enough to protect those with preexisting conditions, especially since Republican attorneys general have sued to void the entire Affordable Care Act. It looks like Democrats are warming up that argument for 2020.

During one tense exchange Thursday, Sen. Bob Casey (D-Pa.) fired back at Cornyn for claiming Republicans have a plan to protect patients should the ACA be thrown out.

“How the hell can you say that you support protections when you have all the power and a bill did not pass that would support the Affordable Care Act?” Casey said. “You’ve had eight years of bellyaching about it, and you haven’t done a damn thing about it.”

As the hearing went on, Democrats praised the bipartisan legislation at hand but listed other proposals they would like to see, including the revival of the Trump administration’s now-defunct rebate rule. That would have forced the pharmacy benefit managers who negotiate drug prices for government health plans to refund some of those discounts to customers. (Grassley, for his part, asked Wyden to work with him on incorporating the proposal into their legislation.)

Still, Grassley referred to the opposition among his own Republican colleagues as his “most vexing problem.” At one point, when Sen. John Thune (R-S.D.) gently suggested that stripping out the inflation caps would leave them with “a big, bipartisan margin on this bill coming out of here,” Grassley didn’t miss a beat.

“It could get us a unanimous vote in this committee, but it would also leave the taxpayers with $50 billion more cost,” he said before calling on the next senator.

KHN’s ‘What The Health?’: Cue The Drug Price Debate

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The Republican and Democratic leaders of the Senate Finance Committee this week unveiled a sweeping proposal that seeks to lower prescription drug prices for the Medicare and Medicaid programs. The bill promptly drew opposition from the powerful pharmaceutical industry. But both parties seem set on trying to pass a drug price bill in advance of the 2020 elections.

Meanwhile, the bipartisan leaders of the other Senate committee that oversees prescription drugs announced that their bill would not come to the Senate floor before the chamber’s summer recess, meaning the earliest the full Senate would take up any drug pricing issues is this fall.

This week’s panelists are Julie Rovner from Kaiser Health News, Paige Winfield Cunningham of The Washington Post, Rebecca Adams of CQ Roll Call and Alice Miranda Ollstein of Politico.

Among the takeaways from this week’s podcast:

  • As key drug pricing plans move through Congress, Democrats are stuck with a hard reality: passing changes that might satisfy voters also gives President Donald Trump a big win on one of his campaign issues. Republicans, on the other hand, feel pressured to move a bill along because several of the administration’s initiatives have cratered.
  • Critics of Senate Finance Committee Chairman Chuck Grassley’s plan argue that although it might keep the cost of current drugs lower for many patients, it does nothing to stop drugmakers from putting exorbitant prices on new drugs.
  • Under pressure generated by former late-night TV personality Jon Stewart, Congress passed and sent to Trump legislation to replenish the fund that pays for 9/11 first responders who became sick from exposure to toxic substances.
  • A judge’s decision to allow short-term health insurance plans that don’t meet ACA standards again focuses attention on the fact that the president and his administration have great leeway in interpreting many provisions of the health law. The judge noted that the ACA didn’t put any restrictions on the short-term plans but that the Obama administration had. Trump was free to change that.
  • Oklahoma’s suit against Johnson & Johnson, alleging it helped fuel the opioid epidemic in the state, has garnered much attention. But an even larger lawsuit is coming in September based in Ohio. That suit is being compared to an effort in the 1990s by a consortium of states that sued tobacco companies and won a massive settlement.

Also, Rovner interviews KHN’s Jenny Gold, who wrote the latest KHN-NPR “Bill of the Month” feature about the high cost of kidney dialysis. If you have an outrageous medical bill you’d like to share with us, you can do that here.

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

Julie Rovner: The Los Angeles Times’ “Rising Health Insurance Deductibles Fuel Middle-Class Anger and Resentment,” by Noam Levey

Alice Miranda Ollstein: The New York Times’ “Neil Armstrong’s Death, and a Stormy, Secret $6 Million Settlement,” by Scott Shane and Sarah Kliff

Rebecca Adams: ProPublica’s “Health Insurers Make It Easy for Scammers to Steal Millions. Who Pays? You.” By Marshall Allen

Paige Winfield Cunningham: The New York Times’ “Politicians Tackle Surprise Bills, but Not the Biggest Source of Them: Ambulances,” by Sarah Kliff and Margot Sanger-Katz

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle PlaySpotify, or Pocket Casts.

Watch: Out-Of-Network Outrage After A $540K Charge For Dialysis

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Sov Valentine of Plains, Mont., ran up an out-of-network bill for lifesaving kidney dialysis that topped half a million dollars in just 14 weeks. Kaiser Health News Editor-in-Chief Elisabeth Rosenthal discussed the latest NPR-KHN “Bill of the Month” installment on “CBS This Morning” on Thursday.

Rosenthal said the case exemplifies what happens when an insurer and a provider disagree, and the patient gets stuck with an outrageous bill. “It’s hostage-taking of poor Sov Valentine,” she said.

Your Go-To Guide To Decode Medical Bills

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Do you have an exorbitant or baffling medical bill? Join the KHN and NPR’s Bill-of-the-Month Club and tell us about your experience. We’ll feature a new one each month.

Submit Your Bill

In 2018 Kaiser Health News and NPR teamed up to create “Bill of the Month,” a crowdsourced investigative series in which we dissect and explain medical bills you send us. We have received nearly 2,000 submissions of outrageous and confusing medical bills from across the country.

Each month we select one bill to thoroughly investigate, often resulting in the bill being resolved soon after the story is published. But what about the large number of Americans who receive surprise medical bills that reporters can’t examine?

Kaiser Health News gives you this user-friendly toolkit to help patients understand some of the ins and outs of medical billing, what to do if you receive a surprise medical bill and things to keep in mind before getting medical care. Here’s your go-to guide to decode medical bills.

First Kidney Failure, Then A $540,842 Bill For Dialysis

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For months, Sovereign Valentine had been feeling progressively run-down. The 50-year-old personal trainer, who goes by “Sov,” tried changing his workout and diet to no avail.

Finally, one Sunday, he drove himself to the hospital in the small town of Plains, Mont., where his wife, Jessica, happened to be the physician on call. “I couldn’t stop throwing up. I was just toxic.”

Send Us Your Medical Bill

Do you have an exorbitant or baffling medical bill? Join the KHN and NPR’s Bill-of-the-Month Club and tell us about your experience. We’ll feature a new one each month.

Submit Your Bill

It turned out he was in kidney failure and needed dialysis immediately.

“I was in shock, but I was so weak that I couldn’t even worry,” he said. “I just turned it over to God.”

He was admitted to a nearby hospital that was equipped to stabilize his condition and to get his first dialysis session. A social worker there arranged for him to follow up with outpatient dialysis, three times a week. She told them Sov had two options, both about 70 miles from his home. They chose a Fresenius Kidney Care clinic in Missoula.

A few days after the treatments began, an insurance case manager called the Valentines warning them that since Fresenius was out-of-network, they could be required to pay whatever the insurer didn’t cover. The manager added that there were no in-network dialysis clinics in Montana, according to Jessica’s handwritten notes from the conversation. (The insurance company disputes this, saying that its case manager told Jessica there were no in-network dialysis clinics in Missoula.)

Jessica repeatedly asked both the dialysis clinic staff and the insurer how much they could expect to be charged, but couldn’t get an answer.

Then the bills came.

Valentine, a personal trainer in Plains, Mont., needs dialysis for his end-stage renal disease. When he first started dialysis treatments, Fresenius Kidney Care clinic in Missoula charged $13,867.74 per session, or about 59 times the $235 Medicare pays for a dialysis session.(Tommy Martino for KHN)

Patient: Sovereign Valentine, 50, a personal trainer in Plains, Mont. He is insured by Allegiance, through his wife’s work as a doctor in a rural hospital.

Total Bill: $540,841.90 for 14 weeks of dialysis care at an out-of-network Fresenius clinic. Valentine’s insurer paid $16,241.72. The clinic billed Valentine for the unpaid balance of $524,600.17.

Service Provider: Fresenius Medical Care, one of two companies (along with rival DaVita) that control about 70% of the U.S. dialysis market.

Medical Treatment: Hemodialysis at an outpatient Fresenius clinic, three days a week for 14 weeks.

What Gives: As the dominant providers of dialysis care in the U.S., Fresenius and DaVita together form what health economists call a “duopoly.” They can demand extraordinary prices for the lifesaving treatment they dispense — especially when they are not in a patient’s network. A 1973 law allows all patients with end-stage renal disease like Sov to join Medicare, even if they’re younger than 65 — but only after a 90-day waiting period. During that time, patients are extremely vulnerable, medically and financially.

Fresenius billed the Valentines $524,600.17 — an amount that is more than the typical cost of a kidney transplant. It’s also nearly twice Jessica’s medical school debt. Fresenius charged the Valentines $13,867.74 per dialysis session, or about 59 times the $235 Medicare pays for a dialysis session.

When Jessica opened the first bill, she cried. “It was far worse than what I had imagined would be the worst-case scenario,” she said.

Sov had a different reaction: “To me, it’s so outrageous that I just have to laugh.”

Dialysis centers justify high charges to commercially insured patients because they say they make little or no money on the rates paid for their Medicare patients, who — under the 1973 rule — make up the bulk of their clientele. But nearly $14,000 per session is extraordinary. Commercial payers usually pay about four times the Medicare rate, according to a recent study.

Dialysis companies are quite profitable. Fresenius reported more than $2 billion in profits in 2018, with the vast majority of its revenue coming from North America. The discrepancy in payments between Medicare and commercial payers gives dialysis centers an incentive to treat as many privately insured patients as possible and to charge as much as they can before dialysis patients enroll in Medicare. It may also give dialysis centers an incentive to charge the few out-of-network patients they see outlandish prices.

“The dialysis companies may think they can get closer to what they want from the health plans by staying out-of-network and charging these prices that are totally untethered to their actual costs,” said Sabrina Corlette, a professor at Georgetown University’s Health Policy Institute. “They have the health plans over a barrel.”

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One potential way to save costs on dialysis is to switch to a type that can be done at home, which involves infusing fluid into the abdomen. Called peritoneal dialysis, it is common in Europe but relatively rare in the U.S. In an executive order this month, President Donald Trump announced new incentives to increase uptake of those options.

Brad Puffer, a spokesman for Fresenius Medical Care North America, said the company is working with the Valentines “to immediately resolve the situation.”

“This person was unfortunately a victim of a health care system where insurers are increasingly shifting the financial burden to patients,” Puffer said in a written statement Wednesday. “We are committed to doing the right thing so that our patients are not placed in the middle of these disputes.”

More From Our Bill Of The Month Series

Resolution: As a physician, Jessica Valentine is savvy about navigating the insurance system. She knew it was important to find an in-network provider of dialysis. She and the insurance company case manager both searched on the insurer’s online provider directory, she said, and were unable to find one. The problem may have been searching for a “provider” rather than a “facility” in the directory. Jessica eventually wrote to the Montana insurance commissioner to inquire if the lack of a dialysis provider violated a requirement that insurers maintain an “adequate network” of providers.

With help from the state insurance commissioner, she learned that there was, in fact, an in-network dialysis clinic run by a nonprofit organization that had not turned up in her insurer’s online search or the directory. She immediately arranged for Sov to start getting further dialysis there. But the bills from Fresenius, meanwhile, were adding up.

After a reporter made inquiries, a financial counselor at Fresenius told Jessica that the Valentines qualified for a discount of 50%, based on their income. That would still leave them a bill of $262,400.08.

“It’s still a completely outrageous charge,” Jessica said. “I want to pay what we owe and what’s reasonable and what his care actually cost.”

Unwilling to pay Fresenius more, Allegiance said Jessica should have found the in-network facility earlier. “There is always the potential for customers to misunderstand information about how their health plan works, especially in stressful situations,” a spokesman for Allegiance wrote.

Jessica is considering contacting a lawyer. If all else fails, the Valentines will consider filing for bankruptcy. A family doctor who works at a rural hospital, Jessica now understands why some of her patients avoid testing and treatment for fear of the cost. “It’s very, very frustrating to be a patient, and it’s very disempowering to feel like you can’t make an informed choice because you can’t get the information you need.”

As a physician, Jessica Valentine is savvy about navigating the insurance system. She knew it was important to find an in-network provider for her husband’s dialysis. She and the insurance company case manager both searched on the insurer’s online provider directory, she said, and were unable to find one.(Tommy Martino for KHN)

The Takeaway: Dialysis is a necessary, lifesaving treatment. It is not optional — no matter a patient’s financial situation.

Bill Of The Month Resources

Read More

Insurers are obligated to have adequate networks for all covered medical services in their plans, though “adequacy” is poorly defined.

So, if it looks like there isn’t an in-network option within a reasonable distance — for dialysis or more basic services from orthopedists or dermatologists — keep digging. Keep in mind that dialysis clinics may be listed as “facilities” rather than “providers” in your directory.

If none are available, seek help from your state’s insurance commissioner. Report your experiences — that’s one way the commissioner can learn that the names listed in the directory aren’t taking patients or are 50 miles away, for example.

If you have insurance through an employer, you can contact your benefits department to go to bat for you. If there is no in-network option, you should get a dispensation to go out-of-network at in-network rates and with in-network copayments.

If you receive a bill for out-of-network care, don’t merely write the check. Ask for an itemized bill and review the charges. You can also ask your insurance company to negotiate with the provider on your behalf. See if the bill counts as a “surprise bill” under your state’s law, in which case you could be “held harmless” from excessive charges.

And when all else fails, try to negotiate directly with the provider. They might have a financial assistance policy, or be willing to lower the cost significantly to avoid turning you over to a debt collector that would pay them pennies on the dollar.

NPR produced and edited the interview with Kaiser Health News’ Elisabeth Rosenthal for broadcast. Nick Mott of Montana Public Radio provided audio reporting.

Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

On A Mission To Help People Control Diabetes — And Save Money On Insulin

Kaiser Health News:States - July 25, 2019

In a former church parsonage in Grundy County, Tenn., Karen Wickham ladled out her lentil stew as people arrived for an evening health education class.

Wickham and her husband, Steve, are white-haired, semi-retired nurses who have dedicated the last years of their working lives to helping people with Type 2 diabetes control and even reverse the condition with diet and exercise.

Wendy Norris is in the group, and she has brought along her father and daughter. Since her diagnosis several years ago, Norris said, her doctor prescribed insulin shots and told her to watch what she ate.

She recalled thinking at the time, “Well, what does that mean?”

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The Wickhams have set out to answer that question in Tennessee’s Grundy County, which ranks lowest on the scale of residents’ health. Grundy’s population of 13,000 has the shortest life expectancy in the state and an elevated rate of diabetes (16% of adults), which can eventually result in blindness, kidney failure or amputations.

Norris said trying to overhaul her diet by herself was confusing and difficult. And when things didn’t change, the doctor just kept increasing her dosage of insulin.

But then Norris lost her health insurance. The injectable insulin cost her hundreds of dollars a month — money she simply didn’t have.

“I felt like I was stuck having to take three or four shots a day [for] the rest of my life,” she said. She enrolled in one of the six-week seminars the Wickhams offer and is seeing results in how many shots she needs: “I’ve got it down to one already.”

With slide presentations, the Wickhams explain the difference between sucrose and glucose, and the science behind the fact that certain foods, like potatoes, spike blood sugar, while sweet potatoes don’t. They preach eating as much fiber as a stomach can stand, and dropping almost every kind of sweetened beverage.

Steve and Karen Wickham explain course materials to participants in their seminar on Type 2 diabetes in Grundy County, Tenn. The six-week seminar offers detailed instruction on the biology of diabetes, diet and exercise — and provides plenty of individualized support.(Blake Farmer/WPLN)

And they demonstrate ways to burn all those calories. Steve even invented the “Beersheba Boogie” — after the Grundy town of Beersheba Springs — asking participants to raise their knees and pump their fists while marching in place.

Support For Hard Changes

All the workshop participants have to find a way to get active at home or in a rugged state park nearby because there’s no gym anywhere in the county. There’s not a proper grocery store anywhere nearby either, so healthy cooking can become a real chore.

These communitywide obstacles reveal why it can be a struggle for people to maintain their health in rural America. But the Wickhams are working to overcome those barriers.

During one education session, as participants shared their latest health stats, Steve called out: “Her blood sugar is going down! Give her a hand.”

If it sounds like a revival meeting, it kind of is. Steve and Karen Wickham say they are compelled in this work by their Christian faith as Seventh-day Adventists — a denomination known for a focus on health. They first moved to Grundy County to take care of ailing parents, and once settled in their scenic mountain retreat, they grew disturbed by the suffering they saw in their neighbors.

“I think God holds us responsible for living in the middle of this people and doing nothing,” Steve Wickham said.

Related Coverage

Many people think of Type 2 diabetes as practically incurable, though it has long been known that the condition can be reversed with weight loss and exercise. But research shows people need lots of help to change their lifestyle, and they rarely get it.

“I had taken care of diabetic patients for so long, and I knew the progression,” Karen said. “If you truly want the people to get better, you have to treat it with lifestyle interventions.”

Those changes can be hard to start and even harder to maintain.

“Nobody, actually, will make all of the lifestyle changes that we recommend,” Steve said. “But if you’re making the kind of choices that lead you to a healthier lifestyle, then you get better.”

A More Hopeful Message

Along with their lifestyle counseling, the Wickhams always give a disclaimer, advising people to consult with their doctors. They also acknowledge that their seminars are not yet “evidence-based” or backed by peer-reviewed scientific literature.

But there are studies showing that people with blood sugar levels in the “prediabetes” range can get back to normal blood sugar by losing 5% of their body weight.

And weight loss and exercise have already been shown to lower hemoglobin A1c levels, a test physicians use to monitor a patient’s blood sugar over two to three months.

In addition, new research from Dr. Roy Taylor of Newcastle University in England shows promise for true remission.

“Doctors tell their patients, ‘You’ve got a lifelong condition. We know it’s going to steadily get worse.’ Then they turn around and their patients aren’t losing weight or doing exercise, but they’ve given them this utterly depressing message,” he said.

Taylor’s research finds that by losing 30 pounds or so, Type 2 diabetes can be reversed in the early stages.

Ultimately, Taylor hopes, better nutrition will become the preferred response to high blood sugar in the next decade.

“I think the main headwinds [against progress] are just conceptual ones — of scientists and doctors believing this is an irreversible condition because of what we’ve seen,” he said.

Even the American Diabetes Association has been changing its views. The advocacy group has a new position on reversal:

“If a patient wishes to aim for remission of Type 2 diabetes, particularly within six years of diagnosis, evidence-based weight management programs are often successful.”

Dr. John Buse, chief of endocrinology at the University of North Carolina medical school, helped write the new position on reversal.

“We’ve known, literally since the 17th century, that diet is the key to managing diabetes,” he said.

But it’s hard to write a prescription for a lifestyle change.

“Doctors don’t have the time to do it well, so we have often used the sort of short shrift,” he said. “‘Eat less carbohydrates and walk every day’ … that has basically no impact.”

The Wickhams are doing their part to add to the scientific data, tracking the blood sugar of the participants in their program. And the anecdotal, short-term evidence they’ve gathered is resonating far beyond Grundy County. They’ve been traveling more and more lately.

Steve Wickham, who is a nurse, draws blood at the midpoint of his and wife Karen’s six-week diabetes seminar. The hemoglobin A1c levels measured by the lab test help patients monitor whether the diet and exercise changes they’re engaged in are making a difference in their blood sugar levels.(Blake Farmer/WPLN)

The couple just sold their retirement home so they can say “yes” to all the invitations they’ve received, mostly from Seventh-day Adventist groups, to present their program to other communities around the country.

This story is part of a reporting partnership that includes Nashville Public Radio, NPR and Kaiser Health News.

Maryland Orthopedic Practice Agrees to Provide Deaf 6-year-old a Qualified Interpreter

HHS Gov News - July 24, 2019

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), has entered into a Voluntary Resolution Agreement (VRA) with Mid-Maryland Musculoskeletal Institute (MMI). The agreement resolves a complaint alleging that MMI did not ensure effective communication with a deaf or hard of hearing patient, in violation of Section 504 of the Rehabilitation Act of 1973 (Section 504) and Section 1557 of the Affordable Care Act (Section 1557). MMI is an orthopedic practice in Maryland that provides a full-range of orthopedic services, including onsite physical therapy. MMI receives Federal financial assistance (FFA) through its participation in the Medicare and Medicaid programs and is subject to the requirements of Section 504 and Section 1557.

The complaint alleged that MMI failed to provide a qualified American Sign Language interpreter to a deaf six-year-old requiring physical therapy, in violation of both Section 504 and Section 1557. The complaint was filed in 2017 and was the fifth complaint alleging that MMI failed to provide effective communication to individuals who are deaf or hard of hearing. OCR and MMI agreed to resolve the current matter to ensure that individuals seeking services from MMI who are deaf or hard of hearing receive effective communication to participate in the activities and services provided by MMI, in accordance with Section 504 and Section 1557.

MMI and OCR have agreed that MMI will take steps to improve and upgrade its review and assessment of sign language interpreters. In addition, MMI will provide staff training in effective communication and OCR will provide MMI with substantive technical assistance and feedback in response to reports MMI will be sending to OCR regarding its ongoing compliance activities.

“Our system of informed consent breaks down when medical facilities fail to communicate effectively with patients,” explained OCR Director Roger Severino. “Section 504 of the Rehabilitation Act and Section 1557 of the Affordable Care Act require health care providers to afford individuals who are deaf or hard of hearing an equal opportunity to benefit from health care services. That means providing auxiliary aids and services such as sign language interpreters.”

Collectively, Section 504 and Section 1557 prohibit discrimination based on disability and often require that health care facilities provide auxiliary aids and services in health programs or activities that receive HHS funding, such as nursing homes and hospitals.

More information on OCR resources, federal resource, and other organization resources related to effective communication with individuals with a disability can be found at: https://www.hhs.gov/civil-rights/for-individuals/special-topics/hospitals-effective-communication/disability-resources-effective-communication/index.html.

A copy of the voluntary resolution agreement is located at https://www.hhs.gov/sites/default/files/MMI-vra.pdf.

For additional information on OCR’s work on effective communication for persons who are deaf or hard of hearing, visit: https://www.hhs.gov/civil-rights/for-individuals/disability/effective-communication/index.html.

To learn more about Section 1557 of the Patient Protection and Affordable Care Act, visit https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html.

To learn more about non-discrimination and health information privacy laws, and to find information on filing a complaint, visit us at https://www.hhs.gov/ocr.

Follow OCR on Twitter at http://twitter.com/HHSOCR.

Federal Suit Alleges ‘Staggering’ Urine Drug Testing Fraud At Tennessee Pain Clinics

The Justice Department on Monday accused a defunct chain of Tennessee-based pain clinics of cheating Medicare and other taxpayer-funded health insurers out of at least $25 million in needless urine drug tests and genetic testing.

The civil lawsuit names Comprehensive Pain Specialists, also known as Anesthesia Services Associates PLLC; four of its physician owners; and a former top executive. The doctors include Tennessee Republican State Sen. Steven Dickerson and Peter Kroll, both anesthesiologists.

Special Reports Investigation

Liquid Gold

By Fred Schulte and Elizabeth Lucas Photos by Heidi de Marco Nov 6

Pain doctors soak up profits by screening urine for drugs.

At its peak, CPS ran 60 pain clinics in a dozen states and treated some 48,000 patients per month, according to the suit. It shut down abruptly last summer, leaving many chronic pain patients scrambling to find a new source of narcotic medicines.

The Justice Department fraud case centers largely on the company’s lucrative urine-testing lab in Brentwood, Tenn., which CPS financed with a $1.5 million loan. The suit also alleges overbilling from acupuncture and other services offered to patients.

CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized Medicare billings for urine drug tests.

Medicare and other federal programs paid over $70 million from 2011 to 2018 for CPS-ordered urine tests, an amount the lawsuit called “staggering.” TennCare, the state’s Medicaid program, paid more than $9 million more during that time.

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“For this reason, CPS considered [urine tests] to be ‘liquid gold’ — with revenues of tens of millions of dollars for what was largely unnecessary medical testing,” according to the suit.

The chain’s owners and then-CEO John Davis “viewed every CPS patient as an opportunity to make money, without regard to the individualized need for treatment,” the suit alleges. Davis was convicted last year in Nashville on federal criminal health care fraud charges. He has since filed a motion for a new trial.

Dan Martin, an attorney representing Kroll, said in an emailed statement: “We are aware of the allegations and very familiar with the actual facts. Dr. Kroll did not engage in any wrongdoing whatsoever, and we look forward to correcting the government’s misunderstanding of the facts.”

Dickerson’s attorney, Ed Yarbrough, also issued a statement that read: “Dr. Dickerson is an honest man. We will prove that in court.”

In its investigation, KHN, with assistance from researchers at the Mayo Clinic, found that spending on urine screens and related genetic tests quadrupled from 2011 to 2014 to an estimated $8.5 billion a year — more than the entire budget of the Environmental Protection Agency. The federal government paid medical providers more to conduct urine drug tests in 2014 than it spent on the four most recommended cancer screenings combined.

CPS was among the nation’s most aggressive testers. KHN found that in 2014 five of its medical professionals stood among the nation’s top billers. Anita Bayles, a nurse practitioner working at a CPS clinic in Cleveland, Tenn., generated $1.1 million in urine-test billings that year, according to Medicare records analyzed by KHN.

The Justice Department suit says that CPS believed Bayles ordered too many urine tests and overprescribed opioids and in September 2016 decided to fire her. But the decision was reversed by CEO Davis “because of her ability to generate revenues,” according to the suit. Bayles could not be reached for comment.

Though CPS ran six or more urine tests a year on many patients receiving narcotics, its doctors often did not review the results to make sure patients did not abuse them, according to the suit.

Kroll, who also served as CPS’ medical director, told KHN in 2017 that the high volume of tests was justified to keep patients safe and to reduce chances of black market sales of pills. Kroll billed Medicare $1.8 million for urine tests in 2015, the KHN analysis of Medicare billing records found.

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Kroll said in a 2017 interview that he and Dickerson came up with the idea to open a high-quality pain practice over a cup of coffee at a Nashville Starbucks in 2005.

But the Justice Department alleges that CPS expanded rapidly through bilking the government, conduct that its top executives and founders “failed to take any action to stop,” according to the suit.

In what is called a “particularly egregious example of this fraudulent conduct,” the Justice Department alleged that Kroll caused over 2,500 claims to be submitted to Medicare, for which CPS was paid almost $350,000, during a 10-day period in May 2017 when Kroll was on vacation in Italy.

“Because of these fraudulent claims, Kroll’s billing privileges with Medicare have been revoked,” according to the suit.

The lawsuit states that Medicare officials began investigating overcharging for urine testing at CPS in 2014 and eventually directed the company to repay the government $27.4 million in an extrapolated penalty. But CPS aggressively appealed the decision and managed to get it overturned and stay in business.

Once among the largest pain management groups in the Southeast, CPS crumbled amid financial woes that included nearly a dozen civil suits alleging unpaid debts, as well as the criminal case against Davis. In a court filing in December, the company said that it had terminated all of its employees and that its debts “greatly exceed its assets.”

In total, Medicare paid CPS over $150 million from 2011 to 2018, a large part of which was related to urine testing, while TennCare paid CPS over $32.5 million, according to the suit.

The Justice Department complaint consolidates several whistleblower cases filed against the company by doctors and other former employees. Federal whistleblower cases seek recovery of money paid improperly and can include treble damages, or three times the amount of the original overpayment.

One of the whistleblowers said he toured the lab with CPS executives and observed an “overpowering and unpleasant smell of urine.” In response, a CPS executive said, “To me, it smells like money,” according to the whistleblower’s suit.

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