Judge Blocks Kentucky Medicaid Work Requirement

[UPDATED at 9:20 p.m. ET]

A federal judge on Friday struck down a Trump administration decision allowing states to force low-income adults to work to qualify for Medicaid.

The 60-page ruling, which is likely to be appealed, was hailed by advocates for the poor. But it could limit the number of states expanding Medicaid under the Affordable Care Act.

“The Secretary never adequately considered whether [the work requirement] would in fact help the state furnish medical assistance to its citizens, a central objective of Medicaid,” wrote Judge James Boasberg. “This signal omission renders his determination arbitrary and capricious.”

Boasberg also noted that “the Secretary never provided a bottom-line estimate of how many people would lose Medicaid with Kentucky HEALTH in place. This oversight is glaring, especially given that the risk of lost coverage was ‘factually substantiated in the record.’”

The case has been closely watched because work has never been a condition for receiving health coverage through Medicaid.

“Today’s decision is disappointing,” said Seema Verma, administrator of the Centers for Medicare & Medicaid Services. “States are the laboratories of democracy and numerous administrations have looked to them to develop and test reforms that have advanced the objectives of the Medicaid program. The Trump administration is no different.”

The administration is now reviewing its legal options, she said.

The ruling by the U.S. District Court immediately blocks Kentucky from moving ahead with implementing its work requirement, which was scheduled to begin its rollout Sunday.

“Even a temporary implementation of Kentucky HEALTH could cause serious harm,” Boasberg wrote in his decision.

But Adam Meier, secretary of Kentucky’s Cabinet for Health and Family Services, dismissed the court’s ruling, saying it was very narrow. He also offered words of caution.

“While we disagree with the Court’s ruling … we look forward to working with CMS to quickly resolve the single issue raised by the Court so that we can move forward with Kentucky HEALTH,” he said in an email. “Without prompt implementation of Kentucky HEALTH, we will have no choice but to make significant benefit reductions.”

Critics of the work requirement, however, applauded the court’s finding, saying that it reinforced and emphasized Medicaid’s mission.

“Medicaid is about health insurance. Period,” said Frederick Isasi, executive director of Families USA, a consumer advocacy group that supported the health law. “And policies that make it harder for people to get health insurance run counter to the program’s purpose.”

Judy Solomon, vice president of the left-leaning Center on Budget and Policy Priorities, agreed, calling the decision “a big victory.” She said this work requirement rejection should apply to the other states looking to implement it.

Those on the other side of the issue took a different view.

“It’s a setback, but I would not call it a blow,” said Angela Rachidi, a research fellow with the conservative American Enterprise Institute. She said she believes that the ruling will affect only Kentucky and that other states will move forward with the same provision, which could illicit other lawsuits.

“Today’s decision is clearly erroneous and should be reversed swiftly,” said Jonathan Ingram, vice president of research at the Foundation for Government Accountability, which favored the work requirements and opposes the health law.

Kentucky Gov. Matt Bevin, a Republican, had threatened to scale back the health program if the courts rejected the mandate, a move that could leave hundreds of thousands of low-income adults without coverage.

Kentucky was the first of four states that won federal approval this year to advance a work requirement, a historic change in the federal-state program’s 53-year history. The others are Arkansas, Indiana and New Hampshire. It’s unclear if this federal court ruling invalidates the other states’ work requirement plans.

“This is a big roadblock for the four states looking to implement these already approved waivers,” said Matt Salo, executive director of the National Association of Medicaid Directors. “The court decision acknowledged that there will be appeals, and I suspect this may well end up at the Supreme Court eventually.”

Seven more states have applications pending with the federal government: Arizona, Kansas, Maine, Mississippi, Ohio, Utah and Wisconsin.

Kentucky’s program would have required nondisabled adults each month to participate in 80 hours of work, job training, education or other volunteer service to remain covered. Those failing to meet the requirement can regain coverage the month after they complete 80 hours of community engagement in a 30-day period or by taking a state-approved health literacy or financial literacy course.

Those exempted include pregnant women, full-time students, primary caregivers of a dependent and beneficiaries who are considered medically frail or have an acute medical condition that would prevent them from complying.

State officials estimate about 200,000 adults would have to comply with the new work requirements by year’s end.

Critics say the work requirement would lead many low-income people to lose their health coverage, and with it their access to care. They note Kentucky’s own projections show that 95,000 Medicaid enrollees would fall from the rolls within five years. They fear such a directive could have a chilling effect on people signing up for Medicaid or make it harder for people to qualify.

About 500,000 adults were added to Medicaid in Kentucky after the state in 2014 expanded coverage to everyone with incomes below 138 percent of the federal poverty level, or about $16,700 for a single adult.

Adding a work requirement has been seen in some states as a way to give political cover to Republicans, who after initially resisting the expansion decided to pursue it.

The Republican-controlled Virginia legislature in May approved expanding Medicaid contingent on such a policy. Trump administration officials said the work requirement gives low-income adults an incentive to enter the workforce. Proponents argue that working or doing community service would improve enrollees’ health.

States that are implementing the policy have exempted large swaths of people, such as those who are pregnant, going to school, getting treatment for opioid addiction, taking care of a sick relative or suffering from a medical condition that prevents them from working.

Critics argue that people need Medicaid to get healthy so they can work. The work requirement, they add, was unnecessary because the large majority of Medicaid enrollees already work or go to school or care for a relative.

A Kaiser Family Foundation report estimated just 6 percent of adult Medicaid enrollees would be affected because they either already work or meet one of many exemptions. (Kaiser Health News is an editorially independent program of the foundation.)

But the idea has strong public backing. About 70 percent of Americans said they support states imposing a work requirement on nondisabled adults, according to a Kaiser Family Foundation poll last year.

Advocacy groups filed the lawsuit against the federal government and Bevin on behalf of 16 Kentucky Medicaid recipients. They claim the work requirement violates the 1965 law establishing Medicaid because it would reduce low-income people’s access to health care.

The decision also overturned the entire Kentucky Medicaid waiver approved by the Trump administration in January, saying that “preserving the status quo — including plaintiffs’ continuity of coverage — is appropriate.”

Under Kentucky’s plan, premiums would range from $1 a month for people with little or no income and up to $37.50 a month.

Those above the poverty line who fail to pay would be locked out of coverage for six months and must pay past-due premiums to regain coverage.

Those below the poverty line who don’t pay would have their reward accounts for receiving vision and dental benefits docked.

Heather Hahn, a senior fellow at the nonpartisan Urban Institute, said the ruling was important because it focused attention on the purpose of Medicaid, but she warned this was only the first battle in the legal war over the future of the program.

“There is a lot of momentum for work requirements, and I would expect people to try other avenues to move them forward,” she said.

Gov. Bevin filed a countersuit against those same 16 Medicaid recipients in a federal court in Frankfort, Ky., to uphold the work requirements and other provisions.

The Kentucky Hospital Association and the Kentucky Association of Health Plans filed briefs supporting Bevin in Frankfort while dozens of scholars representing some of the nation’s most prestigious schools of public health are backing the Medicaid recipients in the Washington case.

A decision is pending in the Frankfort lawsuit.

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Missouri appeals court tosses $55 million J&J talc-powder verdict

(Reuters) – A Missouri appeals court on Friday threw out a $55 million verdict against Johnson & Johnson in a lawsuit by a woman who claimed she developed ovarian cancer after using talc-based products, including J&J’s baby powder, citing a U.S. Supreme court ruling on where such cases can be brought.

FILE PHOTO: A bottle of Johnson and Johnson Baby Powder is seen in a photo illustration taken in New York, February 24, 2016. REUTERS/Mike Segar/Illustration

South Dakota resident Gloria Ristesund had been awarded $5 million in compensatory damages and $50 million in punitive damages in the 2016 verdict.

She alleged that her decades-long use of J&J talc-based products for feminine hygiene caused her cancer, and that the company had failed to warn consumers about the risks.

J&J denied the allegations, saying decades of testing have shown its cosmetic talc-based products to be safe.

The healthcare conglomerate is battling some 9,000 cases claiming its talc-based products cause ovarian cancer and, in some cases, mesothelioma, a rare cancer closely linked to asbestos exposure, amid allegations the products were contaminated with asbestos fibers. J&J has said its talc products do not contain asbestos or cause any form of cancer.

The unanimous three-judge panel of the Missouri Court of Appeals in the Eastern District, in overturning the verdict, did not rule on the merits of the allegations.

The judges instead said the verdict could not stand following a 2017 U.S. Supreme Court decision that limits where companies can be sued for personal injuries.

The high court ruled that state courts cannot hear claims against companies that are not based in the state or when the alleged injuries did not occur there.

J&J is based in New Jersey and Ristesund exclusively purchased and used the company’s talc products in South Dakota and Minnesota, according to court records.

J&J, in a statement, said it was extremely pleased with the court’s decision to recognize that the trial should have never occurred.

Ristesund’s case was one of more than 60 related talc lawsuits consolidated in Missouri state court, where juries have a reputation for issuing high-paying verdicts. But only one of those cases involved a woman from Missouri, leading many of the cases to be tossed on jurisdictional grounds.

During the appeals process, Ristesund asked the court for permission to present additional evidence tying J&J to Missouri. The judges on Friday rejected her request, saying she had ample opportunity to present such evidence over the past two years.

Reporting by Tina Bellon; Editing by David Gregorio and Bill Berkrot

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Trump’s Next High Court Pick Likely To Target Abortion. Is That What The Public Wants?

President Donald Trump has vowed that his nominees to the Supreme Court will vote to overturn Roe v. Wade, the landmark 1973 ruling that legalized abortion nationwide.

He seems to have made good on this promise with the appointment to the high court of Neil Gorsuch, whom experts expect to rule that way if given the chance.

Trump will now get another opportunity to reshape the bench with this week’s retirement announcement by Justice Anthony Kennedy.

But a Kaiser Family Foundation poll out early Friday suggests that’s not what most of the public wants.

The foundation’s June tracking poll found that Americans oppose overturning Roe V. Wade by 38 percentage points — 67 vs. 29 percent.

Among Democrats and independents, support for keeping the ruling intact is even stronger, 81 percent and 73 percent respectively, according to the poll.

But the opposition does not hold across party lines.

A majority of Republicans — 53 percent — said they want the case reversed. (Kaiser Health News is an editorially independent program of the Kaiser Family Foundation.)

Respondents to the poll also opposed recent Trump administration efforts to restrict federal funding for Planned Parenthood on the grounds that it uses non-federal funds to perform abortions.

A total of 57 percent opposed the new rules, including 67 percent of Democrats and 55 percent of independents. Even a plurality of Republicans opposed the rules — 48 percent, compared with 46 percent who expressed support.

Those findings are in line with a recent deep dive into public opinion on abortion by Gallup.

Gallup, which has been asking Americans about abortion since 1962 — more than a decade before Roe v. Wade was decided — found that unlike other social issues, for which public opinions have changed over time, abortion views have stayed relatively stable. And the public is equally divided between those who call themselves “pro-choice” (48 percent) and “pro-life” (48 percent).

Still, Gallup found that within those percentages, the public remains muddled, and generally in favor of restrictions, such as how long into a pregnancy an abortion can be performed or the reasons a woman is seeking the abortion. Just under 30 percent said abortion should be legal under any circumstances, while only 18 percent said it should be illegal under any circumstances. Fifty percent say it should be legal “only under certain circumstances.”

Like the Kaiser Family Foundation, Gallup found strong support for Planned Parenthood, with 62 percent saying they hold a “favorable opinion” of the reproductive health group.

Republicans were the only major demographic group with an unfavorable opinion of Planned Parenthood (63 percent) along with those who identify themselves as “pro-life” (59 percent).

But even in those groups more than a third of respondents approved of Planned Parenthood. Large majorities of Democrats, independents, men, women and people of all age groups have a favorable opinion of the organization, despite recent attacks on it by Trump and congressional Republicans.

Gallup said that support has remained relatively consistent since 2015, although margins have grown narrower since the 1990s.

The Kaiser Family Foundation poll was conducted June 11-20 among 1,492 adults. The margin of error is +/-3 percentage points for the full sample.

Gallup’s findings on abortion attitudes are based on its annual Values and Beliefs poll, conducted May 1-10.  It has a margin of error of +/-4 percentage points. Its Planned Parenthood poll was done in June and has a margin of error of +/-3 percentage points.


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

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Top Policy Expert’s Ties To Giant Drugmaker Often Go Unstated

When Dr. Mark McClellan sat for an in-depth 30-minute question-and-answer session at an April health policy forum, the audience was filled with top researchers, advocates and Capitol Hill staffers eager to hear what insight the former head of the Food and Drug Administration would dispense.

He did not disappoint.

In response to a question about how competition might drive down the cost of new drugs made from living cells, McClellan said, “That is a great example of where more clarity from FDA about what exactly is required could potentially open up more biosimilar competition.”

McClellan is director of the Margolis Center for Health Policy at Duke University, the academic position by which he’s commonly identified. But he frequently has not disclosed another position he’s held since late 2013: He earned $285,000 last year on the board of pharmaceutical giant Johnson & Johnson, a company accused of blocking the sale of Pfizer’s Inflectra biosimilar, which competes against J&J’s blockbuster Remicade, a rheumatoid arthritis drug.

According to corporate financial filings, McClellan has been compensated with more than $1 million in cash and stock awards since taking that post.

McClellan also receives compensation as a member of the advisory board of privately held Alignment Healthcare, which employs doctors and provides chronic-care management for Medicare Advantage plans in three states. Alignment Healthcare declined to disclose his compensation.

The issue of conflicts of interest has become more pressing in recent years as drug prices soar and health care companies reach out to the academic and policy community for advice — often with generous payments attached, ethics experts say.

Sen. Claire McCaskill (D-Mo.) introduced a bill in June that would require drugmakers to report payments to patient advocacy groups and professional societies. If passed, it would toughen the Sunshine Act, which requires pharmaceutical companies to report payments to teaching hospitals and physicians, detailing how much was paid annually to doctors for travel, speaking and food.

As a board member to these for-profit health care companies, McClellan has a fiduciary obligation “not to injure them” when writing articles and speaking, said Stephen Bainbridge, law professor at UCLA.

And while there is no legal requirement to disclose board memberships when writing for journals or speaking, Bainbridge and other experts agreed there is an ethical obligation.

“There’s certainly a potential conflict of interest there,” Bainbridge said, adding that while serving on the board of Johnson & Johnson “you are dealing with an enormous company that has fingers in a lot of different pies.”

McClellan said in an emailed statement that he provides specific disclosures on topics on which his interests might give the appearance of conflict, including in medical journals and at speaking engagements.

“My board memberships are public information and are broadly known within the field, and I stand by the independence and integrity of all my work,” McClellan said.

Ellen de Graffenreid, director of communications at the Duke-Margolis Center, said it was “clear that Dr. McClellan disclosed his position on the Johnson & Johnson Board when a potential conflict of interest existed — that is, when the publication mentions drugs or devices that may intersect with J&J’s business.” She said that while he serves on the J&J board, he “does not advocate for any positions on behalf the company.”

McClellan is a prolific writer and speaker about how the U.S. health care system operates. He left his work at the Brookings Institution to become the founding director of Duke-Margolis in 2015. He ran the FDA from 2002 to 2004 and served as administrator of the U.S. Centers for Medicare & Medicaid Services from 2004 to 2006 before joining Brookings.

In a majority of the articles McClellan wrote for the Journal of the American Medical Association, he did not disclose his corporate connections when he filled out forms concerning potential conflicts of interest. Of 15 papers he wrote since 2013, McClellan disclosed his relationship with Johnson & Johnson three times.

Johnson & Johnson is a Fortune 500 health care giant, with more than $76 billion in annual sales and a range of products including pharmaceuticals, medical devices and consumer products that include brand names Aveeno, Tylenol and Neutrogena.

“I don’t think there’s any reason to cover up or ignore those [corporate] relationships,” said Arthur Caplan, a professor of bioethics at New York University School of Medicine. “In general … I would say disclose more.”

Journals, conferences and policy forums generally ask contributors to list their potential conflicts of interest — financial relationships that might in some way sway their opinion or color the audience’s perception of information they relay. But the experts themselves decide which connections to list.

At the April forum addressing high drug prices, which was hosted by Kaiser Permanente’s Institute for Health Policy, neither the forum’s agenda, nor the speaker’s introduction at the event mentioned McClellan’s Johnson & Johnson role. (Kaiser Health News is not affiliated with Kaiser Permanente.)

Kaiser Permanente’s John Nelson said speakers at the forums typically have extensive backgrounds and “thus we only provide abbreviated biographies when introducing them.” Kaiser Permanente declined to say whether they knew of McClellan’s corporate roles.

Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, said he favors disclosure of corporate roles and thinks “many [people] would argue that it should be for the reader and not the author” to determine whether there is a conflict of interest.

The question of when to disclose industry or nonprofit funding has been debated for decades, said Dr. Sandro Galea, who wrote about conflicts of interest and schools of public health last year in JAMA.

“There are public and private actors and both importantly shape the environment in which we are in,” Galea said, adding that it has been “relatively standard practice” for those in academia to determine for themselves whether there is a conflict to disclose.

Bioethics professor Caplan said he could understand why some authors would choose not to disclose a board membership in every article, particularly if the article wasn’t directly related to the company or its products. Caplan serves as an unpaid chair of a compassionate use advisory committee based at New York University and funded by Janssen, which is a division of Johnson & Johnson.

“Just because you have a connection to a company, in my opinion, you don’t necessarily generate a conflict for everything that you do,” Caplan said. “We have to get more sophisticated” about conflicts of interest, though he advocates personally for full disclosure.

Elite medical journals, including JAMA and the New England Journal of Medicine, have streamlined the conflicts of interest question by using a standard disclosure form created by the International Committee of Medical Journal Editors.

JAMA media relations manager Deanna Bellandi declined to release McClellan’s ICMJE forms and said, “We publish what authors provide.”

The New England Journal of Medicine publishes the ICMJE forms with its manuscripts. McClellan disclosed his role at Johnson & Johnson in a 2015 letter to NEJM about the 21st Century Cures Act, a sweeping law that increases funding for disease research and alters the regulatory system for drugs and medical devices. But he did not disclose any corporate roles in two recent articles for NEJM Catalyst, a separate publication that requires authors to fill out a separate disclosure form. Those 2017 articles focused on payment reform and private-sector entrepreneurship in health care.

When completing the standard ICMJE disclosure form, an author fills out a series of sections. Section 3 notes: “You should disclose interactions with ANY entity that could be considered broadly relevant to the work.” And it tells the author to report “all sources of revenue paid (or promised to be paid) directly to you or your institution on your behalf over the 36 months prior to submission of the work.”

The Duke-Margolis Center and McClellan have been at the forefront of discussions on the merits of using real-world evidence, a somewhat controversial topic that could alter the way drugs are regulated and approved. The idea is that once a drug is on the market, the patients’ experience might in part supplant rigorous and expensive clinical trials.

Johnson & Johnson, whose executives are open proponents of the use of real-world evidence, did not respond to requests for comment.

McClellan did not disclose his J&J board membership in a 2017 white paper about real-world evidence, which was funded in part by the FDA. In September 2017, McClellan’s role at J&J was not disclosed during a public event done in coordination with the FDA. In December, Duke-Margolis announced a Real-World Evidence Collaborative, which is funded by pharmaceutical companies including Johnson & Johnson.

In May, a $4.2 million FDA grant was reposted for bids after concerns that Duke-Margolis was the sole bidder listed on the grant. The grant focuses on the drug approval process and research initiatives in the 21st Century Cures Act, including the potential benefits of using real-world evidence to analyze whether a drug works instead of rigorous and expensive clinical trials.

“Billions of dollars ride on the evidence that the FDA will accept for whether or not a drug is safe and effective,” said Avorn, whose center does similar research on drug pricing.


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

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FDA approves Dermira’s wipe for excessive armpit sweating

(Reuters) – Dermira Inc (DERM.O) said on Friday its topical cloth for excessive armpit sweating was approved by the U.S. Food and Drug Administration, providing patients with an easy-to-use option for an often embarrassing condition.

A man wipes his forehead while sitting in Central Park in New York July 5, 2012. REUTERS/Eric Thayer

Shares of the company were up more than 25 percent at $11.09 in trading before the bell.

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

The treatment, Qbrexza, works by blocking receptors responsible for sweat gland activation and can be used once a day, the company said in a statement.

About 10 million people are affected with the condition, known as primary axillary hyperhidrosis, which results in sweating beyond what is needed for regulating normal body temperature.

The condition can affect a person’s psychological well-being and overall quality of life due to constant stressing over the appearance of underarm sweat marks and working to conceal them.

“What we hear from patients is, ‘Wow, I’m glad it’s not just me. I’m embarrassed to talk to somebody about it, or I talked to a physician who couldn’t do anything about it,’” Chief Executive Officer Tom Wiggans told Reuters prior to the approval of the treatment.

Currently, Allergan’s (AGN.N) Botox injection is used to treat the condition. Other treatments include antiperspirants and costlier alternatives such as laser therapy, as well as localized surgery like liposuction to remove sweat glands.

Qbrexza, indicated to treat patients above the age of nine years, received a “broad” label, Cantor Fitzgerald analyst Louise Chen said.

“This is a differentiator for Dermira, especially when one thinks about patients who might choose between (Qbrexza) and other available treatments.”

Dermira said it expected to launch the drug in October this year and that it was not aiming for a large prescribing base. Brokerage Cowen estimates sales of $250 million to $300 million by 2023 for the drug.

Reporting by Manas Mishra and Sharnya G in Bengaluru; Editing by Anil D’Silva

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Robots May Soon Join Ranks of Alzheimer’s Caregivers

News Picture: Robots May Soon Join Ranks of Alzheimer's CaregiversBy Dennis Thompson
HealthDay Reporter

Latest Alzheimers News

THURSDAY, June 28, 2018 (HealthDay News) — Robots work on assembly lines and assist doctors in the operating room. They manage inventory in warehouses and vacuum floors in homes.

And one day soon, they could help care for Alzheimer’s patients.

Several teams of scientists from around the world are investigating ways in which robots might help manage the daily living tasks of people with Alzheimer’s disease.

Some robots help patients in and out of bed, remind them to take medication, measure their mood and provide regular updates to human caregivers.

A South Korean-made robot called Silbot3 has shown promise in this area, said researcher Elizabeth Broadbent. She’s an associate professor of health psychology with the University of Auckland in New Zealand.

“It is designed to enable people to stay at home for longer before needing to go into a care home,” Broadbent said.

“While a human could help with these things, the burden on caregivers of people with dementia is very high. Some people do not have a caregiver at home and caregivers often need a break during the day to get other things done. Robots can help provide extra care,” she explained.

Other research teams have focused on using robots to combat the loneliness and isolation that can affect some Alzheimer’s patients.

Broadbent and her colleagues have found that a Japanese baby seal robot called Paro can help calm people with dementia and keep them company.

“It can be good for people who cannot look after a real animal,” Broadbent suggested.

Another team has taken this approach a step further, using a robot named MARIO.

MARIO has been built and programmed to “provide companionship and support the person with dementia to connect and/or remain connected to their family and friends, and stay engaged in activities and events that interest them,” said researcher Dympna Casey. She’s a professor with the National University of Ireland-Galway’s School of Nursing and Midwifery.

The robot offers a number of individualized applications that promote social connectivity, Casey said.

These include more general offerings like game apps, news apps and apps that play music, as well as programs more specifically geared to helping the patient feel less lonely:

  • The “My Memories” app presents photographs from the patient’s past, with the robot prompting a conversation about the content of the photo.
  • “My Family and Friends” gathers social media information to keep patients informed about loved ones and friends.
  • “My Calendar/Events” reminds users of special events happening in their families or communities.

Tests of MARIO in hospitals and residential care facilities have provided positive results, Casey said.

“People with dementia were overall very accepting of the robot, as were carers and relatives. They had positive perceptions toward MARIO, and of having social robots in dementia care,” Casey said. “People with dementia enjoyed their interactions with MARIO and they often referred to MARIO as he or she, and some referred to MARIO as ‘a friend.'”

James Hendrix, director of global science initiatives for the Alzheimer’s Association, said that robots could prove very useful in helping patients with dementia.

Robots could provide badly needed assistance for weary caregivers, he said.

“Caregivers of people with dementia carry a really heavy burden,” Hendrix said. “If there’s a way we can lighten that burden for folks a little bit, make it a little easier for them, that’s going to help the person with dementia as well. Their care partner is just going to be that much more rested, that much more healthy, and that much more happy.”

These robots also could help doctors better care for patients, by collecting data that tracks their mental decline and other health problems, Hendrix said.

On the other hand, Hendrix believes there should always be a role for human caregivers.

“I don’t want to see that we totally impersonalize the care and support of people with dementia, that we warehouse them somewhere and they’re managed by robots,” Hendrix said. “The robotics provide tools of support for the human caregiver, and we still have that human touch.”

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SOURCES: Elizabeth Broadbent, Ph.D., associate professor, health psychology, University of Auckland, New Zealand; Dympna Casey, Ph.D., a professor, National University of Ireland-Galway’s School of Nursing and Midwifery; James Hendrix, Ph.D., director, global science initiatives, Alzheimer’s Association


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Geriatric Assessments Could Fine-Tune Cancer Care For Older Adults

In a move to improve cancer care for older adults, the American Society of Clinical Oncology is recommending that all patients age 65 and older receive a geriatric assessment when considering or undergoing chemotherapy.

The goal is to better identify which patients can tolerate intensive chemotherapy, and which patients may need modified treatment regimens because of underlying conditions, such as cognitive impairment, that often go undetected by oncologists.

Fewer than 25 percent of older cancer patients currently get these assessments, which evaluate a person’s functioning (what he can and cannot do), psychological status, nutrition, cognition, social circumstances and other, coexisting medical conditions, and which can predict the potential toxicity of chemotherapy.

The new guideline, ASCO’s first in the field of “geriatric oncology,” may have significant potential to change medical practice. “These recommendations will capture the attention of oncologists, I think, and that will be incredibly valuable,” said Corinne Leach, strategic director of cancer and aging research at the American Cancer Society.

They recognize a shifting demographic reality for cancer specialists, who are treating increasingly older patients as life spans lengthen across the globe. In the U.S., 60 percent of patients newly diagnosed with cancer (an estimated 1.7 million people this year) are age 65 or older, as are more than 60 percent of cancer survivors.

Yet evidence about how best to treat older adults with cancer is weak because older adults are underrepresented in clinical trials. And most oncologists have received little training in how to manage older patients’ unique vulnerabilities.

When researchers asked 305 community oncologists about evaluating older patients, 89 percent acknowledged “the care of older adults with cancer needs to be improved,” according to a recently published study. Fewer than 25 percent said they were “very confident” they could identify dementia or accurately assess a patient’s functioning or risk of falling — factors associated with poorer outcomes for cancer treatment.

Still, resistance to change is evident. “We’re all inundated with trying to keep up with new standards of care, and I doubt there will be any broad acceptance of the rigor called for in this guideline,” said Dr. Frederick Schnell, medical director of the Community Oncology Alliance.

The burden on physicians shouldn’t be significant, however: The streamlined assessments recommended in the ASCO guideline take only about 20 minutes to   complete. Patients fill out surveys during most of that time; about five minutes is required for a nurse or physician assistant to administer several brief tests.

The assessment can identify people at increased risk of experiencing serious side effects from chemotherapy — infections, fatigue, diarrhea, dehydration and other problems that affect more than half of older patients. Physicians can then take steps to address these vulnerabilities such as prescribing physical therapy for an older patient with muscle weakness or ordering a nutritional consultation for someone who has become malnourished. Also, they can alter chemotherapy regimens to minimize the potential for harm.

Currently, most oncologists decide whether older patients can benefit from chemotherapy by using the “eyeball test,” an assessment that relies primarily on their experience and judgment. “This isn’t enough to understand factors that put older adults at risk; it takes a deeper dive,” said Dr. Arti Hurria, director of the Center for Cancer and Aging, professor of medical oncology and therapeutics research at City of Hope, a comprehensive cancer center in Duarte, Calif., and co-chair of the panel that produced the new guidelines.

An oncologist walking into a room in a busy clinic might find an older patient already on the exam table, for instance, and miss the fact that she needed assistance getting out of a chair and getting into a gown — important signs of functional impairment that could be aggravated by chemotherapy, Hurria said. Or, “a very pleasant older patient might smile kindly at you and agree with everything you’re saying, and she might not have understood a thing you said” because of undetected cognitive impairment that could worsen and interfere with treatment, she explained.

Dr. William Dale, a geriatrician and Arthur M. Coppola Family Chair in Supportive Care Medicine at City of Hope and another co-chair of the guideline panel, tells of an 83-year-old woman whom he saw several years ago, with lung cancer metastasized to her brain. Her family requested a consultation because she’d become withdrawn and forgetful — a sign of accelerating cognitive impairment, they suspected.

Should she have chemotherapy and whole brain radiation, or would that worsen her memory lapses, the patient and family wondered?

One result stood out when Dale ordered a geriatric assessment: This older woman wasn’t cognitively impaired, she was psychologically distressed. “She wasn’t eating, she wasn’t interacting with other people, she appeared not to want treatment, but all this was due to depression,” Dale recalled. With counseling, the patient decided to undergo chemotherapy and radiation treatment, which he called “remarkably successful.”

Just as genetic tests are being used to personalize care for older cancer patients, geriatric assessments can be employed for this purpose — at considerably less expense, said Dr. Supriya Gupta Mohile, editor-in-chief of the Journal of Geriatric Oncology and director of geriatric oncology at the James Wilmot Cancer Institute at the University of Rochester.

She tells of a 78-year-old man with invasive bladder cancer who came in for a consultation. From the medical chart, she learned the patient had hypertension, diabetes and depression, all reasonably well-controlled. From a geriatric assessment, she discovered that he lived alone, had cognitive impairment, relied on his daughter to deliver meals and was at high risk of falling.

“The patient and his daughter were worried about his safety at home, his cognition getting worse, and fatigue and how that might affect his ability to function,” Mohile said. “His goal was to stay independent, at home, and not be hospitalized or go to rehabilitation.”

The standard of care for this condition was three to four months of chemotherapy before surgery, but Mohile recommended that the older patient skip chemotherapy and have surgery immediately after reviewing the geriatric assessment with her patient and his family.

Every older patient considering chemotherapy should request an evaluation of this kind, even if your physician doesn’t offer it, said Dr. Heidi Klepin, associate professor of hematology and oncology at Wake Forest School of Medicine in North Carolina. “Ask for your doctor to consider your ability to do the things you most care about doing and for care to be individualized to your unique circumstances.”


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

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Aging Cost and Quality Navigating Aging

Cancer End Of Life

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Amazon to buy PillPack in potentially disruptive drug retail push

(Reuters) – Amazon.com Inc said on Thursday it would buy small online pharmacy PillPack, a move that will put the world’s biggest online retailer in direct competition with drugstore chains, drug distributors and pharmacy benefit managers.

A sign marks the corporate offices of PillPack in Somerville, Massachusetts, U.S., June 28, 2018. REUTERS/Brian Snyder

The deal’s potential to disrupt major players across the drug supply chain nationwide prompted a sell-off in shares of possible rivals, while sending Amazon shares up 2.7 percent.

PillPack supplies pre-sorted prescription drugs and other services to people who take multiple medications, a growing market as the U.S. population ages and requires treatment for multiple complex, chronic conditions.

The value of the deal was not disclosed. Bloomberg reported it to be $1 billion, citing a person it said was familiar with the matter.

Pharmacy chains and drug wholesalers lost around $14 billion in market value, while Amazon gained about $5.5 billion.

Shares of CVS Health were down 6.3 percent after falling as much as 10 percent, while Walgreen Boots Alliance was off nearly 10 percent. Shares of drug wholesalers McKesson Corp, Cardinal Health and AmerisourceBergen also fell sharply.

The news comes just a week after a joint venture of Amazon, Berkshire Hathaway Inc and JPMorgan Chase & Co named a chief executive who will be tasked with significantly cutting healthcare costs.

WARNING SHOT

Although brick-and-mortar stores might feel the effects of Amazon’s competition, the biggest battles will likely be fought by mail-order pharmacies, which generally serve patients with chronic conditions such as diabetes and heart disease that may require drugs to control blood pressure, cholesterol and other problems.

“PillPack has tens of thousands of customers across the country, will do over $100 million in revenue this year, and has launched PharmacyOS … designed specifically for customers with complex medication regimens,” company spokeswoman Jacquelyn Miller said in an email.

“Amazon’s acquisition of PillPack is a warning shot in what is about to become a major battle within the pharmacy space,” said Neil Saunders, managing director of GlobalData Retail.

Pharmacy benefit managers (PBMs), such as CVS and Express Scripts, which negotiate prescription drug pricing for employers and health plans, also run large mail-order pharmacies, offering incentives to patients to fill their prescriptions with them.

Doctors, insurers and PBMs have long said patients not properly taking their medicines is one of the main reasons for increased healthcare costs, leading to hospitalizations and more severe health issues. Companies like PillPack and Express Scripts that offer care management services to improve patient compliance are seen as increasingly important in helping control rising costs.

FILE PHOTO: An Amazon package is seen after being delivered in London, Britain February 29, 2016. REUTERS/Toby Melville/File Photo

With Amazon’s announcement Mizuho analyst Ann Hynes, in a note, said pending health insurer/PBM mergers of Aetna Inc with CVS and Cigna Corp with Express Scripts “are even more critical now.”

NOT WORRIED

Walgreen CEO Stefano Pessina, on a conference call after reporting quarterly results, said he was “not particularly worried” about the PillPack deal.

“The pharmacy world is much more complex than just delivering certain pills or certain packages,” Pessina said.

That said, Pessina added, “We know that we have to change the level of our services to the customers, and we are working quite hard on that direction.”

Some analysts played down the immediate threat.

Morningstar analyst Vishnu Lekraj said he did not believe the deal would make Amazon “a major disruptor” in the near term.

A sign marks the corporate offices of PillPack in Somerville, Massachusetts, U.S., June 28, 2018. REUTERS/Brian Snyder

“I believe they bought this to learn about the market and to determine if they are able to make larger investments,” he said.

Cantor Fitzgerald analyst Steven Halper noted that PBMs typically require health plan members to use their own mail order pharmacies.

“Even if PillPack is a network provider today, it does not mean it will be a network provider in the future, especially if Amazon has designs of significantly ramping its prescription volume,” he said.

Express Scripts dropped PillPack from its network in April 2016, alleging that it had misrepresented itself as a retail pharmacy. The two reached an agreement a month later.

PillPack holds pharmacy licenses in all 50 states. It is an in-network pharmacy for some PBMs and for major Medicare Part D plans, a federal drug benefit to help Medicare beneficiaries pay for self-administered prescription medicines.

PillPack had attracted interest from Walmart Inc, which was looking to buy it for less than $1 billion, CNBC here in April. The deal is expected to close during the second half of 2018.

To view a graphic on Amazon disrupts the health and pharmacy space, click: reut.rs/2tCLjss

Reporting by Sonam Rai and Ankur Banerjee in Bengaluru; additional reporting by Ben Hirschler in London and Michael Erman and Jilian Mincer in New York, writing by Bill Berkrot; Editing by Anil D’Silva, Bill Rigby and Richard Chang

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AI ambulances and robot doctors: China seeks digital salve to ease hospital strain

HANGZHOU, China/SHANGHAI (Reuters) – In the eastern Chinese city of Hangzhou, an ambulance speeds through traffic on a wave of green lights, helped along by an artificial intelligence (AI) system and big data.

A woman touches a screen on a robot developed by iFlytek at the outpatient hall of People’s Liberation Army General Hospital in Beijing, China March 16, 2017. Zhao Naiming/Qianlong.com via REUTERS

The system, which involves sending information to a centralized computer linked to the city’s transport networks, is part of a trial by Alibaba Group Holding Ltd. The Chinese tech giant is hoping to use its cloud and data systems to tackle issues hobbling China’s healthcare system like snarled city traffic, long patient queues and a lack of doctors.

Alibaba’s push into healthcare reflects a wider trend in China, where technology firms are racing to shake up a creaking state-run health sector and take a slice of spending that McKinsey & Co estimates will hit $1 trillion by 2020.

Tencent-backed WeDoctor, which offers online consultations and doctor appointments, raised $500 million in May at a valuation of $5.5 billion. Ping An Good Doctor, a similar platform backed by Ping An Insurance, raised $1.1 billion in an IPO this year.

“The opportunity is growing very fast,” said Min Wanli, the Hangzhou-based chief machine intelligence scientist at Alibaba’s cloud division.

Alibaba is working with a hospital in Shanghai using data to predict patient demand and allocate doctors. In Zhejiang province, the company is working on AI-assisted diagnosis tools to help analyze medical images such as CT scans and MRIs.

“You need to go through very specialized training in order to read these images, but we know that experts are a very scarce resource,” said Min.

Chinese hospitals are increasingly using technology to bridge the gap between urban centers and remote parts of the country where doctors are in short supply. Using document-sharing systems and livestreaming video, specialists can direct more junior medical staff on-site doing patient diagnoses.

DXY, one of China’s biggest online networks of doctors, offers consultations on the WeChat social media platform for patients with chronic diseases such as diabetes, with a team of nurses and doctors providing medical advice.

China is pressing to reduce healthcare costs that are soaring as the population ages, putting huge strains on the state insurance system.

At the same time, Beijing has been promising better access to healthcare and improved grass-roots care – despite a lack of family doctors – which has brought technology into the spotlight as a way of maximizing stretched resources.

“Educating doctors is going to take too long,” said Rogier Janssens, Beijing-based general manager of Germany’s Merck KGaA’s biopharma business in China. He added that smartphones could help deliver primary care faster and cheaper.

“There are hundreds of millions of people who still go without care for relatively simple diseases.”

FILE PHOTO: Screens showing traffic data of Hangzhou city are seen during a media tour of City Brain, an AI-powered traffic-management system by Alibaba Cloud, in Hangzhou, Zhejiang province, China April 10, 2018. REUTERS/Stringer/File Photo

China’s healthcare system has long grappled with a shortage of doctors, exacerbated by low wages and a dearth of local clinics and general practitioners. That means patients often crowd into large, specialist hospitals for even minor ailments.

Beijing has been trying to fix the problem, setting targets to increase the number of family doctors across the country.

However, the government has been slow to embrace technology within the healthcare system, held back by the challenge of digitalizing a sprawling, fragmented hospital system still dominated by public hospitals and state-run firms.

ONLINE DRUG SALES

The policy winds may be starting to change. Beijing has enacted legislation over the last two years that has included strong support for internet-based basic healthcare services.

Premier Li Keqiang said this year that healthcare tech could “help alleviate the problem of inaccessible and expensive public health services that have long been a big concern”.

Now, Beijing may be about approve the sale of some prescription drugs online, creating a major opportunity for local and global firms, according to companies in the sector.

Janssens of Merck KGaA said the company had “good indications” that policymakers were addressing the issue of pharmaceutical e-commerce “as we speak”.

Li Tiantian, the founder and chairman of DXY, said the health ministry had met with healthcare companies like his own and planned to soon release a policy on “internet hospitals”, which would open up some online sales.

“I think the new policy will be released very soon, potentially in July,” he said.

The policy would allow approved hospitals to consult, prescribe and sell drugs to chronic disease patients online. However, regulatory concerns over safety and pushback from state-run distributors sank a similar plan several years ago.

Li added that Ningxia autonomous region, in north-central China, had already been approving some internet hospital providers on a test basis.

Global drugmakers are taking notice. A move to open up online sales – if approved nationwide – would help shake up a drug market dominated by state-owned distributors and public hospitals, where most medicines are still prescribed and sold.

Merck KGaA, for example, recently announced a tie-up with Alibaba Health focused on systems to help track medicines to avoid counterfeiting, but also on online drug sales and potential direct-to-patient sales online.

FILE PHOTO – A screen displaying Tencent Miying, an AI-powered medical imaging service, is seen next to visitors at the fourth World Internet Conference in Wuzhen, Zhejiang province, China, December 3, 2017. REUTERS/Aly Song/File Photo

FALSE HOPE?

In the United States, technology firms like Amazon, Google and Apple have made pushes into healthcare, with mixed results, often finding sprawling medical markets tougher to crack than entertainment or media.

Technology firms in China also face major obstacles.

One is convincing patients to see doctors online or getting hospitals to spend extra money on high-tech tools that promise efficiency boosts or improvements for patients. And regulators still have concerns about drug sales online.

Doctors and industry insiders also said that technology alone could not solve the issues facing the sector.

“Technology is important but is not enough on its own,” said DXY’s Li, a former doctor. He said the most immediate benefit was creating new channels for simple primary care.

Wang Aihu, a cardiologist at Beijing Chaoyang Hospital, said medical centers were increasingly using online appointment and payment systems, and that he conducted internet consultations for patients in remote regions.

He added that his hospital may eventually have “AI-powered medical imaging systems or robot doctors”, but these could not replace medical staff.

“These promising technologies will help accelerate and improve diagnoses, but will not replace good doctors, who are still needed to verify and correct diagnostic results,” he said.

That hasn’t stopped one hospital in Beijing doing a “man vs machine” standoff this month to detect neurological disorders including brain tumors. A robot developed by the prestigious Tsinghua University and iFlytek, a local firm, has also taken and passed China’s medical exam for doctors.

For most people in China, however, AI ambulances and robot doctors may need to wait a bit longer.

Tony Li, 55, a cancer patient in Shanghai, said he had seen little cutting-edge tech in Chinese hospitals in regular visits over the past few years.

“From what I heard, some of the newest technologies can help doctors identify tumors at earlier stages, and that’s great,” he said. “But the internet has a tendency of exaggerating things, giving us enormous false hope.”

Alibaba Cloud’s Min acknowledged the company was still working to prove the value of its technology, and that many hospital administrators were still suspicious of things like cloud computing.

But, he said, “In China, once a new technology is proven useful then everybody is crazy about it.”

Reporting by Adam Jourdan; Additional reporting by Shanghai newsroom; Editing by Philip McClellan

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