Demand For Popular Short-Term Insurance Plans Could Surge If Health Law Is Relaxed

Short-term health plans have been around for decades, bridging coverage gaps for people who are between jobs or have recently graduated from school, among other things. After the health law passed, some people gravitated toward them because they were willing to trade comprehensive coverage for a cheaper sticker price — even if it meant paying a tax penalty for not having the comprehensive coverage required in the law. Sales increased.

Now, as Republicans look for ways to weaken the health law’s coverage requirements and explore the possibility of not enforcing the requirement that people have health insurance, short-term plans may be poised to grow even more. If that happens, consumer advocates warn it could be bad for consumers.

As their name suggests, short-term plans provide coverage for a limited period of time, often six months or less. They generally don’t cover such things as preexisting conditions, maternity services or prescription drugs. The policies typically have maximum coverage limits of about $1 million. Insurers can turn people down if they’re sick and may decide not to renew someone’s policy. All of these practices are prohibited in plans that qualify as individual insurance under the Affordable Care Act.

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Precisely because of these limitations, however, the premiums are typically a lot cheaper than those for ACA-compliant coverage. In the fourth quarter of 2016, the average monthly premium a shopper would pay for a short-term plan sold through online insurance vendor ehealth.com was $124, compared with $393 for someone who bought a regular Obamacare plan and didn’t qualify for premium subsidies.

When the health law passed, insurers increasingly began offering short-term plans that stretched the definition of “short,” sometimes providing coverage for as long as 364 days.

“Carriers were exploiting a loophole in the law that defined a health insurance plan as one that was 365 days,” said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. “If they were shorter they didn’t have to comply with ACA protections.”

Short-term plans serve a tiny but growing proportion of the roughly 22 million people who have coverage on the individual market. At the end of 2013, before the health law’s major reforms took effect, there were approximately 108,800 people covered by these policies, which earned premiums of $97.5 million, according to figures from the National Association of Insurance Commissioners. Two years later, roughly 148,100 people had short-term plans and premium earnings have grown to $160.5 million.

Some insurers have taken notice. Online health insurance vendor Health Insurance Innovations launched Agile Health Insurance in the spring of 2015 to focus on sales of short-term plans. In the third quarter 2016, Agile sold 21,000 short-term policies.

“These short-term plans are not regulated like Obamacare plans, so carriers have a lot of flexibility in benefits and pricing,” said Sam Gibbs, Agile’s executive director. “It’s almost like the old individual market before the ACA.”

And that’s just the problem, said some policy experts.

time clock short term plan“To many consumers it looks like health insurance, except it’s cheaper,” said Karen Pollitz, a senior fellow at the Kaiser Family Foundation. But the plans don’t protect people when unforeseen events occur such as a car accident or a cancer diagnosis. With a short-term plan, if you get sick or you’re in the hospital when your plan comes up for renewal, “it won’t be renewed,” Pollitz said. (KHN is an editorially independent program of the foundation.)

Not all insurers embrace widespread sale of short-term plans. “The big health insurance companies are really mixed on this,” said Timothy Jost, emeritus professor at Washington and Lee University School of Law and an expert on the health law. “They see this as a seriously destabilizing force in the market, this crap coverage.”

Last October, the Obama administration issued a final rule that would make it more difficult for consumers to buy short-term plans to substitute for regular Obamacare plans. The regulation, which takes effect April 1, said short-term plans must be less than three months in duration. People can request a renewal of the policies, but insurers can turn them down. The policies and related materials also have to prominently display a warning that they don’t satisfy the law’s requirement that people have health insurance.

Some hope that the rule may be changed or rescinded by the Trump administration or overturned by the new Congress under the little-used Congressional Review Act. Neither option can happen at the stroke of a pen, however.

Health insurance brokers and agents are one group that would like to continue to sell longer term short-term plans.

“Our folks do a lot of business with short-term plans,” said Marcy Buckner, vice president of government affairs at the National Association of Health Underwriters, an industry group. The regulation is one that the group will request that the Trump administration rescind.

“In most areas [a short-term plan] is cheaper, and it’s some consumers’ way of saying, ‘I don’t need all of those things,’” said Buckner.

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Categories: Insurance, Insuring Your Health, Syndicate, The Health Law

Tags: Regulations

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Trump pushes drugmakers for lower prices, more U.S. production

By Roberta Rampton and Deena Beasley
| WASHINGTON/LOS ANGELES

U.S. President Donald Trump on Tuesday met with top executives from some of the biggest drugmakers, calling on them to boost U.S. production and lower prices, while he also promised to speed up approval times for new medicines.

Trump reiterated that the government was paying too much for medicines in its health programs for older, disabled and poor people and said he would soon appoint a new U.S. Food and Drug Administration leader.

At the same time, the meeting between Trump and the pharmaceutical executives signaled a defusing of tensions between the two that have kept drug stocks in check since the presidential election. Shares of most of the group rallied Tuesday following the meeting, even as the broader stock market slid.

High drug prices have become a national issue during the past two years as healthcare costs rise. Pharmaceutical stocks have seesawed since Trump was elected, rising on hopes that he would not enact changes and more recently falling on comments about what actions he might take to lower their prices.

“Trump is a populist above all else, and having these (drug) prices skyrocket, he’s commented that under his administration, this is not going to happen,” said market strategist Quincy Krosby of Prudential Financial in Newark, New Jersey.

She said Trump was playing a balancing act between controlling prices and loosening regulations. “I don’t think the majority of Americans want all regulations lifted from drug makers.”

Attending the meeting were top executives at Merck & Co Inc, Johnson & Johnson, Celgene Corp, Eli Lilly & Co, Amgen Inc and Switzerland’s Novartis AG as well as the head of the Pharmaceutical Research and Manufacturers of America lobbying group.

According to a transcript of the televised portion of the meeting, Amgen Chief Executive Officer Robert Bradway promised to add 1,600 U.S. jobs at his California-based biotechnology company.

Lilly and Merck said by email after the meeting that they were encouraged by Trump’s focus on innovation.

Lilly said discussion topics also included stronger trade agreements, tax reform and removing “outdated regulations that drive up costs and slow innovation.”

“Tax, deregulation – those are things that could really help us expand operations,” Lilly CEO Dave Ricks said.

Officials at the other companies did not immediately respond to requests for additional comment.

Shares of the six companies were mostly higher, for an overall gain averaging 0.7 percent, compared with a 0.4 percent drop in the broad S&P 500. The Nasdaq Biotech Index was up 0.9 percent, reversing earlier losses, and the S&P 500 health care index gained 0.6 percent.

“ASTRONOMICAL” PRICING

Trump told the drugmakers that pricing had been “astronomical.”

“We have to get prices down for a lot of reasons. We have no choice, for Medicare and Medicaid,” Trump said, citing the nation’s government insurance programs for the elderly, the poor and the disabled that together are the largest U.S. purchaser of medications.

Trump also said currency devaluation by other countries had increased drugmakers’ outsourcing their production, and he called on the companies to make more of their products in the United States.

Foreign countries must pay fair share for drug development costs, he added. “We’re going to end global freeloading.”

The United States typically pays more for drugs than any other developed nation.

Novartis CEO Joe Jimenez, who is chairman-elect of the industry lobbying group, said last week that he wanted to talk to Trump about efforts to develop pricing models that would pay for clinical results rather than a flat price per pill, as well as plans to replace the Affordable Care Act, which is popularly known as “Obamacare.”

Trump spooked pharmaceutical and biotech investors by saying on Jan. 11, before his inauguration, that drug companies were “getting away with murder” on what they charged the government for medicine and that he would do something about it.

Company executives, meanwhile, have tried to tread a careful line in defending their industry while expressing optimism that the United States would continue to reward scientific advances.

“Regulations – great, streamlining the FDA, perhaps,” Jack Ablin, chief investment officer at BMO Private Bank in Chicago said. “But if Trump is going to address his constituency, drug prices have to come down. So I think this is maybe a Pyrrhic victory.”

(Additional reporting by Eric Beech, Ben Hirschler, John Miller, Deena Beasley, Chuck Mikolajczak and Rodrigo Campos; Editing by Lisa Von Ahn)


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Cambodia reports outbreak of H5N1 bird flu in southeast


Cambodia has reported an outbreak of the highly pathogenic H5N1 bird flu virus among backyard poultry in the southeastern part of the country, the World Organisation for Animal Health (OIE) said on Tuesday.

The virus was found in chickens in the region of Svay Rieng last week, killing 68 birds and leading to the destruction of 322 others, the Cambodian farm ministry said in a statement posted on the OIE website.


(Reporting by Sybille de La Hamaide. Editing by Jane Merriman)

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'Mental Flossing' May Cut Cognitive Risk in Elderly

Action Points

  • Engaging in mentally stimulating activities even in late life may be protective against new-onset mild cognitive impairment (MCI), according to a prospective observational study.
  • Note that the associations of mentally stimulating activities with risk of MCI may vary according to carrier status of APOE ε4, a genotype that is a well-known risk factor for MCI and Alzheimer Disease.

Mentally stimulating activities may diminish the risk of mild cognitive impairment (MCI) in older people — even in apolipoprotein E ε4 (APOE4) carriers, researchers found.

In the population-based Mayo Clinic Study of Aging, several activities — playing games, doing crafts, using the computer, and socializing — were each associated with a significantly decreased risk of MCI in cognitively normal people age 70 and up over a median follow-up of 4 years, Yonas Geda, MD, of the Mayo Clinic in Scottsdale, Ariz., and colleagues reported online in JAMA Neurology.

They also found that using a computer and enjoying regular social activities were each tied to a decreased risk of incident MCI in APOE4 carriers.

“Cognitively normal elderly individuals who engage in specific mentally stimulating activities even in late life have a decreased risk of incident MCI,” the researchers wrote. “The associations may vary by APOE4 carrier status.”

These results “fall into the growing category of studies showing that an enriched social environment has health benefits,” said Mitchell Elkind, MD, professor of neurology and epidemiology at Columbia University, who wasn’t involved in the study.

Yet Elkind cautioned that since the study is observational, there are unmeasured confounders that make it difficult to draw any conclusions about whether the mentally stimulating activities caused the reduction in cognitive impairment — or if something else did.

“An alternative explanation is that those who engage in mentally stimulating activity in late life are simply those who have always engaged in such activity, and perhaps were predisposed to do so because of some inherent characteristic that itself put them at reduced risk for later cognitive impairment,” Elkind told MedPage Today. “Or, it may be that those who engage in mental activity are actually engaging in physical activity too, and it is the physical activity that is driving the effect.”

For the study, Geda and colleagues assessed 1,929 cognitively normal participants enrolled in the population-based Mayo Clinic Study of Aging in Olmsted County, Minn., an ongoing study of normal cognitive aging and MCI among persons 70 years or older.

Participants in the study — which ran from April 2006 to June 2016 — were followed to the outcome of incident MCI. All were white, the median age at baseline was 77, half were female, the median educational level was 14 years, and 26.7% were APOE4 carriers.

Mentally stimulating activity was defined as reading books, doing crafts such as knitting and quilting, computer use, playing games, and social activities such as going to movies and or to the theater. That activity was surveyed in the year prior to study enrollment, and neurocognition was assessed at baseline and re-evaluated every 15 months.

Over a median follow-up of four years, 456 participants developed new-onset MCI.

The researchers found in adjusted analyses that the following mentally stimulating activities were associated with a diminished risk of incident MCI:

  • Playing games (HR 0.78, 95% CI 0.65-0.95)
  • Engaging in craft activities (HR 0.72, 95% CI 0.57-0.90)
  • Using the computer (HR 0.70, 95% CI 0.57-0.85)
  • Social activities (HR 0.77, 95% CI 0.63-0.94)

Analyses by MCI subtype — amnestic versus non-amnestic — showed significant associations between a decreased risk of amnestic MCI and craft activities (HR 0.76), computer use (HR 0.75), and social activities (HR 0.74). Only computer use (HR 0.42) was associated with a diminished risk of non-amnestic MCI, but the researchers noted they may have had limited power due to a smaller sample size for non-amnestic MCI.

When assessed by APOE4 genotype, the researchers found that only computer use (HR 0.65, 95% CI 0.46 to 0.92) and social activities (HR 0.62, 95% CI 0.43 to 0.89) were associated with a decreased risk of incident MCI.

“We consistently observed the lowest risk of incident MCI in participants who engaged in any type of mentally stimulating activity and were APOE4 non-carriers compared with the reference group,” they wrote. “In contrast, participants who were APOE4 carriers and did not engage in mentally stimulating activities tended to have the highest risk for incident MCI, with the exception of engaging in craft activities.”

The researchers acknowledged they couldn’t disentangle the reasons why reading didn’t appear to have the same impact on decreasing incident MCI risk as computer use, but it may be that a “particular mental activity may require specific technical and manual skills and that these could be the factors that might be associated with a decreased risk of cognitive decline.”

Elkind noted that the 14-year median level of education in the study population is “rather high compared to other populations, especially minority populations among whom the risk of dementia is higher.”

He said it would be helpful to have more imaging data showing both the structure of the brain — looking for silent infarcts, for example — and brain function: “Ideally, the next step would be a randomized clinical trial of some sort among people who are at risk of cognitive decline to see whether those who engage in this activity have better cognitive outcomes.”

Still, Elkind said it’s important to recognize that more data have shown that mental, social, and physical activities all stimulate and promote brain activity and clinicians should encourage patients of all ages to engage in more “mental flossing.”

“Most literature suggests that the benefits of early or mid-life activities are even greater than those of getting active later in life,” he told MedPage Today. “Because of the importance of early-life exposure to stimulation, and its effects on increasing cognitive reserve, it is important to realize that whatever benefits we are seeing in late life would likely be much greater if we could extend these activities to young children, especially those from impoverished backgrounds.”

This study was supported by the National Institute on Aging, the National Institute of Mental Health, the Robert Wood Johnson Foundation, the Robert H. and Clarice Smith and Abigail Van Buren Alzheimer’s Disease Research Program, the European Regional Development Fund, the Arizona Alzheimer’s Consortium, and the Edli Foundation.

Some co-authors reported relationships with drug companies involved in Alzheimer’s disease research and development.

2017-01-30T16:00:00-0500

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Paracardial Fat a CV Risk Factor in Older Women

Action Points

  • Note that this observational study suggests that paracardial fat is linked to coronary artery calcification among postmenopausal women.
  • The relationship is not as strong in pre-menopausal women however, suggesting a role for estrogen in paracardial fat deposition.

Among postmenopausal women and women with low estrogen levels, high volumes of paracardial adipose tissue (PAT) were associated with an increased risk for cardiovascular disease, researchers reported.

The presence of coronary artery calcification (CAC) among postmenopausal women was significantly associated with greater amounts of PAT, the fat surrounding the parietal pericardium of the heart (per 1 SD unit greater in Log PAT) (OR 2.02, 95% CI, 1.02-3.99; P=0.04), according to Samar R. El Khoudary, PhD, MPH, of the Epidemiology Data Center at the University of Pittsburgh and colleagues.

The results of SWAN (the Study of Women’s Health Across the Nation), published online in the Journal of the American Heart Association, found that higher volumes of PAT were also linked to an increased extent of CAC among postmenopausal versus premenopausal women and early peri-menopausal women (OR 79.83, 16.88-176.67; P=0.01). This relationship was also strongest among women with lower levels of estradiol (P for interaction=0.004).

While the researchers did find a link between epicardial adipose tissue (EAT) with increased risk for the presence or extent of CAC, the relationship was not modified by menopausal status.

“For the first time, we’ve pinpointed the type of heart fat, linked it to a risk factor for heart disease, and shown that menopausal status and estrogen levels are critical modifying factors of its associated risk in women,” El Khoudary said in a press statement.

Because lower estrogen levels and menopausal status were only linked to the associations between PAT and CAC, and not with EAT, the authors wrote that these findings “add to the lines of evidence that EAT and PAT are distinct heart fat depots with different endocrine properties, and thus should be evaluated separately.”

The team also noted that additional research is required to fuller understand why estradiol levels were related only to the relationship between PAT and CAC, and not with EAT, but suggested that “it is possible that estrogen receptors Er-a are more expressed in PAT than in EAT, which in turn could make any changes in E2 levels impact PAT more than EAT.”

Levels of estrogen and menopausal status significantly modified the relationship between PAT and CAC (P for interaction ≤ 0.01). Additionally, after the researchers adjusted for endogenous estradiol levels and hormone therapy use, the associations between PAT and CAC extent were less significant. However, the cardioprotective impacts of hormone therapy use are largely ambiguous, due to “the lack of any publication on the impact of hormone therapy use on heart fat volumes,” the team said.

Participant data were collected through the ongoing SWAN study. The final analysis included 478 women in menopause (58% pre-/early peri-, 10% late peri-, 32% post-menopausal). Data on CAC, EAT, and PAT volumes were measured with electron beam computerized tomography scans. The presence of CAC was classified as a CAC Agatstron score ≥ 10.

Due to the potentially harmful effects of high volumes of PAT among postmenopausal women, the authors emphasized the importance of finding ways to mitigate the risk for cardiovascular disease through methods to reduce fat surrounding the heart.

A previous meta-analysis identified the benefits of diet and bariatric surgery with significant reductions in heart fat, such as PAT. The study found that exercise alone did not have a significant benefit for heart fat reduction. The authors cited another study, which reported that “heart fat can be decreased by 17% in abdominally obese postmenopausal women on weight-loss interventions of equal energy deficit with or without aerobic exercise.”

Regarding the new study, El Khoudary and co-authors noted that, overall, the cross-sectional design may limit the findings, in addition to the small sample size. The team recommended additional studies in the future to evaluate the role of hormone therapy on heart fat volume accumulation and the impact of hormone therapy on the associations between heart fat volumes and subclinical measures of atherosclerosis.

El Khoudary added: “Epicardial and paracardial fat are distinct types of heart fat that are found to be greater in postmenopausal women for different reasons with different effects on heart disease risk — and thus should be evaluated separately when searching for ways to help women avoid heart disease.”

The study was funded by grants from the National Institutes of Health and the American Heart Association (AHA).

Some authors disclosed receiving grants from the AHA or the National Institutes of Health during the conduct of the study.

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    F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner

2017-01-30T00:05:00-0500

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TSRI study offers first look at early stages of brain development in patients with Fragile X syndrome

A new study led by scientists at The Scripps Research Institute (TSRI) is giving researchers a first look at the early stages of brain development in patients with Fragile X syndrome, a disorder that causes mild to severe intellectual disability and is the most common genetic cause of autism spectrum disorder.

“We’re the first to see that these changes happen very early in brain development,” said TSRI Professor Jeanne Loring, who led the study, published this week in the journal Brain. “This may be the only way we’ll be able to identify possible drug treatments to minimize the effects of the disorder.”

Fragile X syndrome typically occurs when the Fragile X Mental Retardation (FMR1) gene on the X chromosome is epigenetically silenced. People born with the syndrome can show symptoms of hyperactivity, seizures and intellectual disability. Other Fragile X symptoms, such as delayed speech and problems with social interactions, resemble symptoms of autism spectrum disorder.

To better understand the biology of this syndrome and the possibility for early treatment, scientists need to know how the brain of a person with Fragile X syndrome develops—starting with the first weeks in the womb. The problem is that it has been impossible to study the brain so early in development.

Loring’s team tackled this problem using their expertise with induced pluripotent stem cells (iPSCs), which can be taken from almost any tissue in an adult and reprogrammed to become a different kind of tissue. In this case, the researchers used samples from juveniles and adults with Fragile X syndrome and induced the cells to become neurons in a lab dish.

The research revealed that multiple iPSC lines with Fragile X syndrome showed delayed neurodevelopment compared with a non-Fragile X control group, suggesting that the same thing might happen when a fetus develops in utero. The study also suggested that the Fragile X cells had delayed development in formation of neuronal synapses, the connections that neurons make between regions of the brain to send messages. “The cells are in the brain, but they don’t migrate properly or connect correctly,” said Loring.

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The scientists also discovered a second, more surprising aspect of the syndrome. The mutation on the X chromosome appeared to trigger genome-wide changes to DNA modifications. These changes, made through a process called DNA methylation, alter gene expression.

“We were really surprised to find that, and it suggests the protein that is lost in Fragile X syndrome has some regulatory role,” said study first author Michael J. Boland, a researcher at TSRI at the time of the study, now at Columbia University.

Working with TSRI alumnus Kristopher L. Nazor, Boland found that these DNA methylation changes appeared to affect many genes associated with autism spectrum disorder, which may help explain why the two disorders show many similarities.

The researchers said they plan to take a closer look at the DNA methylation patterns discovered in this study. They also hope to use the same iPSC reprogramming techniques to study other disorders that start before birth.

“Now we have the tools to ask the questions to advance people’s health,” said Loring.
In addition to Loring, Boland and Nazor, authors of the study, “Molecular analyses of neurogenic defects in a human pluripotent stem cell model of Fragile X syndrome,” were Ha T. Tran, Candace L. Lynch and Pietro Paolo Sanna of TSRI; Attila Szücs of the University of California, San Diego, and Eötvös Loránd University; Ryder Paredes of California State University, Channel Islands; and Flora Tassone of the University of California, Davis.

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Trying To Solve The Alzheimer’s Puzzle

Despite a 99 percent failure rate and another major setback last month, Alzheimer’s researchers are plowing ahead with hundreds of experiments — and a boost in federal money — to try to a crack a deadly disease that has flummoxed them for decades.

A law passed by Congress in December and signed by President Obama sets aside $3 billion over 10 years to fund research of brain diseases and precision medicine, a shot in the arm for Alzheimer’s research. The law, called the 21st Century Cures Act, also includes prize money to encourage Alzheimer’s experiments.

But billions of dollars have so far made little progress in decoding the memory-robbing disease, which affects 5 million Americans. Alzheimer’s is currently the nation’s sixth leading cause of death. Decades of research have not produced a single drug that alters the disease’s course.

December began with another major setback: Eli Lilly shared disappointing results of a late-stage clinical trial of its experimental drug solanezumab, which failed to significantly slow Alzheimer’s progression.

But scientists aren’t giving up on the main hypothesis behind Eli Lilly’s trial: that Alzheimer’s can be defeated by using drugs to attack amyloid “plaques” that build up in the brain of Alzheimer’s patients. Some scientists believe these cause the disease.

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Many observers still hold out hope for another promising anti-amyloid drug, Biogen’s aducanumab, which in an early trial improved cognitive decline in a small number of patients.

Other potentially groundbreaking research aims to intervene before patients even feel any symptoms. Using PET scans, scientists can now identify amyloid plaques building up in a patient’s brain years before they develop Alzheimer’s. The A4 study, for instance, is testing solanezumab in adults who are accumulating amyloid plaques, but showing no outward signs of Alzheimer’s, such as memory loss or cognitive decline.

Other scientists are targeting what they believe is the true culprit, the protein tau, which creates “tangles” in the brain, the disease’s other primary marker.

The experiments continue against a bleak backdrop: No new Alzheimer’s therapies have won federal approval since 2003, and Alzheimer’s clinical trials have had a 99 percent failure rate. Patients can access only four Food and Drug Administration-approved Alzheimer’s drugs that alleviate symptoms but do not prevent, slow or reverse brain damage.

“The history of clinical trials results has been a history of disappointment,” said Keith Fargo, director of scientific programs and outreach at the Alzheimer’s Association.

Still, 77 Alzheimer’s drugs are currently being investigated or developed, according to the trade group PhRMA. And other experiments seek to repurpose FDA-approved drugs for other conditions, such as diabetes or cancer, to see if they can help Alzheimer’s patients — and cut several years from the drug development process.

Non-pharmaceutical solutions are also being explored. Observational studies have shown that people who exercise more and have healthier diets seem to get the disease later in life. Researchers are now conducting trials to more closely measure the effects of exercise and diet. One randomized trial underway at Wake Forest University, dubbed EXERT, is testing the effects of high-intensity aerobic exercise on adults with mild cognitive impairment by enrolling them in exercise programs at a YMCA.

Even before last month’s passage of the 21st Century Cures Act, public funding for Alzheimer’s research has been rising. The National Institutes of Health allocated almost $1 billion to Alzheimer’s research in fiscal 2016 — a $350 million increase over the previous year, according to Laurie Ryan, chief of NIH’s Dementias of Aging Branch. There are 468 open clinical trials related to Alzheimer’s, and over a hundred more in progress, listed on the government database ClinicalTrials.gov.

Meanwhile, Alzheimer’s advocates still grapple with a basic question: Is the rate of Alzheimer’s actually going down? A study in JAMA in November found that even as scientists have made no progress in changing Alzheimer’s course, overall dementia rates, which include Alzheimer’s and other dementias, appear to be dramatically declining. The paper cast doubt over a major talking point of the Alzheimer’s lobby: That as baby boomers age, the number of Americans living with Alzheimer’s will explode from the current 5 million to 14 million in 2050. The study also suggested that lifestyle changes may make a difference.

While some heralded that as good news, others downplayed the finding.

Even if dementia rates drop, Alzheimer’s remains a major killer, and the number of afflicted people will likely still rise, because the US population is aging so rapidly, predicted Fargo. He also questioned the study’s methods, which relied largely on telephone interviews.

“It’s not time to let our foot up off the gas,” Fargo said.

Eli Lilly’s closely watched trial, dubbed Expedition 3, was the latest potential breakthrough to fall flat. In 2,100 people with mild dementia, solanezumab failed to show significant results compared to a placebo.

Some critics said the failure casts doubt on the hotly disputed hypothesis that Alzheimer’s is triggered by the buildup of amyloid plaques.

But Eli Lilly spokeswoman Nicole Hebert said more work is needed to test the hypothesis, because the trial explored just one method of removing amyloid, on one subgroup of people. She said the company is pursuing seven other lines of attack.

“Rumors of the death of the amyloid hypothesis have been around for many years, and they’re probably premature,” Fargo agreed.

Fargo noted that brain imaging has shown that amyloid plaques start to build up 15 to 20 years before signs of dementia appear. So to really test the amyloid hypothesis, he said, scientists may have to intervene earlier than they did in Expedition 3.

Despite the latest failure, Fargo said, “there’s still more optimism in Alzheimer’s research right now than there has been for 10 years.”

The answer to Alzheimer’s, Ryan said, is not going to be one “magic bullet,” but an array of solutions tailored to different patients.

Will scientists ever find a cure?

Dr. Ron Petersen, director of the Alzheimer’s Disease Research Center at the Mayo Clinic, isn’t betting on it. But there’s still “a lot going on to be hopeful about,” he said.

“I think slowing the progression and/or delaying the onset, are realistic goals.”

KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.

Categories: Mental Health, Pharmaceuticals, Public Health, Syndicate

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Drug Prices, Opioids, And Obamacare: A Conversation With Assemblyman Jim Wood

California policymakers are facing a busy year, as a Republican-controlled Congress inches closer to rolling back key provisions of the Affordable Care Act and debate over high drug costs continues.

Assemblymember Jim Wood, D–Healdsburg, helps set priorities for health policymaking as chairman of the Assembly Health Committee. The former family dentist represents a 300-mile Northern California coastal stretch that spans from Sonoma County all the way up to the Oregon border.

“If you look at my district, it’s almost a microcosm of California,” said Wood, referring to the mix of rural, conservative communities and more progressive ones like the City of Santa Rosa. Half the medical providers in his district are clinics that have a hard time attracting physicians, he said. Some constituents must travel long distances for medical care.

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Wood took on some of these rural health challenges during his first year as committee chair last year. He proposed measures that allowed small hospitals to directly hire doctors and clinics to bill Medi-Cal for mental health workers, which secures a funding stream for therapists working in underserved areas. Both were signed into law by Governor Brown.

Wood also held the first of three hearings on drug prices last October. The next two will be held in the coming months.

Wood said “alleviating the pain” from the potential repeal of the Affordable Care Act in California tops his priorities. California Healthline spoke with Wood about his 2017 goals. The interview was edited for length and clarity.

Q: California Healthline produced a county-by-county map of which California counties would lose the most in terms of health coverage from an ACA repeal. In terms of per share of population, Humboldt and Mendocino, two counties in your district, were the highest in the state. One in five residents in those counties had Obamacare. Does that surprise you?

No, it doesn’t surprise me. I have two of the top 10 counties that stand to lose the most. It’s very troubling. There is a lot of poverty in certain parts of my district. And the repeal will hit the people that can least afford it the most, and that’s really unfortunate.

Q: What can you do as a state lawmaker to protect health care in California amid the potential repeal of the Affordable Care Act?

The most important thing we can do is communicate. Ultimately, I can’t vote on it. What I want to do is everything I can to educate my colleagues. And try to find ways to educate our Congressional delegates. I don’t believe a lot of members really understand the issue that well … or know just how dramatic [a repeal] would be.

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Assemblymember Jim Wood, D–Healdsburg, is a former family dentist. (Courtesy of Jim Wood)

Q: Now that Democrats have a supermajority in the legislature again, would you support efforts to raise revenue either by taxing individuals or corporations to make up the potential loss of federal subsidies for Covered California or the Medi-Cal expansion?

I think it’s too early to say until we really understand how the federal government plans to dismantle this. There’s a potential to do that with the supermajority. But, anytime you look to do something complicated like that, there’s no guarantee that you’re going to get every Democrat to vote for that.

Q: Are you afraid that the Affordable Care Act is going to overshadow all other health policymaking in California this year, or do you see the legislature pushing ahead on other issues?

It will be the top of the list of things we work on, but I do believe there are other things we need to forge ahead with as well. Working on the opioid [overdose epidemic], and the other thing I’m concerned about is the rapidly rising cost of prescription medications. We need to try to understand the system better, and find ways to bring more transparency, and bring more clarity about how this system works … There are so many players, and so many variables; just throwing piecemeal plans at this problem isn’t going to help anyone.

Q: You convened the drug price hearing at the end of October last year. Did anything come of that in terms of sparking legislation?

We are looking at a couple of things internally that may surface as bills, but I’m still working through that. The biggest takeaway is it’s a very complicated system.

Q: Last year there was a big push around SB1010 [a bill that would have required advance notice about drug price increases]. Was there anything that you learned or saw during that process that made you think that we need to have a public hearing because people don’t know enough?

Absolutely. In the Assembly health committee, it was clear to me by the questions that the members of my committee just didn’t know as much about this subject as my colleagues in the Senate did. That’s why I committed to doing the hearings.

Q: What did you learn about drug pricing that you identified as problematic or that needs to be addressed by the California legislature?

We just fundamentally don’t understand how the money flows, quite frankly. There are rebates that go back and forth between manufacturers and pharmacy benefit managers and health plans. Where does the consumer benefit from that? We’re trying to understand some of that.

The supply chain and the distribution of medications, and the generics and how patents are arrived at. We just saw a U.S. Senate report released last month [about] the arbitrary price increases on generic medications that have been around for 30, 40, 50 years sometimes that are just opportunities for companies to make money without any real consumer benefit. There’s just a lot of things we don’t know, and it appears that certain aspects of the industry don’t want to tell us. So how do we get that information?

Q: What kind of policies would you like to see to address the opioid epidemic? Is that an issue in your district in particular?

It’s a huge issue in my district. One of my counties [Mendocino] has one of California’s highest mortality rates from opioid overdoses. There have to be some solutions. I think one of them is, ultimately, can we find a way of changing our prescribing patterns and be a little more in tune with what the patient’s needs might be? I don’t want to see anyone in any kind of pain, but I don’t also believe that for a simple procedure, someone needs to be prescribed 40 pain pills when six or eight could do. You wind up with all this extra medication floating around.

The goal at this point is to work with the California Department of Public Health with their existing task force. Hopefully, expanding that task force, and try to get some real policy deliverables that we can work on. The task force has been together for almost two years now. Two years is a fair amount of time. And I’d love to see some recommendations sooner rather than later. I’m waiting for those.

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

Categories: California, California Healthline, Medi-Cal, Mental Health, Pharmaceuticals, Syndicate, The Health Law

Tags: California State Assembly, Drug Costs, Prescription Drugs, Substance Abuse

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Menopause May Influence Risk for Seronegative RA

Action Points

  • Note that this large observational study based on administrative data suggests an increased risk of seronegative rheumatoid arthritis (RA) among women after menopause.
  • The effect of menopause on seropositive RA was much less pronounced.

Postmenopausal women have more than double the risk of seronegative rheumatoid arthritis (RA) compared with premenopausal women, with the highest risk found among those experiencing early natural menopause, a new analysis from the Nurses’ Health Studies (NHS) reveals.

The pooled hazard ratio for developing RA among postmenopausal women enrolled in the NHS and NHS II was 2.1 (95% CI 1.4-3), according to Camilla Bengtsson, PhD, of the Karolinska Institute in Stockholm, Sweden, and colleagues.

And for those who had natural menopause at age 44 or younger, the pooled hazard ratio was 2.4 (95% CI 1.5-4), the team reported online in Arthritis Care & Research.

The study also found that postmenopausal women had only a marginally increased risk of seropositive RA.

Along with other recent research, the results of this new study “suggest that menopausal transition may influence the development of seronegative RA,” the authors wrote.

“Our findings add to the growing literature supporting the idea that seronegative and seropositive RA may have different epidemiological risk factors.”

Although environmental factors such as smoking and genetic factors such as HLA-DRB shared epitope alleles have been associated with seropositive RA, the risk factors for seronegative RA are less clear.

For the study, the researchers used data from two large U.S. cohorts: the NHS, which began in 1976 with female nurses born between 1921 and 1946; and NHS II, which was launched in 1989 and includes women born between 1947 and 1964. Since the start of both cohorts, participants have answered questionnaires biennially.

The new analysis included 109,443 women from the NHS and 112,523 from the NHS II. Women were excluded if they had RA at baseline.

In total, 1,096 incident RA cases were included in the analysis, with 401 patients found to be seronegative for both rheumatoid factor and anti-citrullinated protein antibodies and 695 seropositive for one or both of the autoantibodies.

The researchers determined the menopausal status of the women and categorized those who were menopausal as natural and surgical. Women with a hysterectomy and bilateral oophorectomy were categorized as menopausal at the time of the surgery.

Women age 45 and older had an increased risk of RA compared with younger women, with peak hazard ratios for both seropositive and seronegative RA at ages 55 to 59. The authors pointed out that this age is after the menopausal transition in most women.

The risk for seronegative RA was increased in both NHS (HR 1.8, 95% CI 1.1-3) and NHS II (HR 2.4, 95% CI 1.4-3.9) when considered separately, after adjusting for age, questionnaire cycle, median household income, body mass index (BMI), pack-years of smoking, breastfeeding, and parity.

Any age at menopause was associated with an increased risk of seronegative RA.

The researchers also looked at other covariates, including alcohol consumption, oral contraceptive use, age at menarche, and irregular menses. But since these did not substantially alter the estimates, these were not included in the final model.

In addition, they gathered information on postmenopausal hormone therapy (PMH) use. As the authors explained, if increased RA risk at the time of menopause is due to hormonal fluctuations, then PMH could theoretically reduce RA risk.

However, neither current nor long-term (8 or more years) use of PMH was associated with risk of seronegative RA.

As for seropositive RA, current PMH use had an increased risk in the NHS (HR 1.4, 95% CI 1.1-1.9) but not in NHS II. Long duration of PMH use was significantly associated with risk of seropositive RA, but age at initiation of PMH was not associated with either type of RA.

A potential limitation of the study was that RA cases could have been misclassified as non-cases since the authors relied on medical records rather than physical examination. Self-reported exposure data might have led to misclassification of menopausal factors.

And, the team said, since less is known about risk factors for seronegative RA, unidentified confounders contributing to the association may have been missed.

The study was supported by the National Institutes of Health, the Swedish Council for Working Life and Social Research, the Swedish Rheumatism Association, and the Borje Dahlin fund.

The authors reported no competing interests.

  • Reviewed by
    F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner

2017-01-29T12:00:00-0500

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D.C. Week: Partisan Jousting Marks Price Hearing for HHS Post

WASHINGTON — Earlier this week, Rep. Tom Price, MD (R-Ga.), President Trump’s nominee for Secretary of Health and Human Services, survived a second grilling by Senate Democrats. Committee members demanded answers regarding Price’s controversial stock trades and his views on Medicaid block grants.

Partisan Jousting Marks Price Hearing for HHS Post

President Trump’s nominee to lead the Health and Humans Services Department, Rep. Tom Price, MD, endured another round of aggressive questions from Democrats during a confirmation hearing before the Senate Committee on Finance on Tuesday.

Both the President and the Vice President are on the record saying Price will be a critical player in designing a replacement for the Affordable Care Act, which Trump ordered repealed in an executive order signed Jan. 20, so Democrats attacked with a laser focus.

Committee chairman Sen. Orrin Hatch (R-Utah) said that Price has been the target of “grossly exaggerated and distorted attacks,” referencing Senate Democrats’ investigation into Price’s stock trades as well as aggressive questioning last week during a “courtesy hearing” before the Senate HELP Committee.

“I have never seen this level of partisan rancor,” Hatch said.

Trump: U.S. Will Withdraw from TPP

President Trump announced Monday that he intends to have the U.S. withdraw from the Trans-Pacific Partnership, although experts differed about the withdrawal’s effect on the pharmaceutical industry.

The president signed a memo to the U.S. Trade Representative making the withdrawal official, although it is seen as largely symbolic since the Senate had not yet ratified the partnership and many observers thought ratification was unlikely.

“It is the policy of my Administration to represent the American people and their financial well-being in all negotiations, particularly the American worker, and to create fair and economically beneficial trade deals that serve their interests,” the memo said.

The TPP includes many provisions that would involve the U.S. pharmaceutical industry, including some that would increase the number of entities that were patentable and others that might result in restoring certain patent periods for brand-name drugs. Industry had lobbied for these provisions, but they were unpopular with international aid groups such as Médecins Sans Frontières, who argued that it would keep generic drugs unavailable in poor countries.

ACA Divisions in the Spotlight at House Hearing

Divisions over the Affordable Care Act (ACA) were on full display Tuesday at a House Budget Committee hearing on problems with the law.

The ACA “has been nothing but a series of broken promises,” interim committee chair Rep. Diane Black (R-Tenn.) said at the start of the hearing. “Patients have lost doctors and insurance plans, premiums and deductibles have skyrocketed … and small businesses have been forced to reduce their benefits and wages.”

“Obama promised that this law would lower premiums by $2,500 a year for an average family. In reality, the complete opposite has been true,” she continued. “For working folks across the country, more money out of their paychecks just to pay for healthcare makes life much harder … As a nurse for over 40 years, I know we can do better.”

HHS ‘Gag Order’ Not That Unusual, Experts Say

The Trump administration’s “gag order” on the Department of Health and Human Services (HHS), which prevents the agency from communicating with Congress and other public officials, may be discomforting to some, but it’s not entirely unusual, say experts.

“It’s not unreasonable, since there are no administration appointees as of yet at HHS, so [there is] no one to represent the Administration’s positions,” Gail Wilensky, PhD, a senior fellow at Project HOPE in Bethesda, Md. and former administrator under President George H.W. Bush of what is now the Centers for Medicare & Medicaid Services, wrote in an email.

On Tuesday, the Huffington Post reported that HHS sub-agency officials “have been told not to send ‘any correspondence to public officials’ … Instead, they have been asked to refer questions to agency leadership until the leadership has had time to meet with incoming White House staff about the new administration’s policies and objectives, according to a congressional official who was also informed of the communications freeze.”

But the article also noted that the freeze was limited: “Bill Hall, a spokesman for HHS, said that the agency was not restricting all forms of communications with the public or the media, but instead was directing officials to limit communications about proposed or pending regulations. ‘There is no directive to do otherwise.'” The administration’s memo also indicated that the freeze would stay in effect only until Feb. 3.

Group Angles for More Value-Based Payment Efforts

Paying physicians based on their quality of care and outcomes needs to be better encouraged, a group of healthcare executives and experts said here.

“The transition between fee-for-service payment in healthcare to a value-based type of payment is the most significant and important development in healthcare since the widespread adoption of health insurance,” Mike Leavitt, former Secretary of Health and Human Services under President George W. Bush and now a healthcare consultant, said at a briefing Wednesday sponsored by the American Society of Anesthesiologists, the Healthcare Leadership Council, and several other organizations.

“Much has been learned, but we are not yet as good at this as we need to be, and we need to put pressure on the system to adopt this,” he said. “Not political pressure, but on achieving the economic stimulation — not in [the form of a] government subsidy, but the pressure of payers to continue this moving forward.”

Next Week

On Tuesday, the House Energy & Commerce Subcommittee on Oversight & Investigations will discuss strengthening Medicaid.

And the Kaiser Family Foundation and the Committee for a Responsible Federal Budget will examine ACA repeal-and-replace strategies.

On Wednesday, the House Committee on Education and the Work Force will discuss patient-centered solutions to healthcare reform.

And the House Energy & Commerce Subcommittee on Health will discuss strategies for strengthening Medicaid.

On Thursday, the same House E & C Subcommittee will discuss insurance reform.

2017-01-28T12:00:00-0500

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