Category Archives: Health

Experts split sharply over experimental Alzheimer’s drug

February 28, 2020

courtesy of NAELAeBulletin:

SAN DIEGO (AP) — A company that claims to have the first drug to slow mental decline from Alzheimer’s disease made its case to scientists Thursday but left them sharply divided over whether there’s enough evidence of effectiveness for the medicine to warrant federal approval.

Excitement and skepticism have surrounded aducanumab since its developers stopped two studies earlier this year because it didn’t seem to be working, then did a stunning about-face in October and said new results suggest it was effective at a high dose.

During Thursday’s presentation at an Alzheimer’s conference in San Diego, the developers convinced some experts that the drug deserves serious consideration. But others were dubious.

Changes made during the study and unusual analyses of the data made the results hard to interpret. And the newly released results showed the drug made only a very small difference in thinking skills in one study and none in the other.

Alzheimer’s patients and families are desperate for any help, no matter how small, adding pressure on the Food and Drug Administration to approve something.

But with conflicting results, “I don’t see how you can conclude anything other than that another trial needs to be done,” said the Mayo Clinic’s Dr. David Knopman, who was involved in one of the studies.

Laurie Ryan, a dementia scientist at the National Institute on Aging, agreed: “We need more evidence.”

Other doctors who consult for the drug’s developers cheered the results. Dr. Paul Aisen, a dementia specialist at the University of Southern California, said they were “consistent and positive” in showing a benefit at a high dose — “a truly major advance.”

Aducanumab aims to help the body clear harmful plaques, or protein clumps, from the brain. Cambridge, Massachusetts-based Biogen is developing it with Japan’s Eisai Co.

In afternoon trading, the companies’ stocks were up roughly 4%.

The stakes are high for approval or denial.

More than 5 million people in the U.S. and millions more worldwide have Alzheimer’s. Current drugs only temporarily ease symptoms and do not slow the loss of memory and thinking skills.

But approving a drug that isn’t truly effective could expose patients to financial and medical risks and give other drugmakers less incentive to develop better treatments.

The makers of aducanumab undertook two studies, each enrolling about 1,650 people with mild cognitive impairment or mild dementia from Alzheimer’s.

Those with a gene that raises their risk of the disease were started on a lower dose because they are more likely to suffer inflammation in the brain from medicines that target plaque.

But as the studies went on and concern about this side effect eased, the rules were changed to let such patients get a higher dose.

A Biogen vice president, Samantha Budd Haeberlein, said more people got the higher dose in one study, and that helps explain why it succeeded and the other one failed.

But the new analyses were done on partial results, and with methods not agreed upon at the outset, which makes any conclusions unreliable, independent experts said.

Also, the drug’s benefits may have looked more impressive than they really were because patients in the placebo group worsened more in the positive study than in the one that failed.

“It’s hard to know exactly what happened here,” said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation. “I don’t see how the FDA could approve it.”

Questions also arose about the size of any benefit.

The drug did not reverse decline, only slowed the rate of it compared to the placebo group by 22% in one study. Yet that meant a difference of only 0.39 on an 18-point score of thinking skills.

“It’s a very small amount,” Fillit said.

Still, Maria Carrillo, chief science officer at the Alzheimer’s Association, said it was “the largest reduction that we’ve seen to date,” adding: “It may mean that they remember their loved ones a little longer.”

The drug “is worthy of significant, rigorous exploration” and review by the FDA, she said. “This is an important moment for the Alzheimer’s community.”

Some doctors and patients who helped test the drug are convinced it helped.

One was Charles Flagg, 78, a retired minister from Jamestown, Rhode Island, who received aducanumab until the studies were halted in March. Since he was taken off the medicine, “his cognition, his alertness, his interactions have definitely diminished,” said his wife, Cynthia Flagg.

Biogen stressed the need for an effective treatment and suggested that delaying access to a drug that may work could deprive many people of help while further study is done.

Dr. John Ioannidis, a Stanford University expert on research methods, said patients’ need should not drive the FDA’s decision.

“If we go down that path, we’re likely to introduce a lot of ineffective treatments for diseases that are really common,” he said. “It would be a complete mess.”

Our body systems age at different rates, study finds, pointing to personalized care to extend healthy life

February 27, 2020

courtesy of NAELAeBulletin:

One 50-year-old has the nimble metabolism of a teenager, while another’s is so creaky he developed type 2 diabetes — though his immune system is that of a man 25 years his junior. Or one 70-year-old has the immune system of a Gen Xer while another’s is so decrepit she can’t gin up an antibody response to flu vaccines — but her high-performing liver clears out alcohol so fast she can sip Negronis all night without getting tipsy.

Anyone over 30 knows that aging afflicts different body parts to different degrees. Yet most molecular theories of aging — telomere shortening, epigenome dysregulation, senescence-associated secreted proteins, take your pick — don’t distinguish among physiological systems and organs, instead viewing aging as systemic.

Nonsense, say scientists at Stanford University School of Medicine. In a study published on Monday in Nature Medicine, they conclude that just as people have an individual genotype, so too do they have an “ageotype,” a combination of molecular and other changes that are specific to one physiological system. These changes can be measured when the individual is healthy and relatively young, the researchers report, perhaps helping physicians to pinpoint the most important thing to target to extend healthy life.

“This really presents a new framework to think about aging,” said epidemiologist Norrina Bai Allen of Northwestern University’s Feinberg School of Medicine, an expert in the biology of aging who was not involved in the Stanford study. “It’s an important first step toward showing how different parts of a body in different people can age at different rates.”

Call it personalized medicine for aging. “Individuals are aging at different rates as well as potentially through different biological mechanisms,” or ageotypes, the Stanford scientists wrote.

“Of course the whole body ages,” said biologist Michael Snyder, who led the study. “But in a given individual, some systems age faster or slower than others. One person is a cardio-ager, another is a metabolic ager, another is an immune ager,” as shown by changes over time in nearly 100 key molecules that play a role in those systems. “There is quite a bit of difference in how individuals experience aging on a molecular level.”

Crucially, the molecular markers of aging do not necessarily cause clinical symptoms. The study’s “immune” agers had no immune dysfunction; “liver agers” did not have liver disease. Everyone was basically healthy.

If aging is truly personal, understanding an individual’s ageotype could lead to individualized, targeted intervention. “We think [ageotypes] can show what’s going off track the most so you can focus on that if you want to affect your aging,” Snyder said.

Cardio-agers, for instance, might benefit from tight cholesterol control, periodic ECGs, and screening for atrial fibrillation. Immune agers might benefit from diets and exercise to reduce inflammation.

Then again, they might not. The study did not follow people long enough to tell whether their aging biomarkers did them any harm, or were even harbingers of harm, let alone killed them, Feinberg’s Allen pointed out. “There needs to be a lot more work, and replication of the results,” before they can be the basis for anti-aging interventions, she said.

The short follow-up and small sample size — 106 people — gave other experts pause. One said he “will not comment on it in any way” and declined to elaborate.

One concern revolved around what might otherwise be the study’s strength: the dizzying number of measurements the scientists made on their volunteers, ages 29 to 75, over two to four years. Through blood and saliva and urine tests, genetic analyses, microbiome inspections of their nose and gut, and more, the scientists measured 10,343 genes, 306 blood proteins, 722 metabolites, and 6,909 microbes, among other things, and found they clustered into four ageotypes: liver, kidney, metabolic, and immune.

Different people had different “personal aging molecules” and “distinct aging pathways,” Snyder said. But just as every dish on a menu is unique but can be grouped into “meat” or “fish” or “vegan” or other category, so the molecules fell into the liver, kidney, metabolic, or immune ageotypes. (There is probably a cardio-ageotype and a neuro-ageotype, too, Snyder said, but they didn’t have enough data to characterize those.)

“That we don’t all age identically is well-established,” said biologist Judy Campisi of the Buck Institute for Research on Aging, who has helped develop an “atlas” of aging biomarkers. But the new study “furthers our understanding of why.”

All told, the study generated 18 million data points. While that sounds impressive, it raises the risk that some markers seem to be part of one or another ageotype just by chance.

But Snyder said he is “quite confident” the biomarkers are not statistical artifacts. For one thing, the researchers initially found 184 of them. But using stricter statistics, they narrowed that to 87.

One surprise was that some measurements that increased with age when the participants were averaged decreased in some individuals, while some that fell with age in most people rose in a few. For instance, hemoglobin A1C (a marker of how well cells metabolize glucose) usually rises, and so is part of the metabolic ageotype. But in dozens of people it fell — another hint that different systems age at different rates in different people.

In many of those opposites, the reason might be healthy lifestyle changes. People whose A1C fell significantly, for example, either started eating a healthier diet or lost weight, both of which can improve glucose metabolism. “Lifestyle changes, and perhaps medications, can improve some markers of aging and alter an individual’s aging pattern,” said Snyder (who is 64 and has a metabolic ageotype). In fact, 15 people got biologically younger during the study.

That healthy habits can increase both lifespan and healthspan is not exactly news. But the ageotype approach might let people target their dominant aging pathway.

“The hope is that once you identify the main cause of an individual’s aging, it opens the door to interventions — exercise or diet or intermittent fasting or medications,” said Campisi. “Ideally, a 50-year-old could get a blood test and learn that his kidney is 60 but his heart is 40, and do something about [kidney aging]. This is a step in that direction.”

A Change in Medicare Has Therapists Alarmed

January 22, 2020

courtesy of NAELAeBulletin:
by Paula Span

Nov. 29, 2019

Medicare revamped its reimbursement policy for physical, occupational and speech therapy in nursing homes. That has left some patients with less help.

In late September, a woman in her 70s arrived at a skilled nursing facility in suburban Houston after several weeks in the hospital. Her leg had been amputated after a long-ago knee replacement became infected; she also suffered from diabetes, depression, anxiety and general muscular weakness.

An occupational therapist named Susan Nielson began working with her an hour a day, five days a week. Gradually, the patient became more mobile. With assistance and encouragement, she could transfer from her bed to a wheelchair, get herself to the bathroom for personal grooming and lift light weights to build her endurance.

That progress ended abruptly on Oct. 1, when Medicare changed its payment system for physical, occupational and speech therapy in nursing homes. Ms. Nielson, employed by Reliant Rehabilitation, which supplies therapists to almost 900 nursing facilities, said that her allotted time with the woman was reduced from 60 minutes to just 20 or so minutes a day, not even long enough to help her leave her bed.

“I’m not able to do my job,” Ms. Nielson said. “This person had the potential to do more, and I couldn’t help her.”

The same lament is being expressed by therapists nationwide. Professional organizations, including the American Physical Therapy Association and the American Occupational Therapy Association, report that the new Medicare policy has prompted some nursing home chains and rehab companies to scale back the treatment they provide to patients, and to lay off therapists or switch them to part-time status.

The organizations’ members are also speaking out about the pressure they feel to conduct therapy in groups rather than one-on-one. Medicare allows up to 25 percent of patients’ therapy to take place in groups — and some employers reportedly began requiring that percentage on Oct. 1, whether therapists thought their patients would benefit or not.

“Patients’ needs didn’t change overnight,” said Kara Gainer, director of regulatory affairs for the American Physical Therapy Association. “So what changed?” Although some companies have reacted responsibly to the new system, she said, “some are bad actors who put profits before patients.”

Her members have responded with “concern, fear, outrage,” she added. A new Facebook group, Rehab Therapists for a Union, swiftly attracted more than 20,000 members. A petition on Change.org, asking the Department of Health and Human Services to intervene, garnered 80,000 signatures.

Before Oct. 1, Medicare reimbursed nursing homes for therapy based on the number of minutes provided to each patient, up to 720 minutes a week. The goal is to help patients regain mobility and the ability to perform daily tasks, so that they can safely return home.

For years, however, federal investigators and advisers have reported that nursing homes frequently provided the maximum number of minutes of therapy, regardless of whether patients needed that much treatment.

“Therapy was sort of a profit center,” said Sharmila Sandhu, who directs regulatory affairs at the American Occupational Therapy Association. “The more therapy, the higher the reimbursement.”

The new approach, called the Patient-Driven Payment Model, eliminates such incentives; now facilities are paid based on patients’ diagnoses and characteristics. In an email, a spokesman for the Centers for Medicare and Medicaid Services called the P.D.P.M. “a historic reform” that will “appropriately reflect each resident’s actual care needs.”

“This is a well-intended policy, a real sea change in how we pay for care,” said David Grabowski, a health care policy researcher at Harvard Medical School who is organizing a study of the policy’s effects.

But about 70 percent of the nation’s 15,000 or so nursing homes are for-profit and have proved adept at maintaining profit margins despite policy shifts, said Toby Edelman, senior policy attorney at the Center for Medicare Advocacy.

Without volume incentives, nursing homes may direct therapists to administer less therapy and to see patients in groups, reducing the number of professionals required and lowering labor costs.

“The risk before was overprovision of therapy,” Dr. Grabowski said. “Now the real concern is underprovision.”

Medicare Part D: A First Look at Prescription Drug Plans in 2020

December 24, 2019

courtesy of NAELA eBulletin:

During the Medicare open enrollment period  from October 15 to December 7 each year, beneficiaries can enroll in a plan that provides Part D drug coverage, either a stand-alone prescription drug plan (PDP) as a supplement to traditional Medicare, or a Medicare Advantage prescription drug plan (MA-PD), which covers all Medicare benefits, including drugs.

Click here for the entire article and the issue brief

Medicare Premiums to Increase By Almost $10 a Month in 2020

December 24, 2019

After small or no increases the past couple in of years, Medicare’s Part B premium will rise sharply 2020. The basic monthly premium will increase $9.10, from $135.50 a month to $144.60.

The Centers for Medicare and Medicaid Services (CMS) announced the premium increase on November 8, 2019. Not everyone will pay the whole increase, however. Due to a “hold harmless” rule around 70 percent of Medicare recipients’ premiums will not increase more than Social Security benefits, and Social Security benefits are increasing only 1.6 percent in 2020. This “hold harmless” provision does not apply to about 30 percent of Medicare beneficiaries: those enrolled in Medicare but who are not yet receiving Social Security, new Medicare beneficiaries, seniors earning more than $87,000 a year, and “dual eligibles” who get both Medicare and Medicaid benefits.

Meanwhile, the Part B deductible will go from $185 to $198 in 2020, while the Part A deductible will go up by $44, to $1,408. For beneficiaries receiving skilled care in a nursing home, Medicare’s coinsurance for days 21-100 will increase from $170.50 to $176. Medicare coverage ends after day 100. CMS attributed the sudden steep rise in Part B premiums and deductibles on the increased costs of physician-administered drugs.

Here are all the new Medicare payment figures:

  • Part B premium: $144.60 (was $135.50)
  • Part B deductible: $198 (was $185)
  • Part A deductible: $1,408 (was $1,364)
  • Co-payment for hospital stay days 61-90: $352/day (was $341)
  • Co-payment for hospital stay days 91 and beyond: $704/day (was $682)
  • Skilled nursing facility co-payment, days 21-100: $176/day (was $170.50)

So-called “Medigap” policies can cover some of these costs.

Premiums for higher-income beneficiaries ($87,000 and above) are as follows:

  • Individuals with annual incomes between $87,000 and $109,000 and married couples with annual incomes between $174,000 and $218,000 will pay a monthly premium of $202.40.
  • Individuals with annual incomes between $109,000 and $136,000 and married couples with annual incomes between $218,000 and $272,000 will pay a monthly premium of $289.20.
  • Individuals with annual incomes between $136,000 and $163,000 and married couples with annual incomes between $272,000 and $326,000 will pay a monthly premium of $376.00.
  • Individuals with annual incomes above $163,000 and less than $500,000 and married couples with annual incomes above $326,000 and less than $750,000 will pay a monthly premium of $462.70.
  • Individuals with annual incomes above $500,000 and married couples with annual incomes above $750,000 will pay a monthly premium of $491.60.

Rates differ for beneficiaries who are married but file a separate tax return from their spouse. Those with incomes greater than $87,000 and less than $413,000 will pay a monthly premium of $462.70. Those with incomes greater than $413,000 will pay a monthly premium of $491.60.

The Social Security Administration uses the income reported two years ago to determine a Part B beneficiary’s premiums. So the income reported on a beneficiary’s 2018 tax return is used to determine whether the beneficiary must pay a higher monthly Part B premium in 2020. Income is calculated by taking a beneficiary’s adjusted gross income and adding back in some normally excluded income, such as tax-exempt interest, U.S. savings bond interest used to pay tuition, and certain income from foreign sources. This is called modified adjusted gross income (MAGI). If a beneficiary’s MAGI decreased significantly in the past two years, she may request that information from more recent years be used to calculate the premium. You can also request to reverse a surcharge if your income changes.

Those who enroll in Medicare Advantage plans may have different cost-sharing arrangements. CMS estimates that the Medicare Advantage average monthly premium will decrease by 14 percent in 2020, from an average of $26.87 in 2019 to $23 in 2020.

For Medicare’s press release announcing the new premium and deductible amounts, click here.

Home Care Costs Rise Sharply in Annual Long-Term Care Cost Survey

December 24, 2019

When it comes to long-term care costs, the charges for home care are now rising faster than those for nursing home care, according to Genworth’s 2019 Cost of Care survey. In the past year, the median annual cost for home health aides rose 4.55 percent to $52,624, while the median cost of a private nursing home room rose only 1.82 percent to $102,200.

Genworth reports that the median cost of a semi-private room in a nursing home is $90,155, up 0.96 percent from 2018, and the median cost of assisted living facilities rose 1.28 percent, to $4,051 a month. But home care services had sharper increases. The national median annual rate for the services of a home health aide rose from $22 to $23 an hour, and the cost of adult day care, which provides support services in a protective setting during part of the day, rose from $72 to $75 a day, up 4.17 percent annually.

Alaska continues to be the costliest state for nursing home care by far, with the median annual cost of a private nursing home room totaling $362,628. Oklahoma again was found to be the most affordable state, with a median annual cost of a private room of $67,525.

The 2019 survey, conducted by CareScout for the sixteenth straight year, was based on responses from more than 15,178 nursing homes, assisted living facilities, adult day health facilities and home care providers. Survey respondents were contacted by phone during May and June 2019.

As the survey indicates, long-term care is growing ever more expensive. Contact your elder law attorney to learn how you can protect some or all of your family’s assets from being swallowed up by these rising costs.

For more on Genworth’s 2019 Cost of Care Survey, including costs for your state, click here.

For Seniors, Financial Woes Can Be Forerunner to Alzheimer’s

November 18, 2019

courtesy of NAELAeBulletin:

By Deborah DiSesa Hirsch
HealthDay Reporter
TUESDAY, Oct. 29, 2019 (HealthDay News) — Unpaid bills, overdrawn accounts, dwindling investments: When seniors begin experiencing fiscal troubles, early dementia or Alzheimer’s disease could be an underlying cause, researchers say.In the early stages of the disease, people with undiagnosed Alzheimer’s are at high risk of making foolish and dangerous decisions about their finances, mostly because families may not know they need help, researchers say.

“Individuals often aren’t diagnosed early enough, and it’s a perfect storm,” said study author Carole Gresenz, a professor of health systems administration at Georgetown University in Washington, D.C.

“They’re vulnerable to large reductions in liquid assets because they’re not making wise decisions about their finances, savings and checking accounts. This can also reduce net wealth,” added Gresenz.

Ruth Drew, director of information and support services for the Alzheimer’s Association, pointed out that Alzheimer’s destroys the brain.

“As the disease progresses, everyone with Alzheimer’s will reach a point where they need help with their finances and ultimately assistance with daily tasks and around-the-clock care. We have certainly spoken to people whose finances were significantly affected,” she said.

In some cases, people responsible for making major financial decisions, either at work or at home, were unaware of their own mental decline, added Drew, who wasn’t involved with the study.

“Others around them either did not notice or did not feel they could alert the family until there was already significant financial impact,” she said. “By the time we met them, family members were facing the challenges of caring for a person with far fewer financial resources than expected.”

The new study linked Medicare fee-for-service claims data and the national Health and Retirement Study of Americans over the age of 50 for the years 1992 to 2014. The health and retirement study included questions about households’ financial assets and liabilities.

The sample included nearly 8,900 U.S. households, of which nearly 2,800 included someone with Alzheimer’s or related dementia. In these households, the financial “head of the household” had the thinking disorder in 73% of them.

Gresenz said declining financial skills associated with Alzheimer’s may mean unpaid bills, overspending on credit cards or paying too little attention to investments and other forms of wealth. Impaired money sense also makes the elderly more vulnerable to fraud and scams.

The bottom line: “Living in a house with early-stage AD puts both the patient and family members at heightened risk of a large reduction in liquid assets — money that’s easily accessible, like checking, savings, money markets, bonds and stocks,” Gresenz explained. “One reason this is so concerning is that these core financial outcomes are occurring just prior to a time when they will have substantial costs placed on them.”

Alzheimer’s costs $341,000 on average from diagnosis to death, the Alzheimer’s Association says. Families pay 70% of this out of pocket.

Alzheimer’s disease affects 5.5 million people in the United States and 50 million worldwide, the researchers noted. As the U.S. population ages, prevalence of Alzheimer’s will rise, with a near tripling by 2050, they said.

Gresenz said families need to be involved as early as possible.

“It’s always a good idea to check in on loved ones and make sure that the vital financial activities of the household bills are happening, maybe checking credit scores. Even if there are not yet any obvious signs, making sure there’s a safety net,” she said.

“There’s also a role for financial institutions, which could play an important part in protecting elderly individuals,” Gresenz added.

Drew said that when it comes to Alzheimer’s and dementia, it’s never too early to put plans in place.

To older adults themselves, Drew said, “Talk to your financial planner early. When you’re setting up financial plans, put in provisions that say who the trusted people are in your life.” That way, if you start to show symptoms of mental decline, “your banker or financial planner will know who those trusted people are, and will have the paperwork that authorizes them to share their concerns.”

The study was published Oct. 25 in the journal Health Economics.

Researchers find high-intensity exercise improves memory in seniors

November 18, 2019

courtesy of NAELAeBulletin: 

Researchers at McMaster University who examine the impact of exercise on the brain have found that high-intensity workouts improve memory in older adults.

The study, published in the journal Applied Physiology, Nutrition and Metabolism, has widespread implications for treating dementia, a catastrophic disease that affects approximately half a million Canadians and is expected to rise dramatically over the next decade.

Researchers suggest that intensity is critical. Seniors who exercised using short, bursts of activity saw an improvement of up to 30% in memory performance while participants who worked out moderately saw no improvement, on average.

“There is urgent need for interventions that reduce dementia risk in healthy older adults. Only recently have we begun to appreciate the role that lifestyle plays, and the greatest modifying risk factor of all is physical activity,” says Jennifer Heisz, an associate professor in the Department of Kinesiology at McMaster University and lead author of the study.

“This work will help to inform the public on exercise prescriptions for brain health so they know exactly what types of exercises boost memory and keep dementia at bay,” she says.

For the study, researchers recruited dozens of sedentary but otherwise healthy older adults between the ages of 60 and 88 who were monitored over a 12-week period and participated in three sessions per week. Some performed high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT) while a separate control group engaged in stretching only.

The HIIT protocol included four sets of high-intensity exercise on a treadmill for four minutes, followed by a recovery period. The MICT protocol included one set of moderate-intensity aerobic exercise for nearly 50 minutes.

To capture exercise-related improvements in memory, researchers used a specific test that taps into the function of the newborn neurons generated by exercise which are more active than mature ones and are ideal for forming new connections and creating new memories.

They found older adults in the HIIT group had a substantial increase in high-interference memory compared to the MICT or control groups. This form of memory allows us to distinguish one car from another of the same make or model, for example.

Researchers also found that improvements in fitness levels directly correlated with improvement in memory performance.

“It’s never too late to get the brain health benefits of being physically active, but if you are starting late and want to see results fast, our research suggests you may need to increase the intensity of your exercise,” says Heisz.

She cautions that it is important to tailor exercise to current fitness levels, but adding intensity can be as simple as adding hills to a daily walk or increasing pace between street lamps.

“Exercise is a promising intervention for delaying the onset of dementia. However, guidelines for effective prevention do not exist. Our hope is this research will help form those guidelines.”

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This work builds on earlier research from Heisz’s lab that found physical inactivity contributes to dementia risk as much as genetics.

Changes associated with Alzheimer’s disease detectable in blood samples

November 18, 2019

courtesy of NAELAeBulletin:

Researchers have discovered new changes in blood samples associated with Alzheimer’s disease. A new international study was conducted on disease-discordant Finnish twin pairs: one sibling suffering from Alzheimer’s disease and the other being cognitively healthy. The researchers utilised the latest genome-wide methods to examine the twins’ blood samples for any disease-related differences in epigenetic marks which are sensitive to changes in environmental factors. These differences between the siblings were discovered in multiple different genomic regions.

Development of the late-onset form of Alzheimer’s disease is affected by both genetic and environmental factors including lifestyle. Different environmental factors can alter function of the genes associated with the disease by modifying their epigenetic regulation, e.g. by influencing the bond formation of methyl groups in the DNA’s regulatory regions which control function of the genes.

By measuring methylation levels in the DNA isolated from the Finnish twins’ blood samples, the researchers discovered epigenetic marks which were associated with Alzheimer’s disease in multiple different genomic regions. One of the marks appeared stronger also in the brain samples of the patients suffering from Alzheimer’s disease. The link between this mark and Alzheimer’s disease was confirmed in the Swedish twin cohorts.

The researchers observed that the strength of the mark was influenced not only by the disease, but also age, gender and APOE genotype, which is known to associate with the risk of developing Alzheimer’s disease. Furthermore, the mark was stronger in those twins with Alzheimer’s disease who had been smoking.

The function of the gene where the mark is located is still not well understood. The gene product is suspected to inhibit activity of certain brain enzymes that edit the code translated from DNA to direct the formation of proteins. In a previous study conducted on mice, it was noticed that removing this genomic region caused learning and memory problems which are central symptoms of Alzheimer’s disease.

One of the leaders of the research group, Docent at the University of Turku, Riikka Lund explains that even though the results offer new information about the molecular mechanisms of Alzheimer’s disease, more research is needed on whether the discovered epigenetic marks could be utilized in diagnostics.

“The challenges of utilizing these marks include for example the variation of the DNA methylation level between individuals. More research is also needed to clarify potential impact of the marks on disease mechanisms and to identify the brain regions and cell types affected,” Lund says.

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The study was conducted in cross-disciplinary and international collaboration between the researches at University of Turku, Hospital District of Southwest Finland, University of Helsinki, Aalto University, Karolinska Institutet, Jönköping University, and University of Southern California. The research results have been published in the esteemed journal Clinical Epigenetics.

Original publication: Mikko Konki, Maia Malonzo M, Ida K. Karlsson, Noora Lindgren, Bishwa Ghimire, Johannes Smolander, Noora M. Scheinin, Miina Ollikainen, Asta Laiho, Laura L. Elo, Tapio Lönnberg, Matias Röyttä, Nancy L. Pedersen, Jaakko Kaprio, Harri Lähdesmäki, Juha O. Rinne, Riikka J. Lund. Peripheral blood DNA methylation differences in twin pairs discordant for Alzheimer’s disease. Clinical Epigenetics. 2019 September 2;11(1):130. https://dx.doi.org/10.1186/s13148-019-0729-7

Medicare would cover dental and vision if these bills pass Congress

November 18, 2019

courtesy NAELAeBulletin:

by Sarah O’Brien

  • Right now, Medicare’s 60 million beneficiaries can only get dental, vision and hearing coverage through supplemental options such as Advantage plans or standalone insurance policies.
  • Original Medicare — Part A hospital coverage and Part B outpatient care — excludes those services except in limited circumstances.
  • Allowing Medicare to negotiate with drugmakers as outlined in one of the bills would save the government $345 billion from 2023 through 2029, according to an estimate from the Congressional Budget Office.

Medicare beneficiaries would get dental, vision and hearing coverage if several bills now before Congress pass.

In addition, the government would get authority to negotiate prices with drugmakers and create a cap for Medicare out-of-pocket spending on prescription drugs. All have cleared the necessary committees over the last couple of weeks and now await full House action.

“There have been proposals over the years that would do this, but in the past they haven’t gone anywhere,” said David Lipschutz, associate director at the Center for Medicare Advocacy. “It looks like this time something could get passed in at least one chamber of Congress.”

The bills (summarized further below) are generally supported by Democrats and opposed by Republicans. This means that even if the measures get approved in the Democrat-controlled House, they would would face an uphill battle in the Republican-dominated Senate.

Roughly 10,000 baby boomers turn 65 each day and can sign up for Medicare. While the program’s 60 million beneficiaries can access dental, vision and hearing through supplemental options such as Advantage plans or standalone insurance policies, original Medicare — Part A hospital coverage and Part B outpatient coverage — excludes them except in limited circumstances.

Some of the Advantage plans now include comprehensive dental coverage as part of the plan or as an optional supplemental benefit, said Elizabeth Gavino, founder of Lewin & Gavino in New York and an independent broker and general agent for Medicare plans.

However, those benefits also might be limited to the carrier’s dental network or require prior authorization that the treatment is medically necessary, Gavino said.

H.R. 3: Includes provisions to allow the Medicare program to negotiate with drugmakers, cap out-of-pocket spending by beneficiaries on prescriptions at $2,000 and expand the low-income subsidy program, which helps cover Part D premiums and out-of-pocket costs.

H.R. 4650: Would add preventive and screening dental services, including oral exams and cleanings under Part B. It would also cover procedures such as tooth restorations and extractions, bridges, crowns, root canal treatments and implants and dentures. Beneficiaries would chip in the standard 20% for basic treatments and 50% for major treatments.

H.R. 4665: Would add routine eye exams to coverage through Part B, with beneficiaries generally paying 20% of the cost. It also would provide some coverage — $100 — toward contact lenses or eye glasses.

H.R. 4618: Would provide coverage under Part B for hearing exams and hearing aids, with beneficiaries contributing 20%.

This expanded coverage also might come with a cost. While some Advantage plans have no premium, the average is expected to be $23 in 2020, according to the Kaiser Family Foundation. Although down from $27 this year, any amount paid for a premium is on top of what Medicare enrollees pay for Part B: $135.50 is the standard for 2019 and forecast to be $144.30 next year. (Higher earners pay more).

Roughly 22.2 million, or 37%, of Medicare beneficiaries have Advantage plans. The remainder stick with original Medicare, which they can pair with a supplemental policy (i.e., Medigap) and a standalone Part D plan for prescription drug coverage (which also is typically included with Advantage plans).

“The majority of people on Medicare still choose to be in [original] Medicare, so having an expansion of benefits would accrue to everyone,” Lipschutz said. “It would be a significant improvement to the program and fill holes that have been there since its inception.”

The Congressional Budget Office has not yet released an estimate on how the three bills that expand benefits would impact Medicare’s budget. It did, however, offer a preliminary estimate of $345 billion in government savings from 2023 through 2029 if negotiating with drugmakers were allowed under the fourth bill.

At the same time, though, the budget office report notes the bill’s negative effects may include reduced spending on research and development.

In 2018, Medicare spent about $740 billion on 59.9 million beneficiaries through its hospital, outpatient care and prescription drug benefits, according to the latest report from the program’s trustees.

Total Medicare costs are expected to rise to 5.9% of gross domestic product by 2038, up from 3.7% in 2018, the report says. The more immediate concern among opponents of the measures now headed for a possible House vote is that the trust fund for Part A (hospital coverage) is anticipated to be depleted in 2026 unless Congress acts before then. At that point, the program would be able to fund 89% of promised Part A benefits, the trustees report says.

“We are … considering four bills that expand Medicare benefits as this important program is facing bankruptcy and have no responsible way to pay for them,” said Kevin Brady, R-Texas, in his opening remarks during a hearing on the bills in a recent House Ways and Means Committee, where he is the lead Republican.