Estate Planning Blog Articles

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Medicare’s Coverage of New Controversial and Expensive Alzheimer’s Drug Is Limited

The final decision, which comes after a proposed policy released in January, will have significant consequences for millions of Alzheimer’s patients and tens of millions of Medicare enrollees. It’s the latest step in the drug’s contentious path to market, reports CNN’s recent article entitled “Medicare limits coverage of controversial Alzheimer’s drug to those in clinical trials.”

The policy is expected to restrict the number of people who can receive the medication. This coverage policy would also apply to other drugs in this class, such as monoclonal antibodies that target amyloid, or plaque, for the treatment of Alzheimer’s disease, that the FDA may approve in the future.

Biogen, the maker of Aduhelm, called CMS’ decision unprecedented and said it will deny all Medicare enrollees access to the drug and may limit coverage for treatments approved in the future.

“When additional data from this new class of treatments become available, Biogen urges CMS to reconsider today’s decision for all FDA-approved amyloid-beta targeting therapies,” the company said in a statement, noting that it is considering its options.

The CMS made this decision based on evidence and analysis of public feedback, CMS Administrator Chiquita Brooks-LaSure said in a statement. More than 10,000 comments on the proposed policy were submitted.

“CMS has a responsibility to ensure that people with Medicare have equitable and appropriate access to therapies that are reasonable and necessary for use in the Medicare population,” she said. “Through this decision, we are creating a pathway for people with Medicare to quickly access drugs the FDA determines have shown a clinical benefit and encourages manufacturers and trial administrators to ensure that the clinical trials recruit racially diverse participants.”

The agency examined the potential for patient benefits against the significance of serious unknown factors that could result in harm, Dr. Lee Fleisher, CMS chief medical officer, said in a statement.

“There is the potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare, which is a key consideration for CMS when making national coverage determinations,” Fleisher said.

CNN says that Medicare has never required enrollees to participate in a clinical trial for a drug already approved by the FDA that is being used for its intended purpose.

The FDA’s approval of Aduhelm last June brought about questions and concerns about the process, the drug’s efficacy, as well as its annual cost. Biogen initially priced it at about $56,000 a year. The approval was also a big motivator for a huge increase in Medicare Part B premiums for 2022. The standard monthly payment increased to $170.10, up from $148.50 last year, for the more than 63 million enrollees.

Roughly $10 of the premium spike is due to Aduhelm, a CMS official told CNN. The remainder is from a general increase in health care prices and usage, as well as from congressional action that limited the rise in Part B premiums for 2021 amid the coronavirus pandemic.

Reference: CNN (April 7,  2022) “Medicare limits coverage of controversial Alzheimer’s drug to those in clinical trials”

Can a Teddy Bear Help Elderly with Dementia to Communicate?

This cuddly bear engages with individuals with memory disorders.

WGAL’s article entitled “Talking teddy bear gives patients with dementia a new way to connect” reports that Cue Teddy is the brainchild of Dr. Roger Nelson.

Dr. Nelson is a retired physical therapist whose family dealt with dementia. He saw a need that was not being met.

“They lacked this ability of being able to talk and to think and then to connect with other people,” he said.

Dr. Nelson, therefore, teamed up with Rod Tosten, the vice president of IT at Gettysburg College, to bring the bear to life.

“Cue Teddy cues the individual to move and to stay active,” Tosten said.

The bear goes through a series of questions and commands, tapping into three areas of the brain: thought, motion and touch.

“One of the things we’re testing is what colors work well and what kind of fabric works well,” Tosten said.

But why a teddy bear?

“Everybody kind of remembers their first teddy bear they ever got and the name of the teddy bear,” Nelson said.

In addition, making people remember is part of the goal.

“I hope that a lot of people adopt it and use it because it’s a valuable tool,” Nelson said.

“To be able to help other people is just amazing. I just love working on this,” Tosten said.

Cue Teddy is currently in the early stages of development. When it is ready, the two creators will be looking for a partner to mass produce it.

Reference: WGAL (Feb. 14, 2022) “Talking teddy bear gives patients with dementia a new way to connect

Does Lack of Clutter Help with Dementia?

Researchers in Great Britain looked at whether people with dementia were better able to carry out tasks, such as making a cup of tea, at home surrounded by their usual clutter or in a clutter-free environment. The researchers were surprised to find that participants with moderate dementia performed better when surrounded by their usual clutter.

News Medical Life Sciences’ recent article entitled “People with dementia may not benefit from a clutter-free environment” also noted that the different environments made no difference to those with mild and severe dementia. These patients were able to perform at the same level in both settings.

Professor Eneida Mioshi, from the University of East Anglia’s School of Health Sciences, said: “The majority of people with dementia live in their own home and usually want to remain living at home for as long as possible. So it’s really important to know how people with dementia can be best supported at home – one possible route would be by adapting the physical environment to best suit their needs.”

He also noted that as dementia progresses, seniors will gradually lose their ability to carry out daily tasks due to changes in their cognitive, perceptual and physical abilities. The professor went on to say that participation in daily tasks could then be improved, by adapting the individual’s environment.

“To this end, we wanted to investigate the role of clutter in activity participation, given the potential to use de-cluttering to support people with dementia to continue to be independent,” Professor Mioshi explained. “Environmental clutter has been defined as the presence of an excessive number of objects on a surface or the presence of items that are not required for a task.”

Mioshi also said it’s generally assumed that an individual suffering from dementia will be better-able to carry out daily tasks, when their home space is tidy and clutter free. However, he noted that there’s been very little research on this hypothesis.

Occupational therapist and PhD student Julieta Camino carried out the study with 65 participants who were grouped into those with mild, moderate and severe dementia. The participants were asked to carry out daily tasks, including making a cup of tea and making a simple meal, both at their own home and at UEA’s specially designed NEAT research bungalow – a fully furnished research facility that feels just like a domestic living space.

The researchers looked at their performance of activities in both settings, and also measured the amount of clutter in the participants’ homes. The NEAT home setting, however, was completely clutter free. They believed the complete absence of clutter in the research facility would play a beneficial role in helping people with dementia with daily living activities. However, we were wrong. Overall, those with moderate dementia, in particular, performed daily tasks better at home, despite the fact their homes were much more cluttered than the research bungalow.

Moreover, it didn’t seem to make any difference how cluttered the participant’s home was. The only factor that contributed to how well they could carry out tasks at home was their level of cognition – with those with severe dementia encountering the same difficulties to perform the tasks at home and in the research facility.

Sian Gregory, Research Information Manager at Alzheimer’s Society, said: “We can sometimes make assumptions about what might help someone with dementia who’s living at home, like de-cluttering so they can concentrate on tasks like making a cup of tea. But, as this study shows, our ideas might not always be right.

“Challenging assumptions is so important for careers to understand how to help someone with dementia to live well in their environment. That’s why the Alzheimer’s Society funds a variety of studies like this one to evaluate what actually works for people living with dementia today, as well as finding treatments for the future.”

Reference: News Medical Life Sciences (Nov. 26, 2021) “People with dementia may not benefit from a clutter-free environment”

How Do I Hire an Elder Law Attorney?

Elder law attorneys are lawyers who assist the elderly and their family members, and caregivers with legal questions and planning related to aging.

These attorneys frequently are called upon to assist with tax planning, disability planning, probate and the administration of an estate, nursing home placement, as well as a host of other legal issues, says Forbes’ recent article entitled “Hiring An Elder Law Attorney.”

In addition, there are some elder law attorneys who have the designation of Certified Elder Law Attorney (CELA), a certification issued by the National Elder Law Foundation. A Certified Elder Law Attorney must meet licensing and other requirements, including specific experience in elder law matters and continuing education in elder law. However, note that an elder law attorney does not need to have the CELA certification to be an experienced elder law attorney.

There are many elder law attorneys who specialize in Medicaid planning to help protect a senior’s financial assets, if they suffer from dementia or another debilitating illness that may require long-term care. Elder law attorneys also prepare estate documents, such as a durable power of attorney for health and medical needs and a living will. As you age, the legal issues that you, your spouse, and/or your family caregivers must address can also change.

If you are a senior, then you should have durable powers of attorney for financial and health needs, in the event that you or your spouse becomes incapacitated. You might also need an elder law attorney to help you transfer assets if you or your spouse move into a nursing home to avoid spending your life savings on long-term care.

Healthy people over 65 are in the best spot to do more than having estate planning documents prepared. That’s because they have the opportunity to develop a holistic strategy beyond the legal documents. This can give assurances that the family members and professionals they’ve assembled understand the principle of supported decision-making and how it will be implemented.

For example, an elder law attorney may focus on finding the least restrictive residential environment and making other health care and financial choices. An elder law attorney can also protect seniors with diminished capacity, who are being victimized by personal and financial exploitation.

An initial consultation with an elder law attorney will help determine the types of legal services they can offer, and the fees associated with these services.

Reference: Forbes (Oct. 4, 2021) “Hiring an Elder Law Attorney”

Is a Cup of Joe Help Healthy for Seniors?

Nutrition experts and medical researchers are finding all kinds of reasons to recommend indulging in a cup of joe— most based on the fact that coffee is the single greatest contributor to total antioxidant intake, says AARP’s article entitled “Five Surprising Health Benefits of Coffee.”

“Coffee is abundant in bioactive compounds that promote health,” says Kristin Kirkpatrick, a registered dietitian at Cleveland Clinic. As she explains, research published in The New England Journal of Medicine shows that these compounds may improve the gut microbiome (made up of healthy bacteria that aid in digestion and boost immunity) and reduce what’s called oxidative stress, which occurs when free radicals outnumber antioxidants in a way that leads to disease-causing cellular damage in the body. “The beans also have a deep rich hue, and we know that the deeper the color of a plant, the more benefits we can expect for health.”

However, moderation is the key. Three to five eight-ounce cups of coffee — or up to 400 mg of caffeine — per day can be part of a healthy diet. That is plain black coffee, not cappuccinos, lattes and macchiatos. Those are high in calories, sugar and fat. Let’s look at five health benefits of coffee that give you even more reason to enjoy your next cup.

  1. Lowers Your Risk of Type 2 Diabetes. A large review of studies published in Nutrition Reviews found that your risk of developing type 2 diabetes drops by 6% for each cup you drink per day. That’s because coffee is packed with phytochemicals that may act as antioxidants, anti-inflammatory compounds, insulin-sensitivity boosters and more. The same goes for decaffeinated brews. A study published in the Journal of Internal Medicine found that those who drank two to three cups of filtered coffee a day — as opposed to unfiltered coffee (made with a pod, an espresso machine, or a French press) had a 60% lower risk of developing type 2 diabetes than people who drank less than one cup of filtered coffee a day. Those drinking unfiltered coffee didn’t see such a reduction in risk.
  2. Heart Protection. A review of three major studies published recently in Circulation: Heart Failure found that drinking one or more cups of plain caffeinated coffee a day may reduce your risk for heart failure. (Decaf didn’t yield the same benefits.) Among those without diagnosed heart disease, researchers found that drinking up to three cups of coffee a day was associated with a lower risk of stroke, death from cardiovascular disease and death from any cause.

If possible, though, drink filtered coffee because unfiltered coffee contains two compounds that raise LDL cholesterol in some people, and high levels of LDL cholesterol increase your risk for heart disease and stroke.

  1. Boosts brain health. Some research suggests that regular caffeine consumption may offer brain health benefits. In one study of people ages 65 to 84, published in the Journal of Alzheimer’s Disease, those who drank a cup or two of coffee daily had a lower rate of mild cognitive impairment than those who never or rarely consumed coffee. Other studies suggest coffee may also protect against Parkinson’s disease. However, some research shows that having over five or six cups a day may have an adverse health impact on the brain.
  2. Improves your mood. Drinking coffee may reduce your risk of depression by nearly one-third, according to research from Harvard Medical School. The effect may be related to coffee’s anti-inflammatory properties. Coffee also has phytochemicals that feed the good bacteria in our guts. The good bacteria may produce or enhance other compounds that act on the brain and have beneficial effects on mood.
  3. Maximizes workouts. Downing a cup before exercise can make a difference in your workout because coffee improves circulation, endurance and muscular strength. It also may reduce pain, according to a review of research published in 2019 in Sports Medicine. However, it is important to recognize that coffee can also act as a diuretic.

Reference: AARP (Sep. 20, 2021) “Five Surprising Health Benefits of Coffee”

Will Congress Provide more Dollars for Elder Care?

For millions of Americans taking care of elderly or disabled loved ones, resources are very costly. Government assistance is provided through Medicaid, but it’s just for those with the lowest incomes. Many who qualify don’t get the help because many states restrict the number of eligible recipients, resulting in long waiting lists.

NBC News’ recent article entitled “Democrats want billions to pay for elder care. Republicans say the price tag is too high” reports that Democrats have earmarked roughly $300 billion to expand home-based care for seniors and the disabled in the $3.5 trillion spending bill dubbed the American Families Plan. The bill would offer states incentives to lift their income caps to 300 times the poverty level, or about $38,600 per person. Democrats say it would enable an additional 3.2 million people to be eligible for home-based assistance.

However, Republicans are launching an all-out messaging campaign that accuses Democrats of a “reckless tax and spending spree” and saying the American Families Plan would lead to higher inflation and a suffering economy. Democrats say they aren’t afraid of the cost or of Republican claims about inflation. Research shows that the elder care proposal is one of the most popular components of their agenda among likely Democratic voters. Two-thirds of voters said expanding access to home-based care for the elderly and the disabled was important, and 48% strongly favored the expansion.

Progressives have said $3.5 trillion is too little to transform the economy. Moderate Democrats point to the risk of inflation.

U.S. Rep. Katherine Clark (D-MA), who is a member of the House Women’s Caucus, cared for her dad, who suffered a stroke, her mom, who had Alzheimer’s and three young children when she was running for Congress. She said elder care is a priority.

“Even though I had resources and options, it was really, really challenging to me. That story plays out for parents and women across this country every day,” Clark said in an interview. “It is long past time that we recognize how fundamental the care agenda and the care economy is to our economy in general.”

Democrats also would like to pass provisions to guarantee that home health care workers make a living wage through reporting guidelines and by requiring a minimum wage, which would be set by region.

Reference: NBC News (Aug. 21, 2021) “Democrats want billions to pay for elder care. Republicans say the price tag is too high.”

Does Air Pollution Cause Alzheimer’s Disease?

The air quality study was released by the Alzheimer’s Association.

Researchers monitored two groups of at-risk adults, one in Europe and the other in the U.S., over a 10-year period.

WTOP’s article entitled “Study: New evidence shows link between air pollution, Alzheimer’s disease” reports that Dr. Heather Snyder, the vice president of Medical and Scientific Relations at the association, commented that those in Europe who were in less-polluted areas saw a drop in risk by 15% for dementia and 17% for Alzheimer’s disease.

More than six million Americans are living with Alzheimer’s. By the year 2050, this number is expected to increase to nearly 13 million.

The Alzheimer’s Association reports that one in three seniors dies with Alzheimer’s or another dementia. It kills more people than breast cancer and prostate cancer combined.

Women in the U.S. who participated in the study saw a 26% decrease in risk of developing dementia.

This included a reduction in certain categories of pollution, including traffic-related pollution.

Long-term exposure to air pollution was linked to a possible biological connection to physical brain changes that result in Alzheimer’s disease.

“When you actually modify or change air pollution, decrease it, there actually also seems to be a benefit on cognition in a population that are aging,” Snyder said. “I think these data demonstrate the importance of policies and action by federal, state and local governments to address reducing air pollution.”

Snyder remarked that it’s important for those with loved ones battling the disease to take advantage of community resources to see better outcomes overall.

According to the Alzheimer’s Association, more than 11 million people in the United States provide unpaid care for people with Alzheimer’s or other dementias.

in 2020, these caregivers provided an estimated 15.3 billion hours of care, valued at approximately $257 billion.

Reference: WTOP (July 26, 2021) “Study: New evidence shows link between air pollution, Alzheimer’s disease”

What Does Cleveland Clinic Say about the New Alzheimer’s Drug?

When the drug first debuted, the Cleveland Clinic said it would not administer Aduhelm, the new FDA-approved Alzheimer’s medicine. However, the hospital system was promoting the unproven drug on its social media accounts.

Cleveland Clinic was the first major medical center to say it would not administer Aduhelm, and two hospital systems have followed the clinic’s lead. However, the Cleveland Clinic made a sudden change, as just two weeks ago, the clinic said that the drug offered “hope.”

Axios’ recent article entitled “Cleveland Clinic’s about-face on the new Alzheimer’s drug” reports that the hospital posted the article on Facebook (July) and on Twitter (June 29)— about a month after the FDA approved the drug. Each social media post said the treatment has been “a sign of hope” for the patient.

At the end of the article, a patient says: “There are people who could really benefit from this, so let’s give them the drug. We’d all like to take something that may be able to help us. Hope is hope.”

Babak Tousi, a neuro-geriatrician at the Cleveland Clinic, called the drug “a real turning point in the field of dementia.”

However, a footnote at the bottom of the article discloses that Dr. Tousi is a paid adviser to Biogen.

She has received $16,700 from Biogen and the drug’s co-developer Eisai since 2014, according to federal data.

Dr. Tousi also has received more than $25,000 during that time from Eli Lilly, which makes a competing experimental Alzheimer’s drug.

What they are saying: The Cleveland Clinic did not make anyone available for an interview, and calls to Tousi’s office went unanswered.

A Cleveland Clinic spokesperson said the article was about the trial, and “research is fundamental to our mission. We regularly provide updates on studies we are participating in.”

The Cleveland Clinic spokesperson did not address questions about the article being promoted after the FDA’s approval and that the article said the drug offered “hope,” even though there’s conflicting evidence about whether the drug works.

The spokesperson added, “We support continued research in this area, and when additional data become available, we will re-evaluate this medication for use in our patients.”

Reference: Axios (July 19, 2021) “Cleveland Clinic’s about-face on the new Alzheimer’s drug”

Do I Need Long-Term Care Insurance?

Women face some unique challenges as they get older. The Population Reference Bureau, a Washington based think tank, says women live about seven years longer than men. This living longer means planning for a longer retirement. While that may sound nice, a longer retirement increases the chances of needing long-term care.

Kiplinger’s recent article entitled “A Woman’s Guide to Long-Term Care” explains that living longer also increases the chances of going it alone and outliving your spouse. According to the Joint Center for Housing Studies of Harvard University, in 2018 women made up nearly three-quarters (74%) of solo households age 80 and over. Thus, women should consider how to plan for long-term care.

Ability to pay. Long-term care is costly. For example, the average private room at a long-term care facility is more than $13,000/month in Connecticut and about $11,000/month in Naples, Florida. There are some ways to keep the cost down, such as paying for care at home. Home health care is about $5,000/month in Naples, Florida. Multiply these numbers by 1.44 years, which is the average duration of care for women. These numbers can get big fast.

Medicare and Medicaid. Medicare may cover some long-term care expenses, but only for the first 100 days. Medicare does not pay for custodial care (at home long-term care). Medicaid pays for long-term care, but you have to qualify financially. Spending down an estate to qualify for Medicaid is one way to pay for long-term care but ask an experienced Medicaid Attorney about how to do this.

Make Some Retirement Projections. First, consider an ideal scenario where perhaps both spouses live long happy lives, and no long-term care is needed. Then, ask yourself “what-if” questions, such as What if my husband passes early and how does that affect retirement? What if a single woman needs long-term care for dementia?

Planning for Long-Term Care. If a female client has a modest degree of retirement success, she may want to decrease current expenses to save more for the future. Moreover, she may want to look into long-term care insurance.

Waiting to Take Social Security. Women can also consider waiting to claim Social Security until age 70. If women live longer, the extra benefits accrued by waiting can help with long-term care. Women with a higher-earning husband may want to encourage the higher-earning spouse to delay until age 70, if that makes sense. When the higher-earning spouse dies, the surviving spouse can step into the higher benefit. The average break-even age is generally around age 77-83 for Social Security. If an individual can live longer than 83, the more dollars and sense it makes to delay claiming benefits until age 70.

Estate Planning. Having the right estate documents is a must. Both women and men should have a power of attorney (POA). This legal document gives a trusted person the authority to write checks and send money to pay for long-term care.

Reference: Kiplinger (July 11, 2021) “A Woman’s Guide to Long-Term Care”

What’s the Criticism of the New Alzheimer’s Drug?

Three members of the FDA panel overseeing research have resigned since the approval this week, including Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, who said in a letter the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history.”

CNBC’s article entitled “Biogen Alzheimer’s drug and the battle over dementia treatment of the future” reports that last November, in an 8-1 vote, that panel said Biogen’s late-stage study didn’t provide “strong evidence” showing that aducanumab effectively treated Alzheimer’s; two other panelists said that the data was “uncertain.”

While some experts see Aduhelm an “effective treatment” for a disease that affects millions of Americans, others have concerns about the FDA ruling’s implications for the panoply of other potential treatment options that are in late-stage development.

An immediate challenge facing other researchers working on a wider Alzheimer’s drug pipeline will be to keep participants in ongoing trials. In most cases, many Alzheimer’s sufferers will quit other drug studies to pursue treatment with the newly approved Aduhelm. This will make the trial data for those alternative drugs less useful, even though the drugs in question might one day prove safer, more effective, or more appropriate for different stages of the disease’s progression. Nonetheless, Aduhelm’s approval is seen by many as a big boost towards those efforts.

Some major drug companies stopped efforts to research brain diseases, including Pfizer and Boehringer Ingelheim in 2018. Biogen had given up on Aduhelm at one time in the clinical trials in 2019 before reversing its decision. This was after decades of failure in search of a breakthrough.

The National Institutes of Health spent two to three times more on heart disease and cancer research than on dementia in recent years, while a lack of qualified participants for clinical trials also slowed progress.

Aduhelm’s clinical trial data demonstrated that the drug successfully targets and clears out clusters of a specific type of protein that are thought to be responsible for Alzheimer’s. However, it gave insufficient evidence to prove the drug provides patients with cognitive benefits. Known among scientists as aducanumab, it works by offering an array of identical antibodies that are cloned from white blood cells. These antibodies are chosen for their targeting abilities, since they can identify specific proteins, called beta amyloids, that have constructed particular formations in the body. There’s extensive evidence suggesting that these beta amyloid formations, also known as “pathological aggregates” or “plaques,” are a major driver of Alzheimer’s disease, though the exact causal mechanisms are still not fully understood.

“What we’re going to find out from the use of this drug one way or the other, is whether or not the amyloid clearing hypothesis is correct,” says USC health economist Darius Lakdawalla, who argues the continued trialing of Biogen’s drug will prove useful to that confirmatory effort.

“If it is correct, then I think it opens the door for a lot of innovation, a lot of drug candidates that are going to try to clear amyloid in the future pursuit of that hypothesis.”

Reference: CNBC (June 12, 2021) “Biogen Alzheimer’s drug and the battle over dementia treatment of the future”