Thursday, September 16, 2021
The U.S. Food and Drug Administration hearing on Friday, September 17, 2021 to address the question of approval for "booster" doses of Covid-19 vaccines is scheduled to be "open" to the public through online portals. The hearing begins at 8:30 a.m. Eastern time.
The FDA's website helpfully links to the submissions from the drug companies and other interested parties as well to the hearing portal. In contrast to The Lancet article published earlier this week which takes the position that a booster vaccine dose is not "currently" indicated for most members of the public, Pfizer and Moderna each submitted materials to the FDA this week in support of administering third shots beginning six months after an individual's second shot. Pfizer is recommending a full-strength dose for its booster shot, while Moderna is recommending a dose that is 1/3 the level of its original doses. It appears both companies are citing observational studies, clinical trials, and antibody tests in support of their recommendations, including studies in the U.S., Israel, and South Africa, and discuss histories of reactogenicity, adverse events, and risk/benefit assessments.
Here's the useful FDA vaccine hearing webpage and links: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement#event-materials
AARP Research has a new report, Working Caregivers' Worries Over Workplace Return. With some employers bringing employees back to the physical office, will the flexibility provided by working from home completely disappear?
AARP surveyed Americans who provide unpaid care to a family member or friend and work part- or full-time to learn about their concerns coming out of the pandemic. Of the national sample of adults polled by phone, 56% say their employer offered new benefits as a result of the pandemic, such as flexible schedules and the ability to work remotely.
As of July, about half of caregivers (52%) were continuing to work from home at least some of the time and 89% would like that option going forward. Most said it's been easier to juggle the demands of work and caregiving while not having to commute (49% to a great degree and 40% to some degree), according to the AARP survey.
The full report is available here. I have pasted the key findings here for your convenience:
- Working caregivers have felt the strain as the COVID-19 pandemic has ensued. With nearly eight in ten saying the pandemic increased their level of stress. Two in three caregivers (66%) express concern that they will have difficulty juggling responsibilities in the next 12 months.
- More than half of working caregivers say their employer instituted new benefits as a result of the pandemic. The most common benefits instituted were flexible schedules and the ability to work remotely.
- Flexibility is important for working caregivers to successfully balance caregiving with work. In fact, it is so highly valued that more than four in ten caregivers say they would consider looking for a new job if their employer rolled back any of the benefits they instituted during the pandemic.
- A slight majority of working caregivers currently have the ability to work at home at least some of the time and most want to continue with this arrangement.
- Nearly half say working at home has helped them manage their dual roles a great deal.
In addition to balancing responsibilities, working caregivers are most concerned about exposing the person they care for to the coronavirus or leaving them home unattended while they go to work.
Wednesday, September 15, 2021
We know they come out every year. This year is no exception. They are out! What do we learn from them? I'll give you the highlights here (those of you who have looked at the reports before know they are long and detailed....)
The Medicare Trustees' Report, released August 31, 2021, is available here. The introduction explains the impact of COVID, and COVID vaccines, on Medicare, but not "Aduhelm, the Alzheimer’s disease drug that has been recently approved." The introduction also references potential future scientific advances and how that would be factored into projections. The one thing everyone wants to know from the Trustees Annual Report is what is the fiscal health of Medicare? "The estimated depletion date for the HI trust fund is 2026, the same as in last year’s report. As in past years, the Trustees have determined that the fund is not adequately financed over the next 10 years. HI income is projected to be lower than last year’s estimates due to lower payroll taxes." If you don't have time to peruse the entire report, read the introduction. It's very interesting!
Here's an excerpt from the conclusion:
The Trustees project that HI tax income and other dedicated revenues will fall short of HI expenditures in all future years. The HI trust fund does not meet either the Trustees’ test of short-range financial adequacy or their test of long-range close actuarial balance.
The Part B and Part D accounts in the SMI trust fund are expected to be adequately financed because income from premiums and general revenue are reset each year to cover expected costs. Such financing, however, would have to increase faster than the economy to cover expected expenditure growth.
The financial projections in this report indicate a need for substantial changes to address Medicare’s financial challenges. The sooner solutions are enacted, the more flexible and gradual they can be. The early introduction of reforms increases the time available for affected individuals and organizations—including health care providers, beneficiaries, and taxpayers—to adjust their expectations and behavior. The Trustees recommend that Congress and the executive branch work closely together with a sense of urgency to address these challenges.
The 2021 Social Security Trustees' Report is available through this page.
According to a summary provided by the SSA & Medicare Trustees, "Based on our best estimates, the 2021 reports show:"
• The Old-Age and Survivors Insurance (OASI) Trust Fund, which pays retirement and survivors benefits, will be able to pay scheduled benefits on a timely basis until 2033, one year earlier than reported last year. At that time, the fund's reserves will become depleted and continuing tax income will be sufficient to pay 76 percent of scheduled benefits.
• The Disability Insurance (DI) Trust Fund, which pays disability benefits, will be able to pay scheduled benefits until 2057, 8 years earlier than in last year's report. At that time, the fund's reserves will become depleted and continuing tax income will be sufficient to pay 91 percent of scheduled benefits.
Thursday, September 2, 2021
Examining Use and Misuse of Tax-Exempt or Deferred Financial Retirement Savings Plans As Increasing Economic Disparity
Check out "America is Spending A Fortune to Help Rich People Retire in Luxury," authored by Michael Mechanic. Published this week in Mother Jones, the article examines how "America's most affluent" use Roth IRAs and similar "federally subsidized retirement accounts meant for middle-class savers" to maximize their wealth.
But it turns out IRAs are only the tip of the iceberg. The bigger problem, according to Steve Rosenthal, a tax attorney and senior fellow at Urban-Brookings Tax Policy Center, is that, thanks to a series of bipartisan bills Congress has passed over the past quarter-century, the government spends a fortune subsidizing a whole range of retirement plans whose benefits flow overwhelmingly to America’s most affluent. “It’s unbelievable the amounts of dollars at stake, and how tilted they are to the high end,” Rosenthal told me. “It’s just staggering.”
Indeed, such subsidies are the federal government’s single biggest tax-related expense, costing hundreds of billions of dollars per year. From 2020 through 2024, the JCT estimates, tax breaks and deferrals for retirement contributions will cost the Treasury $1.9 trillion—far more than the cost of the child/dependent or earned income tax credits, tax deductions for charitable donations, tax exclusions on long-term capital gains, or corporate tax breaks for employer-provided health and life insurance benefits. “These retirement reform packages are exceptionally confusing and technical and long and really hard for anyone to sort out,” says Rosenthal, a former JCT staff lawyer himself. “But embedded in every one are easter eggs: big giveaways to the retirement industry and to high-net-worth individuals.”
There is a lot to unpack here, and I could certainly see a seminar course built around this topic, including the complexity of finding solutions that don't harm the more-modest investor who will need every dime in retirement.
My thanks to University of Virginia Law Professor Naomi Cahn for sharing the article, and to her colleague at UVA, Professor Michael Doran, who is prominently cited in the article for his critiques of so-called savings reforms that "delivered expensive and unnecessary tax subsidies," that benefited higher income families and the financial services industry.
Wednesday, September 1, 2021
This New York Times article from last week took me a bit by surprise. Many Older Americans Still Aren’t Vaccinated, Making the Delta Wave Deadlier explains
The United States has a far higher share of seniors without full vaccine protection than many other wealthy countries, a key risk factor driving serious Covid-19 illness and death, a Times analysis shows.
As the Delta variant has torn across the country, America’s pace of vaccinations has sped up after months of relative stagnation, and full federal approval of the Pfizer vaccine on Monday could extend that momentum. Just over half of Americans are now fully vaccinated.
But national averages mask the high rate of older Americans who remain deeply vulnerable. Older people still account for most Covid-19 deaths, and in many counties, especially in the South and Mountain West, seniors without full vaccination make up more than 10 percent of the total population.
We know from the experiences of last year how deadly COVID can be to elders. And recent data proves this still to be true. "The Delta variant has hit many areas with clusters of vulnerable seniors particularly hard. Low elderly vaccination rates in Arkansas, Florida, Idaho, Louisiana and Nevada have coincided with surging rates of hospitalization and death." There are still areas of high risk, without a current outbreak, according to the article. There are many reasons for vaccine hesitancy and whether the full FDA approval of Pfizer will move the needle (pun intended) remains to be seen. "Signing up older Americans for their first shot remains a struggle, public health experts say, as people who really wanted a vaccine have already gotten it. While getting to a vaccine provider may still be an issue for some, especially in more rural areas, many more people are resistant to immunization because of their politics and personal beliefs, and those of their friends and family."
Tuesday, August 31, 2021
Apparently I'm not the only person asking about the proper role of antibody tests in determining safety protocols during this current phase of COVID-19 infections. This morning on NPR's Morning Edition program, a strongly expressed piece discounted the value of current antibody tests. At the heart of the story was the following:
[Washington University School of Medicine Immunologist] Ali Ellebedy says that having detectable antibodies from a blood test six months after vaccination "only means that your immune system mounted a successful response then and that you have immune memory."
While scientists have generated a "ton of data" on which antibodies are best at neutralizing the virus, Ellebedy says, the available antibody tests are not designed to specifically pick up whether you have enough of these protective antibodies, especially in the face of evolving variants.
And don't forget the immune system is more than just antibodies, so even with low detectable levels in your blood, you're not defenseless. "Antibody tests — it's really probing just one part of your immune system," says Elitza Theel, who directs the Infectious Diseases Serology Laboratory at the Mayo Clinic.
The NPR piece poses the question of whether a person can "learn anything" from antibody testing. The piece says "Yes, as long as you don't expect it to give you a straightforward answer for how well-protected you are from catching the virus."
For more, I recommend reading or listening (3 minutes) to the NPR segment entitled "Antibody Tests Should Not Be Your Go-To For Checking COVID Immunity." The segment suggests that "the identity of a blood test that can eventually give consumers a reliable indication of their immunity is not far-fetched." Okay. But as I suggest in my previous post on this topic, are there communities available for antibody testing to further the identification of "correlates of protection" that aren't being tapped currently? Could college and university communities and long-term care communities become part of the development of a reliable tool?
Saturday, August 28, 2021
Yesterday, I wrote here about what I'm hearing about use of antibody testing in some long-term care facilities in Pennsylvania. The more I read about antibody testing for COVID-19, the more I'm surprised by the state of the science and the level of apparent uncertainty about appropriate uses for such tests.
I've read published articles suggesting multiple explanations for why such tests have not been widely used as part of the response to COVID-19 and variant infections including:
- Lack of availability of commercially-based testing products
- Lack of reliable testing products
- Lack of FDA protocols to establish reliable tests
- Disagreements (or lack of clarity) over what level of antibodies should be considered "protective"
- Concern that any test results could be misused
- Lack of easily administered tests, especially tests that would not require medically-trained persons for blood draws
See, for example, these two articles by John Hopkins Center researchers: Rachel M. West et al, Antibody (Serology) Tests for COVID-19: A Case Study (May 2021); Rachel West, et al, COVID-19 Antibody Tests: A Valuable Public Health Tool with Limited Relevance to Individuals (November 2020).
As a non-scientist I can understand some of these concerns for the first half of this pandemic, where the issue was whether and to what extent actual infection would provide protection against reinfection. But, with almost 9 months of publicly administered vaccines, it is troubling to think that there could still be concerns about reliability of antibody testing following those vaccinations. Can an illness be called a "breakthrough" infection if the level of immunity wasn't being tested? Or rather, if the immunity status couldn't be reliably detected?
In any event, as I dig deeper, it seems that the U.K. is moving forward this month (August 2021) to "begin offering COVID-19 antibody testing to the general public...for the first time" via a home-administered finger-prick test. From a Reuters report that leans on other media sources:
The government's new programme is intended to produce data on antibody protections for people following infection by different coronavirus variants, according to details of the programme published by multiple media outlets, including Sky News and BBC.
From Tuesday, anyone aged 18 or over in England, Wales, Northern Ireland and Scotland, will be able to opt in to the programme when receiving a PCR test, Sky News reported.
Participants, on testing positive for COVID-19, will be sent two finger-prick tests to complete at home to inform the UK Health Security Agency of the antibody response to different coronavirus variants, BBC reported.
Friday, August 27, 2021
Are LTC Residents "Telling" Us that Antibody Testing is Important for Covid-19 Prioritization for Boosters?
In recent weeks, I've spoken to or read about residents of long-term care facilities being tested for Covid-19 antibodies. Some residents, without being ill, are showing low (or even "no") levels of antibodies, despite having been fully inoculated in the spring of 2021. This doesn't mean there was anything wrong with the original vaccinations, but it does suggest that at least for older persons, the immunity reduces over time. As a result of these test results, the facilities are recommending that families support getting booster shots for their loved ones. That strikes me as using scientific data appropriately, to help prioritize next steps in fighting the troublesome developments with Covid-19.
Why aren't other institutions, including universities, seeking similar information about antibodies or lack thereof? Does it "matter" that a faculty member -- or a student -- or an administrator -- or a staff member -- was "fully vaccinated" in, for example, February 2021, if they aren't still "protected" in September 2021?
Here's what I know so far:
- My own health insurance company requires a "doctor's order" to permit an antibody test to be covered for reimbursement.
- My local pharmacy advertised last spring that its onsite clinic would be offering antibody tests. I learned recently, however, that it never actually set up that program. The pharmacist I talked with didn't know why that decision was reversed.
- My regular physician said I could sign up for a booster shot approximately 9 months from my last of the two-shot original vaccination, and said that therefore I didn't need an antibody test.
- My insurance company asked whether I had a known exposure to Covid-19, implying that if the answer was yes, they would cover testing for a breakthrough-Covid infection, but not for antibody testing unless I had a doctor's order.
I realize one personal anecdote isn't evidence of much of anything. But, is nursing home data already being generated that suggests antibody testing can supply relevant facts, perhaps facts that are "more" relevant than simply a history of immunization?
Thursday, August 19, 2021
Older adults in the United States are functioning better on their own and a shrinking share are living in nursing homes and assisted living settings than a decade ago, new data show.
Disability is down, as a smaller percentage of older adults receive help with daily activities and a larger share manage independently with home modifications and devices, according to 10 years of data from the National Health and Aging Trends Study (NHATS). The physical, sensory, and cognitive capacities of older adults, particularly women, are improving. And older adults are online more than ever before: They are more than twice as likely to use text or email than in 2011.
Despite these encouraging trends, NHATS data also reveal persistent racial and ethnic disparities among older adults, particularly in their ability to carry out daily tasks without help and modify their homes to meet their needs. The data also show that older adults were far less likely to participate in activities they value during the COVID pandemic than in previous years.
Conducted annually, NHATS collects information on the functional ability of older Medicare recipients, aiming to guide efforts to improve quality of life. Many NHATs findings are now available in new interactive dashboards and a companion chartbook, allowing users to dig into the data by demographic subgroup and create a custom picture of how the lives of older Americans—a rapidly growing segment of the population—are changing. (citations omitted)
Click here to access the report and all the nifty charts.
Wednesday, August 18, 2021
There was a bit of a buzz last week with the publication of a new study about metabolism. What We Think We Know About Metabolism May Be Wrong explains the recent study: "[u]sing data from nearly 6,500 people, ranging in age from 8 days to 95 years, researchers discovered that there are four distinct periods of life, as far as metabolism goes. They also found that there are no real differences between the metabolic rates of men and women after controlling for other factors."
We probably only think about our metabolisms when we are trying to lose weight. But as the article explains, the implications are far beyond weight gain and loss.
Central to [the researchers'] findings was that metabolism differs for all people across four distinct stages of life.
There’s infancy, up until age 1, when calorie burning is at its peak, accelerating until it is 50 percent above the adult rate.
Then, from age 1 to about age 20, metabolism gradually slows by about 3 percent a year.
From age 20 to 60, it holds steady.
And, after age 60, it declines by about 0.7 percent a year.
For us in elder law, here is the point: "And around age 60, no matter how young people look, they are changing in a fundamental way...'There is a myth of retaining youth, [one expert said] That’s not what the biology says. In and around age 60, things start to change. ... There is a time point when things are no longer as they used to be.'"
Thanks to Professor Naomi Cahn for sending the link to the article.
Monday, July 19, 2021
We have all heard about the shockingly high temperatures out west. The full impact is yet to be determined, but it is a life-threatening event. Most Oregon heat wave victims were elderly, had no central AC gave us some data about this tragedy.
A preliminary report by Oregon’s Multnomah County found that a majority of the deaths reported during the record-breaking heat wave that began late last month were elderly men who lived alone and did not have central air conditioning....In Portland, which is in Multnomah County, from June 25 and June 28 the city reached triple-digits, even hitting a high of 116 degrees...The report examined deaths from June 28 through July 9. The Multnomah County Medical Examiner’s Office suspected hyperthermia in 71 deaths during this time. The report examined 54 cases where deaths were formally ruled as hyperthermia....Of those 54 deaths, 81.5 percent were ages 60 and older and 90 percent were white. The preliminary data states that 63 percent were males and 78 percent lived alone.... No one who died had central air. (emphasis added)
With climate change, this isn't the first environmental tragedy, nor will it be the last.
Monday, July 12, 2021
Last month the New York Times ran an article on How Deceptive Campaign Fund-Raising Ensnares Older People.
The dirty little secret of online political fund-raising is that the most aggressive and pernicious practices that campaigns use to raise money are especially likely to ensnare unsuspecting older people, according to interviews with digital strategists and an examination of federal donation and refund data.
Older Americans are critical campaign contributors, both online and offline. More than half of all the online contributions processed by [one company] in the last cycle, 56 percent, came from people who listed their occupation as “retired,” federal records show.
Digital operatives in both parties deploy an array of manipulative tactics that can deceive donors of all age groups: faux bill notices and official-looking correspondence; bogus offers to match donations and hidden links to unsubscribe; and prechecked boxes that automatically repeat donations, which are widely seen as the most egregious scheme.
But some groups appear to specifically target older internet users, blasting out messages with subject lines like “Social Security” that have particular resonance for older people, and spending disproportionately on ads for an older audience. In many cases, the most unscrupulous tactics of direct mail have simply been rebooted for the digital age — with ruthless new precision.
The article notes that age is not reported on federal filings, so the depth of this occurring is unclear. However, the NYT looked at refund data correlating with voter rolls for California and reports "that the average age of donors who received refunds was almost 66 on [a republican company] and nearly 65 on ... the equivalent Democratic processing site... Even more revealing: More than four times as much money was refunded to donors who are 70 and older than to adults under the age of 50 — for both Republicans and Democrats." The issue is not limited to political campaigns the article notes. "There is an entire initiative at the Justice Department devoted to elder abuse, and the F.B.I.’s Internet Crime Complaint Center reported nearly $1 billion in losses for those 60 and older in 2020." One expert quoted in the article noted "older people face a double whammy online when combining their generational lack of familiarity with technology and age-related cognitive declines."
The article delves into some reasons for such an impact and examines some of the email messages. It's an interesting read.
Friday, July 9, 2021
During the first part of my summer, I wrote a review on Senator Amy Klobuchar's April 2021 book, Antitrust: Taking On Monopoly Power From the Gilded Age to the Digital Age. That turned out to be a very enjoyable, stimulating task and my article will be published late summer or early fall. This gave me the incentive to rethink how antitrust law, as a form of pro-consumer-protection "competition" rules might affect long-term care, including the concentration of ownership and operation of nursing homes and other types of "senior living." The student editor for the Law Review, Claudia Bernstein (Dickinson Law, Class of 2022), also has been captured by the topic, and she sent me an article today from the New York Times that furthered this inquiry. A key passage:
[In the U.S.] Fewer new businesses are starting. Existing businesses have slowed the pace at which they hire new workers . . . . Workers are less likely to switch jobs or move to a new city. Companies are investing in new buildings and equipment at a lower rate. And small businesses make up a shrinking share of the economy.
Together, these trends suggest that the economy suffers from a lack of fair competition, many economists believe. Large corporations are often able to increase profits not by providing better products than their rivals but instead by being so big that they exercise power over workers and consumers. The government also plays a role, through policies that protect existing companies at the expense of start-ups and new entrants into an industry.
The technical term for excess profits from a lack of competition is “monopoly rents.” Just think about how frustrated you may have been by the customer service from an airline, cable-television provider or health insurer. And then imagine how frustrating it may be to work there. Despite the problems at these companies, consumers and workers don’t always have good alternatives.
In my local area, there is a variation on this problem. As I have written about recently, county officials are proposing to close the county's "nursing home," which in my experience has been well run and served as a viable alternative for necessary services, including memory care. The likely purchaser will be a for-profit company (a modest-size, relatively new tri-state regional player). The county hopes to cease "having to subside the facility with general tax money." But, without those "subsidies," consumers' payment for care will have to increase, affecting residents unlikely to have the ability to pay more. As one article on the history of Pennsylvania's county nursing home conversions concludes:
County-owned homes, once ubiquitous, are becoming less common in Pennsylvania. Facilities that have been privatized generally have lower ratings on common metrics; a York Dispatch study in 2018 found that 15 formerly county-owned facilities sold since 2005 had an average rating of 1.9 stars out of five on the common scale used by the Centers for Medicare and Medicaid Services, while the state’s 21 county-owned homes averaged 3.1 stars [out of a possible 5 stars].
Monday, July 5, 2021
I'm currently working on an article that looks at senior living trends, and came across several interesting, significant data points in a January 2021 article entitled The Future of Headship and Homeownership, by Laurie Goodman and Jun Zhu for the Urban Institute.
The central prediction is that household growth will be "weak" over the next two decades, a decline associated with slowing of U.S. population growth and lower "headship rates" among most age groups. The terms are defined at the beginning of the article.
Further, key takeaways from the article include these findings:
- Almost all net household growth will be from senior households. Of the 16.1 million net new households formed between 2020 and 2040, 13.8 million will be headed by someone over 65.
- All net household growth will be from households of color. Between 2020 and 2040, there will be 16.1 million net new households. Hispanic households will grow by 8.6 million, households of other races (mostly Asian households) will grow by 4.8 million, and Black households will grow by 3.4 million. White households will decline by 0.6 million.
However, despite what at first seems like "better" (if not good news) for households of color, the authors also predict:
- The decline in the homeownership rate will be particularly pronounced for Black households headed by 45-to 74-year-olds. If current policies stay the same, the Black homeownership rate will fall well below the rate of previous generations at the same age and result in an unprecedented number of Black renters over 65; we project elderly Black renters will more than double from 1.3 million in 2020 to 2.6 million in 2040.
Friday, July 2, 2021
Politico ran an interesting story, ‘You don’t have to die in your seat’: Democrats stress over aging members.
Using a Florida Congressman as an illustration, the article notes that "[t]he entire episode has brought into sharp focus an awkward conversation that Democrats have been having for a while: at a time of deep polarization and narrow congressional majorities, do older or infirm members have a responsibility to step down to ensure the party has enough votes to advance its agenda?" The issue is one for both Democrats and Republicans. "Both parties have their share of elderly members ... But Democrats have been grappling with a noticeable generational divide within their ranks for some time — President Joe Biden and top Democratic congressional leaders are all well over 70. Ten of the 12 House members over the age of 80 are Democrats." The article discusses various other issues, including the slim majority held by the Democrats, the desires of younger folks to serve, and perhaps a lessening value of seniority.
Thanks to Professor Naomi Cahn for sending us the article.
Thursday, July 1, 2021
As Covid-19 Eases, Is Germany Again Seeking "Filial Support" (Elternunterhalt) Payments from Children?
It has been a while since I've written a "Filial Friday" post. After more than a year of no calls or requests for information about "Elternunterhalt" payments in Germany, in the last 45 days I've heard from three sets of American citizens who recently received requests for financial contributions to the care of an aging parent in Germany. In each of the instances, the adult children had never heard of Germany's parental maintenance laws before receiving the demand.
First, Germany adopted a threshold annual income for a potentially obligated child of at least 100,000 Euros, effective for claims after January 1, 2020.
Second, it appears that Germany has also clarified that only the adult child's income is considered in determining the amount of the potential support obligation. In the past, the German authorities would routinely ask for "all" income and asset information for the child and any spouse or partner.
For more on this, see this article and another article, from Germany, describing these changes as "reforms." Germany's renewed use of filial support laws began with a ruling by the Federal Court on June 23, 2002. "The legal basis is mainly Section 1601 and 1602 Paragraph 1 BGB," according to a third article.
While I've often seen "claim letters" submitted to adult children living in the U.S., I've never seen a formal administrative proceeding or court proceeding to enforce such a claim if not paid voluntarily. In some instances, I've seen German authorities agree to drop the claim, usually because there is strong evidence that the now needy-parent neglected or mistreated the child while the child was a minor. I have also sometimes seen a voluntary settlement between the U.S. child and the German authorities. But, have any of our readers seen a litigated outcome in a cross-border claim? Do we have any attorneys reading this blog with experience with cross-border claims between the U.S. and Germany?
Wednesday, June 30, 2021
A number of years ago, I had an email correspondence going with Dr. Jason Karlawish, Professor of Medicine, Medical Ethics and Health Policy, and Neurology at the University of Pennsylvania. He was writing and speaking in intelligent, understandable ways about complex issues in degenerative neurocognitive disorders.
My sister brought him back to my attention, as she had just heard Brené Brown's podcast interview with Dr. Karlawish. Dr. Karlawish recently published an important book on The Problem of Alzheimer's. I immediately ordered the book and I'm still reading, but I can tell this is -- and should be -- an important resource for anyone trying to understand or explain the Alzheimer's or other progressive impairments in cognition. Frankly, that means all of us. He is taking on an essential question: "What's a good life when you're losing your ability to determine that life for yourself?" The subtitle of the book helps explain the scope: "How science, culture, and politics turned a rare disease into a crisis and what we can do about it."
I'm sure I'll write more hear about this book as I plunge ever deeper into the clear prose, organized in logical chunks, where I'm finding "gold" embedded on every page. It is not a soothing read, but that is exactly why it is so important.
June 30, 2021 in Cognitive Impairment, Consumer Information, Current Affairs, Dementia/Alzheimer’s, Elder Abuse/Guardianship/Conservatorship, Ethical Issues, Health Care/Long Term Care, Statistics | Permalink | Comments (0)
Tuesday, June 29, 2021
We all have heard the stories about the number of SNF residents dying during the pandemic. The Inspector General for HHS recently issued a report looking at the number of Medicare beneficiaries who died in SNFs during the pandemic, COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020.
The executive summary explains:
Nursing home residents have been particularly affected by COVID-19, as they are predominately elderly, tend to have underlying conditions, and live in close quarters. However, data on the number of nursing home residents who were diagnosed with COVID-19 or likely COVID-19 have not been readily available, particularly for early in the pandemic. Nursing homes are not required to report cases and deaths that occurred before May 8, 2020.
This data snapshot provides objective, standardized data based on Medicare claims for all Medicare beneficiaries in nursing homes throughout the country. This data snapshot is the first in a three-part series. Subsequent work will address the characteristics of the hardest hit nursing homes and strategies used by nursing homes to confront the challenges of the COVID-19 pandemic.
WHAT WE FOUND
- Two in five Medicare beneficiaries in nursing homes were diagnosed with either COVID-19 or likely COVID-19 in 2020.
- Almost 1,000 more beneficiaries died per day in April 2020 than in April 2019.
- Overall mortality in nursing homes increased to 22 percent in 2020 from 17 percent in 2019.
- About half of Black, Hispanic, and Asian beneficiaries in nursing homes had or likely had COVID-19, and 41 percent of White beneficiaries did.
- Understanding the pandemic's effects on nursing home residents is necessary if tragedies like this are to be averted.
Note that this is the first of 3 reports on the topic. The full report is available here.
Thursday, June 10, 2021
The CEO for Biogen, the publicly-traded biotechnology company that developed Aduhelm, issued a statement about the company's policies and plans for the new drug in conjunction with the FDA's announcement of its accelerated approval of the drug for patients with Alzheimer's Disease. He writes in part:
The approval of ADUHELM represents a crucial inflection point in our collective battle against Alzheimer’s disease. By addressing a defining pathology of the disease, this novel therapy has the potential to help fundamentally change the way patients are diagnosed and treated.
I have hoped for years that we would reach a moment like this. We all know the staggering numbers: there have been at least 100 drug development programs discontinued since 2003—the last time a new Alzheimer’s drug was approved. What it tells us is that the path for innovation is not straightforward, especially for something as complex as Alzheimer’s research. The journey during Biogen’s many years of research and development has been humbling, but we have learned from industry’s past research efforts and been determined to follow the science, always driven to address patients’ unmet needs.
ADUHELM is a first-in-class approved therapy: I believe it will be the catalyst to a new era of innovation for Alzheimer’s disease, and the first of many new treatments available to patients. More resources will be drawn into research that can help patients through the disease continuum, explore new pathways, and find potential therapy combinations.
The use of this drug involves some important questions about patient consent, precisely because the drug will most likely be used with people who have "confirmed presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease, consistent with Stage 3 and Stage 4 Alzheimer’s disease," the group of patients who took part in the pre-approval clinical trials. What is the process for obtaining such consent with cognitively-impaired patients?
Several articles have explored this topic outside of the specific drug in question:
In England, the nonprofit organization Physiopedia, offers a detailed protocol for informed consent in the context of cognitive impairment. For example, it suggests assessment of competence involves paying attention to four main abilities:
The person must have sufficient capacity to understand the information. If the study involves a considerable degree of risk, more information must be provided, particularly about possible risks and benefits, and the potential participant must be able to understand such information.
The person must be able to retain, use and weigh up such information long enough to be able to make a decision. In addition, they must also be able to understand what the decision is about, why they are being asked to make it, and what the consequences of making or not making that decision might be.
Possible benefits, risks and inconvenience linked to participating in research must be understood and weighed against the person’s own values and goals, which means that the person must understand how participating might affect him/her personally (High, 1992 and Stanley et al., 1984 in Olde Rikkert et al., 1997).
The person must have the ability to communicate his/her decision.
See also: "Informed Consent in Two Alzheimer's Disease Research Centers: Insights from Research Coordinators," by Christin M. Suver, and others, published April-June 2020, and announcing the plan to use the research to assist in development of "an electronic informed consent (eConsent) designed to boost engagement, enhance trust, and improve understanding by supporting participants' direct agency in the IC process."
Tuesday, June 8, 2021
I used to follow (and regularly blog about) new drugs in the pipeline for Alzheimer's treatment. Then I realized that the drugs weren't making it to the market place. While attending medical programs about R & D, I learned that it was going to be tough to find any magic treatments, much less "cures."
To it was interesting to read this week that for the first time in some 18 years, the FDA has approved use of a new drug, with the marketing name Aduhelm and the generic name Aducanumab (kind of sounds like abracadabra, doesn't it?), manufactured by Biogen.
Aduhelm is described by the FDA as an "amyloid beta-directed antibody," which was approved under an "accelerated approval pathway," to give "patients suffering from a serious disease earlier access to drugs when there is an expectation of clinical benefit despite some uncertainty about the clinical benefit of the drug."
But there is a lot of sobering news accompanying this announcement:
First, the mechanism of delivery: monthly intravenous infusions, which means a clinical visit lasting at least an hour per infusion.
Second, Biogen's own predictions about cost: a "list price" predicted to average $56,000 per year per patient! Yikes.
Third, the critical response from a range of experts in relevant research, pharmacy and health fields about the approval process to date, indicating a history of interruptions in the clinical trials when preliminary results showed little to no evidence of clinical benefit.
Fourth: the need for assessment before the first infusion with an MRI, plus recommended follow up MRIs prior to the 7th and 12th infusions, to assess the potential for ARIA-H, which are amyloid-related abnormalities, also potentially associated with edema in the brain.
Here are some links (and I'll try to keep this list up-to-date as new info comes in):
STAT's commentary, dated June 7, 2021 on FAQs: What You Need to Know about the Alzheimer's Drug Aduhelm
New York Times, dated June 8, 2021: FDA Approves Alzheimer's Drug Despite Fierce Debate Over Whether it Works
June 8, 2021 in Cognitive Impairment, Consumer Information, Current Affairs, Dementia/Alzheimer’s, Ethical Issues, Federal Statutes/Regulations, Health Care/Long Term Care, Medicare, Science, Statistics | Permalink | Comments (0)