— Andrew Joseph, STATNews

— Michael Rubinkam, Associated Press

— Approval’s opponents stress drug’s lack of proven efficacy

— Alzheimer’s Association defends its support

— FDA officials explain their decision

— Contradictory trials fuel controversy

— AD drug costs cause payer shudders

— Medicare faces coverage options

The first half of 2021 ended with two major federal health policy developments: First, in the wake of a an end-of-term Supreme Court decision, Obamacare got to live on as the court rejected yet another, and probably final, judicial challenge to the ACA’s existence. While decided on procedural grounds the 7-2 decision spanned the court’s ideological spectrum, from newly installed conservative Justice Barrett to liberal Justices Breyer, Kagan, and Sotomayor.

Editor’s Note: As Caregiving Policy Digest neared publication two significant developments occurred regarding the FDA’s controversial approval of the Alzheimer’s disease drug aducanumab (Aduhelm). First, responding to considerable public pressure, the agency announced it was revising the drug’s original no-limits prescribing label to narrow usage to patients with early-stage symptoms of the disease — the cohort that was studied in the pre-approval trials. Second, in a highly unusual move, reported by a STATNews team, FDA’s acting commissioner “asked the independent Office of the Inspector General to investigate how agency staff interacted with Biogen in the run-up to the June 7 approval of Aduhelm. The agency cited STAT’s reporting that FDA officials worked hand in hand with Biogen executives to get the drug on the market, including an off-the-books meeting and an unprecedented decision to approve Aduhelm through a regulatory shortcut.” We will continue to follow the ongoing fallout surrounding Aduhelm in coming issues.

While the ACA’s go-ahead garnered its share of news coverage, June’s biggest patient and caregiver development no doubt concerned the Food and Drug Administration’s approval for Biogen’s controversial Alzheimer’s disease amyloid fighter Aduhelm (aducanumab). How controversial? For one thing three members of the unanimous advisory panel voting against FDA approval were upset enough to resign. Public Citizen deemed the decision bad enough to warrant the immediate replacement of the agency’s commissioner. “Aducanumab,” wrote advisory panel member Dr. G. Caleb Alexander, along with neurologist Michael Greicius, “is seen as a potential medication for the roughly two million Americans with mild Alzheimer’s-related cognitive decline. It is one in a series of experimental treatments that involve injecting patients with an antibody meant to remove fragments of brain beta amyloid, a protein considered critical to the development of Alzheimer’s. Several of these possible treatments have been shown to reduce brain levels of amyloid. However, none of these antibodies, including aducanumab, have demonstrated a convincing effect on slowing progression of the disease. Despite this, Biogen has done everything it can in news releases and investor reports, and at scientific conference presentations, to explain away the uncomfortable and disappointing fact that this product has not been proved to work. Biogen says that the results from the failed trial would have been positive had investigators followed the patients longer and that analysis of a subset of patients with longer exposure to the high dose in the second trial supports the positive findings of the first trial. But this post hoc justification simply cannot replace additional, well-designed, blinded, placebo-controlled randomized trials. Given our lack of effective treatments, some may argue that aducanumab is better than nothing. We strongly disagree. In the aducanumab trials, three out of 10 patients exposed to a high dose had brain swelling as a complication, and although this was usually asymptomatic, in some patients it led to confusion, disorientation and falls. The swelling was detected with the use of rigorous safety screening, including routine M.R.I. scans. Such regular screening is unlikely to occur outside of the clinical trials, and because similar symptoms can be seen in progressive Alzheimer’s, distinguishing these adverse effects from disease progression would be especially difficult.”

Taking strong exception to aducanumab’s critics, Alzheimer’s Association CEO Harry Johns told STATNews’ Andrew Joseph that “We came to the conclusion that the science was sound for what is a very large population of people who have not had treatment. Now, clearly, this is not a cure, and it is a marginal difference for people, but a marginal difference can make a real difference for people who have only the devastation of Alzheimer’s to look to. So looking at all the science, looking at all the impact, we chose to strongly endorse approval. The successful trial — and there was a successful trial — showed 22% improvement in what is effectively the cognitive functional side of people’s lives. FDA ultimately approved on what is the amyloid clearance, but the trial showed that for people with mild cognitive impairment due to Alzheimer’s disease or first-stage Alzheimer’s dementia, it can make a difference. And that difference for people who otherwise are going to decline is real. Most of the trials, if not all of the trials, with amyloid-clearing drugs are dose escalated. So if you look at the timeline at what occurred, the dose was escalated not all that long before they pulled the futility data. Then it took time for them to do the analysis. So in that time that they did the analysis, people had dose escalation for a longer period. Those are the people who appear to have benefited. This is all consistent with years of accumulated science on Alzheimer’s, and particularly on amyloid as an approach. So, with this trial it would be reasonable to assume that it would actually be beneficial if it went longer.”

For their part, FDA officials who made the final call on aducanumab argued in The Washington Post that “The decision to approve this drug was based on rigorous science, with thorough evaluation of data from clinical studies. The FDA conducted an extensive review of current and relevant scientific literature and carefully considered feedback from the advisory committee. The evidence was complicated and, in some instances, contradictory. After reviewing the data, we concluded evidence from the trials did not, on its own, convincingly demonstrate a clinical benefit and did not meet the standard for ‘regular’ approval. That’s what we heard from the advisory committee, and we agreed. However, as we continued our review, we concluded that the data met the standard for accelerated approval. This pathway is available under federal law when a drug intended for a serious disease is expected to provide a meaningful advantage over available treatments. A drug may be approved under this pathway when it is shown to improve a measure of a disease and when it is ‘reasonably likely’ that this measure predicts clinical benefit. While aducanumab’s trials suggested — but did not confirm — clinical benefit, they did convincingly and consistently show that the drug reduces amyloid plaque in the brain, a defining pathological characteristic of Alzheimer’s disease. Based on extensive analyses of the data from the aducanumab program, and a thorough review of publicly available information, we concluded that the reduction in amyloid plaque correlates with slowing of disease progression and is reasonably likely to predict clinical benefit.”

“The crux of the controversy over aducanumab,” write The New York Times’ Pam Belluck and Rebecca Robbins, “involved two Phase 3 trials with results that contradicted each other: One suggested the drug slightly slowed cognitive decline while the other trial showed no benefit. The trials were stopped early by a data monitoring committee that found the drug didn’t appear to be showing any benefit. Consequently, over a third of the 3,285 participants in those trials were never able to complete them. Biogen later said that it had analyzed additional data and concluded that in one of the trials a high dose could delay cognitive decline by 22 percent or about four months over 18 months. In the trial’s primary measurement, the high dose appeared to slow decline by 0.39 on an 18-point scale rating memory, problem-solving skills and function. A lower dose in that trial, and high and low doses in the other showed no statistically significant benefit over a placebo.”

As if the question of efficacy weren’t enough, the projected annual per patient cost of $56,000 is causing shudders among payers, most notably Medicare. “If just 500,000 Medicare recipients are prescribed Aduhelm, it would cost the program nearly $29 billion a year, far more than any other medication,” according to a research report published by the Kaiser Family Foundation. ‘At this price,’ said KHN’s Tricia Newman in an Associated Press article, ‘the cost of this one drug alone could top all others covered by Medicare, if it is used widely.’ In addition to higher taxpayer costs, the Kaiser analysis found that domino effects would include higher ‘Part B’ premiums for Medicare’s outpatient coverage and increases in monthly premiums for millions with supplemental ‘Medigap’ plans. As an infusion drug that would be administered in a doctor’s office, Aduhelm is covered by Medicare’s outpatient care benefit. The Part B standard premium, paid by most enrollees, is currently $148.50 a month. Beyond monthly premiums, there would also be impacts on out-of-pocket costs. Many patients taking the medication, including those signed up in Medicare Advantage plans from private insurers, could face thousands of dollars in copayments. The maximum could reach about $11,500, researchers estimated, well beyond the budget of a typical Medicare enrollee. ‘Because Aduhelm is not a cure for Alzheimer’s disease,’ the Kaiser report noted, ‘patients could incur these annual out-of-pocket costs over multiple years.’”

All that is not to say that Medicare lacks any tools to restrict the outlays for Aduhelm. “Among the most extreme options,” report The Wall Street Journal’s Joseph Walker and Thomas M. Burton, “CMS could decide not to cover if it determines the drug falls short of being reasonable and necessary treatment, according to Memorial Sloan Kettering’s Dr. Peter Bach. CMS has rarely made such a move for a drug before, though it has for other medical products. Denial of coverage would likely cause an uproar from patients. A more likely option, said Anand Shah, a former senior official with Medicare and the FDA is that CMS standardizes the criteria through what it calls a national coverage determination, for which it will pay for Aduhelm across the program’s nearly 59 million enrollees. Aduhelm’s cost and the ‘absence of consensus among clinicians,’ said Shah, ‘may tilt the agency towards limiting access only to certain patients.’ Private health insurers that administer the Part B benefit also could place restrictions on Aduhelm’s use, which could mean who gets access would vary by region or insurer. (Finally) Medicare may insist that patients getting Aduhelm become part of a CMS-ordered study that would seek to evaluate which patients it benefits or harms in the real world, and what the electronic and other evidence is.”

With Obamacare rendered secure by the Supreme Court, there remains a gaping coverage hole resulting from the refusal of 12 states to expand Medicaid coverage for millions of their low-income residents. “Fixing the Medicaid expansion gap,” writes The New York Times’ Sarah Kliff, “may face long political odds because it targets benefits to a smaller group of people in states that typically vote Republican. Only three Democratic senators — Jon Ossoff and Raphael Warnock, both of Georgia, and Tammy Baldwin of Wisconsin — represent a state that hasn’t expanded Medicaid. ‘If you were thinking in strictly political terms, advocating for Medicare expansion has a lot more political gold than Medicaid expansion,’ said Joaquin Castro, a Democratic congressman from Texas, which has nearly 1.5 million people shut out of Medicaid eligibility, the most of any state. ‘But that is why we as Democrats need to redouble our efforts to focus on this vulnerable population.’ Recent efforts to bring the expansion to more states have struggled. After Medicaid voter initiatives succeeded in a few states, some other holdout states changed their process to make it harder to secure spots on the ballot. In Mississippi, ballot efforts were recently abandoned after the state’s Supreme Court stopped the ballot initiative process until legislators and voters changed the state’s constitution. Missouri voters passed a Medicaid expansion ballot last summer, but the state’s Republican-led legislature refused to appropriate funding. A state judge ruled in the Missouri government’s favor ..., meaning the program will not go forward as planned on July 1. Medicaid expansion supporters plan to appeal.”

For those seeking to expand the Medicaid safety net, one state has just become a bright spot. “Oklahoma voters,” the Associated Press’ Sean Murphy and Ricardo Alonso-Zaldivar report, “approved coverage expansion — after a decade of Republican resistance in a state that has become emblematic of the political struggle to extend the federal health insurance program in conservative strongholds. More than 123,000 low-income people already have been approved for Medicaid coverage in Oklahoma, a state where nearly 15% of the population has been uninsured — the highest rate in the nation behind Texas, according to the Kaiser Family Foundation. State Medicaid officials say they expect that number to increase to more than 200,000 as more people get approved. Oklahoma voters narrowly approved a constitutional amendment last year to expand eligibility for benefits. Now, an individual who earns up to $17,796 annually, or $36,588 for a family of four, qualifies for Medicaid health care coverage. By contrast, the median income limit for parents in states that didn’t expand their program is about $8,905 for a family of three, according to the Kaiser Family Foundation.”

“For surprise medical bills,” write The New York Times’s Sarah Kliff and Margot Sanger-Katz, “it’s the beginning of the end.” Pursuant to the ban recently enacted by Congress, the Biden administration has published the first set of regulations finalizing the measure set to go into effect early in 2022 (while the regulations are effective immediately, public comments will be accepted within 60 days of publication). “Some experts see the policy as the most important consumer protection in health care to come out of Washington in more than a decade. Outlawing surprise medical bills was the rare health policy that garnered widespread and bipartisan support on Capitol Hill. Legislators were spurred on by numerous stories of patients who faced thousands of dollars in debt for bills they never could have prevented.” As CMS explains in its announcement, the rule will:

Rare signs of congressional bipartisanship also characterized two recently introduced legislative measures. The first: a push to make telehealth services available after the end of the COVID-19 public emergency. “The Connect for Health Act,” writes The Washington Post’s Alexandra Ellerbeck, “would permanently remove geographic restrictions on telehealth, allow patients to do visits from their homes and grant the Health and Human Services secretary the permanent authority to waive telehealth restrictions. The bill is strongly bipartisan. Of the 57 co-sponsors on the bill, about half are Democrat and half are Republican. ‘Especially on health care, Democrats and Republicans have not seen eye-to-eye on anything at all for more than a decade. The single shining exception to that is telehealth,’ said Hawaii Sen. Brian Schatz, the bill’s lead author. Other lawmakers, however, want to take a more cautious approach. Rep. Lloyd Doggett (D-Tex.), chairman of the Ways and Means health subcommittee, has said that he intends to introduce legislation that would lift regulatory restrictions on telehealth, but only on a temporary basis. Doggett said that his bill to extend telehealth waivers through 2022 would give experts and regulators an opportunity to gather more data on telehealth and fashion a far-reaching proposal with more evidence. Doggett points out that the Medicare Payment Advisory Commission has recommended a limited extension. ‘[Our] understanding of the impact of telehealth is largely limited to data and experience covering only a few months during a once-in-a-century pandemic.’”

The second measure garnering widespread support comes in response to the devastating SNF lockouts of family caregivers during the pre-vaccine days of the COVID-19 pandemic. “When the public health emergency was announced in March 2020,” the Center for Medicare Advocacy observes, “families were absolutely and completely barred from facilities. Residents were isolated in their rooms. Families and studies reported enormous physical and mental declines in residents as a result of isolation, loneliness, and neglect. Many residents died alone. The Essential Caregivers Act (H. R. 3733) says unequivocally that the government cannot ever again totally ban families. Regardless of any public health emergency, the bill guarantees that all residents can choose up to two people as essential caregivers who can provide them with assistance 12 hours each day and for an unlimited number of hours at the end of a resident’s life.” (Video coverage of the June 30 bill introduction is available here.)

Pres. Biden’s ambitious plans to expand home and community-based services (HCBS) are not faring so well on Capitol Hill. Seeking to spur their fruition, possibly via a Democratic-controlled reconciliation package, high-ranking Democratic lawmakers in the House and Senate have introduced the Better Care Better Jobs Act. “For too long, seniors and Americans with disabilities who want the choice of good quality long-term care at home and the workers who provide it have gotten short shrift. This bill lays out a transformational investment through Medicaid that will begin to set that right so receiving good quality care in the comfort and safety of home is a real possibility. It is also critical that the workforce who provides home care receive a livable wage, and that family caregivers have more supports when they provide care to their loved ones,” said Senate Finance Committee Chairman Ron Wyden, an original Senate cosponsor of the bill. The Better Care Better Jobs Act would:

The severe impact of COVID-19 on the availability of nursing home staff is documented in a survey conducted by the industry’s lobbying arms. Ninety-four percent of surveyed long-term care facilities have faced staff shortages, according to the American Health Care and Association and National Center for Assisted Living. Key findings include:

Staff shortfalls are affecting not only long-term care facilities; seniors, reports Kaiser Health News’ Phil Galewitz, are waiting months for desperately needed home care. “The need is undeniable, underlined by the math, especially in places like Maine, where 21% of residents are 65 and older. ‘It’s backbreaking work,’ said Kathleen McAuliffe, a home care worker in Biddeford, Maine, who formerly worked as a Navy medic and served in the Peace Corps. She provides homemaker services for a state-funded program run by Catholic Charities. She usually visits two clients a day to help them with chores like cleaning and scrubbing floors, wiping down bathrooms, vacuuming, preparing meals, food shopping, organizing medicines and getting them to the doctor. Her clients range in age from 45 to 85. ‘When I walk in, the laundry is piled up, the dishes are piled up, and everything needs to be put in order. It’s hard work and very taxing,’ said McAuliffe, 68. She makes about $14 an hour. Though the job of taking care of the frail elderly requires broad skills — and training in things like safe bathing — it is generally classified as ‘unskilled’ labor. Working part time, she gets no vacation benefits. ‘Calling us homemakers sounds like we are coming in to bake brownies,’ she said. The American Rescue Plan, approved by Congress in March, provides a 10-percentage point increase in federal Medicaid funding to states, or nearly $13 billion, for home and community-based services. The money, which must be spent by March 2024, can be used to provide personal protective equipment to home care workers, train workers or help states reduce waiting lists for people to receive services. For Maine, the bump in funding from the American Rescue Plan will provide a $75 million increase in funding. But Paul Saucier, aging and disability director at the Maine Department of Health and Human Services, said the money will not make the waitlists disappear, because it will not solve the problem of too few workers.”

Amid all the coverage of the aducanumab controversy, news of an unrelated Alzheimer’s disease research finding offers the tantalizing spector of simplified pre-onset AD diagnosis. “A simple blood test,” reported MedPage Today’s Judy George, “coupled with brief memory tests showed who will develop Alzheimer’s disease in the future with a high degree of accuracy. Combining plasma phosphorylated tau (p-tau), APOE genotype, and scores from 10-minute executive function and memory tests predicted Alzheimer’s disease onset within two to six years among people with memory complaints with 90% certainty, according to Oskar Hansson, M.D., Ph.D., and Sebastian Palmqvist, M.D., Ph.D., both at Lund University in Sweden. When dementia experts examined the same patients, they were about 71% accurate, the researchers noted. ‘The algorithm is being developed for clinics without access to advanced diagnostic instruments,’ Palmqvist said in a statement. ‘In the future, the algorithm might therefore make a major difference in the diagnosis of Alzheimer's within primary healthcare. As of now, it's been tested only on patients who have been examined in memory clinics. Our hope is that it will also be validated for use in primary healthcare as well as in developing countries with limited resources.’”

As noted above, while the Biden administration and Democratic lawmakers continue to push for a major expansion of HCBS resources, a significant pot of money for such care already exists courtesy of the American Rescue Plan Act of 2021 (ARPA). ARPA, AARP explains in a concise guide to the newly available funds, “establishes a temporary enhanced Federal Medicaid Assistance Percentage (FMAP) of 10 percent for eligible state HCBS expenditures spent by states between April 1, 2021 to March 31, 2022. The law stipulates that the FMAP must be used to supplement (not supplant) current state HCBS spending, and to enhance, expand, or strengthen home and community-based services under a state’s Medicaid program. States are currently at work preparing their initial HCBS spending plans and HCBS spending narratives. The preparation of these plans is made more difficult in that the amount of enhanced federal funding involved is currently estimated at around $12.7 billion, with many states receiving more than $100 million in new funding for HCBS services that must be spent over the April 1, 2021 through March 31, 2024 timeframe. While the amount of new funding is considerable, states may be hesitant to make long-term commitments to HCBS program expansions that they must continue to meet after they fully utilize the ARPA funds. Thus, many states are looking to make shorter-term investments in their HCBS infrastructures that will contribute to more efficient delivery of HCBS services and higher quality outcomes for Medicaid beneficiaries. Undoubtedly, there will be ongoing conversations between all the states, advocacy groups, Congress, and CMS as this significant expansion in federal funding for HCBS services proceeds. But as stakeholders work through the details, a certain element of perspective should not be lost: This is an unprecedented opportunity for states to pick of the pace of balancing their LTSS systems.”

There have been so many COVID-19 losses among the nation’s elderly population — including, it now increasingly becomes clear, survivors’ physical strength. As Kaiser Health News’ Judith Graham writes, “No large-scale studies have documented the extent of this phenomenon. But physicians, physical therapists and health plan leaders said the prospect of increased impairment and frailty in the older population is a growing concern. ‘Anyone who cares for older adults has seen a significant decline in functioning as people have been less active,’ said Dr. Jonathan Bean, an expert in geriatric rehabilitation and director of the New England Geriatric Research, Education and Clinical Center at the Veterans Affairs Boston Healthcare System. Bean’s 90-year-old mother, who lives in an assisted living facility, is a case in point. Before the pandemic, she could walk with a walker, engage in conversation and manage going to the bathroom. Now, she depends on a wheelchair and ‘her dementia has rapidly accelerated — she can’t really care for herself,’ the doctor said. Bean said his mother is no longer able to benefit from rehabilitative therapies. But many older adults might be able to realize improvements if given proper attention. ‘Immobility and debility are outcomes to this horrific pandemic that people aren’t even talking about yet,’ said Linda Teodosio, a physical therapist and division rehabilitation manager in Bayada Home Health Care. Teodosio said she and her staff have seen a ‘tremendous increase’ in falls and in the exacerbation of chronic illnesses such as diabetes, congestive heart failure and chronic obstructive pulmonary disease. ‘Older adults got off schedule during the pandemic,’ she explained, and ‘they didn’t eat well, they didn’t hydrate properly, they didn’t move, they got weaker.’ In California, SCAN Health Plan serves a vulnerable population of nearly 15,000 older adults dually eligible for Medicare and Medicaid through its Medicare Advantage plans. That’s how 87-year-old Ronald Lundquist in Palm Springs connected with Jerry Payne, 79, a peer advocate who calls him regularly and helped him come up with a plan to emerge from his pandemic-induced funk. A month ago, Payne had a Fitbit sent to Lundquist. At first, Lundquist walked about 1,500 steps a day; now, he’s up to more than 5,000 steps a day and has a goal of reaching 10,000 steps. ‘I’m sleeping better and I feel so much better all around,’ Lundquist said. ‘My whole attitude and physicality has changed. I tell you, this has been an answer to my prayers.’”

If telehealth expansion marks the most visible healthcare adaptations spawned by COVID-19, hospital care at home could be on the cusp of a similar spurt. “Home administered hospital level services,” writes Kaiser Health News’ Julie Appleby, “is poised to grow after more than a decade as a niche offering, boosted both by hospitals eager to ease overcrowding during the pandemic and growing interest by insurers who want to slow health care spending. But a host of challenges remain, from deciding how much to pay for such services to which kinds of patients can safely benefit. Under the model, patients with certain medical conditions, such as pneumonia or heart failure — even moderate COVID — are offered high-acuity care in their homes, with 24/7 remote monitoring and daily visits by medical providers. In the latest sign that the idea is catching on, two big players — Kaiser Permanente and the Mayo Clinic — announced plans this month to collectively invest $100 million into Medically Home, a Boston-based company that provides such services to scale up and expand their programs. The two organizations estimate that 30% of patients currently admitted to hospitals nationally have conditions eligible for in-home care. Several other well-known hospital systems launched programs last summer. They join about two dozen already offering the service, including Johns Hopkins Medicine in Baltimore, Presbyterian Healthcare Services in New Mexico and Massachusetts General Hospital. But hospitals have other financial considerations that are also part of the calculation. ‘Hospitals that have surplus capacity, whether because they have newly built beds or shrinking populations or are losing business to competitors, are not going to be eager about this,’ said Dr. Jeff Levin-Scherz, co-leader of the North American Health Management practice at consultancy Willis Towers Watson. (Nevertheless) ‘We’re seeing tremendous momentum,’ said Dr. Bruce Leff, a Johns Hopkins Medical School geriatrician who has studied and advocated for the hospital-at-home approach since he helped establish one of the nation’s first programs in the mid-1990s. Leff and other proponents say various studies show in-home care is just as safe and may produce better outcomes than being in the hospital, and it saves money by limiting the need to expand hospitals, reducing hospital readmissions and helping patients avoid nursing home stays. Gerard Anderson, a health policy professor at Johns Hopkins University Bloomberg School of Public Health, said hospitals likely see the potential, long term, for ‘huge profit margins’ through ‘saving a lot of capital and personnel expense by having the work done at home.’ But Anderson worries that broad expansion of hospital-at-home efforts could exacerbate health care inequities. ‘It’s realistic in middle- and upper-middle-class households,’ Anderson said. ‘My concern is in impoverished areas. They may not have the infrastructure to handle it.’”

Polypharmacy is in the news again. “The last straw for Leslie Hawkins,” writes The New York Times’ Paula Span, “was her mother’s 93rd-birthday gathering in 2018. Her mother, Mary E. Harrison, had long contended with multiple health problems, including diabetes and the nerve pain it can cause; hypertension; anxiety; and some cognitive decline. She was prone to falling. ‘She was out of it,’ recalled Ms. Hawkins, 57. On her mother’s birthday, she said, ‘A bunch of us went to Olive Garden, and Mommy sat there asleep, slumped over in her wheelchair. I decided, nope.’ Ms. Hawkins and one of her brothers took their mother to see a geriatrician at Johns Hopkins Hospital. ‘She didn’t really participate,’ said the geriatrician, Dr. Stephanie Nothelle. Fortunately, Ms. Hawkins had brought a list of the 14 medications Ms. Harrison was taking, several of which alarmed her new doctor. ‘I started chipping away at them,’ Dr. Nothelle said. ‘Fourteen prescriptions? Unfortunately, that’s pretty common for older patients’ The phenomenon is called polypharmacy, sometimes defined as taking five or more medications, as two-thirds of older people do. For older patients, the most commonly prescribed inappropriate medicines include proton pump inhibitors like Nexium and Prilosec, benzodiazepines like Xanax and Ativan, and tricyclic antidepressants, according to an analysis of Medicare data published last year. Over-the-counter products and supplements can also prove problematic. ‘We spend hundreds of millions every year to bring meds to market and figure out when to start using them, and next to nothing trying to figure out when to stop them,’ said Dr. Caleb Alexander, an internist and epidemiologist at the Johns Hopkins University School of Medicine. Yet among older people, adverse drug reactions account for one in 11 hospital admissions.”

“Hence,” Span continues, “the Drive to Deprescribe campaign, launched last month by the Society for Post-Acute and Long-Term Care Medicine, known as AMDA, which represents medical directors and administrators of long-term care facilities, where polypharmacy is particularly prevalent. The initiative calls for a 25 percent reduction in medication use within a year, with AMDA monitoring the results. ‘An ambitious goal,’ said Dr. Sabine von Preyss-Friedman, co-chair of the Drive to Deprescribe work group. ‘But if you only do a little here and a little there, you don’t move the needle.’ To date, 2,000 facilities have enrolled, along with three major consulting pharmacies that serve them. That represents a fraction of the nation’s 15,000 nursing homes, with several large chains unrepresented, but ‘we are still recruiting,’ Dr. von Preyss-Friedman said. Another milestone in the polypharmacy battle: the U.S. Deprescribing Research Network, established in 2019 and funded by the National Institute on Aging. So far, it has awarded nine grants to test effective deprescribing strategies. ‘Stopping a medication is not just the reverse of starting one,’ said Dr. Michael Steinman, a geriatrician at the University of California, San Francisco, and co-director of the network. ‘It’s often much harder.’ Inertia can easily take over, with prescriptions being refilled year after year without anyone exploring why they were initially written, whether one drug duplicates another or whether the medications remain necessary or effective.”

One particularly devastating consequence of wrongfully or overly prescribing for aging patients is the increased risk of falls. As The Washington Post’s Marlene Cimons reports, “In 2017, an estimated 94 percent of older adults received a prescription for a drug that increased their risk of falling, a startling increase from 57 percent in 1999. The rate of death caused by falls in older adults more than doubled during the same time period. ‘These drugs are doing what they are supposed to be doing, but also are working off target,’ says Amy Shaver, a postdoctoral researcher at the University of Buffalo School of Public Health and Health Professions, and lead author of a recent study that yielded the findings. ‘There are valid reasons to prescribe them. But they can be problematic.’ Experts aren’t suggesting that physicians stop prescribing or — in the case of OTC products — stop recommending these drugs. ‘But patients should ask about side effects,’ Shaver says. ‘They should make sure all their doctors know all the drugs they are on, which often is not the case, particularly if they take more than one. They may get one drug from a specialist and another from their primary care physician, and they end up with medications that have interactions — but their providers don’t know about them. Even if they have been on a medication for a while, they need to remain vigilant and look for the warning labels on their medications and ask questions.’ Greg Rhee, assistant professor of medicine (in psychiatric epidemiology) and public health (in health policy and management) at the University of Connecticut School of Medicine, also suggests that prescribers look for safer options, if they exist, particularly among anticholinergic drugs. These are medications that block the action of the neurotransmitter acetylcholine, which can cause involuntary muscle contractions. Doctors typically prescribe them for urinary, respiratory, and gastrointestinal disorders, and also for treating depression. Rhee has studied the effects of anticholinergic drugs. He says they can cause cognitive impairment — including memory problems — dementia, drowsiness, sedation, even hallucinations, all of which can increase the possibility of falls.”

Punctuating the concerns about prescribing practices, AARP’s Public Policy Institute has recently published a study documenting the widespread concurrent use of anticholinergic and acetlylcholinesterase inhibitor drugs among older adults with dementia. “Commonly done; never advised,” the study authors write. “Acetylcholine is the main neurotransmitter in the body. It functions to activate muscles and has an important role in attention, learning, memory and motivation. Anticholinergic drugs block the transmission of acetylcholine in the central and peripheral nervous systems, while Acetylcholinesterase inhibitors (AChEIs) increase its availability by blocking the enzyme (acetylcholinesterase) that breaks it down. The concurrent prescribing of anticholinergics and AChEIs is considered to be a ‘never event’ — that is, a medical error that should never occur because the two drugs have opposing mechanisms of action. There is strong evidence of a link between anticholinergic drugs and impaired physical functioning, cognitive decline, and even death among older adults, and the American Geriatrics Society flags them for extra caution. Nonetheless, anticholinergic drugs are widely prescribed for older adults. Anticholinergic drug use is even more problematic among older adults with dementia who take acetylcholinesterase inhibitors (AChEIs) to slow the progression of their symptoms. AARP’s study was designed to determine if anticholinergic use among older adults with dementia taking AChEI puts them at higher risk for adverse outcomes and concludes that it does. Older adults with dementia who had concomitant anticholinergic and AChEI use were 18 percent more likely to experience a fall, 16 percent more likely to have a fracture, and 25 percent more likely to have a traumatic brain injury (TBI) than those taking AChEI alone. Nearly one-third (29 percent) of adults ages 65 years and older in the sample who were taking AChEI drugs for dementia were concurrently prescribed anticholinergic drugs for 30 or more days.”

AARP has revisited the subject of family responsibilities discrimination (FRD), reporting that “the number of lawsuits filed by employees claiming they’ve been discriminated against due to caregiving has increased significantly. In addition to being targeted for layoffs and denied leave, caregivers say they are receiving unfairly negative evaluations, punitive workloads, and schedule changes designed to force them to quit. Is it illegal for an employer to treat an employee poorly because the employee cares for a family member? The answer is a confusing ‘probably.’ A caregiver’s legal rights depend on the city and state where they work. An earlier study, Caring Locally for Caregivers, released by the AARP Public Policy Institute and the Center for WorkLife Law at UC Hastings Law, uncovered family responsibilities discrimination laws that protect family caregivers in Delaware and 32 local jurisdictions of all sizes, from New York City and San Francisco to Champaign, Illinois, and Adrian, Michigan. And 52 more local jurisdictions have FRD laws that might cover caregiving for adult family members; the laws are silent about what types of caregiving are protected. More FRD laws are needed to ensure protection of caregivers as the number of employees providing care — already a whopping 25 million — continues to grow. Some legislative action is already underway. A bill to prohibit FRD was introduced in the U.S. Senate in the last Congress by Sen. Cory Booker (D-NJ) and is expected to be re-introduced in 2021. A good first step for advocates would be to focus on jurisdictions that have laws that protect some caregivers but that fail to cover (or are unclear about whether they cover) caregivers for adults. An amendment that defines the terms used in the law may not be difficult to pass, and model language exists.”

Another new study from AARP highlights the financial strain family members experience from contributing to loved ones’ care. Three-quarters of the family caregivers surveyed reported spending an average of $7,242 annually on out-of-pocket costs related to caregiving, “AARP's new report shows the stark reality family caregivers face today,” said Nancy LeaMond, chief advocacy and engagement officer for AARP. “While financial challenges cross all segments of society, they hit hardest for Hispanic/Latino, African American and younger caregivers — as well as those caring for loved ones with dementia. Family caregivers are the backbone of America's long-term care system, and that backbone is breaking.” The Caregiving Out-of-Pocket Costs study surveyed nearly 2,400 family caregivers of various ages and ethnicities from March 15 to April 25, 2021. Contributing to a loved one's housing expenses — paying for rent, mortgage, assisted living, home modifications and more — accounted for more than half of all costs incurred by caregivers surveyed. Medical expenses added up quickly, too. One-fifth of caregiver spending, more than $1,200 per year, went to direct payments for health care providers, hospitals, therapists, medical equipment and devices, in-home care, and adult day care. Family caregivers, Leamond notes, are struggling financially, spending over a quarter of their income to care for parents, spouses and other loved ones. Many are at the breaking point; some are drowning in debt. They desperately need direct support to defray the cost of caring.”

Add one more role that Zoom and other online conferencing tools have performed during the pandemic: enabling nursing home residents to testify on their own behalf before legislative bodies. As Kaiser Health News’ Susan Jaffe writes, “Patty Bausch isn’t a Medicaid expert, lawyer or medical professional. But she still thinks Connecticut legislators need her input when they consider bills affecting people like her — the roughly 18,000 residents who live in the state’s nursing homes. With help and encouragement from Connecticut’s Long-term Care Ombudsman Program, Bausch signed up and testified remotely before a legislative hearing this year. Speaking into an iPad provided by the ombudsman’s office, Bausch testified without ever leaving her room at the Newtown Rehabilitation & Health Care Center, where she has lived since having a stroke three years ago. Bausch explained why she supported a $12.50 raise in the $60 monthly allowance the state provides Medicaid residents to pay for personal items, such as toiletries, phone bills or even a greeting card. Her words reflected experience few other witnesses offered. ‘I know what it’s like to have no money,’ she said later. ‘I live it.’ Jeanette Sullivan-Martinez, who has lived at the Pendleton Health & Rehabilitation Center in Mystic, Connecticut, since 2008, has testified in person and virtually as president of the Statewide Coalition of Presidents of Resident Councils. She has multiple sclerosis, limited movement in her arms and hands and is unable to walk. When she testified in person in 2019, she was accompanied by a nursing aide and made the hour-long trek to Hartford and back in a van that could accommodate her wheelchair. When Sullivan-Martinez testified using her tablet this year, all she needed was someone to help her connect to the hearing from her nursing home room. With several dozen witnesses scheduled before her, she also made sure it was plugged in so the battery wouldn’t run down during the long wait.”

Early in his training, Dr. Ian R. Ross’s encounter with an intermittently delirious hospital patient provided an indelible lesson in the “frailty of personhood and how humanistic care can be a guiding light through the fog. An acute confusional state robs patients of their awareness, inhibitions, and character. But this process often starts with the loss of dominion over one’s own body inherent in hospitalization. A complete stranger, wielding a constricting blood-pressure cuff or sharp needle, may enter one’s room unannounced at any time. Sleep is interrupted by the alarm on an infusion pump or the checking of vital signs every four hours. Fall precautions and busy staff prevent patients from moving around regularly or at will — they may remain in bed for much of the day. Even the choice of what to eat can be taken away. The cumulative result is dehumanization. In the hospital, we physicians often meet our patients at the worst moments of their lives: they may be exhausted, in pain, and separated from their normal support systems. They are at their most vulnerable even before delirium strips them of what remains of their dignity. Finding common ground with our patients can sometimes be sobering and unsettling, but it can also help humanize our care. An opening for personhood can take many forms — requesting art or music therapy for a creative patient, for example, or pet therapy for a patient who longs to hold their dog, or arranging for a hospitalized veteran to be visited by an active service member. Although delirium is commonplace, we cannot forget how devastating it can be for each person who experiences it.”

The New York Times’ Ted Alcorn translates the growing shortage of home care workers into a wrenching account of Andy Maskin and Chloe Meads’ seemingly insurmountable task of keeping Henry, their severely disabled seven-year-old son, alive. “Since infancy, Henry, who has spinal muscular atrophy, a rare muscle-wasting disorder, has had intensive, round-the-clock nursing at home, with Ms. Mead and her husband serving as fall backs when a nurse unexpectedly cancels a shift. But the recent shortage of home-care nurses has forced the couple, who live in Queens, to handle longer and longer periods on their own — as many as 36 hours at a stretch. By this spring, gaps appeared. Ms. Mead said that when she called her home care agency, they responded, ‘We have nobody.’ To make matters worse, her daughter had recently been diagnosed with Type 1 diabetes, so the couple now had to look after two children with life-threatening conditions. The recurrent all-nighters have stretched both parents thin. ‘I would like to believe that I’m always going to be 100 percent sharp, but what if I’m so exhausted that I make a mistake with something?’ Ms. Mead asked. For single parents, the difficulties are compounded. Sarin Morris, a 40-year-old mother in Clifton, N.J., has sole responsibility for her 4-year-old, Sam, whose rare neurological disorder has left him on a ventilator and prone to seizures. He is prescribed 20 hours a day of nursing care but has never had nurses to cover it all. Weekends are the worst, she says. She has struggled to get any nursing coverage at all, and from Saturday night to Monday morning she is alone with her son, sometimes lying in bed beside him so his seizures will wake her if she dozes off. When a nurse finally relieves her, she rests a few hours before heading to work. ‘It’s a nightmare,’ she said. ‘I don’t remember the last time I got a full night’s sleep in my bed.’ Out of desperation, Ms. Morris has considered enrolling in nursing school, in hopes of earning a living at her son’s bedside. But Ms. Morris is daunted by the tuition for the two-year nursing program at a nearby university, over $25,000. Her current job pays $13 an hour, and she has no savings.”

Critical care physician Daniela J. Lamas returns to The New York Times opinion page to make the case, persuasively and eloquently, for more rapid and extensive lifting of family visitation restrictions. “Family members are not just visitors,” she writes, “they are essential members of the care team. Family presence has been shown to decrease delirium, the waxing and waning mental status that can plague patients after critical illness, and those of us at the bedside know the power of a familiar presence for calming an agitated patient. To say nothing of the pain experienced by the family members themselves, these innocent bystanders, forced to wait by the phone and struggle with limited access to the people they love. And yet the rules remain. At my hospital, there are still no family members allowed in the emergency department, whether or not the patient might have the coronavirus. In most cases, people say goodbye to their loved ones at the door, and hope they will be able to see them again soon. Once patients are admitted to the hospital, most are allowed only one visitor daily between certain hours. My colleagues and I, who work in the intensive care unit, find leniency and secure exceptions where we can. But there are unmeasured harms here, too. Looking back, I know that I have fought for some patients and families more than for others. Perhaps it is the family that pushes the most, perhaps it is the family that resonates in some way with my own. It shouldn’t be so arbitrary. That’s why we need rules that allow all our patients to see the people who love them. Until we do, there is a real risk that our exceptions and inconsistencies will deepen the inequities in access that already plague our healthcare system. Hospital policies also need to shift the focus away from the end of life as the time when visitors are most essential. I’ve frequently found myself caring for lonely and scared COVID-19 patients for weeks, just to have them worsen and finally be allowed visitors when they are so sick that they can barely communicate with their loved ones.”

The Associated Press’s Michael Rubinkam gets this issue’s final word on ongoing nursing home visitation restrictions. “A recent survey by National Consumer Voice for Quality Long-Term Care, an advocacy group, found time limits on visits remain commonplace, ranging from 15 minutes to two hours. Some facilities limit visiting hours to weekdays, making it difficult for people who work during the day, or restrict visits to once or twice a week. In Ohio, Bob Greve was desperate for a change of scenery after being cooped up in his Cincinnati-area nursing home for most of the last year. But the administrator wouldn’t permit a visit to his son’s house because of COVID-19 concerns — even though both men are fully vaccinated. The policy led Greve to a ‘breaking point,’ according to his son, Mike Greve, who said his 89-year-old father called six, eight, even 10 times a day out of boredom and frustration and talked constantly about getting out. Mike Greve said he pressed the nursing home administrator for outside forays, only to be told: ‘If I let you take your father out, I have to let everybody else.’ Finally, the administrator called him into the office, offered to allow his father out for a visit and said the policy would be changed for everyone else, too. Father and son spent a glorious afternoon soaking in the sunshine at Greve’s house, where his dad spotted a deer. ‘He said, “Hallelujah” I don’t know how many times,’ Greve said. ‘“I don’t know how you got me out, but I’m so happy I could cry.”’”

Today Was A Good Day — a 25-minute documentary — offers different perspectives on the everyday life of a caregiver, as seen through the eyes of three Southeast Michigan residents who have taken on the many roles and responsibilities of caring for an aging parent. A discussion followed the screening, moderated by FCA Executive Director Kathleen Kelly, and featuring panelists Dr. Paula Duren, Roger Young, and FCA Family Consultant Norell Wheeler. Click here to view the film and panel discussion.

In our primarily English-speaking health care and legal systems, Spanish-speaking family caregivers may find themselves overwhelmed, poorly served, and even mistreated. Fortunately, FCA offers compassionate, evidence-based assistance and support in Spanish at no cost. Family Consultant Adriana Sanchez, who has a master’s degree in clinical counseling, provides Spanish-language services to family caregivers in the San Francisco Bay Area. Continued here and in Spanish here.

The July-August issue of ¿Qué Pasa? is now available. And click here to subscribe! FCA is unique among national caregiver organizations by providing direct support to family and friend caregivers as the Bay Area Caregiver Resource Center — one of the 11 caregiver resource centers in California.

The California Caregiver Resource Centers (CRCs) are proud to provide regular educational and informative events to family caregivers. This is a coordinated effort to offer a wide range of free, virtual programs in multiple languages (Spanish, Cantonese, Mandarin, Vietnamese, Tagalog) and with topics of interest to family caregivers. These programs are open to ALL family caregivers in California. This month’s topics include: health and wellness, financial planning, self-care, and fun interactive activities. A full listing of events is available in a linkable PDF here.

On June 30, FCA, in partnership with the Lewy Body Dementia Association (LBDA) and the Brain Support Network, held an online screening of SPARK with panel discussion. Read more about the film in a Q&A with LBDA Executive Director Todd Graham here. View the SPARK trailer here.

Editor: Alan K. Kaplan, (attorney and health policy consultant)

Contributor: Kathleen Kelly (executive director)

Layout: Francesca Pera (communications specialist)

Send your feedback or questions to akkaplan@verizon.net or info@caregiver.org.

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