Vol. 25, No. 5 | October 2023

Two Separate Worlds 

“For much of the previous year, I watched my mother disappear into a husk of herself in the memory care unit of an assisted-living home. The world is arranged to discreetly conceal this side of life from us. We prefer to see, and very much to be on, the side with well-dressed couples promenading through the streets, eating at elegant cafes, having drinks at bars or clubs, going to cinemas, buying used books and silk scarves. It’s not as if the pretty facade is false and the obverse the ugly truth; it’s all life. We just try, for as long as possible, to keep that other side hidden from ourselves. But at some point, by the end of our lives that other side is the only one we’ll get to see anymore. It’s where we’ll live. We’ll have been banished from the other, lovelier world, because we’ve now become one of the things that need to be concealed. It’s always an odd shock to walk out of a hospital or nursing home back into the supposedly normal world — like walking out of a matinee into bright daylight, reality restored, the clock magically turned back. I still remember how furtively exhilarating it was to punch in the code to release the lock of my mother’s memory care unit and how guilty I felt closing the door against a resident who casually tried to slip out along with me. I felt I was getting away with something, as if my escape were undeserved.” (Tim Kreider, the New York Times) 

AARP’s 2023 LTSS SCORECARD 

IN THIS SECTION

• AARP’s Latest LTSS “Scorecard:” Pluses and Minuses

• AARP’s Latest LTSS “Scorecard:”: Pluses and Minuses 

Minnesota comes out on top in AARP’s latest deep drive into states’ efforts to bolster long-term services and supports. The “LTSS Scorecard,” in its fifth edition published in late September, profiles 50 indicators organized within five elements: affordability and access, choice of setting and provider, safety and quality, support for family caregivers and community integration. 

All 50 states plus the District of Columbia are ranked in five tiers:

• Tier 1: 1) Minnesota; 2) Washington state; 3) District of Columbia; 4) Massachusetts; 5) Colorado; 

• Tier 2; 6) New York; 7) Oregon; 8) Hawaii; 9) Vermont; 10) New Jersey; 11) California; 12) Rhode Island; 13) Connecticut; 14) Maryland; 15) Wisconsin; 16) Maine. 

• Tier 3; 17) Delaware; 18) Nebraska; 19) North Dakota; 20) New Mexico; 21) Pennsylvania; 22) Arizona; 23) Iowa; 24) New Hampshire; 25) Illinois; 26) Alaska; 27) Indiana; 28) Virginia; 29) Utah; 30) Kansas; 31) Michigan; 32) Ohio; 33) Montana; 34) Texas; 35) Idaho. 

• Tier 4; 36) South Dakota; 37) Arkansas; 38) Missouri; 39) Georgia; 40) Wyoming; 41) North Carolina; 42) Kentucky; 43) Florida; 44) Nevada; 45) Louisiana; 46) Oklahoma. 

• Tier 5; 47) Tennessee; 48) Mississippi; 49) South Carolina; 50) Alabama; 51) West Virginia. 

The report, sprinkling bits of hope along with many recommendations, warns that major gaps in long-term care for older adults persist in all 50 states long since COVID tossed a societal monkey wrench into the nation’s caregiving system. The long-term care system, AARP reports, has mostly failed to rebound even more than three years after COVID-19 began. Nevertheless, “for the indicators in which we can track change over time, more states made significant progress in the last three years (2020–2023) than the previous three years (2017–2020). For the first time, the Scorecard finds more than half of Medicaid LTSS spending for older people and adults with physical disabilities went to HCBS, at a rate of 53 percent in FY 2020 (from which the 2023 Scorecard scores and ranks states). In addition, 12 states spend the majority of Medicaid LTSS funding for older people and adults with physical disabilities on HCBS (up from seven states in 2009). The indicator showing the most improvement nationally is Self-Direction Enrollment, which increased by 10 percent or more in 35 states. Since the first Scorecard edition, the total number of people who self-direct services more than doubled from just under 740,000 in 2009 to more than 1.5 million in 2021. Among the five dimensions, support for family caregivers shows the most consistency from the previous 2020 Scorecard. States that already have policies that support family caregivers in place do not need to change but rather maintain their policy framework and ensure effective implementation of laws passed. States that do well supporting family caregivers tend to have stronger overall LTSS systems; the scores and ranks of family caregiver support showed the highest correlation out of all five dimensions to overall scores and ranks.”

IN THIS SECTION

• CMS Proposes SNF Minimum Staffing Requirements 
• Proposal Includes Limited Hardship Exemption and Staggered Startups 
• LPN Omission Sparks Concern 
• Overall Reactions Range Widely 
• Kaiser Assesses SNF Staffing Compliance Capability 
• Essay Urges Better Caregiver-Hospital Inpatient Integration 
• Senate Hearing Spotlights Inadequate Home Health Care Access 

• CMS Proposes SNF Minimum Staffing Requirements 

Highlighting caregiving news in September 2023: the long-awaited publication of proposed long-term care minimum staffing requirements. As discussed in CMS’ September 1 announcement, the proposal calls for: 

• minimum nurse staffing standards of 0.55 hours per resident day (HPRD) for Registered Nurses (RNs) and 2.45 HPRD for Nurse Aides (Nas); 

• a requirement to have an RN onsite 24 hours a day, seven days a week; 

• enhanced facility assessment requirements; and 

• a staggered implementation approach and possible hardship exemptions for select facilities. While these proposed minimum standards, if finalized, would be applied across all LTC facilities, CMS also expects facilities to staff above these minimum baseline levels to address the specific needs of their unique resident population based on the facility assessment and resident acuity levels.

The proposed regulations can be accessed here; comments must be received by November 6. Two comprehensive resources pertaining to SNF staffing levels include 1) slides from a recent webinar presented by the National Consumer Voice for Quality Long-Term Care (“Unpacking CMS’ Proposed Minimum Staffing Standard”) and 2) a White Paper, published by the LTCCC (“Addressing the Nation’s Chronic Nursing Home Understaffing Crisis”). 

• Proposal Includes Limited Hardship Exemption and Staggered Startups

CMS aims to hold nursing homes accountable for ensuring that residents receive safe and high-quality care. “While we fully expect that LTC facilities will be able to meet our proposed minimum staffing standards, we recognize that in some instances, external circumstances may temporarily prevent a facility from achieving compliance despite the facility’s demonstrated best efforts. Moreover, some LTC facilities are still experiencing challenges in hiring and retaining certain nursing staff because of local workforce unavailability, which was exacerbated by the COVID-19 pandemic. Therefore, CMS proposes to allow for a hardship exemption in limited circumstances. To give LTC facilities time to achieve compliance with the proposed minimum staffing requirements, CMS proposes that implementation of the final requirements will occur in three phases over a 3-year period for all non-rural facilities. In light of the unique challenges that rural LTC facilities face, especially as it relates to staffing, we are proposing a later implementation date for rural facilities: three years to meet the proposed 24/7 RN requirement and five years to meet the proposed minimum staffing requirements.”

• LPN Omission Raises Concern

One proposal omission raising concern among many advocates concerns the role of LPNs in the daily lives of some of Sniff residents. As PHI stated in its initial response, “More than two decades ago, a study commissioned by CMS found that 4.1 hours of care per resident day (HPRD) was necessary to support quality care, including 0.75 RN hours, 0.55 LPN/LVN hours, and 2.8 CNA hours. In contrast, the proposed rule only puts forward two lower-level occupation-specific standards—0.55 RN hours and 2.45 CNA hours, with no requirements for LPNs/LVNs.” As Modern Healthcare’s Diane Eastabrook observes, “LPNs make up about 13% of nursing home staff and as much as 75% of clinical staff at some facilities. LPNs are trained to perform routine clinical tasks such as taking patients’ vital signs, administering medication, inserting catheters and dressing wounds–all under the supervision of a registered nurse. In many nursing homes, LPNs also often oversee certified nursing assistants, who perform more personal duties for patients such as bathing and feeding. RNs also perform clinical tasks, but typically serve in more supervisory roles such as managing care teams, infection control, education and training.”

• Overall Reactions Range Widely

Reactions to the proposed regulations have been intense and wide-ranging. “‘The standards are a lot lower than what a lot of experts, including myself, have called for over the years,’ said Harvard Medical School professor David Grabowski, in an article by Kaiser Health News’ Jordan Rau. ‘There are some real positives in here, but I wish the administration had gone further.’ Added Richard Mollet, executive director of the Long Term Care Community Coalition (LTCCC): ‘Fundamentally, this standard is wholly inadequate to meet the needs of nursing home residents.’ Executives in the nursing home industry, on the other hand, said that without extra money from Medicare or Medicaid, the requirement would be financially unattainable. ‘It’s meaningless to mandate staffing levels that cannot be met,’ Katie Smith Sloan, the president and chief executive of LeadingAge, an association that includes nonprofit nursing homes, said in a statement. ‘There are simply no people to hire — especially nurses. The proposed rule requires that nursing homes hire additional staff. But where are they coming from?’”

• Kaiser Assesses SNF Staffing Compliance Capability 

Meanwhile, a report by the Kaiser Family Foundation assessed SNFs’ current ability to comply with the proposals: 

Among all nursing facilities, fewer than 1 in 5 could currently meet the required number of hours for registered nurses and nurse aides, which means over 80% of facilities would need to hire nursing staff; 

90% of for-profit facilities would need to hire additional nursing staff compared with 60% of non-profit and government facilities; 

The percentage of nursing facilities that would meet the requirements in the proposed rule varies from all in Alaska (100%) to nearly none in Louisiana (1%); 

CMS estimates that complying with the proposed rule will cost $40 billion in the 10 years after the final rule takes effect. Such costs are likely to be passed on to public and private payers for nursing facility services, including residents and their family members who paid $45 billion in out-of-pocket costs for care in nursing homes and other institutional LTSS settings in 2020.

• Essay Urges Better Caregiver-Hospital Inpatient Integration

A Health Affairs essay offers a renewed focus on the challenge of integrating caregivers into hospitalized patients’ treatment. While efforts in various states have expanded in the wake of the widespread adoption of the Care act, the authors argue that “policies designed to integrate caregivers into health care delivery have been sporadic and limited in scope. Part of this may be due to caregivers being viewed as outside of the traditional purview of health care. Another challenge is related to the national growth of Medicaid managed care organizations, which have made it difficult to regulate caregiver-related policies that fall under LTSS in the Medicaid program. Hospitalizations can be stressful for both patients and caregivers, but efforts to improve caregiver integration can provide patients and caregivers with the support they need. By increasing health systems’ ability to record caregiver contact information, states can promote the systematic identification of caregivers so that they can better contribute to and implement post-acute care plans. Expanding the use of caregiver needs assessments may provide an avenue for caregivers to access the necessary resources from health systems and communities. Strategies, which provide guidance on holistic caregiver training to clinical staff and increase the availability of multicultural materials, can promote equitable access to education and training for all caregivers. Finally, with improved data collection systems, states can better understand the facilitators and barriers to caregiver integration and incorporate that information into future policy and programmatic efforts.”

• Senate Hearing Spotlights Inadequate Home Health Care Access

Appearing before a mid-September Senate Finance Health Subcommittee hearing, witnesses voiced strong support for greater access to home healthcare. CMA Director Judith Stein reiterated a basic message: “enforce the law that already exists.” She described the need for payment policies, oversight measures, audits, and quality measures to be aligned with the law’s criteria for coverage in order to ensure that Medicare covers medically necessary home health care for all beneficiaries who qualify. Stein reported calls to the Center from beneficiaries and families across the country describing denials of coverage for incorrect reasons. “For example, coverage and care are denied on the grounds that Medicare covers only one to five hours per week of home health aide services (when the law provides up to 28-35 hours) or that coverage is only allowed when a patient can improve contrary to the recognition that maintenance nursing and therapy services are covered.” 

IN THIS SECTION

• North Carolina Joins Medicaid Expansion States 
• “Glitch” Pauses Medicaid Redeterminations 
• Hospice Quality of Care Concerns Prompt CMS Scrutiny 

• North Carolina Joins Medicaid Expansion States

After a years-long battle North Carolina is poised to accept Obamacare’s generosity and expand its Medicaid program. December 1 is the launch date, reports the Associated Press, and on that day an additional 600,000 low-income Carolinians should become eligible for government health insurance. The man who fought for seven years to make it happen, Democratic governor Ray Cooper, celebrated the influx of billions of dollars from the federal government that he says will boost rural hospitals, create jobs and help those suffering with pain and illness that they can't otherwise afford to treat. “Through expansion, adults age 19-64 get coverage even if they make too much to qualify for traditional Medicaid but too little to receive even heavily subsidized private insurance. For example, a single person who makes up to about $20,000 or someone in a family of three that makes $34,000 would benefit. Top Republican leaders said they changed their opinion on expansion because traditional Medicaid was on firmer fiscal ground compared to the early 2010s. They were also attracted to a financial bonus for the state from Congress should North Carolina accept expansion.”

• “Glitch” Pauses Medicaid Redeterminations

While North Carolina residents awaited the welcome onset of healthcare insurance, a different scenario was unfolding in more than half the states engaged in the Medicaid redetermination process underway since the end of the Covid-19 public health emergency. Thirty states, reported the Boston Globe’s Jessica Bartlett, “are pausing the removal of thousands of people from Medicaid rolls after the federal government identified a ‘glitch’ that had mistakenly deprived half a million eligible people across the country of state-sponsored insurance. States use an auto-renewal process to determine if people are eligible for Medicaid, using information available through state wage data and other sources. Federal officials say such a process makes it easier for people to renew their Medicaid insurance or remain on its sister program, the Children’s Health Insurance Program. However, CMS said it had noticed when looking at data and talking to states that the automatic renewal system was assessing eligibility at the family level rather than the individual level, even though individuals in a family might have different eligibility for the program. For example, children are likely to be eligible for Medicaid or CHIP even if their parents no longer qualify. ‘Every single one of those states,’ said Dan Tsai, director of the Center for Medicaid & CHIP Services, ‘is required to pause procedural disenrollments for anyone impacted by this glitch, to reinstate people until they can regain coverage, and continue pausing procedural disenrollments until they have a fix in place to ensure no eligible individuals are losing their Medicaid enrollment because of this issue.’”

• Hospice Quality of Care Concerns Prompt CMS Scrutiny

Concerns about hospice quality of care (Policy Digest, August 2023) have elicited a response from CMS: “Recent media reporting, and research by CMS, have identified instances of hospices certifying patients for hospice care when they were not terminally ill and providing little to no services to patients. The media reports identified that these activities led to a rapid growth in potentially fraudulent hospices, particularly in Arizona, California, Nevada, and Texas. This reporting also brought attention to a trend of ‘churn and burn’ schemes where a new hospice opens and starts billing, but once that hospice is audited or reaches its statutory yearly payment limit, it shuts down, keeps the money, buys a new Medicare billing number, transfers its patients over to the new Medicare billing number, and starts billing again.” CMS’s response, following site visits to all Medicare certified hospices and the identification of 400 meriting further administrative action, involves several initiatives: a pilot project to review hospice claims in Arizona, California, Nevada, and Texas following an individual’s first 90 days of hospice care; screening hospice certifying physicians to ensure they are qualified to treat Medicare beneficiaries, including making sure they have active licenses and do not have felony conviction records, and implementing new survey and enforcement requirements, with a goal of making sure that hospices enrolled in Medicare are fully able to provide high quality care. 

IN THIS SECTION

• SNF Covid-19 Infections Spike 
• SNF Vaccination Delays Spark Alarm 
• Doctors Confront Medical Practices’ “Moral Injury”

• SNF Covid-19 Infections Spike

While many Americans feel life has returned to normal, Covid-19 has not finished inflicting disruption and misery. “AARP’s COVID-19 Dashboard,” the Center for Medicare Advocacy reports, “shows an alarming increase in COVID-19 infections among nursing home residents and staff during the four weeks ending August 20, 2023, with cases doubling and deaths increasing by 80%, compared to the previous four weeks. Resident cases of COVID-19 have increased for nine consecutive weeks and staff cases, for 11 consecutive weeks. Moreover, the data show that as of August about 500,000 residents and 1.5 million nursing home staff were not up to date on vaccinations. At the same time, Skilled Nursing News’ Shelby Grebbin reports, “There’s some comfort in the fact that the latest surge will be countered with a plentiful supply of antiviral treatments. Two antivirals – Paxlovid and Lagevrio – are distributed for free by the U.S. government, and facilities can access these through their long-term care pharmacy. ‘The good news is that we are better equipped to prevent and manage Covid-19 than ever before thanks to life-saving vaccines and treatments,’ said AHCA/NCAL spokesperson Rachel Reeves. Reeves added that AHCA/NCAL continues to encourage the long term care community and the general public to use appropriate infection prevention control practices, such as staying away from others when sick, practicing proper hand hygiene, and staying up to date on their vaccinations. Also important to infection control going forward, observes Dr. Jasmine Travers, assistant professor at New York University’s Rory Meyers College of Nursing, is having nursing homes make more private rooms and private bathrooms available to residents. ‘We have to just go back to the policies that were in place earlier on in the pandemic that were really supportive of keeping down the spread of the pandemic, because in some ways, we’ve gotten lax with the lifting of the emergency efforts and the mandates of vaccinations and such.’”

• SNF Vaccination Delays Spark Alarm

Compounding the upsurge in infections, many nursing homes, report Kaiser Health News’ Jordan Rau and Tony Leys, “will not begin inoculations until well into October or even November, though infections among this vulnerable population are rising. ‘The distribution of the new Covid-19 vaccine is not going well,’ said Chad Worz, the chief executive of the American Society of Consultant Pharmacists. ‘Older adults in those settings are certainly the most vulnerable and should have been prioritized.’ Even once the shots are available, nursing homes face continuing resistance to the vaccines among nurses and aides. Without state mandates for workers to be vaccinated, most nursing homes are relying on persuasion, and that is often proving difficult. ‘The United States has been phenomenal in screwing up vaccinations,’ said David Nace, chief medical officer of UPMC Senior Communities in Pittsburgh. ‘This idea that some are under Part B and some are under Part D and some can be billed by a pharmacy — who in God’s name came up with this?’ Jim Wright, the medical director of Our Lady of Hope Health Center and two other nursing homes in Richmond, Va., said that rewards and respectful persuasion were not enough to sway his homes’ employees. They tend to be in their 20s and 30s, and are not worried about catching Covid, which many have already weathered. ‘They most likely will not do it to protect the residents or protect themselves. I don’t know what the answer is.’”

• Doctors Confront Medical Practices’ “Moral Injury”

“In July 2018, psychiatrist Wendy Dean published an essay with Simon G. Talbot, a plastic and reconstructive surgeon, that argued that many physicians were suffering from a condition known as moral injury. Military psychiatrists use the term to describe an emotional wound sustained when, in the course of fulfilling their duties, soldiers witnessed or committed acts — raiding a home, killing a noncombatant — that transgressed their core values. Doctors on the front lines of America’s profit-driven health care system, Dean and Talbot submitted, were also susceptible to such wounds, as the demands of administrators, hospital executives and insurers forced them to stray from the ethical principles that were supposed to govern their profession. Emergency Room doctors have found themselves at the forefront of these trends as more and more hospitals have outsourced the staffing in emergency departments in order to cut costs. Not long ago, I spoke to an emergency physician, whom I’ll call A. During her training, a patient with a terminal condition somberly informed her that his daughter couldn’t make it to the hospital to be with him in his final hours. A. promised the patient that he wouldn’t die alone and then held his hand until he passed away. Interactions like that one would not be possible today, she told me, because of the new emphasis on speed, efficiency and relative value units, a metric used to measure physician reimbursement that some feel discourages them from spending too much time on less remunerative functions, like listening and talking to patients. ‘It’s all about R.V.U.s and going faster’ A. said. ‘Your door-to-doctor time, your room-to-doctor time, your time from initial evaluation to discharge.’” (Eyal Press, the New York Times)

IN THIS SECTION

• New Dementia Risk Score Shows Strong Predictive Value 
• Alzheimer’s Experts Debate Leqembi Rollout 
• “Magic Mushrooms” Tame Major Depression 
• Psychiatrists Weigh Psychedelic Pros and Cons 
• FDA Advisors Nix ALS Drug 
• NurOwn Decision Challenges Drug Approval Standards

• New Dementia Risk Score Shows Strong Predictive Value 

Add one more entry into the available dementia risk scores designed to identify at-risk individuals across ages and geographical locations. Twelve European researchers have published the “UK Biobank Dementia Risk Score (UKBDRS)” that, MedPages’ Judy George reported, includes “11 predictive variables: age, education, parental history of dementia, material deprivation, history of diabetes, stroke, depression, hypertension, high cholesterol, household occupancy (living alone), and sex. ‘Importantly, our score highlights the importance of modifiable risk factors,’ Oxford University co-developer Raihaan Patel, PhD told MedPage Today. ‘While age and APOE were the strongest predictors, modifiable factors such as diabetes, depression, and high blood pressure also played a key role.’ The UKBDRS outperformed three other widely-used risk scores -- the Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) score, the Australian National University Alzheimer's Disease Risk Index (ANU-ADRI), and the Dementia Risk Score (DRS). ‘Dementia risk scores are important as they indicate who is at highest risk of dementia, which is potentially reversible,’ dementia expert Dr. Gill Livingston observed. ‘This gives individuals information and therefore power to change the course of their lives. It helps doctors answer the question about what to do to prevent dementia and intervene. Finally, it helps researchers find out who they should target for interventions to prevent dementia -- if someone is not at risk, then the intervention will not help.’ The study,” wrote George, “came with some caveats. Dementia was defined differently in each cohort, and the study was made up mostly of men. ‘There are still improvements required before this score is suitable for clinical practice,’ Patel noted. ‘While the score performed well across two U.K. cohorts, further evaluation across more diverse groups of people both within and beyond the U.K. is required.’

• Alzheimer’s Experts Debate Leqembi Rollout

Now that leqembi (lecanemab) has become the first anti–amyloid drug ever to receive traditional approval from the US Food and Drug Administration (FDA), attention has shifted to determining who should get the drug. JamaNetwork’s Rita Rubin provides a wide-ranging and very informative analysis of the relevant considerations involved in making such decisions. “Mayo Clinic neurologist David Knopman and his colleagues are preparing to administer lecanemab, but he’s not sure how much patients stand to gain from it. The phase 3 trial ‘delayed progression at 18 months by about 5 months. Is that clinically meaningful? I don’t know. What really counts is where you are at 36 months. Is it still a 5-month delay? That’s trivial. On the other hand if the difference between treated patients and untreated patients continues to increase as time passes, it’s a win.’ Questions about long-term clinical benefit aren’t the only ones that make Knopman anxious. Post hoc subgroup analyses of clinical trial data found that lecanemab didn’t seem to be of much benefit to patients younger than 65 years or women. Although the trial found that, overall, lecanemab delayed progression by 27%, the difference between the treated and placebo groups was 43% in men and only 12% in women. ‘The 27% average difference between the lecanemab and placebo groups is just that, an average,’ added Donna Wilcock, PhD, MS, a professor of AD research at the Indiana University School of Medicine. ‘I think what we’ve failed to think about is that is the average for everyone who participated in the trial. It makes it a little frustrating when people say that’s going to be the outcome for every patient. Probably a reasonable number of people out there stand to have their quality of life extended beyond belief from this drug, On the other hand, because of adverse events related to the drug, some treated patients might decline more quickly than they would have if they hadn’t received it. Unfortunately, in the trials, once you try and break your group down to those subgroup analyses, you lose all your power. The next leap will be how do we identify those who will truly benefit?’”

• “Magic Mushrooms” Tame Major Depression

While treatments for dementia-related illnesses dominate recent news headlines, other mental disturbances continue to generate their share of potential breakthroughs. Major depressive disorder (MDD), a significant cause of human suffering and death by suicide, may be amenable to the injection of psilocybin (“magic mushrooms”), according to a new study conducted by a large number of US researchers. “Treatment with a 25-mg dose of psilocybin administered with psychological support,” the researchers reported, “was associated with a statistically and clinically significant reduction in depressive symptoms compared with a niacin placebo. Improvements in depression were apparent within 8 days of psilocybin dosing, consistent with a rapid onset of action, and were maintained across the 6-week follow-up period, without attenuation of the effect. Psilocybin was generally well-tolerated, with most adverse events being of mild or moderate severity and generally limited to the acute dosing period.”

Psychiatrists Weigh Psychedelic Pros and Cons

In an editorial accompanying the study, authors Rachel Yehuda, PhD and Amy Lehrner observed that “When a psychedelic is taken with the proper preparation, intention, facilitation, and therapeutic environment, the patient can use the experience to gain new insights that can catalyze healing and recovery. The psychedelic allows feelings such as self-compassion, forgiveness, understanding, and self-acceptance to surface that can be powerful antidotes to shame, guilt, anger, isolation, disconnection, or other negative emotions that patients find difficult to discuss in therapy and that do not seem to be mitigated by traditional antidepressants. These experiences have been associated with symptom reduction and may represent an important mechanism of action. The psychedelic approach Is radically different from traditional approaches that seek to suppress depressive symptoms by targeting presumptive underlying pathophysiology or biological dysregulation. The benefits of psychopharmacotherapy and psychotherapy are often small and incremental, and true remission is generally not obtained for months or years. Furthermore, psychotropic medications require chronic use, can be difficult to discontinue, and cause a variety of adverse effects. In contrast, psychedelic therapies address the cause of symptoms rather than merely suppressing them. Here, a medication is administered acutely for only a few sessions—sometimes even a single medication session—in the context of a therapeutic framework that provides the opportunity to integrate and synthesize the revelations that occur during the medication session. Clinically significant response rates are robust and can be maintained for weeks or months. However, it is clear that despite the enthusiasm, psychedelic therapies do not represent a panacea for every patient. It is important to analyze and understand adverse outcomes in psychedelic trials and conduct longitudinal studies to determine how sustained the effects will be and what may initiate a recrudescence of symptoms. Future studies will help identify who is most likely to benefit from psychedelics, whether booster or repeated treatment is safe and beneficial, and what the optimal dose and therapeutic frameworks are.”

• FDA Advisors Nix ALS Drug

Passions ran high when the FDA convened an advisory meeting September 28 to consider the status of BrainStorm’s NurOwn, a potential treatment for the devastating diagnosis of ALS. At the meeting’s end, reported StatNews’ Damian Garde, “the agency’s expert advisers voted 17-1 with one abstention that the case for NurOwn, a treatment from BrainStorm Cell Therapeutics, was based too heavily on convoluted clinical trial results and compelling but unreliable anecdotal evidence. BrainStorm’s medicine is made up of stem cells harvested from patients’ own bone marrow that are then manipulated to secrete proteins that promote nerve growth. Those cells are then delivered back to ALS patients through injections into the spine, where they are meant to slow or even halt ALS’s destruction of motor neurons. The FDA’s dim view of NurOwn’s data was hardly a surprise considering the treatment’s regulatory history. In 2021, the agency broke with its established tradition and issued a public statement describing NurOwn’s observed benefits as ‘not at all statistically significant’ and concluding that its ‘data do not support the proposed clinical benefit of this therapy.’ A year later, the FDA took another rare action and sent BrainStorm what’s called a refuse-to-file letter, spelling out how the NurOwn data did not meet the standard for consideration, much less approval.”

• NurOwn Decision Challenges Drug Approval Standards

BrainStorm’s treatment has become the latest flashpoint in a societal debate over how to balance the needs of patients with grave diseases against the traditional standards of reviewing new medicines. After years of public pressure, the FDA has been increasingly flexible with new treatments for ALS, approving two drugs in the past year despite each falling short of the traditional evidentiary standard. NurOwn’s development has also proved divisive in the ALS community, with some physicians and advocates arguing the drug’s repeated failures to show significant benefits in clinical studies makes approval out of the question. Other patients and doctors argue that its supporting data, while undeniably problematic, justify making it available to the roughly 20,000 ALS patients in the U.S. who otherwise have little hope of arresting an incurable disease that gradually erodes motor function and leads to death within about five years of diagnosis. ‘With NurOwn, the risk is minimal,’ said Brooke Eby, a 34-year-old with ALS who testified at the meeting. ‘With ALS, the risk is inevitable.’” 

IN THIS SECTION

• Anti-Discrimination and Adult Protective Services Proposed Regulations 
• Alzheimer’s Advisory Council October 30 Meeting 
• Guide to Liability for SNF Residents’ Bills

• Anti-Discrimination and Adult Protective Services Proposed Regulations 

HHS has issued two sets of proposed regulations: the first would strengthen the prohibition of discrimination on the basis of disability in the delivery of healthcare, child welfare and other human services under section 504 of the Rehabilitation Act of 1973; the comment period ends November 13 and full information can be accessed here. The second proposal would establish the first-ever federal regulations for adult protective services programs; the comment period also ends November 13 and full information can be accessed here.

• Alzheimer’s Advisory Council October 30 Meeting 

HHS has announced that the next meeting of the Advisory Council on Alzheimer’s Research, Care and Services will be held on October 30 from 12 PM to 4:30 PM EST. The meeting will be virtual and will stream live here. For further information see here.

• Guide to Liability for SNF Residents’ Bills

Justice in Aging’s National Consumer Law Center has published an updated guide to family and friends’ liability for a SNF resident’s bill. The Q and A format covers issues such as the imposition of liability through the resident’s admission agreement, the “fine print” agreement’s pitfalls, and spousal and adult child financial obligations.

With October 1 marking his 99th birthday, and late September finding him and his wife Rosalynn being driven through a Plains, Georgia festival, the 39th President of the United States was praised by New York Times essayist Dr. Daniela J. Lamas for his approach to the eventual end of his life. “As he now approaches what has been reported to be his ‘final chapter,’ Mr. Carter’s decision to enter hospice and to continue publicizing that choice is a fitting final gift of candor from a former president to an American public that has long been uncomfortable with our own mortality. Here in the hospital where I work as a critical-care doctor, the very word ‘hospice’ so often conjures the idea of death and defeat. That is why hospice services are so often engaged late, in the days immediately before death, if at all. Half of patients in hospice are enrolled for only 18 days or less. One-tenth are in hospice for only one or two days before they die. After all, to choose this path is to acknowledge that we will all end, a reality that few of us are willing to face until there is no choice left. But Mr. Carter and his family were able to see it differently.

After a series of short hospital stays, this winter Mr. Carter made what for so many is an impossible decision. He would opt for hospice care in order to remain at home rather than undergo further medical interventions — even though, we now know, he was not in his final days. This is not to say that home hospice is the only ‘right’ way to die. Mr. Carter is surrounded by family with the resources to care for him if his symptoms worsen. Home hospice is not designed to offer care 24 hours a day, seven days a week. Instead, the system largely relies on families to care for the people they love, and there are many families for whom this is not possible or for whom the harsh realities of the dying process are simply too much to bear. Dying at home is not the only way to preserve grace and dignity at the end, but for some, it is the right way. Over the past four decades, President Carter has helped to build and renovate thousands of homes through Habitat for Humanity, offering safety and stability to those who would otherwise have none. It is only fitting that a man who has built homes for so many others would return to his own home as he sees his time growing short. And when his time in hospice draws to a close, there is likely to be no medical team rushing in, no chest compressions or shocks. There will be only a final breath, and then there will be quiet.”

• Are you a caregiver of an adult over 50 years old, and willing to try Routinify services at no cost?
• Are you or a loved one living with early symptoms of Alzheimer’s disease or mild cognitive impairment?
• Equity in Caregiving
• Inviting grandchildren, nieces/nephews, siblings, and step-kin to participate in a telephone-based dementia caregiving study
• Learning from Family and Friends Who Helped with Dementia Care
• Nationwide Study for Understanding and Improving Surgical Decision-Making for Persons Living with Dementia, their Family Caregivers, and their Providers – Patients and Caregivers Needed
• Participate in a Study About Dementia and Caregiver Stress
• Participate in a study about Understanding Informal Caregivers

• Caring for a Parent with Dementia
• Help-Seeking Behaviors and Service use for Mental Health in East Asian American Informal Caregivers of Persons Living with Dementia
• Looking for past and present caregivers to volunteer to participate in a research study
• Measuring Emotional Distress in Caregiver and Patients with Primary Brain Tumors
• The Couples Lived Experience Study - Boston University
• The Impacts of Caregiving and Social Support on Stress for Multiple Sclerosis Caregivers

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