Long-Term Care

Nursing Home Residents Overlooked in Scramble for Covid Antibody Treatments

 
Of the dozens of patients Dr. Jim Yates has treated for covid-19 at his long-term care center in rural Alabama, this one made him especially nervous.

The 60-year-old man, who had been fully vaccinated, was diagnosed with a breakthrough infection in late September. Almost immediately, he required supplemental oxygen, and lung exams showed ominous signs of worsening disease. Yates, who is medical director of Jacksonville Health and Rehabilitation, a skilled nursing facility 75 miles northeast of Birmingham, knew his patient needed more powerful interventions — and fast.

At the first sign of the man’s symptoms, Yates had placed an order with the Alabama Department of Public Health for monoclonal antibodies, the lab-made proteins that mimic the body’s ability to fight the virus. But six days passed before the vials arrived, nearly missing the window in which the therapy works best to prevent hospitalization and death.

“We’ve been pushing the limits because of the time frame you have to go through,” Yates said. “Fortunately, once we got it, he responded.”

Across the country, medical directors of skilled nursing and long-term care sites say they’ve been scrambling to obtain doses of the potent antibody therapies following a change in federal policy that critics say limits supplies for the vulnerable population of frail and elder residents who remain at highest risk of covid infection even after vaccination.

“There are people dying in nursing homes right now, and we don’t know whether or not they could have been saved, but they didn’t have access to the product,” said Chad Worz, CEO of the American Society of Consultant Pharmacists, which represents 1,500 pharmacies that serve long-term care sites.

Before mid-September, doctors and other providers could order the antibody treatments directly through drug wholesaler AmerisourceBergen and receive the doses within 24 to 48 hours. While early versions of the authorized treatments required hourlong infusions administered at specialty centers or by trained staff members, a more recent approach allows doses to be administered via injections, which have been rapidly adopted by drive-thru clinics and nursing homes.

Prompt access to the antibody therapies is essential because they work by rapidly reducing the amount of the virus in a person’s system, lowering the chances of serious disease. The therapies are authorized for infected people who’ve had symptoms for no more than 10 days, but many doctors say they’ve had best results treating patients by Day 5 and no later than Day 7.

After a slow rollout earlier in the year, use of monoclonal antibody treatments exploded this summer as the delta variant surged, particularly in Southern states with low covid vaccination rates whose leaders were looking for alternative — albeit costlier — remedies.

By early September, orders from seven states — Alabama, Florida, Georgia, Louisiana, Mississippi, Tennessee and Texas — accounted for 70% of total shipments of monoclonals.

Those Southern states, plus three others — Arkansas, Kentucky and North Carolina — ordered new courses of treatment even faster than they used their supplies. From July 28 to Sept. 8, they collectively increased their antibody stockpiles by 134%, according to a KHN analysis of federal data.

Concerned the pattern was both uncontrolled and unsustainable given limited national supplies, officials with the Department of Health and Human Services stepped in to equalize distribution. HHS barred individual sites from placing direct orders for the monoclonals. Instead, they took over distribution, basing allocation on case rates and hospitalizations and centralizing the process through state health departments.

“It was absolutely necessary to make this change to ensure a consistent product for all areas of the country,” Dr. Meredith Chuk, who is leading the allocation, distribution and administration team at HHS, said during a conference call.

But states have been sending most doses of the monoclonal antibody treatments, known as mAbs, to hospitals and acute care centers, sidestepping the pharmacies that serve long-term care sites and depleting supplies for the most vulnerable patients, said Christopher Laxton, executive director of AMDA, the Society for Post-Acute and Long-Term Care Medicine.

While vaccination might provide 90% protection or higher against serious covid in younger, healthier people, that’s not the case for the elders who typically live in nursing homes.

“You have to think of the spectrum of immunity,” Laxton said. “For our residents, it’s closer to 60%. You know that 4 out of 10 are going to have breakthrough infections.”

The mAb treatments have been authorized for use in high-risk patients exposed to the virus, and experts in elder care say that is key to best practices in preventing outbreaks in senior facilities. That could include, for example, treating the elderly roommate of an infected nursing home patient. But because of newly limited supplies, many long-term care sites have started to restrict use to only those who are infected.

Still, some states have worked to ensure access to mAbs in long-term care sites. Minnesota health officials rely on a policy that prioritizes residents of skilled nursing facilities for the antibody therapies through a weighted lottery. In Michigan, state Medical Director Dr. William Fales directed emergency medical technicians and paramedics to the Ascension Borgess Hospital system in Kalamazoo to help administer doses during recent outbreaks at two centers.

“The monoclonal antibodies made a huge difference,” said Renee Birchmeier, a nurse practitioner who cares for patients in nine of the system’s sites. “Even the patients in the assisted living with COPD, they’re doing OK,” she said, referring to chronic obstructive pulmonary disease. “They’re not advancing, but they’re doing OK. And they’re alive.”

Long-term care sites have accounted for a fraction of the orders for the monoclonal treatments, first authorized in November 2020. About 3.2 million doses have been distributed to date, with about 52% already used, according to HHS. Only about 13,500 doses have gone to nursing homes this year, according to federal data. That doesn’t include other long-term care sites such as assisted living centers.

The use is low in part because the treatments were originally delivered only through IV infusions. But in June, the Regeneron monoclonal antibody treatment was authorized for use via subcutaneous injections — four separate shots, given in the same sitting — and demand surged.

Use in nursing homes rose to more than 3,200 doses in August and nearly 6,700 in September, federal data shows. But weekly usage dropped sharply from mid-September through early October after the HHS policy change.

Nursing homes and other long-term care sites were seemingly left behind in the new allocation system, said Cristina Crawford, a spokesperson for the American Health Care Association, a nonprofit trade group representing long-term care operators. “We need federal and state public health officials to readjust their priorities and focus on our seniors,” she said.

In an Oct. 20 letter to White House policy adviser Amy Chang, advocates for long-term care pharmacists and providers called for a coordinated federal approach to ensure access to the treatments. Such a plan might reserve use of a certain type or formulation of the product for direct order and use in long-term care settings, said Worz, of the pharmacy group.

So far, neither the HHS nor the White House has responded to the letter, Worz said. Cicely Waters, a spokesperson for HHS, said the agency continues to work with state health departments and other organizations “to help get covid-19 monoclonal antibody products to the areas that need it most.” But she didn’t address whether HHS is considering a specific solution for long-term care sites.

Demand for monoclonal antibody treatments has eased as cases of covid have declined across the U.S. For the week ending Oct. 27, an average of nearly 72,000 daily cases were reported, a decline of about 20% from two weeks prior. Still, there were 2,669 confirmed cases among nursing home residents the week ending Oct. 24, and 392 deaths, according to the Centers for Disease Control and Prevention.

At least some of those deaths might have been prevented with timely monoclonal antibody therapy, Worz said.

Resolving the access issue will be key to managing outbreaks as the nation wades into another holiday season, said Dr. Rayvelle Stallings, corporate medical officer at PruittHealth, which serves 24,000 patients in 180 locations in the Southeast.

PruittHealth pharmacies have a dozen to two dozen doses of monoclonal antibody treatments in stock, just enough to handle expected breakthrough cases, she said.

“But it’s definitely not enough if we were to have a significant outbreak this winter,” she said. “We would need 40 to 50 doses. If we saw the same or similar surge as we saw in August and September? We would not have enough.”

Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.

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Caring for an Aging Nation

Health care for the nation’s seniors looms large as the baby-boom generation ages into retirement. President Joe Biden tacitly acknowledged those needs in March with his proposal to spend $400 billion over the next eight years to improve access to in-home and community-based care.

The swelling population of seniors will far outpace growth in other age groups. That acceleration — and the slower growth in other age groups — could leave many older Americans with less family to rely on for help in their later years. Meanwhile, federal officials estimate that more than half of people turning 65 will need long-term care services at some point. That care is expensive and can be hard to find.

Spending for paid long-term care already runs about $409 billion a year. Yet that staggering number doesn’t begin to reflect the real cost. Experts estimate that 1 in 6 Americans provide billions of dollars’ worth of unpaid care to a relative or friend age 50 or older in their home.

As the country weighs Biden’s plan, here’s a quick look at how long-term care works currently and what might lie ahead.

A Variety of Services

More than 65,000 paid, regulated service providers cared for 8 million Americans in 2016, according to the most recent federal report. In addition, AARP estimates more than 50 million people provide unpaid care, generally to family members.

Home Health Care

Care that occurs in the home, usually done by an unpaid caregiver or by a health aide, who may be employed by an agency (does not include hospice services).

12,200 home health care agencies

Community Support Services

Supplemental care including services such as adult day care centers and transportation.

4,600 adult day care centers

286,300 adults enrolled in adult day care service centers

Assisted Living/Retirement Communities

Residential facilities that can offer a variety of care levels, including assisted living centers and memory care.

28,900 assisted living and other residential care communities

811,500 residents

Nursing Homes

Full-time residential facilities that offer 24-hour supervision and nursing care.

15,600 nursing homes

1.35 million residents

Note: Data from 2016

Source: National Center for Health Statistics

Note: Data from 2016
Source: National Center for Health Statistics

Booming Number of Seniors

As baby boomers age, 10,000 people a day pass their 65th birthday. The Census Bureau estimates that more than 94.6 million people will be 65 or older in 2060.

From January to June 2018, the percentage of older adults age 85 and over needing help with personal care was more than twice the percentage for adults ages 75-84 and five times the percentage for adults ages 65-74.

8% of 75-84

21% of 85+

The Cost of Long-Term Care Services

From 2004 to 2020, the cost for facility and in-home care services has risen, on average, between 1.88% and 3.8% each year.

The median income for a household in which the head of the household is 65 or older was $47,357 in 2019.

Sources: GenworthU.S. Census Bureau

The Physical – And Financial – Burden

Source: HHS Office of the Assistant Secretary for Planning and Evaluation
Source: HHS Office of the Assistant Secretary for Planning and Evaluation
Source: University of Massachusetts-Boston Center for Social and Demographic Research on Aging Gerontology Institute
Source: U.S. Government Accountability Office

The $61 Billion Price Tag

Medicaid pays for the majority of long-term care services, but Americans also pay $61 billion out-of-pocket.

Note: Data from 2018
Source: Congressional Research Service

Medicaid

The federal-state health care insurance program for low-income and disabled Americans is the single-largest payer of long-term and community-based care and some in-home services. To qualify, many families must “spend down,” or reduce the older adult’s income and assets. And waiting lists for in-home care services in many states are long.

Medicare

The federal health insurance program for seniors and certain people with disabilities usually pays for acute care and post-acute, skilled nursing care and home health care services.

Other Public Programs

Other public spending comes from different sources, including states, localities, the Veterans Health Administration and the Children’s Health Insurance Program. Over half of this spending covered long-term care services given at residential care facilities for people with various mental health conditions and developmental disabilities.

Out-of-Pocket

These costs, paid for by individuals, include deductibles and copays for services as well as the direct payments made toward covering long-term care.

Private Insurance

Private health care plans usually cover payments for some limited home health and skilled nursing related to rehabilitation. Long-term care insurance may also help with these costs.

Other Private Funding

These funds generally come from nonprofit philanthropic groups, private individuals or corporations.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

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