Published this week in the New York Times, this article describes the decaying state of Greenwood Leflore Hospital, a 117 year-old facility in the Mississippi Delta that may be within months of closure. While rural hospitals across the country are struggling, Mississippi’s firm opposition to Medicaid expansion has exacerbated the problem in that state, by depriving providers of an additional $1.4B per year in federal funds. Instead, only a few of the state’s 100-plus hospitals actually turn an annual profit, and uncompensated care costs are almost 10 percent of the average hospital’s operating costs.
Despite a dozen or more hospitals at imminent risk of closure, Mississippi officials would rather use the state’s $3.9B budget surplus to lower or eliminate the state income tax.
The Gist:Expanding Medicaid doesn’t just reduce rates of uncompensated care provided by hospitals, it changes the volume and type of care they provide.
Further, Medicaid expansion has been found to result in significant reductions in all-cause mortality.
Ensuring that low-income residents in Mississippi and other non-expansion states have access to Medicaid would allow providers to administer more preventive care and manage chronic diseases more effectively, before costly exacerbations require hospitalization.
US District Judge Reed O’Connor ruled on Thursday that the Affordable Care Act’s (ACA’s) requirement for most insurers to cover certain preventative care services without cost-sharing is unlawful. Judge O’Connor—who invalidated the entire ACA in 2018, before the Supreme Court reversed that ruling—had already sided with the plaintiffs in Braidwood vs. Becerra last September, on the grounds that mandatory coverage of HIV prevention treatment, also known as PrEP therapy, violated their religious beliefs. His latest ruling applies to the ACA-mandated preventive services that are compelled by the US Preventative Services Task Force (USPSTF), on the grounds of the task force’s makeup and the fact that some of its recommendations predate the ACA. Services covered for no cost today include screening tests for a variety of cancers, sexually transmitted infections, and diabetes. The ruling does not impact other ACA preventative care services, like contraceptive services and children’s immunizations, as they are based on the recommendations of other government advisory groups. The immediate impact of this week’s ruling is unclear, as the Biden administration has already filed an appeal and may seek to stay the ruling, while most insurance contracts are set on an annual basis.
The Gist: Given the reasoning laid out in Judge O’Connor’s Braidwood v. Becerra ruling last fall, this decision was expected. As with previous attempts to repeal the ACA that have come through his district, the ultimate fate of the ACA’s cost-free preventative care services will likely be decided by the US Supreme Court. It’s possible that the Court may find the narrow targeting of this case more reasonable, making no-cost preventive care coverage optional for employers.
If that happens, millions of Americans could again have to pay for some of the most common and highest-value healthcare services. That additional financial burden, along with tightening of health plan benefit designs, could create barriers to access and exacerbate health disparities.
The plaintiffs in Braidwood v. Becerra filed a motion on Monday asking a US District Court judge in Texas—the same judge who ruled the entire ACA unconstitutional in 2018—to block enforcement of the ACA’s no-cost requirement for preventive care services. This judge already sided with the plaintiffs in September, ruling the government cannot require a company to fully cover preventive HIV drugs, also known as PrEP therapy, for its employees, on the grounds that doing so violates owners’ religious freedom.
In that ruling, the judge also asserted that the government’s system for deciding what preventive care services should be covered under the ACA is unconstitutional. This latest motion now asks him to invalidate all parts of the ACA requiring preventive health services on the grounds that the Preventive Services Task Force was never appointed by Congress, and thus lacks the authority to say which services insurers must cover. The final ruling is expected early next year, after which the case will certainly be appealed, regardless of outcome.
The Gist: Given the judge’s initial ruling in Braidwood last month, this motion from the plaintiffs was expected. While the US Supreme Court reversed a 2018 ruling by this judge that struck down the entire ACA, it could potentially find the narrow targeting of this case more reasonable, making preventive care coverage optional for employers.
If that happens, millions of Americans would once again have to pay for some of the most common and highest-value healthcare services, including screening tests for a variety of cancers, sexually transmitted infections, and diabetes. That additional financial burden, along with likely tightening of health plan benefit designs, would create barriers to access and exacerbate health disparities.
In a randomized controlled trial (RCT) study of 85K Europeans, published this week in the New England Journal of Medicine, colonoscopies were found to reduce incidence of colorectal cancer by only 18 percent—much less than earlier large studies—and have no impact on ten-year colorectal cancer mortality rates. This is the first study to directly compare individuals invited to receive colonoscopies with a control group receiving no cancer screening.
While the study’s findings surprised many researchers, an important caveat to the headline takeaways is that a secondary analysis of study participants who actually completed their colonoscopies found a 50 percent reduction in death, though the decision to accept the invitation likely correlates with other factors that improve mortality outcomes.
The Gist: We were surprised to learn this was the first RCT to assess the effectiveness of colonoscopies—15M of which are performed in the US each year—and which comprise a $36B market. While the study’s results need careful interpretation, it reminds us that much of established medical consensus has yet to be “proven” by rigorous scientific research.
While we don’t expect this study’s results to significantly change colonoscopy recommendations, it does place greater emphasis on the question of value generated by widespread preventative screenings. Colonoscopy will almost certainly remain the gold standard for colon cancer screening in the US, but if these results bear out, other less invasive types of screening, like home-based fecal immunochemical testing, could be viewed as equivalent options and receive more traction.
Obamacare enrollment at a record-high 14.5 million
Congress may not fund premium subsidies in 2023
The Affordable Care Act marks its 12th anniversary Wednesday, and despite a record 14.5 million enrollees, the Biden administration is preparing for the possibility that millions could lose coverage next year.
The $1.9 trillion pandemic stimulus package (Public Law 117-2), signed March 2021, reduced Obamacare premiums to no more than 8.5% of income for eligible households and expanded premium subsidies to households earning more than 400% of the federal poverty level. The rescue plan also provided additional subsidies to help with out-of-pocket costs for low-income people. As a result, 2.8 million more consumers are receiving tax credits in 2022 compared to 2021.
But without congressional action, the subsidies—and the marketplace enrollment spikes they ushered in—could be lost in 2023. A new HHS report released Wednesday, shows an estimated 3.4 million Americans would lose marketplace coverage and become uninsured if the premium tax credits aren’t extended beyond 2022.
In a briefing with reporters Tuesday, Chiquita Brooks-LaSure, administrator for the Centers for Medicare & Medicaid Services, said her agency is “confident that Congress will really understand how important the subsidies were” to enrolling more people this year. The CMS would “pivot quickly,” however, to implement new policies and outreach plans if the subsidies aren’t extended as open enrollment for 2023 begins in November.
“That said, today and tomorrow we are celebrating the Affordable Care Act,” Brooks-LaSure added. “As part of that process, we’ve been reminding ourselves that sometimes it takes some time to pass legislation. And just like the Affordable Care Act took time, we’re confident that Congress is going to address these critical needs for the American people.”
After years of legal and political brawls that turned the landmark legislation into a political football, Obamacare “is at its strongest point ever,” Brooks-LaSure said. The 14.5 million total enrollees—those who extended coverage and those who signed up for the first time—is a 21% increase from last year. The number of new consumers during the 2022 open enrollment period increased by 20% to 3.1 million from 2.5 million in 2021.
This week, the Department of Health and Human Services will highlight the impact of the ACA and the Biden administration’s efforts to strengthen the law. The CMS recently announced a new special enrollment period opportunity for people with household incomes under 150% of the federal poverty level who are eligible for premium tax credits. The new special enrollment period will make it easier for low-income people to enroll in coverage throughout the year.
Troubled times could be around the corner, however, as millions of people with Medicaid coverage could become uninsured after the public health emergency ends. Under the Families First Coronavirus Response Act (Public Law 116-127), signed March 2020, states must maintain existing Medicaid enrollment until the end of the month that the public health emergency is lifted. Once the continuous enrollment mandate ends, states will resume Medicaid redeterminations and disenrollments for people who no longer meet the program’s requirements.
Dan Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services at CMS, said the agency is working with states to make sure people who lose Medicaid coverage can be transferred into low- and no-cost Obamacare coverage.
“A substantial portion of individuals who will no longer be eligible for Medicaid will be eligible for other forms of coverage,” including marketplace coverage, Tsai told reporters Tuesday.
In a statement, President Joe Biden acknowledged the law’s great impact. “This law is the reason we have protections for pre-existing conditions in America. It is why women can no longer be charged more simply because they are women. It reduced prescription drug costs for nearly 12 million seniors. It allows millions of Americans to get free preventive screenings, so they can catch cancer or heart disease early—saving countless lives. And it is the reason why parents can keep children on their insurance plans until they turn 26.”
Access to healthcare in childhood has long term effects on health outcomes, but many children in the US are either uninsured or underinsured, meaning they often don’t have access to the care they need. Why is that and what can we do about it?
The healthcare industry’s staffing shortage crisis has had clear consequences for care delivery and efficiency, forcing some health systems to pause nonemergency surgeries or temporarily close facilities. Less understood is how these shortages are affecting care quality and patient safety.
A mix of high COVID-19 patient volume and staff departures amid the pandemic has put hospitals at the heart of a national staffing shortage, but there is little national data available to quantify the shortages’ effects on patient care.
The first hint came last month from a CDC report that found healthcare-associated infections increased significantly in 2020 after years of steady decline. Researchers attributed the increase to challenges related to the pandemic, including staffing shortages and high patient volumes, which limited hospitals’ ability to follow standard infection control practices.
“That’s probably one of the first real pieces of data — from a large scale dataset — that we’ve seen that gives us some sense of direction of where we’ve been headed with the impact of patient outcomes as a result of the pandemic,” Patricia McGaffigan, RN, vice president of safety programs for the Institute for Healthcare Improvement, told Becker’s. “I think we’re still trying to absorb much of what’s really happening with the impact on patients and families.”
An opaque view into national safety trends
Because of lags in data reporting and analysis, the healthcare industry lacks clear insights into the pandemic’s effect on national safety trends.
National data on safety and quality — such as surveys of patient safety culture from the Agency for Healthcare Research and Quality — can often lag by several quarters to a year, according to Ms. McGaffigan.
“There [have been] some declines in some of those scores more recently, but it does take a little while to be able to capture those changes and be able to put those changes in perspective,” she said. “One number higher or lower doesn’t necessarily indicate a trend, but it is worth really evaluating really closely.”
For example, 569 sentinel events were reported to the Joint Commission in the first six months of 2021, compared to 437 for the first six months of 2020. However, meaningful conclusions about the events’ frequency and long-term trends cannot be drawn from the dataset, as fewer than 2 percent of all sentinel events are reported to the Joint Commission, the organization estimates.
“We may never have as much data as we want,” said Leah Binder, president and CEO of the Leapfrog Group. She said a main area of concern is CMS withholding certain data amid the pandemic. Previously, the agency has suppressed data for individual hospitals during local crises, but never on such a wide scale, according to Ms. Binder.
CMS collects and publishes quality data for more than 4,000 hospitals nationwide. The data is refreshed quarterly, with the next update scheduled for October. This update will include additional data for the fourth quarter of 2020.
“It is important to note that CMS provided a blanket extraordinary circumstances exception for Q1 and Q2 2020 data due to the COVID-19 pandemic where data was not required nor reported,” a CMS spokesperson told Becker’s. “In addition, some current hospital data will not be publicly available until about July 2022, while other data will not be available until January 2023 due to data exceptions, different measure reporting periods and the way in which CMS posts data.”
Hospitals that closely monitor their own datasets in more near-term windows may have a better grasp of patient safety trends at a local level. However, their ability to monitor, analyze and interpret that data largely depends on the resources available, Ms. McGaffigan said. The pandemic may have sidelined some of that work for hospitals, as clinical or safety leaders had to shift their priorities and day-to-day activities.
“There are many other things besides COVID-19 that can harm patients,” Ms. Binder told Becker’s. “Health systems know this well, but given the pandemic, have taken their attention off these issues. Infection control and quality issues are not attended to at the level of seriousness we need them to be.”
What health systems should keep an eye on
While the industry is still waiting for definitive answers on how staffing shortages have affected patient safety, Ms. Binder and Ms. McGaffigan highlighted a few areas of concern they are watching closely.
The first is the effect limited visitation policies have had on families — and more than just the emotional toll. Family members and caregivers are a critical player missing in healthcare safety, according to Ms. Binder.
When hospitals don’t allow visitors, loved ones aren’t able to contribute to care, such as ensuring proper medication administration or communication. Many nurses have said they previously relied a lot on family support and vigilance. The lack of extra monitoring may contribute to the increasing stress healthcare providers are facing and open the door for more medical errors.
Which leads Ms. Binder to her second concern — a culture that doesn’t always respect and prioritize nurses. The pandemic has underscored how vital nurses are, as they are present at every step of the care journey, she continued.
To promote optimal care, hospitals “need a vibrant, engaged and safe nurse workforce,” Ms. Binder said. “We don’t have that. We don’t have a culture that respects nurses.”
Diagnostic accuracy is another important area to watch, Ms. McGaffigan said. Diagnostic errors — such as missed or delayed diagnoses, or diagnoses that are not effectively communicated to the patient — were already one of the most sizable care quality challenges hospitals were facing prior to the pandemic.
“It’s a little bit hard to play out what that crystal ball is going to show, but it is in particular an area that I think would be very, very important to watch,” she said.
Another area to monitor closely is delayed care and its potential consequences for patient outcomes, according to Ms. McGaffigan. Many Americans haven’t kept up with preventive care or have had delays in accessing care. Such delays could not only worsen patients’ health conditions, but also disengage them and prevent them from seeking care when it is available.
Reinvigorating safety work: Where to start
Ms. McGaffigan suggests healthcare organizations looking to reinvigorate their safety work go back to the basics. Leaders should ensure they have a clear understanding of what their organization’s baseline safety metrics are and how their safety reports have been trending over the past year and a half.
“Look at the foundational aspects of what makes care safe and high-quality,” she said. “Those are very much linked to a lot of the systems, behaviors and practices that need to be prioritized by leaders and effectively translated within and across organizations and care teams.”
She recommended healthcare organizations take a total systems approach to their safety work, by focusing on the following four, interconnected pillars:
Culture, leadership and governance
Patient and family engagement
Learning systems
Workforce safety
For example, evidence shows workforce safety is an integral part of patient safety, but it’s not an area that’s systematically measured or evaluated, according to Ms. McGaffigan. Leaders should be aware of this connection and consider whether their patient safety reporting systems address workforce safety concerns or, instead, add on extra work and stress for their staff.
Safety performance can slip when team members get busy or burdensome work is added to their plates, according to Ms. McGaffigan. She said leaders should be able to identify and prioritize the essential value-added work that must go on at an organization to ensure patients and families will have safe passage through the healthcare system and that care teams are able to operate in the safest and healthiest work environments.
In short, leaders should ask themselves: “What is the burdensome work people are being asked to absorb and what are the essential elements that are associated with safety that you want and need people to be able to stay on top of,” she said.
To improve both staffing shortages and quality of care, health systems must bring nurses higher up in leadership and into C-suite roles, Ms. Binder said. Giving nurses more authority in hospital decisions will make everything safer. Seattle-based Virginia Mason Hospital recently redesigned its operations around nurse priorities and subsequently saw its quality and safety scores go up, according to Ms. Binder.
“If it’s a good place for a nurse to go, it’s a good place for a patient to go,” Ms. Binder said, noting that the national nursing shortage isn’t just a numbers game; it requires a large culture shift.
Hospitals need to double down on quality improvement efforts, Ms. Binder said. “Many have done the opposite, for good reason, because they are so focused on COVID-19. Because of that, quality improvement efforts have been reduced.”
Ms. Binder urged hospitals not to cut quality improvement staff, noting that this is an extraordinarily dangerous time for patients, and hospitals need all the help they can get monitoring safety. Hospitals shouldn’t start to believe the notion that somehow withdrawing focus on quality will save money or effort.
“It’s important that the American public knows that we are fighting for healthcare quality and safety — and we have to fight for it, we all do,” Ms. Binder concluded. “We all have to be vigilant.”
Conclusion
The true consequences of healthcare’s labor shortage on patient safety and care quality will become clear once more national data is available. If the CDC’s report on rising HAI rates is any harbinger of what’s to come, it’s clear that health systems must place renewed focus and energy on safety work — even during something as unprecedented as a pandemic.
The irony isn’t lost on Ms. Binder: Amid a crisis driven by infectious disease, U.S. hospitals are seeing higher rates of other infections.
“A patient dies once,” she concluded. “They can die from COVID-19 or C. diff. It isn’t enough to prevent one.”
Cost-sharing is the practice of making individuals responsible for part of their health insurance costs beyond the monthly premiums they pay for health insurance – think things like deductibles and copayments. The practice is meant to inspire more thoughtful choices among consumers when it comes to healthcare decisions. However, the choices it inspires can often be more harmful than good.
But the hits keep coming. One of the most popular benefits offered by the ACA, free preventive care through manyemployer-based and marketplace insurance plans, is under attack by another legal domino, Kelley v. Becerra. As University of Michigan law professor Nicholas Bagley sees it, “[t]his time, the law’s opponents stand a good chance of succeeding.”
We are public health and economics researchers at Boston University who have been studying how preventive care is covered by the ACA and what this means for patients. With this policy now in jeopardy, health care in the U.S. stands to take a big step backward.
One way it has tried to reach both goals is to prioritize preventive services that maximize patient health and minimize cost, like cancer screenings, vaccinations and access to contraception. Eliminating financial barriers to health screenings increases the likelihood that common but costly chronic conditions, such as heart disease, will be diagnosed early on.
Section 2713 of the ACA requires insurers to offer full coverage of preventive services that are endorsed by three federal groups: the U.S. Preventive Services Task Force, the Advisory Committee on Immunization Practices and the Health Resources and Services Administration. This means that eligible preventive services ordered by your doctor won’t cost you anything out of pocket. For example, the CARES Act used this provision to ensure COVID-19 vaccines would be free for many Americans.
Removing the financial barrier has drastically reduced the average cost of a range of preventive services. Our study found that the costs of well-child visits and mammograms were reduced by 56% and 74%, respectively, from 2006 to 2018. We also found that the ACA reduced the share of children’s preventive checkups that included out-of-pocket costs from over 50% in 2010 to under 15% in 2018.
Residual costs for preventive services remain
Despite these reductions in costs, there are limitations to this benefit. For example, it doesn’t cover follow-up tests or treatments. This means that if a routine mammogram or colonoscopy reveals something that requires further care, patients may have to pay for the initial screening test, too. And some patients still receive unexpected bills for preventive care that should have been covered. This can happen, for example, when providers submit incorrect billing codes to insurers, which have specific and often idiosyncratic preventive care guidelines.
We also studied the residual out-of-pocket costs that privately insured Americans had after using eligible preventive services in 2018. We found that these patients paid between $75 million to $219 million per year combined for services that should have been free for them. Unexpected preventive care bills were most likely to hit patients living in rural areas or the South, as well as those seeking women’s services such as contraception and other reproductive health care. Among patients attempting to get a free wellness visit from their doctor, nearly 1 in 5 were later asked to pay for it.
Nevertheless, the preventive health provision of the ACA has resulted in significant reductions in patient costs for many essential and popular services. And removing financial barriers is a key way to encourage patients to use preventive services intended to protect their health.
The threat of Kelley v. Becerra
The plaintiffs who brought the latest legal challenge to the ACA, Kelley v. Becerra, object to covering contraception and preexposure prophylaxis (PrEP) for HIV on religious and moral grounds. The case is currently awaiting decision in a district court in Texas, but seems to be headed to the Supreme Court.
The case rests on two legal issues: 1) violation of the nondelegation doctrine, and 2) the appointments clause of the Constitution. The nondelegation doctrine is a rarely used legal argument that requires Congress to specify how their powers should be used. It essentially argues that Congress was too vague by not specifying which preventive services would be included in Section 2713 up front. The appointments clause specifies that the people using government powers must be “officers of the United States.” In this case, it is unclear whether those in the federal groups that determine eligible preventive care services qualify.
Texas District Judge Reed O’Connor has indicated so far that he takes a kind view toward the plaintiff’s case. He could rule that this provision of the ACA is unconstitutional and put the case on a path to the Supreme Court.
Patients stand to lose more than just money
If Section 2713 were repealed, insurers would have the freedom to reimpose patient cost-sharing for preventive care. In the short run, this could increase the financial strain that patients face when seeking preventive care and discourage them from doing so. In the long run, this could result in increased rates of preventable and expensive-to-treat chronic conditions. And because Section 2713 is what allows free COVID-19 vaccines for those with private health insurance, some patients may have to pay for their vaccines and future boosters if the provision is axed.
The ACA has been instrumental in expanding access to preventive care for millions of Americans. While the ACA’s preventive health coverage provision isn’t perfect, a lot of progress that has been made toward lower-cost, higher-value care may be erased if Section 2713 is repealed.
Lower-income patients will stand to lose the most. And it could make ending the COVID-19 pandemic that much harder.
HENRY KOTULA 