SCOTUS upholds Obamacare preventive care mandate 

https://nxslink.thehill.com/view/6230d94bc22ca34bdd8447c8o3k52.isr/aae298b7

The Supreme Court on Friday upheld a key Affordable Care Act requirement that insurance companies cover certain preventative measures recommended by an expert panel.  
Justices upheld the constitutionality of the provision in a 6-3 decision and protected access to preventative care for about 150 million Americans.   

The justices found that the secretary of the Department of Health and Human Services has the power to appoint and fire members of the U.S. Preventative Services Task Force (USPSTF).   

The cases started when a small business in Texas and some individuals filed a lawsuit against the panel’s recommendation that pre-exposure prophylaxis (PreP) for HIV be included as a preventative care service.   

They argued that covering PreP went against their religious beliefs and would “encourage homosexual behavior, intravenous drug use, and sexual activity outside of marriage between one man and one woman.”  

The plaintiffs further argued that the USPSTF mandates are unconstitutional because panel members are “inferior officers” who are not appointed by the president or confirmed by the Senate.   

While the panel is independent, they said that since their decisions impact millions of people members should be confirmed.   

A U.S. district judge in 2023 ruled that all preventative-care coverage imposed since the ACA was signed into law are invalid and a federal appeals court judge ruled in agreement last year.   

The Biden administration appealed the rulings to the Supreme Court, and the Trump administration chose to defend the law despite its long history of disparaging Obamacare.   

Though public health groups celebrated the ruling Friday, some noted another potential outcome.  

“While this is a foundational victory for patients, patients have reason to be concerned that the decision reaffirms the ability of the HHS secretary, including our current one, to control the membership and recommendations of the US Preventive Services Task Force that determines which preventive services are covered,” Anthony Wright, executive director of Families USA, said in a statement.  

“We must be vigilant to ensure Secretary Kennedy does not undo coverage of preventive services by taking actions such as his recent firing of qualified health experts from the CDC’s independent vaccine advisory committee and replacing them with his personal allies.” 

The ACA’s Promise of Free Preventive Health Care Faces Ongoing Legal Challenges

An ongoing legal challenge is threatening the guarantee of free preventive care in the Affordable Care Act (ACA).

Six individuals and the owners of two small businesses sued the federal government, arguing that the ACA provision “makes it impossible” for them to purchase health insurance for themselves or their employees that excludes free preventive care. The plaintiffs argue that they do not want or need such care. They specifically name the medication PrEP (used to prevent the spread of HIV), contraception, the HPV vaccine, and screening and behavioral counseling for sexually transmitted diseases and substance use; however, they seek to invalidate the entire ACA preventive benefit package.

A federal trial court judge agreed with some of their claims and invalidated free coverage of more than 50 services, including lung, breast, and colon cancer screenings and statins to prevent heart disease.

This ruling, which is currently being appealed, strips free preventive services coverage from more than 150 million privately insured people and approximately 20 million Medicaid beneficiaries who are covered under the ACA’s Medicaid expansion.

This suit was first filed in 2020. The plaintiffs in the case, Braidwood Management v. Becerra, continue to oppose the entire preventive benefit package, which consists of four service bundles: services rated “A” or “B” by the United States Preventive Services Task Force (USPSTF); routine immunizations recommended by the Advisory Committee on Immunization Practices (ACIP); evidence-informed services for children recommended by the Health Resources and Services Administration (HRSA); and evidence-informed women’s health care recommended by HRSA. The trial judge invalidated all benefits recommended by the USPSTF after March 23, 2010, the date the ACA became law. (The court also exempted the plaintiffs on religious grounds from their obligation to cover PrEP.) The Fifth Circuit put the trial court’s decision on temporary hold while the case is on appeal.

The Fifth Circuit, one of the nation’s most conservative appeals courts, will hear the Biden administration’s appeal of the trial court’s USPSTF ruling and the entirety of the plaintiffs’ original challenge, thereby putting all four coverage guarantees in play. The court also will hear whether the ruling should apply only to the plaintiffs or to all Americans.

The trial court held that the USPSTF lacks the legal status necessary under the Constitution to make binding coverage decisions, and that the Secretary of the U.S. Department of Health and Human Services (HHS) — who can make such binding decisions — lacks the power to rectify matters by formally adopting USPSTF recommendations. The judge concluded that federal law fails to require that members be presidential nominees confirmed by the Senate under the Appointments Clause; in the judge’s view, this means that members are not politically accountable for their decisions, which is constitutionally problematic. The judge also ruled that federal law makes the USPSTF the final coverage arbiter, which means that the HHS Secretary, who is nominated and confirmed under the Appointments Clause and thus politically accountable, cannot cure the constitutional problem by ratifying USPSTF recommendations.

On appeal, the Biden administration argues that the USPSTF passes constitutional muster because the HHS Secretary, who oversees the Task Force, is a nominated and confirmed constitutional officer. Alternatively, the administration argues the appeals court should interpret the statute as allowing the HHS Secretary to ratify USPSTF recommendations, since the law specifies that USPSTF members are independent of political pressure only “to the extent practicable.” The administration makes similar arguments on behalf of ACIP and HRSA.

The plaintiffs argue that secretarial ratification cannot cure the constitutional problems with all three advisory bodies. According to the plaintiffs, none of the advisory bodies has the status of constitutional officers demanded by the Appointments Clause, and so their recommendations must remain recommendations only, unenforceable by HHS on insurers, health plans, and state Medicaid programs.

The second issue is the scope of the remedy if the law is found unconstitutional. The trial court did not limit its holding to the four individual plaintiffs and two companies who sued, but instead applied its order nationwide. The Biden administration argues that, if the coverage guarantee is unconstitutional, the court only should prohibit HHS from enforcing the preventive services provision against the plaintiffs who brought the lawsuit and should allow the coverage guarantee to remain in force for the rest of the country. Citing an amicus brief filed by the American Public Health Association and public health deans and scholars, the administration argues that barring HHS from enforcing the preventive services requirement nationwide “pose[s] a grave threat to the public health” by decreasing Americans’ access to lifesaving preventive services. The plaintiffs argue that a nationwide prohibition is necessary, the broader public interest in free preventive coverage is irrelevant, and insurers will voluntarily continue to offer free preventive coverage if people want it.

The administration’s arguments on appeal have attracted amicus briefs by bipartisan economic scholars, organizations concerned with health equity and preventive health, health care organizations, and 23 states.

Crucially, the economists point out that, prior to the ACA, comprehensive free preventive coverage was extremely limited because it is not in insurers’ interest to make a long-term economic investment in members’ health. Indeed, prior to the ACA, insurers did not even uniformly cover the basic screenings for newborns to detect treatable illnesses and conditions.

Amicus briefs supporting the plaintiffs have been filed by Texas and an organization dedicated to “protecting individual liberties . . . against government overreach.” All briefing will be complete by November 3, 2023, with oral argument thereafter. A decision is likely in early to mid-2024. Whatever the outcome, expect a Supreme Court appeal given the size of the stakes in the case.

Colonoscopies fail to reduce colon cancer deaths in landmark study

https://mailchi.mp/4587dc321337/the-weekly-gist-october-14-2022?e=d1e747d2d8

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. 

The next attack on the Affordable Care Act may cost you free preventive health care

The next attack on the Affordable Care Act may cost you free preventive  health care

Many Americans breathed a sigh of relief when the Supreme Court left the Affordable Care Act (ACA) in place following its third major legal challenge in June 2021. This decision left widely supported policies in place, like ensuring coverage regardless of preexisting conditions, coverage for dependents up to age 26 on their parents’ plan and removal of annual and lifetime benefit limits.

But the hits keep coming. One of the most popular benefits offered by the ACA, free preventive care through many employer-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.

What did the ACA do for preventive health?

The Affordable Care Act tried to achieve the twin ideals of making health care more accessible while reducing health care spending. It created marketplaces for individuals to purchase health insurance and expanded Medicaid to increase coverage for more low-income people.

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.

Cartoon – Importance of Prevention

Hands on Wisconsin: Facts are the vaccine for conspiracies | Opinion |  Cartoon | madison.com

Cartoon – Preventable Diseases

Sack cartoon: Vaccinations | Star Tribune

Cartoon – Anti Vaxx Message is Spreading

Political Cartoon on Twitter: "Graeme Keyes on Doctors worried as anti- vaccination messages escalate from social media misinformation to personal  threats - political cartoon gallery in London https://t.co/dePcTdnXF6…  https://t.co/UH1eOU4nPh"

How Many More Will Die From Fear of the Coronavirus?

Fear of contracting the coronavirus has resulted in many people missing necessary screenings for serious illnesses, like cancer and heart disease.

Seriously ill people avoided hospitals and doctors’ offices. Patients need to return. It’s safe now.

More than 100,000 Americans have died from Covid-19. Beyond those deaths are other casualties of the pandemic — Americans seriously ill with other ailments who avoided care because they feared contracting the coronavirus at hospitals and clinics.

The toll from their deaths may be close to the toll from Covid-19. The trends are clear and concerning. Government orders to shelter in place and health care leaders’ decisions to defer nonessential care successfully prevented the spread of the virus. But these policies — complicated by the loss of employer-provided health insurance as people lost their jobs — have had the unintended effect of delaying care for some of our sickest patients.

To prevent further harm, people with serious, complex and acute illnesses must now return to the doctor for care.

Across the country, we have seen sizable decreases in new cancer diagnoses (45 percent) and reports of heart attacks (38 percent) and strokes (30 percent). Visits to hospital emergency departments are down by as much as 40 percent, but measures of how sick emergency department patients are have risen by 20 percent, according to a Mayo Clinic study, suggesting how harmful the delay can be. Meanwhile, non-Covid-19 out-of-hospital deaths have increased, while in-hospital mortality has declined.

These statistics demonstrate that people with cancer are missing necessary screenings, and those with heart attack or stroke symptoms are staying home during the precious window of time when the damage is reversible. In fact, a recent poll by the American College of Emergency Physicians and Morning Consult found that 80 percent of Americans say they are concerned about contracting the coronavirus from visiting the emergency room.

Unfortunately, we’ve witnessed grievous outcomes as a result of these delays. Recently, a middle-aged patient with abdominal pain waited five days to come to a Mayo Clinic emergency department for help, before dying of a bowel obstruction. Similarly, a young woman delayed care for weeks out of a fear of Covid-19 before she was transferred to a Cleveland Clinic intensive care unit with undiagnosed leukemia. She died within weeks of her symptoms appearing. Both deaths were preventable.

The true cost of this epidemic will not be measured in dollars; it will be measured in human lives and human suffering. In the case of cancer alone, our calculations show we can expect a quarter of a million additional preventable deaths annually if normal care does not resume. Outcomes will be similar for those who forgo treatment for heart attacks and strokes.

Over the past 12 weeks, hospitals deferred nonessential care to prevent viral spread, conserve much-needed personal protective equipment and create capacity for an expected surge of Covid-19 patients. During that time, we also have adopted methods to care for all patients safely, including standard daily screenings for the staff and masking protocols for patients and the staff in the hospital and clinic. At this point, we are gradually returning to normal activities while also mitigating risk for both patients and staff members.

The Covid-19 crisis has changed the practice of medicine in fundamental ways in just a matter of months. Telemedicine, for instance, allowed us to pivot quickly from in-person care to virtual care. We have continued to provide necessary care to our patients while promoting social distancing, reducing the risk of viral spread and recognizing patients’ fears.

Both Cleveland Clinic and Mayo Clinic have gone from providing thousands of virtual visits per month before the pandemic to hundreds of thousands now across a broad range of demographics and conditions. At Cleveland Clinic, 94 percent of diabetes patients were cared for virtually in April.

While virtual visits are here to stay, there are obvious limitations. There is no substitute for in-person care for those who are severely ill or require early interventions for life-threatening conditions. Those are the ones who — even in the midst of this pandemic — must seek the care they need.

Patients who need care at a clinic or hospital or doctor’s office should know they have reduced the risk of Covid-19 through proven infection-control precautions under guidelines from the Centers for Disease Control and Prevention. We’re taking unprecedented actions, such as restricting visiting hours, screening patient and caregiver temperatures at entrances, encouraging employees to work from home whenever possible, providing spaces that allow for social distancing, and requiring proper hand hygiene, cough etiquette and masking.

All of these strategies are intended to significantly reduce risk while allowing for vital, high-quality care for our patients.

The novel coronavirus will not go away soon, but its systemic side effects of fear and deferred care must.

We will continue to give vigilant attention to Covid-19 while urgently addressing the other deadly diseases that haven’t taken a pause during the pandemic. For patients with medical conditions that require in-person care, please allow us to safely care for you — do not delay. Lives depend on it.

 

 

 

Cartoon – Times are Tough

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Measles deaths ‘staggering and tragic’

https://www.bbc.com/news/health-50659893?fbclid=IwAR3gBbcdBh9DpvLZetL7k8uvV5VXxk5TBy1bNtDYeRKEcpGy2Xx58ydn39s

Measles

More than 140,000 people died from measles last year as the number of cases around the world surged once again, official estimates suggest.

Most of the lives cut short were children aged under five.

The situation has been described by health experts as staggering, an outrage, a tragedy and easily preventable with vaccines.

Huge progress has been made since the year 2000, but there is concern that incidence of measles is now edging up.

In 2018, the UK – along with Albania, the Czech Republic and Greece, lost their measles elimination status.

And 2019 could be even worse.

The US is reporting its highest number of cases for 25 years, while there are large outbreaks in the Democratic Republic of Congo, Madagascar and Ukraine.

The Pacific nation of Samoa has declared a state of emergency and unvaccinated families are hanging red flags outside their homes to help medical teams find them.

What is measles?

  • Measles is a highly infectious virus spread in droplets from coughs, sneezes or direct contact
  • It can hang in the air or remain on surfaces for hours
  • Measles often starts with fever, feeling unwell, sore eyes and a cough followed by a rising fever and rash
  • At its mildest, measles makes children feel very miserable, with recovery in seven-to-10 days – but complications, including ear infections, seizures, diarrhoea, pneumonia and brain inflammation, are common
  • The disease is more severe in the very young, in adults and in people with immunity problems

What are the numbers?

The global estimates are calculated by the World Health Organization (WHO) and the US Centers for Diseases Control and Prevention.

They show:

  • In 2000 – there were 28.2 million cases of measles and 535,600 deaths
  • In 2017 – there were 7.6 million cases of measles and 124,000 deaths
  • In 2018 – there were 9.8 million cases of measles and 142,000 deaths

Measles cases do not go down every year – there was an increase between 2012 and 2013, for example.

However, there is greater concern now that progress is being undone as the number of children vaccinated stalls around the world.

“The fact that any child dies from a vaccine-preventable disease like measles is frankly an outrage and a collective failure to protect the world’s most vulnerable children,” said Dr Tedros Ghebreysus, director-general of the WHO.

How are the numbers calculated?

Every single case of measles cannot be counted. In 2018, only 353,236 cases were officially recorded (out of the 7.8 million estimated).

So scientists perform complex maths for each country.

They take reported cases, the population size, deaths rates, the proportion of children vaccinated and more to eventually produce a global estimate.

Dr Minal Patel, who performed the number-crunching, told the BBC: “We’ve had a general trajectory downwards for deaths, which is great. Everyone involved in vaccination programmes should be very proud.

“But we’ve been stagnating in numbers of deaths for about the past seven years, and what’s really concerning is from last year we’ve gone up, and it looks like we’ve gone backwards.”

What is going on?

In short, not enough children are being vaccinated.

In order to stop measles spreading, 95% of children need to get the two doses of the vaccine.

But the figures have been stubbornly stuck for years at around 86% for the first jab, and 69% for the second.

Why enough children are not being vaccinated is more complicated – and the reasons are not the same in every country.

The biggest problem is access to vaccines, particular in poor countries.

The five worst-affected countries in 2018 were Democratic Republic of Congo, Liberia, Madagascar, Somalia and Ukraine.

The Ebola outbreak in Liberia (2014-16) and plague in Madagascar (2017) have taken a toll on their healthcare systems.

“Democratic Republic of Congo, Somalia and Ukraine, the other countries hardest-hit by measles, each face conflicts, with DRC additionally battling a serious Ebola outbreak and rampant distrust,” Prof Heidi Larson, from the London School of Hygiene & Tropical Medicine, explained.

The other issue is people who do have access to vaccines choosing not to immunise their children.

Will things be worse next year?

It looks likely.

The number of reported cases by mid-November this year was 413,000 compared with 353,000 for the whole of last year.

What do the experts say?

Henrietta Fore, Unicef’s executive director, said: “The unacceptable number of children killed last year by a wholly preventable disease is proof that measles anywhere is a threat to children everywhere.”

Dr Seth Berkley, chief executive of Gavi, the Vaccine Alliance, said: “It is a tragedy that the world is seeing a rapid increase in cases and deaths from a disease that is easily preventable with a vaccine.

“While hesitancy and complacency are challenges to overcome, the largest measles outbreaks have hit countries with weak routine immunisation and health systems.”

Prof Larson said: “These numbers are staggering. Measles, the most contagious of all vaccine-preventable diseases, is the tip of the iceberg of other vaccine-preventable disease threats and should be a wake-up call.”