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Tuesday, June 3, 2025

Ballad Health’s Hospital Monopoly Underperformed. Then Tennessee Lowered the Bar

 Despite years of patient complaints and quality-of-care concerns, Ballad Health — the nation’s largest state-sanctioned hospital monopoly — will now be held to a lower standard by the Tennessee government, and state data that holds the monopoly accountable will be kept from the public for two years.

Ballad is the only option for hospital care for most of the approximately 1.1 million people in a 29-county swath of Appalachia. Such a monopoly would normally be prohibited by federal law. But under deals negotiated with Tennessee and Virginia years ago, the monopoly is permitted if both states affirm each year that it is an overall benefit to the public.

However, according to a newly renegotiated agreement between Ballad and Tennessee, the monopoly can now be considered a “clear and convincing” benefit to the public with performance that would earn a “D” on most A-to-F grading scales.

And the monopoly can be allowed to continue even with a score that most would consider an “F.”

“It’s an extreme disservice to the people of northeast Tennessee and southwest Virginia,” said Dani Cook, who has organized protests against Ballad’s monopoly for years. “We shouldn’t have lowered the bar. We should be raising the bar.”

The Ballad monopoly, which encompasses 20 hospitals and straddles the border of Tennessee and Virginia, was created in 2018 after lawmakers in both states, in an effort to prevent hospital closures, waived federal antitrust laws so two rival health systems could merge. Although Ballad has largely succeeded at keeping its hospitals open, staffing shortages and patient complaints have left some residents wary, afraid, or unwilling to seek care at Ballad hospitals, according to an investigation by KFF Health News published last year.

In Tennessee, the Ballad monopoly is regulated through a 10-year Certificate of Public Advantage agreement, or COPA — now in its seventh year — that establishes the state’s goals and a scoring rubric for hospital performance. Tennessee Department of Health documents show Ballad has fallen short of about three-fourths of the state’s quality-of-care goals over the past four fiscal years. But the monopoly has been allowed to continue, at least in part, because the scoring rubric doesn’t prioritize quality of care, according to the documents.

Angie Odom, a county commissioner in Tennessee’s Carter County, where leaders have clashed with Ballad, said she has driven her 12-year-old daughter more than 100 miles to Knoxville to avoid surgery at a Ballad hospital.

After years of disappointment in Tennessee’s oversight of the monopoly, Odom said she was “not surprised” by Ballad’s new grading scale.

“They’ve made a way that they can fail and still pass,” she said.

Virginia regulates Ballad with a different agreement and scoring method, and its reviews generally track about one or two years behind Tennessee’s. Both states have found Ballad to be an overall benefit in every year they’ve released a decision.

Neither Ballad Health nor the Tennessee Department of Health, which has the most direct oversight of the monopoly, answered questions submitted in writing about the renegotiated agreement. In an emailed statement, Molly Luton, a Ballad spokesperson, said the company’s quality of care has steadily improved in recent years, and she raised repeated complaints from the hospital system about KFF Health News’ reporting. The news organization has reviewed every complaint from Ballad and has never found a correction or clarification to be warranted in the coverage.

Tennessee Health Commissioner Ralph Alvarado, who has more than once described the regulation of Ballad Health as a matter of national importance, has declined or not responded to more than a dozen interview requests from KFF Health News to discuss the monopoly.

“Our effort and progress serve as a model for health care in Tennessee, the Appalachia Region, and the entire nation,” Alvarado said in a May news release about the monopoly, adding, “We do not take our role lightly as we remain committed to transparency in our COPA oversight.”

Tennessee’s revised agreement was negotiated behind closed doors for more than a year and announced to the public in early May. As part of that announcement, Tennessee said it wouldn’t score Ballad next year, to give the company time to adjust to the new scoring process.

Under that process, the minimum score Ballad needs to meet to show a “clear and convincing” public benefit has been lowered from 85 out of 100 to 70 out of 100. The new agreement also awards Ballad up to 20 points for providing Tennessee with data and records — for example, a report on patient satisfaction — regardless of the level of performance documented. The state can also raise or lower Ballad’s overall score by up to 5 points in light of “reputable information” that is not spelled out in the scoring rubric.

Therefore, Ballad can score as low as 65 out of 100, with nearly a third of that score awarded for merely giving information to the state, and still be found to be a “clear and convincing” benefit to the public, which is the highest finding Tennessee can bestow, according to the agreement. And Ballad could score as low as 55 out of 100 without the monopoly facing a risk of being broken up, according to the new agreement.

The agreement also increases how much of Ballad’s annual score is directly attributed to the quality of care provided in its hospitals, from 5% to 32%. But the agreement obscures how this will be measured.

Tennessee sets “baseline” goals for Ballad across dozens of quality-of-care issues — like infection rates and speed of emergency room care — and then tracks whether Ballad meets the goals. The new agreement resets these baselines to values that were not made public, leaving it unclear how much the goals for Ballad have changed. Health department spokesperson Dean Flener said the new baselines would not be disclosed until 2027.

Cook, the longtime leader of protests against Ballad, said she believes Tennessee is attempting to silence data-supported criticism until the final year of the 10-year COPA agreement, which ends in 2028.

By then, any outrage would be largely moot, she said.

“If you are going to wait until the last year to tell us the new measurements, why bother?” Cook said. “It is clear, without a shadow of a doubt, that the Tennessee Department of Health is putting the needs and concerns of a corporation above the health and well-being of people.”

https://kffhealthnews.org/news/article/ballad-health-copa-hospital-monopoly-underperformed-tennessee-lowered-standards-pubic-health-benefit-appalachia/

Over 1,000 former rugby players in concussion lawsuit

 The number of former rugby players taking legal action against sports governing bodies on claims they suffered brain injuries during their careers has grown to more than 1,000, a British law firm said on Monday.

Rylands Garth, based in London, said more than 520 ex-players from rugby union and rugby league joined the lawsuit by Friday last week, which was the deadline for new applicants set by a court ahead of a hearing in July and before the case potentially goes to trial next year.

It takes the total number of players who are part of the lawsuit to approximately 1,100, Rylands Garth said in a statement.

The former players contend, according to Rylands Garth, that “rugby governing bodies failed to take reasonable action to protect them from the impacts of concussive and sub-concussive blows during their playing careers, despite knowing of the risks.”

Claimants are seeking compensation from World Rugby, the English Rugby Football Union and Welsh Rugby Union — governing bodies in 15-a-side rugby — and the English Rugby Football League and British Amateur Rugby League Association — from 13-a-side rugby league — for lost earnings, medical bills and care costs associated with their injuries, the firm said.

“Rylands Garth is also calling for urgent and substantive reform of the game to better protect the safety of current and future players — including the creation of an independent brain health ombudsman for the sport,” it said.

Among those to have previously joined the class action was World Cup-winning former England hooker Steve Thompson, former New Zealand prop Carl Hayman and former Wales flanker Alix Popham.

“This surge in claimants exposes the deep-rooted issues in rugby,” Rylands Garth said, adding: “Players continue to play almost all-year round, with many elite players soon to embark on extremely physical summer tours across the rugby world. We will continue to fight for justice for those who gave so much to the game.”

In a joint statement issued by World Rugby, the RFU and the WRU, the governing bodies said they “are aware of the latest update shared by the claimants’ legal representatives with the final number of claimants.”

“We now await full details of their diagnosis and the claims being made. Our thoughts are with any former player facing challenges.

“Across the game, we continue to build on a strong foundation of world-leading initiatives designed to make rugby union as safe as possible.”

That includes “smart mouthguard technology in the elite game, trials of lower tackle height in the community game, and the continued rollout of brain health services to support former players.”

Rylands Garth said it also represents approximately 130 former soccer players who are taking similar legal action against soccer governing bodies. The next court hearing for the soccer case is due on June 26.

https://apnews.com/article/rugby-concussion-lawsuit-6caba05ed6a9be1b54f12e1770f807c6

'All International Travelers Should Get Measles Vaccinations, CDC Says'

 U.S. health officials have changed their advice to international travelers about measles, saying that Americans should be vaccinated against the virus no matter where they're going.

U.S. residents are recommended to get measles-mumps-rubella shots, anyway. But the CDC previously emphasized the importance of vaccination for travelers going to countries with outbreaks.

Last week, the CDC updated its guidanceopens in a new tab or window to call for vaccinations for travelers going to all other countries.

Ashley Darcy-Mahoney, PhD, NNP, a researcher at George Washington University's nursing school, called the update significant.

Colorado outbreakopens in a new tab or window last month stemmed from an international flight that landed in Denver, she noted. The CDC travel notice change reflects a recognition that people are not just being exposed to measles in countries where it's spreading, but also in airplanes and during travel, she added.

"We're seeing a shift from localized outbreaks to transmission in transit," and the CDC seems to be responding to that, Darcy-Mahoney said.

The travel notice advises two doses for all Americans ages 1 year and older. An early dose is advised for traveling infants ages 6 months to 11 months. The U.S. has seen more than 1,000 measles casesopens in a new tab or window so far this year.

https://www.medpagetoday.com/infectiousdisease/vaccines/115873

Ex-Moderna vaccine law prof eyes throwing in towel on vaccines

 It's going to become unnecessarily harder to develop and make new vaccines. I've witnessed firsthand the dynamic nature of the vaccine industry, especially during my tenure at Moderna. It's a rocky business that is dealing with a rapidly occurring negative shift.

During the COVID pandemic, companies navigated market uncertainty while rushing to develop, test, and manufacture vaccines. A big difference maker was a national demand and collective understanding of the public health need for vaccines -- we all wanted to get out of our homes and back to our daily lives. The corresponding purchase commitments those companies secured with unprecedented government partnership made it viable for them to step forward and produce vaccines in an otherwise uncertain marketplace.

That all feels like ancient history now as our nation's health officials impose new obstacles in the form of increased regulatory hurdles and misrepresentation of what exactly constitutes science. It starts with the very tropes these officials deploy, insisting on "gold-standard science" and parents "doing their own research."

But we have moved beyond mere words. Now, several developments are coalescing to create a significant degree of unpredictability in the vaccine marketplace. Recent administration actions signal increasing trouble and significant obstacles in getting vaccines onto the market.

In recent months, the foundation of America's vaccine enterprise -- development, regulation, and access -- has begun to erode. A series of quiet but seismic changes at the FDA and CDC should concern anyone who cares about public health.

The seismic shift began with the delay of the February meeting of the CDC's Advisory Committee on Immunization Practices (ACIP) and the publishing of disclosures of "conflicts" for ACIP members, an unusual move that could discourage qualified experts from serving. NIH research cuts have also been implemented, including a reduction in overhead support for research institutions, the elimination of grants related to vaccine hesitancy and pandemic-related studies, and grant review pauses.

Leadership at FDA's Center for Biologics Evaluation and Research (CBER) has also been destabilized. The departure of senior leaders, followed by the appointment of Vinay Prasad, MD, MPH -- a frequent critic of public health orthodoxy -- as its director, signals a marked shift in direction. The agency failed to meet critical deadlines, including the licensure decision for Novavax's COVID-19 vaccine. FDA Commissioner Marty Makary, MD, MPH, dismissed the delay, saying the agency must prioritize "gold-standard science."

Yet transparency has not been the hallmark of this new regime. In a striking departure from past practice, the FDA selected flu strains for the 2025-2026 vaccine without convening its external advisory committee for public deliberation. Meanwhile, the agency has shed more than 3,500 staff members, with implications for its scientific rigor and institutional memory.

In the span of 10 days, the administration shattered ordinary processes and procedures, blurring lines between the role of respective HHS agencies. Notably, on May 20, Makary and Prasad announced a new regulatory approachopens in a new tab or window to COVID-19 vaccine approvals in the New England Journal of Medicine, shifting to a risk-based model. This change alters the FDA-approved indication, not through CDC and ACIP recommendations, but by agency fiat.

The forceful unilateral policymaking culminated in an odd video appearanceopens in a new tab or window with HHS Secretary Robert F. Kennedy Jr. flanked by the heads of FDA and NIH, with no HHS public health officials in sight. The leaders directly discouraged further vaccination of pregnant persons and children and announced it was superseding the recommendations of ACIP.

In parallel, the government has canceled key vaccine contracts, including one for Moderna's H5N1 vaccineopens in a new tab or window, and is now requiring placebo-controlled trials for all new vaccine candidates -- regardless of feasibility, precedent, or deep ethical concerns.

Together, these decisions signal not just a policy shift, but a chilling retreat from the infrastructure that made the U.S. a leader in vaccine innovation and access. These shifts and the promotion of discredited safety concerns from the top not only make the already arduous task of creating and producing vaccines harder, but also erode public trust essential for widespread vaccine adoption.

Unpredictable and politically driven regulatory approaches cultivate an environment of enormous uncertainty for vaccine developers and manufacturers. These interconnected forces will eventually have a chilling effect on both public perception of the industry and the industry's willingness to stay in the game.

If the past is prologue, many vaccine manufacturers will give up the high costs and relatively low returns of vaccine market participation. In 1967, 26 manufacturers produced vaccines. That number dwindled to 17 in 1980 and 5 by 2004.

Consequently, we risk the forfeiture of the vaccines of today and tomorrow, potentially stripping our society of the tools that have for two and a quarter centuries successfully defended us against the scourge of deadly diseases.

Richard Hughes IV, JD, MPHopens in a new tab or window, is an attorney and advisor in the biopharma sector, with a particular focus on vaccines. He was vice president of public policy at Moderna during the COVID-19 pandemic and teaches vaccine law at George Washington University.

https://www.medpagetoday.com/opinion/second-opinions/115888

Study Supports Lowering Colon Cancer Screening Age

 

  • A single-center study supported recommendations to lower the colorectal cancer screening age from 50 to 45.
  • Screening colonoscopy outcomes were slightly less frequent in people ages 45-49 versus 50-54.
  • Only the risk of any adenoma was significantly lower in the younger age group.

A single-center study supported recent U.S. recommendations that lowered the colorectal cancer screening age to 45.

Screening colonoscopy outcomes were slightly less common in people ages 45-49 compared with those 50-54 years old, but only the risk for any adenoma was significantly lower in the younger group (35.4% vs 40.8%; adjusted risk ratio [aRR] 0.86, 95% CI 0.82-0.90), reported Jeffrey Lee, MD, MPH, of Kaiser Permanente Northern California in Pleasanton, and colleagues in JAMAopens in a new tab or window.

None of the other colonoscopy findings differed significantly between the two age groups:

  • Advanced adenoma (3.8% vs 4.1%; aRR 0.90, 95% CI 0.75-1.09)
  • Advanced serrated lesion (1.5% vs 1.8%; aRR 0.85, 95% CI 0.63-1.14)
  • Any sessile serrated lesion (10.2% vs 10.4%; aRR 0.98, 95% CI 0.88-1.10)
  • Colorectal cancer (0.1% vs 0.1%; aRR 0.56, 95% CI 0.15-2.07)

There were no significant differences in neoplasia prevalence between the age groups by sex.

The findings suggest there's no need to reduce adenoma or sessile serrated lesion detection rate benchmarks because of the infusion of younger patients into the screening pool, Lee told MedPage Today.

"Doctors should not be worried that just because we've infused a bunch of young adults recently [into the screening pool] ... that we have to change those targets ... because we find similar rates regardless of age," Lee said.

Veroushka Ballester, MD, a spokesperson for the American Gastroenterological Association who wasn't involved with the research, said the findings support the 2021 changeopens in a new tab or window in U.S. Preventive Services Task Force (USPSTF) guidance that colorectal cancer screening should begin at age 45 instead of 50 for average-risk patients.

"Although screening colonoscopy outcomes were generally slightly less frequent among the younger group compared with the older group, by showing comparable detection rates of advanced lesions and sessile serrated lesions between the 45-49 and 50-54 age groups, the study reinforces the rationale behind the revised screening age recommendations," Ballester told MedPage Today.

Aasma Shaukat, MD, MPH, a gastroenterologist at NYU Langone Health in New York, who also wasn't involved with the study, said the findings are in line with other work showing younger adults have a slightly lower prevalence of adenomas compared with older people.

Shaukat said the current findings are "expected," but further research is needed to show more definitively whether lowering the colorectal cancer screening age to 45 was the right thing to do.

"Say 10 years go by and we actually see a reduction in colon cancer incidence and mortality compared to 45- to 49-year-olds that aren't screened or weren't being screened," she said. "Those kinds of data will tell us if it was a correct decision."

The USPSTF issued the change in 2021 in part because of rising rates of colorectal cancer among young people. "It's incredibly alarming because we don't know why" it's happening, Lee told MedPage Today.

At the same time, there have been few reports on screening colonoscopy neoplasia yields among younger adults following the guideline change, Lee and colleagues noted.

The researchers examined data from screening colonoscopies that took place at Kaiser Permanente Northern California between 2021 and 2024. A total of 12,031 patients had screening colonoscopy; 4,380 were ages 45-49 and 7,651 were 50-54.

Women made up 47.3% of the overall cohort and 42.8% of participants were white. Median body mass index was 26.5 and 24% had a history of tobacco smoking.

Lee and colleagues cautioned that Asian Americans made up 30.4% of the study cohort, which is higher than the general population and may influence the generalizability of the findings.

Disclosures

Lee reported no disclosures.

Co-authors reported relationships with the National Cancer Institute, Medial Research, the Patient-Centered Outcomes Research Institute, Freenome, and Geneoscopy.

Shaukat reported relationships with Iterative Health, Freenome, UniversalDx, and Motus GI.

Ballester reported no conflicts.

Primary Source

JAMA

Source Reference: opens in a new tab or windowLee JK, et al "Screening colonoscopy yields among adults aged 45 to 49 years after lowering colon cancer screening age" JAMA 2025; DOI: 10.1001/jama.2025.7479.


https://www.medpagetoday.com/gastroenterology/coloncancer/115887

Trump Administration Revokes Federal Guidance Protecting Emergency Abortions

 The Trump administration announced on Tuesday that it would revoke guidance to the nation's hospitals that directed them to provide emergency abortions to women when they are necessary to stabilize their medical condition.

That guidanceopens in a new tab or window was issued to hospitals in 2022, weeks after the U.S. Supreme Court upended national abortion rights in the U.S. It was an effort by the Biden administration to preserve abortion access for extreme cases in which women were experiencing medical emergencies and needed an abortion to prevent organ loss or severe hemorrhaging, among other serious complications.

The Biden administration had argued that hospitals -- including states with near-total bans -- needed to provide emergency abortions under the Emergency Medical Treatment and Active Labor Act. That law requires emergency rooms that receive Medicare dollars to provide an exam and stabilizing treatment for all patients. Nearly all emergency rooms in the U.S. rely on Medicare funds.

"The Trump Administration would rather women die in emergency rooms than receive life-saving abortions," Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement. "In pulling back guidance, this administration is feeding the fear and confusion that already exists at hospitals in every state where abortion is banned. Hospitals need more guidance, not less, to stop them from turning away patients experiencing pregnancy crises."

Anti-abortion advocates praised the move, however. Marjorie Dannenfelser, president of SBA Pro-Life America, said in a statement that the Biden-era policy had been a way to expand abortion access in states where it was banned.

"Democrats have created confusion on this fact to justify their extremely unpopular agenda for all-trimester abortion," she said. "In situations where every minute counts, their lies lead to delayed care and put women in needless, unacceptable danger."

An Associated Press investigationopens in a new tab or window last year found that, even with that guidance, dozens of pregnant women were being turned away from emergency rooms, including some who needed emergency abortions.

The Centers for Medicare and Medicaid Services, which investigates hospitals that are not in compliance, said in a statementopens in a new tab or window on Tuesday that it was rescinding the Biden-era guidance. The agency, however, will continue to enforce the law, "including for identified emergency medical conditions that place the health of a pregnant woman or her unborn child in serious jeopardy."

But CMS added that it would also "rectify any perceived legal confusion and instability created by the former administration's actions."

The Biden administration sued Idahoopens in a new tab or window over its abortion law that initially only allowed abortions to save the life of the mother. The federal government had argued before the U.S. Supreme Court last year that Idaho's law was in conflict with the federal law, which requires stabilizing treatment that prevents a patient's condition from worsening.

The U.S. Supreme Court issued a procedural ruling in the case last year that left key questions unanswered about whether doctors in abortion ban states can terminate pregnancies when a woman is at risk of serious infection, organ loss or hemorrhage.

https://www.medpagetoday.com/washington-watch/washington-watch/115893

Canadian wildfires still raging: Should Americans’ anger be raging, too?

 


Regarding the ongoing and incessant Canadian wildfires, some have said that there's nothing Canada can really do about them.

Year after year after year.

That is bunk.

First of all, some of the fires have been started by arson.

One thing Canada could do is lock those sick bastards up for life. Think that's harsh? For burning down large swaths of the beautiful forests of Canada and causing tens of thousands of people to be evacuated, disrupting their life in every way? And who knows how many (painful) deaths of animals have occurred? Doubtless, many thousands. And think of the sickness and death caused — not just in Canada but in its neighbor to the south.

Think of those with COPD and various other diseases and susceptibilities. Think of the elderly. Burning down half of Canada, trashing its lush boreal forests, slaughtering countless animals, dispossessing tens of thousands of Canadian citizens, adversely affecting the health of (or even killing) countless others across the border in a foreign nation, and making people cancel their vacations and skip going outside entirely? This is not worth life in prison?

Hell, Canada jails people for ‘misgendering’ someone or for praying outside of an abortion clinic or potentially anywhere else in public -- or for criticizing the national government.

Some of those unfortunately aggrieved people spend longer in jail than the arsonists!

And, by the way, some ‘experts’ claim that one of the reasons for the fires is that we are not following the ancient practices of the indigenous peoples.

What is meant by that? I don’t believe they had the technology and tools to clear vast tracts of land of dead trees, underbrush, etc. The only thing I can think of is the proverbial ‘rain dance.’ The rest of us can't do rain dances because that would be cultural appropriation. So every single indigenous person in Canada should be rain dancing right now until those fires are vanquished, if they wish to have any of their precious forests left intact. Get to it! Carney, make it happen, eh?!

And now Canada is begging for help from other countries? Like, I don't know, perhaps its neighbor to the south, the United States of America?

Really?! We didn't start the fires, but Canada wants us to come and help put them out? After Canadians in and out of government have mocked, sassed, and trashed us for months, and disrespected our national anthem? Well, if we not only have to protect the Great White North militarily but put out its effing fires, perhaps it should more seriously consider becoming the 51st state. For its sake, not ours.

We’ve all heard the phrase, “Where there's smoke there's fire.” Well, that's not true in this case. Much of the densely populated north central and northeastern tier of the United States is smothered in Canadian smoke and being slowly asphyxiated.

Yet there are no fires here.

The majority of Americans who have never been on a Canadian fishing trip and who don’t live in the north central and northeastern states might not realize two very important things: first, the smoke is, at times, impossible to avoid and dangerously thick and low to the ground, and, second, the only thing more prevalent than forest land in much of Canada is water. It is, gloriously, everywhere. Rivers, flowages, lakes -- massive bodies of water seemingly sprawl everywhere. Might not the latter be used to save the former? Does Canada not have enough firefighting aircraft such as airtankers and water scoopers? If not, why not? Does it want its forests to burn?

Why am I not hearing about the staggering amount of greenhouse gases these fires are releasing into the atmosphere? And yet, ironically, a few more of these gigantic fires and another volcanic eruption or two and the earth might enter a period of cooling due to the vast amount of smoke, soot, ash, and particulates blocking the suns rays.

It would be very neighborly of Canada — one might even say polite — if those in the Canadian government lit a fire … under their own asses and pulled out all the stops to finally extinguish these fires before more people and animals — and Canada’s once-beautiful forests — are destroyed.

Eh?

https://www.americanthinker.com/blog/2025/06/canadian_wildfires_still_raging_should_americans_anger_be_raging_too.html