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Tuesday, January 31, 2023

House Votes to End Covid Precautions as G.O.P. Uses Pandemic in Political Attacks

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Republicans in Congress are seeking to capitalize on discontent about the federal coronavirus response while the party’s presidential contenders are vying to be the biggest foe of restrictions.


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Quotation of the Day: On contradictions

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Si un hombre nunca se contradice, será porque nunca dice nada.

Miguel de Unamuno




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Deer Could Be a Reservoir of Old Coronavirus Variants, Study Suggests

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Even after Delta became the dominant variant in humans, Alpha and Gamma continued to circulate in white-tailed deer, according to new research.


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Caldwell Regional Medical Center Opens In Kansas

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Nonprofit healthcare provider Caldwell Regional Medical Center opened in Caldwell, Kan., according to the website kwch.com.

The 42,000-square-foot project replaces Sumner County Hospital District No. 1.

The new medical center houses inpatient and outpatient services, including cardiopulmonary, emergency, laboratory, pediatric therapy, radiology, sleep lab, surgical, and transitional care services.

The project team includes LK Architecture (architect; Wichita, Kan.), MKEC (civil and structural engineer; Wichita), and Hutton (construction manager; Wichita).


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The Navy’s Dolphins Have a Few Things to Tell Us About Aging

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In her youth, Blue was a standout mine-hunter for the U.S. military. She and her colleagues are now at the vanguard of geriatric marine mammal medicine.


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Monday, January 30, 2023

Biden Administration Plans to End Covid Public Health Emergency in May

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The end of the emergency will bring about a complex set of policy changes, and it signals a new chapter in the government’s pandemic response.


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Biden administration plans to end COVID-19 emergency declarations May 11

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Heart-related deaths rose sharply in 2020


Heart-related deaths rose sharply during first year of COVID pandemic

04:42

The White House is planning to end COVID-19 emergency declarations on May 11, the most public signal yet that the Biden administration now believes the worst of the pandemic is over, the White House announced Monday.

The announcemnt was in a formal statement of opposition to two GOP bills set to be voted on in the House this week that would immediately end the national emergency and public health emergency first enacted during the Trump administration that quickly opened up federal money and resources to cities and states responding to the pandemic. The Democratic-led Senate is unlikely to vote on the legislation.

May 11 will mark more than three years of the U.S. being under an emergency related to the pandemic. Former President Donald Trump declared a national emergency over COVID-19 on March 13, 2020, retroactive to March 1, 2020. 

The White House has said the proposed GOP legislation “would create wide-ranging chaos and uncertainty throughout the health care system — for states, for hospitals and doctors’ offices, and, most importantly, for tens of millions of Americans.” It also would lead to an abrupt end of Title 42, the pandemic-era rule that has blocked undocumented immigrants from crossing the U.S.-Mexico border amid public health concerns. The White House noted the policy is subject to a U.S. Supreme Court case and that it remains committed to gradually winding down the program 

A public health emergency provided funding and resources from the Department of Health and Human Services to state and public health systems and hospitals, while the national emergency allowed FEMA and the Pentagon to help with the deployment of medical supplies and vaccines and measures taken by several agencies to shore up the nation’s economy.

The Centers for Disease Control said there were 3,756 new deaths attributed to COVID-19 last week, and 3,726 hospitalizations in the same period. 

More than 1.1 million Americans have died from the disease, according to the CDC. 

— Kathryn Watson contributed to this report 


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Joe Biden: COVID national, public health emergencies to end May 11

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WASHINGTON — President Joe Biden informed Congress on Monday that he will end the twin national emergencies for addressing COVID-19 on May 11, as most of the world has returned closer to normalcy nearly three years after they were first declared.

The move to end the national emergency and public health emergency declarations would formally restructure the federal coronavirus response to treat the virus as an endemic threat to public health that can be managed through agencies’ normal authorities.

It comes as lawmakers have already ended elements of the emergencies that kept millions of Americans insured during the pandemic. Combined with the drawdown of most federal COVID-19 relief money, it would also shift the development of vaccines and treatments away from the direct management of the federal government.


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Flashpoint Therapeutics’ cancer vaccine takes nanotech approach

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To do so, researchers will apply what Mirkin calls “rational vaccinology” to design the structure of vaccines, controlling the location of the two main components—adjuvants and antigens—to increase effectiveness many times over.

By designing the proper structure, cancer vaccines can be transformed from ineffective to curative, which is pretty exciting, said Mirkin, who was on Crain’s 2020 Tech 50 list and was a member of the 40 Under 40 Class of 2001.

“Historically, cancer vaccines have not been effective because structure had not been considered,” he said, even though other pharmaceutical drugs are developed with painstaking attention to structure.

Instead, Mikrin noted, conventional vaccines have simply thrown together antigens, which target the immune system, and adjuvants, stimulators that increase the effectiveness of the antigen, and hope they work.

“Out of that blended mish-mosh, an immune cell might pick up 50 antigens and one adjuvant or one antigen and 50 adjuvants,” Michelle Teplensky, a former Northwestern postdoctoral associate and co-founder of Flashpoint with Mirkin, said in a statement. “But there must be an optimum ratio of each that would maximize the vaccine’s effectiveness.”

Spherical nucleic acids invented and developed by Mirkin allow scientists to pinpoint exactly how many antigens and adjuvants are being delivered to cells and enable tailoring of how the vaccine components are presented and the rate at which they are processed, Northwestern said in a statement.

In a study authored by Teplensky, now an assistant professor at Boston University, and published this morning in Nature Biomedical Engineering, data shows Flashpoint Therapeutics’ approach to creating a cancer vaccine structure has been more effective compared with vaccines built in a more conventional way.

Armed with the new study, several years of research and studies, and 10 patents for the approach, Mirkin said vaccines will be in clinical trials by next year.

Flashpoint announced its existence earlier this month with pre-seed funding of $15 million. It is currently raising a seed funding round to build a pipeline beginning with three cancer vaccines, said CEO and co-founder Adam Margolin: first targeting cervical cancer, then determining two other kinds of cancer vaccines to pursue.

In addition, Flashpoint will pursue partnerships with other companies to co-develop cancer vaccines using rational vaccinology, Margolin said.

Margolin, currently based in Palo Alto, Calif., was CEO of NextVivo and for three years was chair of the Icahn School of Medicine at Mount Sinai’s genetics department in New York City.

“The opportunity blew me away,” he said of helping launch the company. “Because it’s the best shot I’ve seen to make a really big impact on cancer.”

Download Modern Healthcare’s app to stay informed when industry news breaks.

The company said, based on in vivo mouse studies, the Flashpoint approach yields 35 times increased co-delivery of adjuvants and antigens to immune cells, 80 times stronger immune activation and 6.5 times greater tumor killing.

“While the notion of effective cancer vaccines was kind of a holy grail . . . they just haven’t reached efficacy,” Margolin said. Current vaccines are moving, slowly in the right direction, proving they’re safe and well tolerated and producing some clinical response, he added.

“But with our approach, what if it’s not incremental change but a step change? That’ll break the market wide open,” he said.

With co-founders based in California (Margolin), Boston (Teplensky) and Evanston (Mirkin), the company will draw experts from wherever they are found, Margolin said, pointing to a leadership team that also includes Mark Booth, former president of Takeda Pharmaceuticals North America and currently executive vice president at EVP TerSera Therapeutics; lawyer Raymond Nimrod, who won an important CRISPR patent lawsuit in 2022; Nick Manusos, previously leader of business development for Takeda; and Marta New, who helped build more than 35 preclinical biotech companies at Baxter Ventures and Agent Capital and will concentrate on drug development at Flashpoint.

An earlier version of this story incorrectly stated the name of Flashpoint Therapeutics. This story first appeared in Crain’s Chicago Business.


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Some addiction treatment centers turn big profits by scaling back care

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Near the end of his scheduled three-month stay at a rehab center outside Austin, Texas, Daniel McKegney was forced to tell his father in North Carolina that he needed more time and more money, he recently recalled.

His father had already received bills from BRC Recovery totaling about $150,000 to cover McKegney’s treatment for addiction to the powerful opioid fentanyl, according to insurance statements shared with KHN. But McKegney, 20, said he found the program “suffocating” and wasn’t happy with his care.

He was advised against the long-term use of Suboxone, a medication often recommended to treat opioid addiction, because BRC does not consider it to be a form of abstinence. After an initial five-day detox period last April, McKegney’s care plan mostly included a weekly therapy session and 12-step group meetings, which are available for free around the country.

McKegney said a BRC staffer recommended he stay a fourth month and even sat in on the call to his dad.

“They used my life and [my] father’s love for me to pull another 20 grand out of him,” said McKegney, who told KHN he began using fentanyl again after the costly stay.

BRC did not respond to specific concerns raised by McKegney. But in an emailed statement, Mandy Baker, president and chief clinical officer of BRC Healthcare, said that many of the complaints patients and former employees shared with KHN are “no longer accurate” or were related to COVID safety measures. 

But addiction researchers and private equity watchdogs said models like the one used by BRC — charging high patient fees without guaranteeing access to evidence-based care — are common throughout the country’s addiction treatment industry.

The model and growing demand are why addiction treatment has become increasingly attractive to private equity firms looking for big returns. And they’re banking on forecasts that predict the market will grow by $10 billion — doubling in size — by the end of the decade as drug overdose and alcohol-induced death rates mount.

“There is a lot of money to be made,” said Eileen O’Grady, research and campaign director at the Private Equity Stakeholder Project, a watchdog nonprofit that tracks private equity investment in health care, housing, and other industries. “But it’s not necessarily dovetailing with high-quality treatment.”

In 2021, 127 mergers and acquisitions took place in the behavioral health sector, which includes treatment for substance use disorders, a rebound after several years of decline, according to investment banking firm Capstone Partners. Private equity investment drove much of the activity in an industry that is highly fragmented and rapidly growing, and has historically had few guardrails to ensure patients are getting appropriate care.

Nashville Recovery Center building
BRC Recovery, a private equity-backed addiction treatment company, bought Nashville Recovery Center in 2021. Private equity investment has driven much of the recent activity in substance abuse treatment, an industry that is highly fragmented and has historically had few guardrails to ensure patients are getting appropriate care.

Blake Farmer for KHN


Roughly 14,000 treatment centers dot the country. They’ve proliferated as addiction rates rise and as health insurance plans are required to offer better coverage of drug and alcohol treatment. The treatment options vary widely and are not always consistent with those recommended by the federal Substance Abuse and Mental Health Services Administration. While efforts to standardize treatment advance, industry critics say private equity groups are investing in centers with unproven practices and cutting services that, while unprofitable, might support long-term recovery.

Baker said the company treats people who have been unsuccessful in other facilities and does so with input from both clients and their families.

Private equity skimps on the known standards

Centers that discourage or prohibit the use of FDA-approved medications for the treatment of substance use disorder are plentiful, but in doing so they do not align with the American Society of Addiction Medicine’s guidelines on how to manage opioid use disorder over the long term.

Suboxone, for example, combines the pain reliever buprenorphine and the opioid-reversal medication naloxone. The drug blocks an overdose while also reducing a patient’s cravings and withdrawal symptoms.

“It is inconceivable to me that an addiction treatment provider purporting to address opioid use disorder would not offer medications,” said Robert Lubran, a former federal official and chairman of the board at the Danya Institute, a nonprofit that supports states and treatment providers.

Residential inpatient facilities, where patients stay for weeks or months, have a role in addiction treatment but are often overused, said Brendan Saloner, an associate professor of health policy and management at Johns Hopkins Bloomberg School of Public Health.

Many patients return to drug and alcohol use after staying in inpatient settings, but studies show that the use of medications can decrease the relapse rate for certain addictions. McKegney said he now regularly takes Suboxone.

“The last three years of my life were hell,” he said.

Along with access to medications, high-quality addiction treatment usually requires long-term care, according to Shatterproof, a nonprofit focused on improving addiction treatment. And, ideally, treatment is customized to the patient. While the “Twelve Steps” program developed by Alcoholics Anonymous may help some patients, others might need different behavioral health therapies.

But, when looking for investments, private equity groups focus on profit, not necessarily how well the program is designed, said Laura Katz Olson, a political science professor at Lehigh University who wrote a book about private equity’s investment in American health care.

With health care companies, investors often cut services and trim staff costs by using fewer and less trained workers, she said. Commonly, private equity companies buy “a place that does really excellent work, and then cut it down to bare bones,” Olson said. During his stay, McKegney said, outings to see movies or go to a lake abruptly stopped, food went from poke bowls and pork tenderloin to chili that tasted like “dish soap,” and staff turnover was high.

Nearly three years ago, BRC landed backing from NewSpring Capital and Veronis Suhler Stevenson, two private equity firms with broad portfolios. Their holdings include a payroll processor, a bridal wear designer, and a doughnut franchise. With the fresh funds, BRC started an expansion push and bought several Tennessee treatment facilities.

NewSpring Capital and Veronis Suhler Stevenson did not respond to emails and phone calls from KHN.

High prices and low overhead = big business

Before the sale to BRC, Nashville Recovery Center co-founder Ryan Cain said, roughly 80% of the center’s offerings were free. Anyone could drop by for 12-step meetings, to meet a sponsor, or just play pool. But the new owners focused on a new high-end sober living program that cost thousands of dollars per month and relied on staffers who were in recovery themselves.

“You have a perfect breeding ground to be able to take advantage of a lot of really good-hearted, well-intentioned people,” said former Nashville Recovery Center staffer Mitzi Dawn, who is in recovery and now works at another treatment facility. Dawn hosted a “Sing and Share” that was canceled soon after the takeover.

Mitzi Dawn
Mitzi Dawn was on staff at Nashville Recovery Center and left after the center was acquired by BRC Recovery and her popular “Sing and Share” event was canceled. She says she worried about her colleagues, since most are in recovery as she is.

Blake Farmer for KHN


In 2021, Nanci Milam, 48, emptied her 401(k) retirement fund to go through the sober living program and tackle her alcohol addiction. She had been sober for only six months when she was hired as a house manager, overseeing some of the same residents she had gone through the program with. She had to handle other residents’ medications, which she said she could have abused. Milam said she was fortunate to maintain sobriety. 

“I think it served their need. And I was ambitious. But it should not have happened,” said Milam, adding that she left because the company hadn’t helped her start her certification as a drug counselor as promised.

A licensing violation reported to Tennessee regulators in late 2021 involved a staffer who was later fired for having sex with a resident in a storage area. And KHN obtained a copy of a 911 call placed in August 2022 — after a resident drank half a bottle of mouthwash — during which a staffer admitted there was no nurse on-site, which some other states require.

Removing the burden from consumers

The regulations of treatment providers largely focus on health and safety rather than clinical guidelines. Only a handful of states, including New York and Massachusetts, require that licensed addiction treatment centers offer medication for opioid use disorder and follow other best practices.

“We have a huge issue in the field where licensing standards don’t comport with what we know to be the most effective quality-of-care standards,” said Michael Botticelli, former director of the Office of National Drug Control Policy during the Obama administration and a member of a clinical advisory board for private equity-backed Behavioral Health Group. Some organizations, including Shatterproof, guide patients toward appropriate care. The federal and state governments largely direct public funds to centers that meet clinical quality-of-care standards.

But access to treatment is limited, and desperate patients and their families often don’t know where to turn. State or federal regulators aren’t policing claims from rehab facilities, like the “99% success rate” touted by BRC.

“We cannot put the burden on patients and their families” to navigate the system, said Johns Hopkins’ Saloner. “My heart really breaks for people who have thrown thousands of their dollars at programs that are bogus.”

When her niece was ready for inpatient rehab in summer 2020, Marina said that sending her to BRC was a “knee-jerk reaction.” Marina, a physician in Southern California, requested to be identified only by her middle name to protect the privacy of her niece, who suffers from alcohol addiction.

She had researched the facility three years earlier but didn’t investigate deeper because she was worried her niece would change her mind. BRC advertised success stories on the television show “Dr. Phil” and posted affirmations on social media.

Marina agreed to BRC’s upfront cost of $30,000 a month for a three-month stay in Texas, which she paid for out-of-pocket because her niece lacked insurance. She allowed KHN to review some of her niece’s pharmacy and treatment bills.

Marina said she paid for a fourth month, but said ultimately the program didn’t help her niece, who remains “horribly sick.” She said her niece felt constant guilt and shame at rehab. Marina thought there was inadequate medical oversight, and said the program “nickeled and dimed” her for additional services, like physicians’ visits, that she thought would be included.

“It almost doesn’t matter if you are educated and intelligent,” Marina said. “When it’s your loved one, you are just desperate.”


KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.




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Sunday, January 29, 2023

Utah becomes first state to ban gender-affirming care for trans youth in 2023

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Utah Governor Spencer Cox signed a bill Saturday that bans hormone replacement therapy and gender-affirming surgery for transgender youth, making Utah the first state in 2023 to ban such care.

Senate Bill 16 provides new restrictions on trans youth seeking medical care in Utah, specifically banning “hormonal transgender treatment to new patients who were not diagnosed with gender dysphoria” before the bill went into effect, and “sex characteristic surgical procedures on a minor for the purpose of effectuating a sex change.”

SB16 also requires the Department of Health and Human Services to conduct “a systematic review of the medical evidence regarding hormonal transgender treatments,” and subsequently, to “provide recommendations to the Legislature.”

Cox said in a statement that the bill is not “perfect,” but ultimately wrote in its defense, “More and more experts, states and countries around the world are pausing these permanent and life-altering treatments for new patients until more and better research can help determine the long-term consequences.”

“While we understand our words will be of little comfort to those who disagree with us, we sincerely hope that we can treat our transgender families with more love and respect as we work to better understand the science and consequences behind these procedures,” Cox added.

The Utah chapter of the ACLU was quick to condemn the bill on Twitter, writing, “Trans kids are kids — they deserve to grow up without constant political attacks on their lives and health care.”

“We will defend that right,” the organization added. “We see you. We Support You.”

Cox had not publicly signaled support or disapproval for the bill until signing it this weekend. The governor previously made headlines in 2022 for vetoing a bill that would bar trans athletes from playing girls’ sports, citing suicide statistics.

“Rarely has so much fear and anger been directed at so few,” wrote Cox in a letter to the state’s legislative leaders at the time.

“I don’t understand what they are going through or why they feel the way they do. But I want them to live,” he added.

The legislature ultimately overrode Cox’s veto. 

According to the U.S. Department of Health and Human Services, “Early gender affirming care is crucial to overall health and well-being” for trans and nonbinary youth, “as it allows the child or adolescent to focus on social transitions and can increase their confidence while navigating the healthcare system.”

Thousands of New Yorkers took to the streets of Manhattan to participate on the Reclaim Pride Coalition’s (RPC) fourth annual Queer Liberation March, where no police, politicians or corporations were allowed to participate. This year, the march highlighted Trans and BIPOC Lives, Reproductive Justice, and Bodily Autonomy.

Erik McGregor/LightRocket via Getty Images


But the rights of trans Americans have continued to be up for debate in America, with more and more states introducing legislation that restricts or bans access to healthcare, prohibits trans people from participating in sports concurrent with their gender identities and more.

Experts say that access to gender-affirming care can be a life-or-death issue for trans youth. A study published in the journal Pediatrics found that nearly 51% of female-to-male respondents had attempted suicide, while the average youth suicide rate in the U.S. is 9%, according to a 2022 study by UCLA.

Studies have shown that access to medical transition can be a major step in improving quality of life for trans people. An analysis of 56 peer-reviewed works by the What We Know Project found that in 93% of the studies, gender transition improved the overall well-being of trans respondents. 

Even so, more than two dozen states tried to enact measures that would either heavily restrict or completely ban access to gender-affirming care for trans youth in 2022, according to The Hill.

Additionally, 20 bills that targeted trans medical care were pre-filed in at least nine states for 2023, including Utah.




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Video of Tyre Nichols Beating Raises Questions About Medical Response

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Two emergency medical technicians who first evaluated Mr. Nichols have been suspended until an investigation is complete.


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Barbara Stanley, Influential Suicide Researcher, Dies at 73

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Her simple idea, for patients to write down a plan that would help them weather a suicidal crisis, rapidly spread in clinical settings.


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Senior Housing That Seniors Actually Like

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“Granny flats” are popping up in backyards across the country, affording Americans a new housing option. Some communities are not happy about it.


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source https://financetin.com/senior-housing-that-seniors-actually-like/financetin.com

Saturday, January 28, 2023

The post-Roe fight over abortion

USDA cracking down on “organic” claims

Friday, January 27, 2023

Will oncologists participate in the Enhancing Oncology Model? – Healthcare Economist

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In the past, I have written about the Enhancing Oncology Model (EOM), including an overview of the EOM program as well as a more detailed review of EOM’s payment methodology. A new paper in JAMA Health Forum by Kocher and Adashi (2023) describes their perspective on the EOM program.

First, they provide a nice overview of the program:

The EOM is a voluntary 6-month, 2-sided, risk-based payment model for clinicians caring for Medicare patients with 7 common cancer types beginning on July 1, 2023, for 5 years. The EOM provides practices with $70 per patient per month to fund a set of activities that are focused on enhanced patient experience, quality improvement, and cost saving. Clinicians receive an additional $30 per patient per month for dually eligible patients and may earn up to a 4% bonus if their total cost of care is below an estimated cost benchmark and they achieve quality targets. Additionally, clinicians must make a performance-based recoupment payment of up to 2% if the total cost of care exceeds the benchmark. 

The authors bring up the fact that EOM’s predecessor–the Oncology Care Model (OCM)–was not particularly successful based on the evidence.

…the OCM model was not cost-effective, and Medicare lost $377 million testing this model based on analyses of the initial 5 performance periods [See Hansol 2021, Keating 2021] Despite payments for care coordination, no change was noted in emergency department visits, hospitalizations, and quality of care. Small end-of-life cost savings were derived from a 1% reduction in hospitalizations. Patient satisfaction was found to be unchanged. The OCM did generate cost savings for some cancer types, including breast cancer, lung cancer, colorectal cancer, and lymphoma.

EOM is a voluntary program. The authors voice concern about physician participation for four reasons: (i) monthly care management payments are lower than under OCM, (ii) cost savings benchmarks will be difficult to achieve, (iii) physicians will incur downside financial risk if costs are above predicted levels and (iv) EOM imposes additional reporting and service requirements., and (

…EOM offers clinicians less of an economic incentive to participate since monthly payments are lower and the knowledge from the OCM is that exceeding the savings benchmark will be hard. While some savings were generated for specific cancer types during the OCM performance periods studied, the savings ranged from 2.2% for high-risk breast cancer to 3.2% for lung cancer—both of which are below the 4% bonus payment threshold set by the EOM…

[Additionally] Clinicians must offer 24-hour/7-day access, care navigation, and care planning and adhere to evidence-based guidelines, collect patient-reported outcomes data, perform social needs screening, collect data on health equity and quality improvement, and use a certified electronic medical record. While most practices likely already offer most of these services because they were also OCM requirements, additional costs may be incurred to ensure compliance. If a practice needs to make investments to meet these requirements, they may not be cost-effective for practices with small numbers of eligible patients

We will see in the coming years how well EOM is able to attract oncologists to participate in the EOM program.

References:

  • Kocher RP, Adashi EY. A New Approach to Cancer Bundled Payments in Medicare—The Enhancing Oncology Model. InJAMA Health Forum 2023 Jan 6 (Vol. 4, No. 1, pp. e224904-e224904). American Medical Association.
  • Hassol  A, West  N, Newes-Adeyi  G,  et al. Evaluation of the Oncology Care Model: performance periods 1-5. January 2021. https://innovation.cms.gov/data-and-reports/2021/ocm-evaluation-pp1-53.
  • Keating  NL, Jhatakia  S, Brooks  GA,  et al; Oncology Care Model Evaluation Team.  Association of participation in the Oncology Care Model with Medicare payments, utilization, care delivery, and quality outcomes.   JAMA. 2021;326(18):1829-1839. doi:10.1001/jama.2021.1764

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Conjoined twins separated by Texas doctors after “historic” 11-hour surgery

Expert Panel Votes for Stricter Rules on Risky Virus Research

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The White House will decide whether to adopt the panel’s recommendations on so-called gain of function experiments.


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Why medical schools are withdrawing from U.S. News’ rankings

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University of Chicago’s Pritzker School of Medicine on Thursday joined a growing list of elite schools to end their participation in U.S. News & World Report’s medical school rankings.

In a letter to U.S. News, Dr. Mark Anderson, Pritzker’s dean, cited concerns about methodology and equity, asking U.S. News to convene stakeholders—including medical school applicants, current medical students and other medical schools—to determine a better way to measure schools and report on what matters to applicants.

The series of medical school deciding to reject the rankings program by no longer submitting data started with Harvard Medical School, which announced its decision Jan. 17. It was followed by Stanford University School of Medicine, Perelman School of Medicine at the University of Pennsylvania, Columbia University Vagelos College of Physicians and Surgeons, Icahn School of Medicine at Mount Sinai and now University of Chicago’s medical school. 

So far, institutions like Stanford University School of Medicine and the Icahn School of Medicine have emphasized that their health systems are still participating in the U.S. News “Best Hospitals” rankings, as the list uses different methodologies. 

However, Mount Sinai said it plans to re-evaluate its participation in other U.S. News rankings over time, and others may follow suit. 

Despite consistently placing high on the list—Harvard Medical School was rated No. 1 in research—the universities expressed the desire to be judged on more wide-ranging criteria, including the diversity of their student population, commitment to social justice, research accomplishments, societal impact and values of students and faculty. They argue those factors are a more accurate and equitable way for prospective students to evaluate colleges.

“The U.S. News rankings reduce us to a number that does not do justice to these profoundly important attributes, instead perpetuating a narrow focus on achievement that is linked to reputation and is driven by legacy and privilege,” said Dr. Dennis Charney and Dr. David Muller, deans at the Icahn School of Medicine in a news release. 

The rankings rely on a number of factors, including student test scores, graduation rates and debt levels, as well as faculty salaries and per-student spending, which critics say are heavily influenced by institutional wealth.

College presidents, provosts and admission deans also rate the academic quality of their peer schools in a survey as part of the ranking. 

U.S. News’ mission is to help the millions of students that look at its medical school rankings make decisions by providing data and solutions, said Eric Gertler, the company’s CEO and executive chairman, in a statement responding to Harvard’s decision. 

“We know that comparing diverse academic institutions across a common data set is challenging, and that is why we have consistently stated that the rankings should be one component in a prospective student’s decision-making process,” he said. 

A main consideration for medical schools when considering whether or not to participate in rankings is how it will affect their image. 

Rankings garner the attention of applicants and their families but they are not directly related to a school’s ability to make a good physician, said Dr. Holly Humphrey, president of the Josiah Macy Jr. Foundation, which funds the advancement of education and training for health professionals. 

“The most important way that one comes to understand the educational process at that school is through multiple data sources and the many ways in which an individual interfaces with an institution,” she said. “The experience of talking to faculty, students and individuals who have been patients.” 

Similarly, a school’s reputation, which is separate from its rating, is another way that schools can market themselves to prospective students, said Stephen Greyser, marketing professor at Harvard Business School. 

Instead of relying on rankings, medical schools should tout the successes and accomplishments of former students, residents and interns, which could spread through word of mouth or targeted advertisements in renowned journals or other sites, Greyser said. 

Overall, a ranked list cannot capture the complexity of how suited a particular medical school is to any given student, regardless of methodology, said George Daley, dean of Harvard Medical School, in a news release.

“Rankings create perverse incentives for institutions to report misleading or inaccurate data, set policies to boost rankings rather than nobler objectives, or divert financial aid from students with financial need to high-scoring students with means in order to maximize ranking criteria,” Daley said.

To help students better evaluate their options, the Stanford School of Medicine plans to begin independently reporting its own performance data starting March 1, said Dr. Lloyd Minor, the school’s dean, in a news release. The data will include faculty accomplishments and impact in education, research and patient care. 

“Our decision, along with those of a growing number of peer institutions, is necessary to lead a long-overdue examination of how medical education quality is evaluated and presented to aspiring students,” Minor said.  


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More than 7,600 fake nursing diplomas issued in Florida in alleged wire fraud scheme

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25 charged in fraudulent nursing diploma scheme centered in South Florida


25 charged in fraudulent nursing diploma scheme centered in South Florida

02:41

Thousands of practicing nurses in the U.S. could potentially be working with bogus academic credentials after federal officials uncovered an alleged scheme at three South Florida nursing schools. The Department of Justice said Wednesday that the schools, now closed, allegedly issued more than 7,600 fake and unearned nursing diplomas. 

The schools involved in the alleged scheme include Siena College, Palm Beach School of Nursing and Sacred Heart International Institute. The Justice Department has charged more than two dozen people for their alleged involvement, saying they “engaged in a scheme to sell fraudulent nursing degree diplomas and transcripts obtained from accredited Florida-based nursing schools.” Each of those defendants now faces up to 20 years in prison. 

According to charging documents, many of those involved in the alleged scheme are from out-of-state, including people from New York and New Jersey. The nurses with the fake degrees went on to work in various settings, including for homebound children, assisted living facilities and veteran affairs, and in several states, documents show, including Ohio, New York, New Jersey, Massachusetts, Georgia, Maryland and Texas. 

The alleged schemes took place between 2016 and 2021. 

Those who got the fake diplomas were able to take the national nursing board exam and then obtain licenses and jobs in “various states” as registered nurses (RNs), licensed practical nurses (LPNs) and vocational nurses (VNs),” the DOJ said. 

Markenzy Lapointe, U.S. Attorney for the Southern District of Florida, said a scheme such as this “erodes public trust in our health care system.” 

“Not only is this a public safety concern, it also tarnishes the reputation of nurses who actually complete the demanding clinical and course work required to obtain their professional licenses and employment,” Lapointe said. 

Among those charged are Burlington County, New Jersey, residents Stanton Witherspoon and Alfred Sellu and Westchester County, New York, resident Rene Bernadel. Prosecutors said the three “solicited and recruited” people seeking nursing credentials and then worked with Eunide Sanon of Siena College “to create and distribute false and fraudulent diplomas and transcripts” that were sold to “thousands” of nursing applications. Those papers incorrectly stated that the aspiring nurses had attended the Broward County nursing program and completed their courses and clinicals, prosecutors allege.

The other schools named allegedly did the same.

American Nurses Association President Jennifer Mensik Kennedy said Thursday that the “coordinated conspiracy” is “disturbing” and “deeply unsettling.” 

“Nursing is without a doubt a highly specialized and ethical profession requiring rigorous and life-long education and training to acquire unmatched clinical expertise. You don’t achieve this overnight,” she said. “There are no shortcuts in nursing – our patients and clients depend on us. It is both a demanding and rewarding profession that requires individuals to be adaptive to the evolving and complex health care landscape to ensure the delivery of safe and quality patient care.”

The actions of those involved, including the schools that were once accredited, are “simply deplorable,” she said. 

“This undermines everything the nursing profession represents and stands for and is in direct opposition to the Code of Ethics for Nurses,” she said. “Furthermore, these unlawful and unethical acts disparage the reputation of actual nurses everywhere who have rightfully earned the title of the ‘Most Trusted and Ethical Professionals’ through their education, hard work, dedication and time.”


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ARCH, General Catalyst launch clinical trial tech company Paradigm

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Paradigm, a clinical trial technology company, has launched out of stealth with $203 million in Series A funding.

Paradigm will use the money to build a clinical research platform for provider and biopharmaceutical customers. The company has also acquired Deep Lens, a clinical trial patient recruitment company focused on oncology, for an undisclosed price.

Paradigm was conceived by venture capital firm ARCH Venture Partners and co-created by ARCH and General Catalyst, another venture capital firm. Along with ARCH and General Catalyst, investors in this stealth round include F-Prime Capital, GV, LUX Capital and Mubadala Capital, which is the state-owned investment firm for United Arab Emirates.

ARCH tapped clinical research industry veteran Kent Thoelke to Paradigm. Thoelke was chief scientific officer at PRA Health Sciences, which clinical research organization ICON acquired in 2021.

Along with Thoelke, Paradigm’s executive team includes a number of pharmaceutical digital health veterans. Milind Kamkolkar, the former chief data officer at Sanofi, is chief operating officer and Jonathan Hirsch, founder of real-world evidence company Syapse, is chief strategy and growth officer.

Clinical trials have become a popular target for disruption both by technology and retail players. There were 17 deals for digital health companies developing clinical trial technology, collectively valued at nearly $300 million, last year, according to Digital Health Business & Technology’s database. This potential has drawn interest from drugmakers such as GSK, the British pharmaceutical giant, which signed a four-year deal in September with Medable, a clinical trial software unicorn.

Retailers such as Walgreens Boots Alliance, CVS Health and The Kroger Co. have also entered the fray. Walgreens launched a clinical trial business in June to build a decentralized platform and offer in-person locations for recruiting and conducting clinical trials. CVS Health started a clinical trial division in 2021 and teamed with Medable for a virtual component last year. On Wednesday, Kroger announced its own clinical trial initiative in partnership with Persephone Biosciences.

This story first appeared in Digital Health Business & Technology.


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Thursday, January 26, 2023

Hive hackers gang that targeted hospitals infiltrated by FBI

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WASHINGTON — The FBI and international partners have at least temporarily disrupted the network of a prolific ransomware gang they infiltrated last year, saving victims including hospitals and school districts a potential $130 million in ransom payments, Attorney General Merrick Garland and other U.S. officials announced Thursday.

“Simply put, using lawful means we hacked the hackers,” Deputy Attorney General Lisa Monaco said at a news conference.

Officials said the targeted syndicate, known as Hive, operates one of the world’s top five ransomware networks and has heavily targeted hospitals and other healthcare providers. The FBI quietly gained access to its control panel in July and was able to obtain software keys to decrypt the network of some 1,300 victims globally, said FBI Director Christopher Wray. Officials credited German police and other international partners.

Related: Healthcare vendors are the new front of the cybersecurity war

It was not immediately clear how the takedown will affect Hive’s long-term operations, however. Officials did not announce any arrests but said they were building a map of Hive’s administrators, who manage the software, and affiliates, who infect targets and negotiate with victims, to pursue prosecutions.

“I think anyone involved with Hive should be concerned because this investigation is ongoing,” Wray said.

On Wednesday night, FBI agents seized computer infrastructure in Los Angeles that was used to support the network. Two Hive dark web sites were seized: one used for leaking data of non-paying victims, the other for negotiating extortion payments.

“Cybercrime is a constantly evolving threat, but as I have said before, the Justice Department will spare no resource to bring to justice anyone anywhere that targets the United States with a ransomware attack,” Garland said.

Garland said that thanks to the infiltration, led by the FBI’s Tampa office, agents were able in one instance to disrupt a Hive attack against a Texas school district, stopping it from making a $5 million payment.

The operation is a big win for the Justice Department. The ransomware scourge is the world’s biggest cybercrime headache with everything from Britain’s postal service and Ireland’s national health service to Costa Rica’s government crippled by Russian-speaking syndicates that enjoy Kremlin protection.

The criminals lock up, or encrypt, victims’ computer networks, steal sensitive data and demand large sums. The extortion schemes have evolve to where data is stolen before the ransomware is activated and is effectively held hostage. Pay up in cryptocurrency or the criminals release it publicly.

As an example of Hive’s threat, Garland said it had prevented a hospital in the Midwest in 2021 from accepting new patients at the height of the COVID-19 epidemic.

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The online takedown notice, alternating in English and Russian, mentions Europol and German partners in the effort. The German news agency dpa quoted the public prosecutor’s office in Stuttgart as saying cyber specialists in the southwestern town of Esslingen were decisive in penetrating Hive’s criminal IT infrastructure after a local company was victimized.

In a statement, Europol said companies in more than 80 countries, including oil multinationals, have been compromised by Hive. It said Europol assisted with cryptocurrency, malware and other analysis, and that law enforcement agencies from 13 countries were involved in the effort.

A U.S. government advisory last year said Hive ransomware actors victimized over 1,300 companies worldwide from June 2021 through November 2022, receiving approximately $100 million in ransom payments. It said criminals using Hive’s ransomware-as-a-service tools targeted a wide range of businesses and critical infrastructure, including government, manufacturing and especially health care and public health facilities.

Even though the FBI offered decryption keys to some 1,300 victims around the world, Wray said only about 20% reported potential issues to law enforcement.

“Here, fortunately, we were still able to identify and help many victims who didn’t report. But that is not always the case,” Wray said. “When victims report attacks to us, we can help them and others, too.”

In some cases, cybersecurity experts say, victims quietly pay ransoms without notifying authorities — and even if they’ve been able to quickly restore their networks — because the criminals have stolen files that could be extremely damaging to them if leaked online, such as information that could be used in identity theft.

John Hultquist, the head of threat intelligence at the cybersecurity firm Mandiant, said the Hive disruption won’t cause a major drop in overall ransomware activity but is nonetheless “a blow to a dangerous group.”

“Unfortunately, the criminal marketplace at the heart of the ransomware problem ensures a Hive competitor will be standing by to offer a similar service in their absence, but they may think twice before allowing their ransomware to be used to target hospitals,” Hultquist said.

But Brett Callow, an analyst with the cybersecurity firm Emsisoft, said the operation is apt to lessen ransomware crooks’ confidence in what has been a very high reward-low risk business.

“The information collected may point to affiliates, launderers and others involved in the ransomware supply chain,” Callow said.

And analyst Allan Liska of the cybersecurity firm Recorded Future said the operation shows “law enforcement’s multi-pronged strategy of arrests, sanctions, seizures and more is working to slow down ransomware attacks.” He predicted it would lead to indictments, if not actual arrests, in the next few months.

The ransomware threat captured the attention of the highest levels of the Biden administration two years ago after a series of high-profile attacks that threatened critical infrastructure and global industry. In May 2021, for instance, hackers targeted the nation’s largest fuel pipeline, causing the operators to briefly shut it down and make a multimillion-dollar ransom payment that the U.S. government largely recovered.

Federal officials have used a variety of tools to try to combat the problem, but conventional law enforcement measures such as arrests and prosecutions have done little to frustrate the criminals.

The FBI has obtained access to decryption keys before. It did so in the case of a major 2021 ransomware attack on Kaseya, a company whose software runs hundreds of websites. It took some heat, however, for waiting several weeks to help victims unlock afflicted networks.

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Covid Vaccines Targeting Omicron Should Be Standard, Panel Says

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As advisers to the Food and Drug Administration endorsed ending one era of the Covid vaccination campaign, they also grappled with its future.


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Feds allege fake nursing credentials scheme in Florida

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Federal authorities say they’ve uncovered a conspiracy to provide prospective nurses with bogus diplomas and credentials allowing them to sit for board exams—and care for patients if they managed to pass despite not earning nursing degrees.

Three now-closed Florida nursing schools were involved in a scheme that distributed fraudulent credentials to more than 7,600 people, the Justice Department alleges in recently unsealed indictments announced Wednesday.

The U.S. Attorney for the Southern District of Florida charged 25 people with involvement in an plot that gave aspiring nurses an unlawful shortcut to becoming registered nurses or licensed practical/vocational nurses, according to a news release and court documents.

Recruiters from Delaware, Florida, New Jersey, New York, and Texas and program administrators at Siena College of Health in Lauderhill, Palm Beach School of Nursing in West Palm Beach and Sacred Heart International Institute in Boca Raton are among those charged. The defendants could face up to 20 years in prison. Court documents did not identify the attorneys representing the accused and Modern Healthcare was unable to determine who they are or how to contact them for comment. The U.S. attorney’s office did not respond to requests for that information.

The allegedly phony documents were aspiring nurses’ tickets to qualify for the national nursing board exam that, if they passed, granted them nursing licenses. While the schools are based in Florida, the people who bypassed nursing school took nursing jobs nationwide, according to the Justice Department.

Adults ranked nursing as the most trusted profession for the 21st year in a row, according to a Gallup poll conducted last year. Federal officials expressed concern that the alleged scheme unfairly taints all nurses.

“Not only is this a public safety concern, it also tarnishes the reputation of nurses who actually complete the demanding clinical and course work required to obtain their professional licenses and employment,” U.S. Attorney Markenzy Lapointe said in the news release. “A fraud scheme like this erodes public trust in our healthcare system.”

As a consequence of the alleged fraud, nurses are caring for patients but did not ethically earn the right to do so, FBI acting Special Agent in Charge Chad Yarbrough said in the news release. “There are over 7,600 people around the country with fraudulent nursing credentials who are potentially in critical healthcare roles treating patients,” he said.

This investigation is part of a Health and Human Services Department Office of Inspector General probe called Operation Nightingale, through which it partners with law enforcement agencies to crack down on cases affecting healthcare safety and quality.

“To date, we have not learned of nor uncovered any evidence of patient harm stemming from these individuals potentially providing services to patients,” an OIG spokesperson said in a statement. The OIG is working with state licensing boards to determine the best way to deal with people holding fraudulent nursing credentials, the spokesperson said.


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Sanford-Fairview merger: Minnesota AG Keith Ellison asks for delay

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The $14 billion merger between Sanford Health and Fairview Health Services may be held up over concerns from a top Minnesota regulator.

The nonprofit Midwestern health systems announced a deal in November that they aim to close by March 31. But Minnesota Attorney General Keith Ellison (D) has asked Sioux Falls, South Dakota-based Sanford Health and Minneapolis-based Fairview Health Services to postpone their proposed merger, citing his office’s continuing investigation into its consequences.

The attorney general’s office has not decided “if there will be a cause for legal action,” Chief Deputy Attorney General John Keller said at a community meeting in Worthington, Minnesota, Wednesday, according to his prepared remarks. The state legislature also is planning hearings, he said.

“It is more important to do this right than to do it fast, and that is why the parties’ existing timeline concerns the attorney general’s office,” Keller said. “As a result, we have formally asked the parties to delay the March 31 closing date, and we await their formal response,” Keller said.

Sanford and Fairview say they are working to ensure the attorney general’s office has the information it needs.

“This merger is about doing more for those we serve, and every day we delay merging Sanford and Fairview is a missed opportunity to realize the significant benefits for our patients, our people and the communities we serve. This merger is also about taking critical steps to provide the necessary financial sustainability to serve Minnesota communities for generations to come,” the health systems said in a joint statement.

Sanford and Fairview will need to stay focused on closing their deal while also cooperating with Ellison, said Matthew Anderson, a senior lecturer of health policy and management at the University of Minnesota.

The health systems should act quickly to reduce merger costs, maintain momentum, and mitigate uncertainty among current or potential employees, insurers, vendors and other stakeholders, Anderson said. The companies also needs to move swiftly to get ahead of any other state actions, he said. But they need to maintain good relationships with the state government and the University of Minnesota, where Fairview owns a hospital, he said.

“Throwing sand in the face of the attorney general would be a high-risk move,” Anderson said. “If the AG asked to slow the proposed merger down and the parties say no, does that create the perception that they are trying to hide something?”

The University of Minnesota has expressed concern that the proposed merger is moving too fast and that its interests have not been adequately considered, Keller said. Fairview acquired the M Health Fairview University of Minnesota Medical Center in Minneapolis 26 years ago.

Sanford CEO Bill sought to allay those worries at the meeting in Worthington on Wednesday. According to his prepared remarks, Gassen said the merged company would honor its agreements with the University of Minnesota and its flagship medical center. The current arrangement expires in 2026.

“That leaves more than enough time for the combined system to work with the university on the terms of a repurchase of the medical center it sold to Fairview in 1997, and determine what a future clinical relationship could look like,” Gassen said. “Nothing—I repeat, nothing—will change for the University of Minnesota as a result of this merger.”

There are no plans to close facilities because of the merger Gassen said. If the deal were approved, he would be president and CEO of the combined system and Fairview CEO James Hereford would be co-CEO for a year. The new company would assume the Sanford Health name, operate more than 50 hospitals and employ roughly 80,000 people.

Sanford Health and Fairview Health Services unsuccessfully attempted to merge in 2013 but encountered resistance from Ellison’s predecessor, Lori Swanson (D). Swanson likewise expressed concern about the deal’s effects on the University of Minnesota hospital. Sanford withdrew from the deal in response to the attorney general’s objections.

Both health systems tout financial stability as a key justification for the new deal, but questions remain if it could improve their finances.

Fairview posted operating losses through the first nine months of 2022, according to its most recent financial report, leading to a credit rating downgrade this month. Fairview recorded a $213.8 million operating loss on $4.9 billion of operating revenue, compared with a $120.9 million operating loss on $4.75 billion of operating revenue over the same period the prior year. Its days cash on hand dropped from 158 to 118 over that span. The company, which has $1.57 billion in outstanding debt, also posted annual operating losses in 2019, 2020 and 2021.

While credit rating agencies don’t participate in mergers and acquisition approvals, Moody’s Investors Service downgraded Fairview from A3 to Baa1 and assigned it a negative outlook. The company’s weak operating performance will be difficult to reverse, especially amid high labor and supply costs and relatively low inpatient volumes, according to the Moody’s report. Fairview has a solid market position, good scale, adequate cash-to-debt levels and significant income from its specialty pharmacy operations, but the decline in its investment income will provide less of a buffer from its operating losses, Moody’s wrote.

Sanford reported a $32.8 million operating income on $5.12 billion of operating revenue through the first nine months of 2022. That was down from $284.2 million in operating income on $5.22 billion of revenue over the same period the prior year. Its days cash on hand dropped from 154 to 118 over that span.


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Children’s Health System Of Texas, UT Southwestern Medical Center Plan Pediatric Hospital

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Dallas-based Children’s Health System of Texas and UT Southwestern Medical Center are planning a new pediatric campus in Dallas, according to the website dmagazine.com.

The $2.5 billion project will replace Children’s Health’s main campus, called Children’s Medical Center Dallas, with a new 532-bed pediatric hospital.

The new facility will house a 90-bay emergency department, more than 90 newborn intensive care unit beds, and labor and delivery program with 30 beds.

Plans also call for a new administrative building, ambulatory care center with 250 exam rooms, utility plant, and parking facilities, according to the website dallasnews.com.

Construction is expected to begin in 2024 with completion slated in 2028.


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Wednesday, January 25, 2023

Digital health vendor contracts with employee benefits managers shift

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Cost savings is not the only metric employers are considering when selecting digital health solutions. Ellen Kelsay, CEO of the employer-focused nonprofit advocacy organization Business Group on Health, said large employer members in her organization are looking for digital health solutions that can integrate with each other and traditional care providers. 

“A lot of these virtual health solutions were offered as a one-off,” Kelsay said. “They are a well-intentioned and compelling one-off solution, but the sustainability isn’t there if these systems aren’t integrated more holistically.”

Companies selling to employers have taken notice of the changing priorities. At the J.P. Morgan Healthcare Conference earlier this month, Teladoc Health CEO Jason Gorevic promoted the company’s whole-person telehealth efforts that include primary care, mental health and specialty visits. The company recently put all its virtual health offerings onto one app.

“There are a lot of virtual care companies out there that are more narrowly focused, smaller in scale and are nipping at the edges of single [software] solutions,” Gorevic said.

The phrase “point solution,” an industry term for software products that only focus on one area of medical care, has become derisive among investors, buyers and other digital health companies. Those kind of companies are going to see a shakeout in the market, said Donald Trigg, CEO of healthcare navigation company Apree Health, which formed when Castlight Health and Vera Whole Health merged.

“There are some macro tailwinds around cost and there’s an appetite coming out of COVID for an integrated solution offer as opposed to the blizzard of point solutions that we’ve seen over the last number of years,” Trigg said.

Omada Health, a chronic care digital health company, has started selling to health systems including a partnership with Intermountain that was announced earlier this month. Sean Duffy, CEO of Omada Health, said employers are starting to tire of having too many digital health solutions.

“We’re seeing more request for proposals where employers are like, ‘I just need to consolidate my point solutions,” Duffy said.

Some companies in the space may have look to for potential merger and acquisition partners, experts say. At the very least, companies should better understand what employers are looking for in digital health solutions.

“The more they can prove over time that they’ve actually improved patient experiences and outcomes, it will bode well for their sustainability within the market,” Kelsay said. “But a lot of these companies come and talk about the merits of their own solution in a vacuum. They’re not paying attention to what success will look like for the patient and the employer.”

This story first appeared in Digital Health Business & Technology. 


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