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Wednesday, February 15, 2023

Community Health Systems results, guidance

 Community Health Systems, Inc. (NYSE: CYH) (the "Company") today announced financial and operating results for the three months and year ended December 31, 2022.

The following highlights the financial and operating results for the three months ended December 31, 2022.

  • Net operating revenues totaled $3.142 billion.

  • Net income attributable to Community Health Systems, Inc. stockholders was $414 million, or $3.18 per share (diluted), compared to $178 million, or $1.34 per share (diluted), for the same period in 2021. Excluding the adjusting items as presented in the table in footnote (e) on page 16, net income attributable to Community Health Systems, Inc. stockholders was $1.50 per share (diluted), compared to $1.15 per share (diluted) for the same period in 2021.

  • Adjusted EBITDA was $404 million, including $2 million of pandemic relief funds.

  • Net cash provided by operating activities was $9 million for the three months ended December 31, 2022, which included payment of approximately $73 million of 2020 social security taxes deferred pursuant to the CARES Act, compared to net cash used in operating activities of $531 million, which included repayments of Medicare accelerated payments in the amount of $814 million, for the same period in 2021.

  • Approximately $378 million principal amount of notes outstanding were extinguished during the three months ended December 31, 2022.

  • On a same-store basis, admissions increased 4.4 percent and adjusted admissions increased 8.2 percent, compared to the same period in 2021.

Set forth below is selected information concerning the Company’s projected consolidated operating results for the year ending December 31, 2023. These projections are based on the Company’s historical operating performance, current trends and other assumptions that the Company believes are reasonable at this time. The 2023 guidance should be considered in conjunction with the assumptions included herein. See pages 19, 20 and 21 for a list of factors that could affect the future results of the Company or the healthcare industry generally.

 

The following is provided as guidance to analysts and investors:

2023 Projection Range
Net operating revenues (in millions)$

12,200

 

to$

12,600

 

Adjusted EBITDA (in millions)$

1,475

 

to$

1,625

 

Net loss per share - diluted$

(0.65

)

to$

(0.05

)

Weighted-average diluted shares (in millions)

130.0

 

to

131.0

 

The following assumptions were used in developing the 2023 guidance provided above:

  • The Company’s projections exclude the following:
    • Effect of debt refinancing activities, including gains and losses from early extinguishment of debt;
    • Impairment of goodwill and long-lived assets;
    • Previously recorded pandemic relief funds and the potential recognition of additional pandemic relief funds;
    • The impact of any potential future divestitures;
    • Gains or losses from the sales of businesses;
    • Employee termination benefits and restructuring costs;
    • Resolution of government investigations or other significant legal settlements;
    • Costs incurred in connection with divestitures; and
    • Other significant gains or losses that neither relate to the ordinary course of business nor reflect the Company’s underlying business performance.

Other assumptions used in the above guidance:

  • Expressed as a percentage of net operating revenues, depreciation and amortization of approximately 4.2% for 2023. Additionally, this is a fixed cost and the percentages may vary based on changes in net operating revenues. Such amounts exclude the possible impact of any future hospital fixed asset impairments.
  • Interest expense is estimated to be between $815 million and $835 million while cash paid for interest, which excludes the amortization of deferred financing costs, is expected to be $760 million to $780 million. Total fixed rate debt is expected to average approximately 100% of total debt during 2023.
  • Expressed as a percentage of net operating revenues, net income attributable to noncontrolling interests of approximately 1.1% to 1.2% for 2023.
  • Expressed as a percentage of net operating revenues, provision for income taxes of approximately 0.8% to 0.9% for 2023.

A reconciliation of the Company’s projected 2023 Adjusted EBITDA, a forward-looking non-GAAP financial measure, to the Company’s projected net loss attributable to Community Health Systems, Inc. stockholders, the most directly comparable GAAP financial measure, is shown below (in millions):

 
Year Ending
December 31, 2023
LowHigh
Net loss attributable to Community Health Systems, Inc. stockholders (1)$

(84

)

$

(6

)

Adjustments:
Depreciation and amortization

510

 

530

 

Interest expense, net

815

 

835

 

Provision for income taxes

99

 

116

 

Net income attributable to noncontrolling interests

135

 

150

 

Adjusted EBITDA (1)$

1,475

 

$

1,625

 

(1)

The Company does not include in this reconciliation the impact of certain items not included in the Company’s forecast set forth above that would be included in a reconciliation of historical net income (loss) attributable to Community Health Systems, Inc. stockholders to Adjusted EBITDA such as, but not limited to, losses (gains) from early extinguishment of debt, impairment and (gain) loss on sale of businesses and expense from government and other legal matters and related costs, in light of the fact that such items are not determinable, and/or the inherent difficulty in quantifying such projected amounts, on a forward-looking basis.

  • Capital expenditures are projected as follows (in millions):
 

2023

 Guidance

Total

 

$

450

to

$

500

  
  • Net cash provided by operating activities are projected as follows (in millions):
 

2023

 Guidance

Total

 

$

675

to

$

825

  • Diluted weighted-average shares outstanding are projected to be approximately 130 million to 131 million for 2023.

https://www.chs.net/investor-relations/press-room-media-releases/

FDA advisers recommend approval of over-the-counter naloxone to fight opioid overdose

 government advisory committee voted unanimously on Wednesday to recommend that naloxone nasal spray, a medication used to reverse opioid overdoses, be sold and distributed without a prescription.

The vote serves as a recommendation to the Food and Drug Administration as the agency considers whether to make the product, commonly known as Narcan, available over the counter. While the FDA isn’t bound by the result, it almost always adheres to the recommendations of its scientific advisory committees.

The 19-0 result came after hours of discussion regarding the medication’s safety — and whether non-health care professionals could follow instructions in Narcan’s packaging well enough to effectively administer it in an emergency.

First responders and community organizations have used naloxone to reverse opioid overdoses for decades. It comes in several forms, including a general intramuscular injection, a nasal spray, and a mechanized auto-injector.

Public health and medical experts widely view naloxone as the best and only tool available to reverse opioid overdoses. But its prescription status — and perhaps more importantly, its cost — have prevented it from being manufactured and distributed at a larger scale.

Following years of widespread calls to increase naloxone access, the FDA issued a preliminary assessment in November that some naloxone products could safely and effectively be made available over the counter, and is currently considering that status for the nasal spray. While Narcan’s cost varies widely, a two-pack of 4-milligram spray typically retails for between $35 and $65.

Two manufacturers are applying for nonprescription status: Emergent BioSciences — the focus of Wednesday’s meeting — and Harm Reduction Therapeutics, a nonprofit organization. The FDA granted both companies a priority review and is likely to issue an approval decision within months.

Despite voting to recommend the product’s approval, the FDA’s scientific advisers and key agency leaders had harsh words for Emergent.

Among their criticisms: The company’s user-friendliness tests didn’t include time limits, and included leading language that may have yielded misleadingly low rates of user error. Some of the company’s study groups also failed to include significant numbers of limited-literacy participants.

Emergent also made changes to the labeling and instructions that would accompany an over-the-counter version of Narcan, prompting a stern rebuke from Theresa Michele, the director of the FDA’s Office of Nonprescription Drugs.

“The sponsor tested one thing and then proposed something else — and now they’re proposing a third thing,” she said at one point. The FDA must approve all labels and instructions that would accompany the medication.

The study did record a number of frequent user errors — in particular, spraying naloxone into the air rather than into the overdose victim’s nostril and failing to wait the recommended 2-3 minutes between doses if the individual remains unresponsive.

Naloxone’s broader safety profile, however, went unquestioned by committee members. The few concerns expressed pertained mostly to the withdrawal symptoms that overdose victims often experience upon being revived with naloxone, especially when responders use more naloxone than necessary.

The committee members also stressed that naloxone is safe even when inadvertently given to individuals who are mistakenly believed to be overdosing. It would have no effect, for instance, when given to somebody experiencing a hypoglycemic episode or heart attack.

The advisers, however, appeared to uniformly agree that the urgency of the U.S. overdose crisis far outweighed the potential delays associated with gathering new data and running user-friendliness tests on new instructions.

The U.S. is currently experiencing roughly 110,000 annual drug overdose deaths, the large majority of which are caused by illicit opioids like fentanyl and heroin.

STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.

https://www.statnews.com/2023/02/15/naloxone-otc-opioisa-fda-panel-recommends/

Amedisys Guidance, Asset Sales, Agreements

 2023 Guidance

  • Adjusted net service revenue is anticipated to be in the range of $2.244 billion to $2.274 billion.

  • Adjusted EBITDA is anticipated to be in the range of $230 million to $240 million.

  • Adjusted diluted earnings per share is anticipated to be in the range of $4.13 to $4.36 based on an estimated 32.9 million shares outstanding.

This guidance excludes the effects of any future acquisitions and potential share repurchases, if any are made.

Personal Care Divestiture

On February 10, 2023, we signed a definitive agreement to sell our personal care line of business (excluding the Florida operations). The divestment is expected to close during the second quarter of 2023.

BlueCross BlueShield of Tennessee Palliative Care Partnership

We also announced a new agreement between Contessa Health Management, LLC, an Amedisys subsidiary, and BlueCross BlueShield of Tennessee to provide members in Middle Tennessee with palliative care in the comfort of their home.

https://finance.yahoo.com/news/amedisys-reports-fourth-quarter-end-211000824.html

AI on AI: Cardio Journal Editor Interviews ChatGPT

 The artificial intelligence (AI) chatbot ChatGPT is creeping into science and medicine — prompting Douglas L. Mann, MD, editor-in-chief of JACC: Basic to Translational Science, to take it out for a test drive.

ChatGPT (OpenAI), which stands for Chat Generative Pre-trained Transformer, is a natural language processing tool that allows users to have a personalized conversation with an AI bot capable of providing detailed responses to any question posed.

Mann, who has previously written about the potential perils of AI technology in healthcare, engaged ChatGPT (OpenAI) in a point–counterpoint discussion about the role of AI translational medicine.

"The first impression is that it's this amazing new technology that is reasonably efficient and accurate and returns answers blindingly fast. I was totally stunned," Mann told theheart.org | Medscape Cardiology.

Dr Douglas Mann

"But then when you drill down, the responses lack the type of nuanced insight that a person with in-depth knowledge of the field might provide. That's what’s missing right now," said Mann, with Department of Internal Medicine – Cardiology Division, Washington University School of Medicine, St. Louis, Missouri.

As detailed in a perspective piece published online January 18 in JACC: Basic to Translational Science, he first posed the question: "Why Is AI The Future of Translational Medicine?"

Within about one minute, ChatGPT produced five paragraphs, concluding with the following, copied here verbatim with no editing for grammar, style, or content.

"In conclusion, AI is likely to play an increasingly important role in the future of translational medicine, due to its ability to analyze large datasets quickly and accurately, to identify patterns and trends, and to help develop personalized treatments and new drugs. As AI technologies continue to advance, it is likely that we will see even more applications of AI in the field of translational medicine, which will have the potential to improve patient care and outcomes."

Next, Mann asked ChatGPT: "Why Will AI Not Be The Future of Translational Medicine?" Again, it returned five paragraphs, with the following conclusion (verbatim).

"In conclusion, while AI has the potential to be a useful tool in the field of translational medicine, it is unlikely to be the future of this field. There are a number of limitations to the use of AI in this context, including the potential for bias and incomplete data, the inability to understand the complexity of biological systems, and the ethical implications of using these technologies. As a result, it is important to be cautious about relying too heavily on AI in the field of translational medicine, and to ensure that it is used in a responsible and ethical manner."

Mann said he found both sides of the argument "factual and to some extent compelling," but lacking depth.

"To me, it was like what a first-year medical student could generate just scanning the internet, although I do think that as the systems become more sophisticated, they may be able to interject some insight that you can't get from the internet," Mann said.

Editor-in-Chief Chatbot?

He's not alone. In a recent survey on progress in AI, fully half of AI experts estimated that an AI system capable of human-level thinking would be available by 2059.

"Given that this date is well beyond my tenure as editor-in-chief for JACC: Basic to Translational Science, I am reasonably confident that I will be able to hold onto my editorial position and that I will not be replaced by an editor-in-chief chatbot in the near term," Mann writes.

Still, Mann believes AI-generated content will become an increasingly "important voice" in scientific and medical journals in the not-too-distant future. Some research papers have already been submitted to journals citing ChatGPT as a co-author — prompting much debate and putting journal editors on edge.

"The journals are circling the wagons now about not letting AI-generated content be used," Mann said.

Last month, The World Association of Medical Editors (WAME) published a position paper — Recommendations on ChatGPT and Chatbots in Relation to Scholarly Publications. Among the recommendations: chatbots cannot be authors.

Dr Adam Powell

Adam C. Powell, PhD, president of Payer+Provider Syndicate, also thinks ChatGPT and similar technologies will play an "increasingly important role in generating journalistic content, and that content may soon find its way into medical and scientific journals."

Powell also sees a role for AI in helping clinicians produce personalized content for their practices.

"Rather than providing patients with generic instructions, using AI, it will be possible to adapt instructions to the cultural needs, reading levels, and stylistic preferences of the patients receiving them," Powell told theheart.org | Medscape Cardiology.

"Likewise, AI can help answer patient and physician questions, and help illustrate connections between concepts," Powell said.

For example, Powell asked ChatGPT to write 150 words, citing 5 sources, explaining why not all patients should receive imaging for lower back pain, to which it responded (citing 3 sources):

"Imaging for lower back pain, such as X-rays, CT scans, and MRIs, is often unnecessary and can lead to potential harm for patients. According to the American College of Physicians, routine imaging for lower back pain is not recommended for most patients as it has been shown to not improve patient outcomes and can lead to overdiagnosis and overtreatment (Qaseem et al., 2017).

Similarly, the Choosing Wisely initiative, a national effort aimed at reducing unnecessary medical tests, also advises against routine imaging for lower back pain without clear indications such as severe or progressive neurological deficit, suspected spinal cord compression, or an underlying systemic disease (Smith et al., 2013).

Additionally, exposure to ionizing radiation from imaging tests can increase the risk of cancer and other harmful effects (Smith et al., 2013). The use of imaging for lower back pain can also result in increased costs for both patients and healthcare systems (Qaseem et al., 2017). Instead, non-imaging approaches, such as physical therapy and pain management, have been shown to be effective in managing lower back pain (Foster et al., 2018).

In conclusion, not all patients should receive imaging for lower back pain as it can lead to potential harm and has limited benefits. Non-imaging approaches should be considered as first-line treatments."

Powell then asked ChatGPT to write 150 words at a 4th grade reading level, humorously explaining why not all patients should receive imaging for lower back pain, to which it responded:

"Imaging tests like X-rays, CT scans, and MRIs are like detective work for doctors, helping them find out what's going on inside your body. But just because they can see what's happening doesn't mean they always should!

Think of it like this: if you have a tummy ache, you don't want to go on a wild goose chase looking for the cause. The same goes for your back! Just because your back hurts, doesn't mean you need an X-ray. It's like looking for a lost toy in your room when it's probably just in your pocket!

Plus, some imaging tests use radiation, which is like super strong sunshine. Too much sunshine can give you a sunburn, and too much radiation can be bad for your body. So, imagine if you had to go on a sunny vacation every time your back hurt! That would be too much sunshine, and not good for you.

So, what should you do instead? Well, sometimes just moving around and stretching can help your back feel better. You can also talk to your doctor about other options, like physical therapy, or medicine to help with the pain.

In conclusion, imaging tests aren't always necessary for your back pain. It's better to start with simpler solutions and save the detective work for the big mysteries!"

Powell said the main negative consequence that he envisions is that "persuasively written, factually inaccurate content will be produced."

Mann and Powell report no relevant financial relationships.

JACC: Basic Transl Sci. Published online January 18, 2023. Full text

https://www.medscape.com/viewarticle/988341

'Congenital Heart Disease Care Braces for Effects of Roe v. Wade'

 Cardiology and the broader medical community lost no time in denouncing last June's US Supreme Court ruling that overturned the 1973 Roe v. Wade decision establishing abortion rights, or in detailing its threats to medical ethics and women's health and safety.

Now they should lose no time confronting another threat from the ruling that looms over the clinical workforce, policymakers, third-party payers, and young patients of all kinds, urges a commentary released this week.

"The overturning of Roe v. Wade will increase births, and this will include children with birth defects, such as congenital cardiac disease," it states. "The strain on the health care system needs to be assessed and planned for."

The report estimates a "best-case scenario" of 539 additional infant cardiac surgeries in the United States the first year after implementation of new restrictions on abortion in the wake the tumultuous Dobbs v. Jackson Women’s Health Organization decision.

Their surgeries likely wouldn't stop with the first, so those 539 cases would account for an estimated 7243 further congenital cardiac procedures over the next decade "after including the additional volume from patients aged 1 to 17 years," notes the commentary, published February 13 in the Journal of the American College of Cardiology. Its lead author is Ashwin Palaniappan, a student at the Warren Alpert Medical School of Brown University, Providence, Rhode Island.

The added annual cases would equal "the size of a pretty substantial congenital heart program," senior author Brett R. Anderson, MD, MBA, told theheart.org | Medscape Cardiology.

Could the field at current staffing levels and resources for pediatric cardiac surgery handle that many added cases? Possibly, if they were spread across the United States, proposed Anderson, a pediatric cardiologist and outcomes researcher at Columbia University Irving Medical Center, New York City.

But they are not spread across the country. The burden will belong to the 20 or more states that have restricted or plan to restrict abortion access. Hospitals in those states, Anderson said, "as they plan out for the next 10 years, need to anticipate that the volume of pediatric procedures is going to go up." Their health systems and providers "should start planning for these additional lives and how they are going to step up manpower for them."

Preparations are also needed at the state and national levels to address the added financial burden, the report states. "The average inpatient costs alone of managing a patient with congenital heart disease surgically in their first year of life is approximately $127,000, and $58,000 for each year from ages 1 to 17," adjusted for inflation. With further procedures as each child grows older, the total added inpatient bill over a decade, they write, could reach $820 million.

"What are the implications for insurance companies, and for Medicaid?" Anderson posed. "And how are they going to ensure that kids get access to all kinds of care, not just cardiac care?"

Indeed, ripple effects from the added cases could "extend beyond the new babies with congenital cardiac defects to other children who are unable to receive timely intervention," the article notes.

For example, children with congenital heart disease "use a lot of health care resources," Anderson said. They see not only pediatric cardiologists and cardiac surgeons, but likely will need special care from gastroenterologists, pulmonologists, and a range of other specialists.

That means "wait times for the average child who needs to see their pulmonologist for asthma are going to go up," she noted. "There just is not going to be the room in the medical community to absorb these extra healthcare lives."

Analysis of the "full scope of the impact" of last year's high court decision is needed to prepare for and mitigate "the consequences of limited access to abortion," the report states, "so that we can be better prepared to care for our patients and be better equipped to advocate on their behalf in the future."

The authors report no relevant financial relationships.

J Am Coll Cardiol, 2023. Published online February 13. Full Text

https://www.medscape.com/viewarticle/988337