CMS Proposes Nearly 3.4% Cut in Medicare Physician Fees for 2024

WASHINGTON — The Centers for Medicare & Medicaid Services (CMS) is proposing a nearly 3.4% cutopens in a new tab or window to the “conversion factor” used to set the Medicare Physician Fee Schedule for 2024, and physician groups are none too happy about it.

“The proposed 2024 Medicare Physician Fee Schedule (PFS) raises significant concerns for medical groups related to its 3.4% reduction to the conversion factor, which further increases the gap between physician practice expenses and Medicare reimbursement rates,” Anders Gilberg, MGA, senior vice president for government affairs at the Medical Group Management Association here, said Thursday afternoon in a statementopens in a new tab or window. (Disclosure: Gilberg is a member of the MedPage Today editorial board.) “Medicare already largely fails to cover the cost of furnishing care to beneficiaries, and the proposed cut to the 2024 conversion factor compounds the problem.”

“While the ACR [American College of Rheumatology] appreciates CMS’ continued recognition of the value of complex care provided by rheumatologists and other cognitive care specialists … we are gravely concerned that the proposed rule’s physician payment cuts contained in CMS’ conversion factor would add to physicians’ uncertainty about their continued ability to provide the highest quality of care to Medicare patients,” ACR president Douglas White, MD, PhD, said in a statementopens in a new tab or window.

The conversion factor is the multiplier that Medicare applies to relative value units (RVUs) to calculate reimbursement for a particular service or procedure under Medicare’s fee-for-service system. The 2024 conversion factor of $32.74 includes both a 2.17% decrease required for budget neutrality reasons and a 1.25% increase that was included in last year’s Consolidated Appropriations Act (CAA); the CAA also increased the 2023 conversion factor.

Those two percentages — a 2.17% decrease partially offset by a 1.25% increase — would normally be considered a 0.92% decrease in physician pay, but the percentages were calculated based on the original conversion factor for 2023 — $33.06 — which was then increased to $33.88 by the raise from the CAA; comparing that number to this year’s $32.74 number results in the nearly 3.4% cut. (See p. 1191 of the proposed ruleopens in a new tab or window for more details.)

The American Medical Association (AMA) also panned the cut, with AMA president Jesse Ehrenfeld, MD, MPH, calling it “a critical reminder that patients and physicians desperately need Congress to develop a permanent solution that addresses the financial instability and threatens access to care.”

“When adjusted for inflation, Medicare physician payment already has effectively declined 26% from 2001 to 2023 before additional inflation and these cuts are factored in,” Ehrenfeld said in a statementopens in a new tab or window. “Physicians are one of the only providers without an automatic inflationary increase … Physicians need relief from this unsustainable journey.”

There was one group that applauded the agency, however. “CMS showed its commitment to supporting value-based care and growing participation in accountable care organizations (ACOs) in this proposed rule,” Clif Gaus, ScD, president and CEO of the National Association of ACOs (NAACOS), which represents accountable care organizations, said in a statementopens in a new tab or window. “It addresses several issues that NAACOS has been advocating for, including improvements in quality reporting, more fair benchmarking policies, a smooth transition to a new risk adjustment model, keeping advanced payments for new ACOs who transition to risk, [and] helping ACOs who serve high-cost beneficiaries and others.”

“NAACOS thanks CMS for its continued leadership on this issue and its willingness to address the barriers standing in the way of clinicians and health systems who want to provide higher quality, more cost-effective, coordinated care for patients,” he said.

The fee schedule’s effects, however, vary by specialty. In the 2024 fee schedule, the big loser is interventional radiology, whose fees are estimated to decrease by an estimated 4%. Other losers were nuclear medicine, vascular surgery, and diagnostic radiology, whose fees will decrease by 3%.

The American Society for Radiation Oncology (ASTRO) was not happy with an estimated 2% cut for radiation oncologists and radiation therapy centers. “ASTRO is disappointed that CMS once again undervalues the impact of radiation oncology and intends to cut reimbursement by an additional 2% in 2024 for this essential cornerstone of cancer care,” Geraldine Jacobson, MD, MPH, chair of the ASTRO board of directors, said in a statementopens in a new tab or window.

“Medicare spends less on all radiation therapy services than it does on just three top cancer drugs, although radiation is utilized by twice as many beneficiaries,” she added. “Despite this outsized value, CMS has cut radiation oncology physician fee schedule payments by over 20% in the last decade – more than nearly all other physician specialties.

On the other side of the ledger, the total allowed charges for family practice and endocrinology will increase by an estimated 3%. A number of other specialties will see an estimated 2% increase, including clinical social workers, clinical psychologists, general practitioners, rheumatologists, and nurse practitioners, according to CMS.

For its part, CMS touted several new services that would be covered under the fee schedule. “In alignment with the goal of the Biden-Harris Administration’s Cancer Moonshot for everyone with cancer to have access to covered patient navigation services, CMS is proposing payment for Principal Illness Navigation services to help patients navigate cancer treatment and treatment for other serious illnesses,” the agency said in a press releaseopens in a new tab or window. “These services are also designed to include care involving other peer support specialists, such as peer recovery coaches for individuals with substance use disorder.”

The proposed rule also calls for coverage of some dental services for cancer patients. “Access to oral and dental health services that promote health and wellness allows people with Medicare to achieve the best health possible,” the release continued. “In this proposed rule, CMS is … proposing that payment can be made for certain dental services prior to and during several different cancer treatments, including, but not limited to, chemotherapy.”

Do-It-Yourself Medications: Self-Injected Drugs on the Rise

July 14, 2023 – “I’ve always been a little wary of needles,” Heather, 65, a resident of Southern California, said as she reminisced about a long-ago high school biology class. The instructor asked them all to prick their finger to find out their blood type. It took her the whole hour to work up her nerve, said Heather, who asked that her real name not be used to protect her privacy, but she did it.

Several decades later, the challenge surfaced again. Her doctor decided to add the lowest dose of Ozempic (semaglutide), injected once a week, to her dose of oral metformin to help manage her blood sugar.

“It’s a tiny little needle, and it’s an automatic injector,” Heather told herself, yet she felt like she was right back in high school biology class. So her husband did the honors for the first dose. It wasn’t nearly as bad as she imagined, she said. The needle, she said, was short and fine.

“I felt the medicine going in a little bit and some stinging. The next week, I did it on my own,” she said.

Heather’s off the Ozempic now, her blood sugar managed well again just with metformin. But she, as well as the rest of us, should expect to be taking more injectables in the future, experts say. The era of do-it-yourself medicine, via self-injection at home, is here, growing, and shows no signs of slowing down.

In the past, self-injected medicine was mainly insulin, injected by those with diabetes, along with anti-coagulants for those at high risk of blood clots, said Eric J. Topol, MD, editor-in-chief of Medscape (WebMD’s sister publication for health care professionals), a professor of molecular medicine, and executive vice president of Scripps Research in La Jolla, CA.

“Fast forward,” Topol said. “Now we have all these autoimmune disease drugs [that can be self-injected]. We have these anti-obesity, anti-diabetes drugs, we have the powerful low-cholesterol agents, the drugs like Repatha [evolocumab]. We have people taking two or three different injectable drugs every other week.”

All this, he said, comes after many people, just 2 years ago, claimed they had “needle phobia” when offered a COVID-19 vaccine. In one U.K. study, researchers who polled more than 15,000 adults and matched them to a general population sample concluded that about 10% of vaccine hesitancy was due to fear of blood, needles, or invasive medical procedures.

“And now we are in a world where we are training the public to inject themselves,” Topol said.

The market for self-injected drugs is increasing, with no signs of slowing down, according to analysts’ reports. While estimates range greatly, one analysis estimated that the global self-injection devices market size was $6.6 billion in 2021 and would grow nearly 6% a year from 2022 to 2030.

Self-injected devices include prefilled syringes or pens and auto-injectors. As of August 2021, according to a market review, nearly 80 auto-injectors have been developed by more than 20 drug companies. When researchers evaluated 2,964 shots given from the auto-injectors, just 12 device malfunctions occurred, for a failure rate of 0.40%.

Chances are, someone you know self-injects a medication, such as Humira (adalimumab) for arthritis, Repatha (evolocumab) to manage cholesterol, Dupixent (dupilumab) for asthma or, yes, Ozempic (semaglutide) for diabetes control or Wegovy (semaglutide) for weight loss.

Three key things are driving this trend, according to George I’ons, head of product strategy for Owen Mumford Ltd. in Oxford, U.K., which designs, develops, and makes injectable drug delivery systems for drug, biotech, and generics industries. These include:

  • Staff shortages at medical clinics and hospitals
  • Financial pressures on health care systems
  • A growing aging population, likely to need more medications on a regular basis

Having patients give themselves shots, when possible, not only saves clinic time and expense, but also spares the patients a trip to the clinic, of course, and often a copay. “The more people can do for themselves, the less you need to occupy staff time,” I’ons said. That means more time staff can spend on areas that really need attention. That 20 or 30 minutes of clinic time that don’t need to be spent giving someone medicine can be put to valuable use, he said.

Improved Devices, Needles

While the needle phobics may shudder at the self-injector trend, ongoing device improvements are aimed at comfort. For instance, I’ons said, “a lot of auto-injectors hide the needle before and after use.” The user feels just a piece of plastic against the skin.

Needles have often gotten so thin, that at least with some devices, “you could quite easily not even feel the thing going in,” he said. For insulin delivery, I’ons said, the needles have gotten thinner and shorter over the years.

But not all medicines delivered by self-injector can use the smallest needle, he said. Some drugs, because of their viscosity, or thickness, may need bigger needles.

When people complain of discomfort as the medication is injected, they could be feeling not the tiny needle, but the drug itself, or one of its inactive ingredients, I’ons said. He cited the case of drug maker AbbVie removing the buffer, citrate, from Humira (adalimumab) and offering a citrate-free version in 2018 because the citrate was linked to pain where people got the shot.

Companies said they are focused on technology advances to make self-injection less unpleasant. “Significant advances in technology, as well as our investments in R&D, have allowed Lilly to explore a variety of different injection methods over the years,” Nadia Ahmad, MD, associate vice president and medical director of obesity clinical development for Eli Lilly & Company, said in a statement.

Some people prefer the shots over pills, she said, because “in some cases, it may lead to higher adherence and better efficacy through consistent use.”

At Amgen, an executive said demand is growing from patients and providers “to have flexibility when it comes to administration of our medicines.” Jyothis George, vice president and global medical therapeutic area head in general medicine at Amgen, said in a statement that for Repatha, for example, grew 32% in the first quarter of this year.  In February, the FDA approved self-administration of Tezspire (Tezepelumab-ekko), developed by Amgen and AstraZeneca, for patients with severe asthma.

Education Helps Self-Injection Skills

Introducing patients to self-injections is part of the day’s work for Amy Hess-Fischl, a certified diabetes educator and registered dietitian who works as a diabetes educator at the University of Chicago. “As they sit down, I hand them a needle, a syringe, and say, ‘Go ahead and inject.’ Once they do that, they say, ‘Oh my God, it’s so small.’” It gets the anxiety of the unknown out of the way, she said.

She’s talking about insulin injections. “When it comes to these other injectables, with so many, you don’t even see the needle.”

She reminds patients that the needles are decreasing in size, in general, in both the length and the thickness, or gauge. Some needles are now so short and so small, they can be compared to an eyelash, she said.

She reminds patients, too, that self-injecting can be empowering. “It’s about patient-centered care. I think this new revolution in injectables is going to improve patient-centered care and reduce anxiety.”

Support and education are important, she said. While there are online resources for self-injecting, the human touch remains important, she said. Any health care providers prescribing a self-injected medication, Hess-Fischl said, “needs to have a plan about where to send this patient to be successful.” If the health care provider doesn’t come through, she suggests patients call the drugmaker, and staff there should be able to give instruction, or tell them where to get the instruction.

The Next Market?

While many drugs can be self-injected, not all can. Many patients with chronic diseases depend on drugs that must be delivered with an IV, which means spending hours in a clinic or other facility.

One barrier is the high viscosity of some of these medicines, making it impossible to make and inject some of the monoclonal antibodies at the small volumes needed for shots under the skin.

Science could change that, said Jeffrey Hackman, CEO and chairman of Comera Life Sciences, who has come up with ways to change some biologics into forms that could be given under the skin and self-injected by the patient at home.

“I don’t think we can ever get out of IV medicines [entirely],” he said. But he has hopes that some biologics now given via IV at clinics will be self-injected at home within the next 5 to 7 years, and much more quickly than the process now requires.

SOURCES:

Heather, former Ozempic user, Southern California.

Eric J. Topol, MD, editor-in-chief, Medscape; professor of molecular medicine and executive vice president, Scripps Research, La Jolla, CA.

George I’ons, head of product strategy, Owen Mumford Ltd., Oxford, U.K.

Medical Device and Diagnostic Industry: “An expert look at issues driving up the demand for self-administration drug-delivery devices that combine pre-filled safety-engineered aspects.”

Psychology of Medicine: “Injection fears and COVID-19 vaccine hesitancy.”

Journal of Pharmaceutical SciencesCaffeine as a Viscosity Reducer for Highly Concentrated Monoclonal Antibody Solutions.”

Grandview Research: “Self-Injection Devices Market Size, Share & Trends Analysis Report by Product (Autoinjectors, Needle-free Injectors), By Usability (Disposable, Reusable), By Application (Cancer, Pain Management), By Region, And Segment Forecasts, 2022-2030.”

Nadia Ahmad, MD, associate vice president, medical director of obesity clinical development, Eli Lilly & Co., Indianapolis.

Amy Hess-Fischl, diabetes educator, University of Chicago.

AbbVie: “Getting to Know Humira (adalimumab) Citrate-Free.”

Jeffrey Hackman, CEO, chairman, Comera Life Sciences, Woburn, MA.

Jyothis George, vice president, global medical therapeutic area head, general medicine, Amgen.

AI in Medicine: ‘Give It a Try, Take It For a Ride’

In this exclusive video, Harlan Krumholz, MD, SM, of the Yale School of Medicine and Yale New Haven Hospital in Connecticut, discusses uses of large language models like ChatGPT in healthcare settings and how to use new artificial intelligence (AI) technology responsibly.

Krumholz is the director of the Center for Outcomes Research and Evaluation, the Harold H. Hines Jr. Professor of Medicine, and a professor in the Institute for Social and Policy Studies, Investigative Medicine and of Public Health.

The following is a transcript of his remarks:

I’m always surprised that so many people have heard of ChatGPTopens in a new tab or window and other AI platforms but there are still a lot of people who haven’t tried it yet, so they really don’t know what the experience is like and maybe they’re not really familiar or clear about it.

Hi, I’m Harlan Krumholz from the Yale School of Medicine, and I just wanted to take a few minutes to talk about these new models and to provide a little context in case you’re one of those who hasn’t had a chance to really try them out yet.

These AI models, like ChatGPT, are called large language models. Sometimes you hear people offhand saying LLMs — large language models — it makes you sound like you’re in the know if you say that. Well, these are foundation models that are trained on massive, diverse, large datasets and can be applied for numerous downstream tasks.

For medicine, these can be used as chatbots for patients. What are chatbots? Chatbots are automated tools that can interact with patients to elicit information and even give advice without the need for a human being involved. They can be used for interactive note-taking or they can augment the performance of people doing procedures. They can generate reports like radiology reports, they’re helping basic scientists identify targets for drug development, they can be used for bedside decision support.

Sound too good to be true? Well, at least at this stage, it is a bit too good to be true. I mean, it’s a remarkable tool. I think we’re at a juncture in history; it’s a step function with what these are able to achieve compared with what I was seeing was able to be achieved with AI before this. Now, this is about taking unstructured data — not data that fits into a case report form or into a given field — but take unstructured data like notes and texts and be able to make sense of it and then be able to feed it back appropriately when people are asking questions.

Now, you may know that there are a lot of people who are raising warnings about this AI. They’re thinking that we’re moving too fast. There are even some people who think this could be the end of humanity. Now, lest you think that this is only about people who are untethered to the reality of the world, these are actually very smart people, very well-steeped in AI that are expressing concerns, and governments are stepping forward and wondering who should really be able to control these kind of tools and how they might be applied.

There’s another feature to these — well, let me say, it’s both a feature and a bug — that is, these models are capable of creativity. So you could say, “I want to write a note to someone and I want it to be done in the form of a Shakespearean sonnet.” Well, it can actually produce that, or in the style of anyone that you can think of. That’s creativity.

But every once in a while you’ll be asking it a question about reality — and believe it or not, these are called hallucinations of the AI — that is, it can provide an answer that may even seem reasonable, but actually it’s made up. This happened to a lawyer who was using it to develop references for a court caseopens in a new tab or window, and it turned out that some of the references were actually made-up references, quite to the embarrassment of the individual and perhaps to some professional harm.

So there’s a lot to sort out with these, and there are a range of possibilities. Like I said, it’s a juncture in history, but I urge you to give it a try. For example, in clinic this weekend — I do a clinic with medical students — we were taking some of the more perplexing patients and putting their symptoms into this. By the way, you just put in, “I have a patient with these symptoms.” You want to be careful by the way, this isn’t mostly HIPAA [Health Insurance Portability and Accountability Act] overseen, so we were being vague but still put in the symptoms. It generated a pretty good differential diagnosis.

This can be used for a wide variety of teaching, but you do need some expertise to know whether or not what it’s giving you is real and whether you can trust it and rely on it.

A recent New York Times articleopens in a new tab or window came out and I was quoted as saying, “You’d be crazy not to try this.” And I’ll say this, too, I really urge clinicians and healthcare professionals to become familiar with this kind of technology. Give it a try, take it for a ride. Get familiar with what’s coming out, because I think on the horizon you’re going to see this in medicine and you’re going to see this being applied in a wide variety of ways.

You’re already seeing Epic making an agreementopens in a new tab or window with OpenAI who developed this platform, ChatGPT, to be able to integrate it into Epic for many of the tedious tasks that need to be done — report generation and so forth — that that could actually make lives better for physicians and make the chart more complete.

Now, we talk a lot about ChatGPT, but just by the way, there are a lot of these large language models out there. ChatGPT is just one of them. And many people are suggesting that in future generations, these are only going to get more powerful and there will be competition among the tech companies and other newly emerging companies that are going to try to leverage the rapid advances. In the last 6 months, again by the way, people have said that there’s been more advances in the field of AI than they’d seen in a decade.

So, I think we’re on the cusp of a different moment in history. This issue in medicine is going to be very important. Also, what needs to be regulated? What is it that can come into medicine that doesn’t need to be regulated? And what can we really trust? As clinicians, we don’t really need to understand exactly how it works, but we need to know whether we can trust it. That’s going to take some additional time and testing. We’re not quite sure how it’s going to fit, but I’m sure in the end this will help transform medicine, hopefully for the betterment of patients. We need to be involved to ensure that there’s not unintended harm that occurs as new technology gets introduced.

But I’m optimistic about the possibilities and, again, I urge you to give them a try.

Injectable Ketamine Shows Promise in Treatment-Resistant Depression

Twice-weekly subcutaneous ketamine helped alleviate symptoms of treatment-resistant depression, according to the phase III KADS study.

Among those who received at least one flexible treatment dose (0.5-0.9 mg/kg), ketamine was more than 12-times better at inducing remission of depression than the benzodiazepine midazolam (remission rate 19.6% vs 2.0%, OR 12.1, 95% CI 2.1-69.2, P=0.005), reported Colleen Loo, MD, MBBS, of the University of New South Wales in Sydney, Australia, and colleagues.

Remission was defined as a Montgomery-Åsberg Rating Scale for Depression (MADRS) score of 10 or lower at the end of a 4-week course of either treatment.

Remission according to a less stringent definition — a MADRS score of 12 or under — also favored the injectable ketamine group (22% vs 4%, P=0.007), study authors wrote in The British Journal of Psychiatryopens in a new tab or window.

In this flexible-dosed cohort, the reduction in average MADRS score by treatment end was 5.5 points (95% CI 2.1-8.7) better in the ketamine group, with significantly higher response rates based on a 50% improvement in MADRS score (29% vs 4%, P=0.001).

“For people with treatment-resistant depression — so those who have not benefitted from different modes of talk-therapy, commonly prescribed antidepressants, or electroconvulsive therapy — 20% remission is actually quite good,” said Loo in a statement. “This is a huge and very obvious difference and brings definitive evidence to the field which only had past smaller trials that compared ketamine with placebo.”

Ketamine wasn’t significantly better than midazolam when tested in a fixed-dose cohort, who only received the lower 0.5 mg/kg dose. Here, 6.3% of those on ketamine and 8.8% of those on midazolam achieved remission (OR 1.3, 95% CI 0.2-8.2, P=0.76).

Ketamine and midazolam were both administered subcutaneously into the abdominal wall twice per week for 4 weeks, with at least 3 days between treatments. The fixed-dose cohort received 0.5 mg/kg ketamine and 0.025 mg/kg midazolam. In the flexible-dosing cohort, participants had dose escalation steps of 0.6, 0.75, and 0.9 mg/kg ketamine and 0.03, 0.0375, and 0.045 mg/kg midazolam if participants had not improved by 50% from pretreatment baseline in MADRS scores at sessions two, four, and six.

Overall, ketamine was well-tolerated with most adverse events, like sedation, light-headedness, reduced concentration, and dissociation, resolving quickly.

“Because there are no subjective effects from the saline, in previous studies it became obvious which people were receiving the ketamine and which people received placebo,” Loo pointed out. “In using midazolam — which is not a treatment for depression, but does make you feel a bit woozy and out of it — you have much less chance of knowing whether you have received ketamine, which has similar acute effects.”

IV racemic ketamineopens in a new tab or window, while widely studied for years, is not currently FDA approved for depression. It’s approved as an anestheticopens in a new tab or window, but is often used as an off-label depression treatment. Esketamine nasal spray was FDA approvedopens in a new tab or window in 2019 as a concomitant treatment with an oral antidepressant for treatment-resistant depression. However, the treatment has come with several barriers to accessopens in a new tab or window, including difficulty with insurance coverage.

“With the S-ketamine nasal spray, you are out of pocket by about $1,200 for every treatment by the time you pay for the drug and the procedure, whereas for generic ketamine, you’re paying around $300-350 for the treatment including the drug cost,” Loo said, citing prices in Australia. “This is why we’re applying for a Medicare item number to fund this treatment now, because it’s such a powerful treatment.”

“And if you consider that many of these people might spend many months in hospital, or be unable to work and are often quite suicidal, it’s quite cost effective when you see how incredibly quickly and powerfully it works,” she noted. “We’ve seen people go back to work, or study, or leave hospital because of this treatment in a matter of weeks.”

The recent ELEKT-D randomized trialopens in a new tab or window found IV ketamine not only matched, but outperformed the “gold standard” for treatment-resistant depression — electroconvulsive therapy (ECT). Following a 3-week treatment period, 55.4% of the patients in the ketamine group and 41.2% of those in the ECT group had a treatment response, a 14.2% difference (95% CI 3.9-24.2, P<0.001).

“People are recommended ECT treatment for their depression when all other treatments have been ineffective,” Loo added. “Most studies exclude people who have had ECT because it is very hard for a new treatment to work where ECT has not.”

In the current trial, 24% of participants had failed to respond to treatment with ECT.

  • author['full_name']

    Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.

Disclosures

The study was funded by the Australian National Health and Medical Research Council.

Loo reported relationships with the Clinical Advisory Board for Douglas Pharmaceuticals, Janssen Cilag, and is the Medical Director of Neurostimulation and Interventional Psychiatry at Ramsay Health Care.

Primary Source

The British Journal of Psychiatry

Source Reference: Loo C, et al “Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for treatment-resistant depression (KADS study): Randomised double-blind active-controlled trial” Br J Clin Psychol 2023; DOI: 10.1192/bjp.2023.79.

Half-Dose TNKase Holds Up for Pharmaco-Invasive Reperfusion in STEMI

When timely angioplasty is unavailable to older ST-segment elevation myocardial infarction (STEMI) patients, a modified pharmaco-invasive reperfusion strategy could be reasonable, according to the STREAM-2 trial.

Half-dose tenecteplase (TNKase) produced ECG changes that were at least comparable to those after primary percutaneous coronary intervention (PCI) in a cohort presenting within 3 hours of STEMI symptom onset but unable to undergo primary PCI within 1 hour, reported a group led by Frans Van de Werf, MD, PhD, of KU Leuven, Belgium.

After last angiography, majority (≥50%) resolution of ST-segment elevation was achieved in 85.2% of those assigned pharmaco-invasive treatment with tenecteplase vs 78.4% of peers who had upfront primary PCI (P=0.05). Residual median sums of ST deviations measured 4.5 vs 5.5 mm (P=0.02).

The STREAM-2 trial results were published in Circulationopens in a new tab or window and were previously presented at the American College of Cardiologyopens in a new tab or window meeting earlier this year.

Although tenecteplase dosing was halved for safety reasons in this population of people 60 years and older, brain bleeds were nevertheless higher than expected, echoing the excess intracranial hemorrhages (ICHs) with standard-dose tenecteplase in the preceding STREAM-1 trialopens in a new tab or window.

Van de Werf and colleagues reported that in STREAM-2, there were 10 strokes in total: six ICHs occurred in the pharmaco-invasive arm (1.5%), zero ICHs in the primary PCI arm, three ischemic strokes in the pharmaco-invasive arm (0.75%), and one ischemic stroke in the primary PCI arm (0.5%).

They stressed that all six ICHs were in people under age 75 and three of them were protocol violations: two tenecteplase recipients got therapeutic doses of unfractionated heparin during rescue PCI despite full-dose IV and subcutaneous enoxaparin being given shortly before, and one person turned out to have uncontrolled hypertension.

“We cannot discriminate why the ICH rate we observed was higher than anticipated despite the use of half-dose tenecteplase, but major protocol violations in half of the cases were probably contributing factors,” study authors said, noting that this observation “reinforces the need for clear and timely communication regarding given treatments between various members of the health care team when rapid transitions in STEMI care unfold.”

In any case, the 30-day composite endpoint counting death, shock, heart failure, or reinfarction was equal between groups (12.8% of tenecteplase arm vs 13.3% of primary PCI group, RR 0.96, 95% CI 0.62-1.48).

“In summary, provided that contraindications to fibrinolysis are observed and excess anticoagulation is avoided, a pharmaco-invasive treatment as used in this trial is an effective reperfusion strategy in older, early presenting patients with STEMI,” Van de Werf’s team wrote. With primary PCI, the two “reperfusion therapies appear to be legitimate options in appropriately selected patients within a global context in which it is not possible to achieve timely PCI.”

Current STEMI guidelines recommend primary PCI for reperfusion of STEMI when performed within 2 hours after first medical contact — an unattainable goal for many patients presenting initially to non-PCI-capable hospitals. In this case, a pharmaco-invasive strategy is an endorsed alternative.

STREAM-2 was an open-label trial conducted in 49 centers in 10 countries. Participants averaged 70.5 years of age and nearly one-third were women. The median Thrombolysis In Myocardial Infarction (TIMI) risk score was 4.

STEMI patients were randomly assigned 2:1 to half-dose tenecteplase followed by coronary angiography and PCI if indicated (n=401) or upfront primary PCI (n=203).

Overall median times from symptom onset to randomization were 97 minutes for pharmaco-invasive and 92 minutes for primary PCI patients. Median times from randomization to tenecteplase or sheath insertion were 10 and 81 minutes, respectively.

Whereas patients randomly assigned to pharmaco-invasive treatment received tenecteplase within 10 minutes no matter their randomization location, the time to sheath insertion was shorter for patients randomized to PCI while they were in an ambulance vs at a community hospital (median 65 vs 110 minutes).

For 42.2% patients randomly assigned to tenecteplase, urgent angiography was performed for possible rescue PCI at a median time of 142 minutes from randomization.

TIMI flow grade 3 at last angiography was approximately 87% in both groups.

The incidence of major non-intracranial bleeding was below 1.5% across study arms.

“The use of half-dose tenecteplase with improved antithrombotic treatment in the pharmaco-invasive strategy, more frequent use of radial access (>90% in both groups), and advances in interventional technologies may have contributed to the lower-than-anticipated and comparable clinical efficacy outcomes and low incidence of major non-intracranial bleeding in our higher-risk population,” the investigators posited.

  • author['full_name']

    Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in

Disclosures

The study was funded by KU Leuven, Life Science Research Partners, and Boehringer Ingelheim.

Van de Werf reported institutional grants from Boehringer Ingelheim.

Primary Source

Circulation

Source Reference: Van de Werf F, et al” Half-dose tenecteplase or primary percutaneous coronary intervention in older patients with ST-segment–elevation myocardial infarction in STREAM-2: A randomized, open-label trial” Circulation 2023; DOI: 10.1161/CIRCULATIONAHA.123.064521.

AKI Cleared of Worsening CKD Trajectory

Acute kidney injury (AKI) didn’t predict worsening kidney function in people with chronic kidney disease (CKD), a prospective study showed.

According to findings from the Chronic Renal Insufficiency Cohort (CRIC) study, CKD patients hospitalized for AKI saw a statistically insignificant drop in estimated glomerular filtration rate (eGFR) during a nearly 4-year follow-up period, reported Chi-yuan Hsu, MD, MSc, of the University of California San Francisco, and colleagues.

During this time, there were decreases of -0.38 mL/min/1.73 m2 (95% CI -1.35 to 0.59) for eGFR based on serum creatinine (SCr) level and a 0.04 mL/min/1.73 m2 (95% CI -0.30 to 0.38) change in SCr slope (eGFRcr) after each AKI per year, the researchers wrote in Annals of Internal Medicineopens in a new tab or window.

Similar findings were seen when looking at eGFR based on cystatin C level (eGFRcys), marked by only a -0.15 mL/min/1.73 m2 (95% CI -2.16 to 1.86) change after each AKI and -0.56 mL/min/1.73 m2 (95% CI -1.28 to 0.17) change in eGFRcys slope per year.

Measured annually, these models were fully adjusted for several factors including pre-hospitalization eGFR, urine protein-creatinine ratio, diabetes, heart failure, systolic blood pressure, receipt of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin-receptor blockers (ARBs), and more.

Hsu’s group pointed out that there have been conflicting data on this topic, with a few prior studies finding that AKI was associated with more rapid subsequent loss of eGFRcr, like one publishedopens in a new tab or window late last year.

“[T]his study more rigorously addressed methodological limitations presented in prior published studies to conclude that the independent association between mild to moderate AKI and worsening subsequent kidney function trajectory appears to be small,” they explained.

“Our results suggest that much of the kidney disease observed after AKI may already be present before AKI,” the researchers noted. “Thus, efforts focused on ameliorating the effects of the AKI episode may have only a small effect on overall CKD burden.”

“A better strategy may be to focus on flattening the eGFR slope and treating proteinuria before the AKI episode,” Hsu’s group continued. “However, a diagnosis of AKI does present an opportunity to identify high-risk patients and implement evidence-based interventions to slow CKD progression.”

The multicenter prospective study looked at data from 3,150 patients with CKD, 433 of whom had at least one AKI episode. Of these episodes, nearly all (92%) were stage 1 or 2 in severity. A quarter of these AKI episodes lasted 3 or more days. Most patients (74%) had just one episode, with only 3% having four or more episodes during follow-up. AKI was defined by a 50% or greater increase in inpatient SCr measurement from nadir to peak.

Of the patients included, 44% were female and 43% were Black. AKI was more common in patients with diabetes, heart failure, and those using ACEIs or ARBs.

Study limitations included a lack of details surrounding the nature of the AKI events and the inability to adjudicate causes of AKI.

  • author['full_name']

    Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.

Disclosures

The CRIC study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases.

Hsu and co-authors reported relationships with the National Institutes of Health, UpToDate, Satellite Healthcare, McMasters Keith Butler, Aria Pharma, Lewis Brisbois, LG Chem, Triangle Insights Group, Bristol-Myers Squibb Research, Janssen Research & Development, Novartis Research, CSL Behring Research, Edwards Life Sciences, BioMerieux, SeaStar Medical, AM Pharma, Amgen, Fresenius Kidney Care, DaVita Inc., Michigan Board of Medicine, National Kidney Foundation, Public Library of Science, American Medical Association, Travere Therapeutics, Otsuka Pharmaceuticals, and Hartford Hospital.

Primary Source

Annals of Internal Medicine

Source Reference: Muiru AN, et al “Risk for chronic kidney disease progression after acute kidney injury: findings from the Chronic Renal Insufficiency Cohort Study” Annals of Intern Med 2023; DOI: 10.7326/M22-3617.

How to Prevent Addiction Patients From Leaving Treatment Against Medical Advice

It’s widely known that length of stay is one of the most important determinants of success in substance use disorder (SUD) treatment. Data has proven that the longer we can keep patients engaged, the betteropens in a new tab or window their long-term prognosis.

Unfortunately, it’s also one of the hardest factors for providers to overcome. Between the difficulties of withdrawal and the overwhelming desire for substances driven by the disease, far too many patients choose to walk away. In fact, research shows the rate of patients leaving against medical adviceopens in a new tab or window (AMA) has increased substantiallyopens in a new tab or window over the last several years, from 10-15% in 2017 up to 23% in 2019.

If we’re lucky, we get them back in treatment before tragedy strikes. According to the literature, over 35% of patients who leave healthcare facilities AMA return within 30 days, and 16% get readmitted. Sadly, many don’t make it back. Clearly it would be far better for them to stay the first time around.

Anecdotally, the variables thought to drive AMA discharge have focused on demographics: patients who are young, male, and local are presumed to be at greater risk. However, data show otherwise. In fact, demographics have very little, if anything at all, to do with it. Instead, the three main variables that are associated with AMA discharge are psychosocial. Here’s what providers can do to help patients overcome those obstacles.

Life Circumstances

Many patients believe the circumstances in their life make it impossible for them to stay in treatment. For example, I had one patient with a wife and three children whose utility company was prepared to cut off service to their home for nonpayment. The patient felt strongly that his wife couldn’t function without him while he was in rehab. But is that accurate? Or is that merely his perception? Could someone else in the family step in to help while he got treatment?

As providers, we must help patients determine if these circumstances are accurate, and if not, help them see a more evidence-based reality. Of course, life circumstances can also contribute to the SUD condition. Difficult family dynamics, trauma, co-dependence, and co-occurring mental health issues can all play a role in the context that contributes to SUD. Sometimes separationopens in a new tab or window from those circumstances can be the best course of action.

That’s why it’s essential to conduct biopsychosocial assessments upon intake to get to the heart of these conditions. Start by asking questions about the patients’ social and family dynamics and what brought them to treatment. This evaluation can help get to the “why” behind their substance use and their desire for treatment. Cognitive interpersonal psychotherapy can help patients reframe their point of view on their circumstances, help them see how they may have contributed to the SUD, and ultimately, how completing treatment can help them stop using and provide coping skills to deal with difficult circumstances going forward.

Motivation

Intrinsic motivation is essential for successful treatment. Very rarely will external motivation be effective, including ultimatums or threats of incarceration, job loss, or divorce. Patients must learn to visualize sobriety, what it feels like for them, and what it can mean for their future. They have to want it and see it as a real possibility.

When external motivators are the driving force behind seeking treatment, the use of motivational interviewing can help patients to shift their “why.” This technique helps patients connect the things they care about and their future goals with sobriety, and boost their confidence in believing they can achieve those goals.

I had one patient, a young man, who had been in and out of our facility several times. His mother and brothers would force him to come, and he made it clear he was only here to detox, didn’t want group therapy, and would go right back to using in short order. On his most recent admission, we talked about the importance of group therapy and helped him develop a better understanding of his disease and what recovery could actually do for him beyond detox. This time, it clicked. Instead of being coerced into treatment, he asked to stay longer, doing intense outpatient therapy every morning and going to work in his family’s auto shop every afternoon. It has made a huge difference in his prognosis.

Readiness

Patients who aren’t ready to acknowledge the negative impact substances have had on their lives are at greater risk of AMA discharge. They might believe they have their substance use under control or can get it under control on their own. To avoid leaving treatment AMA, they have to first recognize the problems their untreated disease has caused in their relationships, financial situation, and personal health and safety, and understand that it is nearly impossible to overcome addiction on their own.

For as much as we’ve made progress in educating the public that addiction is a disease, a surprising number of SUD patients still don’t see it that way. As part of the process, we have to help them see SUD as a chronic conditionopens in a new tab or window, like diabetes or cancer, that has to be managed long-term through lifestyle change. The goal of treatment is to put that disease in remission and teach them skills to help keep it that way.

Helping patients know what to expect in treatment is a key factor in readiness and avoiding AMA. The first few days of treatment are tough. Patients are often still under the influence for several days after admission, which makes them much more likelyopens in a new tab or window to discharge AMA as substances cloud their judgment. Providers must explain the impact substances have on their brain and why the urge to leave likely isn’t valid — it’s the substance talking.

Providers should explain the physical challenges of detox and withdrawal. The discomfort, especially when patients are unprepared for it, can be a huge driver in AMA discharge when patients know they can leave, use again, and feel “better” immediately. Employing medication-assisted treatment (MAT), especially for alcohol and opioid use disorder, can substantially loweropens in a new tab or window the likelihood of AMA discharge.

Knowing that these psychosocial variables are the most important factors in AMA discharge means that we, as providers, can actually help patients to overcome them. We obviously can’t change patients’ age, gender, or any other demographic, but we can — through targeted therapy — help them change their way of thinking about the disease to give them the best chance of success through holistic treatment and targeted interventions.

Jesus Perez, PsyD, is a licensed psychologist and clinical director of Recovery First Treatment Centeropens in a new tab or window, an American Addiction Centers facilityopens in a new tab or window.

Novel application of jaw advancement surgery helps treat OSA and improves facial appearance

Neighborhood environment can increase risk of COVID-19 hospitalization, study reveals

The range of COVID-19 symptoms varies-; some feel a mild cold, others are hospitalized, while others perish. Many studies have linked the severity of COVID-19 symptoms with an individual’s biological factors, but less is known about the impact of non-biological factors, such as the environment in which people live.

A new study that published on June 14, 2023, in the journal PLoS ONE, is the first to show that the neighborhood-built environment might pose an independent risk determining the individuals hospitalized due to COVID-19 illness.

The authors found that in a cohort of more than 18,000 individuals with SARS-CoV-2 infections, living in multi-family building, living in a neighborhood with higher air pollution (PM2.5) levels and living in a neighborhood with lower walkability and bike-ability were associated with a greater incidence rate of hospitalization, even when controlling for socioeconomic vulnerability and individual-level demographic and medical characteristics. Neighborhoods with higher public transit quality and access were also associated with a higher incidence rate of hospitalization.

The study identified differences between the two largest ethnic groups in the region. Higher PM2.5 levels posed a higher rate of hospitalization for Latinx individuals, and density and overcrowding showed stronger associations for non-Hispanic White individuals.

The findings could help inform public health and urban planning initiatives in lowering the risk of hospitalizations linked to COVID-19 and other respiratory pathogens.

“For urban planners, the findings underline what we’re already trying to do to build healthier communities-;create more walkability, bike-ability and infrastructure that will reduce air pollution,” said Alessandro Rigolon, associate professor at the University of Utah and lead author of the study. “From a public health perspective, the findings can help testing and vaccination campaigns target areas with higher air pollution or multi-family housing.”

The study also exposed how urban policies from the past continue impact the daily lives of many communities.

“We found much higher rates of COVID-19 hospitalizations along the I-25 and I-70 corridors and in the industrial areas of North Denver,” said Jeremy Németh, professor at the University of Colorado Denver and co-author of the study. “These are the same areas that have experienced decades of disinvestment and increased air pollution due to racist land-use policies levied on our cities in the early 20th century.”

Neighborhood-built environments

The study analyzed the neighborhood characteristics in the Denver Metro Area associated with hospitalizations of 18,042 people who tested positive for SARS-CoV-2 between May and December in 2020, before vaccines became extensively available. Researchers from two of the Denver Metro Area’s major health care systems, Denver Health and University of Colorado Hospital, reviewed more than 30,000 cases of eligible individuals. They limited the cohort to those living in the greater metro area, and matched available health record data for each case. Variables pulled from the medical record included age and body mass index (BMI), evidence of tobacco use, hypertension, chronic lung disease, some forms of cardiovascular disease and chronic kidney disease. Researchers at the University of Colorado Denver then converted addresses of people in the final cohort to their geospatial coordinates and assigned environmental variables accordingly.

Ethical oversight and approval for the study was granted by the Colorado Multiple Institutional Review Board and all protected health information was anonymized prior to sharing.

“Very few studies are comprehensive like ours. We’re able to control for some individual level factors that, for people with COVID-19, would lead to higher chances of being hospitalized,” said Rigolon.

With biological factors largely accounted for, the authors identified four characteristics of a neighborhood that might contribute to COVID-19 hospitalization: density and overcrowding, including living in an overcrowded home or multi-family building; environmental hazards, such as air pollution levels (PM 2.5) and proximity to highways; environmental amenities, including access to parks; and mobility options, including public transit access, walkability and bike-ability.

The authors were unsurprised that individuals with compromised lung and immune systems who face chronic air pollution would be unable to respond as well to the respiratory disease and would be more likely to need hospitalization after contracting COVID-19. Their finding that higher PM2.5 levels impacted Latinx individuals more than non-Hispanic White individuals underscores a worldwide problem-;air pollution disproportionately affects People of Color. While findings support making existing neighborhoods more walkable and bikeable, the authors emphasized that future planning efforts to reduce emissions should center the principles of environmental justice. Since walkability was particularly protective in Latinx communities, the authors suggest that cities should prioritize investing to make Latinx-dominant neighborhoods pedestrian-friendly.

The result for density and overcrowding underscore the need for vaccination and testing efforts to focus on areas with multi-family housing to mitigate risk of severe disease. Because living in transit-rich neighborhoods was associated with higher risk of hospitalization from COVID-19, public health measures like educational campaigns and outreach in these areas are particularly important.

“So many health disparities track along geographic lines. We’ve long suspected that more than just pre-existing medical conditions were to blame for the disparities. It was interesting to work with the urban planning teams to pinpoint exactly which environmental factors were partially to blame for disproportionate rates of hospitalizations that we keep seeing. This will help public health leaders continue to advocate for healthier cities, and it helps inform outreach efforts to address COVID-19 and other respiratory illnesses,” said Sarah Rowan, associate professor of medicine at University of Colorado School of Medicine, Denver Health infectious diseases physician and the study’s senior author.

Neighborhoods in other areas, other diseases?

The authors would like to replicate this study in other regions such as in the Salt Lake Valley in Utah, which has similar environmental and population characteristics as the Denver Metro Area. They’d also like to expand to other respiratory diseases where people are hospitalized, such as the flu. Though it took multiple years to process the massive quantity of patient records, studies that can look at health outcomes and the built environment on an individual level are valuable.

“Urban planning was born out of public health concerns in the U.S. when cities were getting very crowded, very polluted and sanitation was an issue. It’s only natural that urban planners do research that involves public health,” said Rigolon.

Additional contributing authors include Brenn Anderson-Gregson, Ann Rae Miller and Priyanka deSouza of the Department of Urban and Regional Planning, University of Colorado Denver; Brian Montague and Kristine M. Erlandson of the Division of Infectious Diseases, University of Colorado School of Medicine; and Cory Hussain, University of Colorado School of Medicine and Denver Health.

Source:
Journal reference:

Autoimmune Afib; Inappropriate ICD Shocks Down; Dissolving Cardiac Sensors

FDA approved expanded use of inclisiran (Leqvio) for primary hyperlipidemiaopens in a new tab or window atop its existing indications of atherosclerotic cardiovascular and heterozygous familial hypercholesterolemia, Novartis announced.

An estimate gives users of low-dose colchicineopens in a new tab or window an extra 2 years free of myocardial infarction, stroke, or cardiovascular death in a lifetime. (European Journal of Preventive Cardiology)

A mouse model supports the existence of an autoimmune pathogenesis of atrial fibrillationopens in a new tab or window. (Circulation)

New omnipolar mapping technologyopens in a new tab or window produced slightly higher voltages that were helpful for guiding ventricular tachycardia ablation. (HeartRhythm)

In Denmark, people with congenital heart disease are prone to more out-of-hospital cardiac arrestopens in a new tab or window (OHCA), with typical odds of survival. (European Heart Journal)

Bystander response and OHCA survival rates were improved with activation of volunteer responder networksopens in a new tab or window in several European regions. (Journal of the American College of Cardiology)

Contemporary implantable cardioverter-defibrillators carry a low risk of inappropriate shocksopens in a new tab or window, at 1.6% in 2 years, based on postmarketing data. (EP Europace)

The MIB1 geneopens in a new tab or window was identified as having a role in whether a person develops a bicuspid aortic valve. (JAMA Cardiology)

One-year outcomes of taking direct oral anticoagulants or vitamin K antagonists after transcatheter aortic valve replacementopens in a new tab or window were comparable in a real-world German population. (Heart)

An artificial intelligence model has been taught to identify low ejection fraction and various types of valvular heart diseaseopens in a new tab or window based on chest X-rays. (The Lancet Digital Health)

Separate from socioeconomic status, population well-beingopens in a new tab or window was independently associated with cardiovascular outcomes. (JAMA Network Open)

Black women with a history of hypertensive disorders of pregnancy have an estimated 66% higher long-term risk of strokeopens in a new tab or window. (NEJM Evidence)

Tenecteplase (TNKase)opens in a new tab or window performed comparably to alteplase in the subset of stroke patients with large vessel occlusions in the ACT trial. (JAMA Neurology)

At least 3 months after COVID-19 hospitalizationopens in a new tab or window, people still had excess emergency visits or hospitalizations for cardiovascular diagnoses, according to records from Alberta, Canada. (JACC: Advances)

Health Canada declared a shortage of dipyridamoleopens in a new tab or window, forcing patients to put off myocardial perfusion scans. (CBC News)

Four years after lower-extremity femoropopliteal peripheral intervention for intermittent claudication, the incidence of repeat revascularization rose to 16.7%, and amputations grew to 4.3%.opens in a new tab or window (JACC: Cardiovascular Interventions)

Scientists report how they created a dissolving cardiac deviceopens in a new tab or window, roughly the size of a postage stamp, that can temporarily perform electrical mapping and pacing. (Science Advances)

Researchers found that impaired heart rate variability in sepsisopens in a new tab or window can hinge on reduced responsiveness of cardiac pacemaker cells. (PNAS)