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Tuesday, July 2, 2024

Medicare's Financial Incentives Still Falling Flat for Home Dialysis Uptake

 Financial incentives used in Medicare's End-Stage Renal Disease Treatment Choices (ETC) Model didn't move the needle on home dialysis use and kidney transplantation uptake during its first 2 years.

According to a cross-sectional study, the proportion of kidney failure patients receiving home dialysis living in areas testing the ETC model increased from 12.1% to 14.3%, as compared with 12.9% to 15.1% in control regions, for a nonsignificant difference-in-difference [DiD] of -0.2 percentage points (95% CI -0.7 to 0.3), reported Amal Trivedi, MD, MPH, of Brown University School of Public Health in Providence, Rhode Island, and colleagues.

The null findings held true when the data were further stratified by sociodemographic measures, including age, sex, race and ethnicity, dual Medicare and Medicaid enrollment, and poverty quartile.

A similar pattern followed when it came to kidney transplant uptake. There was an increase from 0.29% to 0.32% in ETC regions versus 0.29% to 0.30% in control regions (DiD estimate 0.02 percentage points, 95% CI -0.01 to 0.04), according to the study in JAMA Health Forumopens in a new tab or window.

The findings were simultaneously presented at the AcademyHealth 2024opens in a new tab or window annual research meeting in Baltimore.

"Payment penalties and bonuses used in the ETC model, despite being significantly larger than those used in prior kidney care quality incentives, do not appear to be moving the needle significantly on provider behavior," co-author Kalli Koukounas, MPH, also of Brown University School of Public Health, told MedPage Today.

While this could be due to a number of reasons, Koukounas pointed out that patient-level and socioeconomic barriers are likely contributing.

Lack of stable housing, having to learn and self-administer complex medical regimens, lack of caregiver support, and the financial burden of home modifications and higher utility bills likely contribute to the slow uptake of home dialysis.

"The application of pay-for-performance incentives to dialysis facilities and clinicians does not address these patient-level barriers," said Koukounas.

As for kidney transplants, she said it could take several years to notice a significant impact from the ETC model, as the process of receiving a transplant is both lengthy and complex.

The model was launched in 2021opens in a new tab or window by CMS with the intention of increasing the use of home dialysis, kidney transplant, and transplant waitlisting among traditional Medicare beneficiaries. It randomly selected 30% of the nation's hospital referral regions for mandatory participation, which included all dialysis facilities and managing clinicians in those regions. Participants in these test regions received payment incentives and penalties on the basis of their attributed patients' use of home dialysis and kidney transplant or waitlisting.

The model is slated to run through 2027. By that year, payment bonuses and penalties will hit 8% and -10%, respectively. In the first 2 years, these ranged from bonuses of 4% to penalties of -5%.

While prior analyses of the ETC modelopens in a new tab or window have reported mixed findings, Koukounas pointed out the current study evaluated the first 2 years of implementation across the entire kidney failure population, inclusive of both incident and prevalent patients. That being said, she still wasn't surprised by the findings given prior reports.

According to previous research from Koukounas' own team on the first year of the ETC model, she said they found that facilities who served patients with high social risk were disproportionately penalized by the ETC model.

"This is not an uncommon effect among pay-for-performance programs, but is nonetheless cause for concern, particularly due to the fact that kidney failure already has large racial, ethnic, and socioeconomic care disparities," she said. "This finding coupled with the lack of consistent evidence that the ETC model is improving outcomes may raise concerns about the continued implementation of the model through its scheduled end date."

The analysis included 724,406 patients with kidney failure. The average age was 62.2 and 42.5% were female.

Compared with control regions, ETC regions had a higher proportion of Black patients (35.4% vs 30.5%) and a lower proportion of white (48.7% vs 50.4%) and Hispanic patients (5.9% vs 8.6%). It also included more people in Southern (47.8% vs 43.8%) and Northern (17.2% vs 14.7%) census regions and fewer in the Midwest (17.8% vs 20.8%) and West (17.2% vs 20.6%) regions. ETC areas also had slightly fewer dual beneficiaries (41.5% vs 42.8%) mostly driven by fewer full dual beneficiaries (32.7% vs 35.1%).

"Going forward, both policymakers and physicians can work together to consider how best to confront the structural barriers that limit the uptake of higher quality care, especially among socioeconomically disadvantaged patient populations," said Koukounas.

Disclosures

The study was supported by grants from the National Institute of Minority Health and Health Disparities, Agency for Healthcare Research and Quality, and National Institute of Diabetes and Digestive and Kidney Disease.

Koukounas and co-authors reported relationships with Group 17a, National Institute on Minority Health and Health Disparities, the National Institute on Aging, Brown University, Otsuka, Calliditas, the U.S. Department of Veterans Affairs. and the U.S. Department of Defense.

Primary Source

JAMA Health Forum

Source Reference: opens in a new tab or windowKoukounas KG et al "Pay-for-performance incentives for home dialysis use and kidney transplant" JAMA Health Forum 2024; DOI: 10.1001/jamahealthforum.2024.2055.


https://www.medpagetoday.com/nephrology/esrd/110928

Biden Administration Proposes Rule for Workplaces to Address Excessive Heat

 The Biden administration proposed a new rule Tuesday to address excessive heat

opens in a new tab or window in the workplace, as tens of millions of people in the U.S. are under heat advisories due to blistering temperatures.

If finalized, the measure would protect an estimated 36 million U.S. workers from injuries related to heat exposure on the job -- establishing the first major federal safety standard of its kind. Those affected by excessive heat in the workplace include farmworkers, delivery and construction workers, landscapers, and indoor workers in warehouses, factories, and kitchens.

President Joe Biden planned to highlight the rule on Tuesday in remarks after getting a briefing on extreme weather at the D.C. Emergency Operations Center.

The Democratic president began the briefing by noting the risks this year of potential damage: "What we're going to face this summer -- it's going to be significant."

Despite increased awareness of the risks posed to human healthopens in a new tab or window by high temperatures, extreme heat protectionsopens in a new tab or window -- for those routinely exposed to heat index readings above 80 degrees Fahrenheit (27 degrees Celsius) -- have lagged.

Under the proposed rule, employers would be required to identify heat hazards, develop emergency response plans related to heat illness, and provide training to employees and supervisors on the signs and symptoms of such illnesses. They would also have to establish rest breaks, provide shade and water, and heat acclimatization -- or the building of tolerance to higher temperatures -- for new workers.

Penalties for heat-related violations in workplaces would increase significantly, in line with what workplaces are issued for violations of Occupational Safety and Health Administration rules, a senior White House administration official said.

An estimated 2,300 people in the U.S. died from heat-related illness in 2023. Workers with prolonged exposure to extreme heat are among the most vulnerable to related health risks, such as heatstroke and other illnesses, according to the CDC and the National Oceanic and Atmospheric Administration.

As the hottest month of the year gets underway, millions of Americans will be at greater riskopens in a new tab or window of heatstroke, dangerous dehydration, and heat-related heart stress.

The Labor Department has been developing a standard for how workplaces deal with heat since 2021, with OSHA having held meetings last year to hear about how the proposed measures could affect small businessesopens in a new tab or window.

Heat protection laws in the U.S. have faced steady industry opposition, including from chambers of commerce and other business associations. Many say a blanket mandate would be difficult to implement across such a wide range of industries.

California, Colorado, Oregon, Minnesota, and Washington are the only states with workplace standards for heat exposure. Some regulations have recently come under attack by Republicans. Over the past year, Florida and Texas, led by Gov. Ron DeSantis and Gov. Greg Abbott, both Republicans, passed legislation preventing local governmentsopens in a new tab or window from requiring heat protections for outdoor workers.

If finalized, the Biden administration's rule would override state measures, and states with existing procedures to deal with heat would have to institute measures that are at least as stringent as the finalized federal rule.

https://www.medpagetoday.com/publichealthpolicy/environmentalhealth/110932

Vapers May Be Less Likely to Undergo Lung Cancer Screening

 E-cigarette use among individuals eligible for lung cancer screening was independently associated with a reduced likelihood of screening, a cross-sectional study of U.S. adults revealed.

Compared with those who never used e-cigarettes, current vapers had a lower odds of ever undergoing lung cancer screening (OR 0.79, 95% CI 0.62-1.00) and of being up to date on screening (OR 0.67, 95% CI 0.51-0.88), reported researchers led by Qian Wang, MD, MPH, of Case Western Reserve University in Cleveland.

The associations were more apparent for former (rather than current) smokers of traditional cigarettes. For individuals who previously smoked, those who used e-cigarettes appeared less likely to have undergone lung cancer screening (OR 0.73, 95% CI 0.52-1.04) and had a 46% lower chance of being up to date on screening (OR 0.54, 95% CI 0.37-0.80) compared with those who never used e-cigarettes.

No associations were seen between past e-cigarette use and lung cancer screening use, according to the findings in JAMA Network Openopens in a new tab or window.

"Former smokers who use e-cigarettes remain at increased risk of lung cancer and should be targeted by interventions to improve adherence to LCS [lung cancer screening]," Wang and co-authors concluded.

E-cigarettes are increasingly being used as cessation aidsopens in a new tab or window for smokers seeking to quitopens in a new tab or window traditional cigarettes, the research team explained in their introduction, but there have been growing concerns about the potential for lung cancer riskopens in a new tab or window with long-term use, among otheropens in a new tab or window concernsopens in a new tab or window.

"Emerging research suggests that e-cigarettes contain definite and probable carcinogens and cause similar cancer-associated gene deregulations as combustible tobacco," wrote Wang and co-authors. "However, it has been shown that two-thirds of individuals currently using e-cigarettes consider e-cigarettes to be less harmfulopens in a new tab or window than combustible cigarettes. Thus, individuals who use e-cigarettes may have lower awareness of lung cancer risks."

Their study included more than 20,000 individuals who met the current criteria for lung cancer screening set by the U.S. Preventive Services Task Force (USPSTF). The task force first recommended screening via low-dose CT in 2013, but broadened its criteriaopens in a new tab or window for eligibility in 2021.

"I would not see this as 'Well, you shouldn't be smoking an e-cigarette,'" said Nancy Rigotti, MD, of Massachusetts General Hospital in Boston, of the findings from Wang's group. "If you're smoking an e-cigarette and you used to smoke, you still need lung cancer screening."

"It's a reminder for us that we need to make sure that everybody who has recently or are currently smoking cigarettes and fits the eligibility criteria for lung cancer screening gets lung cancer screening," said Rigotti, who was not involved in the study.

Current USPSTF guidelines recommend annual screening via low-dose CT for adults ages 50 to 80 years who have at least a 20 pack-year smoking history and who either currently smoke or have quit in the past 15 years.

But in clinical practice, uptake of the screening recommendations has been "woefully lowopens in a new tab or window," noted Ashley Prosper, MD, of the University of California Los Angeles, who also was not involved in the study.

In the current sample, just 27% of the individuals had undergone lung cancer screening.

"Barriers to lung cancer screening adherence are myriad," Prosper told MedPage Today via email. These include "factors such as participant characteristics (insurance status, income, race, education), healthcare provider factors (whether or not a recommendation for lung screening is made by a provider to an eligible patient), and a number of psychological variables that are unique to lung screening as compared to other cancer screenings -- such as the fear of discovering a lung cancer and stigma associated with smoking."

Wang and colleagues' study included 22,713 individuals from within the 2022 Behavioral Risk Factor Surveillance System who met current USPSTF guidelines for lung cancer screening.

Median age was 62 years and 56% were men. Most were white (77%), while 9% were Black, 7% were Hispanic, and 7% were of another race. Individuals had a median 39 pack-year history of cigarette smoking: a majority still smoked (59%) while the rest were former smokers (41%; median 6 years since quitting).

With regard to e-cigarette use, a majority (55%) had never used them, while 35% were former users and 9% were current users. The vast majority (81%) of the sample had had a routine checkup in the prior year, and nearly two-thirds said they were in good general health.

Overall, 5,885 individuals had undergone screening, with 3,472 (14.6%) up to date on screening and 2,513 (11.4%) no longer up to date.

People who underwent screening tended to be older (64 vs 61 years for those never screened); have lower income, poorer health, more comorbidities, and a greater smoking history (43 vs 38 pack-years); and they were more likely to have attempted quitting in the prior year (18% vs 14%) and live in the Northeast. Individuals in the screening group were also more likely to have reported never using e-cigarettes (57% vs 55%) and were less likely to be uninsured (2% vs 7%).

Study limitations cited by Wang and colleagues included the cross-sectional design, use of self-reported screening and smoking information, and the fact that the study could not account for switching between traditional cigarettes and e-cigarettes and the impact of that on screening uptake.

Disclosures

Wang reported no disclosures. Co-authors reported relationships with Regeneron, Mirati, AstraZeneca, Amgen, Sanofi, Pharmaceutical Product Development, and Axella.

Prosper is a member of the American College of Radiology's Lung CT Screening Reporting & Data System (Lung-RADS), is co-director of UCLA's Lung Screening Program, and reported a relationship with the National Institutes of Health.

Rigotti reported a relationship with Achieve Life Sciences.

Primary Source

JAMA Network Open

Source Reference: opens in a new tab or windowWang Q, et al "E-cigarette use and lung cancer screening uptake" JAMA Netw Open 2024; DOI: 10.1001/jamanetworkopen.2024.19648.


https://www.medpagetoday.com/radiology/diagnosticradiology/110935

Supreme Court won’t hear tech liability challenge from teen groomed on Snapchat

 The Supreme Court will not consider a challenge to the scope of a federal law immunizing tech companies from liability for their users’ content brought by a teenager who was allegedly groomed by a teacher on Snapchat. 

The anonymous Texas teen said his high school science teacher used the image-based instant messaging app to groom him, induce his drug abuse and then sexually assault him when he was 15 years old. 

The teen sought to hold Snap Inc. liable for having “negligently designed an environment rife with sexual predators and then lured children in.” His lawyers also claimed Snap “knew or should have known,” given its internal technology, that the teen was being groomed.

His petition, filed with the high court in March, sought to put Section 230 of the Communications Decency Act to a new test. The law says internet service providers cannot be held liable as the “publisher” or “speaker” of content on their platforms.

Instead of holding Snap liable as a publisher or speaker, the teen asked the high court to consider whether Section 230 immunizes internet service providers from any lawsuit regarding their own misconduct just because third-party content is also involved. 

“American teenagers’ social media use is nearly universal. Every time a teenager refreshes a feed, he or she could be the target of online abuse. Yet social media companies are not taking reasonable and obvious steps to protect children online, and courts have applied Section 230 to cut off any means to hold them accountable,” the petition reads. 

“This Court’s review is needed now,” it continues. “Further delay means further unaccountability and more tragedy, like the abuse that occurred here.”

Justice Clarence Thomas, joined by Justice Neil Gorsuch, wrote in a dissent that there would be “other opportunities” for the matter to be addressed by the high court, though warning that there is “danger in delay.” 

“Social-media platforms have increasingly used §230 as a get-out-of-jail free card,” Thomas wrote. 

The teenager’s lawyers called the scope of the law an issue of “exceptional importance,” suggesting that his case could serve as an ideal vehicle to address the matter. They also argued that Congress has done little to act on Section 230’s broad protections and “almost certainly will not do so now.”

“Even if there were any hope of Congressional action, this Court should not sit on its hands waiting for Congress to do something when, properly interpreted, Section 230 does not bar claims, like Doe’s, which are based on an internet platform’s own misconduct,” they wrote. “Overbroad immunity under Section 230 is a judicially created problem, and this Court’s intervention is the solution.”

Snap meanwhile urged the justices to deny the teen’s petition, calling it a “poor vehicle” for the “referendum” sought on Section 230.

“The petition invites the Court to consider the limits of [Section 230], but the facts of this case, as alleged in petitioner’s complaint, place Snap squarely within the heartland of that provision,” Snap’s lawyers wrote in court filings. 

https://thehill.com/regulation/court-battles/4751471-supreme-court-tech-liability-shield/

'Confidence in Zelensky drops in Europe, ‘warms’ for Putin in some places: Pew'

 Global confidence in Ukrainian President Volodymyr Zelensky to do the right thing has declined across a broad grouping of countries, including in Europe, according to a Pew survey published Tuesday. 

The findings contrast with a slight improvement in global opinion toward Russian President Vladimir Putin, in particular among young people, although overall confidence in the Russian leader remains low.

The Pew survey underscores how support for Ukraine is straining among its Western allies and that efforts to isolate Putin are faltering two years into the war.

And the survey comes shortly before President Biden hosts the NATO summit in Washington that will mark the alliance’s 75th anniversary, during which ongoing support for Ukraine will be at the top of the agenda.

Survey respondents were also asked their opinion of NATO, of which the median viewed the alliance favorably, but has ticked down in the U.S., Spain, the United Kingdom and Sweden — which only became a member in March. 

More than 44,000 people in 36 countries were surveyed across North and South America, Europe, Asia, the Middle East and Africa. 

Overall, an average of 46 percent of respondents said they do not have confidence in Zelensky to do the right thing, compared to 40 percent who said they do.

“We’ve only started asking about him since the war broke out in 2022, and then he received quite high favorability or confidence,” said Moira Fagan, research associate at Pew Research Center specializing in international survey research.

“But since then, it has declined and in many European-allies cases, the confidence in Zelensky has declined significantly over the past year.”

Poland showed the most drastic decline in its opinion toward Zelensky and Ukraine, a reflection of tensions that have played out between Warsaw and Kyiv over trade and border disputes. Poland also hosts between 1 million and 2 million Ukrainian refugees.

The Pew survey found that smaller, but significant decreases of confidence in Zelensky have also occurred in Australia, France, Germany, the Netherlands, Spain, South Africa, South Korea, Sweden and the U.S.

Fagan said that one possible explanation is fatigue in some of these countries, linked to some respondents’ answers that they view their countries’ support for Ukraine as “enough” or “too much.” These answers also reflect growing partisan gaps on views toward support for Ukraine, with conservatives and those who identify as right-wing more critical of assistance for Kyiv. 

“We also know that people who are right-wing populist party supporters are less likely to have expressed confidence in Zelensky than people who do not support right-wing populist parties in Europe,” Fagan continued, pointing to the growing success of these parties in the recent European parliamentary elections as linked to the attitudes reflected in the survey. 

Previous findings from Pew found that among American respondents, there is a stark divide between Republicans and Democrats over support for Ukraine, mirroring criticisms from Republican-lawmakers opposing U.S. military and economic support for Ukraine.

Among respondents in survey results published in May, 49 percent of Republicans and those who lean-Republican said the U.S. provides too much support to Ukraine, compared to 16 percent of Democrats or those who lean-Democrat. 

“This is something that we see just huge partisan divides on in the United States and those partisan divides getting larger as well, particularly on the support for Ukraine,” Fagan said.

On the other side, while a median of 65 percent of respondents hold a negative view of Putin since Russia invaded Ukraine in February 2022, opinions have “warmed slightly” in several countries, the survey authors wrote.  

In most of the surveyed countries, younger adults are more likely than older people to have a favorable opinion of Russia, the authors wrote. In Peru, for example, 63 percent of adults under 35 said they have a positive opinion of Russia, compared to 31 percent of adults ages 50 and older. 

In Germany, confidence in Putin is up 9 points and favorable views toward Russia have increased 5 points since 2023, they wrote. Argentines have also recorded a more favorable view toward Russia, an 11-point increase, and 9 points more confidence in Putin over the past year. 

“Rising shares of right-wing populists are confident in Putin in several countries, including France, Germany, Hungary, the Netherlands, Sweden and the UK,” the survey authors wrote.

Still, much of the world remains largely negative toward Russia and Putin, Fagan explained, and categorized the changes as “modest overall.”

“Views of Putin and Russia, sort of as a pair, are both still far more negative than positive around the world. There’s some regional variation there as well, where you get more negativity in Europe, a little bit more favorability in parts of the Asia Pacific, Latin America, for example.” 

Attitudes toward NATO are overall positive in much of the world, the survey found, with surprising increases recorded in Turkey and Hungary, Fagan added. 

“Turkey in particular, which is a country that has historically not been quite favorable towards NATO, favorability has doubled since we last surveyed in Turkey in 2019,” she said.

Forty-two percent in Turkey approve of NATO, up from 21 percent in 2019. (The survey was suspended during the pandemic). 

And Hungary also has shown an increasingly positive view toward NATO, with more than 8 in 10 adults saying the alliance is important for their country’s security. This could appear at odds with Hungarian Prime Minister Viktor Orbán’s antagonism toward Europe and Ukraine, and support for Putin and former President Trump, who has threatened to exit NATO.

“What is striking there is that they’ve [Hungary] grown statistically, significantly more favorable toward NATO over the past year,” Fagan said.

“Looking at the context of contributions to the war, Hungary ranked last among all 13 of these NATO member countries that we survey in terms of relative contribution to the Ukrainian war effort, but they do not see the organization very unfavorably. So it’s an interesting balance.”

https://thehill.com/policy/international/4752155-pew-survey-zelensky-putin/

'Google emissions rose 13 percent from AI energy consumption'

 Google’s emissions rose 13 percent last year despite the tech giant’s goals to become net-zero by the end of the decade as artificial intelligence (AI) drives an increase in energy consumption. 

“As we further integrate AI into our products, reducing emissions may be challenging due to increasing energy demands from the greater intensity of AI compute, and the emissions associated with the expected increases in our technical infrastructure investment,” Google wrote in its annual environmental report

The company aims to cut its total greenhouse gas emissions in half by 2030 and invest in carbon removal solutions to neutralize its remaining emissions. 

However, since its baseline year of 2019, Google’s emissions have ticked up 48 percent, rising from the equivalent of 9.7 million tons of carbon dioxide to 14.3 million tons, according to the report released Tuesday. 

Google’s data center electricity consumption grew by 17 percent last year, to more than 24 terawatt hours, translating to about 7 percent to 10 percent of global data center electricity consumption. 

“AI is at an inflection point and many factors will influence its ultimate impact—including the extent of AI adoption, our ability to mitigate its footprint, and the pace of continued innovation and efficiency,” Google noted in the report. 

“While we remain optimistic about AI’s potential to drive positive change, we’re also clear-eyed about its potential environmental impact and the collaborative effort required to navigate this evolving landscape,” it added.

https://thehill.com/policy/technology/4752225-google-emissions-ai-energy/

FDA approves Lilly’s new Alzheimer’s drug after delay

 The Food and Drug Administration (FDA) on Tuesday approved Eli Lilly’s Alzheimer’s drug, the company announced, clearing the way for another entry into the market of a new class of drugs that moderately slows the disease’s progression. 

The agency last month held an advisory panel meeting to scrutinize the safety and effectiveness of the drug, called donanemab, after delaying approval in March.  

The decision to require a panel meeting came as a surprise to the company, which submitted its traditional approval application of donanemab to the FDA last year and anticipated getting the green light by early 2024.   

FDA’s independent advisers unanimously backed recommending approval.  

Donanemab, now marketed as Kisunla, is a monoclonal antibody that targets a brain plaque called amyloid. It’s intended to treat early-stage disease and is administered monthly by intravenous infusion.  

The drug will be available in the coming weeks, Lilly said.  

According to Lilly, donanemab slowed Alzheimer’s disease progression by 35 percent relative to placebo treatment, in an 18-month clinical trial that enrolled 1,700 patients with early-stage disease. In practical terms, that translated to delaying progression by about four months.   

There were serious risks identified in the trial, raising concerns that the risk outweighed the benefit. Three people died after developing serious brain bleeding or swelling.   

Anti-amyloid drugs can significantly reduce the levels of a sticky plaque in the brain called amyloid beta, but questions remain about the clinical significance and degree of benefit.  

More than 6 million people in the United States are diagnosed with Alzheimer’s, and that number is expected to rise as the population ages. There is no cure, but there are about 1 million people with early-stage disease who could benefit most from the drug.  

“This is real progress. Today’s approval allows people more options and greater opportunity to have more time. Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease,” Joanne Pike, president and CEO of the Alzheimer’s Association said in a statement.

Donanemab is the third amyloid-targeting Alzheimer’s drug to get the green light from FDA since 2021. Biogen and Eisai jointly developed Aduhelm and Leqembi, though Aduhelm was plagued by controversy from the start and was discontinued in January.   

Unlike Leqembi, donanemab use can be stopped after amyloid plaque is removed to minimal levels, which Lilly said can result in lower treatment costs and fewer infusions. 

The price of each vial of Kisunla is $695.65 Lilly said, which equates to $32,000 for a year. That’s more than Leqembi, which costs patients an estimated $26,500 a year. But patients don’t stop taking Leqembi.

The actual cost will depend on how long patients take the treatment, though Lilly noted Medicare Part B will cover and provide some reimbursement—patients will be responsible for a 20 percent coinsurance after meeting their deductible.  

https://thehill.com/policy/healthcare/4752326-fda-approves-eli-lilly-alzheimers-drug/