Hospitals altered charity care policies during pandemic: study

 

• A number of tax-exempt hospitals expanded their charity care policies during the COVID-19 pandemic, but unclear and unpublicized eligibility criteria remain common and deserve regulatory attention, according to a study published Tuesday in JAMA Network Open.
• Researchers comparing charity care policies at 151 tax-exempt hospitals for 2019 and 2021 found that 47 (31%) of the providers expanded charity care, while 12 (8%) made restrictive changes.
• A total of 127 (84%) hospitals updated their policies, and 77 (51%) made substantial changes, in categories such as income eligibility cutoffs, asset limitations and service exclusions. Even so, vague eligibility criteria were common, the study found.

Hospitals are required to provide charity care to maintain tax-exempt status. The Affordable Care Act also made it a requirement that tax-exempt hospitals publish their policies online with clear eligibility criteria and covered services.

In practice, the content of published charity care policies has tended to vary widely, the JAMA Network Open study found. The analysis comes on the heels of a New York Times investigation of Washington-based health system Providence that found the provider saddled patients with debt who should have been eligible for financial assistance.

California has heightened its focus on the right to charity care. The state’s attorney general, Rob Bonta, earlier this summer warned hospitals that failure to alert patients about free or reduced-cost care violates state law. The warning followed complaints to Bonta’s office that hospitals were not providing notices in a language that patients understood.

The JAMA research found that the most common changes to charity care policy statements between December 2019 and December 2021 involved expansion of eligibility criteria. Policy changes mostly specified income cutoffs for free and discounted care, residency status, presumptive eligibility, duration of coverage and underinsured eligibility.

Despite the generally positive changes, the researchers found reasons for concern, including the nearly 8% of hospitals that restricted charity care through eligibility requirements and coverage changes and policies that continue to use vague language. Nonspecific language is common in charity care policies, the report said.

“Policy makers should consider requiring greater transparency and simplification for hospital charity care policies to ensure adequate access to care for uninsured and underinsured patients,” the researchers concluded.

https://www.healthcaredive.com/news/JAMA-hospitals-charity-care/632713/

DOJ silent on appeal as UnitedHealth-Change deal close looms

 The Department of Justice has yet to file an appeal in the case against UnitedHealth’s $13 billion acquisition of Change Healthcare, raising questions about whether the DOJ will let the deal go through. 

The agency moved to block the health giant from closing the deal that gives UnitedHealth the ability to mine data from billions of healthcare claims including from its health insurance rivals, the DOJ alleged. But on Sept. 19, Federal Judge Carl Nichols ruled in favor of the merger, dealing a blow to the agency.

UnitedHealth had previously agreed it would not close the deal any earlier than ten days following an eventual ruling, but UnitedHealth has not made a public announcement that the deal has closed.        

Antitrust legal experts told Healthcare Dive it appears the deal may close soon, which would be viewed as a major setback for the DOJ, which has lost two merger cases this year. Last week, a federal judge said U.S. Sugar could acquire its rival Imperial Sugar despite the DOJ’s attempts to block the deal. 

In fact, the DOJ has already said it will file an appeal in the Sugar case it lost, a ruling that came days after the UnitedHealth-Change decision. In that case, the DOJ conceded that it’s important to stop combinations early rather than attempt to “unscramble” assets after a deal closes.

However, the DOJ could still appeal the UnitedHealth-Change ruling. Its earlier deal reached with UnitedHealth doesn’t prevent DOJ from appealing. 

“In any challenge to a merger, it is always beneficial for those challenging it to seek to have the merger enjoined before the matter actually closes,” Jim Burns, a partner at Williams Mullen and chair of its Antitrust and Trade Regulation Practice Group, told Healthcare Dive. 

But all signs indicate that the DOJ has decided not to appeal, a former government official with antitrust expertise told Healthcare Dive. 

To alleviate other antitrust concerns, UnitedHealth agreed to divest ClaimsXten to private equity group TPG Capital.

The DOJ has not responded to requests for comments about seeking a possible settlement with UnitedHealth.   

UnitedHealth did not provide additional comment on the DOJ’s lack of appeal or whether a settlement is in the works.

https://www.healthcaredive.com/news/doj-no-appeal-unitedhealth-change-deal-close/632998/

Cytokinetics: Positive New Data From Heart Failure Trial

Treatment with Aficamten Associated with Significant Improvements in Symptoms and Quality of Life

Additional Data Presented in Poster Session Shows Patients with Worsening Heart Failure and LVEF ≤30% Have Disproportionately High Risk of Heart Failure Hospitalization

https://finance.yahoo.com/news/cytokinetics-presents-data-redwood-hcm-134500721.html

Circulation of Virus Tied to Paralysis in Kids Is Rising, CDC Says

 The U.S. is experiencing increased circulation of enterovirus D68 (EV-D68), a virus linked with a rare neurologic complication that can cause paralysis in children, according to CDC surveillance data.

Alongside increasing cases of rhinovirus (RV) and EV, mounting emergency department visits for acute respiratory illness have been reported in children and adolescents, and EV-D68 is turning up in more and more of these cases, reported Kevin C. Ma, PhD, of the CDC's Epidemic Intelligence Service, and colleagues.

"Health care facilities should be prepared for possible increases in pediatric health care use associated with severe EV-D68-associated respiratory illness," the group warned in the Morbidity and Mortality Weekly Report.

The findings follow recent reports from providers about rising pediatric hospitalizations potentially linked with the virus, and of particular concern is that biennial outbreaks of EV-D68 -- typically falling on even years (2014, 2016, 2018) -- have been linked to increasing cases of acute flaccid myelitis (AFM).

"Providers should have a high index of clinical suspicion for AFM in patients with acute flaccid limb weakness, neurologic signs and symptoms, or neck or back pain who have a recent history of respiratory illness or fever," wrote Ma and colleagues. "Children with AFM can experience rapid progression of weakness and should be promptly hospitalized and referred to specialty care."

So far this year, 15 cases of AFM have been confirmed (of 45 under investigation), but the circulation of EV-D68 is currently similar to peak levels observed in 2018, when 238 cases of the rare neurologic complication were recorded. The year 2020 was an exception, at 33 cases, with the lower number attributed to increased precautions due to COVID-19. AFM cases in years ending in odd numbers (2015, 2017, 2019) ranged from 22 to 47.

Acute respiratory illness from EV-D68 typically affects young children, the group explained, and severity varies.

While "typical signs and symptoms include cough, nasal congestion, wheezing, and dyspnea," infections with EV-D68 can also exacerbate asthma or reactive airway disease (RAD), and "children with a history of asthma/RAD might be more likely to require medical care," according to Ma and co-authors.

To assess EV-D68 trends, the CDC investigators gathered and analyzed data from three sources: emergency department visits for acute respiratory illness or asthma/RAD in the National Syndromic Surveillance Program; positive RV/EV test results from the National Respiratory and Enteric Virus Surveillance System (NREVSS); and the detection of EV-D68 in children hospitalized or visiting emergency department for acute respiratory illness in the New Vaccine Surveillance Network (NVSN).

NREVSS data showed that the weekly positive RV/EV results in 2022 appeared to be increasing at a rate comparable to that of past EV-D68 outbreak years, doubling from 15.8% to 31.4% from week 32 to week 35. This marked the fourth highest proportion when compared to prior years (31.7% in 2015 to 41.5% in 2014, for example).

Of 5,633 children in the NVSN presenting to emergency departments with acute respiratory illness from March to September 2022, RV/EV was detected in 26.4%. Overall, EV-D68 was identified in 17.4% of these RV/EV cases, but that number surged to 56% by the end of the surveillance period.

In addition to looking out for AFM, the CDC advised that clinicians should also consider and test for polio, due to the clinical similarity of acute flaccid paralysis from poliovirus, and "given the detection of a paralytic polio case and wastewater samples positive for poliovirus in New York during summer 2022."

Disclosures

No conflicts of interest were disclosed.

Primary Source

Morbidity and Mortality Weekly Report

Source Reference: Ma KC, et al "Increase in acute respiratory illnesses among children and adolescents associated with rhinoviruses and enteroviruses, including enterovirus D68 -- United States, July-September 2022" MMWR 2022; DOI: 10.15585/mmwr.mm7140e1.

https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/100957

CDC Warns of Severe Monkeypox in People With HIV, the Immunocompromised

 Be alert for potentially severe manifestations of monkeypox in patients who are immunocompromised or co-infected with HIV, the CDC told healthcare workers on Thursday.

"People who are immunocompromised due to HIV or other conditions are at higher risk for severe manifestations of monkeypox than people who are immunocompetent," the agency said in a health advisory to its Health Alert Network, adding that "the HIV status of all sexually active adults and adolescents with suspected or confirmed monkeypox should be determined."

Of the patients with severe manifestations "for whom CDC has been consulted," the majority had HIV with CD4 counts below 200 cells/mL, indicating "substantial immunosuppression," the agency noted.

These severe manifestations have included cases involving atypical or persistent rash requiring amputation of an extremity; secondary bacterial or fungal infections; lesions in sensitive areas resulting in severe pain or urethral or bowel strictures; and comorbidities involving organ systems, including myocarditis, transverse myelitis, bowel lesions, penile necrosis, and others.

The news arrives as the U.S. records its third known monkeypox-associated death in Ohio. To date, over 25,000 monkeypox cases have been reported in the U.S., 38% of which involved patients co-infected with HIV.

Researchers have highlighted monkeypox severity and outcomes in people with HIV before.

For example, a study in The Lancet about a 2017-2018 monkeypox outbreak in Nigeria reported seven deaths in a population of 122 patients, with four of the seven co-infected with HIV.

More recently, papers on the current outbreak have reported conflicting results about the association between monkeypox severity and HIV co-infection. CDC data involving more than 1,300 monkeypox patients showed a higher rate of hospitalizations for those with HIV (8% vs 3% for those without HIV), with higher rates for those whose HIV was not virally suppressed. Conversely, German researchers reported that the clinical characteristics in HIV-infected versus non-infected monkeypox patients were largely similar.

The new CDC advisory recommends that monkeypox treatment include optimization of immune function for people with immunocompromising conditions, such as limiting the use of immunosuppressive medications when "not otherwise clinically indicated," and offering antiretroviral therapy for those living with HIV.

Severe immunocompromising conditions can including those with autoimmune disease where immunodeficiency is a clinical component; leukemia or lymphoma, transplant recipients; and those treated with high-dose steroids, alkylating agents, antimetabolites, radiation, or tumor necrosis factor (TNF) inhibitors.

On a case-by-case basis, medications such as oral and intravenous tecovirimat (Tpoxx), cidofovir or brincidofovir, and vaccinia immune globulin intravenous should be considered, "although there are no data on effectiveness in treating human monkeypox with these medical countermeasures," according to the CDC.

Clinicians should gather repeat lesion swabs in patients with persistent monkeypox DNA, and continue tecovirimat beyond 14 days (but not more than 90 days), "until there is clinical improvement," the advisory stated.

Modifications to the dose, frequency, and duration of tecovirimat may be necessary, depending on the patient's clinical condition, disease progression, or therapeutic response. The advisory encouraged clinicians to consult with the CDC Monkeypox Response Clinical Escalations team when appropriate.

The following severe manifestations seen in monkeypox patients were reported to the CDC, although the advisory did not include information about HIV status:

• Atypical or persistent rash with coalescing or necrotic lesions, or both, some of which have required extensive surgical debridement or amputation of an affected extremity

• Lesions on a significant proportion of the total body surface area, which may be associated with edema and secondary bacterial or fungal infections among other complications

• Lesions in sensitive areas (including mucosal surfaces such as the oropharynx, urethra, rectum, and vagina) resulting in severe pain that interferes with activities of daily living

• Bowel lesions that are exudative or cause significant tissue edema, leading to obstruction

• Severe lymphadenopathy that can be necrotizing or obstructing (such as in airways)

• Lesions leading to stricture and scar formation resulting in significant morbidity such as urethral and bowel strictures, phimosis, and facial scarring\

The CDC advisory also noted reports of individuals with severe monkeypox involving multiple organ systems and associated comorbidities, including oropharyngeal lesions inhibiting oral intake; pulmonary involvement with nodular lesions; neurologic conditions, including encephalitis and transverse myelitis; cardiac complications, including myocarditis and pericardial disease; ocular conditions including severe conjunctivitis; sight-threatening corneal ulcerations; and urologic involvement including urethritis and penile necrosis.

The advisory also urged healthcare providers and public health jurisdictions to encourage patients to enroll in the AIDS Clinical Trials Group STOMP trial to evaluate the efficacy of tecovirimat for monkeypox.

https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/101007

EU regulator backs wider use of AstraZeneca COVID drug

 Europe's medicines regulator has backed using AstraZeneca's preventative COVID-19 drug as a treatment for the disease and also endorsed its therapy against a major cause of pneumonia.

The regulator's recommendations are usually followed by the European Commission when it takes a final decision on drug approvals.

AstraZeneca said on Friday the European Medicines Agency (EMA) had backed Evusheld as a treatment for adults and adolescents with COVID who do not need supplemental oxygen and who are at increased risk of their disease worsening.

The antibody cocktail was previously only approved as a preventative treatment for people with compromised immune systems who see little or no benefit from vaccines.

The EMA also endorsed Beyfortus for the prevention of RSV lower respiratory tract disease in infants.

RSV is a leading cause of pneumonia in toddlers and the elderly, but the complex molecular structure of the virus and safety concerns have stymied efforts to develop a vaccine since the virus was first discovered in 1956.

AstraZeneca is developing Beyfortus, chemically called nirsevimab, along with Sanofi. Others in the race to get an RSV vaccine or therapy approved include Pfizer, J&J, Moderna and GSK.

In July, the company forecast prescriptions of the COVID therapy would help drive group sales growth of more than 20% this year. The long-acting antibody treatment, launched in December, generated $445 million of sales in the second quarter.

https://www.yahoo.com/video/2-eu-regulator-backs-wider-063125723.html

EU health regulator says COVID pandemic not over

 An official at the European Union's drugs regulator said on Tuesday the COVID-19 pandemic was not over, contradicting U.S. President Joe Biden, and that a planned vaccination campaign in the region during the cold season was key to fighting it.

"We in Europe still consider the pandemic as ongoing and it's important that member states prepare for rollout of the vaccines and especially the adaptive vaccines to prevent further spread of this disease in Europe," the European Medicines Agency's (EMA) Chief Medical Officer Steffen Thirstrup told a media briefing, referring to vaccines targeting specific strains of the virus.

He was asked to comment on Biden's remark in an interview broadcast on Sunday that "the pandemic is over".

"I cannot obviously answer why President Biden came to that conclusion," Thirstrup said.

The World Health Organization has said the pandemic remains a global emergency but the end could be in sight if countries use the tools at their disposal.

During the media briefing, EMA officials reaffirmed a call by the agency's Executive Director Emer Cooke made last week in a Reuters Next Newsmaker interview that people in Europe should take whatever COVID-19 booster is available and recommended to them in the coming months.

Apart from the original COVID vaccines, the EMA has in recent weeks endorsed a number of vaccines adapted to the Omicron variant of the virus for use as booster shots to ease the burden from a feared surge in infections during autumn and winter in Europe.

The EMA's head of vaccines strategy, Marco Cavaleri, said the agency was also looking into the use of the adapted shots as a primary course of vaccination and that there were discussions on the types of data that could support such an approval

https://www.yahoo.com/news/eu-health-regulator-says-covid-140955025.html