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Tuesday, October 25, 2022

Centene to add Express Scripts as PBM in 2024

 Centene has awarded its Pharmaceutical Benefit Management contract to Cigna's Express Scripts, the PBM said Oct. 25. 

Starting in 2024, Express Scripts will manage prescriptions for Centene's 20 million plan members. 

"Selecting our future PBM partner represents a major value creation plan milestone and positions us to capture significant value for our members, partners, and stakeholders in 2024 and beyond," Centene CEO Sarah London said in an Oct. 25 news release

https://www.beckerspayer.com/contracting/centene-to-add-express-scripts-as-pbm-in-2024.html

Novartis to uphold generic drug supply despite surging energy costs

 Novartis said its generic drugs division Sandoz would continue to provide medicines to all of its European markets because a surge in energy costs can be offset by efficiency measures.

“We feel confident we can maintain supply of our generics to European markets and markets around the world and we believe we have built adequate contingency plans for energy to ensure our plants are adequately supplied and similarly are able to offset inflation through productivity measures,” Chief Executive Vas Narasimhan told journalists in a call after the release of third-quarter results.

“I could imagine that more broadly in the generic sector this could be very challenging,” he added.

The generic drugmakers’ association in Europe last month warned that production of some medicines may have to be stopped because health systems are not raising reimbursement prices even as energy costs surge. 

https://www.pharmalive.com/novartis-to-uphold-generic-drug-supply-despite-surging-energy-costs/

Bristol Myers Q3 Sales Fall on Revlimid, Forex Pressure

 Drugmaker Bristol Myers Squibb said on Tuesday its third-quarter sales fell from last year as generic competition ate into sales of its blockbuster cancer drug Revlimid in the United States, as well as the effect of the weak euro and pound.

Sales and earnings in the quarter were still better than expected as sales of Revlimid did not drop as much as some analysts had predicted and the company maintained its full year forecasts.

Bristol Myers reported third-quarter revenue of $11.22 billion, down from $11.62 billion a year ago. Analysts had expected $11.1 billion, according to Refinitiv data. Excluding the impact of foreign exchange, the company said its revenue in the quarter would have been flat.

Sales of Revlimid, which began facing generic competition in the United States earlier this year, fell 28% to $2.4 billion in the quarter, above analyst estimates of around $2.2 billion.

The company still expects full year sales of the drug in the range of $9 to $9.5 billion, "probably at the upper end of that range," Chief Financial Officer David Elkins said in an interview.

Elkins said Bristol has also been able to manage inflationary pressure so far despite higher raw material, energy and shipping costs.

"The question all of us have as far as inflation is concerned is the rate at which it will continue and how persistent it will be over time. But to date we've been able to manage the inflationary increases on our business," he said.

Sales of blood thinner Eliquis, which Bristol shares with Pfizer, rose 10% to $2.65 billion and its cancer immunotherapy Opdivo rose 7 percent to $2.05 billion. Sales from its recently launched drugs rose to $553 million from $344 million last year.

The company said profit in the quarter fell to $4.26 billion, or $1.99 a share, excluding certain items. That compares with $4.34 billion, or $1.93 per share, a year earlier. Analysts had projected earnings per share of $1.83.

https://money.usnews.com/investing/news/articles/2022-10-25/bristol-myers-q3-sales-fall-on-revlimid-forex-pressure

Johnson & Johnson's blood cancer therapy gets U.S. FDA approval

 The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's JNJ.N therapy for treating a type of multiple myeloma, giving another treatment option to patients with the incurable blood cancer, the regulator said on Tuesday.

https://www.nasdaq.com/articles/johnson-johnsons-blood-cancer-therapy-gets-u.s.-fda-approval

Persistent Hypertension Common, Predictable a Year After Preeclampsia

 The study covered in this summary was published on medRxiv.org as a preprint and has not yet been peer reviewed.

Key Takeaway

  • Significant predictors of persistent hypertension (HTN) 1 year after pregnancy were identified in a cohort of women with gestational HTN or preeclampsia.

  • They included blood pressure (BP) in the mild-HTN range prior to discharge, elevated BP (≥130/80 mm Hg) 6 weeks postpartum, and higher body-mass index (BMI) 1-year postpartum.

Why This Matters

  • Identification of risk factors for persistent HTN a year after hypertensive disorders of pregnancy (HDP) may aid in mitigating risk for long-term HDP sequalae, which can include cardiovascular events.

Study Design

  • The retrospective, case-control study included women diagnosed with HDP during pregnancy, intrapartum, or postpartum between January 2014 and December 2019 at a single academic medical center in the Midwest.

  • The study included adult women who received prenatal care at a hospital or clinic and received a diagnosis of HDP during pregnancy, intrapartum, or during their postpartum hospitalization.

  • Cases were defined as women with HTN of stage 1 or higher 1 year after pregnancy. Controls were defined as women with normal BP, that is systolic <130 mm Hg and diastolic <80 mm Hg, 1 year after pregnancy.

  • Participants were excluded if they had chronic pregestational HTN, did not have 1-year follow-up, or were pregnant at 1-year postpartum.

Key Results

  • A total of 1445 women, representing 11.6% of deliveries at the institution during the study period, were identified with HDP or chronic HTN during pregnancy. After excluding those with chronic HTN or without a 1-year follow-up and those who had become pregnant by 1 year postpartum, 595 women were eligible for analysis.

  • Of the 595 participants, 268 (45%) had showed persistently elevated BP at 1-year postpartum.

  • Those 268 women with persistently elevated HTN were significantly older; had higher BMI at first prenatal visit, delivery, and 1-year postpartum; and were less likely to be nulliparous.

  • Participants with persistent HTN were more likely to be discharged with mildly elevated BP during their delivery hospitalization and the first 2-4 days postpartum, and have higher BP at 6 weeks postpartum.

  • In a bivariate analysis, persistent HTN 1-year postpartum was significantly associated with older age; higher BMI early in pregnancy, at delivery, and at 1-year postpartum; and mildly elevated BP prior to discharge and at 6 weeks postpartum (P < .001 for all associations).

  • In the adjusted analysis, persistent HTN 1-year postpartum was significantly associated with taking antihypertensive meds at 1-year postpartum, higher BMI, mild HTN at discharge, and HTN at 6 weeks postpartum.

Limitations

  • The study had a limited population of Hispanic persons.

  • Women who were lost to follow-up or who became pregnant by 1-year postpartum were not included.

  • The study has all the inherent limitations of its retrospective design and cannot address causality.

Disclosures

  • No financial disclosures or potential conflicts were reported. The study did not receive funding.

This is a summary of a preprint research study, "Factors associated with persistent hypertension one year postpartum in persons with gestational hypertension or preeclampsia," written by M. Christine Livergood from the Medical College of Wisconsin, Milwaukee, and colleagues on medRxiv.org, provided to you by Medscape. This study has not yet been peer reviewed. The full text of the study can be found medRxiv.org.

https://www.medscape.com/viewarticle/982985

Hospitals Said They Lost Money on Medicare Patients

 Atrium Health, the largest hospital system in North Carolina, has declared publicly that in 2019 it provided $640 million in services to Medicare patients that were never paid for, by far the largest “community benefit” it provided that year.

Like other nonprofit hospitals around the nation, Atrium logs losses on the federal health insurance program for seniors and people with disabilities as a community benefit to satisfy legal requirements for federal, state, and local tax breaks.

But for the same year that Atrium’s website says it recorded the $640 million loss on Medicare, the hospital system claimed $82 million in profits from Medicare and an additional $37.2 million in profits from Medicare Advantage in a federally required financial document, according to a report released Oct. 25 by the North Carolina state treasurer’s office.

The lack of clarity about whether health systems like Atrium gain or lose money treating Medicare recipients reflects how loosely the federal government regulates the way hospitals calculate their community benefits.

As a result, the analysis of North Carolina hospitals’ financial data concluded, what taxpayers get from local nonprofit hospitals in return for tax exemptions worth billions of dollars a year is unclear.

“There is no transparency, no accountability, and no oversight,” said North Carolina State Treasurer Dale Folwell, a Republican who is critical of Atrium and other hospitals’ business practices. “With the hospital cartel, it is always profits over people.”

Atrium did not make officials available for an interview. In a statement, spokesperson Dan Fogleman said the hospital system reported $85 million in services to Medicare patients that weren’t paid for in its most recent cost report to the Centers for Medicare & Medicaid Services.

“And, as labor, equipment, supplies and inflation continue to drive health care costs higher, the gap between Medicare payments and costs incurred to deliver the quality care we provide has grown in the post-Covid inflationary environment,” Fogleman said.

More than half of the hospitals in the United States are nonprofits or government-run. The federal government requires them to operate emergency rooms open to all patients regardless of their ability to pay, accept patients insured by Medicare, and use surplus funds to improve facilities and patient care to demonstrate they are giving back to the community.

Even though their tax-exempt status is based on charitable acts, nonprofit hospital systems sat on more than $283 billion in assets from stocks, hedge funds, venture capital, and private equity and other investments in 2019, according to a 2021 KHN analysis of IRS filings.

The hospital systems used most of that to produce income and classified only $19 billion, or about 7% of their total investments, as principally devoted to their nonprofit missions, the analysis found.

The new North Carolina report describes how hospitals’ self-reported Medicare profit margins differed from the financial picture they provided to the public through IRS records, annual reports, and community benefit documents.

Although most hospitals have complained of significant Medicare losses, the analysis of data from more than 100 North Carolina hospitals found that most made profits on Medicare from 2015 to 2020.

IRS audits are supposed to protect the public from fraud and abuse, but the system has major gaps, said health economists and federal watchdog groups.

Federal law requires the IRS to review community benefit activities at least once every three years. Yet the agency did not “have a well-documented process to ensure that those activities are being reviewed,” said a 2020 report from the Government Accountability Office.

In response to GAO recommendations, IRS leaders updated the system last year to help ensure the agency could identify cases in which hospitals were suspected of not meeting requirements.

The IRS referred nearly 1,000 hospitals nationwide to its audit division for violations of the Affordable Care Act from 2015 to 2019, but the IRS could not identify if they were related to community benefits, the GAO said.

The tax agency has no authority to determine what activities hospitals must perform to comply with the law, the GAO said. An analysis of IRS data found 30 hospitals that reported no spending on community benefits in 2016, “indicating potential noncompliance,” the report said.

“Perhaps this is the result of the IRS being underfunded,” said Vivian Ho, a health economics professor at Rice University in Houston, who worked on the North Carolina report. “They don’t have the resources to reconsider what information they should seek.”

It is critical that the government collects accurate information from hospitals because the data affects all patients, Ho said.

Federal law forbids IRS employees from discussing tax information submitted to the agency by people or organizations, IRS spokesperson Anthony Burke said in response to questions about how effectively the government monitors hospitals.

Hospitals have long used what they report as losses on Medicare to justify charging patients with private insurance higher prices. According to a study released in 2021 by the Rand Corp., a nonprofit research organization, hospitals across the nation charge private insurers more than what they receive from Medicare for the same services.

In the Affordable Care Act, federal lawmakers mandated that to maintain their tax-exempt status, nonprofit hospitals must conduct a community health needs assessment, maintain a written financial assistance policy, set billing and collections limits, and set a limit on charges.

In written responses to KHN, the North Carolina Healthcare Association, which lobbies on behalf of hospitals, said hospitals provided $1.2 billion in charity care in 2020. It added that those community benefits can include a lot of different activities, such as covering the gap between how much a procedure costs and what a provider is reimbursed, volunteering by staff, and paying for medical outreach programs.

“Providing care to vulnerable populations is part of their nonprofit mission,” the statement said.

Atrium spends millions of dollars per year to provide care to people who need behavioral health care “but have no safety net — even from the state,” the association said.

Fogleman, the Atrium spokesperson, said an advisory commission has consistently told Congress that Medicare payments do not cover the full costs of services at most hospitals, including Atrium’s.

In North Carolina, large hospital systems received $1.8 billion in tax breaks in 2020, according to the state treasurer’s office.

The same year, lobbyists for North Carolina hospitals reported collectively losing $3.1 billion on Medicare, according to the office’s report. Other data shows they made $87 million in profit.

From 2015 to 2020, the report concludes, 35 hospitals posted profits from Medicare each year.

Other hospitals listed in the report did not respond to requests for comment.

The American Hospital Association contends that the federal government reimburses providers significantly less than it costs to care for Medicare recipients. Unlike private insurers, the federal government does not negotiate prices with hospitals. Medicare bases the amount it pays on hospitals’ locations, labor costs, and other factors.

Melinda Hatton, the association’s general counsel, said in a statement that “underpayments” totaled more than $75 billion in 2020. “These data show that few, if any, hospitals break even much less make a profit on the basis of Medicare payments,” she said.

But Glenn Melnick, a health economics and finance professor at the University of Southern California who reviewed the North Carolina data, said no one is certain how nonprofit hospitals are calculating their numbers.

“The nonprofit hospital systems are getting so big, we need greater transparency,” Melnick said. “Health care is amazingly expensive, and it will bankrupt us if we don’t get it under control.”

Nonprofit hospitals receive significantly more in tax breaks than they spend on community investment or charity care, according to a report released this year by the Lown Institute, a think tank in Needham, Massachusetts.

Using 2019 data from the IRS, researchers found that out of 275 hospital systems across the country, 227 spent less on community investments or charity care than they got in tax breaks. The deficit totaled more than $18 billion, the report said.

Leah Kane is a senior attorney for consumer protection at the Charlotte Center for Legal Advocacy, a nonprofit that provides civil legal assistance to people who cannot afford an attorney. She said her agency receives calls from people who were not offered charity care from hospitals.

She said her group is worried that hospitals are offering charity care to uninsured patients but not to other people, like the underinsured, who don’t have the income to pay thousands of dollars for treatment not covered by their insurance plans.

“People are angry and stressed out,” Kane said. “They don’t know what this [debt] will mean for their lives.”

https://khn.org/news/article/north-carolina-hospitals-medicare-report/

Covid-19 vaccine study links side effects with greater antibody response

 People who reported experiencing side effects to the Pfizer/BioNTech and Moderna Covid-19 vaccines such as fever, chills or muscle pain tended to have a greater antibody response following vaccination, according to new research.

Having such symptoms after vaccination is associated with greater antibody responses compared with having only pain or rash at the injection site or no symptoms at all, suggests the paper published Friday in the journal JAMA Network Open.

“In conclusion, these findings support reframing postvaccination symptoms as signals of vaccine effectiveness and reinforce guidelines for vaccine boosters in older adults,” the researchers – from Columbia University in New York, University of Vermont and Boston University – wrote in their paper.

But even though some people may have small, localized side effects or no symptoms at all, the vaccine still elicits robust immune responses in them too. Nearly all study participants exhibited a positive antibody response after completing a two-dose Pfizer/BioNTech or Moderna vaccine series.

“I don’t want a patient to tell me that, ‘Golly, I didn’t get any reaction, my arm wasn’t sore, I didn’t have fever. The vaccine didn’t work.’ I don’t want that conclusion to be out there,” said Dr. William Schaffner, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center and medical director of the National Foundation for Infectious Diseases, who was not involved in the new study.

“This is more to reassure people who have had a reaction that that’s their immune system responding, actually in a rather good way, to the vaccine, even though it has caused them some discomfort,” Schaffner said.

The researchers analyzed data on 928 adults who self-reported what symptoms they experienced after receiving Pfizer/BioNTech or Moderna Covid-19 vaccinations, as well as submitted a dried blood spot to test for antibodies. Most of the participants were White adults, with a mean age of 65.

The researchers found that after either vaccine dose, 446 or 48% of participants reported systemic symptoms while 12% reported only local symptoms and 40% reported no symptoms at all.

Meanwhile, antibody reactivity was observed in 444 or 99% of participants with systemic symptoms, 99% of those with only local symptoms and 98% of those with no symptoms.

“A lot of people have speculated over the years whether people who had more of a reaction to the vaccine might actually have that represent a more vigorous immune response,” Schaffner said. “And these data would appear to support that.”

https://www.cnn.com/2022/10/24/health/covid-antibody-response-vaccines/index.html