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Updated: 1 hour 14 min ago

STAT+: Cigna to pay $172 million in Medicare Advantage fraud settlement

6 hours 15 min ago

Health insurer Cigna is paying more than $172 million to settle allegations that it committed fraud by knowingly submitting inaccurate diagnoses of its Medicare Advantage members, the company and Department of Justice announced Saturday.

The settlement stems from a wide-ranging government investigation into the coding practices of Medicare Advantage insurers, as well as a specific whistleblower lawsuit against Cigna that the DOJ joined last year.

That lawsuit alleged Cigna’s home visit program “regularly generated false and invalid diagnosis codes for certain serious, complex conditions that cannot be reliably diagnosed in a home setting and without extensive diagnostic testing or imaging,” the DOJ said.

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STAT+: J&J agrees not to enforce patents on a key tuberculosis drug in dozens of poor countries

Sat, 09/30/2023 - 11:27

In an unexpected turnabout, Johnson & Johnson announced it would not enforce any of its patents for a key tuberculosis medicine in 134 low- and middle-income countries, the second time in recent weeks that a manufacturer has agreed to widen access to products needed to combat the infectious disease.

The move comes after the health care giant has recently faced accelerating demands to alter its pricing and patenting policies for the drug, which is called bedaquiline and is considered the backbone in treatment used to combat multi-drug resistant tuberculosis. Advocacy groups have argued J&J was preventing access in countries with the highest rates of the infectious disease.

A sustained campaign targeting J&J was building for years, but took a new turn this past summer when novelist and social media influencer John Green posted a video on YouTube that criticized the company for placing untold numbers of patients in jeopardy. The effort, which was coordinated with different groups, including Partners in Health and Doctors Without Borders, placed J&J on the defensive.

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GLP-1 drugs are transforming diabetes, obesity and more. Could a Nobel be next?

Sat, 09/30/2023 - 01:30

Next week, 50 medical experts from the Karolinska Institutet in Stockholm will meet to award the 2023 Nobel Prize for Physiology or Medicine. The vote takes place on Oct. 2, but betting-minded scientists are already beginning to make their picks for who might take home the gold.

Seasoned Nobel prognosticators will point out that the medicine prize often cycles between super-basic molecular biology and inventions that actually cure people. Last year’s award for paleogenomics falls more toward the former, suggesting an advance with a more clinical focus could well be in the Nobel Assembly’s sights this year. There are many compelling candidates, including the mRNA technology that helped halt the Covid-19 pandemic. But the explosive impact of metabolism-correcting, weight-moderating drugs like Ozempic, Wegovy, and Mounjaro also has some prize forecasters wondering if perhaps the discoveries that have led up to these treatments might find their way to the Nobel spotlight.

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Dianne Feinstein’s struggle with shingles reflects the long increase in cases

Fri, 09/29/2023 - 15:23

The trailblazing life of Senator Dianne Feinstein of California, who died on Friday, covers nearly a century of American history, including changes in health care and medicine. Her struggle with shingles, which sent her to the hospital in February and contributed to the deterioration of her health — leading to encephalitis and facial paralysis — also reflects the great shifts regarding that disease.

Shingles occurs as a reactivation of the chickenpox virus (varicella-zoster virus, or VZV), one that had yet to be isolated when Feinstein was born (it was in 1953), and caused 3 million cases a year until the 1990s.

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STAT+: Court allows Medicare drug price negotiation to proceed

Fri, 09/29/2023 - 15:07

WASHINGTON — A federal court judge allowed a new Medicare drug price negotiation program to proceed while the court deliberates whether it is constitutional.

The case centers on Democrats’ new law, which empowered the Medicare program to start negotiating lower prices for certain medicines that are especially expensive for the government. Judge Michael Newman, a Trump appointee to the U.S. District Court for the Southern District of Ohio, ruled against the U.S. Chamber of Commerce, which had sued the federal government and asked for the program to be stopped while litigation continues.

Medicare officials announced the first 10 drugs they would negotiate over last month, and the deadline for the pharmaceutical companies to sign agreements to start bargaining is Oct. 1. The Chamber of Commerce had requested a decision on the preliminary injunction by that date.

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STAT+: FDA seeks to regulate lab-developed tests, closing the ‘Theranos loophole’

Fri, 09/29/2023 - 12:32

The Food and Drug Administration on Friday announced its intention to start regulating tests developed in laboratories — closing the “Theranos loophole” that has allowed inaccurate tests to slip through the cracks.

Lawmakers came close last year to passing a bill that would have given the FDA this authority, but it was ultimately rejected by Republicans who sympathized with the labs in academic medical centers and hospitals who opposed the provision. FDA Commissioner Robert Califf said at the time that if the bill failed, the agency would take matters into its own hands.

The proposed rule fulfills that promise, adding lab diagnostics to the list of devices that fall under FDA enforcement — a move that patient groups and non-lab test makers support, and that laboratories are likely to dispute. When the FDA started regulating medical devices in 1976, lab-developed tests were simple and offered mostly to local patient populations. The agency generally allowed labs to use these tests without submitting proof of their efficacy.

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STAT+: Unitaid slams J&J over pricing and patents for a tuberculosis drug

Fri, 09/29/2023 - 11:46

In a highly unusual move, Unitaid has publicly criticized Johnson & Johnson over its pricing and patenting policies for a key drug used to combat tuberculosis.

The global health organization released a letter urging the company to drop so-called secondary patents for its medicine, known as bedaquiline, and to make negotiated prices for the drug available to all countries, regardless of existing arrangements for making purchases.

The missive was sent one month after J&J reached an agreement with the Stop TB Partnership, which was created by the United Nations, to allow generic companies to make cheaper versions in dozens of low- and middle-income countries. The move lowered the cost of the pill to $130 for a six-month course of treatment, a 55% drop from the previous price of $289.

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STAT+: Generic makers fall short when providing access to low- and middle-income countries, analysis finds

Fri, 09/29/2023 - 09:31

A handful of the largest purveyors of generic medicines have made only halting progress to ensure their drugs are accessible for patients in low- and middle-income countries, a new analysis found.

For instance, just one of 50 different treatments marketed by these companies — Teva Pharmaceuticals, Sun Pharmaceutical, Cipla, Hikma Pharmaceuticals, and Viatris — had a pricing strategy in place that considered a patient’s ability to pay.

And while the analysis found there are plans to expand access to 41 of those drugs, the strategies are “very limited in scope” and, in particular, “do not address affordability considerations for the poorest patients, including those who are uninsured and must pay out-of-pocket for medicine,” according to the nonprofit Access to Medicine Foundation, which issued the report.

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STAT+: Sales from controversial drug discount program rose to $54 billion last year

Fri, 09/29/2023 - 08:43

Prescription medicines purchased in the U.S. under a controversial government discount program amounted to $53.7 billion in 2022, an 18% increase from the previous year, according to the U.S. Health Resources & Service Administration, which oversees the program.

The latest data mark a steady rise in sales under the 340B Drug Discount Program, which requires drugmakers to offer discounts that are typically estimated to be 25% to 50% — but could be higher — of all outpatient drugs used by hospitals and clinics that primarily serve lower-income patients. There are roughly 12,400 entities participating in the program, a number that has grown substantially.

Since it began 30 years ago, the program has ballooned and fed into the national clash over the cost of medicines. Some $44 billion in medicines were purchased under the 340B program in 2021, which was up from $38 billion the previous year. In 2016, 340B sales were $16.2 billion.

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STAT+: Up and down the ladder: The latest comings and goings

Fri, 09/29/2023 - 07:21

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Faeth Therapeutics hired Debbie Chirnomas as chief medical officer. Previously, she worked at Arvinas, where she was vice president, oncology clinical development.

But all work and no play can make for a dull chief medical officer.

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WHO recommends dropping component of many flu vaccines

Fri, 09/29/2023 - 06:18

The World Health Organization has recommended dropping a component of many flu vaccines because the viruses it protects against appear to have been driven into extinction in the Covid-19 pandemic.

A family of viruses known as influenza B/Yamagata has not been seen since March 2020, when flu circulation worldwide declined to very low levels in the face of the onslaught of Covid and the protections people took to avoid contracting it. Flu transmission eventually resumed, but of the tens of thousands of influenza B viruses detected and subtyped in the years since, B/Yamagata viruses have not been seen.

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STAT+: Pharmalittle: Deadline looms for drugmakers to negotiate with Medicare; GOP senator probes 340B program at two hospitals

Fri, 09/29/2023 - 05:51

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is exceedingly modest. Weather permitting, we expect to promenade with the official mascots, take a nap or three and, perhaps, hold another listening party with Mrs. Pharmalot. The rotation will likely include this, this, this, and this. And what about you? Now that autumn is here, this is a fine time to traipse through apple orchards and pumpkin patches. This may also be an opportunity to catch up on your reading. You could binge-watch by the telly. Or reach out to someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The deadline for drugmakers to sign agreements to negotiate with Medicare on pricing is fast approaching, The Hill reminds us. Major drugmakers have until Sunday to agree to participate in the program or potentially face heavy taxes and lose their ability to sell through Medicare. With courts yet to impose an injunction in a clutch of pending lawsuits, several companies appear ready to proceed, including Merck, AstraZeneca, Bristol-Myers Squibb, and Boehringer Ingelheim. Those that do not negotiate can withdraw their products from Medicare, losing a highly lucrative income source. The alternative is an excise tax on a selected product’s sales in the U.S., starting at 65%.

The top-ranking Republican on the U.S. Senate health committee is investigating two hospitals — Cleveland Clinic and Bon Secours — over their use of the 340B government program that provides big drug discounts in return for serving low-income communities, STAT reports. At issue is whether Congress intended 340B to directly benefit low-income and uninsured patients or whether it was meant to help finance the hospitals, which could use the money as they see fit to add services. Hospitals say they use the money to provide such services as free care for uninsured patients, but drugmakers argue that hospitals and chain pharmacies abuse the program and divert its cash flows to other uses.

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Women spend 20% more per year on out-of-pocket health costs, says report

Fri, 09/29/2023 - 01:30

Women of all ages pay a total of $15.4 billion more than men on annual out-of-pocket medical expenses, according to a new report from Deloitte. In 2021, that meant that women paid about 20% more than men — only 2% of which could be accounted for by maternity care.

The fact that the way benefits are currently designed “puts a disproportionate cost on women, above and beyond maternity, was the thing that really surprised us,” said Kulleni Gebreyes, a physician who runs Deloitte’s health care practice and also serves as the company’s U.S. chief health equity officer.

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STAT+: Taysha Gene Therapies’ plan to tackle rare diseases is crumbling

Fri, 09/29/2023 - 01:30

In 2020, as biotech stocks surged amid the pandemic, a startup called Taysha Gene Therapies raised over $300 million off an audacious promise: It was going to license and develop gene therapies for at least 18 different rare and serious neurological diseases.

The effort brought hope for many rare disease families, some of whom had raised money to fund the UT-Southwestern scientist who designed the treatments after they saw no other options for their children.

Last week, the grand plan took perhaps a final blow. Taysha announced it would discontinue development of a treatment for giant axonal neuropathy, or GAN, a fatal, degenerative disease known to affect fewer than 100 people worldwide. The FDA, Taysha said, had requested an additional clinical trial that would be infeasible.

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Opinion: AI-driven data analysis could exacerbate misaligned incentives in biomedical research

Fri, 09/29/2023 - 01:30

This summer OpenAI released Code Interpreter, a plug-in for the popular ChatGPT tool that allows it to take in datasets, write and run Python code, and “create charts, edit files, perform math, etc.“ It aims to be nothing short of the ideal statistical collaborator or research software engineer, providing the necessary skill and speed to overcome the limitations of one’s research program at a fraction of the price.

It is a bad omen, then, that while statisticians are known for pestering researchers with difficult but important questions like “What are we even trying to learn?”, Code Interpreter responds to even half-baked requests with a cheerful “Sure, I’d be happy to.” There are risks to working with a collaborator that has both extraordinary efficiency and an unmatched desire to please.

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STAT+: Brigham and Women’s exec opens up about the Dana-Farber Cancer Institute split, and what it means for the future of cancer care

Thu, 09/28/2023 - 14:32

The severing of ties between two of Boston’s biggest health care giants has placed one of the nation’s largest health care systems in the position of figuring out how, exactly, to fill a new hole in its oncology services, at a time when cancer care is changing rapidly.

Earlier this month, Dana-Farber Cancer Institute surprised the medical community and even its partner, Brigham and Women’s Hospital, when it announced that it would end their nearly 30-year collaboration. The split will take a few years to play out — Dana-Farber and Brigham and Women’s have a contract into 2028 — but has shaken patients and physicians.

Anne Klibanski, chief executive of Brigham and Women’s parent organization, Mass General Brigham, placed the blame on Dana-Farber executives. The two parties had been in discussions about extending their contract for months when the split was announced. “The decision was made by the Farber. It was announced. Now, we just have to plan forward,” she said. Klibanski shared her views on the split at a meeting with Boston Globe opinion editors on Thursday.

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STAT+: GOP senator probes drug discount programs at Cleveland Clinic, Bon Secours

Thu, 09/28/2023 - 13:56

WASHINGTON — The top-ranking Republican on the Senate health committee is launching an investigation into two hospitals’ use of a government program that provides big drug discounts in return for serving low-income communities.

At the foundation of the debate over the so-called 340B program is whether Congress intended it to directly benefit low-income and uninsured patients or whether it was meant to help finance those hospitals, which could use the money as they see fit to add services.

Hospitals say they use the money to provide such services as free care for uninsured patients, free vaccinations, mental health clinics, and community health programs. But drugmakers have long argued that hospitals and chain pharmacies abuse the program and divert its cash flows to other uses. They also say the 340B program fuels the consolidation of health care systems as hospitals buy up private doctor practices to expand the 340B revenue stream.

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Listen: Who discovered GLP-1? Plus: BrainStorm at the FDA and biotech’s slump

Thu, 09/28/2023 - 12:52

When is negative data positive enough? Who gets credit for scientific breakthroughs? And wasn’t biotech supposed to bounce back?

We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Elaine Chen joins us to explain the story of Svetlana Mojsov, a chemist who played a vital role in the discovery of GLP-1 who has spent decades fighting for proper recognition. We also discuss the latest news in the life sciences, including the FDA hearing on a BrainStorm Cell Therapeutics’ polarizing ALS treatment, the end of the road for a once-vaunted drug developer, and the sorry state of biotech stocks.

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Exodus of life scientists from academia reaches historic levels, new data show

Thu, 09/28/2023 - 12:49

New data released Thursday by the National Science Foundation show the exodus of young life scientists from the Ivory Tower to industry has reached the highest level in nearly three decades, deepening concerns about the future of academic science in the U.S.

Among newly minted life science Ph.D.s in 2022 who had firm next steps, roughly 53% planned to pursue postdoctoral research, a temporary period of additional training that is virtually a requirement for those hoping to land a faculty job. That’s a sizable step down from the nearly 58% of graduates who went on to do a postdoc in 2021. Ph.D. graduates are now pursuing postdocs at the lowest rate since at least 1995, based on STAT’s review of NSF data available online.

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STAT+: Drug industry payments to eye docs boosted Medicare spending on pricier treatments

Thu, 09/28/2023 - 07:15

Ophthalmologists who accepted payments from drug companies were less likely to prescribe a cheaper medicine to treat an eye disease that causes blindness in older people, rather than a pair of more expensive alternatives, according to a new study. This led Medicare to spend an additional $643 million during a recent six-year period.

Specifically, 28% of the physicians who received money were believed unlikely to prescribe Avastin, an older cancer medicine that is often used to combat age-related macular degeneration. By comparison, 46% of the physicians who did not accept industry payments were more likely to prescribe the medicine, instead of two costlier treatments that have been approved specifically to treat the eye disease.

As a result, Medicare shelled out an estimated $642.8 million from 2013 to 2019, presumably due to the company payments, according to the study, which was published in JAMA Health Forum. The researchers examined Medicare Part B data that encompassed nearly 21,600 ophthalmologists who accepted money from Roche and Regeneron Pharmaceuticals, which sell the pricier eye treatments.

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