About Covid-19
Say goodbye to the COVID-19 vaccination card. The CDC has stopped printing them “Now that COVID-19 vaccines are not being distributed by the federal government, the U.S. Centers for Disease Control and Prevention has stopped printing new cards.
The federal government shipped more than 980 million cards between late 2020, when the first vaccines came out, through May 10, according to the latest available data from the CDC.”
FDA authorises Novavax's updated COVID vaccine “Novavax announced Tuesday that the FDA granted an emergency-use authorisation (EUA) for an updated formula of its adjuvanted COVID-19 vaccine targeting the Omicron subvariant XBB.1.5 in people ages 12 and over. According to the company, it expects a recommendation from the US Centers for Disease Control and Prevention ‘imminently,’ adding that doses of the shot, dubbed NVX-CoV2601, will likely be available within the next few days.”
Moderna reports trial success for dual Covid and flu vaccine “Moderna’s combined Covid-19 and influenza vaccine was as effective as separate shots in an early stage trial, giving the US biotech company hope that the more convenient way of protecting against the diseases could be approved by 2025.”
Nirmatrelvir-Ritonavir [Paxlovid] and COVID-19 Mortality and Hospitalization Among Patients With Vulnerability to COVID-19 Complications “In this cohort study of 6866 individuals with COVID-19, treatment with nirmatrelvir and ritonavir was associated with lower risk of death or hospitalization in the most clinically extremely vulnerable individuals but not in less vulnerable individuals.”
About healthcare quality and safety
Most common sentinel events in first half of 2023: Joint Commission “The six most frequently reported sentinel events for the first half of 2023:
Falls — 47 percent
Unintended retention of foreign object — 9 percent
Assault, rape, sexual assault or homicide — 8 percent
Wrong-site surgery, such as wrong procedure, patient or implant — 8 percent
Suicide — 5 percent
Delay in treatment — 5 percent
Most sentinel events, or 88 percent, happened in a hospital in the first six months of 2023. Eighteen percent were associated with a patient's death, 63 percent with severe temporary harm and 7 percent with permanent harm.”
About health insurance/insurers
Federal Budgetary Effects of the Activities of the Center for Medicare & Medicaid Innovation From the CBO: “CBO currently estimates that CMMI’s activities increased direct spending by $5.4 billion, or 0.1 percent of net spending on Medicare, between 2011 and 2020… Specifically, CMMI spent $7.9 billion to operate models, and those models reduced spending on health care benefits by $2.6 billion…
Looking ahead, CBO currently projects that CMMI’s activities will increase net federal spending by $1.3 bil-lion, or 0.01 percent of net spending on Medicare, over the center’s second decade, which extends from 2021 to 2030.”
The report also explains performance of some specific programs, such as ACOs.
Comment: If the purpose of CMMIs experiments was to find models that reduced healthcare costs, one can accept the losses as an investment. However, narrowing of programs to include “successes” or modifications of existing programs do not seem to be part of the “grand plan.” Some programs have been extended, but the savings are very small compared to overall Medicare spending.
Court strikes down Trump-era rule that allowed insurers to not count copay assistance “Patient advocacy groups are declaring victory after a federal judge struck down a Trump-era policy that allowed health insurers not to count drug manufacturer copay assistance toward a beneficiary’s out-of-pocket costs.
That policy allowed health plans to increase out-of-pocket prescription drug costs for consumers, advocacy groups claimed.
The case—brought forward by three patients, the HIV+Hepatitis Policy Institute, the Diabetes Leadership Council and the Diabetes Patient Advocacy Coalition against the Department of Health and Human Services—will now only permit insurers to use copay accumulators for branded drugs that have a generic equivalent, if allowed by state law. Copay accumulators are features within insurance plans where manufacturers' payments do not count toward a patient’s deductible or out-of-pocket maximum, according to the American Society of Clinical Oncology.”
Comment: The purpose of the policy was to prevent pharma companies from charging very high prices and then offering individuals rebates. The patients benefitted, but the insurance companies were stuck with large costs.We will need to wait and see if this decision results in higher premiums.
Feds Rein In Use of Predictive Software That Limits Care for Medicare Advantage Patients “The federal government will try to even the playing field next year, when the Centers for Medicare & Medicaid Services begins restricting how Medicare Advantage plans use predictive technology tools to make some coverage decisions.”
Federal judge denies request to block Medicare negotiation “A federal judge on Friday declined to block the Medicare Drug Price Negotiation program, meaning companies will have to play ball with the government for the time being.
U.S. District Judge Michael J. Newman ruled against a request for a preliminary injunction on the program that was requested by the Chamber of Commerce in its lawsuit to stop negotiations.”
Drugmakers sign on to negotiate Medicare prices under protest “All the drugmakers that make the 10 prescription medicines subject to the first-ever price negotiations for the U.S. Medicare health program, including Amgen and Novartis , said they signed on to participate in the talks by the Oct. 1 deadline.
The penalties for not doing so would have been steep: drugmakers would have to pay 65% to 95% taxes on their drug's Medicare sales or withdraw all of their products from the Medicare and Medicaid programs, which together provide health benefits to 158 million Americans.”
The next two articles remind me of the Jimmy Durante quotation:
“Everybody wants to get into the act!”
Meijer jumps into health insurance market with new Blue Cross partnership “Blue Cross Blue Shield of Michigan’s newest Medicare Advantage plan for senior citizens comes with an allowance that enrollees can spend at Meijer Inc. stores across the state.
Under the Medicare Plus Blue PPO + Meijer plan that begins enrollment this month, subscribers will get a $660 allowance to buy health-related items such as vitamins, bandages, medications and equipment. They can also use it to purchase healthy foods if they have a chronic medical condition.”
Instacart, Alignment to launch co-branded Medicare Advantage plan “Grocery delivery company Instacart is launching a co-branded Medicare Advantage plan next year with Alignment Healthcare in 13 counties across California and Nevada.
Pending regulatory approvals, 3.9 million Medicare-eligible individuals will have access to the new plans, which will feature $50 to $100 quarterly grocery allowances through Instacart, a complimentary Instacart+ membership with free delivery on qualifying orders, technical support for setting up an account and placing orders, and Alignment Health's new "virtual storefront" on Instacart where members can shop for recommended products.
Cigna to pay $172 million in Medicare Advantage fraud settlement “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.”
Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Aetna, Inc. (Contract H5521) Submitted to CMS “With respect to the seven high-risk groups covered by our audit, most of the selected diagnosis codes that Aetna submitted to CMS for use in CMS's risk adjustment program did not comply with Federal requirements. For 155 of the 210 sampled enrollee-years, the medical records that Aetna provided did not support the diagnosis codes and resulted in $632,070 in overpayments. On the basis of our sample results, we estimated that Aetna received at least $25.5 million in overpayments for 2015 and 2016. As demonstrated by the errors found in our sample, Aetna's policies and procedures to prevent, detect, and correct noncompliance with CMS's program requirements, as mandated by Federal regulations, could be improved.”
About hospitals and healthcare systems
National Hospital Flash Report “Key Takeaways
1. Hospital performance in August improved compared to July as margins continue to stabilize.
While margins are still below historical levels, there is less variance and an overall trend of positive margins in 2023.
2. Lengths of stay in 2023 continue to decline.
Patients continue to resume more normal patterns of accessing care.
3. Expenses increased but were offset by increased revenue.
Labor expenses also declined alongside less contract labor utilization, reflecting overall financial stability.
About pharma
AstraZeneca pays $425M to settle heartburn drug lawsuits “Biopharmaceutical company AstraZeneca has agreed to pay $425 million to settle product liability suits over two heartburn drugs, Prilosec and Nexium, according to an Oct. 3 news release…
Many of the claims alleged that the two drugs led to kidney injuries that over time could evolve into end-stage renal disease.”
Novartis completes Sandoz spin-off “Novartis on Wednesday completed the spin-off of its generics and biosimilars business Sandoz, finalising its transition to an innovative medicines business focused on four core therapeutic areas of cardiovascular, renal and metabolic (CRM), immunology, neuroscience and oncology.”
Court tosses $223.8 million verdict against J&J in talc cancer case “A New Jersey appeals court on Tuesday threw out a $223.8 million verdict against Johnson & Johnson that a jury had awarded to four plaintiffs who claimed they developed cancer from being exposed to asbestos in the company's talc powder products.
The Superior Court of New Jersey, Appellate Division found that a lower court judge should not have allowed some of the scientific expert testimony the plaintiffs presented to jurors at trial.”
Boehringer launches 81% discounted biosimilar of AbbVie's Humira “Germany's Boehringer Ingelheim on Monday launched an unbranded version of its biosimilar of AbbVie's Humira with a list price 81% cheaper than the blockbuster rheumatoid arthritis drug.
The company in July launched a branded biosimilar, Cyltezo, priced at a 5% discount to Humira's current list price of $6,922 per month. Boehringer's close-copies of Humira are the only ones that can be substituted for the original without consulting the prescriber after being designated as interchangeable by the U.S. Food and Drug Administration.” However: Save Billions or Stick With Humira? Drug Brokers Steer Americans to the Costly Choice “The biggest hitch seems to be the PBMs. Express Scripts and Optum Rx, two of the three giant PBMs, have put biosimilars on their formularies, but at the same price as Humira. That gives doctors and patients little incentive to switch. So Humira remains dominant for now.”
Discounted drug purchases under 340B grew 22% to $54B across 2022, HRSA reports “Discounted prescription drugs purchased wholesale under the 340B program grew 22.3% to $53.7 billion from 2021 to 2022, according to data published by the Health Resources and Services Administration (HRSA).”
15 biggest pharmacies by prescription revenue FYI
Regulatory tracker: Pfizer's Humira biosimilar wins interchangeability tag from FDA “Pfizer's Abrilada, the company's biosimilar version of AbbVie's Humira, has won an interchangeability designation from the FDA.
The tag means that the drug can be substituted at the pharmacy counter by a pharmacist. Abrilada is only the second Humira biosim to gain the designation, following Boehringer Ingelheim's Cytelzo.”
AbbVie continues winning streak as leading TV drug ad spender while budgets start to swell again A current list of top spenders FYI.
After short FTC fight, Amgen wraps up $27.8B Horizon buyout “Amgen has completed its $27.8 billion acquisition of Horizon Therapeutics after fending off a legal challenge by the U.S. antitrust watchdog.
The California-based drugmaker made the announcement Friday following a signoff from the High Court of Ireland the prior day.”
Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss “This study found that use of GLP-1 agonists for weight loss compared with use of bupropion-naltrexone was associated with increased risk of pancreatitis, gastroparesis, and bowel obstruction but not biliary disease.”
About the public’s health
What is the current state of health and healthcare in the US? Well worth reading (lots of graphs make it easy). The bottom line(s): Government spending on healthcare is at an all-time high (dollars and percent of spending), yet life expectancy has declined and the percent uninsured has not changed.
Artificial sweeteners: the health controversy that will not go away From the Financial Times: The crux of the problem is that artificial sweeteners alter glucose metabolism through their effects on the gut microbiome.
So having a diet drink with fries may be worse that having the fries alone.
AN EPIDEMIC OF CHRONIC ILLNESS IS KILLING US TOO SOON An excellent article from The Washington Post that is well-worth reading.
CDC to recommend some people take an antibiotic after sex to prevent sexually transmitted infections “Certain people should consider taking an antibiotic treatment after having unprotected sex to prevent sexually transmitted infections (STIs), the Centers for Disease Control and Prevention (CDC) will soon recommend.
The agency just released a draft of its recommendations for who should use the drug regimen, known as doxy-PEP, and how, and the agency will be accepting public feedback on that draft until Nov. 16. In its drafted guidelines, the CDC says that doxy-PEP should be given to those most heavily impacted by the recent surge in bacterial STIs in the U.S.: men who have sex with men (MSM), as well as transgender women.”
Discrimination exposure impacts unhealthy processing of food cues: crosstalk between the brain and gut “We show that discrimination is associated with increased food-cue reactivity in frontal-striatal regions involved in reward, motivation and executive control; altered glutamate-pathway metabolites involved in oxidative stress and inflammation as well as preference for unhealthy foods. Associations between discrimination-related brain and gut signatures were skewed towards unhealthy sweet foods after adjusting for age, diet, body mass index, race and socioeconomic status. Discrimination, as a stressor, may contribute to enhanced food-cue reactivity and brain–gut–microbiome disruptions that can promote unhealthy eating behaviors, leading to increased risk for obesity. Treatments that normalize these alterations may benefit individuals who experience discrimination-related stress.
Britain proposes ban on cigarettes for younger generations “Britain's government on Wednesday proposed banning younger generations from ever buying cigarettes, a move that would give the country some of the world's toughest smoking rules and hurt the sales of major tobacco firms.
If passed into law, the smoking age would rise by one year every year, potentially phasing out smoking among young people almost completely as soon as 2040, a briefing paper said.
‘A 14-year-old today will never legally be sold a cigarette,’ Prime Minister Rishi Sunak told the Conservative Party conference, where he announced the plan.”
Comment: New Zealand has already enacted such a program.
CDC finds 22 states had an adult obesity prevalence of 35% or higher in 2022 “According to CDC data, 22 states had an adult obesity prevalence of 35% or higher in 2022, up from 19 in 2021 and none in 2012.”
About healthcare IT
There's a generational gap in satisfaction with telehealth, J.D. Power finds “Telehealth continues to enjoy elevated popularity thanks to the COVID-19 pandemic, but significant generational gaps persist in satisfaction, according to a new analysis from J.D. Power.
The report found that patient satisfaction with telehealth lands at a 698 score on a 1,000-point scale. Millennials and Generation Zers reported the highest satisfaction scores, while baby boomers and members of the Silent Generation had the lowest satisfaction.
Overall trust is a concern to watch, according to the report, as that produced the lowest scores. However, telehealth received higher marks for satisfaction with the clinicians patients interact with and for patients feeling their needs are met during a visit.”
About healthcare personnel
More than 75,000 Kaiser Permanente workers begin multistate strike “More than 75,000 Kaiser Permanente workers walked off the job Wednesday in what is set to be the largest health-care strike in U.S. history, seizing on momentum in the labor movement across multiple industries.
Workers in California, Oregon, Colorado and Washington state launched the three-day strike, with direct implications for thousands of patients. A smaller number — about 400 pharmacists and optometrists — in Virginia and D.C. plan to stop work for one day.”
Overworked and Understaffed, More Than 1 in 4 US Nurses Say They Plan to Leave the Profession A really good discussion of the problem.
About health technology
Nobel Prize in medicine awarded to scientists who laid foundation for messenger RNA vaccines “The Nobel Prize in medicine was awarded Monday to two scientists whose research laid the groundwork for messenger RNA vaccines that transformed the threat of the coronavirus pandemic.
Early in her career, Katalin Kariko, 68, a Hungarian-born scientist, saw mRNA’s medical potential and pursued it with ferocious and single-minded tenacity that exiled her to the outskirts of science. After a chance meeting over the photocopier at the University of Pennsylvania 25 years ago, she worked closely with Drew Weissman, 64, an immunologist who saw the potential for the technology to create a new kind of vaccine.”
FDA moves to tighten oversight of laboratory-developed tests to make them safer and more accurate “The US Food and Drug Administration is proposing to step up its oversight of a growing category of medical tests called laboratory-developed tests.
The FDA approves and clears many types of lab tests for blood, saliva or tissue if they are used by many different hospitals or labs. But for almost 50 years, the agency has given individual labs leeway to develop and use their own tests in-house, as long as the labs met certain standards.”
About healthcare finance
Healthcare Dealmakers A great summary of recent deals.
Lilly to surf radiopharmaceutical wave with $1.4B acquisition of Point Biopharma “Eli Lilly is snapping up Point Biopharma Global for $1.4 billion, marking an official entrance into the radiopharmaceutical cancer therapeutic space.
Lilly will acquire all of Point’s outstanding shares at $12.50 apiece for a total of $1.4 billion. The transaction has already received the stamp of approval from the boards of both companies and is expected to close near the end of this year, subject to customary closing conditions.
The price is an 87% premium to Point's closing stock value on Oct. 2—$6.68 per share—and a 68% premium to the 30-day volume-weighted average price.”