About Covid-19
Fauci says data from NIH’s mix-and-match Covid vaccine booster trials will soon be ready:
“The National Institutes of Health is on the verge of concluding trials that mix initial vaccine doses from one manufacturer with booster shots from another manufacturer, Dr. Anthony Fauci said.
Data on J&J’s mix-and-match study could be ready within a week, while Pfizer’s trial might be completed by mid-October, he said. Moderna’s mix-and-match study data is already available.”
U.S. Judge upholds COVID-19 vaccine requirement for those with 'natural immunity': “A U.S. judge upheld the University of California’s COVID-19 vaccine requirement against a challenge by a professor who alleged he had immunity due to a prior coronavirus infection, in what appears to be the first ruling on the issue.
U.S. District Court Judge James Selna in Santa Ana, California, said the university system acted rationally to protect public health by mandating the vaccine and not exempting individuals with some level of immunity from an infection.”
Louisiana health system issues $200 monthly premium to employees with unvaccinated partners: “Louisiana-based Ochsner Health is charging employees up to $100 per bi-weekly pay period if their partners are unvaccinated.
The provider said the move is to manage the costs of COVID-19 for employees who become ill…
The surcharge goes into effect in 2022 and affects only spouses or domestic partners who are both covered by the employee's health insurance and qualify for vaccination. Ochsner previously mandated vaccinations for all employees.”
About pharma
Merck to buy Acceleron for about $11.5 bln in rare disease drug push: “The deal gives Merck access to Acceleron's rare disease drug candidate, sotatercept, which the company expects could bring in billions of dollars in sales, and comes as Keytruda moves toward the loss of market exclusivity in 2028.
The lung cancer treatment accounted for 36.7%, or $4.18 billion, of Merck's total sales in the second quarter.”
For 20 Top-Selling Drugs Worldwide, Big Pharma Revenue from U.S. Sales Combined Exceeded Revenue from the Rest of the World: “Key Findings:
U.S. sales of the 20 top-selling drugs worldwide totaled $101.1 billion while sales to the rest of the world totaled nearly $57 billion. In other words, the U.S. spent almost double what the rest of the world combined did on these top 20 drugs.
For 17 of the 20 top-selling drugs worldwide in 2020, pharmaceutical corporations made more money from U.S. sales than from sales to all other countries in the rest of the world combined.
For 11 of the 20 top-selling drugs worldwide, U.S. sales revenue was double revenue to the sales of the rest of the world or more.
11 of the 13 pharmaceutical companies selling these top drugs made more money in the United States from these drugs than they did in the rest of the world combined.”
HHS ends Trump-era rule 340B targeting community health clinics: “The Health Resources and Services Administration has formally rescinded a proposed rule targeting community health clinics participating in the 340B Drug Pricing Program. The regulation, which the Trump administration proposed last year, would have required community health centers to pass the 340B discounts they get for insulin and Epi-Pens directly to patients.
HRSA is withdrawing the regulation due to ‘excessive administrative costs and the burdens that implementation would have imposed on health centers,’ the agency wrote in a notice published in the Federal register Thursday.”
Magnitude of the Placebo Response Across Treatment Modalities Used for Treatment-Resistant Depression in Adults: “In this systematic review and meta-analysis of 3228 patients with treatment-resistant depression in 50 randomized clinical trials, the placebo effect size was large and consistent across treatment modalities. Response and remission rates associated with placebo effect were comparable across modalities…
The findings of this study suggest a placebo effect size benchmark may be used to interpret the findings of past and future clinical trials.”
Hikma Buys Injectables Specialist Custopharm In $400m+ Deal: “Hikma has agreed to acquire US sterile injectables specialist Custopharm in a deal that includes a $375m upfront purchase price and a further $50m in milestone payments. The transaction is set to bolster Hikma’s near-$1bn injectables business that currently accounts for around two-fifths of turnover.”
Judge denies Pfizer's request to run 2 programs to subsidize patients for expensive heart drug: “Pfizer’s efforts to blunt the anti-kickback policies of the U.S. government took a hit Friday as a federal district court dismissed its plan to assist Medicare patients in paying for one of the company's most expensive drugs.
In ruling in favor of the Department of Health and Human Services (HHS), Southern District of New York Judge Mary Kay Vyskocil denied Pfizer clearance to run two programs that would reimburse patients for their pricey heart medications Vyndaqel and Vyndamax, which cost $225,000 annually.”
About health insurance
Biden administration announces rule on implementing ban on 'surprise' medical billing: This link is for a summary from The Hill. For a full explanation from CMS see this link.
Medicare appeals backlog trimmed by 79%: “HHS met its backlog goals for fiscal year 2021, reducing its Medicare appeals backlog by 79 percent at the administrative law judge level, according to a Sept. 28 status report. It's on track to meet the next reduction target as well.”
CMS official: Don't expect a lot of fully risk-based payment models going forward: “Centers for Medicare & Medicaid Services Chief Operating Officer Jon Blum detailed the agency’s vision for value-based care during the National Association of Accountable Care Organizations' fall conference Thursday.
‘I don’t think that CMS will be promoting models that have more risk just for the sake of having more risk,’ said Blum.
Although Blum said it is still important to have risk-based models, there are data that show downsides of full-risk payment models.
‘We know that when we [incentivize] risk we see some downsides to that,’ Blum said. ‘We see stronger incentives for more diagnosis code submissions, some of which might be appropriate, some of which not.’
Another concern is when you have ‘more transformation towards risk that tends to favor those who are better capitalized and can afford risk,’ he added.”
UnitedHealthcare maintains largest Medicare Advantage footprint with 2022 expansion: “UnitedHealthcare shared its plans to expand Medicare Advantage plans in 2022 to 276 counties, continuing its dominant market control.
The expansion to another 3.1 million potential members means UnitedHealthcare reaches 94 percent of Medicare-eligible consumers nationwide…”
About healthcare IT
HHS releases HIPAA guidelines for vaccine, the workplace: 4 things to know: “Four things to know:
HIPAA doesn't prohibit businesses or individuals from asking customers about their COVID-19 vaccination status. HIPAA only applies to covered entities, such as hospitals, payers and their business associates.
HIPAA doesn't prevent individuals from disclosing their vaccination status to business owners or employees of an establishment.
HIPAA doesn't block a covered entity or business from requiring its employees to disclose their vaccination status to their employers. HIPAA doesn't apply to employment records — even covered entities — when they are acting in their capacity as employers.
HIPAA does prohibit a physician's office from disclosing protected health information, such as COVID-19 vaccination status, to a patient's employer.
To read more, click here.”
Amazon Adds More to Halo—Introducing Halo View, Halo Fitness, and Halo Nutrition: “Amazon announced expansions to Amazon Halo with three new additions to the Halo family: Halo View, a new health tracker with an AMOLED color display for at-a-glance access to Halo health metrics; Halo Fitness, a new service with hundreds of studio-quality workout classes; and Halo Nutrition, a new experience to help build healthy eating habits.”
About the public’s health
The rising cost of healthcare system complexity: From Accenture. The entire report is interesting, but the one portion that is highlighted in the media today is: “If people with low healthcare system literacy used the emergency room at the same rate as their more informed peers, Accenture estimates that the US healthcare system could save $47 billion every year in medical costs.
This cost saving assumes that their excess emergency room visits would shift to less expensive sites, such as primary care physician offices, urgent care centers, retail health clinics and telehealth visits.”