About Covid-19
CDC revises 'up to date' term on COVID-19 vaccination “The CDC revised its "up to date" COVID-19 vaccination term Sept. 30 to include the primary series and the recently authorized omicron-targeting booster.”
Supreme Court declines 10 states' challenge to CMS' vaccine mandate “The U.S. Supreme Court on Oct. 3 declined a case brought by 10 states challenging the Biden administration's rule that requires employees to be vaccinated against COVID-19 if they work in healthcare facilities that receive federal funding.”
U.S. CDC ends country-specific COVID travel health notices “The Centers for Disease Control and Prevention (CDC) said on Monday it had ended its COVID-19 country travel health notices as fewer countries reported enough data for accurate assessments.”
About health insurance/insurers
A boost for biosimilars payments unveiled by CMS “CMS announced Monday that it had started to implement a temporary reimbursement boost for biosimilars that is mandated in the Inflation Reduction Act.
Under the law, the add-on payment for biosimilars administered in physician offices, hospital outpatient departments, and ambulatory surgical centers will be 8% of the average sales price (ASP) or the reference drug. Prior to enactment of the IRA, the add-on payment for biosimilars was 6% of the reference product’s ASP.”
Comment: Physicians will still be incentivized to use the most expensive products.
Federal employee health-care premiums to rise 8.7 percent on average “Premiums in the health-care program for federal employees and retirees will increase by 8.7 percent on average for 2023 — the largest increase in more than a decade, the government announced Friday.
That change in Federal Employees Health Benefits Program premiums is significantly larger than the 3.8 percent average increase for 2022, although closer to the 5-7 percent range of most other recent years.
The cost increase is a reflection of rising prices for some drugs and higher uses of professional services and outpatient treatments, said the Office of Personnel Management.”
About hospitals and healthcare systems
7-hospital system files for bankruptcy “Pipeline Health System, which includes seven hospitals in three states, filed for Chapter 11 bankruptcy Oct. 2.
El Segundo, Calif.-based Pipeline said the decision to enter bankruptcy was prompted by several factors, including financial challenges tied to skyrocketing costs and delayed payments from insurance plans.”
Trinity Health reports $1.4B annual loss “Higher labor costs put pressure on Trinity Health's margins in fiscal year 2022, according to financial documents released Sept. 30.
Livonia, Mich.-based Trinity Health posted revenue of $19.93 billion in the 12 months ended June 30, down from $20.16 billion a year earlier. The health system said net patient service revenue was up 1.8 percent year over year, primarily because of increased outpatient volume and payment rates.”
About pharma
OIG raises concerns about accelerated approval pathway “More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years past their confirmatory trial deadlines, according to a recent report released by the US Department of Health and Human Services Office of Inspector General (OIG)…
OIG’s report examined 278 drugs approved by the FDA Center for Drug Evaluation and Research (CDER) between 1992 and December 2021 to estimate the number of drug applications that completed confirmatory trials. The authors of the report also evaluated Medicare and Medicaid claims data between 2018 and 2021 for drug applications that received accelerated approval but had not yet completed confirmatory trials.
The authors of the report found 104 drug applications (37.8%) have not completed confirmatory trials, 35 drug applications (33.6%) had one or more trials that missed a completion date, and 4 drug applications had significantly passed the originally-planned clinical trial completion date by between 5–12 years. For the 139 drug applications (50.0%) where confirmatory trials were completed, the average time to completion was 48 months.”