About Covid-19
CDC sets first target for indoor air ventilation to prevent spread of Covid-19 “The US Centers for Disease Control and Prevention has extensively updated its ventilation guidance on helping prevent indoor transmission of the virus that causes Covid-19.
The agency had advised people to ventilate indoor air before, but this is the first time a federal agency has set a target – five air changes per hour – for how much rooms and buildings should be ventilated.”
Air quality experts cheered the updated recommendations.”
Getting to the Truth About the Effectiveness of Masks in Preventing COVID-19 The effectiveness of masking at the community level has been debated since the onset of the Covid-19 pandemic. The answers are not straightforward, but this editorial from the editors of the Annals of Internal Medicine is a great summary of what we know and how to interpret results.
About health insurance/insurers
CMS redefines its definition of “Marketing” for Medicare Advantage plans and requires sign-off on materials. “…we are expanding our interpretation of the regulatory definition of ‘marketing’ to include content that mentions any type of benefit covered by the plan and is intended to draw a beneficiary's attention to plan or plans, influence a beneficiary's decision-making process when selecting a plan, or influence a beneficiary's decision to stay enrolled in a plan (that is, retention-based marketing) and thus subject to review.”
About pharma
Estimated Annual Spending on Lecanemab and Its Ancillary Costs in the US Medicare Program “Lecanemab, an antidementia medication with modest clinical benefit, received accelerated US Food and Drug Administration (FDA) approval. Traditional FDA approval of lecanemab could occur in 2023, prompting Medicare to reconsider coverage restrictions and potentially enabling widespread use. Lecanemab’s $26 500 proposed annual acquisition cost and ancillary spending (eg, imaging) could increase Medicare spending, possibly leading to beneficiary premium increases…
If 85 687 (lower bound) eligible patients received lecanemab, Medicare would spend $2.0 billion annually (95% CI, $1.8-2.2 billion). If 216 536 (upper bound) eligible patients received lecanemab, Medicare would spend $5.1 billion annually (95% CI, $4.6-5.7 billion). Estimated annual per-patient coinsurance could reach $6636.”
New menopause drug for hot flashes gets FDA approval “The Food and Drug Administration approved the once-a-day pill from Astellas Pharma to treat moderate-to-severe symptoms, which can include sweating, flushing and chills.
Astellas’ drug, Veozah, uses a new approach, targeting brain connections that help control body temperature. The FDA said the medication will provide “an additional safe and effective treatment option for women,” in a statement.”
U.S. Supreme Court declines bid by Teva to hear ‘skinny labeling’ case with implications for generic drug access “After months of anticipation, the U.S. Supreme Court declined to hear an appeal of a lower court ruling that throws into question whether generic companies can ‘carve out’ uses for their medicines and supply Americans with cheaper alternatives to brand-name drugs.
At issue is skinny labeling, which happens when a generic company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.”
About the public’s health
FDA blocks marketing on 6,500 flavored e-cigarette products “The Food and Drug Administration on Friday blocked 10 companies from marketing or distributing 6,500 flavored e-liquid and e-cigarette products, part of its campaign against tobacco products being marketed to youths.
The agency said the product applications covered a variety of flavored e-cigarettes, including some with flavors such as Citrus and Strawberry Cheesecake, as well as Cool Mint and Menthol. The FDA said the companies in question did not provide sufficient evidence that marketing the products would be appropriate for public health.”
About healthcare personnel
Envision files for bankruptcy: 6 details “Nashville, Tenn.-based Envision Healthcare has filed for Chapter 11 bankruptcy five years after New York City-based KKR & Co. acquired Envision in a $9.8 billion deal.”
Federal government’s $1 billion effort to recruit next generation of doctors at risk “Over the last three years, millions of taxpayer dollars were pumped into the National Health Service Corps to hire thousands more doctors and nurses willing to serve the country’s most desperate regions during the COVID-19 pandemic in exchange for forgiving medical school debts. Now, with the health emergency over, the program’s expansion is in jeopardy – even as people struggle to get timely and quality care because of an industry-wide dearth of workers.
Funding for the program expires at the end of September, although President Joe Biden asked Congress to sign off an extra half-billion dollar for the project in his budget.”