About Covid-19
COVID DATA TRACKER WEEKLY REVIEW From the CDC: “As of May 5, 2022, there are 78 (2.42%) counties, districts, or territories with a high COVID-19 Community Level, 316 (9.81%) counties with a medium Community Level, and 2,826 (87.76%) counties with a low Community Level. This represents a slight (0.75 percentage points) increase in the number of high-level counties, a small (+1.86 percentage points) increase in the number of medium-level counties, and a corresponding (−2.61 percentage points) decrease in the number of low-level counties…
As of May 4, 2022, the current 7-day moving average of daily new cases (64,781) increased 21.4% compared with the previous 7-day moving average (53,362).”
And in a related article: Coronavirus wave this fall could infect 100 million, administration warns “The Biden administration is warning the United States could see 100 million coronavirus infections and a potentially significant wave of deaths this fall and winter, driven by new omicron subvariants that have shown a remarkable ability to escape immunity.
The projection, made Friday by a senior administration official during a background briefing as the nation approaches a covid death toll of 1 million, is part of a broader push to boost the nation’s readiness and persuade lawmakers to appropriate billions of dollars to purchase a new tranche of vaccines, tests and therapeutics.”
Moderna urges court to dismiss patent claims on COVID-19 shot “Moderna filed a motion to dismiss a lawsuit filed by two small biopharma companies seeking damages for violation of certain U.S. patents related to the company’s blockbuster COVID-19 shot, branded as Spikevax.
RNA therapeutics company Genevant Sciences and clinical-stage biotech Arbutus Biopharma filed the case in February, holding Moderna and an affiliate of the vaccine maker accountable for the infringement.”
Effect of oral nirmatrelvir on Long COVID symptoms: a case series NOTE: This article is a case series and not a controlled trial. It also has not been peer reviewed. Nevertheless, its potential importance is worth reporting. “We report three cases that demonstrate that variability in the timing of nirmatrelvir [ Paxlovid] may be associated with different outcomes and underscores the need for systematic study of antiviral therapy for this disease condition.”
About health insurance
Big payers ranked by Q1 revenues See the list of the “top 6” and click for individual details.
And in a related story (not one of the “top 6”): Kaiser posts net loss of $961M in Q1 “Driven mainly by nonoperating losses, Oakland, Calif.-based Kaiser Permanente recorded a net loss of $961 million in the first quarter of 2022, down from a net income of $2 billion in the same quarter in 2021, according to financial data released May 6.”
About hospitals and healthcare systems
Hospitals Look to Raise Treatment Costs as Nurses’ Salaries Increase “Some hospitals grappling with rising nurse salaries are seeking to raise prices by up to 15%, touching off contract fights with health insurers and businesses and threatening higher premiums.
HCA Healthcare Inc. and Universal Health Services Inc. are among the hospitals asking health plans to pay them more for care to offset mounting nurse costs.
Neither of the chains would specify the price increases they are requesting, but people familiar with negotiations say some hospitals are asking to increase their prices by 7.5% to 15%.
The requests are more than the 4% to 6% price increases that hospitals typically seek, according to employers and insurers. The hospitals usually won an average 3% price increase in recent years, according to Altarum, a nonprofit that does healthcare research.”
About pharma
Cerebral under federal investigation for possible violations of controlled substances law See the last few posts on this blog for background. The story continues…”Mental health startup Cerebral said Saturday it is under investigation by the Department of Justice (DOJ) for ‘possible violations’ of the Controlled Substances Act.
Cerebral Medical Group received a grand jury subpoena from the U.S. Attorney’s Office for the Eastern District of New York on Friday evening, the company said in a statement. The Controlled Substances Act regulates the distribution of potentially addictive medicines like Adderall and Xanax.”
Walgreens Says Insurers Must Defend It In Opioid Cases “Walgreens has sued at least 25 insurance companies, including several units of AIG, Liberty Mutual and Great American Insurance, in Illinois state court, seeking a ruling they must defend and indemnify the pharmacy retailer in nationwide opioid litigation. Walgreens is facing more than 2,500 lawsuits claiming it illegally contributed to an oversupply of opioids that has caused a national addiction epidemic and is suing at least 25 insurance companies, saying they must defend and indemnify the pharmacy retailer in nationwide opioid litigation.”
About the public’s health
E-Cigarette Use and Risk of Cardiovascular Disease: A Longitudinal Analysis of the PATH Study (2013–2019) “Dual use of cigarettes and e-cigarettes was associated with a significantly increased risk of CVD compared with nonuse. The cardiovascular risk of dual use did not differ from the risk among those exclusively smoking cigarettes. Other recent cross-sectional analyses have also reported no significant association between e-cigarette use and CVD out-comes.”
States prepare for summer launch of new 988 suicide prevention number “This summer, every state will be rolling out 988 as the new National Suicide Prevention Lifeline number to call for mental health crises -- similar to how people can call 911 for medical emergencies.
But in some states, questions remain around funding the transition, staffing call centers and having response teams ready.
The transition to 988 is ‘not optional,’ according to the US Department of Health and Human Services' Substance Abuse and Mental Health Services Administration.
No more than half of states have enacted or introduced legislation in preparation for 988's debut, scheduled for July 16, according to data from the National Academy for State Health Policy.”
About health technology
FDA Clarifies “Refuse to Accept” Policy for 510(k) Submissions “Under the Medical Device User Fee and Modernization Act (MDUFA) and its successive amendments, the FDA must meet performance goals related to the agency’s review of medical device submissions, based on the timeliness of those reviews. The FDA’s Refuse to Accept (RTA) policy provides for an early review of all submissions in accordance with specific acceptance criteria and enables the agency to inform a submitting party whether it a submission is “administratively complete” within 15 days of its filing.
The FDA says that the guidance, titled ‘Refuse to Accept Policy for 510(k)s,’ is intended to ensure consistency in acceptance decisions made by the agency and to help submitters better understand the types of information needed by the FDA to conduct its review.”