About Covid-19
CDC is leaving it up to states to set guidelines for mask-wearing, director says: “CDC Director Dr. Rochelle Walensky said Wednesday the U.S. agency is leaving it up to states and local health officials to set guidelines around mask-wearing even after the World Health Organization urged fully vaccinated people to continue the practice.”
EMA Lists Five Drugs as Preferred COVID-19 Therapeutics: “The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal antibodies and Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib).
The agency recommended antibodies from GlaxoSmithKline, Celltrion, Eli Lilly and Regeneron for use in early-stage patients at risk of progressing to severe COVID-19 and Olumiant for treatment of hospitalized COVID-19 patients on oxygen.”
COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sites: “ASPR [The HHS Assistant Secretary for Preparedness and Response], in partnership with the Johns Hopkins University Applied Physics Laboratory, has developed the COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sites (mAbs Calculator). The mAbs Calculator is a free, data-informed decision support tool that is based on a comprehensive simulation framework. The mAbs Calculator can be used to inform staffing decisions and resource investments needed for COVID-19 monoclonal antibody therapeutic infusion sites.”
FDA revokes emergency nods for KN95 respirators and disinfecting hardware as mask supplies rebound: “The agency said it is pulling all emergency authorizations for disposable masks that are not approved by the National Institute of Occupational Safety and Health (NIOSH), such as imported KN95 respirators.
Manufacturers of decontamination and bioburden reduction systems had already asked the agency to rescind their emergency use authorizations, the FDA said. Because supplies of NIOSH-approved respirators have increased significantly..”
White House launches ‘surge response’ teams to delta variant hot spots: “The White House-coordinated teams will include a mix of virtual support and on-the-ground personnel, helping deploy additional supplies as requested by local officials, such as testing or therapeutics. Staff will come from the CDC, the Federal Emergency Management Agency and the Office of the Assistant Secretary for Preparedness and Response in the Department of Health and Human Services. The White House also may ramp up paid promotions about the benefits of vaccination in areas that officials deem high risk.”
About pharma
ICER stands by view on Biogen's Aduhelm, says sharp price cut needed: “Biogen would need to drastically lower the price of its new Alzheimer's drug for treatment to be cost effective, according to a revised report from the Institute for Clinical and Economic Review, which affirmed the influential nonprofit group's earlier conclusion that the company's clinical trial evidence is insufficient to prove a health benefit.
Biogen priced Aduhelm, as the drug is now called, at an average list cost of $56,000 a year. Assuming a level of efficacy suggested by blending results from the company's two Phase 3 trials, one of which failed, ICER calculated treatment would be cost effective only at prices between about $3,000 and $8,400, a reduction of 85% to 95%.”
About health insurance
CD&R Sets Deal for Majority Stake in Vera Whole Health: Back to the future????
”Private-equity firm Clayton Dubilier & Rice LLC is buying a majority stake in Vera Whole Health Inc., officials with both companies said…
Vera, based in Seattle, has created a new model of employer- sponsored healthcare in which the employer or insurance provider pays a flat monthly per-patient fee that covers all of the employee’s healthcare needs. Under the company’s model, the primary- care physician is the leader of a team of healthcare providers who communicate with each other and oversee the patient’s health.”
I guess they never heard about Kaiser’s origins in the 1930s and capitated HMO plans.
HHS Announces Rule to Protect Consumers from Surprise Medical Bills: “Today, the Biden-Harris Administration, through the U.S. Departments of Health and Human Services (HHS), Labor, and Treasury, and the Office of Personnel Management, issued "Requirements Related to Surprise Billing; Part I," an interim final rule that will restrict excessive out of pocket costs to consumers from surprise billing and balance billing…
Among other provisions, today's interim final rule:
Bans surprise billing for emergency services. Emergency services, regardless of where they are provided, must be treated on an in-network basis without requirements for prior authorization.
Bans high out-of-network cost-sharing for emergency and non-emergency services. Patient cost-sharing, such as co-insurance or a deductible, cannot be higher than if such services were provided by an in-network doctor, and any coinsurance or deductible must be based on in-network provider rates.
Bans out-of-network charges for ancillary care (like an anesthesiologist or assistant surgeon) at an in-network facility in all circumstances.
Bans other out-of-network charges without advance notice. Health care providers and facilities must provide patients with a plain-language consumer notice explaining that patient consent is required to receive care on an out-of-network basis before that provider can bill at the higher out-of-network rate.”
Consumer protections in the rule will take effect beginning on January 1, 2022.
About the public’s health
Healthiest Communities Rankings 2021: At the top was Los Alamos County, N.M. But five Colorado Counties were in the top 10. See the article for the components of the rankings and where your county ranks.
About healthcare quality
Leapfrog Decries CMS Patient Safety Measure Proposal in IPPS: “Patient safety organization The Leapfrog Group has joined more than 75 other healthcare organizations and individuals in speaking out against a proposed patient safety measure change included in the CMS Inpatient Prospective Payment System (IPPS) Inpatient Quality Reporting (IQR) Program.
The measure, ‘Deaths Among Surgical Inpatients with Serious Treatable Complications,’ measures the death rate among those receiving surgery on an in-patient basis when that death occurred due to a patient safety incident.”
It is not known why CMS is making this change.
About pharma
States Step Up Push to Regulate Pharmacy Drug Brokers: A good summary on what is happening with these efforts.