About the public’s health
PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS: This announcement is for the Phase 3 conclusion and includes the previous efficacy (94.5%) data. It will still be another month or so before the vaccine hits the market. A related article, The Health 202: Coronavirus vaccines are one thing Trump got right, has a really good graphic explanation of the mRNA vaccine process as well as how Pfizer will keep specimens cold for shipment.
Immunity to the Coronavirus May Last Years, New Data Hint:”The research, published online, has not been peer-reviewed nor published in a scientific journal. But it is the most comprehensive and long-ranging study of immune memory to the coronavirus to date.”
Hospitals Can’t Go On Like This: “Now new data released by the Department of Health and Human Services quantify the crisis in America’s hospitals in closer detail. At The Atlantic’s request, HHS provided data on the number of hospitals experiencing staffing shortages. From November 4 to November 11, 958 hospitals—19 percent of American hospitals—faced a staffing shortage. This week, 1,109 hospitals reported that they expect to face a staffing shortage. That’s 22 percent of all American hospitals.
In eight states, the situation is even more dire. More than 35 percent of hospitals in Arkansas, Missouri, North Dakota, New Mexico, Oklahoma, South Carolina, Virginia, and Wisconsin are anticipating a staffing shortage this week.”
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home: “The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only.
The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.”
Imputed State-Level Prevalence of Achieving Goals To Prevent Complications of Diabetes in Adults with Self-Reported Diabetes — United States, 2017–2018: “Effective management of hemoglobin A1C, blood pressure, cholesterol, and avoiding smoking (ABCS) is important in preventing complications from diabetes…
During 2017‒2018, the proportion of U.S. adults with self-reported diabetes who met ABCS goals was suboptimal. Only 26.4% met all the ABCS goals, 75.4% met the A1C goal, 70.4% met the blood pressure goal, 55.8% met the cholesterol goal, and 86.0% were current nonsmokers.”
First ever vaccine listed under WHO emergency use: WHO “listed the nOPV2 vaccine (Bio Farma, Indonesia) for emergency use to address the rising cases of a vaccine-derived polio strain in a number of African and East Mediterranean countries. Countries in WHO’s Western Pacific and South-East Asia regions are also affected by these outbreaks. The emergency use listing, or EUL, is the first of its kind for a vaccine and paves the way for potential listing of COVID-19 vaccines.”
Britain to ban new petrol cars by 2030 on road to net zero emissions: “Britain will ban the sale of new petrol and diesel cars and vans from 2030, five years earlier than previously planned, as part of what Prime Minister Boris Johnson is casting as a ‘green revolution’ to cut emissions to net zero by 2050.”
FDA to make emergency use authorization data public for COVID-19 vaccines: “The U.S. Food and Drug Administration said on Tuesday it would make public reviews of all data and information regarding the emergency use authorization (EUA) granted to COVID-19 drugs and vaccines.”
Ranking the effectiveness of worldwide COVID-19 government interventions: A comprehensive evaluation of non-pharmacological interventions around the world.
About pharma
House Passes Bill Targeting Orphan Drug Exclusivity: “The U. S. House of Representatives on Tuesday passed a bill that would require drugmakers to prove they don't expect to recoup research and development costs through sales of a new drug if they want market exclusivity under a shield for drugs that treat rare diseases.”
Purdue Pharma Gets Court Approval For $8B Deal With Feds: “A New York bankruptcy Judge on Tuesday approved Purdue Pharma's $8 billion settlement of federal felony charges stemming from its OxyContin sales and said Purdue's former owning family can pay $225 million in fines without violating court orders.”
China pharma shares fall as western rivals lead in vaccine trials: “Successful trials of western pharmaceutical groups’ coronavirus vaccines have sliced more than $13bn off the market capitalisation of Chinese rivals, hitting Beijing’s ambitions to lead the global fight against the pandemic. An index tracking shares of 14 vaccine producers listed in Shanghai and Shenzhen has dropped 11 per cent since Pfizer first announced its positive phase-three trial results earlier this month, and is down about a third from its peak in August.”
About health insurance
CMS: Estimated improper Medicare payments down $15B since 2016: “CMS said the improper payment rate in Medicare fee-for-service declined to 6.27% in the 2020 federal fiscal year that ended in September. The rate is down from 7.25% in fiscal 2019 and 2020 is the fourth consecutive year that the rate is below 10%.
The decline in 2020 was primarily due to improvements in two areas. The first is home health, where CMS clarified documentation requirements and educated providers, resulting in a $5.9 billion decline in estimated improper payments from fiscal 2016 through 2020.
Another area that saw reductions was skilled nursing facilities, which saw a $1 billion decline in estimated improper payments in the last year.”
US Oncology Network Achieves Record Patient Enrollment for Oncology Care Model Program: “A total of 100,000 patients are now enrolled Centers for Medicare & Medicaid Innovation’s (CMMI) Oncology Care Model (OCM), as a result of the efforts of The US Oncology Network (The Network). Participation of The Network in OCM has saved Medicare a collective $122 million in the first 6 performance periods (PP).”
Healthcare exec pleads guilty to part in $1.2B Medicare fraud scheme: “Mr. Davydov was one of 24 defendants charged in April 2019 for his alleged participation in the overarching $1.2 billion healthcare fraud scheme. According to federal prosecutors, the complex scam began with telemarketers calling Medicare beneficiaries and getting them to accept free or low-cost durable medical equipment braces, regardless of medical necessity. The call centers would allegedly transfer Medicare beneficiaries to telemedicine companies for consultations with physicians, who allegedly prescribed the orthopedic braces to patients whom they had never met. The call centers would sell the prescriptions to DME companies, which shipped the braces to beneficiaries, billed Medicare and paid kickbacks to physicians, according to prosecutors.
Mr. Davydov received and completed the physicians' orders and billed Medicare and private insurers for the braces. He concealed his ownership of the medical equipment companies by falsely reporting to Medicare that various straw owners owned the companies, according to the Justice Department.”