Breaking News: FDA advisers recommend Pfizer-BioNTech coronavirus vaccine, with agency action expected soon
About pharma
BREAKING: High Court Says Ark. Law Regulating PBMs Not Preempted: “The U.S. Supreme Court handed a win to Arkansas Thursday in its fight to regulate the industry that controls health plans' prescriptions, overturning the Eighth Circuit's decision that a 2015 law banning pharmacy benefit managers from shortchanging local pharmacies flouted the Employee Retirement Income Security Act.”
This decision will have a major impact on how states can regulate PBMs.
About the public’s health
Yes, your boss can fire you if you refuse to get a Covid vaccine: The headline speaks for itself. Read the article for more details.
Willingness to Get COVID-19 Vaccine Ticks Up to 63% in U.S.:
“63% in U.S. would be willing to receive FDA-approved COVID-19 vaccine
Current figure is an increase from 50% in September and 58% in October
Republicans, non-White adults, 45- to 64-year-olds least willing”
WHO: People Living Longer, but With More Disabilities: “New global health estimates find people are living six years longer now than 20 years ago, but many more people are living with disabilities that affect their quality of life.
The World Health Organization reports life expectancy has gone up from 67 years to 73 years since 2000. Over this period, it notes progress has been made in reducing deaths from a number of communicable diseases.” And in a related story: WHO reveals leading causes of death and disability worldwide: 2000-2019: “Noncommunicable diseases now make up 7 of the world’s top 10 causes of death, according to WHO’s 2019 Global Health Estimates…. This is an increase from 4 of the 10 leading causes in 2000. The new data cover the period from 2000 to 2019 inclusive…Heart disease has remained the leading cause of death at the global level for the last 20 years. However, it is now killing more people than ever before. The number of deaths from heart disease increased by more than 2 million since 2000, to nearly 9 million in 2019. Heart disease now represents 16% of total deaths from all causes.” On the latter point, here is a more detailed article: Global Burden of Cardiovascular Diseases and Risk Factors, 1990–2019: Update From the GBD 2019 Study.
Crimped U.S. dry ice supply complicates rural U.S. vaccine release: “More than a dozen U.S. states, including Washington, New Mexico, Mississippi, Louisiana and Indiana, told Reuters they are rushing to secure dry ice to replenish suitcase-sized shipping containers from Pfizer. Once opened, if being used as temporary storage by a vaccination center, the vaccines can last a total of 30 days with re-icing every five days, Pfizer said.
The company said it believes there is sufficient dry ice supplies to serve the needs of all 50 states without serious constraints.”
Male sex identified by global COVID-19 meta-analysis as a risk factor for death and ITU admission: “…whilst there is no difference in the proportion of males and females with confirmed COVID-19, male patients have almost three times the odds of requiring intensive treatment unit (ITU) admission… and higher odds of death… compared to females. With few exceptions, the sex bias observed in COVID-19 is a worldwide phenomenon.” The article also explains sex differences in immune system responses for this disparity (see the Discussion section).
‘There’s No Place for Them to Go’: I.C.U. Beds Near Capacity Across U.S.: The headline speaks for itself; the article provides more details.
For the first time, the U.S. will reward nursing homes for controlling the spread of infectious disease: “More than 9,000 nursing homes have been able to show progress in controlling the novel coronavirus infection, according to the Department of Health and Human Services, and will share $523 million in incentive payments as a reward, starting Wednesday.”
First U.S. Shipments of Pfizer Vaccine Will Be 2.9 Million Doses: “Gustave Perna, the army general who serves as Warp Speed’s chief operating officer, said on a call with reporters Wednesday that the U.S. plans to distribute 2.9 million doses in the first round of shipments following authorization of Pfizer’s still-experimental vaccine. The rest will be held back to be distributed to states and other jurisdictions when the first people vaccinated are due for their second dose 21 days later.”
Johnson & Johnson cuts size of Covid-19 vaccine study due to prevalence of disease in U.S.: ”Johnson & Johnson is cutting the size of its pivotal U.S. Covid-19 vaccine trial — the only major study testing a single dose of a Covid vaccine — from 60,000 volunteers to 40,000 volunteers.
The change is being made possible by the fact that Covid-19 is so pervasive across the country, according to a person familiar with the matter. The more virus there is in the U.S., the more likely it is that participants will be exposed to it, meaning researchers will be able to reach conclusions based on a smaller trial.”
About healthcare personnel
Judge voids rule pricing H-1B doctors out of areas that need them: “The administration argued by that the changes were ‘urgently necessary’ to ensure that the employment of H-1B visa holders ‘did not have an adverse impact on the wages and working conditions of similarly employed U.S. workers’ during the COVID-19 public health emergency.” If this rule went into effect, rural and other high-need areas would not be able to afford hiring these international medical graduates.”
Hospitals and health systems
Tenet to Acquire Portfolio of Surgery Centers from SurgCenter Development: “Tenet Healthcare Corporation today announced that it will acquire a portfolio of up to 45 ambulatory surgery centers (ASCs) (the “Portfolio”) from SurgCenter Development (SCD). The Portfolio will be operated by Tenet’s United Surgical Partners International (USPI) subsidiary as part of its industry-leading ambulatory surgery platform.
SCD, founded in 1993, is a leading developer of physician-owned ASCs with a history of establishing high-quality centers in partnership with physicians with demonstrated leadership in musculoskeletal surgeries. The 45 centers are located in Arizona, Florida, Indiana, Louisiana, Maryland, Ohio, New Hampshire, Texas and Wisconsin.
Under the terms of the transaction, the Company will purchase majority interests in up to 45 centers by fully acquiring SCD’s interests, and partially acquiring interests from physician partners, for approximately $1.1 billion in cash and the assumption of approximately $18 million of center-level debt.”
About diagnostics
C2N Earns CE Mark for Alzheimer’s Blood Test:”C2N Diagnostics has been granted CE mark certification for PrecivityAD, a mass spectrometry-based blood test for Alzheimer’s disease.
The diagnostic is now cleared in Europe for evaluating patients being assessed for Alzheimer’s disease who show mild cognitive impairment or very mild dementia.”
SOLVD Health Receives CE Mark for Genetic Risk Assessment for Opioid Use Disorder: “Using a simple cheek swab sample, the risk assessment is designed to analyze 15 genetic variants involved in the brain reward pathway to identify patients who may be at increased risk for OUD. Healthcare providers can use this personalized risk information to make more informed decisions about the use of oral opioids for acute pain when developing pain management plans for their patients. This technology received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) in February 2018.”
About health insurance
Positive Outcomes for High- Need, High-Cost Beneficiaries in Medicare Advantage [MA] Compared to Traditional Fee-For-Service Medicare: MA plans beat traditional Medicare on a number of metrics, including 57% lower rates of avoidable hospitalizations and 41% lower prescription drug costs. The results were possibly achieved by more primary care visits: their costs were 41% higher.
Humana to offer Primary Care First model across 48 states:”Humana will offer the model to qualified primary care providers across the 48 contiguous states and the District of Columbia who are in-network for Medicare Advantage PPO and HMO plans, the insurer announced…
Under the model, Humana will offer participating providers a monthly prospective capitated payment, which will account for performance on achievement in quality and outcomes metrics. Humana said the model will also offer an opportunity for income stabilization for primary care practices hit hard financially by the pandemic.
Eligible providers must focus chiefly on primary care services and have more than 125 Humana Medicare Advantage PPO and/or HMO members aligned with them, the insurer said.”
About healthcare IT
Amazon launches new tool to help healthcare organizations standardize data:”Amazon's cloud division rolled out a new tool to make it easier for healthcare organizations to search and analyze data.
Amazon HealthLake is a HIPAA-eligible service for healthcare and life sciences organizations that aggregates an organization’s complete data across various silos and disparate formats into a centralized Amazon Web Services (AWS) data lake and automatically normalizes this information using machine learning…”