About Covid-19
Biden administration to announce most Americans will need coronavirus booster shots: “Administration officials believe people should get additional shots eight months after being fully vaccinated…
Administration of boosters would not occur until mid- or late September, after an application from Pfizer-BioNTech for the additional shots is cleared by the Food and Drug Administration, the individuals said.” In a related article: COVID-19 CPT coding and guidance, the AMA reviews coding for the vaccines, including Pfizer and Moderna third shots. Further: Pfizer, BioNTech submit early data to FDA to support COVID-19 vaccine booster: “Pfizer and partner BioNTech announced Monday that they have submitted Phase I data to the FDA supporting the use of a third dose of their COVID-19 vaccine BNT162b2. The companies stated that these findings will also be submitted to the European Medicines Agency and other regulatory bodies in the coming weeks.” And finally: A million Israelis get third dose, with early data showing heightened protection: “According to health ministry figures, the results are very promising. Third-dose recipients appear to be 2.5 times more protected from infection than those who received two doses of the Pfizer vaccine. The added protection appears to reach its peak about a week after the third dose is given.
Amid rising cases, last month Israel became the first nation in the world to begin administering booster shots to those 60 and over. On Friday, Israel began giving third doses to people ages 50 and up.”
UPDATE ON ACTEMRA®(TOCILIZUMAB) SUPPLY IN THE U.S.: From Roche: “The dramatic emergence of the COVID-19 Delta variant, as well as the unexpected slowing of vaccination rates in the U.S., has led to an overwhelmingly high incidence of COVID-19 hospitalizations in certain areas of the country. This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV-- well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase…
[Despite efforts to increase the supply,] we are experiencing a temporary stockout of Actemra IV in the U.S. for 200mg and 400mg SKUs, as of Monday, August 16th, and have notified our customers. We currently have a short supply of the 80mg SKU, and we anticipate stockout by the end of the week.
We expect the next scheduled replenishments to arrive by the end of August. However, if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”
Man shot 6 times waits more than a week for surgery after hospital is overwhelmed by covid:
A great ethics case. The shooting victim was an innocent bystander. The Covid patients at Ben Taub Hospital in Houston (where the ICU is at 103 % of capacity) could have prevented their disease if they were vaccinated. Who “deserves” the beds more?
Association of Vaccine Type and Prior SARS-CoV-2 Infection With Symptoms and Antibody Measurements Following Vaccination Among Health Care Workers: “Clinically significant symptoms following dose 1 were associated with prior SARS-CoV-2 infection, confirming prior reports. Clinically significant symptoms following vaccination were more frequent following dose 2 and receipt of the Moderna vaccine.”
GSK and CureVac’s second Covid vaccine yields stronger response: “The second-generation Covid-19 vaccine from GlaxoSmithKline and its partner CureVac induces a stronger immune response than the German biotech’s first vaccine, according to a new study. In an animal study, which has yet to be peer reviewed, the companies said the mRNA vaccine could induce antibodies capable of tackling several variants of concern, including Beta, Delta and Lambda. The new vaccine elicited a response more quickly and created a higher level of antibodies than CureVac’s first-generation vaccine. It was also better at activating B and T cells, other important elements of the immune system’s response. In a phase 3 trial, CureVac’s first vaccine had an average efficacy of 48 per cent. The partners plan to start a phase 1 clinical trial on humans of the second-generation vaccine in the fourth quarter.”
Association of Age and Pediatric Household Transmission of SARS-CoV-2 Infection: “This study suggests that younger children may be more likely to transmit SARS-CoV-2 infection compared with older children, and the highest odds of transmission was observed for children aged 0 to 3 years.”
Covid Vaccines Produced in Africa Are Being Exported to Europe: “South Africa is still waiting to receive the overwhelming majority of the 31 million vaccine doses it ordered from Johnson & Johnson. It has administered only about two million Johnson & Johnson shots. That is a key reason that fewer than 7 percent of South Africans are fully vaccinated — and that the country was devastated by the Delta variant.
At the same time, Johnson & Johnson has been exporting millions of doses that were bottled and packaged in South Africa for distribution in Europe, according to executives at Johnson & Johnson and the South African manufacturer, Aspen Pharmacare, as well as South African government export records reviewed by The New York Times.”
About pharma
Merck joins other drugmakers in cutting off sales to 340B contract pharmacies: “Merck became the latest drugmaker to cut off sales of 340B-discounted products to contract pharmacies, despite warnings from the federal government that similar moves by other companies violate the program’s statute.
The drug giant wrote to 340B entities last week that if they do not join the company’s program integrity initiative then it will cut off sales to most contract pharmacies starting on Sept. 1.”
Blues plans pass on including aducanumab on formulary: A short summary of which plans are not going to cover the drug.
FDA Requests Feedback on Older Approved Generic Drugs: “The FDA is asking for public comments on how it regulates generic drugs that were approved prior to the Hatch-Waxman Amendments of 1984, which established the current abbreviated new drug application (ANDA) process for generics.
Dubbed PANDAs (Pre-Hatch-Waxman ANDAs) by the agency, the drugs were first approved even earlier, between 1938 and 1962, when the agency only required drugs to be proven safe rather than both safe and effective.”
About healthcare IT
Bias and fairness assessment of a natural language processing opioid misuse classifier: detection and mitigation of electronic health record data disadvantages across racial subgroups: “We identified bias in the false negative rate (FNR = 0.32) of the Black subgroup compared to the FNR (0.17) of the White subgroup. Top features included “heroin” and “substance abuse” across subgroups. Post-hoc recalibrations eliminated bias in FNR with minimal changes in other subgroup error metrics. The Black FNR subgroup had higher risk scores for readmission and mortality than the White FNR subgroup, and a higher mortality risk score than the Black true positive subgroup (P < .05).”
AI can lead to both under- and over diagnosis of conditions due to model biases. The authors caution that: “From model design through deployment, bias and data disadvantages should be systematically addressed.”
TELEHEALTH RESEARCH INCUBATOR: Research Snapshots: A really good analysis of the costs and efficiency of telehealth visits. The report lays out a series of questions and then answers them.
For example, telehealth visits, on average, are several minutes longer and cost slightly more than in-person visits. But throughput is higher with telemedicine (no surprise). Telehealth also leads to more followup visits than in-person care.
About the public’s health
Biden administration approves largest increase to food assistance benefits in SNAP program history: “Benefits will rise by 25 percent on average, an infusion of cash that advocates say better reflects the modern cost of a basic diet.”
First Tick-Borne Encephalitis Vax Approved in the U.S.— TicoVac has been available abroad for 45 years: “It has been a long road to U.S. approval for TicoVac, which the manufacturer noted has been approved outside the country since 1976 -- over 170 million doses have been administered since that time. TicoVac, also marketed in Europe under the name FSME-Immun, is an inactivated whole virus vaccine that mimics the tick-borne encephalitis found in nature, and induces neutralizing antibodies against the virus, Pfizer said.”
‘Tainted’ Blood: Covid Skeptics Request Blood Transfusions From Unvaccinated Donors: “‘We are definitely aware of patients who have refused blood products from vaccinated donors,’ said Dr. Julie Katz Karp, who directs the blood bank and transfusion medicine program at Thomas Jefferson University Hospitals in Philadelphia.
In practical terms, blood centers have only limited access to donated blood that has not in some way been affected by covid. Based on samples, Katz estimated that as much as 60% to 70% of the blood currently being donated is coming from vaccinated donors. Overall, more than 90% of current donors have either been infected with covid or vaccinated against it, said Dr. Michael Busch, director of the Vitalant Research Institute, who is monitoring antibody levels in samples from the U.S. blood supply.
’Less than 10% of the blood we collect does not have antibodies,’ Busch noted.”
About healthcare professionals
ASA Position Statement on AANA Name Change: The American Society of Anesthesiologists (ASA) is gravely concerned with the American Association of Nurse Anesthetists’ (AANA) adoption of the new name ‘American Association of Nurse Anesthesiology.’ Medical title misappropriation, including AANA’s name change and their blatant encouragement of their members to use the term ‘nurse anesthesiologist,’confuses patients and creates discord in the care setting, ultimately risking patient safety.
The term ‘anesthesiologist’ has always been used to differentiate physicians trained in the science and study of anesthesiology from non-physicians, including nurse anesthetists.”
About health insurance
More than half of medical practices report being forced to pay to receive electronic payments from insurers: From an MGMA poll:
”Of those who responded “yes” (57%) to being charged fees for EFT payments in the poll:
10% stated they were charged a fee of 1% of their total reimbursement
43% responded they were charged 2%
43% stated they were charged 3%
4% indicated they were charged 4% or more per EFT transaction…
The Association has called on CMS to repost prior industry guidance that was removed in 2017, or for CMS to clearly restate this guidance in a definitive manner. Additionally, MGMA believes if CMS will not provide clear guidance, the agency should clearly state why it is not using its authority to prohibit these abuses.”
Medicare Paid New Hospitals Three Times More for Their Capital Costs Than They Would Have Been Paid Under the Inpatient Prospective Payment System: From the HHS OIG: Medicare regulations require that established hospitals be paid for capital costs through the Inpatient Prospective Payment System (IPPS). These regulations also allow new hospitals to be exempt from the IPPS payment methodology for capital costs and, instead, to be paid for these costs on a cost reimbursement basis for their first 2 years of operation. The stated rationale for this IPPS exemption is that new hospitals may not have adequate Medicare utilization in those initial 2 years and may have incurred significant startup costs.
Our objective was to determine the potential cost savings to Medicare if the IPPS exemption were removed such that capital payments to new hospitals would be paid under the IPPS…
We identified significant potential cost savings to Medicare if the IPPS exemption were removed and capital payments to new hospitals were made through the IPPS. For the 112 new hospitals that we reviewed, Medicare paid a total of $283 million more for capital costs than it would have paid if these hospitals had been paid through the IPPS. The IPPS exemption resulted in new hospitals being paid three times more-or an average of almost $1.3 million more per cost report-under the reasonable cost methodology than if they had been paid for their capital costs under the IPPS…
We recommend that CMS review the findings in this report and, if it determines that a separate payment methodology for capital costs at new hospitals is no longer warranted, change its regulations to require new hospitals to have their Medicare capital costs paid through the IPPS with an option for payment adjustments or supplemental payments if necessary.”
Waste in the Medicare Program: a National Cross-Sectional Analysis of 2017 Low-Value Service Use and Spending: “We used Medicare claims and enrollment data for 100% of fee-for-service beneficiaries aged 65 and older continuously enrolled in parts A, B, and D for two years in 2017: 15,168,134 beneficiaries, requiring at least one and up to three years of claims history preceding the 2017 measurement year…
Among the included beneficiaries, 5,389,619 (35.5%) had at least one low-value service, accounting for 10 million distinct services... The three most frequent services were as follows: opioids for acute low back pain (2.8 million, 28.5%), preoperative baseline laboratory studies (2.6 million, 25.6%), and oral antibiotics for acute upper respiratory or external ear infections (1.4 million, 13.9%)—comprising over two-thirds of low-value services measured (68%).
Cumulative low-value service spending varied from $723 million ($48 per capita) at the claim-line-level to $2.1 billion ($140 per capita) at the claim-level... Spending per service varied from $6.32 for bleeding time testing at the claim-line-level to $7344.39 for renal artery revascularization at the claim-level..”
The total cost of all these unnecessary tests is ~$212.6 billion.
Health Disparities: This link is for an excellent special JAMA issue on this topic.