About Covid-19
J&J seeks US clearance for COVID-19 vaccine booster doses: “Johnson & Johnson asked the Food and Drug Administration on Tuesday to allow extra shots of its COVID-19 vaccine as the U.S. government moves toward expanding its booster campaign to millions more vaccinated Americans.
J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company’s one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators.”
CMS: Employer plans can't deny benefits to unvaccinated customers but can offer premium discounts: “Employer group health plans cannot deny benefits to customers who have not gotten the COVID-19 vaccine but can offer premium discounts to customers who decide to get the shot, new guidance from the Centers for Medicare & Medicaid Services (CMS) said.
But plans that increase premiums on the unvaccinated will have that increase count toward whether that coverage is affordable under the Affordable Care Act (ACA).”
EMA panel backs broad use of Comirnaty as COVID-19 vaccine booster dose in adults: “The European Medicines Agency announced Monday that a booster dose of Pfizer and BioNTech's mRNA-based COVID-19 vaccine Comirnaty may be considered at least six months after the second dose for people aged 18 years and older. The regulator noted that the Committee for Medicinal Products for Human Use (CHMP) is currently evaluating data on a booster dose of Moderna's mRNA-based vaccine Spikevax.
According to the EMA, the committee looked at data showing a rise in antibody levels when a booster dose of Comirnaty is given approximately six months after the second shot in people from 18 to 55 years old. The agency added that the risk of inflammatory heart conditions or other very rare side effects after a booster is not known and is being monitored.”
AstraZeneca seeks FDA emergency nod for antibody to prevent COVID-19: “AstraZeneca announced Tuesday that it submitted an emergency-use authorisation (EUA) request to the FDA for AZD7442, its long-acting antibody combination, for prophylaxis of symptomatic COVID-19. The company, which noted that this is the first regulatory filing for AZD7442, is currently in talks with the US government regarding a supply agreement.”
FOR UNVACCINATED, REINFECTION BY SARS-COV-2 IS LIKELY: “Strong protection following natural infection is short-lived.
’Reinfection can reasonably happen in three months or less,’ said Jeffrey Townsend, the Elihu Professor of Biostatistics at the Yale School of Public Health and a lead author of the study. ‘Therefore, those who have been naturally infected should get vaccinated. Previous infection alone can offer very little long-term protection against subsequent infections.’”
A year after COVID vaccine waiver proposal, WTO talks are deadlocked: “Trade sources on Monday say negotiations are deadlocked and directionless a year after South Africa and India introduced a proposal to temporarily waive intellectual property rights on COVID-19 vaccines and therapies at the World Trade Organization, as reported by the Financial Post.
Over 100 nations backing the waiver believe it will help save lives by allowing developing countries to produce COVID-19 vaccines. Yet, a handful of countries remain opposed. In May, Washington threw its weight behind the proposal, raising expectations of a breakthrough that has so far failed to materialize.”
Johnson & Johnson asks FDA to authorize booster shot: “Pharmaceutical company Johnson & Johnson on Tuesday asked the Food and Drug Administration to grant emergency use authorization for a booster dose of its one-shot coronavirus vaccine, becoming the third company to ask the Biden administration to approve additional doses.
The FDA’s expert advisory committee is scheduled to meet Oct. 14 and 15 to discuss whether to authorize both J&J’s and Moderna’s booster shots. The agency already has authorized a booster for people who received Pfizer-BioNTech’s two-shot regimen.”
More memory B cells exist in those fully vaccinated with previous SARS-CoV-2 infection, study says: “A new study by University of Minnesota Medical School researchers is revealing that some people who received an mRNA vaccination for COVID-19 have greater immune responses compared to others. While the vaccine induces strong immune responses against the virus in almost everyone, data shows those who were previously infected with the virus have even greater immune responses after vaccination compared to fully vaccinated people who never had COVID-19.”
Acute Myocarditis Following COVID-19 mRNA Vaccination in Adults Aged 18 Years or Older: “In this population-based cohort study of 2 392 924 individuals who received at least 1 dose of COVID-19 mRNA vaccines, acute myocarditis was rare, at an incidence of 5.8 cases per 1 million individuals after the second dose (1 case per 172 414 fully vaccinated individuals). The signal of increased myocarditis in young men warrants further investigation.”
New study finds that a second dose provides optimal protection to individuals infected between doses: “Previously infected individuals who received one dose of the vaccine had much higher IgG antibody levels than fully vaccinated workers who were never infected. However, infection after the first dose (and before the second) did not increase IgG levels, and individuals infected after the first dose who never received the second had similar antibody levels to those who received one dose and were never infected. Individuals in the cohort infected post-vaccination had IgG antibody levels at 21 and 50 days similar to those never infected who received the same number of doses and much lower than those infected pre-vaccination.”
NICE updates managing COVID guideline with new monoclonal antibody recommendations: “The new advice recommends offering a combination of casirivimab and imdevimab (known as Ronapreve, REGEN-COV, or REGEN-COV2, made by Regeneron Pharmaceuticals) to COVID-19 patients aged 12 and over who are in hospital. Eligible patients will need to be seronegative, meaning they do not have existing levels of SARS-CoV-2 antibodies in their system.
If patients do already have SARS-CoV-2 antibodies (seropositive) or their antibody status cannot be determined, then they should not be offered monoclonal antibody therapy, as they will receive no benefit from the treatment. In comparison, evidence shows that patients who are seronegative see a significant reduction in mortality when compared to normal care.”
J&J’s COVID-19 Shot Might Be Linked to Deep Vein Blood Clotting: “he European Medicines Agency (EMA)’s safety committee said Johnson & Johnson’s (J&J) COVID-19 vaccine might be associated with cases of deep vein blood clotting — such as the leg, arm or groin — and recommended adding the rare side effect to the shot’s product information.
The EMA’s Pharmacovigilance Risk Assessment Committee noted the very rare side effect is separate from the blood clots and low blood platelets previously seen in some recipients of the J&J and AstraZeneca COVID-19 vaccines, which previously prompted the expert panel to call for adding a warning to the labeling information for those products.”
FDA won't extend shelf life of J&J Covid vaccine doses, may extend life of millions of Moderna shots: “The government will not extend the shelf life of hundreds of thousands of unused Johnson & Johnson Covid vaccine doses, but may soon extend the life of millions of Moderna vaccine doses, according to an internal email obtained by NBC News.”
FCC Announces Latest Awards From COVID-19 Telehealth Program: “More than 70 healthcare organizations will received federal funds for new connected health projects through the Federal Communications Commission’s COVID-19 Telehealth Program.
The FCC this week announced a second round of approved applications for the program, which was relaunched this year after a successful run in 2020. The latest round of 72 awards accounts for more than $41 million in funding, following nearly $42 million in awards announced in August for 62 healthcare organizations.
‘The FCC has now approved a total of over $83 million in funding applications for Round 2 of its COVID-19 Telehealth Program,’ Acting FCC Chairwoman Jessica Rosenworcel said in a press release.”
About health insurance
UnitedHealthcare, Anthem behind on billions of payments to hospitals: “The country's two largest insurers — UnitedHealthcare and Anthem — are behind on billions of dollars of payments to hospitals due to new reimbursement rules, claims issues and retroactive claims denials…
For instance, Richmond-based Virginia Commonwealth University Health alleged Anthem owes the provider $385 million, according to the Oct. 5 article. Over 40 percent of payments are more than 90 days old, violating state law dictating that insurers must pay claims within 40 days.
The American Hospital Association told reporters that complaints span across the country. Between June 30, 2019, and June 30, 2021, Anthem's unpaid claims rose from 43 percent to 53 percent, accounting for $2.5 billion.”
Provider Performance and Experiences under the Merit-based Incentive Payment System: From the GAO:
Eight [of 11] stakeholders questioned whether the program helps to meaningfully improve quality of care or patient health outcomes. For example, they said that the design of the program may incentivize reporting over quality improvement, with providers choosing to report on quality measures on which they are performing well, rather than on measures in areas where they may need improvement. [Emphasis added] According to CMS, the MIPS Value Pathways (MVP)—a new way of meeting reporting requirements in 2023—will help to address some of these challenges by standardizing performance measurement across specific specialties, medical conditions, or episodes of care. The development of clinically cohesive sets of measures and activities should minimize providers’ selection burden in choosing measures and activities to report for each MVP, officials said.”
Centene to grow geographic footprint in Medicare Advantage by 26% for 2022: “Centene Corporation will increase its Medicare Advantage (MA) footprint by 26% in 2022, the insurer announced Monday.
The company plans to expand into 327 additional counties and three new states: Massachusetts, Nebraska and Oklahoma. That will bring its reach to 48 million potential beneficiaries across 36 states and 1,575 counties.
At present, Centene boasts 1.1 million MA members in 33 states.”
About hospitals and health systems
Jefferson Health, Einstein Healthcare finalize merger, create 18-hospital system: “More than three years after signing a letter of intent to merge, Jefferson Health and Einstein Healthcare Network have finalized the deal.
The combination of the Philadelphia-based organizations brings together two academic medical centers and creates an integrated 18-hospital system with more than 50 outpatient and urgent care locations.”
About pharma
Henrietta Lacks' family sues biotech company over cells, says it "chose to use her body for profit": “The estate of Henrietta Lacks sued a biotechnology company on Monday, accusing it of selling cells that doctors at Johns Hopkins Hospital took from the Black woman in 1951 without her knowledge or consent as part of ‘a racially unjust medical system.’
The estate's federal lawsuit says Thermo Fisher Scientific Inc., of Waltham, Massachusetts, knowingly mass produced and sold tissue that was taken from Lacks by doctors at the hospital.”
U.S. Supreme Court rejects challenge to New York tax on opioid companies: “The U.S. Supreme Court on Monday cleared the way for New York to collect a $200 million surcharge imposed on opioid manufacturers and distributors to defray the state’s costs arising from the deadly epidemic involving the powerful painkilling drugs.
The justices declined to hear an appeal by two trade groups representing drug distributors and generic drug makers and a unit of British-based pharmaceutical company Mallinckrodt of a lower court’s decision upholding the surcharge.
The law’s challengers included the Association for Accessible Medicines, whose members include drugmakers Teva Pharmaceutical Industries and Mallinckrodt, and the Healthcare Distribution Alliance, which represents wholesale distributors.
The alliance’s members include the three largest drug distributors, McKesson Corp, AmerisourceBergen Corp and Cardinal Health. They recently proposed paying $21 billion to resolve lawsuits accusing them of fueling the epidemic.”
After settling criminal price-fixing case, Novartis' Sandoz inks $185M civil deal with feds: “Nineteen months after settling the criminal portion of a federal price-fixing lawsuit, Novartis' generics unit Sandoz is paying up to resolve civil allegations.
After agreeing to pay $195 million last March to resolve criminal claims related to its part in a price-fixing scheme, the company has now inked a civil deal worth $185 million.
Specifically, the civil portion of the lawsuit relates to illegal payments the companies received for the sale of goods at rigged prices, the feds say.”
Association of Statin Therapy Initiation With Diabetes Progression: “Statin use was associated with diabetes progression in patients with diabetes—statin users had a higher likelihood of insulin treatment initiation, developing significant hyperglycemia, experiencing acute glycemic complications, and being prescribed an increased number of glucose-lowering medication classes.”
About the public’s health
Red Cross asks for routine blood donations amid national shortage: “The national blood inventory is at its lowest level for this time of the year since 2015, according to the Red Cross.
For certain blood types — O positive and O negative — there has been less than a half day’s supply available at times in September. However, the Red Cross said that blood and platelets of all types are needed by hospitals.”
Francis Collins to step down as NIH director by year's end: “National Institutes of Health Director Francis Collins plans to step down by the end of the year after nearly three decades at the agency, including 12 years at the helm, the agency announced Tuesday.
The 71-year-old physician-geneticist led the agency under three consecutive presidents — making him the first presidentially appointed NIH director to serve in more than one administration and the longest-serving NIH director.”
HHS Issues Final Regulation Aimed at Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services: “Today, the U.S. Department of Health and Human Services (HHS) issued a final rule to strengthen the Title X family planning program, fulfilling the Biden-Harris Administration’s commitment to restore access to equitable, affordable, client-centered, quality family planning services. For more than half a century, Title X family planning clinics have played a critical role in ensuring access to a broad range of family planning and preventive health services including breast and cervical cancer screening and STI/HIV testing for than 190 million low-income or uninsured individuals. Title X is the only federal grant program dedicated solely to providing individuals with comprehensive family planning and related preventive health services.”
That's Not Just Gum on the Soles of Your Shoes...: A VERY good reason to take your shoes off when you come in the house:
”In a worldwide analysis of more than 11,500 collected isolates, similar C. diff positivity rates (26%) were found in healthcare (23% in outdoor settings; 17% in public buildings) and non-healthcare (24% and 17%, respectively) settings, reported Jinhee Jo, PharmD, of the University of Houston in Texas, and colleagues.
Shoe soles had the greatest C. diff positivity rate at 45%, Jo said in a presentation at the virtual IDWeek. The most common strains were FP310 (11%) found only in non-healthcare settings, F106 (15%) in both settings, and F014-020 (16%) in both settings.”
About healthcare IT
Leading Health Systems Launch Graphite Health, a New Member-Led Non-Profit Company to Accelerate Digital Transformation of Health Care: “Graphite Health, a member-led company intent on transforming digital health care to improve patient outcomes and lower costs, launched today and announced its first three organizing members, SSM Health, Presbyterian Healthcare Services, and Intermountain Healthcare. Modeled on Civica Rx, a health utility company, Graphite Health will focus on health care interoperability challenges.
Building on a common data language, Graphite Health is creating a standardized, interoperable data platform that enables a secure and open marketplace to streamline the distribution of digital health solutions for both health systems and entrepreneurs. For entrepreneurs, the common data language addresses inefficiencies in data translation and supports the development of plug-and-play digital applications. In turn, health system members can implement trusted digital tools as easily as anyone can download an app from an app store to a smartphone. These improvements will lead to more convenience, better quality care, lower costs, and overall efficiency.”