About Covid-19
COVID DATA TRACKER WEEKLY REVIEW From the CDC: “Currently, there are 14 (0.43%) counties, districts, or territories with a high COVID-19 Community Level, 175 (5.43%) counties with a medium Community Level, and 3,035 (94.14%) counties with a low Community Level. This represents a very slight (−0.19%) decrease in the number of high-level counties, a small (+1.55%) increase in the number of medium-level counties, and a corresponding (−1.36%) decrease in the number of low-level counties. Twenty-two (39.28%) of 56 jurisdictions had no high- or medium-level counties this week.
To check your COVID-19 community level, visit COVID Data Tracker.”
COVID-19 Travel Recommendations From the CDC: “There are no Level 4 COVID-19 Travel Health Notices at this time.”
See the site for country-specific recommendations.
New CDC team: A weather service to forecast what’s next in pandemic “A new team of federal health scientists officially embarks Tuesday on a mission to provide what has often been absent from the nation’s response to the coronavirus pandemic: better, faster information about what’s likely to happen next in this public health emergency and in future outbreaks…
About 100 scientists will analyze technical data and communicate policy options to decision-makers and the public about how the virus is behaving and who is most at risk — in user-friendly terms…
The Center for Forecasting and Outbreak Analytics, which starts with $200 million in funding, was created last summer to improve understanding by the CDC and the government more broadly of the coronavirus — and future outbreaks — in real time. White House officials plan to formally launch the effort Tuesday at a summit on strengthening U.S. early-warning systems for health threats.”
Moderna's bivalent beta booster betters Spikevax versus omicron, pointing to promise of variant-specific jabs “Moderna’s bivalent COVID-19 vaccine has bettered the antibody response of Spikevax against omicron when given as a booster..
The clinical data are on the bivalent vaccine Moderna developed in response to the beta variant, not the omicron-specific booster it is testing in another phase 2/3 clinical trial.”
Comment: Will we be chasing variants for Covid-19 vaccines as we do annually for influenza vaccines? Regarding the latter, researchers are looking for a “universal vaccine” that will be effective against all strains.
4 Michiganders with COVID-19 strain unique to mink were likely 1st U.S. spillover cases “Four Michiganders — a taxidermist, his wife and two mink farm employees — were infected with a unique coronavirus strain connected to minks, leading Michigan health officials and the CDC to conclude they likely contracted the first known U.S. cases of so-called animal-to-human virus ‘spillover.’
Michigan’s four mink-connected COVID-19 cases — the only known animal-to-human cases in the U.S. to date — infected more people than was previously known.”
About health insurance
Supreme Court nixes appeal on Arkansas' Medicaid work requirements program “The Supreme Court has shot down a case surrounding the legality of Medicaid work requirements, sending the case back to a lower court with instructions to dismiss it entirely.
The decision on Monday in Becerra vs. Gresham comes more than a year after the court canceled oral arguments in the work requirements case in March 2021. While a major policy priority for the Trump administration, President Joe Biden’s Centers for Medicare and Medicaid Services has moved to unwind the requirements.
The Supreme Court remanded the case during back to the U.S. Court of Appeals for the District of Columbia, alongside instructions to dismiss the case as moot. Justices did not elaborate further on the reasons behind the decision, which was included in a list of orders on Monday.”
Medicare Advantage Outperforms Fee-For-Service Medicare on Cost Protections for Low-Income and Diverse Populations “Low-income Medicare beneficiaries are more likely to enroll in Medicare Advantage than higher-income beneficiaries. Over 46 percent of beneficiaries under 200 percent of the Federal Poverty Level (FPL)2 were enrolled in Medicare Advantage, compared with 28 percent of beneficiaries over 400 percent of the FPL (data not shown). The difference between the two programs is growing; in 2018, 40 percent of low-income Medicare beneficiaries chose Medicare Advantage. This 6 percentage point difference is a 15 percent increase year over year in the number of low-income Medicare beneficiaries choosing Medicare Advantage….
On average, beneficiaries enrolled in Medicare Advantage spend less on out-of-pocket costs and premiums than those in FFS Medicare. Medicare Advantage beneficiaries report spending $1,965 less on out-of-pocket costs and premiums compared to FFS Medicare beneficiaries… This difference in out-of-pocket spending has grown by $325 since 2018. Between 2018 and 2019, health care spending rose 5 percent for Medicare Advantage beneficiaries and 9 percent for FFS Medicare beneficiaries.”
Anthem pays $4.5M to Indiana hospitals in ER billing dispute “For five years, health insurer Anthem Inc. has tried to clamp down on what it considered unnecessary, expensive visits to emergency rooms by denying claims or downgrading reimbursements for ER visits that turned out not to be life-threatening…
A group of 11 Indiana hospitals complained that Anthem’s policy was unlawful and breached their contracts, costing them millions of dollars. And a federal arbitrator has agreed, ordering Anthem to pay them $4.5 million.
Anthem, which fought the case for two years, says it has complied with the order.
But the hospitals say they can claim at least another $12 million from Anthem for tens of thousands of additional claims that it says Anthem has downgraded and not paid in full. And the count of improperly denied or downgraded claims, they say, is growing by the day.”
About hospitals and healthcare systems
CMS pitches inpatient payment rule for 2023: 10 things to know “CMS released its annual Inpatient Prospective Payment System proposed rule April 18, which proposes a reimbursement boost for acute care hospitals.
A really good summary of some of the major features of the 1,786-page proposed rule. The comment period closed on June 17.
Focusing on the overall payment and implications is: Hospitals to receive a proposed 3.2% payment increase in 2023 “CMS estimates that payments to hospitals will increase in 2023 by $1.6 billion. The proposed increase applies to acute care hospitals that successfully participate in the Hospital Inpatient Quality Reporting Program and are meaningful electronic health record users.
The 3.2% increase reflects a market basket update of 3.1% reduced by a projected 0.4 percentage point productivity adjustment and an increase of 0.5% required by statute. In addition, CMS projects Medicare disproportionate share hospital payments and Medicare uncompensated care payments combined will decrease by approximately $0.8 billion…
In addition, in this proposed rule, CMS is proposing to suppress the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) and five Hospital Acquired Infection measures for the 2023 program year. Similarly, CMS is proposing to suppress all six measures in the Hospital-Acquired Condition Reduction Program for the 2023 program year. If finalized, hospitals would not be given a measure score, a Total HAC score, or receive a payment penalty.”
The AHA has expressed mixed feelings about these proposals in this press release: AHA Statement on FY 2023 Proposed IPPS Rule
About pharma
After rivals' FDA rebuffs, GSK targets class-first oral approval in chronic kidney disease anemia “The FDA has accepted GSK’s application for daprodustat as an oral therapy for patients with anemia of chronic kidney disease (CKD), the company said Tuesday. The FDA plans to deliver its daprodustat verdict by Feb. 1, 2023, GSK said…
Overall, daprodustat’s studies showed the drug helped improve or maintain target hemoglobin levels without an increase of major cardiovascular events versus standard of care—an erythropoietin stimulating agent (ESA)—across both dialysis and non-dialysis patients, GSK said.”
Comment: Dialysis is a bundled service, and, according to CMS, includes “Erythropoiesis stimulating agents (ESAs) and their oral or other forms of administration that are for the treatment of ESRD.” It will be interesting to see how GSK prices this oral medication vis-a-vis the generically-available injectable agents.
Johnson & Johnson, after weak quarter of vaccine sales, will no longer include it in guidance “Johnson & Johnson never came up with a name for its COVID-19 vaccine. Similarly, it never found a niche for the jab, despite its hype as a convenient single-shot option to the double-dose vaccines from Moderna, Pfizer-BioNTech and AstraZeneca.
And after a disappointing quarter of sales, the company will no longer include…the vaccine in its revenue projections…
J&J's COVID vaccine sales for the first quarter were $457 million, far off from Wall Street’s estimate of $785 million. In January, when the company reported that 2021's vaccine sales reached $2.4 billion, it projected 2022 sales to come in at between $3 billion and $3.5 billion.”
Johnson & Johnson inks $99M opioid settlement with West Virginia: report “J&J stated that the $99 million settlement will directly support local community efforts to seek “meaningful progress” in addressing the opioid crisis in West Virginia. The company emphasized that its marketing and promotion of prescription opioid medications were “appropriate and responsible” and that its three opioid medications accounted for less than 1% of total opioid prescriptions in West Virginia and the U.S. since launch.
Echoing its previous statements regarding opioid addiction settlements, J&J said the settlement is not an admission of liability or wrongdoing.”
Biotech's top 10 money raisers of 2021 FYI
About the public’s health
Weekly U.S. Influenza Surveillance Report From the CDC:
—The cumulative hospitalization rate in the FluSurv-NET system is higher than the end-of-seasons rates for the 2020-2021 and 2011-2012 seasons, but lower than the rate seen at this time during the four seasons preceding the COVID-19 pandemic.
—Three influenza-associated pediatric deaths were reported this week. There have been 19 pediatric deaths reported this season.
—CDC estimates that, so far this season, there have been at least 4.3 million flu illnesses, 42,000 hospitalizations, and 2,500 deaths from flu.”
Potential Gains in Life Expectancy [LE] Associated With Achieving Treatment Goals in US Adults With Type 2 Diabetes “This study quantified the potential gains in LE associated with different levels of biomarkers in patients with diabetes. Differences in HbA1c and BMI were found to have the strongest association with LE gain from a population perspective. At the individual level, we observed a large variation in the benefits associated with better diabetes care, associated with patients’ individual characteristics. The benefit of biomarker control was most pronounced in younger adults, and diminished as people aged. Better control of biomarkers can potentially increase the LE by 3 years in an average person with T2D in the US. For individuals with very high levels of HbA1c, SBP, LDL-C, and BMI, controlling biomarkers can potentially increase LE by more than 10 years.”
Comment: The benefit of “tight control” of diabetes has been contentious. This study gives some credence to its value.
Johns Hopkins Beats $1B Guatemalan Syphilis Study Suit “A Maryland federal judge on Monday freed Johns Hopkins University and the Rockefeller Foundation against a $1 billion suit filed by Guatemalans who claimed that the institutions participated in controversial syphilis experiments on them in the 1940s, finding two doctors involved in the experiments didn't act on their behalf. U. S. District Judge Theodore D. Chuang said there wasn't sufficient evidence to show that the Rockefeller Foundation was responsible for the acts of two doctors or that university professors conspired to violate the Alien Tort Statute in a suit over experiments performed on more than 1,300 prisoners, soldiers and psychiatric patients…”
While many people are familiar with the Tuskegee study, this “research” is less well-known. For more information, see: First, Do No Harm: The US Sexually Transmitted Disease Experiments in Guatemala
About healthcare personnel
HHS directs $227M toward community health worker training programs “The Biden administration is directing $226.5 million in American Rescue Plan funding toward a new multiyear training program for community health workers and health support workers, the U.S. Department of Health and Human Services (HHS) announced Friday.
Funded using American Rescue Plan dollars, the Community Health Worker Training Program aims to add 13,000 new professionals the administration said play a vital role in connecting the public to local health resources.”