About Covid-19
Today’s top story:
Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine: “CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. [Emphasis added] This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”
Studies Confirm Racial, Ethnic Disparities In COVID-19 Hospitalizations And Visits: “Days after declaring racism a serious public health threat, the Centers for Disease Control and Prevention released a pair of studies further quantifying the disproportionate impact of COVID-19 on communities of color.
The studies, published Monday in Morbidity and Mortality Weekly Report, examine trends in racial and ethnic disparities in hospitalizations and emergency room visits associated with COVID-19 in 2020.”
B.1.1.7 variant more transmissible but does not increase disease severity, two new studies suggest: “Two new studies suggest that the B.1.1.7 coronavirus variant, which was first identified in the United Kingdom, is more transmissible, but the variant does not appear to impact disease severity…
One of the studies, published on Monday in The Lancet Infectious Diseases, found no evidence in a sample of hospitalized patients that the B.1.1.7 variant is associated with severe Covid-19. However, the variant was associated with increased viral load, which supports the growing evidence that it is more easily transmitted.
The other study, also published Monday in The Lancet Public Health, found no statistically significant association between the B.1.1.7 variant and the types or duration of Covid-19 symptoms people said that they experienced.”
Recent Rise in U.S. Covid-19 Cases Driven by Younger People: “In addition to school sports, large outbreaks have been tied to the recent Easter holiday and spring breaks.” Also, this group is the last to be immunized.
About health insurance
HHS approves waiver for Illinois to expand Medicaid postpartum coverage to one year: “The Department of Health and Human Services (HHS) announced it approved a waiver for Illinois to ensure Medicaid eligibility for pregnant and postpartum women for 12 months [from 60 days], the first state to get such a waiver.
HHS Secretary Xavier Becerra said during a press conference Monday that the wavier approval is part of a series of measures the agency is taking to address maternal health outcomes. Becerra also said HHS has made $12 million in funding available for improving rural health maternal outcomes.”
Beneficiaries in Medicare Advantage Receive Better Value and Spend 40% Less than Beneficiaries in Medicare FFS: The study was done by UnitedHealth, but the numbers ring true: “The annual health care spending—on individual premiums and out-of-pocket (OOP) cost sharing for medical, pharmacy, and ancillary services—by a 73 year-old beneficiary of average health in MA ($3,558) is as much as 41% less than for a comparable beneficiary in FFS.”
Fifth Circuit Court Will Not Reconsider Decision Reversing Ruling That Would Have Awarded Nearly $500 Million To States In A Lawsuit Over ACA’s Insurance Provider Fees: “Modern Healthcare reports the US Court of Appeals for the Fifth Circuit voted 11-5 to ‘not reconsider its decision to reverse a ruling that would have awarded nearly $500 million to states in a lawsuit over the ACA’s insurance provider fees.’ Modern Healthcare adds, ‘The provision required that states--on behalf of their Medicaid Managed Care Organizations--pay the fee to the federal government,’ but ‘the fee was repealed by Congress in 2021.’”
Rectifying the ACA Family Glitch Could Drive ACA Premiums Down: Approximately 5.1 million individuals are caught in the Affordable Care Act’s ‘family glitch,’ according to a recent Kaiser Family Foundation (KFF) analysis.
Under the Affordable Care Act, an employee may qualify for subsidized marketplace coverage if their employer-sponsored health plan’s premium costs more than 9.83 percent of their household income.
However, only the cost of the individual employee’s coverage is taken into account. Dependents are excluded from the calculation.
Thus, if an employee’s premium falls below 9.83 percent of their household income but the cost of adding their dependents puts them above that threshold, the employee nevertheless would not be eligible for lower-cost Affordable Care Act coverage.”
Data Note: 2021 Medical Loss Ratio Rebates: “The ACA requires health insurers to publicly report the portion of their premium dollars spent on health care costs, quality improvement, and other activities in each state they operate in. MLR rebates are based on a 3-year average, meaning that 2021 rebates will be calculated using insurers’ financial data in 2018, 2019, and 2020. Rebates issued in 2021 will go to consumers who were enrolled in rebate-eligible plans in 2020.
Using preliminary data reported by insurers to state regulators and compiled by Mark Farrah Associates, we find that insurers estimate they will be issuing a total of about $2.1 billion across all markets – the second-largest amount since rebates were first issued in 2012 under the ACA. This year’s rebates are roughly $400 million lower than last year’s record high of $2.5 billion, but more than 50% higher than the amount in 2019 ($1.4 billion, which, at the time, was a record high). These amounts are preliminary estimates, and final rebate data will be available later this year. Some insurers have not yet filed their 2021 rebate estimates.”
About healthcare IT
Supreme Court Ruling May Help Providers With mHealth Messaging Strategies: “The court earlier this month sided with Facebook in a case involving the Telephone Consumer Protection Act (TCPA), ruling that the company didn’t have to adhere to TCPA guidelines because it doesn’t use a messaging system that randomly or sequentially stores or generates a telephone number. In doing so, the court essentially redefined an automatic telephone dialing system, or autodialer.
Writing in the Health Care Law Today blog, attorneys for the Foley & Lardner law firm said the court’s ruling will allow healthcare providers to send out ‘health care messages’ by text without needing prior written consent from patients.”
Optum's 8 biggest health IT acquisitions, investments in the past year: FYI.
31 numbers that show how big Epic, Cerner, Allscripts & Meditech are in healthcare: FYI.
One impressive statistic is that more than 250 million patients have an electronic record in Epic.
Direct-To-Consumer Telemedicine Visits For Acute Respiratory Infections Linked To More Downstream Visits: “Use of direct-to-consumer telemedicine—on-demand virtual care for minor medical issues—is growing rapidly. Although it may yield immediate savings by diverting health care from higher-cost settings, these savings could be countered if direct-to-consumer telemedicine increases follow-up care and, therefore, episode costs. Comparing downstream care utilization data from a large, commercial payer for the period 2016–19, we found that patients with initial visits for acute respiratory infection were more likely to obtain follow-up care within seven days after direct-to-consumer telemedicine visits (10.3 percent) than after in-person visits (5.9 percent)…The telemedicine cohort had fewer (0.5 percent versus 0.6 percent) emergency department visits—a small but statistically significant difference—but more subsequent office, urgent care, and telemedicine visits.”
Use of Online Physician Ratings and Reviews by Older U.S. Adults: Results of a National Survey: “In this nationally representative survey, we found that more than 4 in 10 U.S. adults aged 50 to 80 years have now used online physician rating sites. These sources of information are more likely to be used by women, persons with higher levels of education, and those with a chronic medical condition. Numerous other factors seem to be much more influential among older adults when they select a physician, as suggested by previous research. Yet, online ratings and reviews were perceived to be very important nearly as often as word-of-mouth recommendations from family and friends and more often than where a physician trained or attended medical school.”
About pharma
FDA Revokes Five ANDAs for Generic Opioids: “The companies repeatedly failed to file required annual reports for the ANDAs and to ‘satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS), the agency said.
The drugmakers whose ANDAs were revoked are Lavipharm Laboratories of East Windsor, N.J., Scherer Laboratories, based in Plano, Tex., and Everylife of Seattle, Wash.”
FDA names Patrizia Cavazzoni as permanent director of CDER: “The FDA disclosed Monday that Patrizia Cavazzoni was appointed the permanent director of the agency's Center for Drug Evaluation and Research (CDER). She had been heading the division on an interim basis since last year when Janet Woodcock, currently the FDA's acting commissioner, relinquished the role to help lead an effort to accelerate COVID-19 therapies under Operation Warp Speed.”
The Biden administration has been slow to appoint permanent personnel at the FDA, so this action is an important step.
Biden picks former New Jersey attorney general to lead DEA: “President Biden has selected Anne Milgram, a former state attorney general, prosecutor and longtime advocate for reform of the criminal justice system, to lead the Drug Enforcement Administration, the White House announced on Monday.”
MIT and UCSF researchers create CRISPR 'on-off switch' that controls gene expression without changing DNA: Fascinating technology that could, in some cases, bypass some of the “cutting errors” of CRISPR procedures.
”The gene editing system CRISPR-Cas9 makes breaks in DNA strands that are repaired by cells—a process that can be hard to control, resulting in unwanted genetic changes. Researchers at the Massachusetts Institute of Technology and the University of California, San Francisco (UCSF) designed an alternative technology that changes gene expression without damaging DNA, and they believe it could be useful for both research and drug development.
The researchers used their system, dubbed CRISPRoff and CRISPRon, to induce pluripotent stem cells to transform into neurons. They also used it to silence the gene that makes the protein Tau, which has been implicated in Alzheimer’s disease. They described their research in the journal Cell.”
2021 Global RepTrak 100: Pharma, biotech and life sciences rank 8th among 13 industries. This reputation survey is fascinating. The overall #1 company is LEGO.