About Covid-19
Trends in Number of COVID-19 Cases and Deaths in the US Reported to CDC, by State/Territory Reported COVID-19 cases in the U.S. are no longer dropping and began to plateau around June 8.
FDA panel split on approach to COVID-19 vaccines for younger children: “Members of the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) disagreed as to whether the agency should grant emergency use authorizations (EUAs) for COVID-19 vaccines for children at a 10 June meeting.
Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as the fall and flu season approach and the risk of contracting respiratory infections increases…
Some members of the committee who were wary of EUAs in younger age groups said there was insufficient justification and safety data to support emergency use in this population and were concerned about recent reports from Israel that cited elevated cases of myocarditis, or inflammation of the heart, in males ages 16 to 30 who received both doses of Pfizer-BioNTech’s mRNA-based vaccine Comirnaty.”
Diabetes mainstay metformin tamps down lung inflammation in COVID models: “The researchers tested metformin in a mouse model of severe lung inflammation that can result from COVID-19—a dangerous condition called acute respiratory distress syndrome (ARDS). The drug inhibited the onset of ARDS and relieved its symptoms, they reported in the journal Immunity.”
AstraZeneca's COVID-19 antibody combination fails post-exposure prevention trial: “AstraZeneca’s anti-SARS-CoV-2 antibody combination has failed a phase 3 clinical trial designed to assess its ability to prevent symptomatic COVID-19 in people recently exposed to the pandemic coronavirus.
While the Storm Chaser study missed its primary endpoint, a subgroup analysis of people who tested negative for COVID at baseline offered encouragement to AstraZeneca.”
Many Post-Covid Patients Are Experiencing New Medical Problems, Study Finds: “The study, tracking the health insurance records of nearly two million people in the United States who contracted the coronavirus last year, found that one month or more after their infection, almost one-quarter — 23 percent — of them sought medical treatment for new conditions.
Those affected were all ages, including children. Their most common new health problems were pain, including in nerves and muscles; breathing difficulties; high cholesterol; malaise and fatigue; and high blood pressure. Other issues included intestinal symptoms; migraines; skin problems; heart abnormalities; sleep disorders; and mental health conditions like anxiety and depression.”
NIH study suggests coronavirus may have been in U.S. as early as December 2019: “The new report, published in the journal Clinical Infectious Diseases, bolsters earlier studies indicating that the virus entered the country under the radar and may have been spreading in the first two months of 2020, well in advance of warnings to that effect from the Centers for Disease Control and Prevention.
A volunteer in Illinois who gave blood on Jan. 7, 2020 — in a study unrelated to the emergent virus — tested positive for antibodies to SARS-CoV-2, according to the NIH report. It noted that the antibodies typically take 14 days, on average, to develop, and this ‘suggests the virus may have been present in Illinois as early as December 24, 2019.’”
About pharma
Mississippi becomes the first state to jointly sue drug makers and PBMs over the cost of insulin: “In a first-of-its-kind move, the Mississippi attorney general last week filed a lawsuit accusing several drug makers and pharmacy benefit managers of conspiring to set prices for insulin, the life-savings diabetes treatment that has become a poster child for the high cost of prescription medicines.
The lawsuit alleged that the manufacturers benefited from a scheme in which prices were ‘artificially’ inflated to win placement on formularies, the list of medicines for which insurance is provided.”
Teva Files Lawsuit Against Eli Lilly Over Patents for Migraine Drug: “Teva Pharmaceuticals has filed a new patent infringement complaint against Eli Lilly over competing migraine drugs.
Teva’s latest suit in an ongoing battle with Eli Lilly came just hours after the U.S. Patent and Trademark Office issued two new patents on Teva’s migraine drug, Ajovy (fremanezumabin).”
Divisive Drug Patent Proposal From Trump Era Is on Biden Agenda: “The Biden administration is forging ahead with a divisive, Trump-era regulatory proposal that would limit the government’s ability to control prices on drugs developed from federally funded research.
The National Institute of Standards and Technology set an October deadline to update the Bayh-Dole Act, the 1980 law that enables universities to retain patent rights on inventions discovered from government-funded research. The proposal would clarify the law—which allows the government to step in and license federally funded inventions to third parties in certain circumstances—can’t be exercised by an agency primarily to lower costs.
The government has consistently rebuffed calls to use “march-in rights” to control the price of certain medicines. But pressure to do so has mounted during the pandemic, with lawmakers and activists urging the Biden administration to seize control of Covid-19 treatments to ensure more widespread availability.”
Association of California’s Prescription Drug Coupon Ban With Generic Drug Use: “Drug manufacturers sometimes offer co-payment coupons to offset patient out-of-pocket costs. Although coupons can help patients afford necessary medications, they increase overall drug spending by encouraging use of expensive brand-name drugs over less expensive generics. Coupons are prohibited by Medicare and Medicaid, but they are available for commercially insured patients. Several states are considering restricting coupon use to promote generic substitution and control drug spending. In October 2017, California passed a law that banned use of co-payment coupons for brand-name drugs once interchangeable generic versions of those products have become available…
[The law] banning use of co-payment coupons for brand-name drugs with direct generic competitors was associated with no significant increase in generic substitution in its first year.”
About healthcare devices
Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices: “Following the company update on April 26, 2021, Royal Philips… provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.” The foam can degrade into a carcinogen.
Do Magnets in Consumer Electronics Disable Implanted Medical Devices?: “‘We believe the risk to patients is low and the agency is not aware of any adverse events associated with this issue at this time,’ Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. Yet as more products containing strong magnets are expected to come on the market, the agency offered precautions for consumers who have implanted devices including pacemakers and implantable defibrillators.”
About health insurance
AMERICAN RESCUE PLAN IMPACT: MORE THAN 1M CONSUMERS PAY LESS THAN $10 PER MONTH: “The Centers for Medicare & Medicaid Services (CMS) released a report Monday morning that found more than 1 million consumers have coverage through HealthCare.gov that costs $10 or less per month.
The findings underscore the financial impact of the advance payments of premium tax credits (APTC) introduced through the American Rescue Plan (ARP), which President Joe Biden signed into law in March.”
Humana to acquire onehome in bid to expand value-based home care: “Humana will acquire One Homecare Solutions, or onehome, in a bid to grow its value-based home healthcare offerings…
The home health company has provided care to Humana members since 2015 and has pioneered a value-based model in both Texas and Florida.”
Centene to pay more than $140M to settle Medicaid overpayment allegations in Ohio, Mississippi: “Centene will pay $143 million to settle allegations from attorneys general in two states that a pharmacy benefit manager subsidiary misrepresented costs to obtain Medicaid overpayments.”
About hospitals and health systems
Hospitals held for ransom by flood of robocalls: 5 details: “Robocalls are the No. 1 consumer complaint filed with the Federal Communications Commission, and robocalls to hospitals are a significant portion of the problem, creating a new type of ransomware attack on hospitals and a threat to public safety.
The illegal calls flood hospital networks and are often perpetuating fraud. The nonstop flow of calls undermines hospitals' ability to perform patient care by keeping staff on phone lines unnecessarily and impairing operational capacity, according to a June 11 FCC news release.”
How America’s top hospitals hound patients with predatory billing: A really good investigative piece in Axios. Some highlights:
—”Just 10 hospitals are responsible for 97% of court actions against patients” By far, the most actions are by VCU Medical Center in Richmond, VA
—”The top 100 hospitals, on average, charged patients 7x the cost of service, with markup calculated from the American Hospital Directory's cost-to-charge ratio. And private, for-profit hospitals average nearly a 12x markup.”
Check the Figures as well.
Best Children’s Hospitals by Specialty: From US News.
Early Hospital Compliance With Federal Requirements for Price Transparency: “As of March 2021, a small proportion of US hospitals were compliant with the major requirements of the new federal rule requiring disclosure of negotiated prices. Hospitals exhibited selectively higher compliance with the requirement of a price estimator for patients to view personalized out-of-pocket costs for shoppable services; a smaller proportion made their data fully accessible to the public by posting a machine-readable file with payer-specific negotiated rates.
Selective compliance was especially pronounced for the 100 highest-revenue hospitals, a low proportion of which fully disclosed their negotiated rates despite high compliance with the price estimator tool requirement.”
California lawmakers blast HCA-owned hospital, allege dangerous staffing levels, hostile management: “The letter, signed by state Sen. Dave Cortese, Assemblyman Ash Kalra and Assemblyman Alex Lee, accuses Good Samaritan of having dangerous staffing levels despite its parent company reporting a $3.7 billion profit last year.”
About healthcare IT
Health Union Acquires WEGO Health: From the press release: “ Health Union, the leader in building online health solutions for people living with chronic conditions, today announced that it has acquired WEGO Health, the world's largest network of patient leaders - advocates, community leaders, creators and influencers. Combining Health Union's targeted scale and depth in the condition experience with WEGO Health's breadth of patient leaders in nearly all health conditions, Health Union aims to change the face of social health, connecting people in meaningful and innovative ways.”