About Covid-19
CDC signs off on children’s coronavirus vaccine, allowing providers to begin immunizing kids ages 5 to 11 immediately
ADDENDUM: Yesterday, news media reported that global Covid-19 deaths surpassed 5 million. In reviewing the list of countries, China’s absence is notable.
Novavax Files for COVID-19 Vaccine Authorization in Canada, EU: “Novavax has completed regulatory submissions with Health Canada and the European Medicines Agency for authorization of its COVID-19 vaccine, NVX-CoV2373, and said it will seek an FDA Emergency Use Authorization for the shot by year’s end.”
Vaccination and Safety Protocols: From the federal government: Many new answers to questions businesses may have about vaccination status of employees.
About healthcare IT
Northwell Health and Aegis Ventures to form first-of-its-kind artificial intelligence venture to drive better, more equitable, and lower-cost healthcare: “-Northwell Health, New York’s largest healthcare provider, and Aegis Ventures, a New York-based startup studio, today announced they are forming a joint venture (JV) that will ideate, launch, and scale AI-driven companies to address healthcare’s most challenging quality, equity, and cost problems. The JV will assemble leading medical, technology, and business resources to create a first-of-its-kind company creation platform for healthcare innovation. Aegis Ventures intends to invest at least $100 million of seed-stage funds through the platform to catalyze a significant multiple of that amount from the venture capital and investment community.
The JV will work with stakeholders across the Northwell system to create new patient care solutions through collaboration with frontline clinicians, working side-by-side from ideation to implementation, to develop innovations that use AI to predict, diagnose, and manage health conditions. The parties have already started work on solutions related to improving maternal health outcomes and chronic disease prediction.”
About pharma
Opioid Makers Win Major Victory in California Trial: “Four manufacturers of prescription opioids won the pharmaceutical industry’s first major legal victory in the opioid crisis, turning aside claims by local California governments that they contributed substantially to the epidemic…
’There is simply no evidence to show that the rise in prescriptions was not the result of the medically appropriate provision of pain medications to patients in need,’ wrote Judge Peter Wilson of Orange County State Superior Court, who presided over a four-month bench trial.
The manufacturers include Johnson & Johnson, which has a nationwide opioids settlement offer pending; Teva, a maker of generic opioids based in Israel; Allergan, a subsidiary of AbbVie; and Endo Pharmaceuticals.”
Federal judge rules HHS' efforts to punish pharma over 340B restrictions 'arbitrary and capricious': “The pharmaceutical industry scored a muted win in its long-running feud with the Department of Health and Human Services (HHS) over 340B program discounts Friday when a federal court judge granted Eli Lilly’s bid to vacate two administrative actions aimed at drugmakers.
U.S. District Court Judge Sarah Evans Barker ruled that a December advisory opinion from HHS’ Office of the General Counsel and a May enforcement letter from the Health Resources and Services Administration (HRSA) were ‘arbitrary and capricious’ and in violation of the Administrative Procedures Act.
But while Barker ordered the two actions to be set aside and vacated, she also specified that HHS did not exceed its statutory authority or act unconstitutionally in regard to the May enforcement letter.”
About hospitals and health systems
National Hospital Flash Report: October 2021: Among the highlights: “High numbers of high-acuity patients coupled with escalating expenses continued to stress the nation’s hospitals and health systems in September. Actual hospital operating margins remained close to the prior month’s levels. The median Kaufman Hall Operating Margin Index was 3.2% in September, not including federal CARES Act funding. With the aid, it was 4.1%…
Expenses continued to climb. Total Expense per Adjusted Discharge was up 2.6% YTD and 12.9% YOY. Labor expenses rose across all measures even as the number of hospital workers per patient bed declined, reflecting higher pay as hospitals compete for healthcare professionals amid nationwide labor shortages. Non-labor expenses also rose due to significant increases in drug and supply expenses driven in part by worldwide supply chain issues.”
About the public’s health
Every Country Affected: The Tobacco Industry Used the COVID-19 Pandemic to Build Influence With Governments in 80 Countries: “A new report from tobacco industry watchdog STOP reveals that the tobacco industry embraced the COVID-19 pandemic as an opportunity to gain influence, meddle in life-saving health policies and secure preferential treatment. Reports from civil society organizations in 80 countries, analyzed in the Global Tobacco Industry Interference Index 2021, show that no country was immune to the industry’s efforts to use lobbying and donations, often connected to pandemic response, to its advantage…”
Among the specific findings: “Although tobacco is an addictive and harmful product, at least ten governments deemed the tobacco industry and cigarettes to be ‘essential’ during the pandemic or a vital part of their economic recovery efforts, including Bangladesh, Brazil, Jordan, Malaysia, New Zealand, Peru and Sudan.
Countries that have not signed the global treaty, the World Health Organization Framework Convention on Tobacco Control (FCTC), face high levels of industry meddling. These include Argentina, the Dominican Republic, Indonesia, Switzerland and the U.S.A.” [Emphases in the original]
About healthcare devices
DRH Proposed Guidances for Fiscal Year 2022 (FY2022): This past week, the FDA’s Center for Devices and Radiological Health (CDRH) published proposed and finalized guidelines for which it is interested in receiving external feedback. Among the targeted areas is Clinical Decision Support Software.
A smart knee implant promises to ‘help write the future of orthopedic technology.’ Surgeons aren’t so sure: Is newer, smarter technology better technology?
“Last month, surgeons implanted the first of a new, souped-up knee implant, developed by Zimmer Biomet as a way to passively collect data about recovery after one of medicine’s priciest and most common procedures…
But the surgeons who will need to embrace the implant caution that while the device has potential, insights are likely far off — if the data turns out to be useful at all.
’Technology has to be proven that it’s going to improve outcomes in order to be used,” Calin Moucha, the chief joint replacement surgeon at the Mount Sinai health system in New York said. “So, you know, even though this sounds like a cool idea … this isn’t going to improve our outcomes.’”
The US Copyright Office just struck a blow supporting the right to repair: “The US Copyright Office is expanding a legal shield for fixing digital devices, including cars and medical devices. This morning, the office submitted new exemptions to Section 1201 of the Digital Millennium Copyright Act, which bars breaking software copy protection. The resulting rules include a revamped section on device repair, reflecting renewed government pressure around “right to repair” issues.
The Register of Copyrights recommends Section 1201 “anti-circumvention” exemptions every three years, a process that has offered legal protections for everything from unlocking cellphones to ripping DVD clips for classroom use. In addition to renewing these and several other exemptions, this latest rulemaking adopts repair-related proposals from the Electronic Frontier Foundation, iFixit, and other organizations.”
EU orders Illumina to keep Grail a separate company: “Illumina announced on Aug 18 that it had completed its acquisition of Grail even though the Commission, which oversees EU competition policy, had not completed its investigation into the merger. That review is currently set to run until Feb. 4….
The measures provide that Grail be kept separate from Illumina and run by independent managers, that the two companies do not share confidential information, the interactions be kept at arms length and that Grail work on alternative options in case the Commission rejected the merger.”
About health insurance
Biden administration doubling down on ACA open enrollment outreach campaigns with health equity in mind: “The Biden administration has extended the Affordable Care Act (ACA) open enrollment period by one month and invested in a more robust outreach campaign as part of its efforts to bolster the legislation.
The Centers for Medicare & Medicaid Services (CMS) kicked off Monday the start of the HealthCare.gov open enrollment period, which has been extended to Jan. 15, 2022…
’Four out of five consumers will be able to find plans for $10 per month or less with this newly expanded financial assistance,’ Brooks-LaSure said during a call with reporters Monday.”
A significant problem that remains is the out-of-pocket expenses.
1 in 3 insured workers would consider leaving jobs if health insurance weren’t a factor: “Key findings
One in three workers (either full-time or part-time) with health insurance (33%) said they would be very or somewhat likely to leave their jobs in the near future if health insurance wasn’t a factor.
26% of Americans with health insurance would be very or somewhat likely to start their own business if health insurance wasn’t a factor.
People who get most of their health insurance information from social media are much more likely to have ever avoided testing (39% of those getting most of their health insurance information from social media vs. 14% of those relying most on other sources) and care (22% vs. 8%) for COVID-19.
A combined 70% of Americans either don’t know whether you can get financial assistance to get a plan from the federal health insurance marketplace (61%) or believe you cannot (9%).”
Geisinger to pay $18.5M to settle allegations of fraudulent billing: “Danville, Pa.-based Geisinger Community Health Services will pay $18.5 million to resolve allegations that it improperly billed Medicare for hospice and home health services, the Justice Department said Nov. 1.
The settlement resolves self-disclosed violations of Medicare billing rules and includes filings submitted by Geisinger between January 2012 and December 2017.
According to the voluntary disclosure, the billing errors were related to Medicare rules involving physician certifications of terminal illness, patient elections of hospice care and physician face-to-face encounters with home health patients.”
Medicare drops end-stage renal disease payment rule that aims to close health equity gaps: “The Centers for Medicare & Medicaid Services (CMS) finalized a rule that updates payment rates for the End-Stage Renal Disease Prospective Payment System (ESRD PPS) and makes changes to the quality incentive program and the ESRD Treatment Choices (ETC) model. The goal of the changes is to encourage dialysis providers to decrease disparities in home dialysis and transplant rates, part of a larger effort by the Biden administration.
It marks the first CMS Innovation Center model to directly address health equity.” [Emphasis added]
Texas Medical Association files suit against surprise billing rule's 'unlawful' arbitration process: “The Texas Medical Association (TMA) has brought a lawsuit against the Biden administration arguing that the interim final rule on surprise billing goes against the intent of Congress and will ultimately harm patients.
Filed Thursday in the U.S. District Court for the Eastern District of Texas, the case (PDF) is an escalation of the broad pushback the Department of Health and Human Services (HHS) received from providers after releasing the interim final rule in late September.”
Teladoc ramping up focus on virtual primary care with plans to take on financial risk: “During the company's third-quarter earnings call last week, Teladoc CEO Jason Gorevic said the company will take on degrees of risk, from clinical measures of care to risk corridors to, ultimately, full capitation.”