About Covid-19
Sweeping new vaccine mandates for 100 million Americans: The big story is the President’s announcement of federal mandates/initiatives to require vaccination. A key to this requirement is using federal payments as a criterion. This link is to a clear, accessible article about the announcement.
But, of course: Republican governors threaten to sue over Biden’s sweeping vaccine mandates
And in another related article: Businesses Question Logistics, Cost of Biden Vaccine Plan: For example, “Betsy Booren, vice president of regulatory and technical affairs for the association, said packaged-goods companies now face pressing questions such as how to document compliance and how their performance will be tracked. Businesses are also dealing with ‘vaccine hesitancy’ in the workforce, which is compounded by the fact that only the Pfizer-BioNTech shot has been fully cleared by regulators. Industry-specific guidelines from different regulators will also be key, she said.”
Unvaccinated people were 11 times more likely to die of covid-19, CDC report finds: “People who were not fully vaccinated this spring and summerwere more than 10 times more likely to be hospitalized, and 11 times more likely to die of covid-19, than those who were fully vaccinated, according to one of three major studies published Friday by the Centers for Disease Control and Prevention that highlight the continued efficacy of all three vaccines amid the spread of the highly contagious delta variant.
A second study showed that the Moderna coronavirus vaccine was more effective in preventing hospitalizations than its counterparts from Pfizer-BioNTech and Johnson & Johnson. That assessment was based on the largest U.S. study to date of the real-world effectiveness of all three vaccines, involving about 32,000 patients seen in hospitals, emergency departments and urgent-care clinics across nine states from June through early August.”
An Anti-Vaccine Book Tops Amazon's COVID Search Results. Lawmakers Call Foul: “Amazon is under pressure from Democrats in Congress over how its algorithms promote hoax COVID-19 cures, including the livestock dewormer ivermectin, as well as anti-vaccination claims and other medical misinformation.”
Lilly's COVID-19 antibody combo cleared for nationwide use as feds say it can tackle the dominant delta variant: “Only a few days after Eli Lilly's COVID-19 antibody combo of bamlanivimab and etesevimab made its return to more than 20 states, federal officials are resuming distribution nationwide.
In a Thursday alert, officials said Lilly's drug "can be used in all U.S. states, territories, and jurisdictions" based on data about variants circulating nationwide. Since Eli Lilly's combo is expected to be effective against the delta variant—and because that variant is now dominant in the United States—officials are ready to again endorse the drugs.”
An average Covid-19 hospitalization costs Medicare about 150 times more than it does to vaccinate one beneficiary: “Covid-19 vaccines are provided at no direct cost to residents of the United States, but Medicare reimburses health care providers up to $150 to fully vaccinate beneficiaries with both doses of the two-dose regimen vaccines by Pfizer/BioNtech and Moderna, per billing documents published by the US Centers for Medicare and Medicaid Services. That's $40 for each dose administered and $35 to administer the shots at the individual's home or group living setting.
Meantime, the average cost to hospitalize a Medicare beneficiary with Covid-19 is $21,752 over an average stay of 9.2 days, according to research published in August in the Annals of Internal Medicine. That's approximately 145 times the cost of vaccinating a Medicare beneficiary.”
About pharma
Comprehensive Plan for Addressing High Drug Prices: A Report in Response to the Executive Order on Competition in the American Economy: This report, released yesterday, “presents principles for equitable drug pricing reform through competition, innovation, and transparency; describes promising legislative approaches; and summarizes actions already underway or under consideration across the Department of Health and Human Services (HHS)…
The report identifies three guiding principles for drug pricing reform:
Make drug prices more affordable and equitable for all consumers and throughout the health care system - Support drug price negotiation with manufacturers and stop unreasonable price increases to ensure access to drugs that can improve health for all Americans
Improve and promote competition throughout the prescription drug industry - Support market changes that strengthen supply chains, promote biosimilars and generics, and increase transparency
Foster scientific innovation to promote better health care and improve health - Support public and private research and make sure that market incentives promote discovery of valuable and accessible new treatments, not market gaming
Support for Bold Legislative Action. The report highlights potential legislative policies Congress could pursue to advance the principles described above, including:
Drug price negotiation in Medicare Parts B and D, with those negotiated prices also available to commercial plans (including the Marketplace) and employers who want to participate
Medicare Part D reform, including a cap on catastrophic spending to protect beneficiaries from unaffordable out-of-pocket costs
Legislation to slow price increases over time on existing drugs
Legislation to speed the entry of biosimilar and generic drugs, including shortening the period of exclusivity, and policies in Medicare Part B to increase the prescribing of biosimilars by clinicians
Prohibition on “pay-for-delay” agreements and other anti-competitive practices by drug
manufacturers
Investment in basic and translational research to foster innovation, including the President’s proposal to create the Advanced Research Projects Agency for Health (ARPA-H)”
GSK, Pfizer and Johnson & Johnson race toward $10B-plus RSV vaccine market: analyst: “GSK, Pfizer and GlaxoSmithKline are all in late-stage testing for their RSV shots. Sanofi, while it's a leading vaccine player worldwide, is taking another approach with its late-stage RSV program. The company and partner AstraZeneca are working on a prophylactic monoclonal antibody for infants, and they plan to file for approval next year.”
BMS, Pfizer Snag Appeals Court Victory for Blockbuster Eliquis: “The U.S. Court of Appeals for the Federal Circuit has upheld a prior victory for Bristol Myers Squibb and Pfizer covering two Eliquis (apixaban) patents, positioning the companies to keep exclusivity in the U.S. for the blockbuster oral anticoagulant until April 1, 2028.
The case hinged on the drug’s composition of matter patent and a formulation patent. In a court ruling in August 2020, the U.S. District Court for the District of Delaware found that the two patents in question were valid and infringed.”
FDA Revises Q&A Guidance on Pandemic-Era Generic Drug Development: “The FDA has revised its guidance on generic drug development and application submission during the COVID-19 public health emergency, providing additional information and clarification of existing policies but no policy changes.
First published in April of this year, Development of Abbreviated New Drug Applications (ANDAs) During the COVID-19 Pandemic — Questions and Answers is a compilation of questions from industry and answers from FDA about generic drug product development and application assessment during the pandemic. Topics also include marketing and exclusivity.”
Amazon-backed biotech Mammoth raises $200m for diseases push: “Mammoth Biosciences, the biotech co-founded by Nobel Prize winner Jennifer Doudna and that counts Amazon as a backer, has raised almost $200m to expand its use of novel Crispr-associated proteins into an effort to cure genetic diseases. The California-based start-up is now valued at $1bn following a $150m round led by venture capitalists Redmile Group, with participation from Foresite Capital. It follows a $45m fundraising the company had in late 2020. Mammoth hunts the world for new versions of the bacterial immune system that can be used as a gene-editing tool known as Crispr, or clustered regularly interspaced short palindromic repeats.”
Bausch pays whopping $300M to settle Glumetza pay-for-delay lawsuit after 800% price hike: “Bausch Health, which industry watchers may remember by its former name Valeant, has been riddled in controversy for years over its defense of diabetes med Glumetza. Now, the company will pay millions to put those charges to rest.
Bausch has agreed to dish out $300 million to settle a 2019 lawsuit that claimed the Canadian drugmaker paid off its generic rivals nearly a decade ago, allowing the company to jack up prices for the type 2 diabetes heavyweight by 800% shortly thereafter, according to a Wednesday court filing.”
About health insurance
Cigna, Oscar Health expanding cobranded plans into Illinois: “Cigna and Oscar Health are expanding their cobranded health plans in Illinois, the companies announced on Thursday.
The plans, which target small businesses, will be available in Chicago, as well as DuPage, Kane, Lake and McHenry counties. The expanded footprint is pending regulatory approval…
The plans, which are available for companies with between zero and 50 employees, are built on Cigna's provider network in tandem with Oscar's technology stack.
The partner plans have been scaling up its footprint at a rapid clip, expanding into additional areas of California and into Connecticut.”
UnitedHealth hit with class-action reimbursement suit: “A class-action lawsuit filed Sept. 7 accuses UnitedHealth of failing to fairly reimburse out-of-network providers by bypassing rates established by vendor contracts.
Specifically, the lawsuit points to member experiences that allege UnitedHealth ignored discounted rate agreements between vendors and providers, allegedly violating vendor contract plans.
The move is a violation of the Employee Retirement Income Security Act of 1974, the lawsuit alleges, as the uneven application of rates benefits the insurer and its employer customers, not members.
The plaintiffs include three health plan members whose coverage is either administered or underwritten by UnitedHealthcare, all of whom are representing similar parties.”
About hospitals and health systems
Nonprofit hospitals provided $105B in community benefits in 2018: AHA: “Tax-exempt hospitals spent $105 billion on community benefits in 2018, according to a new report from the American Hospital Association.
Nonprofit hospitals are exempt from paying taxes. In return, they provide community benefits such as charity care, financial assistance programs, population health initiatives, underwriting medical research, among other benefits.
The new AHA analysis examined hospital and health systems' group and individual Schedule H tax filings submitted to the Internal Revenue Service for tax year 2018, the most recent data available.
The AHA report found that tax-exempt hospitals spent 13.9 percent of their total annual expense on community benefits. Further about half, 6.4 percent, of that expense involved offering financial assistance to patients and subsidizing underpayments from Medicaid and other government payers.”
HCA sells off dozens of its newly acquired home care locations to keep the focus on core networks: “HCA Healthcare just locked in its $400 million majority stake purchase of Brookdale Senior Living’s home health and hospice business in July, yet the hospital chain is already looking to trim off the fat with some extra dealmaking.
On Wednesday, the hospital chain announced that it has entered into a preliminary agreement with home care provider LHC Group to sell off nearly 50 home health locations, hospices and therapy agencies across 22 states.”
Challenges to Public Health Reporting Experienced by Non-Federal Acute Care Hospitals, 2019: An ONC Data Brief. Note the date of the study; it was published this month.
HIGHLIGHTS:
“In both 2018 and 2019, half of all hospitals reported a lack of capacity to electronically exchange information with public health agencies.
In 2019, seven in ten hospitals experienced one or more challenges related to public health reporting.
Small, rural, independent, and Critical Access hospitals were more likely to experience a public health reporting challenge compared to their counterparts.
The types of public health reporting challenges experienced by hospitals varied substantially at the state-level.”