About COVID-19
Hackers altered Moderna, Pfizer data from EU before posting online to undermine public's trust in vaccines: “Hackers who leaked the European Medicines Agency's COVID-19 vaccine data from Moderna and Pfizer manipulated the information before publishing it online, the EMA announced Jan. 15.
In an update on the cyberattack, the EMA said the leaked documents included internal and confidential emails about the COVID-19 vaccine evaluation process and that ‘some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.’”
US approaches 400,000 coronavirus deaths: “The US recorded 1.5 million new Covid-19 cases in the past seven days, according to the most recent data from Johns Hopkins University, an 11% drop from the previous week. Cases declined in 35 states week-over-week, and 18 states saw a drop in the number of deaths.
But with a longer range view, last week's apparent improvement falls much closer to average. Over the past month, the number of new Covid-19 cases recorded each day has ranged from nearly 101,000 to more than 302,000; over the past seven days, new cases averaged about 218,000 daily.”
Emergence of SARS-CoV-2 B.1.1.7 Lineage — United States, December 29, 2020–January 12, 2021: “A more highly transmissible variant of SARS-CoV-2, B.1.1.7, has been detected in start highlight12end highlight U.S. states…
The increased transmissibility of the B.1.1.7 variant warrants universal and increased compliance with mitigation strategies, including distancing and masking. Higher vaccination coverage might need to be achieved to protect the public. Genomic sequence analysis through the National SARS-CoV-2 Strain Surveillance program will enable a targeted approach to identifying variants of concern in the United States.”
Biden pledges to build scores of new vaccine sites and prioritize older Americans: “President-elect Joe Biden pledged to put Americans 65 and older near the front of the line for coronavirus vaccines and to expand the number of vaccination sites to quickly make up for the Trump administration's bungled response.
Biden vowed to use available supplies more efficiently and equitably to supercharge the effort to get shots into arms after Trump’s promise to vaccinate 20 million people before Jan. 1 fell far short.”
Israel trades Pfizer doses for medical data in vaccine blitz: “After sprinting ahead in the race to inoculate its population against the coronavirus, Israel has struck a deal with Pfizer, promising to share vast troves of medical data with the international drug giant in exchange for the continued flow of its hard-to-get vaccine.”
The Trump administration bailed out prominent anti-vaccine groups during a pandemic: “Five prominent anti-vaccine organizations that have been known to spread misleading information about the coronavirus received more than $850,000 in loans from the federal Paycheck Protection Program, raising questions about why the government is giving money to groups actively opposing its agenda and seeking to undermine public health during a critical period.
The groups that received the loans are the National Vaccine Information Center, Mercola Health Resources, the Informed Consent Action Network, the Children’s Health Defense and the Tenpenny Integrative Medical Center, according to the Center for Countering Digital Hate, an advocacy group based in the United Kingdom that fights misinformation and conducted the research using public documents. The group relied on data released in early December by the Small Business Administration in response to a lawsuit from The Washington Post and other news organizations.”
Previous coronavirus infection may offer less protection from new variant: “Previous infection with the coronavirus may offer less protection against the new variant first identified in South Africa, scientists said on Monday, although they hope that vaccines will still work.
Studies also found that the new variant binds more strongly and readily to human cells. That helps explain why it seems to be spreading around 50% quicker than previous versions, leading South African epidemiologist Salim Abdool Karim said.”
Key Capital COVID-19 Oral Pill Vaccine Records 90% Reduction in Virus Infectivity in Early Study: “The preliminary tests conducted by a leading Asian research institute have shown safety and a 90% reduction on virus infectivity in mammalian cells following exposure to the active vaccine. This laboratory testing highlights the vaccine methodology and ability to inactivate and/or prevent viral infection and its potential for oral mucosal administration.”
WHO cites human behavior more than variants as virus spreads: “The World Health Organization's emergencies chief said Friday that the impact of new variants of COVID-19 in places like Britain, South Africa and Brazil remains to be seen, citing human behavior for some recent rises in infection counts.”
Panel: China, WHO should have acted quicker to stop pandemic: “A panel of experts commissioned by the World Health Organization has criticized China and other countries for not moving to stem the initial outbreak of the coronavirus earlier and questioned whether the U.N. health agency should have labeled it a pandemic sooner.
In a report issued to the media Monday, the panel led by former Liberian President Ellen Johnson Sirleaf and former New Zealand Prime Minister Helen Clark said there were ‘lost opportunities’ to adopt basic public health measures as early as possible.” Here is the full preliminary WHO report.
About healthcare IT
Health Insurer Pays $5.1 Million to Settle Data Breach Affecting Over 9.3 Million People: “Excellus Health Plan, Inc. has agreed to pay $5.1 million to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to a breach affecting over 9.3 million people. Excellus Health Plan is a New York health services corporation that provides health insurance coverage to over 1.5 million people in Upstate and Western New York.
On September 9, 2015, Excellus Health Plan filed a breach report stating that cyber-attackers had gained unauthorized access to its information technology systems.”
It is still amazing how long these actions take.
A look inside Anthem's new digital incubator: “As healthcare continues to evolve, legacy players are aiming to be the first to gain access to the latest innovations.
At Anthem, that effort has meant launching its own Digital Incubator, which pairs financial backing with mentorship and opportunities for partnerships with universities and corporations…
For [example], the incubator hosts challenges for would-be innovators to compete for prizes while developing solutions targeting key health issues. This week, ADI opened applications for community health challenges, with specific focus areas targeting health literacy, food insecurity and medication adherence…
In addition, ADI has entrepreneurs in residence who are given the opportunity to work alongside the payer's leadership and other executives, including through one-on-one mentorship.”
So long, fax machines? CMS finalizes rule aimed at streamlining prior authorizations, improving data sharing: “The Trump administration finalized a rule aimed at improving the sharing of healthcare data between payers and providers and streamlining prior authorization.
The rule, released Friday (PDF) by the Centers for Medicare & Medicaid Services (CMS), requires payers in certain government programs to build application programming interfaces (APIs) for data exchange and prior authorization. It tackles a common complaint from providers that prior authorization has increased in use among plans and takes up too much time away from patients.
Officials said the final rule also builds on efforts to drive interoperability and empower patients by promoting secure electronic access to health data.”
Health benefits platform Accolade is buying telehealth startup 2nd.MD for $460M:”Accolade plans to pay $460 million to acquire 2nd.MD, a company that helps patients get expert medical opinions via video or phone.
The deal will create the most comprehensive, integrated healthcare navigation experience in the industry, Accolade officials said.
By adding 2nd.MD's services, Accolade will help employers address the urgent medical needs that face employees in 2021.”
UnitedHealthcare Expands Access to Virtual Care, Including a New Virtual Primary Care Offering: “To help improve access to local care providers, UnitedHealthcare has updated a policy to help encourage the use of virtual care and enable eligible members to meet with their physicians virtually. Effective Jan. 1, the policy applies to fully insured and self-insured employer plans and will continue to reimburse local primary care physicians, specialists and select therapy providers for administering certain care through telehealth as an alternative to in-person visits.
The new Virtual Primary Care service, which is designed to make it easier for people to establish and maintain a relationship with a primary care physician, is currently available for members enrolled in certain employer-sponsored fully insured or self-funded health plans in 11 states. The service, offered in collaboration with a national telehealth provider group, is expected to be expanded to more states in 2021 and is part of a broader UnitedHealthcare effort to help enable members to use technology to access care.”
New computational tool reliably differentiates between cancer and normal cells from single-cell RNA-sequencing data: “n an effort to address a major challenge when analyzing large single-cell RNA-sequencing datasets, researchers from The University of Texas MD Anderson Cancer Center have developed a new computational technique to accurately differentiate between data from cancer cells and the variety of normal cells found within tumor samples. The work was published today in Nature Biotechnology.
The new tool, dubbed CopyKAT (copy number karyotyping of aneuploid tumors), allows researchers to more easily examine the complex data obtained from large single-cell RNA-sequencing experiments, which deliver gene expression data from many thousands of individual cells.”
About pharma
The top 10 largest biopharma M&A deals in 2020: The article has details bout each of the ten deals.
Ineos gives Oxford £100m to set up antibiotic research institute: “Oxford university has received £100m, its largest donation for science, from chemicals group Ineos to set up an antibiotics research institute to counter the growing threat from deadly superbugs. The gift from the UK’s largest private company will help tackle antimicrobial resistance, which scientists estimate kills at least 750,000 people worldwide a year and could lead to as many as 10m deaths annually by 2050 unless a new generation of drugs is found.”
Rite Aid Must Face Trial For Inflated Drug Price Claims: “A Delaware Superior Court judge on Friday sent toward trial some litigation claims filed by a group of health insurance and pharmacy benefit companies asserting Rite Aid charged the companies too much for prescriptions included in the drugstore chain's discount drug card program.”
About health insurance
CMS issues changes to Medicare Advantage and Part D meant to improve coverage, access: “The Centers for Medicare and Medicaid Services issued a final rule Friday that will require Part D plans to offer a real-time benefit-comparison tool starting January 1, 2023…
The changes are generally effective for the 2022 plan year and will potentially lower enrollee cost sharing on some of the most expensive prescription drugs, CMS said. The final rule will allow enrollees to know in advance and compare their out-of-pocket payments for different prescription drugs.”
Part D plans already have a total annual cost computation (on the medicare.gov website) so it is not clear how this rule would be of benefit.
Kemp, Trump proposal to block ACA shopping website draws legal fight: “Advocates for the federal health insurance program known as Obamacare filed a lawsuit Thursday challenging Georgia’s plan to block access to coverage through the program’s online marketplace.
The federal lawsuit argues that in allowing Georgia to ignore certain provisions of the Affordable Care Act, the Trump administration was illegally attempting to gut the law, which has withstood repeated challenges in Congress and the courts.”
Insurers ordered to give up claims data for FTC study of healthcare mergers and acquisitions: Another use of insurance data: “The Federal Trade Commission sent orders to six health insurers for claims data to help it study the effect of hospital acquisitions of physician groups.
This study is part of a broader initiative announced by the FTC to revamp its merger retrospective program and better equip the agency to challenge healthcare mergers.
The FTC sent orders to Aetna, Anthem, UnitedHealthcare, Cigna, Florida Blue and Health Care Service Corp. The orders ask the insurers to provide patient-level claims data for inpatient, outpatient and physician services.”
A breakdown of 14 recent CMS actions: A good summary of each of these actions.
About the public’s health
HHS finalizes rule that imposes term limits for career federal scientists: “Health and Human Services published a final rule that institutes term limits top career government scientists.
The agency’s final rule issued late Friday imposes five-year terms for policy level directors across the entirety of HHS’ divisions that include the Health Resources and Services Administration and Food and Drug Administration centers…
The first term for these agency directors will start ending on staggered dates in December 2021 and the rule would affect 66 career scientists.
HHS said that the scientists will not be fired or have their pay reduced under the rule but instead would be appointed somewhere else in the agency.”
Look for the Biden administration to reverse this rule.