Today's News and Commentary

About health insurance

CMS Increases Medicare Payments for At-Home COVID-19 Vaccinations: ”Prior to this announcement, at-home vaccine administration warranted a $40 reimbursement for providers per dose; providers will now receive $75 per dose, or $150 for a two-dose vaccine. The increase in payment covers any costs associated with at-home vaccinations and accounts for the time a provider needs to monitor the beneficiary after the shot. The payment rates will be adjusted geographically…
Difficulty with vaccine storage temperatures and travel make administering at-home vaccines a significant challenge for many providers. In conjunction with CMS’ announcement, the Centers for Disease Control and Prevention (CDC) released guidelines for providers who are administering at-home vaccines.”

Nevada becomes 2nd state with ‘public option’ insurance law: “The new law requires insurers that bid to cover Medicaid recipients and state employees to also bid to offer a so-called public option plan. State officials would select certain providers to be in-network for the public option plan and mandate that they charge 5% less in monthly premiums than the average plan on the state insurance marketplace created by the Affordable Care Act and 15% less four years after it is first offered.” And in a related article:
New health insurance plan aimed at cutting costs is headed to Colorado governor’s desk: “Under the bill, the state will require insurers to offer the Colorado Health Benefit Option by Jan. 1, 2023, in all 64 counties. It’ll be available for the individual and small group marketplaces, which cover about 15% of Coloradans, and by 2025, its premiums will have to be 15% less than the rates insurers offered in 2021 (adjusted for medical inflation). It will also set benchmarks for the types of care covered under the plan, including pediatric care and other essential benefits.”

About the public’s health

Tobacco Use Prevalence and Transitions From 2013 to 2018 Among Adults With a History of Cardiovascular Disease: “Among adults with CVD who are current tobacco users, the most commonly used product was cigarettes (82.8%), followed by any type of cigar (23.7%), and e‐cigarette use (23.3%). E‐cigarette use without concurrent cigarette use among participants with prevalent CVD was uncommon (1.1%).Factors associated with tobacco use were younger age, male sex, had lower education level, and lack of knowledge about the association between smoking and CVD…
Despite known harmful cardiovascular effects, over one fourth of adults with prevalent CVD use tobacco products and few quit smoking over the 4 waves of the PATH [Population Assessment of Tobacco and Health] set.”

Effect of Matching Therapists to Patients vs Assignment as Usual on Adult Psychotherapy Outcomes Albert Schweitzer allegedly said that medicine is not only a science but also the art of letting our own individuality interact with the individuality of the patient. “In this study, mental health care was enhanced by prospectively assigning patients to empirically good-fitting therapists, which requires minimal disruptions within a mental health care system.”

About Covid-19

The COVID lab-leak hypothesis: what scientists do and don’t know: From Nature, this article is the best one I have read about the lab-leak hypothesis.

Latest Data on COVID-19 Vaccinations Race/Ethnicity: “These recent trends suggest a narrowing of racial gaps in vaccinations at the national level, particularly for Hispanic people, who have recently received a larger share of vaccinations compared to their share of the total population (28% vs. 17%). While these data provide helpful insights at a national level, to date, CDC is not publicly reporting state-level data on the racial/ethnic composition of people vaccinated.”

Immunogenicity of Ad26.COV2.S vaccine [J&J vaccine]against SARS-CoV-2 variants in humans: ”These data show that neutralizing antibody responses induced by Ad26.COV2.S were reduced against the B.1.351 and P.1 variants, but functional non-neutralizing antibody responses and T cell responses were largely preserved against SARS-CoV-2 variants. These findings have implications for vaccine protection against SARS-CoV-2 variants of concern.”

U.S. signs $1.2 bln deal for 1.7 mln courses of Merck's experimental COVID-19 drug: “Merck & Co Inc said on Wednesday the U.S. government has agreed to pay about $1.2 billion for 1.7 million courses of its experimental COVID-19 treatment, if it is proven to work in an ongoing large trial and authorized by U.S. regulators.
The oral antiviral treatment, molnupiravir, aims to stop COVID-19 from progressing and can be given early in the course of the disease, similar to Tamiflu to treat influenza.
The treatment course being tested in the trial is an oral dose given every 12 hours for five days.”

FDA's vaccine advisers to discuss rules for authorizing Covid-19 shots for kids: “Vaccine advisers to the US Food and Drug Administration will meet [today] to discuss what information the agency should ask for in considering the go-ahead for vaccinating children under 12 -- including how many children need to be enrolled in clinical trials and how much safety data will be needed.
Members of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will not be asked to discuss specific vaccines or to vote on any issues, but instead will weigh in on what specific extra information companies will have to provide in seeking authorization or approval for children.”

Coronavirus: US has distributed $395bn in stimulus payments since March, IRS says: FYI

Prime Day deal? Amazon lands FDA go-ahead to sell COVID-19 tests directly to consumers: “The FDA’s emergency use authorization allows the retail giant’s subsidiary STS Lab Holdco to sell its Amazon Real-Time RT-PCR test kits to anyone 18 years or older without requiring buyers to obtain a prescription or show proof of any COVID symptoms or recent contact with the virus.
The EUA also allows for pooled testing, in which up to five individual samples may be combined and tested at the same time, exponentially increasing the reach of Amazon’s lab resources.
After each nasal swab kit is sent to one of Amazon’s processing labs using the included prepaid shipping label, users will receive notifications via text message and email once their test results are ready. The results can then be accessed through an online portal located at AmazonDx.com…”

DOL Issues Long-Awaited COVID-19 Safety Rule: “The ETS [Emergency Temporary Standard] issued by OSHA, the DOL's workplace safety arm, will require employers in the health care sector to maintain social distancing protocols, make sure that patients are properly screened for virus symptoms and give workers paid time off to get vaccinated and recover from vaccine side effects as encouragement to get the shot. The ETS includes a carve-out for certain workplaces where all workers are fully vaccinated and people who may have COVID-19 are barred.
OSHA also issued a series of voluntary guidelines for employers that operate outside of the health care context to protect unvaccinated workers, particularly industries like meatpacking and high-volume retail where close contact between people is common.”

Meet the influencers making millions by dealing doubt about the coronavirus vaccines.: A great expose’ about who is making money by spreading misinformation about vaccines.

Moderna files for FDA authorization of its COVID-19 vaccine for adolescents: “Moderna said June 10 it has requested emergency use authorization from the FDA for its COVID-19 vaccine for use in children ages 12 to 17. 
The drugmaker already filed for approval for the age group in Canada and Europe.”

Federal agencies can lift caps on number of employees working on-site, Biden administration announces: “The Biden administration Thursday told federal agencies that they no longer have to limit the number of employees allowed in the workplace, but kept in place an expansive telework policy that was instituted during the coronavirus pandemic, an approach that could slow the return to federal buildings.
The long-awaited guidance, the first major announcement on pandemic staffing the administration has issued since January, reversed a previous 25 percent cap on capacity inside federal offices.”

Johnson & Johnson's COVID-19 vaccine scores longer shelf life just as millions of doses were set to expire: “The U.S. FDA has extended the shelf life for J&J’s single-shot vaccine from three months to four and a half, the drugmaker said Thursday. The agency based its decision on ongoing stability studies that found the vaccine could last longer when kept at refrigerated temperatures.”

About pharma

35 top over-the-counter health products recommended by pharmacists: FYI

Pharma funded more than 2,400 state lawmaker campaigns in 2020, new STAT analysis finds: “In the last two years, at least 2,467 state legislators — over one-third of all state lawmakers nationwide — used pharmaceutical industry cash to fund their campaigns, according to a new STAT analysis of campaign finance records that spans the full 2020 election cycle. The industry wrote over 10,000 individual checks totaling more than $9 million.”
If you look at the interactive map, many of the donations were a few hundred dollars. But some state legislatures had overwhelming percentages of recipients of such funds.

About healthcare devices

Facebook plans first smartwatch for next summer with two cameras, heart rate monitor: “Facebook is taking a novel approach to its first smartwatch, which the company hasn’t confirmed publicly but currently plans to debut next summer. The device will feature a display with two cameras that can be detached from the wrist for taking pictures and videos that can be shared across Facebook’s suite of apps, including Instagram…”

As more devices come on the market, it is a good opportunity to review the International Medical Device Regulators Forum Strategic Plan 2021 - 2025: “While technology has opened up opportunities to incorporate new features and functionalities in modern medical devices to enhance their performance, it has also posed additional regulatory challenges such as:

  • accessibility,

  • cybersecurity,

  • interoperability,

  • data integrity, and

  • data security etc…

Personalised medical devices that deliver targeted or patient specific therapy for better clinical outcomes are gaining popularity. Personalised treatments including:

  • personalised digital therapies (e.g. cognitive behaviour therapy software for treatment of insomnia) and

  • personalised implants (e.g. orthopaedic implant designed and manufactured to fit an individual patient’s anatomy)

These necessitate additional considerations to traditional clinical evaluation requirements and clinical study designs. “

About hospitals and health systems

Rural hospitals may get paid to become standalone ERs:”Rural hospitals that close inpatient beds and revamp as standalone emergency rooms may receive more funding under a proposal buried in the almost 6,000-page stimulus act signed late last year..
The measure included in the act, sponsored by Sen. Chuck Grassley, R-Iowa, calls for these rural hospitals to revamp their service offerings to obtain the rural emergency hospital designation. Hospitals that obtain this designation will receive more funding.
Rural hospitals with fewer than 50 beds can apply for the designation, which takes effect in 2023.”

About healthcare IT

Announcing Avaneer Health: Accelerating Healthcare Delivery and Powering the Next Generation of Care Experiences: See if you agree with this assessment: Reading this press announcement is like going through a thesaurus of business buzz words without understanding what the product is. This statement is as close as it gets to an explanation: “Avaneer Health is a member-based, secure and open network supporting utilities developed for and by the healthcare industry.” The owners include “Aetna, Anthem, Cigna, Cleveland Clinic, HCSC, IBM, The PNC Financial Services Group, Inc. and Sentara Healthcare. Avaneer Health incorporated in 2020 as the Health Utility Network, Inc. and is now known as Avaneer Health.”

Mayo joins $32M funding round to boost cybersecurity of healthcare communication platform: “Nuvolo, a cloud-based workplace communication platform, secured $32 million to improve its cybersecurity technologies, the company announced June 9. 
Rochester, Minn.-based Mayo Clinic is the latest company to join the series C financing round, investing $1 million to support Nuvolo's cybersecurity developments.”