Calif. AG Wins Senate Confirmation To Lead HHS: “Thursday's 50-49 vote was among the closest in recent years for an HHS secretary. It came on the heels of Republican opposition focused largely on abortion, religious freedom and doubts about the attorney general's health care chops. Sen. Susan Collins, R-Maine, was the only Republican to vote in favor of confirmation.”
About Covid-19
Trump urges all Americans to get COVID vaccine: 'It's a safe vaccine' and it 'works': Announced (where else?) on a Fox News interview. We will see if it makes a difference among the large number of Republicans who refuse to get vaccinated.
FDA grants its first full approval to a COVID-19 diagnostic test: Yes, you read that correctly.
”For the first year of the pandemic, the FDA worked hard to make it clear that each green light it gave to a COVID-19 diagnostic test kit—over 340 to date—amounted to only an emergency authorization and not a full approval, meaning it had not been reviewed to its highest standards and could only be used for a limited time as the country fought off the pandemic.
Now, the agency has granted its first official endorsement, allowing a respiratory panel test from BioFire Diagnostics to be sold into the foreseeable future.
The diagnostic is designed to screen deep nasal swab samples for multiple infections to help identify coronavirus cases among people with symptoms similar to the flu, respiratory syncytial virus and the bugs behind the common cold.”
FDA Orders Eli Lilly, Regeneron to Evaluate COVID-19 Antibody Cocktails Against Variants:”In a revision of its Emergency Use Authorizations (EUAs) for Eli Lilly’s and Regeneron’s antibody combination therapies for COVID-19, the FDA is requiring the companies to assess the therapies against the mutant strains of the SARS-CoV-2 virus.”
Thai sniffer dogs can detect COVID-19 in sweat, project shows: Fascinating!
Covid-19 antibodies present in about 1 in 5 blood donations from unvaccinated people, according to data from the American Red Cross: “Between mid-June 2020 and early March 2021, the American Red Cross tested more than 3.3 million donations from unvaccinated people in 44 states for the presence of Covid-19 antibodies. Overall, about 7.5% of the donations tested in that time frame were positive for Covid-19 antibodies, meaning the donors had likely been infected with the coronavirus at some point.”
European regulator says AstraZeneca's coronavirus vaccine is 'safe and effective' but link to rare blood clots cannot be ruled out: “Europe's medical regulator said Thursday that it believed AstraZeneca's vaccine was ‘safe and effective,’ but it could not rule out a link to highly unusual types of blood clots and said a warning would be added to the product.
Many of the countries in Europe that had paused the use of the Oxford-AstraZeneca vaccine — including Germany, France, Italy and Spain — announced they would resume Friday or early next week. Ireland said it would announce its decision on Friday and Sweden next week.”
CDC IDs new COVID-19 variants of concern as hot spots reemerge: “The Centers for Disease Control and Prevention (CDC) said two coronavirus variants first detected in California, B.1427 and B.1429, are now considered as variants of concern. The CDC said the variants may be 20% more transmissible.”
Pelican Diagnostics Receives CE Mark for COVID-19 Saliva Test: “Canary Global’s company Pelican Diagnostics has earned the CE mark for its COVID-19 Ultra-Rapid Mobile Test, a saliva test that takes under two minutes.
The test kit is comprised of a handheld reusable digital reader and disposable testing cartridges that analyze spike and nucleocapsid proteins in saliva samples to detect the virus.”
Better Covid Vaccines Are Coming, WHO’s Chief Scientist Says: “Six-to-eight new immunizations may complete clinical studies and undergo regulatory review by the end of the year, Soumya Swaminathan, the Geneva-based agency’s chief scientist, said in an interview Saturday…
The current crop of experimental vaccines use alternative technologies and delivery systems, and include more single-shot inoculations, and vaccines that are administered orally, via a nasal spray, and through the skin using a type of patch. These could bring immunizations that are better suited to specific groups, such as pregnant women, according to Swaminathan.”
Of 300-plus imaging-based AI models for COVID-19 diagnosis, zero suitable for clinical use: “Out of more than 300 published machine learning models for detecting COVID-19 from chest images, zero passed a recent research review, experts detailed Monday in Nature.”
Pfizer execs discuss hiking vaccine price after pandemic wanes: Surprised?
Effectiveness of three versus six feet of physical distancing for controlling spread of COVID-19 among primary and secondary students and staff: A retrospective, state-wide cohort study: “Lower physical distancing policies can be adopted in school settings with masking mandates without negatively impacting student or staff safety.”
Medicago Evaluates Plant-Derived COVID-19 Vaccine Candidate: “Medicago and GlaxoSmithKline (GSK) have launched a global phase 3 trial evaluating Medicago’s plant-derived COVID-19 vaccine candidate when combined with GSK’s pandemic adjuvant.”
According to Medicago’s website: “We use a plant-based platform to develop our vaccines. This approach uses living plants as bioreactors to produce non-infectious versions of viruses (called Virus-like Particles, or VLPs). Learn more about our proprietary plant-based platform here.
VLPs mimic the native structure of viruses, helping them to be easily recognized by the immune system. However, they lack core genetic material which makes them non-infectious and unable to replicate.”
New Study Shows How Mutations in SARS-CoV-2 Allow the Virus to Evade Immune System Defenses: “The research, published March 16 in Cell, shows that a mutated SARS-CoV-2 from a chronically infected immunocompromised patient is capable of evading both naturally occurring antibodies from COVID-19 survivors as well as lab-made antibodies now in clinical use for treatment of COVID-19.
The patient case was originally described Dec. 3, 2020, as a New England Journal of Medicine report by scientists at Brigham and Women’s Hospital a few weeks before the U.K. and South African variants were first reported to the World Health Organization.”
Assessment of protection against reinfection with SARS-CoV-2 among 4 million PCR-tested individuals in Denmark in 2020: a population-level observational study: “We used a large national surveillance dataset [approximately 4 million individuals (69% of the population of Denmark)] of individually referable PCR test results to estimate the degree to which previous infection with SARS-CoV-2 results in protection against repeat infection. We found protection in the population to be 80% or higher in those younger than 65 years, but to be approximately 47% in those aged 65 years and older.”
This type of study can inform public health policy about whom should get priority for booster shots; however, as production gears up, nearly everyone will be able to get one.
About health insurance
MEDPAC’s 2021 Report to Congress on Medicare Payment Policy: As usual, this annual report has a great analysis of the Medicare program with recommendations to Congress for the next year. Overall, the Commission recommends many cuts to the program. See Appendix A on page 481 for a brief summary of the recommendations.
Biden administration begins throwing out Medicaid work rules: “Federal Medicaid officials on Wednesday sent letters to Arkansas and New Hampshire officials, informing them that the administration had formally scrapped the federal government’s permission for the states to mandate that some enrollees work, volunteer or attend school as a condition of coverage.”
Part D Payment Modernization Model Calendar Year (CY) 2022 Fact Sheet: Some key provisions include: “Based on stakeholder feedback and other considerations, CMS is not moving forward with two Model design changes discussed in the January 19, 2021 CY 2022 RFA: (1) the Part D Formulary Flexibilities, and (2) removal of downside risk for CY 2022. For CY 2022, the PDM Model will continue to test a modernized Part D payment structure in which participating Part D sponsors take two-sided risk for CMS’ federal reinsurance subsidy spending for participating plan benefit packages (PBPs), relative to their Spending Target Benchmark(s).”
Also, Part D sponsors have the opportunity “to implement several Part D programmatic flexibilities aimed at reducing out-of-pocket costs and improving the quality of care for beneficiaries.”
Humana introduces CenterWell brand for payer-agnostic healthcare offerings: “Health insurer Humana announced a new brand this week, CenterWell, which encompasses and connects a range of the company's payer-agnostic healthcare services offerings. The first Humana-owned care services to adopt the new brand will be its senior-focused primary care facilities that have operated as ‘Partners in Primary Care’ in several states and as ‘Family Physicians Group’ in the Orlando area.
The move comes as Humana is pushing to expand its healthcare services capabilities, from primary care and pharmacy to home care, to strengthen its payer-agnostic portfolio. The new CenterWell brand will unite these services.”
Is Humana mimicking United’s Optum?
Highmark Makes a $220M Impact in the Fight Against Healthcare Fraud, Waste and Abuse in 2020: “Highmark’s Financial Investigations and Provider Review (FIPR) department generated more than $220 million in savings related to fraud, waste and abuse in 2020, and has made a cumulative financial impact of nearly $1.1 billion in such activity since 2015. By deploying sophisticated artificial intelligence programs and partnering with health systems, public health officials, law enforcement and other health stakeholders, FIPR is protecting Highmark customers and ensuring health care dollars are spent on high-value care.
Highmark prevented significant fraud, waste and abuse across its lines of business in 2020. That includes nearly $130 million in savings related to employer-based health insurance, $50 million from the Blue Card program (which provides Highmark customers with access to national Blue Cross Blue Shield networks), $22 million from Medicare Advantage, $9 million from the Affordable Care Act marketplace, and $8 million from the Federal Employee Program.”
Primary Care First Model Options: From CMS: “The practice solicitation period for PCF Cohort 2 opened on March 16, 2021 and will close on April 30, 2021. The payer solicitation period for PCF Cohort 2 began on March 16, 2021, and will close on May 28, 2021.”
About pharma
US regulator signals "aggressive" new approach to pharmaceutical mergers: “The US Federal Trade Commission (FTC) on Tuesday announced the formation of a working group, in collaboration with competition regulators in the EU, UK and Canada, to update how they review buyouts in the pharmaceutical industry amid concerns such deals may drive up drug prices or stifle innovation. Rebecca Kelly Slaughter, acting chair of the FTC, said ‘we intend to take an aggressive approach to tackling anticompetitive pharmaceutical mergers.’”
Trends in fall‐related mortality and fall risk increasing drugs among older individuals in the United States,1999–2017: “The percent of persons who received at least one prescription for a fall risk increasing drug increased from 57% in 1999 to 94% in 2017 (p for trend <.0001).” Perhaps an electronic alert would be helpful; but with these percentages, massive education campaigns should also be instituted.
Judge halts 340B dispute rule, siding with Eli Lilly in lawsuit over program: “The opinion, issued late Tuesday, grants a preliminary injunction sought by Eli Lilly, which sued the feds over the rule. The ruling comes as Lilly and several other drugmakers restricted sales of drugs discounted under the 340B program to contract pharmacies, which are third parties that dispense the products on behalf of the covered entities.
The ruling from the U.S. District Court for the Southern District of Indiana focused on whether the Department of Health and Human Services (HHS) followed federal law when the rule was finalized last December.
The decision puts on hold a key mechanism that hospitals, community health centers and other 340B providers had planned to use to challenge drug companies that restricted sales of discounted products to contract pharmacies.”
Purdue Pharma unveils $10bn opioid settlement plan to exit from bankruptcy: “Purdue Pharma is proposing a $10bn plan to emerge from bankruptcy that calls for it to be transformed into a company funnelling profits into the fight against the opioid crisis.
Those efforts would include a significant boost – more than $4bn – from members of the Sackler family who own the Connecticut-based pharmaceutical giant…
Most of the parties in the case are onboard. But attorneys general representing 23 states and the District of Columbia issued a statement saying the offer ‘falls short of the accountability that families and survivors deserve’. They want more money from the Sackler family members and for Purdue to wind down in a way that ‘does not excessively entangle it with states’.”
Leading Children’s Hospitals and Phlow Corp. form an Unprecedented Coalition to Deliver Essential Medicines to Address Pediatric Drug Shortages: “Phlow Corp., a U.S.-based, public benefit corporation…, today joins in announcing the launch of a groundbreaking Children’s Hospital Coalition: Powered by PhlowTM (CHC). This first-in-kind coalition brings together some of the top children’s hospitals across the nation, in collaboration with Phlow, to provide certainty in availability and access for key medicines necessary to sustain life and conquer disease and to address the nation’s broken essential medicines supply chain.”
About healthcare IT
Companies of all sizes, including Amazon’s own workforce, will be able to access Amazon Care’s on-demand healthcare service, boosting workplace benefits for employees nationwide: This article was in many media outlets today, including the front page of the Wall Street Journal. Here is what Amazon’s website said (news media copied from it):
”The service enables employees to connect with medical professionals via chat or video conference… and eliminates lengthy wait and travel times to get medical attention. Amazon Care has two components: 1) virtual care, which connects patients to medical professionals via the Amazon Care app (available for both Android and iOS) and allows patients to quickly, conveniently, and confidently chat live with a nurse or doctor, via in-app messaging or video; and 2) in-person care, where Amazon Care can dispatch a medical professional to a patient’s home for additional care, ranging from routine blood draws to listening to a patient’s lungs, and also offer prescription delivery right to a patient’s door. Until now, Amazon Care has been exclusively available to Amazon employees and their families in Washington state. Today, Amazon is announcing that Amazon Care is available to serve other Washington-based companies. Additionally, beginning this summer, Amazon Care will expand its virtual care to companies and Amazon employees in all 50 states across the U.S. Finally, Amazon Care’s in-person service will expand to Washington, D.C., Baltimore, and other cities in the coming months. To learn more, visit www.amazon.care.”
Who Is (and Isn't) Receiving Telemedicine Care During the COVID-19 Pandemic: “More than a 20-fold increase in the incidence of telemedicine utilization following March 13, 2020 was observed. Conversely, the incidence of office-based encounters declined almost 50% and was not fully offset by the increase in telemedicine. The increase in telemedicine was greatest among patients in counties with low poverty levels (β=31.70, 95% CI=15.17, 48.23), among patients in metropolitan areas (β=40.60, 95% CI=30.86, 50.34), and among adults compared with children aged 0–12 years (β=57.91, 95% CI=50.32, 65.49).”
FCC fines insurance telemarketers record $225M: “According to the commission, the robocalls were attempting to sell short-term, limited-duration health insurance plans. The calls falsely claimed to be selling health plans from commercial payers like Aetna, Blue Cross Blue Shield, Cigna and UnitedHealth Group.”
The Boom in Out-of-State Telehealth Threatens In-State Providers: “A year into the pandemic, telehealth has become widely accepted. Some states are now looking to make permanent the measures that have fueled its growth. But with it have come some unintended consequences, such as a rise in fraud, potential access problems for vulnerable groups and conflicts between out-of-state and in-state health providers.”
The article provides “real world” examples.
Doctor On Demand, Grand Rounds combine to form multibillion-dollar digital health company: “Owen Tripp, CEO of Grand Rounds, will serve as the CEO of the expanded business. Both companies will continue to operate under their existing brands for the time being, officials said in a statement.
Doctor on Demand CEO Hill Ferguson will continue to run that side of the company and will join the board.
Terms of the transaction were not disclosed…
The combination of Doctor on Demand and Grand Rounds will combine Grand Rounds’ data-driven clinical navigation platform and patient advocacy tools with Doctor On Demand’s virtual care offering. It will accelerate the adoption of virtual care in key areas including primary care, specialty care, chronic condition management, and behavioral health, the companies said.”
CMS cuts 4 telehealth services accidentally added to Medicare coverage list: “CMS released a notice March 17 walking back four telehealth service codes that the agency said were inadvertently included on its final list because of technical errors….
Here are the four telehealth codes CMS removed:
1. 96121: Neurobehavioral status exam by physician or other qualified health professional
2. 99221: Initial hospital care
3. 99222: Initial hospital care
4. 99223: Initial hospital care “
About healthcare professionals
NM High Court Says Med Mal Damages Cap Is Constitutional: The $600k cap on damages was held to be constitutional in the state. Different states have come to different conclusions with respect to whether malpractice limits for non-economic damages are constitutional.
About hospitals and health systems
Low Compliance From Big Hospitals On CMS’s Hospital Price Transparency Rule: “…we collected the price transparency files for the largest 100 hospitals in the US (by certified bed count) from late January 2021 to early February 2021 and sought to determine the extent to which these hospitals were complying with the regulation…
Of the 100 hospitals in our sample, 65 were unambiguously noncompliant. Of these 65,
12/65 (18 percent) did not post any files or provided links to searchable databases that were not downloadable.
53/65 (82 percent) either did not include the payer-specific negotiated rates with the name of payer and plan clearly associated with the charges (n = 46) or were in some other way noncompliant (n = 7).
Of the remaining 35 hospitals in our sample, at least 22 hospitals appeared to be compliant and certain hospitals clearly exceeded the regulations in terms of the amount of information they shared.”
California hospital must pay charity care costs, appellate court rules: The ACA reduced the uninsured population, so hospitals are wondering if they still have the same charity care requirements in their states/localities. This appeals court said they do.
About the public’s health
New diabetes guidelines lower screening age to 35 for some adults: “Screening for Type 2 diabetes and prediabetes should start at age 35 for people who are considered overweight, instead of the currently recommended age 40, a draft set of guidelines from the U.S. Preventive Services Task Force recommends.
The update, prompted by the rising number of Americans who are overweight or obese, could result in millions more being eligible for the blood test as part of regular medical exams. The guidelines are specifically intended for people who are overweight — a body-mass index of 25 to 30 — or obese, a BMI of 30 or above. Excess weight is a major risk factor for diabetes.”
'Painless' glucose monitors pushed despite little evidence they help most diabetes patients: “There's little evidence continuous glucose monitoring (CGM) leads to better outcomes for most people with diabetes — the estimated 25 million U.S. patients with Type 2 disease who don't inject insulin to regulate their blood sugar, health experts say.”
The article is a really good business case study.
About healthcare technology
Roche to Purchase GenMark Diagnostics in $1.8 Billion Deal: “GenMark offers respiratory pathogen panels that identify the most common viral and bacterial organisms associated with upper respiratory infection, including SARS-CoV-2. It received FDA Emergency Use Authorization in October 2020 and a CE mark in September 2020 for a rapid molecular panel that detects more than 20 respiratory pathogens, including the coronavirus.”
GE Healthcare debuts pocket-sized, wireless ultrasound: “GE Healthcare launched a new handheld, wireless ultrasound device, capable of scanning anywhere within the body and small enough to be carried around in a clinician’s pocket.
The Vscan Air is an addition to the company’s family of portable ultrasound systems which first launched in 2010. The device connects with the user’s own smartphone, and includes a two-sided design—when flipped over, it can be used for both shallow and deep tissue without switching probes during exams.”
This device is truly a disruptive technology.
