Today's News and Commentary

About the business of healthcare

20 largest healthcare companies in the world for 2021: Forbes released its 19th annual list of the 2,000 largest public companies in the world, with 20 healthcare companies in the top 200.”
The largest healthcare company on the list (at 21st place) is UnitedHealth Group with a market value of about $370B.

About Covid-19

CDC says fully vaccinated Americans no longer need masks indoors or outdoors in most cases: “Americans who are fully vaccinated can go without masks or physical distancing in most cases, even when they are indoors or in large groups, federal officials said Thursday, paving the way for a full reopening of society.”

COVID-19 far from under control in Americas, says PAHO: “Nearly 40% of all global deaths from COVID-19 reported last week happened in the Americas, and nearly 80% of the region's intensive care units are filled with COVID-19 patients, the Pan American Health Organization (PAHO) said on Wednesday.”

Effects of different types of written vaccination information on COVID-19 vaccine hesitancy in the UK (OCEANS-III): a single-blind, parallel-group, randomised controlled trial: This study highlights the importance of customizing the message to the stakeholder.
“In the approximately 10% of the population who are strongly hesitant about COVID-19 vaccines, provision of information on personal benefit reduces hesitancy to a greater extent than information on collective benefits. Where perception of risk from vaccines is most salient, decision making becomes centred on the personal. As such, messaging that stresses the counterbalancing personal benefits is likely to prove most effective. The messaging from this study could be used in public health communications.”

CMS requires nursing homes to report COVID-19 vaccination rates: ”The goal of the requirement included in an interim final rule announced Tuesday by the Centers for Medicare & Medicaid Services is to identify facilities that could need more help to respond to the pandemic.”

Early data suggest mixing COVID-19 vaccines leads to more reactions: “Preliminary results from a UK trial testing a "mix and match" approach to COVID-19 vaccines indicate that volunteers who received one dose of AstraZeneca's Vaxzevria followed by Pfizer/BioNTech's BNT162b2, or vice versa, were more likely to develop reactions, compared to those who got the same vaccine for both prime and boost. Findings from the University of Oxford-led Com-COV trial, which began in February, were published Wednesday in The Lancet as correspondence and focused only on initial reactogenicity and safety data.”

CDC says it's OK to get a Covid-19 vaccine alongside other vaccines: “The American Academy of Pediatrics also said Wednesday it supports giving routine childhood vaccines together with coronavirus vaccines.”

About the public’s health

THE PUBLIC’S PERSPECTIVE ON THE UNITED STATES PUBLIC HEALTH SYSTEM: Key findings from a poll conducted for the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health:
—”There is broad public support for substantially increasing federal spending on public health. About seven in ten adults (71%) favor substantially increasing federal spending on improving the nation’s public health programs, while 27% are opposed.
—A large majority of the public (72%) believes the activities of public health agencies are extremely or very important to the health of the nation.
—The public’s rating of the nation’s public health system and medical system have changed over time, with positive ratings of the public health system declining from 43% to 34% from 2009 to 2021, and positive ratings of the medical system increasing from 36% to 51% from 2009 to 2020.
—In terms of overall trust in the recommendations made to improve health, in the middle of the Covid-19 pandemic, the public currently trusts nurses, healthcare workers, and doctors more than public health institutions and agencies.
—In both 2009 and 2021, the public rated the job performance of the Centers for Disease Control and Prevention (CDC) higher than the nation’s public health system overall. In 2021, 54% of the public gave the CDC positive job performance ratings (excellent or good), while 59% did in 2009.”

Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial: Yet another study showing the futility of ovarian cancer screening.
”The reduction in stage III or IV disease incidence in the MMS [multimodal screening] group was not sufficient to translate into lives saved, illustrating the importance of specifying cancer mortality as the primary outcome in screening trials. Given that screening did not significantly reduce ovarian and tubal cancer deaths, general population screening cannot be recommended.”

About pharma

Feds stop sending Eli Lilly’s COVID-19 cocktail to Illinois on concerns of P.1 variant: “Eli Lilly's COVID-19 antibody bamlanivimab already lost its solo FDA authorization as viral variants cropped up. Now, the company's two-antibody combo is running into trouble.
Federal officials are pausing shipments of the bamlanivimab-etesevimab cocktail to Illinois because of worries about one specific variant called P.1.
In a notice last week, authorities raised concerns about the combo's effectiveness against that variant, first identified in Brazil. The Office of the Assistant Secretary for Preparedness and Response said it is pausing distribution of the antibody cocktail, plus etesevimab alone, in the state.”

Amazon Pharmacy launches new prescription services: “The first feature, the Amazon Prime prescription savings benefit, allows Prime members to search for their medications and compare costs at Amazon Pharmacy and more than 60,000 other retail pharmacies. 
Amazon cited a national survey that found that only 11 percent of customers shopped online for better prices when faced with higher than anticipated costs for prescriptions. 
Amazon Pharmacy said its Prime prescription savings benefit offers up to 80 percent discounts on generic drugs and 40 percent off brand-name drugs when paying without insurance. 
The second new feature allows Amazon Pharmacy customers to check their insurance co-pay before ordering their medication. Customers can enter their insurance and prescriber information and then request an expected copay price from the medication information page.”

About healthcare IT

Big Tech's health IT moves: 23 acquisitions from Apple, Amazon, Microsoft & Google: An interesting timeline of these companies’ activities starting with Microsoft’s founding in 1975.

200,000 VA patients' health records found exposed online: “A database containing medical records of almost 200,000 U.S. military veterans was recently discovered to have been exposed online by a vendor contracted by the Veterans Administration.”

About healthcare systems

Health system financial results for Q1: Eight systems’ financial performance for Q1. For several, note the importance of non-operating income contribution to the net.

Mayo Clinic, Kaiser Permanente to scale up hospital-at-home efforts with $100M investment into Medically Home: “Medically Home installs a suite of communications devices, remote patient monitoring devices, emergency response systems and other supplies such as durable medical equipment in a patient’s home so that providers can treat high-acuity patients outside of the costly hospital setting.
Providers use these integrated tools to coordinate care from a “command center” that allows continuous monitoring and on-demand communication with patients around the clock. Should the patient require additional support, such as a delivery of oxygen, the startup’s rapid-response logistics system can also ensure patients receive additional support—for instance, delivering oxygen—to their home within hours rather than days.”

About healthcare quality and safety

Patient Safety Excellence & Outstanding Patient Experience: Awards from from Healthgrades.

Association Between Anesthesiologist Volume and Short-term Outcomes in Complex Gastrointestinal Cancer Surgery: If volume-quality relationships exist, are they related to the surgeon or hospital or both? This article emphasizes the importance of other healthcare professionals as part of the “team.”
This study found that, among adults who underwent complex gastrointestinal cancer surgery, those who received care from high-volume anesthesiologists had a lower risk of adverse postoperative outcomes compared with those who received care from low-volume anesthesiologists. These findings support organizing perioperative care to increase anesthesiologist volume to optimize patient outcomes.”

Today's News and Commentary

About health insurance

Biden: 1M sign up for health care during special enrollment: “President Joe Biden said Tuesday that 1 million Americans had signed up for health insurance under ‘Obamacare’ during a special enrollment period for those needing coverage during the coronavirus pandemic.
Biden reopened the HealthCare.gov insurance markets in February for a special six-month sign-up opportunity that will go through Aug. 15. His coronavirus relief package also boosted taxpayer subsidies, making the coverage a much better deal for new and current customers.”

Neidorff says Centene-Magellan deal nearing finish line: “Centene Corporation CEO Michael Neidorff said the insurer is on track to close its acquisition of Magellan Health in short order.
Neidorff said during an appearance at CNBC's Healthy Returns Summit on Tuesday that the $2.2 billion deal has cleared review from the Department of Justice and is awaiting approval in two more states soon.”

Adverse Selection in Medicaid: Evidence from Discontinuous Program Rules: “In this paper, we exploit a discontinuous premium increase at the federal poverty level in Michigan’s Medicaid expansion program to test low-income individuals’ sensitivity to premiums using linked enrollment and claims data. At the cutoff, average premiums increase by $3.15 and the probability of disenrollment increases by 2.3 percentage points. Increased disenrollment occurs among those with fewer documented medical needs at baseline, but not among those with greater medical needs. These results suggest healthier low-income individuals may be sensitive to even modest health insurance premiums, and that premiums may induce adverse selection in Medicaid plans.”
Nothing new as far as behavioral outcomes; the study does show exquisite quantitative sensitivity.

32 hospitals sue HHS over reimbursement for low-income patients: “Thirty-two hospitals that operate in states that didn't expand Medicaid sued HHS in an attempt to adjust their Medicare disproportionate share hospital payments, according to court documents
The plaintiff hospitals, in Alabama, Florida, Georgia, Texas, South Carolina, North Carolina, Oklahoma, Tennessee and Missouri, argue that the "collateral refusal" to recognize these patients as eligible for Medicaid made them receive far less than expansion states that treated an equivalent proportion of low-income patients.”

About Covid-19

WHO and global leaders could have averted Covid calamity, experts say: “A swift international response could have stopped the 2019 Covid-19 outbreak in China becoming a global catastrophe in 2020, according to a scathing report on the response of world leaders and the World Health Organization to the pandemic. An expert review by the Independent Panel for Pandemic Preparedness and Response, commissioned by the WHO, sets out lessons for preventing future pandemics and makes dozens of recommendations for reform, including more surveillance power for the WHO.”
To summarize from the report [emphases are in the original]:
”There is a need for:

  • Stronger leadership and better coordination at national,
    regional and international level, including a more focused and independent WHO, a Pandemic Treaty, and a senior Global Health Threats Council.

  • investment in preparedness now, and not when the next crisis hits, more accurate measurement of it, and accountability mechanisms to spur action;

  • an improved system for surveillance and alert at a speed that can combat viruses like SARS-CoV-2, and authority given to WHO to publish information and to dispatch expert missions immediately;

  • a pre-negotiated platform able to produce vaccines, diagnostics, therapeutics and supplies and secure their rapid and equitable delivery as essential global common goods;

  • access to financial resources, both for investments in preparedness and to be able to inject funds immediately at the onset of a potential pandemic.”

Uber, Lyft to Provide Free Rides to Covid-19 Vaccine Sites Until July 4: “Ride-sharing companies Uber Technologies Inc. and Lyft Inc. will make all rides to and from vaccination sites free until July 4 under a new partnership with the White House.”

States won't get Johnson & Johnson vaccines next week: “White House officials told governors on a private call Tuesday that new supply of the J&J shot wasn't immediately available for ordering, POLITICO has learned. It wasn’t immediately clear whether the federal government would ship out J&J doses through federal distribution channels, such as those for pharmacy chains and community health centers.”

Biden health official says COVID-19 vaccine booster shots will be free: “David Kessler, the chief science officer for the White House's COVID-19 response team, told senators at a hearing on Tuesday that the federal government has funding to purchase the next round of vaccines, so individuals won't have to pay.”

WHO labels a Covid strain in India as a ‘variant of concern’ — here’s what we know: “The World Health Organization named the B.1.617 strain as one of the ‘variants of concern’ …
Early studies that have yet to be peer reviewed suggest increased transmissibility and reduced neutralization, the UN health agency said.”

New Vaccine Blocks COVID-19 and Variants, Plus Other Coronaviruses: “A potential new vaccine developed by members of the Duke Human Vaccine Institute has proven effective in protecting monkeys and mice from a variety of coronavirus infections -- including SARS-CoV-2 as well as the original SARS-CoV-1 and related bat coronaviruses that could potentially cause the next pandemic.
The new vaccine, called a pan-coronavirus vaccine, triggers neutralizing antibodies via a nanoparticle. The nanoparticle is composed of the coronavirus part that allows it to bind to the body’s cell receptors, and is formulated with a chemical booster called an adjuvant. Success in primates is highly relevant to humans.”

About healthcare quality and safety

Top 10 Patient Safety Concerns 2021: From ECRI. Racial and ethnic disparities top this year’s list. The items and order vary from year to year. For example, in 2018, diagnostic errors headed the list and disparities was not mentioned.

About pharma

Rescission of Trump-Era Insulin, Epinephrine Rule Moves Forward: “The HHS is proposing to a rescind a Trump administration drug rule that required community health centers to pass on all their insulin and epinephrine discount savings to patients.
The proposal to retract the rule is under review at the White House Office of Management and Budget. Once it clears, the Department of Health and Human Services can publish it at any time.”

FTC Distributes Nearly $60 Million From Suboxone Settlements: “The Federal Trade Commission (FTC) is mailing almost $60 million to 51,875 victims of alleged schemes by Reckitt Benckiser and its former subsidiary Indivior to block generic competitors from producing lower-cost versions of the opioid abuse medication Suboxone (buprenorphine-naloxone).
The FTC reached a $50 million-settlement with Reckitt Benckiser in July 2019 and a $10 million-settlement with Indivior in July 2020.”

CVS offering same-day pharmacy delivery through CarePass program: “CarePass members can now receive eligible prescriptions within hours through new free same-day deliver options, CVS Pharmacy said in an announcement. Program participants can also add other items to their prescription delivery orders, including vitamins, first aid, pain relief and grocery, CVS said.
Same-day delivery in partnership with Shipt is currently available at 8,000 CVS stores across 47 states.”

Pelosi drug price plan threatened by centrist defections: “House Democrats’ push to tack a sweeping drug price negotiation bill to President Joe Biden’s infrastructure package was always going to face a fight in the evenly divided Senate. But the legislation is also hitting troubled waters in the House.
At least 10 caucus moderates are signaling opposition to Democrats’ drug pricing negotiation bill — more than enough to potentially force House Speaker Nancy Pelosi into dropping the reforms from infrastructure legislation Democrats hope to pass along party lines. Pelosi can only spare two Democratic defections on partisan legislation because of the party’s slim House majority.”

FDA Approves First T Cell Progenitor to Enter Human Trials: “The FDA has approved Smart Immune’s investigational new drug (IND) application for ProTcell, a T cell progenitor-based biotherapy candidate, marking the first time the agency has cleared a product of its kind to enter clinical trials.
Paris, France-based Smart Immune said ProTcell will enter a U.S. phase 1/2 trial by fall, where it will be evaluated as a treatment for acute lymphocytic leukemia and acute myelocytic leukemia.”

Sanofi hit with charges of 'widespread' email deletion in legal saga stemming from Zantac recalls: “In a new filing from lawyers representing more than 70,000 former patients, Sanofi is accused of "widespread" destruction of employee emails tied to its 2019 recall of the drug, which preceded the FDA's outright ban in 2020. The company and many others face lawsuits alleging they concealed cancer risks from the drug, and the new filing outlines alleged roadblocks the drugmakers have put up to delay the legal process, the plaintiffs' lawyers say.”

How Big Pharma Finds Sick Users on Facebook: “The social media giant, through its power to target users based on their interests, is especially attractive to pharmaceutical companies looking to sell drugs to potential patients. The Washington Post reported last year that health and pharmaceutical companies spent almost $1 billion on just Facebook mobile ads in 2019. The draw? Unlike a traditional TV or radio ad, Facebook’s ad categories help those companies target their drug ads at users who likely suffer from a specific illness the drug treats.”

About healthcare professionals

2021 SURVEY OF FINAL-YEAR MEDICAL RESIDENTS: Among the highlights:
—”86% of final-year residents received 11 or more recruitment offers during their training, suggesting job opportunities are still available for most medical residents.” But the number of offers is down.
—”Geographic location is the most important factor residents consider when examining a job opportunity, followed by adequate personal time and lifestyle considerations.
—More medical residents (45%) would prefer hospital employment as their first practice setting than any other type of setting.
—21% of medical residents said they would not choose medicine again if they had their education and training to do over.”

Baptist Health System offers $20K sign-on bonuses to nurses, care associates: “Baptist Health System in San Antonio is offering new nurses, as well as patient care and lab associates, up to $20,000 sign-on bonuses…”

About healthcare IT

Teladoc Health Launches “myStrength Complete” As First Unified Mental Health Care Experience: “Teladoc Health, Inc… announced the launch of myStrength Complete, an integrated mental health service providing personalized, targeted care to consumers in a single, comprehensive experience. The announcement comes as more than half of people with mental health concerns report that they do not know where to start when getting care, highlighting the importance of the digital front door myStrength Complete will provide.”

Huma rakes in $200M to grow the digital health ecosystem surrounding its remote care platform: “After a turbo-charged 2020 that saw Huma launch a variety of remote monitoring and clinical trial partnerships to track and treat COVID-19, resulting in its being named Europe’s fastest-growing healthcare company, the London-based startup is doubling down on that growth…
Huma—originally founded in 2011 as Medopad—will receive $130 million up front from a group of investors led by Leaps by Bayer and Hitachi Ventures. The group also includes Samsung Next, Sony Innovation Fund, Unilever Ventures and HAT Technology & Innovation Fund.”

Today's News and Commentary

About Covid-19

Update on Covid-19 statistics from the Washington Post: Great overview of trends. The good news:
In the past week in the U.S.:
New daily reported cases fell 20.7%
New daily reported deaths fell 5.8%
Covid-related hospitalizations fell 9.2%

CDC Limits Review of Vaccinated but Infected; Draws Concern: “Federal health officials this month decided to limit how they monitor vaccinated people who have been infected with Covid-19, drawing concern from some scientists who say that may mean missing needed data showing why and how it happens…
Rare breakthrough cases are expected since no vaccines are 100% effective. But tracking and sequencing the cases helps in figuring out who may be more at risk, whether new variants evade the vaccines and when protection from the shots begins to wane. At the same time, those infected -- some of whom are suffering widespread medical issues, even if they’re not hospitalized -- say they feel lost as a result of the lack of information.”

CDC: Covid is airborne farther than 6 feet — here’s what that means for returning to the office: “The Centers for Disease Control and Prevention latest updated guidance about how Covid spreads, emphasizes that the virus can be spread through the air via “very fine droplets and aerosolized particles” from an infected person who is more than 6 feet away…
The CDC says that there have been instances when people were infected with Covid despite maintaining physical distance from others. For example, if people spend a prolonged period of time (from 15 minutes to hours) in a space, the virus can linger in the air and infect someone else who walks through. Or in situations where people are shouting, singing or breathing heavily, that can increase the risk of transmission.”

Effect of Covid19 on asthma exacerbation: “For Black/African-American and Hispanic/Latinx individuals with moderately severe asthma, there was nearly a halving of asthma exacerbations [AEX] following the COVID19 pandemic, a decrease most significant for individuals working outside of the home and in those without type 2 inflammation suggesting environmental or common viral triggers for asthma exacerbations…Potential explanations for the observed decreases in AEX may include decreased exposure to environmental and occupational factors, reduced respiratory infections , and/or changes in stress.”

Novavax pushes back COVID-19 vaccine approval plans to third quarter: “Novavax disclosed Monday that it is now looking at a third-quarter filing for authorisation of its COVID-19 vaccine candidate NVX–CoV2373 in the UK, US and Europe, as it works to gather data required for submission…
The company also indicated during its quarterly earnings report on Monday that it does not expect to reach its production goal of 150 million doses per month until the fourth quarter of this year, later than its previous third-quarter target. Instead, it now anticipates producing 100 million doses per month by the end of the third quarter. Novavax shares slipped as much as 9% on the news…
[T]he company has struggled with accessing raw materials needed to make its vaccine, including bags, filters and cell culture media…”

HHS PLANS TO OPEN UP BILLIONS IN HOSPITAL COVID-19 GRANTS IN COMING WEEKS: “The Biden administration plans to open applications for billions of dollars in grants for hospitals and other health care providers before the end of May after months of delay…
Currently, providers have only been reimbursed for a portion of their losses through June 2020. The next tranche of grant money will deplete most of the remaining cash in the $178 billion fund to help providers with expenses and losses related to the pandemic.”

HHS officials tells Congress COVID-19 booster vaccine shot could be needed: “‘The increased age, waning antibodies over time and new variants increase the probability that booster doses may be needed,’ said David Kessler, M.D., chief science officer of COVID response for the Department of Health and Human Services, during a Senate hearing Tuesday.
Kessler added that the federal government is planning to have doses available for the American people if a booster shot is necessary.”

About the public’s health

Efficacy of dietary supplements containing isolated organic compounds for weight loss: a systematic review and meta-analysis of randomised placebo-controlled trials: “While some dietary supplements containing isolated organic compounds warrant further investigation to determine efficacy and safety, there is currently insufficient evidence to recommend any of these dietary supplements for weight loss.”

Associations of six adiposity-related markers with incidence and mortality from 24 cancers—findings from the UK Biobank prospective cohort study: “All adiposity markers had similar associations with overall cancer incidence. BMI was associated with a higher incidence of 10 cancers (stomach cardia (hazard ratio per 1 SD increment 1.35, (95% CI 1.23; 1.47)), gallbladder (1.33 (1.12; 1.58)), liver (1.27 (1.19; 1.36)), kidney (1.26 (1.20; 1.33)), pancreas (1.12 (1.06; 1.19)), bladder (1.09 (1.04; 1.14)), colorectal (1.10 (1.06; 1.13)), endometrial (1.73 (1.65; 1.82)), uterine (1.68 (1.60; 1.75)), and breast cancer (1.08 (1.05; 1.11))) and overall cancer (1.03 (1.02; 1.04)).”

Annual Screening Mammography Associated With Lower Stage Breast Cancer Compared With Biennial Screening: This article continues the ongoing debate about proper screening protocols for breast cancer. This research did not address the burden of false positives.

About health insurance

Health insurer shares hit all-time highs: “Several commercial health insurers recorded all-time high share prices on May 10, according to historical share price data.
UnitedHealth Group's shares closed at $420.89 on May 10, a new all-time high for the health insurance and services company. Cigna and Anthem shares also closed at all-time highs on May 10, $266.91 and $401.90, respectively, and Humana's shares hit an all-time high of $469.97 the same day.”

Colorado House advances Democrat-backed insurance plan: “A Democrat-backed bill designed to curb health insurance costs for individuals and small businesses hit hard by the pandemic has advanced in the Colorado House.
Lawmakers worked from Thursday evening to early Friday debating the bill, which would require insurers to lower premiums for people and small businesses buying their own insurance by 18% by 2025 in any county where they now offer coverage. Democrats say the bill would make health care more affordable for 18,000 residents.
Health care providers, including hospitals, could be fined under the bill if they don’t reach those goals in part by offering a standardized plan to be developed by the commissioner of insurance.”
The bill was dramatically revised following fierce opposition from the health care industry. The original version called for a so-called ‘public option’ asking private insurance companies to reduce current premium rates for individual plans by 20% by 2024.”

IRS raises limit on health savings account contributions: “The IRS raised the annual limit people with high-deductible health plans can contribute to their health savings accounts.
For 2022, a single person with a high-deductible health plan can put $3,650 into their HSA, and an individual person with family coverage can put $7,300 into their HSA. Those limitations are up $50 and $100, respectively…”

U of Miami to pay $22M, allegedly converted physician offices to run up bills: “The University of Miami agreed to pay $22 million to resolve allegations that it violated the False Claims Act by ordering medically unnecessary laboratory tests and submitting false claims through its laboratory and off-campus hospital-based facilities.  
According to prosecutors, University of Miami converted several physician offices to hospital-based facilities to seek reimbursement at higher rates. While Medicare allows providers to convert offices to hospital-based facilities, they need to meet certain requirements and provide proper notice to CMS. Prosecutors claim University of Miami knowingly didn't provide the required notice and as a result submitted false claims related to its hospital facilities. “

About pharma

States Probe Business Practices of Pharmacy Benefit Managers [PBMs]: “Several states are investigating pharmacy benefit managers, with some saying they are focused on whether the companies fully disclosed details about their business and potentially received overpayments under state contracts, according to state officials and documents.
States including Ohio, Oklahoma, Georgia, New Mexico, Kansas, Arkansas and Mississippi, as well as the District of Columbia, are scrutinizing PBMs, according to the offices of state attorneys general and auditors, as well as public documents including state contracts and securities filings.
Details about the investigations’ focus are typically not public. Officials with some states said they were looking at companies in their Medicaid programs and state-employee plans. Among the companies under scrutiny are units of Centene Corp. , UnitedHealth Group Inc. and CVS Health Corp.”

Today's News and Commentary

About Covid-19

FDA authorizes Pfizer coronavirus vaccine for adolescents 12 to 15 years old: “The decision that the two-shot regimen is safe and effective for younger adolescents had been highly anticipated by many parents and pediatricians, particularly with the growing gap between what vaccinated and unvaccinated people may do safely. Evidence suggests that schools can function at low risk with prevention measures, such as masks and social distancing. But vaccines are poised to increase confidence in resuming in-person activities and are regarded as pivotal to returning to normalcy.”

Moderna says its COVID-19 vaccine is 96% effective in kids ages 12-17

EU leaders confront US over vaccine patent waiver demands: “EU leaders have confronted the Biden administration over its calls for Covid-19 vaccine patent waivers and urged the US to export jabs directly if it wants to help poor countries in need.
German Chancellor Angela Merkel said after a two-day EU leaders’ summit in Porto, Portugal, that suspending intellectual property rights was no solution to supply shortages and called for a focus on ramping up production instead.
France’s President Emmanuel Macron and top EU officials echoed the German premier’s rhetoric…”

International COVID-19 trial to restart with focus on immune responses: “The clinical trial, named Solidarity and coordinated by the World Health Organization (WHO), will test three drugs that dampen inflammation, an approach that has already shown promise in people hospitalized with COVID-19…
When the WHO launched Solidarity in March 2020, the study was focused on antiviral drugs. By October, the trial had enrolled more than 11,000 participants hospitalized with COVID-19 in 30 countries. But it also found that none of the four drugs that it tested (remdesivir, interferon, the malaria drug hydroxychloroquine, and a combination of HIV drugs called lopinavir and ritonavir) saved lives or shortened hospital stays…
Now, after a pause to sort out which therapies to try next, the trial hopes to focus instead on reining in immune responses that can contribute to severe forms of COVID-19.”

About hospitals and health systems

National Hospital Week starts May 9

Kaiser's net income hits $2B in Q1: “Oakland, Calif.-based Kaiser Permanente recorded a net income of $2 billion in the first quarter of 2021, up from a net loss of $1.1 billion recorded in the same quarter last year, according to financial data released May 7. 
For the quarter ended March 31, the integrated healthcare provider with 39 hospitals recorded operating revenue of $23.2 billion, up from $22.6 billion recorded in the same quarter last year. Additionally, Kaiser saw its expenses rise 3.7 percent to $22.2 billion. Kaiser attributed the expense increase to several positives, including growth in its health plan.
Kaiser said its health plan membership grew by 129,000 members in the first quarter. It now has more than 12.5 million members.”

Catholic Health launches specialty pharmacy: ”Specialty drugs are often expensive, hard to manage and have significant side effects, and as a result, patients struggle to adhere to them, Catholic Health said. The system's specialty pharmacy initiative will consist of pharmacists with advanced clinical training to help patients manage their specialty medications. 
The health system will also provide pharmacy liaisons to help patients navigate the complex process of obtaining and complying with specialty medications and managing their costs. The liaisons will manage financial assistance applications, insurance authorizations and medication refills, Catholic Health said.”

Jefferson Health drops policy linking physician bonuses, patient fundraising referrals: “Jefferson Health said the decision to link referrals to bonus pay was a ‘modest incentive for departmental chairs’ and was done to ‘advance the culture of philanthropy.’ The health system also said it was modeled after other medical organizations.”

About the public’s health

Air pollution from farms leads to 17,900 U.S. deaths per year, study finds: “Animal agriculture is the worst emitter, researchers say, responsible for 80 percent of deaths from pollution related to food production. Gases associated with manure and animal feed produce small, lung-irritating particles capable of drifting hundreds of miles. These emissions now account for more annual deaths than pollution from coal power plants. [Emphasis added]Yet, while pollution from power plants, factories and vehicles is restricted under the Clean Air Act, there is less regulation of air quality around farms.”

Biden administration revives anti-bias protections in health care for transgender people: “The Biden administration said Monday it would provide protections against discrimination in health care based on gender identity and sexual orientation, reversing a policy of its predecessors that had been a priority for social conservatives and had infuriated civil liberties advocates.”

Cigna CEO says preventive care is back to pre-pandemic levels: “Cigna CEO David Cordani said preventive care procedures including mammograms, colonoscopies, childhood vaccinations and cervical cancer screenings among its members are back to levels not seen since before the COVID-19 shutdowns of early 2020.”

About healthcare IT

Walmart to acquire telehealth company MeMD as Amazon Care signs first customer: “Walmart is going all-in on telehealth, opening a new front to compete with Amazon.
The retail giant announced Thursday that its healthcare division, Walmart Health, plans to acquire multi-specialty telehealth provider MeMD.”

SURESCRIPTS LEADS INDUSTRY TRANSFORMATION TO NCPDP’S SCRIPT STANDARD V2017071 TO STRENGTHEN PATIENT SAFETY AND IMPROVE WORKFLOW EFFICIENCY: “On September 1, 2021, Surescripts will sunset v10.6 of its E-Prescribing and Medication History services, as part of the industry’s migration to the National Council of Prescription Drug Programs (NCPDP) SCRIPT Standard v2017071 that is required by the Centers for Medicare & Medicaid Services (CMS) for Medicare Part D. All electronic health records (EHR) vendors, health systems, pharmacies and pharmacy benefit managers (PBMs) who utilize Surescripts E-Prescribing or Medication History must complete their migrations to SCRIPT Standard v2017071 by September 1, 2021, in order for their users to continue to use these services.”

About healthcare costs

Fidelity’s 20th Annual Retiree Health Care Cost Estimate Hits New High: A Couple Retiring Today Will Need $300,000 to Cover Medical Expenses, an 88% Increase Since 2002: “According to Fidelity, a 65-year old, opposite-gender couple retiring this year can expect to spend $300,000in health care and medical expenses throughout retirement. For single retirees, the 2021 estimate is $157,000 for women and $143,000 for men.”

Today's News and Commentary

About Covid-19

Less than a third of parents say they'd let their child get Covid-19 vaccine right away, survey finds: “CNN reported that only about 29% of parents of children under 18 said they would get their child vaccinated against COVID-19 "right away" as soon as the child was eligible, according to Kaiser Family Foundation (KFF) survey of 2097 adults published Thursday.
An additional 32% said they would wait to see how the vaccine is working before getting their child inoculated, while 15% of parents said their child would be vaccinated only if their school requires it and 19% said they definitely would not let their children get the vaccine, according to KFF.”

Moderna says its COVID-19 vaccine is 96% effective in teens: ”Evidence that Moderna's vaccine is effective in teens comes as rival Pfizer is expected to receive federal authorization by early next week to use its COVID-19 vaccine in adolescents. Federal approval of one or more vaccines against the disease could enable many American middle and high school students to be vaccinated before the start of the 2021-22 school year.”

Pfizer COVID vaccine protects against worrying coronavirus variants: “People in Qatar who received two doses of the Pfizer–BioNTech vaccine were 75% less likely to develop a case of COVID-19 caused by B.1.351 than were unvaccinated people, and had near-total protection from severe disease caused by that strain.”

‘It’s pretty marginal’: Experts say Biden’s vaccine waiver unlikely to boost supply quickly: “The Biden administration’s support of a petition to ease patent protections for vaccines elevated the global battle against the coronavirus as a central plank of U.S. foreign policy, but myriad hurdles remain before that stance could become international policy — if ever.
As a result, it could be months, or longer, before the World Trade Organization reaches an agreement to temporarily waive the protections and years before countries build factories and amass the materials and expertise to produce the vaccines, experts say.”

WHO grants emergency use authorization for Chinese-made Sinopharm coronavirus vaccine: “The step means that the vaccine, developed by Sinopharm with the Beijing Institute of Biological Products, can be used to bolster WHO-backed efforts such as the Covax initiative to share doses equitably around the world.”

Salesforce, Google, Facebook. How Big Tech Undermines California’s Public Health System: Great piece of investigative journalism from Kaiser Health News (KHN): “California Gov. Gavin Newsom has embraced Silicon Valley tech companies and health care industry titans in response to the covid-19 pandemic like no other governor in America — routinely outsourcing life-or-death public health duties to his allies in the private sector.
At least 30 tech and health care companies have received lucrative, no-bid government contracts, or helped fund and carry out critical public health activities during the state’s battle against the coronavirus, a KHN analysis has found. The vast majority are Newsom supporters and donors who have contributed more than $113 million to his political campaigns and charitable causes, or to fund his policy initiatives, since his first run for statewide office in 2010.”

About hospitals and health systems

Hospitals get 1st CMS warning on price transparency failure: “CMS said it began proactive audits of hospital websites and reviewed complaints submitted to its website after Jan. 1, but didn't issue its first round of warning letters until April. 
Hospitals will have 90 days to address the findings in the noncompliance letter from CMS. The agency will then re-review upon expiration of that 90-day window. If the hospital is still not in compliance, it may receive a second warning letter or it may be sent a request for a corrective action plan, CMS said.”

Hospitals lose jobs for 4th straight month: “Hospitals lost 5,800 jobs in April, marking the fourth month of job loss this year, according to the latest jobs report from the U.S. Bureau of Labor Statistics.
The April count compares to 600 hospital jobs lost in March, 2,200 jobs lost in February and 2,100 jobs lost in January. Before January, the last job loss was in September, when hospitals lost 6,400 jobs.
Overall, healthcare lost 4,100 jobs last month — compared to 11,500 jobs added in March — and employment in the industry is down by 542,000 since February 2020.
Within ambulatory healthcare services, dentist offices saw 3,700 added jobs; physician offices saw 11,300 job gains; and home healthcare services lost 6,700 jobs in April. 
Nursing and residential care facilities lost 19,500 jobs last month, compared to 3,200 jobs lost the month prior.”
In a related article: Best U.S. States for Healthcare Jobs in 2021: Massachusetts heads the list, Wyoming is at the bottom.

About medical equipment

BD to spin off $1B diabetes care business into standalone public company: “After nearly a century spent building out its portfolio of insulin pens and syringes, BD is finally ready to let its diabetes care business leave the nest.
While reporting financial results for the second fiscal quarter of the year, during which revenues grew more than 15% to $4.9 billion, BD also laid out its plans to spin off its diabetes-focused segment.
The split is expected to be completed in the first half of 2022, after which the segment will become a completely separate, publicly traded company…”

About pharma

Industry Profile: Pharmaceuticals/Health Products: These companies spent about $92M on lobbying in the first quarter, on track to what would be a record year.

CVS Caremark 2020 Drug Trend Report: This report is from the PBM division of CVS. Some highlights:
—Specialty medications accounted for 52% of drug spending.
—98% of utilization increase is from conditions with new therapies and indications
—Five therapeutic categories drive 90% of specialty costs

FDA Hopes to Resume On-Site Inspections by September: “Under the most-likely scenario, the agency estimates that it can take care of 851 (26 percent) of the 3,229 human and animal medical product domestic inspections scheduled but not yet completed in the rest of fiscal 2021.”

USE AND ESTIMATED IMPACT OF MEDICATIONS THAT RAISE BLOOD PRESSURE AMONG US ADULTS WITH HYPERTENSION: NATIONAL CROSS-SECTIONAL STUDY: “In this nationally representative study of US adults, nearly 1 in 5 with hypertension reported taking medications associated with BP elevation, many of which have therapeutic alternatives that are not associated with BP elevation. Attention to polypharmacy and prescribing cascades may be a promising approach to improving BP control and reducing medication burden.”

About health insurance

1 in 6 US workers say they keep unwanted jobs for health insurance: “The survey, conducted by West Health and Gallup, found that 16 percent of adult workers in the U.S. have stayed in jobs that they might have otherwise left because they do not want to lose their employer-sponsored health insurance.
Black workers were 50 percent more likely to find themselves in this situation. According to the survey, 21 percent of Black adults are currently in a job they want to leave but won’t out of fear of losing health insurance benefits, compared to 14 percent of white adults.”

American Antitrust Institute expresses concern about proposed Optum-Change Healthcare deal: The American Antitrust Institute (AAI) is warning that UnitedHealth Group's planned acquisition of Change Healthcare could stifle competition.
The nonprofit, which advocates for more aggressive antitrust enforcement from the feds, wrote in a letter (PDF) to the Department of Justice (DOJ) that the deal is "likely to harm competition and consumers."
For one, the merger would eliminate a key rival to UnitedHealth's Optum, which operates an analytics arm of its own, OptumInsight. The deal could also lead UHG to favor its own health plan, UnitedHealthcare, over other insurers that may contract with Optum for technology services.”

Cigna's Medicare Advantage enrollment up 11% year over year: “For the 2021 plan year, the insurer grew its county footprint by 22%, moving into five new states and 67 new counties…
Cigna reported $1.2 billion in profit for the first quarter of 2021, on par with the prior-year quarter and surpassing Wall Street analysts' projections.
Cigna also beat the Street on revenue for the quarter, according to Zacks Investment Research, posting $41 billion. That's also an increase over the first quarter of 2020, where Cigna reported $38.5 billion.”

About the public’s health

Sugar-sweetened beverage [SSB] intake in adulthood and adolescence and risk of early-onset colorectal cancer [EO-CRC] among women: “Higher SSB intake in adulthood and adolescence was associated with a higher risk of EO-CRC among women. Reduction of SSB consumption among adolescents and young adults may serve as a potential strategy to alleviate the growing burden of EO-CRC.”

About medical devices

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017: “This study suggests that high-risk medical devices approved via PMA [premarket approval] associated with a greater risk of recall than previously reported. Most recalls are for devices with 510(k) clearance, also raising safety concerns. Strengthening postmarketing surveillance strategies and pivotal trials may improve device safety.”











Today's News and Commentary

About Covid-19

KFF COVID-19 Vaccine Monitor - April 2021: “The share of adults who say they’ve gotten at least one dose of a vaccine or intend to do so as soon as possible inched up from 61% in March to 64% in April, while the share who want to “wait and see” before getting vaccinated – a group that had been steadily decreasing in size since over several months – remained about the same in April (15%) compared to March (17%). Among Republicans, a group that has been slower to embrace the vaccine, over half now say they’ve gotten at least one dose or will do so as soon as they can. The share of Republicans who say they will “definitely not” get vaccinated decreased from 29% in March to 20% in April but remains substantially larger than the share among Democrats or independents…
Among those who are open to getting vaccinated but have not yet tried to get an appointment, reasons range from safety concerns to logistical barriers to questions about eligibility, and vary widely by vaccination intention. Those who say they want the vaccine as soon as possible mainly cite logistical concerns and information needs; those in the wait and see group mainly express safety concerns or a lack of research, and those who say they’ll get the vaccine only if required mainly say they don’t feel they want or need the vaccine. By contrast, when those who say they will “definitely not” get vaccinated are asked if there is anything that might change their mind, the answer is a resounding ‘no.’”

HHS announces $250M in new funding to get COVID-19 vaccines to medically underserved areas: “The Department of Health and Human Services (HHS) announced $250 million in new funding to create a community-based workforce that can help get people in medically underserved areas vaccinated for COVID-19.”

Pfizer Pursuing COVID-19 Vaccine Full Approval This Month: “Pfizer said it plans to file for full approval of its COVID-19 vaccine by the FDA later this month — an approval that would allow the companies to market the vaccine directly to consumers and allow the product to stay on the market beyond the pandemic.
The FDA granted Emergency Use Authorization (EUA) for the vaccine, co-developed with BioNTech, on Dec. 11, 2020, for individuals 16 years of age and older, but the authorization is only good through the end of the public health emergency.”

US backs temporary waiver of IP rights for COVID-19 vaccines: “The US will support a proposal to temporarily lift intellectual-property (IP) protections for COVID-19 vaccines, joining an effort to increase supply and access of the inoculations around the world. …
The news sent stock prices of major COVID-19 vaccine developers on a downward slope, with Moderna, BioNTech and Novavax shares falling as much as 9.7%, 8.9% and 11%, respectively. Meanwhile, Pfizer shares slipped as much as 2.6%, a day after saying it expects its BioNTech-partnered coronavirus vaccine to reach sales of $26 billion this year.”

Children Now Account For 22% Of New U.S. COVID Cases. Why Is That?: “The number of children contracting COVID-19 in the U.S. is much lower than the record highs set at the start of the new year, but children now account for more than a fifth of new coronavirus cases in states that release data by age… Just one year ago, child COVID-19 cases made up only around 3% of the U.S. total…
Experts link the trend to several factors – particularly high vaccination rates among older Americans.”

Moderna says Covid booster shot generates promising immune response against variants found in South Africa, Brazil: “It found the booster dose increased neutralizing antibody responses against the original virus as well as B.1.351 and P.1, two variants that have since spread to other countries, including the U.S…
The preliminary results, which Moderna says will be published online, have not yet been peer-reviewed.”

Moderna pulled in $1.7B with its COVID-19 vaccine rollout, but it's just getting started: “With additional supply agreements under its belt, Moderna now predicts its vaccine will generate $19.2 billion by year’s end. In comparison, rival drugmaker Pfizer posted $3.5 billion in COVID-19 vaccine sales during its first quarter and also upped its anticipated 2021 revenues to a whopping $26 billion.”

About pharma

Report Says Almost 3,500 Gene, Cell and RNA Therapies in Drugmaker Pipelines: “Cancer drugs still lead research and development, with nearly 1,200 therapies in development for the first quarter of 2021, according to the report. Next in line after oncology are treatments for neurological disorders, with 35 drugs in the pipeline from the preclinical to preregistration stages.”

Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs: “This cross-sectional study found that 5 years after their approval in the US, 15% of novel drugs (5 of 34 drugs) were approved in all countries where they were tested; among 70 countries contributing research participants, 7% (5 countries) received market access to the drugs they helped test within 1 year of US approval and 31% (22 countries) did so within 5 years. Approvals were faster in high-income countries, and access was lowest in African countries.”

AbbVie's Humira regains top pharma TV spender spot, while sibling brands Rinvoq and Skyrizi tag along: “AbbVie's Humira drop didn’t last long. While the blockbuster immunology med dropped out of the No. 1 pharma TV spending spot in March, it bounced right back in April.
AbbVie spent almost $23 million on national media buys for Humira, according to real-time TV ad tracker iSpot.tv, which landed it squarely atop the list again—just as it has quite reliably over the past five years.”

About the public’s health

Don't pass the salt - WHO issues benchmarks for sodium content in food: “The new WHO benchmarks, for 64 food and drink categories, are aimed at guiding health authorities in its 194 member states in talks with the food and beverage industry.
For example, potato crisps should contain a maximum of 500 mgs of sodium per 100g serving, pies and pastries up to 120 mgs and processed meats up to 360 mgs, according to its benchmarks.”

About healthcare professionals

Recent Changes in Physician Practice Arrangements: Private Practice Dropped to Less Than 50 Percent of Physicians in 2020: Some highlights from this AMA report:
”2020 was the first year in which less than half (49.1 percent) of patient care physicians worked in a private practice—a practice that was wholly owned by physicians. This marks a drop of almost 5 percentage points from 2018, when 54.0 percent of physicians worked in physician-owned practices, and a drop of 11 percentage points since 2012. In 2020, almost 40 percent of physicians worked directly for a hospital or for a practice at least partially owned by a hospital or health system.
The shift toward larger practice size, which has been ongoing for many years, also appears to have accelerated between 2018 and 2020. The percentage of physicians in practices with at least 50 physicians increased from 14.7 percent in 2018 to 17.2 percent in 2020.
Fifty percent of physicians were employed, 44.0 percent had an ownership stake in their practice, and 5.8 percent were independent contractors in 2020. The employee percentage was up from 47.4 percent in 2018 and 41.8 percent in 2012.”

About healthcare IT

It's World Password Day: 10 tips and insights for hospital leaders: FYI

Proposed Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement: “…MGMA is concerned that providing increased access to protected health information (PHI) with fewer guardrails, particularly around organizations outside the purview of HIPAA, will have unintended consequences for the security and privacy of patient data. We are also cautious about increasing access rights in ways that have the potential to substantially increase the administrative burdens placed on medical practices or create scenarios in which medical practices are more likely to face penalties due to the infeasibility of complying with more stringent requirements.”
Read the entire letter from MGMA to Robinsue Frohboese, Acting Director of the Office for Civil Rights.

Majority of healthcare decision-makers prioritize virtual care delivery, says Philips report: “A whopping 89% of U.S. healthcare leaders say they're currently heavily investing in telehealth, though many expect to shift gears toward artificial intelligence in the future.”

About payers

US Health Insurer Margins Remarkably Stable in 2020; 2021 Uncertainty Remains: “The combined 2020 operating EBITDA margin was approximately 7.5% for the seven largest publicly traded health insurers in the U.S., essentially unchanged from 2019. Fitch Ratings originally anticipated that the pandemic’s impact on the sector would be manageable, but the actual level of stability in full-year operating performance was unexpected.Combined financial leverage declined modestly at YE 2020 compared with YE 2019, despite the fact that most insurers issued debt in 2020 and drew on credit facilities, primarily to pre-fund near-term maturities, redeem existing debt and bolster liquidity as capital market uncertainty increased.”

Changes in US Medicaid Enrollment During the COVID-19 Pandemic: “Medicaid enrollment increased as the US’s COVID-19 pandemic and economic shutdown began in March 2020, with approximately 5 million more people covered nationally by September 2020. This increase occurred in both expansion and nonexpansion states, as found in a previous shorter-term analysis, although we found evidence suggesting that growth was larger in expansion states. Enrollment simplification steps were not associated with Medicaid growth. Unexpectedly, we found that enrollment growth was greater in states with smaller changes in unemployment in 2020. This may indicate that Medicaid growth is associated with factors other than job loss, including reduced work hours making more people eligible, greater focus on health care during the pandemic, and the maintenance of effort requirement passed by Congress in March 2020, which offered states more funding in exchange for a requirement that they not disenroll anyone from Medicaid during the public health emergency.”

UnitedHealthcare To Offer New Post-Discharge Support for Retirees with Employer Group Medicare Advantage Plans: “UnitedHealthcare announced it will be launching UnitedHealthcare® Healthy at Home, a new offering designed to help retirees safely transition back home after being discharged from a hospital or skilled nursing facility.
UnitedHealthcare Healthy at Home, specifically created for its Group Retiree Medicare Advantage plans…
[Benefits will include:]
Post-Discharge Meal Delivery, which will provide up to 28 meals (two meals per day for two weeks) following all inpatient or skilled nursing facility discharges for retirees when referred by a UnitedHealthcare advocate. The most vulnerable members are proactively contacted by UnitedHealthcare advocates following their discharge to receive these services.
Post-Discharge Transportation, which will include up to 12 one-way rides to and from medically related appointments and to the pharmacy following every inpatient or skilled nursing facility discharge when referred by a UnitedHealthcare advocate.
In-Home Personal Care, which will provide up to six hours of in-home personal care following all inpatient and skilled nursing facility discharges. Retirees receive assistance with activities of daily living to support their recovery and follow-up care to help reduce the risk of hospital readmission.
Services will be available every time a retiree is discharged from a hospital or skilled nursing facility.”

Dignity Health hospital pays $10M to settle improper billing allegations: “The settlement resolves allegations that Dignity Health and Neurosurgical Associates billed Medicare for concurrent and overlapping surgeries in violation of federal regulations and reimbursement policies. Prosecutors claim that the surgeries were often doubly or triply concurrent.”

UPDATED Coronavirus tracker: 940K have signed up on Healthcare.gov during SEP[Special Enrollment Period]: The window continues through Aug. 15.

Today's News and Commentary

About healthcare IT

April data breaches double March numbers: “In March, there were 1,116,997 health records compromised in data breaches at 36 organizations.
In April, that number nearly doubled to 2,121,186 health records affected at 41 organizations.
March's numbers tripled those affected in February, when just 351,709 health records were compromised, signalling that cyberattacks on healthcare organizations are not slowing down.”

Cerner's net earnings increase 17% in Q1: “Cerner reported $172.3 million in net earnings for the first quarter of 2021, up 17 percent from $147.2 million during the same period last year.”

About the public’s health

US birth rate falls to lowest point in more than a century: “The U.S. birth rate fell 4% last year, the largest single-year decrease in nearly 50 years, according to a government report being released Wednesday.
The rate dropped for moms of every major race and ethnicity, and in nearly every age group, falling to the lowest point since federal health officials started tracking it more than a century ago.”
The implications are immense…including future scarcity of employees and their contribution to the much larger older population’ s Social Security and Medicare Part A (not to mention general taxes).

Vitamin, Mineral, and Multivitamin Supplementation to Prevent Cardiovascular Disease and Cancer: From the USPTF:
The USPSTF recommends against the use of beta-carotene or vitamin E supplements for the prevention of cardiovascular disease or cancer.
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of multivitamin supplements (other than beta-carotene or vitamin E supplements) the prevention of cardiovascular disease or cancer.

About Covid-19

Pfizer says it will seek clearance in September for its vaccine to be used in children aged 2 to 11: The headline is the message.
And in a related article: Pfizer hikes outlook as COVID-19 vaccines sales forecast to hit $26 billion this year

About pharma

Ex-Theranos CEO's Defense Emerges In Pre-Trial Battle“Former Theranos CEO Elizabeth Holmes' wire fraud defense surfaced Tuesday when her attorneys urged a California federal judge to allow jurors at her upcoming criminal fraud trial to hear that exaggeration is part of Silicon Valley's startup culture…”
So lying is OK if everyone is doing it?

About medical devices

NIH-backed device is first to offer long-term wireless monitoring of Parkinson's patients' brain activity: “The system includes a neurostimulation device implanted on a patient’s chest, with thin wires connected to electrodes in the brain. Those electrodes track brain activity and transmit the collected data to a nearby pocket-sized device. The receiver, in turn, uploads the data via Bluetooth to a tablet and cloud-based server.
Working in the opposite direction, neurologists can analyze the data to adjust the electrical signals sent to the brain through the electrodes. Those signals regulate activity in the motor control areas of the brain, offering a treatment option for neurological disorders that affect movement such as Parkinson’s.”

About healthcare professionals

A Primary Care Physician for Every American, Science Panel Urges: “The federal government must aggressively bolster primary care and connect more Americans with a dedicated source of care, the National Academies of Sciences, Engineering and Medicine warn in a major report that sounds the alarm about an endangered foundation of the U.S. health system…
he authors recommend that all Americans select a primary care provider or be assigned one, a landmark step that could reorient how care is delivered in the nation’s fragmented medical system.
And the report calls on major government health plans such as Medicare and Medicaid to shift money to primary care and away from the medical specialties that have long commanded the biggest fees in the U.S. system.”
HMOs have been working this way for decades. Procedural specialists will not let the dollars shift to primary care physicians in either fee for service or traditional Medicare or Medicaid.

About quality and safety

CEO Coalition Sets New Safety Standard for Healthcare Workers: “To catalyze a future in which all care team members feel protected and safe at work, 10 health system CEOs from across the United States joined forces to declare a renewed commitment to improving safety, well-being, and equity for all who work in healthcare…
The CEO Coalition’s Declaration of Principles expands the definition of safety to include safeguarding psychological and emotional well-being of team members, promoting health justice by declaring equity and anti-racism as core components of safety, and ensuring physical safety, which includes a zero-harm program to eliminate workplace violence, both physical and verbal.”

About payers

Request to Delay Mandatory Reporting of eCQMs and MIPS CQMs and Implement Changes to theMedicare Shared Savings Program Quality Overhaul: The twelve organization members of the National Association of ACOs have asked CMS to delay and modify some of the reporting requirements “in the Final 2021 Medicare Physician Fee Schedule Rule (CMS-1734-P), as published in the Federal Register on December 28, 2020.” Read the letter with its rationale and 6 suggestions.

Today's News and Commentary

About healthcare systems

Higher Medicare Spending On Imaging And Lab Services After Primary Care Physician Group Vertical Integration: Yet another study showing how integration raises costs:
”After vertical integration, the monthly number of diagnostic imaging tests per 1,000 attributed beneficiaries performed in a hospital setting increased by 26.3 per 1,000, and the number performed in a nonhospital setting decreased by 24.8 per 1,000. Hospital-based laboratory tests increased by 44.5 per 1,000 attributed beneficiaries, and non-hospital-based laboratory tests decreased by 36.0 per 1,000. Average Medicare reimbursement rose by $6.38 for imaging tests and $0.57 for laboratory tests, which translates to $40.2 million and $32.9 million increases in Medicare spending, respectively, for the entire study period.”

Local providers, community organizations band together against Mass General Brigham's proposed expansion: “Expansions planned by Mass General Brigham (formerly Partners HealthCare) are facing organized opposition from a collection of local providers, community organizations and business groups that say the development will increase healthcare costs and threaten the availability of existing services.”

2021 WINNING HOSPITALS: AVOIDING OVERUSE: “The Lown Institute Hospitals Index is the first ranking to apply overuse criteria to over 3,100 U.S. hospitals to assess their success at avoiding tests and procedures that offer little to no clinical benefit to patients.” Check the lists of best and worst ranked hospitals and comparison with US News Best Hospitals list.

About Covid-19

New U.S. COVID cases fall for third week, deaths lowest since July: “New cases of COVID-19 in the United States fell for a third week in a row, dropping 15% last week to 347,000, the lowest weekly total since October, according to a Reuters analysis of state and county data.
Nearly a third of the country's population has been fully vaccinated as of Sunday, and 44% has received at least one dose of a COVID-19 vaccine, according to the U.S. Centers for Disease Control and Prevention.”

White House will make unordered vaccine supply available to other states: “The White House on Tuesday told states that coronavirus vaccine doses they choose not to order will become available to other states — the most significant shift in domestic vaccine distribution since President Biden took office, and part of an effort to account for flagging demand in parts of the country.”

$100 as an Incentive to Get a Shot? Experiment Suggests It Can Pay Off: “A cash reward works best with Democrats, and relaxing safety guidelines seems to motivate Republicans, a survey study shows.”

F.D.A. to Authorize Pfizer Vaccine for Adolescents by Early Next Week: The headline is the message.

HHS launches new vaccine reimbursement program for providers: “The Department of Health and Human Services, through the Health Resources and Services Administration, has announced a new program for providers to cover the cost of administering COVID-19 vaccines to patients enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing. 
The COVID-19 Coverage Assistance Fund addresses a provider need to be reimbursed for uncompensated costs. Providers cannot bill patients for COVID-19 vaccination fees.”

Biden administration rolls out COVID-19 vaccine text-line: “The service will launch alongside a vaccine finder website and a to-be-released 1-800 number to help connect individuals with appointments in their area.”

Moderna to supply up to 500 million COVID-19 vaccine doses to COVAX: “Moderna announced Monday that it has signed an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of its COVID-19 vaccine mRNA-1273. An initial 34 million doses will be delivered to the COVAX vaccine-sharing facility in the fourth quarter, while Gavi retains the option to procure an additional 466 million doses in 2022.”

DuPage County judge orders Elmhurst Hospital to allow COVID-19 patient to receive controversial medication: This order sets a very dangerous precedent. “A DuPage County judge on Monday ordered Elmhurst Hospital to allow a comatose woman suffering from COVID-19 to receive a medication the Food and Drug Administration says could be unsafe, but the legal fight appears bound to escalate…
Elmhurst Hospital’s attorney, Joseph Monahan, said at the hearing none of its doctors would agree to administer ivermectin for COVID-19, and that an internal ethics panel concluded its use couldn’t be justified. He argued that judges shouldn’t overrule medical decisions.”

About healthcare IT

Telehealth use falls 16% in 1 month: “Telehealth usage among individuals with private insurers fell month-over-month for the first time since September, dropping by 16 percent in February, according to healthcare data cost organization Fair Health…
The top five reasons for telehealth visits in February were mental health conditions (54.6 percent), joint and soft tissue diseases and issues (3.2 percent), developmental disorders (3 percent), acute respiratory diseases and infections (2.2 percent), and hypertension (1.8 percent).”

CMS names winner of AI health outcomes competition: “CMS chose Austin, Texas-based health data analytics company ClosedLoop.ai and Danville, Pa.-based Geisinger as the winner and runner-up, respectively, of the agency's Artificial Intelligence Health Outcomes challenge.
CMS launched the challenge in March 2019 to encourage companies to create AI tools that predict unplanned healthcare facility admissions and adverse events within 30 days.”

HCSC leads $280M funding round for digital health benefits startup : “HCSC inked a partnership with Collective Health in March to bring the startup's claims management and digital health benefits services to HCSC members. The insurer will start offering Collective Health's digital programs to self-funded Blue Cross and Blue Shield customers in Illinois and Texas in 2022, with plans to expand into all HCSC markets.”

Changes in Clinician Attitudes Toward Sharing Visit Notes: Surveys Pre-and Post-Implementation: “Following implementation, more primary and specialty care clinicians agreed that sharing notes with patients online was beneficial overall. Fewer had concerns about more time needed for office visits or documentation. Most thought patients would worry more and reported being less candid in documentation.”

2020 National Progress Report: This annual report from Surescripts is an excellent overview of e-prescribing. To put the company’s importance into perspective, “The Surescripts Network Alliance connects virtually all electronic health record (EHR) vendors, pharmacy benefit managers (PBMs), pharmacies and clinicians, plus an increasing number of health plans, long-term and post-acute care organizations, specialty hubs and specialty pharmacy organizations…[there are] 324 million patients in our master patient index, representing 98% of the U.S. population.”

EHR Vendor Fined $3.8M for Illegal EHR Kickback Scheme: “CareCloud offered and provided its “Champions Program” clients money bonuses, cash equivalent credits, and percentage success payments to suggest its EHR solution to potential clients, DOJ explained. Potential customers were unaware of the illegal kickback practice or participant agreements that prohibited negative information or conversation about the EHR vendor.
According to the published statement, these marketing ploys allegedly resulted in sales for the EHR vendor and caused providers to submit false claims to the federal government. These claims are associated with incentive payments for the Medicare and Medicaid EHR Incentive Programs, or meaningful use program, and the Merit-Based Incentive Payment System, or MIPS.”

About payers

Blue Health Insurers Drop Revenue Rule That Limited Competition: “The Blue Cross Blue Shield Association said it dropped a rule that limited competition among its member insurers, moving to implement a key aspect of an antitrust settlement the companies reached last year with customers.
The settlement hasn’t won final approval from the federal judge presiding over the litigation, so it isn’t being fully implemented…
Previously, the rule was that two-thirds of a Blue licensee’s national net revenue from health plans and related services must stem from Blue-branded business.”

CVS Health boosts guidance after posting $2.2B in profit for Q1: “CVS is boosting its earnings outlook to between $7.56 and $7.68 per share and expects full-year cash flow from operations of between $12 billion and $12.5 billion.
CVS' Aetna subsidiary boasted 23.6 million members in the first quarter, an increase of 214,000 compared to the end of 2020. The company said this reflects growth in its government plans but is partially offset by some declines in commercial membership.”
The Caremark and retail divisions also showed growth.

Health Insurer Financial Performance in 2020: From the Kaiser Family Foundation:
”We find that, by the end of 2020, gross margins per member per month across these four markets remained relatively high and medical loss ratios were relatively low or flat compared to recent years. These findings suggest that many insurers remained profitable through 2020. According to a recent KFF analysis, commercial insurers are going to owe substantial rebates to consumers this year under the Affordable Care Act’s (ACA) Medical Loss Ratio provision. For Medicaid, application of risk sharing arrangements that many states have in place may ultimately reduce overall margins calculated using the annual NAIC data.” As usual for this site, there are many helpful graphics.

About healthcare finance

Value of healthcare IPOs more than double to $13.8B in Q1: “The total valuation of global healthcare initial public offerings in the first quarter of 2021 more than doubled, to $13.8 billion, according to a new report from S&P Global Market Intelligence. In the first quarter of 2020, the value of these offerings was $5.4 billion. 
In the first quarter, 84 healthcare companies went public, the highest number of first-quarter IPOs in the last five years, according to the report.”

About pharma

Pharmacy-related buprenorphine access barriers: An audit of pharmacies in counties with a high opioid overdose burden: Highlights of the research:
Nearly 30 % of pharmacies reported limitations to filling buprenorphine prescriptions.
—One in five pharmacies would not fill buprenorphine prescriptions entirely.
—Limitations were more common among independent pharmacies and those in south.

Fewer Pharmacies In Black And Hispanic/Latino Neighborhoods Compared With White Or Diverse Neighborhoods, 2007–15: About a third of the neighborhoods in the 30 largest cities lack convenient access to a pharmacy.

Today's News and Commentary

Because of the hiatus since last Tuesday, today’s posting has highlights from last week.

Biden isn't shying away from big new health-related spendingA really good summary of the health content from last week’s Presidential address. For example, Biden proposed permanent ACA premium subsidies and “called on Congress to pass legislation allowing the federal government to directly negotiate lower prices for some drugs in Medicare – a proposal the White House backed away from including in the American Families Plan.” Nothing was mentioned bout Medicare eligibility expansion.

About Covid-19

How Pfizer Makes Its Covid-19 VaccineA really good explanation of the science behind the manufacturing.

Reaching ‘Herd Immunity’ Is Unlikely in the U.S., Experts Now Believe: “Now, more than half of adults in the United States have been inoculated with at least one dose of a vaccine. But daily vaccination rates are slipping, and there is widespread consensus among scientists and public health experts that the herd immunity threshold is not attainable — at least not in the foreseeable future, and perhaps not ever.
Instead, they are coming to the conclusion that rather than making a long-promised exit, the virus will most likely become a manageable threat that will continue to circulate in the United States for years to come, still causing hospitalizations and deaths but in much smaller numbers.”

CVS and Walgreens Have Wasted More Vaccine Doses Than Most States Combined: “The Centers for Disease Control and Prevention recorded 182,874 wasted doses as of late March, three months into the country’s effort to vaccinate the masses against the coronavirus. Of those, CVS was responsible for nearly half, and Walgreens for 21%, or nearly 128,500 wasted shots combined.
CDC data suggests that the companies have wasted more doses than states, U.S. territories and federal agencies combined. Pfizer’s vaccine, which in December was the first to be deployed and initially required storage at ultracold temperatures, represented nearly 60% of tossed doses.”

About healthcare quality

Overall Hospital Quality Star Rating: CMS explains its 2021 hospital star rating methodology. In summary:
“The new 2021 methodology uses a simple average of measure scores to calculate measure group scores and Z-score standardization to standardize measure group scores for these 5 measure groups 

  1. Mortality

  2. Safety of Care

  3. Readmission

  4. Patient Experience

  5. Timely & Effective Care”

The Leapfrog Group releases latest Hospital Safety Grades of U.S. hospitals, with straight ‘A’ hospitals sharing insights on how they were prepared for COVID-19: “Across all states, highlights of findings from the spring 2021 Leapfrog Hospital Safety Grade include:

  • Thirty-three percent of hospitals received an "A," 24% received a "B," 35% received a "C," 7% received a "D," and less than 1% received an "F"

  • Five states with the highest percentages of "A" hospitals are Massachusetts, Idaho, Maine, Virginia, and North Carolina

  • There were no "A" hospitals in South Dakota or North Dakota”

Fortune/IBM Watson Health 100 Top Hospitals 2021: Health Systems: FYI.

Hospice Tax Status and Ownership Matters for Patients and Families: This article is an editorial commenting on research into the headline’s issue. The tax status of ownership does make a difference: On average,  for-profit compared with nonprofit hospices “provide narrower ranges of services to patients, use less skilled clinical staff, care for patients with lower-skilled needs over longer enrollment periods, have higher rates of complaint allegations and deficiencies, and provide fewer community benefits, including training, research, and charity care. For-profit hospices are more likely than nonprofit hospices to discharge patients prior to death, to discharge patients with dementia, and to have higher rates of hospital and emergency department use.”

 About the public’s health

Cost-effectiveness Analysis of Nutrition Facts Added-Sugar Labeling and Obesity-Associated Cancer Rates in the US: “This economic evaluation of Nutrition Facts added-sugar labeling and obesity-related cancer rates estimated that implementing the policy was associated with a reduction of 30 000 new cancer cases, 17 100 cancer deaths, and $1600 million in medical costs among US adults over a lifetime. This policy would generate net savings of $704 million from a societal perspective and $1590 million from a health care perspective…
These findings suggest that the added-sugar labeling is associated with reduced costs and lower rates of obesity-associated cancers. Policymakers may consider and prioritize nutrition policies for cancer prevention in the US.”

Screening for Hypertension in Adults US Preventive Services Task Force Reaffirmation Recommendation Statement: “The USPSTF recommends screening for hypertension in adults 18 years or older with office blood pressure measurement. The USPSTF recommends obtaining blood pressure measurements outside of the clinical setting for diagnostic confirmation before starting treatment. (A recommendation).”
See the accompanying editorial.

USDA dietary guidelines are driven by milk marketing concerns — not nutrition — lawsuit alleges: Three doctors filed a lawsuit Wednesday in federal court against the U.S. Department of Agriculture for its guidance in December suggesting that Americans consume three servings of dairy each day. The doctors allege in the lawsuit filed in the U.S. District Court for the Northern District of California that the dietary guidelines contradict current scientific and medical knowledge, harming the quarter of Americans who are lactose-intolerant. They also suggest that the USDA is looking out for the interests of the meat and dairy industries rather than the health of Americans.”

HHS Releases New Buprenorphine Practice Guidelines, Expanding Access to Treatment for Opioid Use DisorderSigned by HHS Secretary Xavier Becerra, the Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder exempt eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives from federal certification requirements related to training, counseling and other ancillary services that are part of the process for obtaining a waiver to treat up to 30 patients with buprenorphine.” 

FDA Moves To Ban Cigarettes And Flavored Cigars: “The U.S. Food and Drug Administration says it is moving to ban menthol cigarettes and flavored cigars, based on the evidence of the addictiveness and harm of the products. Tobacco companies have long targeted African Americans with advertising for menthol cigarettes.”

Weight Gain After Smoking Cessation and Risk of Major Chronic Diseases and Mortality: Many smokers who want to quit are worried that the resultant weight gain was just as bad for their health. as tobacco use. This study puts that concern to rest: “In this nationally representative cohort study of 16 663 Australian adults studied between 2006 and 2014, people who quit smoking had significantly lower risk of death than those who continued smoking regardless of change to weight and body mass index after quitting. Neither weight change nor body mass index change following smoking cessation was significantly associated with the risk of cardiovascular disease, type 2 diabetes, cancer, or chronic obstructive pulmonary disease.”

About healthcare professionals

NP practice authority by state: “Twenty-three states and the District of Columbia grant nurse practitioners full practice authority as soon as they earn their licenses, according to the American Association of Nurse Practitioners. 

Physician Flash Report: April 2021: From Kaufman Hall:
Key findings from the quarterly report include:

·       Median Investment/Subsidy per Physician FTE rose 6.8% from 2019 to $239,656 in 2020

·       Physician Compensation per FTE declined 1.6% from 2019 to $303,181 in 2020

·       Physician wRVUs per FTE fell 8.4% from 2019 to 2020

·       Net Revenue per Physician wRVU rose just 1.4% from 2019 to 2020

·       Total Direct Expense per Physician FTE fell 4.9% from 2019 to $782,518 in 2020

Cross-state licensing process now live in 30 states: “Prior to the COVID-19 pandemic, a major force in supporting telehealth expansion was the Interstate Medical Licensure Compact (IMLC), which was designed to preserve state regulation of medical practice while making it easier for physicians to provide care remotely  and in person to patients in other states…
Louisiana became the compact’s 32nd member in October, joining 29 other states, Guam and the District of Columbia. Legislation to join the compact has been introduced this year in Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Rhode Island, and Texas.”

About hospitals and health systems

How CHS, Tenet, HCA and UHS fared in Q1: Mixed results for these systems. Still need to factor out government Covid support to look at underlying fundamentals. 

Hospital payments increase 2.8% under CMS proposed rule: Before taking into account Medicare disproportionate share hospital payments and Medicare uncompensated care payments, the proposed increase in operating payment rates, increases in capital payments, increases in payments for new medical technologies, increases in payments due to implementation of the imputed floor and other proposed changes will increase hospital payments in FY 2022 by $3.4 billion, or 2.8%...
The proposed rule would require hospitals to report vaccination rates among healthcare staff. CMS is proposing the adoption of the COVID-19 Vaccination Coverage among Healthcare Personnel Measure to require hospitals to report COVID-19 vaccinations of workers in their facilities.
One of the biggest proposals is the repeal of the mandate that hospitals disclose their privately negotiated [ Medicare Advantage] rates with payers.”

Quality Declines When Hospitals Have Trouble Borrowing: “In the first paper to directly study the effects of a credit crunch on hospital quality, researchers found that hospitals tend to deliver lower-quality care and worse patient outcomes when they respond to tightening credit by making up the difference through increased patient revenue.”

About health insurance

Some health insurers ending waivers for Covid treatment feesStarting at the end of last year — and continuing into the spring — a growing number of insurers are quietly ending those fee waivers for Covid-19 treatment on some or all policies…”
However, federal law requires insurers to waive costs for Covid-19 testing and vaccination.

Obamacare Cost-Sharing Change Cuts Out-Of-Pocket Costs By $400CMS on Friday significantly changed how Affordable Care Act exchanges will run next year, intending to lower out-of-pocket costs for Obamacare customers, streamline enrollees’ user experience and update how insurers are paid for the risks they take on their members. 
In its second update to the annual benefit and payment parameters rule, the agency announced consumers’ maximum out-of-pocket costs will be limited to $8,700 for individuals and $17,400 for plans that cover multiple people. The update is $400 lower than previous caps, CMS said.”

How Corporate Executives View Rising Health Care Cost and the Role of GovernmentA really good analysis of this issue from the Kaiser Family Foundation. For a quick view, look at the graphics. In summary: “The responding employers largely believe that the cost of health benefits is excessive. While in general respondents felt that employers individually or collectively can have an impact on health care costs, more than four in five believe that the cost of providing health benefits will become unsustainable at some point in the next five to ten years, and that there will need to be a greater role for government in providing coverage and controlling costs. Respondents generally expressed some agreement with a variety of policies that would expand the government’s role in health benefits, including limiting provider prices in non-competitive situations and expanding options for employees and others to enroll in public programs.”

CMS extends hip and knee replacement model for 3 years: “The Biden administration has extended through 2024 a bundled payment model that aims to lower costs and improve quality for hip and knee replacements…
The rule also makes some adjustments to price calculations.
The Comprehensive Care for Joint Replacement model aims to pay providers based on total episodes of care for hip and knee replacements to curb costs and improve quality.”

CVS Health launches $100 million venture fund: “The fund will initially launch with $100 million allocated for investments and will focus on companies with the potential for technology-enabled innovation and disruption in digital health care that are anchored in CVS Health's core strategy. CVS Health Ventures will build relationships with early-stage companies via investment as well as by offering expertise and insights from CVS Health's unique perspective.
CVS Health has already made more than 20 direct investments through the CVS and Aetna businesses.”

BCBS Association beats lawsuit over cancer coverage: “Roslyn Gonzalez sued BCBSA for denying coverage of proton beam radiation therapy to treat a malignant tumor in her lower left abdomen. BCBSA had deemed the treatment experimental.
In fall 2020, BCBSA filed a motion to dismiss the case, arguing Ms. Gonzalez's state-law claims against the health insurance company were preempted by The Federal Employees Health Benefits Act. The court agreed with BCBSA.”

Humana Announces Agreement to Acquire remaining 60 Percent Interest in Kindred at Home, Accelerating Integration of the Nation’s Largest Home Health Provider into Humana’s Payer-Agnostic Healthcare Services PlatformHumana Inc…announced it has signed a definitive agreement to acquire the remaining 60 percent interest in Kindred at Home (KAH), the nation’s largest home health and hospice provider, from TPG Capital (TPG)… for an enterprise value of $8.1 billion, which includes Humana’s existing equity value of $2.4 billion associated with its current 40 percent minority ownership interest. KAH employs approximately 43,000 caregivers providing home health, hospice and community care services to over 550,000 patients annually. KAH has locations in 40 states, providing extensive geographic coverage with approximately 65 percent overlap with Humana’s individual Medicare Advantage membership.”

How Lowering the Medicare Eligibility Age Might Affect Employer-Sponsored Insurance Costs: “We find that, if people age 60-64 were no longer enrolled in employer-sponsored insurance, costs for employer health plans could drop by up to 15%. Similarly, if all people age 55 and over were no longer enrolled in employer-sponsored insurance, costs for employer plans could drop by as much as 30%. And if all people age 50 and over were no longer enrolled in employer-sponsored insurance, costs for employer plans could drop up to 43%. However, there are reasons to suspect the actual impact on employer-sponsored costs and premiums would be much smaller.”

The Utilization and Costs of Grade D USPSTF Services in Medicare, 2007–2016: “During the study period, we identified 95,121 unweighted Medicare patient visits, representing approximately 2.4 billion visits. Each year, these seven Grade D services were utilized 31.1 million times for Medicare beneficiaries and cost $477,891,886. Three services—screening for asymptomatic bacteriuria, vitamin D supplements for fracture prevention, and colorectal cancer screening for adults over 85 years—comprised $322,382,772, or two-thirds of the annual costs of the Grade D services measured in this study.”

About pharma

Several companies reported first quarter earnings- a mixed bag:
BMS backs annual guidance despite 3% drop in Opdivo sales in Q1
Merck & Co.'s Q1 sales stagnate as hit to vaccines wipes out Keytruda growth
Gilead's Q1 sales up 16% driven by Veklury
AbbVie lifts annual earnings outlook as Q1 sales surge 51%
AstraZeneca's Q1 sales top forecasts, boosted by cancer drugs

Landmark trial over the opioid crisis is set to start next week at ground zero: “The landmark trial in West Virginia against drug distributors known as the “Big Three” — AmerisourceBergen, Cardinal Health and McKesson — comes after an 11th-hour settlement averted an Ohio trial in October 2019 and coronavirus-related delays stalled opioid cases across the country.
It’s described as the country’s most complex civil case, and thousands of local governments and jurisdictions are arguing that the companies had a responsibility to ensure that the billions of pain pills pumped into their communities were not diverted for illegal use. The distributors say they complied with the law, delivering drugs approved by the government to pharmacies.”

U.S. lawmakers introduce eight antitrust bills aimed at drug prices: “Two of the bills, one in the House and another in the Senate, is aimed at stopping product-hopping, or making a minor change to a medication to win a new patent.
Others would seek to ban pay-for-delay patent settlements, where brand name drug companies pay generics to delay entering the market. Another enables the Federal Trade Commission to ban sham citizen petitions, where drug companies petition the Food and Drug Administration about a generic company seeking approval for a rival drug with the goal of delaying its approval.”

Pharmaceutical Innovation and Invention Index: “The PII aims at ranking companies in their ability to bring products from Phase I/II to market and commercialize them successfully, and utilizes a range of clinical, regulatory and commercial metrics to do this, ranging from the corporate level down to individual products.” See how companies rank.

 New PhRMA report shows nearly 90 medicines in development to fight drug-resistant infections, but future pipeline remains challenging“To address the challenges of early and late-stage clinical development and to overcome the market's failure to drive innovation for new antimicrobial medicines, innovative partnerships and initiatives within and between the public and private sectors have evolved. The biopharmaceutical industry in particular is taking action through the AMR Action Fund. This fund aims to bring two to four new antimicrobials to market by 2030, focusing on innovative medicines that address the highest priority public health needs. This industry-driven effort will also work to drive comprehensive policy reforms that are needed to advance new reimbursement methodologies and create incentives that enable appropriate patient access, creating a sustainable ecosystem for antimicrobial R&D and commercialization.”

The top 15 biopharma licensing deals of 2020Cancer-related assets accounted for more than half (eight) of the top 15, with four in the cancer immunotherapy area, demonstrating that biopharma's appetite for this area is far from sated. Collectively, the cancer deals had a value (biobucks included) of almost $24 billion out of a total of just over $40 billion overall.”

About diagnostics

LabCorp, still riding the COVID-19 testing wave, exceeds its own expectations with $4.2B Q1 revenue: “In total, LabCorp saw its revenues jump to $4.16 billion for the first three months of the year, a nearly 50% increase compared to 2020's initial quarter. The company’s net earnings, meanwhile, registered a billion-dollar annual increase that brought it firmly out of the red, from last year’s $317 million loss to approximately $770 million in earnings.
As a result, LabCorp upped its outlook for the remainder of 2021. The company is now expecting total annual revenues to increase by 2% to 6.5%, compared to its previous predictions that revenues would fall somewhere between a 1% loss and a 4.5% increase.
The vast majority of the quarter’s revenues were driven by organic growth, one-third of which came from COVID testing alone.” 

About healthcare IT

CMS proposes modifications to the Promoting Interoperability ProgramThe proposed rule would make it mandatory for hospitals to report on four measures, rather than allowing a pick-and-choose approach, as had been the case before:

  • Syndromic Surveillance Reporting.

  • Immunization Registry Reporting.

  • Electronic Case Reporting.

  • Electronic Reportable Laboratory Result Reporting.

Teladoc Q1 revenue more than doubles to $454M as telehealth visits continue to climbDespite a historically weak flu season, the telehealth giant delivered 3.2 million virtual visits in the first quarter of 2021, up 56% compared to the first quarter in 2020.”

 

 

 

 

Today's News and Commentary

HealthcareInsights.MD will resume Monday, May 3

About Covid-19

The public’s concerns over the Johnson & Johnson coronavirus vaccine are widespread, Post-ABC poll finds: “Fewer than 1 in 4 Americans not yet immunized against the coronavirus say they would be willing to get the vaccine made by Johnson & Johnson, according to a Washington Post-ABC News poll that finds broad mistrust of the shot’s safety after federal health officials paused its use.
The nationwide survey shows that slightly fewer than half of U.S. adults overall say they consider the Johnson & Johnson vaccine very or somewhat safe after its use was halted this month following reports of rare, severe blood clots.”
As before, the most reluctant are Republicans, particularly those under age 39.

Israel said probing link between Pfizer shot and heart problem in men under 30: “The report said that out of more than 5 million people vaccinated in Israel, there were 62 recorded cases of myocarditis in the days after the shot. It found that 56 of those cases came after the second shot and most of the affected were men under 30.”

U.S. CDC says children can get within 3 feet at summer camp: “Children attending summer camp can get within 3 feet (1 meter) of each other but should wear masks to limit the spread of COVID-19, according to fresh guidance issued by the U.S. Centers for Disease Control and Prevention.”

EU official: Vaccinated Americans can visit Europe this summer: ”Ursula von der Leyen, president of the European Commission, told The New York Times in Brussels on Sunday that EU member states will ‘accept, unconditionally’ people who are inoculated with European Medicines Agency-approved vaccines.”

Waiving IP rules will not deliver more Covid vaccines: “Scaling up manufacturing is the best way to inoculate the world and end the pandemic.” And in a related article:
Sanofi inks 3rd COVID-19 vaccine production pact, this time helping Moderna with fill and finish work: ”Sanofi will perform fill and finish services from its site in Ridgefield, N.J. beginning in September, helping to produce up to 200 million doses. It's Sanofi's third COVID-19 vaccine production pact after its own GlaxoSmithKline-partnered candidate suffered a midstage setback last year. The drugmaker is also helping produce the Pfizer and Johnson & Johnson shots.”

Vaccine makers say IP waiver could hand technology to China and Russia: “Vaccine makers have warned US officials that temporarily scrapping patents for Covid-19 shots would risk handing novel technology to China and Russia, according to people familiar with the talks. As industry lobbying has escalated in Washington, companies have warned in private meetings with US trade and White House officials that giving up the intellectual property rights could allow China and Russia to exploit platforms such as mRNA, which could be used for other vaccines or even therapeutics for conditions such as cancer and heart problems in the future. J&J, Pfizer, Moderna and Novavax did not respond to requests for comment.”

About the public’s health

Study finds Lyme-carrying ticks next to beaches and ‘pretty much wherever we looked’: ”Disease-carrying ticks, commonly associated with wooded areas, are also abundant near beaches in Northern California, according to a study. They weren’t found on beaches themselves, but in the brush and vegetation beachgoers may walk through to get to the sand.”

It's time for FDA to end the tobacco epidemic: “The U.S. Food and Drug Administration will respond by April 29 to a citizen petition urging a ban on the sale of menthol cigarettes. The agency should announce that it intends to take that step while also requiring tobacco companies to reduce the amount of nicotine in cigarettes to non-addictive levels. Together, these actions would provide a monumental victory for public health, a generational advancement in our nation’s efforts to achieve health equity, and a significant step forward to protect ourselves against future pandemics.”

Blood banks phase out collecting convalescent plasma, but fear a US blood shortage: “Overall, hospital demand for plasma has diminished, and blood banks are reporting they have enough plasma stockpiled if there is once again a demand, since it has a year-long shelf life.
But while plasma needs have subsided, blood banks now face a blood shortage, which is expected to only get worse through the summer.”

About pharma

FDA to scrutinize unproven cancer drugs after 10-year gap: “Each year the U.S. approves dozens of new uses for cancer drugs based on early signs that they can shrink or slow the spread of tumors. 
But how often do those initial results translate into longer, healthier lives for patients?
That seemingly simple question is one of the thorniest debates in medicine. It spills into public view Tuesday as the Food and Drug Administration convenes the first meeting in a decade to consider clawing back approvals from several cancer drugs that have failed to show they extend or improve life.”

About healthcare IT

Cancer software security breach hits 40 health systems: Yale New Haven Health, Lifespan & more: The headline is the story.

FDA retracts HHS plan to deregulate mobile health apps: “The FDA and HHS are backtracking on previous plans to end regulatory review of 83 mobile health devices after determining the basis for the proposed plan was flawed.
On Jan. 15, HHS published a notice proposing to exempt the mobile health devices from the regulation requirement. The FDA said there is no evidence that HHS consulted with, involved or even notified the FDA before issuing the notice, an April 16 release said.”

AliveCor seeks to bar U.S. sales of Apple Watch alleging ECG patent infringement: “Health technology company AliveCor, maker of connected electrocardiogram devices, is trying to ban U.S. sales of the Apple Watch, claiming the tech giant allegedly infringed on three of its patents.”

Accolade plans to acquire virtual primary care provider PlushCare in a $450M stock and cash deal: “Health benefits platform  Accolade is expanding into primary care with plans to acquire PlushCare in a deal valued at $450 million.
Under the terms of the agreement, the purchase price of up to $450 million will consist of $40 million in cash, $340 million in Accolade common stock, and up to an additional $70 million of value payable upon the achievement of defined revenue milestones following the closing, the company said in a press release issued Friday.”

About hospitals and health systems

National Hospital Flash Report Summary: April 2021: “Year-to-date (YTD) margins increased and volumes continued to decline, while revenues and expenses rose across most metrics compared to the first three months of 2020. Year-over-year (YOY) margin increases were particularly pronounced. Those gains, however, are largely due to measuring March 2021 performance against the same period last year, when hospitals were hit with devastating losses from national shutdowns and halting of outpatient procedures during the first month of the pandemic…
Hospitals saw gains across many key performance metrics, due in part to increasing outpatient activity. Without federal CARES funding, Operating Margin increased 34.5% or 2.5 percentage points YTD, and 69.5% or 5.2 percentage points month-over-month (MOM).”

Today's News and Commentary

About Covid-19

Johnson & Johnson vaccine use should resume with a warning about risk of rare blood clots, CDC advisers recommend

CDC recommends pregnant women get coronavirus vaccine: “At a White House briefing on the coronavirus Friday, CDC Director Rochelle Walensky said that vaccination surveillance systems showed ‘no safety concerns’ for more than 35,000 women in their third trimester or for their babies.”
The recommendation is also important because of evidence of increased infection severity during pregnancy.

Pfizer COVID-19 shot effective for people with chronic diseases- Israel study: “The vaccine was 80% effective against symptomatic infection for people with heart or chronic kidney diseases, 86% for people with type 2 diabetes, 75% for cerebrovascular disease, and 84% for people suffering from immunodeficiency, according to the Clalit Research Institue study.”

B.1.526 SARS-CoV-2 variants identified in New York City are neutralized by vaccine-elicited and therapeutic monoclonal antibodies: “The findings suggest that current vaccines and therapeutic monoclonal antibodies will remain protective against the B.1.526 variants. The findings further support the value of wide-spread vaccination.”

COVID-19 hospitalizations tumble among U.S. senior citizens: “COVID-19 hospitalizations among older Americans have plunged 80 percent since the start of the year, dramatic proof the vaccination campaign is working. Now the trick is to get more of the nation’s younger people to roll up their sleeves.
The drop-off in severe cases among people 65 and older is so dramatic that the hospitalization rate among this highly vaccinated group is now down to around the level of the next-youngest category, Americans 50 to 64.”

How long does protection from COVID-19 vaccines last?: Nothing new, but it is a good summary. The short answers:
”Experts don’t know yet because they’re still studying vaccinated people to see when protection might wear off. How well the vaccines work against emerging variants will also determine if, when and how often additional shots might be needed…
So far, Pfizer’s ongoing trial indicates the company’s two-dose vaccine remains highly effective for at least six months, and likely longer. People who got Moderna’s vaccine also still had notable levels of virus-fighting antibodies six months after the second required shot. 
Antibodies also don’t tell the whole story. To fight off intruders like viruses, our immune systems also have another line of defense called B and T cells, some of which can hang around long after antibody levels dwindle. If they encounter the same virus in the future, those battle-tested cells could potentially spring into action more quickly.”

Shift to virtual care during COVID-19 saved 1.7M gallons of fuel, 15K tons of CO2 emissions: CommonSpirit Health: One consistent benefit of the pandemic is the positive environmental effect of business slowdowns. This article is the first one I have seen that was specific to a healthcare system.

Low-dose Administration of MERS DNA Vaccine Candidate Induces Potent Immunity and Protects From Virus Challenge in Preclinical Models: Recall that MERS is a coronavirus illness. This new technique uses low dose, intradermal (in the skin) injections to confer immunity. If the animal model success is duplicated in humans, it could be used for prevention of other coronavirus infections (like SARS-CoV-2).

Johnson & Johnson said blood clots have been reported with all Covid-19 vaccines. The author of the study they cited says they're wrong: “When news broke that Johnson & Johnson's COVID-19 vaccine might be linked to rare, potentially fatal blood clots, the company responded by pointing to a study it said had shown there were reports of clots with Pfizer and Moderna's vaccines as well, reported CNN.
However, the study's leader author Eun-Ju Lee disputes the claim, saying ‘we didn't find anyone with blood clots’ with Moderna and Pfizer's vaccines, ‘we didn't find any of those scary things that are happening with Johnson & Johnson.’”

About pharma

Pelosi pushes for drug pricing measure amid uncertainty from White House: “House Democrats on Thursday reintroduced their signature legislation to lower drug prices, known as H.R. 3, and Pelosi pointedly noted in a statement that including it in Biden's proposal is important for Democratic lawmakers. The measure would allow the secretary of Health and Human Services to negotiate lower drug prices, a long-held Democratic goal.”

Biogen's sales fall 24% in Q1 as aducanumab decision looms large: As biosimilars have eaten into Biogen’s profit, the company is looking to FDA approval for its Alzheimer’s drug.

About health insurance

CMS gives massive $80M increase to navigators for 2022 coverage plan year: “The Biden administration will give Affordable Care Act (ACA) navigators $80 million for the 2022 plan year, reversing slides in funding that occurred during the Trump administration.” And in a related article:
How Agents Influence Medicare Beneficiaries’ Plan Choices: This Commonwealth Fund research found that: “Nearly all (96%) Medicare Advantage and Part D plans contract with agents, who are not required to represent all available plans. An analysis across five markets of three large, online broker plan selection tools found that, on average, each tool includes less than half (43.3%) of Medicare Advantage plans and less than two-thirds (64.7%) of Part D plans. In the analysis of online searches, more than one-third (36%) of results from the first page led to agents’ or health insurers’ websites.
Conclusion: Agents play an important role for beneficiaries; however, the existing approach affects information about coverage options and may not optimally serve beneficiaries’ needs by limiting their choice.”

How UnitedHealth plans to make Optum a $100B business: “UnitedHealth Group bought its first medical practice 15 years ago and now aims to make providing healthcare its next $100 billion business, according to Insider
UnitedHealth Group's OptumCare business comprises 56,000 physicians and 1,600 clinics, and it's on track to add at least 4,000 affiliated, contracted and employed physicians this year. OptumCare is the bulk of a business unit called OptumHealth, and executives are aiming to grow it from a $40 billion business to a $100 billion one by 2028, according to the report. 
OptumHealth CEO Wyatt Decker, MD, told Insider that moving physicians into ‘value-based’ arrangements and away from fee-for-service care is one way the business will grow revenue. He said physicians will be paid to keep patients healthy rather than billing health plans for every patient visit or test.”

Ill. Physician Gets 1 Year For Faking $1M Worth Of Tests - “A physician was sentenced to a year and a day in prison in Illinois federal court Thursday for defrauding Blue Cross Blue Shield of Illinois and Medicare of nearly $1 million by submitting thousands of claims for tests his patients never received. U. S. District Judge Ronald Guzman handed down the sentence to Pranav Patel about four months after the physician, who owned Palos Medical Care SC, admitted he submitted more than 10,000 false claims to BCBS and the federal government between 2008 and 2013 for diagnostic tests he never actually provided to patients.”

About the public’s health

Oxford Malaria vaccine proves highly effective in Burkina Faso trial: “The vaccine, developed by scientists at the Jenner Institute of Oxford University, showed up to 77% efficacy in a trial of 450 children in Burkina Faso over 12 months.
The hunt for a malaria vaccine has been going on the best part of a century. One, the Mosquirix vaccine developed by GlaxoSmithKline, has been through lengthy clinical trials but is only partially effective, preventing 39% of malaria cases and 29% of severe malaria cases among small children in Africa over four years. It is being piloted by the World Health Organization in parts of Kenya, Ghana and Malawi.
The Oxford vaccine is the first to meet the WHO goal of 75% efficacy against the mosquito-borne parasite disease. Larger trials are now beginning, involving 4,800 children in four countries.”

Texting option weighed for upcoming ’988′ suicide hotline: “Recognizing that many Americans rely on texting, U.S. regulators are weighing whether to require that phone companies allow people to text a suicide hotline. 
The Federal Communications Commission last summer voted to require a new “988” number for people to call to reach a suicide-prevention hotline. Phone companies have until July 2022 to implement it.
Once it’s in place, people will be able to dial 988 to seek help, similar to how 911 is used for emergencies. Currently, the National Suicide Prevention Lifeline uses a 10-digit number, 800-273-TALK (8255), which routes calls to about 170 crisis centers.”
Are texts going to be answered quicker than calls? Are responses also by text? Has texting been more effective? The only clear advantage is for “those who are deaf, hard of hearing or have speech disabilities.” Is texting more convenient when you need a phone anyway to text?

About healthcare systems

Kaiser Reaches $11.5M Settlement To Wrap Up Race Bias Suit: “Kaiser Permanente will pay $11. 5 million to resolve a lawsuit accusing the health care giant of underpromoting and underpaying a class of more than 2,000 Black workers, according to Thursday filings in California state court. The settlement, filed alongside a same-day complaint in San Francisco Superior Court, would cover claims from approximately 2,225 California-based African American or Black employees who worked in administrative support or consulting services at Kaiser or its related entities between January 2015 and March 2021.”



Today's News and Commentary

About Covid-19

Scientists warn of challenges to find antiviral pill to treat Covid: A good review of this issue.

Johnson & Johnson trial shows vaccine effective, even against variants: “Johnson & Johnson's single-shot coronavirus vaccine protected against symptomatic and asymptomatic infection, and prevented hospitalization and death in all participants 28 days after vaccination, according to new clinical trial results published Wednesday.
The vaccine was 67 percent effective on average against moderate to severe–critical COVID-19 at least 14 days after administration, and 66 percent effective at 28 days after vaccination, according to data published in the New England Journal of Medicine
The vaccine was about 77 percent effective against severe/critical COVID-19 at 14 days after administration, and 85 percent after 28 days.”

European countries to resume J&J COVID vaccine deliveries: “European countries prepared on Wednesday to resume deliveries of Johnson & Johnson’s COVID-19 vaccine and speed up the rollout after Europe’s drug regulator backed the shot.”

COVID vaccines and kids: five questions as trials begin: A good review of this topic from Nature.

Biden presses employers to provide paid time off for vaccine shots, recovery: “‘I’m calling on every employer large and small in every state to give employees the time off they need, with pay, to get vaccinated,’ Biden said. ‘No working American should lose a single dollar from their paycheck because they chose to fulfill their patriotic duty of getting vaccinated.’”

U.S. sees significant drop in vaccinations over past week: “About 3 million Americans are getting vaccinated daily, an 11 percent decrease in the seven-day average of daily shots administered over the past week. The unprecedented drop is rivaled only by a brief falloff that occurred in February, when winter storms forced the closure of vaccination sites and delayed shipments nationwide.”

Burned out by the pandemic, 3 in 10 health-care workers consider leaving the profession: The headline is the story.

About hospitals and healthcare systems

HCA reports $1.4B in profit in Q1 thanks to higher patient acuity, stable payer mix: “HCA Healthcare posted nearly $14 billion in revenue and $1.4 billion in profit for the first quarter of the year as the hospital chain continues to face lingering volume declines from the pandemic.
HCA’s earnings report, released Thursday, shows revenues are up in the first quarter, generating $13.9 billion compared to the $12.8 billion in the first quarter of 2020. The system’s $1.4 billion in profit was up compared to the $581 million it generated in the same period in 2020.”

Hospital adjusted expenses per inpatient day across 50 states: FYI

Forbes' top 27 hospitals for diversity: FYICincinnati's Children Hospital is at the top of the list.

About pharma

House votes to extend ban on fentanyl-like substances: “The House easily passed legislation on Wednesday to extend a ban on copycats of fentanyl, a highly addictive synthetic opioid, that is set to expire on May 6 without congressional action.
Lawmakers passed the bill by voice vote to extend through Oct. 22 the federal government's ability to regulate fentanyl analogues as one of the most strictly controlled drugs with no accepted medical use and a high potential for abuse.”

Roche confirms outlook despite drug sales falling 14% in Q1:
Pharmaceuticals division sales: CHF 10.6 billion ($11.5 billion), down 14%
—Overall revenue: CHF 14.9 billion ($16.2 billion; forecasts of CHF 15 billion), down 1%

Combining AstraZeneca's 'good' cholesterol booster with PCSK9 inhibition shows promise in heart disease: “…the company has early data showing an experimental antibody drug increases HDL-C in monkeys and people. Combining the drug with a PCSK9 inhibitor appears to have a synergistic effect.”

Drug spending is climbing amid the pandemic, but not at hospitals: “The country's total drug spending rose by nearly 5 percent in 2020, but drug spending at hospitals declined by the same percentage, according to a report published April 21 by the American Society of Health-System Pharmacists.
Total U.S. drug spending was $535.3 billion in 2020. The drug spending categories that experienced the biggest increases were home healthcare (13 percent), mail-order prescriptions (9 percent) and clinics (8 percent). 
Drug spending at hospitals decreased by 5 percent, as patients delaying care amid the pandemic correlated with decreased drug utilization in hospitals.”

Eli Lilly retakes innovation crown, while Bristol Myers rates most inventive pharma in annual study: “If you gave a pharma a molecule, which one would make the most of it? Eli Lilly, according to IDEA Pharma’s most recent evaluation.
It ranks innovation as a measure of a pharma company’s ability to deliver a ‘return on invention’ over the past five years.”

Biotech Stocks Fall Out of Favor After Disappointing Trial Results, Big Rally: “Biotech shares have slumped in recent months, stung by setbacks in clinical trials and a rotation away from growth stocks after a steep rally in 2020.
The Nasdaq Biotechnology Index has fallen 10% from its Feb. 8 record, lagging behind the S&P 500, which has gained 6.6%, and the technology-laden Nasdaq Composite, which has slipped 0.3%, over that period. The decline has left the biotech index up 2.2% for the year, compared with respective gains of 11% and 8.2% for the other two indexes.”
The article offers several reasons for this poor performance.

About healthcare IT

Cerner inks 2nd life insurance industry partnership: “Cerner is teaming up with the MIB Group, which provides data-driven underwriting services to life insurance companies, as the EHR vendor looks to build on its life insurance industry initiatives.
In March, Cerner partnered with New York Life Insurance Co., giving the New York City-based mutual life insurer access to – with patient consent – Cerner's hospital clients' EHRs in near real time.
MIB provides data-driven risk management and digital services; through the new agreement, MIB will manage access to 54 million patient medical records from Cerner, as well as 5,400 distinct patient portals.”

Google cracks down on insurance advertisements posted on search engine: “Starting next month, Google will require health insurers to apply for certification for their ads to run on the search engine.
The tech giant announced Tuesday that it will only allow insurance ads from certified government exchanges, first-party providers and licensed third-party brokers.”

About health insurance

New health plans that track internet activity face federal litigation: “The U.S. Department of Labor is fighting a federal judge's decision that allows two companies to sell health plans to people who agree to internet tracking…
The employee health plans are offered to people who agree to become ‘limited partners’ of a firm called Data Marketing Partnership. Under the agreement, individuals' internet activity is tracked and sold…
The new plans wouldn't be required to offer the ACA's 10 essential health benefits or insure people with preexisting conditions. However, proponents of the plans argue they don't violate federal or state laws.”

Today's News and Commentary

About Covid-19

Most Americans say they should be vaccinated before the U.S. donates Covid-19 shots elsewhere: “Three-quarters of Americans believe the U.S. government should start donating Covid-19 vaccines to other countries, but only after every person in the U.S. who wants a vaccine has received one, according to a new survey from STAT and The Harris Poll.
At the same time, just over half of Americans said they agree with the idea that the Biden administration should immediately start donating vaccines to other countries in order to achieve global herd immunity, which reflects growing concern that the coronavirus cannot be contained until most of the world is vaccinated…
Not surprisingly, there are diverging views among different slices of those polled. More members of Gen Z and millennials — 59% and 65%, respectively — than middle-aged or older Americans believe the U.S. government should start to immediately donate Covid-19 vaccines to other countries. And 63% of Democrats support immediate donations, compared with just 43% of Republicans.”

The US is vaccinating millions of Americans daily. But here's why Covid-19 cases and hospitalizations are up: “In the past seven days, the US reported an average of more than 67,100 new Covid-19 infections daily, according to Johns Hopkins University data. That's slightly below where the average was a week prior, but it's still 25% above where it was nearly a month ago.
And about 44,000 Covid-19 patients were in US hospitals as of Sunday, the most recent day that data was available, according to the US Department of Health and Human Services. That number has generally been inching up since late March, when it dipped to around 37,900.
Experts say there are several reasons for the rise in these numbers, including dangerous coronavirus variants -- such as the more contagious B.1.1.7 strain that has helped fuel another surge in Michigan. Pandemic fatigue and more Americans moving around have also likely contributed to the rise.”

FDA unlocks pooled COVID-19 screening for previously authorized tests: “The FDA is making it easier for the makers of authorized COVID-19 tests to have multiple samples tested at once—allowing more people to be screened more regularly while using fewer resources.
This pooled testing approach has been previously green-lit by the agency for individual companies since last summer; the strategy only checks single samples when the larger batch returns a positive result.
Now, the FDA will begin issuing amendments to a potentially broad number of its past authorizations for certain molecular diagnostics—including those for people who are showing no symptoms, and only require a simple swab of the front of the nose, compared to the deeper nasopharyngeal swabs common during the early phases of the pandemic.”

The US spat over the vaccine IP waiver: A really good summary of the issue of sharing IP for the
Covid-19 vaccines.

GOP Reps Introduce Bill To Get Vaccines To Citizens First: “The same day that adults in all 50 states became eligible for the COVID-19 vaccine, Republican legislators introduced a bill on Monday to prioritize U.S. citizens and green card holders for the shot over everyone else in the country.
U.S. Reps. Fred Keller and Mike Kelly, R-Pa., and Rep. Nancy Mace, R-S.C., said that the Saving Hypodermic injections and Offering vaccines to Taxpayers Swiftly, or SHOTS, Act would instruct the U.S. Department of Homeland Security to ‘ensure that American citizens and lawful permanent residents are given priority to receive the COVID-19 vaccine over those visiting or who have entered the United States illegally.’”
The legislators obviously missed the memo that everyone needs to be immunized if “American citizens and lawful permanent residents” are to be safe.

House Democrats launch investigation into J&J contractor Emergent: “House Democrats have launched an investigation into Emergent BioSolutions, the embattled contract manufacturer of Johnson & Johnson's coronavirus vaccines, to find out if the company used its relationship with a key Trump administration official to secure federal contracts.
In a letter sent to the company's CEO and its executive chairman, Democrats on the Oversight Committee and the Select Subcommittee on the Coronavirus Crisis said they were concerned Emergent won contracts ‘despite a track record of increasing prices without justification and failing to meet contract requirements.’”

About health insurance

Anthem raises outlook as it posts $1.7B in Q1 profit:”Profits were up 9.3% from the first quarter of 2020, according to the insurer's financial release, when the company brought in $1.5 billion.
Revenues were $32.4 billion for the quarter, which fell short of expectations from Zacks Investment Research. Revenue was also up 9.3% year over year, Anthem said, from $29.6 billion in the first quarter of 2020.”
The expectations in this sector were for profits to decline as Covid-19-postponed care surged back.

Aetna bringing CVS-centric plan to new markets with eye on further expansion: “Aetna first unveiled its Connected Plan last year, and now it's bringing the design to new markets with its sights on even further expansion.
The Aetna Connected Plan with CVS Health centers the capabilities of the insurer's parent company, including its retail pharmacies, MinuteClinics and HealthHUB stores. After launching in the Kansas City market, the plan is now coming to Southern California and St. Louis.
Aetna is aiming to offer the plan in 15 markets by the end of the year…”

Texas’ Obamacare Medicaid Provider Fee Case Headed to SCOTUS: “Texas and five other states will be asking the U.S. Supreme Court to hear their objections to an Obamacare program that cost them nearly $500 million in ‘health insurer premium’ fees imposed on Medicaid managed care companies.
The U.S. Court of Appeals for the Fifth Circuit agreed to halt the issuance of a mandate confirming the states’ liability for the tax until Sept. 6 or the states’ filing of a petition for review by the nation’s top court, whichever occurs first.
The Affordable Care Act’s Section 9010 taxes health insurers on the premiums they charge states for Medicaid managed care...”

2019 Medicare Current Beneficiary Survey Early Look: This report was just released (despite the date on the headline): Highlights:
77% of Medicare beneficiaries report good, very good, or excellent health.
48% of Medicare beneficiaries report having one or more disabiities.
The vast majority of Medicare beneficiaries are satisfied with health care quality, ease of access, and cost (see Table 4)

Mass. Eye And Ear Agrees To Pay $2.7M To Resolve Fraud Complaint: “A Boston hospital that specializes in eye, ear, nose and throat ailments has agreed to pay $2.7 million to resolve federal fraud allegations, Acting U.S. Attorney for Massachusetts Nathaniel Mendell announced Tuesday.
Prosecutors say Massachusetts Eye and Ear improperly billed government health care programs for certain office visits, defrauding the country of more than a million dollars.”

Oscar Health launches tech platform business +Oscar: “Oscar's health plans are built on the technology infrastructure, and it has entered into a number of partnerships with others in the industry, including Cigna and Cleveland Clinic, that harness that tech stack to enhance the member experience and simplify administrative tasks.
Through +Oscar, provider-sponsored health plans and regional insurers can operate at a similar level of efficiency to larger payers despite the smaller scale, Oscar Health said.”

Cigna accuses Connecticut physician practice of price gouging: “A Connecticut physician practice suing Cigna over COVID-19 payments exploited a national health emergency and overcharged insurers for diagnostic tests, Cigna claimed in recent court filings.
The price gouging claims come amid a legal battle between Cigna and Murphy Medical Associates, an internal and preventive medical practice in Southwestern Connecticut. In an amended complaint filed March 24, Murphy Medical accused Cigna of failing to provide coverage for COVID-19 testing and related services.”

Assessment of Potentially Preventable Hospital Readmissions After Major Surgery and Association With Public vs Private Health Insurance and Comorbidities: “This cohort study using a weighted sample of 1 937 354 patients found that 18% of readmissions within 90 days of hospital discharge were for a potentially preventable cause. Public insurance, compared with private insurance, was associated with an increased risk of potentially preventable readmission….
This study suggests that improved access to ambulatory care in the postoperative period, particularly for high-risk patients, may be associated with a substantial reduction in postoperative readmissions after major surgery.”

About healthcare IT

Global investment in telehealth, artificial intelligence hits a new high in Q1 2021: “Telehealth investment hit an all-time high of $4.2 billion in just 139 deals in the first quarter, almost doubling the $2.2 billion raised in the same quarter a year ago, according to CB Insights.
That's the highest global funding for telehealth during one quarter on record, according to the company's first-quarter 2021 report. Funding also was up 18% from the $3.6 billion raised in the fourth quarter of 2020.”

The telehealth services Blue Cross Blue Shield is making permanent: “While Blue Cross Blue Shield has not made a companywide announcement on where telehealth stands after the pandemic, its subsidiaries have been individually sharing where they are in their plans.”
The article has brief statements on what 7 Blues Plans are doing.

The association between perceived electronic health record usability and professional burnout among US nurses: “The mean nurse-rated EHR SUS [System Usability Scale: 0-100] score was 57.6 (SD 16.3). A score of 57.6 is in the bottom 24% of scores across previous studies and categorized with a grade of ‘F.’ On multivariable analysis adjusting for age, gender, race, ethnicity, relationship status, children, highest nursing-related degree, mean hours worked per week, years of nursing experience, advanced certification, and practice setting, nurse-rated EHR usability was associated with burnout with each 1 point more favorable SUS score and associated with a 2% lower odds of burnout (OR 0.98; 95% CI, 0.97–0.99; P < .001)…[In other words,] EHR usability and the odds of burnout were strongly associated with a dose-response relationship.”
See hospitals and health systems below for a nursing shortage article.

About pharma

Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics: “This study found that older adults and Black patients were underrepresented in postmarketing studies of novel cancer therapeutics to a similar degree that they were underrepresented in premarketing studies. These findings suggest that postmarketing studies are not associated with improvements to gaps in demographic representation present at the time of FDA approval.”

J&J's sales of prescription drugs up 9.6% in Q1, topping forecasts:
—Prescription drug sales: $12.2 billion (forecasts of $12.1 billion), up 9.6%
—Overall revenue: $22.3 billion (forecasts of $22 billion), up 7.9%
—Profit: $6.2 billion, up 6.9%
”The company noted that sales growth of prescription drugs was driven by Darzalex, Erleada, Imbruvica, Invega Sustenna/Xeplion/Invega Trinza/Trevicta, Stelara and Tremfya, partially offset by declines for Remicade and Zytiga due to biosimilar and generic competition.
Johnson & Johnson noted that its COVID-19 vaccine Ad26.COV2.S generated sales of $100 million in the first quarter, despite its use being paused in the US and rollout delayed in Europe due to concerns over blood clots.”

FDA loses ‘drug or device’ argument again: “A federal appeals court has ruled that the FDA must regulate a barium sulfate product ingested before imaging as a device rather than a drug. The decision counts as a win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body.
Genus has manufactured Vanilla SilQ since 2015 and sought regulation for it as a device because the opacity of its barium sulfate component enables healthcare providers to visualize the gastrointestinal tract. Barium sulfate is an inert metal salt that does not chemically interact with human cells or tissue, as a drug does…
Genus estimated the cost of seeking clearance to market its product as a device at $60,000, whereas seeking approval to market it as a drug could exceed $500,000, plus a continuing annual cost of more than $186,000, according to the court order dismissing the FDA’s motion for summary judgment…
[T]he appeals court agreed with a lower court in ruling that the FDCA [Food Drug and Cosmetic Act] ‘unambiguously forecloses the FDA’s interpretation,’ granting summary judgment in Genus’s favor and vacating the FDA decision to classify Genus’s products as drugs. ‘We agree with the district court that the text, statutory structure and legislative history of the Act make plain that the Congress did not grant the FDA such sweeping discretion,’ circuit judge Karen L. Henderson wrote for the court.”
Since some products can be classified as a device or drug at the FDA’s discretion, this decision is significant in the boundaries it puts on such discretion.

About hospitals and health systems

Hospital executives report high nursing vacancies, greater reliance on costly travel nurses: “Thirty-six percent of hospital executives say they anticipate more than 25 openings this year compared to 17% in 2020, while 21% anticipated more than 50 opens and 11% predicted more than 100 open positions, according to a survey conducted by Avant Healthcare Professionals
Seventy percent of the respondents reported losing anywhere from 5% to 30% of their staff as a direct result of COVID-19.New graduates and internal recruitment are the primary strategies these organizations will employ to address those vacancies, although many fewer respondents said they were focusing on that second option in 2021 compared to the year prior (45% versus 70%).”

Tenet posts $97M in profit in Q1 due to higher acuity patients: “Hospital chain Tenet Healthcare posted $97 million in profit in the first quarter of the year, up slightly from the $94 million it earned the same period in 2020 before the COVID-19 pandemic took hold.
Overall, Tenet Wednesday reported $3.9 billion in revenue for the hospital segment, up by nearly 3% from the $3.8 billion in the first quarter of 2020. Patient service revenue was also $3.6 billion in the first quarter compared with $3.5 billion in the first quarter of 2020.
‘The increase in revenues was primarily due to higher patient acuity and commercial payer mix, which more than offset lower patient volumes as a result of COVID,’ Tenet said…”

Today's News and Commentary

About Covid-19

All U.S. adults now eligible for COVID-19 vaccine: how to find a shot: “American adults in all 50 states as well as the District of Columbia and Puerto Rico are now eligible for the coronavirus vaccine as of Monday, meeting President Biden's goal of April 19 eligibility…
Perhaps the easiest resource to use to find a vaccine — and one the Centers for Disease Control points people toward — is VaccineFinder.org.”

New U.S. COVID cases fall 0.4% last week, after rising for four weeks: “Health experts say new cases have plateaued at a high level as more infectious variants of the virus offset progress made in vaccinations. The country logged nearly 70,000 new cases per day in the week ended April 18, compared with 55,000 new cases a day in March and about 30,000 new cases this time last year.”

J&J vaccine should be administered with warning label, EU regulator says: “The European Medicines Agency, the European Union's equivalent to the FDA, said April 20 that the bloc should not ban Johnson and Johnson's COVID-19 vaccine, but a label should be added to warn about the rare possibility of blood clots.”

‘I’m still a zero’: Vaccine-resistant Republicans warn that their skepticism is worsening: “Although more than half of U.S. adults have received at least one dose of coronavirus vaccine, more than 40 percent of Republicans have consistently told pollsters they’re not planning to be vaccinated.” The article offers why participants in a small focus group were not swayed by certain information.

Statement on the seventh meeting of the International Health Regulations (2005) Emergency Committee regarding the coronavirus disease (COVID-19) pandemic: One recommendation from the WHO in this long list Is: “Do not [emphasis in original] require proof of vaccination as a condition of entry, given the limited (although growing) evidence about the performance of vaccines in reducing transmission and the persistent inequity in the global vaccine distribution. States Parties are strongly encouraged to acknowledge the potential for requirements of proof of vaccination to deepen inequities and promote differential freedom of movement.”

COVID-19 neuropathology at Columbia University Irving Medical Center/New York Presbyterian Hospital: The brain abnormalities in COVID-19 patients are thought to be the result of systemic inflammation rather that direct viral infection of the central nervous system.

About health insurance

AHA counters site-neutral Medicare payments with study highlighting hospitals' more complex outpatients: ”The American Hospital Association (AHA) is reinforcing its longstanding position against the Department of Health and Human Services’ (HHS') site-neutral payments with new research suggesting hospital outpatient departments are treating poorer, more complex Medicare patients than independent physicians' offices are.
The study, which was conducted for the AHA by KNG Health Consulting and published on its website, reviewed claims from a 5% sample of Medicare beneficiaries who had at least one visit to an outpatient setting between Jan. 1, 2012, and June 3, 2019…
The linchpin of AHA’s interest in the two settings is a legal back and forth regarding the 2019 Outpatient Prospective Payment System rule (PDF), which brings reimbursement to each setting in line with the end goal of reducing payment disparity.”

Insurers are integrating telehealth companies:
Evernorth Completes Acquisition of MDLIVE to Expand Access to Virtual Care: “Evernorth, the health services portfolio of Cigna Corporation, today announced that it has completed its acquisition of MDLIVE, a privately held, leading 24/7 virtual care delivery platform. The transaction, first announced on February 26, expands Evernorth’s capabilities to lower the cost of care – while increasing access to health care providers – through virtual visits that can be accessed from the home or anywhere.” And:
Optum launches virtual care offering nationwide: 5 things to know: “The new virtual care product, dubbed Optum Virtual Care, is now live in all 50 states, said OptumHealth CEO Wyatt Decker during UnitedHealth Group's Q1 2021 earnings call transcript…”

Humana overcharged Medicare nearly $200M, inspector general finds: “Health insurer Humana failed to comply with some federal coding requirements, resulting in overpayments of $197.7 million, according to an inspector general's report released April 20.
Under the Medicare Advantage program, CMS makes monthly payments to organizations according to a system of risk adjustment determined by the health status of each enrollee. According to the federal audit, Humana failed to submit some diagnosis codes to CMS for use in the risk adjustment program.”

Health insurance execs push back against tax in Connecticut: “In a letter to Connecticut Gov. Ned Lamont, payer executives argued against a bill that would impose a $50 million tax on insurance companies, potentially driving businesses out of the state, according to the Hartford Courant.
The April 13 letter was signed by Anthem CEO Gail Boudreaux, Harvard Pilgrim Health Care and Tufts Health Plan CEO Thomas Croswell, Cigna CEO David Cordani, UnitedHealth Group President and COO Dirk McMahon and CVS Health CEO Karen Lynch.”

About the public’s health

Biden Administration Considering Rule to Cut Nicotine in Cigarettes: “The Biden administration is considering requiring tobacco companies to lower the nicotine in all cigarettes sold in the U.S. to levels at which they are no longer addictive, according to people familiar with the matter.
Administration officials are considering the policy as they approach a deadline for declaring the administration’s intentions on another tobacco question: whether or not to ban menthol cigarettes.”

Toward a fine-scale population health monitoring system: “Epidemiology research often relies on definitions of race and ethnicity, but these population labels may not adequately capture disease burdens and environmental factors impacting specific sub-populations. Here, we propose a framework for repurposing data from electronic health records (EHRs) in concert with genomic data to explore the demographic ties that can impact disease burdens…This work reinforces the utility of linking genomic data to EHRs and provides a framework toward fine-scale monitoring of population health.”

About healthcare personnel

Healthcare loses 44,000 jobs during Q1 2021, while spending, prices continue to grow: “Employment in the U.S. healthcare industry has dropped by 44,000 jobs over the course of the first quarter of 2021…
These job losses came alongside continued spending growth recovery and increases in overall healthcare prices.
Modest employment gains in February and March were unable to offset January’s substantial decline of 80,000 healthcare jobs.
Many of these losses were felt among hospitals, which lost 37,000 jobs in the first quarter, and nursing and residential care, which dropped 38,000 jobs. On the other hand, ambulatory care settings picked up 37,000 new jobs in the first three months of the year.
Overall, the healthcare industry has lost a total of 557,000 jobs since February 2020’s pre-COVID-19 peak, a 3.1% decline.”

About pharma

Relatively Few Drugs Account for a Large Share of Medicare Prescription Drug Spending: Among the study’s findings:
—”The 10 Top-Selling Part D Drugs - Less than 1% of Covered Drugs - Accounted for 16% of Net Total Part D Spending in 2019” and
—”The Top 50 Part B Drugs - Less Than 10% of Covered Drugs - Accounted for 80% of Total Part B Drug Spending in 2019”
Cost-control efforts will not be affected by such concentrated spending.

California counties seek billions of dollars from drugmakers in opioid trial: “Johnson & Johnson, Teva, Endo and AbbVie’s Allergan are accused of falsely marketing painkillers and knowingly underplaying the risk of addiction in order to increase sales, in litigation brought by three California counties and the city of Oakland, which are seeking billions of dollars in damages.”

Six Individuals Sentenced for Nearly $8 Million Health Care Fraud Involving Northern Virginia Pharmacies: “According to court documents, Mohamed Abdalla, 48, of Allendale, New Jersey, owned multiple pharmacies in northern Virginia, including Medex Health Pharmacy in Falls Church and Royal Care Pharmacy in Fairfax. As the owner of these pharmacies, Abdalla oversaw and executed two related schemes to defraud health care benefit programs. One scheme involved the payment or receipt of unlawful kickbacks for expensive drugs and devices in violation of the federal Anti-Kickback Statute. Another scheme involved billing federal, state, and private health care benefit programs for numerous expensive drugs and devices that were not medically necessary, not prescribed by a physician, or were not received by a beneficiary.”

About healthcare IT

2021 White Paper: Setting Healthcare on FHIR [Fast Healthcare Interoperability Resources]: A good monograph updating the status of FHIR and IT interoperability, in general.

Promise and peril: How artificial intelligence is transforming health care: A good, in-depth (221 pages) look at this topic from STAT and the Commonwealth Fund.

Today's News and Commentary

About Covid-19

CVS, Walgreens begin rolling out over-the-counter COVID tests from Abbott, Ellume and more: The tests are available without a prescription.

Worldwide COVID-19 death toll tops a staggering 3 million: “The global death toll from the coronavirus topped a staggering 3 million people Saturday amid repeated setbacks in the worldwide vaccination campaign and a deepening crisis in places such as Brazil, India and France.
The number of lives lost, as compiled by Johns Hopkins University, is about equal to the population of Kyiv, Ukraine; Caracas, Venezuela; or metropolitan Lisbon, Portugal. It is bigger than Chicago (2.7 million) and equivalent to Philadelphia and Dallas combined.
And the true number is believed to be significantly higher because of possible government concealment and the many cases overlooked in the early stages of the outbreak that began in Wuhan, China, at the end of 2019.”

Study of More Than 3,000 Members of the US Marine Corps. Reveals Past COVID-19 Infection Does Not Fully Protect Young People Against Reinfection: “Although antibodies induced by SARS-CoV-2 infection are largely protective, they do not completely protect against reinfection in young people, as evidenced through a longitudinal, prospective study of more than 3,000 young, healthy members of the US Marines Corps…”

Pfizer, Moderna turned down J&J request to probe COVID-19 vaccine clotting risks: report: Interesting marketing ploy by J&J to involve its competitors in looking for clotting complications. Pfizer and Moderna are required to look for complications, so there is no public health advantage to this joint effort.

About pharma

Facebook unveils AI model to mix up cancer-curing cocktails with existing drugs: “The social media giant’s AI research department and the Helmholtz Zentrum München, a research center in Germany focused on environmental health, unveiled an open-source AI model designed to determine the viability of repurposing existing drugs into new pharmaceutical cocktails.
Researchers and biologists now have free access to the Compositional Perturbation Autoencoder, or CPA, which evaluates the effects of drug combinations in varying dosages—a complicated task, as the number of possibilities can accelerate exponentially into the billions as more medicines are thrown into the mix.
The model predicts not only how the drugs interact with one another, but also how they might work together to attack specific cell types and interrupt diseases.”

Surprise: AstraZeneca's $39B Alexion buy clears a newly vigilant FTC without a hitch: “In an anticlimactic announcement Friday, AZ said the U.S. Federal Trade Commission has cleared the $39 billion deal first unveiled in December. 
None of the extra antitrust hurdles that analysts had feared for the marriage actually happened. The FTC didn’t attach any extra conditions to the deal. In fact, the go-ahead simply followed the 30-day waiting period triggered when the companies refiled their transaction for review on March 16.”

Merck Halts Development of MK-7110 for COVID-1: “Merck announced that it will end research and development on MK-7110, an experimental oral drug for treatment of hospitalized coronavirus patients that had shown promise in a late-stage trial.
The pharma titan said last week that it would drop its efforts on the drug — which it obtained through a $425 million acquisition of OncoImmune in November 2020 — after the FDA said it would need to see additional data beyond OncoImmune’s study to potentially grant Emergency Use Authorization.”

The top 10 ad spenders in Big Pharma for 2020: “Total pharma advertising spending topped $6.58 billion in 2020, according to Kantar measured media. That’s just a notch above the 2019 total of $6.56 billion, but still noteworthy in a year that saw U.S. advertising spend drop by 13% overall…
Pharma spending on digital video—desktop and mobile—increased 43%, while print and out-of-home channels dropped by 16% and 81%, respectively, according to Kantar.
Pharma TV advertising remained the cornerstone of spending with $4.58 billion, a whopping 75% of the total spend. That’s up just slightly from 2019 when national TV was 73% of pharma’s investment.”
#1 on the list of top spenders is Humira.

About health insurance

Trump tried to shrink Medicaid. Here's how Biden will try to expand it.: A really good overview of the Biden Administration’s Medicaid expansion initiatives. And in a related article: Biden officials rescind Trump’s okay for Texas’s $100 billion-plus Medicaid plan: “‘[W]e are rescinding the approval issued on January 15, 2021,’ because it did not go through the full federal rulemaking process, Liz Richter, the acting administrator of the Centers for Medicare and Medicaid Services, wrote in a letter to Texas officials obtained by The Washington Post.”

Nonprofit Health Plans Launch Telehealth-First Options to Increase Access and Affordability: ”When Covid-19 drove an increased need for telehealth in care delivery and coverage, nonprofit health plans Harvard Pilgrim, Kaiser Permanente, and Priority Health adapted their reimbursement models for members across the United States and accelerated their time lines for bringing cost-effective virtual care insurance products to market.”

Voya research shows employees are biased toward HDHPs [High Deductible Health Plans]: The headline should say “against” HDHPs. “New research from Voya shows employees have a bias against HDHPs and the reason for that is as simple as marketing…’When we replaced the high deductible health plan name and called it something more generic, the share of people choosing high deductible health plans doubled. So just the name itself can have a really significant impact on how people think about what plan they should choose.’
Sixty-three percent of the people surveyed by Voya said they would choose the plan with the lowest deductible. As part of the study Voya designed an experiment asking participants to choose between a PPO and an HDHP. The experiment was set up in a way that the HDHP was always the optimal financial choice, despite this, 65% of those surveyed still chose the PPO plan.”



Today's News and Commentary

About Covid-19

U.S. preparing for 1-year COVID-19 booster shots; Pfizer chief sees need: “The United States is preparing for the possibility that a booster shot will be needed between nine to 12 months after people are initially vaccinated against COVID-19, a White House official said on Thursday.
While the duration of immunity after vaccination is being studied, booster vaccines could be needed, David Kessler, chief science officer for President Joe Biden's COVID-19 response task force told a congressional committee meeting.”

Up to 10% of young adults who recover from COVID-19 at risk for reinfection: “About 10% of 18- to 20-year-olds included in the analysis developed a case of the virus despite being infected earlier in the pandemic, the data showed.”

CureVac preps its COVID-19 shot for deployment as J&J, AZ holdups slow Europe's rollout: “CureVac, which has started a rolling review process for its two-dose vaccine with the European Medicines Agency, plans to release late-stage trial results in the coming weeks, CEO Franz-Werner Haas said on a call with analysts Thursday. Depending on the results, the company expects that EU authorization for its shot, CVnCoV, could come in the beginning of June…”

The dogtor is in: Study finds dogs can sniff out COVID-19 with 96% accuracy: The headline is the story.

Web-based calculator for individual Covid-19 mortality risk: Enter your info to get an estimate.

U.S. to spend $1.7 billion on fighting variants: ”The Biden administration announced Friday it is allocating $1.7 billion to fight coronavirus variants, as the virus continues to mutate into more deadly and infectious forms.
The spending is aimed at improving the detection, monitoring and mitigation of the variants, as the original strain of the novel coronavirus now makes up only about half of all cases in the country. The White House said a central goal of the effort will be increasing the country’s capabilities for genomic sequencing to better understand and track mutations.”

About the public’s health

The Impact of Social Determinants of Health on Health Equity and Their Root Causes: A nice overview of the issue and insurance recommendations from AHIP.

About health insurance

A Public Option for Health Insurance in the Nongroup Marketplaces: Key Design Considerations and Implications: A good overview of questions and possible answers by the CBO.

3 takeaways from Brooks-LaSure's confirmation hearing to become administrator of CMS: The three categories were: Making telehealth flexibility permanent; Improving dual-eligible care coordination; and Flexibility and certainty for states applying for waivers.
No opposition is expected to her confirmation.

Employers Must Find, Tell Laid-Off Workers of Health Subsidies: “Employers have little time to waste in identifying and notifying laid-off employees who qualify for free health-care coverage under the American Rescue Plan signed into law last month by President Joe Biden.
The law provides fully subsidized coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA) from April 1 through Sept. 30 for employees who were involuntarily laid off or lost their job-based health plans due to reduced hours during the Covid-19 pandemic.”

About pharma

FDA Approves Genentech’s Xolair for Self-Injection Across Indications: “The agency approved the company’s supplemental Biologics License Application (sBLA), allowing the self-injected product to be used for treating moderate-to-severe persistent allergic asthma, chronic idiopathic urticaria and nasal polyps. The drug works by targeting and blocking the antibody immunoglobulin E.
Patients must have ‘no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections with no hypersensitivity,’ Genentech said.”
Because of its cost, this drug has been on many prior-authorization lists. With a change to self-administration, it will probably move from the medical to the pharmacy benefit and be subject to new reviews.

Biden administration poised to change Trump restrictions on fetal tissue research: The announcement is expected today, but details are not yet out.

Global shortage of innovative antibiotics fuels emergence and spread of drug-resistance: “The world is still failing to develop desperately needed antibacterial treatments, despite growing awareness of the urgent threat of antibiotic resistance, according to report by the World Health Organization. WHO reveals that none of the 43 antibiotics that are currently in clinical development sufficiently address the problem of drug resistance in the world’s most dangerous bacteria.”

About healthcare IT

Roche, Biocorp begin French rollout of add-on device connecting insulin pens to smartphone apps: “The French device maker’s smart sensor connects to most disposable insulin injection pens to collect data about each injection. Mallya automatically transmits that data to Roche’s Gluci-Chek smartphone app over Bluetooth. The dosage, insulin type, date and time information can then be logged and shared with healthcare providers via the Roche Diabetes Care Platform.
The sensor collects data with at least 99% accuracy, according to Biocorp, and it has received a CE mark for distribution in Europe. It lasts about two years and can be recharged through a USB port.”

TELEHEALTH IMPACT: PATIENT SURVEY ANALYSIS: “The patient survey was drafted by the COVID-19 Telehealth Impact Study Work Group” to answer these questions:

  1. “How well did telehealth serve the clinical needs of patients during the COVID-19 pandemic?

  2. For what reasons did patients seek care through telehealth?

  3. What were the strengths and weaknesses of telehealth related to quality of care?

  4. What are patients’ expectations for the use of telehealth after the pandemic?”

The report has helpful graphics to answer those questions by age, insurance, rurality and “all.”

In a sharp rebuke, health officials toss Trump-era proposal to exempt medical AI tools from review: “In a searing rebuke, the Biden administration is formally withdrawing a last-minute proposal by the Trump administration to exempt a wide swath of medical devices and artificial intelligence tools from regulatory review.
Officials with Biden’s Health and Human Services Department and the federal Food and Drug Administration posted a document on the federal register indicating that they will not proceed with the proposed exemptions.”

FCC will begin accepting applications for its $250M COVID-19 telehealth program starting April 29: “The Federal Communications Commission has set a date for healthcare providers to submit applications for the second round of the COVID-19 Telehealth Program, which will distribute nearly $250 million to support telehealth services.
The window opens at noon on April 29 and will last one week until May 6, 2021, according to the FCC. Interested providers will be able to submit their applications through a dedicated portal to be made available on the agency’s COVID-19 Telehealth Program webpage.”

RCM vendor data breach affects 136,000: 5 hospitals, health systems involved: “An investigation concluded that a former employee saved PHI to personal folders and uploaded the files to a public website.
There are at least five health systems and hospitals affected by the breach. HHS' data breach portal reported 135,908 individuals have been affected.”

About healthcare professionals

Medscape Physician Compensation Report 2021: The Recovery Begins: Read the report for a full analysis. At the top is plastic surgery. At the bottom is pediatrics.

Optum on track to exceed physician hiring goal, CEO says: “The company announced plans to add 10,000 physicians in 2021 earlier this year, and Wyatt Decker, CEO of OptumHealth, said Optum is on track to exceed that number. Optum now has 56,000 affiliated, contracted and employed physicians.”

Today's News and Commentary

About Covid-19

J&J's COVID-19 vaccine remains paused in US as advisory panel seeks more data: “Advisers to the US Centers for Disease Control and Prevention (CDC) said Wednesday that they need further data in order to make recommendations on how to respond to reports of cerebral venous sinus thrombosis (CVST) in some people administered Johnson & Johnson's COVID-19 vaccine Ad26.COV2.S. The Advisory Committee on Immunization Practices (ACIP) is expected to meet again within a week to 10 days.”

Novavax Admits Supply Shortages Will Delay Vaccine Production: “Novavax said it does not expect to hit its target of manufacturing 150 million COVID-19 vaccine doses per month until the third quarter of this year.
The production delay is caused in part by problems with the bioreactors used to grow cells needed for manufacturing the vaccine.”

Former world leaders call on Biden to suspend Covid-19 vaccine patents: “A group of 175 former world leaders and Nobel laureates is urging the US to take “urgent action” to suspend intellectual property rights for Covid-19 vaccines to help boost global inoculation rates. A measure to allow countries to temporarily override patent rights for Covid-related medical products was proposed at the World Trade Organization by India and South Africa in October, and has since been backed by nearly 60 countries. Doing so would allow developing countries to make their own copies of the vaccines that have been developed by pharmaceutical companies without fear of being sued for intellectual property infringements.”

AstraZeneca vaccine elicits stronger T-cell response in elderly than Pfizer jab: “The Oxford/AstraZeneca vaccine induced a stronger cellular immune response in elderly adults than the BioNTech/Pfizer shot, potentially providing more protection against severe Covid-19 and new virus variants. In the first head-to-head comparison of the two vaccines, scientists discovered that both shots elicited an antibody response in the group of over-80s, tested five to six weeks after the first shot. However, participants who received the AstraZeneca jab were more likely to also have a T-cell response.”

Many millions have been vaccinated against the coronavirus; 396 were later hospitalized with Covid-19: “About 5,800 people who have been vaccinated against coronavirus have become infected anyway, the US Centers for Disease Control and Prevention tells CNN. 
Some became seriously ill and 74 people died, the CDC said. It said 396 -- 7% -- of those who got infected after they were vaccinated required hospitalization.
This is the CDC's first public accounting of breakthrough cases, and the agency is searching for patterns based on patient age and gender, location, type of vaccine, variants and other factors.”

About healthcare IT

Coding to Hide Health Prices from Web Searches Is Barred by Regulators: “Federal regulators said healthcare pricing data that health insurers must post under a new requirement shouldn’t be blocked from web searches, issuing new guidance after The Wall Street Journal reported that hospitals used special coding that shielded such information from Google and other search engines.
Under new federal requirements, both hospitals and insurers must reveal long-confidential pricing data, including the rates that insurers pay for services. Hospitals were supposed to post data at the start of this year, while insurers must comply beginning in 2022. The hospital industry had fought the requirement in court but lost.”

IBM finds more cyberattacks against COVID-19 vaccine supply chain: “A hacking campaign detected by IBM tried to attack the organizations involved in manufacturing, transporting and storing COVID-19 vaccines last year. Now it has been found to be a much bigger operation than was originally thought.”

VA pauses $16B Cerner EHR rollout for 3rd time: 6 details: The long saga continues: “The Department of Veterans Affairs is pausing deployment activities for its new $16 billion Cerner EHR system at a second site until it has completed a strategic review of the project and shared the results with Congress, according to an April 14 Federal News Network report.”

About the public’s health

Explore the Management Top 250: How does your company rank in the 2020 analysis of well-run companies for customers, employees and investors?: By far the #1 company is Microsoft. The highest ranked healthcare company is Merck (#11).

About health insurance

What if the American Rescue Plan’s [ARPA]Enhanced Marketplace Subsidies Were Made Permanent? Estimates for 2022: “We find the number of people uninsured would drop by 4.2 million, or almost 14 percent, in 2022 if the ARPA’s enhanced marketplace subsidies were permanent and consumers, employers, and insurers responded to the new subsidy schedule as if it were fully phased in. We estimate subsidized marketplace enrollment would increase by 5.1 million people, an increase of 60 percent in 2022. Because of our different assumptions and models, our estimates differ from those by the Congressional Budget Office (CBO).”

Change Healthcare shareholders approve $13B UnitedHealth deal: ”Shareholders of Change Healthcare approved a $13 billion deal to become part of UnitedHealth Group's OptumInsight…
The approval comes as the deal is facing scrutiny from the Department of Justice. The American Hospital Association had urged the department to investigate the deal, which the association claims is anticompetitive.“

Patient Recruiter Sentenced to Prison for $3.3 Million Cancer Genetic Testing Fraud Scheme: “According to court documents, [Andre] Scott was the owner of Scott Global, a telemarketing call center located in Orlando. The evidence showed that Scott targeted Medicare beneficiaries with telemarketing phone calls falsely stating that Medicare covered expensive cancer screening genetic testing, or ‘CGx’ tests. Each test cost as much as $6,000. After beneficiaries agreed to take the test, the evidence showed Scott paid unlawful bribes and kickbacks to telemedicine companies to obtain doctor’s orders authorizing the tests.”

About pharma

Biologics Legislation Is Headed to Biden's Desk for Signature: “The Advancing Education on Biosimilars Act would require more robust federal efforts to educate the public about biosimilars, and the Ensuring Innovation Act would impose more restrictions on what biologics and generics drugs qualify for product exclusivity protections.” The latter Act cuts the ability of pharma companies to maintain exclusivity by using patents on all chemical entities in the product. For non-biologics, the Act strikes ‘‘‘active ingredient (including any ester or salt of the active ingredient)’ each place it appears” and inserts ‘‘‘active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations)…’” The Acts await Presidential signatures.

Thermo Fisher Scientific to Acquire PPD, Inc., a Leading Clinical Research Organization: “Thermo Fisher Scientific Inc….and PPD, Inc….,a leading global provider of clinical research services to the pharma and biotech industry, today announced that their boards of directors have approved a definitive agreement under which Thermo Fisher will acquire PPD for $47.50 per share for a total cash purchase price of $17.4 billion plus the assumption of approximately $3.5 billion of net debt…
Upon close of the transaction, PPD will become part of Thermo Fisher's Laboratory Products and Services Segment.”

 

Today's News and Commentary

About Covid-19

Inhaled steroid speeds recovery in Covid patients at home, study finds: “A widely available asthma drug has been found to reduce the recovery time for Covid-19 patients treated at home by an average of three days, according to a large clinical study in the UK led by Oxford university. The interim results for the inhaled steroid, known as budesonide, provide the first statistically powerful evidence for a drug speeding recovery in people who are not hospitalised.”

Moderna study finds COVID-19 vaccine 90 percent effective six months after dose: “Moderna announced on Tuesday that their coronavirus vaccine was 90 percent effective six months after a person receives their second dose.
’Vaccine efficacy starting two weeks following the second dose and based on the updated adjudicated cases remains consistent with prior updates, including greater than 90% against all cases of COVID-19, and greater than 95% against severe cases of COVID-19,’ the company announced.
Moderna is working for its vaccine to be fully approved by the U.S. as it is only under emergency authorizations from the Food and Drug Administration.”

Pfizer expects to meet US supply target ahead of schedule as authorities halt use of J&J shot: ”Pfizer can meet its supply target with the US government two weeks early as it boosts production, the company's chief executive said on Tuesday.”

Regeneron Says Its COVID-19 Antibody Combination Cuts Symptomatic Infections:”Regeneron Pharmaceuticals said its COVID-19 antibody cocktail, REGEN-COV (casirivimab with imdevimab) reduced the risk of symptomatic infections by 81 percent in a late-stage trial…
Those treated with the antibody combination who suffered from symptomatic infection generally saw their symptoms end in one week vs. three weeks for the placebo arm in the study conducted with the NIH’s National Institute of Allergy and Infectious Diseases.” Here are the latest NIH treatment recommendations, including use of monoclonal antibodies.

A Guide To The 1st Appellate Clash Over COVID-19 Coverage: “On Wednesday, the Eighth Circuit will become the first appellate court to consider whether COVID-19 closures trigger business interruption insurance when it hears an Iowa dental clinic's appeal of an order that Cincinnati Insurance doesn't have to cover its pandemic-related losses.” The article provides an overview of this important, contentious issue.

Europe won't renew AstraZeneca, Johnson & Johnson COVID-19 vaccine contracts next year: report: “The European Commission has opted against renewing its vaccine contracts with AstraZeneca and J&J once they expire at the end of the year, Italian newspaper La Stampa reported Wednesday, citing an unnamed source from the Italian health ministry…
Both shots have come under scrutiny over rare but serious cases of blood clots in people who had received the vaccines, prompting several countries to halt use of the AZ shot while the European Medicines Agency completed a follow-up safety review. Meanwhile, AstraZeneca has struggled to meet the delivery targets it originally laid out, while J&J just this week said it would delay its vaccine rollout in the bloc over safety concerns.”

About healthcare IT

Biden outlines health IT funding priorities: “The extensive list includes billions in funding for public health data modernization, broadband and 5G expansion, social determinants of health, cybersecurity and more.” See the article for spending details.

Anthem, K Health, Blackstone launching joint digital health venture: “Hydrogen Health is backed by investment from Blackstone and Anthem, and K Health CEO Allon Bloch will serve as the new company's chief executive. Financial terms were not disclosed.
The new venture will harness K Health's artificial intelligence tools to bring new digital health offerings to the consumer and employer markets, according to an announcement from the companies. Hydrogen Health will develop new platforms targeting the direct-to-consumer, direct-to-employer and direct-to-insurer markets.”

CMS bans coding hospitals use to hide prices from web searches: The update is that: “Leaders of the House Energy and Commerce Committee sent a letter April 13 to HHS calling for strict enforcement of the price transparency requirements. The letter cited evidence of hospitals' lack of compliance, including the Journal's analysis of more than 3,100 sites that use the search-blocking code, according to the report.”

100 Million More IoT Devices Are Exposed—and They Won’t Be the Last: Not strictly healthcare-related, but this Wired e-zine article explains details of why the systems are vulnerable.

About the public’s health

Syphilis Cases in California Drive a Record-Setting Year for STDs Nationwide: “In California and the U.S., about half of syphilis cases are in men who have sex with men. More than a third of women in the West who have syphilis also use meth, which has surged in recent years. These are just some of the trends causing overall national cases of sexually transmitted diseases to hit an all-time high for the last six years in a row, reaching 2.5 million. And the consequences are now trickling down to babies, who are contracting syphilis from their mothers: Congenital syphilis rates nearly quadrupled between 2012 and 2019.”

6th Circ. OKs Ohio Down Syndrome Abortion Law: “The majority of the Sixth Circuit has undone a block on an Ohio law that criminalizes abortion based on a Down syndrome diagnosis, ruling that ‘the right to an abortion before viability is not absolute.’ In a divided Tuesday decision, the appellate court reversed a lower court's preliminary injunction blocking H. B. 124, with the majority saying that the state is allowed to regulate previability abortions so long as those regulations don't put too much of a burden on women who want an abortion.”

2021’s Best & Worst States for Children’s Health Care: FYI. The best is DC. The worst is Texas.

High number of meals consumed in U.S. have low nutritional value: “About 65% of adult meals and 80% of children's meals from restaurants had low nutritional value In 2018, the most recent year for which information is available…” Anyone surprised?

About pharma

US agency says women can get abortion pill via mail: “Women seeking an abortion pill will not be required to visit a doctor’s office or clinic during the COVID-19 pandemic, U.S. health officials said Tuesday in the latest reversal in an ongoing legal battle over the medication.
The Food and Drug Administration announced the policy change a day earlier in a letter to the American College of Obstetricians and Gynecologists, one of several medical groups that has sued over the restriction put in place under the Trump administration.”

Rethink specialty pharma benefits: A good, current review of specialty drugs and the methods companies are using to hold down costs.

About health insurance

House passes bill to avert Medicare cuts: “The House on Tuesday approved a bill that would put off automatic cuts to Medicare provider payments until the end of the year.
The bill passed with a strong bipartisan majority of 384-38…
The automatic cuts were originally put into place by the 2011 Budget Control Act, which set up an annual 2 percent reduction in Medicare payments as one of its mechanisms for reducing the debt. Congress has never allowed the cuts to take place, however, voting to overturn them regularly over the past decade.”

Medicaid, CHIP Enrollment Increased After 2 Years of Decline: “Actual data, as opposed to projected data, showed the Medicaid and CHIP combined enrollment from February 2020 to October 2020 reached 7.2 million. Using preliminary data, experts anticipate that in November 2020 that number rose half a million to hit 7.7 million enrollees.”

Today's News and Commentary

About Covid-19

Today’s top story:

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine: “CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. [Emphasis added] This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”

Studies Confirm Racial, Ethnic Disparities In COVID-19 Hospitalizations And Visits: “Days after declaring racism a serious public health threat, the Centers for Disease Control and Prevention released a pair of studies further quantifying the disproportionate impact of COVID-19 on communities of color. 
The studies, published Monday in Morbidity and Mortality Weekly Report, examine trends in racial and ethnic disparities in hospitalizations and emergency room visits associated with COVID-19 in 2020.”

B.1.1.7 variant more transmissible but does not increase disease severity, two new studies suggest: “Two new studies suggest that the B.1.1.7 coronavirus variant, which was first identified in the United Kingdom, is more transmissible, but the variant does not appear to impact disease severity…
One of the studies, published on Monday in The Lancet Infectious Diseases, found no evidence in a sample of hospitalized patients that the B.1.1.7 variant is associated with severe Covid-19. However, the variant was associated with increased viral load, which supports the growing evidence that it is more easily transmitted.
The other study, also published Monday in The Lancet Public Health, found no statistically significant association between the B.1.1.7 variant and the types or duration of Covid-19 symptoms people said that they experienced.”

Recent Rise in U.S. Covid-19 Cases Driven by Younger People: “In addition to school sports, large outbreaks have been tied to the recent Easter holiday and spring breaks.” Also, this group is the last to be immunized.

About health insurance

HHS approves waiver for Illinois to expand Medicaid postpartum coverage to one year: “The Department of Health and Human Services (HHS) announced it approved a waiver for Illinois to ensure Medicaid eligibility for pregnant and postpartum women for 12 months [from 60 days], the first state to get such a waiver.
HHS Secretary Xavier Becerra said during a press conference Monday that the wavier approval is part of a series of measures the agency is taking to address maternal health outcomes. Becerra also said HHS has made $12 million in funding available for improving rural health maternal outcomes.”

Beneficiaries in Medicare Advantage Receive Better Value and Spend 40% Less than Beneficiaries in Medicare FFS: The study was done by UnitedHealth, but the numbers ring true: “The annual health care spending—on individual premiums and out-of-pocket (OOP) cost sharing for medical, pharmacy, and ancillary services—by a 73 year-old beneficiary of average health in MA ($3,558) is as much as 41% less than for a comparable beneficiary in FFS.”

Fifth Circuit Court Will Not Reconsider Decision Reversing Ruling That Would Have Awarded Nearly $500 Million To States In A Lawsuit Over ACA’s Insurance Provider Fees: Modern Healthcare reports the US Court of Appeals for the Fifth Circuit voted 11-5 to ‘not reconsider its decision to reverse a ruling that would have awarded nearly $500 million to states in a lawsuit over the ACA’s insurance provider fees.’ Modern Healthcare adds, ‘The provision required that states--on behalf of their Medicaid Managed Care Organizations--pay the fee to the federal government,’ but ‘the fee was repealed by Congress in 2021.’”

Rectifying the ACA Family Glitch Could Drive ACA Premiums Down: Approximately 5.1 million individuals are caught in the Affordable Care Act’s ‘family glitch,’ according to a recent Kaiser Family Foundation (KFF) analysis.
Under the Affordable Care Act, an employee may qualify for subsidized marketplace coverage if their employer-sponsored health plan’s premium costs more than 9.83 percent of their household income.
However, only the cost of the individual employee’s coverage is taken into account. Dependents are excluded from the calculation.
Thus, if an employee’s premium falls below 9.83 percent of their household income but the cost of adding their dependents puts them above that threshold, the employee nevertheless would not be eligible for lower-cost Affordable Care Act coverage.”

Data Note: 2021 Medical Loss Ratio Rebates: “The ACA requires health insurers to publicly report the portion of their premium dollars spent on health care costs, quality improvement, and other activities in each state they operate in. MLR rebates are based on a 3-year average, meaning that 2021 rebates will be calculated using insurers’ financial data in 2018, 2019, and 2020. Rebates issued in 2021 will go to consumers who were enrolled in rebate-eligible plans in 2020.
Using preliminary data reported by insurers to state regulators and compiled by Mark Farrah Associates, we find that insurers estimate they will be issuing a total of about $2.1 billion across all markets – the second-largest amount since rebates were first issued in 2012 under the ACA. This year’s rebates are roughly $400 million lower than last year’s record high of $2.5 billion, but more than 50% higher than the amount in 2019 ($1.4 billion, which, at the time, was a record high). These amounts are preliminary estimates, and final rebate data will be available later this year. Some insurers have not yet filed their 2021 rebate estimates.”

About healthcare IT

Supreme Court Ruling May Help Providers With mHealth Messaging Strategies: “The court earlier this month sided with Facebook in a case involving the Telephone Consumer Protection Act (TCPA), ruling that the company didn’t have to adhere to TCPA guidelines because it doesn’t use a messaging system that randomly or sequentially stores or generates a telephone number. In doing so, the court essentially redefined an automatic telephone dialing system, or autodialer.
Writing in the Health Care Law Today blog, attorneys for the Foley & Lardner law firm said the court’s ruling will allow healthcare providers to send out ‘health care messages’ by text without needing prior written consent from patients.”

Optum's 8 biggest health IT acquisitions, investments in the past year: FYI.

31 numbers that show how big Epic, Cerner, Allscripts & Meditech are in healthcare: FYI.
One impressive statistic is that more than 250 million patients have an electronic record in Epic.

Direct-To-Consumer Telemedicine Visits For Acute Respiratory Infections Linked To More Downstream Visits: “Use of direct-to-consumer telemedicine—on-demand virtual care for minor medical issues—is growing rapidly. Although it may yield immediate savings by diverting health care from higher-cost settings, these savings could be countered if direct-to-consumer telemedicine increases follow-up care and, therefore, episode costs. Comparing downstream care utilization data from a large, commercial payer for the period 2016–19, we found that patients with initial visits for acute respiratory infection were more likely to obtain follow-up care within seven days after direct-to-consumer telemedicine visits (10.3 percent) than after in-person visits (5.9 percent)…The telemedicine cohort had fewer (0.5 percent versus 0.6 percent) emergency department visits—a small but statistically significant difference—but more subsequent office, urgent care, and telemedicine visits.”

Use of Online Physician Ratings and Reviews by Older U.S. Adults: Results of a National Survey: “In this nationally representative survey, we found that more than 4 in 10 U.S. adults aged 50 to 80 years have now used online physician rating sites. These sources of information are more likely to be used by women, persons with higher levels of education, and those with a chronic medical condition. Numerous other factors seem to be much more influential among older adults when they select a physician, as suggested by previous research. Yet, online ratings and reviews were perceived to be very important nearly as often as word-of-mouth recommendations from family and friends and more often than where a physician trained or attended medical school.”

About pharma

FDA Revokes Five ANDAs for Generic Opioids: “The companies repeatedly failed to file required annual reports for the ANDAs and to ‘satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS), the agency said.
The drugmakers whose ANDAs were revoked are Lavipharm Laboratories of East Windsor, N.J., Scherer Laboratories, based in Plano, Tex., and Everylife of Seattle, Wash.”

FDA names Patrizia Cavazzoni as permanent director of CDER: “The FDA disclosed Monday that Patrizia Cavazzoni was appointed the permanent director of the agency's Center for Drug Evaluation and Research (CDER). She had been heading the division on an interim basis since last year when Janet Woodcock, currently the FDA's acting commissioner, relinquished the role to help lead an effort to accelerate COVID-19 therapies under Operation Warp Speed.”
The Biden administration has been slow to appoint permanent personnel at the FDA, so this action is an important step.

Biden picks former New Jersey attorney general to lead DEA: “President Biden has selected Anne Milgram, a former state attorney general, prosecutor and longtime advocate for reform of the criminal justice system, to lead the Drug Enforcement Administration, the White House announced on Monday.”

MIT and UCSF researchers create CRISPR 'on-off switch' that controls gene expression without changing DNA: Fascinating technology that could, in some cases, bypass some of the “cutting errors” of CRISPR procedures.
”The gene editing system CRISPR-Cas9 makes breaks in DNA strands that are repaired by cells—a process that can be hard to control, resulting in unwanted genetic changes. Researchers at the Massachusetts Institute of Technology and the University of California, San Francisco (UCSF) designed an alternative technology that changes gene expression without damaging DNA, and they believe it could be useful for both research and drug development.
The researchers used their system, dubbed CRISPRoff and CRISPRon, to induce pluripotent stem cells to transform into neurons. They also used it to silence the gene that makes the protein Tau, which has been implicated in Alzheimer’s disease. They described their research in the journal Cell.”

2021 Global RepTrak 100: Pharma, biotech and life sciences rank 8th among 13 industries. This reputation survey is fascinating. The overall #1 company is LEGO.

Today's News and Commentary

About Covid-19

As vaccinations keep rising, so do Covid-19 hospitalizations among those who aren't vaccinated: “First, the good news: The United States reported a record-high 4.6 million doses of vaccines administered in one day, according to data published Saturday by the Centers for Disease Control and Prevention…
Now the bad news: For the third straight week, new Covid-19 cases and hospitalizations are increasing, according to CDC Director Dr. Rochelle Walenky.”

Nearly half of new US virus infections are in just 5 states: “New York, Michigan, Florida, Pennsylvania and New Jersey together reported 44% of the nation’s new COVID-19 infections, or nearly 197,500 new cases, in the latest available seven-day period, according to state health agency data compiled by Johns Hopkins University. Total U.S. infections during the same week numbered more than 452,000.”
Those states account for 22% of the total US population.

States have been slow to order allotted vaccine doses, spurring calls for new approach: “States have delayed ordering hundreds of thousands of vaccine doses available to them even as coronavirus outbreaks escalate — a sign the nation is moving past its supply pinch and now faces more acute challenges related to demand, staffing and inoculation of hard-to-reach populations…
State and county officials offered different explanations for not ordering their full allocations each week. Many cited the difficulty of matching first and second doses. Others pointed to reduced demand, staffing challenges and inadequate communication between state and local officials.”

AWS [Amazon Web Services] to distribute $12 million in 2021 and expand scope of its initiative to fight COVID-19.: “In the first phase of the initiative, AWS helped 87 organizations in 17 countries ranging from nonprofits and research institutions to startups and large businesses. We have awarded $8 million supporting a range of diagnostic projects, including molecular tests for antibodies, antigens, and nucleic acids; diagnostic imaging; wearables; and data analytics tools that use artificial intelligence and machine learning to detect the virus.
As we launch the next phase, we are excited to broaden the AWS Diagnostic Development Initiative’s scope and distribute the remaining $12 million this year. Starting April 12, we are expanding the scope to three new areas: 1) early disease detection to identify outbreaks at the individual and at the community level; 2) prognosis to better understand disease trajectory; and 3) public health genomics to bolster viral genome sequencing worldwide.”

Japanese drug regulator to fast track any modified vaccines to fight variants: “The Japan Times reported that modified vaccines against new variants of COVID-19 will not require clinical trials in Japan if the production process and handling are similar to those of the original authorised vaccine.
The Pharmaceuticals and Medical Devices Agency (PMDA) said companies will still need to submit data from clinical trials overseas that shows immune response to the variants when they apply for Japanese approval.”
This move is unusual for the VERY cautious PMDA.

Here's how the U.S. compares to other countries on the coronavirus pandemic: A really good review and analysis of the current status of this topic.

South African variant may evade protection from Pfizer vaccine, Israeli study says: “The South African variant, B.1.351, was found to make up about 1% of all the COVID-19 cases across all the people studied, according to the study by Tel Aviv University and Israel’s largest healthcare provider, Clalit.
But among patients who had received two doses of the vaccine, the variant’s prevalence rate was eight times higher than those unvaccinated - 5.4% versus 0.7%.”
The study had very small numbers and the results make no sense. Why would vaccination increase infection almost 8 times more than in those unvaccinated?

Regeneron says antibody cocktail prevented Covid when given as simple injection, not an IV: “The study enrolled 1,500 healthy volunteers, each of whom shared a home with someone who tested positive for SARS-CoV-2, and randomized them to receive a single dose of its antibody treatment, given subcutaneously as four shots, or placebo. After 29 days, 11 patients in the treatment group developed Covid-19 compared to 59 on placebo. And for the subjects who got Covid-19 despite treatment, their symptoms resolved after one week, compared to three weeks for those on placebo. In 204 patients who had already tested positive for the SARS-CoV-2 virus at the study’s outset, the injection reduced their chances of progressing to symptomatic Covid-19 by 31%.”

More Black Americans open to vaccines after outreach efforts: “A poll by The Associated Press-NORC Center for Public Affairs Research in late March found that about 24% of Black American adults said they will probably or definitely not get vaccinated. That’s down from 41% in January. The latest number shows Black Americans leaning against getting shots in almost the same proportion as white Americans at 26% and Hispanic Americans at 22%.
Dr. Georges Benjamin, executive director of the American Public Health Association, said attitudes toward the vaccine among Black Americans have taken “almost a 180-degree turnaround” as outreach campaigns have worked to combat misinformation.
He credited Black physicians, faith leaders and other community organizers for being trusted messengers during the pandemic, which has killed more than 550,000 Americans.”

About healthcare IT

How Americans Feel About Telehealth: One Year Later: A quick-read survey that highlights how much has changed in one year.

In a change, patients can now read the clinical notes written by their physicians: This “spring, new federal rules went into effect that will allow patients to see the clinic notes physicians write, which advocates say will improve patients’ knowledge of their own health….
But not all doctors are as enthusiastic, concerned that patients might misinterpret what they see in their doctors’ notes, including complex descriptions of clinical assessments and decisions.”

Microsoft accelerates industry cloud strategy for healthcare with the acquisition of Nuance: “Microsoft Corp and Nuance Communications, Inc. today announced they have entered into a definitive agreement under which Microsoft will acquire Nuance for $56.00 per share, implying a 23% premium to the closing price of Nuance on Friday, April 9, in an all-cash transaction valued at $19.7 billion, inclusive of Nuance’s net debt… Mark Benjamin will remain CEO of Nuance, reporting to Scott Guthrie, executive vice president of Cloud & AI at Microsoft. The transaction is intended to close this calendar year….
Nuance’s products include the Dragon Ambient eXperience, Dragon Medical One and PowerScribe One for radiology reporting, all leading clinical speech recognition SaaS offerings built on Microsoft Azure.”

Google is exploring a health record tool for patients: ”After 13 years, Google is coming back for patient health records. The tech giant has launched an early user feedback program aimed at exploring how patients might want to see, organize, and share their own medical record data.
The work could inform the creation of a consumer-facing medical records tool along the lines of Apple’s Health Records app.”
Stand-alone apps are way behind current trends for interoperable systems and data exchange (see recent postings on anti-blocking laws). From the provider standpoint, any system that does not also have a financial (billing/collections) component is worthless.

FDA clears its first plug-in AI video system for spotting polyps during colonoscopy: “The GI Genius, developed by Cosmo Pharmaceuticals and distributed internationally by Medtronic, is designed to be compatible with all agency-approved endoscopy video systems. On the physician’s feed, the add-on system highlights areas of interest, allowing for closer visual inspections, tissue biopsies or ablation, with the goal of finding cancers when they may be easier to treat.”

About healthcare tech

Medline Industries Explores Sale:”Medline Industries Inc. is exploring a sale that could value the big medical-supply company at as much as $30 billion and mark the latest in a recent string of large leveraged-buyout bids.
The family-owned company has hired Goldman Sachs Group Inc. to run the process, according to people familiar with the matter. There is no guarantee the company will ultimately be sold. The process is at an early stage, the people said, with some adding that an IPO or minority investment is also a possibility.”

The top 10 medtech M&A deals of 2020: FYI

About pharma

Ohio Expects To Save $240 Million In Medicaid Drug Costs By Running Its Own PBM: “Ohio officials expect that consolidating the seven private pharmacy benefit managers that run its Medicaid managed-care system into a single, state-regulated PBM will save more than $240 million every year. The change will go in effect starting in early 2022.
Officials will administer PBM services through Gainwell Technologies, a state-regulated PBM that will replace the seven PBMs currently operating in the managed-care system.”