Today's News and Commentary

About health insurance

More than 2.5 Million Americans Gain Health Coverage During Special Enrollment Period: “New data released [yesterday] by the Centers for Medicare and Medicaid Services (CMS) shows more than 2.5 million people enrolled in health coverage on HealthCare.gov and state Marketplaces during the Biden-Harris Administration’s 2021 Special Enrollment Period (SEP), which will close in five days on August 15th. Additional data released by CMS today shows that a record high of nearly 81.7 million people are now receiving coverage through Medicaid and the Children’s Health Insurance Program (CHIP) as of March 2021.”

Senate passes infrastructure bill that restarts sequester cuts, delays rebate rule: “The package would reinstall starting in 2022 a 2% payment cut to all Medicare payments to providers. The cut was installed as part of sequestration, but Congress paused it last year at the onset of the pandemic.”

A Post-Merger Integration Agenda for Health Care Payers: From BCG: A good summary of the payer M&A activity over the past few years.

CMS pulls Medicaid work rules in 3 more states: “Health officials in Ohio, South Carolina and Utah received word from CMS on Aug. 10 that Medicaid work requirements would be revoked in their states…”

About Covid-19

Texas sees most COVID-19 hospitalizations in 6 months: “The third wave of COVID-19 in Texas continues to tax the state’s health care systems as 10,000 COVID-19 sufferers have been hospitalized for the first time since early February, state health officials reported.
Meantime, local governments and courts continue to chip away at Gov. Greg Abbott’s ban on mask and social distancing mandates as a state district judge in San Antonio granted a temporary restraining order to allow San Antonio and Bexar County to require public school students to mask up and quarantine unvaccinated students exposed to COVID-19.”

Novavax Says U.S. Will Pause Funding for Production of Its Vaccine: “Novavax, the Maryland firm that won a $1.75 billion federal contract to develop and produce a coronavirus vaccine, said on Thursday that the federal government would not fund further production of its vaccine until the company resolves concerns of federal regulators about its work.
The firm’s disclosure came in a quarterly filing with the Securities and Exchange Commission.”

KFF COVID-19 Vaccine Monitor: Parents and the Pandemic: Among the highlights:
— “As children around the country head back to school, nearly half of parents of children ages 12-17, the age group currently eligible to receive a COVID-19 vaccine, say their child has already been vaccinated (41%) or they will get the vaccine right away (6%)…
— A majority (58%) of parents of 12-17 year-olds say their child’s school should not require students to be vaccinated for COVID-19, and a similar share (54%) of parents of all school-age children say schools should not require vaccination even once the FDA has fully approved the use of a COVID-19 vaccine in children.
— More than six in ten (63%) of all parents of children who attend school think their child’s school should require unvaccinated students and staff to wear masks at school, although most Republican parents (69%) oppose such a requirement and parents of unvaccinated children are evenly divided.”

3rd COVID shot highly potent in Israel's immunocompromised, early study shows: “According to early results from research carried out at Beilinson Medical Center in Petah Tikva, the COVID-19 vaccine booster shot is highly effective among immunocompromised people, doubling the number of people who developed antibodies among patients who have received heart, lung or kidney transplants…” In a related article: Israel’s Covid infections surge as government rolls out booster shots: “Almost 80 per cent of the adult population has been fully vaccinated, one of the highest rates in the world, but more than 6,000 people tested positive for Covid-19 on Monday, according to the health ministry. Nearly 650 people were in hospital and 400 of them were in serious condition, it said, without indicating how many had already been vaccinated. Just under 5 per cent of coronavirus tests were coming back positive, in a sign that the nation was in the midst of a major Covid increase…”

How to reach the unvaccinated: the risks of bribery and coercion: A good overview of what countries are doing and the pros and cons of the approaches. A couple comments: “ ‘As vaccine supplies increase in the developed world, governments are rushing to introduce incentives and mandates to increase uptake — without always thinking through the consequences that it might harden the views of those who are hesitant,’ says Professor Heidi Larson, founding director of the Vaccine Confidence Project at the London School of Hygiene & Tropical Medicine.
[Stephen Reicher, a professor of psychology at the University of St Andrews] notes that incentives also come with risks. ‘Some scientific literature suggests that they can decrease what is called your intrinsic motivation,” he says. “In other words, you get vaccinated because you get a reward for it, not because you believe it is the right thing to do.’”

BD and CerTest Biotec Gain CE Mark for Test for COVID-19 Variants: “The test, which runs on the BD MAX real-time PCR platform, can distinguish between the original COVID-19 virus and three variants, Alpha, Beta and Gamma, the companies said.
The test kit also includes three options for specimen collection: nasopharyngeal, oropharyngeal and saliva.”

Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021: Published yesterday from the CDC:
“Rare serious adverse events have been reported after COVID-19 vaccination, including Guillain-Barré syndrome (GBS) and thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination and myocarditis after mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccination…
[However], continued COVID-19 vaccination will prevent COVID-19 morbidity and mortality far exceeding GBS, TTS, and myocarditis cases expected.”

COVID-19 vaccine safety update: The European Medicines Agency (EMA) has requested more data from BioNTech about possible certain possible vaccine-related conditions: erythema multiforme, glomerulonephritis, nephrotic syndrome, and “menstrual disorders.” All are rare and not a reason to avoid the vaccine.

At least 1 million people got unauthorized third booster shot: “The Centers for Disease Control and Prevention estimates that more than 1 million people who have received the Moderna or Pfizer vaccine have gone back for an unauthorized third booster shot.
Florida is among the states reporting the highest number of people opting for a booster shot, followed by Ohio, California, Illinois and Tennessee.”

CDC guidance now official: Pregnant women should get coronavirus vaccine: “The Centers for Disease Control and Prevention recommended Wednesday that pregnant women be vaccinated against the coronavirus, updating its advice after it found no increased risk of miscarriage among those who have been immunized.”

Alabama Just Tossed 65,000 Vaccines. Turns Out It's Not Easy To Donate Unused Doses: While Alabama is in the headline, the article discussed how many states need to dispose of outdated vaccines and why donating them is not easy.

About healthcare professionals

High trust in doctors, nurses in US, AP-NORC poll finds: “At least 7 in 10 Americans trust doctors, nurses and pharmacists to do what’s right for them and their families either most or all of the time, according to the poll from the University of Chicago Harris School of Public Policy and The Associated Press-NORC Center for Public Affairs Research.
The poll shows high levels of trust among both Democrats and Republicans; men and women; and white, Black and Hispanic Americans…
Polling from the nonprofit Kaiser Family Foundation in June also showed people trusted doctors for information about the vaccine more than other sources like the Centers for Disease Control and Prevention and Dr. Anthony Fauci, the U.S. government’s top infectious disease expert.”

About the public’s health

Screening for Gestational DiabetesUS Preventive Services Task Force Recommendation Statement: “The USPSTF recommends screening for gestational diabetes in asymptomatic pregnant persons at 24 weeks of gestation or after. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for gestational diabetes in asymptomatic pregnant persons before 24 weeks of gestation. (I statement)”

Perceptions on Barriers and Facilitators to Colonoscopy Completion After Abnormal Fecal Immunochemical Test Results in a Safety Net System: “In this qualitative study of 21 primary care physicians (PCPs) and staff members, barriers to follow-up colonoscopy completion included environmental factors (ie, social determinants of health and organizational factors) and patient cognitive factors. Resources that addressed these barriers (eg, insurance assistance, appointment reminders, and bowel preparation education) were associated with improved colonoscopy completion.”

Trends in Consumption of Ultraprocessed Foods Among US Youths Aged 2-19 Years, 1999-2018: “In this serial cross-sectional study of nationally representative data from 33 795 US youths aged 2-19 years, the estimated percentage of total energy consumed from ultraprocessed foods increased from 61.4% to 67.0%, whereas the percentage of total energy consumed from unprocessed or minimally processed foods decreased from 28.8% to 23.5%.”

Religious Groups Win Pass On Abortions, Transgender Care: “A Texas federal judge has ruled that several religious medical providers can't be punished by the federal government for refusing to provide abortions or gender transition-related care, despite an anti-bias provision in the Affordable Care Act.”

About pharma

Groups make own drugs to fight high drug prices, shortages: A good overview of how non-pharma companies are producing drugs to fight shortages and high costs.

Judge Limits Attorney Contingency Fees to 15 Percent in $26 Billion Opioid Settlement: “A federal judge has capped contingency fees at 15 percent for lawyers representing plaintiffs poised to earn large amounts from the pending $26 billion opioid lawsuit settlement by the three largest U.S. drug distributors and Johnson & Johnson (J&J).”

Ex-Roche Employee Sentenced to Prison for Cheating the Drugmaker Out of Nearly $10 Million: “The defendant and an accomplice pleaded guilty to commercial fraud, document forgery and commercial money laundering, after being charged with embezzling the funds from January through August 2017.”

Big Pharma’s Q2 growth, ranked: Regeneron, Pfizer lead the way as sales rebound from pandemic depths: “More than half of Big Pharma companies reported revenue increases greater than 15% over the same quarter in 2020, which was marred by lockdowns and the shock to the economic system that ensued at the start of the pandemic…
Companies that registered the most dramatic revenue growth were the ones that have developed COVID-19 treatments. In fact, this was the case for all six of the firms that exceeded a 20% increase, including Regeneron (up 163%) with $2.59 billion in sales for its antibody drug REGEN-COV and Pfizer (92%) with $7.8 billion in COVID-19 vaccine sales.”
Check the graphic for data on specific companies.

Perfect packaging? J&J's latest innovation challenge crowdsources single dose ideas:
“…Johnson & Johnson Innovation looks to crowdsource the best ideas in single-dose packaging for its latest JLABS Quickfire challenge.
The contest focuses on single-dose packages but also aims for ideas that incorporate child safety measures, environmentally friendly materials and adherence helpers…
The new unit-dosing challenge follows up on a Pill Protect safer medicine storage challenge that ended in July. Gatekeeper Innovation won with its solution for a child-resistant prescription pill minder. J&J kicked off that challenge with an eye toward making over the popular multiday pill boxes that people fill weekly with their meds…”
A great example of “listening to the voice of the customer.”

About healthcare IT

Telemedicine company owner indicted in $784M fraud scheme: Another Medicare, multi-year scam:
”According to prosecutors, Mr. Harry and his co-conspirators solicited kickbacks and bribes from durable medical equipment suppliers and marketers in exchange for orders. His telemedicine companies also allegedly paid physicians to write orders for braces and other equipment regardless of medical necessity. The scheme resulted in the durable medical equipment suppliers fraudulently billing Medicare more than $784 million, of which Medicare ended up paying about $247 million. 
Prosecutors also say Mr. Harry directed suppliers not to pay his telemedicine companies but instead to pay shell companies opened in straw owners' names in the U.S. and foreign countries in an effort to conceal the scheme. Mr. Harry committed income tax evasion between 2015 and 2018 by receiving the proceeds in the accounts of shell companies, according to the indictment.”

TytoCare Launches New Integration with Epic for Seamless Asynchronous Telehealth Exams: TytoCare, the global health care industry's first all-in-one modular device and examination platform for AI-powered, on-demand, remote medical exams, has expanded its integration within MyChart enabling frictionless asynchronous workflow. The integrated workflow enables health systems to easily access TytoCare-generated data in a patient's EHR (Electronic Health Record), clinicians to access TytoCare exam data directly within Epic, and seamless remote patient monitoring.
The new integration was developed as a result of a collaboration between TytoCare and University of Miami Health System in June 2020.”

Fitbit moves deeper into healthcare with LifeScan deal to combine diabetes devices, consumer wearables: “Smartwatch maker Fitbit inked a deal with LifeScan to integrate its health tracking apps with the company's glucose monitoring devices to help patients with diabetes management.”

HIMSS21 Update

About healthcare quality

NCQA launches program to streamline quality reporting: “The National Committee for Quality Assurance announced a program this week geared toward ensuring the validity of clinical data used for quality reporting and other initiatives.  
The Data Aggregator Validation program is aimed at giving health plans, government entities and care delivery organizations confidence in the validity of their clinical data. It does so, says the NCQA, by evaluating how organizations ingest, transform and output that data. “