Today’s posting includes highlights from Thursday, Friday last week , over the weekend and today.
About Covid-19
Low dose of Pfizer-BioNTech vaccine is safe and effective in children ages 5 to 11, companies’ study finds: “A lower dose of the Pfizer-BioNTech coronavirus vaccine — one-third the amount given to adults and teens — is safe and triggered a robust immune response in children as young as 5 years old, the drug companies announced in a news release Monday morning…
The companies still must prepare and submit the data to the Food and Drug Administration, a process they expect to complete by the end of September.”
FDA Advisory Panel Rejects Widespread Pfizer Booster Shots: “An influential federal advisory panel has soundly rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans.
The vote Friday, 16-2, was a blow to the Biden administration’s effort to shore up people’s protection against the virus amid the highly contagious delta variant.
Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on safety of extra doses.
And they complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.” The over age 65 group and immunocompromised persons were recommended to have the booster.
And in a related story: Studies show good COVID booster effect, waning 2nd-dose protection: “Several new studies on the Pfizer/BioNTech mRNA COVID-19 vaccine describe good effectiveness against the Delta (B1617.2) variant after a booster dose and high but waning protection against infection and severe illness 6 months after the second dose.
Other, much smaller, studies demonstrated the safety of third mRNA vaccine doses. And a new British study on waning two-dose effectiveness coincides with the recent decision by UK officials to recommend booster doses.”
SARS-like viruses may jump from animals to people hundreds of thousands of times a year: “Only two new coronaviruses have spread globally the past 2 decades: SARS-CoV, which caused an outbreak of severe acute respiratory syndrome (SARS) in 2003, and SARS-CoV-2, the virus that causes COVID-19. But that may just be the tip of the iceberg of undetected infections with related viruses emerging from bats, a new paper claims. In a preprint … researchers estimate that an average of 400,000 people are likely infected with SARS-related coronaviruses every year, in spillovers that never grow into detectable outbreaks.
Although that number comes with big caveats, ‘It should be eye-opening to the entire scientific community that we don’t know very much about the frequency of zoonotic spillover,’ says virologist Angela Rasmussen of the University of Saskatchewan, who was not involved in the work. That needs to change, she says, ‘because otherwise we grossly underestimate it.’”
The E.U. adopts a new strategy to counter future pandemics.: “The European Union announced on Wednesday the creation of a new biomedical authority designed to better respond to future pandemics, as it seeks to avoid repeating the mistakes that plagued its early response to the coronavirus.
Ursula von der Leyen, the president of the European Commission, the bloc’s executive arm, also pledged to donate 200 million extra coronavirus vaccine doses to middle- and low-income countries by mid-2022, in addition to 250 million already promised by the end of the year.”
U.S. to buy hundreds of millions more doses of Pfizer vaccine to donate to the world: “The Biden administration is buying hundreds of millions more doses of the Pfizer-BioNTech coronavirus vaccine to donate to the world, according to two people familiar with the deal, as the United States looks to increase efforts to share vaccine with the global population.
The administration is expected to purchase 500 million doses, but the terms are not finalized, said the people with knowledge of the deal, who spoke on the condition of anonymity because they were not authorized to discuss the donation.”
U.S. Buys 1.4 Million Doses of Regeneron’s COVID-19 Antibody Cocktail: “Regeneron Pharmaceuticals and the U.S. government have struck a deal for a further 1.4 million doses of REGEN-COV (casirivimab/imdevimab), the company’s antibody cocktail for prevention and treatment of COVID-19, bringing the government’s purchased total to almost 3 million doses.
The N.Y.-based drugmaker will provide the 1,200-mg doses for $2,100 each, making the supply agreement worth an estimated $2.94 billion.”
FEMA to cover NYC Health + Hospitals' $900M COVID-19 tab: “The U.S. government has agreed to reimburse NYC Health + Hospitals for nearly $900 million in pandemic-related emergency expenses…
NYC Health + Hospitals, which oversees New York City's 11 public hospitals, filed the request with the Federal Emergency Management Agency in October 2020. The public hospital system sought the funding to offset costs incurred from hiring extra staff and expanding capacity to care for hospitalized COVID-19 patients.”
U.S. administers about 385.6 million doses of COVID-19 vaccines -CDC: “The United States has administered 385,586,012 doses of COVID-19 vaccines as of Sunday morning and distributed 466,561,785 doses, the U.S. Centers for Disease Control and Prevention said.
Those figures are up from 384,911,290 vaccine doses the CDC said had gone into arms by Sept. 18 out of 466,569,635 doses delivered.
The agency said 211,776,515 people had received at least one dose, while 181,382,976 people were fully vaccinated…”
Oregon physician who spread COVID-19 misinformation gets license revoked: Among other reasons for the revocation: “Dr. LaTulippe and his wife, who ran the clinic with him, allegedly didn't wear masks from March 2020 to December 2020. According to the board, he also told older adults and children that wearing a mask was very dangerous for them because it causes or contributes to multiple serious health conditions, such as strokes, carbon dioxide poisoning and collapsed lungs.”
The days of full covid coverage are over. Insurers are restoring deductibles and co-pays, leaving patients with big bills.: “In 2020, as the pandemic took hold, U.S. health insurance companies declared they would cover 100 percent of the costs for covid treatment, waiving co-pays and expensive deductibles for hospital stays that frequently range into the hundreds of thousands of dollars.
But this year, most insurers have reinstated co-pays and deductibles for covid patients, in many cases even before vaccines became widely available.”
See the state-specific graphic showing where the largest insurers are at with this policy.
Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers: ”The FDA recommends that clinical laboratory staff and health care providers:
—Consider any positive result from tests using the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP Kits to be presumptive. Consider retesting positive patient specimens performed in the last two weeks with an alternate authorized test.
Consider communicating to patients who received positive results using the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP Kits, starting in June 2021, that they may have had a false positive test result.”
About the public’s health
Rapid test to distinguish bacterial and viral infections wins US approval: “US regulators have approved the first test that distinguishes rapidly and reliably between bacterial and viral infections, helping doctors to avoid unnecessary prescriptions that are fuelling global antibiotic resistance. The MeMed BV test, developed by the Israeli biotech company MeMed with $30m grant funding from the EU and US Department of Defense, does not directly detect the cause of an infection. Instead it analyses the ‘host response’ — the different ways that the human immune system responds to bacteria and viruses.”
This test, if it proves itself in the field, could be an absolute “game changer” and become a standard of care. It would certainly help reduce the increase in drug-resistant bacteria. One problem: At $100 per test, it is much cheaper to still prescribe a generic antibiotic- whether or not it is clinically indicated. A $10-25 range is much more palatable.
Tobacco group Philip Morris wins control of inhaler company Vectura: “PMI, which makes Marlboro cigarettes, outbid the US private equity firm Carlyle for control of Vectura, prompting complaints from healthcare charities that said Big Tobacco was an unsuitable owner of a healthcare business. PMI has said it wants to shift its business away from cigarettes, with some saying the group should be encouraged to reinvent itself.”
Biden adds measles to list of diseases that could require quarantine: “President Joe Biden on Friday signed an executive order adding measles to a list of communicable diseases that could require quarantine after several Afghan refugees were diagnosed with the highly contagious disease after arriving in the United States.
The action makes measles one of the diseases for which federal health authorities have the authority to issue quarantine orders requiring people who have been diagnosed with measles or exposed to it to self-isolate to protect public health, a White House official said in a statement.”
Trends in Human Papillomavirus Vaccine Safety Concerns and Adverse Event Reporting in the United States: Perception is everything:
”This cross-sectional analysis of the 2015 to 2018 National Immunization Survey indicates a 79.9% increase in the proportion of parents who refused the HPV vaccine for their adolescents due to safety concerns. In contrast, estimates from the national vaccine safety surveillance system found that the HPV vaccine adverse event reporting rate per 100 000 doses distributed decreased from 44.7 in 2015 to 29.4 in 2018.”
What measures would instill confidence in the face of overwhelming safety/benefit data? Some vaccine experts are saying that the “anti-vax” sentiments for Covid-19 are spilling over into feelings about other vaccines.
About health insurance
Biden’s HHS Extends Obamacare Open Enrollment Period by 30 Days: “The 2022 Affordable Care Act marketplace enrollment period will increase from 45 to 75 days this year, and states will have the option to allow people with low incomes to sign up for coverage year-round, the Biden administration announced Friday.
Over the objections of Obamacare marketplace insurers, a final rule by the Centers for Medicare & Medicaid Services (RIN 0938-AU60)
extends the marketplace open enrollment period from Nov. 1 to Jan. 15, 2022, for states that use the HealthCare.gov website. Enrollment previously ended on Dec. 15.
States that use their own insurance marketplaces and enrollment platforms can establish different end dates for the annual enrollment period—as long as they conclude on or after Dec. 15, 2021, the CMS said.”
CMS blocks 3 UnitedHealthcare Medicare Advantage plans from 6 states: “CMS placed sanctions on three of UnitedHealthcare's Medicare Advantage plans, barring them from being sold in six states.
The penalties come from a CMS oversight and enforcement group that found that between 2018 and 2020, the plans did not meet the 85 percent threshold of premium revenue spent on Medicare Advantage members...
As a result, UnitedHealthcare cannot offer select Arkansas, New Mexico and Midwest plans to new members until 2023, assuming it hits the 85 percent threshold in 2022.”
And in a related story: Anthem hit with federal penalty over plan spending: “MMM Healthcare, an Anthem subsidiary, was served a federal penalty by CMS for failing to hit the 85 percent premium spending threshold, banning it from select enrollments starting Jan. 1, 2022.
The sanctions stem from MMM Healthcare failing to spend 85 percent of premium revenue on its Medicare Advantage members.”
These two CMS actions highlight the downside of not complying with the mandated Medical Loss Ratio provisions.
Florida cardiologist pays $6.75M to settle allegations he falsified EHR notes for profit: “Ashish Pal, MD, an Orlando, Fla.-based cardiologist, paid $6.75 million to resolve allegations from the Justice Department that he violated the False Claims Act by performing medically unnecessary procedures for profit.”
National Health Care Fraud Enforcement Action Results in Charges Involving over $1.4 Billion in Alleged Losses: “The Department of Justice announced today criminal charges against 138 defendants, including 42 doctors, nurses, and other licensed medical professionals, in 31 federal districts across the United States for their alleged participation in various health care fraud schemes that resulted in approximately $1.4 billion in alleged losses.
The charges target approximately $1.1 billion in fraud committed using telemedicine (the use of telecommunications technology to provide health care services remotely), $29 million in COVID-19 health care fraud, $133 million connected to substance abuse treatment facilities, or ‘sober homes,’ and $160 million connected to other health care fraud and illegal opioid distribution schemes across the country.”
RIP Medical Debt, TransUnion relieve $5B in medical debt: “RIP Medical Debt, a nonprofit that purchases and forgives medical debt, and TransUnion Healthcare, the credit reporting agency's subsidiary for healthcare revenue cycle management, have jointly relieved more than $5 billion in medical debt…
After forgiving the debt, RIP Medical Debt will send notices to the patients to help them repair their credit reports, renew access to resources and remove barriers to seeking healthcare.”
Biden-Harris Administration Announces Record-Breaking 12.2 Million People Are Enrolled in Coverage Through the Health Care Marketplaces: “A new report released today by the Department of Health and Human Services (HHS) shows that more than 2.8 million people newly gained access to affordable health care under the Biden-Harris Administration through the 2021 Special Enrollment Period (SEP) on HealthCare.gov and State-based Marketplaces.. With the gains made during the SEP, there are now a record-breaking 12.2 million people enrolled in the federal and state marketplaces. Additionally, there is historic enrollment today through Medicaid and the Children’s Health Insurance Program (CHIP) with over 82.3 million people relying on these programs as of April 2021.”
What Will Happen to Unprecedented High Medicaid Enrollment After the Public Health Emergency?: “Researchers at the Urban Institute report that states have the power to slow the pace of this disenrollment and can provide assistance finding alternative coverage options for these individuals. Additional findings include:
— The continuous coverage requirement of the Families First Coronavirus Response Act, which prohibited state Medicaid agencies from disenrolling beneficiaries during the public health emergency, would increase Medicaid enrollment by an estimated 17 million people from the start of the pandemic to the expected expiration of the PHE at the end of 2021, reaching a total of 76.3 million Medicaid enrollees under age 65.
—One-third of adults losing Medicaid coverage in 2022 would be eligible for Marketplace premium tax credits if the enhanced tax credits in the American Rescue Plan Act were made permanent.
—Of the children losing Medicaid in 2022, 57 percent would be eligible for the Children’s Health Insurance Program, and an additional 9 percent would be eligible for Marketplace coverage with tax credits.”
CMS won't enforce payer interoperability rules: “CMS is issuing new guidance on data exchange provisions included in its May 2020 interoperability rule, saying it will hold off on enforcement until finalized rules are issued.
The enforcement discretion was announced through a series of Sept. 15 FAQ additions and affects the payer-to-payer data exchange provision outlined in the interoperability policies, according to an announcement.
The announcement means that the Jan. 1, 2022, deadline for payers to comply with data exchange policies established by the CMS Interoperability and Patient Access final rule will not come with hard-and-fast enforcement.”
How Health Insurance Coverage in Texas Compares to Other States: The reason for the headline is that Texas has the highest uninsured rate. See the list of other states for comparison.
17 health plans land top scores on NCQA's 2021 report card: “The National Committee for Quality Assurance collectively awarded 17 commercial, Medicaid and Medicare plans perfect 5.0 scores after a review of over 1,000 health plans.
NCQA's 2021 list combines Healthcare Effectiveness Data and Information Set, Consumer Assessment of Healthcare Providers & Systems, and NCQA Accreditation standards scores to rank each plan on a 5.0-point scale.”
Read the article for the names of the 17 plans. For more information, see the NCQA website.
About hospitals and health systems
Henry Ford, Michigan State unveil joint brand for 30-year partnership: “Detroit-based Henry Ford Health System and Michigan State University in East Lansing have unveiled a unified brand of their partnership: Henry Ford Health + Michigan State University Health Sciences.
The organizations announced the new brand Sept. 15, about eight months after beginning a 30-year partnership. Under the partnership, the health system and university are collaborating on clinical research, cancer care, training, socioeconomic challenges that affect their communities and diversity among healthcare professionals.”
Intermountain, SCL Health to merge into 33-hospital system: “Salt Lake City-based Intermountain Healthcare and Broomfield, Colo.-based SCL Health have signed a letter of intent to merge, the organizations announced Sept. 16.
The combined system will have more than 58,000 employees, operate 33 hospitals and 385 clinics across six states and provide health insurance to about 1 million people.”
Ascension bounces back with $5.7B net income: “St. Louis-based Ascension rebounded in fiscal year 2021, ending the period with higher revenue and net income, according to financial documents.
The 146-hospital system reported operating revenue of $27.2 billion in fiscal year 2021, up from $25.3 billion a year earlier.
Net patient service revenue increased in the most recent fiscal year, but the growth wasn't attributed to higher patient volume. Hospital admissions, emergency room visits and urgent care visits declined year over year due to surges of COVID-19 and patient hesitation to seek care, the system said.
Ascension's expenses climbed 3.8 percent to $26.7 billion in fiscal year 2021. The increase was attributed to several factors, including higher salaries, wages and supply expenses.
Ascension ended the most recent fiscal year with operating income of $676.3 million, compared to an operating loss of $639.4 million in fiscal year 2020.”
CommonSpirit Health bounces back in FY21 with $1B operating gains: “CommonSpirit Health has posted an operating revenue gain of $998 million and operating margin of 3% for the fiscal year ending June 30—a stark turnaround from the $550 million loss and negative 1.9% operating margin of the year prior.
That total includes $523 million tied to pretax gains from the sale of joint venture sales, the Catholic nonprofit noted in its annual filing, although excluding that sale still leaves the system with a $475 million operating gain…
The Chicago-based system also did quite well by its investment portfolio, notching a net investment income of $3.4 billion for the year.”
About pharma
Pfizer recalls all Chantix lots nationwide over concerns of cancer-causing impurity: “Pfizer on Thursday said it's expanding its Chantix recall to the consumer level to include all batches of the drug at the 0.5-mg and 1-mg doses. The company is recalling the drug as a ‘precautionary measure’ because the medicine contains unacceptable levels of N-nitroso-varenicline, a type of nitrosamine, and because there are now ‘alternative suppliers’ of the medicine for the U.S.”
DOJ moves to block Purdue Pharma deal shielding Sacklers: “The Department of Justice (DOJ) moved on Wednesday to block Purdue Pharma’s controversial bankruptcy deal that shields members of the Sackler family from being sued in future opioid-related lawsuits.
U.S Trustee for the DOJ William Harrington filed a request for an expedited stay to prevent the OxyContin-maker’s agreement that a federal judge signed off on earlier this month from going into effect. The DOJ throughout Purdue Pharma’s bankruptcy has blasted the settlement as ‘unlawful’ and ‘unconstitutional.’”
Excision's CRISPR gene editing therapy for HIV is heading into human testing after FDA clearance: “HIV integrates its genetic material into the genome of a host cell, meaning available therapies just can’t remove it. A team of scientists at Temple University and the University of Nebraska Medical Center managed to remove the virus completely from mice during preclinical testing using a combination of CRISPR and antiretroviral therapy. They also found no adverse events that could be linked to the therapy in the study, published back in 2019.”
The life-saving medicine that is killing the planet: “Inhalers made by GSK and relied on by asthmatics the world over contain a greenhouse gas 1,500 times more powerful than carbon dioxide, says Dr Christer Janson, a respiratory physician and professor at Uppsala University. Those tiny puffs that propel medicine into a patient’s lungs are the company’s biggest single contribution to global warming…
The company states that 8 per cent of its carbon emissions come from its own operations, 45 per cent from its suppliers, 6 per cent from logistics and 40 per cent from its products, ‘mostly metered dose inhalers’…
Promoting the use of alternative ‘dry powder’ inhalers, which GSK also makes, should help. These are less common in the US and UK but the most common variety in Scandinavia. ‘There is half a tonne difference of CO2 equivalent per patient per year,’ says Janson. In terms of an individual’s carbon impact, ‘that’s the difference between a vegetarian and meat diet”, he says. Dry powder varieties are not suitable for everyone, so GSK is also experimenting with better propellants.”
Global Generics & Biosimilars Awards 2021 Finalists: FYI, a list of companies in many different categories of awards.
Democrats’ Stumble on Drug Prices Shows Power of Industry: “Three House Democrats on a key committee voted against the measure on Wednesday. There are still ways for House leaders to keep the provision in the final bill, but the House Democratic majority is so slim that those three legislators, if determined, could represent a significant barrier to passing the broader package.”
The article provides a good analysis of the power of pharma companies and the contribution the savings from pharma proposals would have on the federal infrastructure spending bill (>$500 billion).
About healthcare IT
Data-powered consult service shown to help doctors diagnose illness, guide treatments: “Researchers at Stanford Medicine have breathed new life into old electronic health records to help doctors stumped by tough cases.
They created the Clinical Informatics Consult Service, a resource for physicians seeking insights into illnesses that are challenging to diagnose and treat. Unlike a standard physician-to-physician consultation, doctors can tap into findings from thousands, and sometimes millions, of cases to find information that might help them understand their patients’ cases…
It’s fueled by a powerful search engine created by a team researchers who sort through massive datasets of health records that have been wiped of identifying information to protect patient privacy. Using information like medical histories, vital signs, lab results, prescriptions and more, the researchers parsed the data to find other cases to inform questions they receive about incoming patients…
The service is available at Stanford Health Care through Atropos Health, a company that licenses the technology from Stanford, and is also available to other health care and medical institutions for a fee. The search engine is freely available for noncommercial use via the Office of Technology Licensing at Stanford University.”
FDA Starts New Office of Digital Transformation, Affecting Devices: “The FDA is reorganizing its information technology, data management and cybersecurity functions into a new Office of Digital Transformation in a move that will have implications for medical devices.
The new office’s cybersecurity function will be especially relevant to devices, given increasing concerns about the vulnerability of some devices to online hacking.”
Diagnostic Errors, Health Disparities, and Artificial Intelligence: A Combination for Health or Harm?: A very thoughtful article with examples of how AI can worsen or ameliorate healthcare disparities.
Northwell Health and Walgreens partner on 5-year digital agreement: “Northwell Health and Walgreens have announced a five-year strategic affiliation in New York State.
The digital agreement makes Northwell telehealth providers accessible on the Walgreens Find Care platform, expanding community member access to virtual emergency care services from board-certified emergency medicine physicians. Pediatric specialists are also available.
Walgreens is being offered as an in-network pharmacy provider for Northwell's 76,000 employees. Since September 1, Northwell Health's employees could fill their non-specialty prescriptions at a Walgreens pharmacy.
Northwell and Walgreens are also exploring a retail health clinic collaboration at select Walgreens store locations throughout the tristate area, which would create additional access to primary care, particularly in underserved communities, the companies said.”
Which companies are involved is not as important as the example of the scope of joint venture deals across sectors.
About healthcare legislation
Fall 2021 Hill Watch: From Bloomberg Government: A roundup on pending legislation and proposals in the works.(See pages 40-43)
About healthcare finance
SPAC Attack: The 10 biggest in healthcare: See the graphic for the 15 largest SPACs in healthcare and their investment interests.
