Today's News and Commentary

About the public’s health

FDA says Pfizer coronavirus vaccine contains extra doses, expanding nation’s supply: The miracle of Hanukkah is that oil in the re-dedicated Temple’s Menorah was only supposed to last one day, but instead lasted eight days. As shortages of the COVID-19 vaccine have become a problem, this announcement is welcome news.
“The government’s existing supply of the first authorized vaccine can be stretched further after pharmacists began to notice that vials contain more than the expected five doses.
The FDA is in touch with Pfizer about how to handle this issue, the agency said. In the meantime, regulators say those extra doses from a single vial can be used.” The extra amounts are more than usually exists in multidose vials.

FDA advisers recommend second coronavirus vaccine, with agency action expected soon: “Moderna’s coronavirus vaccine got the greenlight from a Food and Drug Administration advisory committee Thursday, paving the way for authorization of a second shot aimed at slowing a pandemic that has killed nearly 310,000 people in the United States.
The panel voted almost unanimously — 20 in favor, with one abstention — that the benefits of the highly effective vaccine outweighed its risks for people 18 years of age and older. The FDA plans to authorize the vaccine Friday, according to knowledgeable individuals who spoke on the condition of anonymity because they were not authorized to speak publicly about the schedule.”

.Allergists' Group Offers Advice on Pfizer COVID-19 Vaccine: “The American College of Allergy, Asthma and Immunology COVID-19 Vaccine Task Force is now offering guidance about the risk of an allergic reaction for people who receive the vaccine, as the U.S. rollout begins…
People with common allergies to medications, foods, inhalants, insects and latex are not more likely than the general public to have an allergic reaction to the Pfizer vaccine. The benefits and risks of the vaccine should be explained to these patients, the task force said.
The vaccine should be given in a health care setting where anaphylaxis can be treated. All people who receive the vaccine must be monitored for at least 20 to 30 minutes after injection for any harmful reactions. Anaphylactic reactions should be treated immediately, with epinephrine as the first-line therapy.
The vaccine shouldn't be given to people with a known history of a severe allergic reaction to polyethylene glycol, a component of the vaccine known to cause anaphylaxis, according to the task force.”

How Effective Is the Mask You’re Wearing? You May Know Soon: “A division of the Centers for Disease Control and Prevention is working to develop minimum filter efficiency standards, and labels showing which products meet them, for the vast and bewildering marketplace for masks and other face coverings.
The National Institute for Occupational Safety and Health, a division of the C.D.C. known as NIOSH, has been quietly writing guidelines with an industry-standard-setting organization, ASTM International (formerly the American Society for Testing and Materials), that are expected to be made public next month.”

U.S. HHS to give $4.5 billion more to pandemic-hit healthcare providers: “HHS said the funding would meet close to 90% of the losses healthcare providers have reported from the COVID-19 pandemic in the first half of the year.
Payment distribution began on Wednesday and will continue through January 2021, the department said.”

About healthcare IT

Highmark Health Partners With Google Cloud to Raise Standard for Customer and Clinician Engagement in Health: “In its efforts to reinvent the health care experience and enrich the relationship between people and their clinicians, Highmark Health and Google Cloud today announced a six-year strategic partnership to build and maintain the innovation engine behind Highmark's Living Health model.
The Living Health model is designed to eliminate the fragmentation in health care by re-engineering the healthcare delivery model with a more coordinated, personalized, technology-enabled experience. In addition to offering seamless, simpler and smarter interactions with patients, the Living Health model is designed to free clinicians from time-consuming administrative tasks while providing them with timely data and actionable information about each patient. Living Health is not just focused on improving the patient-clinician relationship, it is about changing the way health care delivery operates.”

Just what the doctor ordered: Mental health and wellness apps: “Kaiser Permanente physicians and therapists now have the ability to refer their patients to evidenced-based mental health and wellness apps through the organization's electronic health record system. With a simple referral to an app, Kaiser Permanente patients can begin using it on their own or under the guidance of a clinician — at no cost.”

10 health IT acquisitions over $100M in 2020: A year-end summary.

About pharma

Most doses of Lilly, Regeneron's COVID-19 antibody treatments are going unused: “Moncef Slaoui, chief scientific advisor to the US government's Operation Warp Speed programme, estimates that only 5% to 20% of the roughly 65,000 doses of COVID-19 antibody treatments shipped to states around the country every week end up going to patients. He suggested this was disappointing because these therapies, viewed as a potential ‘bridge’ to avert serious coronavirus illness until vaccines become widely available, could cut hospitalisations by half if given early enough in the course of infection…
Slaoui attributed the surplus of unused doses to the challenges of administering the antibody drugs, which is done by intravenous infusion in a hospital or outpatient setting, within a few days of patients contracting COVID-19, before they might feel sick. States and healthcare organisations have to set up safe places for patients to receive the treatment. Moreover, if patients are not getting tested or do not obtain their test results within a short window after they fall ill, they cannot benefit from the drugs.”

About health insurance

Intermountain, UnitedHealthcare launch ACO: “Through the ACO, Salt Lake City-based Intermountain and UnitedHealthcare will work together to coordinate care for the health insurer's Medicare Advantage members, 136,000 of which live in Utah. For eligible members who receive care from Intermountain primary care physicians, UnitedHealthcare will tie the physicians' payment to the health outcomes experienced by its members.”

About healthcare professionals

CommonSpirit, Morehouse medical school launch initiative to increase Black doctors nationwide: “CommonSpirit Health and the Morehouse School of Medicine announced a 10-year, $100 million partnership to develop and train more Black physicians in an effort to address one of the underlying causes of health disparities…”

About healthcare spending

National Health Care Spending In 2019: Steady Growth For The Fourth Consecutive Year: This article is the annual breakdown of healthcare costs reported in Health Affairs. It is by subscription, but if you can get a copy it is always worthwhile. Here is the abstract:
”US health care spending increased 4.6 percent to reach $3.8 trillion in 2019, similar to the rate of growth of 4.7 percent in 2018. The share of the economy devoted to health care spending was 17.7 percent in 2019 compared with 17.6 percent in 2018. In 2019 faster growth in spending for hospital care, physician and clinical services, and retail purchases of prescription drugs—which together accounted for 61 percent of total national health spending—was offset mainly by expenditures for the net cost of health insurance, which were lower because of the suspension of the health insurance tax in 2019.”



Today's News and Commentary

About the public’s health

Over-the-counter home test for COVID-19 gets US green light: “U.S. regulators Tuesday authorized the rapid coronavirus test, which can be done entirely at home…
Regulators granted emergency use for a similar home test last month, but that one needs a doctor’s prescription…
The kit includes a nasal swab, a chemical solution and a testing strip. The test connects digitally to a smart phone app that displays the results and then helps interpret them. Users can also connect with a health professional via the app.” Priced at about $30 per test, it is still too expensive to do frequently.

KFF COVID-19 Vaccine Monitor: December 2020: This research is an update on who wants to receive the vaccine. While the rates of acceptance are rising, there are still segments of the population who will refuse to get it:
“About a quarter (27%) of the public remains vaccine hesitant, saying they probably or definitely would not get a COVID-19 vaccine even if it were available for free and deemed safe by scientists. Vaccine hesitancy is highest among Republicans (42%), those ages 30-49 (36%), and rural residents (35%). Importantly, 35% of Black adults…say they definitely or probably would not get vaccinated, as do one third of those who say they have been deemed essential workers (33%) and three in ten (29%) of those who work in a health care delivery setting.”

Dashboards | Covid-19 Diagnostics: The Rockefeller Foundation provides an interactive, online dashboard of COVID-19 diagnostics :
”This set of interactive dashboards provides users with a mechanism to sort and filter three separate databases using key product features (including diagnostic target, platform type, sensitivity, specificity, time to results, throughput, etc.). While they function in a similar manner, the selection and sort criteria vary depending upon which of the three databases is being viewed: tests, swabs, or equipment.”

Patient-Reported Experiences of Discrimination in the US Health Care System: “In this nationally representative cross-sectional survey study, 21% of 2137 US adult survey respondents indicated that they had experienced discrimination in the health care system, and 72% of those who had experienced discrimination reported experiencing it more than once. Racial/ethnic discrimination was the most frequently reported type of discrimination respondents experienced.” The rate of discrimination is higher than commonly believed. Clearly, enhanced training and awareness needs to be implemented.

Household Transmission of SARS-CoV-2: “In this meta-analysis of 54 studies with 77 758 participants, the estimated overall household secondary attack rate was 16.6%, higher than observed secondary attack rates for SARS-CoV and Middle East respiratory syndrome coronavirus. Controlling for differences across studies, secondary attack rates were higher in households from symptomatic index cases than asymptomatic index cases, to adult contacts than to child contacts, to spouses than to other family contacts, and in households with 1 contact than households with 3 or more contacts..
These findings suggest that households are and will continue to be important venues for transmission, even in areas where community transmission is reduced.”

About pharma

Feds rebuff Pfizer’s pleas to speed up supplies of COVID vaccine raw materials: reports: “Pfizer could provide more than the 100 million doses it promised in its original contract with the U.S. government in the first half of next year—but only if Trump administration officials demand that suppliers of raw materials quickly fulfill the company’s orders. And CEO Albert Bourla is calling on the government to use the Defense Production Act to do just that.
The Trump administration hasn't done so yet because they’ve focused on providing those materials to vaccine makers that did take federal R&D funding, like Moderna, according to unnamed sources who spoke to the New York Times.”

Trump's drug cards clear key hurdle following pressure from White House: “…the Special Interest Group for Inventory Information Approval System Standards, or SIGIS, helps govern electronic point-of-sale transactions, and its approval is essential for mass-producing millions of cards.
The panel had come under pressure from the White House and Treasury Department to support the plan. After weeks of appeals from the administration, it did so Monday — stunning even some officials who were involved with the plan and believed the panel wouldn't budge.”

Centene makes deal to acquire rare disease specialty pharmacy PANTHERx: “Centene announced a deal to acquire PANTHERx, the largest specialty pharmacy in the U.S. which specializes in dispensing orphan drugs that treat rare diseases.
The insurer did not disclose the financial terms of the deal that was announced Tuesday. It is the latest move by an insurer to acquire a specialty pharmacy that dispenses high-cost drugs.”

About healthcare IT

Cerner Announces Agreement to Acquire Health Division of Kantar: “Cerner Corporation… today announced an agreement to acquire Kantar Health, a division of Kantar Group, for $375 million in cash, subject to adjustment. Kantar Health is a leading data, analytics and real-world evidence and commercial research consultancy serving the life science industry. With this acquisition, Cerner plans to harness data to improve the safety, efficiency and efficacy of clinical research across life sciences, pharmaceuticals and health care at large. This acquisition is expected to allow Cerner’s Learning Health Network SM client consortium to more directly engage with life sciences for funded research studies.”

Amazon wants to offer primary care to other employers, report says: “The program offers employees telemedicine and in-person healthcare services. Virtual services include in-app visits with a physician, nurse practitioner or nurse for employees seeking medical advice, diagnosis, treatment or referrals. 
Now, Amazon plans to sell Amazon Care to other large companies in an effort to help them lower the cost of healthcare, according to the report. The company plans to save companies money by bypassing health plans and brokers.”

About hospitals and health systems

The potential for rapid consolidation of health systems: From a Deloitte report:
”The top 10 health systems now control 24% market share and their revenue grew at twice the rate of the rest of the market…
Compared to today, in 2030, we expect:

·       Inpatient hospital revenue will be 35% lower.

·       The demand for hospital beds will be 44% lower (our median estimate), meaning hospitals will be smaller and there will be fewer hospitals…

·       Of the 390 metropolitan statistical areas (MSAs) across the United States, 61 are most likely to see consolidation based on our forecasted 67% lower demand for hospitals beds in their MSA.

·       Hospitals in the other 329 MSAs are also likely to consolidate, though perhaps to a lesser degree; we predict demand for beds in these areas will decline between 21% and 56%.”

About health devices

Medical Device Tracking—How It Is and How It Should Be: “To our knowledge, in the US, there is no national, publicly accessible registry for tracking postmarket experiences with medical devices. As a rigorous testing process before FDA approval or clearance is lacking for most devices, postmarket tracking is essential. Numerous private device registries use the UDI [unique device identifier] to monitor long-term outcomes for breast implants, cardiac pacemakers, implantable defibrillators, and other devices. However, participating physicians may not be able to view each other’s submissions, and nonparticipating physicians cannot view submissions. The data are proprietary and not publicly available. Congress should authorize the infrastructure to create a national and publicly accessible registry that uses the UDI for tracking postmarket medical outcomes and safety.”

Today's News and Commentary

About the public’s health

FDA Analysis Of Moderna COVID-19 Vaccine Finds It Effective And Safe: “The Food and Drug Administration released a detailed analysis Tuesday morning of the COVID-19 vaccine from drugmaker Moderna that supports the authorization of the company's vaccine for emergency use. 
The FDA's briefing document along with one from Moderna were posted two days before a group of experts will convene to advise the agency on whether to grant the vaccine emergency authorization for use, or EUA, during the pandemic.”

What the Pandemic Christmas of 1918 Looked Like: “You will show your love for dad and mother, brother, sister and the rest of ‘em best this year by sticking to your own home instead of paying annual Christmas visits, holding family reunions, and parties generally.”— Acting Health Commissioner, State of Ohio. Dec 21, 1918
Lots of parallels in this article from the Smithsonian.

China plans set up of new disease control agency in COVID-19 aftermath -Caixin: “China is considering setting up a new disease control agency as part of its public health reforms following the deadly COVID-19 pandemic, Caixin reported on Monday…
The new disease control agency may combine the departments of the National Health Commission with the China Center for Disease Control and Prevention, Caixin reported.”
As the language indicates, it is not a surety the agency will be established. Also, the major issues in the past have been transparency and trust.

How influencers are being recruited to promote the Covid-19 vaccine: This in-depth article from Vox builds on yesterday’s post about media spending to promote acceptance of the SARS-CoV-2 vaccines. It emphasizes various approaches and recalls past social marketing campaigns. Here is a classic article about getting people to behave a certain way by citing normative behavior. And yet another from today’s NY Times that explains why paying people to get the vaccine is not a good idea. A motto to keep in mind: Pay enough or don’t pay.

Why many countries failed at COVID contact-tracing — but some got it right: “A handful of places stand out as exemplars of successful contact-tracing — including South Korea, Vietnam, Japan and Taiwan. Many of these have cracked down on COVID-19 early, isolated infected people and their contacts and used personal data such as mobile-phone signals to track obedience. Not all of those techniques are transferable to countries now struggling to contain massive outbreaks. But they still provide some lessons.”
The article discusses successes and failures of contact tracing.

New Online COVID-19 Mortality Risk Calculator Could Help Determine Who Should Get Vaccines First: This calculator will give you a personal risk score based on age, sex, race, height/weight, and underlying diseases. It takes into account the risk where you live.

America’s health rankings 2020: From the United Health Foundation. Too much here to summarize; some good (lowered food insecurity) and some bad (higher number of uninsured). And a related study from Peterson-KFF: State of the U.S. Health System: 2020 Update.

The silent epidemic that is three times as deadly as COVID: From the World Economic Forum:

  • “Diabetes is rising across the globe, killing 4.2 million people last year.

  • Middle- and low-income countries are seeing the biggest increases.

  • Over 460 million people already live with diabetes.

  • By 2045 over 700 million people will have the condition.”

About pharma

Lilly makes another gene therapy play with $1B deal to buy Prevail TX: “Eli Lilly has joined the ranks of big pharma companies building a position in gene therapy, paying $26.50 per share to take control of New York-based Prevail Therapeutics and its two clinical-stage development programs…
The startup’s lead therapy—PR001—has now advanced into phase 1/2 testing for GBA1-positive PD as well as neuronopathic Gaucher disease, along with a second candidate (PR006) for frontotemporal dementia with GRN mutations.”

AstraZeneca's shares fall as much as 9% on news of Alexion deal: ”While analysts were positive on the assets that AstraZeneca will gain through the purchase, such as the anti-complement C5 monoclonal antibodies Soliris (eculizumab) and Ultomiris (ravulizumab), those from Cowen and Liberum called the price ‘considerable’ and ‘hefty,’ respectively.”

Novartis Gains EU Approval for Leqvio: “The drug is a small interfering RNA treatment meant for patients with atherosclerotic cardiovascular disease who require LDL-C reduction. The Swiss drugmaker said the drug is meant to be given twice a year as a long-term treatment.
The FDA is currently reviewing an NDA for Leqvio for the treatment of adults with high levels of LDL-C and is expected to make a decision by year’s end.”

About health insurance

Faith-Based Groups Get Additional Protections Under Rule: “Faith-based organizations will be treated the same as secular organizations in federal programs, according to a rule finalized by nine federal agencies Monday.
The rule also clarifies that ‘faith-based organizations do not lose their legal protections and rights just because they participate in federal programs and activities,’ including their right to conscience protections, the Department of Health and Human Services said.
The rule was issued by the HHS with the Departments of Justice, Homeland Security, Labor, Education, Housing and Urban Development, Agriculture, Veteran’s Affairs, and the Agency for International Development.”

Medicare Part D Reforms: Who Wins and Who Loses: An in-depth analysis of this issue by the American Enterprise Institute. The bottom line is that the changes will not do much to lower costs for beneficiaries.

Harvard Pilgrim, Tufts Insurance Merger Faces Scrutiny; Regulators Want Divestiture: “Federal and state regulators are opposing a major health insurance merger between Harvard Pilgrim and Tufts Health Plan, now called Health Plan Holdings, but say the deal can still move forward if Tufts agrees to sell off its New Hampshire operations to a rival company.
Citing the risk of less competition and increased prices, the U.S. Attorney and the state Attorney General filed an antitrust lawsuit on Monday.” It is reported today that the planned sale will be to UnitedHealth Group.

About healthcare IT

Surescripts, Audacious Inquiry team up to improve data sharing during disasters: “Surescripts and health IT company Audacious Inquiry are teaming up to make patients' medication history data more easily accessible to providers during disasters like hurricanes and the COVID-19 pandemic.
As part of the collaboration, Surescripts, an electronic prescribing company, will integrate medication history data into Audacious Inquiry’s Patient Unified Lookup System for Emergencies (PULSE) tool…
Audacious Inquiry developed PULSE as a health IT tool to be used during emergencies such as hurricanes, pandemics, tornadoes or terrorist attacks where patients are displaced and clinicians or emergency response personnel are providing care in alternate care settings like field hospitals, medical shelters or quarantine sites.
PULSE Enterprise is a cloud-based software solution that allows electronic patient data to be viewed by providers in non-routine healthcare settings and to public health authorities performing clinical case augmentation and epidemiological assessments.”

Amazon Halo fitness tracker, which measures body fat and listens to you, launches for everyone: “Amazon’s Halo wearable is now available for anyone to purchase, the company announced Monday. The Halo is a health and fitness tracker that comes with a subscription service and smartphone app. Users can track their body fat percentages, activity levels and their emotional state, using a feature called ‘Tone.’”

Today's News and Commentary

About the public’s health

FDA clears nation's first COVID-19 vaccine: On Friday, this story was the most important one of the past week. And today: First vaccine administered in the United States: “Coronavirus vaccines were given to Americans for the first time on Monday, beginning with Sandra Lindsay, a critical care nurse at New York’s Long Island Jewish Medical Center.”

New coronavirus variant identified in England, health secretary says: “‘Britain has identified a new variant of the novel coronavirus, Health Secretary Matt Hancock said Monday, noting that it ‘may be associated with the faster spread in the south of England.’
Officials have linked more than 1,000 cases to the variant, according to an initial analysis, and ‘numbers are increasing rapidly,’ Hancock said.
’I must stress at this point that there is currently nothing to suggest that this variant is more likely to cause serious disease, and the latest clinical advice is that it’s highly unlikely that this mutation would fail to respond to a vaccine,’ he said.”

HHS rolls $250M ad campaign with Fauci, science focus front and center: “The ‘Tell Me More digital video campaign kicks off the delayed and then restarted Department of Health and Human Services (HHS) effort initially bid-out in September. In the opening video, Fauci reassures that with science and public health tools the pandemic will end, while additional videos dive into details of the science of the virus and vaccine development.”
This strategy may work in some population segments, but research has shown that no matter how well the science is explained, it will not convince some people of the vaccine’s necessity. Campaigns need to take into account the unique cultural experiences of certain groups when crafting the messages.

Getting Covid Vaccines to People Will Cost States Billions They Don’t Have: ”The federal government is providing the vaccine, along with syringes, needles, face masks and shields. But state leaders say they must hire medical workers, provide community outreach and education, set up vaccination clinics and ensure storage capacity for vaccines. Some states are also concerned about having enough supplies, such as gloves and gowns, to protect health-care workers as well as people getting vaccinated.”

New Zealand lifts all Covid restrictions, declaring the nation virus-free: The headline speaks for itself. Always good to be reminded about how success can be achieved.

Australia Scraps COVID-19 Vaccine Supply Deal With CSL: “The Australian government has scrapped a supply deal with CSL for 51 million doses of its COVID-19 vaccine co-developed with the University of Queensland, after trial participants falsely tested positive for HIV.”
A good example why vaccines need extensive testing. However, what if this vaccine were the only one that was proven to be effective?

About pharma

AstraZeneca to buy Alexion for $39 billion as part of immunology push: “AstraZeneca indicated that upon closing of the transaction, which is scheduled to complete in the third quarter of next year, it will form a dedicated rare disease unit to be headquartered in Boston, Massachusetts. The UK drugmaker noted that the unit will be led by members of Alexion's current senior management team.  
The price of the purchase represents a premium of around 45% to Alexion's closing share price on December 11.”

Hospitals and Pharmacists File Lawsuit Over Drug Companies’ Refusals of 340B Discounts: “Five national hospital organizations and an organization of hospital pharmacists representing participants in the 340B drug pricing program filed a federal lawsuit today against the U.S. Department of Health and Human Services (HHS) over the department’s failure to enforce program requirements and halt drug company actions that undermine the program. The groups are joined in the lawsuit by three 340B hospitals serving patient communities in need that have been harmed by the companies’ refusals to provide discounts on prescription drugs dispensed at community-based pharmacies, as required by the 340B program.”

The top 10 R&D programs laid to rest in 2020: Throughout the year many articles are written about promising new drug therapies. Here is a list of the top ten that did not make it. And at the successful end of the process: Recommendations for 15 new drugs lead decisions from CHMP's [European Medicines Agency's Committee for Medicinal Products for Human Use] meeting


About health insurance

Health insurers balk at last-minute deal in Congress on surprise medical bills: “The Democratic and Republican leaders of three House committees and one Senate committee said this weekend they agreed on an approach [this link has a chart with the important provisions of this proposal] to resolving surprise medical bills, opening the door to include it in the government funding package Congress is trying to finalize this week…
Under the measure, an independent arbiter would settle disagreements between providers and insurers over how much to pay for surprise medical bills. Insurers and patient groups, who argue this would favor doctors, had instead wanted payments tied to median in-network rates, in what’s known as a ‘benchmarking’ approach.”
If this legislation passes, it could be the first step to a de facto regionally based, uniform fee schedule.

About hospitals and health systems

Moody's - 2021 outlook for US not-for-profit and public healthcare sector remains negative on constrained revenue, rising costs: Among the report’s findings:

  • “Median operating cash flow will drop 10%-15% in 2021 from Moody's annualized third-quarter 2020 estimate

  • Softer demand for certain services due to coronavirus fears will continue until pandemic ends”

Fall 2020 Leapfrog Hospital Safety Grade: This link provides access to hospitals across the country and how they fared with respect to multiple quality criteria. For a “big picture,” see: Where are the 29 Leapfrog straight-'A' hospitals? and Where are the 16 Leapfrog 'F' hospitals?

About medical devices

TGA Releases New Regulations on Personalized Medical Devices: “Australia’s Therapeutic Goods Administration (TGA) has released new regulatory requirements for personalized medical devices that will become effective Feb. 25, 2021.
The TGA said that increasing use of 3D printing for medical applications is raising questions about the adequacy of the current medical device regulatory framework to mitigate the risks to patients.”
Here is the original proposal the TGA published last year. It could serve as a template for the way we handle this issue in the U.S.

About healthcare IT

Microsoft rolls out COVID-19 vaccine management platform as nationwide distribution gets: underway: “The tech giant is working with business partners including Accenture, Avanade, EY, and Mazik Global to deploy vaccine management solutions that enable registration capabilities for patients and providers, phased scheduling for vaccinations, streamlined reporting, and management dashboarding with analytics and forecasting…”

Assessment of Electronic Health Record Use Between US and Non-US Health Systems: “In this cross-sectional study of the EHR metadata of 371 health systems in the US and abroad, US clinicians vs non-US clinicians were found to spend more time per day actively using the EHR, receive more system-generated messages, write a higher proportion of automatically generated note text, and spend more time using the EHR after hours.
Findings from this study suggest that US clinicians compared with non-US clinicians had a higher EHR burden, which could be alleviated by minimizing EHR uncertainties and consolidating documentation requirements.”

Today's News and Commentary

About the public’s health

ICYMI: U.S. FDA advisers overwhelmingly back authorizing Pfizer COVID-19 vaccine

Here is a summary on how the distribution will work.

Military-grade camera shows risks of airborne coronavirus spread: Superb video and expert commentary of spread patterns of breathing.

Probe: CDC official says she was ordered to delete email: “A senior manager with the Centers for Disease Control and Prevention told congressional investigators she was ordered to delete an email suggesting attempted political interference by the Trump administration in coronavirus reports to the public, according to a transcript released Thursday.” The information that was supposed to be changed dealt with pediatric transmission of SARS Co-V 2.

Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine: “Sanofi and GlaxoSmithKline’s COVID-19 vaccine has failed to trigger the desired immune response in people aged 50 years and older, forcing the partners to rethink the antigen formulation. The setback is expected to delay the availability of the vaccine from mid-2021 to near the end of next year.”

Study Finds Young People Quit or Reduced Vaping Habits During the Pandemic: Some good news from the pandemic: “A combination of stay-at-home orders and vape and smoke shop closures contributed to why many young adults and people under 21 years old quit or reduced vaping.
A national study looking at the e-cigarette habits among young adults and underage youth during the coronavirus disease 2019 (COVID-19) pandemic has found that 67.7% of e-cigarette users who changed their vaping habits during the pandemic had reduced their use or quit entirely.”

Many Black Americans, Republicans AND Women Aren’t Sure About Taking A COVID-19 Vaccine: The article provides a breakdown on attitudes by age, race, gender and political affiliation.

Flu vaccine distribution hits all-time high in the United States, CDC report says: “More doses of the influenza vaccine have been distributed in the United States this season than ever before, according to a new report from the Centers for Disease Control and Prevention. 
Roughly 188 million doses had been distributed as of Nov. 27, the CDC said in a weekly vaccination report updated Wednesday. That’s the most doses distributed in the country during a single flu season. 
At this point in the flu season last year, about 169.1 million doses had been distributed, the CDC says.”

Rising inequality of infant health in the U.S.: “Our results reveal that infant health inequality increased since 2010 across a variety of health measures at birth.”

About health insurance

COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing: Here is an updated FAQ statement from CMS.

Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage: “The Patient Protection and Affordable Care Act (ACA) provides that certain grandfathered group health plans and health insurance coverage that existed as of the law’s enactment are subject to some of the ACA’s requirements, such as the prohibition on preexisting condition exclusions, but are exempt from certain other requirements.”
This link is to the final rule with will be published 12/15/20. In the meantime, you can go here for a summary. Briefly, the rule first “clarifies that grandfathered group health coverage that is a high deductible health plan (HDHP) may increase fixed-amount cost-sharing requirements, such as deductibles, to the extent necessary to maintain its status as an HDHP without losing grandfather status. This change ensures that participants and beneficiaries enrolled in that coverage remain eligible to contribute to a health savings account. Second, the final rule provides an alternative method of measuring permitted increases in fixed-amount cost sharing that allows plans and issuers to better account for changes in the costs of health coverage over time.”

Affordable Care Act Approval Tied for High: “Americans' support for the 2010 Affordable Care Act, also known as Obamacare, has increased to a record-tying high of 55% after averaging 51% from 2017 through 2019. The act was less popular when President Barack Obama was in office, averaging 44% and never reaching 50%.” The variance is huge: Democrats favor by 94% and Republicans favor by 13%.

Moody's: Outlook stable for health insurers in 2021 despite COVID-19, policy pressures: “Moody's analysts expect the macroeconomic trends to be manageable for health plans next year, according to the report, with moderate earnings growth and telehealth and value-based care models helping to drive down cost pressures.
However, three key factors could turn that outlook negative, Moody's said: the pandemic, health policy changes or a worsened economic downturn. For example, insurers are likely to continue waiving costs for treatment and testing associated with COVID-19 through the middle of next year, if not longer.”

About hospitals and health systems

A look at the most expensive hospital construction projects in 2020: Considering the hit hospitals have taken this year, it is amazing that we see such major projects.

Fitch Ratings 2021 Outlook: U.S. Not-For-Profit Hospitals and Health Systems:”Fitch Ratings has changed its sector outlook to stable from negative for 2021, reflecting our expectation that results in 2021 will be consistent with the overall weak margins in 2020. Fitch believes that the acute care sector will remain pressured by the challenging operating environment in 2021, but not to a greater extent than in 2020. Fitch views it as unlikely that the sector will see significant government-mandated ‘stay-at-home’ orders, which should enable providers to continue serving non-COVID-19 patients (both elective and emergent) alongside a steady volume of COVID-19 patients. Traditional surgical and specialty care volume has not fully returned to 2019 levels, but some of the volume gaps may be filled by COVID-19 cases.”

About pharma

Abortion medication restrictions remain blocked during pandemic, judge rules: “U.S. District Judge Theodore D. Chuang in Maryland said the health risks have ‘only gotten worse’ since he first blocked restrictions in the summer in response to concerns about exposure to the coronavirus.
Requiring an in-person visit to a medical facility to obtain the drugs needed to induce abortion, Chuang said, is unduly burdensome.”

STATEMENT ON HRSA’S FINAL 340B ADMINISTRATIVE DISPUTE RESOLUTION RULE: “The Health Resources & Services Administration today released a final rule to implement an administrative dispute resolution process for the 340B drug pricing program. As Congress mandated in 2010, the process would establish a government panel to settle disagreements between covered entities and pharmaceutical manufacturers, such as a hospital’s claim that a drug company overcharged for 340B drugs.”

Rani Therapeutics nets $69M to transform injections into its easy-to-swallow 'robotic pill': “Rani Therapeutics has secured $69 million in new funding to move forward with the manufacturing and clinical testing of its “robotic pill”—a small, swallowable capsule that promises to shepherd more delicate drugs past the stomach before releasing them into the bloodstream.
The pill aims to make it easier for a patient to take therapies that typically require an injection or infusion, including treatments for diabetes, arthritis and other diseases.”

About healthcare IT

HHS proposes HIPAA changes: 7 things to know: “HHS' Office for Civil Rights released proposed modifications to the HIPAA Privacy Rule Dec. 10.
The Notice of Proposed Rulemaking is part of HHS' Regulatory Sprint to Coordinated Care initiative, which analyzes federal regulations that interfere with healthcare providers and health plans' efforts to better coordinate care for patients.
The proposed changes to the HIPAA Privacy Rule include strengthening individuals' access to their own health information, facilitating greater family and caregiver involvement in the care for individuals and access to their PHI during emergencies or health crises and reducing administrative burdens on HIPAA-covered providers and health plans.”

Today's News and Commentary

Breaking News: FDA advisers recommend Pfizer-BioNTech coronavirus vaccine, with agency action expected soon

About pharma

BREAKING: High Court Says Ark. Law Regulating PBMs Not Preempted: “The U.S. Supreme Court handed a win to Arkansas Thursday in its fight to regulate the industry that controls health plans' prescriptions, overturning the Eighth Circuit's decision that a 2015 law banning pharmacy benefit managers from shortchanging local pharmacies flouted the Employee Retirement Income Security Act.”
This decision will have a major impact on how states can regulate PBMs.

About the public’s health

Yes, your boss can fire you if you refuse to get a Covid vaccine: The headline speaks for itself. Read the article for more details.

Willingness to Get COVID-19 Vaccine Ticks Up to 63% in U.S.:

  • “63% in U.S. would be willing to receive FDA-approved COVID-19 vaccine

  • Current figure is an increase from 50% in September and 58% in October

  • Republicans, non-White adults, 45- to 64-year-olds least willing”

WHO: People Living Longer, but With More Disabilities: “New global health estimates find people are living six years longer now than 20 years ago, but many more people are living with disabilities that affect their quality of life. 
The World Health Organization reports life expectancy has gone up from 67 years to 73 years since 2000. Over this period, it notes progress has been made in reducing deaths from a number of communicable diseases.” And in a related story: WHO reveals leading causes of death and disability worldwide: 2000-2019: “Noncommunicable diseases now make up 7 of the world’s top 10 causes of death, according to WHO’s 2019 Global Health Estimates…. This is an increase from 4 of the 10 leading causes in 2000. The new data cover the period from 2000 to 2019 inclusive…Heart disease has remained the leading cause of death at the global level for the last 20 years. However, it is now killing more people than ever before. The number of deaths from heart disease increased by more than 2 million since 2000, to nearly 9 million in 2019. Heart disease now represents 16% of total deaths from all causes.” On the latter point, here is a more detailed article: Global Burden of Cardiovascular Diseases and Risk Factors, 1990–2019: Update From the GBD 2019 Study.

Crimped U.S. dry ice supply complicates rural U.S. vaccine release: “More than a dozen U.S. states, including Washington, New Mexico, Mississippi, Louisiana and Indiana, told Reuters they are rushing to secure dry ice to replenish suitcase-sized shipping containers from Pfizer. Once opened, if being used as temporary storage by a vaccination center, the vaccines can last a total of 30 days with re-icing every five days, Pfizer said.
The company said it believes there is sufficient dry ice supplies to serve the needs of all 50 states without serious constraints.”

Male sex identified by global COVID-19 meta-analysis as a risk factor for death and ITU admission: “…whilst there is no difference in the proportion of males and females with confirmed COVID-19, male patients have almost three times the odds of requiring intensive treatment unit (ITU) admission… and higher odds of death… compared to females. With few exceptions, the sex bias observed in COVID-19 is a worldwide phenomenon.” The article also explains sex differences in immune system responses for this disparity (see the Discussion section).

‘There’s No Place for Them to Go’: I.C.U. Beds Near Capacity Across U.S.: The headline speaks for itself; the article provides more details.

For the first time, the U.S. will reward nursing homes for controlling the spread of infectious disease: “More than 9,000 nursing homes have been able to show progress in controlling the novel coronavirus infection, according to the Department of Health and Human Services, and will share $523 million in incentive payments as a reward, starting Wednesday.”

First U.S. Shipments of Pfizer Vaccine Will Be 2.9 Million Doses: “Gustave Perna, the army general who serves as Warp Speed’s chief operating officer, said on a call with reporters Wednesday that the U.S. plans to distribute 2.9 million doses in the first round of shipments following authorization of Pfizer’s still-experimental vaccine. The rest will be held back to be distributed to states and other jurisdictions when the first people vaccinated are due for their second dose 21 days later.”

Johnson & Johnson cuts size of Covid-19 vaccine study due to prevalence of disease in U.S.: ”Johnson & Johnson is cutting the size of its pivotal U.S. Covid-19 vaccine trial — the only major study testing a single dose of a Covid vaccine — from 60,000 volunteers to 40,000 volunteers.
The change is being made possible by the fact that Covid-19 is so pervasive across the country, according to a person familiar with the matter. The more virus there is in the U.S., the more likely it is that participants will be exposed to it, meaning researchers will be able to reach conclusions based on a smaller trial.”

About healthcare personnel

Judge voids rule pricing H-1B doctors out of areas that need them: “The administration argued by that the changes were ‘urgently necessary’ to ensure that the employment of H-1B visa holders ‘did not have an adverse impact on the wages and working conditions of similarly employed U.S. workers’ during the COVID-19 public health emergency.” If this rule went into effect, rural and other high-need areas would not be able to afford hiring these international medical graduates.”

Hospitals and health systems

Tenet to Acquire Portfolio of Surgery Centers from SurgCenter Development: “Tenet Healthcare Corporation today announced that it will acquire a portfolio of up to 45 ambulatory surgery centers (ASCs) (the “Portfolio”) from SurgCenter Development (SCD). The Portfolio will be operated by Tenet’s United Surgical Partners International (USPI) subsidiary as part of its industry-leading ambulatory surgery platform.
SCD, founded in 1993, is a leading developer of physician-owned ASCs with a history of establishing high-quality centers in partnership with physicians with demonstrated leadership in musculoskeletal surgeries. The 45 centers are located in Arizona, Florida, Indiana, Louisiana, Maryland, Ohio, New Hampshire, Texas and Wisconsin.
Under the terms of the transaction, the Company will purchase majority interests in up to 45 centers by fully acquiring SCD’s interests, and partially acquiring interests from physician partners, for approximately $1.1 billion in cash and the assumption of approximately $18 million of center-level debt.”

About diagnostics

C2N Earns CE Mark for Alzheimer’s Blood Test:”C2N Diagnostics has been granted CE mark certification for PrecivityAD, a mass spectrometry-based blood test for Alzheimer’s disease.
The diagnostic is now cleared in Europe for evaluating patients being assessed for Alzheimer’s disease who show mild cognitive impairment or very mild dementia.”

SOLVD Health Receives CE Mark for Genetic Risk Assessment for Opioid Use Disorder: “Using a simple cheek swab sample, the risk assessment is designed to analyze 15 genetic variants involved in the brain reward pathway to identify patients who may be at increased risk for OUD. Healthcare providers can use this personalized risk information to make more informed decisions about the use of oral opioids for acute pain when developing pain management plans for their patients. This technology received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) in February 2018.”

About health insurance

Positive Outcomes for High- Need, High-Cost Beneficiaries in Medicare Advantage [MA] Compared to Traditional Fee-For-Service Medicare: MA plans beat traditional Medicare on a number of metrics, including 57% lower rates of avoidable hospitalizations and 41% lower prescription drug costs. The results were possibly achieved by more primary care visits: their costs were 41% higher.

Humana to offer Primary Care First model across 48 states:”Humana will offer the model to qualified primary care providers across the 48 contiguous states and the District of Columbia who are in-network for Medicare Advantage PPO and HMO plans, the insurer announced…
Under the model, Humana will offer participating providers a monthly prospective capitated payment, which will account for performance on achievement in quality and outcomes metrics. Humana said the model will also offer an opportunity for income stabilization for primary care practices hit hard financially by the pandemic.
Eligible providers must focus chiefly on primary care services and have more than 125 Humana Medicare Advantage PPO and/or HMO members aligned with them, the insurer said.”

About healthcare IT

Amazon launches new tool to help healthcare organizations standardize data:”Amazon's cloud division rolled out a new tool to make it easier for healthcare organizations to search and analyze data.
Amazon HealthLake is a HIPAA-eligible service for healthcare and life sciences organizations that aggregates an organization’s complete data across various silos and disparate formats into a centralized Amazon Web Services (AWS) data lake and automatically normalizes this information using machine learning…”

Today's News and Commentary

About health insurance

New Study Shows Why the Coronavirus Pandemic is Leading Many Americans to Enroll in a Medicare Advantage Plan For 2021: “Key Findings

  • 35% are enrolled in a MA plan for 2021 because they’ve had it before and prefer it, 29% like the prescription drug coverage, 16% like the affordability, and 9% like the supplemental benefits.

  • Of those who decided on a MA plan because of supplemental benefits, 35% cited COVID-19 supplemental benefits specifically, while 27% cited telehealth benefits.

    45% are switching from an original Medicare plan in 2020 to a Medicare Advantage plan in 2021.

  • Of those enrolled in a MA plan for 2021, 65% compared all of their Medicare options before enrolling, while 26% did a ‘brief amount of research.’”

Trends in Diagnosis Related Groups for Inpatient Admissions and Associated Changes in Payment From 2012 to 2016: Revisions in DRG payments are supposed to reflect more accurate severity of illness and resultant resource use. But according to this study. “between 2012 and 2016, the proportion of admissions assigned to a DRG with major complication or comorbidity increased for 15 of the top 20 reimbursed DRG families. This change was not accompanied by commensurate increases in disease severity but was associated with increased payment.”

Addressing Commercial Health Plan Abuses to Ensure Fair Coverage for Patients and Providers: This AHA paper details the problems hospitals face due to prior authorization and medical necessity denials.
But the fundamental problems are the fragmented healthcare system with selective institutional contracting and the perverse incentives of the fee-for-service system.

About healthcare quality

The Leapfrog Group Announces 2020 Top Hospitals and Pandemic Heroes of the Year Awards: The headline speaks for itself. Check the website for details.

About the public’s health

States are receiving vaccines based on the size -- not the risk -- of their populations: ”The overarching goal is to get the vaccine out the door as quickly and efficiently as possible — not to spend time quibbling over how to precisely allocate it based on the exact needs of each state.”

The threat of antibiotic resistance — in charts: This Financial Times review is an excellent global summary of the problem. The US has the lowest rate of antibiotic resistance, with Canada as a close second. The highest rates, by far are in Russia and Pakistan. Per capita antibiotic use are highest in Vietnam and Serbia.

UK preparing to study 'mix-and-match' approach to COVID-19 vaccination:”Rather than receiving two doses of the same vaccine, participants in the study will receive one dose of either BNT162b2, an mRNA-based candidate, or AZD1222, which uses a replication-deficient chimpanzee viral vector, followed a few weeks later by a single dose of the vaccine they did not receive initially.
Although late-stage studies have shown that two doses of BNT162b2 given 21 days apart have an efficacy rate of 95%, researchers want to explore whether the immune response can be increased by using this ‘heterologous boost’ approach.”

Genetic screens identify host factors for SARS-CoV-2 and common cold coronaviruses: “…we identified phosphatidylinositol phosphate biosynthesis and cholesterol homeostasis as critical host pathways supporting infection by all three coronaviruses. By contrast, the lysosomal protein TMEM106B appeared unique to SARS-CoV-2 infection. Pharmacological inhibition of phosphatidylinositol kinases and cholesterol homeostasis reduced replication of all three coronaviruses. These findings offer important insights for the understanding of the coronavirus life cycle and the development of host-directed therapies.”

 UK probing if allergic reactions linked to Pfizer vaccine: “British regulators warned Wednesday that people who have a history of serious allergic reactions shouldn’t receive the new Pfizer-BioNTech vaccine as they investigate two adverse reactions that occurred on the first day of the country’s mass vaccination program.
The U.K.’s Medical and Healthcare Products Regulatory Agency is looking into whether the reactions were linked to the vaccine. The two people affected were staff members with the National Health Service who had a history of allergies, and both are recovering. Authorities have not specified what their reactions were.
In the meantime, the regulator has issued the warning for anyone who has had a significant allergic reaction to a vaccine, medicine or food. That includes anyone who has been told to carry an adrenaline shot or others who have had potentially fatal allergic reactions.”

New WHO campaign to help COVID-era quitters kick the habit: “‘Commit to Quit’ campaign will advocate for stronger national policies, increasing access to cessation services, raising awareness of tobacco industry tactics, and empowering tobacco users to make successful attempts through ‘quit and win’ initiatives, WHO said. 
For instance, Florence, an artificial intelligence (AI)-driven 24/7 digital health worker, will tirelessly provide accurate information, help people make a quitting plan, and recommending help-lines and support apps. 
The campaign will focus on twenty-two high-burden countries, where the majority of the world’s tobacco users live.”

Some States Balk After C.D.C. Asks for Personal Data of Those Vaccinated: “The Trump administration is requiring states to submit personal information of people vaccinated against Covid-19 — including names, birth dates, ethnicities and addresses, raising alarms among state officials who fear that a federal vaccine registry could be misused.” Compared to many other countries, including Canada, our country has a great distrust of government; these days, it seriously hampers public health programs.

CorVent Earns FDA Emergency Clearance for Multi-Patient Ventilator System: “The system provides primary critical care support and is designed to rapidly expand ventilation capacity in hospitals for patients with acute respiratory distress syndrome.”

Income-Related Inequalities in Affordability and Access to Primary Care in Eleven High-Income Countries: This Commonwealth Fund study is worth reading. Among the findings:
”More than one-third (36%) of U.S. adults with lower income have two or more chronic conditions — significantly more than in other countries…
More than one-quarter (28%) of U.S. adults with lower income said that, in the past year, they worried about being able to afford basic necessities such as food or housing, a significantly greater proportion than seen in other countries, where 6 percent to 22 percent reported this.
Half of U.S. adults with lower income don’t get needed care because it’s too costly. In the survey, 50 percent reported skipping doctor visits, recommended tests, treatments or follow-up care, or prescription medications in the past year because of the cost.”

About healthcare IT

Critical vulnerability makes GE radiological devices vulnerable to hacking: “A critical vulnerability puts more than 100 of GE Healthcare's radiological devices at risk of being hacked, with attackers able to access and alter sensitive personal health information.
Uncovered by cybersecurity researcher CyberMDX, the flaw involves default passwords found on GE's product management software and affects CTs, PET scanners, molecular imaging devices, MR systems, mammography solutions, X-ray machines, and ultrasound systems.”

About pharma

Changes in Drug List Prices and Amounts Paid by Patients and Insurers: “This study’s findings suggest that drug list prices more than doubled over a 7-year study period. Despite rising manufacturer discounts and rebates, these price increases were associated with large increases in patient out-of-pocket costs and insurer payments.”

An Aldehyde Responsive, Cleavable Linker for Glucose Responsive Insulins: “A glucose responsive insulin (GRI) that responds to changes in blood glucose concentrations has remained an elusive goal. Here we describe the development of glucose cleavable linkers based on hydrazone and thiazolidine structures.” Imagine a Type 1 diabetic patient who can take insulin that is bound to another compound. When glucose rises, the “free” insulin is released as needed to lower blood sugar.
This science could be a real breakthrough in diabetic treatment.

About healthcare IT

Android's version of the Apple health records app rolls out to 230 health systems: “The Android app CommonHealth—which enables users to access and share their health records, such as COVID-19 and lab tests—is now connected to 230 U.S. health systems.
By the end of this month, CommonHealth will connect to more than 340 health systems, according to a group of healthcare researchers and software developers that worked on the app. 
The platform allows users of the Android operating system to collect and manage their health data on their mobile devices in a similar way that Apple Health Record operates on iOS. The CommonHealth project extends the health data portability and interoperability model pioneered by Apple Health to the 55% of Americans with Android devices, or 85% globally.”

Today's News and Commentary

About hospitals and health systems

Court Rejects FTC Challenge To Philly Hospital Merger: “A Pennsylvania federal court on Tuesday rejected a bid from the Federal Trade Commission and the state to block a $599 million merger between Philadelphia-area health care systems Jefferson Health and Albert Einstein Healthcare Network. U. S. District Judge Gerald J. Pappert issued an order and opinion that denied a request for a preliminary injunction, saying that enforcers failed to properly view the health care market in southeastern Pennsylvania.” In another story about FTC actions: 5 hospital deals challenged by the federal government in 2020.

About the public’s health

‘Natural Immunity’ From Covid Is Not Safer Than a Vaccine: Excellent article explains the headline.

Trump to order government to vaccinate Americans first: “President Trump will sign an executive order on Tuesday affirming that Americans should receive coronavirus vaccines before any are distributed to other nations.”

WHO trial finds no benefit of 4 drugs for hospital COVID patients: “None of the four once-promising drugs evaluated for the treatment of COVID-19 in the ongoing World Health Organization (WHO) Solidarity Trial—remdesivir, hydroxychloroquine, lopinavir, or interferon-beta-1a—prevented in-hospital death, reduced the need for ventilation, or shortened the duration of hospitalization.”

FDA Analysis Of Pfizer COVID-19 Vaccine Finds It Effective And Safe: “The Food and Drug Administration released a detailed analysis Tuesday morning of the COVID-19 vaccine from Pfizer and its partner BioNTech ahead of a Thursday meeting of a group of independent experts that will advise the agency on whether to grant the vaccine an emergency use authorization.
The agency's analysis finds "no specific safety concerns identified that would preclude issuance of an EUA." Serious reactions were rare. Side effects are common, however, with a majority of study volunteers experiencing reactions at the site of injection, headaches and fatigue. 
The analysis also affirms the previously stated vaccine effectiveness of 95%, assessed a week after two doses of vaccine. The vaccine doses are given 21 days apart.”

‘Route out’ of pandemic: UK gives 1st COVID-19 vaccine doses: “ A retired British shop clerk received the first shot in the country’s COVID-19 vaccination program Tuesday, the start of an unprecedented global immunization effort intended to offer a route out of a pandemic that has killed 1.5 million.
Margaret Keenan, who turns 91 next week, got the shot at 6:31 a.m. on what public health officials have dubbed “V-Day.” She was first in line at University Hospital Coventry, one of several hospitals around the country that are handling the initial phase of the United Kingdom’s program. As luck would have it, the second injection went to a man named William Shakespeare, an 81-year-old who hails from Warwickshire, the county where the bard was born.” The latter patient prompted the media to dub the event “The Taming of the Flu.”

WHO against mandatory COVID-19 vaccines:”The World Health Organization said on Monday (Dec 7) that persuading people on the merits of a COVID-19 vaccine would be far more effective than trying to make the jabs mandatory.
The WHO said it would be down to individual countries as to how they want to conduct their vaccination campaigns against the coronavirus pandemic.”

Here’s Why Vaccinated People Still Need to Wear a Mask: “…some vaccinated people get infected without developing symptoms, and could then silently transmit the virus — especially if they come in close contact with others or stop wearing masks.
If vaccinated people are silent spreaders of the virus, they may keep it circulating in their communities, putting unvaccinated people at risk.”
Recall the vaccine has a failure rate of 5%. It means that even if we vaccinate everyone in the country (VERY unlikely) there could be 1.75 million people infected.

A chimeric hemagglutinin-based universal influenza virus vaccine approach induces broad and long-lasting immunity in a randomized, placebo-controlled phase I trial: This trial addresses the problem of needing annual, targeted flu vaccine because of different antigens.
“Vaccination was found to be safe and induced a broad, strong, durable and functional immune response targeting the conserved, immunosubdominant stalk of the hemagglutinin. The results suggest that chimeric hemagglutinins have the potential to be developed as universal vaccines that protect broadly against influenza viruses.”

Not enough Pfizer vaccine doses? Blame the feds, not the company: reports: “Pfizer struck a deal with the U.S. government for 100 million doses of its COVID vaccine over the summer, but when the company offered more, President Donald Trump’s administration declined, according to anonymous sources who spoke to the New York Times.
Pfizer had offered 200 million doses in its first contract with the U.S.—enough to vaccinate 100 million people—but Operation Warp Speed opted for half that amount, added the Washington Post, which also cited anonymous sources. The company would not be able to supply additional doses until the summer, the sources said.”

Pfizer’s Vaccine Offers Strong Protection After First Dose: “The efficacy of the vaccine after the first dose is about 52 percent, according to Dr. William C. Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development. After the second dose, that rises to about 95 percent.”

Output of Oxford-AstraZeneca doses held up: “The UK government’s vaccines task force acknowledged on Monday that just 4m doses of the vaccine developed by Oxford university and AstraZeneca would be delivered this year, imported from the Netherlands and Germany. Earlier in the year, the task force had said it envisaged production of 30m doses in the UK by year-end…
The original plan was for all British doses to be produced through a supply chain set up by Oxford university and AstraZeneca in the UK.”

COVID-19 Reported Patient Impact and Hospital Capacity by Facility: This healthdat.gov link is the first publication of individual facility capacity.

Senate stimulus negotiators try to reach deal on whether companies can be sued over virus outbreaks: “One of the thorniest issues facing the bipartisan stimulus negotiations is the insistence by Senate Republicans that businesses and other entities have sweeping immunity from coronavirus-related lawsuits.
Many Democrats have refused to agree to such language, saying it could imperil workers.
But now both sides are attempting to craft a compromise on the “liability shield,” worried that the prolonged impasse could derail the broader spending bill at a time when the economy appears to be softening.”

About health insurance

CMS delays radiation oncology payment model till July:”CMS confirmed its radiation oncology payment model will not start until July in the 2021 Hospital Outpatient Prospective Payment Final Rule…
The payment model will test prospective, bundled payments to providers for 16 cancer types, aiming to improve care outcomes for radiotherapy patients while lowering Medicare costs. Under the model, payments would cover 90-day episodes of care.”

About healthcare IT
New smartphone tool to track side effects of the coronavirus vaccine may be vulnerable to manipulation: “The text-messaging system, called v-safe, is intended to provide early indications about possible adverse reactions from the vaccines. Using the messaging program, people who have received the shots can report symptoms and other health effects, such as missed work. Their responses could prompt phone calls from a team of safety professionals.
But the technology is raising red flags for some health and technology experts, who say hackers or anti-vaccine activists may be able to access the software to create false or misleading reports.”

Today's News and Commentary

About healthcare financing

Most interesting health tech M&A deals in 2020: As December winds down, news media are starting to report lists of the year’s superlatives. Here is one of them.

About the public’s health

Xavier Becerra has been defending the ACA in court. Now he could manage it: “President-elect Joe Biden announced this morning he is nominating [California Attorney General Xavier] Becerra (D) — who has little health policy experience but has emerged as the nation’s defender of the Affordable Care Act — to helm the 80,000-employee agency that manages Healthcare.gov, regulates prescription drugs and oversees the government’s sweeping Medicare and Medicaid insurance programs.
Biden has also picked Rochelle Walensky, an infectious-disease specialist at Massachusetts General Hospital, to direct the Centers for Disease Control and Prevention within HHS.”
Becerra also has a history of blocking system mergers.

US Covid-19 hospitalizations hit another record high: “It took almost 100 days for the US to reach 1 million coronavirus infections after the first cases were confirmed on January 20. But in the first five days of the month, from Tuesday to Saturday, 1,000,882 cases were reported in the US, according to data from Johns Hopkins University.
More than 14.7 million confirmed cases had been reported in the US as of Sunday night, and more than 282,200 people have died.
As of Saturday, the US averaged 190,948 new cases over the last week, another record high, according to a CNN analysis of Johns Hopkins data.”

Trump’s Operation Warp Speed promised a flood of covid vaccines. Instead, states are expecting a trickle: “Instead of the delivery of 300 million or so doses of vaccine immediately after emergency-use approval and before the end of 2020 as the Trump administration had originally promised, current plans call for availability of around a tenth of that, or 35 to 40 million doses.”

How Covid test supply shortages could cause a 'public health crisis' of undiagnosed STIs: “Labs across the country have been facing dire shortages of supplies as the number of Covid-19 tests being processed has skyrocketed. But with so many supplies directed toward Covid-19 testing, it's increasingly becoming more difficult for patients to get an accurate diagnosis for sexually transmitted infections, common but serious illnesses like pneumonia and other potentially life-threatening infections.”

Joint associations of accelero-meter measured physical activity and sedentary time with all-cause mortality: a harmonised meta-analysis in more than 44 000 middle-aged and older individuals: 11 minutes per day of moderate to vigorous activity is all it took to reduce mortality.

New Mexico shut down nearly everything to keep hospitals from being overwhelmed by covid. It wasn’t enough: Governor Lujan Grisham (D) ” is on the verge of acknowledging just how grim conditions have become: She will, she said in an interview, soon allow hospitals to move to ‘crisis standards,’ a move that frees them to ration care depending on a patient’s likelihood of surviving.” This move is unprecedented.

FDA Authorizes Covid-Flu Combo Test for Home-Collected Samples: “The FDA authorized Quest Diagnostics RC Covid-19 + Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for Covid-19 + Flu by individuals who are suspected of respiratory viral infection consistent with Covid-19 when home collection is determined to be appropriate by an individual’s healthcare provider.”

Covid vaccines will be available for private purchase in India: “Serum Institute of India, the world’s largest vaccine manufacturer, has a licence to produce the shot and has already manufactured 40m doses. Once the jab is approved for use, Serum will initially supply the Indian government but then expects to sell 20m-30m doses to private facilities, according to Adar Poonawalla, chief executive.”
Consider how a secondary private market for these vaccines will affect price, availability and equity.

About health insurance

About 523,000 people select healthcare plans in the fourth week of open enrollment: “That brings the total number of enrollees to 2.9 million, a slight jump over last year but with more days to sign up over 2019.”

Supreme Court to hear appeal to reinstall New Hampshire, Arkansas work requirement program: “The Supreme Court agreed Friday to take up an appeal from Arkansas, New Hampshire and the Trump administration to reverse a lower court’s ruling to strike down both states' Medicaid work requirements program.
A decision, expected next June, could have major ramifications for other work requirement programs that have been tied up in court.
Arkansas and New Hampshire are two of four states whose work requirement program was set aside by a court ruling. The other states are Kentucky and Michigan. Kentucky later pulled the program in 2019 after a Democrat became governor.”

About hospitals and health systems

Financial updates from 9 health systems: A short financial performance summary of 9 large systems. Recall that many statements look good because of federal aid.

About pharma

FTC Staff Issues FY 2017 Report on Branded Drug Firms' Patent Settlements with Generic Competitors: “According to a new FTC staff report, the total number of final Hatch-Waxman patent settlements entered by pharmaceutical companies in FY 2017 was close to the record high in FY 2016. Despite the high number of settlements, those that include the types of reverse payments that are likely to be anticompetitive remain very low.” In other words, pay-for-delay actions to generic companies are very low. [Despite the FY 2017 timeframe, this report was issued a few days ago.]

Novo Nordisk to Stop Shipping 340B Discounted Medications to Contract Pharmacies: “Novo Nordisk has announced that effective Jan. 1, it will stop distributing discounted medications to community-based pharmacies of covered entity hospitals under the 340B Drug Pricing Program, joining other drugmakers who have taken similar steps to combat what they claim are duplicate discounts created under the program’s expansion to include contract pharmacies.”

Sanofi Plans to Unveil Price of COVID-19 Vaccine Following Phase 1/2 Trial Results: “Sanofi is aiming to price its messenger RNA-based COVID-19 vaccine, NVX-CoV2373, at less than $12.20 (10 euros) per dose and said it will finalize the price after it releases the results of its phase 1/2 trial.”

Drug industry trade groups sue Trump admin over drug pricing rule: “Drug industry trade groups filed two lawsuits against the Trump administration on Friday challenging new U.S. rules to lower drug prices, potentially undermining one of President Donald Trump’s flagship efforts to take on high drug costs.
The suits were filed by PhRMA, the pharmaceutical industry trade group, and a group of biotechnology industry trade organizations, including Biotechnology Innovation Organization (BIO), in federal courts in Maryland and California, respectively.” And in a related story: Most Favored Nation [MFN] Rule’s Impact on Medicare Beneficiaries OOP Costs: “Avalere’s analysis finds that the vast majority of beneficiaries in Medicare FFS would not see a reduction in their OOP costs from the MFN model because more than 94% of FFS Part B beneficiaries using MFN drugs have supplemental coverage (e.g., Medigap, employer sponsored insurance, Medicaid) that covers some or all of their cost-sharing for Part B drugs. Avalere estimates that less than 1% of beneficiaries in Medicare would see reduced OOP costs (in a given year) if the demo were to include the 50 drugs listed in the IFC [Interim Final Rule with Comment Period].”

CRISPR, Vertex's gene-editing therapy shows promise in beta thalassaemia, sickle-cell disease: This story was published in many media outlets today.
”CRISPR Therapeutics and Vertex Pharmaceuticals announced new data showing that 10 patients given the investigational CRISPR/Cas9-based gene-editing therapy CTX001 had a "consistent and sustained response" to treatment. The findings come from two Phase I/II trials and build on results disclosed last month from seven patients with transfusion-dependent beta thalassaemia (TDT) or severe sickle-cell disease (SCD).”

About healthcare IT

Future of AI and Digital Healthcare: “For the first time, a joint The Lancet & Financial Times Commission entitled Growing up in a digital world: Governing health futures 2030 is exploring the convergence of digital health, artificial intelligence (AI) and other frontier technologies with universal health coverage (UHC) to support attainment of the third Sustainable Development Goal (SDG).”
If you can access the Financial Times site, it is a really interesting dive into this topic.

Today's News and Commentary

About the public’s health

Pfizer Slashed Its Original Covid-19 Vaccine Rollout Target After Supply-Chain Obstacles: “Pfizer and Germany-based partner BioNTech SE had hoped to roll out 100 million vaccines world-wide by the end of this year, a plan that has now been reduced to 50 million.” The proof of efficacy came a bit later than anticipated, but most of the problem is sourcing adequate supplies for manufacturing the vaccine.

Moderna's 3-month data raise hopes for COVID-19 vaccine durability: ” Antibody levels stayed elevated in the 90 days after people received the second dose of Moderna’s COVID-19 vaccine, raising hopes that the prophylactic can provide protection for one year.”

Moderna Plans to Begin Testing Its Coronavirus Vaccine in Children: “The drugmaker Moderna said on Wednesday that it would soon begin testing its coronavirus vaccine in children ages 12 through 17. The study, listed Wednesday on the website clinicaltrials.gov, is to include 3,000 children, with half receiving two shots of vaccine four weeks apart, and half getting placebo shots of salt water.” In a related article: US Passes 1.3 Million COVID-19 Cases in Children.

Biden taps Murthy as nation’s top doctor, offers Fauci key role as covid team takes shape: “Vivek H. Murthy, a former U.S. surgeon general, has been asked to reprise the role in an expanded version in the new administration, according to an individual familiar with the decision.”

Coronavirus live updates: CDC advises people to wear masks indoors at all times, except at home: “The Centers for Disease Control is recommending “universal mask use” outside people’s homes as part of guidance published Friday aimed at slowing the spread of the coronavirus as the nation braces for what is expected to be the darkest period of the pandemic.
This is the first time the agency has advocated for universal mask use indoors.”

Facebook says it will remove coronavirus vaccine misinformation: “…Facebook said it planned to take down Covid-19 vaccine falsehoods entirely if the claims had been discredited or contradicted by health groups including the World Health Organization, the United States Food and Drug Administration and the Centers for Disease Control and Prevention.”

Obama, Bush, Clinton Say They're Willing To Get Coronavirus Vaccine On Camera: The headline speaks for itself. The question is: Does their endorsements resonate with enough population sectors to make a difference in immunization rates?

HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth: A significant provision of this amendment is:
”If a person is authorized under the Declaration to order or administer Covered Countermeasures by means of telehealth, any state law that prohibits or effectively prohibits such a person from doing so is preempted. Nothing in the amendment, however, preempts state laws that may allow for easier access to telehealth services.” While this provision will facilitate diagnosis and treatment across state lines, its constitutionality may be challenged on the basis of states’ rights.

About health insurance

13 insurers extending COVID-19 cost-sharing waivers into 2021: The headline speaks for itself.

Today's News and Commentary

About the public’s health

The US has reported its highest one-day Covid-19 death tally: Over 2,800:”More than 2,800 Covid-19 deaths were reported Wednesday in the United States -- the most the country has ever reported in a single day -- as health care officials say their staff and facilities are struggling to support burgeoning numbers of patients.
The number of Covid-19 patients in US hospitals Wednesday -- 100,226, according to the COVID Tracking Project -- also is the highest reported on a given day during the pandemic.”

Vaccination cards will be issued to everyone getting Covid-19 vaccine, health officials say: “The Department of Defense released the first images of a Covid-19 vaccination record card and vaccination kits Wednesday.” See the article for a picture of the card.

The U.S. has spent billions stockpiling ventilators, but many won’t save critically ill COVID-19 patients: “With the COVID-19 pandemic sweeping across its shores earlier this year, the U.S. government in April announced orders for almost $3 billion of ventilators for a national stockpile, meant to save Americans suffering from severe respiratory problems brought on by the disease.
But of the 140,000 machines added since then by the government to the U.S. Strategic National Stockpile, almost half were basic breathing devices that don’t meet what medical specialists say are the minimum requirements for ventilators needed to treat Acute Respiratory Distress Syndrome, the main cause of death among COVID-19 patients, according to a Reuters review of publicly-available device specifications and interviews with doctors and industry executives.”

How Risk of Exposure to the Coronavirus at Work Varies by Race and Ethnicity and How to Protect the Health and Well-Being of Workers and Their Families: This in-depth report from the Urban Institute is worth reading. Among the findings:
”We find that Black, Native American, and Hispanic/Latinx workers are more likely than white workers to have jobs that place them at greater risk of exposure to and transmission of the coronavirus. More than half of all Black, Native American, and Hispanic/Latinx workers have essential or nonessential jobs that must be done in person and close to others, compared with 41 percent of white workers. In addition, Black, Native American, and Hispanic/Latinx workers who must work in person and close to others have lower incomes than white workers in these jobs and are less likely to have health insurance. Finally, Black, Native American, and Hispanic/Latinx households face greater risks of transmission of the virus at home because they are more likely to have a worker who works in person and close to others and to live in households with multiple generations of adults.”

Anthony Fauci slams U.K.'s speedy review of Pfizer, BioNTech COVID shot: “‘If you go quickly and you do it superficially, people are not going to want to get vaccinated,”’NIAID director Anthony Fauci told Fox News. ‘We have the gold standard of a regulatory approach with the FDA.’
The U.K.'s Medicines and Healthcare Products Regulatory Authority (MHRA) did not do it as carefully,’ he added.”

UN commission reclassifies cannabis, no longer considered risky narcotic: “In reviewing a series of World Health Organization (WHO) recommendations on marijuana and its derivatives, the CND [Commission on Narcotic Drugs] zeroed-in on the decision to remove cannabis from Schedule IV of the 1961 Single Convention on Narcotic Drugs — where it was listed alongside deadly, addictive opioids, including heroin. 
The CND’s 53 Member States voted to removed cannabis – where it had been placed for 59 years – from the strictest control schedules, that even discouraged its use for medical purposes.  
With an historic vote of 27 in favour, 25 against, and one abstention, the CND has opened the door to recognizing the medicinal and therapeutic potential of the commonly-used but still largely illegal recreational drug.”

Food insecurity rates high among people with heart disease:”People with atherosclerosis, particularly those who earn a low income and have other socioeconomic disadvantages, are more likely to experience food insecurity than those without the condition, according to new research.
Researchers analyzed several socioeconomic factors from self-reported data for 190,113 U.S. adults. Among the 18,442 (8.2%) adults with atherosclerosis, about 1 in 7 – or 14.6% – reported being food insecure. That was compared with 9.1% among those without atherosclerosis.
The findings also showed food insecurity affects nearly 1 in 2 people with the condition who also are among the most disadvantaged socioeconomic groups.”

The 2020 report of The Lancet Countdown on health and climate change: responding to converging crises: An excellent report about climate change and health.
“The Lancet Countdown is an international collaboration established to provide an independent, global monitoring system dedicated to tracking the emerging health profile of the changing climate.
The 2020 report presents 43 indicators across five sections: climate change impacts, exposures, and vulnerabilities; adaptation, planning, and resilience for health; mitigation actions and health co-benefits; economics and finance; and public and political engagement. This report represents the findings and consensus of the 35 leading academic institutions and UN agencies that make up The Lancet Countdown, and draws on the expertise of climate scientists, geographers, engineers, experts in energy, food, and transport, economists, social, and political scientists, data scientists, public health professionals, and doctors.

About pharma

Regeneron and UPenn Forge Gene Therapy Pact for COVID-19 Antibody Cocktail:”Regeneron has partnered with the University of Pennsylvania (UPenn) to develop a gene therapy nasal delivery system for its COVID-19 antibody cocktail, casirivimab and imdevimab, which received an Emergency Use Authorization from the FDA last month for mild-to-moderately ill coronavirus patients at high risk.”

HHS enlists CVS to pilot administering Eli Lilly's antibody drug to high-risk patients: “The Trump administration has purchased an additional 650,000 doses of Eli Lilly's antibody treatment for COVID-19 and enlisted CVS Health to pilot administering the therapy to patients in long-term care facilities and at home.”

About health insurance

CMS' outpatient payment rule for 2021: 5 things to know: An excellent short summary of the 1312 page final rule.
Here is another short summary of the changes.

About healthcare IT

North Korean Hackers Are Said to Have Targeted Companies Working on Covid-19 Vaccines: ”North Korean hackers have targeted at least six pharmaceutical companies in the U.S., the U.K. and South Korea working on Covid-19 treatments, according to people familiar with the matter, as the regime seeks sensitive information it could sell or weaponize.”

Today's News and Commentary

About the public’s health

Covid-19: Pfizer/BioNTech vaccine judged safe for use in UK from next week: Today’s top story.
”The first doses are already on their way to the UK, with 800,000 due in the coming days, Pfizer said.
Health Secretary Matt Hancock said the NHS will contact people about jabs.
Elderly people in care homes and care home staff have been placed top of the priority list, followed by over-80s and health and care staff.
But because hospitals already have the facilities to store the vaccine at -70C, as required, the very first vaccinations are likely to take place there - for care home staff, NHS staff and patients - so none of the vaccine is wasted.”

Phased Allocation of COVID-19 Vaccines: The CDC recommends that the first recipients of a SARS-CoV-2 vaccine are health care personnel and long term care facility residents. This document gives the rationale for the decision and who is next to receive the vaccine.
As an aside, when you first search for this information, you will find pages of media reporting on this decision. It takes some work to get the original document. Perhaps there is a role for search engines to list original documents at the top and reporting after (instead of by popularity of clicks).

CDC says 2-week coronavirus quarantines can be cut to 10 or 7 days: “The move reflects the agency’s recognition that the two-week quarantine rule is onerous for many people and that most of the public health benefit from quarantining people exposed to the virus can be gained with a more flexible approach.
The CDC acknowledges that this new guidance involves a trade-off. The existing 14-day recommendation reflects the ability of the virus to incubate for a long period before symptoms appear. But lack of compliance — for example, among people who are reluctant to talk to contact tracers because they fear they or their friends or family members could lose a job or two weeks of income — can undermine the public health benefit from that standard.”

First shipments of Pfizer vaccine to be delivered December 15: “The first shipments of Pfizer's coronavirus vaccine will be delivered on December 15, according to an Operation Warp Speed document obtained by CNN on Tuesday.
The document, provided to governors ahead of a call with the Vice President Monday, also estimated the first shipment of Moderna's vaccine will be delivered on December 22.
Those distribution dates are contingent upon a decision by the US Food and Drug Administration to authorize each vaccine for emergency use. Pfizer submitted an application to the FDA on November 20, and Moderna submitted an application on November 30.”
A related article gives a really good timeline over the next year of the approval and rollout processes.

Decline in SARS-CoV-2 Antibodies After Mild Infection Among Frontline Health Care Personnel in a Multistate Hospital Network — 12 States, April–August 2020: “Among 156 frontline health care personnel who had positive SARS-CoV-2 antibody test results in spring 2020, 94% experienced a decline at repeat testing approximately 60 days later, and 28% seroreverted to below the threshold of positivity. Participants with higher initial antibody responses were more likely to have antibodies detected at the follow-up test than were those who had a lower initial antibody response.
What are the implications for public health practice?
SARS-CoV-2 antibodies decline over weeks following acute infection. Negative SARS-CoV-2 serologic results do not exclude previous infection, which has significant impacts on how serologic studies are interpreted.”

Cancer patients may shed viable COVID-19 virus for 2 months: “A New England Journal of Medicine study yesterday of cancer patients with COVID-19 demonstrated viral RNA shedding for up to 78 days and live virus for up to 61 days, suggesting extended infectiousness in patients whose immune system is suppressed.”

COVID-19 Susceptibility in Bronchial Asthma: The results of this research are not what you might think.
”No significant impact of antileukotrienes, inhaled corticosteroids, and long-acting beta-blockers use was revealed on COVID-19 positivity proportions. Multiple logistic regression analysis adjusted for sex, age, smoking, and comorbidity revealed a negative association of asthma with the likelihood of being positive for COVID-19 [emphasis added] (odds ratio, 0.71; 95% CI, 0.58-0.87; P = .001).”

Trump Covid vaccine czar says side effects ‘significantly noticeable’ in 10% to 15% of recipients: “President Trump’s coronavirus vaccine czar said Pfizer’s and Moderna’s Covid-19 vaccines are safe, with only 10% to 15% of volunteers reporting ‘significantly noticeable’ side effects [redness and pain at the injection site as well as fever, chills, muscle aches and headaches].
The side effects can last up to a day and a half, said Dr. Moncef Slaoui, who is leading the Trump administration’s Covid-19 vaccine program Operation Warp Speed.”

Leaked documents reveal China's mishandling of the early stages of Covid-19: A really interesting investigative report from CNN. The problem starts here and then “goes downhill”:
”In a report marked ‘internal document, please keep confidential,’ local health authorities in the province of Hubei, where the virus was first detected, list a total of 5,918 newly detected cases on February 10, more than double the official public number of confirmed cases, breaking down the total into a variety of subcategories. This larger figure was never fully revealed at that time, as China's accounting system seemed, in the tumult of the early weeks of the pandemic, to downplay the severity of the outbreak.”

About pharma

The $38B pie: Pfizer, Moderna COVID-19 vaccines set for lion's share of 2021 sales: “In fact, the top five players are set to divvy up about $38.5 billion in sales, Bernstein analysts figure, with the first-to-market companies reaping more than half of that. Pfizer, which just won U.K. approval Wednesday, is in line for $14.3 billion in COVID-19 vaccine sales next year, followed by $10.9 billion for Moderna, $6.4 billion for AstraZeneca, $3.9 billion for Novavax and $3 billion for Johnson & Johnson, according to the projections.”

About diagnostics

In potential ‘gamechanger,’ blood test may accurately predict Alzheimer’s: “Scientists in Sweden and Britain now believe blood tests can be used to predict Alzheimer’s years before the onset of symptoms.
Writing in the journal Nature Aging, they described how they developed and validated models of individual risk based on the levels of two key proteins in blood samples taken from more than 550 patients with minor cognitive impairments.
The model, based on these two proteins, had an 88 percent success rate in predicting the onset of Alzheimer’s in the same patients over the course of four years.”

About health insurance

Ala. Judge Gives Initial OK To $2.67B BCBS Antitrust Deal: “Citing ‘historic and substantial’ structural reform terms and a massive, $2.67 billion class damage award, a federal judge in Alabama granted preliminary approval late Monday to a settlement of claims that the nation's Blue Cross plans conspired for years to thwart competition nationwide. U. S. District Judge R. David Proctor noted in his memorandum opinion that the agreement in the Northern District of Alabama includes one of the largest class payouts in history, in a case that alleged a long-running health insurance market-control conspiracy affecting tens of millions of insured members.”

UnitedHealth Group Updates Business Outlook Ahead of Investor Conference: “Under the updated outlook, UnitedHealth Group revenues for 2020 are expected to approximate $257 billion, with net earnings to approach $15.90 per share and adjusted net earnings to approach $16.75 per share. Adjusted net earnings exclude from net earnings only the after-tax non-cash amortization expense pertaining to acquisition-related intangible assets.
UnitedHealth Group will also introduce its initial 2021 outlook, which includes revenues of $277 billion to $280 billion, net earnings of $16.90 to $17.40 per share, and adjusted net earnings of $17.75 to $18.25 per share. These figures include approximately $1.80 per share in potential net unfavorable impact to accommodate continuing COVID-19 effects, such as: treatment and testing costs; the residual impact of people deferring care in 2020; and unemployment and other economic-driven factors. Cash flows from operations are expected to range from $20 billion to $21 billion in 2021.”

Today's News and Commentary

About the public’s health

Operation Warp Speed Chief: 100 percent of Americans will be able to get vaccine by June: “‘We will have over 300 million doses available to the American public, well before [June],’ stated retired Lt. Gen. Paul Ostrowski, Director of Supply, Production & Distribution for Operation Warp Speed.”

SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis: “No study detected live virus beyond day 9 of illness, despite persistently high viral loads, which were inferred from cycle threshold values. SARS-CoV-2 viral load in the upper respiratory tract appeared to peak in the first week of illness, whereas that of SARS-CoV peaked at days 10–14 and that of MERS-CoV peaked at days 7–10.
Interpretation:
Although SARS-CoV-2 RNA shedding in respiratory and stool samples can be prolonged, duration of viable virus is relatively short-lived….
[The] highest risk of transmission occurs very early in the disease course (a few days before and within the first 5 days after symptom onset)…”

Dr. Scott Atlas resigns from Trump administration: He did not give a reason and the White House did not comment.

Serologic testing of U.S. blood donations to identify SARS-CoV-2-reactive antibodies: December 2019-January 2020: “To determine if SARS-CoV-2 reactive antibodies were present in sera prior to the first identified case in the U.S. on January 19, 2020, residual archived samples from 7,389 routine blood donations collected by the American Red Cross from December 13, 2019 to January 17, 2020, from donors resident in nine states (California, Connecticut, Iowa, Massachusetts, Michigan, Oregon, Rhode Island, Washington, and Wisconsin) were tested at CDC for anti-SARS-CoV-2 antibodies…
[The] findings suggest that SARS-CoV-2 may have been introduced into the United States prior to January 19, 2020 [emphasis added].
So…did it originate in Wuhan?

OSHA Let Employers Decide Whether to Report Health Care Worker Deaths. Many Didn’t: “Workplace safety regulators have taken a lenient stance toward employers during the pandemic, giving them broad discretion to decide internally whether to report worker deaths. As a result, scores of deaths were not reported to occupational safety officials from the earliest days of the pandemic through late October.” This piece is a fascinating (and troubling) expose from Kaiser Health News (KHN).

States Fear Shortfall of Supplies for Vaccine Rollout, U.S. Watchdog Says: ”Thirty-eight states told the Government Accountability Office that they were concerned about having enough supplies to distribute and administer vaccines, according to the report Monday by the nonpartisan agency. Between a third and half of states had shortages of some testing supplies in October, including rapid point-of-care tests, the GAO found.”

About pharma

London A.I. Lab Claims Breakthrough That Could Accelerate Drug Discovery: “DeepMind, a lab owned by the same parent company as Google, said on Monday that its system, called AlphaFold, had solved what is known as “the protein folding problem.” Given the string of amino acids that make up a protein, the system can rapidly and reliably predict its three-dimensional shape.
This long-sought breakthrough could accelerate the ability to understand diseases, develop new medicines and unlock mysteries of the human body.”

CarepathRx and UPMC Announce Landmark Partnership to Bring Comprehensive Pharmacy Care Solutions to More Patients: “CarepathRx will acquire the management services organization responsible for the operational and strategic management of {UPMC subsidiary] Chartwell while UPMC becomes a strategic investor in CarepathRx.” The acquisition price is reported to be $400 million.

Crestor to be divested to Grünenthal in Europe: “AstraZeneca has agreed to sell the rights to Crestor (rosuvastatin) and associated medicines in over 30 countries in Europe, except the UK and Spain, to Grünenthal GmbH (Grünenthal)…
AstraZeneca will continue to manufacture and supply Crestor to Grünenthal during a transition period. AstraZeneca will also continue selling the medicine in other countries, including those in North America, in Japan, China and other emerging markets…
The divestment is anticipated to close in the first quarter of 2021, subject to customary closing conditions and regulatory clearances, upon which Grünenthal will make an upfront, non-contingent payment to AstraZeneca of $320m and may also make future milestone payments of up to $30m.”
This sale will become important if the medication is included in reference pricing for US drugs.

About healthcare providers

Thousands of Doctors’ Offices Buckle Under Financial Stress of COVID: This article is a good update about how COVID-19 has financially affected medical practice.

About hospitals

National Hospital Flash Report (November 2020): This Kaufman Hall report goes through the end of October and details the aggregate financial performance of 900 hospitals. For example, “eight months into the pandemic, the Kaufman Hall median operating Margin Index* remained below 2019 performance at 2.4% YTD through October with CARES Act funding, and -1.6% without CARES. The Kaufman Hall Operating EBITDA Margin Index was 7.3% YTD with the federal aid and 3.8% without CARES.”

About healthcare IT

Google Cloud teams up with Deloitte, KPMG to launch healthcare interoperability program for providers and payers: “On Monday, the tech giant's cloud division announced a Healthcare Interoperability Readiness Program designed to help healthcare organizations understand the current status of their data and where it resides, map out a path to standardization and integration and make use of data in a secure, reliable, compliant manner.
Google Cloud worked with industry consultants and partners like Bain & Company, Boston Consulting Group, Deloitte, HCL Technologies, KPMG, MavenWave, Pluto7, SADA and 8K Miles to develop the program with tailored services, technologies and strategies, according to Aashima Gupta, global director, healthcare strategy and solutions at Google Cloud and Amit Zavery, vice president, business application platform at Google Cloud, in a blog post published Monday.”

Today's News and Commentary

About the public’s health

Cocoa Increases Mental Agility And Cognitive Ability, Finds Study: Start off the week with some good news.
”Researchers at the University of Birmingham have found in a new study that increased consumption of flavanols can increase your mental agility.The study revealed that people given a cocoa drink containing high levels of flavanols were able to complete certain cognitive tasks more efficiently than when drinking a non-flavanol enriched-drink. Flavanols, a sub-group of plant flavonoids, are present in cocoa, grapes, apples, tea, berries and other foods. They give fruits and vegetables their bright colors and are known to have a beneficial effect on cardiovascular health, but their effects on brain health are not well understood.”

New ‘Green’ Mediterranean Diet May Be Even Healthier for You: “Researchers say a new ‘green’ Mediterranean diet is healthier for you than even the traditional Mediterranean diet.
The green version replaces the minimal amount of red meat allowed in the traditional Mediterranean diet with plant-based protein.
Experts say plant proteins have additional health benefits that include anti-inflammatory characteristics.”

'A natural disaster ... in all 50 states' is unfolding just as travelers disperse nationwide after Thanksgiving: Now back to reality…an update on COVID-19 statistics.

Moderna to file for FDA emergency use authorization for COVID-19 vaccine: “Moderna announced that it plans to file with the FDA Monday for an emergency use authorization for its coronavirus vaccine, which the company said has an efficacy rate of 94.1%.”

Biden’s other health crisis: A resurgent drug epidemic: “Biden, who has stocked his team with addiction experts with extensive backgrounds in public health, will emphasize new funding for substance abuse treatment and prevention, while calling to eliminate jail time for drug use. It’s a departure from his tough-on-crime approach as a senator — and from President Donald Trump’s frequent focus on a law enforcement response to the drug crisis, which experts said undercut necessary public health measures.”

Estimated incidence of COVID-19 illness and hospitalization — United States, February–September, 2020: This research indicates the number of reported COVID-19 cases may have underestimated the true incidence.
”We estimated that through the end of September, 1 of every 2.5 (95% Uncertainty Interval (UI): 2.0–3.1) hospitalized infections and 1 of every 7.1 (95% UI: 5.8–9.0) non-hospitalized illnesses may have been nationally reported. Applying these multipliers to reported SARS-CoV-2 cases along with data on the prevalence of asymptomatic infection from published systematic reviews, we estimate that 2.4 million hospitalizations, 44.8 million symptomatic illnesses, and 52.9 million total infections may have occurred in the U.S. population from February 27–September 30, 2020.”

Democrat Schumer says $30 bln in federal funds needed to distribute COVID vaccine: The headline speaks for itself.

Biden adds new members to COVID-19 task force: “The new members are Jane Hopkins, RNMH; Jill Jim, PhD; and David Michaels, PhD.
Ms. Hopkins, who immigrated to the U.S. from Sierra Leone, worked for more than two decades as a bedside nurse, most recently in the Seattle area, and is executive vice president of SEIU Healthcare 1199NW. 
Dr. Jim is a Navajo Nation member and executive director of Window Rock, Ariz.-based Navajo Nation Department of Health. 
Dr. Michaels, a former Occupational Safety and Health Administration administrator, is an epidemiologist and professor at the George Washington University School of Public Health in Washington, D.C.”

The task force is wonderfully diverse with respect to race and gender, but lacks logistics and social marketing expertise.

United Begins Flying Pfizer’s Covid-19 Vaccine: Speaking of logistics… “United Airlines Holdings Inc. on Friday began operating charter flights to position doses of Pfizer Inc.’s Covid-19 vaccine for quick distribution if the shots are approved by regulators, according to people familiar with the matter.
The initial flights are one link in a global supply chain being assembled to tackle the logistical challenge of distributing Covid-19 vaccines. Pfizer has been laying the groundwork to move quickly if it gets approval from the Food and Drug Administration and other regulators world-wide.”

About health insurance

CMS proposed rule reduces user fee in ACA exchanges: “In the proposed annual Notice of Benefit and Payment Parameters for the 2022 Proposed Rule released late Wednesday afternoon, CMS is proposing to reduce the user fee for federally facilitated exchange issuers from 3% to 2.25% of premium for the 2022 benefit year. This will add to the 0.5% reduction in the user fee rate included in the 2020 payment notice, for a total reduction of 1.25% over the past four years. 
CMS proposes to reduce the user fee for issuers offering plans through state-based exchanges that use the federal platform to 1.75% of premium…
CMS is continuing to allow states to implement Section 1332 waivers to waive certain ACA statutory requirements. This proposal allows states to decentralized enrollment through insurers and web brokers rather than using HealthCare.gov.”

CMS announces new flexibilities for care outside of a hospital setting amid COVID-19 surge: “The Centers for Medicare and Medicaid Services has approved waivers for six health systems to provide acute care at home.
The hospitals include  Brigham and Women's Hospital in Massachusetts; Huntsman Cancer Institute in Utah; Massachusetts General Hospital in Massachusetts; Mount Sinai Health System in New York City; Presbyterian Healthcare Services of New Mexico; and UnityPoint Health of Iowa.“

About pharma

Canada blocks bulk exports of some prescription drugs in response to Trump import plan: It was inevitable… “‘Certain drugs intended for the Canadian market are prohibited from being distributed for consumption outside of Canada if that sale would cause or worsen a drug shortage,’ Health Minister Patty Hajdu said in a statement.
‘Companies will now also be required to provide information to assess existing or potential shortages, when requested, and within 24 hours if there is a serious or imminent health risk,’ the statement said.”

The Colchicine Debacle Revisited: This article is a great case study of what happens when “unapproved” drugs that have been used for decades get FDA approval and attendant market exclusivity. The result is, for example, that “Medicaid spending for colchicine increased almost 3000%, from $1.1 million in 2008 to $32.2 million in 2017…
[T]he manufacturer increased the price of colchicine from what had previously been only a few cents to $5 a tablet…”

About healthcare IT

Universal Patient Identifier and Interoperability for Detection of Serious Drug Interactions: Retrospective Study: “Among a population of 49.7 million patients, 242,646 serious drug-drug interaction alerts occurred in 3 years. Of these, 2388 (1.0%) crossed insurance and were discovered because the pharmacy benefit manager used a unique patient identifier. We estimate that up to 10% of serious drug-drug alerts in the United States go undetected by pharmacy benefit managers because of unexchanged information or pharmacy benefit managers that do not use a unique patient identifier. These information gaps may contribute, annually, to up to 6000 patients in the United States receiving a contraindicated medication.”
Is the solution a pharmacy issue or should we (finally) assign unique patient identifiers, like other countries do?

California medical center server issue exposed patient data for 4.5 years: “FMC determined that the misconfiguration existed from around Dec. 16, 2015, to July 31, 2020. The medical center said it cannot rule out unauthorized access to patient records that were present on the server during the time period. Patient data contained on the server includes names, medical images, dates of birth, identification numbers and ordering providers.” While data compromises are, unfortunately, commonplace, this one was unusually long.

About hospitals and health systems

Cleveland Clinic's net income triples in Q3: “The 18-hospital system's revenue climbed to $2.72 billion in the third quarter of this year, up from $2.65 billion in the same period of 2019, according to recently released unaudited financial documents. The increase in revenue was driven by $77 million in grants received through the Coronavirus Aid, Relief and Economic Security Act and employee retention credits. 
The system's net patient service revenue decreased $4.5 million in the third quarter of 2020 compared to the same period of 2019. Inpatient admissions declined 5.3 percent year over year in the third quarter of this year and were down 7.4 percent in the first nine months of 2020.”
These trends have been typical, especially declining patient revenue and admissions as well as reliance on the federal relief funds.

Today's News and Commentary

About the public’s health

CDC may shorten COVID-19 quarantine period guidelines: The shortened time was not specified.

These are the top coronavirus vaccines to watch: This article updates the number of SARS-CoV-2 vaccines in the pipeline and what stage they are at.

Initial Batch Of COVID-19 Vaccines Will Go To States Based On Population, Not Risk: “Instead of waiting for the advisory committee's recommendations, [Operation Warp Speed]… allocated the first 6.4 million doses to states, based on overall population. ‘I finally made the decision, late Friday night,’ said Gen. Gustave Perna, head of logistics for Operation Warp Speed, at the briefing Tuesday. ‘So states could prioritize based on [their] amount,’ meaning how many doses of vaccine each state will receive.”

Evidence Builds That an Early Mutation Made the Pandemic Harder to Stop: “…one mutation near the beginning of the pandemic did make a difference, multiple new findings suggest, helping the virus spread more easily from person to person and making the pandemic harder to stop.
The mutation, known as 614G, was first spotted in eastern China in January and then spread quickly throughout Europe and New York City. Within months, the variant took over much of the world, displacing other variants.” More recently, however: No evidence for increased transmissibility from recurrent mutations in SARS-CoV-2: “At this stage we find no evidence for significantly more transmissible lineages of SARS-CoV-2 due to recurrent mutations.”

Symptoms associated with a positive result for a swab for SARS-CoV-2 infection among children in Alberta: “About two-thirds of the children who tested positive for SARS-CoV-2 infection reported symptoms. The symptoms most strongly associated with a positive SARS-CoV-2 swab result were anosmia/ageusia, nausea/vomiting, headache and fever.”

Zeteo Biomedical Partners With Iowa State University on Nasal COVID-19 Vaccine: “The Austin, Tex., company will contribute its ZEOx2 nasal delivery technology, including devices that support powder and reconstituted powder-to-liquid vaccine formulations that can be administered by either healthcare providers or patients. The company said the nasal delivery devices are commercially scalable to deliver millions of vaccine doses per day.”

With more data on its COVID-19 vaccine, Russian institute offers new evidence of success: “Joining the flood of press releases announcing positive results from COVID-19 vaccine trials, developers of Russia’s Sputnik V vaccine today reported 91.4% efficacy from a second interim analysis of more than 18,000 people, bolstering a claim the team made on 11 November with scant evidence.” While this country will not be using this vaccine, it is important that it really works; many countries will be using this vaccine.

6.4 million COVID-19 vaccine doses expected to be shipped to states by mid-December: ”An estimated 6.4 million doses of Pfizer’s vaccine will be distributed to states and territories by mid-December, assuming it receives Food and Drug Administration (FDA) authorization by that point, Operation Warp Speed officials told reporters Tuesday. 
State officials were notified Friday how many doses they should expect to receive in the initial distribution, and they will make their own decisions about who will be prioritized for the first doses.”

U.S. infectious disease group backs Gilead's remdesivir for COVID-19 treatment: “The Infectious Diseases Society of America (IDSA) in updated guidelines said its experts back the drug for use in severe COVID-19 patients based on a clinical trial showing it reduced hospital stays. The WHO study that led to its recommendation against the drug suggested it had no benefit in saving lives or reducing the need for mechanical breathing assistance.”

Parents' Age Key to Whether Kids Get Vaccinated Against COVID, Study Finds: “Younger parents are much less likely than older ones to plan to vaccinate their children and themselves against COVID-19.”

Oxford Covid vaccine 'bottlenecks' mean UK's full order will not be ready until end of next year: “According to the news source, AstraZeneca is facing an uphill battle, having already fallen behind schedule. During the first wave, the company targeted 30 million doses ready for use in the UK by September, but now expects only four million by the end of the year.
In total, the firm says it will have produced 20 million doses by the end of 2020, but these shots will not yet have been poured into vials, which takes time…”

Aetna pilot harnesses CVS pharmacists to address Medicaid members' social needs: “Through the HealthTag initiative, CVS Health pharmacists and pharmacy employees are empowered to offer more personalized information when Aetna Medicaid members come to pick up prescriptions, providing the members with health information beyond how to take their medications appropriately.
Inside the prescription bag, members are provided additional details on how to access community services to address social concerns like food, housing or transportation. The network of these organizations is backed by Unite Us, a social care coordination program.”

About health insurance

CMS Issues Final Rule to Amend the U.S. Department of Health and Human Services’ Risk Adjustment Data Validation [RADV] Program: “For 2019 benefit year HHS-RADV and beyond, CMS is finalizing the following three modifications to the error rate calculation:

  • CMS will modify the way that it groups medical conditions in HHS-RADV within the same hierarchical condition category (HCC) coefficient estimation groups in risk adjustment to determine failure rates for those HCCs. This modification seeks to better account for the difficulty in categorizing certain conditions and to, therefore, refine how the error rate calculation measures risk differences within and between condition groupings.

  • CMS will make changes that would reduce the magnitude of risk score adjustments for issuers close to the threshold used to determine whether an issuer is an outlier. Currently, issuers whose failure rates are not significantly different from issuers just inside the threshold may see significant changes to their risk scores and transfers, creating a “payment cliff” for issuers just outside the threshold. Adjusting the magnitude of risk score adjustments intends to mitigate this effect.

  • CMS will modify the error rate calculation in cases where certain outlier issuers have a negative failure rate. A low failure rate is not always due to more accurate data submission. A low failure rate can also be due to not identifying conditions that should have been reported in risk adjustment. The final rule refines the error rate calculation to mitigate the impact of adjustments that result from error rates driven by these newly found conditions.”

Connecticut Comptroller Lembo Launches "Network Of Distinction" To Deliver Highest-Quality Care And Save On Costs: “The Office of the State Comptroller is partnering with Signify Health to improve health outcomes for certain common procedures and save on costs through a new ‘Network of Distinction’ program. The doctors, hospitals and provider groups in the network will provide improved patient outcomes at a competitive fixed price for care from evaluation to recovery.
This innovative ‘episode of care’ delivery and payment model establishes a new industry standard by aligning clinical and financial incentives for the state employee health plan and the Connecticut Partnership Plan, totaling more than 220,000 members. Under the initial agreement, 180 health care provider groups have committed to meet a set of quality care standards at the lowest possible cost. New groups will continue to be added throughout the year.”

About healthcare financing

JD Health to raise up to $4bn in Hong Kong IPO: “JD Health, the healthcare unit of Chinese ecommerce group JD.com, will raise up to $4bn in Hong Kong next month, in what is likely to be one of the world’s biggest initial public offerings this year. The company, which sells pharmaceuticals and health services online, said an initial sale of 382m shares could bring in as much as $3.5bn, according to a term sheet seen by the Financial Times. That would value JD Health at up to $28.5bn.”

Today's News and Commentary

About pharma

AstraZeneca probes 'mistake' behind 90% COVID-19 vaccine efficacy: As previously reported, the vaccine dose that was 90% efficacious was a half dose followed by a full dose. That regimen was mistakenly given to some volunteers but proved better than two full doses.

Moderna to charge $25-$37 for COVID-19 vaccine, says CEO: ”Moderna will charge governments between $25 and $37 per dose of its COVID-19 vaccine candidate, depending on the amount ordered, Chief Executive Stephane Bancel told German weekly Welt am Sonntag (WamS).
‘Our vaccine therefore costs about the same as a flu shot, which is between $10 and $50,’ he was quoted as saying.
On Monday, an EU official involved in the talks said the European Commission wanted to reach a deal with Moderna for the supply of millions of doses of its vaccine candidate for a price below $25 per dose.”

Purdue Pharma Pleads Guilty to Felonies Over OxyContin Sales:”Purdue Pharma LP pleaded guilty Tuesday to three federal felonies related to the marketing and distribution of its powerful opioid painkiller OxyContin, ending the bankrupt company’s exposure to U.S. government action but leaving other liabilities to state and local governments looming.”

3 pharmacy industry groups sue to stop new US drug import rule: “Three pharma industry groups are suing HHS and the FDA to block a rule that would allow the importation of certain prescription drugs from Canada.
The groups filing the suit are Pharmaceutical Research and Manufacturers of America, Partnership for Safe Medicines and the Council for Affordable Health Coverage.”

Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person: “ Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person (post-exposure prophylaxis).” It is only approved for those age 12 and older. Many sites list the cost at $150, but say couponing will bring the out of pocket expense down.
About health insurance

Employers start sending workers shopping for health coverage: This article is a reminder about a subject previously reported:
”Instead of offering one or more options, some companies are turning health insurance shopping over to employees.
A federal rule change last year stoked this new approach. It allows employers to reimburse workers for coverage they bought without paying a tax penalty. 
The concept sends employees to individual insurance markets where they can find more choices for coverage. It also protects employers from huge annual cost spikes. But it’s a big change for workers who are used to having their employer give them benefit choices every year.
This new approach — known as an Individual Coverage Health Reimbursement Arrangement or ICHRA — started with coverage plans for this year. More workers will likely see them offered this fall during their company’s annual sign-up window for 2021 coverage.”

Texas and Louisiana can cut Medicaid funding for Planned Parenthood, federal appeals court rules: “The ruling was handed down by the 5th U.S. Circuit Court of Appeals in New Orleans. While it expressly reversed decisions in Texas and Louisiana, it also affects Mississippi, which is under 5th Circuit jurisdiction. The issue is likely to go next to the U.S. Supreme Court.
Opponents of legal abortion have long sought to deny federal Medicaid funding for Planned Parenthood clinics.”

Insurer Participation on the ACA Marketplaces, 2014-2021: “For the third straight year, several insurers are entering the market or expanding their service area in 2021. This year, we find that 30 insurers are entering the individual market across 20 states (Table 1) and an additional 61 insurers are expanding their service area within states they already operated. There will be an average of 5.0 insurers per state in 2021, up from a low of 3.5 in 2018 but still below the peak of 6.0 in 2015. The number of insurers per state ranges from one company operating in Delaware to thirteen operating in Wisconsin.” The article has some helpful graphics that explain the trends.

Cigna CEO, Board Sued for ‘Black Ops’ Effort to Kill Anthem Deal: “A Massachusetts-based pension fund alleges that Cigna CEO David Cordani sought to “poison” the deal after failing to secure the top post in the merged company. He hired lawyers and public relations specialists to help in a ‘Trojan Horse’ campaign, the fund claims. The deal, which would have created the largest U.S. health insurer, collapsed in 2017.”

About the public’s health

There was a 28% increase in child Covid-19 cases over the last two weeks, American Academy of Pediatrics says: “There were more than 144,000 new cases of Covid-19 reported among children last week, the American Academy of Pediatrics (AAP) said Monday.
Over the last two weeks, there has been a 28% increase in child Covid-19 cases and children now account for more than 11% of all confirmed coronavirus cases in the US, according to the AAP.
About 144,145 new cases among children 17 and under were reported from November 12 to 19, AAP said.”

Assessment of 135 794 Pediatric Patients Tested for Severe Acute Respiratory Syndrome Coronavirus 2 Across the United States: “Among the 5374 patients with positive test results, 359 (7%) were hospitalized for respiratory, hypotensive, or COVID-19–specific illness. Of these, 99 (28%) required intensive care unit services, and 33 (9%) required mechanical ventilation. The case fatality rate was 0.2% (8 of 5374).”
”This study suggests that for most pediatric patients, the risk of SARS-CoV-2 infection appears low, but higher concern may be warranted for patients with medically complex conditions or those of minority race/ethnicity.”

A $10 Covid-19 Test? Walmart Heirs Back Startup Developing At-Home Tests: “The billionaire Walton family that controls Walmart Inc. is among a group of investors backing a startup aiming to design at-home Covid-19 tests to sell for as little as $10 at the retail giant’s stores and elsewhere.
NowDiagnostics Inc., based 20 miles south of Walmart’s corporate headquarters, has filed requests for emergency authorization from the U.S. Food and Drug Administration for a Covid-19 antibody blood test, according to the Springdale, Ark., company.
It is also developing two at-home Covid-19 tests that would use a patient’s saliva and deliver results in minutes, said Chief Executive Kevin Clark.”

About healthcare quality

Variations in processes for guideline adaptation: a qualitative study of World Health Organization staff experiences in implementing guidelines: “The contrasting models of guideline adaptation encountered in the interviews show the differing processes employed by WHO staff in different regions in the world. One is a Copy or Customise model of adaptation through consultation with local health authorities and stakeholders. This model takes parts of WHO guidelines and applies them as is or in modified form in-county, while taking into account the local epidemiology, system capacity and existing policies. The other model is based on capacity building where WHO regional offices help build and support national guideline development and adaptation programs so national guidelines can be developed based on WHO or other evidence-based guidelines using thorough framework for evidence evaluation to inform the strength of recommendations in the local setting. The actual processes of guideline adaptation revealed by our interviews existed along a spectrum between these 2 models.”

About health policy

Association of State Certificate of Need Regulation With Procedural Volume, Market Share, and Outcomes Among Medicare Beneficiaries: “Among Medicare beneficiaries who underwent a range of surgical procedures from 2016 through 2018, there were no significant differences in markers of hospital volume or quality between states without vs with certificate of need laws. Policy makers should consider reevaluating whether the current approach to certificate of need regulation is achieving the intended objectives and whether those objectives should be updated.” See also the accompanying editorial: Revisiting States’ Experience With Certificate of Need.
This research is in a long line of other studies that show how ineffective CON regulations are.

Today's News and Commentary

About public policy

Court: Tennessee can enforce Down syndrome abortion ban:”A federal appeals court ruled Friday that Tennessee can begin outlawing abortions because of a prenatal diagnosis of Down syndrome, as well as prohibit the procedure if it’s based on the race or gender of the fetus.”

Modernizing and Clarifying the Physician Self-Referral Regulations: In a strictly fe-for-service environment, these self-referral laws are important to avoid financial conflicts of interest. But with increasing value arrangements where risks and rewards are shared among providers, these restrictions need to be loosened to provide proper incentives.
“This final rule establishes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It also establishes a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; establishes a new exception for donations of cybersecurity technology and related services; and amends the existing exception for electronic health records (EHR) items and services. This final rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.” Here is a shortened CMS Fact Sheet of the changes,

About hospitals and health systems

Ascension's net income hits $1B in Q1: Hospitals and systems will start to report Q1 results when some elective services opened up. Now that we are into a pandemic relapse, we may see Q2 results look like they did during the first wave of COVID-19.

About pharma

Amazon’s drugs unlikely to prove fatal to pharmacies, say experts: “CVS, Walgreens, Cigna and United — will begin Monday’s trading a combined $40bn lighter” after Amazon announced its expanded pharmacy service last Tuesday. But many experts predict that it will not have a big impact on retail pharmacies and PBMs because of existing contracts and patient relationships. Also, physicians must want to break established patterns and be able to easily prescribe on the Amazon platform. The one segment that makes sense for Amazon to take over is the low, fixed-price 90 day prescription that some pharmacies now offer for common generics. The “free” delivery feature ia also attractive, helping customers stay clear of crowded facilities.

AstraZeneca, Oxford Covid-19 Vaccine Up to 90% Effective in Late-Stage Trials: The vaccine requires two doses and does not have to be kept at the same low temperatures as the Pfizer-BioNTech product. Also, the most efficacious dose was a smaller first one followed by a full dose a month later.

Hey, pharma: When it comes to influencers, forget lifestyle gurus and stick to patient advocates, study says: “Its recent network survey found that only 14% percent of the WeGo users surveyed mostly or completely trust lifestyle influencers, while 51% completely or mostly trust patient influencers. When it comes to branded pharma products, the survey was even more positive for patient influencers: 85% said they would be very or somewhat receptive to an ad from a patient influencer promoting a drug-related to the patient’s condition.”

Frequently Asked Questions Regarding the Department of Health and Human Services’ Announcement on the Unapproved Drugs Initiative: In addition to the executive orders to end drug price rebates and implement foreign country index drug pricing (see Friday’s post), in Friday’s presidential message is an announcement ending the Unapproved Drug Initiative.
Briefly, some drugs were grandfathered into allowed use or came to market without FDA approval. In the former category were very old drugs (like colchicine for gout); the newer ones did not have equivalents practitioners wanted to treat specific conditions. Since 2006, when the Unapproved Drugs Initiative started, some formulations of these unapproved drugs were pulled from the market because of harmful effects. The result was that pharma companies patented and/or obtained monopolies on those pulled drugs by submitting them for approval. From a quality standpoint, it might seem like process was a good idea; however, the approved drugs often raised the prices dramatically- even for the very old generics. For example, a Vizient analysis published today showed that ending the Unapproved Drugs Initiative could save between $7.52 Billion and $26.59 Billion. This case is a perfect example of cost-quality tradeoff. But the fundamental problem is lack of drug price oversight.

About healthcare IT

FDA clears Baxter’s virtually connected, in-home peritoneal dialysis system: “Baxter has received clearance from the FDA for the latest version of its automated peritoneal dialysis system designed for home use, combining it with a digital platform that aims to help patients with kidney disease manage their care remotely.
The Homechoice Claria system was cleared for both adults and children. Its interface is available in 38 languages and features step-by-step, voice-activated instructions through an accompanying app to help guide the user through therapy.”

About the public’s health

Poor Performance of Masks Secured Using Ear Loops: “When comparing a surgical mask with head ties vs a procedure mask with ear loops, there was a large difference in fitted filtration efficiencies (FFEs) (71.5% v 38.1%, respectively).Even more worrying, there was also a similar trend of poor FFE performance for N95 respirators designed with ear loops vs those with head straps…”

About health insurance

CMMI announces participants of Primary Care First Model: “The Primary Care First Model will begin in January 2021 with 916 primary-care practices participating along with 37 payers. The model, first announced in April 2019, is part of the agency's ongoing effort to expand value-based payment options in Medicare toreduce healthcare spending.”
“Primary Care First is oriented around comprehensive primary care functions: (1) access and continuity; (2) care management; (3) comprehensiveness and coordination; (4) patient and caregiver engagement; and (5) planned care and population health...
Eligible practitioners (that each practice applicant must identify by NPI in its application) are those in internal medicine, general medicine, geriatric medicine, family medicine, and/or hospice and palliative medicine.” For more information, check the CMMI summary.

Today's News and Commentary

About the public’s health

Pfizer and BioNTech will seek regulatory clearance of their coronavirus vaccine: Filing is expected today with vaccine availability in mid to late December.

SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis:”Mean duration of SARS-CoV-2 RNA shedding was 17·0 days… in upper respiratory tract, 14·6 days… in lower respiratory tract, 17·2 days… in stool, and 16·6 days… in serum samples. Maximum shedding duration was 83 days in the upper respiratory tract, 59 days in the lower respiratory tract, 126 days in stools, and 60 days in serum. Pooled mean SARS-CoV-2 shedding duration was positively associated with age... No study detected live virus beyond day 9 of illness, despite persistently high viral loads [emphasis added], which were inferred from cycle threshold values. SARS-CoV-2 viral load in the upper respiratory tract appeared to peak in the first week of illness, whereas that of SARS-CoV peaked at days 10–14 and that of MERS-CoV peaked at days 7–10.”

Nearly half of patients say they'd feel safest getting COVID-19 vaccine at doctor's office: survey: “When asked in the second annual ‘State of Patient Access and Engagement’ 2020 survey where consumers would feel safest receiving the COVID-19 vaccine, nearly half chose the doctor's office. The survey, conducted OnePoll and commissioned by DocASAP, a patient access platform, polled 1,000 U.S. adults who had visited a doctor in the last 12 months. It also found one in three respondents said they'd feel safest getting a vaccine at a hospital and 29% said they'd feel safest at a pharmacy.”

Tobacco Product Use Among Adults — United States, 2019: From the CDC: ”In 2019, approximately 20.8% of U.S. adults (50.6 million) currently used any tobacco product. Cigarettes were the most commonly used tobacco product among adults, and e-cigarettes were the most commonly used noncigarette tobacco product (4.5%). The highest prevalence of e-cigarette use was among smokers aged 18–24 years (9.3%), with over half (56.0%) of these young adults reporting that they had never smoked cigarettes…
18.6% reported using two or more tobacco products.”

The evidence doesn't support closing schools to stop the coronavirus: A good overview of this contentious issue. “The nation's top infectious disease expert, Anthony S. Fauci, said last night he too was a proponent of keeping schools open if at all feasible. ‘One of the things we need to do...is try to keep the kids in school,’ Fauci, director of the National Institute for Allergy and Infectious Diseases, told CNN yesterday. ‘My feeling is the default condition is to keep the schools open if you possibly can.’”

Primary Care & COVID-19: Week 22 Survey: Among the results from this survey:
“Patients’ overall health continues to suffer due to the pandemic. Over 85% of respondents report that the mental health of their patients has decreased during the pandemic, with 31% seeing a rise in patients suffering with addiction. Over a third (37%) say their patients with chronic conditions are in “noticeably worse health resulting from the pandemic.” This is due, in part, to visits that are not happening: 56% of surveyed clinicians have seen an increase in negative health burdens due to delayed or inaccessible care.”

AMA urges multifaceted approach to address social determinants of health: “At the Special Meeting of the American Medical Association (AMA) House of Delegates, physicians adopted policies…to address social determinants of health as part of health insurance coverage. The disproportionate impacts of the COVID-19 pandemic have highlighted the need to address nonmedical, yet critical, health needs and the underlying determinants of health — economic stability, neighborhoods, transportation, education and life opportunities, access to food, quality and safe housing, community/social support, and access to health care.”

About healthcare IT

The Sequoia Project Publish Person Matching Case Study with 99.5% Accuracy: The Sequoia Project, a non-profit and trusted advocate for nationwide health information exchange, patient identity management experts collaborated with the Blue Cross Blue Shield Association to apply A Framework for Cross-Organizational Patient Identity Management for the payer community and develop person matching strategies. Today, The Sequoia Project published Person Matching for Greater Interoperability: A Case Study for Payers which demonstrates high matching accuracy rates, and provides actionable insights for improving person identity matching across the payer community, a critical component of successful health information exchange and interoperability.”
Comment: Identity confusion is a not uncommon error in healthcare. While great strides are being made to flawlessly identify patients, the standards do not come close to even acceptable manufacturing errors. At an error rate of 0.5%, assuming everyone in the US is subject to misidentification, the affected number would be about 16.4 million. The fundamental problem is we still do not have a universal patient identifier, a feature which was removed from the original HIPAA legislation.

About health insurance

CMS says 800K more have signed up for coverage on HealthCare.gov in 2nd week: “More than 800,000 additional people signed up for coverage on HealthCare.gov in the second week of open enrollment, according to new data from the Trump administration.
The Centers for Medicare & Medicaid Services (CMS) said Thursday that 803,741 enrolled in plans through HealthCare.gov between Nov. 8-14. Through two weeks, 1.6 million have enrolled in coverage.
That includes 170,284 new customers and 633,457 people renewing coverage in week two, CMS said.”

About pharma

Trump Administration Finalizes Proposal to Lower Drug Costs by Targeting Backdoor Rebates and Encouraging Direct Discounts to Patients: This final rule affects rebates from drug companies to Medicare Part D and PBMs. (See the article for an explanation for why the rule was put in place.) HHS allowed these rebates because there was a “safe-harbor” protection. This final rule eliminates the protection. Medicaid Managed Care Organizations will still have a “safe-harbor” protection on rebates.

Trump Administration Announces Prescription Drug Payment Model to Put American Patients First: From the HHS Fact sheet: “The Centers for Medicare & Medicaid Services (CMS) is announcing a new payment model, the Most Favored Nation (MFN) Model (or the ‘MFN Model’), and issuing a corresponding Interim Final Rule with Comment Period (IFC). The MFN Model will lower prescription drug costs by paying no more for high-cost Medicare Part B drugs and biologicals (hereinafter called ‘drugs’) than the lowest price that drug manufacturers receive in other similar countries. The MFN Model will also pay providers a flat add-on amount for each dose of an MFN drug, instead of a percentage of each drug’s cost, removing the tie between drug cost and the add-on amount. Beneficiaries will pay lower coinsurance for these high-cost Part B drugs and will not pay coinsurance on the add-on payment. The MFN Model will require participation of Medicare providers and suppliers that receive separate Medicare Part B fee-for-service payment for the model’s included drugs, with certain exceptions, and begin nationally January 1, 2021…
The MFN Model will test paying Part B drugs at comparable amounts to the lowest adjusted price paid by any country in the Organisation for Economic Co-operation and Development (OECD) that has a Gross Domestic Product (GDP) per capita that is at least 60 percent of the U.S. GDP per capita…
The mandatory MFN Model will operate for seven years, from January 1, 2021 to December 31, 2027.”
Comments: Go to this website to see the large number of countries that will be in the 60% bracket (start on the right and go to the left until you get to Estonia). Also, note this announcement is an Interim Final Rule open for comment.

Surprise Federal Drug Rule Directs Insurers to Reveal What They Pay for Prescription Drugs: “Health insurance companies will have to give their customers estimated out-of-pocket costs for prescription drugs and disclose to the public the negotiated prices they pay for drugs, under an unexpected new Trump administration rule.
The administration said those requirements, part of a broader rule issued Oct. 29 forcing health plans to disclose costs and payments for most health care services, will promote competition and empower consumers to make better medical decisions.
The new rule does not, however, apply to Medicare or Medicaid.
The drug price provisions, which would not begin until 2022, were a surprise because they were not included in the original proposed rule issued in 2019.”

A living WHO guideline on drugs for covid-19: These updates from the WHO are ongoing and published by BMJ. The update includes remdesivir (not recommended, weak evidence) and corticosteroids (recommended only for severe or critically ill patients). The evidence for these recommendations is included in tabs below the introductory graphic. In a related article: Eli Lilly arthritis drug gets FDA nod for emergency use with remdesivir to treat COVID-19:”The U.S. Food and Drug Administration on Thursday approved the emergency use of Eli Lilly and Co’s arthritis drug, baricitinib, in combination with Gilead Sciences Inc’s remdesivir, to treat COVID-19 patients. Baricitinib, sold under the brand name of Olumiant, is an FDA-approved oral medication to treat moderately-to-severely active rheumatoid arthritis.”

Are patients more adherent to newer drugs?: “This study has investigated the relationship between drug quality that we captured by a drug’s vintage as measure of productivity of treatment and medication adherence in the US working population. We demonstrate that patients tend to be more adherent to newer drugs. The medicine possession ratio increases by 2.5 percentage points when the mean vintage of a drug increases by ten years. This effect may appear small, but our estimates indicate that a 10-year increase in drug vintage has the same effect on medication adherence as a 0.35 USD reduction in copayment per day of therapy. Also, our estimates of vintage reflect averaged effects across all drugs of the same vintage, some of which may be more effective in terms of effectiveness than others.”
Comment: This article is likely to be used by the pharma industry to support its case for innovation expenses; but the results should be cautiously interpreted. After reading the article I could not find an answer to a concern I had about the methodology: Patients whose drugs do not work for their illness or who develop side effects will stop them and be classified as non-compliant. For these patients, newer drugs are likely to be used and, if they work, will appear as a higher level of compliance than the discontinued ones. The research is couched in economic theory with little medical input.

Today's News and Commentary

About the public’s health

Covid-19 has killed 250,000 people in the US. That's 10 times the deaths from car crashes in a year: The headline speaks for itself. In a related article: 3 million Americans currently contagious with coronavirus: analysis.

Oxford Covid vaccine could build immunity in older people – study: “The ChAdOx1 nCov-2019 vaccine has been shown to trigger a robust immune response in healthy adults aged 56-69 and over 70…
According to the researchers, the trial demonstrated similar immune responses across all three age groups – 18-55, 56-69, and 70 and over.” The results are from a Phase 2 study.

More people are getting COVID-19 twice, suggesting immunity wanes quickly in some: This report contrasts with the one posted yesterday that immunity can last years. Obviously there is a range of immune responses.

Mysteries of COVID Smell Loss Finally Yield Some Answers: An understandable explanation of this symptom from Scientific American. The short version: “Disruption of the olfactory epithelium could explain the loss of smell. Yet it remains unclear whether the damage is done by the virus itself or invading immune cells…”

A covid-fighting tool is buried in your phone. Turn it on.: “About 100 million Americans now have the ability to get pop-up notifications from local health authorities when they’ve personally spent time near someone who later tested positive for the coronavirus.
But exposure notifications only work if you and the people around you turn them on. Yes, you!
There’s early evidence this anonymous smartphone technology works — but so far isn’t helping very many Americans…”

The Coronavirus Is Airborne Indoors. Why Are We Still Scrubbing Surfaces?: ”Hand washing with soap and water for 20 seconds — or sanitizer in the absence of soap — is still encouraged to stop the virus’s spread. But scrubbing surfaces does little to mitigate the virus threat indoors, experts say…”

INSIGHT - COVID toll turns spotlight on Europe's taboo of data by race:”Many European countries avoid breaking down data along racial or ethnic lines out of concern over privacy or discrimination, but COVID-19's outsized impact on Black and Asian people has exposed flaws in the approach, some scientists and activists said.
They want more comprehensive data collection across the continent to improve understanding about how and why COVID-19 affects different communities, and thereby help countries tailor testing and care to better protect them.”

Azar expects 40M COVID-19 vaccine doses ready to distribute by end of December: “Department of Health and Human Services Secretary Alex Azar expects 40 million doses of Pfizer and Moderna’s COVID-19 vaccines will be ready for distribution by the end of December as providers must gear up now to allocate the doses.
Azar gave an update on vaccine distribution as part of Operation Warp Speed on Wednesday.”

About healthcare IT

2020 HIMSS Cybersecurity Survey: A great source of information from a survey of 168 cybersecurity experts. Some of the findings:

• “Most organizations are experiencing significant security incidents. Significant security incidents are the norm.

• Phishing is the most common type of significant security incident. Phishing is the number one type of significant security incident; most phishing is either general phishing or spear-phishing occurring via e-mail.

• Top threat actors include online scam artists and cybercriminals. Online scam artists (e.g., phishers) and cybercriminals are targeting many healthcare organizations.

• Financial information is king. Threat actors typically seek the following: (i) financial information, (ii) employee information, and (iii) patient information.

Initial hook is by phishing. Phishing e-mail is the typical initial point of compromise.

• Workforce members are the first line of defense. Internal security teams and internal personnel, including non-IT professionals, typically report significant security incidents to the organization.

• Disruption is the Primary Impact. Disruption of information technology (“IT”) operations and business operations are typical outcomes of cyber-attacks. Disruption of clinical care or damage or destruction of clinical care systems and devices also occurs.”

Virtual Healthcare Use Among Medicare Advantage Members Before and During the COVID-19 Pandemic: An insightful analysis of virtual healthcare use in the senior market.
“Mental health conditions and/or substance use disorders were the largest group of primary diagnoses treated virtually, with growth in virtual services of more than 5,000 percent in 2020 compared to 2019.
Older members (ages 75+) used a smaller share of virtual services in March-May 2020 than would be expected based on their 2019 in-person utilization, but still used substantially more virtual services in 2020 than in 2019.”

Bayer initiates new G4A Digital Health Partnerships Program: “Bayer will support five new startup companies as part of the company’s G4A Digital Health Partnerships Program. Focus will be on fostering the development of a digital health ecosystem, while driving forward integrated healthcare solutions in the fields of cardiometabolic and renal diseases, oncology, and women’s health. The participating digital healthcare companies were selected by Bayer from over 400 applications from over 65 countries based upon current and future strategic fit, development stage and assessment.”
Read the article for more in formation about the five companies.

About health insurance

Review of Contract Year 2021 Medicare Advantage supplemental healthcare benefit offerings: This report was prepared by Milliman and assessed the growth of MA supplemental benefits for contract years 2019-2021. The following categories all increased in frequency: Adult Day Health Services, Home-Based Palliative Care, In-Home Support Services, Support for Caregivers of Enrollees, and Therapeutic Massage.”

Appeals court sides with hospitals in latest challenge of DSH payment calculations: “A federal appeals court upheld a ruling that would allow hospitals to calculate their disproportionate share hospital (DSH) payments using Medicaid patients as well as patients eligible for treatment under experimental Medicaid ‘demonstration projects’ approved by the Department of Health and Human Services (HHS).
The opinion, issued Friday, upheld the decision of a lower court that sided with 10 Florida hospitals seeking to include days of care funded by Florida’s Low Income Pool, an approved Medicaid demonstration project. Through the pool, the state and federal governments jointly reimbursed hospitals for care provided to uninsured and underinsured patients.”

About pharma

Judge Strikes Opioid Claims Against Prescribers: “The Ohio federal judge overseeing the multidistrict litigation over the opioid crisis on Wednesday struck pharmacies' claims that third-party healthcare workers were liable for writing opioid prescriptions, saying they're using previously rejected arguments.”

Today's News and Commentary

About the public’s health

PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS: This announcement is for the Phase 3 conclusion and includes the previous efficacy (94.5%) data. It will still be another month or so before the vaccine hits the market. A related article, The Health 202: Coronavirus vaccines are one thing Trump got right, has a really good graphic explanation of the mRNA vaccine process as well as how Pfizer will keep specimens cold for shipment.

Immunity to the Coronavirus May Last Years, New Data Hint:”The research, published online, has not been peer-reviewed nor published in a scientific journal. But it is the most comprehensive and long-ranging study of immune memory to the coronavirus to date.”

Hospitals Can’t Go On Like This: “Now new data released by the Department of Health and Human Services quantify the crisis in America’s hospitals in closer detail. At The Atlantic’s request, HHS provided data on the number of hospitals experiencing staffing shortages. From November 4 to November 11, 958 hospitals—19 percent of American hospitals—faced a staffing shortage. This week, 1,109 hospitals reported that they expect to face a staffing shortage. That’s 22 percent of all American hospitals.
In eight states, the situation is even more dire. More than 35 percent of hospitals in Arkansas, Missouri, North Dakota, New Mexico, Oklahoma, South Carolina, Virginia, and Wisconsin are anticipating a staffing shortage this week.”

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home: “The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only. 
The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.”

Imputed State-Level Prevalence of Achieving Goals To Prevent Complications of Diabetes in Adults with Self-Reported Diabetes — United States, 2017–2018: “Effective management of hemoglobin A1C, blood pressure, cholesterol, and avoiding smoking (ABCS) is important in preventing complications from diabetes…
During 2017‒2018, the proportion of U.S. adults with self-reported diabetes who met ABCS goals was suboptimal. Only 26.4% met all the ABCS goals, 75.4% met the A1C goal, 70.4% met the blood pressure goal, 55.8% met the cholesterol goal, and 86.0% were current nonsmokers.”

First ever vaccine listed under WHO emergency use: WHO “listed the nOPV2 vaccine (Bio Farma, Indonesia) for emergency use to address the rising cases of a vaccine-derived polio strain in a number of African and East Mediterranean countries. Countries in WHO’s Western Pacific and South-East Asia regions are also affected by these outbreaks. The emergency use listing, or EUL, is the first of its kind for a vaccine and paves the way for potential listing of COVID-19 vaccines.”

Britain to ban new petrol cars by 2030 on road to net zero emissions: “Britain will ban the sale of new petrol and diesel cars and vans from 2030, five years earlier than previously planned, as part of what Prime Minister Boris Johnson is casting as a ‘green revolution’ to cut emissions to net zero by 2050.”

FDA to make emergency use authorization data public for COVID-19 vaccines: “The U.S. Food and Drug Administration said on Tuesday it would make public reviews of all data and information regarding the emergency use authorization (EUA) granted to COVID-19 drugs and vaccines.”

Ranking the effectiveness of worldwide COVID-19 government interventions: A comprehensive evaluation of non-pharmacological interventions around the world.

About pharma

House Passes Bill Targeting Orphan Drug Exclusivity: “The U. S. House of Representatives on Tuesday passed a bill that would require drugmakers to prove they don't expect to recoup research and development costs through sales of a new drug if they want market  exclusivity under a shield for drugs that treat rare diseases.”

 Purdue Pharma Gets Court Approval For $8B Deal With Feds: “A New York bankruptcy Judge on Tuesday approved Purdue Pharma's $8 billion settlement of federal felony charges stemming from its OxyContin sales and   said Purdue's former owning family can pay $225 million in fines without violating court orders.” 

 China pharma shares fall as western rivals lead in vaccine trials: “Successful trials of western pharmaceutical groups’ coronavirus vaccines have sliced more than $13bn off the market capitalisation of Chinese rivals, hitting Beijing’s ambitions to lead the global fight against the pandemic. An index tracking shares of 14 vaccine producers listed in Shanghai and Shenzhen has dropped 11 per cent since Pfizer first announced its positive phase-three trial results earlier this month, and is down about a third from its peak in August.”

About health insurance

CMS: Estimated improper Medicare payments down $15B since 2016: “CMS said the improper payment rate in Medicare fee-for-service declined to 6.27% in the 2020 federal fiscal year that ended in September. The rate is down from 7.25% in fiscal 2019 and 2020 is the fourth consecutive year that the rate is below 10%.
The decline in 2020 was primarily due to improvements in two areas. The first is home health, where CMS clarified documentation requirements and educated providers, resulting in a $5.9 billion decline in estimated improper payments from fiscal 2016 through 2020.
Another area that saw reductions was skilled nursing facilities, which saw a $1 billion decline in estimated improper payments in the last year.”

US Oncology Network Achieves Record Patient Enrollment for Oncology Care Model Program: “A total of 100,000 patients are now enrolled Centers for Medicare & Medicaid Innovation’s (CMMI) Oncology Care Model (OCM), as a result of the efforts of The US Oncology Network (The Network). Participation of The Network in OCM has saved Medicare a collective $122 million in the first 6 performance periods (PP).”

Healthcare exec pleads guilty to part in $1.2B Medicare fraud scheme: “Mr. Davydov was one of 24 defendants charged in April 2019 for his alleged participation in the overarching $1.2 billion healthcare fraud scheme. According to federal prosecutors, the complex scam began with telemarketers calling Medicare beneficiaries and getting them to accept free or low-cost durable medical equipment braces, regardless of medical necessity. The call centers would allegedly transfer Medicare beneficiaries to telemedicine companies for consultations with physicians, who allegedly prescribed the orthopedic braces to patients whom they had never met. The call centers would sell the prescriptions to DME companies, which shipped the braces to beneficiaries, billed Medicare and paid kickbacks to physicians, according to prosecutors. 
Mr. Davydov received and completed the physicians' orders and billed Medicare and private insurers for the braces. He concealed his ownership of the medical equipment companies by falsely reporting to Medicare that various straw owners owned the companies, according to the Justice Department.”