Today's News and Commentary

About the public’s health

WHO sees limited COVID-19 vaccine doses in early 2021: “The World Health Organization’s chief scientist said on Monday she expected there to be ‘very limited’ COVID-19 vaccine doses available in the first half of 2021.”

Use of adenovirus type-5 vectored vaccines: a cautionary tale: Different techniques are being investigated for effective SARS-CoV-2 vaccines. One of theses methods uses a viral delivery system. This article cautions that this type of virus has been used before in attempting to develop an HIV vaccine.
”Over a decade ago, we completed the Step and Phambili phase 2b studies that evaluated an Ad5 vectored HIV-1 vaccine administered in three immunisations for efficacy against HIV-1 acquisition. Both international studies found an increased risk [emphasis added] of HIV-1 acquisition among vaccinated men.”

A cervical cancer-free future: First-ever global commitment to eliminate a cancer: “WHO‘s Global Strategy to Accelerate the Elimination of Cervical Cancer, launched today, outlines three key steps: vaccination, screening and treatment. Successful implementation of all three could reduce more than 40% of new cases of the disease and 5 million related deaths by 2050.
Today’s development represents a historic milestone because it marks the first time that 194 countries commit to eliminating cancer - following adoption of a resolution at this year’s World Health Assembly.”
The article has the metrics that will be used in evaluating the success of this program.

Pfizer to start pilot delivery program for its COVID-19 vaccine in four U.S. states: “Pfizer Inc has launched a pilot delivery program for its experimental COVID-19 vaccine in four U.S. states, as the U.S. drugmaker seeks to address distribution challenges facing its ultra-cold storage requirements.
Pfizer’s vaccine, which was shown to be more than 90% effective in preventing COVID-19 based on initial data, must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F).”

Effect of School-Based Body Mass Index Reporting in California Public Schools: It is important to know what works as well as what does not. “Body mass index reports alone do not improve children’s weight status and may decrease weight satisfaction. To improve student health, schools should consider investing resources in evidence-based interventions.”

 About healthcare quality

Fortune and IBM Watson Health Recognize Top-Performing U.S. Cardiovascular Hospitals: “Extrapolating the results of this year's study, if all Medicare inpatients received the same level of care as those treated in the award-winning facilities more than 7,000 additional lives and over $1.6 billion could be saved annually, and more than 5,000 additional bypass and angioplasty patients could be complication-free.” Where is the Cleveland Clinic?

Cesarean Delivery and Gender of Delivering Physicians: ”Female physicians are less likely to perform cesarean delivery and less likely to prefer it. This was observed across different health systems and populations.”

About pharma

Amazon launches digital pharmacy: “The e-commerce giant on Tuesday unveiled Amazon Pharmacy, a section of its retail website and mobile application that lets people order medication. Shoppers can pay using their health insurance. Prime members who don’t use their insurance are eligible for discounts on generic and brand-name drugs on Amazon’s site or at about 50,000 participating pharmacies…
Walgreens Boots stock was down 8.8 percent this morning.”

Special Fraud Alert: Speaker Programs: This announcement is from HHS’ Inspector General. The framing as a fraud alert is novel.
”This Special Fraud Alert highlights the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies. For purposes of this Special Fraud Alert, speaker programs are generally defined as company-sponsored events at which a physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company.” 

Trump officials preparing to move forward with major step to lower Medicare drug prices:”The Trump administration is preparing to move forward with a major proposal to lower drug prices and rulemaking could come as soon as this week, according to people familiar with the effort.
The move, fiercely opposed by the pharmaceutical industry, would implement President Trumps’ ‘most favored nation’ proposal and lower certain Medicare drug prices to match prices in other wealthy countries.”

Evaluation of Time to Benefit of Statins for the Primary Prevention of Cardiovascular Events in Adults Aged 50 to 75 Years: “These findings suggest that statin medications for the primary prevention of cardiovascular events may reduce cardiac events for some adults aged 50 to 75 years with a life expectancy of at least 2.5 years; no data suggest a mortality benefit.”

A network medicine approach to investigation and population-based validation of disease manifestations and drug repurposing for COVID-19:”We identified that melatonin usage (odds ratio [OR] = 0.72, 95% CI 0.56–0.91) is significantly associated with a 28% reduced likelihood of a positive laboratory test result for SARS-CoV-2 confirmed by reverse transcription–polymerase chain reaction assay…
Importantly, melatonin usage (OR = 0.48, 95% CI 0.31–0.75) is associated with a 52% reduced likelihood of a positive laboratory test result for SARS-CoV-2 in African Americans after adjusting for age, sex, race, smoking history, and various disease comorbidities using PS [propensity score] matching.”
The results are interesting, but so is the technique used to extract the information.

About healthcare IT

Telemedicine and Office-Based Care for Behavioral and Psychiatric Conditions During the COVID-19 Pandemic in the United States: A good summary of the data about this process.

Trends in Outpatient Care Delivery and Telemedicine During the COVID-19 Pandemic in the US: This article is more general than the one above. “In this national study of a commercially insured population, growth in telemedicine use offset roughly two-thirds of the decline in in-person visit volume during the COVID-19 pandemic. Although there was geographic variation in the magnitude of changes, every state experienced a drop in total visits, illustrating the broad scope of deferred care during the first months of COVID-19.”

Newest clinical assessment tool allows AllianceRx Walgreens Prime cancer patients to manage care online: “Cancer patients who self-administer their therapy can now better manage their care online, thanks to the latest digital clinical assessment available only through AllianceRx Walgreens Prime. The newly-released self-serve tool simplifies patients’ online experiences when refilling their prescriptions. Earlier this year, AllianceRx Walgreens Prime announced the release of clinical assessments available for patients with chronic inflammatory disease, multiple sclerosis, cystic fibrosis, idiopathic pulmonary fibrosis, organ transplants, lipid and blood disorders. The addition of oncology to the clinical assessments means 85% of AllianceRx Walgreens Prime patients are eligible to use the online clinical assessment tool.”

About health insurance

Medicare Advantage Provider to Pay $6.3 Million to Settle False Claims Act Allegations:”Kaiser Foundation Health Plan of Washington, formerly known as Group Health Cooperative (GHC), agreed to pay $6,375,000 to resolve allegations that it submitted invalid diagnoses to Medicare for Medicare Advantage beneficiaries and received inflated payments from Medicare as a result…”

About hospitals and health systems

Premier, 34 systems partner with global medical manufacturer to create domestic gown maker: “Premier and 34 health systems including AdventHealth and Henry Ford Health System partnered with global medical manufacturer DeRoyal to create a new joint venture dedicated to the production of isolation gowns.” Recall hospitals are also getting into the generic pharma business to lower costs and meet shortage needs.

Today's News and Commentary

About the public’s health

Moderna's COVID-19 Vaccine Shines In Clinical Trial: Today’s top story. Like Pfizer-BioNTech’s vaccine, this one is also based on messenger RNA. The vaccine is reported to be about 95% effective after 2 doses. It does not require as stringent freezing as does the one from Pfizer-BioNTech.

Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration: How fast are “usual” vaccines developed? “Since 2010, most novel vaccines approved by the FDA required about 8 years [emphases added] of clinical development and were based on evidence from a median of 7 clinical trials, including at least 2 pivotal efficacy trials that were randomized, masked, and used a comparator group. These pivotal efficacy trials enrolled a median of 5000 patients, who were followed up for serious adverse events for at least 6 months.”

Unexpected detection of SARS-CoV-2 antibodies in the prepandemic period in Italy: “This study shows an unexpected very early circulation of SARS-CoV-2 among asymptomatic individuals in Italy several months before the first patient was identified, and clarifies the onset and spread of the coronavirus disease 2019 (COVID-19) pandemic. Finding SARS-CoV-2 antibodies in asymptomatic people before the COVID-19 outbreak in Italy may reshape the history of pandemic.”

Premature Years of Life Lost [PYLL] Due to Cancer in the United States in 2017: Just so we don’t lose track of other major illnesses during the pandemic, this article puts cancer deaths in perspective:
”PYLL was defined as the sum of the total years of life lost prior to age 75 years…The largest number of PYLL in 2017 was due to deaths from cancers of the lung/bronchus (891,313; 20.8%), colon/rectum (409,538; 9.6%), and breast (400,643; 9.4%). Cancers with the highest PYLLs generally also caused the largest number of deaths and had the highest mortality rates, with the exception of prostate cancer (5.1% of deaths, 2.0% of PYLL). In contrast, PYLLs per death were greatest for deaths due to cancers of testis (mean = 34.0 years), bones/joints (26.4), and other endocrine sites including thymus (25.2).” In sum, in 2017 there were more than 4 million PYLL.

J&J tops list of healthcare supply chains amid COVID vaccine effort—and Pfizer wins kudos, too: “J&J topped Gartner's top 25 list of healthcare supply chains for the second year in a row, just as the drugmaker gears up to distribute up to 1 billion doses of its investigational COVID-19 vaccine, Ad26.COV2.S, in 2021…Further down Gartner's list were fellow drugmakers Novo Nordisk (No. 11), Pfizer (No. 15), Roche (No. 21) and Biogen (No. 25). The list also highly ranked distributor McKesson (No.4), the U.S. government's partner in rolling out a range of COVID-19 vaccines to American patients.”

The Hot New Covid Tech Is Wearable and Constantly Tracks You: The article provides examples of all the entities using, or planning to use, wearable tracking devices that could pick up early signs of COVID-19.

About health insurance

Evaluation Of Medicare Alternative Payment Models: What The Data Show : This article is an excellent update evaluating the success of these different models. For example:
”The evidence indicates that ACOs continue to realize value-based care’s goal of providing better care at lower costs. Data from MedPAC, researchers at Harvard University, and the analytic firm Dobson DaVanzo and Associates show that ACOs are lowering Medicare spending annually by 1 percent to 2 percent. Knowing Medicare Parts A and B cost $636 billion in 2018, a 2 percent reduction in spending would save nearly $200 billion when compounded over a decade, assuming Medicare spending would grow at 4.5 percent per year without ACOs.
Importantly, based on the authors’ analysis of Centers for Medicare and Medicaid Services Public Use Files, ACOs also hit an average quality score of more than 94 percent in 2019, the latest year for which Medicare data are available.”

 Insurers' strong financial performance continues in Q3 as they brace for a potentially rocky Q4: “Major national health insurers continued to largely turn a significant profit in the third quarter, though numbers didn't quite reach the sky-high figures reported in the first half of the year.
And some warned that the fourth quarter could be ugly, with pent-up utilization and costs related to COVID-19 coming to a head.”
See the article for a good summary of the performances of the major companies.

About pharma

Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial: “We assessed the efficacy and safety of inhaled nebulised interferon beta-1a (SNG001) for the treatment of patients admitted to hospital with COVID-19…Patients who received SNG001 had greater odds of improvement and recovered more rapidly from SARS-CoV-2 infection than patients who received placebo, providing a strong rationale for further trials.”
As with many other drugs in this situation, more research needs to confirm its effectiveness.

Recommendations for five new drugs lead decisions from CHMP's November meeting: This article provides a good summary of what is happening in the pharma industry viewed through drug actions in the EU: “At its November meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended five drugs for approval, including one following a re-examination, as well as six line extensions. Meanwhile, the committee issued one negative opinion following a re-examination, with three companies also withdrawing marketing applications.”

11 drugs PBMs are adding back to their formularies after dropping last year: The headline speaks for itself; the article lists these medicines and the PBMs that re-added them.

About healthcare professionals

Authority of VA Professionals To Practice Health Care: This statement from the Federal Register is a really important departure from state-specific licensure laws. The immediate impact will be on telemedicine.
“The Department of Veterans Affairs (VA) is issuing this interim final rule to confirm that its health care professionals may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice. Specifically, this rulemaking confirms VA's current practice of allowing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other State requirement, thereby enhancing beneficiaries' access to critical VA health care services. This rulemaking also confirms VA's authority to establish national standards of practice for health care professionals which will standardize a health care professional's practice in all VA medical facilities.”

About healthcare quality

A Call for Action: Insights From a Decade of Malpractice Claim: A really good summary of trends by specialty and cause. For example, the top two allegations are surgery/procedure-related (29.2%) and diagnosis-related (27.3%). Together they account for 59% of payments.

Today's News and Commentary

About healthcare IT

Amwell® Announces Results for Third Quarter 2020: The telehealth company announced 3Q results. Compared to the same period last year:

• “Total active providers of approximately 62,000 at the end of the third quarter increased 930% compared to a year ago

• Total visits of 1,414,000 in the third quarter increased 450% compared to a year ago

• Revenue of $62.6 million in the third quarter increased 80% compared to a year ago…

• Net loss was $(64.6) million, compared to $(24.1) million”

About the public’s health

The US has added half a million new coronavirus cases since Monday: “The US has added more than half a million new Covid-19 cases since hitting 10 million on Monday, according to data from Johns Hopkins University. 
At this rate, the number should pass 11 million in the next four days, making for the fastest addition of another million yet, John Hopkins data show.”

Trump Administration Partners with Chain and Independent Community Pharmacies to Increase Access to Future COVID-19 Vaccines: “To maximize access to COVID-19 vaccines for all Americans, the U.S. Department of Health and Human Services (HHS)… announced the U.S. government’s partnerships with large chain pharmacies and networks that represent independent pharmacies and regional chains. Through the partnership with pharmacy chains, this program covers approximately 60 percent of pharmacies throughout the 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands.”

Survey: Americans Likely to Attend Large Holiday Gatherings Despite COVID-19: “A new national survey by The Ohio State University Wexner Medical Center finds that although a majority of Americans plan to take precautions at holiday gatherings, such as social distancing and asking those with COVID symptoms not to attend, many will also put themselves at risk. Nearly two in five report they will likely attend a gathering with more than 10 people and a third will not ask guests to wear masks.”
And in a related story: At dinner parties and game nights, casual American life is fueling the coronavirus surge as daily cases exceed 150,000.

Progress Toward Regional Measles Elimination — Worldwide, 2000–2019: Not everything can be blamed on COVID-19.
“During 2000–2016, annual reported measles incidence decreased globally; however, measles incidence increased in all regions during 2017–2019. Since 2000, estimated measles deaths decreased 62% and measles vaccination has prevented an estimated 25.5 million deaths worldwide. No WHO region has achieved and maintained measles elimination.”
In the US: “From January 1 to December 31, 2019, 1,282* individual cases of measles were confirmed in 31 states. This is the greatest number of cases reported in the U.S. since 1992. The majority of cases were among people who were not vaccinated against measles.”
Laxness in attention to currency of vaccinations as well as availability (in developing countries) are contributing factors. Of course, in developed countries, the anti-vaxers are part of the problem.

COVID-19 fatality rate down 30% since April, study finds: “In the United States, COVID-19 now kills about 0.6% of people infected with the virus, compared with around 0.9% early in the pandemic…”
The “statistics reflect that doctors have figured out better ways to care for patients, including the use of blood thinners and oxygen support. Effective treatments, such as the generic steroid dexamethasone, have also been identified.”

CureVac Says Its COVID-19 Vaccine Can Be Stored Under Normal Refrigeration: “German drugmaker Curevac says its COVID-19 vaccine candidate, CVnCoV, can remain stable for at least three months at 41 degrees Fahrenheit (5 degrees Celsius), making it easier to distribute than some competitors’ vaccines.
This storage temperature would present fewer distribution challenges than the Pfizer/BioNTech vaccine that must be kept at an ultra-cold -94 degrees Fahrenheit (-70 degrees Celsius).”
However, this vaccine will not be one of the first ones on the market.

About health insurance

CMS: More than 800K signed up for ACA plans on HealthCare.gov on first week of open enrollment:”The Centers for Medicare & Medicaid Services, which reported the numbers late Thursday, said that there were 173,344 new consumers and 645,021 who renewed their coverage for 2021.”

Medical groups implore Congress to extend moratorium on sequester cuts as COVID-19 ramps up: “A collection of provider and payer groups are imploring Congress to continue a moratorium on Medicare payment cuts instituted under the sequester.
The letter sent Friday by more than 20 groups to congressional leaders is concerned that the moratorium installed under the CARES Act expires on Jan. 1. The groups want the moratorium to extend through the COVID-19 public health emergency, which has been renewed by the federal government several times.
The groups said that the moratorium needs to be extended as healthcare facilities are under massive financial stress with new surges of COVID-19.”

Mechanicsburg Physician To Pay $850,000 To Resolve Potential Liability Under The False Claims Act: “The United States Attorney’s Office for the Middle District of Pennsylvania announced today that Nava K. Nawaz, M.D. of Mechanicsburg, PA has agreed to pay the United States $850,000 to resolve allegations that she submitted fraudulent travel claims to the Medicare program.  As part of the settlement, Dr. Nawaz has also agreed not to seek or be an owner or operator of a laboratory for the next 18-months. According to U.S. Attorney David J. Freed, Dr. Nawaz used her laboratory company Perll Diagnostics, Inc. to defraud Medicare by submitting over 23,000 false and inflated travel reimbursement claims for specimen collection and testing between 2014 and 2017.  In doing so, the government contends that Dr. Nawaz misrepresented the distances traveled by Perll’s lab technicians and wrongly obtained taxpayer dollars for travel that never occurred.”
Notice how cases like this one almost always involve Medicare or Medicaid, as opposed to private insurance.

About pharma

Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: “In this preliminary study, adult outpatients with symptomatic COVID-19 treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days; however, determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.”

Today's News and Commentary

About the public’s health

STAT-Harris Poll: Most Americans won’t get a Covid-19 vaccine unless it cuts risk by half:The latest poll on this issue: “Six in 10 Americans said they are somewhat or very likely to get a Covid-19 vaccine if doing so would lower the risk of becoming infected by about half, according to a new survey from STAT and The Harris Poll. The poll also found that more Americans say they are likely to get a vaccine, practice social distancing, and wear a mask if they or someone they know has contracted Covid-19.”

Association of Racial/Ethnic and Gender Concordance Between Patients and Physicians With Patient Experience Ratings:”In this study, higher Press Ganey survey scores were associated with racial/ethnic concordance between patients and their physicians; thus, efforts to improve the patient experience among racially/ethnically discordant patient-physician dyads may be necessary to improve health care delivery.”

These are the top coronavirus vaccines to watch: This article is the latest in periodic updates from The Washington Post.

About health insurance

Medicare beneficiaries can get monoclonal antibody COVID-19 treatments at no cost: “Medicare beneficiaries won't have to pay out-of-pocket for monoclonal antibody treatments of COVID-19 for the duration of the public health emergency, the Centers of Medicare and Medicaid announced…”

Biden Plan to Lower Medicare Eligibility Age to 60 Faces Hostility From Hospitals: The article is a good summary of this proposal and potential problems with and barriers to its enactment.

CVS Health invests nearly $9 million for new Orlando affordable housing: “CVS Health, the corporation that emerged from a drug-store chain, is investing $8.7 million to help build affordable housing in Orlando, officials announced Tuesday.
The project — Fairlawn Village — is a $24 million, 116-unit affordable housing complex that is part of the city of Orlando’s master plan for the Mercy Drive corridor, an area once dominated by blight.”
Hospitals have set up most of these housing programs…this spin is a bit unusual.

Virginia physician convicted on 52 charges related to billing fraud scheme:”A federal jury convicted Javaid Perwaiz, MD, on Nov. 9 of 52 counts related to his scheme to perform unnecessary hysterectomies and other surgeries on women and bill insurers for the procedures, according to the Department of Justice. 
According to court records, Dr. Perwaiz billed government and commercial insurers for millions of dollars of surgeries that were not medically necessary for his patients between 2010 and 2019. In many cases, Dr. Perwaiz allegedly told patients they needed the surgeries to avoid cancer to get them to agree to the procedures. 
Evidence presented at trial also showed that Dr. Perwaiz falsified records for his obstetric patients so he could induce their labor early to ensure he would be able to conduct and be reimbursed for the deliveries, according to the Justice Department.”
It is very disturbing that he was found out by insurance fraud and not with quality review by peers.

About healthcare providers

Direct primary care provider acquires 230 clinics, changes name: “Paladina changed its name to Everside after completing the acquisition of Charlotte, N.C.-based Healthstat's 230 clinics. Everside now operates 350 health clinics in 32 states and has partnerships with several health systems, including Chicago-based CommonSpirit Health and St. Louis-based SSM Health.”

Today's News and Commentary

The Supreme Court heavily weighed the issues of severability and standing when it heard oral arguments in the ACA case yesterday. The consensus seems to be that the entire law (with or without the mandate) will be upheld by at least a 5-4 vote. Here is what the NY Times , Washington Post and Bloomberg Law say.

About the public’s health

Agency Review Teams: Here are the review teams that will direct the transition for the Biden-Harris transition.

Scientific Brief: Community Use of Cloth Masks to Control the Spread of SARS-CoV-2: From the CDC: “Experimental and epidemiological data support community masking to reduce the spread of SARS-CoV-2. The prevention benefit of masking is derived from the combination of source control and personal protection for the mask wearer.” [Emphasis added]

Preexisting and de novo humoral immunity to SARS-CoV-2 in humans:”Using diverse assays for antibodies recognizing SARS-CoV-2 proteins, we detect preexisting humoral immunity. SARS-CoV-2 spike glycoprotein (S)-reactive antibodies were detectable by a flow cytometry-based method in SARS-CoV-2-uninfected individuals and were particularly prevalent in children and adolescents.”
This finding may explain why children usually do not get as severe COVID-19 illness as do adults.

Amid cold chain blues, Pfizer looks to powder vaccine formula in 2021: report: “Pfizer on Monday revealed stellar early results from its phase 3 COVID-19 vaccine trial, but the news was quickly met with concerns about access as the vaccine comes with hefty cold chain requirements. Pfizer, for its part, already has its sights set on a next-generation formula that could help resolve those storage concerns, the drugmaker's top scientist said.”

Tested by a pandemic, pharma supply chain showed resilience: The headline speaks for itself and gives examples.

Almost 1 in 5 Parents Are 'Vaccine Hesitant,' Study Finds: “Nearly one in five American parents described themselves as ‘hesitant about childhood shots’ in 2019, a new U.S. government study finds.
That was fewer than the one in four who expressed hesitancy about vaccines in 2018.
The new research found real consequences from vaccine hesitancy. Rates of flu vaccination were 26 percentage points lower in children of "vaccine-hesitant" parents in both years studied.”

Several state leaders are urging residents to stay home as Covid-19 hospitalizations hit a record level: The headline speaks for itself.

Suburban Chicago Businessman Charged With Swindling Hospitals in Connection With Attempted Purchase of $2.6 Million in PPE: The orders were never filled, though the money was received. And a related story: More than Half of Disposable Gowns ECRI Tested Fail to Meet Necessary Protection Standards
About healthcare IT

Updates on 10 hospital malware attacks: Just a reminder that this problem is still very much with us.

The US Government Will Pay Doctors to Use These AI Algorithms: “The US Centers for Medicare & Medicaid Services (CMS) recently said it would pay for use of two AI systems: one that can diagnose a complication of diabetes that causes blindness, and another that alerts a specialist when a brain scan suggests a patient has suffered a stroke. The decisions are notable for more than just Medicare and Medicaid patients—they could help drive much wider use of AI in health care.
Both products are already cleared by the Food and Drug Administration and are in use by some providers. But new devices and treatments generally aren’t widely used until the US government authorizes payments for Medicare and Medicaid patients. Private insurers often take their cues on whether to cover a new invention from CMS, although they usually pay higher rates.”

Effect of an Electronic Health Record “Nudge” on Opioid Prescribing and Electronic Health Record Keystrokes in Ambulatory Care: “Autocompleting prescription forms with guideline-recommended values was associated with a large increase in guideline concordance in an organization where baseline concordance was low, but not in an organization where it was already high. The redesign markedly reduced the number of keystrokes needed to place orders, with important implications for EHR-related stress.” This method could be applied to other prescriptions, like antibiotics.

Association of Display of Patient Photographs in the Electronic Health Record With Wrong-Patient Order Entry Errors: “The results of this study suggest that capturing patient photographs and displaying them in the electronic health record may be a simple and cost-effective strategy for reducing wrong-patient errors.”

About pharma

Health officials to begin distribution of Eli Lilly antibody drug this week: “The federal government will begin distributing Eli Lilly's coronavirus antibody treatment this week, but supplies will be limited and getting the drug into infected patients will be a challenge, officials said.
The drug itself is administered through an IV infusion that takes more than an hour and requires another hour of observation afterward, officials said.”

About health insurance

Court sides with UnitedHealth in mental health denial case: “UnitedHealthcare didn't violate federal or state parity laws in denying coverage for out-of-state mental health services sought by one of its members, an appellate court said in a Nov. 9 opinion.
The opinion comes as UnitedHealthcare faces growing scrutiny of its mental health coverage denials. 
On Nov. 4, a federal judge ordered UnitedHealth Group to redo 67,000 medical claims for behavioral healthcare that it previously denied. The order followed a March 2019 ruling that found UnitedHealth instituted guidelines that denied care to patients needing mental health treatment to cut costs.”

Harvard Pilgrim Health Care and Doctor On Demand Launch SimplyVirtual: “Harvard Pilgrim Health Care today announced the launch of SimplyVirtualSM, a new, innovative model for health care that gives members access to virtual visits with primary care providers (PCPs) and care team support through its existing partner, Doctor On Demand. The new plan will be available to large employers (51+ subscribers) in Connecticut, with a January 1, 2021 effective date. SimplyVirtualSM is the first virtual primary care plan being offered by a health insurance company in Connecticut.”

ACA Offers Protection as the COVID-19 Pandemic Erodes Employer Health Insurance Coverage: The study was done by the RWJF:

• “The share of adults with employer-sponsored insurance fell from 64.9 percent in late March/early April to 63.4 percent in mid-to-late September, which is equivalent to about 3.1 million adults.

• The drop in employer coverage did not correspond with a statistically significant increase in the uninsurance rate, which was 11.5 percent in March/April and 11.9 percent in September.   

• The losses in employer coverage were mostly offset by increases in Medicaid/CHIP and nongroup coverage.”

About healthcare providers

Rite Aid unveils its 'stores of the future' in bid to become healthcare destination: “Rite Aid has officially unveiled its new concept stores as it overhauls its brand to keep up with competitors like CVS Health and Walgreens.
The pharmacy chain opened the third store built around its ‘Stores of the Future’ model in Moscow, Pennsylvania, with plans to open further stores in other markets over the next several months.
The redesigned stores, which are part of the company's broader RxEvolution brand overhaul, bring pharmacists out from behind the counter to enable them to communicate more directly with customers, and includes an overhauled assortment of products aimed at ‘clean, healthy living,’ Rite Aid said.”

Oak Street Health opens 13 health centers in Q3 as revenue jumps 57%: “The company has yet to be profitable and reported that its losses deepened during the quarter to $59 million, compared to a loss of $33 million in the third quarter of 2019. Net share per share came to a loss of 15 cents.
Oak Street now operates 67 centers serving around 90,000 patients with about 66% of those patients are under capitation agreements.”

Today's News and Commentary

As mentioned yesterday, arguments start today in the Supreme Court over the future of the ACA.

About the public’s health

SARS-CoV-2 survives for 9 hours on human skin: “ARS-CoV-2 can survive on human skin for about 9 hours — significantly longer than influenza A virus — underscoring the importance of hand hygiene, researchers said.
Recent studies have looked at how long SARS-CoV-2 can survive on surfaces, with one analysis demonstrating that the virus was still viable for up to 28 days on glass, polymer currency, stainless steel, vinyl and paper currency.”

HHS Released More Coronavirus Vaccine Contracts As Election Results Unfolded: The concern is lack of full transparency and consumer protections, including prices.

About health insurance

2019 MLR [Medical Loss Ratio] Rebates by State: Based on MLR reports filed through October 16, 2020, CMS issued national totals and per state amounts. The total is $2.458B with an average across all markets of $219 per person. Large rebates were expected because of the huge number of delayed elective procedures during the COVID-19 pandemic.

Screening for High Blood Pressure in Children and AdolescentsUS Preventive Services Task Force Recommendation Statement: “The USPSTF concludes that the evidence to support screening for high blood pressure in children and adolescents is insufficient and that the balance of benefits and harms cannot be determined.”

About pharma

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19: “Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) [to Eli Lilly & Co.] for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.”

Trial results reveal that long-acting injectable cabotegravir [CAB LA] PrEP is highly effective in preventing HIV acquisition in women: The WHO published a study showing that “CAB LA is significantly more effective in preventing HIV acquisition than oral PrEP in an intention-to-treat analysis from this trial.” The problem now is distribution and guaranteeing that it can be administered monthly.

Accelerating Regulatory Product Development and Approval for Drugs and Biologics in the US: This monograph is very timely as many products are being approved through this process to combat the COVID-19 pandemic.

About hospitals and health systems

Medical tourism craters during coronavirus pandemic, hospitals lose billions: The headline speaks for itself.

About healthcare IT

Cigna Ventures, Humana, and Optum Ventures Among Investor Set Re-Upping in Buoy Health Series C Financing: “Buoy Health, the AI-powered healthcare navigation platform, today announced the completion of a $37.5 million Series C funding round. Cigna Ventures and Humana led the funding round and were joined by Optum Ventures, WR Hambrecht + Co, and Trustbridge Partners. To date, Buoy has raised $66.5 million…
Buoy will use the proceeds to further buildout its IP with respect to artificial intelligence and other technologies…”
Check the Buoy website for details about how it works. What is newsworthy is the payer investment.

FDA clears Apple Watch sleep app that intervenes to stop nightmares caused by PTSD: “The FDA has cleared an app for the Apple Watch to help people suffering from nightmares or post-traumatic stress disorder (PTSD) get a better night’s sleep.
Dubbed Nightware, the prescription app monitors the wearer’s heart rate and movement while they sleep—and, if they’re having a nightmare, gently prods them out of the dream without aiming to wake them up completely, using the smartwatch’s vibrations.”

Today's News and Commentary

Despite some of the really important news today, the lead healthcare story is that tomorrow the Supreme Court will hear California v. Texas, deciding the fate of the ACA.

About the public’s health

PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19 ACHIEVED SUCCESS IN FIRST INTERIM ANALYSIS FROM PHASE 3 STUDY: This messenger RNA vaccine is the first of its kind. Here is what Pfizer reported today:

• “Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis

• Analysis evaluated 94 confirmed cases of COVID-19 in trial participants

• Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected

• Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November

• Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints”

The Health 202: Biden is expected to unwind dozens of Trump-era health-care changes: A really good summary of these projected policy changes as well as who may serve in healthcare posts in the new government.

President-elect Joe Biden announces Covid task force: Read the article for the listing and also, see: President-Elect Biden Has A Plan To Combat COVID-19. Here's What's In It for the agenda go the task force.

United States nears 10 million coronavirus cases: Sadly, the headline speaks for itself.

Biden team held COVID-19 talks with Operation Warp Speed drugmakers before election: “In their talks, Biden’s advisers indicated to drug company officials that his administration would not be interested in making changes to Warp Speed that would disrupt work in getting new drugs and vaccines to market, Bloomberg reported, adding his administration will want to assist the companies’ efforts when Biden assumes office.”

FDA authorizes first test that screens for Covid-neutralizing antibodies:

• “The Food and Drug Administration announced on Friday that it has authorized the first serology test that screens for neutralizing antibodies caused by a previous coronavirus infection.

• Neutralizing antibodies prevent viruses from infecting cells, though questions remain about how long antibodies against Covid-19 last and how much protection they provide.

• Patients and health providers should not interpret the positive results of the test to mean that patients are protected against Covid-19, the FDA said.”

An Explanation for Some Covid-19 Deaths May Not Be Holding Up: “Recent studies have created doubts about an agent in cytokine storms, and suggest that treatments for it may not help.”

About pharma

Biogen Alzheimer’s drug in doubt after criticism from expert panel: “The future of Biogen’s potential blockbuster Alzheimer’s treatment was thrown back into doubt on Friday when an unusually combative scientific panel contradicted the positive conclusions of staff at the US drug regulator. 
The panel voted that the company’s main trial data did not provide enough evidence that the drug, aducanumab, really worked.”

Sandoz ships first medicine in collaboration with Civica Rx to supply US hospitals: Sandoz Inc. “announced that it has shipped pantoprazole sodium for injection, 40 mg to Civica Rx to supply the hospitals it serves as part of a multiyear collaboration to help reduce supply shortages, with several other medicines on the way before the end of the year.
Pantoprazole is the first Sandoz medicine to ship to Civica since entering into the agreement in July… Sandoz previously announced it will supply six injectable medicines under the Civica private label to its 1,200 US hospitals.”

The 2020 Fierce Pharma Marketing Awards: See who won and what their ad campaigns looked like.

About health insurance

A battle of Blue Cross plans is brewing: “A tentative $2.7 billion settlement of an antitrust case would free Blue Cross plans to invade each other's markets. Under the deal, the Blue Cross Blue Shield Association agreed to loosen a rule that barred such competition.”

Medicare’s ‘Part B’ outpatient premium to rise by $3.90: “Medicare’s ‘Part B’ monthly premium for outpatient care will go up by $3.90 next year to $148.50, officials announced late Friday afternoon. 
For most retirees, the health care cost increase will claim a significant slice of their Social Security cost-of-living adjustment, or COLA. It works out to nearly 20% of the average retired worker’s COLA of $20 a month next year.”

About healthcare IT

Pear Therapeutics Announces Publication of Real-World Data Demonstrating Impact of reSET-O for Patients with Opioid Use Disorder: “Data from more than 3000 patients prescribed and using reSET-O across the U.S. supports high real-world engagement and a positive association between product use and outcomes of reduced illicit opioid use and retention in treatment.”
reSET-O is an FDA-approved app that is used with buprenorphine.

Digital stethoscope maker Eko nets $65M to develop home telehealth offerings: “The company’s Duo stethoscope captures both heart sounds and electrocardiogram readings, and is connected to an AI program that received an FDA clearance at the top of this year to detect the signs of atrial fibrillation and heart murmurs.”

Today's News and Commentary

About health insurance
Medicaid Expansion and Mortality Among Patients With Breast, Lung, and Colorectal Cancer: “Among patients with newly diagnosed breast, colorectal, and lung cancer, Medicaid expansion was associated with a decreased hazard of mortality in the postexpansion period, which was mediated by earlier stage of diagnosis.”

Nashville school district leader overhauls maternity benefit pricing:Vanderbilt University and Nashville teachers created “MyMaternityHealth — a maternity benefit that bundles all costs associated with pregnancy and delivery into one price for employers. The price is adjusted based on whether the individual pregnancy is low, medium or high-risk. By eliminating out of pocket costs, employees save approximately $2,500 each time they have a baby.”

A New Item on Your Medical Bill: The ‘Covid’ Fee: “The coronavirus pandemic has made the practice of health care more costly as providers must wear protective gear and sanitize equipment more often, even as they face declining revenue. Two groups of providers have been particularly hard hit. Dentists have lost billions since patients began postponing nonurgent dental care this spring. And assisted living facilities, grappling with lower overall demand, have also been forced to admit fewer residents to help stop the spread of infection
To address this financial shortfall, some health providers are turning directly to patients. Surprise ‘Covid’ and ‘PPE’ fees have turned up across the country, in bills examined by The New York Times.”

Trends in Birth Rates After Elimination of Cost Sharing for Contraception by the Patient Protection and Affordable Care Act: “In this cross-sectional study, the elimination of cost sharing for contraception under the ACA was associated with improvements in contraceptive method prescription fills and a decrease in births among commercially insured women. Women with low income had more precipitous decreases than women with higher income, suggesting that enhanced access to contraception may address well-documented income-related disparities in unintended birth rates.”

About the public’s health

More state officials announce restrictions as US tops 100,000 new Covid-19 infections for second day in a row: The headline speaks for itself as the number of national cases continues to grow.

CDC seeks input on proposal to centralize COVID-19 laboratory test reporting:”The Centers for Disease Control and Prevention would like to partner with one or more organizations to enable centralized reporting from COVID-19 testing entities to public health departments, the agency said this week in a request for information.”

World Health Assembly charts course for COVID-19 response and global health priorities: The headline speaks for itself.

Prothrombotic autoantibodies in serum from patients hospitalized with COVID-19: “Patients with COVID-19 are at high risk for thrombotic arterial and venous occlusions. Lung histopathology often reveals fibrin-based occlusions in the small blood vessels of patients who succumb to the disease…
These findings suggest that half of patients hospitalized with COVID-19 become at least transiently positive for aPL [Antiphospholipid] antibodies and that these autoantibodies are potentially pathogenic.”

Distinct antibody responses to SARS-CoV-2 in children and adults across the COVID-19 clinical spectrum: Children and adults develop different antibody patterns if infected with SARS-CoV-2. More specifically, this research suggests “a distinct infection course and immune response in children independent of whether they develop MIS-C [multisystem inflammatory syndrome]…” This finding has “implications for developing age-targeted strategies for testing and protecting the population.”

First COVID-19 Vaccine Doses To Go To Health Workers, Say CDC Advisers: “Health care workers will almost certainly get the first doses of COVID-19 vaccine in the U.S. when one is approved, according to Dr. José Romero, head of the committee that develops evidence-based immunization guidelines for the Centers for Disease Control and Prevention.”

About hospitals and health systems

19 hospitals with strong finances: While this article is FYI, note that six of the nineteen are children’s hospitals.

About pharma

Some financial results from pharma companies:
BMS bumps up full-year profit estimate as Q3 sales surge 75%;
Teva posts wider loss in Q3 after $4.6-billion impairment charge;
Eisai's sales gain, profit slips in second quarter

Controversial Alzheimer’s drug gets boost from FDA staff: “A [Biogen] drug that would be the first new treatment for Alzheimer’s disease in nearly two decades received a vote of confidence Wednesday from Food and Drug Administration clinical reviewers, who said ‘exceptionally persuasive’ data showed the drug slowed cognitive decline caused by the devastating ailment.”

Antirheumatic metallodrug can resurrect 'last resort' antibiotics to kill multi-drug resistant superbugs: “A research team from Hong Kong University discovered “that by repurposing an antirheumatic gold drug, auranofin (AUR), ‘last-resort’ antibiotics can be resensitized for treatment of infections caused by multidrug-resistant superbugs including bloodstream infections, pneumonia and wound infections.
The findings provide insights into development of inorganic pharmaceutics and new therapeutic approach for superbug infections.”
This finding, if reproduced, could have a significant impact on the growing problem of drug resistant infections.

A decision algorithm to promote outpatient antimicrobial stewardship for uncomplicated urinary tract infection: ”Kanjilal et al. applied a machine learning approach calibrated to local hospital electronic health record data to predict the probability of resistance to first- and second-line antibiotic therapies for uncomplicated UTI. The algorithm then recommended the least broad-spectrum antibiotic to which a given isolate was predicted nonresistant. Use of the pipeline reduced both broad-spectrum and ineffective antibiotic prescription for UTI in the patient cohort relative to clinicians, suggesting the clinical potential of the approach.”
The frequency of urinary tract infections has caused an increase in drug resistance. This successful use of an algorithm for treatment decision-making may alleviate that problem and lower cost.

About healthcare IT

FCC’S Connected Care Pilot Program Application Window to Open on November 6: Public Notice Outlines Application Submission Process and Eligible Services: “The Connected Care Pilot Program is open to nonprofit and public eligible health care providers, located anywhere in the country. Specifically, the Pilot Program will use Universal Service Fund monies to help defray the costs of connected care services for eligible health care providers, providing support for 85% of the cost of eligible services and network equipment, which include: (1) patient broadband Internet access services; (2) health care provider broadband data connections; (3) other connected care information services; and (4) certain network equipment. The Pilot Program will not provide funding for end-user devices.”

About supply chains

Vizient to Acquire Intalere, Expanding its Supply Chain Capabilities: Vizient announced “that it has signed an agreement under which it will acquire Intalere from Intermountain Healthcare, enhancing itself as a leader in the health care supply chain. Intermountain Healthcare will now partner with Vizient for supply chain solutions and services, thereby expanding their current relationship with Vizient in clinical and cost analytics.”

AAFP [ American Academy of Family Practice], Other Groups Decry DEA Telemedicine Rule-making Delay: More than “80 health care professional, insurer, behavioral health and telehealth provider groups ― including the AAFP ― recently sent to the Drug Enforcement Administration, calling for the agency to ‘expedite and complete its efforts to implement a telemedicine special registration process enabling providers to safely prescribe controlled substances remotely.’
In the Oct. 26 missive to DEA Acting Administrator Timothy Shea, the organizations urge that the special registration process outlined in a provision of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 be finalized so physicians and other qualified health care professionals can use telemedicine to prescribe certain medications to treat substance use disorders.”

Today's News and Commentary

About the public’s health
Rich Countries Reserve Billions Of Covid-19 Vaccine Doses Even Before There Is One: “Currently there are nearly 200 Covid-19 candidates that are moving forward through the development and clinical trials processes, and over ten candidates are already in Phase-3 large-scale trials, the analysis found. The confirmed purchases from countries cover nearly four billion doses of vaccines, with another five billion doses under negotiation. 
There will not be enough vaccine to cover the world’s population until 2024, according to current models taking into account the manufacturing capacity.”

The US just reported more than 100,000 new Covid-19 infections, the most cases in a single day since pandemic's start: The headline speaks for itself.

More than a million Americans live without indoor plumbing — and most of them live in big cities: “An estimated 471,000 households or 1.1 million individuals lack connection to piped water, according to a recent study.
Researchers also revealed racial disparities in access to water in urban areas across the United States.”

Cigna says health utilization continued to rebound in Q3: “Cigna, which posted a $1.39 billion profit in the third quarter, said that healthcare use remains slightly below average when not taking into account costs for COVID-19. The insurer's performance in the quarter was bolstered by its newly rebranded Evernorth subsidiary.  
Cigna executives said that utilization was 95% below [I think they meant 95% of normal levels]normal levels without factoring COVID-19 costs.”

About pharma

Merck to Acquire VelosBio: “Merck… and VelosBio Inc. today announced that the companies have entered into a definitive agreement pursuant to which Merck, through a subsidiary, will acquire all outstanding shares of VelosBio for $2.75 billion in cash, subject to certain customary adjustments. VelosBio is a privately held clinical-stage biopharmaceutical company committed to developing first-in-class cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1).”

About healthcare markets

Health care still loves a divided Congress: “Health care stocks skyrocketed after Tuesday's election results indicated Republicans likely will maintain control of the Senate, all but assuring continued gridlock in both chambers of Congress…
The winners: Health insurance companies, pharmaceutical companies and medical device firms scored the biggest stock gains.”

About healthcare IT

The 146 telehealth services Medicare is covering during the pandemic: “CMS since March has expanded the number of services Medicare will cover when provided via telehealth to help support access to healthcare during the COVID-19 pandemic.”

About healthcare professionals

Assessment of Changes in Rural and Urban Primary Care Workforce in the United States From 2009 to 2017: “In this study, the density of primary care clinicians increased overall, yet rural-urban disparities in the primary care workforce are increasing in the US.”

About health insurance

UnitedHealth ordered to reprocess 67,000 mental health claims:”UnitedHealth Group must redo 67,000 medical claims for behavioral healthcare that it previously denied, a federal judge ordered Nov. 4. 
The order comes after a March 2019 ruling from Judge Joseph Spero of the U.S. District Court of Northern California. He ruled that a UnitedHealth unit instituted guidelines that denied care to patients needing mental health treatment to cut costs.”

Today's News and Commentary

About the public’s health
Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers: “The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2.” This FDA notice contains recommendations for minimizing this problem.

These are the top coronavirus vaccines to watch: This article is a really good summary by The Washington Post. Ten are in Phase III testing.

Pfizer to bypass gov't, use its own network to ship COVID-19 vaccine: “The pharma company will seek to ensure ‘end-to-end visibility and control’ in its distribution of millions of doses of its vaccine, once it's approved for use in the United States, according to Pfizer Vice President for Biopharma Global Supply Chain Tanya Alcorn.
Alcorn said rather than tap healthcare logistics provider McKesson, as recommended by federal regulators, the serious challenges involved in doling out a vaccine requires Pfizer to keep tight control of distribution.”

Special Diets Among Adults: United States, 2015–2018: From the CDC:
”Data from the National Health and Nutrition Examination Survey

• In 2015–2018, 17.1% of U.S. adults aged 20 and over were on a special diet on a given day.

• More women were on a special diet than men, and more adults aged 40–59 and 60 and over were on a special diet than adults aged 20–39.

• More non-Hispanic white adults (17.8%) were on a special diet than non-Hispanic black (14.7%) and non-Hispanic Asian (14.9%) adults.

• The most common type of special diet reported among all adults was a weight loss or low-calorie diet.

• From 2007–2008 through 2017–2018, the percentage of adults on any special diet, weight loss or low-calorie diets, and low carbohydrate diets increased, while the percentage of adults on low-fat or low-cholesterol diets decreased.”

Climate change: US formally withdraws from Paris agreement: “After a three-year delay, the US has become the first nation in the world to formally withdraw from the Paris climate agreement.
President Trump announced the move in June 2017, but UN regulations meant that his decision only takes effect today, the day after the US election.
The US could re-join it in future, should a president choose to do so.”

California dialysis measure fails, mixed results for tobacco taxes in state-level ballot measures: Here are some health-related ballot decisions from yesterday’s state election proposals.

About healthcare IT

2020-2025 Federal Health IT Strategic Plan: This document is a detailed outline of the mission, vision and goals for the Office of the National Coordinator for the next five years.

Pediatrician Electronic Health Record Time Use for Outpatient Encounters: “Pediatric physicians spent an average of 16 minutes per encounter using their EHR. Chart review (31%), documentation (31%), and ordering (13%) functions accounted for most of the time. The distribution of time spent by providers using their EHR is highly variable within subspecialty but is similar across specialties.”

Interview with current Administrator of The Centers for Medicare & Medicaid Services on how the pandemic bolstered digital health use: Among the key points is: “Before the pandemic, 14,000 Medicare beneficiaries used telehealth weekly—but from mid-March to early-July, over 10 million beneficiaries received care via telehealth.”

About health insurance

New York ER docs sue UnitedHealth for alleged underpayments: The story is state-specific but the issue has been in the news around the country.

The feds paid $1.5B to states to cover uninsured COVID-19 costs. These states got the most: “The federal government has paid out $1.5 billion to cover the testing and treatment of uninsured COVID-19 patients, and states with high uninsured rates are getting the most dollars…
The state with the highest COVID-19 reimbursement per person was New Jersey with $586 per case.”

DC Circ. Judge Dubious Of Medicare Overpayment Rule Fight:  “ A D. C. Circuit judge didn't seem swayed Tuesday by UnitedHealthcare Insurance Co. 's push to affirm a lower court order vacating a Medicare Advantage overpayment rule with multibillion-dollar implications for reimbursement as she pressed an attorney for the country's largest seller of private Medicare policies to explain why the rule is unlawful.”

Centers for Medicare and Medicaid Services announces 51 direct contracting entities:”Direct contracting is the next CMMI model and is based on Next Generation, Medicare Shared Savings and Medicare Advantage plans…
The 51 direct contracting entities serve beneficiaries in 39 states as well as in the District of Columbia and Puerto Rico.”

About pharma
McKesson Indicates Opioid Settlement Could Reach $21 Billion: “McKesson and two other U.S. drug distributors could pay an estimated $21 billion to resolve thousands of state lawsuits over their alleged role in fueling the opioid addiction epidemic, according to McKesson’s latest quarterly report.”

About medical devices

FTC OKs Stryker's $4B Wright Medical Deal, With Divestitures “The Federal Trade Commission is requiring medical device company Stryker Corp. to divest all its ankle replacement and finger joint implant products before going forward with its slated $4 billion acquisition of rival Wright Medical Group NV, the agency said Tuesday, in an effort to quell antitrust concerns stemming from the proposed merger. The FTC said Stryker will have to divest its ankle and finger joint businesses to DJO Global Inc. and give the company transition assistance so it can become an ‘independent, viable, and effective competitor’ in those markets.”

About healthcare professionals

Association Between Industry Payments to Physicians and Device Selection in ICD Implantation: “Patients were more likely to receive ICD or CRT-D [implantable cardioverter-defibrillator or cardiac resynchronization therapy-defibrillator, respectively] from the manufacturer that provided the highest total payment to the physician who performed an ICD or CRT-D implantation than each other manufacturer individually.”

Trends in Industry Payments to Physicians in the United States From 2014 to 2018: “Open Payments, a federal transparency program reporting industry-physician financial relationships since 2013, was established out of concern for undue industry influence on health care decision-making and costs…
Annual payment values decreased for physicians receiving lower-value total payments (≤$50 000), potentially due to transparency, organizational restrictions on industry interactions, or decreased direct-to-physician marketing.Physicians receiving higher-value total payments (>$50 000) continued to receive similar or greater amounts, perhaps reflecting evolving industry strategy that concentrates payments, for which greater return on investment is anticipated.”

Today's News and Commentary

About the public’s health

Cases of Covid-19 in children on rise, with highest 1-week spike yet: ”There were 61,000 new cases in children during the last week of October, ‘which is larger than any previous week in the pandemic,’ the AAP [American Academy of Pediatrics] said in a statement. From the onset of the pandemic through October 29, more than 853,000 children have tested positive for Covid-19, the AAP said, including nearly 200,000 new cases during the month of October…
(E)arly research has suggested children may not get fever, cough or shortness of breath as often as adults. Fever and cough was found in 56% and 54% of children in one study, compared to 71% and 80% of adults, according to the CDC. Shortness of breath was found in only 13% of pediatric patients, compared to 43% of adults. Sore throat, headache, muscle pain, fatigue and diarrhea were also less commonly reported in children.”

Top Trump adviser bluntly contradicts president on covid-19 threat, urging all-out response: “‘We are entering the most concerning and most deadly phase of this pandemic … leading to increasing mortality,’ said the Nov. 2 report from Deborah Birx, coordinator of the White House coronavirus task force. ‘This is not about lockdowns — it hasn’t been about lockdowns since March or April. It’s about an aggressive balanced approach that is not being implemented.’
Birx’s internal report, shared with top White House and agency officials, contradicts Trump on numerous points…”

A Health Opportunity Cost Threshold for Cost-Effectiveness Analysis in the United States: “Cost-effectiveness analysis is an important tool for informing treatment coverage and pricing decisions, yet no consensus exists about what threshold for the incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life-year (QALY) gained indicates whether treatments are likely to be cost-effective in the United States…
Given available evidence, there is about 14% probability that the threshold exceeds $150 000 per QALY and about 48% probability that it lies below $100 000 per QALY…
Given current evidence, treatments with ICERs above the range $100 000 to $150 000 per QALY are unlikely to be cost-effective in the United States.”

Health agencies resist Trump civil service executive order: “President Donald Trump’s executive order making it easier to fire federal employees is meeting fierce resistance within the Food and Drug Administration, amid fears the White House is planning a purge of senior health officials it views as disloyal.
The order — which Trump issued on Oct. 21 — would strip certain civil service and due process protections from career federal employees who make policy.
FDA officials see it as laying the groundwork for an across-the-board effort to replace longtime career scientists with political allies in a second Trump term.”

HHS Appeals LGBTQ-Friendly Decision in Obamacare Regulation Row: “The Health and Human Services Department is appealing a September federal district court decision barring it from enforcing a rule that would allow certain religious organizations to discriminate against LGBTQ people in connection with health care.
The agency filed its notice of appeal Oct. 31 in a case brought by Whitman-Walker Clinic Inc., health-care providers, and advocates for LGBTQ people. The plaintiffs challenged HHS’s rewrite of a rule implementing the Affordable Care Act’s anti-discrimination provision, Section 1557.”

About health insurance

Georgia’s latest 1332 proposal continues to violate the ACA: This article from USC-Brookings is an excellent analysis of the Georgia ACA waiver reported yesterday.

Geographic Variation In Medicare Per Capita Spending Narrowed From 2007 To 2017: “The difference in Medicare price- and risk-adjusted per capita spending between hospital referral regions (HRRs) in the top decile and those in the bottom decile decreased from $3,388 in 2007 to $2,916 in 2017—a reduction of $472, or 14 percent. The spending convergence occurred almost entirely between 2009 and 2014, during the early years of the Affordable Care Act (ACA). The highest-spending HRRs in 2007 had the lowest annual growth rates from 2007 to 2017, and the lowest-spending HRRs in 2007 had the highest annual growth rates. We also found that a greater supply of postacute care providers, especially hospice providers, significantly predicted lower spending growth across HRRs after the implementation of the ACA.”

California health system pays $31.5M to settle drug overbilling case: “From December 2016 to May 2019, Memorial Health Services submitted claims to Medi-Cal for outpatient prescription drug reimbursements that were higher than the actual cost the system paid for the drugs. The health system disclosed the overcharges to the Office of the Inspector General in October 2019.
…FY 2020 EPS guidance, now anticipating GAAP EPS to be in a range of $24.70 to $24.95and Adjusted EPS in a range of $18.50 to $18.75.
FY 2020 EPS guidance reflects fourth quarter 2020 losses of approximately $2.55 per share on a GAAP basis, approximately $2.40 per share on an Adjusted basis.
As previously noted, Humana anticipates fourth quarter losses to reflect the continued support for its constituents, along with the impact of increasing utilization, and COVID-19 testing and treatment costs
Increases full year expected individual Medicare Advantage membership growth to approximately 375,000 members from the previous range of 330,000 to 360,000 members, representing expected year-over-year growth of approximately 10 percent.”

Today's News and Commentary

Philip R. Lee, MD passed away at age 96. He was a giant in the field of healthcare public policy. Here is a fitting tribute to his career: UCSF Remembers Philip Lee, Former Chancellor and Health Care Reformer Who Served 2 US Presidents

About health insurance
2022 Medicare Advantage and Part D Advance Notice Part II: On Friday, CMS “released Part II of the Calendar Year (CY) 2022 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). CMS released Part I of the CY 2022 Advance Notice on September 14, 2020. CMS will accept comments on both parts of the CY 2022 Advance Notice through Friday, November 30, 2020, before publishing the final Rate Announcement by April 5, 2021.” Medicare Advantage (MA) and Part D payments are expected to increase by 2.82% in 2022.

‘Obamacare’ sign-ups begin as millions more are uninsured: Open enrollment started yesterday and lasts until December 15.

BCBS Insurers Reach $2.67B Antitrust Deal In Alabama: “The nation's Blue Cross Blue Shield insurers tentatively agreed late Friday to a $2.67 billion class settlement fund and sweeping anti-competitive practice reforms to settle a long-running multi-district suit based in Alabama federal court that was filed by dozens of subscriber groups. A memorandum in support of the deal filed by attorneys for subscribers in the Northern District of Alabama described the deal as ‘historic,’ with far-reaching competitive benefits."

HHS grants Georgia a waiver to bypass the ACA: The previously reported application has been approved for the period January 1, 2022 through December 31, 2026. A summary is on page 5 of the document. It is yet unclear, but likely, that a Biden win will overturn this type of waiver.

Medicare Fines Half of Hospitals for Readmitting Too Many Patients:”The penalties are the ninth annual round of the Hospital Readmissions Reduction Program created as part of the Affordable Care Act’s broader effort to improve quality and lower costs. The latest penalties are calculated using each hospital case history between July 2016 and June 2019, so the flood of coronavirus patients that have swamped hospitals this year were not included.”

About the public’s health

Study links Trump rallies to more than 700 Covid deaths: “President Donald Trump's campaign rallies between June and September may have caused some 30,000 coronavirus infections and more than 700 deaths, according to a new study by Stanford University economists.”

The Latest: Trump says he may fire disease specialist Fauci: “President Donald Trump is suggesting that he will fire the nation’s top infectious disease expert after Tuesday’s election, as he expresses frustration that the coronavirus remains in the news amid a nationwide spike of COVID-19.”

Transmission of SARS-COV-2 Infections in Households — Tennessee and Wisconsin, April–September 2020: From the CDC: “Findings from a prospective household study with intensive daily observation for ≥7 consecutive days indicates that transmission of SARS-CoV-2 among household members was frequent from either children or adults.
Household transmission of SARS-CoV-2 is common and occurs early after illness onset. Persons should self-isolate immediately at the onset of COVID-like symptoms, at the time of testing as a result of a high risk exposure, or at time of a positive test result, whichever comes first. All household members, including the index case, should wear masks within shared spaces in the household.”

THE SCIENCE OF SUPERSPREADING: The article is a great explanation (with helpful graphics) of how superspreading works.

The Challenges of Contact Tracing as U.S. Battles COVID-19: This study from the Pew Research Center highlights why contact tracing is difficult— about 40% of respondents would be not at all/not too likely to speak with a public health official about the corona virus outbreak if they were contacted by phone, text or in person.

Gloves in demand for hospitals facing shortages due to COVID-19: Premier: “A survey of 905 hospitals that are members of Premier found 40% are having a shortage of nitrile exam gloves.
The survey found that 28% face a N95 mask shortage, and another 10% need more gowns.”

5th Circ. To Rehear Planned Parenthood Texas Abortion Suit: “The Fifth Circuit agreed on Friday to rehear en banc Whole Woman's Health and multiple Planned Parenthood affiliates' suit challenging a 2017 Texas statute that limits physicians performing second-trimester abortions, vacating a divided panel's opinion finding the law violates the 14th Amendment by overburdening women. A majority of the Fifth Circuit judges voted in favor — on the court's own motion — to rehear the case en banc…”

FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order:”As the U.S. Food and Drug Administration continues our work to address the current pandemic, we are also looking ahead to prepare for the next potential public health emergency. A recent executive order directed the agency, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.”
Here is a list of those items.

About pharma
FTC nod clears way for merger between Pfizer's Upjohn unit, Mylan: In order to overcome antitrust concerns, the FTC said that “it is requiring that the rights and assets related to Upjohn's amlodipine besylate/atorvastatin, phenytoin, prazosin, spironolactone, gatifloxacin and medroxyprogesterone be divested to Prasco. The parties must also divest the rights and assets related to Mylan's eplerenone. In addition, the proposed order also requires prior FTC approval before Pfizer, Mylan or Viatris [the new company’s name] may gain an interest in, or exercise control over, any third party's rights to levothyroxine, sucralfate and varenicline.
The regulator noted that the divested generic drugs will continue to be manufactured by Upjohn and Mylan's current suppliers, reducing the risk of any supply interruptions…”

Novartis changes its position of 340B drugs: The company will still provide discounted drugs to contract pharmacies, but only if those facilities are within 40 miles of the 340B hospital’s location.

About healthcare IT

Teladoc Health Completes Merger with Livongo: The merger was completed within 3 months.

Nearly 700,000 health records breached in October: “In October, 35 organizations reported to HHS a total of 692,490 individuals being affected by data breaches.” Check the article for a summary. Wonder why people do not trust healthcare systems to keep their data private? However…

More than half of Americans would use virtual care, UnitedHealth Group survey finds: “According to UnitedHealth Group's fifth annual UnitedHealthcare Consumer Sentiment Survey, which examines Americans’ opinions about multiple areas of healthcare, a survey-record 56% said it is likely they would use virtual care for medical services.”

Today's News and Commentary

About healthcare professionals

2020 Physician Compensation Report: Overall, huge differences still persist between cognitive and procedural specialties. Lots of details in this study worth considering.

About hospitals and healthcare systems

Universal Health Services, Inc. Reports 2020 Third Quarter Financial Results: “Universal Health Services, Inc. announced today that its reported net income attributable to UHS was $241.3 million, or $2.82 per diluted share, during the third quarter of 2020, as compared to $97.2 million, or $1.10 per diluted share, during the comparable quarter of 2019. Net revenues increased 3.2% to $2.913 billion during the third quarter of 2020 as compared to $2.822 billion during the third quarter of 2019.”

Hospital Bankruptcy Surge Looms as Virus Rages, Stimulus Lapses: Despite the above story: “Even before the Covid-19 pandemic, providers were pushed to their breaking points, especially those in rural areas. At least 30 hospitals entered bankruptcy in 2019, and at least three dozen have done the same so far this year, according to data compiled by Bloomberg.”

Ascension expands pharmacy services: This move continues a trend of hospitals into this sector.
”Ascension Rx—the newly launched model for its nationwide pharmacy—presents specialty treatment packaging and supply, infusion remedy and medicine administration, together with monetary assist coordination. A brand new specialty pharmacy in Austin, Texas is slated to open subsequent spring, which can present prior authorization, treatment administration help for suppliers and affected person consults with scientific pharmacists, amongst different wraparound providers. 
Ascension, which has greater than 140 hospitals throughout 19 states, can be engaged on a centralized nationwide mail order pharmacy service, executives mentioned.”

About the public’s health
Internal Documents Reveal COVID-19 Hospitalization Data The Government Keeps Hidden: “NPR has obtained documents that give a snapshot of data the U.S. Department of Health and Human Services collects and analyzes daily. The documents — reports sent to agency staffers — highlight trends in hospitalizations and pinpoint cities nearing full hospital capacity and facilities under stress. They paint a granular picture of the strain on hospitals across the country that could help local citizens decide when to take extra precautions against COVID-19.
Withholding this information from the public and the research community is a missed opportunity to help prevent outbreaks and even save lives, say public health and data experts who reviewed the documents for NPR.”

Flu vaccine may lower risk for severe COVID-19, study suggests: “People who received the flu vaccine in the year before testing positive for COVID-19 are nearly 2 1/2 times less likely to be hospitalized with a severe form of the disease than those who were not vaccinated, an analysis published Wednesday by the Journal of the American Board of Family Medicine found.
In addition, those vaccinated against the flu within a year of being diagnosed with COVID-19 were more than three times less likely to be admitted to an intensive care unit because of the new coronavirus, according to researchers at the University of Florida.”

Fauci says first U.S. COVID-19 vaccines could ship late December or early January: “Based on current projections from vaccine front-runners Moderna Inc and Pfizer Inc, Americans will likely know ‘sometime in December whether or not we have a safe and effective vaccine,’ Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a live chat on Twitter and Facebook.”

Death Rates Have Dropped for Seriously Ill Covid Patients:”…as the virus continued its rampage over the summer and fall, infecting nearly 8.5 million Americans, survival rates, even of seriously ill patients, appeared to be improving. At one New York hospital system where 30 percent of coronavirus patients died in March, the death rate had dropped to 3 percent by the end of June.
Doctors in England observed a similar trend.”

Vaccine Makers Can Skip U.S. Inspections: “FDA regulations don’t require what’s known as a pre-approval inspection for products seeking emergency use, said Jerry Weir, director of the Division of Viral Products in the FDA’s vaccines office. Weir spoke last week at a meeting of FDA advisers to discuss standards for Covid-19 vaccines…
FDA’s Weir said vaccine developers seeking an emergency authorization will have to submit complete details of their manufacturing process and show they’ve established a quality control unit.”
Some vaccines are being manufactured by newer companies without extensive manufacturing experience, like Moderna. Also, some newer techniques are being used for vaccines, such as RNA-based antigens. The last thing we want is for the public to lose confidence in vaccines from lack of quality oversight. See a related article: Sanofi, SK flu shots halted in Singapore as South Korea post-vaccination deaths climb to 59: “Singapore has temporarily pulled its backing for SK Bioscience’s SKYCellflu Quadrivalent and Sanofi Pasteur’s VaxigripTetra, the Ministry of Health said Sunday. Among the seven brands administered to people who died in South Korea, these two are the only ones also available in Singapore…
As of Monday, at least 59 people, mostly in their 70s and 80s, have died in South Korea following flu vaccination, up from 46 Saturday. That’s among more than 14.7 million people who have been inoculated this season.”

Vaccine bond sale raises $500m to fund immunisation programmes: “The money was raised for Gavi, the UN-backed vaccines alliance, by a financing vehicle, the International Finance Facility for Immunisation. The deal on Thursday attracted more than $1.5bn of orders for the three-year debt, and offered investors a yield of 0.44 per cent.”

Unions Sue OSHA For Rule Protecting Health Care Workers:”A coalition of nurses' and teachers' unions asked the Ninth Circuit on Thursday to make the U.S. Department of Labor move forward with a long-delayed rule to protect health care workers from infectious diseases as U.S. coronavirus cases surge.
The DOL's Occupational Safety and Health Administration bungled its obligation to protect health care workers from workplace hazards by failing to issue a rule after more than a decade of uneven development, the unions said in their petition for a writ of mandamus to the Ninth Circuit.”

Survey: Majority of U.S. Adults Concerned About Medical Bankruptcy, Debt:”56% of U.S. adults said they were either somewhat or very concerned that a health situation in their household could lead to bankruptcy or debt. 28% of U.S. adults carry medical debt. 32% of U.S. adults have $500 or less in savings for medical bills…
Of those who reported having medical debt, 65% had debts exceeding $1,000.”

BCBS of Illinois to pay hospitals $100M to improve health equity: “The program's first priority is to support hospitals with the highest concentration of BCBSIL members who are at risk of contracting COVID-19. Hospitals that join the equity program must commit to reducing health disparities for BCBSIL patients over the next three years. BCBSIL said it will add to and replace existing bonus structures with the new program, and about $100 million in funding will go to hospitals that participate in the program.”

About healthcare IT

Artificial intelligence model detects asymptomatic Covid-19 infections through cellphone-recorded coughs:”In a paper published recently in the IEEE Journal of Engineering in Medicine and Biology, the team reports on an AI model that distinguishes asymptomatic people from healthy individuals through forced-cough recordings, which people voluntarily submitted through web browsers and devices such as cellphones and laptops.”

Early results from DETECT study suggest fitness trackers and smartwatches can predict COVID-19 infection: “Examining data from the first six weeks of their landmark DETECT study, a team of scientists from the Scripps Research Translational Institute sees encouraging signs that wearable fitness devices can improve public health efforts to control COVID-19.
The DETECT study, launched on March 25, uses a mobile app to collect smartwatch and activity tracker data from consenting participants, and also gathers their self-reported symptoms and diagnostic test results. Any adult living in the United States is eligible to participate in the study by downloading the research app, MyDataHelps.”

CMS Finalizes Calendar Year 2021 Payment and Policy Changes for Home Health Agencies and Calendar Year 2021 Home Infusion Therapy Benefit: Of significance is the permanence of coverage for telehealth. “Home health agencies (HHAs) can utilize telecommunications technologies in providing care to beneficiaries under the Medicare home health benefit, as long as any provision of remote patient monitoring or other services furnished via a telecommunications system or audio-only technology are included on the plan of care. The use of such telecommunications technology or audio-only technology must be tied to the patient-specific needs as identified in the comprehensive assessment. CMS will not require a description of how such technology will help to achieve the goals outlined on the plan of care; rather, documentation in the medical record should explain how such services will help facilitate treatment outcomes.”

Allscripts Announces Third Quarter 2020 Results: “GAAP net income in the third quarter of 2020 totaled $1 million compared with net loss of $6 million in the third quarter of 2019. Non-GAAP net income in the third quarter of 2020 was $33 million compared with $28 million in the third quarter of 2019.
GAAP earnings per share in the third quarter of 2020 was $0.00 compared with loss per share of $0.03 in the third quarter of 2019. Non-GAAP diluted earnings per share in the third quarter of 2020 were $0.20 compared with $0.17 in the third quarter of 2019.” Revenue decreased 9.5% compared to the same period last year.

CERNER REPORTS THIRD QUARTER 2020 RESULTS IN LINE WITH COMPANY EXPECTATIONS: “On a U.S. Generally Accepted Accounting Principles (GAAP) basis, third quarter 2020 net earnings were $357 million and diluted earnings per share were $1.16. Third quarter 2019 GAAP net earnings were $82 million and diluted earnings per share were $0.26.
Adjusted Net Earnings for third quarter 2020 were $222 million, compared to $212 million of Adjusted Net Earnings in the third quarter of 2019. Adjusted Diluted Earnings Per Share were $0.72 in the third quarter of 2020, in line with the Company’s expectations and up 9 percent compared to $0.66 of Adjusted Diluted Earnings Per Share in the year-ago quarter.” Revenue fell 3% from the same period last year.

About pharma
REGN-COV2 INDEPENDENT DATA MONITORING COMMITTEE [IDMC]RECOMMENDS HOLDING ENROLLMENT IN HOSPITALIZED PATIENTS WITH HIGH OXYGEN REQUIREMENTS AND CONTINUING ENROLLMENT IN PATIENTS WITH LOW OR NO OXYGEN REQUIREMENTS: “…based on a potential safety signal and an unfavorable risk/benefit profile at this time, the IDMC recommends further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending collection and analysis of further data on patients already enrolled. The IDMC also recommends continuing enrollment of hospitalized patients requiring either no or low-flow oxygen as the risk/benefit remains acceptable in these cohorts. Finally, the IDMC recommends continuation of the outpatient trial without modification.”

Moderna gearing up for COVID-19 vaccine launch as it takes in $1.1 billion in supply deposits:The headline speaks for itself.

About health care technology

Medtronic to pay over $9M to settle false claims suit:”Medtronic has agreed to pay a total of more than $9 million dollars to settle allegations that it paid kickbacks to a South Dakota neurosurgeon, federal prosecutors announced today.
The Minnesota-based medical devicemaker is accused of violating the False Claims Act and failing to accurately report to CMS payments it made to Dr. Wilson Asfora, allegedly to induce him to use one of its implantable devices. Medtronic also allegedly held more than 100 events over a nine-year period at a restaurant owned by Asfora.”

Today's News and Commentary

About healthcare professionals
Physician survey details depth of pandemic’s financial impact:”The average number of in-person visits to physician offices fell from 97 per week to 57, according to the survey of 3,500 physicians who provided at least 20 hours of patient care a week prior to the pandemic.
Physicians averaged a 32% drop in revenue since February, the AMA survey shows. About one in five doctors saw revenue drop by 50% or more, while nearly one-third saw declines of between 25% and 49%. Only 19% of physicians reported no drop in revenue.”

About healthcare IT

HHS extends interoperability rule deadlines: 10 key compliance dates: This short summary has key compliance dates, starting April 5, 2021 with information blocking provisions.

Medical Device Security Stymied by Legacy Tech, Flawed Segmentation: An interesting article that explains how a large number of medical devices connected to non-secure, legacy programs at hospitals poses a great hacking threat.

FBI warns ransomware assault threatens US healthcare system: “In a joint alert Wednesday, the FBI and two federal agencies warned that they had “credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers.” The alert said malicious groups are targeting the sector with attacks that produce “data theft and disruption of healthcare services.”
The cyberattacks involve ransomware, which scrambles data into gibberish that can only be unlocked with software keys provided once targets pay up. Independent security experts say it has already hobbled at least five U.S. hospitals this week, and could potentially impact hundreds more.”

With pending Livongo deal, Teladoc's virtual care business is booming:”Teladoc continues to see surging demand for its virtual care services even as the use of telehealth across the country has slowly declined from hitting peaks in April.
Teladoc, one of the nation's top telehealth providers, reported 2.8 million total virtual visits during the third quarter, up 206% from 928,000 visits in the third quarter of 2019.
Total telehealth visits in 2020 have jumped 163% from 2.9 million visits during the first nine months of 2019 to 7.6 million visits this year.”

About the public’s health

COVID-19 Trends in Tennessee: Summer turns to Fall: This Vanderbilt study provides yet another reason to wear masks: “Hospitals that predominantly serve patients from areas without masking requirements… continue to see the highest rate of growth in hospitalizations. As the percentage of patients residing in mask-requirement counties increases, the growth curve ‘flattens,’ indicating much lower growth in hospitalizations.”

White House could have traced and contained its covid-19 outbreak. It chose not to.: With regard to the Rose Garden ceremony celebrating the nomination of Amy Coney Barrett: “Officials say the White House called off early efforts to get to the bottom of the outbreak, including sequencing the genomes of virus samples from infected individuals. This genetic analysis could have revealed shared mutations that linked cases in Washington and other affected communities.”

Random effects key to containing epidemics: “…scientists have discovered, using mathematics and computer simulations, why dividing a large population into multiple subpopulations that do not intermix can help contain outbreaks without imposing contact restrictions within those local communities….
The main reason subdividing the population works is because the epidemic is completely extinguished in a significant fraction of the subgroups. This "extinction effect" occurs when infection chains spontaneously terminate.
Another way subdividing works is by desynchronizing the full population. Even if outbreaks occur in the smaller communities, the peaks may come at different times and cannot synchronize and add up to a large number.”

About pharma

REGENERON'S COVID-19 OUTPATIENT TRIAL PROSPECTIVELY DEMONSTRATES THAT REGN-COV2 ANTIBODY COCKTAIL SIGNIFICANTLY REDUCED VIRUS LEVELS AND NEED FOR FURTHER MEDICAL ATTENTION: The company announced that data on “ an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Regeneron has shared these results with the U.S. FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes.”

Eli Lilly still confident in benefits of Covid antibody treatment despite end to hospital study: “Eli Lilly’s coronavirus antibody treatment can still be beneficial to Covid-19 patients, despite the recent end to a government-run study, CEO Dave Ricks told CNBC.
Ricks said the antibody treatment appears to be more effective in people who are earlier in their diagnoses. The stopped study looked at hospitalized patients.
’It’s disappointing, of course. We would have liked to have shown a benefit in the hospital,’ he said.”

COVID-19 fighter remdesivir racks up $873M as Gilead plays defense on unflattering WHO data:”Gilead Sciences started charging for remdesivir in July. Given its status then as the only drug authorized for COVID-19 in the U.S., industry watchers immediately forecast multibillion-dollar sales for this year.
But new clinical data have now put the Big Biotech in defense mode—and prompted analysts to dial down their expectations.
In the third quarter, Gilead sold $873 million of remdesivir, handily topping Wall Street’s previous estimate of $772 million. The drug was fully approved by the FDA last week, under the brand name Veklury, to treat hospitalized COVID-19 patients…
Veklury’s efficacy—as well as the FDA’s decision to approve it—recently came under serious question after a large study by the World Health Organization (WHO) found it offered ‘little or no effect’ in hospitalized COVID-19 patients, in terms of recovery time, requirement for ventilators and death rate.”

About health insurance

Molina Healthcare beats the Street with $185M in Q3 profit:Molina Healthcare earned $185 million in profit for the third quarter, beating Wall Street expectations.
That's up from the third quarter of 2019, when the insurer brought in $175 million in profit…
Molina attributes the jump in revenue to notably higher premium revenues both in the third quarter and across the first nine months of 2020. Premium revenues were up by 16.8% compared to the prior-year quarter and are 11.3% higher than the first three quarters of 2019.”

HHS to dole out $333M in incentive payments to nursing homes that improved COVID-19 care: “The Department of Health and Human Services (HHS) will start distributing about $333 million in performance payments to over 10,000 nursing homes that reduced COVID-19 infections and deaths over a two-month period.
The agency said the announcement illustrates how tying relief payments to outcome-based payments can yield positive results for improving quality.”

Blue Cross of California Partnership Plan Fined $1.2M for Failing to Authorize Medically Necessary Services: “The California Department of Managed Health Care (DMHC) has taken enforcement action including $1,205,000 in fines against Blue Cross of California Partnership Plan, Inc. (Blue Cross) for its failure to timely implement two Independent Medical Review (IMR) determinations to authorize coverage for medically necessary services. The Medi-Cal managed care plan confirmed receiving the Department's notifications of the IMR decisions but failed to timely authorize the enrollees' services.”

Final rule for disclosure of insurance company cost information (from the Departments of the Treasury (IRS), Labor and HHS: “The final rules set forth requirements for group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information upon request to a participant, beneficiary, or enrollee (or his or her authorized representative), including an estimate of the individual’s cost-sharing liability for covered items or services furnished by a particular provider. Under the final rules, plans and issuers are required to make this information available on an internet website and, if requested, in paper form, thereby allowing a participant, beneficiary, or enrollee (or his or her authorized representative) to obtain an estimate and understanding of the individual’s out-of-pocket expenses and effectively shop for items and services. The final rules also require plans and issuers to disclose in-network provider negotiated rates, historical out-of-network allowed amounts, and drug pricing information through three machine-readable files posted on an internet website, thereby allowing the public to have access to health coverage information that can be used to understand health care pricing and potentially dampen the rise in health care spending. The Department of Health and Human Services (HHS) also finalizes amendments to its medical loss ratio (MLR) program rules to allow issuers offering group or individual health insurance coverage to receive credit in their MLR calculations for savings they share with enrollees that result from the enrollees shopping for, and receiving care from, lower-cost, higher-value providers.” Unlike hospitals, which have to disclose 300 stoppable services starting the January 1, insurers will be required to provide a list of 500 shoppable services via the online tool for plan years that begin on or after Jan. 1, 2023. Cost information for additional services will be required on or after Jan. 1, 2024.

About hospitals and health systems

CHS shares jump 30%: “Shares of Franklin, Tenn.-based Community Health Systems soared 30 percent Oct. 28 after the for-profit hospital chain said its longtime CEO would step down and it released better-than-expected financial results for the third quarter.”

Today's News and Commentary

About the public’s health

Western States Join California’s Scientific Safety Review Workgroup to Ensure Safety of COVID-19 Vaccine: “Washington, Oregon and Nevada have joined California’s COVID-19 Scientific Safety Review Workgroup, which will independently review the safety and efficacy of any vaccine approved by the FDA for distribution.”

Coronavirus antibodies decline after infection, study finds, raising questions about herd immunity: “Researchers from Imperial College London screened 365,000 people in England over three rounds of testing between June 20 and Sept. 28.
Analysis of finger-prick tests carried out at home found that rather than people building immunity over time, the number of people with antibodies that can fight Covid-19 declined roughly 26%.”

U.S. Preventive Services Task Force Issues Draft Recommendation on Screening for Colorectal Cancer:”For the first time, the Task Force is recommending that screening start at age 45. This is a B recommendation. The Task Force continues to strongly recommend screening people who are 50 to 75 years old. This is an A recommendation.” (Emphases in original.)

COVID-19 Mitigation Behaviors by Age Group — United States, April–June 2020:”Self-reported engagement in mitigation behaviors (mask wearing, handwashing, physical distancing, crowd and restaurant avoidance, and cancellation of social activities) differed significantly by adult age group. During April–June 2020, the prevalence of these behaviors was lowest among adults aged 18–29 years and highest among those aged >60 years. Whereas mask wearing increased over time, other reported mitigation behaviors decreased or remained unchanged.”

About health insurance

Anthem Reports Third Quarter Results, Reaffirms Commitment to Stakeholders During COVID-19 Pandemic: Anthem sustained an operating loss decline of 86.8% for the 3rd quarter compared to the previous year’s period. For the 9 months so far, both revenue and profit are up about 17.5%.

New CMS Proposals Streamline Medicare Coverage, Payment, and Coding for Innovative New Technologies and Provide Beneficiaries with Diabetes Access to More Therapy Choices: “The proposed rule would expand the interpretation regarding when external infusion pumps are appropriate for use in the home and can be covered as DME under Medicare Part B, increasing access to drug infusion therapy services in the home. The proposed rule also drastically reduces administrative burdens – such as complicated government coverage, payment and coding processes – that block innovators from getting their products to Medicare beneficiaries in a timely manner…
If finalized, today’s proposed rule will also expand Medicare coverage and payment for continuous glucose monitors (CGMs)…”

2019 Quality Payment Program (QPP) Performance Results: From CMS: “We’re pleased to share that the maximum MIPS payment adjustment for exceptional performance during the 2019 reporting year will be the highest since the program began. Clinicians with a final score equal to or above 75.00 points will receive a positive payment adjustment in 2021 of up to 1.79%…
Some other clinicians, however, may see lower than expected positive payment adjustments. This is because the Quality Payment Program is required by law to be budget neutral, and more clinicians who may have faced maximum negative adjustments qualified for reporting exceptions under the MIPS Extreme and Uncontrollable Circumstances policy. As a result, there is a smaller pool of dollars from negative payment adjustments that can be redistributed and used for the positive payment adjustments.”

Anthem to pay $594M share in pending Blues plan antitrust settlement: “Anthem is paying a substantial portion of Blues plans' tentative antitrust settlement, which is estimated to be nearly $3 billion, executives said on a call with investors on Wednesday morning.
Anthem has penciled in $594 million for its contribution to the $2.7 billion settlement. The Blue Cross and Blue Shield Association reportedly agreed to the settlement in a lengthy class action suit late last month…
In the suit, filed in 2012, Blues plans were accused of conspiring to split up geographic regions to avoid competing against one another directly. That lack of competition drove up costs, the plaintiffs allege.”

About healthcare IT

Aetna Pays $1,000,000 to Settle Three HIPAA Breaches: Read the OCR announcement for further details. The events occurred in 2017.

Healthcare technology

Exact Sciences snaps up liquid biopsy company Thrive in $2.15B deal:”Exact Sciences is adding early cancer detection to its pipeline through its buyout of Thrive Earlier Detection for  up to $2.15 billion in cash and stock. The deal comes just three months after Thrive raised $257 million in venture dollars to push its liquid biopsy test into a registrational trial.”

About pharma

Eli Lilly nabs $375M deal to supply COVID-19 antibody to U.S. government despite trial failure: “Eli Lilly may have deep-sixed trials of its COVID-19 antibody treatment in hospitalized patients for lack of efficacy, but that’s not stopping the U.S. government from placing a huge bet on the drug’s success in other settings.
The government struck a $375 million deal with the company for 300,000 vials of the antibody treatment, bamlanivimab (LY-CoV555), provided it wins an emergency use authorization from the FDA…”

Today's News and Commentary

About the public’s health

Pharmacies See Record Flu Shot Demand in First Season With Covid: For example:“CVS Health Corp. has already surpassed the 9 million flu shots it gave during the entire previous season and expects to double that number by the end of this cycle, a spokesman said. Walgreens Boots Alliance has administered 60% more doses in its U.S. stores than at this point last year, said Rina Shah, group vice president of pharmacy operations.”

Medicare and Medicaid to cover early Covid vaccine: “The Trump administration this week will announce a plan to cover the out-of-pocket costs of Covid-19 vaccines for millions of Americans who receive Medicare or Medicaid, said four people with knowledge of the pending announcement.
Under the planned rule, Medicare and Medicaid will now cover vaccines that receive emergency use authorization from the Food and Drug Administration, the people said, which is a change from current policy.” 

Sugary Drinks, Artificially-Sweetened Beverages, and Cardiovascular Disease in the NutriNet-Santé Cohort: Consumption of both sugary drinks and artificially sweetened beverages are associated with increases in the incidence of cardiovascular disease.

Illinois study tracks evolution of SARS-CoV-2 virus mutations:”A group of graduate students in a spring-semester Bioinformatics and Systems Biology class at Illinois tracked the mutation rate in the virus’s proteome – the collection of proteins encoded by genetic material – through time, starting with the first SARS-CoV-2 genome published in January and ending more than 15,300 genomes later in May.
The team found some regions still actively spinning off new mutations, indicating continuing adaptation to the host environment. But the mutation rate in other regions showed signs of slowing, coalescing around single versions of key proteins.” The slower mutating areas appear to code for successful adaptations to spreading.

America’s pandemic: This piece is a Washington Post documentary about how recent past Presidents have handled actual or threatened public health crises.

About pharma

Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial: “The ACTIV-3 clinical trial is being run by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and is the only study evaluating the efficacy of bamlanivimab in hospitalized COVID-19 patients. Based on an updated dataset from the trial reviewed on October 26, no additional COVID-19 patients in this hospitalized setting will receive bamlanivimab. This recommendation was based on trial data suggesting that bamlanivimab is unlikely to help hospitalized COVID-19 patients recover from this advanced stage of their disease. In this updated dataset, differences in safety outcomes between the groups were not significant.”

Bayer Acquires Asklepios BioPharmaceutical to Broaden Innovation Base in Cell and Gene Therapy:”Bayer AG… announced the acquisition of Asklepios BioPharmaceutical, Inc. (AskBio), a US-headquartered biopharmaceutical company specialized in the research, development and manufacturing of gene therapies across different therapeutic areas. AskBio’s development portfolio includes investigational pre-clinical and clinical stage candidates for the treatment of neuromuscular, central nervous system, cardiovascular and metabolic diseases.”
The purchase price is $2 billion upfront and up to $2 billion in success-based milestone payments.

Florida fails to attract bidders for Canada prescription drug importation program:”Florida’s plan to import cheaper prescription drugs from Canada — designed by Gov. Ron DeSantis and endorsed by President Donald Trump — has tasted its first bitter pill.
No private firms bid on Florida’s $30 million contract to set up and operate a drug importation program. Bids were due at the end of September.
The setback is likely to delay by at least several months Florida’s effort to become the first state to import drugs.”

About health insurance

Health Literacy Key to Better Health Outcomes: A really good piece about how improved healthcare literacy can improve health status and save money. For example, prevent about 1 Million hospital visits and save $25 billion per year.

Today's News and Commentary

About pharma

Business Groups Rally Behind J&J's $465M Opioid Appeal: “The U. S. Chamber of Commerce, a defense bar organization called the Product Liability Advisory Council and other lobbying groups have urged the Oklahoma Supreme Court to overturn a nearly half-billion-dollar judgment against Johnson & Johnson in the nation's first and only opioid-crisis trial. The Product Liability Advisory Council in a Thursday brief said product liability law is more than adequate to protect consumers, not public nuisance law. If the verdict is not overturned, then product liability law's aims to protect consumers and encourage economic activity will be thwarted and the floodgates would open for more novel public nuisance claims…”

Shorter course of antibiotics OK for children with pneumonia who are improving: “Among children with community-associated pneumonia who have improved by day 5, study findings showed that additional days of antibiotic therapy did not confer additional benefits…”

About the public’s health

More than 83,000 new coronavirus cases recorded in US for second-straight day:”About 35 states reported more new cases in the last week than the previous week, Johns Hopkins noted. New Jersey and Michigan both reported records for single-day cases, with 1,994 cases and 3,338, respectively. 
And Illinois reported its highest single-day total since the pandemic began, with 6,161 new cases.”

Drug-resistant superbug thriving in hospitals hit hard by COVID-19: As if we didn’t have enough to worry about, Candida auris spread continues in hospitals and may increase among those with COVID-19.

Vaccine hopes rise as Oxford jab prompts immune response among old as well as young adults: “One of the world’s leading COVID-19 experimental vaccines produces an immune response in both young and old adults, raising hopes of a path out of the gloom and economic destruction wrought by the novel coronavirus.
The vaccine, developed by the University of Oxford, also triggers lower adverse responses among the elderly, British drug maker AstraZeneca Plc, which is helping manufacture the vaccine, said on Monday.”

Covid-19 vaccine trials from AstraZeneca, Johnson & Johnson to restart: The headline speaks for itself.

Aspirin Use is Associated with Decreased Mechanical Ventilation, ICU Admission, and In-Hospital Mortality in Hospitalized Patients with COVID-19: The message is in the headline. The dose of aspirin was only 81mg. The authors caution: “However, a sufficiently powered randomized controlled trial is needed to assess whether a causal relationship exists between aspirin use and reduced lung injury and mortality in COVID-19 patients.”

About hospitals and health systems

Texas COPA law may pave the way for more hospital M&A: Remember Certificate of Need regulations? It’s “opposite” are relatively new Certificate of Public Advantage (COPA) laws, which allows states to override FTC concerns for mergers. The link has an excellent podcast discussion of these laws with a focus on a Texas hospital merger case.

Sanford Health plans to merge with Intermountain Healthcare: “The combined organization would employ more than 89,000 people, and operate 70 hospitals and 435 clinics across seven states. It would also provide senior care and other services in 366 locations in 24 states, and insure 1.1 million people. 
The organization would be headquartered in Salt Lake City, Utah — which is Intermountain's current headquarters — while keeping corporate offices in Sioux Falls, South Dakota where Sanford is headquartered.”

HCA Healthcare Reports Third Quarter 2020 Results: “Consistent with the Company’s preview of third quarter 2020 results, revenues in the third quarter of 2020 increased to $13.311 billion, compared to $12.694 billion in the third quarter of 2019. Net income attributable to HCA Healthcare, Inc. totaled $668 million, or $1.95 per diluted share, compared to $612 million, or $1.76 per diluted share, in the third quarter of 2019.”

Kaiser Permanente to build medical center in Maryland: “Kaiser Permanente Aspen Hill Medical Center will house an ambulatory surgery center as well as space for primary care, obstetrics, urology, pain management and ophthalmology. It will also have a pharmacy, imaging and laboratory services.
The first phase of the project will include building a 130,000-square-foot facility and 542 parking spaces. In the second phase, a 50,000-square-foot addition will be added and a parking garage with 304 spaces will be built.”
The facility is expected to open in 2022.

About health insurance

CMS delays radiation oncology payment model following fierce opposition from physician community: “The Centers for Medicare and Medicaid Services has decided to delay the start of its mandatory radiation oncology bundled payment model following fierce opposition from the physician community. 
CMS had planned to launch the effort on Jan. 1; however, the go-live date will now move to July 1, 2021…”

UnitedHealth Ships Flu Kits to Medicare Recipients: “UnitedHealthcare… plans to provide at-risk patients with 200,000 kits that include Tamiflu, the prescription antiviral treatment; a digital thermometer; and a coronavirus P.C.R. diagnostic test. People can take the test at home and then mail it in for laboratory analysis, helping patients and doctors determine the cause of their symptoms, which is particularly important because the coronavirus and flu have similar symptoms but differ in treatment.”

Trump Administration Health Reimbursement Arrangements Put ACA Subsidies at Risk: The monograph explains what individual coverage health reimbursement arrangements (ICHRAs) are and how they can put employees’ premium tax credits at risk when they buy an ACA compliant plan. It also describes how such arrangements can distort insurance markets by separating employees who are healthier from those with chronic conditions.

About healthcare IT

First VA medical center (finally) goes live on Cerner EHR as part of $16B project: “The Department of Veterans Affairs' achieved a major milestone Saturday in its decades-long, multi-billion-dollar effort to upgrade its aging health IT systems.
Mann-Grandstaff VA Medical Center in Spokane, Washington went live with a new Cerner EHR system this weekend, the first site as part of VA's massive medical records project.
It marks progress in the latest effort to upgrade the VA's system, a $16 billion technology project that's been plagued by delays, leadership turnover, and infrastructure problems since it kicked off in 2018.”

Today's News and Commentary

About pharma

FDA approves first COVID-19 drug: antiviral remdesivir:  “The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health.
It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month.”
Recall that the WHO does not endorse its efficacy.

4 AbbVie brands land on pharma's top TV spenders list for September: ”The top 10 brands spent $182 million, the highest monthly total since January, according to data from real-time TV ad tracker iSpot.tv. AbbVie’s Humira led the way as usual, but with an even bigger budget of $57.7 million, an increase of 45% over what the Illinois drugmaker spent on the product in August.”

About the public’s health

Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial): “Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality. This trial has high generalisability and approximates convalescent plasma use in real life settings with limited laboratory capacity. A priori measurement of neutralising antibody titres in donors and participants might further clarify the role of convalescent plasma in the management of covid-19.”

U.S. signs international declaration challenging right to abortion and upholding ‘role of the family’: “The United States joined Brazil, Egypt, Hungary, Indonesia and Uganda on Thursday to co-sponsor a nonbinding international antiabortion declaration, in a rebuke of United Nations human rights bodies that have sought to protect abortion access.
Secretary of State Mike Pompeo and Health and Human Services Secretary Alex Azar participated in the virtual signing ceremony.”

Mich. Law Gives Employers Immunity From COVID-19 Suits: “Michigan Gov. Gretchen Whitmer on Thursday signed bills that allow workers to stay home if they have COVID-19 symptoms and grant immunity to employers from lawsuits filed by workers or customers who contract the coronavirus so long as they are following federal, state and local safety laws.” This immunity is something the Republicans wanted to include in COVID-19 financial relief packages; the Democrats refused. Interesting that a Democratic governor approved of this measure. Perhaps other states will follow suit.

Wikipedia and W.H.O. Join to Combat Covid Misinformation: “As part of efforts to stop the spread of false information about the coronavirus pandemic, Wikipedia and the World Health Organization announced a collaboration on Thursday: The health agency will grant the online encyclopedia free use of its published information, graphics and videos.”

About health insurance

Trump says he hopes Supreme Court strikes down ObamaCare: In a “60 minutes” interview, Trump said he hopes the Supreme court will strike down the ACA. He was very vague about a plan to replace it. He reiterated those statements in last night’s debate.

About healthcare IT

Correlations Between COVID-19 Cases and Google Trends Data in the United States: A State-by-State Analysis: “This study documents the feasibility of syndromic surveillance of internet search terms to monitor new infectious diseases such as coronavirus disease 2019. This information could enable better preparation and planning of health care systems.” 

About diagnostics

Quest Diagnostics ups guidance, notches major sales growth and gives back CARES Act cash: “The New Jersey-based testing company has seen sales hit $2.78 billion for the third quarter, up more than 42% on the year-ago period, with sales up 11% to $6.43 billion for the nine-month period. 
What’s driving this growth? COVID-19 testing. The company has now performed more than 22 million molecular and serology tests to date, what it says is ‘more than any other provider.’” 

Today's News and Commentary

About health insurance

MA Enrollees Can Access COVID-19 Supplemental Benefits in 2021: “New analysis from Avalere finds that… MA plans will continue to increase their supplemental benefit offerings in 2021. More plans will offer primarily health-related benefits, such as meals and transportation. In addition, 1 in 3 MA plans will start offering new types of supplemental benefits specifically related to the pandemic, such as no cost-sharing for COVID-19 testing and care packages.”
Read the report for more details.

Harvard Pilgrim Health Care partners with Foodsmart to offer comprehensive nutrition support to its members “Harvard Pilgrim Health Care has partnered with Foodsmart by Zipongo, a telenutrition and digital foodcare solution based in San Francisco, CA.Foodsmart is a digital nutrition platform that offers online food ordering, immunity-boosting recipes, meal planning for the whole family, and more. The Foodsmart NutriQuiz helps monitor progress against health goals, and facilitates personalization of meal plans and grocery lists based on eating habits, food preferences, allergies, and nutrition needs.” This article explains a recent example of insurers addressing non-medical needs of members.

Cohere Health Announces Partnership with Humana to Modernize Prior Authorization and Improve Physician and Member Experience:”Humana will employ the CohereNext Platform to streamline prior authorizations in musculoskeletal treatment in Alabama, Georgia, Indiana, Kentucky, Michigan, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia and West Virginia. The platform will initially serve approximately 2 million members and more than 3,500 physician practices.”
How will this system for one “organ system” enhance coordination of patient care, particularly if other entities are managing other disease categories?

About the public’s health

CDC expands definition of who is a ‘close contact’ of an individual with covid-19:”The updated guidance, which health departments rely on to conduct contact tracing, now defines a close contact as someone who was within six feet of an infected individual for a total of 15 minutes or more over a 24-hour period, according to a CDC statement Wednesday.”

California Will Independently Verify COVID-19 Vaccine: The headline speaks for itself. Illinois will also independently verify vaccines.

About pharma

Community health centers sue HHS to install method to handle 340B violations after drugmaker feud: “An association representing community health centers is suing the Department of Health and Human Services (HHS), seeking help in combating drug manufacturers that are refusing to give their products to 340B contract pharmacies…
The centers want HHS to install a dispute resolution process to give 340B entities a pathway to remedy program violations.
The lawsuit comes after several drug companies announced they won’t provide 340B-discounted products to contract pharmacies, third-party entities that are hired by a 340B entity to dispense the drugs.”

Remdesivir’s hefty price tag ignores NIH investment in its creation: “Research from the Center for Integration of Science and Industry… determined that between gathering knowledge behind remdesivir’s chemical structure and molecular target, the NIH invested as much as $6.5 billion between 2000 and 2019. This is referred to as ‘basic research’ that might never have resulted in a drug. Instead, the work was performed to learn about the inner workings of cells and organisms and how these systems function as a whole.” This article raises the question of whether governmental investment should be recouped either directly or through lower prices pharma companies charge. The article points out that march-in rights that were “established by Congress under the Bayh-Dole Act, allow the federal government to retain patent rights for inventions developed with government funding, but have never been used. March-in-rights… would allow other distributors to help manufacture remdesivir, increasing the supply and lowering its cost.”

Today's News and Commentary

About the public’s health

State of Global Air 2020: Among the most shocking findings was that nearly “500,000 newborns died in 2019 as a result of air pollution exposure.”

Do Masks On Plane Flights Really Cut Your Risk Of Catching COVID-19?: You should read the entire article if you are contemplating flying, but the “bottom line” is that: “All together, these data suggest masks are working — and working well.”

Long-term effects of PM2·5 [fine particulate matter] on neurological disorders in the American Medicare population: a longitudinal cohort study: “We provide evidence that exposure to annual mean PM2·5 in the USA is significantly associated with an increased hazard of first hospital admission with Parkinson's disease and Alzheimer's disease and related dementias. For the ageing American population, improving air quality to reduce PM2·5 concentrations to less than current national standards could yield substantial health benefits by reducing the burden of neurological disorders.”

Microplastics Are Seeping Out of Baby's Bottle, Study Shows: “High levels of microplastic particles are released from baby bottles during formula preparation, researchers discovered during lab testing.
Infants are likely exposed to an average daily dose of nearly 1.6 million microplastic particles through baby formula they drink from heated plastic bottles, researchers estimated in the Oct. 19 issue of Nature.
It's not clear whether these particles represent either an immediate or long-term health risk to growing babies, however.”

OraSure’s At-Home Saliva Sample Collection System Authorized for Emergency Use: “The EUA allows the device to be used in healthcare settings or by patients at home to collect and ship saliva samples for approved COVID-19 test kits. The collection system was previously cleared in the EU.”

About pharma

Purdue Pharma Pleads Guilty to Criminal Charges for Opioid Sales: “The Justice Department announced an $8 billion settlement with the company. Members of the Sackler family will pay $225 million in civil penalties but criminal investigations continue.” 

About health insurance

CMS to allow Nebraska to install voluntary Medicaid wellness and work requirements: “The Trump administration has approved a waiver to let Nebraska offer extra benefits to new Medicaid beneficiaries that in turn meet work and wellness requirements.
The waiver, approved Tuesday by the Centers for Medicare & Medicaid Services (CMS), comes as the agency’s efforts to install work requirements in several states have been struck down by federal courts.
Nebraska’s waiver applies to people who are eligible for Medicaid under the Affordable Care Act’s expansion, which the state recently implemented after a successful ballot initiative. Pregnant women, elderly adults, children and disabled adults are not eligible to participate in the program.”