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.”

Today's News and Commentary

About the public’s health

The coronavirus pandemic has caused nearly 300,000 more deaths than expected in a typical year: An update. “The CDC said the novel coronavirus, which causes covid-19, has taken a disproportionate toll on Latinos and Blacks, as previous analyses have noted. But the CDC also found, surprisingly, that it has struck 25- to 44-year-olds very hard: Their “excess death” rate is up 26.5 percent over previous years, the largest change for any age group.”

WTO Holds Off On Waiving IP For COVID-19 Vaccines:”Member states of the WTO's Council for Trade-Related Aspects of Intellectual Property Rights on Friday declined to take an unprecedented step to waive provisions of the TRIPS Agreement, a global treaty governing international property rights, according to Amnesty International and other civil society organizations familiar with the talks.”

Government watchdog to investigate allegations of Trump interference at CDC, FDA: The Government Accountability Office (GAO) agreed to launch the investigation at the request of several Democratic senators.

Volunteers to be infected with coronavirus in world’s first ‘human challenge’ trials in London:”Up to 90 fit people aged 18-30 will be deliberately infected with virus in effort to accelerate vaccine development.”

Harvard-CU Boulder Portable Air Cleaner Calculator for Schools.v1.2: This calculator tells you how to choose an air filter given the size of the space in which it is placed.

American Society for Microbiology Finds Shortages of Testing Supplies in Labs: “The American Society for Microbiology (ASM) has announced that its online data collection tool has found crucial pandemic supply shortages, including a lack of commercial COVID-19 tests and routine laboratory diagnostics in clinical labs.
Of the 117 Clinical Laboratory Improvement Amendments (CLIA)-certified labs running the tool, 73 percent have a shortage of commercial testing kits for COVID-19, 65 percent of labs have a shortage of nonCOVID-19 testing supplies for routine bacteria and 70 percent of labs are short on supplies for testing for sexually transmitted infections, ASM said.”

STAT-Harris Poll: The share of Americans interested in getting Covid-19 vaccine as soon as possible is dropping:”“Overall, 58% of the U.S. public said they would get vaccinated as soon as a vaccine was available when asked earlier this month, down considerably from 69% who said the same thing in mid-August. That change suggests growing concern that the regulatory approval process for a Covid-19 vaccine has been politicized by the Trump administration in the run-up to the presidential election.”

About health insurance

CMS: Average ACA plan premiums to drop by 2% in 2021 as more insurers join exchanges: “The Centers for Medicare & Medicaid Services announced Monday that the premium decline is part of a larger trend with the insurance exchanges, where premiums for the average plan has declined by 8% since 2018.” This prediction contrasts with the 1% increase that the Kaiser Family Foundation reported yesterday.

Hospitals Denied Full Court Review in Medicare Drug Pay Suit: “Hospitals objecting to a Trump administration rule that cut their Medicare payments for certain drugs by billions of dollars per year failed to convince the full District of Columbia Circuit to rehear the case.
In an unsigned Oct. 16 order, the U.S. Court of Appeals for the District of Columbia Circuit denied a petition for en banc review filed by the American Hospital Association and several individual hospitals.”

Best Insurance Companies for Medicare Part D Prescription Drug Plans 2021: The ratings are from US News, based on Medicare data.

KFF Health Tracking Poll – October 2020: The Future of the ACA and Biden’s Advantage On Health Care: “The latest KFF Health Tracking Poll finds a large majority of the public – including majorities of Democrats (91%), independents (81%), and Republicans (66%), now say they do not want to see the Supreme Court overturn the ACA’s pre-existing condition protections. The share who do not want to see these protections overturned has increased by double digits from one year ago for each group.
Six in ten adults say they do not want to see the Supreme Court overturn the entire ACA, up 10 percentage points from one year ago. This includes majorities of both Democrats (89%) and independents (66%), but three-fourths of Republicans still want to see the entire law overturned. Overall views of the Affordable Care Act are slightly more positive this month, with 55% of the public saying they view the law favorably. This ties its highest favorability measured in ten years of KFF polling (tied with February 2020).”
Read the entire poll results.

About hospitals and healthcare systems

Healthgrades 2021: REPORT TO THE NATION: “The Healthgrades 2021 Report to the Nation analyzes the performance of nearly 4,500 hospitals as measured by risk-adjusted mortality and complication rates. The analysis shows wide performance gaps persist among hospitals…
Healthgrades’ recent assessment of 32 of the most common procedures and conditions in the country show that if all hospitals, as a group, performed similarly to 5-star rated hospitals, on average: 218,785 lives could potentially have been saved and complications in 148,681 patients could potentially have been avoided from 2017- 2019.” Much more information in this report and is worth reading.

About pharma

HHS lawyer: Trump’s drug cards could violate election law: “The health department’s top lawyer is warning in an internal memo that President Donald Trump's plan to give seniors $200 discount cards to buy prescription drugs could violate election law, according to three officials with knowledge of those legal concerns.
The lawyer’s objection, coupled with his advice to seek approval from the Department of Justice, is a significant blow to Trump’s hope to promote the hastily devised plan before Election Day.”

About healthcare IT

Nation's First Implant of Bluetooth-Connected Heart Device at St. Elizabeth[Edgewood, KY]: “The smartphone connectivity in this device is expected to substantially improve patient remote monitoring rates and patient engagement in monitoring. Research has shown that better patient engagement and compliance with monitoring translates into reduced hospitalizations, better clinical outcomes, and improvement in survival. The smartphone connectivity offers patients flexibility compared to traditional bedside monitors. The app allows easy transmission of data manually and access to device status such as battery longevity, all done in a cybersecure mode with enabled two-way authentication.”

American Telemedicine Association Partners with ORCHA to Launch Review Process in the U.S. to Ensure Patients Have Access to Safe and Effective Apps: “The American Telemedicine Association (ATA)… announced a new partnership with ORCHA (Organization for the Review of Care and Health Apps) to create a review process for the U.S. to enable healthcare providers, insurers, and employers to give patients access to safe and effective health apps. ORCHA’s automated, intelligent review engine allows healthcare organizations to assess thousands of apps against more than 300 measures in order to build and manage a health app program…
ORCHA has evaluated more than 4,000 health apps currently available in the U.S. against its criteria and found only 15% meet quality thresholds. Most apps fail to meet healthcare, security or usability standards established to safeguard patients.  Such quality standards apply across apps for all health conditions, from fitness to heart conditions.”

Research Report: COVID-19 Pandemic Shifts Innovation Priorities at Health Systems: Telehealth/virtual care has become, by far, the highest priority. But  only 20 percent said that they would continue providing these services if reimbursement rates returned to pre-COVID-19 levels. 

Today's News and Commentary

About pharma

WHO stands by COVID-19 study casting doubt on benefit of Gilead's Veklury: “Interim findings from the World Health Organization's (WHO) global Solidarity trial have been posted to the medRxiv preprint server, and the agency says Gilead Sciences' Veklury (remdesivir) and the other drug regimens tested had "little or no effect" on 28-day mortality or the in-hospital course of COVID-19 among hospitalised patients. The data appear to corroborate a recent report based on a copy of the study that was obtained by the Financial Times.”

About the public’s health

bioLytical Receives CE Mark for One-Minute COVID-19 Test: “The portable test kit delivers results in one minute from a single drop of blood and doesn’t require any additional processing equipment, providing all the needed materials in a single pouch.” Testing is getting faster and faster.

Walgreens, CVS will offer free COVID-19 vaccines at long-term care facilities: “The vaccines will be free, and the partnership covers long-term care settings including skilled nursing facilities, nursing homes, assisted living facilities, residential care homes and adult family homes.” 

COVID-19 testing capacity outpacing desire to get swabbed: “The Trump administration says more than 120 million tests will be available in October nationwide. But far fewer Americans are actually being tested: only around 1 million per day, less than 30 million per month.”

State health officials tell Congress they need $8.4B for COVID-19 vaccination effort:”State public health officials are urging Congress to provide at least $8.4 billion in emergency funding for distributing a coronavirus vaccine, warning that they do not currently have enough money to carry out the immense logistical effort. 
The letter to bipartisan congressional leaders came from the Association of State and Territorial Health Officials (ASTHO), a group that represents state public health departments, and the Association of Immunization Managers (AIM), which represents states’ vaccination officials.”

Key coronavirus model predicts nearly 80 percent rise in deaths by February:”A key model foresees approximately 171,000 more coronavirus related deaths by February 2021, a number that would represent a spike of 78 percent.
The model from the Institute for Health Metrics and Evaluation at the University of Washington School of Medicine suggests there will be roughly 389,087 deaths by Feb. 1.
If all Americans use face masks, the model’s best-case scenario projects 314,000 deaths by that date. The model, however, foresees more than 477,000 deaths if mask mandates are eased.”

CMS data shows 21% of Medicare beneficiaries forego care: “The data showed that the most common type of care that beneficiaries delayed was going to the dentist (43%) followed by a regular checkup at 36%.
Another 36% reported not getting treatment for an ongoing condition and 32% for a diagnostic or medical screening.
CMS found that 45% of beneficiaries cited COVID-19 risk as the reason for not going to a medical facility.”
The data is a few months old so need a newer study to see if the trends are holding.

Prostate Cancer Incidence and Survival, by Stage and Race/Ethnicity — United States, 2001–2017: “Additional years of data show continued increases in the incidence of distant stage prostate cancer in the United States. The percentage of distant stage prostate cancer increased from 4% in 2003 to 8% in 2017. Five-year survival for distant stage prostate cancer improved from 28.7% during 2001–2005 to 32.3% during 2011–2016; for the period 2001–2016, 5-year survival was highest among Asian/Pacific Islanders (42.0%), followed by Hispanics (37.2%), American Indian/Alaska Natives (32.2%), Black men (31.6%), and White men (29.1%).”
The question is how often and in what populations do you need to screen. This period coincides with recommendations to decrease PSA testing.

About health insurance

Feds approve Georgia health insurance changes sought by Kemp:”Georgia will become the first state to offer federally subsidized health insurance to its residents only through private brokers under a plan being approved by President Donald Trump’s administration.
A separate part of the plan would offer Medicaid to some of the state’s poorest able-bodied adults, but only on the condition that they work, volunteer, receive job training or attend school.”

2021 Premium Changes on ACA Exchanges and the Impact of COVID-19 on Rates: “We find that the majority of rate changes for 2021 are still moderate, with increases or decrease of a few percentage points. Proposed rate changes range from a -42.0% decrease to a 25.6% increase, though half fall between a 3.5% decrease and 4.6% increase…” More details are in the survey.

About healthcare systems

Direct primary care provider to acquire 230 clinics: “Paladina Health, a Denver-based direct primary care provider, has signed an agreement to acquire Healthstat, a Charlotte, N.C.-based provider of onsite and virtual primary care. 
Paladina currently operates 120 clinics in 19 states. Through the Healthstat acquisition, Paladina will add 230 clinics in 13 additional states.” 

MOST HOSPITALS EXPANDING ASC INVESTMENTS: “In two years, the number of hospitals owning or affiliating with more than one ASC jumped 17 percentage points. In 2020, 75% of hospitals with 200-plus beds have more than one ASC. Payer pressures and other market forces have softened hospitals’ historically defensive posture toward ASCs, paving the way for overall growth, lower operating costs and heightened patient satisfaction.” 

The Impact of the COVID-19 Pandemic on Outpatient Care: Visits Return to Prepandemic Levels, but Not for All Providers and Patients: “Visits to ambulatory providers fell nearly 60 percent by early April. Since then visits have rebounded, returning in the past month to prepandemic levels.” Read this update from the Commonwealth Fund for more details.

Today's News and Commentary

About pharma

FDA extends pregnancy warning for common pain relievers: “Pregnant women should avoid a group of common pain relievers including Advil and Aleve for the last four months of pregnancy, federal health officials said Thursday, expanding the warning from three months.
The Food and Drug Administration said the fever-and-pain-reducing drugs can cause a rare but serious complication that can harm the fetus. They can lead to kidney problems in the fetus that can result in low levels of amniotic fluid that fills the womb.
The warning applies to a family of anti-inflammatory drugs that includes both over-the-counter ingredients like ibuprofen and prescription-strength drugs like Celebrex.”

Gilead questions WHO study that cast doubts on drug's COVID-19 benefits:”The American company told Reuters the data appeared inconsistent, the findings were premature and that other studies had validated the drug’s benefits.
In a blow to one of the few drugs being used to treat people with COVID-19, the WHO said on Thursday its “Solidarity” trial had concluded that remdesivir appeared to have little or no effect on 28-day mortality or length of hospital stays among patients with the respiratory disease.”

Pharma, take note: Millennials plan to spend more on meds, study says: “WPP's global media group, Mindshare, began surveying consumers in mid-March to find out what people were thinking about the then-emerging pandemic…
Overall, 77% of those surveyed planned to increase spending or spend the same amount on prescription medications.
However, when analyzed by generation, 26% of millennials—compared with only 9% of baby boomers—said they expect to increase their spending. It's not that boomers will spend less; 85% expect to spend the same amount. They just aren't likely to buy more. For comparison, 41% of millennials expect to keep their spending steady.”

About health insurance

Medicaid Enrollment & Spending Growth: FY 2020 & 2021: From the Kaiser Family Foundation:

• “After relatively flat enrollment growth in FY 2020 (0.04%), states responding to the survey expect Medicaid enrollment to jump in FY 2021 (8.2%) attributed to the FFCRA’s MOE requirements and to the economic downturn that started late in FY 2020.

• Across all reporting states, states were anticipating that total Medicaid spending growth would accelerate to 8.4% in FY 2021 compared to growth of 6.3% in FY 2020. Enrollment was the primary factor identified as putting upward pressure on expenditure growth in FY 2021.”

President Trump’s Medicare drug discount cards face uncertain path: “Three weeks after President Trump announced the government would send tens of millions of older Americans $200 to help pay for medicine, the election-season idea is mired in uncertainty over whether such drug discount cards are legal, proper or will ever exist.” Read the article for more details.

Georgia gets Trump approval for Medicaid work requirements, partial expansion: “The Trump administration has given Georgia the green light to partially expand Medicaid without federal support, and to impose work requirements on Medicaid beneficiaries.
The plan announced by Gov. Brian Kemp (R) Thursday stops short of the full-scale Medicaid expansion supported by Democrats, which would cover thousands more low-income adults regardless of their employment status.
Kemp’s plan, called "Pathways to Coverage," would cover adults who meet the work requirements and who earn no more than 100 percent of the federal poverty level — $12,760 a year for an individual.”

The Potential Effects of a Supreme Court Decision to Overturn the Affordable Care Act: Updated Estimates: “Using projections of coverage and spending in 2022 that account for an anticipated partial economic recovery from the COVID-19 recession, researchers estimate overturning the Affordable Care Act (ACA) would leave an additional 21 million people uninsured.”

Blue Shield of California’s Innovative Drug Cost Transparency Initiative Provides $10 Million in Prescription Savings: “Knowing that doctors treat dozens of patients per day, Blue Shield of California first released a tool that empowers doctors at the point of prescription – while the patient is still sitting in front of them during a visit. Integrated seamlessly into electronic records systems, this tool acts like an online shopping cost-comparison engine, displaying appropriate drug alternatives along with the patient’s copay and the total drug cost for each.”

Appeals court skeptical of AHA in lawsuit over HHS price transparency rule: “A trio of appellate judges was very skeptical of the hospital industry’s arguments that a controversial price transparency rule set to go into effect in January should be struck down…
The rule requires facilities to post payer-negotiated rates for 300 shoppable services. The idea is to give consumers a way to price shop among different hospitals for certain services.”

About the public’s health

Global Burden of Disease: This link is to tomorrow’s special issue of The Lancet. A great topical review.

The Third Coronavirus Surge Has Arrived: We worried about the second wave of the infection. Now, this article from The Atlantic explains we are experiencing the third wave: “After a month of warning signs, this week’s data make it clear: The third surge of the COVID-19 pandemic in the United States is under way. Outbreaks have been worsening in many states for more than a month, and new COVID-19 cases jumped 18 percent this week, bringing the seven-day average to more than 51,000 cases a day. Though testing rose by 8 percent nationally, that’s not enough of an increase to explain the steep rise in cases. Meanwhile, COVID-19 hospitalizations, which had previously been creeping upward slowly, jumped more than 14 percent from a week earlier.”

About hospitals and health systems

47 hospitals closed, filed for bankruptcy this year: A list of the casualties (so far) due to the decreased elective care volumes caused by the COVID-19 pandemic.

Today's News and Commentary

About health insurance

UnitedHealth Group Reports Third Quarter Performance: Updating yesterday’s post about increased revenue, UnitedHealth reported “earnings of $3.30 per share and adjusted earnings of $3.51 per share declined 10%, while care patterns disrupted by the pandemic moved closer to normal levels.”

Competition shrank in majority of health insurance markets where it is scarcest: “Between 2014 and 2019, the share of markets that were highly concentrated increased from 71% to 74%. Moreover, more than half (52%) of the markets that were highly concentrated in 2014 grew even more concentrated by 2019.”

CMS adds 11 new telehealth services to Medicare coverage: These services have been approved during the Covid pandemic. And in a related article: Blue Cross Blue Shield covers telemedicine permanently for federal workforce program.

FDA decision to stop quick review of lab developed tests [LDTs] raises payment concerns for labs:The FDA announcement “last week that it will no longer review COVID Emergency Use Authorization [EUA] submissions for laboratory-developed tests has created new uncertainty for laboratories amidst an already tumultuous environment.”
The decision “raises questions around reimbursement and liability protections for those tests moving forward. It could also impact the ability of new lab developed tests to compete in the market. That's because an EUA, which the new LDTs won't have, are seen by many clinicians and payors as a mark of quality.

Gen Re Announces U.S. Medicare Supplement Market Survey 2019 Results: “Key results from this year’s survey include:

• Across all participants, $23.3 billion in total Medicare Supplement in-force premium was reported for 2019, an increase of 5.8% over reported results for 2018.

• For companies actively selling and reporting premium and lives for both 2017 and 2018, sales premium and lives grew by 21.0% and 12.8%, respectively.

• Lapse rates averaged 10.6% for open blocks of business and 14.0% for closed blocks in 2019.

• Plan G was the most popular plan sold in 2019, accounting for 54.2% of new sales premium and 55.5% of new lives. [See the Medicare section of the Book for explanations of the different supplement choices.]

• Nearly 61% of the active companies who participated in the survey report selling Medicare Supplement plans on a direct-to-consumer basis (via phone, mail, online or a combination of these methods where a traditional agent receiving traditional paid compensation is not involved), and 6% are looking to develop this capability.”

About pharma

Walgreens Boots Alliance Reports Fiscal Year 2020 Results: Highlights:

• “Sales increased 2.0 percent to $139.5 billion, up 2.5 percent on a constant currency basis

• Operating income decreased 73.7 percent to $1.3 billion; Adjusted operating income decreased 24.9 percent to $5.2 billion, down 24.8 percent on a constant currency basis

• EPS decreased 88.0 percent to $0.52; Adjusted EPS decreased 20.8 percent to $4.74, down 20.6 percent on a constant currency basis; reflecting an estimated adverse COVID-19 impact of approximately $1.06

• Net cash provided by operating activities was $5.5 billion, a decrease of $109 million compared with fiscal 2019; Free cash flow increased 5.6 percent to $4.1 billion”

Rite Aid unveils new strategy, revamped stores to remain competitive with CVS, Walgreens: “The revamped stores, some of which will open this month, will feature a pharmacy that looks more like an Apple Store Genius Bar, virtual care rooms that will enable consumers to remotely connect with care teams and a new assortment of products with a focus on both traditional medicine and alternative ‘remedies’ like essential oils…”

About healthcare IT

Press Ganey acquires Doctor.com and majority stake in Binary Fountain:”Boston-based patient experience company Press Ganey acquired Doctor.com, a marketing automation platform for medical practices.
It also acquired a majority stake in Binary Fountain, which has an online reputation management platform. 
The combination of the two solutions will make its healthcare consumerism platform the largest in the industry… The platform will be aimed at helping health providers drive digital patient acquisition, retention and reputation management…”

Mayo Clinic, startup launch 'health passport' app with initial focus on COVID-19: “Mayo Clinic is partnering with Los Angeles-based Safe Health Group…  The venture will focus on testing for STDs and common ailments but will initially target COVID-19 through symptom tracking and testing by linking consumers, clinicians and test distribution into one digital solution, called HealthCheck.
HealthCheck is a smartphone and desktop app that's designed to provide real-time health status verification while also protecting consumer privacy, much like a health passport…”

Federal Electronic Health Record Connects With More Community Partners: “The Federal Electronic Health Record Modernization (FEHRM) program office announces the Department of Defense (DOD), Department of Veterans Affairs (VA) and Department of Homeland Security’s U.S. Coast Guard (USCG) significantly expanded their joint health information exchange (HIE) network with the private sector on Oct. 9 after connecting with the CommonWell Health Alliance.
CommonWell brings a nationwide network of more than 15,000 hospitals and clinics to the 46,000 community partners already part of the joint HIE.”

Alexa, do I have COVID-19?: A fascinating article from Nature that updates the emerging science of disease detection by voice recognition technology.

About hospitals and health systems

15 hospital building projects costing $1B or more: It is amazing that this much major construction is going on not only during the COVID-19 pandemic, but also as payment mechanisms are changing, e.g., more telemedicine and risk-based payments.

About the public’s health

COVID-19 in New Zealand and the impact of the national response: a descriptive epidemiological study: A great case study of successful handling of the COVID-19 pandemic: “Here, we investigate the impact of national suppression strategies on the epidemiology of the first wave of COVID-19 in New Zealand and measures of response performance.” Early shutdowns, quarantines and case tracing were among the key successful actions.

Today's News and Commentary

About the public’s health

Covid in the U.S.: Latest Map and Case Count: “At least 826 new coronavirus deaths and 54,512 new cases were reported in the United States on Oct. 13. Over the past week, there have been an average of 52,156 cases per day, an increase of 21 percent from the average two weeks earlier.” And in a related article: Coronavirus cases are rising in U.S., sparking worries the next big wave has begun

Rapid New Covid-19 Test From Access Bio Cleared in U.S.: “A new 10-minute Covid-19 test that doesn’t need added equipment to process has been cleared by the U.S. Food and Drug Administration, manufacturer Access Bio, Inc.said on Tuesday.” The test will cost less than $20.

New poll shows Black Americans see a racist health care system setting the stage for pandemic’s impact: A new nationwide poll by The Undefeated and the Kaiser Family Foundation (KFF) found that 7 in 10 African Americans believe that people are treated unfairly based on race or ethnicity when they seek medical care. It’s a feeling born of unequal history and intensified by the coronavirus pandemic, which is disproportionately ravaging Black lives  both physically and economically.” These findings tie into another study by the same organizations: Half of Black adults say they won’t take a coronavirus vaccine:”Overall, 65% of Black adults said they are not too confident or not at all confident that the development of a coronavirus vaccine is taking the needs of Black people into account.”

Pfizer to enroll kids as young as 12 in COVID-19 vaccine study: The headline speaks fro itself.

About health insurance

Hospitals can't use CARES Act grants to repay Medicare loans, HHS says: The headline speaks for itself.

Medicare Preparing Rule to Ensure Swift Access to Covid Vaccine: “The Centers for Medicare & Medicaid Services has a plan to ensure full payment for and speedy access to new Covid-19 vaccines and treatments for Medicare beneficiaries, agency Administrator Seema Verma said Tuesday at a virtual conference.Although Congress has made clear it wants Medicare to cover the cost of a Covid-19 vaccine without cost-sharing, Verma said it can take one to three years to work out payment issues for vaccines and other treatments…”

UnitedHealth Group rakes in $3.2B in Q3 profit: A followup to yesterdays post about health insurance profitability.

Verma says value-based care models haven't made good return on investment: “She did not elaborate on which models specifically did not perform well.
However, Center for Medicare and Medicaid Innovation Director Brad Smith pointed in a separate speech last month to bundled payment models that tie Medicare payments together for certain procedures into one bundle for a total cost of care. Smith said that the bundled models did not lead to significant quality and savings improvements, but he said the models did spur transformation among providers.
Smith said that models which focused on a global budget fared much better, giving Maryland’s Total Cost of Care model as an example. Under the model, Maryland has a per capita limit for Medicare costs in the state.
Verma also gave praise to CMS’ Pathways to Success model that overhauled the program managing accountable care organizations (ACOs).
Pathways required ACOs to take on financial risk at a shorter period than the Medicare Shared Savings Program created under the Obama administration. This meant that ACOs had to pay back Medicare if it did not meet certain savings targets.”

 About pharma

7 health systems form specialty pharmacy alliance: “Seven health systems are uniting to form the Health System Owned Specialty Pharmacy Alliance, or HOSP, to advocate for health system-owned specialty pharmacies. 
The group will advocate for the interests of integrated specialty pharmacies and promote best practices to deliver the best patient care and patient outcomes, the organization said in a news release.”

Study of Lilly's COVID-19 antibody LY-CoV555 paused over potential safety issue : No other information is available about this action.

J&J Strikes $5B Deal Pushing 3,000 Opioid Suits Toward End: “Johnson& Johnson on Tuesday disclosed that it's offering up to $5 billion to end a nationwide torrent of litigation accusing it of contributing significantly to America's opioid addiction crisis, a 25% increase on an earlier settlement proposal.”

About healthcare IT

 Dispute between telehealth giants heats up as Teladoc sues Amwell for patent infringement: “Teladoc has accused Amwell of infringing on its patents related to telehealth carts, a digital scope and stethoscope, according to a lawsuit filed Monday in the U.S. District Court for the District of Delaware.”

Google, Optum, Microsoft team up on $13M challenge to prevent next pandemic: “The Trinity Challenge, initially announced in September, will offer about $13 million in funding to recognize and reward insights and innovations across areas including economics, behavioral sciences and epidemiology. Founding members of the challenge span the public, private and social sectors including the Bill & Melinda Gates Foundation, Facebook, Tencent, GlaxoSmithKline, Cambridge University, Imperial College London and Northeastern University…
Solutions for identification could include building early-warning systems and developing new technologies to identify threatening pathogens before they cause great harm…”

About healthcare quality

Misclassification of Hospital Performance Under the Hospital Readmissions Reduction Program [HRRP]: “In this cross-sectional study of hospitals that participated in the HRRP in fiscal year 2019, the percentages of hospitals that should have been penalized by the program, but were not, was 20.9% for acute myocardial infarction, 13.5% for heart failure, and 13.2% for pneumonia. In contrast, the percentages of hospitals that were incorrectly penalized was 10.1% for acute myocardial infarction, 10.9% for heart failure, and 12.3% for pneumonia….
 These findings suggest that the hospital-level 30-day RSRR measure may not reliably distinguish hospital performance in the HRRP. This has important implications for CMS value-based programs that use risk-standardized outcomes to evaluate and compare hospital performance.”  

Today's News and Commentary

About the public’s health

Genomic evidence for reinfection with SARS-CoV-2: a case study:”The patient had two positive tests for SARS-CoV-2, the first on April 18, 2020, and the second on June 5, 2020, separated by two negative tests done during follow-up in May, 2020. Genomic analysis of SARS-CoV-2 showed genetically significant differences between each variant associated with each instance of infection. The second infection was symptomatically more severe than the first.” And in a related article: Dutch researchers report first death from COVID-19 reinfection: “An elderly woman in the Netherlands has died after getting COVID-19 a second time, researchers reported on Monday. It’s the first time a death has been reported from reinfection with coronavirus. 
The patient was an 89-year-old woman who was being treated for Waldenström’s macroglobulinemia, a rare type of white blood cell cancer which is treatable but incurable”

.Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant: The exact nature of the illness has not yet been revealed.

CMS Takes Action to Protect Integrity of COVID-19 Testing: “The Centers for Medicare & Medicaid Services (CMS) is taking every action to ensure U.S. laboratories are fit to deliver reliable, accurate and timely patient test results for coronavirus disease 2019 (COVID-19) by confirming Clinical Laboratory Improvement Amendments of 1988 (CLIA) certifications are up- to-date. A recent record check by CMS resulted in the issuance of 171 cease and desist letters to facilities that did not have proper CLIA certifications in place.”

Dr. Fauci says U.S. faces ‘a whole lot of trouble’ as coronavirus cases rise heading into winter: “The U.S. reported more than 44,600 new cases on Sunday and the seven-day average rose to over 49,200 new cases per day, up more than 14% compared with a week ago, according to a CNBC analysis of data compiled by Johns Hopkins University. Average daily cases were up by more than 5% in 36 states and the District of Columbia, CNBC’s analysis shows.
Similarly, the number of people currently hospitalized with Covid-19 rose by at least 5% in 36 states, according to CNBC’s analysis of data from the Covid Tracking Project, a volunteer project founded by journalists at The Atlantic magazine.”

Economy-Sensitive Conditions: Are Some Pediatric Hospitalizations Triggered By Economic Recessions?:”…a 1 percent increase in unemployment was associated with a 5 percent increase in hospitalizations for substance abuse, a 4 percent increase for diabetes mellitus, and a 2 percent increase both for children with medical complexity and for poisoning and burns. Mean pediatric all-cause hospitalizations increased by 2 percent for every 1 percent increase in unemployment…”

The COVID-19 Pandemic and the $16 Trillion Virus: Economists David Cutler and Lawrence Summers estimate the cost of the COVID-19 crisis will be $16.12Trillion, with about half attributable to loss of GDP.

Excess Deaths From COVID-19 and Other Causes, March-July 2020:”Although total US death counts are remarkably consistent from year to year, US deaths increased by 20% during March-July 2020. COVID-19 was a documented cause of only 67% of these excess deaths.”

Proposal to hasten herd immunity to the coronavirus grabs White House attention but appalls top scientists: Three scientists with distinguished academic appointments are promoting a strategy, which they call Focused Protection. “Martin Kulldorff is an epidemiologist at Harvard University. Sunetra Gupta is an epidemiologist at the University of Oxford. Jay Bhattacharya is a physician and health economist at Stanford Medical School.” They “argue that their approach would decrease the undesirable public health effects of restrictions and closures, which disproportionately affect lower-income people. The declaration does not mention wearing masks, engaging in social distancing, avoiding crowds and indoor environments, or any of the other recommendations pushed by most government and scientific experts.” This policy “has been denounced by other infectious-disease experts and has been called ‘fringe’ and ‘dangerous’ by National Institutes of Health Director Francis Collins.” Also opposing the approach is WHO Director General Tedros Adhanom Ghebreyesus.

Found: genes that sway the course of the coronavirus: “…a U.K. group studying more than 2200 COVID-19 patients has pinned down common gene variants that are linked to the most severe cases of the disease, and that point to existing drugs that could be repurposed to help.”

About pharma

AstraZeneca, U.S. gov't sign deal for COVID-19 antibody treatment: “Pharmaceutical company AstraZeneca has reached a $486 million deal with the U.S. government to supply as many as 100,000 doses of its experimental COVID-19 antibody treatment, if it's ultimately approved.”

Walgreens COO says pandemic has been an 'accelerator' for VillageMD plans: “In the months after Walgreens announced a $1 billion partnership with VillageMD to build hundreds of primary care clinics next to its retail pharmacy stores, there are still only a few locations in Houston.
But that will be changing quickly, said Walgreens' co-Chief Operating Officer Alex Gourlay.
Within the next fiscal year, the company plans to have at least 40 locations open, Gourlay said, speaking at the HLTH 2020 virtual conference Monday. The company has previously said it expects to have at least 500 locations open within the next five years.”

About health insurance

Health Insurer Financial Performance Amid the Coronavirus Pandemic: Profitability has increase for insurers as the Medical Loss ratios have mostly dipped. The individual market MLR is steady at 72% while the Group and Medicare Advantage rates are 78% and 80%, respectively. Net income was not measured. (Recall MLR only includes specified patient care costs, not SG&A expenses.)

About healthcare IT

ROI for pop health IT still not quite in view: “A report from KLAS and CHIME finds that hospitals and health systems are still investing in population health management tools, but many are ‘becoming less optimistic’ about the near-term prospects for value-based reimbursement.”

Comcast's Quil Health launches in-home sensor technology for aging seniors: “Digital health company Quil Health is expanding its reach into home health care with a new sensor-based technology platform aimed at aging seniors and their caregivers.
Quil—the healthcare joint venture of telecom giant Comcast NBCUniversal and Independence Health Group—is offering new technology that combines ambient sensors and voice-activated technology in the home to help caregivers monitor patients' movements…”

IBM Watson launching blockchain 'health pass' to return to public spaces: “IBM's Watson Health division leveraged blockchain technology to develop its digital health pass to be used by employers, schools, stadiums or airline companies.
The digital tool was designed for an organization to establish their own criteria such as COVID-19 test results and temperature scans so that a verified health pass can be generated for an individual, IBM said…
he IBM Digital Health Pass will allow users to share their verified health pass without exposing any of the underlying data used to generate it to ensure privacy protections, the company said.
 IBM Digital Health Pass uses IBM Blockchain and sophisticated cryptographic techniques so that data exchange can be verifiable and trusted, IBM said.”

New services and solutions company, Tegria, to streamline health care delivery: “Tegria, a new company designed to provide next generation technologies and services to the health care sector, launched today with support from Providence, one of the nation's largest health systems. Tegria combines select Providence investments and acquisitions into a comprehensive portfolio of solutions to accelerate technological, clinical and operational advances in health care.” This article is a great example of how a health system has branched into the IT sector as a diversification strategy.

Today's News and Commentary

About pharma

Mallinckrodt files for Chapter 11 bankruptcy: “Opioid claims against the company are to be channeled into one or more trusts which would receive $1.6 billion in structured payments. The company also agreed to pay $260 million over seven years to settle claims it knowingly underpaid Medicaid for Acthar. 
In the bankruptcy filing, Mallinckrodt listed both assets and liabilities in the range of $1 billion to $10 billion. 
The company will continue to operate as normal as it restructures for bankruptcy.”

Health officials scrambling to produce Trump's ‘last-minute’ drug cards by Election Day:”Caught by surprise by President Donald Trump’s promise to deliver drug-discount cards to seniors, health officials are scrambling to get the nearly $8 billion plan done by Election Day, according to five officials and draft documents obtained by POLITICO.”

About health insurance

Trends in Subsidized and Unsubsidized Enrollment [for ACA Exchange Plans]: Among the findings in this report from CMS:

• “From plan years 2016 to 2019, unsubsidized enrollment declined by 2.8 million people, representing a 45 percent drop nationally. At the state level, the percentage change in unsubsidized enrollment over this period ranged from a 4 percent drop in Rhode Island to a 90 percent drop in Iowa.

• The most recent year of enrollment data shows that average monthly enrollment across the individual market nationally decreased by 3 percent between 2018 and 2019.”

Fewer Medicare Advantage plans scored high quality ratings :”Of the 400 Advantage plans with prescription drug coverage that received a rating, roughly 49% earned four stars or higher on a scale of one to five stars, with five being the highest. For 2020 plans, 52% scored four stars or more.” This data is on number of plans as opposed to numbers who enroll in high quality plans (see October 9’s health insurance section).

About the public’s health

The Sweden Myth— How did the country outperform everybody on COVID-19? That's easy -- it didn't: The headline speaks for itself but the article has specifics.

Coronavirus survives for almost a month on cash and phones, study finds: “Australian agency says pathogen stays infectious for ‘significantly longer’ on smooth surfaces.”

Two Black university leaders urged their campuses to join a Covid-19 vaccine trial. The backlash was swift: “The episode illustrates the challenges historically Black colleges and universities face as they seek to leverage their legacies of trust within African American communities to bolster lagging Black enrollment in Covid-19 vaccine clinical trials. Their recruitment efforts will need to overcome the deep-seated suspicions many Black Americans hold toward medical researchers, pharmaceutical companies, and the government that stem from long-standing racial injustices perpetrated by those institutions.
Now, as the four HBCU medical colleges prepare to host Covid-19 vaccine trials on their campuses, there’s hope their efforts will have more success.”

Today's News and Commentary

About healthcare IT

Trump Administration Invests $72 Million in Distance Learning and Telemedicine Infrastructure in 40 States, Puerto Rico and the Virgin Islands: This time the funds are coming from the Dept. of Agriculture.

Telehealth Patient Satisfaction Surges During Pandemic but Barriers to Access Persist, J.D. Power Finds:  “The overall customer satisfaction score for telehealth services is 860 (on a 1,000-point scale), which is among the highest of all healthcare, insurance and financial services industry studies conducted by J.D. Power…
Though telehealth has been pitched as a solution to improve access to healthcare for everyone, more than half (52%) of telehealth users say they encountered at least one barrier that made it difficult to use telehealth. The most common hurdles are limited services (24%); confusing technology requirements (17%); and lack of awareness of cost (15%). Additionally, 35% of telehealth users indicate they experienced a problem during a visit. Tech audio issues (26%) are the most common problem…
Overall satisfaction is 117 points lower among patients with the lowest self-reported health status than among patients who consider themselves to be in excellent health. Similarly, healthier patients are significantly more likely to understand the information provided during the visit, receive clear explanations, feel their visits are highly personalized and obtain a high-quality diagnosis…
Among patients who used a telehealth offering this year, 46% say their top reason for choosing telehealth was safety. That compares with just 13% in 2019.”

About health insurance

HCA to return $6B in CARES Act funding, including more than $4B in Medicare accelerated payments: “In a release, officials at the Nashville, Tennessee-based health system giant said they took a conservative approach to address operational and financial challenges presented by the COVID-19 pandemic. Using available cash and future cash flows from operations, officials said they plan to repay the $1.6 billion in Provider Relief Funds HCA received and $4.4 billion in Medicare accelerated payments.”

CMS alerts providers to changes to Medicare advance loan repayments, giving hospitals more time: “Now, providers have until one year after the first payment was issued to start repaying. Once that first year ends, Medicare will automatically recoup 25% of the Medicare payments otherwise given to a provider or supplier for 11 months.
At the end of that 11-month period, the recoupment will increase to 50% for another six months.
If a provider or supplier can’t repay the total amount during this 29-month period, CMS will issue letters calling for the repayment of any outstanding balance with an interest rate of 4%.”

Average Family Premiums Rose 4% to $21,342 in 2020, Benchmark KFF Employer Health Benefit Survey Finds: “Annual family premiums for employer-sponsored health insurance rose 4% to average $21,342 this year, according to the 2020 benchmark KFF Employer Health Benefits Survey. On average, workers this year are contributing $5,588 toward the cost of family coverage, with employers paying the rest.” Look through the executive summary and graphics for this report. It is an excellent summary of employer sponsored health insurance.

High-Quality Care for Medicare Beneficiaries Continues as Medicare Health and Drug Plans Receive Star Ratings: “Most Medicare beneficiaries – about 77 percent – who enroll in Medicare Advantage plans with drug coverage will be in plans with four or more stars in 2021. That compares with 69 percent of beneficiaries enrolled in such plans in 2017…
[Also}, Medicare beneficiaries will have access to higher-quality stand-alone Medicare Part D prescription drug plans. Based on current enrollment, about 98 percent of beneficiaries enrolled in stand-alone prescription drug plans for 2021 will be in plans with 3.5 stars or higher, an increase from about 70 percent in 2020.”

About pharma

Final Results of National Institute of Allergy and Infectious Diseases’ ACTT-1 Trial Published in New England Journal of Medicine Expand Clinical Benefits of Veklury (remdesivir) for the Treatment of COVID-19: “Overall, treatment with Veklury Resulted in Five Days Faster Recovery and Reduced Disease Progression Compared with Placebo. Veklury Reduced Mortality by 70 Percent at Day 29 in Patients on Low-Flow Oxygen at Baseline in Post-Hoc Analysis.”

As Trump touts his ‘great’ COVID drugs, the pharma cash flows to Biden, not him: “Reversing a trend in which contributions from drugmakers’ political committees and their employees have gone largely to Republican candidates  for president and Congress, so far for 2020 the industry has tilted toward Democrats.”

Trump pushes FDA to quickly clear coronavirus antibody treatments, erroneously calling them a ‘cure’: The headline speaks for itself. Of note is that the treatment was made from stem cells derived from aborted fetuses, which the Trump administration bars for use (the ones used were from before the ban, so are “allowed.”). See: Trump’s antibody treatment was tested using cells originally derived from an abortion.

Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19: From the RECOVERY Collaborative Group: “Among patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care.” Can we finally put this issue to rest?

About the public’s health

COVID-19 Is Now the Third Leading Cause of Death in the U.S.:”COVID-19 became the third biggest cause of deaths in the week of March 30 to April 4, trailing heart disease and cancer. It killed more people than stroke, chronic lower respiratory disease, Alzheimer’s, diabetes, kidney disease or influenza.”

The bizarre abortion order just handed down by the Supreme Court, briefly explained: You will need to read the details to fully appreciate the issue. Briefly, the case hinges on whether relaxation of dispensing abortion medication during the COVID-19 pandemic should be allowed. The SCOTUS punted.

New test detects coronavirus in just 5 minutes:”Researchers have used CRISPR gene-editing technology to come up with a test that detects the pandemic coronavirus in just 5 minutes. The diagnostic doesn’t require expensive lab equipment to run and could potentially be deployed at doctor’s offices, schools, and office buildings”

.About healthcare quality

Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: “Compared with the control group, different financial incentives improved measured statin adherence but not LDL-C levels. This result points to the importance of directly measuring health outcomes, rather than simply adherence, in trials aimed at improving health behaviors.” The study emphasizes the importance of measuring actual versus surrogate outcomes.

Ambulatory Follow-up and Outcomes Among Medicare Beneficiaries After Emergency Department Discharge: “In this cohort study of Medicare beneficiaries discharged from the ED, nearly 30% lacked ambulatory follow-up at 30 days, with variation in follow-up rates by patient and hospital characteristics. Having an ambulatory follow-up visit was associated with higher risk of subsequent hospitalization but lower risk of mortality. Ambulatory care access may be an important driver of clinical outcomes after an ED visit.” There needs to be actual, not presumed, handoffs to assure continuity of care.

About hospitals and health systems

Atrium, Wake Forest Baptist merge to create 42-hospital system:”With the transaction complete, Wake Forest Baptist Health and Wake Forest School of Medicine will become the "academic core" of Atrium Health. The health system said it plans to build a second campus of the school of medicine in Charlotte.”

About healthcare technology

CurveBeam’s CT Imaging System Gets CE Mark: “The system, which can scan anywhere along the lower extremity from the hip and pelvis to the feet, allows patients to stand naturally on both feet during a CT scan. It requires minimal patient radiation shielding and is designed for ease of use.”

Today's News and Commentary

Campaigns spar over debate timing after Trump rejects virtual event: “Trump rejected a decision by a nonpartisan panel to hold a town-hall-style event on Oct. 15 virtually instead of in person.”

About health insurance

Verma doubles down on supporting Medicaid work requirements as enrollment swells: “The head of Centers for Medicare & Medicaid Services reiterated support for Medicaid work requirements as enrollment in the program swells this year…
Her remarks come less than a month after a study in Health Affairs found that work requirements in Arkansas did not lead to more employment.”

How Many Americans Have Lost Jobs with Employer Health Coverage During the Pandemic?: From the Commonwealth Fund: “We estimate that as many as 7.7 million workers lost jobs with ESI [Employer Sponsored Insurance] as of June 2020 because of the pandemic-induced recession. The ESI of these workers covered 6.9 million of their dependents, for a total of 14.6 million affected individuals. Only with time will we know how many job losses are ultimately permanent, resulting in loss of ESI for workers and their dependents.”

Cigna won't cover some hospital-based MRIs, CT scans under new policy: “Cigna will not cover MRIs and CT scans performed in a hospital setting if they don't meet new medical necessity requirements, according to a policy that took effect Aug. 1. 
Other commercial insurers, including Anthem, have similar policies in place. The policies aim to direct patients to less pricey freestanding facilities for imaging services.” Plans have been using utilization review for costly diagnostics for quite a while, e.g., Anthem’s division AIM.

How Much Would Trump’s Coronavirus Treatment Cost Most Americans?: The short answer is: “For someone who isn’t president, that would cost more than $100,000 in the American health system.” Read the article for more details.

 About pharma

AstraZeneca vaccine document shows limit of no-profit pledge: The pledge is only good during the pandemic. AZ decides when it is over and can do so as soon as July, 2021. See also: Moderna Vows to Not Enforce Covid-19 Vaccine Patents During Pandemic: “Moderna Inc. said it wouldn’t enforce patents related to its experimental Covid-19 vaccine while the pandemic continues and is willing to license the patents to others after the pandemic.”

Lilly seeks FDA emergency use for LY-CoV555 in higher-risk COVID-19 patient : “Eli Lilly said Wednesday that it submitted a request to the FDA for emergency-use authorisation (EUA) of LY-CoV555 monotherapy for higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. The neutralising IgG1 monoclonal antibody, also known as bamlanivimab, is being  co-developed with AbCellera.”

Statement on REGN-COV2 Emergency Use Authorization Request: From Regeneron: “Subsequent to our discussions with regulatory authorities, we have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for our REGN-COV2 investigational antibody combination for COVID-19. Under our agreement with the U.S. government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.”

Dexamethasone price has increased 137% in recent months: “The price of the steroid spiked from $0.59 per unit to $1.39 per unit and is currently listed in shortage from both the FDA and the American Society of Health-System Pharmacists.”

 About the public’s health

Renewal of Determination That A Public Health Emergency Exists: From the HHS secretary:
”As a result of the continued consequences of the Coronavirus Disease 2019 (COVID-19) pandemic, on this date and after consultation with public health officials as necessary, I, Alex M. Azar II, Secretary of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby renew, effective October 23, 2020, my January 31, 2020, determination, that I previously renewed on April 21, 2020 and July 23, 2020, that a public health emergency exists and has existed since January 27, 2020, nationwide.”

The vice presidential debate: 6 healthcare takeaways: A good summary of the major healthcare points from last night’s debate. VP Pence said the Administration has a healthcare plan, but the question is: Where is it?

Survival of SARS-CoV-2 and influenza virus on the human skin: Importance of hand hygiene in COVID-19: “The 9-h survival of SARS-CoV-2 on human skin may increase the risk of contact transmission in comparison with IAV [Influenza A Virus], thus accelerating the pandemic. Proper hand hygiene is important to prevent the spread of SARS-CoV-2 infections.”

About healthcare professionals

Latest $20 billion round of CARES Act physician relief now open:”The Department of Health and Human Services (HHS) is disbursing another $20 billion in financial relief for physician practices and other health care delivery organizations and clinicians that is part of the Coronavirus Aid, Relief and Economic Security (CARES) Act.”

About healthcare technology

Heritable Human Genome Editing: From the National Academy of Sciences, Engineering and Medicine: “Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues…
From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses.”
The report is free to download.

Today's News and Commentary

About the public’s health

Trump’s determination to attend next week’s debate seen as part of pattern of recklessness: I was wrong when I predicted the second debate would be canceled. But it will take a lot of energy (and breath) to achieve the same level of interruption we saw in the last contest.

Prestigious medical journal calls for US leadership to be voted out over Covid-19 failure “In an unprecedented move, the New England Journal of Medicine on Wednesday published an editorial written by its editors condemning the Trump administration for its response to the Covid-19 pandemic -- and calling for the current leadership in the United States to be voted out of office.”

White House Agrees to FDA’s Guidelines for Vetting Covid-19 Vaccines: The article is a good explanation of the chronology of the President’s reversal in opposing FDA guidelines for vaccine approval.

Forget October. Warp Speed chief says first COVID shot data—from Pfizer and Moderna—won't appear till later this year: “Operation Warp Speed head Moncef Slaoui said early efficacy data on vaccines will be available over the next several months, with Pfizer and Moderna's in a first wave in November or December…”

Face masks: what the data say: You know what the data says…but the article is a great summary of research findings.

In the U.S., states — not science — decide what counts as a coronavirus outbreak “The nation’s patchwork pandemic response has led to wide disparities in data reporting and even in definitions for basic medical concepts. In the absence of federal standards, states have adopted divergent and sometimes scientifically questionable approaches to disease control, which experts say have allowed the virus to spread.”

Trends in the Age of Cigarette Smoking Initiation Among Young Adults in the US From 2002 to 2018: Some bad news: “In this repeated cross-sectional study including 71 756 young adults aged 22 to 23 years, the proportion of ever smokers who initiated cigarette smoking in early adulthood more than doubled between 2002 and 2018, and the proportion of daily cigarette smokers who transitioned to daily smoking in early adulthood also increased from 38.7% in 2002 to 55.9% in 2018.”

The Surgeon General’s Call to Action to Control Hypertension: Click on the website and scroll down to this title for a full list of documents. Briefly, the Surgeon General’s publications have two sections:: Section 1 ”summarizes the current state of hypertension control, including the economic costs and disparities between different population groups…
Section 2 presents three overall goals to support improvements in hypertension control: 
Goal 1. Make hypertension control a national priority.
Goal 2. Ensure that the places where people live, learn, work, and play support hypertension control.
Goal 3. Optimize patient care for hypertension control.”

About healthcare technology

Nobel Prize in chemistry goes to CRISPR pioneers Doudna, Charpentier: “The 2020 Nobel Prize in chemistry was awarded to Jennifer Doudna, Ph.D., and Emmanuelle Charpentier, Ph.D., for their 2012 discovery of the genome-editing tool CRISPR-Cas9. It was the first time two women have won a science Nobel Prize.
Charpentier, now director of the Max Planck Unit for the Science of Pathogens in Berlin, stumbled upon a previously unknown RNA while studying the bacterium Streptococcus pyogenes. That RNA turned out to play a role in CRISPR-Cas9, a mechanism that bacteria use to defend against viruses. She published her findings in 2011 and then teamed up with Doudna, a biochemist at the University of California, Berkeley.”

Cleveland Clinic’s Top 10 for 2021: Their annual listing of top 10 influential technologies. Always worth a read.

STERIS Expands Healthcare Consumables Offering with Acquisition of Key Surgical for approximately $850 million: The headline speaks for itself.

About healthcare IT

HHS threatens to withhold federal funding from hospitals that fail to report coronavirus data:”…hospitals will be given 14 weeks to comply with the requirements before enforcement is implemented…”

2020 breaks record in digital health investment with $9.4B in funding: “With $9.4 billion invested up through the third quarter, 2020 will be the largest funding year for digital health to date.
The sector is on track to hit $12 billion in funding by the end of the year, compared to $7.4 billion invested in 2019 and $8.2 billion invested in 2018, according to investment firm Rock Health's latest digital health funding report.”

CHIME names 2020 'Most Wired' hospitals: Read the article for the list.

Modest increases in physician productivity can offset the cost of medical scribes:”New research led by Neda Laiteerapong MD, Associate Professor of Medicine at the University Chicago Medicine, indicates the real value of adding this healthcare professional to a medical practice. It gives physicians more time to treat patients, add new ones, and schedule more return visits. This research also indicates that the initial cost of employing a medical scribe can be offset in a year or less, after which the possibility of increased profit follows.
‘We did an economic evaluation, a pretty common technique for healthcare administrators,’ Laiteerapong said. ‘And we did it for a total of 30 specialties, plus physician assistants and nurse practitioners.’ The study was published October 6, 2020, in Annals of Internal Medicine.”

Facebook, Twitter Take Action After Trump Falsely Claims Flu Deadlier Than COVID-19:”Facebook and Twitter took measures to screen against misinformation after President Trump put posts on both sites that falsely claimed COVID-19 is less deadly than the flu in ‘most populations.’
Facebook took down Trump's post, saying that users are not allowed to make false claims about the severity of the pandemic. The social network says the post broke its rules against harmful misinformation.
Twitter allowed the president's tweet to stay up with a warning label. The company said it is in violation of Twitter's ‘rules about spreading misleading and potentially harmful information related to COVID-19.’ But it added that the company "has determined that it may be in the public's interest for the Tweet to remain accessible."

Here's how Google, Amazon, Facebook and Apple are targeting the health insurance market: “Google, Facebook, Apple and Amazon have invested heavily in personal health monitoring devices and virtual care and have been able to integrate these capabilities into health insurance offerings relatively easily.” The article provides a nice summary of what the companies are doing.

Effect of Passive Choice and Active Choice Interventions in the Electronic Health Record to Cardiologists on Statin Prescribing: “In passive choice, cardiologists had to manually access an alert embedded in the EHR to select options to initiate or increase statin therapy. In active choice, an interruptive EHR alert prompted the cardiologist to accept or decline guideline-directed statin therapy. Cardiologists in the control group were informed of the trial but received no other interventions…
The passive choice and active choice interventions did not change statin prescribing. In the subgroup of patients with clinical ASCVD [arteriosclerotic cardiovascular disease], the active choice intervention led to a small increase in statin prescribing at the optimal dose, which could inform the design or targeting of future interventions.”

About pharma

Mississippi pharmacy owners charged in $18M healthcare fraud scheme:”Dempsey Bryan Levi and Jeffrey Wayne Rollins, owners of Garden's Pharmacy in Ocean Springs, Miss., allegedly wrote prescriptions for compounded pain creams based on how much money they'd bring in and not for medical need. They fraudulently billed insurers, including the military insurer Tricare, out of millions of dollars, the U.S. Justice Department lawsuit claims.” The case points out the ongoing problems with compounding pharmacies.

FDA ad watchdog slaps two pharmas with warning letters for promo emails, Google link: “The Office of Prescription Drug Promotions (OPDP) reprimanded Nephron for emails promoting budesonide, while Nalpropion’s warning centered on a Google link promoting Contrave. Warning letters are OPDP’s strongest rebuke for improper pharma promotions.” Budesonide was promoted as helping treat COVID-19 and the FDA was “concerned that Nalpropion is continuing promotion of Contrave in a manner that… fails to adequately convey risk information.”

About health insurance

Humana saved $4B through its value-based care programs last year:”The insurer released its annual look at its value-based care initiatives Wednesday, which found Humana's Medicare Advantage (MA) members would have incurred those additional costs had they been enrolled in traditional, fee-for-service Medicare plans.
Humana said that 67% of its MA members, or 2.41 million beneficiaries, are treated by primary care physicians who are enrolled in value-based arrangements.”

Startup Medicare Advantage insurer Clover Health is going public: ”The payer, which offers tech-enabled Medicare Advantage plans, will become publicly traded by merging with Social Capital Hedosophia Holdings Corp., a special purpose acquisition company.
Through the deal, Clover will be valued at $3.7 billion in enterprise value.”

Blue Cross Blue Shield Association Names Kim A. Keck As New President And Chief Executive Officer: Read the article to learn more about her.

With MA open enrollment on the horizon, Walmart formally launches insurance brokerage: “Walmart is formally launching its new insurance brokerage ahead of Medicare open enrollment kicking off next week.
Walmart Insurance Services is licensed in all 50 states and the District of Columbia, according to a blog post from the retail giant, and will offer Part D, Medicare Advantage and Medicare supplement plans from a slew of insurers including UnitedHealthcare, Humana, Anthem and WellCare Health Plans, which is now a subsidiary of Centene Corporation.
It will also include plans from Amerigroup, Simply Health, Clover Health and Arkansas Blue Cross and Blue Shield. [As mentioned yesterday] Walmart will also be teaming up with Clover to offer its own co-branded MA plans.”

About hospitals and health systems

Hospital groups demand CMS halt expansion of certain physician-owned hospitals in payment rule: “Several major hospital groups and systems are pushing for the Trump administration to halt a proposed expansion of certain physician-owned hospitals in an upcoming payment rule.
Several groups posted comments on the Centers for Medicare & Medicaid Services’ (CMS') proposed hospital payment rule for 2021, furious about the change. Hospitals also opposed the elimination of the Inpatient Only Procedure List that details which procedures aren’t payable under the Outpatient Prospective Payment System (OPPS).”