Today's News and Commentary

About COVID-19

At current supply rate, it would take Kaiser 4+ years to get enough vaccines for all CA patients: The article highlights the vaccine shortage. “Kaiser's CEO says Kaiser cares for 9.3 million Californians and has so far received only 300,000 COVID-19 vaccine doses.”

One-dose COVID-19 vaccine candidate that can be stored at room temperature prompts immunity in animals:”Two vaccine candidates built from gene-therapy technology and developed by Mass General Brigham scientists elicited strong immune responses in mouse and nonhuman primate models, the researchers reported on the journal preprint site bioRxiv. The team received a grant of up to $2.1 million from the Bill & Melinda Gates Foundation to further develop the vaccine technology, called AAVCOVID.
The vaccines, which remain stable when stored at room temperature, use an adeno-associated virus (AAV) vector to deliver genetic sequences of SARS-CoV-2, the virus that causes COVID-19. That generates antigens of the virus’s signature spike protein, in turn prompting an immune response.”

Demographic Characteristics of Persons Vaccinated During the First Month of the COVID-19 Vaccination Program — United States, December 14, 2020–January 14, 2021: “During the first month of the U.S. COVID-19 vaccination program, approximately 13,000,000 persons received ≥1 dose of vaccine. Among persons with demographic data, 63.0% were women, 55.0% were aged ≥50 years, and 60.4% were non-Hispanic White.”

Google Cloud launches vaccine management tools as tech giants jump into distribution efforts: “The company launched artificial intelligence and machine learning tools Monday to help organizations forecast and model COVID-19 cases to better inform vaccine allocation. The cloud-based tools also are designed to assist with vaccine distribution, appointment scheduling, eligibility screening and communications.
The technology, called the Intelligent Vaccine Impact solution, also analyzes consumer sentiment around the COVID-19 vaccine. Understanding how local communities feel about the risks and benefits of the vaccine is critical to being able to increase confidence in vaccination, Google Cloud executives said. The sentiment analysis tool, which was developed in partnership with behavioral intelligence data company Syntasa, will help public health agencies develop a more tailored and informed vaccination campaign.”

A fast, at-home coronavirus test will be available to Americans this year: “The White House announced Monday it is buying 8.5 million rapid coronavirus tests that can be taken at home without a prescription and that yield immediate results.
The $231.8 million contract will allow the Australian company Ellume, which manufacturers the tests, to quickly scale up its production and create a manufacturing facility in the United States. Once running, that factory will be able to produce 19 million tests per month.”

GSK, Clover end COVID-19 vaccine tie-up as Chinese firm advances with Dynavax: “GlaxoSmithKline and Clover Biopharmaceuticals decided to discontinue their COVID-19 vaccine partnership, which was exploring the UK drugmaker's pandemic adjuvant system with Clover's trimeric SARS-CoV-2 spike (S-Trimer) protein-based candidate. On Monday, Clover said it now plans to initiate a global Phase II/III trial of its vaccine adjuvanted with Dynavax's CpG 1018 plus alum in the first half of 2021, with an interim analysis potentially available by mid-year. Shares in Dynavax were up as much as 40% on the news.”

First-to-market Pfizer expects a whopping $15B from its COVID-19 shot in 2021: “More and more COVID-19 vaccines are nearing the market, but mRNA shots from Pfizer and Moderna are still working off a head start in the global rollout. Now, Pfizer has revealed just what that head start could be worth this year.
Short answer: $15 billion. And it could be more.
The company said Tuesday that it's expecting that much in sales from its BioNTech-partnered mRNA shot this year. In last year’s fourth quarter, the vaccine chipped in $154 million.”

About health insurance

Two Youngstown-area physicians indicted for health care fraud and kickback schemes; third charged by bill of information: “At the time of the allegations, Wahib was a Doctor of Osteopathic Medicine and an obstetrics and gynecological (“OBGYN”) specialist; Canby was a Doctor of Osteopathic Medicine and an OBGYN specialist and Kapon was a Doctor of Medicine.  All three physicians were licensed in the State of Ohio and practiced medicine in the Youngstown area.    
According to the indictment, Wahib is accused of conspiring, from March of 2014 through January of 2017, to pay kickbacks to Canby and Kapon to induce them to order gonorrhea and chlamydia testing to be performed by Wahib on specimens of Canby’s and Kapon’s patients. Wahib allegedly then billed and was paid by the federal government for this testing.  Wahib and Canby are also accused of conspiring, through this scheme, to test Canby’s and Wahib’s patients when it was medically unnecessary to do so.”

Higher Medicare Advantage Star Ratings Are Associated With Improvements In Patient Outcomes: The study’s authors “found that enrollees experiencing a one-star MA rating increase were 20.8 percent less likely to voluntarily leave their plan to enroll in another plan or traditional Medicare. When hospitalized, they were 3.4 percent more likely to use a higher-quality hospital and 2.6 percent less likely to be readmitted within ninety days. Our findings suggest that MA star ratings may capture key domains of an MA plan’s quality; however, the differences in outcomes that they capture might not all be clinically meaningful.”

Many Uninsured Adults Have Not Tried to Enroll in Medicaid or Marketplace Coverage: Findings from the September 2020 Coronavirus Tracking Survey: Key findings from this RWJ Foundation study:
—”Just 29.3 percent of uninsured adults tried to obtain Medicaid or CHIP coverage. Most commonly, those who did not try did not think they would qualify.
—Nearly half of all uninsured adults (47.0%) did not look for information on marketplace coverage, nor tried to obtain Medicaid or CHIP coverage.
—About half of uninsured adults (53.9%) heard a lot or some about the marketplaces; just under two-thirds (64.9%) heard nothing or only a little about financial assistance for marketplace coverage.
—Almost half of uninsured adults familiar with marketplace plans did not look for information on them, most commonly because of cost concerns.”

About pharma

Controlling Pain After Surgery Doesn’t Have to Mean Opioids, Study Shows: “Comparison of opioid-sparing approach with standard care shows no difference in patient satisfaction, but less pain among those counseled to use opioids only as backup.”

Judge Rules Against HHS Attempt to Stop Gilead Sciences’ Counterclaims for HIV Patents: “A federal judge in Delaware has ruled that the U.S. government can’t block a lawsuit by Gilead Sciences, which asserts that four HHS patents for HIV drugs are invalid.
In an initial lawsuit, HHS alleged that HIV drugs developed by Gilead infringe on its patents, including for Truvada (emtricitabine/ tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide). But Gilead argues in a counter-lawsuit that data used to develop the drugs came from a collaboration with HHS and that the federal government had not disclosed that it was seeking the patents.”

About healthcare personnel

100 Best Jobs: Skim this list…it is remarkable how many jobs are in the healthcare sector.

About health systems

HCA Healthcare Reports Fourth Quarter 2020 Results and Provides 2021 Guidance: “Key fourth quarter metrics (all percentage changes compare 4Q 2020 to 4Q 2019 unless otherwise noted):

• Revenues totaled $14.293 billion

• Net income attributable to HCA Healthcare, Inc. totaled $1.426 billion, or $4.13 per diluted share

• Adjusted EBITDA totaled $3.118 billion

• Cash flows used in operating activities totaled $3.583 billion (includes the return, or early repayment, of over $6 billion in CARES Act funds)

• Same facility admissions and same facility equivalent admissions declined 3.4 percent and 7.5 percent, respectively”

About healthcare IT

Health tech funding snapshot—Paige nets $100M; TimelyMD banks $60M to expand teletherapy for college students: A good update about recent tech funding.

Nebraska Health Information Exchange Joins SDOH Data Group: “CyncHealth (formerly NEHII, or the Nebraska Health Information Initiative), the state’s health information exchange, has joined the Gravity Project, a community-led HL7 Fast Healthcare Interoperability Resources (FHIR) Accelerator, to enhance social determinants of health (SDOH) data interoperability across its platform.
The Gravity Project is a new community-led effort to develop national standards for SDOH data exchange. It aims to grow a diverse community of healthcare professionals to identify and review terminologies, conduct a gap analysis, and advance recommendations to address the disparities using nationally recognized data standards…
The Gravity Project initially focused on basic SDOH data, such as food insecurity, housing insecurity, and transportation insecurity. However, through its partnership with CyncHealth, the Gravity Project is expanding its coverage to financial strain, material hardship, stress, social isolation, and demographic attributes.
Founded by the University of California San Francisco (UCSF) Social Interventions Research and Evaluation Network (SIREN) in 2018, the Gravity Project consists of over 1,000 healthcare stakeholders.”

Today's News and Commentary

About COVID-19

An antibody that clamps onto the COVID virus’s ‘Achilles heel’: “Laura Walker at the biopharmaceutical company Adimab in Lebanon, New Hampshire, and her colleagues isolated antibodies from the immune cells of a person who had recovered from a 2003 infection with the virus SARS-CoV, which is related to SARS-CoV-2 (C. G. Rappazzo et al. Science https://doi.org/fsbc; 2021). By tinkering with the structure of the antibodies, the researchers created one, called ADG-2, that was particularly effective at disabling SARS-CoV-2 in a lab dish.
The engineered antibody also disabled a variety of related coronaviruses.When given to mice, it stopped SARS-CoV-2 from reproducing in the rodents’ lungs and protected the animals from respiratory disease.”

Moderna asks FDA to authorize 5 additional doses per Covid vaccine vial to speed distribution, source tells CNBC: “Moderna has asked the U.S. Food and Drug Administration for permission to fill its Covid-19 vaccine vials with up to five additional doses to ease a bottleneck in manufacturing, according to a person familiar with the matter.
The change would allow Moderna to put 15 doses in the same size vials now cleared to hold 10, alleviating pressure on the part of the manufacturing process known as fill/finish, said the person, who declined to be named because the application isn’t yet public.”

Eli Lilly antibody treatment ineffective against South Africa coronavirus variant, study says: “Eli Lilly's COVID-19 monoclonal antibody treatment, bamlanivimab, is ineffective in treating patients infected with B.1.351, the novel coronavirus variant first identified in South Africa, according to a study published Jan. 28 in the medical preprint server bioRxiv.”
The drugmaker also tested its antibody treatment against, B.1.1.7, the variant first identified in the U.K., finding it to be just as effective as it had been against earlier versions of the novel coronavirus.CDC issues sweeping mask mandate for planes, public transportation in U.S.: “Masks must be worn at train and subway stations, bus terminals and airports nationwide, as well as on planes, trains and other types of public transportation in the United States, according to a far-reaching federal public health order issued late Friday.
The order, which will take effect at 11:59 p.m. Monday, adds details to the mandate President Biden signed on his first full day in office.”

Daily Covid Toll in U.S. Remains Enormous, but Cases Are Falling: “The past few weeks in the United States have been the deadliest of the coronavirus pandemic, and residents in a majority of counties remain at an extremely high risk of contracting the virus. At the same time, transmission seems to be slowing throughout the country, with the number of new average cases 40 percent lower on Jan. 29 than at the U.S. peak three weeks earlier.” The article has useful, updated graphics.

Vaccine Monitor: Nearly Half of the Public Wants to Get a COVID-19 Vaccine as Soon as They Can or Has Already Been Vaccinated, Up across Racial and Ethnic Groups Since December: From the Kaiser Family Foundation. Interesting updates, including breakdown of who is most likely to want the COVID-19 vaccine and what messages are more effective in motivating people to get vaccinated. The top two: The vaccines are highly effective in preventing illness: 57 percent and The vaccine will protect you from getting sick: 56 percent.

About pharma

Magellan Rx Medical Pharmacy Solution Impact: 90% of New Authorizations for Oncology Biosimilars: “Magellan Rx Management, a division of Magellan Health, Inc., today released preliminary results from its oncology biosimilar medical pharmacy solution that targets new-to-market oncology therapeutic biosimilars….As of May 2020, health plan customers who…partner with Magellan Rx have achieved a 90% rate for authorization for the first two therapies with biosimilar availability.”

About hospitals and health systems

6 health systems opening hospitals: Despite COVID-19 challenges, this trend continues.

About health financing

Lyra Health now worth $2.3B on heels of massive funding round: “Spurred by the demand for mental health services during the pandemic,[emphasis added] Lyra Health is now worth more than $2 billion.
The startup scored $187 million in new financing as it looks to expand its services and bring more technology to its platform.
The Burlingame, California-based company, which provides mental health benefits for large employers, has more than doubled its customer base in 2020 and extended its services to support more than 2 million members..”

About the public’s health

Americans can’t cut back on salt. One likely reason: Packaged and prepared foods are filled with it.: As more people are eating at home, and have more control over what they eat, this article is a good reminder about another health hazard—this one is easy to address. “Even though the vast majority of public health experts regard too much salt as a killer and urge you to do whatever you can to cut back, Americans find that difficult. One reason is that more than 70 percent of salt in the American diet comes from packaged and prepared foods, according to the Food and Drug Administration, not from the salt shaker at home.”

About health insurance

Cigna Master Precertification list: The news media picked up on the change that some cardiac imaging tests (like CT angiography) no longer require precertification; however, this list is a good reminder of the interventions that still require review.

MACPAC wants Congress to automatically boost FMAP during recessions:  ”Medicaid and CHIP Payment and Access Commission on Friday voted to recommend that Congress automatically increase the federal share of Medicaid spending during recessions.
Under the policy, the federal government would temporarily raise the Federal Medical Assistance Percentage based on increases in state unemployment and reductions in total wages and salaries, rather than requiring Congress to approve each increase as it does now.”
MACPAC can only recommend policies to Congress.

Health insurer helps fund Bronzeville [Chicago neighborhood] affordable housing: “UnitedHealth Group is providing $15.4 million—more than half the total cost—for the construction of a 53-unit building of affordable apartments in the Bronzeville neighborhood. The project, 508 Pershing at Oakwood Shores, is being developed the Community Builders, a nonprofit…”

About healthcare IT

More than 900K health records breached in January: As long as these frequent and large breaches occur, the public is not likely to support true interoperability.

Today's News and Commentary

BHI [Blue Health Intelligence] 2020 Year-end data Digest: Worth a look for some year-end trends. Among the findings:

• “Men faced several health challenges in 2019, and, in many cases, had significantly higher rates of disease than women. Higher rates of alcohol abuse, opioid abuse, and nicotine dependence were observed in all age groups of men 19 and older.

• Obesity increased in both adults and children from 2016-2019. Children ages 2-4 showed the highest annual increase (20.6%). “Childhood obesity puts children at increased risk of cardiac disease, diabetes, breathing difficulties, joint and musculoskeletal discomfort, and gastrointestinal issues,” the report notes. “Being overweight also can result in social and psychological problems such as low self-esteem, anxiety, and depression.”

• Skin cancer and melanoma rates differ widely from state to state, and not always in the expected ways. Typically, warmer and sunnier states have higher rates of skin cancer, but in 2019, rates for Maine, Massachusetts, and Pennsylvania were higher than the southern states of Texas and Louisiana. Of note, Hawaii and Alaska – two states at opposite ends of the weather spectrum – shared the lowest rate of melanoma.

• HPV played a significant role in the higher rates of certain cancers in men, which are linked to men’s higher use of nicotine and alcohol. On a positive note, BHI found the rate of HPV vaccination rose 7.8 percentage points for males from 2016 through 2019, compared with 5.9 percentage points for females.

• Telehealth skyrocketed in the first nine months of 2020. BHI specifically noted a 50-fold increase in the utilization of virtual healthcare services by commercially insured individuals from March 2019 to March 2020 and a 100-fold increase from April 2019 to April 2020.”

About health insurance

Hospitals get ‘raw deal as CMS rejects site-neutral pay cut exemptions: “CMS may claw back millions of dollars in payments after the agency denied reimbursement rate cut exemptions for hospitals' off-campus outpatient facilities. CMS rejected more than 60% of the mid-build exceptions, which would preserve hospitals' higher reimbursement rates if they had the documentation to prove their off-campus outpatient departments were being constructed when the Bipartisan Budget Act was passed in 2015.”

About Covid-19

U.S. handling of American evacuees from Wuhan increased coronavirus risks, watchdog finds: “As the first American evacuees from Wuhan, China, touched down at a California military base a year ago, fleeing the epicenter of the coronavirus outbreak, they were met by U.S. health officials with no virus prevention plan or infection-control training — and who had not even been told to wear masks, according to a federal investigation.
Later, those officials were told to remove protective gear when meeting with the evacuees to avoid ‘bad optics,’ and days after those initial encounters, departed California aboard commercial airline flights to other destinations.”

J&J Vaccine Provides Strong Shield Against Severe Covid: “In a study of more than 43,000 people, the vaccine prevented 66% of moderate to severe cases of Covid-19, according to a company statement Friday. And it was particularly effective at stopping severe disease, preventing 85% of severe infections and 100% of hospitalizations and deaths.” While not as high a prevention rate as Moderna and Pfizer products, it can be produced in very large quantities, only requires a single dose and does not have the same handling (refrigeration) limitations as do the other two vaccines.

Novavax vaccine almost 90 percent effective in trial, but not against South Africa variant: “Efficacy was strong in the U.K. trial, at 89.3 percent, the company said. But in a separate, smaller trial in South Africa, where a more contagious variant of the virus has taken hold, efficacy fell sharply to 49.4 percent, though it was somewhat higher, at 60 percent, among participants who did not have HIV.”

German authorities recommend against use of AstraZeneca's COVID-19 vaccine in over-65s: “The recommendation, which supports use in adults between 18 and 64 years, follows reports earlier in the week from German media outlets that the efficacy of AstraZeneca's vaccine was only 8% effective in people over 65. AstraZeneca called the reports ‘completely incorrect,’ while the German health ministry has also since refuted the claims.”

AstraZeneca's COVID-19 shot scores European authorization as production holdups linger: “The vaccine, the result of AZ's collaboration with Oxford University, is conditionally approved across Europe in people ages 18 and older. A broad rollout in EU member countries will follow, but in recent days, a reduction in first-quarter supply has dominated headlines.”

About pharma

In a win for PBMs, Biden administration delays rebate rule: “The Department of Health and Human Services has pushed back the start date for the rule, which was set to take effect on Friday, to March 22. The regulation, revived by President Donald Trump's HHS late last year, would replace protections for drug rebates in Medicare Part D with protections for discounts provided directly to consumers.”

Merck’s Keytruda Nabs EU Approval for Colorectal Cancers: “The approval is for first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair-deficient colorectal cancer.”

McKinsey in advanced talks with US states to settle opioid claims: “McKinsey is in advanced discussions with several US states’ attorneys-general to pay hundreds of millions of dollars to settle civil claims about its role in advising drug companies held responsible for the country’s opioid epidemic…
The consultancy firm has previously apologised for its role in trying to boost sales of OxyContin. Last year, it said its work with Purdue was designed to support legal prescription of opioids for patients with ‘legitimate medical needs.’”

About healthcare quality

Patient Safety Watchdog The Leapfrog Group Funded for National Initiative on Preventing Harm from Diagnostic Error: “The Leapfrog Group, a national watchdog organization of employers and other purchasers focused on patient safety and quality, today announced Recognizing Excellence in Diagnosis, a new national initiative to publicly report and recognize hospitals for preventing patient harm due to diagnostic errors. Developed in collaboration with The Society to Improve Diagnosis in Medicine (SIDM) and key experts, the project is funded with a two-year grant of $1.2 million by the Gordon and Betty Moore Foundation.” Disclosure: I am on SIDM’s finance committee.

Hospitals agree to follow higher quality standards to get more money from Medicaid, which covers 1/3 of state's population: “With up to 28 rural Kentucky hospitals vulnerable to closure if their finance don't improve, Tuesday's announcement of a new payment model to increase the amount Kentucky's hospitals are paid for Medicaid patients is cause for their celebration…
In order to receive these funds, hospitals will have to abide by higher quality standards that are still being decided by KHA [Kentucky Hospital Association] and the Cabinet for Health and Family Services. Quality standards include things like hospital-acquired infections, medication errors and readmission rates.”

Association of Graduate Medical Education [GME] With Hospital Performance and Patient Outcomes: “This study found a negative linear correlation between GME funding and patient mortality and a positive correlation between GME funding and resident BCE [Board Certification Examination] pass rates in adjusted regression models. The findings also suggest that hospitals that receive more GME funding are not more financially stable.”

Allocation of National Institutes of Health Funding by Disease Category in 2008 and 2019: “In this study, NIH spending for most diseases seemed to be based primarily on the level of NIH spending more than 10 years earlier, despite changes in burden of disease. Congress and the NIH should examine the allocation process to ensure NIH investments are responsive to changes in the health of the population.”

About healthcare IT

Florida Medicaid website hacked for 7 years, hundreds of thousands affected: “Tallahassee-based children Medicaid health plan Florida Healthy Kids Corp. began notifying members Jan. 27 of a 7-year data breach that exposed the personal information of hundreds of thousands of  health plan applicants. 
The health plan was notified Dec. 9 of the security breach  and launched an investigation, which found there had been "significant vulnerabilities" since 2013 on its website and databases that support the online children health insurance application. The vulnerabilities lasted from November 2013 to December 2020, when the health plan temporarily shut down its website. 
The health plan said it discovered that several thousand applicants' information was inappropriately accessed and tampered with as a result of the breach. Information of applicants and enrollees that was exposed included Social Security numbers, dates of birth, names, addresses and financial information.”

22 Million U.S. Seniors Lack Broadband Internet Access; First Time Study Quantifies Digital Isolation of Older Americans as Pandemic Continues to Ravage Nation: The headline speaks for itself. More details, including the full report are in the article.

Today's News and Commentary

About COVID-19

Coronavirus variant first seen in South Africa identified in South Carolina: “The highly transmissible variant of the coronavirus first identified in South Africa has infected two people in South Carolina with no travel history, state officials announced Thursday. These are the first cases in the United States involving the B. 1.351 variant, and the patients’ lack of travel suggests the variant is already spreading in the community following an undetected introduction.”

Novartis says it's ready to pitch in on manufacturing rivals' COVID-19 vaccines, diagnostics: “Right after Sanofi stepped in to help produce Pfizer/BioNTech coronavirus vaccines in Europe, Novartis is exploring whether it can deploy its own manufacturing network to boost COVID-19 supplies. Separately, the U.S. is weighing the Defense Production Act to compel drugmakers to produce Pfizer or Moderna mRNA vaccines.”

How Covid-19 mutations are changing the pandemic: A good summary about what the mutations are and how they will affect control efforts.

China rolls out anal swab coronavirus test, saying it’s more accurate than throat method: “Chinese state media outlets introduced the new protocol in recent days, prompting widespread discussion and some outrage. Some Chinese doctors say the science is there. Recovering patients, they say, have continued to test positive through samples from the lower digestive tract days after nasal and throat swabs came back negative.”

Time to double or upgrade masks as coronavirus variants emerge, experts say: “The discovery of highly transmissible coronavirus variants in the United States has public health experts urging Americans to upgrade the simple cloth masks that have become a staple shield during the pandemic.
The change can be as simple as slapping a second mask over the one you already wear, or better yet, donning a fabric mask on top of a surgical mask. Some experts say it is time to buy the highest-quality KN95 or N95 masks that officials hoping to reserve supplies for health-care workers have long discouraged Americans from purchasing.”

About healthcare quality

Measuring Patient Experience of Medicare Advantage Beneficiaries: From a study conducted by NORC at the University of Chicago that was commissioned by Better Medicare Alliance/Center for Innovation in Medicare Advantage Policy
”Recommendations:
—Modernize patient experience measurement in MA by updating the survey language to reflect the diversity of today’s beneficiaries, along with the evolution of MA benefit offerings and how care is delivered today.

—Provide more granular CAHPS results to health plans while protecting beneficiary confidentiality to empower better health plan quality improvement.

—Remove MA-PD CAHPS questions from the patient experience MA Star Ratings that health plans cannot directly impact, and increase the patient experience MA Star Ratings weights from two to four, only after changes are made to modernize MA patient experience measurement.

—Explore ways to reduce burden on the beneficiary survey respondent to improve response rates. Tactics to achieve this goal include:

• Reduce the length of the survey by removing provider-focused questions that sit outside the control of the health plan

• Help respondents orient to the patient experiences the survey seeks to measure

• Use appropriate financial incentives to encourage participation

• Pilot a web-mode option

• TestnovelCAHPSscoringapproachesthatleverageproviderCAHPS data, which, if successful, can facilitate a reduction in survey length”

Primary care docs make up minority of spending on low-value care, study finds: “Low-value spending—that is, costs incurred for services that experts in the field agree aren't very valuable—is less likely to occur due to primary care docs compared to other physicians, a new research report concluded…
[T]he research report found, for the majority of primary care docs, services performed or ordered accounted for less than 9% of their patients’ low-value spending. That amounted to less than 0.3% of their total Medicare Part B spending.
Most primary care physician referrals accounted for less than 16% of their patient's low-value spending or less than 0.5% of their total Medicare Part B spending.”

The Joint Commission and Joint Commission Resources launch new data transparency initiative for health care organizations: “The Joint Commission and Joint Commission Resources (JCR), Inc. today announced a new data transparency initiative – DASH™ (Data Analytics for Safe Healthcare). The initiative offers three business intelligence tools in the form of dashboards and performance improvement resources to power customers’ performance improvement efforts on their journey to zero harm.  
The three business intelligence tools include:  

• Accelerate PI™ (The Joint Commission): Provides data on quality measures selected because of their validity, importance and known evidence-based improvement strategies. Compares an organization to national, state and Joint Commission accredited organization averages.

• SAFER™ Dashboard (The Joint Commission): Presents the findings from accreditation survey reports in a dashboard to empower timely, data-driven decisions that drive the delivery of safe, high-quality care.

• Illuminate Analytics™ (JCR): Offers greater visibility on the collective performance of a JCR customer to help draw meaningful, actionable conclusions from disparate data sources (i.e. Tracers with AMP® and consulting data).”

Top 10 health technology hazards for 2021, ranked by ECRI Institute:

“1. Emergency use authorization device management: Complexity of managing medical devices with COVID-19 EUAs.  

2. Drug name auto-display: Drug entry fields that populate after only a few letters can cause fatal medication errors. 

3. Telehealth adoption: Rapid roll-outs of virtual care technologies may leave patients' data at risk. 

4. Imported N95-style masks: May fail to protect healthcare workers from infectious respiratory diseases. 

5. Consumer-grade devices: Relying on these products can lead to inappropriate healthcare decisions. 

6. UV disinfection: Quick deployments of UV disinfection devices can reduce effectiveness and increase exposure risks. 

7. Software vulnerabilities: Weaknesses in third-party software components present cybersecurity challenges. 

8. Artificial intelligence in diagnostic imaging: These technologies may misrepresent certain patient populations. 

9. Remote operation risks: Remotely operating medical devices designed for bedside use introduces new risks. 

10. 3D printing quality: Lack of quality assurance of 3D-printed patient medical devices may harm patients. 
Click here to view the full report.”

About health insurance

Medicaid Expansion Would Have a Larger Impact Than Ever during the COVID-19 Pandemic: From the Urban Institute: “As of December 2020, 36 states and the District of Columbia had expanded Medicaid eligibility under the Affordable Care Act (ACA). We find that if the remaining 14 states had expanded eligibility in 2020, 4.4 million fewer people would have been uninsured that year. Absent the COVID-19 pandemic, the difference would have been 3.8 million. Thus, Medicaid expansion in the remaining states would increase health coverage even more under the pandemic. We also find young adults have the highest uninsurance rates under current law and would gain more coverage from Medicaid expansion than any other age group. And though further expansion would not increase the already high Medicaid eligibility thresholds for children, more children would be enrolled as their parents seek such coverage.”

17 States Back Trump's Medicaid Work Requirements Revival: “A coalition of 17 state attorneys general urged the U. S. Supreme Court to reject a lower court's decisions barring the Trump administration's revival of a pilot project that would allow Arkansas and New Hampshire to impose work requirements in Medicaid programs. In a 42-page amicus brief filed Tuesday, the attorneys general argue that although the suit's current focus is on imposing work requirements on Medicaid recipients, allowing the D. C. Circuit's decision to stand could jeopardize the validity of other waiver programs that millions of Americans rely on.”

About healthcare IT

Artificial Intelligence (AI) Strategy: From HHS, this document outlines an approach to managing AI:
”Together with its partners in academia, industry and government, HHS will leverage AI to solve previously unsolvable problems by continuing to lead advances in the health and wellbeing of the American people, responding to the use of AI across the health and human services ecosystem, and scaling trustworthy AI adoption across the Department.”
Check Fig 3.2 on page 7.

About pharma

International Prescription Drug Price Comparisons: Here is the summary findings from this RAND report:

“Prices in the United States are higher than those in all comparison countries

• U.S. prices were 256 percent of those in the 32 comparison countries combined.

• In comparisons with individual countries, U.S. prices ranged from 170 percent of prices in Mexico to 779 percent of prices in Turkey.

• The gap between U.S. prices and prices in other countries was larger for brand-name originator drugs.

• U.S. prices were 84 percent of prices in all non-U.S. countries for unbranded generics.

• U.S. prices were 190 percent of prices in other countries after adjusting U.S. prices downward to account for rebates and other discounts.”

Biden kills Trump plan on opioid-treatment prescriptions: “The Biden administration said Wednesday that it is canceling a last-minute plan by the Trump administration to let more physicians prescribe an opioid-treatment drug, despite exhortations from lawmakers and physician groups to keep it….
The Trump administration’s plan was plagued by legal and operational problems, including a failure to get necessary clearance from the White House budget office, said two officials who spoke on the condition of anonymity because they were not authorized to discuss it.
’The Biden-Harris administration absolutely supports broader access to medication-based treatment for opioid use disorder, and is working to find ways to lift burdensome restrictions on medications for opioid use disorder treatment,’ said a spokesperson for the White House’s drug policy office.”

Today's News and Commentary

About COVID-19

Sanofi, after R&D setback, lends a hand to vaccine rival Pfizer for coronavirus shot production “Following its midstage coronavirus R&D setback, vaccine giant Sanofi is still looking for ways to help in the world’s effort to beat back the pandemic. It’s teaming up with leading vaccine players Pfizer and BioNTech to produce 100 million doses of the rival vaccine—even as Sanofi works to push its own programs through clinical testing.”

Biden administration aims to have enough vaccine for most Americans by summertime: “Biden’s administration will purchase 100 million doses each of the vaccines made by Pfizer Inc and BioNTech, and Moderna Inc, increasing the overall total doses to 600 million, with delivery expected by summer.
The previous purchase target was 400 million doses.”

Google Maps will soon display Covid-19 vaccination sites: ”The feature is rolling out in the coming weeks, beginning in four states: Arizona, Louisiana, Mississippi and Texas…
The results, which will also be shown in search results in designated information panels, include details about whether an appointment is required, if the vaccine is only available to certain groups and if there's a drive-thru. Google said it's working with ‘authoritative sources’ for the information, including local governments and retail pharmacies. Information about vaccine sites will roll out to other states and countries later.”

Eli Lilly says antibody combo significantly cuts COVID-19 death risk: “The results from a final-stage clinical trial of more than 1,000 patients testing the combination of bamlanivimab and etesevimab found just 11 hospitalizations in patients taking the therapy, compared to 36 events in patients taking a placebo, a 70 percent reduction compared to a placebo.
There were 10 deaths total, all of which occurred in patients taking placebo, and no deaths in patients taking bamlanivimab and etesevimab together.
Lilly said the trial also demonstrated ‘strong evidence that the therapy reduced viral load and accelerated symptom resolution.’
…The announcement comes just days after Lilly reported that treatment with bamlanivimab alone cut nursing home staff and residents’ risk of developing symptomatic COVID-19 infections by 57 percent against placebo. 
With the new data, Lilly could ask the Food and Drug Administration to authorize the treatment as a preventive measure. Currently, bamlanivimab is authorized for emergency use for the treatment of mild to moderate COVID-19 in high-risk patients.”

Biden says he’s ‘bringing back the pros’ for virus briefings: “Beginning Wednesday, administration experts will host briefings three times a week on the state of the outbreak, efforts to control it and the race to deliver vaccines and therapeutics to end it…
Wednesday’s briefing will be conducted virtually, rather than in person at the White House, to allow for questions from health journalists and to maintain a set timing no matter the schedule in the West Wing. It will feature Jeff Zients, the Biden administration’s coordinator for pandemic response; his deputy, Andy Slavitt; Fauci; Dr. Marcella Nunez-Smith, the chair of Biden’s COVID-19 equality task force; and Dr. Rochelle Walensky, the director of the CDC.” Here is a link to today’s briefing from a hour ago..

FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers: “As part of the U.S. Food and Drug Administration… has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products’ safety. Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizer or other drugs.”

COVID-19 Clinical management: living guidance: The latest update from WHO has 5 new conditional recommendations, including: “A conditional recommendation for use of pulse oximetry monitoring at home as part of a package of care…”

UI researchers develop quicker method of antibody testing: “Researchers at the University of Illinois have developed a new way to test for antibodies. This can give people results in just 15 minutes. This one only needs a drop of blood. The other ones require more than that.
This blood sample also doesn’t have to be sent away to another lab for testing and can be processed on-site. Each tests only costs $2 to perform. One of the reasons this new method is important is because it will allow people who’ve had the COVID-19 vaccine to see how well it worked.”

Data and Policy to Guide Opening Schools Safely to Limit the Spread of SARS-CoV-2 Infection: The CDC says that preventive measures in K-12 are largely working and should be continued: “…the preponderance of available evidence from the fall school semester has been reassuring insofar as the type of rapid spread that was frequently observed in congregate living facilities or high-density worksites has not been reported in education settings in schools.”
However, “…some school-related activities have increased the risk of SARS-CoV-2 transmission among students and staff. Numerous media reports of COVID-19 outbreaks among US high school athletic teams suggest that contact during both practices and competition, and at social gatherings associated with team sports, increase risk.”

Large majorities of the region’s nursing home workers have declined the coronavirus vaccine: “A large percentage of nursing home workers in D.C., Maryland and Virginia have declined to take the coronavirus vaccine, officials say, presenting a major challenge in the region’s plans to protect its most vulnerable residents…
In an internal document obtained by The Washington Post, Maryland health officials said that as of Tuesday, only about 58 percent of the doses allocated to nursing home staff and residents had been administered — even though vaccination clinics have been conducted at every facility. Tredonna Kum, an administrative organizer for 1199 SEIU, which represents nursing home workers in Maryland and D.C., estimated that up to 80 percent of members chose not to be vaccinated during the first wave of clinics…
In North Carolina, the top public health official said in early January that most nursing home workers had declined the vaccine. In Ohio, more than 60 percent of nursing home workers opted out during the first wave of vaccination clinics, said Gov. Mike DeWine (R). Officials in Connecticut have reported similar numbers. 
David Grabowski, a Harvard University health policy professor, said the numbers shouldn’t surprise anyone familiar with long-term care facilities, where low wages and poor labor conditions — and earlier missteps fighting the coronavirus pandemic — have created a well of mistrust, especially among the Black and Latino workers who dominate the industry.”

Make the air in your home safer during COVID-19 by increasing ventilation and filtration: A useful infographic on ventilation and filtration procedures for the home..

HCA Healthcare forms consortium with AHRQ and research institutions to accelerate COVID-19 research: “HCA Healthcare is proud to announce that we’ve formed a consortium of prominent public and private research institutions to use HCA Healthcare’s vast data on COVID-19 hospital care to improve patient outcomes and public knowledge. The institutions – including the federal Agency for Health Research and Quality (AHRQ), Johns Hopkins University, Duke University, Meharry Medical College, Harvard Pilgrim Health Care Institute, and others – will gain access to the data in a research program directed by the HCA Healthcare Research Institute (HRI).”

About health insurance

Anthem Reports Fourth Quarter and Full Year 2020 Results: The company report starts with a long list of initiatives before financial performance is presented. In short, 2020 4th Q profit was $551 million, a 41% decrease compared to the same period in 2019. Earnings for the full year were $4.6 billion compared to $4.8 billion in 2019.

Federal action on surprise medical bills: What doctors should know: This article from the AMA is a good summary of the surprise billing provisions (not just for physicians).
”Patient protections included in the No Surprises Act include:

• A provision that patients may not be billed beyond the recognized in-network cost-sharing amount.

• If a patient relies on erroneous network directory information to choose a physician, the plan cannot impose a cost-sharing amount greater than in-network rates and it must count toward the patient’s in-network out-of-pocket-maximum and in-network deductible.

• Unless notice and consent requirements are met in non-emergency situations, if a provider submits a bill to a patient in excess of in-network cost sharing and the patient pays, the provider must refund with interest.

• If a provider contract is terminated without cause, a “continuing patient” can continue for either 90 days or the date when no longer a continuing patient, whichever is earlier.”

Partners in Primary Care Announces 2021 Growth Plans for Its Senior-Focused Care Facilities: “ Partners in Primary Care announced… the details of its 2021 expansion. Having opened 15 new centers in 2020, plans for 2021 include up to 20 more centers, including entering the Atlanta market, additional centers in the Houston area and five more in Louisiana, including Lafayette and the North Shore outside of New Orleans as well as two new centers in Nevada.
The planned center openings will bring the total number of centers Partners in Primary Care operates (including its Orlando, Florida-based Family Physicians Group facilities) to nearly 80 centers. By 2023, Partners in Primary Care expects to operate approximately 100 centers.”
Partners in Primary Care is a payer-agnostic subsidiary of Humana Inc. focused on primary care for seniors. About healthcare IT

Ransomware Activity Targeting the Healthcare and Public Health Sector: “This joint cybersecurity advisory was coauthored by the Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the Department of Health and Human Services (HHS). This advisory describes the tactics, techniques, and procedures (TTPs) used by cybercriminals against targets in the Healthcare and Public Health (HPH) Sector to infect systems with ransomware, notably Ryuk and Conti, for financial gain.”
One non-technical finding is that stealing medical chart information for fraudulent billing is far more profitable than stealing credit card and other similar personal data.
And in a related article: 13 healthcare provider malware, ransomware and phishing incidents for January.

Trends in EMR Interoperability: From The College of Healthcare Information Management Executives (CHIME) and KLAS Research, this report is an up-to-date survey of the state of EMR interoperability. While rates have doubled over the last 3 years, there is still a long way to go to make sure systems achieve their full potential. Included in this study is use of FHIR.
About health professionals

January 2021 Physician Flash Report: From KaufmanHall: “Although physician practices saw some gains in the third quarter of 2020, most performance measures remained well below 2019 levels. Many practices saw an uptick in productivity and revenues in the late summer and early fall with the easing of social distancing policies and limits on non-urgent care .
As a result, health systems experienced a 9 .5% decrease in the level of investment needed to subsidize inadequate physician revenues between July and October 2020, with the median Subsidy per Physician Full-Time Equivalent (FTE) dropping to $194,632 across all specialties. Year-over-year, Subsidy per Physician FTE was up just 0.5% in October, after climbing 14.1% year-over-year from January to July—reflecting the effects of sizable volume and revenue swings brought about by the COVID-19 crisis .
After suffering significant declines early in the pandemic, many organizations saw volumes rebound somewhat by October. This enabled an increase in physician productivity.”

About the public’s health

Millions earmarked for public health emergencies were used to pay for unrelated projects, inspector general says: “Federal officials repeatedly raided a fund earmarked for biomedical research in the years leading up to the covid-19 pandemic, spending millions of dollars on unrelated salaries, administrative expenses and even the cost of removing office furniture, according to the findings of an investigation into a whistleblower complaint shared with The Washington Post.
The investigation, conducted by the inspector general of the Department of Health and Human Services and overseen by the Office of Special Counsel, centered on hundreds of millions of dollars intended for the development of vaccines, drugs and therapies by the Biomedical Advanced Research and Development Authority or BARDA, an arm of the federal health department.
The unidentified whistleblower alleged that officials in the office of the assistant secretary for preparedness and response at HHS, which oversaw the biomedical agency, wrongly dipped into the money set aside by Congress for development of lifesaving medicines, beginning in fiscal 2010 and continuing through at least fiscal 2019, spanning both the Obama and Trump administrations.”

National Obesity Monitor: The Adult Obesity Rate (ages 20+) for 2017-2018 was 42.4% and the Youth Obesity Rate (ages 2-19) for 2017-2018 was 19.3%, a record high.

Today's News and Commentary

About COVID-19

U.S. new COVID cases down 21% in past week, deaths fall from peak: “The United States reported a 21% drop in new cases of COVID-19 last week, as all but one state reported declines in new infections, and the number of coronavirus patients in hospitals also fell.
The country reported 1.2 million new cases in the week ended Jan. 24, down from 1.5 million new cases in the previous week. It was the biggest decline on both a percentage and absolute basis in the past year, according to a Reuters analysis of state and county reports.”

Disgraced COVID-19 studies are still routinely cited: “In June 2020, in the biggest research scandal of the pandemic so far, two of the most important medical journals each retracted a high-profile study of COVID-19 patients. Thousands of news articles, tweets, and scholarly commentaries highlighted the scandal, yet many researchers apparently failed to notice. In an examination of the most recent 200 academic articles published in 2020 that cite those papers, Science found that more than half—including many in leading journals—used the disgraced papers to support scientific findings and failed to note the retractions…
Both of the retracted COVID-19 papers, one in The New England Journal of Medicine (NEJM) and the other in The Lancet, were based on what appeared to be a huge database of patient records compiled from hospitals worldwide by Surgisphere, a small company operated by vascular surgeon Sapan Desai, who was a co-author on each article. The 22 May 2020 Lancet paper ostensibly showed that hydroxychloroquine, an antimalarial drug promoted by former President Donald Trump and others, could harm rather than help COVID-19 patients. Its publication led to a temporary halt in a major clinical trial and inflamed an already-divisive debate over the drug, which has proved to be useless against COVID-19. The 1 May NEJM article corroborated other evidence that people already taking certain blood pressure medicines did not face a greater risk of death if they developed COVID-19.”

White House expected to tell governors they will get more coronavirus vaccine starting next week: “The weekly allocation is forecast to go from about 8.6 million doses to about 10 million doses. The vaccine is distributed on a population basis among 64 jurisdictions, including 50 states, eight territories and six major cities.” And in a related story: Biden says 100-day goal on vaccinations may rise to 150 million instead of 100 million

Johnson & Johnson is 'comfortable' meeting coronavirus vaccine delivery promises, CFO says: “J&J expects to report phase 3 data for its one-dose vaccine by early next week, execs said Tuesday.”

Amid Covid Health Worker Shortage, Foreign-Trained Professionals Sit on Sidelines:”Yet a large, highly skilled workforce of foreign-educated doctors, nurses and other health practitioners is going largely untapped due to licensing and credentialing barriers. According to the Migration Policy Institute think tank in Washington, D.C., some 165,000 foreign-trained immigrants in the U.S. hold degrees in health-related fields but are unemployed or underemployed in the midst of the health crisis.”

Study shows vaccine nationalism could cost rich countries US$4.5 trillion: “A new study commissioned by the ICC [International Chamber of Commerce] Foundation has found that the global economy stands to lose as much as $9.2 trillion if governments fail to ensure developing economy access to COVID-19 vaccines, as much as half of which would fall on advanced economies.
The study clearly demonstrates the economic case to invest in the Access to COVID-19 Tools (ACT) Accelerator, the global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines.
While other analyses have highlighted the economic costs of vaccine nationalism, this new study is the first to incorporate both supply and demand shocks, domestic and foreign, at the sector level, for an open economy operating within global supply chains.”

About the public’s health

Supreme Court wipes out lower court rulings in Texas abortion battle: “The Supreme Court handed a victory to advocates of abortion rights Monday, wiping off the books lower court rulings that had upheld a Texas order banning nearly all abortions in the state during the coronavirus pandemic.
Gov. Greg Abbott ordered a halt to nonessential medical procedures in late March to conserve hospital resources and personal protective equipment. Attorney General Ken Paxton then said the order applied to ‘any type of abortions,’ including medication abortions that do not involve surgery.”

About health insurance

Five New Guilty Pleas In Nationwide Telemedicine Pharmacy Health Care Fraud Conspiracy: “[Yesterday,] Larry Everett Smith, 50, of Tampa, Florida, pleaded guilty before Senior District Judge Ronnie Greer to one count of conspiracy to commit health care fraud… Smith faces a term of up to 10 years in prison. 
The First Superseding Indictment, returned December 1, 2020, charged Smith and others with a nationwide conspiracy to defraud pharmacy benefit managers out of $174,202,105 by submitting $931,356,936 in bills to the pharmacy benefit managers for fraudulent prescriptions purchased from a telemarketing company. The indictment alleges the conspiracy began in mid-2015 and lasted through the first months of 2018.” 

Blues plans' high-performance network [HPN] saving 11% on care compared to PPO: ”BCBSA said 45 companies have signed on to offer the Blue HPN plan to employees, reaching 55 markets and 340,000 potential members.
The plan is the only HPN available in the 10 largest U.S. cities, BCBSA said.”

Biden admin has more than $1B in unspent funds to help bolster ACA exchanges: “The Trump administration may have accumulated more than $1 billion in unspent user fee funds that can be used to bolster the Affordable Care Act (ACA) if President Joe Biden starts a special enrollment period, a new analysis finds.
The analysis, released Monday by the Kaiser Family Foundation, outlined ways the Biden administration could improve sign-ups for the ACA’s insurance exchanges, especially as job losses from the COVID-19 pandemic have spurred interest in the exchanges.
Biden is reportedly going to sign an executive order Thursday that will initiate a new open enrollment for the ACA…”

About hospitals and health systems

Most Hospitals Expanding ASC [Ambulatory Surgery Center] 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 Cost of Quarantine: Projecting the Financial Impact of Canceled Elective Surgery on the Nation's Hospitals: The latest study of COVID-19 related hospital losses:
“National revenue loss due to major elective surgery cessation was estimated to be $22.3 billion (B). Recovery to market equilibrium was conserved across strata and influenced by pre- and post-COVID capacity utilization. Median recovery time was 12-22 months across all strata. Lower pre-COVID utilization was associated with fewer months to recovery.”

Through a $500 Million Partnership with the State of Ohio, JobsOhio and Ohio Development Services Agency, Cleveland Clinic Forms Global Center for Pathogen Research & Human Health: “Headquartered in Cleveland and spanning Cleveland Clinic’s international footprint in Florida, London and Abu Dhabi, the Global Center for Pathogen Research & Human Health will bring together a research team focused on broadening understanding of viral pathogens, virus-induced cancers, genomics, immunology and immunotherapies. It will expand upon Cleveland Clinic’s existing programs and expertise, with newly recruited world leaders in immunology, cancer biology, immune-oncology and pathogen research as well as technology development and education. Researchers will expand critical work on studying, preparing and protecting against public health threats such as HIV/AIDS, Dengue fever, Zika and COVID-19.”

Today's News and Commentary

About hospitals and health systems

'Tumultuous' year for hospitals results in 55% drop in median operating margin, Kaufman Hall finds: “Hospitals across the U.S. saw their median 2020 operating margin drop 55.6 percent throughout 2020, without taking into account federal relief aid, according to a new report from healthcare consulting firm Kaufman Hall. When factoring in Coronavirus, Aid, Relief and Economic Security Act cash, hospitals saw their median operating margins dip 16.6 percent…
Overall, hosptials saw their median operating margin at 0.3 percent in 2020, without funding from the CARES Act. With funding, the median operating margin was 2.7 percent.”

About COVID-19

Transcript: Dr. Deborah Birx on "Face the Nation," January 24, 2021: The entire interview is interesting but this remark was especially revealing: “I saw the president presenting graphs that I never made. So, I know that someone- or someone out there or someone inside was creating a parallel set of data and graphics that were shown to the president. I know what I sent up and I know that what was in his hands was different from that. You can't do that. You have to use the entire database--”

Low Patient Portal Adoption Could Stymie COVID-19 Vaccine Rollout:”Up to 45 percent of patients ages 50 and older don’t have a patient portal, the very tool most providers across the country are using to communicate with patients about the COVID-19 vaccine, according to new data out of the University of Michigan’s Institute for Healthcare Policy and Innovation.
This could seriously hamper provider efforts to notify patients as they become eligible for the COVID-19 vaccine and, at some organizations, take the next steps to schedule a vaccination.”

U.S. CDC says 21.8 million doses of COVID-19 vaccines administered: “U.S. Centers for Disease Control and Prevention said it had administered 21,848,655 doses of COVID-19 vaccines in the country as of Sunday morning.
The tally of vaccine doses is for both Moderna Inc’s vaccine and one by Pfizer Inc and BioNTech as of 6 a.m. EST (1100 GMT) on Sunday, the agency said.
It said 18,502,131 people had received one or more doses, while 3,216,836 people got the second dose as of Sunday.”

FDA rolls back N95 mask reuse to 4 decontamination cycles: “The FDA has rolled back its emergency authorizations for N95 respirator decontamination systems, cutting down the number of times the agency said each mask could be safely reused.
During the early stages of the pandemic, when supplies of personal protective equipment and N95 filters were at a minimum, the FDA allowed masks to be reprocessed up to 20 times with certain hardware.“

Fauci: Vaccinations will help coronavirus variants from emerging: Another good reason to vaccinate the population quickly.
”Covid-19 vaccinations will not only help stop the virus from spreading, they will also hamper the coronavirus' ability to mutate into new variants, Dr. Anthony Fauci said on Thursday. 
’Viruses don't mutate unless they replicate,’ Fauci, the director of the National Institute of Allergy and Infectious Diseases, said at a news briefing at the White House, his first under the administration of President Joe Biden.
’And if you can suppress that by a very good vaccine campaign, then you could actually avoid this deleterious effect that you might get from the mutations,"‘Fauci said.”

Merck cans both its COVID-19 vaccines due to weak clinical data: “Merck has stopped development of its two COVID-19 vaccine candidates after getting a look at phase 1 data. The vaccine powerhouse said neither candidate triggered immune responses comparable to those achieved by rival jabs, leading Merck to cut its losses and focus on COVID-19 therapeutics.”

2 in 5 Americans live where COVID-19 strains hospital ICUs: “Straining to handle record numbers of COVID-19 patients, hundreds of the nation’s intensive care units are running out of space and supplies and competing to hire temporary traveling nurses at soaring rates. Many of the facilities are clustered in the South and West.
An Associated Press analysis of federal hospital data shows that since November, the share of U.S. hospitals nearing the breaking point has doubled. More than 40% of Americans now live in areas running out of ICU space, with only 15% of beds still available.”

Israel sees 60% drop in hospitalizations for age 60-plus 3 weeks after 1st shot: “Full effects of Pfizer’s shots only kick in around a month after inoculation, but data from Israel shows there is a stark drop in infections even before that point.”

Moderna vaccine protects against British and South African variants, company says: “The coronavirus vaccine developed by Moderna triggers an immune response that protected in laboratory tests against two variants of the virus first detected in Britain and South Africa, the company said Monday.
The finding was largely encouraging but contained a clear warning sign: Even though the vaccine generated disease-fighting antibodies that worked against the South African variant, that efficacy was diminished. Moderna said there was a reduction in response, prompting the company to design a new potential vaccine that could be added to the current two-dose regimen.”

Pfizer ships fewer Covid vaccine vials to U.S. after Trump FDA label change: “Pfizer is counting extra coronavirus vaccine it uses to top off each of its vials toward its commitment to deliver 200 million shots for the U.S. pandemic response — even though there aren't enough syringes capable of squeezing out the extra fluid.”

Civica Rx lays out $124M sterile injectables plant, pegged to supply COVID-19 drugs and more: “Construction has already started on the 120,000-square-foot plant, pegged to come online within the next three years, Civica said. The facility will ultimately crank out 90 million vials and 50 million prefilled syringes per year, focusing on drugs for COVID-19 patients as well as meds used in emergency rooms, intensive care units and surgeries.”

Researchers are developing color-changing stickers for masks to detect COVID-19: “The sticker is a test strip and blister pack that can be placed on N95, surgical or cloth masks and detect SARS-CoV-2 in the user's breath or saliva…
As the person wearing the mask breathes, the test strip aims to detect protein-cleaving molecules produced from a COVID-19 infection. Once the user removes the mask and test materials, they squeeze out the contents of the blister pack onto the test strip. If the test strip turns a specific color, it means infection molecules are present.”

Davos Agenda: What you need to know about the future of global health: These health goals are COVID-19 driven. Read the article for the World Economic Forum Agenda.

Today's News and Commentary

About COVID-19

High‐Resolution Agent‐Based Modeling of COVID‐19 Spreading in a Small Town: This simulation looks at effectiveness of targeted interventions versus generalized measures in controlling COVID-19. The model was based on New Rochelle, NY. The authors concluded:
“To illustrate the model's value in analyzing prospective ‘what‐if’ questions, we performed an immunization study in which we evaluated several vaccination strategies of future importance. In particular, we compared the impact of vaccination of select group of vulnerable individuals, including school employees, retirement home employees and residents, and the totality of the two thousand hospital employees in the town, a randomly selected group of 2000 individuals, and 20 000 randomly selected individuals out of the 80 000 people living in New Rochelle. Our results suggest that prioritizing vaccination of high‐risk individuals has a marginal effect on the count of COVID‐19 deaths. Predictably, a much more significant improvement is registered when a quarter of the town is vaccinated. Importantly, the benefits of the restrictive measures in place during the first wave greatly surpass those from any of these selective vaccination scenarios.” [Emphasis added]

Lilly's bamlanivimab cuts risk of COVID-19 by up to 80% at nursing homes: “Eli Lilly announced Thursday that in a Phase III study, bamlanivimab was shown to significantly reduce the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities. The findings from the BLAZE-2 COVID-19 prevention trial suggest the risk was decreased by up to 80% in people administered the antibody therapy versus those in the same facility given placebo.”

Single Covid vaccine dose in Israel 'less effective than we thought': “Israel's coronavirus tsar Nachman Ash warned that a single dose of the Pfizer/BioNTech coronavirus vaccine may be providing less protection than originally hoped…
By contrast, those who had received their second dose of the Pfizer vaccine had a six- to 12-fold increase in antibodies, according to data released earlier this week by Sheba Medical Center in Tel Hashomer.
Pfizer itself says a single dose of its vaccine is about 52% effective, although some countries, including the UK, have delayed administering second doses in a bid to maximise the number of people given a first dose.”

Some states want to buy their own COVID vaccines. The Biden administration says no.: “The Biden administration is rejecting calls from some states to buy COVID-19 vaccine doses directly from Pfizer, as governors hunt for ways to supplement their limited supply of shots.
The divide on that question counts among the early pandemic challenges facing the 46th president, as his team tackles a nationwide vaccine effort that has progressed unevenly in the face of overwhelming demand.
‘We need to have a national approach to vaccinations, and must ensure states aren't competing against each other like they did with PPE, ventilators, and tests,’ spokesperson T.J. Ducklo said in a statement.”

Timing of second Covid vaccine doesn't need to be exact. Just get it, experts say.: “‘The second dose should be administered as close to the recommended interval as possible,’ the CDC said in an update to its website Thursday. ‘However, if it is not feasible to adhere to the recommended interval, the second dose of Pfizer-BioNTech and Moderna Covid-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose.’”

New CDC director says Covid vaccine won't be in every pharmacy by late February: “The new director of the Centers for Disease Control and Prevention said Thursday that the Covid-19 vaccine would not be widely available by late February as the Trump administration previously said.”

Executive Order on Protecting Worker Health and Safety: No specific actions are in this order; it directs government agencies to study and come up with policies to protect workers from COVID-19. Particularly, it invokes OSHA protections.

About health insurance

ACO participation reaches new low as advocates press Biden for major changes: “The number of ACOs for 2021 is below the ACOs that started with the Trump administration in 2017 (480), according to new data from the Centers for Medicare & Medicaid Services, which oversees the program. ACO participation reached a record high of 561 in 2018 but has declined down to 518 in 2019 and 517 last year, federal data shows.
While participation in the program has shifted and declined over the years, ACOs still continue to generate savings for Medicare. The program generated $2.4 billion in gross savings for Medicare in 2019 compared with 1.7 billion in 2018…”

CMS Clarifies 2021 PFS [Physician Fee Schedule] Reimbursements for Remote Patient Monitoring: “In the final rule, to qualify for reimbursement under CPT codes 99457 and 99458, CMS mandated at least 20 minutes of interactive communication time between provider and patient over a calendar month, but that interactive communication couldn’t be part of the 20 minutes of RPM care. The agency has now clarified that “interactive communication” can include both in-person and connected health channels.”

MA Plans See 99% Member Satisfaction Among Non-White Members: “The results indicated that 98 percent of seniors on Medicare Advantage were satisfied with their health plan. Non-white Medicare Advantage beneficiaries expressed even higher satisfaction, with 99 percent reporting that they were satisfied with their coverage.
Similar percentages of members were satisfied with how their health plan managed the pandemic (98 percent) and the network of providers and healthcare systems available to them (97 percent).
The survey also asked which common supplemental health benefits the participants utilized. Vision care was most commonly used with 64 percent of Medicare Advantage members having used this supplemental benefit.”
Caveat: Medicare beneficiaries who choose MA plans are a self-selected group who seek such cost and benefit advantages compared to traditional Medicare with its enhanced freedom of choice.

UnitedHealthcare, Humana & more: 7 payers expanding telehealth strategies: The article is a good brief summary of where these companies stand on telehealth benefits, and hence, where the industry is going. One major trend coming out of the COVID-19 experience is making telehealth a permanent benefit.

9th Circ. Delays Public Charge Ruling As Justices Mull Case: “The Ninth Circuit permitted the U. S. Department of Homeland Security to implement the so-called public charge rule on Wednesday, saying it will delay the effective date of its ruling barring the policy while the U. S. Supreme Court considers the rule's legality. In a one-page order, the appeals court granted DHS' request that it stay its mandate halting enforcement of the Trump administration's public charge rule, which makes it more difficult for immigrants on or deemed likely to use certain public benefits to obtain green cards.”

Orange County insurance brokers help pay off more than $2.1M in medical debt for those in need: “More than 80 employees across the company have donated their own money to help erase more than $2.1 million worth of medical debt. It's for people who live at or below 200% of the poverty line in Orange County…
Through a partnership with the non-profit RIP Medical Debt, every $100 donated forgives $10,000 in medical debt.”
One of many such examples of RIP Medical Debt helping pay off medical bills.

About pharma

FDA approves 1st long-acting HIV drug combo, monthly shots: “U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with the AIDS virus.
Thursday’s approval of the two-shot combo called Cabenuva is expected to make it easier for people to stay on track with their HIV medicines and to do so with more privacy. It’s a huge change from not long ago, when patients had to take multiple pills several times a day, carefully timed around meals..
Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen unit, and a new drug — cabotegravir, from ViiV Healthcare. They’re packaged together and given as separate shots once a month. Dosing every two months also is being tested.”

HHS Freezes Rule Affecting Community Health Center’s 340B Drug Discounts: “The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021…
Pursuant to the regulatory rule freeze, the Department of Health and Human Services (HHS) has frozen a final rule that would have blocked community health centers (i.e., federally qualified health centers) from receiving future grant funding unless the health centers provided a complete pass-through of 340B discounts on insulin and epi-pens to low-income patients (the 340B Insulin Pass-Through Rule).  Community health centers staunchly opposed the 340B Insulin Pass-Through Rule, arguing that it would have added significant bureaucratic obligations to centers’ operations while making a relatively minimal impact on the costs of drugs provided to center patients. The 340B Insulin Pass-Through Rule was slated to go into effect today, Jan. 22, 2021.
As a result of HHS’ freeze, the effective date of the 340B Insulin Pass-Through Rule has now been delayed until at least March 22, 2021. While there is currently no indication whether the Biden administration will ultimately rescind or revise the 340B Insulin Pass-Through Rule, the delay offers community health centers additional time to develop plans to comply with the 340B Insulin Pass-Through Rule.”

Insys Founder To Pay NJ $5M In Opioid Bribery Settlement: “Convicted Insys Therapeutics founder John N. Kapoor has agreed to pay New Jersey $5 million to resolve allegations that he orchestrated bribes to doctors in the state as part of a nationwide kickback scheme to boost sales of Insys' powerful opioid Subsys, the state's attorney general said Thursday. New Jersey Attorney General Gurbir S. Grewal said Thursday that the deal with Insys' 77-year-old founder Kapoor marks the first settlement the state has made in any civil lawsuit against people and corporations accused of fraudulently peddling opioids and that it does not resolve the claims against bankrupt Insys.”

 About healthcare systems

Implementation of Newly Enacted Hospital Price Transparency: “ADVI Analytics explored the top 20 largest hospitals in the county (as determined by number of beds from Becker’s Hospital Review). We found the results varied greatly amongst the hospitals as some made the required information obvious on their websites while other seemingly buried the links. All of the top 20 hospitals published some type of pricing information but not all appeared to completely comply with the mandate and show information for 300 shoppable procedures. Other issues that we identified with the data included: data was not able to download in a useable format, hospitals did not provide HCPCS codes for services, and variability in hospitals’ terms for the pricing information. Among the data we analyzed, we found the price of code 99203 (Level 3 Evaluation and Management code), one of the most commonly billed services in Medicare, ranged from $200 to $1534. Another high-volume radiology code, 70450 (CT, head or brain, without contrast) ranged from $90 to $2,033.”

Hospitals mark up drug prices by 250% on average, analysis finds: “Hospitals mark up drug prices by 250 percent on average, according to an analysis from Ronny Gal, a senior research analyst at Bernstein. 
Mr. Gal analyzed prices hospitals charge for drugs, with data disclosed as of Jan. 1. He found that hospitals mark up some drugs, such as Epogen, an anemia treatment, by as much as 533 percent compared to the average sales price. This incentivizes hospitals to use expensive branded products instead of biosimilars, he said…
Hospitals also charge a range of prices for the same drug, Mr. Gal said. The average variation is about 36 percent.”
Price gouging and cost shifting…

Today's News and Commentary

President-elect Biden Announces American Rescue Plan (Emergency Legislative Package to Fund Vaccinations, Provide Immediate, Direct Relief to Families Bearing the Brunt of the COVID-19 Crisis, and Support Struggling Communities) This statement is a clear and well-written short text of the Rescue Plan. It is not that long and is worth reading. The full (198 page) version is here. For updates, check this link.

About health insurance

Biden Administration Plans to Expand COBRA, ACA Premium Subsidies: The Rescue Plan will extend and increase premium subsidies for COBRA and Affordable Care Act enrollees, with an estimated cost of approximately $57.0 billion over the next three years.

Independent Evaluation of Comprehensive Primary Care Plus (CPC+): This third annual report from Mathematica found that: “There were a few small favorable impacts of CPC+ on some measures of service use, quality of care, and patient experience for Medicare fee- for-service (FFS) beneficiaries during the first three years, but with CMS’s enhanced payments, CPC+ increased total Medicare expenditures. It is still too early to draw conclusions about the likely longer- term effects of CPC+.”

Proposed Decision Memo for Screening for Colorectal Cancer - Blood-Based Biomarker Tests (CAG-00454N): This page has the latest coverage criteria for Medicare patients to have a blood biomarker screen for colon cancer.

Optum expects to add 10,000 physicians this year: “Currently, OptumCare employs or is affiliated with 50,000 physicians and 1,400 clinics. OptumCare expects that its employed and affiliated physicians will grow by at least 10,000 during 2021, according to UnitedHealth CEO David Wichmann.”

Medicare Advantage Star Ratings: 30 measures to know for 2022: “CMS ranks Medicare Advantage on a quality scale of one to five stars, with five representing excellent performance and one reflecting poor performance. To assign stars, Medicare analyzes how health plans perform on certain measures. At the contract level, CMS only includes the measure if numeric value scores are available for both the current year and prior years.
The 30 measures that will be used to calculate the 2022 Star Ratings for Medicare Advantage plans are”listed in the article.
In addition to quality indicators, the stars also determine payments to these plans.

Two Women Plead Guilty In $109M Medicare Fraud Scheme: “Two women pled guilty Wednesday for their roles in a multimillion-dollar Medicare fraud scheme that profited by selling patient data and using that information to submit $109 million worth of false claims, according to the U. S. Department of Justice. Jessica Jones, 30, of Colorado, and Elizabeth Putulin, 30, of Florida, both entered guilty pleas to one count of conspiracy to commit health care fraud. The two women were accused of conspiring with Juan Camilo Perez Buitrago to submit more than $109 million in false claims for durable medical equipment such as back or knee braces by creating shell companies…”

Healthcare execs, physicians pardoned by Trump: In addition to yesterday’s post, here are additional execs who were pardoned (all for insurance fraud crimes).

About COVID-19

New data back ability of Pfizer, BioNTech's COVID-19 vaccine to foil UK strain: “Pfizer and BioNTech on Wednesday reported results from another in-vitro study indicating that their COVID-19 vaccine BNT162b2 is likely capable of neutralising the rapidly spreading UK strain of SARS-CoV-2, also known as B.1.1.7. The findings, which were published on the preprint server bioRxiv, follow the release of a similar laboratory study earlier this month showing that antibodies from vaccinated people were able to efficiently neutralise variants of SARS-CoV-2 with a key mutation, dubbed N501Y, found in the UK variant, as well as another highly transmissible strain that has emerged in South Africa.” However, Emerging Coronavirus Variants May Pose Challenges to Vaccines: “People who had survived mild infections with the coronavirus may still be vulnerable to infection with a new variant; and more worryingly, the vaccines may be less effective against the variants.”

The 10 Biden officials to watch on the Covid-19 response: Read the article for details.

Amazon offers Biden help with Covid-19 vaccine distribution: “Amazon has extended an offer to President Joe Biden to assist with the national distribution of Covid-19 vaccines, a move that could expedite the federal effort to combat the pandemic.”

Biden's just-released coronavirus strategy keeps vaccine goals modest: The article is an update on this fast-moving program. Today, President Biden will “sign 10 more executive orders and directives aimed at mitigating various pandemic-caused crises. They include:

• Creating a Pandemic Testing Board that can spur a “surge” in the capacity for coronavirus tests.

• Fostering research into new treatments for covid-19.

• Strengthening the collection and analysis of data to shape the government’s response to the crisis.

• Directing the federal occupational safety agency to release and enforce guidelines to protect workers from getting infected.

• Directing the Departments of Education and Health and Human Services to provide guidance on safe reopening and operating for schools, child care providers, and institutions of higher education.

• Requiring mask-wearing in airports and other modes of public transportation including trains, airplanes, maritime vessels and intercity buses.”

Europe’s growing mask ask: Ditch the cloth ones for medical-grade coverings: “Germany on Tuesday night made it mandatory for people riding on public transport or in supermarkets to wear medical style masks: either N95s, the Chinese or European equivalent KN95 or FFP2s, or a surgical mask.
It follows a stricter regulation from the German state of Bavaria this week that required N95 equivalents in stores and on public transport. Austria will introduce the same measures from Monday…
Meanwhile in France, the country’s health advisory council on Monday discouraged the wearing of inefficient cloth and homemade masks, also arguing they may not offer sufficient protection against the more highly transmissible coronavirusvariants.”

47% of Americans say vaccinations are moving too slowly: “A plurality of Republicans and Independents, and a majority of Democrats, say the rollout is moving too slowly.
Among those who feel it’s going too slowly, however, there’s a sharp partisan divide over who’s at fault: 60% of Democrats say President Trump is to blame, while a plurality of Republicans (36%) say state governments are the problem…”
But perhaps the most significant finding in this Axios-Harris poll is: “(69%) of Americans say they are likely to take the COVID-19 vaccine, the highest percentage other than the first time we asked in April 2020 (when 73% said they would take the vaccine).”

About healthcare IT

Tripathi tapped as Biden's national coordinator for health IT: “An expert on interoperability, privacy, and technology standards, Tripathi most recently served as chief strategy officer at Arcadia, a population health management solutions company. Before joining Arcadia, [he] had been president and CEO of the Massachusetts eHealth Collaborative (MAeHC), a nonprofit health IT advisory and clinical data analytics company. MAeHC was formed in 2005 and played a significant leadership role in advising and leading various interoperability and standards activities, including HL7 and FHIR.”

ONC investing $20M to boost COVID-19 vaccine data sharing efforts: “ONC will award nearly $20 million in funds from the Coronavirus Aid, Relief, and Economic Security (CARES) Act signed by former President Donald Trump in March to support the nation’s vaccination efforts to fight the COVID-19 pandemic.
The new investments will support opportunities to track vaccination progress, help clinicians pinpoint and contact high-risk patients, and coordinate appointments for patients due to receive the second dose of the vaccine, according to a press release.”

About diagnostics

Thermo Fisher Scientific to Acquire Point-of-Care Molecular Diagnostics Provider Mesa Biotech: “Thermo Fisher Scientific Inc… today announced it has entered into a definitive agreement to acquire Mesa Biotech, Inc., a privately held molecular diagnostic company, for approximately $450 million in cash. Under the terms of the agreement, Thermo Fisher will pay up to an additional $100 million in cash upon the completion of certain milestones following the close of the transaction. 
Mesa Biotech has developed and commercialized a PCR-based rapid point-of-care testing platform available for detecting infectious diseases including SARS-CoV-2, Influenza A and B, respiratory syncytial virus (RSV) and Strep A.”

In vitro test maker Ortho Clinical Diagnostics files $1.5B Nasdaq IPO: “Ortho Clinical Diagnostics is hoping to pay down a large portion of its debts by riding a wave of COVID-19 and broader in vitro lab testing demands to a $1.5 billion IPO. 
The company is offering 70 million shares on the Nasdaq—slated for the ticker OCDX—that are expected to be priced between $20 and $23 apiece in the coming week. Hitting the midpoint of that range would bestow a market value of $4.9 billion…”

Boston Scientific buys wearable heart monitor maker Preventice for $1.2B, as in-hospital sales take hit from pandemic: “Boston Scientific has moved to acquire the remote cardiac monitoring developer Preventice Solutions, a company it has partnered with and invested in since 2015.
On paper, the transaction features a cash payment of $925 million, plus an additional $300 million tied to the achievement of certain commercial milestones. However, Boston Scientific has built up a 22% stake in Preventice, which is expected to lower the net payments to $720 million upfront and about $230 million in milestone money, respectively.”

About pharma

McLaren Health Care Settles with DEA: “The Agreement is the culmination of a multi-year effort with the DEA, which identified prescribing irregularities at the McLaren Port Huron retail pharmacy in 2018, prompting McLaren to terminate a pharmacist who was diverting opioids for his own personal use. A subsequent review included an exhaustive assessment of pharmacy protocols at other McLaren facilities — in some cases stretching over periods of up to 12 years. At the conclusion of its review, the DEA identified irregularities associated with recordkeeping, dispensing and distribution of controlled substances, particularly among retail pharmacies operating under "legacy" pharmacy protocols that had been in place prior to McLaren's acquisition of their operations.”
The penalty is $7.5M, making it the largest settlement ever for alleged drug diversion.

Today's News and Commentary

Expected immediate actions after today’s inauguration:

President Biden will

• Stop the US withdrawal from the WHO.
  And in a related action: Biden will join WHO-backed vaccine initiative

• Require masks on federal property.

• Restore the global health security and biodefense team.

• Rejoin the Paris climate accord.

About health insurance

CMS and Its Contractors Did Not Use Comprehensive Error Rate Testing Program Data To Identify and Focus on Error-Prone Providers: From the HHS OIG: “CMS and its contractors did not use CERT [Comprehensive Error Rate Testing] to identify and focus on error-prone providers for review and corrective action. Using CERT data, we identified 100 error-prone providers from 2014 through 2017. Of the $5.8 million reviewed by CERT, $3.5 million was incorrect, which is an improper payment rate of 60.7 percent. We determined that during the same period, Medicare made $19.1 billion in FFS payments to these 100 error-prone providers…
We recommend that CMS: (1) review the list of 100 error-prone providers identified in this audit and take specific action as appropriate, such as prior authorization, prepayment reviews, and postpayment reviews, and (2) use annual CERT data to identify individual providers that have an increased risk of receiving improper payments and apply additional program integrity tools to these providers.”

Compounding Pharmacy Mogul Sentenced for Multimillion-Dollar Health Care Fraud Scheme: ”A Mississippi businessman was sentenced… for his role in a multimillion-dollar scheme to defraud TRICARE, the health care benefit program serving U.S. military, veterans, and their respective family members, as well as private health care benefit programs.
Wade Ashley Walters, 54, of Hattiesburg, a co-owner of numerous compounding pharmacies and pharmaceutical distributors, was sentenced… on his guilty plea to one count of conspiracy to commit health care fraud and one count of conspiracy to commit money laundering. U.S. District Judge Keith Starrett of the Southern District of Mississippi ordered Walters to serve a total of 18 years in prison and to pay $287,659,569 in restitution. Walters was remanded into custody following the sentencing hearing. Walters was further ordered to forfeit $56,565,963, representing the proceeds he personally derived from the fraud scheme…
Between 2012 and 2016, Walters orchestrated a scheme to defraud TRICARE and other health care benefit programs by distributing compounded medications that were not medically necessary.”

Trump grants clemency to 143 people in late-night pardon blast: Among the actions was commutation of “the sentence of Salomon Melgen, a West Palm Beach, Fla., eye doctor who was sentenced in 2018 to 17 years in prison, accused of stealing $73 million from Medicare by persuading elderly patients to undergo unnecessary procedures.
Separately, Melgen had been accused of bribing Sen. Robert Menendez (D-N.J.) to intercede on his behalf in the Medicare investigation.”

AMA announces update to COVID-19 vaccine CPT codes: The new codes will be used to bill and track administration of J&J’s vaccine when it is available.

UnitedHealth Group Reports Fourth Quarter and Full Year 2020 Financial Results: ”The full year and fourth quarter results reflect continued strong performance, impacted by COVID-19 care costs, continued voluntary consumer and customer assistance initiatives and other pandemic-related factors. As expected, fourth quarter net earnings of $2.30 per share and adjusted earnings of $2.52 per share declined as care patterns normalized, while COVID-19 costs rose, and further rebate effects were recognized.  The 2020 results were consistent with the outlook provided by the Company at its December 1st, 2020 Investor Conference. 
The Company affirmed its recently issued full year earnings outlook for 2021, including net earnings of $16.90 to $17.40 per share and adjusted net earnings of $17.75 to $18.25 per share. As previously discussed, this outlook includes approximately $1.80 per share in potential net unfavorable impact to accommodate continuing COVID-19 effects, such as: testing and treatment costs; the residual impact of people deferring care in 2020; and unemployment and other economy-driven factors.”

Feds Near Win In Mass. ACA Birth Control Coverage Suit: “A Massachusetts federal judge has ruled that the state can't block a pair of Trump administration rules expanding the religious exemption to the Affordable Care Act's contraceptive mandate, finding that the exemptions don't run afoul of the U. S. Constitution or federal statutes in light of the high court's recent Little Sisters ruling. In a 29-page, Jan. 15 opinion, U. S. District Judge Nathaniel M. Gorton said the state has not established that the final rules are statutorily or constitutionally invalid, and therefore he was denying its bid for summary judgment…”

About COVID-19

Elderly begin to drop out of Novavax vaccine trial to get Pfizer and Moderna shots: Seniors want to know if they were in the placebo group for Novavax’s vaccine. If so, they want to drop out and get a vaccine that is already approved.

Evaluation of Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 Infection at Two Community-Based Testing Sites — Pima County, Arizona, November 3–17, 2020: Published yesterday from the CDC. “Sensitivity of the BinaxNOW [from Abbott] antigen test, compared with polymerase chain reaction testing, was lower when used to test specimens from asymptomatic (35.8%) than from symptomatic (64.2%) persons, but specificity was high. Sensitivity was higher for culture-positive specimens (92.6% and 78.6% for those from symptomatic and asymptomatic persons, respectively); however, some antigen test-negative specimens had culturable virus.”

Lab-Developed Virus Tests Get Authorization Without FDA Input: “The HHS on Tuesday authorized three lab-developed Covid-19 tests in an unusual move that skirts the FDA’s traditional role to review products.
The tests from the Ponce Medical School in Puerto Rico, the University of Louisville Infectious Diseases Laboratory in Kentucky, and the Hospital of the University of Pennsylvania are already on the market, Health and Human Services testing leader Brett Giroir said in an interview Tuesday. The authorizations give them liability protections and insurance coverage through federal laws passed earlier in the pandemic.”

Cheap antiparasitic could cut chance of Covid-19 deaths by up to 75%: “The University of Liverpool’s Andrew Hill and others carried out a meta-analytical breakdown of 18 studies that found that ivermectin was associated with reduced inflammation and a faster elimination of Sars-Cov-2, the virus that causes Covid-19. In six of these trials, the risk of death was reduced by 75 per cent in a subset of patients with moderate to severe Covid-19.”
More data needs to be accumulated. Recall we have had many drugs touted as helping prevent/treat COVID-19. Remember hydroxychloroquine?

US scientists develop blood test for high-risk Covid-19 patients: “Scientists at Washington University School of Medicine in St Louis, US, have developed a new simple and rapid test that can measure mitochondrial DNA in the blood of a Covid-19 patient and identify those who are at highest risk of severe disease or death.”

Moderna to Start New Trial Adding Third Shot of COVID-19 Vaccine: “Participants who received a full two-shot regimen in Moderna’s phase 1 vaccine trial are being given the option to receive a third booster shot” starting in July.
“The study will enroll adults who previously took part in the initial phase 1 study led by the National Institutes of Health [and] aims to assess the safety of an extra shot given a year after the second dose and the additional immune response it elicits.”

Association of Intensive Care Unit Patient Load and Demand With Mortality Rates in US Department of Veterans Affairs Hospitals During the COVID-19 Pandemic: Volume/quality relationships do not always apply.
”In this cohort study of patients with COVID-19 in US VA hospitals, receiving treatment during peak COVID-19 ICU demand, with demand describing the caseload of patients with COVID-19 in the ICU when the patient was treated compared with peak COVID-19 ICU caseload, was consistently and independently associated with COVID-19 ICU mortality. In the extreme case, the adjusted hazard of death was 1.94 for patients with COVID-19 treated in the ICU during periods with greater than 75% to 100% of the peak COVID-19 ICU caseload. The finding that COVID-19 ICU demand was associated with increased mortality for patients with critical COVID-19 early in the pandemic (ie, March-May) and later in the pandemic (ie, June-August) supports the overall study results that suggested that strains on critical care capacity were associated with increased COVID-19 ICU mortality.”
A number of “Limitations” at the end of the article should make the reader interpret these results cautiously.

About pharma

Merck & Co. loses Supreme Court bid to restore $2.5-billion award in Gilead patent dispute: “The US Supreme Court on Tuesday declined to hear arguments by Merck & Co. in its attempt to appeal a lower court ruling that had overturned a $2.5-billion award it won against Gilead Sciences in 2016. The patent infringement case involved the latter's hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir).”

Mylan Can't Escape EpiPen Distributors' Antitrust Claims: “A Minnesota federal judge has refused to throw out a proposed class action that accuses drugmaker Mylan Inc. of paying bribes and kickbacks to a group of pharmacy benefit managers and conspiring to engage in anti-competitive practices that jacked up the price of its anti-allergy injection EpiPen. Mylan and the so-called PBM defendants — Express Scripts, Optum and CVS Caremark — each argued in separate but identical motions to dismiss that they did nothing unlawful outside their normal commercial business practices.”

About healthcare IT

OCR lifts HIPAA penalties for COVID-19 vaccine scheduling apps: 5 details: “HHS' Office for Civil Rights will not impose penalties for potential HIPAA violations of healthcare providers and their business associates who use online or web-based scheduling applications to coordinate COVID-19 vaccine appointments.”

Philips to buy medical device integrator Capsule Technologies for $635M: “Philips has moved to acquire Capsule Technologies—a provider of data platforms that aim to connect all of the medical devices and record systems within a hospital—to help build out its integrated care and vital sign monitoring solutions.
The $635 million cash deal is expected to be completed by the end of March, with Capsule’s 300 employees slated to join Philips’ connected care division. Capsule’s software-as-a-service offerings are currently used by over 2,800 healthcare organizations globally, with development teams based in the U.S. and France, while its platform can connect to over 940 unique devices.”

About healthcare quality

Predicted Cost Savings Achieved by the Radiology Support, Communication and Alignment Network from Reducing Medical Imaging Overutilization in the Medicare Population: “The Radiology Support, Communication and Alignment Network (R-SCAN) is a quality improvement program through which patients, referring clinicians, and radiologists collaborate to improve imaging appropriateness based on Choosing Wisely recommendations and ACR Appropriateness Criteria. R-SCAN was shown previously to increase the odds of obtaining an appropriate, higher patient or diagnostic value, imaging study. In the current study, we aimed to estimate the potential imaging cost savings associated with R-SCAN use for the Medicare population…
We observed a substantial reduction in the costs associated with lesser value imaging in the R-SCAN cohort, totaling $260,000 over 3.5 months. When extrapolated to the Medicare population, the potential cost reductions associated with the decrease in lesser value imaging totaled $433 million yearly.”

About healthcare systems

Community Health Taps Into Junk-Bond Frenzy to Tame Debt: “Community Health Systems Inc., the debt-laden hospital chain that’s been staging a comeback, has more than doubled the size of a bond offering as it takes advantage of some of the lowest yields ever for speculative-grade issuers.
After strong recent earnings results, the company is using the momentum to refinance a high coupon and push out maturities.
Community is selling a $1.8 billion high-yield bond maturing in 2029 and announced a related tender offer Tuesday…
Community Health was once known as one of the most distressed companies in the healthcare sector. But the firm has been selling hospitals to raise cash and refinancing debt to improve its balance sheet. In recent months, the bonds have risen after it posted better-than-expected earnings in the second and third quarters.
The company is rated in the riskiest tier of junk debt, CCC+ by S&P Global Ratings and CCC by Fitch Ratings. Moody’s Investors Service upgraded the company by one notch to Caa2 on Tuesday and viewed the new transaction as a credit positive event.”

Today's News and Commentary

About COVID-19

Hackers altered Moderna, Pfizer data from EU before posting online to undermine public's trust in vaccines: “Hackers who leaked the European Medicines Agency's COVID-19 vaccine data from Moderna and Pfizer manipulated the information before publishing it online, the EMA announced Jan. 15. 
In an update on the cyberattack, the EMA said the leaked documents included internal and confidential emails about the COVID-19 vaccine evaluation process and that ‘some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.’” 

US approaches 400,000 coronavirus deaths: “The US recorded 1.5 million new Covid-19 cases in the past seven days, according to the most recent data from Johns Hopkins University, an 11% drop from the previous week. Cases declined in 35 states week-over-week, and 18 states saw a drop in the number of deaths.
But with a longer range view, last week's apparent improvement falls much closer to average. Over the past month, the number of new Covid-19 cases recorded each day has ranged from nearly 101,000 to more than 302,000; over the past seven days, new cases averaged about 218,000 daily.”

Emergence of SARS-CoV-2 B.1.1.7 Lineage — United States, December 29, 2020–January 12, 2021: “A more highly transmissible variant of SARS-CoV-2, B.1.1.7, has been detected in start highlight12end highlight U.S. states…
The increased transmissibility of the B.1.1.7 variant warrants universal and increased compliance with mitigation strategies, including distancing and masking. Higher vaccination coverage might need to be achieved to protect the public. Genomic sequence analysis through the National SARS-CoV-2 Strain Surveillance program will enable a targeted approach to identifying variants of concern in the United States.”

Biden pledges to build scores of new vaccine sites and prioritize older Americans: “President-elect Joe Biden pledged to put Americans 65 and older near the front of the line for coronavirus vaccines and to expand the number of vaccination sites to quickly make up for the Trump administration's bungled response.
Biden vowed to use available supplies more efficiently and equitably to supercharge the effort to get shots into arms after Trump’s promise to vaccinate 20 million people before Jan. 1 fell far short.”

Israel trades Pfizer doses for medical data in vaccine blitz: “After sprinting ahead in the race to inoculate its population against the coronavirus, Israel has struck a deal with Pfizer, promising to share vast troves of medical data with the international drug giant in exchange for the continued flow of its hard-to-get vaccine.”

The Trump administration bailed out prominent anti-vaccine groups during a pandemic: “Five prominent anti-vaccine organizations that have been known to spread misleading information about the coronavirus received more than $850,000 in loans from the federal Paycheck Protection Program, raising questions about why the government is giving money to groups actively opposing its agenda and seeking to undermine public health during a critical period.
The groups that received the loans are the National Vaccine Information Center, Mercola Health Resources, the Informed Consent Action Network, the Children’s Health Defense and the Tenpenny Integrative Medical Center, according to the Center for Countering Digital Hate, an advocacy group based in the United Kingdom that fights misinformation and conducted the research using public documents. The group relied on data released in early December by the Small Business Administration in response to a lawsuit from The Washington Post and other news organizations.”

Previous coronavirus infection may offer less protection from new variant: “Previous infection with the coronavirus may offer less protection against the new variant first identified in South Africa, scientists said on Monday, although they hope that vaccines will still work.
Studies also found that the new variant binds more strongly and readily to human cells. That helps explain why it seems to be spreading around 50% quicker than previous versions, leading South African epidemiologist Salim Abdool Karim said.”

Key Capital COVID-19 Oral Pill Vaccine Records 90% Reduction in Virus Infectivity in Early Study: “The preliminary tests conducted by a leading Asian research institute have shown safety and a 90% reduction on virus infectivity in mammalian cells following exposure to the active vaccine. This laboratory testing highlights the vaccine methodology and ability to inactivate and/or prevent viral infection and its potential for oral mucosal administration.”

WHO cites human behavior more than variants as virus spreads: “The World Health Organization's emergencies chief said Friday that the impact of new variants of COVID-19 in places like Britain, South Africa and Brazil remains to be seen, citing human behavior for some recent rises in infection counts.”

Panel: China, WHO should have acted quicker to stop pandemic: “A panel of experts commissioned by the World Health Organization has criticized China and other countries for not moving to stem the initial outbreak of the coronavirus earlier and questioned whether the U.N. health agency should have labeled it a pandemic sooner.
In a report issued to the media Monday, the panel led by former Liberian President Ellen Johnson Sirleaf and former New Zealand Prime Minister Helen Clark said there were ‘lost opportunities’ to adopt basic public health measures as early as possible.” Here is the full preliminary WHO report.

About healthcare IT

Health Insurer Pays $5.1 Million to Settle Data Breach Affecting Over 9.3 Million People: “Excellus Health Plan, Inc. has agreed to pay $5.1 million to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to a breach affecting over 9.3 million people.  Excellus Health Plan is a New York health services corporation that provides health insurance coverage to over 1.5 million people in Upstate and Western New York.
On September 9, 2015, Excellus Health Plan filed a breach report stating that cyber-attackers had gained unauthorized access to its information technology systems.”
It is still amazing how long these actions take.

A look inside Anthem's new digital incubator: “As healthcare continues to evolve, legacy players are aiming to be the first to gain access to the latest innovations.
At Anthem, that effort has meant launching its own Digital Incubator, which pairs financial backing with mentorship and opportunities for partnerships with universities and corporations…
For [example], the incubator hosts challenges for would-be innovators to compete for prizes while developing solutions targeting key health issues. This week, ADI opened applications for community health challenges, with specific focus areas targeting health literacy, food insecurity and medication adherence…
In addition, ADI has entrepreneurs in residence who are given the opportunity to work alongside the payer's leadership and other executives, including through one-on-one mentorship.”

So long, fax machines? CMS finalizes rule aimed at streamlining prior authorizations, improving data sharing: “The Trump administration finalized a rule aimed at improving the sharing of healthcare data between payers and providers and streamlining prior authorization.
The rule, released Friday (PDF) by the Centers for Medicare & Medicaid Services (CMS), requires payers in certain government programs to build application programming interfaces (APIs) for data exchange and prior authorization. It tackles a common complaint from providers that prior authorization has increased in use among plans and takes up too much time away from patients.
Officials said the final rule also builds on efforts to drive interoperability and empower patients by promoting secure electronic access to health data.”

Health benefits platform Accolade is buying telehealth startup 2nd.MD for $460M:”Accolade plans to pay $460 million to acquire 2nd.MD, a company that helps patients get expert medical opinions via video or phone.
The deal will create the most comprehensive, integrated healthcare navigation experience in the industry, Accolade officials said.
By adding 2nd.MD's services, Accolade will help employers address the urgent medical needs that face employees in 2021.”

UnitedHealthcare Expands Access to Virtual Care, Including a New Virtual Primary Care Offering: “To help improve access to local care providers, UnitedHealthcare has updated a policy to help encourage the use of virtual care and enable eligible members to meet with their physicians virtually. Effective Jan. 1, the policy applies to fully insured and self-insured employer plans and will continue to reimburse local primary care physicians, specialists and select therapy providers for administering certain care through telehealth as an alternative to in-person visits.
The new Virtual Primary Care service, which is designed to make it easier for people to establish and maintain a relationship with a primary care physician, is currently available for members enrolled in certain employer-sponsored fully insured or self-funded health plans in 11 states. The service, offered in collaboration with a national telehealth provider group, is expected to be expanded to more states in 2021 and is part of a broader UnitedHealthcare effort to help enable members to use technology to access care.”

New computational tool reliably differentiates between cancer and normal cells from single-cell RNA-sequencing data: “n an effort to address a major challenge when analyzing large single-cell RNA-sequencing datasets, researchers from The University of Texas MD Anderson Cancer Center have developed a new computational technique to accurately differentiate between data from cancer cells and the variety of normal cells found within tumor samples. The work was published today in Nature Biotechnology.
The new tool, dubbed CopyKAT (copy number karyotyping of aneuploid tumors), allows researchers to more easily examine the complex data obtained from large single-cell RNA-sequencing experiments, which deliver gene expression data from many thousands of individual cells.”

About pharma

The top 10 largest biopharma M&A deals in 2020: The article has details bout each of the ten deals.

Ineos gives Oxford £100m to set up antibiotic research institute: “Oxford university has received £100m, its largest donation for science, from chemicals group Ineos to set up an antibiotics research institute to counter the growing threat from deadly superbugs. The gift from the UK’s largest private company will help tackle antimicrobial resistance, which scientists estimate kills at least 750,000 people worldwide a year and could lead to as many as 10m deaths annually by 2050 unless a new generation of drugs is found.”

Rite Aid Must Face Trial For Inflated Drug Price Claims: “A Delaware Superior Court judge on Friday sent toward trial some litigation claims filed by a group of health insurance and pharmacy benefit companies asserting Rite Aid charged the companies too much for prescriptions included in the drugstore chain's discount drug card program.”

About health insurance

CMS issues changes to Medicare Advantage and Part D meant to improve coverage, access: “The Centers for Medicare and Medicaid Services issued a final rule Friday that will require Part D plans to offer a real-time benefit-comparison tool starting January 1, 2023…
The changes are generally effective for the 2022 plan year and will potentially lower enrollee cost sharing on some of the most expensive prescription drugs, CMS said. The final rule will allow enrollees to know in advance and compare their out-of-pocket payments for different prescription drugs.”
Part D plans already have a total annual cost computation (on the medicare.gov website) so it is not clear how this rule would be of benefit.

Kemp, Trump proposal to block ACA shopping website draws legal fight: “Advocates for the federal health insurance program known as Obamacare filed a lawsuit Thursday challenging Georgia’s plan to block access to coverage through the program’s online marketplace.
The federal lawsuit argues that in allowing Georgia to ignore certain provisions of the Affordable Care Act, the Trump administration was illegally attempting to gut the law, which has withstood repeated challenges in Congress and the courts.”

Insurers ordered to give up claims data for FTC study of healthcare mergers and acquisitions: Another use of insurance data: “The Federal Trade Commission sent orders to six health insurers for claims data to help it study the effect of hospital acquisitions of physician groups. 
This study is part of a broader initiative announced by the FTC to revamp its merger retrospective program and better equip the agency to challenge healthcare mergers.
The FTC sent orders to Aetna, Anthem, UnitedHealthcare, Cigna, Florida Blue and Health Care Service Corp. The orders ask the insurers to provide patient-level claims data for inpatient, outpatient and physician services.”

A breakdown of 14 recent CMS actions: A good summary of each of these actions.

About the public’s health

HHS finalizes rule that imposes term limits for career federal scientists: “Health and Human Services published a final rule that institutes term limits top career government scientists.
The agency’s final rule issued late Friday imposes five-year terms for policy level directors across the entirety of HHS’ divisions that include the Health Resources and Services Administration and Food and Drug Administration centers…
The first term for these agency directors will start ending on staggered dates in December 2021 and the rule would affect 66 career scientists.
HHS said that the scientists will not be fired or have their pay reduced under the rule but instead would be appointed somewhere else in the agency.”
Look for the Biden administration to reverse this rule.

Today's News and Commentary

Here is a Summary of this week’s annual JP Morgan Conference

About the public’s health

Biden unveils $1.9 trillion relief package: 10 things to know: This article is a good, concise summary of last night’s speech by the President-elect. For more details, see: Biden’s $1.9 trillion Covid relief plan calls for stimulus checks, unemployment support and more

Ex-FDA chief David Kessler to lead COVID-19 vaccine efforts as head of Operation Warp Speed: The rumor of the appointment has been confirmed.

SIU researchers discover new, dominant variant of US COVID-19 virus: “A team led by a researcher at Southern Illinois University Carbondale has discovered a new variant of the COVID-19 virus that is specific to and dominant in the United States, adding to the growing list of mutations such as those discovered in the United Kingdom and South Africa. It might be more easily transmissible than other variants, and its impact on vaccines is uncertain.”

CDC warns highly transmissible coronavirus variant to become dominant in U.S.: “The highly contagious variant of the coronavirus first seen in the United Kingdom will become the dominant strain in the United States within about two months, its rapid spread heightening the urgency of getting people vaccinated, the Centers for Disease Control and Prevention predicted Friday in its most sobering warning yet about mutations in the virus.
In every scenario explored by the CDC, the U.K. strain, which British researchers estimate is roughly 50 percent more transmissible than the more common coronavirus strain, will account for a majority of cases in the United States by some point in March.”

Comparison of Saliva and Nasopharyngeal Swab Nucleic Acid Amplification Testing [NAAT] for Detection of SARS-CoV-2: “In the primary analysis, the saliva NAAT pooled sensitivity was 83.2% (95% credible interval [CrI], 74.7%-91.4%) and the pooled specificity was 99.2% (95% CrI, 98.2%-99.8%). The nasopharyngeal swab NAAT had a sensitivity of 84.8% (95% CrI, 76.8%-92.4%) and a specificity of 98.9% (95% CrI, 97.4%-99.8%). Results were similar in secondary analyses.
These results suggest that saliva NAAT diagnostic accuracy is similar to that of nasopharyngeal swab NAAT, especially in the ambulatory setting. These findings support larger-scale research on the use of saliva NAAT as an alternative to nasopharyngeal swabs.”

SARS-CoV-2 serological tests can generate false positive results for samples from patients with chronic inflammatory diseases: “The majority of the verified serological assays were sensitive to interfering antibodies in samples from patients with chronic inflammatory diseases and therefore may have poor specificity in this context. For these patients, the risk of false positivity should be considered when interpreting results of the SARS-CoV-2 serological assays.” The problem was most pronounced in sero-positive rheumatoid arthritis.

Dollar General Will Pay Workers to Get a Covid-19 Vaccine: The problem with this strategy is that some people perceive the vaccine is dangerous if someone is offering to pay them to get it.

Companies scramble to expand coronavirus vaccine supply: Finally, some good news: “Production of the two coronavirus vaccines authorized in the United States is accelerating, even as companies with experimental vaccines nearing the end of trials struggle to meet ambitious manufacturing targets.
That means the United States should have 200 million doses each from the companies with authorized shots, Pfizer-BioNTech and Moderna — enough to guarantee that more than 70 percent of adults will be able to get the two-shot vaccination by the end of July.”
However: Vaccine reserve was already exhausted when Trump administration vowed to release it, dashing hopes of expanded access

Matching Sinopharm, fellow Chinese biotech Sinovac sees 78% COVID-19 vaccine efficacy: “A little over a week after Sinopharm nabbed the world’s first full approval from Chinese regulators on a 79% efficacy showing for its COVID-19 vax, fellow Chinese native Sinovac, using similar tech, has shown pretty much the same numbers.”

Under the Gun: We need to remember another pandemic. “Over 30,000 Americans die every year of firearm-related injuries, and this number is continuing to rise. In 2017 approximately 40,000 died from a gun injury, a 2.9% increase from 2016. In comparison, deaths related to motor vehicle collisions have fallen, decreasing from one year to the next. Firearm-related deaths now outnumber motor-vehicle deaths for the first time in some states. In the past, the approach to gun violence and other crimes focused on increased law enforcement presence and policing. Public health interventions focused on improving social support for hard-hit communities were rare.”

About healthcare IT

CVS Health launches Symphony™ to support senior safety at home and enhance caregiver peace of mind: “The center of the Symphony ecosystem is the voice-activated Smart Hub which enables hands-free calls with caregivers or emergency responders, while also monitoring motion, temperature, and air quality within the home.
Symphony features a free app for caregivers that provides alerts for falls or other emergencies and assists with facilitating care coordination. Additionally, smart algorithms within the app track and alert caregivers when normal conditions, such as average room temperature or air quality, are disrupted, suggesting when the caregiver may want to check in with their loved one.”

About pharma

The era of bipartisan work on lowering drug prices might be over: The Democrats have always wanted direct negotiations with manufacturers, while Republicans preferred marketplace solutions (like competition). This issue is a perfect example of a shared goal whose accomplishment is deadlocked by tactical differences.

Eli Lilly chips $30M into VC fund aimed at minority-owned healthcare companies: ”The company invested $30 million in Unseen Capital Health Fund, a venture fund aimed at supporting founders of early-stage healthcare companies who are Black or of other racial minorities, Lilly announced on Friday. In addition to identifying, funding and supporting minority-led businesses, the fund will also target companies working on solutions for marginalized communities.
Unseen Capital is already investing in companies and plans to top out its fund at $100 million.”

How a gene linked to the circadian clock could point to new prostate cancer treatments: ”Studies have shown that disruptions in circadian rhythms caused by chronic sleep deprivation and other lifestyle-related issues are linked to an increased incidence of some cancers, including prostate cancer.
Researchers at Sidney Kimmel Cancer - Jefferson Health (SKCC) analyzed that connection and landed on a circadian clock gene that seems to play a major role in prostate cancer progression. They believe their findings could inspire new treatments that target the gene, which is called CRY1, they reportedin the journal Nature Communications.”

Trump administration will let nearly all doctors prescribe addiction medicine buprenorphine: “The change will allow almost all physicians to prescribe the addiction drug buprenorphine, regardless of whether they’ve obtained a government waiver. Previously, doctors had to undergo an eight-hour training and receive the license, known as the “X-waiver,” before they could prescribe buprenorphine. For years, addiction treatment advocates have argued that tight buprenorphine regulations prevent thousands of doctors from providing high-quality addiction care.”

Evaluation of Aspirin Use With Cancer Incidence and Survival Among Older Adults in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial: “In the current study, any aspirin use and aspirin use at least 3 times/week was associated with improved bladder and breast cancer survival. Associations between aspirin use and incidence of any of the investigated cancers or between aspirin use and esophageal, gastric, pancreatic, or uterine cancer survival were not observed.”

About health insurance

CMS Axes MFAR For Good: “CMS on Thursday officially killed its controversial Medicaid fiscal accountability regulation after putting it on ice in September. The Trump administration proposed the rule in November 2019 because it worried that states were gaming the state-federal Medicaid financing system to collect additional federal dollars. But a wide range of stakeholders opposed the rule, including providers, state regulators and governors, patient advocacy groups and some members of Congress. That's because it would have ramped up federal oversight of how states fund their Medicaid programs and possibly led to significant funding cuts.”

CMS finalizes changes to marketplace, payment notice for 2022: “In a final rule [to be published in the Federal Register January 19] released today, for 2022, the Centers for Medicare and Medicaid Services will reduce the user fee for qualified health plans sold through a federally-facilitated exchange from 3% to 2.25% of premium. This is an additional reduction beyond the 0.5 percentage point reduction in the user fee rate included in the 2020 payment notice.
CMS also is finalizing a reduction in the user fee for issuers offering plans through state-based exchanges that use the federal platform from 2.25% to 1.75% of premium. In years past, including 2020 and 2021, this provision has been key to reducing insurance premiums to deliver an 8% average premium reduction across states with exchanges using HealthCare.gov since the 2018 coverage year. 
CMS expects to continue reviewing comments and finalizing other proposed policies in a second final rule to be published at a later date.“

DOJ recovers $1.8B from healthcare false claims cases: 4 things to know: “The Department of Justice obtained more than $2.2 billion in fraud and false claims settlements and judgements in fiscal year 2020, and the bulk of those recoveries came from matters that involved the healthcare industry.”

MedPAC to recommend 2% payment boost for hospitals next year: “The commission said it wants to give the payment boost to both acute-care and long-term care hospitals. The 2 percent payment increase will result in about a $750 million to $2 billion increase in acute-care hospital spending for Medicare and about $50 million for long-term care hospitals.  
MedPAC also plans to recommend no change to the payment rate for physicians in 2022 and a 5 percent decrease for home health firms and inpatient rehabilitation centers.”
These recommendations are advisory ,so they are highly subject to lobbying and other political pressures.

About healthcare quality

Information Sharing Practices Between US Hospitals and Skilled Nursing Facilities to Support Care Transitions: “In this study, US SNFs reported significant shortcomings in the completeness, timeliness, and usability of information provided by hospitals to support patient transitions. These shortcomings are likely associated with a suboptimal transition experience. Shared clinicians represent a potential strategy to improve information sharing but are costly. New payment models such as accountable care organizations may offer a more scalable approach but were only associated with more timely sharing.”
This study found what many clinicians already knew from experience.

About healthcare marketing

NRC Health 2021 Healthcare Consumer Trends Report: Interesting consumer insights across several topics. For example, one interesting finding was: “Year over year, indifference to brands is increasing among healthcare consumers, with percentages of consumers who stated ‘no preference’ increasing from 31% in 2018 to 36% this year. This means that more than a third of consumers currently show no particular preference for a healthcare brand.
As may be expected, the pandemic has only exacerbated these trends. In the wake of COVID-19, 45% of consumers report that they have already changed their healthcare brand preference, and 62% expect their brand preferences to change once the pandemic has ended.” [Emphases in the original]

Today's News and Commentary

About health insurance

Open Enrollment sign-ups for 2021 match 2020's total, says CMS: “The Centers for Medicare and Medicaid Services has released the final weekly enrollment snapshot that shows about 8.3 million people selected individual market plans through the marketplaces using the federal platform during the 2021 Open Enrollment Period. 
This total enrollment is nearly the same as enrollments during the 2020 open enrollment period, despite the fact that New Jersey and Pennsylvania transitioned to state-based exchange platforms starting with the 2021 open enrollment period. As a result of their transition, selections in New Jersey and Pennsylvania are not included in the snapshot. 
After removing these states from the total plan selection totals in the 2020 open enrollment period and comparing year-over-year trends, the results show plan selections this year increased by 7% from 2020, despite a decline in new consumers. Also, for the fourth straight year, the consumer satisfaction rate at the call center remained high – averaging over 90% – throughout the entire stretch.”

35 Next Gen ACOs achieved savings, bonuses in 2019: “The 37 ACOs participating in the model reduced Medicare spending by $558.6 million in 2019, according to the data, and just two of the 37 failed to meet benchmarks and achieve savings.
Based on the data, the 37 ACOs earned a combined $461.9 million in incentive payments from CMS for meeting financial and quality targets. However, taking into account the unearned quality withholds, CMS will pay $354.5 million to the ACOs. 
This means the program resulted in $204 million in direct savings to Medicare after accounting for the incentive payments.”

About the public’s health

Renewal of Determination That A Public Health Emergency Exists: HHS Secretary Azar renewed the declaration of a public health emergency.

HHS launches COVID-19 antibody treatment locator tool: “The U.S. Department of Health and Human Services has launched a treatment locator to help patients and providers find monoclonal antibody therapeutics for COVID-19.
Housed at HHS' Protect Public Data Hub, the tool displays locations that have received shipments of therapeutics under the U.S. Food and Drug Administration authority within the past several weeks.”

Covid infection shown to provide as much immunity as vaccines: ”People who have already contracted coronavirus are as protected against reinfection as those who have received the best Covid-19 vaccines, according to a survey of 20,000 UK healthcare workers, the largest study in the world so far…
prior infection provided at least 83 per cent protection against reinfection. It gave better than 94 per cent protection against symptomatic Covid-19, matching the figures for the most effective Covid-19 vaccines.”
Note that there is a difference between measuring antibody levels and assessing reinfection rates.

Early study shows J&J's one-dose COVID-19 vaccine triggered antibodies in all participants: “As previously reported, neutralising antibody titers against COVID-19 were detected in over 90% of participants after a single vaccination at day 29. The new data showed that among younger adults aged 18 to 55 years, this increased to 100% at day 57, regardless of vaccine dose or age group, while titers then remained stable until at least day 71, which is currently the latest available time point in the ongoing study. Meanwhile, a second dose of Ad26.COV2.S provided an increase in the titer by a factor of 2.6 to 2.9, researchers said. Johnson & Johnson noted that data on durability of immune responses in trial participants aged over 65 years after day 29 will be shared in late January.”

Scientists find antibody that blocks dengue virus: “A team of researchers led by the University of California, Berkeley and the University of Michigan has discovered an antibody that blocks the spread within the body of the dengue virus, a mosquito-borne pathogen that infects between 50 and 100 million people a year. The virus causes what is known as dengue fever, symptoms of which include fever, vomiting and muscle aches, and can lead to more serious illnesses, and even death…
Currently, there are no effective treatments or vaccines for the dengue virus.”
Aside from its potential humanitarian benefits, commercial implications are huge.

DxTerity Offers COVID-19 Tests For Sale on Amazon: “DxTerity's SARS-CoV-2 PCR-based test is the first at-home saliva test to receive Emergency Use Authorization (EUA) by the FDA for symptomatic and asymptomatic testing.” This saliva sample mail-in test costs $110.

About pharma

Drugmakers sue HHS over 340B advisory opinion in feud over contract pharmacy access: “Drug companies AstraZeneca, Eli Lilly and Sanofi filed separate lawsuits seeking to preserve their ability to restrict offering 340B-discounted drugs to contract pharmacies.
The lawsuits, filed Tuesday in different federal courts, seek to get rid of an advisory opinion filed by the Department of Health and Human Services’ (HHS') general counsel that says drug companies must offer 340B drugs to contract pharmacies, which are third-party entities that dispense drugs on behalf of hospitals participating in the program.”

Boehringer partners with Google to bring quantum computing to biopharma R&D: “The three-year pharmaceutical project is the first of its type for Google’s Quantum AI division, and will be co-led by a new Quantum Lab at Boehringer—forming one part of the company’s digital transformation strategy alongside investments in machine learning and data science, as well as digitally powered biomarkers and therapeutics.”

Walgreens announces creation of new tech startup aimed at developing comprehensive patient platform: “Walgreens is establishing a tech-enabled healthcare startup with the goal of creating a new patient platform that blends physical and digital tools, company leadership said…
The startup will put together a customer engagement platform that includes a personalization engine.”

Woodcock to serve as acting FDA commissioner, Sharfstein a contender for top FDA job: “David Kessler is out of the running for nomination as FDA commissioner, leaving Joshua Sharfstein as a front-runner to lead FDA, sources briefed by the Biden transition team told BioCentury. While the list of candidates had narrowed to Kessler and Sharfstein, the delay in naming a candidate for the position could be a sign that other names are being considered. 
Janet Woodcock is expected to be named acting FDA commissioner, according to the sources, who spoke on condition of anonymity. “

He’s in! Shark Tank’s Mark Cuban launches generics maker promising ‘radically’ low-cost drugs: “Cuban has launched a new company, Mark Cuban Cost Plus Drugs, which has a plan to offer low-cost rivals to overpriced generic drugs. The company is launching with one product: albendazole, an antiparasitic. It will charge $20 per tablet, a steep discount to its current average cash price of $225, according to the company’s website.
Cuban’s plan is to disclose the cost of development and distribution for each of its products and then add a 15% margin to land on a wholesale price.”
About healthcare IT

Online therapy app Talkspace to go public in $1.4B deal with blank check firm: “Online therapy app Talkspace plans to go public through a merger with SPAC Hudson Executive Investment Corp. The combined company will operate as Talkspace and intends to be listed on the Nasdaq under the symbol "TALK."
The deal values Talkspace—which connects users with licensed therapists via video chat or text—at $1.4 billion, including debt. The deal will provide the company with $250 million in cash to be used as growth capital, the companies announced Wednesday.”

FDA Releases Action Plan for AI, Machine Learning Medical Software: “The FDA has released its first artificial intelligence and machine learning action plan, a multi-step approach designed to advance the agency’s management of advanced medical software.
The Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan is a response to stakeholder feedback on the FDA’s 2019 regulatory framework for AI and ML-based medical products.”

Google finalizes $2.1B Fitbit acquisition: 5 details: The deal, announced in November of 2019, was completed today. The article has some details.

Today's News and Commentary

About healthcare devices

Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”: “This final rule establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). The Medicare Coverage of Innovative Technology (MCIT) pathway will result in 4 years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2 years thereafter. This rule also implements regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B.
DATES: This final rule is effective on March 15, 2021.”

About healthcare systems

Tenet aims to acquire 25 to 40 surgical centers in 2021 as pivot away from urgent care continues: “Tenet Healthcare plans to spend $150 million to acquire between 25 to 40 ambulatory surgery centers in 2021 as the hospital system continues its pivot to more higher acuity facilities and away from urgent care.”
Very interesting move, considering elective surgery volumes have been down the past year due to COVID-19 concerns. Does this action also signal health systems’ cooling to physician practice acquisition?

Aspirus Health to buy Ascension hospitals, clinics in Wisconsin – Modern Healthcare: ”Ascension will divest seven hospitals, 21 doctor clinics and a medical transport firm in northern and central Wisconsin. Ascension owns 24 hospital campuses and greater than 100 healthcare services throughout the state.
Wausau, Wis.-based Aspirus employs 8,700 staff at 10 hospitals in Michigan’s Higher Peninsula and Wisconsin.”

8 health systems opening hospitals: The article details which systems are opening hospitals. What is interesting is that they have gone ahead with those openings in the face of declining use due to COVID-19.

Cleveland Clinic CEO and President Tom Mihaljevic, M.D., Announces New Mission Statement in State of the Clinic Address: “‘Our mission has served the community for generations, yet our role has evolved with the passage of time,’ Dr. Mihaljevic said in a virtual address to Cleveland Clinic caregivers worldwide. ‘As stewards of this organization, we carry out the will of our founders to reach for higher and nobler ends. So today, I am privileged to unveil our new mission statement for the next 100 years. “Caring for life, researching for health and educating those who serve.[emphasis added]” It stays true to our past, encompasses the present and outlines the future.’”
The announcement highlights the fact that a mission statement is a “living” document that needs to be periodically reevaluated.

About the public’s health

US has suffered its worst day ever for Covid-19 deaths: “The US reported its highest daily number of Covid-19 deaths on Tuesday with more than 4,320 fatalities attributed to the virus.
It marked the second time -- both this month and since the pandemic's start -- that the US reported more than 4,000 Covid-19 deaths in a single day.
Over the past week, the US has averaged more than 3,300 deaths every day, a jump of more than 217% from mid-November.” Despite these numbers: As pandemic worsens, most US states resist restrictions: “As the U.S. goes through the most lethal phase of the coronavirus outbreak yet, governors and local officials in hard-hit parts of the country are showing little willingness to impose any new restrictions on businesses to stop the spread.” The article gives examples of restriction avoidance.

The 10 most under-reported humanitarian crises of 2020: It is important to remember other public health problems in the age of the COVID-19 pandemic. These problems will remain after widespread vaccinations.

Justices say women must obtain abortion pill in person: “The Supreme Court ordered Tuesday that women must visit a doctor’s office, hospital or clinic in person to obtain an abortion pill during the COVID-19 pandemic, though similar rules for other drugs have been suspended during the public health emergency.” The vote was as expected. No opinion was written but the Chief Justice deferred to FDA “experts” on this issue. However, these “expert” opinions may be politically motivated. The Biden administration can reverse the requirement (and probably will).

Cancer Statistics, 2021: This annual report (from the American Cancer Society) is the best information on cancer statistics. Among the overall findings: “After increasing for most of the 20th century, the cancer death rate has fallen continuously from its peak in 1991 through 2018, for a total decline of 31%, because of reductions in smoking and improvements in early detection and treatment. This translates to 3.2 million fewer cancer deaths than would have occurred if peak rates had persisted. Long‐term declines in mortality for the 4 leading cancers have halted for prostate cancer and slowed for breast and colorectal cancers, but accelerated for lung cancer, which accounted for almost one‐half of the total mortality decline from 2014 to 2018.”

Accelerometer measured physical activity [PA] and the incidence of cardiovascular disease: Evidence from the UK Biobank cohort study: “In this study, we found no evidence of a threshold for the inverse association between objectively measured moderate, vigorous, and total PA with CVD. Our findings suggest that PA is not only associated with lower risk for of CVD, but the greatest benefit is seen for those who are active at the highest level.[emphasis added]”

Innovative biopharmaceutical industry comment on COVID-19 vaccines dosing strategies and recommend following the science: Acknowledging the uncontrolled pandemic and relative vaccine shortage, a number of industry organizations are warning that spacing of vaccine administration should follow the scientific data.

Youth Vaping Triples Odds for Adult Smoking: “A new study finds that teens who start vaping are three times more likely to smoke cigarettes in adulthood than those who never started with electronic cigarettes.
Although the number of teens who start smoking cigarettes in high school has declined, vaping has soared. From 2016 to 2019, the number of cigarette smokers among U.S. high school seniors dropped from 28% to 22%, but e-cigarette use increased from 39% to 46%, the researchers found.”

Scientists develop breakthrough COVID-19 antibody test: “Scientists at the University of Denver's (DU) Knoebel Institute for Healthy Aging, in collaboration with two other research entities, have developed and tested a new and highly sensitive antibody test for COVID-19 that is so accurate, it can predict if a patient will experience ‘mild’ COVID symptoms verses more ‘severe’ symptoms.
The test has received an Emergency Use Authorization from the U.S. Food & Drug Administration (FDA).”

A COVID-19 treatment candidate that fuses tiny antibodies from llamas and alpacas shows promise: “By fusing two nanobodies selected from a llama and an alpaca that were immunized with SARS-CoV-2—the novel coronavirus behind COVID-19—the researchers were able to synthesize nanobodies that can simultaneously attack multiple sites of the virus’s spike protein, according to a new study published in Science. The tiny antibodies also fought mutated variants of the virus, the team showed in lab dishes.
A company called Dioscure Therapeutics has spun off from the University of Bonn with plans to bring its lead COVID-19 candidates, DIOS-202 and DIOS-203, into clinical trials this year.”

Hospitals to Report Covid-19 Vaccination Data: “The Health and Human Services Department will start collecting hospital data on how many health-care personnel and patients have gotten Covid-19 vaccines amid a faltering national push to widely and quickly immunize the public.
The agency on Tuesday unveiled the change that asks hospitals to report once a week on progress immunizing health-care personnel and patients. Data won’t initially be made public for individual hospitals, according to senior HHS officials. HHS expects to make the data public after verifying its quality, they said.”

US to require negative Covid-19 test for international air travellers: “The Centers for Disease Control and Prevention will require the test result from January 26. After landing, the CDC recommends travellers take a test three to five days later and remain at home for seven days. Airlines will have to deny boarding to visitors who do not have a negative test result from the previous three days — or documentation that proves they have recovered from the disease.”

Two articles about the efficacy of vaccines:
Chinese vaccine efficacy lower than originally thought in Brazil trials: “Brazilian health officials say a Chinese coronavirus vaccine has demonstrated an overall efficacy rate of 50 per cent, far lower than originally indicated in a blow to one of the Latin American nation’s hopes for defeating the pandemic.”
Australian scientists cast doubt on Oxford/AstraZeneca vaccine: “A group of Australian scientists has called on the government to review its Covid-19 immunisation strategy over concerns that the Oxford/AstraZeneca vaccine was not effective enough to generate herd immunity.”

Johnson & Johnson Expects Vaccine Results Soon but Lags in Production: “Johnson & Johnson expects to release critical results from its Covid-19 vaccine trial in as little as two weeks — a potential boon in the effort to protect Americans from the coronavirus — but most likely won’t be able to provide as many doses this spring as it promised the federal government because of unanticipated manufacturing delays…
Unlike those products, which require two doses, Johnson & Johnson’s could need just one, greatly simplifying logistics for local health departments and clinics struggling to get shots in arms. What’s more, its vaccine can stay stable in a refrigerator for months, whereas the others have to be frozen.”

Operation Warp Speed chief resigns at Biden team’s request, will stay through transition, sources say: “Operation Warp Speed chief advisor Dr. Moncef Slaoui has submitted his resignation at the request of the incoming Biden team under a plan that would see him stay in the role for a month to help with the transition, according to two people familiar with the situation.”

In 'nasty parting shot,' HHS finalizes rule axing LGBTQ nondiscrimination protections:”With little more than a week left to the Trump administration, the Department of Health and Human Services has finalized a rule permitting social-service providers that receive government funds to discriminate based on sexual orientation and gender identity.”
Another policy that a Biden administration will reverse.

Moderna, Uber partner to support uptake of COVID-19 vaccines:”The two companies will work together initially to provide accessible, credible information on vaccine safety through Uber’s in-app messaging, the organizations announced Tuesday.
The two companies will also work with public health and other organizations to identify additional opportunities to support ongoing efforts to broaden access to COVID-19 vaccines.
Uber and Moderna said they are evaluating other options, including incorporating ride scheduling directly into the immunization appointment process, and possibly integrating with vaccine providers’ systems to text reminders and enable patients to book rides in advance of their first or second immunization appointments.”

Immunological characteristics govern the transition of COVID-19 to endemicity: “We are currently faced with the question of how the CoV-2 severity may change in the years ahead. Our analysis of immunological and epidemiological data on endemic human coronaviruses (HCoVs) shows that infection-blocking immunity wanes rapidly, but disease-reducing immunity is long-lived. Our model, incorporating these components of immunity, recapitulates both the current severity of CoV-2 and the benign nature of HCoVs, suggesting that once the endemic phase is reached and primary exposure is in childhood, CoV-2 may be no more virulent than the common cold. We predict a different outcome for an emergent coronavirus that causes severe disease in children. These results reinforce the importance of behavioral containment during pandemic vaccine rollout, while prompting us to evaluate scenarios for continuing vaccination in the endemic phase.”

About pharma

PCMA sues Trump administration over rebate rule:”The Pharmaceutical Care Management Association has filed suit against the Trump administration in an effort to block the recently finalized rebate rule…
In the complaint (PDF), PCMA warns that the rule would lead to higher premiums in Medicare Part D and reflects an ‘erratic and highly irregular administrative process’ in which the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) did not effectively coordinate.”

Health Canada approves Lundbeck's (Pr)VYEPTI (eptinezumab)--the first and only intravenous preventive treatment for migraine: This article is a reminder of the different time frames for drug approvals among countries; the FDA approved this drug last February.

GSK Strikes $224 Million Pact with Eligo for Acne Gene Therapy: “Eligo said its Eligobiotics technology can ‘precisely modify the composition of the skin’s microbiome to treat or reduce the risk of developing moderate-to-severe acne.’” This treatment is a new way to treat acne and should be watched.

New Bayer drugs will not bridge revenue gap, says pharma head: “Potential new blockbuster drugs from German pharma giant Bayer will not be enough to offset a fall in revenues when its two best-sellers go off patent, the group’s head of pharma has told the Financial Times.
Stefan Oelrich, who joined the company in 2018 from rival Sanofi, said Bayer would soon launch up to three new drugs with annual sales potential of €1bn. However, he acknowledged this would not compensate for the effects of the forthcoming patent expiry on both the blood thinner Xarelto and the eye treatment Eylea, which will start this year in stages globally, saying that this was ‘mathematically impossible.’”

About healthcare IT

Biogen teams up with Apple to see whether iPhones can spot cognitive decline: “The study will enroll adults young and old, using the devices to track subtle changes in a person’s movements and interactions that, over time, may add up and correlate with the earliest signs of cognitive impairment.”

Teladoc to pilot CGMs in Type 2 diabetes as Dexcom eyes new growth market: ”Teladoc Health will launch a pilot demonstration of Dexcom’s wearable, continuous glucose monitoring systems in patients with Type 2 diabetes—picking up the torch from the devicemaker’s partnership with Livongo following its $18.5 billion acquisition last year.
The project will start by supplying the blood sugar sensors at no cost to certain members of Teladoc and Livongo’s diabetes program before expanding the pilot’s reach throughout the course of the year.
The goal is to improve outcomes and healthy glucose levels among people with Type 2 diabetes, by providing them with the same real-time recommendations for lifestyle decisions,  visual data and personal trends offered to people with Type 1 diabetes.”

Evaluation of Internet-Based Crowdsourced Fundraising to Cover Health Care Costs in the United States: “From May 2010 through December 2018, more than $10 billion was sought through online medical fundraisers in the US, with more than $3 billion raised. Cancer represented the most common medical condition for which funding was sought, followed by trauma/injury.”

AdventHealth meets CMS quality metrics, saves money with digital health platform: “Through the app, enrolled patients received regular reminders to complete their medication check-ins, submitted photos of themselves taking their medications and received personalized bonus incentives in the form of messages of encouragement from family and friends.”
The “pilot saw a 57% reduction in readmissions for high-risk patients, taking their readmissions from 19% to 8%, ultimately saving the health system $183,000 in care costs.”

Cerner wants to build a $1B data business as it expands reach into pharma market: “Building on its acquisition of clinical research company Kantar Health, health IT giant Cerner is setting its sights on building a $1 billion data business for the healthcare and life sciences industries.
Cerner announced plans in December to acquire the health division of Kantar Group, which provides data, analytics and research to the life sciences industry, for $375 million.
The company is looking to create a leading data insights and clinical research platform and wants to harness data to improve the safety, efficiency, and efficacy of clinical research across life sciences, pharmaceuticals, and health care at large.”

Trump administration to invest $8M in broadband for rural telehealth access: “The Health Resources and Services Administration (HRSA), part of the Department of Health and Human Services, awarded the funding to the Telehealth Broadband Pilot (TBP) program. That program will assess the broadband capacity available to rural health care providers and patient communities to improve their access to telehealth services.”

athenahealth and Humana Collaborate to Improve Healthcare Outcomes for its Members: “The collaboration utilizes intelligence from Humana to empower providers to proactively address patient needs within the native EHR workflows – facilitating care management discussions between providers and patients, making it easier for providers to transition to value-based care programs, and supporting quality program performance goals such as Medicare Advantage Star Ratings…
By marrying patients’ medical records with insights from their health plan data, athenahealth and Humana will integrate supplemental and clinical data in real time to give providers the necessary insights to spot potential time-sensitive gaps in patient care. For instance, patients with diabetes can become overwhelmed with numerous annual appointments including blood pressure screenings, blood sugar control tests, eye exams, and medication reviews. Automatic appointment alerts generated by Humana’s data can help providers stay on top of diabetes management – thereby improving diabetic patients’ healthcare experiences and closing care gaps.”

About health regulation

New rule makes it harder for HHS to penalize guidance violations: “HHS officials bolstered President Donald Trump's deregulation agenda on Tuesday, signing off on a rule that makes it more difficult for regulators to go after individuals and organizations for not following standards laid out in guidance documents. The rule effectively bans the department from penalizing individuals and organizations for noncompliance with a standard or practice if HHS only announced it in a guidance document. It also lays out a substantial process HHS must follow to carry out civil enforcement actions for potential violations. HHS said the rule is necessary to ensure fairness.”

Today's News and Commentary

About healthcare regulation

U.S. health agency mandates review of regulations every 10 years: “The outgoing Trump administration has finalized a rule that will require all new regulations by agencies under the Department of Health and Human Services to be reviewed for relevance every 10 years or face automatic expiration. The department, however, will now have five years to review all existing regulations, instead of the two-year timeline proposed earlier.”

About pharma

Fujifilm Pays $2 Billion to Establish U.S. Cell-Culture Manufacturing Plant: “Fujifilm is investing $2 billion in a high-output U.S. cell-culture manufacturing plant to speed the expansion of its biopharmaceutical contract development and manufacturing organization business.
Scheduled to be operational in 2025, the facility will produce antibodies, recombinant proteins, gene therapies and vaccines, and it will have automated fill-finish and assembly, packing and labeling capabilities.”

Lilly's donanemab slows clinical decline in Alzheimer's disease study: “Eli Lilly said Monday that donanemab, an experimental antibody targeting N3pG-amyloid beta, significantly slowed decline on a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease compared to placebo, meeting the primary endpoint of the Phase II TRAILBLAZER-ALZ trial…
Top-line results demonstrated that donanemab slowed decline on the iADRS by 32% relative to placebo. Eli Lilly also noted that the drug led to "consistent improvements" on all pre-specified secondary goals measuring cognition and function compared to placebo, although statistical significance was not achieved on every measure. Key secondary measures included change from baseline to week 76 on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), ADCS-iADL, Mini Mental State Examination (MMSE) score, and Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scores, as well as brain amyloid and tau deposition.”

Miller School Leads Groundbreaking Trial Treating Severe COVID-19 with Mesenchymal Stem Cells: “The paper describes findings from 24 patients hospitalized at UHealth Tower or UM/Jackson Memorial Hospital with COVID-19 who developed severe acute respiratory distress syndrome. Each received two infusions given days apart of either mesenchymal stem cells or a placebo.
It was a double-blind study…
Researchers found the treatment was safe, with no infusion-related serious adverse events.
Patient survival at one month was 91% in the stem cell treated group versus 42% in the control group. Among patients younger than 85 years old, 100% of those treated with mesenchymal stem cells survived at one month.”

Sanofi acquires immunotherapy biotech Kymab: “French drugmaker Sanofi has announced a deal of up to $1.45bn to buy UK biotech Kymab and confirmed it is studying the possibility of helping manufacture rival Covid-19 vaccines after delays in developing its own jab…
Cambridge-based Kymab is studying the use of a new monoclonal antibody drug known as KY1005 for the treatment of eczema, a skin condition.”

About diagnostics

Abbott Earns FDA OK for Handheld Concussion Blood Test: “Abbott Laboratories has received the FDA’s 510(k) marketing clearance for a test that helps evaluate mild traumatic brain injuries, also known as concussions, using a handheld device.
The blood test is run on the company’s handheld i-STAT Alinity device, producing a result within 15 minutes after the patient’s blood plasma sample is inserted.
The diagnostic assesses plasma samples for biomarkers UCH-L1 and GFAP, two proteins that are seen after a concussion or head trauma.”
This device could be a blockbuster for use on the sports field. But it would be better to prevent injuries in the first place.

About the public’s health

Trump administration reverses stance, will no longer hold back second shots of coronavirus vaccine: “The Trump administration will announce sweeping changes to its vaccination rollout on Tuesday, including making many more doses of the coronavirus vaccine available and urging states to provide shots to anyone 65 and older. The steps are an effort to speed up a delayed and disjointed rollout.
The changes are a sharp departure from the administration’s previous strategy, and they come just days after President-elect Joe Biden announced plans to release nearly all the vaccine supply. Biden is expected to provide a detailed blueprint on reinvigorating the rollout later this week.”

Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020: “During December 14–23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine (11.1 cases per million doses); 71% of these occurred within 15 minutes of vaccination.”

Record low flu cases show how COVID-19 is more contagious and 'less forgiving,' experts say: “As COVID-19 raged last year, the seasonal flu all but vanished, according to data from the U.S. Centers for Disease Control and Prevention.
During the 2019 flu season from Sept. 29 to Dec. 28, the CDC reported more than 65,000 cases of influenza nationwide. During the same period this flu season, the agency reported 1,016 cases.
Health experts said that high vaccination rates against the flu – combined with social distancing, mask-wearing and hand-washing employed to stop the spread of the coronavirus – played a huge role in preventing influenza transmission.”

Trial of COVID-19 blood plasma finds no benefit in severely ill patients: “The decision by the REMAP-CAP trial leaders came after an initial analysis of more than 900 severely ill trial participants in intensive care showed that treatment with the product - an antibody-rich plasma taken from people who have recovered from the pandemic disease - did not improve outcomes.”

Hospitals say syringes supplied by feds waste vaccine doses: “Pharmacists discovered early in the U.S. vaccination push that the standard five-dose vials of the vaccine from Pfizer and its German partner BioNTech often contained enough material for six or even seven shots…
But some syringes distributed by Operation Warp Speed, the federal Covid-19 vaccine program, aren’t efficient enough to extract a sixth dose, according to hospital lobbyists. They say the issue appears to stem from supply chain problems that have troubled the nation’s pandemic response from the start.”

2021 Global Mayors Challenge: “Bloomberg Philanthropies has launched an innovation competition that will identify and accelerate the most ambitious ideas developed by cities in response to COVID-19. The competition will select 50 finalists that represent the world’s leading urban innovations to emerge from the pandemic. Fifteen grand-prize winners will receive $1 million each and robust multi-year support to implement and spread their breakthrough ideas.”

Health Workers’ Antibody Levels Wane After SARS-CoV-2 Infection: Another reason to vaccinate those who had the infection. “Most people who are infected with SARS-CoV-2 develop antibodies to the virus within 2 to 3 weeks. But how long those antibodies last is unclear. To learn more, the Influenza Vaccine Effectiveness in the Critically Ill Network, a group of academic centers studying both influenza and coronavirus disease 2019 (COVID-19), enrolled 3248 health care workers in a seroprevalence study. All worked directly with patients who had COVID-19 at 13 medical centers throughout the US.
Six percent, or 194, of participants had detectable antibodies to SARS-CoV-2 based on enzyme-linked immunosorbent assay test results. About 80% of these antibody-positive health care workers returned for a second antibody test 2 months later.
At the second test, SARS-CoV-2 antibodies had declined in about 94% of those who initially were seropositive. About 28% no longer tested positive for antibodies. Roughly 1 in 5 individuals who had COVID-19 symptoms fell below the threshold for seropositivity at the second test, as did nearly half of participants who were asymptomatic. Older adults and those with lower antibody levels on the initial test were more likely to seroconvert by the second test.
The results suggest that studies using seropositivity as a proxy for previous infection are likely to underestimate the true prevalence of infections, the authors cautioned. They also suggested that the window for collecting convalescent plasma to use as a potential treatment for COVID-19 is narrow.”
About healthcare IT

VA, Fitbit help support Veteran health and wellness during COVID-19 pandemic: “The U.S. Department of Veterans Affairs (VA) announced today a new initiative with Fitbit that will provide eligible Veterans, caregivers and VA staff with access to Fitbit programs and services to help manage stress, improve sleep and increase physical activity during the COVID-19 pandemic.
The initiative will be focused on participants who currently use Fitbit devices.
VA has contracted with Fitbit to initially provide 10,000 eligible Veterans, caregivers and VA staff a one-year free membership to Fitbit Premium. This includes access to guided programs, hundreds of workouts, mindfulness content, a wellness report and a health metrics dashboard. Participants will also have access to Fitbit Health Coaching, one-on-one coaching and guidance from a certified health coach or licensed health professional.”

At all-virtual CES, the spotlight is on touchless tech, robot companions — and smart bathrooms: The annual consumer tech conference is coincident with the JPM conference. This article explains some interesting healthcare applications presented at this virtual show.

About healthcare devices

HHS Moves to End Oversight of Some Gloves, Masks, Ventilators:”Seven types of surgical and examination gloves won’t require FDA oversight anymore, the HHS said Monday in a move to permanently cut regulatory requirements that were initially curtailed during the pandemic.
These gloves are considered class one medical devices, the lowest risk label for medical products the Food and Drug Administration oversees. They’ll now be permanently excluded from the FDA’s medical device regulatory scheme. 
In addition, the Department of Health and Human Services is proposing that certain sterilizers, digital imaging software, face masks, and ventilators be excluded from FDA review.”

About health insurance

Atrius Health, state's largest independent physician group, is in acquisition talks: “The nation’s largest employer of primary-care physicians is in talks to acquire the largest independent doctor group in Massachusetts, a decision that would further cement the national group’s presence in the Bay State. 
Optum, the for-profit health provider arm of UnitedHealth Group, has signed a memorandum of understanding to acquire Atrius Health, a nonprofit that counts 715 physicians across 30 locations in Massachusetts, sources tell the Boston Business Journal.”

Payers Kick Off 2021 Investments in Social Determinants of Health: The article gives many examples of payer partnerships with local organizations.

About healthcare systems

2020 M&A in Review: COVID-19 as Catalyst for Transformation: From Kaufman, Hall & Associates: “In the face of these pressures, it is remarkable that M&A activity for the year stayed within the historic range of activity seen over the past 10 years…”
The anticipated trends for 2021 will compell “healthcare organizations to:

Focus on core business strengths and assess the long-term viability of non-core assets, aligning as needed with partners that offer complementary, innovative, or otherwise unrepresented capabilities Build partnerships to address gaps in the healthcare infrastructure exposed or intensified by the virus, including collaborative partnerships with non-traditional partners

Strengthen intellectual capital resources to be nimbler and more flexible in dealing with the current crisis and in pivoting to new modes of providing care more efficiently, effectively, or uniquely relative to other legacy providers and potential new market entrants”

Today's News and Commentary

A bit of whimsy to start your week:

His Vaccine Story Inspired His Father To Write A Disney Classic

Today is the start of the 4-day annual JP Morgan Healthcare Conference. Obviously, this year it is virtual. Here are some highlights for today:
Novartis' Cosentyx growth, Bristol's M&A shopping list, Vertex's beyond-CF ambitions

Microsoft signs on to Verily, Broad Institute’s Terra open research platform

Sanofi grabs a British biotech, Regeneron hopes for FDA hold lift, Bluebird puts its eggs in two baskets, and more

About health insurance

CMS approves first block grant waiver, giving Tennessee ability to remake Medicaid program: “The Trump administration has approved a federal waiver to enable Tennessee to convert its Medicaid program into a block grant, the first waiver of its kind to be cleared.
It remains unclear whether the waiver, approved Friday by the Centers for Medicare & Medicaid Services (CMS), will survive under President-elect Joe Biden’s administration set to start in a few weeks.
The waiver, which will last for a 10-year period, would create a budgetary cap for federal spending based on recent historical spending and enrollment in Medicaid in the state."

CMS Issues New Roadmap for States to Address the Social Determinants of Health to Improve Outcomes, Lower Costs, Support State Value-Based Care Strategies: This statement clarifies opportunities for states to provide services that would otherwise not be eligible for federal matching. The CMS letter to state health officials provides more details. From that latter document is the statement: “States have flexibility to design an array of services to address SDOH. However, the services and supports that states can cover tend to fall within several categories of services, including housing-related services and supports, non-medical transportation, home-delivered meals, educational services, employment, community integration and social supports, and case management.”
An example of one opinion is:  “Federal financial participation is not available to state Medicaid programs for room and board (except in certain medical institutions ). However, federal financial participation is generally available under certain federal authorities for housing-related supports and services that promote health and community integration, including home accessibility modifications, one-time community transition costs, and housing and tenancy supports, including pre-tenancy services and tenancy sustaining services.”

HHS Announces Plans to Expand the Home Health Value-Based Purchasing Model: “The U.S. Department of Health and Human Services (HHS) announced Friday that it is expanding the Home Health Value-Based Purchasing (HHVBP) Model. First implemented in 2016, the HHVBP Model is currently active in just nine states: Massachusetts, Maryland, North Carolina, Florida, Washington, Arizona, Iowa, Nebraska and Tennessee.
HHS Secretary Alex Azar has already signed off on an expansion, the department noted. Friday’s announcement did not specify the extent of the expansion, but clarified that HHS would execute the implementation through rulemaking no earlier than Jan. 1, 2022.”

How 2020 Has Changed Employee Benefits: “Artemis Health conducted a research study surveying over 300 benefits leaders at companies with 5,000 or more employees to see exactly how their goals, motivations, and challenges have changed in 2020.”
Among the findings:
78% of benefits leaders are prioritizing well-being
Mental health will be a key 2021 priority
2/3 of organizations will be investing in benefits data

About the public’s health

Biden to unveil trillions in pandemic economic relief spending next week: “He said the proposal includes relief for state and local governments grappling with the pandemic, as well as new support for people who lost their jobs or cannot afford rent.
Biden also called for raising the minimum wage to $15, a campaign promise, and for sending out $2,000 in direct cash payments. Democrats sought those cash payouts in the last relief bill, passed in December, but only were able to get Republicans to agree to $600.”

6-month consequences of COVID-19 in patients discharged from hospital: a cohort study: This Chinese study published in The Lancet may or may not reflect a clinical pattern elsewhere. Given that caveat, the results showed: “At 6 months after acute infection, COVID-19 survivors were mainly troubled with fatigue or muscle weakness, sleep difficulties, and anxiety or depression. Patients who were more severely ill during their hospital stay had more severe impaired pulmonary diffusion capacities and abnormal chest imaging manifestations, and are the main target population for intervention of long-term recovery.”
The implication is that, in addition to acute care, chronic services will be needed to care for large populations—exacerbating a personnel shortage.

No evidence homegrown variant is fueling coronavirus surge in the US, CDC says: “There is no evidence the United States has a homegrown variant of coronavirus that's fueling the recent increased spread of the virus, the US Centers for Disease Control and Prevention said Friday
The White House Coronavirus Task Force told states last week ‘there may be a USA variant that has evolved here, in addition to the UK variant that is already spreading in our communities,’ according to reports obtained by CNN.
But the CDC said there was no evidence of that yet.”

Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing: From the WHO: “Countries experiencing exceptional epidemiological circumstances may consider delaying for a short period the administration of the second dose as a pragmatic approach to maximizing the number of individuals benefiting from a first dose while vaccine supply continues to increase. WHO’s recommendation at present is that the interval between doses may be extended up to 42 days (6 weeks), on the basis of currently available clinical trial data.”
The document is an update on recommendations. This 6-week delay recommendation is new.

About healthcare systems

ER operator Adeptus, formerly one of DFW's fastest-growing companies, files for bankruptcy: “Adeptus Health LLC, the operator of a network of independent emergency rooms and once considered one of the fastest-growing companies in Dallas-Fort Worth, filed for voluntary Chapter 7 bankruptcy protection Dec. 18 in the Northern District of Texas.
The Irving-based company listed assets of roughly $6.8 million and debts of about $278.2 million. The filing's largest creditor was listed as Deerfield Partners LP with an outstanding claim of over $209.9 million.
Chapter 7 bankruptcy protection typically provides for the liquidation of a business’ assets to satisfy creditor claims…
The company filed for an initial public offering in 2015 and debuted at $22 a share. Within a year, the stock price hit $100 and Adeptus’ market cap neared $1 billion, according to a story in The Texas Lawbook.
In April 2017, however, the ER operator filed for Chapter 11 bankruptcy protection in the Northern District of Texas.”
During the COVID-19 pandemic, hospitals have been hurting because of a decrease in elective procedures and ancillary charges. Physicians’ offices are likewise hurting because patients are not coming in for followup visits and minor illnesses. However, why should urgent care centers be failing? They are alternatives to hospital ERs for non-emergent illnesses. Details behind the bankruptcy filing would be interesting for a case study.

CommonSpirit to sell 14 hospitals to Essentia Health: “Fourteen hospitals owned by Chicago-based CommonSpirit Health could join Duluth, Minn.-based Essentia Health as early as this summer.
Under a letter of intent announced Jan. 8, CommonSpirit-owned facilities operating under the CHI Health brand in North Dakota and Minnesota would join Essentia Health. The deal includes a full-service tertiary hospital in Bismarck, N.D., and 13 critical access hospitals. Additionally, all CHI Health associated clinics and living communities would join Essentia Health.”

Today's News and Commentary

About the public’s health

US sees five deadliest days since Covid-19 pandemic's start in last two weeks: “In just less than two weeks, the US recorded its five deadliest days since the Covid-19 pandemic's start -- with more than 4,000 virus-related deaths reported Thursday.
The nation's total Covid-19 death toll has now climbed to more than 365,300, according to data from Johns Hopkins University. And another nearly 115,000 people could lose their lives over the next four weeks, according to projections from the University of Washington's Institute for Health Metrics and Evaluation.”

Pfizer vaccine appears to neutralize a key mutation of Covid variants found in UK, South Africa: “The research, published Thursday on preprint server bioRxiv and not yet peer-reviewed, suggested the Pfizer-BioNTech vaccine worked to neutralize the so-called N501Y mutation.
The N501Y mutation has been reported in the more infectious variants. It is altering an amino acid within six key residues in the receptor-binding domain — a key part of the spike protein that the virus uses to gain entry into cells within the body.”

Biden says he will release all available coronavirus vaccine before second doses are administered: “President-elect Joe Biden announced Friday that he plans to release all available coronavirus vaccine after he takes office. The move breaks with the Trump administration, which has favored holding half the vaccine in reserve to ensure people receive their second doses. It would greatly expand the number of Americans who could soon get their first shot, but risks depleting reserves needed for follow-up shots.”

FDA warns new coronavirus variant could trigger false negatives among gold-standard tests: “The FDA is alerting healthcare professionals that mutations in the novel coronavirus’s genetic code—such as the type powering the fast-spreading variant identified in the U.K.—can trigger false negative results in gold-standard COVID-19 tests.
Accuracy can suffer if the alterations occur within the specific region of the virus’s RNA used by molecular diagnostics to line up a positive result, which may vary product to product, the agency said.
While FDA staff said they believe these risks are low, the agency listed three currently authorized tests—Thermo Fisher’s TaqPath combo kit, Mesa Biotech’s hand-held Accula test and Applied DNA Sciences’ Linea assay—that may be compromised by genetic variants.”

California hospitals prepping for grim COVID-19 choices: “California hospitals struggling with a skyrocketing coronavirus surge are trying to prepare for the possibility that they may have to ration care for lack of staff and beds — and hoping they don't have to make that choice.
The state avoided surging cases for months, but now the virus is raging out of control there and across the nation in the wake of Thanksgiving holiday gatherings that authorities say vastly spread infections. Only Arizona tops California in cases per resident.
The state this week ordered hospitals in the hardest-hit areas to delay many elective surgeries in order to free up space.”

UPDATED Coronavirus tracker: 86% of mild COVID-19 cases include loss of smell, study finds: “A new study of 2,500 patients in 18 European hospitals with COVID-19 finds that loss of smell is a symptom 86% of the time for mild cases of the virus.
Sense of smell typically reappeared within 18 to 21 days, according to the study in the Journal of Internal Medicine, though about 5% of those studies had not recovered their sense of smell six months out from recovery.”

Post-infection coronavirus immunity usually robust after 8 months, study shows: “The human body typically retains a robust immune response to the coronavirus for at least eight months after an infection, and potentially much longer, researchers said in a study published in the journal Science. About 90 percent of the patients studied showed lingering, stable immunity, the study found.”

Labcorp to help CDC track COVID-19 mutations as new strain spreads in U.S.: “The Centers for Disease Control and Prevention has tapped Labcorp to help conduct a large-scale genomic study tracking new mutations in the COVID-19 virus—after a fast-spreading variant, first identified in the U.K., has recently surfaced on U.S. shores.
The public health agency plans to collect random samples from across the country, to provide a baseline that will enable national and state-level surveillance programs to hone in on emerging cases. 
With the addition of Labcorp’s facilities, the CDC said it aims to more than double the number of genomic samples sequenced per week.”

U.S. DEPARTMENT OF LABOR’S OSHA ANNOUNCES $3,930,381 IN CORONAVIRUS VIOLATIONS: “Since the start of the coronavirus pandemic through Dec. 31, 2020, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has issued citations arising from 300 inspections for violations relating to coronavirus, resulting in proposed penalties totaling $3,930,381. 
OSHA inspections have resulted in the agency citing employers for violations, including failures to:

• Implement a written respiratory protection program;

• Provide a medical evaluation, respirator fit test, training on the proper use of a respirator and personal protective equipment;

• Report an injury, illness or fatality;

• Record an injury or illness on OSHA recordkeeping forms; and

• Comply with the General Duty Clause of the Occupational Safety and Health Act of 1970”

Arthritis drugs found to reduce risk of death in severe Covid-19 cases: “The immunosuppressants tocilizumab and sarilumab, were found to reduce stays in intensive care by at least seven days on average, according to data released by the UK government-backed Remap-cap study, conducted by researchers at Imperial College London and Utrecht university in the Netherlands…
These are the first immune-modulating drugs found to have an effect on outcomes of hospitalised Covid-19 patients, adding to positive results from the cheap and plentiful steroid dexamethasone.”

The Best Evidence for How to Overcome COVID Vaccine Fears: This article is an excellent review of the headline’s topic. It identifies more reluctant groups and explains strategies to increase immunization rates. For example: “Research shows that {the intervention]… with the biggest proved impact… is to make the desired action—in this case, vaccination—the default. A 2010 study at Rutgers University showed that informing people that a dose of flu vaccine was waiting for them at a specified time and place (although the appointment could be changed) boosted their vaccination rate by 36 percent, compared with a control group that was e-mailed a Web link to schedule their own appointment. In other words, opt out works better than opt in.”

About health insurance

The Affordable Care Act Reduced Income Inequality In The US: “We found that the ACA reduced income inequality and that the decrease was much larger in states that expanded Medicaid than in states that did not. We also decomposed the effect of the ACA on inequality by race/ethnicity, age, and family educational attainment. The ACA reduced inequality both across groups and within these groups. With efforts to repeal the ACA—specifically, California v. Texas—having shifted from Congress to the courts, it remains important to consider the consequences of fully repealing the ACA, which would likely reverse reduced inequality observed under the law.”

How 3 Major Payers Extended Temporary COVID-19 Benefits into 2021: The article provides information on what Aetna, BC/BS companies and Cigna are doing.

Health Care Company Indicted for Labor Market Collusion: “A federal grand jury returned a two-count indictment charging Surgical Care Affiliates LLC and its related entity (collectively SCA), which own and operate outpatient medical care centers across the country, for agreeing with competitors not to solicit senior-level employees, the Department of Justice announced today. These are the Antitrust Division’s first charges in this ongoing investigation into employee allocation agreements.”
SCA is a division of Optum, part of UnitedHealth Group.

Illinois Is the Nation's First State to Extend Health Coverage to Undocumented Seniors: “Healthy Illinois pushed state lawmakers to offer health benefits to all low-income immigrants. But the legislature opted instead for a smaller program that covers people 65 and older who are undocumented or have been legal permanent residents, also known as green card holders, for less than five years. (These groups don't typically qualify for government health insurance.) Participants must have an income at or below the federal poverty level, which is $12,670 for an individual or $17,240 for a couple. It covers services like hospital and doctor visits, prescription drugs, and dental and vision care (though not stays in nursing facilities), at no cost to the patient.
The new policy continues a trend of expanding government health coverage to undocumented immigrants.”
Other countries (like France) cover undocumented residents in order to deliver optimum public health.

Hospitals Lose Fight Over Uncompensated Care Reimbursements:”The Affordable Care Act bars hospitals from challenging HHS Secretary Alex M. Azar II’s calculation of adjustments to Medicare reimbursements for uncompensated care provided to low-income Americans, a federal court in Washington said.
The Health and Human Services Department’s Provider Reimbursement Review Board lacked jurisdiction to consider the hospitals’ objections to their payments, and thus properly dismissed their request for review, the U.S. District Court for the District of Columbia said Thursday.”

Physician Fee Schedule Update: The “Consolidated Appropriations Act, 2021 modified the Calendar Year (CY) 2021 Medicare Physician Fee Schedule (MPFS):

• Provided a 3.75% increase in MPFS payments for CY 2021

• Suspended the 2% payment adjustment (sequestration) through March 31, 2021

• Reinstated the 1.0 floor on the work Geographic Practice Cost Index through CY 2023

• Delayed implementation of the inherent complexity add-on code for evaluation and management services (G2211) until CY 2024

CMS has recalculated the MPFS payment rates and conversion factor to reflect these changes. The revised MPFS conversion factor for CY 2021 is 34.8931.”

Telehealth Claim Lines Increase 3,060 Percent Nationally When Comparing October 2019 to October 2020: “Telehealth claim lines increased 3,060 percent nationally from October 2019 to October 2020, rising from 0.18 percent of medical claim lines in October 2019 to 5.61 percent in October 2020, according to new data from FAIR Health's Monthly Telehealth Regional Tracker. From month to month, coinciding with a surge in COVID-19 cases in October, the telehealth share of medical claim lines rose 10.6 percent nationally, from 5.07 percent in September 2020 to 5.61 percent in October 2020. The data represent the privately insured population, excluding Medicare and Medicaid.
Trends in the four US census regions (Midwest, Northeast, South and West) were similar to those in the nation as a whole. In each region, there were large percent increases in volume of claim lines from October 2019 to October 2020, and smaller increases from September 2020 to October 2020.”

Today's News and Commentary

With the two seat Democratic victory in Georgia, that party now has majority control of the Senate (with VP Harris as the tie-breaker). But it is unlikely Democrats can get the 60 votes needed to break a filibuster to pass major legislation. Only reconciliation bills (which affect finances) can be passed if all Democrats vote together. Given this narrow margin, the media are recommending several things that could be done with respect to health care; but they have forgotten one important change- adding back a “tax” on the uninsured. That measure would make any Supreme Court decision to invalidate the ACA moot.

About pharma

Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults: “Early administration of high-titer convalescent plasma against SARS-CoV-2 to mildly ill infected older adults reduced the progression of Covid-19.” The full article is available from the NEJM.

Trump Signs Bill Allowing FDA Seizure Of Counterfeits: “President Donald Trump on Tuesday signed the Safeguarding Therapeutics Act, a bipartisan bill that would give the U. S. Food and Drug Administration the authority to seize counterfeit medical devices and products, including vaccines…
Under the act, the U. S. Department of Health Human Services will set regulations that allow the manufacturer of an alleged counterfeit product to challenge the decision before the products are destroyed. During this time, the department will store the products at the manufacturer's costs.”

FDA extends immunodeficiency drug's shelf life as pandemic exacerbates shortages: “The FDA has stretched the expiration date of 42 existing lots of Octapharma’s subcutaneous immune deficiency drug cutaquig and granted a 12-month shelf life extension on future lots stored at 36 degrees to 46 degrees Fahrenheit. The drug was previously cleared to last 24 months when refrigerated.”
This article is a reminder that many medications can be kept past the printed expiration date if stored properly.

Walgreens shares rise after its earnings top estimates, fueled by higher drug sales: “Walgreens said its U.S. pharmacy sales picked up in the fiscal first quarter, despite less foot traffic, lower sales of cough, cold and flu medications, and fewer new prescriptions as people skipped the doctor’s office and socially distanced during the Covid pandemic.”

New drug form may help treat osteoporosis, calcium-related disorders: “Purdue University innovators developed a stabilized form of human calcitonin, which is a peptide drug already used for people with osteoporosis. Researchers at Purdue created a prodrug form of the peptide hormone to increase its effectiveness as an osteoporosis treatment.
In humans, calcitonin is the hormone responsible for normal calcium homeostasis. When prescribed to osteoporosis patients, calcitonin inhibits bone resorption, resulting in increased bone mass.
Unfortunately, human calcitonin undergoes fibrillation in aqueous solution, leading to reduced efficacy when used as a therapeutic. As a substitute, osteoporosis patients are prescribed salmon calcitonin…
To decrease the fibrillation propensity and increase the therapeutic benefit of human calcitonin, Purdue researchers phosphorylated specific amino acid residues.”

About the public’s health

U.S. Is Blind to Contagious New Virus Variant, Scientists Warn: “The United States has no large-scale, nationwide system for checking coronavirus genomes for new mutations, including the ones carried by the new variant. About 1.4 million people test positive for the virus each week, but researchers are only doing genome sequencing — a method that can definitively spot the new variant — on fewer than 3,000 of those weekly samples. And that work is done by a patchwork of academic, state and commercial laboratories.
Scientists say that a national surveillance program would be able to determine just how widespread the new variant is and help contain emerging hot spots, extending the crucial window of time in which vulnerable people across the country could get vaccinated. That would cost several hundred million dollars or more.”

CureVac and Bayer join forces on COVID-19 vaccine candidate CVnCoV: “Bayer has signed a collaboration and services agreement with CureVac N.V…., a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA). Under the terms of the agreement, Bayer will support the further development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate CVnCoV. To this end, Bayer will contribute its expertise and established infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information, supply chain performance as well as support in selected countries.”

HPV Vaccination Campaign for Young Adults and Health Care Providers Launches from HHS’ Office on Women’s Health: The HPV VAX NOW campaign was announced yesterday. Its aim is to increase HPV vaccination rates.

Swansea University developing world’s first COVID-19 ‘smart-patch’ vaccine that will measure effectiveness: “The research, from the Institute for Innovative Materials, Processing and Numerical Technologies (IMPACT), will produce the vaccine through the use of microneedles (MNs) to create a ‘smart-patch’. This device will simultaneously measure a patient’s inflammatory response to the vaccination by monitoring biomarkers in the skin…
Microneedles provide a safe and effective method to deliver vaccines with added attributes of requiring lower vaccine doses, permitting low-cost manufacturing, and enabling simple distribution and administration. A microneedle delivery patch is easy to apply and minimally invasive – combined with the proposed measurement capabilities, this new vaccine system would enable a personalised vaccination approach…
The primary goal of this project is to create a prototype of smart vaccine delivery device that can not only deliver the COVID-19 vaccine transdermally but also monitor biomarkers in the skin compartment in a minimally invasive way, offering real-time information on the efficacy of the vaccination. The new method would change the way in which vaccine efficacy trials are performed from a statistical assessment to a scientific measurement of patient inflammatory response to vaccination.”

Pfizer, BioNTech Make Offer to South Africa to Price COVID-19 Vaccine at $10 Per Dose: “The price is about half of what the U.S. and EU negotiated with the companies, but the South African government is reportedly pressing for an even lower price.”
This article raises the question of wealthy nations subsidizing costs in developing countries.

Kaiser Permanente data key to nation’s COVID-19 vaccine surveillance strategy: “Kaiser Permanente’s Vaccine Study Center…, part of the Kaiser Permanente Northern California Division of Research, was chosen by the Centers for Disease Control and Prevention (CDC) to carry out a Rapid Cycle Analysis (RCA) through CDC’s Vaccine Safety Datalink (VSD) network. Organizations that share data through the network include 5 Kaiser Permanente regions, HealthPartners in Minneapolis, and the Marshfield Clinic in Wisconsin.
The surveillance involves casting a wide net through electronic patient records, searching for specific potential adverse health effects, such as strokes or anaphylaxis (severe allergic reaction). Eight health care institutions that participate in the VSD share weekly data reports on the selected diagnoses and data analysts search for any possible connection with a COVID-19 vaccination.
Kaiser Permanente’s Vaccine Study Center has been evaluating vaccines for more than 30 years and carrying out rapid response studies through the Datalink for more than a decade…”

People without symptoms spread virus in more than half of cases, CDC model finds: “Fifty-nine percent of all transmission came from people without symptoms, under the model’s baseline scenario. That includes 35 percent of new cases from people who infect others before they show symptoms and 24 percent that come from people who never develop symptoms at all.”

About health insurance

Best Health Insurance Companies For 2021: Kaiser tops the national list of ranking by consumers. You can also view rankings by state.

What Is The Value Of A Star When Choosing A Provider For Total Joint Replacement? A Discrete Choice Experiment: “We conducted a discrete choice experiment in an outpatient setting (an academic joint arthroplasty practice) to study trade-offs that patients are willing to make in choosing a provider for a hypothetical total joint arthroplasty. Two hundred consecutive new patients presenting for hip or knee pain in 2018 were included. The average patient was willing to pay $2,607 and $3,152 extra for an additional hospital or physician star, respectively, and an extra $11.45 to not travel an extra mile for arthroplasty care. History of prior surgery and prior experience with rating systems reduced the relative value of an incremental star by $539.25 and $934.50, respectively.”

Comparison of Utilization, Costs, and Quality of Medicaid vs Subsidized Private Health Insurance for Low-Income Adults: “Public coverage through Medicaid was associated with more ED visits and fewer office visits than private Marketplace coverage, which may reflect barriers to outpatient care or lower cost-sharing barriers to ED care in Medicaid. Results suggest that Medicaid coverage was substantially less costly to beneficiaries and society than private coverage, with mixed results on health care quality.”
An ongoing coverage question is whether Medicaid-eligible people should be insured through that program or through subsidized private insurance. This research starts to shed some light on the answer.

Today's News and Commentary

About the public’s health

WHO recommends two doses of Pfizer COVID-19 vaccine within 21-28 days: “People should get two doses of the Pfizer and BioNTech vaccine within 21-28 days, the World Health Organization said on Tuesday, as many countries struggled to administer the jabs that can ward off the COVID-19 virus.”

Studies to see if Moderna COVID-19 vaccine doses can be halved may take two months:”Scientists at the National Institutes of Health and Moderna Inc may take about two months to determine whether doses of the company’s COVID-19 vaccine can be halved to double the supply of the shots in the U.S., according to the agency.”

Estimation of US SARS-CoV-2 Infections, Symptomatic Infections, Hospitalizations, and Deaths Using Seroprevalence Surveys: “The SARS-CoV-2 disease burden may be much larger than reported COVID-19 cases owing to underreporting. Even after adjusting for underreporting, a substantial gap remains between the estimated proportion of the population infected and the proportion infected required to reach herd immunity. Additional seroprevalence surveys are needed to monitor the pandemic, including after the introduction of safe and efficacious vaccines.”

WHO team blocked from entering China to study origins of coronavirus: “The World Health Organization said that China has blocked the arrival of a team investigating the origins of the coronavirus pandemic, in a rare rebuke from the UN agency. 
WHO Director-General Tedros Adhanom Ghebreyesus said two scientists on the United Nations team had already left their home countries for Wuhan when they were told that Chinese officials had not approved the necessary permissions to enter the country.
The arrangements had been jointly agreed with China in advance.”

US passes 21 million coronavirus cases and more than 130,000 people are in hospitals: “On a day the United States registered another record for Covid-19 patients in hospitals, the country passed 21 million cases of the coronavirus, according to Johns Hopkins University.
The US, with 21,007,694 cases as of Tuesday evening, has almost as many as the next three nations -- India, Brazil and Russia -- have combined.
The US has added 1 million cases in the past four days.
That's as the record number of hospital patients Tuesday topped 131,200, according to the Covid Tracking Project.”

Trump administration speeds up plan to deliver Covid shots in pharmacies: “Within the next two weeks, Operation Warp Speed, the federal government’s vaccine accelerator, estimates 3,000 to 6,000 pharmacies could begin administering Covid-19 shots, according to a senior HHS official. The administration announced in November that it would work with major pharmacy chains and independent community pharmacies to distribute vaccines but didn't lay out a timetable.”

About pharma

AmerisourceBergen to Buy Alliance Healthcare From Walgreens Boots for $6.5 Billion: “AmerisourceBergen Corp. on Wednesday said it agreed to buy the majority of Walgreens Boots Alliance Inc.'s Alliance Healthcare businesses for about $6.5 billion.
Amerisource, a Valley Forge, Pa., provider of pharmaceutical products, said it would pay $6.275 billion in cash and issue 2 million shares to Walgreens in exchange for European pharmaceutical wholesaler Alliance.
Amerisource said the deal extends its distribution presence and its global platform of higher-margin manufacturer services. Walgreens, based in Deerfield, Ill., said it plans to increase its focus on expanding its core retail pharmacy businesses.
Amerisource and Walgreens also agreed to extend and expand their U.S. commercial agreements through 2029. Walgreens currently owns a roughly 28% stake in Amerisource, according to FactSet.”

GoodRx: 589 drugs have already seen price hikes in 2021: “Since the start of the year, nearly 600 drugs have seen price hikes, according to new data from GoodRx.
So far in January, 589 drugs have had price increases, with an average jump of 4.2%. Of those, 582 are branded products and seven are generics, GoodRx found.”

CMS names an e-prescribing standard for prior authorization to expedite access to medications: “The Centers for Medicare and Medicaid Services has issued a final rule that, for the first time, is requiring that Part D prescription drug plans support a new electronic prior authorization transaction standard for their Part D e-prescribing programs.
This new electronic prior authorization standard is intended to allow prescribers to see that a drug is subject to prior authorization while they are prescribing it. This is meant to ensure that there are secure electronic transactions between prescribers and Part D plan sponsors, and that patients will not experience delays when picking up their prescriptions. 
CMS will begin enforcing the requirements of this rule on January 1, 2022, although Part D sponsors may choose to implement the new transaction standard earlier. CMS said the action is part of its efforts to strengthen Medicare.”

Many health plans now must cover full cost of expensive HIV prevention drugs: “Starting this month, most people with private insurance will no longer have to decide whether they can afford to protect themselves against HIV. Most health plans must begin to cover the drugs without charging consumers anything out-of-pocket (some plans already began doing so last year).
Drugs in this category—Truvada, Descovy and, newly available, a generic version of Truvada—received an “A” recommendation by the U.S. Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an ‘A’ or ‘B’ rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.”
For additional information on this ACA requirement, see: Affordable Care Act preventive items and services.

About hospitals and health systems

115 hospitals sue HHS over Medicare payment calculation: “A group of 115 hospitals sued HHS in an attempt to prevent the department from retroactively changing how it calculates Medicare Part A disproportionate share hospital payments for patients who were enrolled in Medicare Advantage plans under Part C of the Medicare Act.
The federal lawsuit was filed Jan. 4 by a coalition of Nashville, Tenn.-based HCA Healthcare and Irving, Texas-based Christus Health hospitals. The hospitals are states including California, Colorado, Utah and Florida. 
The hospitals' lawsuit concerns a 2004 Medicare policy change that included a new methodology for allocating Medicare Part C days in the disproportionate share hospital calculation formula. 
The U.S. Court of Appeals has ruled against HHS in several different actions brought by hospitals challenging the 2004 policy. The U.S. Supreme Court also recently upheld the appeals court decision, according to the complaint. 
Despite those court rulings, HHS proposed in August 2020 to readopt the calculation policy and apply it retroactively.  
In the lawsuit, the hospitals argue that HHS is disregarding the court decisions.”

CHI Franciscan, Virginia Mason officially merge: 5 things to know: “CHI Franciscan and Virginia Mason officially formed an 11-hospital health system Jan. 5. The system, Virginia Mason Franciscan Health, will be part of Chicago-based CommonSpirit Health.”

Tenet, Methodist Le Bonheur call off sale of 2 hospitals after FTC's lawsuit: “Tenet Healthcare and Methodist Le Bonheur agreed to call off Methodist’s $250 million acquisition of two Memphis-area hospitals after the sale triggered a lawsuit from the Federal Trade Commission.”

About health insurance

UnitedHealth Group's Optum to buy Change Healthcare for $13B: “UnitedHealth Group's Optum unit has agreed to buy Change Healthcare for $7.84 billion in cash plus about $5 billion in debt, the companies said on Wednesday.
The acquisition will strengthen the insurer's portfolio of healthcare technology services and capabilities.
Change Healthcare will join with OptumInsight to provide software and data analytics, technology-enabled services and research, advisory and revenue cycle management offerings, the companies said in a press release.”

Today's News and Commentary

500th Issue

About health insurance

Centene Signs Definitive Agreement to Acquire Magellan Health: ”Centene Corporation… and Magellan Health, Inc… announced that they have entered into a definitive merger agreement under which Centene will acquire Magellan Health for $95per share in cash for a total enterprise value of $2.2 billion. The transaction, which was unanimously approved by the Boards of Directors of both companies, will broaden and deepen Centene's whole health capabilities and establish a leading behavioral health platform.”
Magellan has been used by a number of insurers for behavioral health services. Now we will need to see if others insurers will still contract with the company.

Tufts Health Plan and Harvard Pilgrim Health Care officially come together: ”Harvard Pilgrim Health Care and Tufts Health Plan announced their organizations have formally combined, effective January 1, 2021, having received all regulatory approvals.”
The partners claim: “Over time, more than $100 million in savings is anticipated through administrative synergies which will go directly to mitigating premium increases and member out-of-pocket burden.”

9th Circ. Revives Insurance Rule For Green Card Seekers: “The Ninth Circuit has revived President Donald Trump's proclamation requiring green card applicants to prove they will have access to health insurance, prompting a sharp dissent from one judge who slammed the order as an "unprecedented exercise of unilateral Executive power. ‘Leaning on the U. S. Supreme Court's ruling upholding the president's controversial travel ban, the federal appeals court held Thursday in a split decision that the Trump administration's rationale behind the proclamation — namely, that uninsured immigrants would cost the U. S. financially — was "adequate" to permit the entry bar.’”

Insurer Refuses to Keep Envision Clinicians in Their Network: “UnitedHealthcare has decided not to renew its longstanding partnership with Envision Healthcare in the midst of a national health crisis. This means Envision’s clinicians will not be part of United’s insurance plans starting January 1, 2021.
United’s decision comes at a time when Envision’s 25,000 clinicians have cared for approximately one out of every 10 hospitalized COVID-19 patients. Although Envision does not balance bill patients, it cannot prevent patients from receiving higher surprise bills from United, including bills related to COVID-19 care. While United waives patient cost sharing for in-network COVID-19-related care, United’s cost-sharing waiver does not apply to all out-of-network in-patient COVID-19 costs3. United’s COVID-19 coverage means that one in 10 patients who go to an emergency room may face a surprise gap in coverage.” United says that it was paying Envision’s physicians considerably above its median rates.

About the public’s health

A final EPA rollback under Trump curbs use of health studies: Under the guise of transparency, the Trump administration says that unless all study data is available for review, it will be barred from consideration for policy decisions. The problem is that many public health studies use data that has been “scrubbed” of personal identities; those studies will no longer be eligible for inclusion in those policy decisions.

Association of Cigarette and Electronic Cigarette Use Patterns With Levels of Inflammatory and Oxidative Stress Biomarkers Among US Adults: “In this nationally representative population study of adults, we observed no difference in inflammatory and oxidative stress biomarkers between exclusive e-ciga- rette users and nonusers (no cigarettes or vaping), and levels were lower in exclusive e-cigarette users relative to exclusive smokers. These findings are consistent with recent population studies of inflammatory biomarker4 and toxicant exposure5 in users of e-cigarettes and ciga- rettes and highlight the importance of completely re- placing cigarette smoking with e-cigarettes or quitting the use of both products for cigarette smokers to derive potential health benefits.”

About the public’s health

LA County Paramedics Told Not To Transport Some Patients With Low Chance Of Survival: ”Paramedics in Southern California are being told to conserve oxygen and not to bring patients to the hospital who have little chance of survival as Los Angeles County grapples with a new wave of COVID-19 patients that is expected to get worse in the coming days.
The Los Angeles County Emergency Medical Services Agency issued a directive Monday that ambulance crews should administer supplemental oxygen only to patients whose oxygen saturation levels fall below 90%.
In a separate memo from the county's EMS Agency, paramedic crews have been told not to transfer patients who experience cardiac arrest unless spontaneous circulation can be restored on the scene.”
This real-life case should provoke discussions of medical ethics.

BioNTech says no data to support delayed vaccine booster shot: “BioNTech and partner Pfizer warned on Monday that they had no evidence that their jointly developed vaccine will continue to protect against COVID-19 if the booster shot is given later than tested in trials.”

8 recently launched healthcare marketing campaigns: All are COVID-19 related.

How Eight Covid-19 Vaccines Work: I believe this article from the NY Times is open access. It is a great summary with graphics.

About pharma

PhRMA Denied Early Win In Drug Pricing Law Case: “A California federal judge has refused to grant the Pharmaceutical Research and Manufacturers of America's bid to permanently block a state drug pricing law, shooting down the trade group's bid for an early win on its First Amendment and commerce clause claims. In a Dec. 30 decision, District Judge Morrison C. England Jr. denied PhRMA's motion that sought summary judgment on its First Amendment free speech and commerce clause allegations and also sought a permanent injunction against Senate Bill 17.”

Pfizer Introduces New Logo Playing Up Role in Drug Creation: “The logo, 18 months in the making, replaces the oval, pill-like shape that had enclosed the Pfizer name since 1948 with a helix design to the left of the company name. It retains current elements, including the name, font and blue color. The company is promoting the new design with an ad campaign.”

Feds tell pharma companies to pony up 340B discounts, but it's unclear whether they will: “The HHS’ new advisory opinion doesn’t carry the force of law, but instead communicates the agency’s views on the issue. Drugmakers, for their part, either say they're reviewing the opinion or plan to stick to their own new policies.”

About healthcare philanthropy

15 largest gifts to healthcare organizations in 2020: Read the article for details.