Today's News and Commentary

About health insurance

Haven, the Amazon-Berkshire-JPMorgan venture to disrupt healthcare, is disbanding after 3 years: “Haven, the joint venture formed by three of America’s most powerful companies to lower costs and improve outcomes in health care, is disbanding after three years, CNBC has learned exclusively.
The company began informing employees Monday that it will shut down by the end of next month, according to people with direct knowledge of the matter…
One key issue facing Haven was that while the firm came up with ideas, each of the three founding companies executed their own projects separately with their own employees, obviating the need for the joint venture to begin with, according to the people, who declined to be identified speaking about the matter.”

About hospitals and health systems

Hospitals Say They Will Publish Previously Secret Prices: Just a reminder: “As of Jan. 1, hospitals will be required to publish the prices negotiated privately with each payer for 300 common services for easy use by consumers, and make public the same information for all their procedures in a format that can be read and analyzed by computers.” Check hospital websites to see if they comply. For example, Partners in Boston has listed prices for a couple years; but their pdf. is dated 2018.

About the public’s health

A new mandate highlights costs, benefits of making all scientific articles free to read: “In 2018, a group of mostly European funders sent shock waves through the world of scientific publishing by proposing an unprecedented rule: The scientists they funded would be required to make journal articles developed with their support immediately free to read when published.
The new requirement, which takes effect starting this month, seeks to upend decades of tradition in scientific publishing, whereby scientists publish their research in journals for free and publishers make money by charging universities and other institutions for subscriptions. Advocates of the new scheme, called Plan S (the “S” stands for the intended “shock” to the status quo), hope to destroy subscription paywalls and speed scientific progress by allowing findings to be shared more freely. It’s part of a larger shift in scientific communication that began more than 20 years ago and has recently picked up steam.
Scientists have several ways to comply with Plan S, including by paying publishers a fee to make an article freely available on a journal website, or depositing the article in a free public repository where anyone can download it. The mandate is the first by an international coalition of funders, which now includes 17 agencies and six foundations, including the Wellcome Trust and Howard Hughes Medical Institute, two of the world’s largest funders of biomedical research.”
Read this article from Science for more information. It is truly a revolutionary move.

U.S. distributes over 13.07 million doses of COVID-19 vaccines; 4.2 million administered -CDC: “The U.S. Centers for Disease Control and Prevention said it had administered 4,225,756 first doses of COVID-19 vaccines in the country as of Saturday morning and distributed 13,071,925 doses.”

Coronavirus: BMJ urges NYT to correct vaccine 'mixing' article: “The editor of the British Medical Journal has asked the New York Times to correct an article that says UK guidelines allow two Covid-19 vaccines to be mixed.[Bold in original]
The US publication reported that UK health officials would allow patients to be given a second dose that is a different vaccine to their first…
Dr Mary Ramsay, Public Health England's head of immunisations, said: ‘We do not recommend mixing the Covid-19 vaccines - if your first dose is the Pfizer vaccine you should not be given the AstraZeneca vaccine for your second dose and vice versa.’”

Vaping combined with smoking is likely as harmful as smoking cigarettes alone:

• “Participants who vaped exclusively showed a similar inflammatory and oxidative stress profile as people who did not smoke cigarettes or use e-cigarettes.

• Participants who smoked exclusively and those who used cigarettes and e-cigarettes had higher levels across all biomarkers assessed compared to participants who did not use cigarettes or e-cigarettes.

• Compared to participants who smoked exclusively, those who vaped exclusively had significantly lower levels of almost all inflammatory and oxidative stress biomarkers. However, participants who used cigarettes and e-cigarettes had levels of all inflammatory and oxidative stress biomarkers comparable to those who smoked exclusively.”

CDC hopes to double the number of coronavirus samples checked for new mutations: “The US Centers for Disease Control and Prevention hopes to more than double the number of coronavirus genomes sequenced to watch for new mutations in the US over the next two weeks, a top official said Sunday.
The CDC is now sequencing about 3,000 samples a week and hopes to more than double that to about 6,500 per week, according to Dr. Gregory Armstrong, director of the Office of Advanced Molecular Detection at the CDC's National Center for Emerging and Zoonotic Infectious Diseases.”

Pfizer and BioNTech to offer COVID vaccine to volunteers who got placebo: “Pfizer Inc and its partner BioNTech Se plan to give volunteers who received a placebo in its COVID-19 vaccine trial an option to receive a first dose of the vaccine by March 1, 2021, while staying within the study.
The trial's Vaccine Transition Option allows all participants aged 16 or older the choice to discover whether they were given the placebo, ‘and for participants who learn they received the placebo, to have the option to receive the investigational vaccine while staying in the study,’ the companies said on their website here for trial participants.”

Feds may cut Moderna vaccine doses in half so more people get shots, Warp Speed adviser says: “The federal government is in talks with Moderna about giving half the recommended dose of the company's Covid-19 shot to speed up immunization efforts, the head of the Trump administration's vaccine rollout said on Sunday.
Operation Warp Speed chief adviser Moncef Slaoui said there is evidence that two half doses in people between the ages of 18 and 55 gives ‘identical immune response’ to the recommended one hundred microgram dose, but said the final decision will rest with the FDA.”

About healthcare IT

10 biggest patient data breaches in 2020: Wonder why patients don’t trust healthcare IT systems with their data? “In 2020, 527 healthcare organizations reported to HHS more than 21 million individuals being affected by data breaches.” Recall that smaller breaches need not be reported. And in a related article: Nearly 4M health records breached in December

Allscripts Closes Previously Announced Sale of CarePort Health Business: “On December 31, 2020, Allscripts… closed the previously announced sale of its CarePort Health business to WellSky® Corporation for $1.35 billion. CarePort solutions assist hundreds of hospitals and thousands of post-acute care providers to efficiently coordinate and transition patients through different settings of care.”

About pharma

Italy’s Angelini to buy Swiss biotech group for $1bn: “Italy’s Angelini Pharma has agreed to buy emerging Swiss biotech company Arvelle Therapeutics for up to $960m as it aims to become a leading European player in the treatment of central nervous system and mental diseases. Angelini will pay private-equity backed Arvelle an initial $610m in cash and another $350m following the European Medicines Agency’s approval of a drug for the treatment of epilepsy, which is expected this year, and certain revenue targets.”

Today's News and Commentary

TODAY’ TOP STORY:

Canadian healthcare providers can now practice in Michigan: Michigan Gov. Gretchen Whitmer signed a bill this week to immediately permit reciprocity in licenses, registrations and certifications for Canadian healthcare professionals in Michigan. 
Canadian healthcare professionals can apply for reciprocity as long as they meet the educational, examination and billing requirements of Michigan law. The allowance had been in effect for Canadian health professionals from 2002 until it was allowed to expire in 2012.”
This type of legislation is unique in the US. Reciprocity among states is easing. In the EU, movement of physician across borders is legislated. But a state recognizing another country’s professionals like this is refreshing.

About pharma

HHS Releases Advisory Opinion Clarifying that 340B Discounts Apply to Contract Pharmacies: “On Wednesday, the HHS Office of the General Counsel released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program (340B Program) on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities.
The 340B Program requires drug manufacturers (in exchange for coverage of drugs under Medicaid) to offer substantial discounts to "covered entities," which include safety net hospitals, community health centers, and other institutions that serve vulnerable populations. Estimates suggest that discounts in the 340B Program can range between 25 and 50 percent and that approximately $30 billion of drugs are sold to covered entities each year, representing almost 6 percent of prescription drugs sold in the United States.”

About the public’s health

What Can Be Learned From Differing Rates of Suicide Among Groups: “In data released in 2017, the rate for white Americans was around 19 per 100,000, and it was about 7.1 for both Hispanics and Asian-Americans/Pacific Islanders, and 6.6 for Black Americans, according to the Centers for Disease Control and Prevention.” The article discusses multiple reasons for this discrepancy, especially social support (including religious affiliation).

Discovery of Virus Variant in Colorado and California Alarms Scientists: The virus variant hits a second state.

About health insurance

Obamacare, in Its First Big Test as Safety Net, Is Holding Up So Far: “Final government estimates of the uninsured rate are months away, but at least one survey, from the research group the Commonwealth Fund, shows the share of Americans without coverage was holding steady through the spring. The Affordable Care Act is a crucial reason for that.”

‘Blown away’: Spokane Valley church raising money to help pay off millions in medical debt: “Valley Real Life in Spokane Valley is raising money to help buy off outstanding medical debt owed by those in need in the Pacific Northwest. The church has partnered with a New York-based nonprofit called RIP Medical Debt, which leverages donations to purchase – and then forgive – qualifying debt portfolios for pennies on the dollar.
With still a few weeks left in the church’s fundraising campaign, Valley Real Life Church has raised enough to erase upward of $21 million in debt for struggling individuals and families.”
Charitable purchases of healthcare debt at large discounts has been around for several years and is a great use of those funds.

About medical groups

In 2019, Medical Groups Generated a Profit; Health System-Affiliated Groups a Loss, According to New Survey: “The survey shows the overall median profit/investment (P/I) per provider in 2019 to be -$22,028, an improvement from -$57,426 in 2018. For health system-affiliated medical groups, the overall median loss per provider (also known as ‘investment per provider’) in 2019 was -$163,994 in 2019, slightly better than -$165,050 seen in 2018. For independent medical groups, the profit per provider increased to $12,434 in 2019 from $5,200 in 2018.
The survey also measures median profit/investment (P/I) per physician. This metric includes financial performance divided by number of physicians only, whereas the per provider metric includes advanced practice providers (APPs) in the count of ‘providers.’ In 2019, the overall median per physician was -$32,985, a significant improvement from -$98,840 in 2018. For health system-affiliated medical groups, the overall median loss/investment per physician in 2019 was -$278,505 in 2019, a decline from the -$225,261 seen in 2018. For independent medical groups, the profit per provider increased to $16,603 in 2019 from $6,296 in 2018….
The numbers alone are not necessarily indicative of system-affiliated groups performing worse than independent groups,” said Fred Horton, M.H.A., AMGA Consulting president. “One reason for these divergent trends is that revenue generated from ancillary services, such as scans and lab work, is reflected in the bottom line of independent medical groups, but generally does not accrue to the bottom line of groups affiliated with a system. Another reason is that certain expenses are exclusive to system-affiliated medical groups, for example, system office allocations and centralized service expense allocations. Because of these nuances, we analyze compensation and production alignment, staffing ratios, and general volume-adjusted metrics to make a more apples-to-apples comparison.”
The results and explanations are complex, but they make one wonder whether the system affiliation promises that enticed physicians to affiliate are worth it.
A couple other considerations:
Hospitals affiliated groups can bill more because they can charge facility fees.
The groups that affiliated may have ben distressed and the independent groups did not affiliate because they were profitable.

Today's News and Commentary

About hospitals and health systems

U.S. appeals court upholds Trump health care price disclosure rule: “The 2-0 decision by the U.S. Court of Appeals for the District of Columbia Circuit is a victory for President Donald Trump’s effort to make health care pricing more transparent so patients can be better informed when deciding on treatment.
The American Hospital Association and other hospital groups had challenged the rule, which was issued in November 2019 and is scheduled to take effect on Jan. 1, 2021.”

New Jersey may be the first state to impose per-bed fees on nonprofit hospitals for municipal services: “New Jersey lawmakers approved an unusual measure last week that requires many nonprofit hospitals to pay per-bed fees to their local governments, while preserving their increasingly contested property-tax exemptions.
The legislation, which requires hospitals to pay a fee of $3 a day for each licensed bed, is in response to a landmark 2015 New Jersey Tax Court ruling involving Morristown Medical Center that “the operation and function of nonprofit hospitals do not meet the criteria for property tax exemption” under state law. A 300-bed hospital subject to the fee would pay $328,500 a year.”

About the public’s health

Coronavirus updates: Vaccinations lag as hospitalizations hit record levels: “Although officials projected that the United States would be able to vaccinate 20 million people by the end of December, the Centers for Disease Control and Prevention reported that 11.4 million doses had been sent to states and only about 2.1 million people had received the vaccine’s first dose.”

You’re Infected With the Coronavirus. But How Infected?: “Dozens of research papers published over the past few months found that people whose bodies were teeming with the coronavirus more often became seriously ill and more likely to die, compared with those who carried much less virus and were more likely to emerge relatively unscathed… data on viral load — or at least a rough approximation of it — is readily available, built into results from the P.C.R. tests that most labs use to diagnose a coronavirus infection.”

1st reported US case of COVID-19 variant found in Colorado: “The first reported U.S. case of the COVID-19 variant that’s been seen in the United Kingdom has been discovered in Colorado, Gov. Jared Polis announced Tuesday, adding urgency to efforts to vaccinate Americans. 
The variant was found in a man in his 20s who is in isolation southeast of Denver in Elbert County and has no travel history, state health officials said.”

New US dietary guidelines include babies and toddlers for first time: “The United States Department of Agriculture and the Department of Health and Human Services issued new dietary guidelines, which include recommendations for babies and toddlers for the first time…
Despite this expanded guidance including early life stages, the guidance doesn't follow quantitative recommendations in two key areas -- alcohol and sugar intake -- addressed by an advisory committee's scientific report.”
More politics and lobbying win out at the expense of the public’s health.

Philips, BioIntelliSense and University of Colorado receive U.S. Department of Defense funding for early COVID-19 detection: “
Cambridge, MA – “Royal Philips… and BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, today announced they have been selected by the U.S. Army Medical Research and Development Command (USAMRDC) to receive nearly USD 2.8 million from the U.S. Department of Defense (DoD) through a Medical Technology Enterprise Consortium (MTEC) award to validate BioIntelliSense’s FDA-cleared BioSticker device for the early detection of COVID-19 symptoms. The goal of the award is to accelerate the use of wearable diagnostics for the benefit of military and public health through the early identification and containment of pre-symptomatic COVID-19 cases.
Working with the University of Colorado Anschutz Medical Campus, the clinical study will consist of 2,500 eligible participants with a recent, known COVID-19 exposure and/or a person experiencing early COVID-19 symptoms.”

Regional Variation in Active Surveillance for Low-Risk Prostate Cancer in the US: “In this cohort study of 79 825 men from the Surveillance, Epidemiology, and End Results (SEER) Prostate with Watchful Waiting database, variations across SEER regions appeared to explain 17% of the observed differences in use of active surveillance after adjustment for sociodemographic characteristics and county health resources. Other factors, such as Black race, county-level socioeconomic factors, and specialist densities did not show an association, although Hispanic ethnicity showed a negative association with surveillance use.”
Local area variations have been studied in this country for the past 50 years. Unfortunately they still persist. Health system characteristics, physician practice styles and patient treatment preferences have been shown to be the reasons for the variations.

About healthcare IT

VA's digital health project faces new scrutiny from union, groups inside agency: The saga continues…:
”The Department of Veterans Affairs' $16 billion medical records modernization project is facing new scrutiny just a month after a much-touted software rollout at a VA facility in Spokane, Wash.
One of the department’s unions says it didn't get advance warning the new system would be activated at a VA facility in Las Vegas. Meanwhile, groups within the department are questioning the technical capabilities of the project and who’s managing it. And internal reviews are raising concerns about some important, data-sharing technical capabilities, along with its management structure.”

About health insurance

CPT E/M Office Revisions Level of Medical Decision Making (MDM): A reminder that these coding changes start January 1. This chart from the AMA is really helpful in explaining the decision criteria,

2012-2018 Data on Physician Compensation Methods: Upswing in Compensation through the Combination of Salary and Bonus: An interesting survey of how physician compensation has changed over a few years. “The percentage of physicians who were paid by a single method dropped to 42.7% in 2018 from 51.8% in 2012, with salary and compensation based on productivity being the two most prominent payment methods.”

About pharma

Pfizer Forges Potential $4.2 Billion Deal to Distribute Myovant Sciences’ Orgovyx: “Pfizer is expanding further into oncology thanks to a deal with Myovant Sciences, under which the two companies will cooperate on developing and commercializing Myovant’s newly approved prostate cancer drug Orgovyx (relugolix). Myovant will receive up to $4.2 billion, including an upfront payment of $650 million.”
This drug was previously mentioned in this blog as a once-daily oral treatment for advanced prostate cancer.

Today's News and Commentary

About the public’s health

First case of highly infectious coronavirus variant detected in Colorado: “Colorado officials on Tuesday reported the first known case in the United States of a person infected with the coronavirus variant that has been circulating rapidly across much of the United Kingdom and has led to a lockdown of much of southern England.
Scientists believe the variant is more transmissible but does not make people sicker.”

About pharma

FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs: “ In particular, this program has been strengthened to:  

• Require that prescribers document a patient’s opioid tolerance with each prescription of a TIRF medicine for outpatient use;

• Require outpatient pharmacies dispensing TIRF [transmucosal immediate-release fentanyl] medicines to document and verify a patient’s opioid tolerance before dispensing;

• Require inpatient pharmacies to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized; and

• Require a new patient registry for use, along with other data sources, to monitor for accidental exposure, misuse, abuse, addiction, and overdose.”

About healthcare providers

The Doctor Will See You Once You Sign This Binding Arbitration Agreement: The article explains this change is due to rising malpractice litigation expenses and the increasing trend of venture capital firms owning practices.

About healthcare financing

Private equity pushes into healthcare: 7 latest deals: A good review of what has happened this month.

FDA actions in December

7 recent drug, device approvals: The headline speaks for itself.

Today's News and Commentary

Trump Signs Pandemic Relief Bill After Unemployment Aid Lapses: “The legislative package will provide billions of dollars for the distribution of vaccines, funds for schools, small businesses, hospitals and American families, and money needed to keep the government open for the remainder of the fiscal year. The enactment came less than 48 hours before the government would have shut down and just days before an eviction moratorium and other critical pandemic relief provisions were set to expire.
But it also came after two critical unemployment programs lapsed, guaranteeing a delay in benefits for millions of unemployed Americans.”

About the public’s health

COVID-19 Vaccination Considerations for Persons with Underlying Medical Conditions:From the CDC: “Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19. mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.” The article details recommendations for some high risk groups.

Novavax starts late-stage trial of COVID-19 vaccine in United States: “Novavax Inc has begun a large late-stage study of its experimental COVID-19 vaccine in the United States, the drug developer said on Monday, after delaying the trial twice due to issues in scaling up the manufacturing process.
It will enroll up to 30,000 volunteers across about 115 sites in the United States and Mexico, with two-thirds of them receiving the shot 21 days apart and the rest getting placebo, the company said.”

Biden will invoke Defense Production Act to boost Covid vaccine production, advisor says: “President-elect Joe Biden plans to invoke the Defense Production Act after he takes office next month to boost production of Covid vaccines, a member of his Covid-19 advisory team said.
The wartime production law allows the president to compel companies to prioritize manufacturing for national security purposes.”

Oxford/AstraZeneca Covid vaccine to be approved by UK within days: “The Oxford/AstraZeneca vaccine is seen as game-changing within Whitehall, as its low price and ease of storage will allow the government to vaccinate people more quickly. The BioNTech/Pfizer vaccine, which was approved earlier this month, must be kept at minus 70C and can be moved only four times within a cold chain before being used…
The Oxford vaccine was designed with access in mind. AstraZeneca has pledged to sell it at cost to developing nations in perpetuity. Its ease of storage, with a long-term shelf life protected at conventional refrigeration temperatures, has galvanised hopes that it can be used by much of the developing world.”

Comparing Health Outcomes of Privileged US Citizens With Those of Average Residents of Other Developed Countries: The study should have been done long ago. Policy makers are often arguing that we need to bring the US population up to the “best care in the world” that is enjoyed by our richest citizens. It looks like that goal only gets us half way. The entire article is worth a read. Here are some highlights:
“The health outcomes of privileged White US citizens for 6 health outcomes are better than those for average US citizens; however, the health outcomes of privileged White US citizens for infant mortality, maternal mortality, and AMI [heart attack] are not consistently better than the outcomes of average residents in many other developed countries…
Privileged White US citizens appear to have the best outcome in the world for breast cancer. That outcome is very likely due to the high rate of mammogram screening in the US, which is associated with higher rates of diagnosis of small cancers.However, if undetected, most of these small cancers would not have progressed to large cancers and caused death…
Our results suggest—but do not prove—that health outcomes depend on the system of care, rather than the performance of individual physicians or hospitals.”

About health insurance

Duke Health, Geisinger sue HHS over Medicare payments: “The hospitals' lawsuit takes issue with a Medicare policy change, adopted in 2004, that included a new methodology for allocating Medicare Part C days in the disproportionate share hospital formula. The appeals court has ruled against HHS in three actions challenging its attempts to apply its Part C days policy to deny DSH payments to hospitals. However, the hospitals argue that HHS is disregarding those decisions and a decision by the U.S. Supreme Court.”

Florida physician pleads guilty to $29M fraud: How does our healthcare system let such practices happen in the first place?
“As part of his plea deal, Dr. deGraft-Johnson acknowledged consistently performing two invasive diagnostic angiography procedures on hundreds of patients, whether medically necessary or not. When the patients returned for follow-up office visits, Dr. deGraft-Johnson submitted fraudulent claims to their insurance companies stating he performed atherectomies during the appointments. Using this scheme, the physician admitted he claimed to have performed more than 3,000 of these surgical procedures to clear blockages in arteries in as many as 845 of his patients' legs. 
In court documents released in February, prosecutors provided several examples of Dr. deGraft-Johnson's fraud. In one case, he claimed to have done 14 procedures during a seven-hour period. Prosecutors said the procedures would have taken roughly 28 hours…”

CMS Holds Back Medicaid Rebate Reporting Policy for Two Years: ”The policy will require drugmakers to report discounts to CMS that do not help patients and instead lower costs for health insurers and pharmacy benefit managers (PBMs). It is intended to help ensure that patients see lower out-of-pocket costs through cost-sharing assistance, including copayment assistance cards provided by pharma companies.
CMS said that it is delaying the policy for two years (January 2023) to give manufacturers, insurance companies and PBMs time to make any necessary changes to the reporting systems used to offer discounts in patient assistance programs.”

Today's News and Commentary

About the public’s health

The U.S. has vaccinated just 1 million people out of a goal of 20 million for December: The headline speaks for itself.

A side-by-side comparison of the Pfizer/BioNTech and Moderna vaccines: The “bottom line” is: similar efficacy in trials.
Compared to the Pfizer/BioNTech product, the Moderna vaccine doesn’t have as extreme cold storage needs, requires more than 3 times the dose, and the second dose is given 28 days after the first one (compared to 21 days).

About pharma

Federal judge blocks Trump administration drug pricing rule: “A federal judge on Wednesday blocked a last-minute Trump administration rule aimed at lowering drug prices as of next week.
The rule, scheduled to take effect on Jan. 1, would have tied reimbursements for 50 drugs by Medicare, a U.S. government insurance program, to the lowest prices paid by certain other countries. U.S. District Judge Catherine Blake in Maryland ruled that the administration had rushed the rule without giving the public a chance to comment, in violation of federal law.”

Merck Announces Supply Agreement with U.S. Government for Initial Doses of Investigational Biological Therapy for the Treatment of Patients with Severe and Critical COVID-19: “ Merck… announced it has entered into an agreement with the United States Government to support [$356 million] the development, manufacture and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Merck acquired MK-7110 through the acquisition of OncoImmune, a privately held, clinical-stage biopharmaceutical company…
In September 2020, OncoImmune reported topline findings from an interim efficacy analysis of a Phase 3 study evaluating MK-7110 for the treatment of patients with severe and critical COVID-19. An interim analysis of data from 203 participants (75% of the planned enrollment) indicated that hospitalized patients with COVID-19 treated with a single dose of MK-7110 showed a 60% higher probability of improvement in clinical status compared to placebo, as defined by the protocol. The risk of death or respiratory failure was reduced by more than 50%. The study is ongoing.”

About healthcare quality

New Measures Under Consideration Mark a Milestone for CMS’s Reimagined Quality Strategy to Increase Digital Innovation and Reduce Burden: “ The Centers for Medicare & Medicaid Services… unveiled its 2020 list of quality and efficiency measures under consideration… Every year, CMS evaluates all measures in its programs, proposing to remove those that have become less relevant and proposing new measures that may be more meaningful based on review by external health care experts. This year, almost all of the measures proposed would be collected digitally, meaning information comes from claims and other electronic sources, and would not require doctors to retrieve data manually.”
Read the posting for an explanation of the 20 measures CMS chose.

About healthcare systems

Tenet, Methodist Le Bonheur abandon $350M deal after FTC challenge: “The organizations called off the deal less than two months after the Federal Trade Commission filed a complaintseeking a temporary restraining order and preliminary injunction to stop the transaction pending an administrative trial, which was slated to begin May 18. The Tennessee attorney general's office joined the FTC's complaint.”

Today's News and Commentary

About the public’s health

Trump throws Covid relief bill in doubt by asking Congress to amend it: After being absent in Congressional discussions over the past number of months, the President now says the relief bill should be amended to increase the amounts paid from $600 to $2000 per individual ($4000 per couple). He did not use the word “veto” in his statements, possibly because both houses of Congress have more than enough votes to override it. The Democrats had pushed for more relief while Republicans wanted a smaller amount. One problem is that Congress has adjourned for a winter break and would need to be recalled.

Pfizer and BioNTech to Supply the U.S. with 100 Million Additional Doses of COVID-19 Vaccine: “Consistent with the original agreement announced in July 2020, the U.S. government will pay $1.95 billion for the additional 100 million doses.“ In a related story: The inside story behind Pfizer and BioNTech's new vaccine brand name, Comirnaty: “The name is coined from Covid-19 immunity, and then embeds the mRNA in the middle, which is the platform technology, and as a whole the name is meant to evoke the word community…”

Here's Your COVID Vaccine Rumor Roundup: This article is an excellent explanation debunking the major myths about the COVID vaccines.
And in a related article: The Anti-Vaxx Playbook: “This report, The Anti-Vaxx Playbook, is based on in-depth analysis of speeches and presentations by leading digital anti-vaccine advocates at a meeting they recently held in private over three days; investigation of private anti-vaccine digital spaces; and other intelligence gathered by our researchers. It reveals how anti-vaccine networks are systematically planning to suppress uptake of the Coronavirus vaccine by exploiting digital platforms.
These malignant actors have developed their strategic understanding over years of advocacy and practice. Their strategy is simple. Exploit social media algorithms’ predilection for controversial and engaging content to hammer home three key messages - Covid isn’t dangerous; vaccines are dangerous; and mistrust of doctors, scientists and public health authorities. Despite the variety of styles, tones and themes employed by the anti-vaccine movement, every meme they share is in service to one of these three messages.”
You should read the Executive Summary on page 6.

CDC says new UK strain of coronavirus could 'already be in the United States': However, experts believe the current vaccines should be effective against the mutation.

Lyft, Anthem, JPMorgan Chase and United Way Launch Universal Vaccine Access Campaign: “Lyft, Inc… today announced the launch of a nationwide campaign to support universal access to the coronavirus vaccine. The goal of this effort is to provide 60 million rides to and from vaccination sites for low-income, uninsured, and at-risk communities, when the vaccine becomes available. Corporate partners JPMorgan Chase and Anthem Inc. and community partner United Way will be working alongside Lyft to lead the effort, with many other business, healthcare and technology partners preparing to join the campaign as vaccines become available in the coming weeks.”

About pharma

Takeda offloads heart and metabolism drugs to 3-month-old Chinese firm for $322M: “Takeda has already exceeded the product sell-off goal it set alongside its Shire merger, but the Japanese pharma shows no sign of slowing down.
After making several geography-specific divestitures in different regions of the world, Takeda has turned to China. The company said Monday it agreed to offload some cardiovascular and metabolic drugs in the Chinese mainland to local firm Hasten Biopharmaceutic for $322 million.
The deal covers five drugs, including hypertension med Ebrantil (urapidil); the whole portfolio generated $109.5 million in sales for the fiscal year ended in March.”

Report Shows Prescription Opioid Use in US Declined by 60% From 2011 Peak: “Decreases in prescription opioid volume over the past 9 years have been driven by changes in clinical use, regulatory, and reimbursement policies, and in progressively more restrictive legislation enacted since 2012, according to the report. Further, the declines have been greatest in the highest doses of prescription opioids, or 90 morphine milligrams equivalents per day, which present the highest risk of opioid use disorder.”

U.S. sues Walmart saying pharmacies fueled opioid crisis, retailer rejects allegations: “In a civil lawsuit in U.S. District Court in Delaware, the government said Walmart failed to take its gatekeeping duties as a pharmacy seriously, allegations the company rejected.”

Global investors inject momentum into Hong Kong’s biotech craze: “International investors including BlackRock and Fidelity are anchoring a boom in Hong Kong biotech listings, with Chinese healthcare companies raising a record $21.1bn from share offerings in the city this year. Hong Kong is seeking to supplant New York’s Nasdaq as the world’s largest biotech fundraising centre by 2025. The rush of interest from western investors follows reforms two years ago that allowed biotech groups with no revenue to go public in the Asia finance hub for the first time.”

About health insurance

H.R.1418 - Competitive Health Insurance Reform Act of 2020: An Act: To restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers.
Amendment To McCarran-Ferguson Act.—Section 3 of the Act of March 9, 1945 (15 U.S.C. 1013), commonly known as the McCarran-Ferguson Act…” The law awaits presidential signature.

The McCarran-Ferguson Act is one of the cornerstones of the insurance industry. It provides these companies with limited anti-trust protections and gives states the authority to regulate, tax and license them. With intense consolidation of many health insurance companies, this amendment restores federal ability to prosecute under antitrust provisions of the Sherman and Clayton Acts. The law was obviously opposed by health insurance trade group AHIP, but also by the National Association of Insurance Commissioners.

[For more details see pages 236 and 237 of the U.S. Healthcare System book.]

Congress extends Medicare coverage of immunosuppressive drugs for kidney transplant: “The US Senate passed the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act as part of a broad year-end legislative package, extending Medicare coverage of life-saving immunosuppressive medications for the life of the kidney transplant.
An estimated 375 adult kidney transplant recipients lose their transplant every year due to a lack of coverage of immunosuppressive medications after the prior 36-month Medicare coverage period…
The legislation ensures that Medicare covers the cost of immunosuppressive drugs if no other coverage is available. A non-partisan Congressional Budget Office analysis estimated the legislation will save Medicare more than $400,000,000 over the course of 10 years by averting a return of transplant patients to hemodialysis.”

Today's News and Commentary

The final version of the COVID-19 relief bill has been published. Below are some of the healthcare-specific provisions, summarized by the MGMA. The legislation:

• Temporarily suspends the 2% Medicare sequestration from Jan. 1 through March 31, 2021;

• Increases Medicare payments across the board for CY 2021 from what was finalized in the 2021 Physician Fee Schedule (PFS) by adding $3 billion into the PFS and delaying payment of HCPCS add-on code G2211 for three years;

• Freezes the 2020 qualifying participant thresholds required to achieve alternative payment model (APM) benefits such as the 5% lump sum bonus through 2023;

• Delays the start date for the mandatory radiation oncology APM from July 1, 2021 until Jan. 1, 2022;

• Extends the work geographic index floor under the Medicare program through Dec. 31, 2023;

• Expands access to mental health services furnished through telehealth past the expiration of the COVID-19 public health emergency; and

• Provides for the creation of 1,000 new Medicare-funded graduate medical education (GME) residency positions.

The surprise billing provision was discussed in yesterday’s blog.

About hospitals and healthcare systems

Monitoring for Hospital Price Transparency: A reminder that on January 1 CMS will start to monitor hospitals for compliance with price transparency.

Philadelphia health system merger clears latest FTC challenge: The merger is back on… “An appellate court on Dec. 21 denied the Federal Trade Commission's latest attempt to block a merger between Philadelphia-based Jefferson Health and Einstein Healthcare Network.”

Texas hospital pays $48M to settle false claims allegations: “Prosecutors allege that the hospital, which is partially physician-owned, and its subsidiary THHBP Management submitted claims to Medicare that resulted from illegal physician referrals and kickbacks.
In particular, prosecutors said the hospital violated Stark Law and the Anti-Kickback Statute by requiring physician owners to meet a 48 patient-contact requirement to maintain ownership in the hospital.”

About the public’s health

Johnson & Johnson Takes Big Step Forward With Its Vaccine Trial, Has Potential to Be Single Shot: “Johnson & Johnson took a big step forward this week as they announced their phase 3 trials are now fully enrolled with 45,000 people.” The vaccine does not require very low shipping/storage temperatures and, if proven effective, will require only one dose. It works by incorporating double stranded DNA in a modified adenovirus. The virus infects cells and releases the DNA, which causes manufacture of SARS CoV-2 spike proteins. These proteins provoke an immune response. See: How the Johnson & Johnson Vaccine Works for helpful graphics of tis process.

Trends in Overweight and Obesity Self-awareness Among Adults With Overweight or Obesity in the United States, 1999 to 2016: “Among study participants…, 33.5% were overweight and 34.5% were obese, although 41.3% of persons who were overweight and 9.7% of persons who were obese did not consider themselves to be overweight…
Among persons with obesity, being aware of their obesity… and health professionals' recommendation on losing weight… were independently associated with attempts to lose weight after adjustment for all [other] factors…[such as demographics, income and insurance status].”
Like many other conditions, self-realization of the problem is the first step toward successful treatment. That problem requires a different approach than just assuring compliance with treatment.

About pharma

FDA approves Riabni, third biosimilar to Rituxan: “The list price for rituximab-arrx in the United States will be $716.80 per 100 mg, or $3,584 for a 500-mg single-dose vial. This is 23.7% lower than the list price of its reference product, according to an Amgen press release.” This article is a reminder that biosimilars sell at a lower discount percentage than do generic small molecules.

Biogen Will Settle for $22 Million Over Alleged Drugs Kickback Scheme: “Biogen has agreed to a $22 million settlement to resolve allegations that donations it made to charities were kickbacks to Medicare patients for out-of-pocket costs associated with its multiple sclerosis medications.”

Myovant Sciences’ Oral Therapy for Advanced Prostate Cancer Wins FDA Approval: “A form of androgen deprivation therapy, Orgovyx lowers hormone levels that enable prostate cancer cells to grow. Unlike other treatments in this class, the drug doesn’t have to be injected or implanted under the skin.” Price was not available, but since it is taken orally, it will lower administration costs.

About health insurance

CMS Says 8.2M Americans Enrolled on ACA Federal Exchange for 2021: “The enrollment level is only slightly lower than the 2020 open enrollment season’s 8.3 million enrollment, even though there are fewer states on the federal exchange. Year-over-year plan selection trends rose by 6.6 percent from 2020, similar to its increase from 2019 (6.3 percent).
This year, New Jersey and Pennsylvania joined 12 states and the District of Columbia in shifting to a state-based platform for their state-based exchanges.”

Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (CMS 2482-F) Final Reg: “This final rule advances CMS’ efforts to support state flexibility to enter value-based purchasing arrangements (VBPs) with drug manufacturers for innovative, and sometimes costly drugs therapies, and to provide manufacturers with regulatory flexibility to enter into VBPs with commercial payers, which will benefit Medicaid programs. It also creates minimum standards in state Medicaid DUR programs designed to reduce opioid-related fraud, misuse and abuse.

This final rule also revises regulations regarding:  

• How manufacturers should calculate the average manufacturer price (AMP) of a brand name drug when there is also a sale of an authorized generic;

• How manufacturers should include the discount or rebates provided as part of their patient assistance programs in the calculation of ‘best price’ and AMP, including when they are impacted by pharmacy benefit managers (PBM) accumulator programs;

• State and manufacturer reporting requirements to the Medicaid Drug Rebate Program (MDRP);

• The definition of a CMS-authorized supplemental rebate agreement, to clarify that the rebates under such arrangements for MCO claims must be paid to the state;

• The definition of line extension, new formulation, oral solid dosage form, single source drug, multiple source drug, and innovator multiple source drug for purposes of the MDRP; and,

• Coordination of benefits (COB) and TPL rules related to the special treatment of certain types of care and payment in Medicaid and Children’s Health Insurance Program (CHIP).”

Two Owners of New York Pharmacies Charged in $30 Million Covid-19 Health Care Fraud and Money Laundering Scheme: “An indictment was unsealed in federal court in Brooklyn… charging the two owners of over a dozen pharmacies in New York City and on Long Island, for their roles in a $30 million health care fraud and money laundering scheme in which they exploited emergency codes and edits in the Medicare system that went into effect due to the COVID-19 pandemic in order to submit fraudulent claims for expensive cancer drugs that were never provided, ordered or authorized by medical professionals.”

Oscar Health gearing up to go public: “The startup health insurer filed a draft registration statement on Form S-1 with the Securities and Exchange Commission (SEC). A potential initial public offering will undergo an SEC review…
Oscar's individual and family plans as well as small group and Medicare Advantage coverage will be available across 18 states and 286 counties next year. About 420,000 members were enrolled in its plans as of Sept. 30.”
About healthcare quality

Unnecessary C-sections are a problem in the US. Will publicizing hospital rates change that?: “The Joint Commission… plans to start publicly reporting next year on hospitals with high cesarean section birth rates. The news comes a few weeks after the Department of Health and Human Services unveiled an action plan to improve maternal health, which included reducing low-risk C-section delivery rate by 25%.
Since 1985, the World Health Organization has considered the ideal rate for C-section births to be between 10% to 15%.
However, the Centers for Disease Control and Prevention reports more than 31% of all deliveries in the U.S. were by C-section in 2018. Tricia Elliott, director of Quality Measurement at TJC, says some U.S. hospitals report C-section rates as high as 60%…
High C-section rates are not the problem, said Dr. William Grobman, professor of obstetrics and gynecology at Northwestern University's Feinberg School of Medicine. The problem is variation between hospitals – low C-section rates in some and high rates in others – with no improved outcome for mother and baby.”

Today's News and Commentary

About the public’s health

First shipments of Moderna vaccine roll out, a new weapon in U.S. Covid-19 response: The headline speaks for itself. The vaccine received emergency use authorization late Friday.

Congress seals agreement on $900 billion COVID relief bill: Lots in the bill for economic relief and funding unrelated to the COVID-19 pandemic. As far as health-related provisions, “$22 billion would help states and local governments with COVID-19-related health expenses like testing and vaccines.”

Surprise medical bill prevention included in year-end legislative package: “The measure uses a process known as arbitration to determine how much the insurer will pay the doctor, a shift from earlier versions that would have set the payment rate based on the median rate in that geographic area. 
The latest version moves even further towards doctors and hospitals by banning the arbiter from considering the lower payment rates paid by the Medicare and Medicaid programs.”

Panel: People over 75, essential workers next for vaccines: Even before everyone in the first tier is vaccinated, the CDC recommends “that people 75 and older and essential workers like firefighters, teachers and grocery store workers should be next in line for COVID-19 shots…”

UK says new coronavirus strain is more infectious, but vaccines should still work: The headline speaks for itself. This story is an update of previous reports about the UK from which 40 countries have banned travel.

Federal guidance enables employers to mandate workers get COVID-19 vaccine: This story was previously reported; the guidance comes from the Equal Employment Opportunity Commission. It is a reminder now that more vaccines are on the way.

CVS, Walgreens begin distributing vaccine in long-term care facilities: “Walgreens said its pharmacists would begin giving the shots at nursing homes and assisted living facilities in Ohio, Connecticut and Florida while CVS said it'd give the shots at centers in Ohio and Connecticut.”

COVID-19 Community Profile Report: CNBC calls this report “the most comprehensive data report made public by the federal government since the virus began to spread across the U.S. about nine months ago.”

About healthcare IT

IBM links with Salesforce to offer digital COVID-19 vaccine passports: “Big Blue’s health pass app, which debuted earlier this year, aims to provide individual, sharable health credentials following test results, vaccinations and temperature checks through an encrypted digital wallet on a smartphone…
Now, IBM is working with Salesforce to help employers deliver wellness surveys to employees and customers through its Work.com platform, as well as perform contract tracing and schedule coronavirus test or vaccine appointments.”

The Solarwinds breach — What do CIOs need to do now?: A good summary of the implications of the breach for this major supplier of network security and management software.

About pharma

Agios offloads oncology unit to Servier in $1.8B deal, zeroes in on genetically defined diseases: “Agios Pharmaceuticals’ roots are in cancer drug development, but it’s passing that baton to Servier as it doubles down on its programs in genetically defined diseases, including a drug it’s developing for noncancerous blood diseases.”

Today's News and Commentary

About the public’s health

Some states say Pfizer vaccine allotments cut for next week: “In recent days, governors and health leaders in more than a dozen states have said the federal government has told them that next week’s shipment of the Pfizer-BioNTech vaccine will be less than originally projected.
[For example,] California, where an explosion in cases is straining intensive care units to the breaking point, will receive 160,000 fewer vaccine doses than state officials had anticipated next week — a roughly 40% reduction.”

Federal guidance enables employers to mandate workers get COVID-19 vaccine: “New guidance from the Equal Employment Opportunity Commission allows employers to require workers to get COVID-19 vaccinations, which has major implications for providers…
The guidance applies to all employers and details what procedures a company can take if a person has a health reason why they can’t get the vaccine or has closely held religious objections.
If a worker can’t get the vaccine due to a disability, then employers should conduct an individual assessment on whether the worker poses a direct threat to the health and safety of others in the workplace.”

Increase in Fatal Drug Overdoses Across the United States Driven by Synthetic Opioids Before and During the COVID-19 Pandemic: This CDC report is a reminder that the opioid crisis is still with us and getting worse.

About health insurance

CMS to allow managed care organizations to participate in direct contracting: “The model, announced Thursday by the Centers for Medicare & Medicaid Services (CMS), will allow Medicaid managed care organizations (MCOs) to participate in the global and professional options in the agency’s direct contracting model, which offers voluntary risk-sharing agreements with providers.”

The Coming Crisis For The Medicare Trust Fund: “The Congressional Budget Office (CBO) now projects that the trust fund will be exhausted in 2024, a little more than three years from now, which is the nearest the fund has come to exhaustion in the 55 years of its existence.”

About pharma

REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19: “In this ongoing, double-blind, phase 1–3 trial involving nonhospitalized patients with Covid-19, we investigated two fully human, neutralizing monoclonal antibod- ies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, used in a combined cocktail (REGN-COV2) to reduce the risk of the emer- gence of treatment-resistant mutant virus…
In this interim analysis, the REGN-COV2 antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initi- ated or who had a high viral load at baseline. Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group. (Funded by Regeneron Pharmaceuticals and the Biomedical and Advanced Research and Development Authority of the Department of Health and Human Services…)”

About hospitals and healthcare systems

Tenet to Sell Urgent Care Platform to FastMed: “Tenet Healthcare… and FastMed Urgent Care announced today that they have entered into a definitive agreement under which FastMed will purchase Tenet’s urgent care platform [all 87 facilities], which is operated under the CareSpot and MedPost brands and managed by Tenet’s United Surgical Partners International (USPI) subsidiary.” The divestiture is unusual as hospitals/systems have been expanding their urgent care outpatient facilities.

About healthcare IT

Philips puts down $2.8B for BioTelemetry and its wearable heart monitors: “BioTelemetry, alongside its artificial intelligence-based analytics and other services, helps remotely monitor and diagnose at least 1 million cardiac patients each year. It’s a business that brought in $439 million in sales in 2019, and one that Philips expects to grow by more than 20% in the next four years—especially as the COVID-19 pandemic continues to push patients away from clinics and hospitals and toward telehealth solutions.”

Today's News and Commentary

About the public’s health

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

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

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

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

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

About healthcare IT

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

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

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

About pharma

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

About health insurance

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

About healthcare professionals

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

About healthcare spending

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

About pharma

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

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

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

About healthcare IT

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

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

About hospitals and health systems

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

·       Inpatient hospital revenue will be 35% lower.

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

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

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

About health devices

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

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

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

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

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

• Over 460 million people already live with diabetes.

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

About pharma

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

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

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

About health insurance

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

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

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

About healthcare IT

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

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

About pharma

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

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

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

About health insurance

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

About hospitals and health systems

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

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

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

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

About medical devices

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

About healthcare IT

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

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

Today's News and Commentary

About the public’s health

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

Here is a summary on how the distribution will work.

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

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

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

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

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

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

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

About health insurance

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

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

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

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

About hospitals and health systems

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

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

About pharma

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

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

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

About healthcare IT

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

Today's News and Commentary

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

About pharma

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

About the public’s health

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

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

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

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

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

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

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

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

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

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

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

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

About healthcare personnel

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

Hospitals and health systems

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

About diagnostics

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

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

About health insurance

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

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

About healthcare IT

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

Today's News and Commentary

About health insurance

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

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

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

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

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

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

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

About healthcare quality

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

About the public’s health

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

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

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

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

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

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

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

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

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

About healthcare IT

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

About pharma

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

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

About healthcare IT

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

Today's News and Commentary

About hospitals and health systems

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

About the public’s health

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

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

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

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

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

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

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

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

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

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

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

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

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

About health insurance

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

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

Today's News and Commentary

About healthcare financing

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

About the public’s health

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

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

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

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

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

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

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

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

About health insurance

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

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

About hospitals and health systems

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

About pharma

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

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

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

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

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

About healthcare IT

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

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

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

About health insurance

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