Today's News and Commentary

About pharma

CMS proposed rule aims to foster more Medicaid value-based drug agreements: CMS recognized that the Medicaid requirement for lowest supplier prices has hampered value-based pricing by other payers. This final rule gives states more flexibility for those plans to enter into value-based purchasing agreements with drugmakers based on their product’s performance. “The rule also creates minimum standards for Medicaid drug utilization programs intended to combat opioid fraud and misuse.
CMS also revised how a drugmaker must calculate the average manufacturer price of a brand-name drug that has an authorized generic.”

.WHO cuts hydroxychloroquine from COVID-19 trial again, citing lack of efficacy: “The World Health Organization (WHO) said Wednesday that the ongoing Solidarity Trial, which compares potential treatments for COVID-19, is no longer including the malaria drug hydroxychloroquine. According to Ana Maria Henao Restrepo, medical officer at the WHO's department of immunisation vaccines and biologicals, evidence from both internal and external studies ‘suggest that hydroxychloroquine, when compared with the standard of care in treatment of hospitalised COVID-19 patients, does not result in the reduction of mortality of those patients.’”

WHO: New treatment only meant for severe COVID-19 cases: “The World Health Organization (WHO) on Wednesday said a common drug shown to be effective in treating COVID-19 is meant for use only among those who are suffering the most severe symptoms of the disease, not those who have milder cases.
Scientists at the University of Oxford said Tuesday that their studies had showed dexamethasone was effective in reducing the mortality rate of severely ill patients. The study is the first to show that an already available drug is effective in reducing death rates among COVID-19 patients.”

About the public’s health

Supreme Court stops Trump from canceling DACA program: The relevant issue is the large number of DACA professionals working in healthcare. “The justices, voting 5-4 on the central issues, said the Trump administration didn’t give an adequate justification for rescinding the Deferred Action for Childhood Arrivals program. DACA, as it’s known, protects people who were brought into the country illegally as children.
Chief Justice John Roberts wrote the court’s opinion, joining the liberal justices in saying the rescission of DACA was ‘arbitrary and capricious’ in violation of a federal law that governs administrative agencies.”

Hidden in Plain Sight — Reconsidering the Use of Race Correction in Clinical Algorithms: “Our understanding of race has advanced considerably in the past two decades. The clinical tools we use daily should reflect these new insights to remain scientifically rigorous. Equally important is the project of making medicine a more antiracist field. This involves revisiting how clinicians conceptualize race to begin with. One step in this process is reconsidering race correction in order to ensure that our clinical practices do not perpetuate the very inequities we aim to repair.” The article is an excellent review of specific algorithm adjustments that consider race (look at the Table).

Humana: 'Healthy days' up across all Medicare Advantage markets for first time: Finally some good news (although, a bit dated in view of the past few months). “Humana saw the number of “healthy days” increase across all its Medicare Advantage (MA) markets last year, according to new data released by the insurer.
This marks the first time Humana’s seen such a result since it began tracking the metric as part of its Bold Goal initiative in 2015. Overall, Humana’s MA members saw 816,000 more healthy days than they would have without the program, according to the report.
’Healthy days’ is a population health metric developed by the Centers for Disease Control and Prevention that measures quality of life. Members are surveyed on their physical and behavioral health to track their quality of life long-term.”

Chicago has a unique COVID strain: research: “In addition to the strain from China, researchers found what appears to be the most the predominant version of the virus in the New York area and globally, the statement says. That version generates more of the virus in the upper airways than the one that’s unique to Chicago.” Differences will help clinicians understand the different ways the disease manifests itself and how to target a vaccine that covers different forms.

About health insurance

Direct Contracting Model Options: CMS announced it is accepting letters of intent for its direct contracting model, which will start in April, 2021. This CMS page provides a description of the three types of direct contracting and other program details.

Today's News and Commentary

About healthcare IT

CHIME survey shows huge increases in telehealth use: “Most healthcare executives were doing less than 25 virtual visits a day prior to the COVID-19 pandemic. The majority are now doing 50 telehealth visits a day and a full one-third of executives are doing more than 250 visits a day, according to a survey from the College of Healthcare Information Management Executives (CHIME).
Perhaps not surprising the survey of nearly 200 digital healthcare executives revealed huge increases for virtual visits and appointments.”

NIH launches platform for nationwide coronavirus patient data: “The new platform is funded by the National Center for Advancing Translational Sciences (NCATS), which is part of the NIH. It will systematically collect clinical, laboratory and diagnostic data from health care provider organizations across the country. The NIH will aggregate and harmonize the information into a standard format readily available for use by researchers and health care providers.”

HCSC partners with Epic: 3 things to know:”Health Care Service Corp., the Chicago-based parent of five Blue Cross and Blue Shield health plans, tapped Epic to launch a new health information exchange platform between insurers, providers and patients.”

About pharma

US appeals court strikes down HHS rule requiring drug prices in TV ads: “A U.S. appeals court upheld a ruling June 16 that struck down a rule from HHS requiring drugmakers to put the wholesale prices of their drugs in TV ads…
The U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of the drugmakers, saying that HHS lacked the authority to establish the rule and that it acted "unreasonably" in making it.”

Common cholesterol drugs could slow spread of breast cancer to brain: “A new study from the University of Notre Dame shows drugs used to treat high cholesterol could interfere with the way breast cancer cells adapt to the microenvironment in the brain, preventing the cancer from taking hold. Patients with breast cancer who experience this type of metastasis typically survive for only months after diagnosis.

Statins, a group of drugs commonly prescribed for those with high cholesterol, were shown to interfere with a pathway that allows a cancer cell to recycle cell surface proteins and therefore make it easier for cancer cells to live within the brain.”

PBMs and Drug Spending in 2019: CVS Health and Express Scripts Outperform Prime Therapeutics: This report is a great annual analysis of drug spending. The entire article is worth reading but here is a summary: “Once again, we find that commercial drug spending did not race higher—contrary to what you keep hearing from journalists and politicians. Spending rose by less than 3% in 2019, continuing a multiyear trend of slow growth. At some plan sponsors, total drug spending even declined. For specialty drugs, higher utilization—not drug costs—was again the biggest factor driving specialty spending growth.”

About health systems

Beaumont, Advocate Aurora explore merger: “Southfield, Mich.-based Beaumont and Advocate Aurora, which has dual headquarters in Downers Grove, Ill., and Milwaukee, said they began partnership discussions in late 2019 but paused talks to allow both organizations to focus on the COVID-19 pandemic. On June 17, the health systems signed a nonbinding letter of intent to create a health system that would span across Michigan, Wisconsin and Illinois. “

7 health systems report $1B+ losses in Q1: With respect to the above article, Advocate Aurora had a net loss of $1.3B in Q1. Six other large systems’ results are listed.

About the public’s health

Two-Thirds of Patients With TNBC Do Not Receive Recommended Care: “Almost 70% of women diagnosed with triple-negative breast cancer  (TNBC) do not receive care for their disease that is in accordance with guideline recommendations from the National Comprehensive Cancer Center (NCCN), reported study results out of ASCO20 Virtual, this year’s annual meeting of the American Society of Clinical Oncology.
This despite breast cancer being the most common cancer diagnosed in women and up to 20% of all cases accounted for by the TNBC subtype, which itself is usually diagnosed between age 40 to 50 years…”

Trump health officials pledge COVID-19 vaccine will be free to the 'vulnerable': “Any potential vaccine for COVID-19 will be free for any ‘vulnerable’ American who can't afford it, Trump administration officials pledged Tuesday.”

Trump praises scientists for developing AIDS vaccine that doesn’t exist: “President Donald Trump falsely suggested that scientists have developed a vaccine for AIDS, the late stage of HIV infection in which the virus badly damages the immune system.
‘They’ve come up with the AIDS vaccine,’Trump said during a press conference on police reform, referring to scientists.” In context with other comments he was probably referring to antiretroviral drugs.

White House Left States On Their Own To Buy Ventilators. Inside Their Mad Scramble: As lack of central coordination caused states to compete for resources (like ventilators), prices increased significantly. The article provides examples.

Pandemic spurs massive declines in health spending: This Altarum study found that national health spending was 24.8% lower in April compared to April 2019. Prescription drugs increased to 13% of the total, hospital care was 26%, and physician and clinical services were 15%. Annual figures are usually 9-10%, 30% and 20%, respectively.

About health insurance

Medicaid's legislative agency reports to Congress: 5 takeaways: “The Medicaid and CHIP Payment and Access Commission released its June 2020 Report to Congress, which included recommendations on dually eligible beneficiaries, the Medicare Savings Programs and coordination between Medicaid and Tricare.”

MedPAC urges MA, ACO tweaks to speed up value-based payment reform: “Medicare Advantage and accountable care organizations could be vehicles for much needed value-based payment reform in Medicare, but not without better aligned incentives and improved quality assessment, according to the Medicare Payment Advisory Commission's June report to Congressreleased Monday.
For ACOs in the Medicare Shared Savings Program, the commission suggests HHS use national provider identifiers instead of taxpayer identification numbers. Using TINs could grant some ACOs unwarranted shared savings through favorable patient selection, MedPAC concluded.”

Today's News and Commentary

About hospitals

Best Children's Hospitals 2020-21: Honor Roll and Overview: The latest rankings from US News.

About the public’s health

Parental Hesitancy About Routine Childhood and Influenza Vaccinations: A National Survey: The need for social marketing is still great: “Almost 1 in 15 US parents are hesitant about routine childhood vaccines, whereas >1 in 4 are hesitant about influenza vaccine. Furthermore, 1 in 8 parents are concerned about vaccine safety for both routine childhood and influenza vaccines, and only 1 in 4 believe influenza vaccine is effective.”

U.S. airlines threaten to ban passengers who refuse to wear masks: “U.S. airline passengers who refuse to wear face coverings during the novel coronavirus pandemic could have their flying privileges revoked under tougher enforcement policies, the industry’s main lobby group said on Monday.”

Internal CDC memo forbids staff from speaking with Voice of America: “The April 30 internal email, which was made public in response to a Freedom of Information Act request by the Knight First Amendment Institute, stated that the CDC would not respond to interview requests from ‘anyone affiliated with Voice of America.’The email specifically cited the White House’s disapproval with the network as a reason for the decision. In April, the White House issued a statement condemning the broadcaster and accusing it of spreading Chinese propaganda…” Voice of America Director Amanda Bennett resigned today.

Individualizing Risk Prediction for Positive COVID-19 Testing: Results From 11,672 Patients: “Prediction of a COVID-19 (+) test is possible and could help direct healthcare resources. We [Cleveland Clinic researchers] demonstrate relevance of age, race, gender, and socioeconomic characteristics in COVID-19-susceptibility and suggest a potential modifying role of certain common vaccinations and drugs identified in drug-repurposing studies.”

About pharma

FDA warns hydroxychloroquine may weaken effectiveness of coronavirus drug remdesivir: Another reason to stay away from hydroxychloroquine, especially for prevention.

Potentially lifesaving coronavirus treatment dexamethasone could have ‘immediate impact,’ former FDA chief says:

  • “In one study, the drug cut the risk of death by a third for Covid-19 patients on ventilators and by a fifth for those on supplemental oxygen.

  • The underlying data from the study has yet to be published, but the U.K. researchers who led the trial described the results as a ‘ground-breaking.’”

3 charged in $180M scheme to fraudulently bill federal, private payers for compounded drugs: “According to the indictment, the three defendants conspired to submit the fraudulent bills between September 2011 and January 2016. Of the $180 million, $50 million was defrauded from government payers, namely Medicare and TRICARE, the DOJ said.” Note the fraud involved federal programs. It is rare that such actions involve private insurance.

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Resource recommendation

The Managed Care Digests have been around for 34 years and provide a good source of data about providers, payers and diseases.

About pharma

FDA pulls emergency authorization for hydroxychloroquine as covid-19 treatment: “The Food and Drug Administration has withdrawn its emergency use authorization for hydroxychloroquine to treat coronavirus patients. President Trump had repeatedly promoted the antimalarial drug as a way to prevent or treat covid-19.
The agency said Monday in a statement that ‘it is no longer reasonable to believe’ the drug may be effective against covid-19 or that its benefits outweigh ‘known and potential risks.’”

Promising path found for COVID-19 therapeutics: As the biology of SARS-CoV-2 becomes clearer, a number of new therapies can be investigated. This article explains one of them.

Physicians, nurses and pharmacists among 19 indicted in multimillion-dollar opioid distribution ring: The opioid epidemic is not over as long as theses schemes persist. “The indictment alleges clinic owner John Henry Rankin gave money and illegal benefits to physicians and nurse practitioners who wrote faulty prescriptions for oxycodone, hydrocodone, promethazine with codeine cough syrup and other highly addictive drugs. The court document also accuses Mr. Rankin of recruiting patients into the conspiracy and paying an unlicensed medical worker to issue fraudulent prescriptions while posing as a physician.
The court has accused the distributors of prescribing nearly 2 million illegal doses of Schedule II controlled substances, with the oxycodone and oxymorphone alone holding a conservative street price of more than $41 million.”

About the public’s health

Trump administration revokes transgender health protection:”The Department of Health and Human Services said it will enforce sex discrimination protections ‘according to the plain meaning of the word ‘sex’ as male or female and as determined by biology.’This rewrites an Obama-era regulation that sought a broader understanding shaped by a person’s internal sense of being male, female, neither or a combination.” This announcement preceded today’s ruling by the Supreme Court that sexual orientation could not be the basis of discrimination in the workplace.

Record spikes in new coronavirus cases, hospitalizations sweep parts of U.S.:”New coronavirus cases and hospitalizations in record numbers swept through more U.S. states, including Florida and Texas, as most push ahead with reopening and President Donald Trump plans an indoor rally in Tulsa, Oklahoma…
Nationally, there were over 25,000 new cases reported on Saturday, the highest tally for a Saturday since May 2, in part due to a significant increase in testing over the past six weeks.”

Beijing imposes curbs as coronavirus returns to Chinese capital:”Several districts of the Chinese capital put up security checkpoints, closed schools and ordered people to be tested for the coronavirus on Monday after an unexpected spike of cases linked to the biggest wholesale food market in Asia.
After nearly two months with no new infections, Beijing officials have reported 79 cases over the past four days, the city’s biggest cluster of infections since February.”

How to Use Masks during the Coronavirus Pandemic: A good reminder from Scientific American about how to use a mask effectively.

FDA Approves Merck’s GARDASIL 9 for the Prevention of Certain HPV-Related Head and Neck Cancers: The new version protects against an additional 5 strains of HPV. Those previously immunized will probably receive a course of this vaccine as well.

The $7,000 Covid test: Why states are stepping in to shield consumers: “Insurance regulators from Tennessee to Washington state have stepped up efforts to protect patients from unexpected bills for coronavirus tests, concerned the federal government has failed to shield people from thousands of dollars in out-of-pocket expenses…
The state-by-state guidance and rules come after Congress and the Trump administration this spring assured Americans that coronavirus testing and any necessary trips to doctors and hospitals would be free. But lawmakers didn't limit charges if the testing is done out of network — or prohibit labs or hospitals from billing patients if insurers refuse to pay their posted charges.
Employers and health plans have complained this could lead to staggering costs. One national insurer was billed $6,946 for a coronavirus test in Texas, according to claims data reviewed by POLITICO.

Coronavirus survival comes with a $1.1 million, 181-page price tag: “The bill is technically an explanation of charges, and because Flor [the patient] has insurance including Medicare, he won’t have to pay the vast majority of it. In fact because he had COVID-19, and not a different disease, he might not have to pay anything…” Recall many insurers have waived out of pocket expenses for COVID-19 related conditions, including testing (see article above).

About healthcare IT

The bipartisan HEALTH Act would make permanent Medicare payments for telehealth services at federally qualified health centers and rural health clinics: The temporary reimbursement changes for telehealth may become more permanent. “U.S. Reps. G.K. Butterfield, D-North Carolina, and Glenn Thompson, R-Pa., introduced new legislation this week that would provide for permanent Medicare payments for telehealth services at federally qualified health centers and rural health clinics. 
The Helping Ensure Access to Local TeleHealth, or HEALTH Act, would require the Secretary of Health and Human Services to revise the Code of Federal Regulations to consider telehealth services from an eligible facility to be a ‘visit.’”

FCC Funds 67 More COVID-19 Telehealth Projects, Program Surpasses $100M in Funding: ”The FCC Wireline Competition Bureau has announced the next tranche of approved projects in the COVID-19 telehealth program. The new funding of $20.18 million is for 67 projects. This brings total funding to $104.98 million for 305 providers in 42 states and the District of Columbia. The $200 million COVID-19 telehealth program was created in the CARES Act, which was approved in March.”

10 common reasons for HIPAA violations: “In the past 12 months, there were 393 protected health information breach incidents reported to HHS.” This article is a good summary of the types of infractions with many examples.

Health systems can use PHI to contact former COVID-19 patients on blood, plasma donation without violating HIPAA: 3 details: And here is guidance about what you can do and not violate HIPAA.

Beyond Convenience: Patients’ Perceptions of Physician Interactional Skills and Compassion via Telemedicine:”This [research] supports the notion that clinician-patient relationships can be established in a video-first model, without a previous in-person encounter, and that positive ratings do not seem to be focused solely on prescription receipt.”

About healthcare professionals

Accountable Care Organizations’ Increase In Nonphysician Practitioners May Signal Shift For Health Care Workforce: For the period 2013-2018: “The average proportion of nonphysician practitioners in ACOs grew from 18.1 percent to 38.7 percent, with a commensurate decline in the average share of primary care physicians from 60.0 percent to 42.2 percent. As value-based care models grow in prevalence, their evolving clinician composition may affect workforce patterns in the broader health care delivery system.”

Healthcare Professionals and the Impact of COVID-19: ”Nationally, from March 2019 to March 2020, utilization of professional services decreased 65 percent and professional revenue based on total estimated allowed amounts decreased 45 percent. From April 2019 to April 2020, utilization fell 68 percent and revenue 48 percent.” This article goes into more details and especially highlights specialties that were particularly affected. For example, oral surgery and gastroenterology were the most impacted.

Today's News and Commentary

About the public’s health

Two policy pieces worth reading by leaders in the healthcare field:

Health Care Policy After the COVID-19 Pandemic by Victor Fuchs

The Moral Determinants of Health by Donald Berwick

Prevalence of Gastrointestinal Symptoms and Fecal Viral Shedding in Patients With Coronavirus Disease 2019: “These findings suggest that that 12% of patients with COVID-19 will manifest GI symptoms; however, SAR-CoV-2 shedding was observed in 40.5% of patients with confirmed SARS-CoV-2 infection. This highlights the need to better understand what measures are needed to prevent further spread of this highly contagious pathogen.”

Lack of Health Literacy a Barrier to Grasping COVID-19: The headline speaks for itself. The article is a good explanation of the problem and possible solutions.

Models show rising US COVID-19 cases, deaths in months ahead:The model produced by the Institute for Health Metrics and Evaluation, influential among members of the White House coronavirus task force, updated its projection of fatalities due to the novel coronavirus, showing the US death toll could reach 169,890 by Oct 1. That model shows a second wave of fatal infections, with deaths from the virus dropping off in July and August before rising sharply at the end of September and worsening through October and November.”

As Coronavirus Infections Climb, Washington Moves On to Other Business: Despite the above prediction for a second wave, “there seems to be a tacit agreement between the parties: Democrats have largely stopped harping on social distancing, while Mr. Trump plans to resume his political rallies  — first in Oklahoma, Florida, Arizona and North Carolina — and Republicans refrain from shaming protesters over shedding pandemic precautions.” Of note is that the tickets for Trump’s Tulsa rally have a disclaimer about COVID-19 that is meant to shield organizers from liability.

Trends in Frequency of Sexual Activity and Number of Sexual Partners Among Adults Aged 18 to 44 Years in the US, 2000-2018: “This survey study found that from 2000 to 2018, sexual inactivity increased among US men such that approximately 1 in 3 men aged 18 to 24 years reported no sexual activity in the past year. Sexual inactivity also increased among men and women aged 25 to 34 years. These findings may have implications for public health.”

Association Between Breastfeeding and Ovarian Cancer Risk: Encouragement for breastfeeding is often framed as benefits to the baby. Here is another good reason. “Breastfeeding is associated with a significant decrease in risk of ovarian cancer overall and for the high-grade serous subtype, the most lethal type of ovarian cancer. The findings suggest that breastfeeding is a potentially modifiable factor that may lower risk of ovarian cancer independent of pregnancy alone.”

Antibody testing suggests immune response post-COVID is very variable: “A bunch of recent draft papers have looked at the sort of immune response we're seeing in patients who have cleared the virus after testing positive for it. And the results suggest that it's very variable—as is the quality of the tests that detect it.”

Rwandan researchers discover new rare tuberculosis strain: Let’s see what we do with this information in light of what we have learned about early detection of possible pandemic-related pathogens.

'Surprisingly rapid' rebound in carbon emissions post-lockdown: Because of COVID-19-related reduced travel and other activities, carbon emissions declined significantly. Now that restrictions are relaxing, the rebound in these emissions is occurring more rapidly than expected.

About pharma

FDA approves Nyvepria, biosimilar to pegfilgrastim, to reduce infections:”Pegfilgrastim-apgf (Nyvepria, Pfizer) — a biosimilar to pegfilgrastim(Neulasta, Amgen) — is indicated to reduce infections manifested by febrile neutropenia among patients who receive nonmyelosuppressive anticancer drugs such as chemotherapy that can cause fever and low white blood cell count.” Its introduction could significantly lower treatment costs.

Free samples of prescription drugs cannot be given to pharmacists, EU court rules: “The European Union's Court of Justice on Thursday ruled that free samples of prescription medicines cannot be given to pharmacists, following a request for clarification on the matter by Novartis. The court determined that European directives only allow those entitled to prescribe drugs, namely doctors, to receive free samples, citing the risks associated with their use or the uncertainty of their effects without proper medical supervision.”

Hedge fund manager stands to profit on ‘flip’ of taxpayer-funded coronavirus drug: “The perception that companies are profiteering during a global medical crisis — especially in cases where inventions were funded by taxpayers — poses political dangers to the pharmaceutical industry.” This article is a case study about how this problem is playing out.

Gilead should be allowed 'real pricing' for remdesivir—and a sizable profit, analyst says: “‘If you are going to war, or preparing for war in a capitalist country, you have to let business make money out of the process or business won’t work,’ SVB Leerink’s Geoffrey Porges wrote in a Wednesday note to investors, quoting former U.S. Secretary of War Henry Stimson during World War II…
What kind of a sticker price for remdesivir is acceptable? Around $5,000 per course, in Porges’ view. That was roughly the same as the $4,460 that drug cost watchdog the Institute for Clinical and Economic Review (ICER) came up with recently for the drug to be deemed cost-effective.”

Today's News and Commentary

About pharma

U.S. states accuse 26 drugmakers of generic drug price fixing in sweeping lawsuit: “The lawsuit accused Novartis’ Sandoz unit, Teva Pharmaceuticals’ Actavis unit, Mylan, Pfizer Inc and other drugmakers of conspiring to rig the market between 2009 and 2016 for more than 80 drugs. 
Attorneys general from 46 states, the District of Columbia and four U.S. territories said the defendants prioritized profit over the public interest, depriving millions of consumers of lower prices for needed medication. 
Ten executives, including many sales and marketing directors, are also defendants in the 543-page complaint filed in a federal court in Connecticut.”

Cigna sues dozens of drugmakers in alleged price-fixing scheme: On a similar note: “The lawsuit, filed June 9 in a Pennsylvania district court, alleges the drugmakers conspired to fix, increase, stabilize or maintain prices of generic drugs, allocate customers and markets and rig bids for generic drugs in violation of federal and state antitrust and competition laws.”

What's the ROI on a COVID-19 vaccine? We have no idea, says Pfizer: The development cost and price of the vaccine are not yet known, so the projected ROI cannot be calculated. The interesting story here is how the vaccine is being developed and how it will be rolled out.

340B Program Reached $29.9 Billion in 2019; Now Over 8% of Drug Sales:”According to data provided to Drug Channels by the Health Resources and Services Administration (HRSA), discounted 340B purchases were at least $29.9 billion in 2019. That figure is an astonishing 23% higher than its 2018 counterpart. Since 2014, purchases under the 340B program have tripled.”

Pharmacist-Recommended Product Rankings: “Thousands of pharmacists nationwide were surveyed to pinpoint their recommendations on a range of over-the-counter products. U.S. News, in collaboration with Pharmacy Times, has compiled their responses to show how different brands stack up in more than 130 over-the-counter product categories.”

Personalized Mapping of Drug Metabolism by the Human Gut Microbiome: “The human gut microbiome harbors hundreds of bacterial species with diverse biochemical capabilities. Dozens of drugs have been shown to be metabolized by single isolates from the gut microbiome, but the extent of this phenomenon is rarely explored in the context of microbial communities. Here, we develop a quantitative experimental framework for mapping the ability of the human gut microbiome to metabolize small molecule drugs: Microbiome-Derived Metabolism (MDM)-Screen.”

About healthcare IT

Frequency and Types of Patient-Reported Errors in Electronic Health Record Ambulatory Care Notes: “In this survey study of 136 815 patients, 29 656 provided a response, and 1 in 5 patients who read a note reported finding a mistake and 40% perceived the mistake as serious. Among patient-reported very serious errors, the most common characterizations were mistakes in diagnoses, medical history, medications, physical examination, test results, notes on the wrong patient, and sidedness…
Older and sicker patients were twice as likely to report a serious error compared with younger and healthier patients, indicating important safety and quality implications. Sharing notes with patients may help engage them to improve record accuracy and health care safety together with practitioners.”

FCC Proposes $225M Fine for Spoofed Robocalls and State AGs Follow Suit: “Continuing its campaign against illegal robocalls, particularly the spoofed variety, the Federal Communications Commission (FCC) on June 9, 2020, proposed a $225 million fine – the “largest in the FCC’s 86-year history” – against Texas-based health insurance telemarketers for apparently making approximately 1 billion illegally spoofed robocalls.”

QR codes could provide patients way to keep them out of emergency rooms: Putting a QR code on a child’s cast so parents could scan it for instructions was found to reduce ER visits.

About the public’s health

Annual costs for diagnostic tests up to $25B, antibody tests up to $19B: “The estimated annual cost for diagnostic testing of COVID-19 will range from $6 billion to $25.1 billion, and the cost for antibody testing could vary from $5.2 billion to $19.1 billion, a new study found…
The estimates include both the costs for providing the test itself and any other affiliated healthcare costs like a trip to urgent care.”

Virologists vigorously debunk new study on origins of the novel coronavirus: “Despite overwhelming scientific consensus that the novel coronavirus came from nature, various scientific and pseudo-scientific claims have continued to fan the flames of a conspiracy theory that the virus was engineered in a Chinese lab.”

Coronavirus vaccine developers have a ‘bizarre’ problem. There’s not enough sick people:”The top teams rushing to develop coronavirus vaccines are alerting governments, health officials and shareholders that they may have a big problem: The outbreaks in their countries may be getting too small to quickly determine whether vaccines work..”

J&J moves up COVID-19 vaccine trial to second half of July: The successful trials are going so well that the company is moving up its timetable by two months.

Coronavirus Vaccine Candidates’ Pivotal U.S. Testing to Start This Summer: Other companies are also progressing rapidly on vaccine development.

Moderna, Merck execs see possible speed bumps in COVID-19 vaccine manufacturing:”…behind the scenes, execs at some of the leading players are intensely focused on the details needed to produce the candidates on a massive scale.
For instance? Sourcing raw materials and assembling the labor force needed to produce hundreds of millions of shots in record time, execs for Moderna and Merck said at BIO’s digital conference this week.”

Third of Americans Say They Won't Get a COVID-19 Vaccine, with Black Americans the Most Skeptical: Vaccine development and manufacturing are only the first parts to the solution. “Of the 1,003 U.S. adults who took part in the nationally representative telephone survey, 29 percent said they definitely would get a vaccine if and when one becomes available, while 35 percent said they are unlikely to or definitely would not.”

Association Between Adult Acne and Dietary Behaviors: “In this study, consumption of milk, sugary beverages, and fatty and sugary products appeared to be associated with current acne in adults. Further large-scale studies are warranted to investigate more closely the associations between diet and adult acne.”

Association of Low-Value Testing With Subsequent Health Care Use and Clinical Outcomes Among Low-risk Primary Care Outpatients Undergoing an Annual Health Examination: “Low-value care, or health care services that do not improve patient outcomes or for which harms appear to outweigh the benefits, is estimated to cost the US health care system between $75.7 and $101.2 billion annually.”
This study only looked at overuse of three tests: chest x-rays, an electrocardiogram (ECG) and Papanicolaou (PAP) test done as part of an “annual health exam.” The point of this study was to show that when these tests are done on low risk patients, a large number of unnecessary tests and consultations result.

About health insurance

18 Million Americans Lack Adequate Health Insurance While Facing Greater Risk of Severe Coronavirus, Study Finds: “More than 18 million Americans, most of whom are minorities and low-income individuals, are uninsured or underinsured while also being at increased risk of developing severe cases of COVID-19, a new study by researchers at Harvard Medical School and CUNY's Hunter College has shown.”

Certain Medical Care Arrangements: “This document contains proposed regulations relating to section 213 of the Internal Revenue Code (Code) regarding the treatment of amounts paid for certain medical care arrangements, including direct primary care arrangements, health care sharing ministries, and certain government-sponsored health care programs. The proposed regulations affect individuals who pay for these arrangements or programs and want to deduct the amounts paid as medical expenses under section 213.”
For a summary and analysis of the regulations, see: New Proposed Rule On Health Care Sharing Ministries And Direct Primary Care.

Today's News and Commentary

About hospitals

COVID-19 shouldn't lead to 'opportunistic' health mergers, biz groups say: “Now that healthcare providers have received billions in federal aid to offset their COVID-19 losses, some business groups, regulators and lawmakers want to ensure the money doesn’t fuel a wave of predatory consolidation.” 
For example: “The Pacific Business Group on Health, a consortium of 41 private employers and public purchasers that together spend $100 billion annually providing healthcare to 15 million people, has asked Congress to make healthcare providers pledge not to engage in M&A for 12 months as a condition of receiving aid from the Coronavirus Aid, Relief, and Economic Security Act.”

Henry Ford, Michigan State sign affiliation letter of intent: “Henry Ford Health System in Detroit and Michigan State University in East Lansing have signed a nonbinding letter of intent to create a primary affiliation to share research and clinical care, increase health student education and develop a long-term plan to build a joint research institute in Detroit.”

About healthcare IT

UnitedHealth execs: Patients are using telehealth for convenience, not as a necessity: “According to data from UnitedHealth Group and consumer research company CivicScience, 29% of consumers said they used telehealth in May up from 8% in December. The percentage of consumers who don't plan to use telehealth dropped from 72% in December to 47% in May, according to a consumer poll.
While COVID-19 visits accounted for nearly 1 in 5 virtual visits in March, that dropped to only 4% of visits in May.
In March, less than half (45%) of consumers cited convenience and speed as their primary reasons for using the technology, and that grew to 66% in May.”

About the public’s health

Centers for Medicare & Medicaid Services (CMS) Recommendations Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: “…if States or regions have determined with their public health officials that they passed the Gating Criteria (symptoms, cases, and hospitals) announced on April 16, 2020, then they may proceed to Phase I, and subsequently to Phase II of re-opening.” This site has CMS guidelines for the re-openings.

Does Speaking Japanese Lower The Risk of Spreading Coronavirus? This article is really interesting.

Price Limits Will Scare Off Covid Vaccine Makers, Fauci Warns: “Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the US government should not force drugmakers to lower the costs of COVID-19 vaccines and treatments, but should encourage fair pricing…”

COVID-19–linked syndrome in kids new, distinct, studies suggest: “Two new studies involving a total of 75 children published yesterday in JAMA showed that the pediatric multisystem inflammatory syndrome linked to COVID-19 is novel and different from Kawasaki disease (KD) and toxic shock syndrome (TSS).” The links to the studies are in the article.

This past week, the WHO was not at its best. Here are two articles that explain the issues very well:

WHO Creates 'Confusion' About Asymptomatic Spread. Here's What We Know: The WHO has backtracked on its statement that coronavirus transmission by asymptomatic people is rare.

Who’s to blame? These three scientists are at the heart of the Surgisphere COVID-19 scandal: With respect to the previously-reported withdrawn studies about hydroxychloroquine, this article provides an in-depth profile of the principals behind the scandal.

International Health Care System Profiles: The Commonwealth Fund just published its latest update on 20 international healthcare systems. It is a great resource for this topic.

About health insurance

The Implications of Medicaid Expansion in the Remaining States: 2020 Update: “Even absent the current COVID-19-related economic crisis, if the 15 holdout states had expanded Medicaid eligibility as envisioned under the ACA, 3.9 million fewer people would have been uninsured.”

Today's News and Commentary

About the public’s health

WHO says asymptomatic people usually don't spread coronavirus. Experts doubt that.: This story is all over the media because of its implications on containing the outbreak. Here is the essence of the debate: “ key experts in the United States say the WHO's conclusion presents some big problems. 
It's not that asymptomatic people don’t spread the virus — but that contact tracing is simply bad at detecting it, they argue. The studies cited by WHO relied on only a small number of people in China who claimed to have gotten sick from someone who had symptoms – which is not exactly a rigorous scientific experiment.
They also worry that their findings will lead to confusion.There's a difference between people who truly never showed symptoms of coronavirus and people who were ‘pre-symptomatic,’ who had not yet developed symptoms but eventually would. Then, of course, there are ‘low-symptomatic’ people who are experiencing effects of coronavirus so mild they might not be noticed.”

When 511 Epidemiologists Expect to Fly, Hug and Do 18 Other Everyday Activities Again: The NY Times asked 511 epidemiologist when they expected to re-engage in a number of activities. The answers make interesting reading.

Negative thinking linked to dementia in later life, but you can learn to be more positive: Really, don’t worry, be happy.A new study found that repetitive negative thinking in later life was linked to cognitive decline and greater deposits of two harmful proteins responsible for Alzheimer's disease.”

FDA authorizes COVID-19 saliva test by Phosphorus Diagnostics: “The U.S. Food and Drug Administration on Monday allowed emergency use of a COVID-19 saliva test made by privately held Phosphorus Diagnostics LLC that allows people to send in their saliva samples to the company’s laboratory for testing. 
The company’s sample collection kit, priced at around $140, would be delivered to customers if they are found eligible after completing an online questionnaire.”

Poll: Pandemic does little to alter US views on health care: This AP-NORC poll “found that people are more likely to trust private entities over government at driving innovation in health care (70% to 28%), improving quality (62% to 36%) and providing insurance coverage (53% to 44%). Americans had more confidence in government’s ability to reduce costs, preferring it over the private sector 54% to 44%. All of those preferences are unchanged since before COVID-19 arrived…
While about 3 in 5 said they were very or extremely concerned about Americans in general having access to high quality care, people were less likely than in February to say they were greatly concerned about having access to quality care for themselves (46% to 58%) and about their own health care spending (35% to 44%).”

Social distancing across vulnerability, race, politics, and employment: How different Americans changed behaviors before and after major COVID-19 policy announcements: When it comes to motivating people to social distance practices, one size does not fit all. This research found that the “variation in behavioral drivers including vulnerability, race, political affiliation, and employment industry demonstrates the need for targeted policy messaging and interventions tailored to address specific barriers for improved social distancing and mitigation.”

CMS testing guidelines for uninsured: 5 things to know: “CMS issued a document that outlines state requirements for covering the cost of COVID-19 testing for uninsured Americans, and lists flexibilities that states can use to meet the requirements. “

CDC wants states to count ‘probable’ coronavirus cases and deaths, but most aren’t doing it: “Fewer than half the states are following federal recommendations to report probable novel coronavirus  cases and deaths, marking what experts say is an unusual break with public health practices that leads to inconsistent data collection and undercounts of the disease’s impact.
A Washington Post review found that the states not disclosing probable cases and deaths include some of the largest: California, Florida, North Carolina and New York.”

About pharma

AbbVie's Humira defense may keep prices high, but it's still legal, judge rules: “While AbbVie’s deals with biosimilar companies preserve high prices in the U.S. for several years, the company's strategy doesn't amount to an antitrust violation, U.S. District Judge Manish Shah wrote in an order Monday. “ The strategy the company is using is called a patent thicket. “With that thicket, the company sued companies seeking to market biosimilars and then inked deals to keep competing products off the U.S. market until 2023. As part of those deals, AbbVie gave biosim companies permission to launch in Europe despite existing patents there…”

Stanford team deploys CRISPR gene editing to fight COVID-19: “Bioengineers at Stanford University were working on a system to fight the flu with the gene-editing technology CRISPR when the COVID-19 pandemic emerged in January. So they quickly pivoted to address the new disease—and now they’re reporting they’ve developed a way to inhibit 90% of coronaviruses, including SARS-CoV-2, the cause of COVID-19.”

As COVID-19 social media fatigue sets in, pharma begins to restart other health conversations: “COVID-19 fatigue is setting in with many people, and for pharma companies, that means an opportunity to return to social media messages on other health topics.
Evoke Kyne and its new social media chief Kate Callan have been tracking social media conversations throughout the crisis, and the latest numbers show a 65% drop in global conversations around COVID-19, from 204 million weekly mentions in mid-March to just 71 million in late May. The mood around those conversations is also shifting away from disgust, which is still the top feeling at 34%, toward feelings such as anticipation, now at trending at 15% of the conversation mood.”

About hospitals

World’s best hospitals 2020: In this Newsweek list, five of the top six hospitals are in the US.

About health insurance

N.Y. insurers request nearly 12% increase in premiums: “New York insurers selling plans to individuals asked the state to raise rates by a weighted average of 11.7% with some citing COVID-19 as necessitating higher premiums in 2021.
Oscar sought the largest premium increase on average in the individual market at 19.1%…”

Today's News and Commentary

About healthcare IT

GAO: Mar-a-Lago members acted as advisers on VA initiatives, including $16B Cerner EHR contract: “Three members of President Donald Trump's inner circle acted as advisers by making recommendations on a number of key Department of Veterans Affairs (VA) initiatives, including the Cerner contract, a government watchdog said.
A Government Accountability Office (GAO) report publicly released this week said a review of email exchanges between Florida physician Bruce Moskowitz, Marvel Entertainment Chairman Isaac Perlmutter and financial consultant Marc Sherman indicated the three interacted with VA and other federal officials frequently—at times daily, according to former VA officials—through email and telephone, the GAO wrote.
’The three private citizens acted as advisors by making recommendations regarding, for example, the Cerner contract negotiation, mobile application development, and potential candidates for senior-level VA positions,’ according to the report.”

About healthcare personnel

Hospitals continue to struggle with job losses as other areas of healthcare rebound in May:”Healthcare employment increased by 312,000 in May, but hospitals still lost 27,000 jobs, according to a report issued today from the U.S. Bureau of Labor Statistics.
Job losses continued for hospitals and also for nursing and residential care facilities, which lost 37,000 jobs.
Physicians saw an increase of 51,000 jobs, and dentists and other health practitioners saw increases of 245,000 and 73,000, respectively.”

About the public’s health

Gargling with bleach? Americans misusing disinfectants to prevent coronavirus, survey finds: “More than a third of Americans misused cleaners and disinfectants to try to prevent infection by the coronavirus, according to a survey taken shortly after President Donald Trump publicly asked whether injecting such products could treat COVID-19. 
Washing food with bleach, using household cleaning or disinfectant products on bare skin, and intentionally inhaling or ingesting these products were some of the most commonly reported ‘high-risk’ practices in a May 4 online survey of 502 U.S. adults, the Centers for Disease Control and Prevention (CDC) reported.”

And on a related note: Bleach baths and drinking hand sanitiser: poison centre cases rise under Covid-19: The headline speaks for itself. The article has more of an international scope than the one above.

Associations of Flavored e-Cigarette Uptake With Subsequent Smoking Initiation and Cessation: “Vaping uptake was positively associated with smoking initiation in youth…and in emerging adults... Vaping uptake was associated with cessation in adults…
adults who vaped flavored e-cigarettes were more likely to subsequently quit smoking than those who used unflavored e-cigarettes.”

The effect of large-scale anti-contagion policies on the COVID-19 pandemic: The researchers estimate that these well-known measures employed “across these six countries… prevented or delayed on the order of 62 million confirmed cases, corresponding to averting roughly 530 million total infections.” Of those prevented infections, an estimated 62 million were in the US.

Cuba sets example with successful programme to contain coronavirus: “While the WHO has signaled that Latin America is the new centre of the pandemic, cases in the Communist-ruled island have fallen for two months.” Cuba’s primary care system is a model for public health initiatives.

Coronavirus: WHO advises to wear masks in public areas: The important recommendation that is really new is: Fabric masks should consist of "at least three layers of different material" in order to be effective.

With No Current Cases, New Zealand Lifts Remaining COVID-19 Restrictions: A further reminder what a successful program looks like: “New Zealand Prime Minister Jacinda Ardern says the country has officially eradicated COVID-19 and will return to normal after the last known infected person recovered.
Isolation and quarantine for those arriving from abroad will continue.”

BARDA taps Evidation Health to digitally monitor healthcare workers for early COVID-19 symptoms:”The project will receive funding support from the Biomedical Advanced Research and Development Authority (BARDA) as well as the Bill & Melinda Gates Foundation.
Evidation plans to gather behavior and symptom data—including sleep and activity patterns from wearable devices, plus self-reported health issues—from 300 people with a high risk of being exposed to and possibly contracting the disease, such as healthcare workers and first responders.”

Repositioning of the global epicentre of non-optimal cholesterol:”…countries with the highest level of non-HDL cholesterol—which is a marker of cardiovascular risk—changed from those in western Europe such as Belgium, Finland, Greenland, Iceland, Norway, Sweden, Switzerland and Malta in 1980 to those in Asia and the Pacific, such as Tokelau, Malaysia, The Philippines and Thailand. In 2017, high non-HDL cholesterol was responsible for an estimated 3.9 million (95% credible interval 3.7 million–4.2 million) worldwide deaths, half of which occurred in east, southeast and south Asia.”

California and Some Other States See Coronavirus Cases Rise:”Nearly three months since the U.S. declared a national emergency over the new coronavirus, some states are reporting a rise in new cases as they lift restrictions meant to slow the virus’s spread.
California, Utah, Arizona, North Carolina, Florida, Arkansas and Texas, among others, have all logged rises in confirmed cases, according to a Johns Hopkins tabulation of a five-day moving average. Meantime, New York City, the U.S. area hit hardest by the pandemic, has seen a drop in cases and deaths and plans to begin reopening its economy Monday.”

About pharma

The US government's supply of the only proven Covid-19 drug runs out at the end of the month: “The US government's current supply of remdesivir, the only drug known to work against Covid-19, will run out at the end of the month, Dr. Robert Kadlec, a US Department of Health and Human Services official, told CNN. 
The government's last shipment of the drug will go out the week of June 29. Gilead Sciences, the company that makes the drug, is ramping up to make more, but it's unclear how much will be available this summer.”

The top 10 pharma R&D budgets in 2019: A good summary of who is working on what and how much they are spending. Roche heads the list.

Optum says payers should keep a close eye on these 3 drugs. Here's why: All three are orphan drugs.

About health insurance

COVID-19 Cost Scenario Modeling: Treatment: Wakely prepared this latest update for AHIP, estimating costs of COVID-19 to the insurance industry. “Our previous report estimated the direct impact of COVID treatment costs to be between $56 and $556 billion, while the updated analysis estimates costs of $30 to $547 billion. Incorporating deferred care with the treatment costs generally decreases the overall impact to insurers, resulting in a total impact of between -$76 and $216 billion for 2020 and 2021 combined.”

Today's News and Commentary

About healthcare professionals

Where Is the ID in COVID-19?: “Among the 785 counties with the highest quartile of COVID-19 disease burden… 521 (66.4%) have no ID [Infectious Disease] physician coverage.” This finding highlights shortages must not only be measured in sheer numbers but in geographic distribution, especially in areas of need.

About the public’s health

For your amusement:
Isaac Newton proposed curing plague with toad vomit, unseen papers show: The headline speaks for itself but the story is interesting.

HHS updates COVID-19 lab test data reporting requirements: 6 details:”HHS updated its guidance on the data that should be reported by laboratories as part of the COVID-19 test results…’The requirement to include demographic data like race, ethnicity, age, and sex will enable us to ensure that all groups have equitable access to testing, and allow us to accurately determine the burden of infection on vulnerable groups,’ said ADM Brett P. Giroir, MD, Assistant Secretary for Health..’” The requirements start August 1.

Singapore plans wearable virus-tracing device for all: “Singapore plans to give a wearable device that will identify people who had interacted with carriers of coronavirus to each of its 5.7 million residents, in what could become one of the most comprehensive contact-tracing efforts globally. 
Testing of the small devices, which can be worn on the end of a lanyard or carried in a handbag, follows limited take-up of an earlier smartphone-based system and has further fuelled privacy concerns about contact tracing technology.”

Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study: The FDA updated its approved test list. The list started last month; now two have been voluntarily removed.

Is Cardiovascular Disease Slowing Improvements in Life Expectancy?: From the King’s Fund and the OECD:

“Improvements in life expectancy at birth observed before the COVID-19 epidemic had slowed considerably in most OECD countries in recent years. Longevity gains fell on average 25%, when comparing the period between 2012 and 2017 to a decade earlier. One reason behind this is that cardiovascular disease (CVD) mortality improvements are now substantially lower than what they used to be in some countries. CVD is a major killer in OECD societies, causing many preventable deaths and large social inequalities…
Several reasons underpin this trend. For a start, the prevalence of underlying lifestyle risk factors that cause CVD is rising. Rising trends in obesity and diabetes are estimated to offset the mortality reductions attributed to favourable changes in smoking. OECD estimates that overweight-related diseases will reduce life expectancy by nearly three years by 2050, without further policy action. Furthermore, newly emerging risk factors are contributing to higher CVD mortality, like drug overdose and air pollution. Severe influenza outbreaks in some recent winters, as in 2014-15, could also have impacted on CVD mortality, as influenza and pneumonia can trigger cardiovascular events like heart attacks, and in turn, individuals with CVD may be more susceptible to dying from influenza or pneumonia.”

About health insurers

Anthem offering $2.5B in financial assistance to members, providers impacted by COVID-19: “Anthem will make premium credits of between 10% and 15% available to select individual market plans and fully insured commercial plans. Members enrolled in standalone and group dental plans will receive a 50% credit, Anthem announced Thursday. 
The credits will be provided in July, Anthem said.”

UnitedHealth invests $100M in building affordable housing: “UnitedHealth Group is investing $100 million in building affordable housing units that will also include on-site health services. 
The funding will build 1,000 homes for families and seniors in partnership with Stewards of Affordable Housing for the Future and the National Affordable Housing Trust. The initial batch of units will include 100 apartments in Washington, D.C., 40 apartments in Wharton, Texas, and 30 apartments in Choctaw, Oklahoma. 
UnitedHealth will also put $1 million toward on-site health and wellness services and tracking how access is impacting residents’ health.”

About pharma

Mylan and Lupin Receive European Clearance for Etanercept Biosimilar: “The approval was based on a biosimilarity assessment that demonstrated bioequivalence to Enbrel. In addition, a phase 3 trial in patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to Enbrel for safety, efficacy and immunogenicity.” A continued trend toward biosimilars will bring costs down.

Today's News and Commentary

About pharma

WHO to restart hydroxychloroquine trial after Chicago company’s data questioned: “An international trial using hydroxychloroquine to treat COVID-19 patients will be restarted after questions arose about a study linking the antimalarial drug to increased death and heart risks….
The move adds to the confusion that’s erupted since more than 200 scientists began questioning the study published May 22 [in The Lancet]. Scrutiny has focused on Surgisphere Corp., the Chicago-based firm that provided data for the investigation, with demands for more transparency about its sources and methods of analysis.”
This afternoon, the authors of The Lancet study withdrew their article.

About the public’s health

The C.D.C. Waited ‘Its Entire Existence for this Moment.’ What Went Wrong?: This article from The NY Times has been widely cited in other media outlets and is a great review of the headline topic.

Impact of the COVID-19 Pandemic on Emergency Department Visits — United States, January 1, 2019–May 30, 2020: From the CDC:
The National Syndromic Surveillance Program (NSSP) collects electronic health data in real time…
NSSP found that emergency department (ED) visits declined 42% during the early COVID-19 pandemic, from a mean of 2.1 million per week (March 31–April 27, 2019) to 1.2 million (March 29–April 25, 2020), with the steepest decreases in persons aged ≤14 years, females, and the Northeast. The proportion of infectious disease–related visits was four times higher during the early pandemic period.”

About health insurance

CMS Innovation Center Models COVID-19 Related Adjustments: In response to the COVID-19 pandemic, CMS is making changes to payment models, including bundled payments and ACOs. This chart is a great summary of the payment and quality assessment changes.

Today's News and Commentary

About healthcare devices

Lumendi reports its first 'incisionless appendectomy' procedure: “Lumendi’s disposable DiLumen system attaches to a traditional, standard endoscope and helps stabilize the device’s movements and the surrounding organ, allowing the procedure to be performed completely within the intestine.”

About pharma

Hydroxychloroquine, a drug promoted by Trump, failed to prevent healthy people from getting covid-19 in trial:”The study is the first randomized clinical trial that tested the antimalarial drug as a preventive measure, according to researchers at the University of Minnesota Medical School who conducted the trial. It showed that hydroxychloroquine, which has been touted by President Trump, was no more effective than a placebo — in this case, a vitamin — in protecting people exposed to covid-19.”

Effect of low‐dose aspirin on health outcomes: An umbrella review of systematic reviews and meta‐analyses: Here is the latest on the controversy of using low dose aspirin as primary prevention for cardiovascular disease (CVD). The benefit is a balance between preventing CVD events (like heart attack and stroke) and causing serious bleeding: “…the benefits and risks of low‐dose aspirin for the primary prevention of CVD events in the modern era of preventive management in middle‐aged people (i.e., involving statins, anti‐hypertension medications, smoking cessation, obesity management and other similar interventions) are closely balanced, calling into question the use of aspirin in those without a prior cardiovascular disease event.”

About the public’s health

Ultra-high-throughput clinical proteomics reveals classifiers of COVID-19 infection: This diagnostic process could help focus on patients who might require the most care.
“We use our platform on samples collected from a cohort of early hospitalized cases of the SARS-CoV-2 pandemic and identify 27 potential biomarkers that are differentially expressed depending on the WHO severity grade of COVID-19. They include complement factors, the coagulation system, inflammation modulators, and pro-inflammatory upstream and downstream of interleukin 6. All protocols and software for implementing our approach are freely available. In total, our platform supports the development of routine proteomic assays to aid clinical decision making and generate hypotheses about potential COVID-19 therapeutic targets.”

Fauci says he's 'cautiously optimistic' about Moderna COVID-19 vaccine: “Infectious disease expert Anthony Fauci, M.D., says he's "cautiously optimistic" about biotech company Moderna's COVID-19 vaccine candidate.
But he believes a successful COVID-19 vaccine will not be a ‘one and done’ and will require a booster dose to provide immunity.”

China delayed releasing coronavirus info, frustrating WHO: “Chinese government labs only released the genome after another lab published it ahead of authorities on a virologist website on Jan. 11. Even then, China stalled for at least two weeks more on providing WHO with detailed data on patients and cases, according to recordings of internal meetings held by the U.N. health agency through January — all at a time when the outbreak arguably might have been dramatically slowed.
WHO officials were lauding China in public because they wanted to coax more information out of the government, the recordings obtained by the AP suggest. Privately, they complained in meetings the week of Jan. 6 that China was not sharing enough data to assess how effectively the virus spread between people or what risk it posed to the rest of the world, costing valuable time.”

Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis:“Our search identified 172 observational studies across 16 countries and six continents, with no randomised controlled trials and 44 relevant comparative studies in health-care and non-health-care settings… Transmission of viruses was lower with physical distancing of 1 m or more, compared with a distance of less than 1 m… ; protection was increased as distance was lengthened…Face mask use could result in a large reduction in risk of infection… with stronger associations with N95 or similar respirators compared with disposable surgical masks or similar (eg, reusable 12–16-layer cotton masks…)”

Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions: These draft recommendations from the USPTF are now open for comment. One industry-influencing recommendation: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of electronic cigarettes (e-cigarettes) for tobacco cessation in adults, including pregnant persons.”

Coronavirus fact check: Does the ‘recycled’ air on planes really put you at a high risk of infection?: This article is a really good summary of air quality issues on planes- better than you thought but not as good as you would like it to be.

About health insurance

Which Types of Insurance are Marketplace Enrollees Choosing?: Key findings from this Urban Institute study:
“Health plans issued by Blue Cross Blue Shield companies accounted for nearly half (47%) of the Affordable Care Act marketplace enrollment in 2018, but Medicaid health plans are emerging as competition.

  • Blue Cross Blue Shield-affiliated insurers hold all or close to all of the enrollment in 11 states’ marketplaces (Alaska, Alabama, Delaware, Illinois, Louisiana, North Carolina, North Dakota, New Hampshire, Oklahoma, South Carolina, Wyoming).

  • In another nine states (Arkansas, Florida, Hawaii, Kansas, Michigan, New Jersey, Pennsylvania, Tennessee, West Virginia), Blue Cross Blue Shield plans have the majority of enrollment, though they face increasing competition from other insurer types, typically Medicaid insurers.”

DHHS Office of the Inspector General Semiannual Report to Congress October 1, 2019-March 31, 2020: “During this semiannual reporting period (October 1, 2019, through March 31, 2020), we issued 81 audit reports and 14 evaluation reports. Our audit work identified $605.2 million in expected recoveries, as well as $288.4 million in questioned costs (costs questioned by OIG because of an alleged violation, costs not supported by adequate documentation, or the expenditure of funds where the intended purpose is unnecessary or unreasonable). Our audit work also identified $911.3 million in potential savings for HHS— funds that could be saved if HHS implemented all of OIG’s audit recommendations. “

Why COVID-19 is spurring 'buzz' among employers about reference-based pricing: The interesting facts from this article are that: “…employers spent an average of 241% of Medicare for care in 2017, paying 204% higher than Medicare rates for inpatient care and 293% higher for outpatient care.” In my experience, these rates are much higher than PPO rates, which are often no higher than 150% of Medicare rates. Why have Third Party Administrators for these plans allowed providers to get away with charging so much when they pay far less for their own insured products? 

About the business of healthcare

5 of healthcare's next billion-dollar startups from 2020 Forbes list: Here is a list of these 5 healthcare companies from the Forbes list. It is a real mix of products and services.

About hospitals/health facilities

Physicians acquire 35-hospital health system from private equity firm: “Dallas-based Steward Health Care is now the largest physician-owned healthcare system in the U.S.

Humana Launches Medicare Clinic Expansion In Three Cities: “Humana’s Partners in Primary Care unit will open 20 new senior-focused primary care centers over the next year in the new markets of Las Vegas and Louisiana plus a major expansion in Houston.
It’s the first wave of a three-year expansion of the geographic footprint for Humana’s Partners in Primary Care since the health insurer and private equity giant Welsh, Carson, Anderson & Stowe earlier this year announced a $600 million joint venture to develop primary care centers to treat seniors insured by Medicare Advantage plans.The 35-hospital system announced June 2 that a management group of Steward physicians led by the company's CEO and founder acquired a controlling interest of Steward from Cerberus Capital Management, a private equity firm. The physicians will control 90 percent of the company and Medical Properties Trust will maintain its 10 percent stake.”

Today's news and Commentary

About health insurance

Medicare Advantage, Part D plans face uncertain healthcare world under COVID-19 as they develop bids: Part D plan bids are due today and the media is focusing on the uncertainty of costs due to COVID-19. However, I have not seen any evidence that outpatient prescription drug use is increased or costs are higher during the pandemic. The real incremental costs seem to be for inpatient care, paid by
Part A under the DRG scheme.

Insurers Continue to Waive Customer Costs for Virus Tests, Care: “Health insurance companies are extending practices that ensure beneficiaries can receive free Covid-19 testing and treatment during the pandemic.
At least five insurers, including Aetna and Cigna, have decided to lengthen the period for which they would waive out-of-pocket costs related to the coronavirus past the initial June 1 end date, according to America’s Health Insurance Plans, an industry trade group.”

Trends in Insulin Out-of-Pocket Costs and Reimbursement Price Among US Patients With Private Health Insurance, 2006-2017: Health policy makers have said insulin costs are becoming unaffordable for most diabetics taking the medication. In response, CMS has placed a limit on out of pocket payments for Part D plans. But according to this study: “Although the findings in this study contradict the view that insulin cost-sharing is excessive for many privately insured patients, monthly out-of-pocket payments may be burdensome for low-income individuals. Nevertheless, the data suggest that privately insured patients have been relatively shielded from insulin price increases and that commercial health insurers have accommodated higher insulin prices by increasing premiums or deductibles for all members.”

More states moving to operate their own health exchanges: Uninsured rising: “Among the states transitioning to or considering creating their own marketplaces are Maine, New Jersey, New Mexico, Oregon and Pennsylvania.”

Out-Of-Network Spending Mostly Declined In Privately Insured Populations With A Few Notable Exceptions From 2008 To 2016: The bottom line of this research is that patients are increasingly using in-network physicians when they have a choice. The real problem is “surprise” billing for emergencies or when patients go to contracted facilities but employed physicians are not contracted.

The Potential Health Care Costs And Resource Use Associated With COVID-19 In The United States: “A single symptomatic COVID-19 case could incur a median direct medical cost of $3,045 during the course of the infection alone… If 20 percent of the US population were to get infected, there could be a median of 11.2 million hospitalizations, 2.7 million ICU admissions, 1.6 million patients requiring a ventilator, 62.3 million hospital bed days, and $163.4 billion in direct medical costs over the course of the pandemic.”

About the public’s health

Quest Diagnostics' self-collection COVID-19 test kit gets FDA nod for emergency use: “Quest Diagnostics received emergency use authorization for its self-collection COVID-19 test kit from the FDA.
The company intends more than a half-million test kits to be available by end of June, with plans to make additional kits available on an ongoing basis…The test kit was designed for self-collection by individuals, at home, with a consumer-friendly nasal swab approach, the company said.” But how good is the self-collection process?

Coronavirus may never go away, even with a vaccine: As COVID-19 becomes “endemic,” this article discusses what we should be doing to be able to live with it. As Tom Frieden, former director of the Centers for Disease Control and Prevention said: .”The one thing we have to do is to understand that there is not one thing. We need a comprehensive battle strategy, meticulously implemented.”

Concern About COVID-19 at Medical Facilities Drops: From Gallup: “As the national COVID-19 curve has flattened in the U.S., fewer Americans are concerned about being exposed to the virus while receiving necessary medical treatment. Although 64% of Americans are very (22%) or moderately (42%) concerned, this marks a 20-percentage-point drop from late March/early April.”

Despite widespread economic toll, most Americans still favor controlling outbreak over restarting economy, Post-ABC poll finds: This latest poll has many opinions about Trump v. Biden. Question 18 asks: “What do you think is more important – (trying to control the spread of the coronavirus, even if it hurts the economy), or (trying to restart the economy, even if it hurts efforts to control the spread of the virus)? Do you feel that way strongly or somewhat?” 57% said they felt strongly or somewhat that they preferred to control the spread of COVID-19; 37% preferred to restart the economy.

About healthcare quality

Some Regular Surveys and Review Activities Resuming With Extra Safety Considerations in June: This link explains what The Joint Commission will be doing as it resumes accreditation activities this month.

About hospitals

Covenant breaches to rise amid coronavirus but for most, credit quality likely unaffected: From Moody’s: “Covenant violations will likely rise because hospitals' revenues have declined dramatically, by an average of 30%-40%, because of the suspension of elective procedures amid the coronavirus outbreak…A covenant violation, or technical default, means that a borrower has not met required financial covenants, including debt service coverage and days cash on hand, found in borrowing agreements such as Master Trust Indentures (MTIs) and bank agreements, often called Continuing Covenant Agreements. A technical default, which is not a payment default, would pose a risk to bondholders if investors or lenders elect to accelerate debt in the face of the default. “

About pharma

Lilly Begins World's First Study of a Potential COVID-19 Antibody Treatment in Humans:”This investigational medicine, referred to as LY-CoV555, is the first to emerge from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in just three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19…
The first patients in the study were dosed at major medical centers in the U.S., including NYU Grossman School of Medicine and Cedars-Sinai in Los Angeles.”

Hydroxychloroquine or Chloroquine for Treatment or Prophylaxis of COVID-19: A Living Systematic Review: “There were few controlled studies, and control for confounding was inadequate in observational studies…Evidence on the benefits and harms of using hydroxychloroquine or chloroquine to treat COVID-19 is very weak and conflicting.”

Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19: Gilead announced: “We now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures. Today’s results showed that when treating moderate disease, a 5-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir’s benefit to previously released study results.”

About healthcare IT

Telehealth: A quarter-trillion-dollar post-COVID-19 reality?: “Pre-COVID-19, the total annual revenues of US telehealth players were an estimated $3 billion, with the largest vendors focused in the ‘virtual urgent care’ segment: helping consumers get on-demand instant telehealth visits with physicians (most likely, with a physician they have no relationship with). With the acceleration of consumer and provider adoption of telehealth and extension of telehealth beyond virtual urgent care, up to $250 billion of current US healthcare spend could potentially be virtualized.”

Today's News and Commentary

About the public’s health

The effect of state-level stay-at-home orders on COVID-19 infection rates: Yes, stay-at-home procedures work. New cases of COVID-19 decreased by 58 percent in states that implemented the recommendation.

How risky is it to…? An interesting read from Politico that “provides a snapshot of where Americans see the most danger — and where they’re most out of sync with experts.” Differences are also apparent between Democrats and Republicans.  

Some Countries Have Brought New Cases Down To Nearly Zero. How Did They Do It?: A good international survey of what successful countries did to curb COVID-19. Common elements were early identification of the problem, politically unified responses using prepared plans, and isolation procedures.

US cuts World Health Organization ties over virus response:”President Donald Trump said Friday that the U.S. will be terminating its relationship with the World Health Organization, saying it had failed to adequately respond to the coronavirus because China has “total control” over the global organization.
He said Chinese officials “‘gnored’ their reporting obligations to the WHO and pressured the WHO to mislead the world when the virus was first discovered.
He noted that the U.S. contributes about $450 million to the world body while China provides about $40 million.”

The Trump campaign is creating an alternate reality online about coronavirus | The Fact Checker: This youtube video (produced by the Washington Post fact checkers) details how the administration’s narrative changed the sequence of events in response to COVID-19.

Some Coronavirus Patients Test Positive For Weeks. Interpret Those Results With Caution: “RNA can… be present, and therefore, detected by PCR after a virus has broken down (i.e., become non-infectious) and released its genome into host cells or body fluids. From prior experience with other infectious diseases, we know that PCR tests can be positive for days or weeks after a patient has recovered from the illness and is no longer infectious.
As more testing is being performed for Covid-19, we are learning that some patients can test positive for weeks following their initial diagnosis.”

About health insurance

IRS sets 2021 limits for HSAs: The content is self-explanatory.

Pandemic upends state plans to expand health insurance: The high costs of COVID-19 responses have caused a number of states to halt or reconsider insurance expansion ,such as Medicaid eligibility/benefits/funding.

Association of State Medicaid Expansion With Hospital Community Benefit Spending: In this study, Medicaid expansion was associated with a decrease in nonprofit hospitals’ burden of providing uncompensated care, but this financial relief was not redirected toward spending on other community benefits.”

About pharma

An open letter to Mehra et al and The Lancet: The letter was sent by a long list of international scientists who criticized the methodology of the hydroxychloroquine study that The Lancet recently published.

About healthcare IT

Where Microsoft is headed in healthcare: A brief discussion of MIcrosoft’s healthcare plans. For example: “The company reported 34 million healthcare interactions on Microsoft Teams during the pandemic and has co-developed healthcare-specific solutions with partners including the CDC, Allscripts, Humana, Renton, Wash.-based Providence, Walgreens Boots Alliance and Nuance.”

National Trends in the Safety Performance of Electronic Health Record Systems From 2009 to 2018: “These findings suggest that despite broad adoption and optimization of EHR systems in hospitals, wide variation in the safety performance of operational EHR systems remains across a large sample of hospitals and EHR vendors. Hospitals using some EHR vendors had significantly higher test scores. Overall, substantial safety risk persists in current hospital EHR systems.”

About diagnostics

FDA approves Eli Lilly’s Tauvid dye, its first for mapping Alzheimer’s tau tangles: “The FDA approved its first radioactive diagnostic dye designed to map out the characteristic tau protein tangles found in the brains of people with Alzheimer’s disease—information that previously required an autopsy.” The dye is used with PET scans. This technology could be a major breakthrough in diagnosis if patterns are shown to be unique to this disease.

FDA greenlights ICU AI for predicting fatal COVID-19 complications:”The FDA granted an emergency authorization to CLEW Medical’s remote data monitoring system to help predict and identify COVID-19 patients under intensive care who are most at risk for respiratory failure or insufficient blood flow.
The company’s CLEWICU artificial intelligence software ingests a large range of patient data by linking to electronic medical records, connected medical devices and vital sign monitors, with no need for additional data entry by ICU staff. 
In addition to alerting providers to a patient’s potentially deteriorating condition as a diagnostic aid, the system’s real-time risk classification model also predicts which patients may not require any interventions within an eight-hour period. “
Obviously this technology can be used for other diseases as well.

Today's News and Commentary

About the public’s health

Dr. Fauci: Second wave isn't inevitable if we do this: In a video interview he says we need to follow the science (masks, social distancing, etc.) and not open up public activities too early. Oh, yes…and hydroxychloroquine does not work against SARS-CoV-2

WHO creates foundation to boost funding in coronavirus fight: “The World Health Organization announced on Wednesday the creation of a foundation to tap new sources of funding that could help ease a potential cash shortage as it leads the global fight against the coronavirus pandemic.”

Comparison of Clinical Characteristics of Patients with Asymptomatic vs Symptomatic Coronavirus Disease 2019 in Wuhan, China: “Our finding…suggests that damage to the immune system in asymptomatic infections was milder compared with symptomatic infections. Although patients who were asymptomatic experienced less harm to themselves, they may have been unaware of their disease and therefore not isolated themselves or sought treatment, or they may have been overlooked by health care workers and thus unknowingly transmitted the virus to others. Fortunately, patients with asymptomatic SARS-CoV-2 infection have a shorter duration of viral shedding from nasopharyngeal swabs and lower risk of a recurring positive test result of SARS-CoV-2 from nasopharyngeal swabs, which can provide a reference for improving the prevention and control strategies for patients who are asymptomatic.”

Effects of a Workplace Wellness Program on Employee Health, Health Beliefs, and Medical Use: A Randomized Clinical Trial: Evaluations of workplace wellness programs have revealed widely different results- depending on such factors as the target of the intervention (like smoking cessation or weight loss), the company culture, and method of intervention (such as bonuses, penalties, or other benefits). So each study needs to be interpreted very cautiously when generalizations are made about their effectiveness. In this study: “…a comprehensive workplace wellness program had no significant effects on measured physical health outcomes, rates of medical diagnoses, or the use of health care services after 24 months, but it increased the proportion of employees reporting that they have a primary care physician and improved employee beliefs about their own health.See the editorial as well: Taking Stock of Employer Wellness Program Effectiveness—Where Should Employers Invest?

Half of Americans in new poll say they would get COVID-19 vaccine: The Associated Press-NORC Center for Public Affairs Research poll found that 49 percent of respondents said they would get a vaccine for the disease, which is caused by the novel coronavirus. Twenty percent of respondents said they would not, and 31 percent said they weren’t sure yet.” Safety is the major concern of those who said they would not get the vaccine.  

GSK targets production of 1bn doses of coronavirus vaccine booster: “UK drugmaker GlaxoSmithKline plans to produce 1bn doses of a vaccine booster as it steps up its preparations for an eventual immunisation for coronavirus.” Such boosters, called adjuvants, enhance the immunologic response to vaccines and also may allow a lower effective dose to be used - thus extending the available supply.

EMA Picks University to Lead Real-World Monitoring of COVID-19 Vaccines “European Medicines Agency (EMA) has signed a contract with Utrecht University to lead a research project for real-world monitoring of COVID-19 vaccines once they are authorized in the European Union.”

Thinking twice about the rush to give CPR to COVID-19 patients: From the AMA, here is a discussion of and references on ethical decisions regarding exposure of healthcare workers to contagion while performing CPR.

About pharma

Remdesivir for 5 or 10 Days in Patients with Severe Covid-19:”In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined.” With cost becoming more of a consideration, this finding is good news if results are further confirmed.

FDA finds likely carcinogen in the common diabetes drug metformin. Will recalls follow?:”The FDA found carcinogen contamination in extended-release formulations of metformin, supporting outside laboratory Valisure's findings in early March, a spokesman said Thursday. 
Tested lots of extended-release metformin showed levels of N-Nitrosodimethylamine (NDMA)—a likely human carcinogen that's led to recalls of ‘sartan’ blood pressure drugs and the heartburn remedy Zantac—above acceptable limits, the FDA said. Those elevated levels weren't found in samples of metformin's immediate-release formula.”

Financial ties between leaders of influential US professional medical associations and industry: cross sectional study: “Financial relationships between the leaders of influential US professional medical associations and industry are extensive, although with variation among the associations. The quantum of payments raises questions about independence and integrity, adding weight to calls for policy reform.” You should look at the methodology (is research money that is disclosed a problem?) and differences across organizations (ties involving the American College of Physicians and American Psychiatric Association are markedly lower than for other groups). Also, the article splits the analysis between the ties with pharma and devices.

Merck adopts ‘error catastrophe’ coronavirus drug: “Merck is launching its hunt for a coronavirus treatment with a pill developed by US academics that is designed to force an “error catastrophe” on viruses. The compound, which is known as EIDD-2801, works by planting molecules in a virus’s RNA genetic material that then trigger a cascade of mutations, which ultimately kill it. The drug completed its first safety trial in about 100 human volunteers in the UK and is set to begin extensive clinical testing in the US and UK early in June.”

FDA Approves Only Drug in U.S. to Treat Severe Malaria: “…the U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen…According to the CDC, approximately 2,000 cases of malaria are diagnosed in the United States each year, with 300 of those infected having severe disease.”

6 BCBS companies sue CVS, claiming decadelong insurance fraud scheme: “Six Blue Cross Blue Shield companies filed a lawsuit against CVS Health, claiming the retail pharmacy chain has ‘intentionally engaged’ in a fraud scheme for more than a decade to overcharge for prescription drugs by submitting insurance claims for payment at artificially inflated prices.”

Evidence-Based Quality Scores for Rating Drug Products and Their Utility in Health Systems: This pre-reviewed paper proposes: “A system of quality scores… to enable health-systems and other purchasers and payers of medication to differentiate among drug products according to evidence-based metrics. Metrics influencing the quality scores described herein include both broadly applicable regulatory information and more drug-specific, third-party chemical analysis information.” The quality measure evaluates manufacturing not the actual drug effectiveness.

About healthcare IT

Barriers to Hospital Electronic Public Health Reporting and Implications for the COVID-19 Pandemic: This survey is another reminder about interoperability problems: “Public health agencies’ inability to receive electronic data is the most prominent hospital-reported barrier to effective syndromic surveillance. This reflects the policy commitment of investing in information technology for hospitals without a concomitant investment in IT infrastructure for state and local public health agencies.”

Is the glass half full or half empty? Here are two articles about the same survey whose headlines reach opposite conclusions:
Surveys Suggest Seniors Aren’t Using Telehealth During COVID-19 Crisis: ”In a survey of roughly 1,000 seniors on Medicare Advantage plans conducted earlier this month by the Better Medicare Alliance, just 24 percent said they’ve used telehealth during the COVID-19 crisis. And just 52 percent of the seniors said they’d be comfortable using telehealth to access care, while 30 percent said they’d be uncomfortable and 18 percent were unsure.”

Medicare Advantage members are taking to telehealth: “A new poll found that roughly half of seniors are comfortable using telehealth to get healthcare, and those that do largely say they had a favorable experience.
The poll, conducted by Morning Consult and sponsored by the Better Medicare Alliance, comes as providers and insurers have started to embrace telehealth amid the COVID-19 pandemic.
The survey of more than 1,000 seniors found 52% are comfortable using telehealth for their healthcare, with 30% uncomfortable and another 18% unsure.”

About health insurance

Hospitals not entitled to additional payments after 'two-midnight' rate cut: “A federal appeals court said a group of hospitals that received lower Medicare reimbursement because of a rate reduction implemented by HHS aren't entitled to additional payments, according to court documents.
For fiscal year 2014, HHS implemented a 0.2 percent rate reduction in an effort to reduce costs associated with its ‘two-midnight’ rule. The rule says costs for hospital stays of a least two midnights are presumptively appropriate for reimbursement at inpatient rates. After revisiting the actuarial processes behind the cuts, HHS eliminated the 0.2 percent rate reduction for fiscal year 2017 and implemented a one-time 0.6 percent reimbursement rate increase to account for the three years of cuts.”

Public Option Could Lower Health Insurance Premiums, But Would Not Substantially Raise Number of Insured: This RAND Corporation study, published today, modeled “four scenarios for adding a public option for individual coverage available nationwide” The “researchers found that premiums for public plans could be 10% to 27% lower than private insurance plans because of lower provider payment rates in the public option.”
However, a “public option had much less impact on boosting the number of people with insurance. Under three of the scenarios, the number of uninsured people fell 3% to 8%, while the number of uninsured declined marginally under a fourth scenario studied.”

About healthcare companies

20 healthcare companies with biggest annual profits: The list is from the latest “Fortune 500.”

Today's News and Commentary

About the public’s health

Here’s what we have to do to show a coronavirus vaccine works: A good review of what it takes to develop a successful vaccine against SARS-CoV-2.

New Ranking of Nations Top Employers’ Response to Pandemic: From Forbes, here are highlights of the top 25 companies. The top 5 are: Verizon, Target, At&T, Walmart, an T-Mobile.

They Evoke Darth Vader, but These Masks May Save Your Doctor’s Life: A good pictorial view of what different masks look like and how well they work.

Where U.S. coronavirus cases are on the rise: “Alabama had the biggest weekly increase at 28%, Missouri’s new cases rose 27% and North Carolina’s rose 26%, according to the analysis of data from The COVID Tracking Project, a volunteer-run effort to track the outbreak. 
New cases in Georgia, one of the first states to reopen, rose 21% after two weeks of declines. The state attributed the increase to a backlog of test results and more testing.”

‘The house was on fire.’ Top Chinese virologist on how China and U.S. have met the pandemic: The article is a good summary of what China did to combat the COVID-19 pandemic and what the situation is now.

About pharma

Taxpayers paid to develop remdesivir but will have no say when Gilead sets the price: A reminder that the government funds basic research for many important medications, but does not demand payback from the companies that manufacture and sell the products.

Big Pharmacy Chains Also Fed the Opioid Epidemic, Court Filing Says:”New details emerge in a lawsuit asserting that chains including CVS, Rite Aid and Walgreens sold millions of pills in small towns but rarely flagged suspicious orders to authorities.”

FDA updates COVID-19 compounding guidance with reporting clarification:”The FDA updated two separate guidance documents regarding compounding of fifteen drugs that are currently in shortage; most of them are medicines that treat patients who require intubation and mechanical ventilation. The first applies to outsourcing facilities, while the second applies to smaller pharmacy compounders.”

FDA approves 2 drugs to combat COVID-19 shortages: “The FDA approved an application from Amneal Pharmaceuticals to make dexmedetomidine hydrochloride 0.9 percent sodium chloride injection, which is used to sedate ventilated patients and non-intubated patients during surgery. 
The agency also approved an application from Accord Healthcare to make succinylcholine chloride injection, which is used for general anesthesia and to provide muscle relaxation during surgery or ventilation.”

Exclusive: big pharma rejected EU plan to fast-track vaccines in 2017:”The world’s largest pharmaceutical companies rejected an EU proposal three years ago to work on fast-tracking vaccines for pathogens like coronavirus to allow them to be developed before an outbreak, the Guardian can reveal.
The plan to speed up the development and approval of vaccines was put forward by European Commission  representatives sitting on the Innovative Medicines Initiative (IMI) – a public-private partnership whose function is to back cutting-edge research in Europe – but it was rejected by industry partners on the body.”

About healthcare professionals

Practice closures and staff layoffs resulting from pandemic: “Around 58,000 primary care practices may close by the end of June, according to the American Academy of Family Physicians, while many others have laid off and furloughed stuff.
Via its HealthLandscape interactive web-based tool, AAFP projects that physician practice wages and salaries will plummet by more than $64 billion by the end of June and practice job losses—including physicians—will be slashed by 784,133.
By the end of May, AAFP projects that 38,693 practices will close, 522,756 job losses will occur, and wages and salaries will be reduced by more than $43 billion.
In more bad news, only 47 percent of primary care practices said they had enough cash on hand to stay open for four more weeks, according to an April Primary Care Collaborative survey, and 42 percent are furloughing or laying off staff.”

About hospitals

Ascension reports $2.7B net loss in Q3: A reminder about how much the COVID-19 pandemic has hit hospitals’ finances.

About health insurance

CMS: 88 Part D, Medicare Advantage insurers sign up for insulin copay model: “The Trump administration announced 88 Medicare Advantage and Part D plan sponsors have applied to lower insulin costs for the 2021 plan year in a bid to grapple with the rising expense of the diabetes treatment.
The Centers for Medicare & Medicaid Services (CMS) said Tuesday that means more than 1,750 standalone plans have decided to participate in the Part D Senior Savings Model. Participating Part D plans will provide Medicare beneficiaries with insulin capped at a $35 copay for a monthly supply.
That $35 copay will extend from the beginning of the year and through the Part D coverage gap.”

About healthcare quality

Survival After Cancer Treatment at Top-Ranked US Cancer Hospitals vs Affiliates of Top-Ranked Cancer Hospitals: “These findings suggest that short- and long-term survival after complex cancer treatment were superior at top-ranked hospitals compared with affiliates of top-ranked hospitals.” Consider the implications for brand dilution.

About healthcare IT

List of ransomware that leaks victims' stolen files if not paid: Each of 15 companies is profiled. If so much information is available, why haven’t they been shut down?

Today's News and Commentary

About the public’s health

Cloth Masks May Prevent Transmission of COVID-19: An Evidence-Based, Risk-Based Approach: “When we apply the principles of evidence-based medicine to public policy, there is high-quality, consistent evidence that many (but not all) cloth masks reduce droplet and aerosol transmission and may be effective in reducing contamination of the environment by any virus, including SARS-CoV-2. No direct evidence indicates that public mask wearing protects either the wearer or others. Given the severity of this pandemic and the difficulty of control, we suggest that the possible benefit of a modest reduction in transmission likely outweighs the possibility of harm.” A major caveat: Effectiveness depends on the material, number of layers, how the mask is worn and how often it is used.

WHO warns that 1st wave of pandemic not over, dampens hopes: “As Brazil and India struggle with surging coronavirus cases, a top health expert is warning that the world is still in the very middle of the outbreak, dampening hopes for a speedy global economic rebound and renewed international travel.
‘Right now, we're not in the second wave. We're right in the middle of the first wave globally,’ said Dr. Mike Ryan, the World Health Organization's executive director.”

77 Nobel Laureates Denounce Trump Officials For Pulling Coronavirus Research Grant: “In an open letter to a top Trump Administration official, 77 Nobel prize-winning American scientists say they are ‘gravely concerned’ about the recent abrupt cancellation of a federal grant to a U.S. non-profit that was researching coronaviruses in China. The laureates say that the move, announced on April 24, ‘sets a dangerous precedent by interfering in the conduct of science’ and ‘deprives the nation and the world of highly regarded science that could help control one of the greatest health crises in modern history and those that may arise in the future.”

WHO says 80 million babies are missing out on routine childhood vaccines: As perviously reported, the COVID-19 pandemic has severely curbed needed routine immunizations, particularly for children. This article further quantifies how serious this problem is.

For Parents: Multisystem Inflammatory Syndrome in Children (MIS-C) associated with COVID-19: From the CDC: This publication explains the severe form of COVID-19 that can afflict children.

Safety of sugar substitutes remains inconclusive after years of research: The message is in the headline but the article offers a good summary of the data and current opinions.

‘This Is Not the Hunger Games’: National Testing Strategy Draws Concerns: “The Trump administration’s new testing strategy, released Sunday to Congress, holds individual states responsible for planning and carrying out all coronavirus testing, while planning to provide some supplies needed for the tests.
The proposal also says existing testing capacity, if properly targeted, is sufficient to contain the outbreak. But epidemiologists say that amount of testing is orders of magnitude lower than many of them believe the country needs.”

Here’s How Wuhan Tested 6.5 Million for Coronavirus in Days: And on a similar theme, why can Wuhan test so many people in such a short time and this country cannot do the same?

Findings from investigation and analysis of re-positive cases: From the Korean CDC:

○  Investigation and contact investigation have been completed for 285 (63.8%) of the total 447 re-positive cases (as of 15 May).

○ 59.6% were tested as a screening measure, and 37.5% were tested because of symptom onset. Of the 284 cases for which symptoms were investigated, 126 (44.7%) were symptomatic.

○ From the 285 re-positive cases, a total of 790 contacts were identified (351=family; 439=others). From the monitoring of contacts, as of now, no case has been found that was newly confirmed from exposure during re-positive period alone.(Emphasis added)

The dynamics of humoral immune responses following SARS-CoV-2 infection and the potential for reinfection : “It is clear that most people infected with SARS-CoV-2 display an antibody response between 10 and 14 days after infection. In some mild cases, detection of antibodies requires a long time after symptoms, and in a small number of cases, antibodies are not detected at all, at least during the time scale of the reported studies. There is a paucity of information about the longevity of the antibody response to SARS-CoV-2, but it is known that antibodies to other human coronaviruses wane over time, and there are some reports of reinfection with homologous coronaviruses after as little as 80 days. Thus, reinfection of previously mild SARS-CoV-2 cases is a realistic possibility that should be considered in models of a second wave and the post-pandemic era. Obtaining longitudinal serological data where both binding titres and functional neutralization titres are stratified by age groups and previous disease severity status should be undertaken as a matter of urgency.”

SARS-CoV-2 infection protects against rechallenge in rhesus macaques: And one more article that may provide useful information in humans: “These data show that SARS-CoV-2 infection induced protective immunity against re-exposure in nonhuman primates.”

What Role Should Employers Play in Testing Workers?: Companies have an interest in their workers’ testing results for two reasons: They want them to return to work safely and they act as the insurer for many employees. “While public health experts and government officials have emphasized that widespread testing will be critical to reopening, there is little clear guidance from state and federal agencies on the role employers should play in detecting and tracking the coronavirus. As a result, businesses are largely on their own in sorting out whether to test — and how to do it — to reassure employees and customers. For now, many companies are just waiting.”

The government has spent decades studying what a life is worth. It hasn’t made a difference in the covid-19 crisis:”The calculation — known as Value of a Statistical Life or VSL — is the amount people are willing to spend to cut risk enough to save one life. The VSL at most federal agencies, developed over several decades, is about $10 million. If a new regulation is estimated to avoid one death a year, it can cost up to $10 million and still make economic sense…
Two key federal agencies that previously have used this type of research to support policy decisions under Trump — including the Centers for Disease Control and Prevention and the White House Office of Management and Budget, which oversees federal regulations — say they are not using this type of cost-benefit analysis in their response to the pandemic.” This measure is obviously very different from a Quality Adjusted Life Year (QALY) which economists generally value at $100 thousand.

About pharma

Japan delays approval of Fujifilm drug for treating coronavirus: “Japan has delayed the approval of an anti-flu drug as a potential coronavirus treatment after interim results from its first randomised clinical trial provided no solid evidence of its effectiveness.”

WHO halts hydroxychloroquine trial for coronavirus amid safety fears:”The WHO’s director-general Tedros Adhanom Ghebreyesus said in light of a paper published last week in the Lancet that showed people taking hydroxychloroquine were at higher risk of death and heart problems than those who were not, it would pause the hydroxychloroquine arm of its solidarity global clinical trial.”

Remdesivir for the Treatment of Covid-19 — Preliminary Report: “Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.” Note the focus on hospitalized patients with evidence of lower respiratory tract infection.

About health insurance

Congress said COVID-19 tests should be free — but who’s paying?: This article raises a question I previously asked- who picks up the final bill if COVID-19 related services are”free” to the patient? The article explains a variety of practices but does not give any firm answers. Ultimately, the insurer is responsible but getting to that point is not straightforward.

CMS caps out-of-pocket insulin costs for Medicare: “CMS is capping out-of-pocket insulin costs for Medicare beneficiaries at $35 per month, the agency said May 26. 
More than 1,750 standalone Medicare Part D prescription drug plans will offer the lower insulin copays through the Part D Senior Savings Model for the 2021 plan year.”

About healthcare IT

COVID-19 contact tracing text message scams: This warning comes from the FTC and has examples of scams.

Money still makes the cyber-crime world go round - Verizon Business 2020 Data Breach Investigations Report is live: “Basic human error accounted for 31 percent of Healthcare breaches, with external breaches at 51 percent (up from 42 percent in the 2019 DBIR), slightly more common than insiders at 48 percent (59 percent last year). This vertical remains the industry with the highest number of internal bad actors, due to greater access to credentials.”

Today's News and Commentary

About the public’s health

FDA names 28 antibody tests to be taken off the market: “The 28 serology tests, mostly manufactured overseas, include ones that were voluntarily withdrawn by their sponsors as well as those that neglected to pursue an official FDA Emergency Use Authorization.
Under a policy in place from mid-March through early May, the agency allowed over 180 antibody blood tests to be sold and distributed in the U.S. without federal review but with certain conditions for manufacturers: They must notify the FDA of their plans, perform self-validation studies and carry a label saying the product is not authorized and incapable of diagnosing COVID-19 on its own.”

After Coronavirus, Office Workers Might Face Unexpected Health Threats: “Stagnant plumbing systems in emptied commercial buildings could put returning employees at risk of Legionnaires’ and other illnesses.”

Exclusive: A quarter of Americans are hesitant about a coronavirus vaccine - Reuters/Ipsos poll: “Fourteen percent of respondents said they were not at all interested in taking a vaccine, and 10% said they were not very interested. Another 11% were unsure.
…but experts estimate that at least 70% of Americans would need to be immune through a vaccine or prior infection to achieve what is known as ‘herd immunity,’ when enough people are resistant to an infectious disease to prevent its spread.”

U.S. Gives AstraZeneca $1.2 Billion to Manufacture COVID-19 Vaccine: The UK-based drugmaker [which has a joint venture with the University of Oxford] is partnering with HHS to make at least 300 million doses of the vaccine AZD1222. The funding will go toward development, production and delivery of at least 300 million doses.
The first doses are expected to be delivered as early as October.”

CDC estimates that 35% of coronavirus patients don't have symptoms: “The CDC also says its ‘best estimate’ is that 0.4% of people who show symptoms and have Covid-19 will die, and the agency estimates that 40% of coronavirus transmission is occurring before people feel sick.”

Scientists Warn CDC Testing Data Could Create Misleading Picture Of Pandemic: “The CDC combines the results of genetic tests that spot people who are actively infected, mostly by using a process known as polymerase chain reaction, or PCR, with results from another, known as serology testing, which looks for antibodies in people's blood. Antibody testing is used to identify people who were previously infected.” This mistake can cause authorities to miss a second spike in new cases. Such a mistake was one reason Toronto missed a second big peak during the SARS epidemic in 2003.

As States Start to Ease Coronavirus Restrictions, Few Americans Expect to Stay in Hotels or Fly This Summer, Though Most Plan to Visit a Doctor, Get a Hair Cut and Dine Out: This Kaiser Family Foundation poll revealed marked differences in behavioral attitudes between Democrats and Republicans. For example, 75% of Republicans said they would eat at a restaurant in the next 3 months, while the same response was only 39% for Democrats.

About healthcare costs

Milliman Medical Index [MMI]: Healthcare costs reach $6,553 for the average American, $28,653 for hypothetical family of four: “In 2020, healthcare costs for our hypothetical family of four reached $28,653. Healthcare costs for the average person are at $6,553. While these are averages, the MMI allows for greater specificity thanks to an interactive tool that was first released last year.”

About pharma

Gilead to start selling remdesivir in coming weeks, expects 'multi-year commercial opportunity': “The company will pivot to a commercial plan after the donated supply of 1.5 million doses runs out around June or early July…
The Institute for Clinical and Economic Review [ICER] recently found remdesivir would be cost-effective at $28,670 if the analysis used as a benchmark the common $100,000 per incremental quality-adjusted life-year gained. But the U.S. drug cost watchdog argued that $50,000/QALY should be applied to remdesivir during a public health emergency. After that calculation, ICER pegged a reasonable price at $4,460.”

Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis: “In summary, this multinational, observational, real-world study of [96,000] patients with COVID-19 requiring hospitalisation found that the use of a regimen containing hydroxychloroquine or chloroquine (with or without a macrolide) was associated with no evidence of benefit, but instead was associated with an increase in the risk of ventricular arrhythmias and a greater hazard for in-hospital death with COVID-19. These findings suggest that these drug regimens should not be used outside of clinical trials and urgent confirmation from randomised clinical trials is needed.” And yet…the President still insists his use is justified.

About health insurance

Trump Administration Announces Changes to Medicare Advantage and Part D to Provide Better Coverage and Increase Access for Medicare Beneficiaries: “The Centers for Medicare & Medicaid Services today finalized requirements that will increase access to telehealth for seniors in Medicare Advantage (MA) plans, expand the types of supplemental benefits available for beneficiaries with an MA plan who have chronic diseases, provide support for more MA options for beneficiaries in rural communities, and expand access to MA for patients with End Stage Renal Disease (ESRD).”

Today's News and Commentary

About the public’s health

Differential Effects of Intervention Timing on COVID-19 Spread in the United States: Here is the study reported in many media outlets today that calculates how many lives could have been saved if social isolation were implemented a week earlier. “Specifically, nationwide, 61.6% [95% CI: 54.6%-67.7%] of reported infections and 55.0% [95% CI: 46.1%-62.2%] of reported deaths as of May 3, 2020 could have been avoided if the same control measures had been implemented just one week earlier. We also examine the effects of delays in re-implementing social distancing following a relaxation of control measures. A longer response time results in a stronger rebound of infections and death.”

COVID-19: The CIDRAP Viewpoint: This third-in-a-series report is from the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. It is an excellent review of the process necessary for effective population testing and test interpretation for SARS-CoV-2. One major criticism is lack of systems coordination of all efforts. An important recommendation is that:
“The US secretary of Health and Human Services (HHS) should appoint by July 1, 2020, a blue- ribbon panel of national experts. The panel should include representatives from public health, clinical laboratory, and medicine; the laboratory testing research and development, marketing, and product support industries; ethicists; legal scholars; and elected officials. We have identified eight key objectives for the blue-ribbon panel to address.”

Majority of practices seeing patients in person again: “In a poll of more than 1,000 practice leaders conducted by the Medical Group Management Association  MGMA), 89 percent of practices surveyed indicated they were seeing patients in person again.” And a related article: The Impact of the COVID-19 Pandemic on Outpatient Visits: A Rebound Emerges, looks at actual patient volume increase.

Will government mandate COVID-19 vaccinations?: Recall that pre-COVID-19, many states were changing immunization requirements for children because of measles outbreaks. Now the question arises; When we have a vaccine for SARS-CoV-2, will vaccinations be mandated by federal/state/local governments?

‘It’s something I have never seen’: How the Covid-19 virus hijacks cells: “A deep dive into how the new coronavirus infects cells has found that it orchestrates a hostile takeover of their genes unlike any other known viruses do, producing what one leading scientist calls ‘unique’ and ‘aberrant’ changes.
Recent studies show that in seizing control of genes in the human cells it invades, the virus changes how segments of DNA are read, doing so in a way that might explain why the elderly are more likely to die of Covid-19 and why antiviral drugs might not only save sick patients’ lives but also prevent severe disease if taken before infection.”
The original article in Cell concludes: ”Cell and animal models of SARS-CoV-2 infection, in addition to transcriptional and serum profiling of COVID-19 patients, consistently revealed a unique and inappropriate inflammatory response. This response is defined by low levels of type I and III interferons juxtaposed to elevated chemokines and high expression of IL-6. We propose that reduced innate antiviral defenses coupled with exuberant inflammatory cytokine production [emphasis added]are the defining and driving features of COVID-19.”
In other words, SARS-CoV-2 reduces some antiviral responses while magnifying a harmful response.

Wuhan bans eating wild animals as coronavirus drives a crackdown in China: The headline speaks for itself. It took 2 pandemics (SARS and SARS-CoV-2) to make it happen.

HHS overrides states, lets all pharmacists give COVID-19 tests:”HHS decided May 19 that the Public Readiness and Emergency Preparedness, or PREP, Act preempts state laws restricting pharmacists' ability to order and administer COVID-10 diagnostic tests.”

How COVID-19 Spreads: This information is the latest CDC update. It emphasizes the primacy of person-to-person contact in transmission and measures to lessen that possibility.

Americans Who Rely Most on White House for COVID-19 News More Likely to Downplay the Pandemic: This research from the Pew Research Center for Journalism & Media is a MUST READ to gauge the harmful influence the White house has on dealing with the COVID-19 pandemic.

GOP fronts ‘pro-Trump’ doctors to prescribe rapid reopening:”Republican political operatives are recruiting “extremely pro-Trump” doctors to go on television to prescribe reviving the U.S. economy as quickly as possible, without waiting to meet safety benchmarks proposed by the federal Centers for Disease Control and Prevention to slow the spread of the new coronavirus. 
The plan was discussed in a May 11 conference call with a senior staffer for the Trump reelection campaign organized by CNP Action, an affiliate of the GOP-aligned Council for National Policy. A leaked recording of the hourlong call was provided to The Associated Press by the Center for Media and Democracy, a progressive watchdog group.”

Prostate Cancer Incidence 5 Years After US Preventive Services Task Force [USPTF] Recommendations Against Screening: “For all races/ethnicities combined, incidence for local-stage disease declined beginning in 2007 in men aged 50-74 and ≥75 years though the decline stabilized during 2013-2016 in men aged ≥75 years….In contrast, incidence for regional- and distant-stage disease increased in both age groups during the study period.” The USPTF had recommended eliminating routine PSA testing for men over 75. After that recommendation there was less early stage disease and more late stage disease. These findings raise the questions about the ability to pick up early disease and the high risk of false positives. The long-term solution would be a better test for prostate cancer.

Nasal Gene Expression of Angiotensin-Converting Enzyme 2 in Children and Adults: SARS-CoV-2 has an affinity for ACE2 receptors. This study of 305 people under age 60 shows an “age-dependent expression of ACE2 in nasal epithelium, the first point of contact for SARS-CoV-2 and the human body. Covariate-adjusted models showed that the positive association between ACE2 gene expression and age was independent of sex and asthma.” This finding may account for the fact that children account for less than 2% of identified cases of COVID-19.

READ: CDC reopening guidance: The latest version of this guidance.

Global regulators commit to cooperate on observational research in the context of COVID-19: At a conference co-organized by the European Medicines Agency (EMA) and Health Canada, international regulators agreed to enhance cooperation on three priority areas of observational research during the COVID-19 pandemic: pregnancy research, medicines used in clinical practice and vaccine safety and effectiveness monitoring.

About healthcare IT

Apple and Google launch contact tracing API for COVID-19 exposure: “Apple and Google's exposure notification application programming interface (API) will now be available to states, public health agencies and governments to build apps that will notify people via smartphone if they've come into contact with someone with the coronavirus…” The API became available yesterday “through a new software update in the Android and iOS operating systems…” This technology presumably can be used to track other illnesses, like influenza.

Different Approaches to a Coronavirus Vaccine: This article provides a really good explanation of the different methods being used to prepare vaccines.

Researchers: Nearly Half Of Accounts Tweeting About Coronavirus Are Likely Bots: Researchers at Carnegie-Mellon University “culled through more than 200 million tweets discussing the virus since January and found that about 45% were sent by accounts that behave more like computerized robots than humans. It is too early to say conclusively which individuals or groups are behind the bot accounts, but researchers said the tweets appeared aimed at sowing division in America.”

About pharma

7 things to know about startup drugmaker Phlow: As previously reported, “President Donald Trump this week signed a four-year, $345 million contract with Phlow, a little-known generic drugmaker that was founded less than six months ago, to manufacture drugs for the national medication stockpile.” This article provides more information about this company. In a related story, check: How Civica helped under-the-radar Phlow nab a $354M COVID-19 manufacturing deal.

Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans: “This study found that, in 2019, US health plans covered biosimilars as preferred in only 14% of decisions. It also revealed biosimilar coverage differences across health plans. Reasons for this variation are unknown but may include more successful negotiation of rebates at some plans than others. Because rebate agreements are not publicly disclosed, however, it was not possible to examine this hypothesis empirically…The slow uptake of biosimilars in the US has been attributed to factors such as patent disputes and reference product manufacturer tactics to delay biosimilar market entry. This study suggests that a lack of preferred coverage among health plans may also be delaying uptake.”

About hospitals

States with the Highest Hospital Expenses: Considering that most of hospital costs are personnel and benefits, the order of states here is surprising.

100 great hospitals in America | 2020: The list is from Becker’s Healthcare.

Today's News and Commentary

About the public’s health

Fact-checking Trump’s letter blasting the World Health Organization: The headline is self-explanatory.

Location, location, location: This Castlight research found that: “More than half (54 percent) of America’s counties have zero COVID-19 testing sites. This testing shortfall is not limited to counties with very low populations. Of 1,176 metro counties, meaning they have a population above 50,000, 38 percent have zero testing sites.” Texas and Florida are given as examples and a chart provides data for all states.

Florida Ousts Top COVID-19 Data Scientist: “Rebekah Jones was the manager of the Geographic Information System team at Florida's Department of Health. She helped create a data portal that for months has provided easily accessible and detailed information on COVID-19 cases broken down by ZIP code. The Florida COVID-19 dashboard has been praised by researchers in the state and by Dr. Deborah Birx, the White House coronavirus task force coordinator.
Last week, Jones notified public health researchers in an email that she'd been removed from the project.”

States accused of fudging or bungling COVID-19 testing data: This article is the “other side” of the one above.

Study projects US COVID-19 deaths to triple by end of year:”A new study suggests the number of Americans who will die after contracting the novel coronavirus is likely to more than triple by the end of the year, even if current social distancing habits continue for months on end.
The study, conducted by the Comparative Health Outcomes, Policy and Economics Institute at the University of Washington's School of Pharmacy, found that 1.3 percent of those who show symptoms of COVID-19 die, an infection fatality rate that is 13 times higher than a bad influenza season.”

COVID-19 patients testing positive for second infection not contagious, study shows: “Researchers in Korea found evidence that patients who test positive for COVID-19 a second time aren't capable of infecting others, and may have neutralizing antibodies that protect them from getting sick again.”

Johnson & Johnson Stops Selling Talc-Based Baby Powder In U.S. And Canada: “Johnson & Johnson will stop selling talcum-based baby powder in the United States and Canada after being ordered to pay out billions of dollars related to lost legal battles over claims the product causes cancer.”

Roe v Wade: Woman behind US abortion ruling was paid to recant: “Norma McCorvey, known as Jane Roe in the US Supreme Court's decision on Roe v Wade, shocked the country in 1995 when she came out against abortion.  But in new footage, McCorvey alleges she was paid to switch sides.The documentary, AKA Jane Roe, airs this Friday on the US channel FX. The programme was filmed in the last months of McCorvey's life before her death at age 69 in 2017 in Texas…In her ‘deathbed confession’, as she calls it, a visibly ailing McCorvey says she only became an anti-abortion activist because she was paid by evangelical groups. ‘I was the big fish,’ she said. ‘I think it was a mutual thing. I took their money and they'd put me out in front of the cameras and tell me what to say.’”

U.S. Births Continue to Fall, Fertility Rate Hits Record Low: “The report on provisional data from the Centers for Disease Control and Prevention indicates notable birth and population measures reached record lows in 2019. American women, for example, are now projected to have about 1.71 children over their lifetimes – down 1% from 2018 and below the rate of 2.1 needed to exactly replace a generation.
’The (total fertility) rate has generally been below replacement since 1971 and consistently below replacement since 2007,’ the report says.”
These trends will have a profound effect on future funding of Medicare and Social Security, among other programs.

All 50 States Have Eased Coronavirus Restrictions: “All 50 states have begun to reopen in at least some way, more than two months after the coronavirus thrust the country into lockdown. But there remain vast discrepancies in how states are deciding to open up, with some forging far ahead of others.” This NY Times article surveys these changes and other COVID-19 topics.

About pharma

8 recent drug approvals: Good to see non-COVID-19 activity.