Today's News and Commentary

About Covid-19

U.S. officials say fully vaccinated don't need booster: “U.S. health officials, after meeting with vaccine maker Pfizer, reiterated on Monday that Americans who have been fully vaccinated do not need to get a booster shot, a spokesperson for the Health and Human Services Department said.”
In a related article: WHO: Rich countries should donate vaccines, not use boosters: “Top officials at the World Health Organization say there’s not enough evidence to show that third doses of coronavirus vaccines are needed and appealed Monday for the scarce shots to be shared with poor countries who have yet to immunize their people instead of being used by rich countries as boosters.”

Pfizer-BioNTech and Oxford AstraZeneca COVID-19 vaccine effectiveness and immune response among individuals in clinical risk groups: This article is a preprint of an English study.
”In most clinical risk groups, immune response to vaccination is maintained and high levels of VE [vaccine effectiveness] are seen with both the Pfizer and AstraZeneca vaccines. Reduced antibody response and vaccine effectiveness were seen after one dose of vaccine among the immunosuppressed group, however, after a second dose there is only a small and non-significant reduction in vaccine effectiveness. These findings would support maximising coverage with two doses in immunosuppressed individuals.”

Greece and France join Italy in making Covid-19 shots mandatory for health workers, telling the unvaccinated they won't get paid: Contrast these actions with our piecemeal approach.
”France and Greece both announced new vaccine requirements on Monday, following in the footsteps of Italy, which made vaccinations compulsory for health employees in April.
The UK government, which is pushing ahead with its unlocking plan despite strong warnings from experts, has previously said it will mandate shots for care home staff from October.”
In a related article: Germany won't make COVID-19 vaccination compulsory - Merkel: “Germany will not make vaccination against COVID-19 compulsory, Chancellor Angela Merkel said on Tuesday, adding that ensuring more Germans get vaccinated, sticking to distancing rules and testing should help prevent a fourth wave.”

About health insurance

CMS Proposes Physician Payment Rule to Improve Health Equity, Patient Access: This announcement is CMS’s annual Physician Fee Schedule (PFS) proposed rule, which ranges from telehealth to quality improvement initiatives. The final rule will come after the comment period suggestions are considered. Here are some highlights from MGMA:
—”Setting 2022 Medicare payment rates for physician services. For 2022, CMS is proposing a Conversion Factor of $33.5848 and $21.0442 for Anesthesia (a decrease of -3.75% and -2.39%, respectively, over final 2021 rates);
—Delaying the payment penalty phase of the Appropriate Use Criteria (AUC) program to Jan. 1, 2023 or the Jan. 1 that follows the end of the COVID-19 public health emergency (PHE), whichever is later;
—Allowing audio-only visits for the diagnosis, evaluation, or treatment of mental health disorders furnished to established patients in their homes past the COVID-19 PHE;
—Setting the 2022 MIPS performance threshold at 75 points, and the additional performance threshold for exceptional performance at 89 points; and
—Setting 2023 as the first performance year of the new MIPS Value Pathways (MVPs), with participation options including individual clinicians, single specialty groups, multispecialty groups, subgroups, and APM entities.”

CMS starts process to decide on covering pricey Alzheimer’s drug aducanumab: “The Centers for Medicare & Medicaid Services announced Monday it is opening a National Coverage Determination (NCD) analysis on the drug that will cost patients $56,000 a year. Advocates and experts have called for the agency to move quickly to decide whether to cover the drug.”

Physician sentenced for defrauding 3 insurance companies out of $17 million: “A Florida physician pleaded guilty and was convicted for defrauding Cigna, Blue Cross Blue Shield and Humana out of over $17 million. 
Max Louis Citrin was investigated by the Palm Beach County Sober Homes Task Force after allegations that he was improperly prescribing drugs to sober home residents. State Attorney Dave Aronberg said Mr. Citrin copied and pasted patient symptoms to fraudulently bill companies for unnecessary allergy testing and treatment.”

Humana quietly funded 40 Iora primary care clinics: “Health insurer Humana quietly funded 40 of Iora Health's 47 primary care clinics, according to a Securities and Exchange Commission registration statement…
The filing also showed the Humana-funded clinics exclusively served Humana members until July 2020.”

About the public’s health

Heart risk ‘calculators’ overlook increased risk for people of South Asian ancestry: “When compared to individuals of European ancestry, South Asians had a more than two-fold risk of developing heart disease.
Risk calculators used by clinicians to guide decisions about preventing or treating heart disease do not always reflect the increased cardiac risks faced by people of South Asian descent.
To gain a better understanding of heart disease risks for those of South Asian ancestry and have more accurate assessment tools, more people of South Asian ancestry need to be included in research used to develop these tools.”

Human genome editing: recommendations: Guidelines from the WHO.

About healthcare IT

Could Gen Z Free the World From Email?: Not, strictly speaking, a healthcare article, but it has significant implications for the field. The whole article is worth reading but here is the “takeaway”:
According to a 2020 study from the consulting firm Creative Strategies, there’s a generational gap in primary work tools. The survey found that for those 30 and above, email was among the top tools they used for collaboration. For those under 30, Google Docs was the app workers associated most with collaboration, followed by Zoom and iMessage.”

Bayesian Health Launches with Research-Backed AI Platform Enabling Health Systems to Save Lives: A news release: “Bayesian's AI platform sits within the EMR, analyzing patient data with industry-leading AI/machine learning models. The platform sends accurate and actionable clinical signals within existing workflows when a critical moment is detected, helping physicians and care team members accurately diagnose, intervene, and deliver timely care.
With a research-first foundation of over 21 patents and peer-reviewed research papers, Bayesian's platform is based on technology licensed from the Johns Hopkins University. The platform is configured to scale within health systems, and targets high-priority areas with specific modules such as clinical deterioration, sepsis, pressure injury, and transitions of care.”

Telehealth: A quarter-trillion-dollar post-COVID-19 reality?: McKinsey’s take on telehealth.
Here are the highlights:

  • Telehealth utilization has stabilized at levels 38X higher than before the pandemic. After an initial spike to more than 32 percent of office and outpatient visits occurring via telehealth in April 2020, utilization levels have largely stabilized, ranging from 13 to 17 percent across all specialties. This utilization reflects more than two-thirds of what we anticipated as visits that could be virtualized.

  • Similarly, consumer and provider attitudes toward telehealth have improved since the pre-COVID-19 era…

  • Some regulatory changes that facilitated expanded use of telehealth have been made permanent, for example, the Centers for Medicare & Medicaid Services’ expansion of reimbursable telehealth codes for the 2021 physician fee schedule. But uncertainty still exists as to the fate of other services that may lose their waiver status when the public health emergency ends.

  • Investment in virtual care and digital health more broadly has skyrocketed, fueling further innovation, with 3X the level of venture capitalist digital health investment in 2020 than it had in 2017.4

  • Virtual healthcare models and business models are evolving and proliferating, moving from purely ‘virtual urgent care’ to a range of services enabling longitudinal virtual care, integration of telehealth with other virtual health solutions, and hybrid virtual/in-person care models, with the potential to improve consumer experience/convenience, access, outcomes, and affordability.”

About healthcare professionals

These specialties report the most pronounced gender pay gaps: “Gender disparities in both representation and salary are greatest among cardiology and gastroenterology, according to research published July 12 in JAMA Internal Medicine.
Highlights:
1. “Overall, women comprised about 40 percent of total full-time faculty across ranks. At the instructor and assistant levels, female representation was nearly equal at 47 percent and 46 percent, respectively. That figure dropped at higher ranks, sitting at 24 percent at the professor rank. 

2. Women were the majority in three specialties: general internal medicine, endocrinology and geriatrics. 

3. Women were least represented in procedural specialties such as pulmonology, critical/intensive care, gastroenterology and cardiology, which had the greatest imbalance as only 21 percent were women. 

4. The median annual salary across all ranks for women was within $25,000, except for chief. By specialty, women's salaries were at least 90 percent of men's for 10 of 13 internal medicine specialties. 

5. For cardiology, gastroenterology, and critical/intensive care, women's median salary did not reach 90 percent of men's. While these specialties paid better overall, they also ‘demonstrated the largest gender disparities in both representation and salary, particularly within the higher ranks of cardiology and gastroenterology.’”



Today's News and Commentary

About Covid-19

Check out this cartoon.

Israel starts administering third dose of Pfizer vaccine to at-risk adults: “Israel’s Ministry of Health on Monday began offering a third dose of the Pfizer vaccine to severely immunocompromised adults in what health experts say could be the first phase of an experiment to provide booster shots for older people and the most vulnerable.”

A Covid Test as Easy as Breathing: The article is a good review of Covid-19 diagnostic breath tests in use/underdevelopment.

'Surprising amount of death' will soon occur in these US regions from increased Covid-19 cases, expert says: “The US is averaging about 19,455 new cases over the last seven days, a 47% increase from the week prior, according to data from Johns Hopkins University. And a third of those, CNN Medical Analyst Dr. Jonathan Reiner said, come from five hot spots: Florida, Louisiana, Arkansas, Missouri and Nevada.”

FDA expected to announce new warning on Johnson & Johnson vaccine related to rare autoimmune disorder: “About 100 preliminary reports of Guillain-Barré have been detected after 12.8 million doses of Johnson & Johnson vaccine were administered, the Centers for Disease Control and Prevention said in a statement. These cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 years and older. Available data do not show a pattern suggesting a similar increased risk with the Pfizer-BioNTech and Moderna vaccines, after more than 321 million doses of those vaccines have been administered in the United States. The Guillain-Barré cases will be discussed as part of an upcoming meeting of CDC advisers, the agency said.”

Autoimmunity to Annexin A2 predicts mortality among hospitalised COVID-19 patients: ”Levels of anti-Annexin A2 antibodies at admission strongly predicted mortality among hospitalised COVID-19 patients. Given its critical protective function in the lung, Annexin A2 antagonism may play an important role in the pathophysiology of COVID-19…
This study investigated the possibility that COVID-19 patients have autoimmune antibodies to Annexin A2, a protective protein expressed in the lung and other organs. Since this phospholipid-binding protein is critical for fibrinolysis, lung elasticity, cell membrane repair, and integrity of the pulmonary vasculature, antagonism of Annexin A2 may explain many of the hallmark clinical features of severe COVID-19 cases.”

Republicans push to ban "discrimination" against unvaccinated people: “State Republican lawmakers around the country are pushing bills — at least one of which has become law — that would give unvaccinated people the same protections as those surrounding race, gender and religion.”

Quarter-dose of Moderna COVID vaccine still rouses a big immune response: “Two jabs that each contained only one-quarter of the standard dose of the Moderna COVID-19 vaccine gave rise to long-lasting protective antibodies and virus-fighting T cells, according to tests in nearly three dozen people1. The results hint at the possibility of administering fractional doses to stretch limited vaccine supplies and accelerate the global immunization effort.”

About healthcare IT

HHS Updates Interoperability Standards to Support the Electronic Exchange of Sexual Orientation, Gender Identity and Social Determinants of Health: “With this new update, health IT stakeholders nationwide will have clearer direction toward the standardized, electronic exchange of social determinants of health (SDOH), sexual orientation, and gender identity (SO/GI) among several other updated data elements. This lays the foundation for the provider community to start systemizing the capture and use of SDOH and SO/GI data in the clinical setting. While encouraged, this update does not require health professionals, such as doctors and nurses, to record this data or individuals to share such data. It does however set a path forward for health IT to build in support for exchanging these data as they become applicable to an individual's care.”

Class action filed after HHS warns 130 hospitals, health systems left millions' PHI exposed: “Two patients filed a class action against two radiology companies after more than 1 million patients who received care at hospitals nationwide may have been exposed because of vulnerabilities in medical imaging archiving software.”

About the public’s health

Handful of cities driving urban greenhouse gas emissions - study: “Just 25 big cities – almost all of them in China – accounted for more than half of the climate-warming gases pumped out by a sample of 167 urban hubs around the world, an analysis of emissions trends showed on Monday.
In per capita terms, however, emissions from cities in the richest parts of the world are still generally higher than those from urban centres in developing countries, researchers found in the study https://www.frontiersin.org/articles/10.3389/frsc.2021.696381/ full published in the open access journal Frontiers in Sustainable Cities.”

About pharma

Generics, Retailers Escape Zantac MDL With Preemption: “A Florida federal judge dismissed all claims against manufacturers of the generic form of the heartburn medication Zantac and retailers in sprawling multidistrict litigation alleging the drug contains a known carcinogen, finding that all claims are preempted by federal law. In a 49-page order filed Thursday, U. S. District Judge Robin Rosenberg dismissed claims that the generic makers and retailers failed to warn consumers about the dangers of ranitidine, the generic name for Zantac, saying federal law does not allow them to change the labels from what was approved for the brand name version of the drug.”

FDA Approves Drug to Reduce Risk of Serious Kidney and Heart Complications in Adults with Chronic Kidney Disease Associated with Type 2 Diabetes: “FDA has approved [Bayer Healthcare’s] (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.”

European Parliament Strives to Grant EMA Expanded Authority: “The European Parliament has voted to expand the European Medicines Agency’s (EMA) authority to monitor the supply chain for drugs and medical devices.
The EU lawmakers specifically called for the creation of an EU database ‘aimed at detecting, predicting and preventing shortages of medicinal products,’ and acting as an information exchange between the EMA and national authorities in the EU member states.”

About hospitals and health systems

COMMUNITY BENEFIT: The Lown Institute, listed hospitals that contributed the most and least to their communities based on how much in tax breaks they get from their non-profit status. The overall message is: “72% of private nonprofit hospitals had a fair share deficit, meaning they spent less on charity care and community investment than they received in tax breaks.”

Intermountain Healthcare shutters 25 retail pharmacies, redirects consumers to CVS: “Intermountain Healthcare will be shutting down 25 retail pharmacies and handing off their prescriptions and inventories to CVS Pharmacy beginning in August, the companies announced this week…
In the announcement, leaders from both companies acknowledged that consumers are increasingly interested in retail pharmacies that can deliver additional services and convenient shopping options.”

Average amount generally paid ratio for hospitals, broken down by state: “The average amount generally paid ratio for hospitals across the U.S. is 39.4 percent, according to an analysis of 4,674 hospitals released by Hospital Pricing Specialists
The AGP® ratio is calculated by taking the sum of all claims that have been paid by health insurers divided by the sum of the gross charges for those claims. 
Based on the analysis, hospitals in Maryland have the highest AGP ratio at 81 percent and hospitals in Florida have the lowest ratio at 18.2 percent.”
These findings are one reason listing of gross charges for comparison shopping is not helpful to patients.

Today's News and Commentary

Biden zeros in on healthcare competition in executive order: 10 notes: More details about yesterday’s lead story. Here is the White House Fact Sheet. “The Order includes 72 initiatives by more than a dozen federal agencies…” Many of the actions start with the word “encourages,” so not much will change immediately.

About Covid-19

CDC says students vaccinated against the coronavirus can go maskless in fall: “The Centers for Disease Control and Prevention issued new guidelines for schools Friday that give students who have been vaccinated the option of going maskless this fall while their classmates who have not had shots continue to wear face coverings.
The much-awaited easing of pandemic rules for kindergarten through 12th grade follows the opening of vaccine eligibility this spring to anyone 12 and older.”

Pfizer to seek OK for 3rd vaccine dose; shots still protect: “Pfizer is about to seek U.S. authorization for a third dose of its COVID-19 vaccine, saying Thursday that another shot within 12 months could dramatically boost immunity and maybe help ward off the latest worrisome coronavirus mutant…
Hours after Pfizer’s announcement, U.S. health officials issued a statement saying fully vaccinated Americans don’t need a booster yet.”

Mapping the human genetic architecture of COVID-19: From Nature : “We formed a global network of researchers to investigate the role of human genetics in SARS-CoV-2 infection and COVID-19 severity. We describe the results of three genome-wide association meta-analyses comprised of up to 49,562 COVID-19 patients from 46 studies across 19 countries. We reported 13 genome-wide significant loci that are associated with SARS-CoV-2 infection or severe manifestations of COVID-19. Several of these loci correspond to previously documented associations to lung or autoimmune and inflammatory diseases3–7. They also represent potentially actionable mechanisms in response to infection. Mendelian Randomization analyses support a causal role for smoking and body mass index for severe COVID-19 although not for type II diabetes.”

Guidance for Health Care Leaders During the Recovery Stage of the COVID-19 PandemicA Consensus Statement: “The 10 imperatives in the framework are: (1) acknowledge staff and celebrate successes; (2) provide support for staff well-being; (3) develop a clear understanding of the current local and global context, along with informed projections; (4) prepare for future emergencies (personnel, resources, protocols, contingency plans, coalitions, and training); (5) reassess priorities explicitly and regularly and provide purpose, meaning, and direction; (6) maximize team, organizational, and system performance and discuss enhancements; (7) manage the backlog of paused services and consider improvements while avoiding burnout and moral distress; (8) sustain learning, innovations, and collaborations, and imagine future possibilities; (9) provide regular communication and engender trust; and (10) in consultation with public health and fellow leaders, provide safety information and recommendations to government, other organizations, staff, and the community to improve equitable and integrated care and emergency preparedness systemwide.”

BioNTech/Pfizer plan to trial Delta variant vaccine in August: FYI

About pharma

10 US Approval Decisions To Look Out For In Q3: List available with free trial. One novel introduction: “A pharmacokinetic issue and likely a divided advisory panel are the reasons for a delay with the FDA’s decision on approval of Provention Bio, Inc.’s teplizumab beyond its 2 July PDUFA date. If approved, teplizumab would be the first drug for type 1 diabetes prevention.”

House Dems' report slams drugmaker stock buybacks as Pelosi presses to give Medicare negotiating powers: “A new House oversight report found that 14 of the largest drugmakers in the U.S. spent $577 billion on stock buybacks and dividends from 2016 to 2020 as Democratic leadership presses to give Medicare drug negotiation powers.
The report (PDF), released Thursday from the House Oversight Committee, comes as Congress is exploring giving Medicare the power to negotiate for lower drug prices as part of an infrastructure package.”

Sanofi puts $1B-plus on the table for Eureka's multiple myeloma treatment candidate: “The French Big Pharma penned a licensing agreement with Eureka Therapeutics and Memorial Sloan Kettering [MSK] Cancer Center for the non-CAR use of a new, human binding domain that targets G Protein Coupled Receptor Family C Group 5 Member D (GPRC5D).
Eureka discovered the binding domain using its proprietary antibody discovery platform and was developed under a collaboration with MSK.”

Parexel snapped up, again, as Goldman Sachs, EQT spend $8.5B on the CRO: “The suitors and soon-to-be owners are the Swedish investment firm EQT Private Equity and the U.S. giant Goldman Sachs Asset Management, giving Pamplona a healthy return on the $5 billion it spent on the CRO [contract research organization] in 2017.”

FDA head calls for inspector general investigation of agency’s dealings with Biogen, maker of controversial new Alzheimer’s drug: “Woodcock said on Twitter she was requesting the review because of the ‘ongoing interest and questions’ about the approval of the drug, called Aduhelm, on June 7. She said the review would focus on interactions between representatives of Biogen and the FDA during the process that led to the approval.”

AbbVie, Biogen, Pfizer launch public database linking genes and diseases: Called “ Genebass database, for gene-based association summary statistics…” It will be maintained by the Broad Institute of MIT and Harvard.

Contraceptive mini-pill available over-the-counter without prescription for the first time: “Two types of the oral contraceptive pill will now be sold over the counter in the UK without a prescription.
Later this month, the progesterone-only pill (POP), or ‘mini pill’ as it’s also known, will be available from high-street pharmacies.
The specific brands of pill — called Hana and Lovima — will be accessible without the need to visit a GP, but pills with oestrogen will still require a consultation.”

Colorado Caps Insulin Costs for All Diabetics: “Colorado has become the second state — after Minnesota — to pass a law capping the price of insulin for both insured and uninsured diabetic patients, continuing a trend of states passing legislation to rein in the cost of the life-saving medicine — so far, mostly for people with health insurance — in response to what they see as inaction by Congress and the federal government.
Slated to take effect Jan. 1, 2022, the new law creates an insulin affordability program that will give eligible diabetics access to insulin for 12 months at a cost of no more than $50 for a 30-day supply and allow for a once-a-year emergency insulin prescription priced at $35 or less for a 30-day supply.”

Marlboro maker Philip Morris strikes deal for UK inhaler group Vectura: “One of the world’s largest tobacco groups, Philip Morris International, has struck a £1bn deal to buy a UK developer of inhalers, the next step in what the owner of the Marlboro cigarette brand said was its plan to become a ‘healthcare and wellness company’…
PMI has said it is focusing on respiratory drug delivery as part of its plan to generate at least $1bn in annual revenues by 2025 from what it calls Beyond Nicotine products.”

McKesson Corporation Enters Agreement to Sell Certain European Businesses to the PHOENIX Group: “McKesson Corporation… announced that it has entered into an agreement to sell its European businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX group. This transaction also includes McKesson’s German-based AG headquarters in Stuttgart, Recucare GmbH, its German wound-care business, its shared services center in Lithuania, and its 45% ownership stake in Brocacef, the company’s joint venture in the Netherlands. The transaction is expected to close in 2022, subject to customary closing conditions, including receipt of required regulatory approvals.
The remaining European businesses in the UK, Norway, Austria, and Denmark are not included in this transaction and will continue to be operated by McKesson.”

About health insurance

CMS pitches payment rules for 2022: 21 notes for hospital execs: “CMS has released its annual proposed payment updates for inpatient facilities, kidney care facilities, home health, skilled nursing facilities, hospices, inpatient psychiatric facilities and inpatient rehabilitation facilities.”
The article is a good summary of institutional payment rules for 2022.

As With The Medicare Plan Finder, CMS Efforts To Improve Physician Compare Have Not Worked: The author goes through examples of how the site is not working well.

About healthcare IT

Hospitals lack consistent cybersecurity plan for networked medical devices: “Even as hospitals continue to face cyberattacks that risk patient harm, Medicare lacks consistent oversight of networked device cybersecurity in hospitals, according to a report from the Department of Health and Human Services Office of Inspector General…
Large hospital systems could have around 85,000 medical devices connected to its network, which translates into a broad attack surface…”

Patient Experience in Virtual Visits Hinges on Technology and the Patient-Clinician Relationship: A Large Survey Study With Open-ended Questions: Be wary of studies like this one.
”Adults with a virtual visit between June 21, 2017, and July 12, 2017, were invited to complete a survey of 21 Likert-scale items and textboxes for comments following their visit.” First, the data is 4 years old, and relies on technology at least that old. Second, it is a study of those who actually were willing and did use the technology- a biased group.

VA Cerner rollout price tag climbs to $18.5B: The saga continues…
”The price tag of the Department of Veteran Affairs's Cerner EHR rollout could go up another $2.5 billion, according to a July 7 report by the Office of the Inspector General.
The cost was originally budgeted at $10 billion, then got a 60 percent increase to $16 billion. Now it could need a bump of $2.5 billion to account for IT infrastructure updates, the report said.”

About the public’s health

U.S. cancer death rates declining, report shows: “Death rates between 2014 and 2018 fell for 11 of the 19 most common cancers among men, and 14 of the 20 most common among women, according to the report from the American Cancer Society, Centers for Disease Control and Prevention, National Institutes of Health, and the North American Association of Central Cancer Registries.”

The lie of “expired” food and the disastrous truth of America’s food waste problem: “Forty percent of food produced in America heads to the landfill or is otherwise wasted. That adds up. Every year, the average American family throws out somewhere between $1,365 and $2,275…
There are two vital facts to know about date labels on foods in the US: They’re not standardized, and they have almost nothing to do with food safety…”
Read the article for more details.

About healthcare devices

St. Jude Medical, Alere pay combined $65M to settle DOJ claims they knowingly sold defective devices: “The U.S. Department of Justice (DOJ) collected two separate settlements from medical device makers after the government said they continued to sell defective products for years amid receiving reports of injuries and deaths linked to their hardware. 
Both settlements were announced July 8: St. Jude Medical agreed to pay $27 million, while Alere shelled out $38.75 million. Despite the hefty fines, neither serves as an admission of guilt.
The federal cases were each brought under the False Claims Act and stem from allegations that, by continuing to sell the potentially harmful products to healthcare facilities, where they were used to treat patients enrolled in federal healthcare programs such as Medicare, both companies played a role in securing government payments for devices they knew were defective.”

Avanos Medical Inc. to Pay $22 Million to Resolve Criminal Charge Related to the Fraudulent Misbranding of Its MicroCool Surgical Gowns: “According to court filings, Avanos falsely labeled the gowns as providing the highest [FDA-designated] level of protection against fluid and virus penetration…
In addition, according to court documents, an employee and an agent of Avanos obstructed a July 2016 FDA for-cause inspection of the company’s surgical gown business by making numerous false entries in four documents requested by FDA investigators.”

FDA Releases Final Guidance on its Unique Device Identification System: “The FDA has released a long-awaited final guidance on the form and content of its Unique Device Identification (UDI) system, which has been available in draft form for almost five years.
The UDI must be presented in two forms on device labels and packages — easily readable plain-text and a scannable automatic identification and data capture (AIDC) format.”

About healthcare quality

What Patients Think About Their Hospitals and Ambulatory Surgery Centers: An Analysis of Patient Experience Surveys: From the Leapfrog Group. Read the entire report for details. The “bottom line” is: “Leapfrog’s assessment of CAHPS survey results across different settings of care suggests that despite some positive responses, significant challenges persist, particularly related to communicating about patient understanding of medication protocols, clarity about treatment following discharge, and overall communication. For pediatric patients in hospitals, there are exceptionally troubling signs with parents’ ability to raise concerns about problems and mistakes regarding the care of their children. Outpatient surgical units and ambulatory surgery centers (ASCs) have positive results generally. Regardless, all facilities show signs of patient safety challenges that hospitals and ASCs should address with urgency.”

Today's News and Commentary

Biden to issue executive order to curtail noncompete clauses: This action will have a huge impact on healthcare, affecting both the product and service sectors. In the latter category, it is typical for physician contracts to have a restrictive covenant for a reasonable geographic area and time period. Without such a clause, a practice could help new physicians build their practices. When the practices are built, those physicians could leave with their patients. Stay tuned for legal challenges.
”The president’s order would encourage the Federal Trade Commission (FTC) to ban or limit noncompete agreements.
’Roughly half of private sector businesses require at least some employees to enter noncompete agreements, affecting over 30 million people. This affects construction workers, hotel workers, many blue-collar jobs, not just high-level executives. He believes that if someone offers you a better job, you should be able to take it. It makes sense,’ White House press secretary Jen Psaki said during a press briefing.”

About Covid-19

New study on delta variant reveals importance of receiving both vaccine shots, highlights challenges posed by mutations: “A peer-reviewed report from scientists in France, published Thursday in the journal Nature, found that the delta variant has mutations that allow it to evade some of the neutralizing antibodies produced by vaccines or by a natural infection. A single shot of a two-dose vaccine ‘barely’ offers any protection.
But the experiments found that fully vaccinated people — with the recommended regimen of two shots of the Pfizer-BioNTech or AstraZeneca vaccine — should retain significant protection against the delta variant. That echoes another report authored by a collaboration of scientists in the United States and published Wednesday in the New England Journal of Medicine.”
And in related articles:
Delta variant already dominant in U.S., CDC estimates show: “According to the [CDC]'s estimates the Delta variant became dominant in the country over the two weeks ended July 3, with 51.7% cases linked to the variant that was first identified in India.”
Vaccine Stocks Skid As Delta Variant Becomes More Prevalent U.S. Covid Strain: “Moderna stock toppled 4.9% and BioNTech's slipped 3.6%, while Novavax, which does not yet have an authorized vaccine, slumped 13.7%, the news source said.” Given the data on vaccine effectiveness and the companies’ research to develop new vaccines, this drop in stocks is puzzling.

Quidel recalls Lyra Covid test due to high risk of false negative results: “Quidel has received five complaints about the product, but there are currently no reports of injury or death from its use.”

Kynurenic acid may underlie sex-specific immune responses to COVID-19: “Males and females have different immune responses to SARS-CoV-2 infection, with male sex being a risk factor for mortality, particularly among older individuals. Cai et al. performed metabolomics analysis of serum from COVID-19 patients and uninfected health care workers and identified 17 metabolites that were associated with the disease. However, in male COVID-19 patients only, the amount of the tryptophan metabolite kynurenic acid (KA) correlated with age, inflammation, and disease outcome. KA inhibits glutamate release, and glutamate abundance was reduced in patients who deteriorated. Together, these findings indicate that KA is associated with sex-specific differences in immune responses to COVID-19, suggesting that it might be targeted in male patients.”

SEC claims Parallax Health Sciences, execs misled about COVID-19 tests, PPE: “Without admitting or denying the allegations, Parallax, its CEO Paul Arena, and CTO Nathaniel Bradley consented to judgments permanently enjoining them from future violations of the charged provisions and requiring them to pay penalties of $100,000, $45,000, and $40,000, respectively, according to the SEC…
In the SEC’s complaint filed in the U.S. District Court for the Southern District of New York, the commission says that Parallax issued several press releases over March and April 2020, falsely claiming that the company’s purported COVID-19 test would be ‘available soon.’ The company also said it had medical and personal protective equipment (PPE) — which was in particularly high demand at that early stage of the pandemic — for ‘immediate sale.’
The SEC’s complaint alleges that Parallax’s insolvency prevented it from developing the COVID-19 test. At the same time, company projections demonstrated that even with the funds, it would take more than one year to develop the test. Additionally, the SEC alleges that Parallax never had the medical equipment or PPE that it offered.”

About pharma

Biogen, FDA walk back controversial Aduhelm label after weeks of fierce criticism: “Following weeks of fiery criticism for its wide-labeled approval for Biogen’s Aduhelm for anyone with Alzheimer’s disease, the FDA is now narrowing the recommended window of patients to only those with milder forms of the memory-robbing disease. 
Biogen on Thursday said the FDA approved an updated label for Aduhelm, also known as aducanumab, that recommends the amyloid-beta targeting antibody for people with mild cognitive impairment or mild dementia, aligned with those included in Biogen’s late-stage trials. 
The FDA warns that there is ‘no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.’”

OxyContin maker Purdue wins 15 states' support in controversial $4B bankruptcy plan: “Fifteen states, including Massachusetts and New York, have blessed OxyContin maker Purdue Pharma's controversial bankruptcy reorganization plan, a court filing in the U.S. Bankruptcy Court in White Plains, New York, shows.
Under the deal, Purdue would morph into a nonprofit and secure protection from future opioid litigation. The company's owners, the Sackler family, would pay more than $4 billion in a settlement covering thousands of cases linked to Purdue's role in the opioid crisis.“

Humira's reign as TV ad king is over as AbbVie shifts spending to Rinvoq and Skyrizi: “AbbVie had been ratcheting back the brand’s TV budget over the past few months, but, in May, it stopped spending in arthritis and psoriasis altogether. That left $13 million in ads for Crohn’s disease and ulcerative colitis, only big enough for fourth place, according to data from real-time TV ad tracker iSpot.tv.
Of course, that doesn’t mean parent drugmaker Abbvie is giving up on TV advertising. Quite the opposite: Its next-generation treatments Rinvoq, for rheumatoid arthritis, and Skyrizi for psoriasis are on the list at Nos. 2 and 8, respectively.”

Ex-Genentech staffers plead guilty to trade secrets theft as DOJ targets biotech partners for $101M Sanofi deal: “The two Genentech veterans stole confidential intellectual property related to the company’s top-selling cancer drugs Rituxan, Herceptin and Avastin, plus cystic fibrosis inhalation Pulmozyme, the government said. They then passed that info to Taiwanese firm JHL Biotech, now called Eden Biologics, to help it develop cheap copycats, according to the suit.”

About the public’s health

Dietary recommendations for prevention of atherosclerosis: The latest recommendations on healthy eating. See the Graphical Abstract for a summary.

Mortality Among Persons Entering HIV Care Compared With the General U.S. Population: “Overall 5-year mortality among persons entering HIV care was 10.6%, and mortality among the matched U.S. population was 2.9%, for a difference of 7.7 (95% CI, 7.4 to 7.9) percentage points. This difference decreased over time, from 11.1 percentage points among those entering care between 1999 and 2004 to 2.7 percentage points among those entering care between 2011 and 2017.”
We have certainly come a long way in HIV treatment. Now we can work more on prevention/cure.

Projecting the risk of mosquito-borne diseases in a warmer and more populated world: a multi-model, multi-scenario intercomparison modelling study: Yet another deleterious consequence of global warming: “Rising global mean temperature will increase the climatic suitability of both diseases [malaria and dengue] particularly in already endemic areas. The predicted expansion towards higher altitudes and temperate regions suggests that outbreaks can occur in areas where people might be immunologically naive and public health systems unprepared. The population at risk of malaria and dengue will be higher in densely populated urban areas in the WHO African region, South-East Asia region, and the region of the Americas, although we did not account for urban-heat island effects, which can further alter the risk of disease transmission.”

About hospitals and health systems

UVA Health acquires full ownership of 3-hospital joint venture from Novant Health: “Novant Health UVA Health System’s 260 inpatient beds will push UVA Health’s tally over the 1,000-bed threshold.
The academic health system is led by its 600-bed flagship hospital, UVA Medical Center. It also runs the 106-bed UVA Children’s Hospital, UVA School of Medicine, UVA School of Nursing and UVA Physicians Group.”

Hospital M&A activity shifts to regional partnerships: Kaufman Hall: “Total M&A revenue in the first and second quarter totaled $17.2 billion on 27 transactions. This is the second highest in recent years, according to the report. In 2020, revenue for the same period was $17 billion with 43 transactions. 
In the second quarter, M&A volume was below historic volume with 14 transactions. However the quarter saw a high number of transactions with revenues above $500 million.”

About healthcare IT

Monthly Telehealth Regional Tracker: The site provides monthly telehealth utilization data by region.

Ransomware attack on revenue cycle vendor exposes 1.2 million patients, employees: “A ransomware attack on Practicefirst Medical Management Solutions and PBS Medcode has left more than 1 million people exposed after hackers stole patient files…
An investigation discovered that hackers copied protected health information, exposing 1,210,688 people. Stolen data includes names, Social Security numbers, bank account information, treatment-related information and more.”

Sonde Health Vocal Biomarker Technology Optimized on Qualcomm Snapdragon Mobile Platforms: “Sonde Health announced that it will work with leading chipmaker Qualcomm Technologies, Inc. to optimize Sonde’s vocal biomarker technology for use with the flagship and high-tier Qualcomm® Snapdragon™ 888 and 778G 5G Mobile Platforms to help bring native, machine learning-driven vocal biomarker capabilities to mobile and IoT devices globally. The optimization has the potential to unlock several native health screening and monitoring applications on hundreds of millions of mobile devices that use these Snapdragon mobile platforms.”

About health insurance

Physicians push back against new Aetna cataract surgery policy: “Two professional organizations issued a joint statement voicing their opposition to Aetna's new policy that requires preapproval for all cataract surgeries.
The American Academy of Ophthalmology and American Society of Cataract and Refractive Surgery critiqued the policy change, which makes Aetna the first major health insurer to make such a move. The policy was made effective July 1.
According to the statement, Aetna would deem less than 5 percent of cataract surgeries unnecessary.” 

Aetna, Optum call for rehearing after losing "dummy code" appellate trial: “Aetna and Optum issued a petition for a rehearing July 6 after a federal appellate court sided with a lawsuit that claimed the insurers used "dummy code" to make administrative fees appear to be billable medical charges.
In the petition, the insurers claim judges' decision to allow plaintiff Sandra Peters to sue would open the floodgates for litigation that wasn't proven to harm members. In June, judges ruled Ms. Peters did not need to provide evidence she suffered a loss to sue.”

About healthcare policy

MGMA 2021 mid-year policy update for medical groups: While focusing on medical groups, this article is a good summary of some major policy issues on the table.

Today's News and Commentary

About Covid-19

WHO recommends Roche, Sanofi drugs for COVID-19 to cut death risk: “The World Health Organization on Tuesday recommended using arthritis drugs Actemra from Roche and Kevzara from Sanofi with corticosteroids for COVID-19 patients after data from some 11,000 patients showed they cut the risk of death.”

Coronavirus in the U.S.: Latest Map and Case Count: There are still many states with increasing rates of infection.

Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021: “Continued use of mRNA COVID-19 vaccines in all recommended age groups will prevent morbidity and mortality from COVID-19 that far exceed the number of cases of myocarditis expected. Information regarding the risk for myocarditis with mRNA COVID-19 vaccines should be disseminated to providers to share with vaccine recipients.”

Evaluation of Messenger RNA From COVID-19 BTN162b2 and mRNA-1273 Vaccines in Human Milk: “Vaccine-associated mRNA was not detected in 13 milk samples collected 4 to 48 hours after vaccination from 7 breastfeeding individuals. These results provide important early evidence to strengthen current recommendations that vaccine-related mRNA is not transferred to the infant and that lactating individuals who receive the COVID-19 mRNA-based vaccine should not stop breastfeeding. In addition, any residual mRNA below the limits of detection in our assay would undergo degradation by the infant gastrointestinal system, further reducing infant exposure.”

HHS takes N95 masks, portable ventilators off scarce medical supplies list: “HHS Secretary Xavier Becerra removed 17 items from the list, including N-95 Filtering Facepiece Respirators, portable ventilators and other specified personal protective equipment, supplies and equipment. HHS kept four items on the list, including medical gowns or apparel, certain laboratory reagents and materials, certain drug products, and syringes and hypodermic needles. These designated materials are subject to the hoarding prevention measures authorized under the executive order and the DPA. The action took effect July 1 and terminates Nov. 15, 2021.”

Israel, South Korea to Swap 700,000 Pfizer-BioNTech Covid-19 Vaccines: A great example of international cooperation: “Israel will ship about 700,000 expiring Pfizer/BioNTech coronavirus doses to South Korea, in what is set to be the world's first COVID-19 vaccine swap…
In return, South Korea, which has received just 20% of the 192 million doses it preordered, will send an identical number of doses back to Israel in September or October.”

About the public’s health

Effects of menthol use and transitions in use on short-term and long-term cessation from cigarettes among US smokers: “We compared the probability of 30+ day and 12-month abstinence from cigarette smoking by menthol use status using two cohorts of US adult cigarette smokers who attempted to quit smoking in the Population Assessment of Tobacco and Health…
hese results demonstrate that menthol impaired menthol smokers’ attempts to quit smoking but switching from menthol improved success. This suggests that removing menthol may improve menthol smokers’ success during quit attempts.”
Studies like this one provide the rationale for the FDA’s attempts to ban menthol in tobacco products.

Moderna's first seasonal flu vaccine slides into clinic as pharma giants crowd into mRNA: “Moderna is developing mRNA-1010 to protect against common flu strains as recommended by the World Health Organization. The company is hoping to improve on traditional flu shots which are typically about 40% to 60% effective. Most of these shots are developed using eggs, which Moderna said can cause unintended changes to the vaccine virus.”

About health insurance

Marketplace Premiums and Participation in 2021: From the Urban Institute, a current overview of state-level analysis of ACA marketplace premiums. Just a glance at the spread in the figures in Table 1 will reveal why complaints about price rises and affordability vary so greatly across states .

Expansions could be coming to Medicare: The debate is between extending benefits and lowering the age of eligibility. “The Committee for a Responsible Federal Budget has estimated that lowering the eligibility age to 60 would cost $200 billion over a decade.
In contrast, folding dental, vision and hearing coverage into the traditional Medicare program could cost $358 billion over the next 10 years — and possibly more.” [Emphases in the original.]

Nearly 1 in 5 deliveries could lead to a surprise medical bill, study finds: “The study found that nearly 20% of the families had one or more potential surprise bill for ‘delivery, newborn hospitalizations or both.’
Surprise bills could range based on the types of service provided. For instance, a delivery had one or more potential surprise medical bills with an average liability of $900.
However, a cesarean delivery had a potential liability of $1,825, the study said.”

Comparison of Spending on Common Generic Drugs by Medicare vs Costco Members: “Across more than 1.4 billion Medicare Part D claims for 184 products, the mean (SD) total prices were $12.02 ($18.47) and $24.32 ($41.07) for 30-day and 90-day prescription fills, respectively. Medicare overspent by 13.2% in 2017 and 20.6% in 2018 compared with Costco member prices for these prescriptions. Total overspending increased from $1.7 billion in 2017 to $2.6 billion in 2018.”
So much for Medicare being a prudent buyer.

Hospitals Often Charge Uninsured People the Highest Prices, New Data Show: This article was on the front page of the print edition of The Wall Street Journal today. The article claims that hospital “rates —and wide pricing differences—were confidential until Jan. 1, when a new federal rule required hospitals to make prices public.” Although specifics may only have become available then, this differential has been common knowledge for many years. The reason for the difference is not given until far down in the article: “Hospitals typically have a sticker price, often called the ‘chargemaster’ price, that can be the starting point for negotiations with insurers. Discounts off that sticker price tend to be steeper for those that bring large volumes of patients. Insurance plans offered under government programs like Medicare and Medicaid get even lower rates, tied to prices mandated by federal and state agencies.” In other words, hospitals aren’t out to soak the uninsured; instead they set prices high so their final discounted payments from insurers will be closer to what they want. The uninsured are unfortunate victims of this practice.

Health Insurance Deductibles and Health Care–Seeking Behaviors in a Consumer-Driven Health Care System With Universal Coverage: “In this cross-sectional study, high insurance plan deductibles were associated with forgoing of health care independent of socioeconomic status and preexisting conditions in a universal consumer-driven health care system with good population outcomes in Switzerland. Uncovering health care system design features that could lead to suboptimal population care may help decision makers improve their current health care system design to achieve better outcomes.”
Lesson: Universal coverage alone will not solve utilization problems. The underlying system needs to be properly designed as well.

About pharma

Six biopharma trends to watch in Q3: A good review of this issue.

Perrigo Completes Divestiture Of Generic Rx Business For $1.55 Billion: “Perrigo Company plc , a leading global provider of Consumer Self-Care Products, announced today that it has completed the previously announced sale of its Generic Rx Pharmaceuticals business to Altaris Capital Partners, LLC for $1.55 billion, with customary adjustments, completing Perrigo's transformation to a global consumer self-care company.”

About hospitals and healthcare systems

HCA completes $400M purchase of majority stake in Brookdale Senior Living healthcare services: “HCA Healthcare has finalized its $400 million bid to purchase a majority stake in Brookdale Senior Living’s home health and hospice business as the hospital chain aims to branch out into the home health market.
The new venture adds 80 sites of care for the hospital chain. The nursing home giant Brookdale will retain a 20% equity stake in the healthcare services segment.”

About healthcare IT

Telehealth visits cut healthcare's carbon footprint in half, Kaiser Permanente study finds: Among the study’s findings: “Greenhouse gas emissions from transportation to and from outpatient visits, which increased by about 6 percent between 2015 and 2019, dropped sharply in 2020. 
Ambulatory visit carbon intensity, a new metric that measures the total greenhouse gas emissions associated with a given outpatient visit, dropped by 51 percent. “



Today's News and Commentary

About pharma

Analysis of Launch and Postapproval Cancer Drug Pricing, Clinical Benefit, and Policy Implications in the US and Europe: “During this economic evaluation study period, launch prices of cancer drugs were substantially higher in the US than in the assessed similar high-income European countries, a gap that increased in the years after approval. Cancer drug prices frequently increased faster than inflation in the US but decreased on inflation-adjusted terms in Europe. Price changes were not associated with clinical benefit in any country [emphasis added].”

Regeneron pinpoints gene variants that protect against obesity, launches search for new drugs: “A team at Regeneron Genetics Center has discovered mutations in the gene GPR75 that protect against obesity, they reported in Science. Now, drug developers at Regeneron are using the company’s VelocImmune technology, which generates antibodies from humanized mice, to find drugs that can mimic the protective properties of the GPR75 variants.”

Eli Lilly, Boehringer Ingelheim's Jardiance posts 'blockbuster' heart failure win, setting up 2021 filings: “Eli Lilly and Boehringer Ingelheim’s Type 2 diabetes med Jardiance has been shown to reduce the risk of death and hospitalization from heart failure in patients with preserved ejection fraction (HFpEF). If approved, Jardiance would become the only therapy to improve outcomes in all heart failure patients, regardless of ejection fraction status or whether they have Type 2 diabetes.
Market analysts at Cantor Fitzgerald warned investors not to overlook the news as it might be an indicator of big things to come for the med.”

Innovation on hold during the pandemic? FDA says no with 29 approvals in first half of 2021: “In 2020, the FDA approved 53 new drugs, the second-most in a single year, after 2018’s bounty of 59.
And the momentum has continued through the first half of 2021. With the FDA endorsing its 29th novel drug on June 30, the industry was slightly ahead of last year’s pace.”

Pharmas' return on $5B spent yearly on patient support programs? Only 3% are using them: survey: “Pharma companies spend more than $5 billion on patient support programs every year, but when it comes to uptake, only 3% of patients are actually using them, according to a new survey from Phreesia Life Sciences.
Taking into account people who have ever used any patient support program, the percentage ticks up a bit, but still only gets to 8%…
So why the low usage? Lack of awareness is one clear factor—fewer than one-fourth (23%) of patients said they were extremely or very familiar with patient support programs, while another 18% said they were somewhat familiar.
However, an even bigger culprit in the dismal usage number is low familiarity, said Liz Herbert, senior research manager at Phreesia. Patients may be aware of pharma's financial or educational programs, but many don’t know details. Nor do they know how, or even whether, they could benefit.”
Read the article for more details. What these figures do not tell is the amount of public relations good-will pharma companies garner by having the programs in place. Look at announcements for very expensive medications and you will always see a disclaimer that they will be provided free to those who cannot afford them.

Supreme Court agrees to hear hospital lawsuit challenging HHS' 340B cuts: “The case called American Hospital Association v. Becerra centers on the Medicare reimbursement rate paid for outpatient drugs and whether the Department of Health and Human Services singled out 340B-covered entities.
HHS traditionally set reimbursement rates for drugs based on the average sales price and applied it across all hospital groups. But the lawsuit said that practice changed in 2018 when HHS singled out 340B hospitals, the lawsuit argues.”

About Covid-19

Scientists identify long-sought marker for COVID vaccine success: “Participants who had higher levels of neutralizing antibodies — as well as ‘binding’ antibodies, which recognize the SARS-CoV-2 spike protein — tended to gain stronger, but not total, protection from a symptomatic infection, the Oxford team determined. The team used a model to estimate the antibody levels that corresponded to different levels of vaccine protection against COVID-19 in trials, ranging from 50% to 90% protection.”

Cambridge researchers spot antimalarial, arthritis drugs for COVID-19 repurposing: “The two drugs, antimalarial therapy proguanil and rheumatoid arthritis medication sulfasalazine, showed they could safety inhibit the replication of the SARS-CoV-2 coronavirus behind COVID-19 in both monkey and human cell lines, according to a new study published in Science Advances.”

COVID Falls From America's #1 Killer to #7 by June: ”The disease was the third leading cause of death for much of 2020, but became the leading cause of death in December 2020 and early 2021, reaching a peak of 3,136 deaths per day in January 2021 and far surpassing U.S. deaths from heart disease and cancer during that time.”

Israel Says Pfizer Vaccine Less Effective in Preventing Delta Variant Infection: “The Pfizer-BioNTech coronavirus vaccine has dropped to 64 percent effectiveness in preventing infection in Israel as the delta variant continues to spread across the country, the Health Ministry said on Monday…
The ministry added that the vaccine is 93 percent effective in preventing hospitalizations and severe symptoms.”

Scientists quit journal board, protesting ‘grossly irresponsible’ study claiming COVID-19 vaccines kill: “Several reputed virologists and vaccinologists have resigned as editors of the journal Vaccines to protest its 24 June publication of a peer-reviewed article that misuses data to conclude that ‘for three deaths prevented by [COVID-19] vaccination, we have to accept two inflicted by vaccination.”

Children and COVID-19: State-Level Data Report: “As of June 24, over 4.03 million children have tested positive for COVID-19 since the onset of the pandemic. Over 8,400 child cases were added to the cumulative total last week. This marks the lowest number of weekly cases reported in the past year, since May 2020.”

Efficacy of Portable Air Cleaners and Masking for Reducing Indoor Exposure to Simulated Exhaled SARS-CoV-2 Aerosols — United States, 2021: From the CDC: “A simulated infected meeting participant who was exhaling aerosols was placed in a room with two simulated uninfected participants and a simulated uninfected speaker. Using two HEPA air cleaners close to the aerosol source reduced the aerosol exposure of the uninfected participants and speaker by up to 65%. A combination of HEPA air cleaners and universal masking reduced exposure by up to 90%.”

CDC: 1K US counties have less than 30% of their population inoculated against COVID-19: “About 1,000 U.S. counties, mostly in the Southeast and Midwest, have COVID-19 vaccination coverage of less than 30 percent, CDC Director Rochelle Walensky, MD, said during a July 1 White House COVID-19 briefing.”

Bharat Biotech's COVID-19 vaccine shows 77.8% efficacy at final analysis: “Bharat Biotech announced that in the final analysis of a Phase III study of Covaxin, the coronavirus vaccine demonstrated an efficacy rate of 77.8%, slightly down from a rate of 80.6% reported at an earlier interim analysis…
Further results showed that Covaxin was 93.4% effective against severe symptomatic COVID-19, with 15 cases in the placebo group versus one in the Covaxin arm, and 63.6% effective against asymptomatic COVID-19. Bharat Biotech added that the vaccine was 65.2% effective against the Delta (B.1.617.2) variant.”

We tried out the first statewide vaccine passport: From MIT Technology Review: “When we tested New York’s Excelsior Pass, we found privacy concerns, technical glitches, and questions over who it’s really for.” Read the article for more specifics about usability problems…starting with downloading the app.

About hospitals and health systems

Tying CEO Compensation To Value-Based Purchasing Scores: “First, there is no association between CEO compensation and value delivered, even after adjusting for the number of hospital beds [emphasis added] (p = 0.10). In fact, the hospital with the worst value score has CEO compensation twice as high as the hospital with the third highest value. Second, there is huge variability in value delivered—even within this select group of major teaching hospitals that one would expect to deliver the highest level of care. There is a three-fold difference between the value delivered at the lowest-value hospital and the highest value, granted the highest-value hospital is an outlier (it is the highest-value teaching hospital in the whole country).”

HOSPITALS CUT 5.5K JOBS IN JUNE: Highlights:
”—Hospitals lost 5,500 jobs, and nursing homes lost 9,600 jobs in June.
—Those losses were slightly offset by 2,900 new jobs in ambulatory services.
—Since February 2020, hospitals have lost 102,000 jobs and nursing homes have lost 360,000 job losses.
—The ambulatory services sector has grown 75,400 jobs in that span.
—There were 15.9 million people attached to the healthcare sector workforce in June.”

Pandemic pivots Ochsner Health to new role: PPE manufacturer: “Ochsner Health is starting a new business to make personal protective equipment (PPE). Not only will Ochsner be making gloves, gowns, masks and N95 respirators, it will manufacture the materials used to make those items, such as the liquid nitrile needed for gloves and the spunbond meltblown spunbond (SMS) laminate fabric needed to make masks, gowns and bouffant hair covers.
Ochsner and Alabama-based construction contractor and property developer Trax Development started a joint venture, SafeSource Direct, with $150 million. SafeSource is putting $73 million toward retrofitting an 80,000-square-foot manufacturing facility that will also serve as a headquarters, and $77 million is going for the development of a new facility.”
Healthcare systems have gotten into the generic pharma business, so this next step is not a big surprise.

Ohio health system to pay $21M to resolve false claims allegations: “Akron (Ohio) General Health System, acquired by Cleveland Clinic in 2015, will pay $21.25 million to resolve allegations that it violated the False Claims Act, the U.S. Justice Department said July 2. 
The settlement resolves allegations that the health system, between August 2010 and March 2016, paid certain physicians in excess of fair market value to secure referrals of patients in violation of the Stark Law and submitted claims for services provided to the illegally referred patients in violation of the False Claims Act.”
It is still amazing that hospitals think they can get away with these well-known, illegal practices.

About the public’s health

WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention: FYI- published online today.

Ohio providers can deny care on moral grounds under new law: “Ohio physicians, hospitals and insurers can refuse to offer or pay for a medical service if it violates their moral or religious beliefs under a new provision…
The medical conscience clause is included in the state's $74.1 billion 2022-23 budget, which Gov. Mike DeWine signed July 1. 
The Ohio Hospital Association, Ohio Children’s Hospital Association, Ohio State Medical Association and Ohio Association of Health Plans issued a joint statement opposing the provision during the state's budget process.”

About healthcare IT

Microsoft advises customers to disable printing until cyber vulnerability fixed: “The Computer Emergency Response Team Coordination Center (CERT/CC), part of the Software Engineering Institute at Carnegie Mellon University, this week reported a critical remote code execution vulnerability impacting the Windows Print Spooler service that allows a remote authenticated attacker to execute arbitrary code with system privileges on a vulnerable system. Until Microsoft fixes the PrintNightmare vulnerability, for which the exploit code is publicly available, the company advises customers to disable printing services where possible.”

Ransomware Hackers Demand $70 Million to Unlock Computers in Widespread Attack: “The cyberattack that started to unfold Friday is estimated to have hit hundreds of mostly small and medium-size businesses and tens of thousands of computers. It quickly set off alarms in U.S. national security circles over concern that it could have far-reaching effects…
The hackers behind the latest incident are known as the REvil ransomware group. They are asking for $70 million to unlock all the affected systems but victims of the group can also pay amounts varying between $25,000 and $5 million directly to unlock their systems even if nobody pays the $70 million.”

Virginia payer Dominion National settles 9-year data breach for $2M: 5 details: “Vision and dental insurance provider Dominion National in April 2019 learned that an unauthorized third party had accessed some of its computer servers since August 2010. 
Data stored on the computer servers included current and former member enrollment and demographic information, Social Security numbers, members' postal and email addresses, birth dates, bank account and routing numbers and taxpayer ID numbers. 
The data breach affected 2.9 million individuals, according to the HHS data breach portal.”

Northwestern Memorial HealthCare and Renown Health Affected by Elekta Cyberattack: “The data breach was discovered by Stockholm-based Elekta, which provides a software platform used for clinical radiotherapy treatment for cancer and brain disorders. Elekta issued a statement confirming its first-generation cloud-based storage system was accessed by unauthorized individuals, which affected a subset of customers in North America…
In total, 42 healthcare systems are believed to have been affected by the breach. In some cases, affected facilities had to temporarily halt cancer procedures and arrange for patients to continue their treatment at alternative healthcare facilities.”

New Walgreens CEO Sees ‘Tech Enabled Healthcare’ In Future: However, “‘CEO Rosalind Brewer did not provide much of an update on her strategic vision for the company, only to highlight technology will be a key focus and pharmacy will remain the central anchor of the business,’ Mizuho Securities analyst Ann Hynes wrote in a report last week that followed Walgreens fiscal third quarter earnings that beat analysts’ expectations.”

H1 2021 Digital Health Funding: Another Blockbuster Year…In Six Months: “H1 2021 secured $14.7B in digital health funding, already surpassing all of 2020’s funding. The half closed with 372 deals and an average deal size of $39.6M, spearheaded by 48 mega deals which accounted for 59% of total H1 2021 funding. Public exit activity ballooned with 11 closed IPOs and SPACs, with another 11 SPACs expected to close in 2021.”

About insurers

Iowa insurer not required to cover COVID-19 losses, court rules: “A federal appellate court ruled in favor of Cincinnati Insurance Co. on July 2, finding that the insurer did not have to cover losses stemming from COVID-19 restrictions that an Iowa dental clinic faced.
The initial lawsuit against Cincinnati Insurance Co. came after it refused to compensate Oral Surgeons for nonemergency procedures that were canceled because of pandemic restrictions. That lawsuit fell in favor of the insurer, and the plaintiff appealed to the U.S. Court of Appeals for the 8th Circuit.”
One of these cases will be appealed to the Supreme Court; if heard, it could set a major precedent for the insurance industry.

Surprise billing rule also strikes down insurer ED policies: “A major rule that bans surprise medical bills also outlawed policies that let insurers retroactively deny emergency department claims…
UnitedHealthcare faced major blowback when it proposed a similar policy last month. The insurance giant said the goal of the policy was to encourage patients to get care at other sites such as an urgent care facility rather than going to the ED.
The policy was expected to go into effect July 1. However, UnitedHealthcare decided to delay the policy until at least the end of the COVID-19 public health emergency, which is expected to run through the rest of this year.”

Jury Convicts Medical Imaging CEO In $250M Health Fraud: “The CEO of several medical imaging companies was found guilty by a California federal jury Friday in connection with a $250 million scheme that involved bribes, kickbacks and fraud through the state workers' compensation system for medical services. Sam Sarkis Solakyan, 40, operated diagnostic imaging facilities throughout California and was found guilty of one count of conspiracy to commit honest services mail fraud and health care fraud, and 11 counts of honest services mail fraud. According to the U. S. Attorney's Office for the Central District of California, evidence presented at trial showed that Solakyan conspired with others from mid-2013 to November 2016…”

Today's News and Commentary

About health insurance

Medicaid expansion didn't lead to changes in hospitalizations in safety-net facilities: “The study found no significant changes in safety-net hospitalizations among Medicaid or uninsured patients in states that did and did not expand Medicaid. There were also no major changes among racial and ethnic minority groups or among low-income patients.”

CMS wants to reward dialysis providers for improving home dialysis among low-income beneficiaries: “The Centers for Medicare & Medicaid Services (CMS) released a proposed rule Thursday that updates payment rates for the End-Stage Renal Disease (ESRD) Prospective Payment System and makes changes to the quality incentive program and ESRD Treatment Choices Model. The goal of the changes is to encourage dialysis providers to decrease disparities in home dialysis and transplant rates, part of a larger effort by the Biden administration.”
And in a related article:
CVS, Anthem, Intermountain form coalition to push for regulatory changes for home dialysis: “Founding members of Innovate Kidney Care include Anthem, CVS Kidney Care, Home Dialyzors United (HDU), portable dialysis machine maker Outset Medical and kidney care startups Cricket Health and Strive Health….
The companies cite existing conditions for coverage that apply a one-size-fits-all set of requirements whether dialysis takes place in a clinic or at home. Due to these complex requirements, many organizations don't offer self-dialysis options, leaving large patient populations without access to these benefits.
Innovate Kidney Care is calling for the Centers for Medicare & Medicaid Services (CMS) to change the end-stage renal disease conditions for coverage to remove barriers to home dialysis training and support so more patients can benefit from the flexibility and personalization of home-based treatment.”

STATEMENT ON U.S. SUPREME COURT ORDER IN 340B MEDICARE CUTS LAWSUIT: “The U.S. Supreme Court announced today that it will review a Court of Appeals decision holding that the Centers for Medicare & Medicaid Services (CMS) had the authority to make payment cuts to many 340B hospitals under Medicare’s outpatient prospective payment system (OPPS).”

Walmart Unveils LGBTQ+ Health Care Platform: “Through a partnership with San Francisco-based health care company Grand Rounds, employees on a Walmart medical plan and their covered dependents can take advantage of Included Health, which was created especially for the LGBTQ+ community.”

Justices to Consider Narrowing Medicaid Payment Recovery Source: “The U.S. Supreme Court announced Friday that it will clear up a dispute over how state Medicaid agencies recoup health-care costs paid on behalf of beneficiaries who later recover compensation for the medical expenses from other people.
The case involves a ruling by the U.S. Court of Appeals for the Eleventh Circuit that allowed Florida’s Medicaid agency to recoup payments made for Gianinna Gallardo’s medical care from a settlement she reached with the person who caused her injuries.
Federal Medicaid law requires states to recover money paid out on behalf of beneficiaries whenever they can.”

ToAbout healthcare IT

Picture Archiving Communication Systems (PACS) Vulnerabilities: “Picture Archiving Communication Systems (PACS) are widely used by hospitals, research institutions, clinics and small healthcare practices for sharing patient data and medical images. In 2019, researchers disclosed a vulnerability in these systems that demonstrated if the systems were exploited there could potentially be an issue with exposed patient data. These systems, which can be easily identified and compromised by hackers over the Internet, can provide unauthorized access and expose patient records.”
This HHS report lists systems with “known vulnerabilities.”

Healthcare workers accuse Alexa of possibly recording protected info: “In a class action filed this week, healthcare workers alleged that their Amazon Alexa-enabled devices may have recorded their conversations – including potentially protected information.
Some of the plaintiffs, who include a substance abuse counselor and a healthcare customer service representative, say they work with HIPAA-protected information. Others say they have private conversations with patients…
The plaintiffs' complaints are twofold: They say that users may unintentionally awaken Amazon Alexa-enabled devices and that Amazon uses human intelligence and AI to listen to, interpret and evaluate these records for its own business purposes.”

About Covid-19

J&J's COVID-19 vaccine shows promise against Delta variant: ”An analysis of blood from eight patients showed that immune responses elicited by the vaccine against the Delta variant, first identified in India, were at a higher level than against the Beta variant, which was first identified in South Africa.”

A Revolutionary Solar Fridge Will Help Keep COVID Vaccines Cold In Sub-Saharan Africa: “Rather than store electricity in batteries to power them through the night, these so called "direct-drive" systems store coldness. They are so efficient and so well-insulated that they can stay cold for 3 days even if the solar panels aren't supplying power. And the lack of batteries makes them far simpler to operate and maintain.”
When will we get this cutting edge technology? Imagine uses such as in long-haul refrigeration train cars and trucks.

EU officially launches digital vaccine passport: “The European Union’s digital COVID-19 certificate officially launched today. The certificate allows people to show proof of COVID-19 vaccination, a recent negative test result, or a past COVID-19 infection. 
The certificate, which includes a QR code and digital signature, can either be displayed on a digital device or printed out. People who have the certificate digital COVID-19 certificate have to get an additional COVID-19 test or quarantine when traveling in the EU. The certificate only recognizes COVID-19 vaccines authorized in the EU — that includes the AstraZeneca, Pfizer / BioNTech, Moderna, and Johnson & Johnson shots.”

About pharma

GSK, under pressure to perform, pens $2.2B deal with Alector focused on neuro R&D, Alzheimer's: “The deal is worth a meaty $700 million upfront with up to an additional $1.5 billion in milestone payments, if all goes to plan and the two meds get to the market. 
Those assets are formed of two monoclonal antibodies: AL001 and AL101, which belong to a new field of research known as ‘immuno-neurology’ that seeks to harness the body’s own immune system to fight neurodegenerative disease and that the pair hopes will have the same successes seen with immuno-oncology in cancer.”

About home health

Amedisys snaps up hospital-at-home provider Contessa Health in $250M deal: “Amedisys, a home health, hospice and personal care company, said the $250 million deal adds higher acuity, home-based care to Amedisys’ current service offering and significantly expands Amedisys’ total addressable market for in-home care services from $44 billion to $73 billion.
Contessa Health, founded in 2015, provides hospital-at-home and skilled nursing facility at-home services and partners with health systems and health plans including Mount Sinai Health System, Marshfield Clinic Health System, Ascension Saint Thomas, CommonSpirit Health and Highmark Health. The company has potential plans to expand to more than a hundred hospitals in 28 more states.”

About hospitals and health systems

Characterization of US Hospital Advertising and Association With Hospital Performance, 2008-2016: “In this cross-sectional study of more than 4500 acute care hospitals per year, almost half advertised their services to consumers, yet there was no clear association between advertising and objective performance measures. Hospitals that advertised were more likely to have more net assets and income.”

Today's News and Commentary

About Covid-19

CDC is leaving it up to states to set guidelines for mask-wearing, director says: “CDC Director Dr. Rochelle Walensky said Wednesday the U.S. agency is leaving it up to states and local health officials to set guidelines around mask-wearing even after the World Health Organization urged fully vaccinated people to continue the practice.”

EMA Lists Five Drugs as Preferred COVID-19 Therapeutics: “The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal antibodies and Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib).
The agency recommended antibodies from GlaxoSmithKline, Celltrion, Eli Lilly and Regeneron for use in early-stage patients at risk of progressing to severe COVID-19 and Olumiant for treatment of hospitalized COVID-19 patients on oxygen.”

COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sites: “ASPR [The HHS Assistant Secretary for Preparedness and Response], in partnership with the Johns Hopkins University Applied Physics Laboratory, has developed the COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sites (mAbs Calculator). The mAbs Calculator is a free, data-informed decision support tool that is based on a comprehensive simulation framework. The mAbs Calculator can be used to inform staffing decisions and resource investments needed for COVID-19 monoclonal antibody therapeutic infusion sites.”

FDA revokes emergency nods for KN95 respirators and disinfecting hardware as mask supplies rebound: “The agency said it is pulling all emergency authorizations for disposable masks that are not approved by the National Institute of Occupational Safety and Health (NIOSH), such as imported KN95 respirators.
Manufacturers of decontamination and bioburden reduction systems had already asked the agency to rescind their emergency use authorizations, the FDA said. Because supplies of NIOSH-approved respirators have increased significantly..”

White House launches ‘surge response’ teams to delta variant hot spots: “The White House-coordinated teams will include a mix of virtual support and on-the-ground personnel, helping deploy additional supplies as requested by local officials, such as testing or therapeutics. Staff will come from the CDC, the Federal Emergency Management Agency and the Office of the Assistant Secretary for Preparedness and Response in the Department of Health and Human Services. The White House also may ramp up paid promotions about the benefits of vaccination in areas that officials deem high risk.”

About pharma

ICER stands by view on Biogen's Aduhelm, says sharp price cut needed: “Biogen would need to drastically lower the price of its new Alzheimer's drug for treatment to be cost effective, according to a revised report from the Institute for Clinical and Economic Review, which affirmed the influential nonprofit group's earlier conclusion that the company's clinical trial evidence is insufficient to prove a health benefit.
Biogen priced Aduhelm, as the drug is now called, at an average list cost of $56,000 a year. Assuming a level of efficacy suggested by blending results from the company's two Phase 3 trials, one of which failed, ICER calculated treatment would be cost effective only at prices between about $3,000 and $8,400, a reduction of 85% to 95%.”

About health insurance

CD&R Sets Deal for Majority Stake in Vera Whole Health: Back to the future????
”Private-equity firm Clayton Dubilier & Rice LLC is buying a majority stake in Vera Whole Health Inc., officials with both companies said…
Vera, based in Seattle, has created a new model of employer- sponsored healthcare in which the employer or insurance provider pays a flat monthly per-patient fee that covers all of the employee’s healthcare needs. Under the company’s model, the primary- care physician is the leader of a team of healthcare providers who communicate with each other and oversee the patient’s health.”
I guess they never heard about Kaiser’s origins in the 1930s and capitated HMO plans.

HHS Announces Rule to Protect Consumers from Surprise Medical Bills: “Today, the Biden-Harris Administration, through the U.S. Departments of Health and Human Services (HHS), Labor, and Treasury, and the Office of Personnel Management, issued "Requirements Related to Surprise Billing; Part I," an interim final rule that will restrict excessive out of pocket costs to consumers from surprise billing and balance billing…
Among other provisions, today's interim final rule:

  • Bans surprise billing for emergency services. Emergency services, regardless of where they are provided, must be treated on an in-network basis without requirements for prior authorization.

  • Bans high out-of-network cost-sharing for emergency and non-emergency services. Patient cost-sharing, such as co-insurance or a deductible, cannot be higher than if such services were provided by an in-network doctor, and any coinsurance or deductible must be based on in-network provider rates.

  • Bans out-of-network charges for ancillary care (like an anesthesiologist or assistant surgeon) at an in-network facility in all circumstances.

  • Bans other out-of-network charges without advance notice. Health care providers and facilities must provide patients with a plain-language consumer notice explaining that patient consent is required to receive care on an out-of-network basis before that provider can bill at the higher out-of-network rate.”

Consumer protections in the rule will take effect beginning on January 1, 2022. 

About the public’s health

Healthiest Communities Rankings 2021: At the top was Los Alamos County, N.M. But five Colorado Counties were in the top 10. See the article for the components of the rankings and where your county ranks.

About healthcare quality

Leapfrog Decries CMS Patient Safety Measure Proposal in IPPS: “Patient safety organization The Leapfrog Group has joined more than 75 other healthcare organizations and individuals in speaking out against a proposed patient safety measure change included in the CMS Inpatient Prospective Payment System (IPPS) Inpatient Quality Reporting (IQR) Program.
The measure, ‘Deaths Among Surgical Inpatients with Serious Treatable Complications,’ measures the death rate among those receiving surgery on an in-patient basis when that death occurred due to a patient safety incident.”
It is not known why CMS is making this change.

About pharma

States Step Up Push to Regulate Pharmacy Drug Brokers: A good summary on what is happening with these efforts.

Today's News and Commentary

About health insurance

Justice Department Reports Record Number of Health Fraud Cases: “The Justice Department opened a record number of False Claims Act cases last year involving allegations of health-care fraud, and it’s zeroing in now on those who misuse electronic health records, contribute to the opioid epidemic, abuse senior citizens, manipulate Medicare’s managed care program, and improperly claim Covid-19 relief funds.
‘The department also opened over 900 new matters, including 580 new health fraud matters,’ Michael Granston, deputy assistant attorney general for the DOJ’s commercial litigation branch, said Tuesday during the American Health Law Association’s annual meeting.”

Special Affordable Care Act subsidies available for unemployed Americans starting July 1: “The benefit, part of the Democrats’ $1.9 trillion rescue package enacted in March, allows anyone who receives or is approved to receive unemployment compensation during the year to select policies for as little as $0 a month in premiums and with little cost-sharing requirements, after federal assistance. 
The subsidies are tied to the benchmark silver plan, so those who pick higher-level policies might have to pay a premium. The same goes for those who live in states that require plans to cover additional benefits, such as abortion, that are beyond the law’s essential health benefits.”

Without Extension of ARPA Benefits, Americans Could Face Higher Premiums in Exchanges: “Included in ARPA [American Rescue Plan Act], signed into law by President Biden on March 11, 2021, is a temporary increase in exchange premium tax credits for people already eligible for assistance under the Affordable Care Act (ACA). The law also extends eligibility to people with incomes over 400% of the federal poverty level (FPL), for 2021 and 2022. Under these provisions, approximately 18 million Americans now have access to lower-premium exchange plans – and approximately 8 million are newly eligible for lower premiums. Enhanced APRA tax credits are estimated to save current exchange enrollees an average of 25 percent of current premiums after subsidies. These ARPA tax credit enhancements are set to expire on December 31, 2022.”
The article has examples of what would happen if the Act is not extended.

California hospital beats suit over ER fee nondisclosure: “A California hospital was properly dismissed from a lawsuit alleging it violated state consumer protection laws by failing to disclose emergency room visit fees before treatment, a state appellate court ruled June 29.” 

Hospital chargemaster prices for generics up to 6,000% more than pharmacies, research finds: “Chargemaster prices for generic drugs in hospitals can be 6,000 percent higher than the price of the same drug in a pharmacy, according to an analysis by GoodRx, a pharmacy discount company. 
GoodRx analyzed chargemaster prices for 12 common generic drugs at 16 geographically diverse hospitals across the U.S. and compared the prices to cash prices at pharmacies. The company said cash prices are readily available and provide a good benchmark for the ‘fair’ price consumers should pay for a generic drug.”

33 Million Persons of All Ages Uninsured in 2019: “In 2019, 33.0 million (10.2 percent) persons of all ages were uninsured, according to a study published online June 29 in the National Health Statistics Reports, a publication from the U.S. Centers for Disease Control and Prevention.”
The problem with these data is that they are old. For example, 2019 figures do not take into account more recent Medicaid expansions and ACA enrollments.

Humana Ranked No. 1 Among Health Insurers for Customer Experience: “Humana ranked No. 1 among Health Insurers for customer experience (CX) quality in Forrester’s proprietary 2021 US CX Index™ survey… Along with this notable recognition, Humana also ranked the highest on clear communications and providing transparent prices, rates and fees amongst health insurers.”


About Covid-19

CureVac, the latest experimental coronavirus vaccine, proves just 48 percent effective overall, a disappointing result: “The company emphasizes that in people 60 and younger, vaccine was 77 percent effective against moderate to severe disease.”

Moderna's COVID-19 vaccine shows promise against Delta variant in lab study: “The study was conducted on blood serum from eight participants obtained one week after they received the second dose of the vaccine, mRNA-1273.”

Hepatitis C Antivirals May Fight SARS-CoV-2: “Sofosbuvir/ledipasvir (Harvoni) and nitazoxanide (Alinia) both appeared to clear SARS-CoV-2, the virus that causes COVID-19 in a preliminary trial, said Mohamed Medhat, lecturer in the department of gastroenterology and tropical medicine at Assiut University Hospitals in Assiut, Egypt.
Sofosbuvir/ledipasvir was particularly efficacious, said Medhat, who reported the results at the International Liver Congress 2021.”

Respiratory risk, not death, increased for adults with obesity in ICU with COVID-19: “In the Study of the Treatment and Outcomes in Critically Ill Patients with COVID-19 (STOP-COVID), researchers analyzed the records of adults admitted to the ICU with COVID-19 at 68 U.S. hospitals. Although having a higher BMI was associated with a higher risk for acute respiratory distress syndrome and acute kidney injury requiring renal replacement therapy, there was no increased risk for mortality observed.”
This research offers different results than past studies, including lack of some previously reported inflammatory biomarkers associated with obesity.

About pharma

Takeda, Endo reaped 'many hundreds of millions' through Amitiza pay-for-delay deal, lawsuit claims: “For years, branded drugmakers have used settlements with generics companies to extend market exclusivity. These ‘pay-for-delay’ deals are often criticized as anti-competitive, and now Takeda and Endo are facing scrutiny for their prior accord.
A patent settlement between Takeda and Par Pharmaceutical—now part of Endo—in 2014 delayed generics to Japanese pharma’s constipation drug Amitiza and broke antitrust law, a new proposed class-action lawsuit claims.”

BIOTECHNOLOGY UPDATE: From the OECD, this monograph is an international perspective that includes different biotech sectors, such as health, agriculture and biofuels.

Sanofi commits €400 million annually to new mRNA vaccine unit: “According to Sanofi, [its] new research centre will look at developing mRNA vaccines beyond the coronavirus pandemic, bringing them into routine use against diseases with high unmet need. The company indicated that it expects to have a minimum of six clinical candidates by 2025.”

About healthcare IT

CMS interoperability rule becomes enforced June 30: 6 things to know: The article is a reminder that enforcement of this provision is starting and has some useful highlights.

About diagnostic devices

Philips and the Spanish National Center for Cardiovascular Research (CNIC) collaborate on a new ultra-fast cardiac MRI protocol for research purposes with the aim of benefitting clinical practice in the future: “Reducing the procedure time for full evaluation of heart anatomy and function from about one hour down to a few minutes, this new technique has the potential to increase patient access to precision diagnosis, improve patient comfort due to shorter scan times, and lower the cost of care…
The new technique (called ‘Enhanced SENSE by Static Outer-volume Subtraction (ESSOS)) makes use of the fact that during a breath-hold, everything within the patient’s chest remains static, except their beating heart. After an initial image of the static part (outer volume) has been captured this MRI data is temporarily removed. The MRI signal of the beating heart can now more easily be subtracted from subsequent scan data, allowing up to four times faster acquisition of a 3D image of the heart. This results in a net acceleration factor of up to 32. Once the dynamic information of the beating heart is reconstructed, the static outer volume images are added back to generate a full 3D cardiac image showing heart anatomy and function, and allowing review from different views with good image resolution. If needed, a second contrast-enhanced isotropic 3D single breath-hold scan can reveal the extent of damage to the patient’s heart muscle.”

Today's News and Commentary

About health insurance

Health Care Sharing Ministries: Last Week Tonight with John Oliver: John Oliver discusses how these Ministries are NOT insurance.

Impact of High-Deductible Health Plans on Emergency Department Patients With Nonspecific Chest Pain and Their Subsequent Care: The finding of reduced visit rates with these plans contrasts with older data that said copays do not dissuade emergency visits for heart attacks. Perhaps study differences are due to population selection or perceived severity of illness. Also, in the past, many plans waived out-of-pocket expenses if the patient was admitted.

CMS expanding home health value-based purchasing model nationwide in January 2022: “The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule Monday that accelerates the shift from paying for home health services based on volume to a system that gives incentives to home health agencies for higher quality care.The CY 2022 Home Health Prospective Payment System (HH PPS) proposed rule outlines nationwide expansion of the home health value-based purchasing (HHVBP) model, which was
developed as a pilot by CMS' innovation arm and began in January 2016.”

About Covid-19

SARS-CoV-2 mRNA vaccines induce persistent human germinal centre responses: Another research article that provides evidence of long-lasting immunity from the MRNA vaccines.

Three in 10 Americans Think Pandemic Is Over in U.S.: From Gallup:

  • “29% say pandemic is done; 71% say it is not

  • 62% say lives "somewhat" back to normal; 54% say lives not disrupted now

  • 40% do not expect their lives will ever be normal again”

Masks upgrade cuts infection risk, research finds: “The quality of face masks healthcare workers wear makes a huge difference to their risk of coronavirus infection, Cambridge University Hospitals NHS Foundation Trust research has found.
Wearing a high grade mask known as an FFP3 can provide up to 100% protection. 
By contrast, there is a far greater chance of staff wearing standard issue surgical masks catching the virus.”

New face mask prototype can detect Covid-19 infection: “Engineers at MIT and Harvard University have designed a novel face mask that can diagnose the wearer with Covid-19 within about 90 minutes. The masks are embedded with tiny, disposable sensors that can be fitted into other face masks and could also be adapted to detect other viruses.
The sensors are based on freeze-dried cellular machinery that the research team has previously developed for use in paper diagnostics for viruses such as Ebola and Zika. In a new study, the researchers showed that the sensors could be incorporated into not only face masks but also clothing such as lab coats, potentially offering a new way to monitor health care workers’ exposure to a variety of pathogens or other threats.”

Mixing Pfizer, AstraZeneca vaccines generates strong immune response against COVID-19: study: “Efficacy findings released Monday from the University of Oxford-led Com-COV trial suggest that mixed COVID-19 vaccine schedules using Pfizer/BioNTech's Comirnaty (BNT162b2) and AstraZeneca's Vaxzevria induced ‘high concentrations of antibodies’ against the SARS-CoV-2 spike IgG protein when given four weeks apart. ‘This means all possible vaccination schedules involving [these two] vaccines could potentially be used against COVID-19,’ the authors said after the results were published on The Lancet pre-print server.”

About pharma

: “Available exclusively through Walmart’s private ReliOn brand, the new offering includes analog insulin vials ($72.88) and FlexPen® ($85.88). These products will save customers between 58% to 75% off the cash price of branded analog insulin products, which translates to a savings of up to $101 per branded vial or $251 per package of branded FlexPens®.
The new private label ReliOn™ NovoLog® Insulin (insulin aspart) injection, manufactured by Novo Nordisk, is available in Walmart pharmacies this week, and Sam’s Club pharmacies in mid-July across the United States. ReliOn™ NovoLog® is a rapid-acting insulin analog used to control high blood sugar in adults and children with diabetes. Customers will need a prescription in order to purchase the products and should always consult with their doctor regarding their diabetes management.”

Four biotech companies are forming a coalition to advocate for manufacturing pharmaceutical products within the United States: “The Securing America’s Medicines and Supply coalition (SAMS) is composed of Coherus BioSciences, Teva Pharmaceutical Industries, Zymergen and iRemedy Healthcare Companies. The group aims to boost the U.S. supply chain while also fostering cooperation with U.S. allies to ‘near shore’ pharmaceuticals and medical supplies.”

About healthcare IT

How to Measure the Value of Virtual Health Care: “…the American Medical Association (AMA) and Manatt Health, a legal and consulting firm, have developed a framework for assessing the value of digitally enabled care…
The framework describes several environmental variables that impact distinct value streams, which collectively seek to capture the overall value derived from a specific digitally-enabled model. The environmental variables include practice type, payment arrangement, patient population, clinical use case, and virtual care modality…
Next, the framework includes six value streams: clinical outcomes, quality and safety; access to care; patient and family experience; clinician experience; financial and operational impact; and health equity. The impact of a digitally-enabled-care model should be measured on all these value streams — a Balanced Scorecard approach, if you will, to measuring and realizing the full potential of virtual care.”

About the public’s health

Current Gaps in Breast Cancer Screening Among Asian and Asian American Women in the United States: ”In the United States, recent data demonstrate that the burden of breast cancer among Asian women has increased each year over the past decade. We aim to characterize challenges faced by Asian and Asian American women in the United States related to cultural stigma, socio-economic status, and overall access to breast cancer care. An increased understanding of barriers to breast cancer prevention and treatment efforts is needed to develop more effective strategies aimed at reducing disparities in care among segments of this heterogenous population.'“

About physicians

COVID-19’s Impact On Acquisitions of Physician Practices and Physician Employment 2019-2020: This report, prepared by Avalere, confirms the continued trend of corporate acquisition of physician practices. Among the findings:
—48,400 additional physicians left independent practice and became employees of hospitals or other corporate entities – 22,700 of that shift occurred after the onset of COVID-19
—This represents a 12% increase in the percentage of employed physicians over the two-year study period
—Hospital and other corporate entities acquired 20,900 additional physician practices over the two-year period, resulting in a 25% increase in corporate-owned practices”
At the end of 2020, 69.3% of physicians were employed by hospitals or other corporate entities.

Today's News and Commentary

About the public’s health

Scientists develop hand-held rapid test that can diagnose bacterial infections in less than ONE HOUR: If the technology pans out, it could be a huge public health benefit- cutting down on unnecessary antibiotics and the consequent drug-resistant bacteria.
The test “uses specially-designed molecules that can detect specific proteins, unique to a particular bacteria. 
The molecules are embedded in a microchip - making for a test that's small and easy to use.
The microchip is part of a handheld device, similar to a blood glucose monitor. Users can plug the device - which is about the size of a USB stick - into a smartphone to see their results.”

Helping Drug Users Survive, Not Abstain: ‘Harm Reduction’ Gains Federal Support: “Overdoses have surged during the pandemic. Now, for the first time, Congress has appropriated funds specifically for programs that distribute clean syringes and other supplies meant to protect users.”

Nine prohibited stimulants found in sports and weight loss supplements: deterenol, phenpromethamine (Vonedrine), oxilofrine, octodrine, beta-methylphenylethylamine (BMPEA), 1,3-dimethylamylamine (1,3-DMAA), 1,4-dimethylamylamine (1,4-DMAA), 1,3-dimethylbutylamine (1,3-DMBA) and higenamine: The headline is the story.

Juul agrees to pay North Carolina $40 million to settle vaping accusations: “E-cigarette company Juul agreed to pay North Carolina $40 million to settle allegations that the company aggressively marketed its products to young people, leading to addiction to its high-nicotine vapes, Attorney General Josh Stein announced Monday.”

About Covid-19

WHO recommends masks -- even for vaccinated people -- because of delta variant: “‘Vaccine alone won’t stop community transmission,’ Dr. Mariangela Simao, WHO’s assistant director-general for access to medicines and health products, said during a briefing in Geneva… ‘People need to continue to use masks consistently, be in ventilated spaces, hand hygiene ... the physical distance, avoid crowding. This still continues to be extremely important, even if you’re vaccinated when you have a community transmission ongoing.’”

Why Are People with Obesity More Vulnerable to COVID?: “In a healthy body, adipose tissue plays a positive role, serving as reservoir of energy in times of food scarcity. Fat tissue is also full of immune system cells. And in lean, healthy individuals, it secretes factors that are anti-inflammatory and protective.
If, however, the fat tissue becomes unhealthy, as often happens in people with obesity, it can become dysfunctional and secrete hormones and other chemical signals that promote chronic low-grade inflammation. This constant simmering state—often present in elderly as well as people with obesity—is not the same as normal inflammation, which is self-limiting and part of the body’s response to infection, damaged cells and other threats. Chronic inflammation raises the risk of a number of conditions, including autoimmune diseases, certain cancers and ailments of the heart, pancreas, lungs, stomach and reproductive system. It may also be the reason a high body mass index (BMI) is associated with poorer outcomes from infectious diseases, including COVID-19.
Researchers are still working out the mechanisms by which this inflammation occurs.”

OSHA Updates N95 Mask FAQs: “Internet rumors have been circulating for a while now that assert the N95 masks do not protect wearers from COVID-19 transmission. The main reason given is that the fabric used blocks few, if any, of the smallest virus particles.
OSHA’s addition to its COVID-19 FAQs regarding respirators and particle size posits states: “Will an N95 respirator protect the wearer from the virus that causes COVID-19?” OSHA’s answer is that yes, an N95 respirator is in fact effective in protecting workers from the virus that causes COVID-19.”

AstraZeneca kick-starts new COVID variant-busting vaccine test: “AZD2816 has been built using the same adenoviral vector platform as its existing vax, with minor genetic alterations to the spike protein based specifically on the so-called beta (B.1.351, South African) variant.”

About health insurance

Supreme Court upholds site-neutral pay cuts: “The U.S. Supreme Court on June 28 declined to hear an appeal challenging HHS' site-neutral payment policy, allowing reimbursement cuts to move forward…
In its final Outpatient Prospective Payment System rule of 2019, CMS made payments for clinic visits site neutral by reducing the payment rate for evaluation and management services provided at off-campus, provider-based departments.”
This decision will have a profound impact on hospital finances. One result will be a halt or slowdown in hospital purchases of physician practices. These acquisitions were heavily subsidized by the hospital’s ability to charge a higher rate for the same services the physicians provided while independent.

Few adults are aware of hospital price transparency requirements: About 10% of survey respondents were aware that price transparency was required. About 15% of respondents said they searched for hospital prices in the past year.

Kaiser, Molina, HealthNet accused of running 'ghost networks' in California: “San Diego's city attorney sued three health insurers June 25, accusing Kaiser Permanente, Molina Healthcare and HealthNet of misleading members with inaccurate provider directories. 
In her lawsuit, City Attorney Mara Elliott claimed that the provider directories of Kaiser and HealthNet, a subsidiary of Centene, have error rates of at least 35 percent. Molina's provider directory had an error rate as high as 80 percent, Ms. Elliott alleges.”

HHS Revokes Medicaid Work Requirements in Arizona, Indiana: “The Department of Health and Human Services continued its attack on work requirements in state Medicaid programs, informing Arizona and Indiana that it is withdrawing approval for must-work provisions approved during the Trump administration.
Requiring poor adults to work as a condition of receiving health care would likely decrease Medicaid enrollment without increasing employment, and would be especially inappropriate during the Covid-19 pandemic, the HHS said in the Thursday letters to Arizona and Indiana.”

About healthcare IT

Telehealth use falls 37% from pandemic highs, while demand for healthcare services projected to flatten: report: A report from Trilliant Health is well worth perusing, if not reading in detail. With respect to telehealth, it comment that the myth is everyone loves it. The truth is that less than 15% of the US population used it last year.

Calming Computer Jitters: Help for Seniors Who Aren’t Tech-Savvy: “A recent survey from AARP, conducted in September and October… found that older adults boosted technology purchases during the pandemic but more than half (54%) said they needed a better grasp of the devices they’d acquired. Nearly 4 in 10 people (37%) admitted they weren’t confident about using these technologies…
Before the pandemic, Generations on Line provided free in-person training sessions at senior centers, public housing complexes, libraries and retirement centers. When those programs shut down, it created an online curriculum for smartphones and tablets (www.generationsonline.org/apps) and new tutorials on Zoom and telehealth as well as a ‘family coaching kit’ to help older adults with technology. All are free and available to people across the country.”

Ohio health system employee snooped 7,000+ patients' EHRs for 11+ years: “Canton, Ohio-based Aultman Health Foundation recently began notifying around 7,300 patients that their protected health information had been inappropriately accessed by a former health system employee over the past decade..
The former employee accessed patient information outside the scope of their job responsibilities between Sept. 14, 2009, and April 26, 2021. The employee has not been identified but has been fired and no longer has access to patient data, the health system said. 
The employee accessed patients' names, Social Security numbers, health insurance information, addresses, birthdates and treatment information, according to the report.”

About pharma

J&J agrees to pay $230M to settle New York opioid claim: “Johnson & Johnson has agreed to pay $230 million to New York state to settle claims that the pharmaceutical giant helped fuel the opioid crisis, Attorney General Letitia James said on Saturday.
The drugmaker also agreed to permanently end the manufacturing and distribution of opioids across New York and the rest of the nation, James said in a statement announcing the settlement.”

3 Pharmacies Cut From NY Opioid Trial, CVS Reaches Deal: “Walmart, CVS and Rite Aid have been severed from New York state and two Long Island counties' swiftly approaching opioid trial, a spokesman for plaintiffs firm Simmons Hanly Conroy LLC told Law360 on Friday, while a CVS representative confirmed the counties had reached a deal with the pharmacy. The CVS representative did not state the amount of the deal with Suffolk and Nassau counties but said the settlement reflected the company's position that ‘opioid prescriptions are written by doctors, not pharmacists, and that opioid medications are made and marketed by manufacturers, not pharmacies.’”

Crispr gene-editing ‘revolution’ treats internal organ for first time: Crispr gene-editing has been performed on cells removed from the patient’s body and then re-infused. This new technique directly injects the gene-altering material.
“The Boston-based start-up, working with biotech company Regeneron, treated transthyretin amyloidosis, a devastating disease in which a build-up of a problematic protein hits a patient’s heart and nervous system, cutting their life expectancy…
In its phase 1 trial, a Crispr treatment was inserted in a lipid nanoparticle, which was picked up in the blood by the same tissue that grabs cholesterol globules, and transported to the liver. There, the one-off treatment inactivated the TTR gene and reduced the problematic protein 87 per cent in patients on the highest dose. There were no serious side effects by day 28.”

Novartis says it overpaid Roche's Genentech nearly $210 million in a licensing deal—and it wants its money back: “For years, Novartis said it dutifully shelled out tens of millions to Genentech as part of a patent licensing deal that dated back to 2005. Later, the Swiss pharma discovered it accidentally overpaid by nearly $210 million.
Those are the central arguments in a lawsuit filed by Novartis against its Swiss pharma counterpart seeking $209.5 million. In the suit, which recently made its way to California federal court, Novartis says Genentech isn't coughing up the dough.”

Sanofi offloads 16 consumer health brands to Stada amid CEO Hudson's refocusing effort: “As part of its quest to streamline consumer healthcare—and eventually spin off the unit as a standalone business—Sanofi will offload 16 consumer health products to Germany’s Stada Arzneimittel, the companies said Monday.”

About hospitals and health systems

Key hospital metrics showing recovery, Kaufman Hall says: “Hospitals across the U.S. have seen gains across key metrics in the first five months of 2021 when compared to last year, according to a new report from healthcare consulting firm Kaufman Hall. 
In particular, volumes, margins and revenues were up compared to 2020 levels. The volumes also are starting to approach pre-pandemic levels…
Not including federal relief payments, the median operating margin for hospitals in May was 2.6 percent. With the funding, the median operating margin was 3.5 percent. 
Compared to the first five months of 2020, hospital operating margin rose 95.2 percent year to date, according to the report.
Kaufman Hall attributed the increase in year-to-date margin to patient volume increases, especially compared to the volumes last year when there were national restrictions on elective procedures.”
And in a related article: Hospital Stocks’ Rally Points to Post-Covid Growth

Today's News and Commentary

About Covid-19

More than 1 in 10 people have missed their second dose of Covid-19 vaccine: “As of June 16, about 88% of those who received one dose of vaccine and were eligible for their second -- recommended 21 days after the first Pfizer/BioNTech shot or 28 days after the first Moderna shot -- had completed their two dose series, according to data shared with CNN by the US Centers for Disease Control and Prevention.
That's down from a 92% completion rate earlier in the year.”

U.S. approves Roche drug for emergency use against severe COVID-19: “U.S. health regulators have approved Roche's arthritis drug Actemra for emergency use to treat hospitalized COVID-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds.
The U.S. Food and Drug Administration (FDA) said on Thursday it had issued an emergency use authorization (EUA) for Actemra to treat adults and pediatric patients hospitalized with COVID-19.”

Nearly all COVID deaths in US are now among unvaccinated: “An Associated Press analysis of available government data from May shows that “breakthrough” infections in fully vaccinated people accounted for fewer than 1,200 of more than 853,000 COVID-19 hospitalizations. That’s about 0.1%.
And only about 150 of the more than 18,000 COVID-19 deaths in May were in fully vaccinated people. That translates to about 0.8%, or five deaths per day on average.”

Lilly's COVID antibody combo halted nationwide, dealing huge blow to blockbuster program: “Eli Lilly's COVID-19 antibody cocktail has already been on the outs in several states over fears of reduced variant efficacy. Now, the U.S. has decided to extend that policy nationwide.
With a pair of troubling coronavirus variants on the rise, the U.S. is pausing the national distribution of Eli Lilly’s COVID-19 antibody combo of bamlanivimab and etesevimab until further notice, the HHS Assistant Secretary for Preparedness and Response said Friday.”

U.K. doubles down on Innova's rapid COVID-19 test, after FDA urged users to throw it away: “A week after the FDA urged anyone who had Innova Medical Group’s COVID-19 antigen test to stop using it and toss it in the trash, regulators across the pond have cleared the rapid diagnostic's use and extended its authorization.
The U.K. Medicines and Healthcare products Regulatory Agency said it found no problems in its own assessment of the test, which it carried out after the FDA delivered a warning letter to the company for pre-emptively delivering unreviewed products to a number of customers and making accuracy claims that did not match up with clinical data.”

Israel to reinstate indoor mask mandate next week as COVID-19 cases keep rising: “Coronavirus czar Nachman Ash announced Thursday that the indoor mask mandate, obligating people to cover their mouths and noses to prevent infections, will return early next week in an effort to stem the rise in COVID-19 cases.
In a briefing with journalists Thursday evening, Ash said the outbreak had spread to Kfar Saba, Ramla, Herzliya and other cities, as Health Ministry data showed 169 had been diagnosed Thursday by 6 p.m., the highest daily tally in months.
Ash recommended avoiding flights abroad, especially for people who have not been vaccinated.”

FDA greenlights its first saliva-based COVID-19 antibody test: ”Developed by Diabetomics, the rapid, lateral-flow diagnostic received an agency emergency authorization allowing it to be used at the point of care for adults and children. Designed to deliver a result within 15 minutes, the CovAb test also does not require any additional hardware or instruments.
When administered at least 15 days after the onset of symptoms, when the body’s antibody response reaches higher levels, the test demonstrated a false-negative rate of less than 3% and a false-positive rate of nearly 1%…”

About pharma

Sanofi, Translate Bio start seasonal mRNA flu vaccine trial, gaining early lead over Moderna and Pfizer: “Sanofi and Translate Bio have started a phase 1 clinical trial of an mRNA vaccine for seasonal influenza. The initiation of the study puts the partners ahead of Moderna and Pfizer in the race to show mRNA vaccines are as good or better at preventing flu than existing technologies. 
The validation of mRNA technology by vaccines against COVID-19 has ramped up interest in using the approach to protect against seasonal flu.”

Pfizer halts global distribution of smoking cessation pill as it tests for potential carcinogens: “After finding potential carcinogens in some lots of Chantix, Pfizer late last month halted worldwide distribution of its smoking cessation pill.
The drug maker, which is now running tests, took this step after finding nitrosamine levels that were above an ‘acceptable’ daily intake, according to the company. “

About the public’s health

Trends in Prevalence of Diabetes and Control of Risk Factors in Diabetes Among US Adults, 1999-2018: “In this serial, cross-sectional study of nationally representative data from 28 143 participants in the National Health and Nutrition Examination Survey (NHANES), the estimated age-standardized prevalence of diabetes increased significantly, from 9.8% in 1999-2000 to 14.3% in 2017-2018. Only 21.2% of adults with diagnosed diabetes achieved all 3 risk factor control goals in 2015-2018, including individualized hemoglobin A1c targets, blood pressure less than 130/80 mm Hg, and low-density lipoprotein cholesterol level less than 100 mg/dL.”

Estimated Cost-effectiveness of Solar-Powered Oxygen Delivery for Pneumonia in Young Children in Low-Resource Settings: Often low-cost solutions are first employed in other countries and then find their way to the US. This invention is one such innovation to watch. “The results of this economic evaluation suggest that solar-powered O2 is a cost-effective intervention for pediatric patients with hypoxemia in low-resource settings.”

About health insurance

Missouri judge strikes down state's Medicaid expansion, dealing blow to Centene and Biden admin: “State Judge Jon Beetem issued an opinion Wednesday that the ballot initiative to approve the expansion in August 2020 did not include any requirement for the state to appropriate funds for the expansion…
A federal court ruled in June 2020 before the Aug. 4 vote that the initiative didn’t create a revenue source nor direct the state’s legislature to appropriate funds, according to a release from the governor’s office.
[Gov. MIke] Parsons asked the legislature for $1.9 billion to fund the expansion but was denied.”

About healthcare IT

Startups using AI to tackle malaria, mental health and human trafficking take top awards, and cash, from IBM XPrize: “An Israeli startup that uses artificial intelligence and other tech tools to wipe out malaria took the top prize in IBM Watson's AI competition, nabbing $3 million to expand its operations.
ZzappMalaria, a subsidiary of Sight Diagnostics, developed an AI-powered mobile app and dashboard to tackle malaria on the eradication level, specifically in developing countries…
Aifred Health, a digital health company focused on clinical decision support in mental health, took second place in the AI competition, banking $1 million. The startup uses AI to learn from thousands of patients to help tailor treatment, reducing the time it takes for a patient to reach remission.”

States’ Actions to Expand Telemedicine Access During COVID-19 and Future Policy Considerations: A really good review of this topic from the Commonwealth Fund.

About medical devices

Boston Scientific shells out a hearty $295M for Farapulse's electric-field-generating afib treatment: “Boston Scientific has exercised an option to acquire Farapulse in full, per [a] September 2020 agreement. The company already holds a 27% stake in Farapulse and will put down about $295 million to pick up the remainder…
With Boston Scientific’s support, Farapulse will be able to accelerate its work toward FDA clearance for its ablation system for atrial fibrillation and other cardiac arrhythmias..”

About diagnostics

Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set: Evidence is growing that demonstrates the utility of cancer diagnosis from blood samples (so-called liquid biopsies): “A multi-cancer early detection (MCED) test used to complement existing screening could increase the number of cancers detected through population screening, potentially improving clinical outcomes. The Circulating Cell-free Genome Atlas study (CCGA; NCT02889978) was a prospective, case-controlled, observational study and demonstrated that a blood-based MCED test utilizing cell-free DNA (cfDNA) sequencing in combination with machine learning could detect cancer signals across multiple cancer types and predict cancer signal origin (CSO) with high accuracy. The objective of this third and final CCGA substudy was to validate an MCED test version further refined for use as a screening tool.”
The study concluded:
”In a validation study, an MCED test identified a diversity of cancer signals with high specificity.

The MCED test predicted the origin of the cancer signal with high accuracy across multiple cancer types.

Results support the use of this MCED test on a population scale as a complement [emphasis added] to existing single-cancer screening tests.”

Today's News and Commentary

About health insurers

Cigna to offer $500 incentive for members who switch to a biosimilar drug: “Under the new Shared Savings Program, members will be offered a one-time $500 debit card for healthcare services or medications if they make the decision to switch to a biosimilar…
The program will be made available first to eligible patients taking Remicade, a brand-name biologic that treats a number of inflammatory conditions such as Crohn's disease and psoriasis. Remicade infusion costs can vary, but Cigna claims data suggest the average regimen costs $30,000 per year, with expenses growing depending on the site of administration.”

Bipartisan bill requires Medicare to cover breakthrough devices after approval from FDA: “The legislation, introduced in the House on Wednesday, would require Medicare to cover all breakthrough products approved by FDA for four years. During that time, the Centers for Medicare & Medicaid Services (CMS) would determine whether coverage should be permanent. Sometimes it can take CMS up to three years after a device is approved to grant a national coverage determination that ensures Medicare reimbursement.”

Blues plans banking on Sempre Health's gamified approach to slash medication costs: “Sempre Health has locked up another $15 million in financing as it looks to expand the company’s program to trim costs for behavioral health medication and cut skyrocketing healthcare system losses when patients skip their medications.
The series B funding was led by the Blue Venture Fund—a collaboration of Blue Cross Blue Shield companies, the Blue Cross Blue Shield Association and Sandbox, to which 35 BCBS companies have committed more than $890 million across four funds…
The company provides a mobile text-based platform to insurers to offer large prescription copay discounts to members for filling their prescriptions on time.”

UnitedHealth to be investigated by Mississippi state auditor for overbilling Medicaid: “The Mississippi State Auditor's Office is investigating OptumRX, UnitedHealth Group's pharmacy benefits manager, for allegedly overbilling the state's Medicaid program for prescription drugs…
The investigation comes one week after Mississippi Attorney General Lynn Fitch announced a $55 million settlement with Centene, a payer also accused of overbilling Medicaid for prescriptions.”

Humana, Mom's Meals food delivery pilot boosts members' quality of life: study: “Here’s how it works: fully prepared, refrigerated meals across the nation are provided by Mom’s Meals, which also caters to the Medicaid, Medicare and individual markets.
By the time the year-long program wound down, some 86% of the participating members concurred: the home delivery of diabetes-friendly meals was paramount to their overall well-being, according to results released Monday.”

Express Scripts sues US for $43M: ”Express Scripts, the pharmacy benefit management arm of Cigna, filed a lawsuit June 22 against the United States, alleging that the Internal Revenue Service refused to pay the company $43 million in tax returns. 
According to the suit, the IRS erroneously denied Express Scripts' deductions and refused to refund the PBM more than $18 million in 2010 and nearly $25 million in 2011.”

About Covid-19

Officials note ‘likely association’ between Covid-19 vaccines and rare heart condition in young people: “…younger groups, particularly men under 30, have higher rates of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with the shots from Moderna or Pfizer-BioNTech. Most cases have occurred soon after the second shot of the two-dose regimens.” However: Top federal health officials, professional groups say COVID-19 vaccines safe for adolescents: “The joint statement from more than a dozen federal and professional groups on Wednesday followed a meeting of the Centers for Disease Control and Prevention's vaccine advisory panel regarding reports of heart inflammation in young adults after use of either the Moderna or Pfizer-BioNTech vaccine.
’The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment,’ the groups said.”
But, still: Pfizer, Moderna shots get new FDA safety warning: “The FDA will add a warning about rare instances of heart inflammation to the information sheets for the mRNA vaccines from Pfizer-BioNTech and Moderna.”

Recovery of deleted deep sequencing data sheds more light on the early Wuhan SARS-CoV-2 epidemic: [This article has not been formally peer reviewed.] This story is all over today’s media. The data implications do not seem to support the theory that the virus was caused by a lab leak. But it certainly adds to the credibility challenges to Chinese transparency. Here is the Abstract:
”The origin and early spread of SARS-CoV-2 remains shrouded in mystery. Here I identify a data set containing SARS-CoV-2 sequences from early in the Wuhan epidemic that has been deleted from the NIH's Sequence Read Archive. I recover the deleted files from the Google Cloud, and reconstruct partial sequences of 13 early epidemic viruses. Phylogenetic analysis of these sequences in the context of carefully annotated existing data suggests that the Huanan Seafood Market sequences that are the focus of the joint WHO-China report are not fully representative of the viruses in Wuhan early in the epidemic. Instead, the progenitor of known SARS-CoV-2 sequences likely contained three mutations relative to the market viruses that made it more similar to SARS-CoV-2's bat coronavirus relatives.” Here is further analysis of the findings:
Claim that Chinese team hid early SARS-CoV-2 sequences to stymie origin hunt sparks furor


Covid Illness Anxiety Plummets Amid Some Unease Over Low Vax Rate: Highlights from Monmouth Poll: “Worries about a family member getting seriously ill from the coronavirus have plunged to an all-time low. Currently, 42% of the American public expresses concern about this happening. In prior polls since the pandemic started, that number ranged between 67% and 83%. Even more telling, the number who say they are very concerned about a serious illness in their family from Covid has dropped to 23% from 40% in March, after hitting a pandemic-era high of 60% in January. Prior to that, the number of adults who said they were very concerned ranged from 37% to 50% in polls taken throughout 2020.”

CDC group says there isn’t enough data yet to recommend Covid booster shots: “A booster shot of a Covid-19 vaccine may only be necessary for those most at risk of severe disease, according to a CDC vaccine safety group.
Residents of long-term care facilities, elderly people, health-care personnel and immunocompromised people may need boosters sooner.
The CDC working group said there currently isn’t enough data to recommend a booster shot in the general population.”

About the public’s health

Declines in Births by Month: United States, 2020: “The number of births declined in both the first and second 6 months of 2020 compared with 2019 for nearly all race and Hispanic-origin groups, with larger declines in the second half of 2020 compared with the first half of the year.”

The Pandemic Led To The Biggest Drop In U.S. Life Expectancy Since WWII, Study Finds: “A new study estimates that life expectancy in the U.S. decreased by nearly two years between 2018 and 2020, largely due to the COVID-19 pandemic. And the declines were most pronounced among minority groups, including Black and Hispanic people.” The decline is the largest since WWII.

Association of Meal and Snack Patterns With Mortality of All‐Cause, Cardiovascular Disease, and Cancer: The US National Health and Nutrition Examination Survey, 2003 to 2014: This study concludes it is not just what you eat, but when you eat it: “Fruit‐snack after breakfast, fruit‐lunch, vegetable‐dinner, and dairy‐snack after dinner was associated with lower mortality risks of CVD, cancer, and all‐cause; whereas Western‐lunch and starchy‐snack after main meals had greater CVD and all‐cause mortalities.”

About pharma

Viatris scores a win in long-running EpiPen antitrust lawsuit, but patent settlement charge : heads to trial: “Viatris, the newly-formed company that combined Mylan and Pfizer's Upjohn unit late last year, said it's "pleased" with the Kansas District Court's decision to rule in favor of the company's summary judgement motion in the case…
The judge's latest ruling dismissed all claims related to the Racketeer Influenced and Corrupt Organizations Act, including charges against the company's former CEO Heather Bresch, Viatris said. The court also dismissed the charge that Mylan prevented competition through rebate arrangements with PBMs. 
However, one claim related to patent settlements between Pfizer, which manufactured EpiPen, and Israeli drugmaker Teva remains outstanding and will go to trial, a Viatris spokesperson said. In the case, the plaintiffs claimed the companies abused "sham" patent litigation to forestall Teva's generic version from entering the market.”

Lilly to file for accelerated FDA approval of Alzheimer's drug after Aduhelm OK opens the floodgates: “Lilly plans to file for accelerated approval of its Alzheimer’s disease prospect donanemab later this year, a therapy the company once thought would need boat loads more data to get over the regulatory finish line.”
In a related story: Point32Health challenges Aduhelm, threatens coverage for 1.1M members: “Point32Health may not cover Biogen's new Alzheimer's treatment, Aduhelm, for its commercial members unless the price is reduced.
Point32Health CMO Michael Sherman, MD, told The Boston Globe that the drugmaker was favoring ‘excessive corporate profits’ with the $56,000 price tag over patient interests. Dr. Sherman believes the price of the treatment should be closer to $5,600, 10 percent of the current cost.”

Medicare Spent $2.1 Billion On Discarded Drugs From 2017 to 2019: “Our analysis of data provided by the Centers for Medicare and Medicaid Services (CMS) shows that more than $2.1 billion was wasted on discarded units of drugs from 2017 to 2019.
The majority of this wasted taxpayer money was spent on unused units of chemotherapy and cancer-treating drugs that were thrown away and unavailable for treating other patients in need of the drugs.
Most of this medication and financial waste is due to single-dose vials or containers of medications that include higher doses than are necessary to treat the average patient.” Emphases in the original.

Novartis bets on data, digital technologies to tackle global health challenges: “Novartis announced a collaboration Wednesday with Hewlett Packard that aims to accelerate the use of data and digital technologies in the Swiss drugmaker's global health initiatives, with the goal being to bolster access to healthcare and medicines. Financial terms were not disclosed, but the companies said they plan to start by developing a disease surveillance solution for dengue fever, initially focusing on India…
The initiative will concentrate on three ‘enablers’ of global health; namely identifying and integrating complex data sources related to health, applying artificial intelligence, machine learning and geo-spatial analytics to these data, and expanding access to technology in remote and underserved settings.”

About healthcare IT

It took a pandemic, but the US finally has (some) centralized medical data: “At the beginning of the pandemic, a group of researchers funded by the US National Institutes of Health, or NIH, realized that many questions about covid-19 would be impossible to answer without breaking down barriers to data sharing. So they developed a framework for combining actual patient records from different institutions in a way that could be both private and useful.
The result is the National COVID Cohort Collaborative (N3C), which collects medical records from millions of patients around the country, cleans them, and then grants access to groups studying everything from when to use a ventilator to how covid affects menstrual cycles…
The database is now one of the largest collections of covid records in the world, with 6.3 million patient records from 56 institutions and counting, including records from 2.1 million patients with the virus. Most records go back to 2018, and contributing organizations have pledged to keep updating them for five years. That makes N3C not just one of the most useful resources for studying the disease today, but one of the most promising ways to study long covid.”

Efficacy of Smartphone Active and Passive Virtual Reality [VR] Distraction vs Standard Care on Burn Pain Among Pediatric Patients: A fascinating use for VR: “In this randomized clinical trial that included 90 pediatric patients with burns, participants in the active VR group had significantly lower scores for overall pain compared with participants in the standard care group and for worst pain compared with participants in the passive VR group and the control group.”

Regenstrief study shows EHRs underperforming for primary care: “The study traces the roots of the challenge to the fact that many EHRs were initially designed for specialists and hospitals – without much attention to the specific needs of primary care physicians, ‘whose effective decision-making is grounded in perception and comprehension of a patient's dynamic situation.’
For example, they note, an outpatient doc's choice to stop a patient's use of a particular medication will usually be informed by trends in that patient's blood pressure or cholesterol numbers, or other medications taken over the course of a month – all holistic information with implications for the patient's future health trajectory, but data that isn't always readily seen on a single EHR screen…
Instead, she said, ‘current EHRs are overloading primary care physicians with information in disparate files and folders rather than presenting comprehensive, actionable data in a context that gives meaning.’”

ONC Health IT Framework for Advancing SDOH Data Use and Interoperability: “ONC focuses on four key areas with respect to how health IT can be used to help achieve this: standards and data; infrastructure; policy; and, implementation.” Check the press release for more details.

Today's News and Commentary

About health insurance

Analysis of Medicare Advantage [MA] Plans’ Supplemental Benefits and Variation by County: This research letter provides a needed update on MA plans’ use of these benefits. In summary: “New supplemental benefits can be a tool to address MA beneficiaries’ health and social needs. However, only a relatively small proportion of MA plans (10.1%) are taking advantage of the most complex benefits.”

CMS Supports Modernizing Enrollment on State-Based Exchanges: “Twenty states with state-based exchanges are eligible to receive CMS grant funding, with each awardee receiving approximately $1.3 million…
As many as 21 cooperative agreement grants will be available to applicants. States that operate their exchanges on the federal health insurance marketplace website may still be eligible to apply.
CMS highlighted that these funds could go towards speeding up the eligibility determination process which assess whether individuals qualify for premium tax credits and cost-sharing reductions.
However, the funds may be used in a wide variety of ways to improve Affordable Care Act marketplace enrollment processes.”

4th Circ. revives dummy-code lawsuit against Aetna, Optum: “A federal appeals court on Tuesday reversed a ruling for Aetna Inc and OptumHealth Care Solutions, reviving a potential class action alleging that they agreed to use a ‘dummy code’ to disguise unbillable administrative fees as billable medical treatment.”
The case deals with a self-insured plan Aetna administered and for which it used Optum to subcontract certain services.

Time to pursue patient-centered payment models designed by doctors: A statement from the new AMA president. He makes many good points, however, if fully implemented, there would be an increased fragmentation in the healthcare system (hard to believe that is possible). Further, many of his recommendations would be implemented in a risk-based system, like Medicare Advantage plans that partner with physicians.

Blues plans team up to back new pharmacy solutions company, Evio: “Blue Cross Blue Shield of Massachusetts, Blue Cross Blue Shield of Michigan, Blue Shield of California, Highmark Health and Independence Blue Cross are backing Evio, according to an announcementreleased Tuesday.
The new company aims to establish outcomes-based arrangements with drugmakers, especially for high-cost therapies. In addition, Evio aims to collect and provide real-world evidence for medications to ensure the right product is getting to the right patient.
Evio will initially focus on providing these services to five founding health plans, according to the announcement. The plans collectively cover more than 20 million members nationwide.”

About hospitals and health systems

HCA to sell $2.4B in debt: “HCA Healthcare plans to offer two batches of senior notes worth nearly $2.4 billion to repay a portion of nearly $2.6 billion in senior secured term loans.”

Select Medical's latest deals amp up operations in acute care, outpatient clinics: “Select Medical Corporation announced a handful of new acquisitions and joint venture partnerships that will add seven long-term acute care hospitals and eight outpatient clinics to its already impressive collection of post-acute care facilities.
The company, which operates critical illness recovery, rehabilitation and occupational health locations across 46 states, said it expects the deals to close in the back half of 2021 pending regulatory approval.”

Hemmed In at Home, Nonprofit Hospitals Look for Profits Abroad: A good review of pros and cons of this strategy with examples.

About pharma

Calif. Jury Clears CVS In $121M Drug Overcharge Trial: “A California federal jury on Wednesday cleared CVS Pharmacy Inc. of claims by multiple classes of insured drug buyers that the pharmacy chain overcharged them by more than $121 million for generic drugs, in violation of multiple state consumer protection statutes, according to CVS and attorneys for the classes. After deliberating for less than a day, a unanimous jury cleared CVS of allegations brought by insured drug buyers from six states that the national pharmacy chain unfairly overcharged them for prescriptions under the company's now-defunct nationwide discount program called Health Savings Pass.”

Congress needs to fix the broken market for antibiotic development: “Unlike blockbuster cancer therapies or drugs that people take for years to control high blood pressure, antibiotics must be used judiciously to preserve their effectiveness. And their use is typically discontinued as soon as an infection is cured. That’s one reason antibiotics have not provided a strong return on investment for pharmaceutical companies. From 2014 to 2016, drug companies made more than $8 billion on cancer drugs, but lost $100 million on antibiotics. This poor return on investment also discourages private investment in new antibiotics. In 2019, investors poured $9.7 billion into oncology research, but committed only $132 million to antibiotics research.”
The article calls on Congress to “pass the Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act of 2021, also known as the PASTEUR Act, to stimulate the development of new drugs to fight deadly bacterial infections.”

Senior Democrat outlines new drug pricing plan as talks drag on: Here are the major points of Sen. Widen’s proposal.

CVS cut 72 drugs with 'hyperinflated' prices from its formulary last year: “Posaconazole, an antifungal medication, is priced at $4,500 for a 30-day supply—while an alternative, fluconazole, costs less than $14.
This is an example of a growing trend: medications, including many generics, with ‘hyperinflated’ prices, experts at CVS Caremark say. The pharmacy benefit manager giant culled 72 such drugs from its formulary in 2020 alone, leading to savings of $1.2 billion compared to 2018.”

Teva reaches $925K settlement with Mississippi in price-fixing case—and it hopes other states will follow suit: “The case dates back to 2019 when Mississippi, along with 43 other states, sued 20 generic drugmakers for divvying up markets and setting prices, the lawsuit alleged at the time. Investigations identified over 100 affected drugs for various maladies, including treatments for multiple sclerosis, HIV, ADHD and cancer, they claimed.
In some cases, price hikes that stemmed from backroom conversations were above 1,000%, former Connecticut Attorney General William Tong, who has led the investigation, said at the time.”

AI drug discovery start-up Insilico raises more than $255m: “Insilico, an artificial intelligence-based drug-discovery platform preparing to trial its first treatment in humans, has raised more than $255m from investors including Warburg Pincus and Sequoia Capital China. 
The Hong Kong-based start-up has 16 programmes in development, about half of which are for cancer and one of which is a potential antiviral for Covid-19. It plans to enter clinical trials this year with a novel drug for idiopathic pulmonary fibrosis, which scars the lungs, after discovering and validating the candidate in lab experiments in under 18 months.”

About medical devices

Masimo’s Radius Tº Wearable Thermometer Gets FDA 510(k) Clearance: “Masimo’s wearable, wireless thermometer branded Radius Tº has received 510(k) clearance from the FDA for both prescription and over-the-counter use in patients age five years and up.
Using a proprietary algorithm, Radius Tº provides continuous body temperature measurements that are approximations of sublingual temperatures captured from an oral probe.”

Portable dialysis machine maker Quanta lands $245M to boost U.S. reach: “After starting off 2021 with an FDA clearance for its portable dialysis machine, Quanta Dialysis Technologies has now raised a massive $245 million venture capital round to help roll out its next-generation device to both acute and chronic care settings.
The proceeds will also scale up the U.K.-based company’s operations internationally, with a special focus on boosting its U.S. manufacturing, sales and customer service divisions—in addition to setting the stage for a new clinical trial aimed at garnering an FDA green light for at-home use of its portable dialysis device.
Quanta’s SC+ hemodialysis machine is small enough to fit on top of a cart or tabletop and is currently cleared for use by healthcare professionals in hospitals and skilled nursing facilities.”

About the public’s health

Biden officials aim for the stars with new NIH research arm to push bold, risky biomedical ideas: “After the success of bringing COVID-19 vaccines to the masses in less than a year, U.S. officials are wondering how those lessons can be applied to spur breakthroughs across medicine.
President Biden is proposing a new research agency to sit within the National Institutes of Health, called the Advanced Research Projects Agency for Health (ARPA-H). It would be modeled after the Defense Advanced Research Projects Agency, or DARPA, which has led breakthroughs for the Department of Defense for more than 60 years.
The NIH requested an initial $6.5 billion in funding “to develop breakthroughs—to prevent, detect, and treat diseases like Alzheimer’s, diabetes, and cancer,” according to a paper from several NIH and White House officials published Tuesday in the journal Science.”

Radiology advocates update breast cancer screening guidance to reflect higher risk for minority women: “Breast cancer still looms as the second leading cause of cancer deaths, and two leading imaging groups say women should begin undergoing annual mammograms at age 40, particularly minority populations…
Minority women are 72% more likely to be diagnosed with breast cancer before they turn 50, and 58% more likely to suffer from an advanced stage of disease under the age of 50 compared to non-Hispanic white women. Such groups, which includes Hispanic, American Indian, Asian and non-Hispanic Black individuals among others, are also 127% more likely to die from breast cancer by their 50th birthday.”

Blood, Testing Supply Shortage To Persist Through 2021: “There has been at least a 10% increase in blood transfusions as patients resume care they deferred during the COVID-19 pandemic, many of whom are sicker.. Donations are also down, which have delayed some non-urgent procedures…
More than a third of community blood centers across the country reported having a one-day supply or less, according to America’s Blood Centers’ daily update from 59 community blood centers.”

Today's News and Commentary

About health insurance

Supreme Court declines to hear insurers' appeal seeking full reimbursement of CSR [cost-sharing reduction] payments: “The court declined Monday an appeal from Maine Community Health Options and Community Health Choice over an appellate court decision that plans that engaged in “silver loading” are not eligible to be repaid for lost CSR payments.
The court did not give a reason for not taking up the case, but the decision deals a blow to insurers looking to recoup CSR payments they believe they are owed by the federal government.
The Supreme Court had previously ruled in April 2020 that the federal government had to fully repay insurers for risk-corridor payments under the Affordable Care Act (ACA). The court ruled insurers were entitled to more than $12 billion in unpaid payments.”

About pharma

Blood-Brain Barrier Crossing Renin-Angiotensin Drugs and Cognition in the Elderly: A Meta-Analysis: Perhaps one more factor in considering tailored anti-hypertensive treatments:
”Older adults taking blood-brain barrier-crossing renin-angiotensin drugs exhibited better memory recall over up to 3 years of follow-up, relative to those taking nonpenetrant medications, despite their relatively higher vascular risk burden. Conversely, those taking nonblood-brain barrier-penetrant medications showed better attention over the same follow-up period, although their lower vascular risk burden may partially explain this result. Findings suggest links between blood-brain barrier crossing renin-angiotensin drugs and less memory decline.”

Roche's Alzheimer's antibody lowers biomarkers in inherited form of disease, though impact on symptoms is unclear: This study highlights the problem of using surrogate endpoints as the measure of success.
”In trial participants with dominantly inherited Alzheimer's disease (DIAD), which causes early onset of memory loss and other symptoms, Roche’s drug lowered biomarkers of the disorder and neurodegeneration in the brain, Washington University said in a study published in Nature Medicine.
The study did not show evidence of a cognitive benefit to people with DIAD [emphasis added], though it was not designed to measure the cognitive impact of gantenerumab on people who started taking the drug before they developed symptoms.”

BMS, Eisai Strike $3.1 Billion Deal for Cancer Drug: “Bristol Myers Squibb (BMS) and Eisai have inked a collaboration deal worth up to $3.1 billion focused on Eisai’s experimental cancer drug, MORAb-202, which is aimed at patients with advanced solid tumors.”

GSK to slash dividend in order to fuel growth at pharma unit: ”CEO Emma Walmsley is expected to unveil plans later this week to boost growth at GlaxoSmithKline's pharmaceutical division in an effort to appease investors who have become disillusioned with the company's recent performance. Reports suggested that the executive will unveil a large cut to the drugmaker's dividend at its capital markets day on June 23, with funds to be diverted into drug development, including through alliances and takeovers.”

AbbVie loses bid to have US high court intervene in AndroGel antitrust case: “US Supreme Court justices on Monday declined to hear AbbVie's challenge to a lower court ruling that it violated federal antitrust law by lodging a ‘sham’ patent complaint in order to stifle competition for AndroGel. Last year, a US appeals court said the "objective baselessness" of AbbVie's claims in its 2011 infringement lawsuit against Perrigo, showed that the drugmaker had no hope of winning the case, but rather intended to use the litigation process only to delay Perrigo's proposed generic version of the testosterone replacement treatment.”

Availability of Cost-effectiveness Studies for Drugs With High Medicare Part D Expenditures: “In this cross-sectional study of 250 drugs with the greatest Medicare Part D spending in 2016, cost-effectiveness analyses were unavailable for 46.0%, with these drugs representing 33.0% of Medicare Part D spending. For the 54.0% of drugs with available cost-effectiveness studies, many of the studies did not meet minimum quality standards.” This finding is only the first part of a problem. The other part is that, even if available, data cannot be used to approve/disapprove a therapy. This problem is one of the fundamental reasons prescription drugs cost more in this country than in others.

Merck's Keytruda extends life for cervical cancer patients in first-in-class win: “Adding Keytruda to chemotherapy with or without Roche’s Avastin for the first-line treatment of cervical cancer significantly extended patients’ lives in a phase 3 trial, Merck said Tuesday. The Keytruda regimen also performed better at staving off cancer progression in the study…”

Amgen dealt another blow in closely watched PCSK9 patent case against Sanofi, Regeneron: “In a Monday order (PDF), the U.S. Court of Appeals for the Federal Circuit declined Amgen's request for a rehearing of a prior patent loss on PCSK9 cholesterol drug Repatha. With the decision, Amgen can either try to appeal further or drop the issue.”

About Covid-19

U.S. administers more than 318 mln doses of COVID-19 vaccines - CDC: “The United States has administered 318,576,441 doses of COVID-19 vaccines in the country as of Monday, the U.S. Centers for Disease Control and Prevention said.
Those figures are up from the 317,966,408 vaccine doses the CDC said had gone into arms by June 20.
The agency said 177,342,954 people had received at least one dose while 150,046,006 people are fully vaccinated as of Monday.”
The distribution continues to be uneven with respect to geographic, demographic and political characteristics.

Desperate for Covid Care, Undocumented Immigrants Resort to Unproven Drugs: The headline is the story, but the intro paragraphs to the article exemplify the problem:
”FRESNO, Calif. — On a Tuesday afternoon in April, among tables of vegetables, clothes and telephone chargers at Fresno’s biggest outdoor flea market were prescription drugs being sold as treatments for Covid.
Vendors sold $25 injections of the steroid dexamethasone, several kinds of antibiotics and the anti-parasitic drug ivermectin. Chloroquine and hydroxychloroquine — the malaria drugs pushed by President Donald J. Trump last year — make regular appearances at the market as well, as do sham herbal supplements.”
If reporters can find these abuses, why can’t law enforcement officers remove these public health threats?

New COVID-19 approach exploits protein response in human cells to combat virus: “The mechanism, called the ‘unfolded protein response’ (UPR), is present in human cells infected with SARS-CoV-2... Combining two drugs targeting different prongs of the pathway significantly inhibited viral replication in human lung cell cultures to near undetectable levels, according to results published in the journal PLOS Pathogens.”

About healthcare IT

Algorithmic Bias Playbook: This report, from the University of Chicago, is a very well-done, clear explanation of the problem and steps to correct it:
This playbook will teach you how to define, measure, and mitigate racial bias in live algorithms. By working through concrete examples—cautionary tales—you’ll learn what bias looks like. You’ll also see reasons for optimism—success stories—that demonstrate how bias can be mitigated, transforming flawed algorithms into tools that fight injustice.”

External Validation of a Widely Implemented Proprietary Sepsis Prediction Model in Hospitalized Patients: “In this cohort study of 27 697 patients undergoing 38 455 hospitalizations, sepsis occurred in 7% of the hosptalizations. The Epic Sepsis Model predicted the onset of sepsis with an area under the curve of 0.63, which is substantially worse than the performance reported by its developer.”

Softbank-Backed Pear Therapeutics Plans To Go Public In $1.6 Billion SPAC Deal: “Pear Therapeutics, which has three FDA-authorized apps to treat psychiatric disorders, plans to go public in a $1.6 billion special purpose acquisition corporation, or SPAC deal, the company announced on Tuesday. Pear has raised more than $250 million to date with Softbank leading the startup’s Series D funding round…
The company, which launched in 2017, zeroed in on mental health quickly due to the high unmet need, says McCann, who has an MD and PhD in neurobiology. Pear’s flagship product reSET, developed out of Dartmouth, is a 90-day prescription app that provides cognitive behavioral therapy for the treatment of substance use disorder and is meant to be used alongside outpatient treatment. The list price for a 90-day prescription is $1,665.”

AWS [Amazon Web Services] announces AWS Healthcare Accelerator for startups in the public sector: “The AWS Healthcare Accelerator is a four-week technical, business, and mentorship accelerator opportunity open to U.S.-based healthcare startups or international healthcare startups that have existing U.S. operations. A cohort of 10 healthcare startup companies with an established product-market fit with existing customers and revenue, who seek to use AWS to help solve the biggest challenges in the healthcare industry, will be selected to participate in this new program. The program is tailored to accelerate growth in the cloud, with a focus on solutions like remote patient monitoring, voice technology, analytics, patient engagement, and virtual care. Applications are open today and proposals are due by July 23, 2021.”

The size and discovery delay of the following breaches are noteworthy.

Class action targets Scripps over data breach that exposed 147,000+ patients' info:”Scripps Health is being accused of failing to properly secure and protect patients' health information stored within the San Diego-based system's network, which a malware attack compromised April 29, according to court documents.”

Hacker removes files from New Mexico hospital's computers, exposes 69,000 patients' info: “San Juan Regional Medical Center in Farmington, N.M., recently began notifying nearly 69,000 patients that their protected health information was compromised by hackers. 
SJRMC reported the breach to HHS on June 4, saying it affected 68,792 individuals. The hospital said it discovered that an unauthorized individual accessed its network from Sept. 7-8, 2020, during which the unauthorized individual removed some information, according to a June 4 online notice. 
Some of the files the hacker removed contained patient information including names, Social Security numbers, birthdates, driver's license numbers, financial account numbers and medical record details.”

About healthcare systems

LifePoint Health Announces Agreement to Acquire Kindred Healthcare: “The transaction brings together LifePoint’s national network of community-based hospitals, providers and access points with Kindred’s expertise in delivering long-term acute care, rehabilitation services and behavioral health services…
LifePoint will invest $1.5 billion over the next three years to improve care for the communities that the combined organization will serve…the transaction is expected to be completed in the fourth quarter of 2021.”

About the public’s health

Trends and projections of caesarean section rates: global and regional estimates: “The use of CS has steadily increased worldwide and will continue increasing over the current decade where both unmet need and overuse are expected to coexist [emphasis added]. In the absence of global effective interventions to revert the trend, Southern Asia and sub-Saharan Africa will face a complex scenario with morbidity and mortality associated with the unmet need, the unsafe provision of CS and with the concomitant overuse of the surgical procedure which drains resources and adds avoidable morbidity and mortality. If the Sustainable Development Goals are to be achieved, comprehensively addressing the CS issue is a global priority.”

Today's News and Commentary

About health insurance

VA plans to offer gender-confirmation surgery to transgender veterans, reversing ban: “The Department of Veterans Affairs is moving to provide gender-confirmation surgery through its health-care coverage, reversing a 2013 ban, VA Secretary Denis McDonough announced Saturday.”
It appears the VA will outsource the procedures but pay for them.

Democrats seek new ways to expand Medicaid in holdout states: “There are currently 12 states where Republicans have refused to accept the expansion of Medicaid eligibility provided under ObamaCare, meaning 2.2 million low-income people are left without coverage they otherwise would have…
Efforts to entice the holdout states to expand the program with financial incentives have run into a wall, so Democrats are now turning to the idea of having the federal government step in and provide coverage.
The details of how to do that, however, are still up for debate and pose thorny questions of cost and potential health care industry opposition.”
In a related article: Pandemic Swells Medicaid Enrollment to 80 Million People, a ‘High-Water Mark’: “The latest figures show Medicaid enrollment grew from 71.3 million in February 2020, when the pandemic was beginning in the U.S., to 80.5 million in January, according to a KFF analysis of federal data. (KHN is an editorially independent program of KFF.)
That’s up from about 56 million in 2013, just before many states expanded Medicaid under the Affordable Care Act. And it’s double the 40 million enrolled in 2001.”

About COVID-19

Public is Relaxing its Pandemic Precautions: “Overall, 39% are satisfied with the speed in which local restrictions to prevent the spread of the coronavirus have been rescinded. Nearly as many, 34%, are concerned that the restrictions have been lifted too quickly, while 27% feel things haven’t been relaxed soon enough. But people in urban areas are much more likely to say restrictions have been lifted too quickly than those in the suburbs or rural areas. Democrats are also more likely to regard the restrictions as having been rescinded too quickly compared with Republicans.”
21% of Americans fear contracting COVID-19 from someone they know well, the lowest number since the pandemic began.

How vaccines stack up against CDC's 5 variants of concern: A really good summary. The good news is the vaccines are very protective.

About healthcare financing

23andMe rises in stock market debut after Branson-backed merger: “23andMe went public Thursday through a merger with Richard Branson's blank check company and raised nearly $600 million.
The deal values the personalized medicine and consumer genetic testing company at $3.5 billion.”

Physician social network Doximity plans IPO at $4B valuation: “Doximity, a social network for doctors, plans to raise nearly $536 million through an initial public offering.
At the midpoint of the proposed range, Doximity would command a fully diluted market value of $4.5 billion.”

About pharma

HHS pulls 340B advisory opinion after it fails to throw out AstraZeneca lawsuit: “The Department of Health and Human Services has pulled a controversial advisory opinion that stated drug makers must provide products discounted under the 340B program to contract pharmacies after a heated legal fight with AstraZeneca…
But HHS has not withdrawn a series of letters it sent to AstraZeneca and five other drugmakers last month calling for them to end the restrictions to contract pharmacies.
The Health Resources and Services Administration, which oversees 340B, does not mention the advisory opinion in the letters. The agency wrote that drug makers violated the federal 340B statute when they restricted sales to contract pharmacies.”

Amarin's Vascepa patent defense ends in a loss at the Supreme Court: “On Monday, the United States’ top court declined to take up Amarin’s challenge on a patent loss handed down last September, leaving the prior decision in place. Amarin’s stock was trading down about 10% on Monday morning. 
In September, the United States Court of Appeals for the Federal Circuit ruled in favor of Hikma and other generic challengers, finding that patents on Amarin’s fish oil-derived heart drug Vascepa were invalid based on obviousness.”

The top 10 ESG pharma companies in 2021: “Environmental, Social and Governance (ESG) is the new corporate sustainability yardstick. And investors are pushing ESG accountability—thanks in part to the pandemic—to the front page across industries, including pharma.” The article explains these three features and profile the top 10 pharma companies according to those measures. Boehringer Ingelheim tops the list.

About healthcare IT

Patients are looking to go back to brick-and-mortar post pandemic: “The research found that Gen Z and Millennials were the most likely to be open to telehealth, with 47% of millennials saying they would prefer telehealth over in-person visits once the pandemic has ended. Nearly three-quarters of younger generations reported that one reason they prefer telehealth is convenience.
The silent generation and the Baby Boomers were the least likely to favor in-person visits over telehealth.”

HIPAA and the Leak of “Deidentified” EHR Data: “Although the HIPAA Privacy Rule governs uses of identifiable data, it doesn’t apply to data that are considered deidentified, either as determined by experts or under the ‘safe harbor method,’ which requires removal of 18 specific identifiers (such as name, address, and date of birth)…
Even after many deidentification-related processes, individual patients can potentially be reidentified on the basis of only a handful of attributes. Deidentification technologies relying on encryption could be vulnerable to future advances in computing.
…the United States doesn’t have a comprehensive data-privacy law, and none of the various privacy-related laws or regulations protects patients from the potentially harmful use of deidentified data. There is no duty to report instances in which data have been reidentified or linked to external data sources, such as financial records, and patients have little or no opportunity for redress in cases of reidentification…
Broadly speaking, two approaches could help address the torrential leak of deidentified health record data. One approach would be to establish best practices for data protection among data providers. The other would be to strengthen legal and regulatory protections for patients.”

About the public’s health

AMA adopts guidelines that confront systemic racism in medicine: “Members of the AMA’s House of Delegates representing their peers from all corners of medicine voted to adopt guidelines addressing systemic racism in medicine, including discrimination, bias and abuse, including expressions of prejudice known as microaggressions. The AMA will recommend that health care organizations and systems use the new guidelines to establish institutional policies that promote positive cultural change and ensure a safe, discrimination-free work environment.”
If you read the recommendations, they appear to be identical to those for sexual harassment.



Today's News and Commentary

About health insurance

Fewer Medicare Advantage Plan Members Actively Managed Their Health during Pandemic, J.D. Power Finds: “Following are some of the key findings of the 2021 study:

  • Members’ active management of care declines in 2021: Slightly more than half (55%) of Medicare Advantage plan members actively managed their care in the past year, a decline of nine percentage points from 2019. The two most common ways in which plan members actively manage healthcare are checking whether a treatment or service is covered and asking their doctor or pharmacist for a generic drug instead of a brand name.

  • Communication still misses mark: Despite improvements in satisfaction with information and communication this year, it is the lowest-performing factor evaluated in the study. Overall satisfaction scores are 54 points higher (on a 1,000-point scale) when members successfully engage with their plan to ask a question or solve a problem than when they have no engagement at all.

  • New members cite worse health, lower income than established members: Just 34% of new Medicare Advantage plan members (those ages 65-68 or in their first year with the plan) say they are in “very good” or “better” health and 46% say they have an annual income of $50,000 or more. These compare with 39% of established plan members (ages 69+ and not in the first year of the plan) who say they are in “very good” or “better” health and 56% who earn $50,000 or more.

  • Health plan portals show promise: More than three-fourths (78%) of Medicare Advantage members are registered for their health plan’s member portal—up four percentage points from last year. Two-thirds of members have logged in to their health plan’s portal. Portal use is associated with higher levels of satisfaction and improved member engagement.

Study Rankings

Kaiser Foundation Health Plan ranks highest in Medicare Advantage plan overall satisfaction, with a score of 846. Highmark (834) ranks second and Cigna HealthSpring (822) ranks third.”

7 Fortune 500 health insurers by membership: The top 3:

1. UnitedHealth Group: 49.5 million members

2. Anthem: 43.5 million members

3. Centene: 25.1 million members

4 Philadelphia business owners charged in $10M Medicaid fraud: “Owners of three care coordination agencies allegedly conspired with a transportation company to bill Medicaid for $7.9 million in services from 2017-19 that were never provided to beneficiaries. Two of the companies, Brighter Care Services and Pennsylvania Service Coordination Agency, were accused of defrauding Medicaid an additional $2 million by charging for more services than were provided…”

Medicare Spending on Drugs with Direct-to-Consumer Advertising: Excellent analysis by the GAO:
”Drug manufacturers spent $17.8 billion on direct-to-consumer advertising (DTCA) for 553 drugs from 2016 through 2018, and spending was relatively stable at about $6 billion each year. Almost half of this spending was for three therapeutic categories of drugs that treat chronic medical conditions, such as arthritis, diabetes, and depression. GAO also found that nearly all DTCA spending was on brand-name drugs, with about two-thirds concentrated on 39 drugs, about half of which entered the market from 2014 through 2017.
Medicare Parts B and D and beneficiaries spent $560 billion on drugs from 2016 through 2018, $324 billion of which was spent on advertised drugs. Of the 553 advertised drugs, GAO found Medicare Parts B and D spending for 104 and 463 drugs, respectively. Among the drugs with the highest Medicare spending, some also had the highest DTCA spending. Specifically, among the top 10 drugs with the highest Medicare Parts B or D expenditures, four were also among the top 10 drugs in advertising spending in 2018: Eliquis (blood thinner), Humira (arthritis), Keytruda (cancer), and Lyrica (diabetic pain).”

About the public’s health

Hand Sanitizer Vapors Can Cause Nausea, Dizziness: The FDA is reminding consumers to use sanitizers in well-ventilated areas.

Nutrient Composition of a Selection of Plant-Based Ground Beef Alternative Products Available in the United States: “The percent Daily Value (DV) per 3-ounce cooked portion of each product was determined for nutrients with a DV. The median, interquartile range (IQR), minimum, and maximum nutrient values were calculated for all products by classification as vegan and nonvegan.
Results
The median saturated fat content of the plant-based ground beef alternatives products as a %DV was 4% (IQR 2%). Vitamin and minerals for which median %DV values for plant-based ground beef alternative products were 10% or higher included folate (10%, IQR 10%), niacin (21%, IQR 7%), iron (10%, IQR 5%), phosphorous (10%, IQR 4%), sodium (18%, IQR 7%), manganese (20%, IQR 20%), and copper (24%, IQR 10%). The median dietary fiber content of the plant-based ground beef alternative products was 15% of the DV (IQR 6%). Most of the products contained less protein, zinc, and vitamin B12 than ground beef.”

STDs reach all-time high for sixth consecutive year in the US.: “In 2019 alone, there were more than 2.5 million cases of chlamydia, gonorrhea and syphilis reported, according to the Centers for Disease Control and Prevention. This marks the sixth consecutive year of record-breaking cases of sexually transmitted diseases in the U.S.
The CDC's data looked at states with the highest cases of chlamydia, gonorrhea, syphilis and congenital syphilis. The following numbers were collected from cases in 2019, the most recent data on file, and show a large increase from the reported 1.4 million cases in 2014.”

Dirty Air in Pregnancy Might Raise Baby's Obesity Risk: “The researchers, from the University of Colorado at Boulder, analyzed air pollution data from the U.S. Environmental Protection Agency during the women's pregnancies and then assessed their babies.
Infants whose mothers were exposed to higher levels of air pollution during pregnancy grew unusually fast in their first six months, gaining excess fat that puts them at risk of obesity and related diseases later in life, according to the study.
Specific air pollutants seemed to affect male and female babies differently.”

About hospitals and health systems

Spectrum Health, Beaumont Health announce plans to form 22-hospital system: “Two of Michigan’s largest providers are exploring a potential merger that would yield a 22-hospital nonprofit system staffing more than 64,000 employees.
Spectrum Health and Beaumont Health have signed a letter of intent that places the health systems on track to combine by the fall, the organizations announced Thursday.
In addition to the hospitals, the merged system would also operate 305 outpatient locations and Spectrum’s Priority Health, the third-largest provider-sponsored health plan in the country.”
Recall Beaumont’s previous potential partner was Advocate-Aurora.

Ochsner to take over 7-hospital system: “Rush Health Systems, a seven-hospital system in Meridian, Miss., signed an agreement to join New Orleans-based Ochsner Health.
The organizations said June 17 that they signed a shared mission agreement and expect the deal to be finalized in mid-2022, following necessary regulatory approvals.”
Rush Health Systems is not to be confused with the Chicago-based system with a similar name.

State Supreme Court upholds legality of Colorado hospital fees: “The program requires collection of fees from Colorado hospitals, which are matched by the federal government and then redistributed to hospitals to help them cover Medicaid patients and people in rural areas. The initial provider fee program was started in 2009, a few years later there was a subsequent healthcare affordability and sustainability fee that was added.”
Many other states have used this method to raise monies to obtain federal Medicaid matching funds.

9 hospital construction projects costing $1B+: This list highlights the continuing building boom in this sector.

About healthcare professionals

Device Makers Have Funneled Billions to Orthopedic Surgeons Who Use Their Products: “Every year, a torrent of cash and other compensation flows to these surgeons from manufacturers of hardware for spinal implants, artificial knees and hip joints — totaling more than $3.1 billion from August 2013 through the end of 2019, a KHN analysis of government data found. These bone specialists make up a quarter of U.S. doctors who have accepted at least $100,000 or more, and two-thirds of those who raked in $1 million or more, from the medical device and drug industries last year…”

Top 10 Paying Specialties in the PA Profession in 2020: Some policy experts claim that non-physician professionals could make up deficits in the numbers of primary care doctors. But if salaries for these other specialties are so high, PAs will not be attracted to primary care. Take a look at the list.

Today's News and Commentary

Supreme Court Upholds ACA

The Supreme Court decided (7-2) that the entire ACA stands. The reason is that the plaintiffs lacked standing to bring the suit because they could not show harm. The important issues, such as the severability with respect to the tax (penalty) provision, were not addressed by the majority. It leaves urther challenges open.

About pharma

US plays catch-up with Europe over biosimilar patents: “Europe’s more liberal approach to biosimilar drug patents is continuing to give it an edge over the US in producing lower cost medicines — despite moves by Washington to ease market access for generic manufacturers…
In Europe, the European Medicines Agency (EMA) will not approve a biosimilar in the first 10 years after approving the original drug. But, in the US, the Food and Drug Administration (FDA) will hold off for 12 years.
That difference in timing can be seen in the case of the drug bevacizumab — a treatment for colon and lung cancer and renal-cell carcinoma, sold as Avastin. This year, Europe approved a fifth Avastin biosimilar, whereas the US has approved just two biosimilars for bevacizumab overall, in 2017 and 2019…
Iqvia estimates that expanding the use of biosimilars could reduce the costs of medications in the US by $100bn over five years.”

New Alzheimer’s Drug is Projected to Increase National Health Expenditures [NHE]by More Than One Percent: “The contribution of Aduhelm to prescription drug spending and to NHE grows to more than $73 billion by 2028.”

AstraZeneca's lawsuit over 340B contract pharmacies survives after judge dismisses challenge from HHS: “A federal judge has dismissed the Department of Health and Human Services’ (HHS') bid to toss a lawsuit from drugmaker AstraZeneca over the 340B drug discount program.
The decision by Judge Leonard Stark, delivered Wednesday, ensures the lawsuit over AstraZeneca’s restriction of sales to 340B contract pharmacies will continue.
AstraZeneca and several other drug companies over the past year have restricted sales of 340B-discounted products to contract pharmacies, which are third-party entities that dispense the discounted drugs on behalf of covered entities.”

FDA launches global Generic Drug Cluster: “Described as ‘the first forum established for the world’s leading regulatory agencies to address generic drug development globally,’ the new cluster, wrote FDA, is meant to help harmonize approaches global regulators take to generic drug development through a variety of approaches. FDA announced the launch of the new body in a 14 June tweet from its FDA Drug Information Twitter account.”

GlaxoSmithKline awarded no restitution in high-profile trade-secrets theft case: This decision is odd and may have implications for other, similar, cases.
“The legal filing comes in the case of the U.S. vs. Yu Xue and Tao Li, Chinese nationals who previously pleaded guilty to trade secrets theft to benefit a company they founded, Renopharma…
In August 2018, Xue pleaded guilty to conspiracy to steal GSK’s trade secrets. And the following month, federal prosecutors secured a guilty plea from Li. 
While the government agreed to limit Li’s sentence to no more than seven years and drop other charges, the sides did not agree on any amount of financial loss, leaving the issue up to the court, the judge wrote this week. 
Now, despite arguments from the government that GSK lost more than $1 billion in the ‘fair market value’ of the trade secrets, the court is not awarding any restitution. In doing so, the court found that GSK ‘suffered no pecuniary loss.’”  

About health insurance

Colorado becomes 2nd state to create own public insurance option: “The legislation, signed by Democratic Gov. Jared Polis Wednesday, would create individual and small group health plans starting in 2023. It became the second state after Washington to pass a public insurance option, and several more could come after it.
The standardized plan must offer healthcare coverage on the bronze, silver and gold levels and offer all pediatric and other essential benefits.
Colorado’s insurance commission must also create rules regarding network adequacy for the public option plan.”

Feds sue to block Aon's $30 billion Willis Towers deal: “The U.S. Justice Department sued to block Aon’s proposed $30 billion acquisition of Willis Towers Watson, saying the deal to create the world’s largest insurance brokerage is anticompetitive.
The department’s antitrust division filed a lawsuit in federal court in Washington asking a judge to stop the deal, arguing that it would create too much concentration in the market and hurt businesses, their employees and retirees.”

Democrats devise a way to finally expand Medicaid in resistant states: This morning, Rep. Lloyd Doggett (D-Tex.) introduced “legislation, co-signed by more than 40 House Democrats, that would let cities and counties bypass the states still refusing to expand their Medicaid programs…
Cities, counties or even hospital districts could get special permission from the Centers for Medicare and Medicaid Services to expand Medicaid within their own jurisdiction. The permission, granted through what are known as ‘demonstration projects,’ would last for five years, with an option to extend for an additional five years. It would provide the same federal assistance provided to states; localities would have all of their expansion costs covered for the first three years, with the federal subsidies phased down to 90 percent of costs by the seventh year.”

UnitedHealth Group Releases 2020 Sustainability Report: “The report includes three long-term commitments UnitedHealth Group is making to expand access to care, improve health care affordability and achieve better health outcomes. These commitments are to:

  • Ensure that 85% of members receive preventive care services annually by 2030.

  • Ensure more than 55% of outpatient surgeries and radiology services among members are delivered at high-quality, cost-efficient sites of care by 2030.

  • Close 600 million gaps in care for members by the end of 2025.”

About Covid-19
Despite progress in this country, the virus continues to spread globally. Below are a few articles examining this problem.

WHO says delta Covid variant has now spread to 80 countries and it keeps mutating: “The variant now makes up 10% of all new cases in the United States, up from 6% last week. Studies have shown the variant is even more transmissible than other variants. WHO officials said some reports have found that it also causes more severe symptoms, but more research is needed to confirm those conclusions.”
The good news is that current vaccines are very effective against infection by this variant.

Coronavirus infections rising exponentially in England - REACT study: “The number of people infected with the coronavirus is increasing rapidly in England, doubling every 11 days…
Most infections are happening in children and young adults, but they are rising in older people too, increasing at a similar rate in the over 50s and the under 50s.

Africa sees 44% spike in new Covid infections, 20% increase in deaths: “Weekly cases jumped 44% while fatalities rose 20% over the previous week across Africa, according to the World Health Organization.
African countries currently have the lowest share of vaccines in the world.

U.S. buys 200 mln more Moderna COVID-19 vaccine doses: “The additional Moderna doses, which brings total U.S. orders to 500 million, could be used for primary inoculation, including of children, or as a possible booster shot, the company said.”

Pfizer’s arthritis drug Xeljanz shows lifesaving benefits in hospitalized COVID-19 patients: “Xeljanz reduced the risk of death or respiratory failure among hospitalized patients with COVID-19 pneumonia who didn’t require ventilation, according to data published in the New England Journal of Medicine.

About healthcare IT

CVS Health database leak left 1B user records exposed online: “More than 1 billion search records belonging to CVS Health were accidentally posted online and accessible to the public earlier this year.
The database belonging to the healthcare and retail giant, which was not password protected, was discovered at the end of March by independent cybersecurity researcher Jeremiah Fowler, according to a report published by Website Planet, which conducts research into unsecured internet data.
The database, which was approximately 204 gigabytes in size and totaled 1.1 billion records, had no form of authentication in place to prevent unauthorized entry, the researchers said.
The data exposed online included customer email addresses, user IDs and customer searches on CVS Pharmacy websites for COVID-19 vaccines and other medications, according to the report.”

Penn Medicine releases bedside Epic tool to share EHR data with patients: “Philadelphia-based Penn Medicine has released a digital tool, MyChart Bedside, to share scheduling and updated health information with patients…
The Epic-hosted tool gives patients access to educational materials, descriptions of hospital staff assisting with their treatment, their medications, and other information through hospital iPads.”

About the public’s health

A randomized controlled trial to isolate the effects of fasting and energy restriction on weight loss and metabolic health in lean adults: “Even with net energy intake restricted to that of daily dieters, alternate-day fasting less effectively reduced body fat content and offered no additional short-term improvements in metabolic or cardiovascular health compared to daily energy restriction.”


Today's News and Commentary

About pharma

AHA urges Express Scripts to rescind 340B claims reporting policy: “The American Hospital Association (AHA) wants Express Scripts to rescind a policy that would require contract pharmacies to apply a unique code for claims under the 340B drug discount program…
In a letter to the PBM sent Tuesday, the AHA argues that because the 340B program has stringent government oversight, the policy ‘raises significant questions about Express Scripts' true motivations.’
The organization added that compliance with the policy could add to the burden on providers already struggling as a result of COVID-19. Complying with the requirement requires significant investment in system upgrades and staff, the AHA said.”

Anthem joins generic drug initiative Civica Rx: “Civica Rx, a nonprofit organization created in 2018 to address the problem of chronic drug shortages, said June 16 that Anthem will join the CivicaScript unit as a new health insurance partner. Anthem joins CivicaScript's insurance co-founders: the Blue Cross Blue Shield Association and 17 independent BCBS companies.”

HHS proposes nixing rule affecting insulin and EpiPen discounts for community health centers: “The Department of Health and Human Services (HHS) proposed rescinding a Trump-era rule that required community health centers to fully pass along discounts they received from the 340B drug program for insulin and EpiPens.
HHS said in a notice that the rule finalized by the Trump administration in December 2020 created too much of an administrative burden on community health centers. Back in March, the agency had delayed implementation of the rule until July.”
This action is a bit of a puzzle. Usually Democrats favor lowering drug costs by such methods and are not concerned with bureaucratic expenses.

About health insurance

MedPAC: Part D spending grew 26% from 2013 to 2018 thanks to higher launch prices: “The analysis was part of a report from MedPAC sent to Congress on Tuesday. The analysis found that while Part D spending increased, spending on services covered under the physician fee schedule remained flat…
MedPAC found a wide variation in the per capita drug use from 2013 to 2018.
‘Growth in per capita drug use during this period ranged from -22% in the Kansas portion of the St. Joseph, Missouri-Kansas geographic area, to 40% in the El Centro California, geographic area,’ the report found.
While spending on Part D rose in the five-year period, MedPAC found a slight decline in the use of clinician services in Parts A and B.”
And in a related article about this annual MedPAC Report: MedPAC to Medicare: Cut Down on Those Alternative Payment Models: “The strategy of implementing a plethora of models over the last decade has given the agency an opportunity to build up the evidence base about what works and what does not. While this strategy has yielded valuable information, the commission contends that continuing to test a large number of independent APMs is likely to inhibit the ability of APMs to reach their full potential. We therefore recommend that CMS now take a more holistic approach that involves implementing a smaller, more harmonized portfolio of APMs."

MedPAC's 6 latest spending recommendations to Congress: A quick overview of other MedPAC recommendations. Remember, MedPAC is a strictly advisory body; Congress is not obligated to follow recommendations.

Tufts-Harvard Pilgrim name combined company: “Point32Health is the name of a new health insurance organization formed by the merger of Tufts Health Plan and Harvard Pilgrim Health Care. 
The name was inspired by the 32 points on a compass.”

UnitedHealth: $320B could be saved in next decade by reducing ED visits: “Treating common conditions, including bronchitis and the flu, in primary care settings instead of emergency rooms could save health systems up to $320 billion over the next 10 years, according to UnitedHealth Group's 2020 Sustainability Report.
Two-thirds of visits to hospital emergency departments by patients with private insurance are avoidable, the report said.”

Medical-Debt Charity to Buy, Wipe Out $278 Million of Patients’ Hospital Bills: “RIP Medical Debt, which uses donations to wipe out unpaid medical bills, has reached a deal with nonprofit Ballad Health, a dominant hospital system in Tennessee and Virginia, to buy debt owed by 82,000 low-income patients. Many likely qualified for free care under Ballad’s policy but didn’t get it, executives at Ballad involved in the agreement said. The patients lacked applications, they said.”

About the public’s health

Association Between Childhood Consumption of Ultraprocessed Food and Adiposity Trajectories in the Avon Longitudinal Study of Parents and Children Birth Cohort: News Flash: Children who eat junk food get fat! So glad resources were spent on this study as opposed to helpful interventions. And here is another similar one: Association of a Sweetened Beverage Tax With Purchases of Beverages and High-Sugar Foods at Independent Stores in Philadelphia: While the specifics may be new, the findings are very old: Increase taxes (on sugared drinks, tobacco products, etc.) and use will go down. The only place such action does not work is for luxury items (think: gas guzzler tax for your Ferrari).

Fluorinated Compounds in North American Cosmetics: “These compounds are precursors to PFCAs [per- and polyfluoroalkyl substances] are known to be harmful. The ingredient lists of most products tested did not disclose the presence of fluorinated compounds exposing a gap in U.S. and Canadian labeling laws. The manufacture, use, and disposal of cosmetics containing PFAS are all potential opportunities for health and ecosystem harm. Given their direct exposure routes into people, better regulation is needed to limit the widespread use of PFAS in cosmetics.”
In a popular press article related to the research: More Than Half of Cosmetics Used in U.S. and Canada Contain Cancerous Chemicals, Study Shows According to the Washington Post, on Tuesday, Senators Susan Collins (R-Maine) and Richard Blumenthal (D-Conn.) plan to introduce a new bill titled the No PFAS in Cosmetics Act.

59% OF U.S. ADULTS SAY HEALTH CARE SYSTEM DISCRIMINATES AT LEAST “SOMEWHAT,” NEGATIVELY AFFECTING TRUST: The study, conducted by NORC, is part of the Building Trust initiative of the American Board of Internal Medicine. Among the findings: “Fifty-nine percent (59%) of adult consumers say the health care system discriminates at least “somewhat,” with 49% of physicians agreeing.  
About one in every eight adults (12%) say they have been discriminated against by a U.S. health care facility or office, with Black individuals being twice as likely to experience discrimination in a health care facility compared to white counterparts.”

About Covid-19

CureVac, the latest experimental coronavirus vaccine, proved just 47 percent effective amid spread of variants, preliminary analysis shows: This result highlights why you need to do the field research. “A closely watched coronavirus vaccine invented by the German company CureVac was just 47 percent effective in a large trial at its interim analysis, a disappointing result that may highlight the challenge posed by virus variants.
The results of the 40,000-person trial, announced by news release Wednesday, mark a setback for a promising vaccine based on messenger RNA technology, the same approach at the core of the Pfizer-BioNTech and Moderna vaccines authorized late last year for use in the United States.”

Novavax to File for Emergency Use for COVID-19 Vaccine: ”Novavax said it plans to file for FDA Emergency Use Authorization (EUA) of its two-dose COVID-19 vaccine in the third quarter.”

American COVID-19 Vaccine Poll: “The American COVID-19 Vaccine Poll is a partnership between the African American Research Collaborative and The Commonwealth Fund. The Robert Wood Johnson Foundation supported an expansion of the poll in the Native American community and the W.K. Kellogg Foundation supported expansion in New Mexico.
We surveyed over 12,000 Americans to better understand their access to and opinions about the vaccines, as well as messages and messengers that encourage different groups to get vaccinated.”
This really interesting, interactive site also includes most effective messages/messengers for those reluctant to get vaccinated. Example: Most effective message overall for the unvaccinated: “Getting a COVID-19 vaccine can protect the lives of my family, friends, and those I love.” 43.5% effective.

Most U.S. employers will not require workers to be vaccinated before entering the workplace: “As U.S. employers continue their efforts to encourage workers to get the COVID-19 vaccine, most (72%) will not require or do not plan to require vaccination before entering the workplace, according to a new survey by Willis Towers Watson... Among employers requiring or considering requiring vaccination, more than half (56%) will require documented proof of vaccination. Nearly one in five (19%) will require or consider requiring vaccinations for certain workplace privileges such as indoor gyms and cafeterias.”

Amazon kicks off new role as diagnostics provider by making COVID test available online: ”Using a proprietary COVID-19 test first developed to screen its own workers during the pandemic, Amazon has now made its at-home sample collection kit available to the public online.
The kit can be purchased without a prescription by anyone 18 years and older, retails for $39.99 and can be delivered in one day in some areas.
Each comes with a nose swab and collection tube, as well as a specimen bag and a prepaid shipping label to ship the sample back to one of Amazon’s labs around the country.”

Today's News and Commentary

About Covid-19

Trends in Number of COVID-19 Cases and Deaths in the US Reported to CDC, by State/Territory Reported COVID-19 cases in the U.S. are no longer dropping and began to plateau around June 8.

FDA panel split on approach to COVID-19 vaccines for younger children: “Members of the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) disagreed as to whether the agency should grant emergency use authorizations (EUAs) for COVID-19 vaccines for children at a 10 June meeting.
Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as the fall and flu season approach and the risk of contracting respiratory infections increases…
Some members of the committee who were wary of EUAs in younger age groups said there was insufficient justification and safety data to support emergency use in this population and were concerned about recent reports from Israel that cited elevated cases of myocarditis, or inflammation of the heart, in males ages 16 to 30 who received both doses of Pfizer-BioNTech’s mRNA-based vaccine Comirnaty.”

Diabetes mainstay metformin tamps down lung inflammation in COVID models: “The researchers tested metformin in a mouse model of severe lung inflammation that can result from COVID-19—a dangerous condition called acute respiratory distress syndrome (ARDS). The drug inhibited the onset of ARDS and relieved its symptoms, they reported in the journal Immunity.”

AstraZeneca's COVID-19 antibody combination fails post-exposure prevention trial: “AstraZeneca’s anti-SARS-CoV-2 antibody combination has failed a phase 3 clinical trial designed to assess its ability to prevent symptomatic COVID-19 in people recently exposed to the pandemic coronavirus.
While the Storm Chaser study missed its primary endpoint, a subgroup analysis of people who tested negative for COVID at baseline offered encouragement to AstraZeneca.”

Many Post-Covid Patients Are Experiencing New Medical Problems, Study Finds: “The study, tracking the health insurance records of nearly two million people in the United States who contracted the coronavirus last year, found that one month or more after their infection, almost one-quarter — 23 percent — of them sought medical treatment for new conditions.
Those affected were all ages, including children. Their most common new health problems were pain, including in nerves and muscles; breathing difficulties; high cholesterol; malaise and fatigue; and high blood pressure. Other issues included intestinal symptoms; migraines; skin problems; heart abnormalities; sleep disorders; and mental health conditions like anxiety and depression.”

NIH study suggests coronavirus may have been in U.S. as early as December 2019: “The new report, published in the journal Clinical Infectious Diseases, bolsters earlier studies indicating that the virus entered the country under the radar and may have been spreading in the first two months of 2020, well in advance of warnings to that effect from the Centers for Disease Control and Prevention.
A volunteer in Illinois who gave blood on Jan. 7, 2020 — in a study unrelated to the emergent virus — tested positive for antibodies to SARS-CoV-2, according to the NIH report. It noted that the antibodies typically take 14 days, on average, to develop, and this ‘suggests the virus may have been present in Illinois as early as December 24, 2019.’”

About pharma

Mississippi becomes the first state to jointly sue drug makers and PBMs over the cost of insulin: “In a first-of-its-kind move, the Mississippi attorney general last week filed a lawsuit accusing several drug makers and pharmacy benefit managers of conspiring to set prices for insulin, the life-savings diabetes treatment that has become a poster child for the high cost of prescription medicines.
The lawsuit alleged that the manufacturers benefited from a scheme in which prices were ‘artificially’ inflated to win placement on formularies, the list of medicines for which insurance is provided.”

Teva Files Lawsuit Against Eli Lilly Over Patents for Migraine Drug: “Teva Pharmaceuticals has filed a new patent infringement complaint against Eli Lilly over competing migraine drugs.
Teva’s latest suit in an ongoing battle with Eli Lilly came just hours after the U.S. Patent and Trademark Office issued two new patents on Teva’s migraine drug, Ajovy (fremanezumabin).”

Divisive Drug Patent Proposal From Trump Era Is on Biden Agenda: “The Biden administration is forging ahead with a divisive, Trump-era regulatory proposal that would limit the government’s ability to control prices on drugs developed from federally funded research.
The National Institute of Standards and Technology set an October deadline to update the Bayh-Dole Act, the 1980 law that enables universities to retain patent rights on inventions discovered from government-funded research. The proposal would clarify the law—which allows the government to step in and license federally funded inventions to third parties in certain circumstances—can’t be exercised by an agency primarily to lower costs.
The government has consistently rebuffed calls to use “march-in rights” to control the price of certain medicines. But pressure to do so has mounted during the pandemic, with lawmakers and activists urging the Biden administration to seize control of Covid-19 treatments to ensure more widespread availability.”

Association of California’s Prescription Drug Coupon Ban With Generic Drug Use: “Drug manufacturers sometimes offer co-payment coupons to offset patient out-of-pocket costs. Although coupons can help patients afford necessary medications, they increase overall drug spending by encouraging use of expensive brand-name drugs over less expensive generics. Coupons are prohibited by Medicare and Medicaid, but they are available for commercially insured patients. Several states are considering restricting coupon use to promote generic substitution and control drug spending. In October 2017, California passed a law that banned use of co-payment coupons for brand-name drugs once interchangeable generic versions of those products have become available…
[The law] banning use of co-payment coupons for brand-name drugs with direct generic competitors was associated with no significant increase in generic substitution in its first year.”

About healthcare devices

Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices: “Following the company update on April 26, 2021, Royal Philips… provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.” The foam can degrade into a carcinogen.

Do Magnets in Consumer Electronics Disable Implanted Medical Devices?: “‘We believe the risk to patients is low and the agency is not aware of any adverse events associated with this issue at this time,’ Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. Yet as more products containing strong magnets are expected to come on the market, the agency offered precautions for consumers who have implanted devices including pacemakers and implantable defibrillators.”

About health insurance

AMERICAN RESCUE PLAN IMPACT: MORE THAN 1M CONSUMERS PAY LESS THAN $10 PER MONTH: “The Centers for Medicare & Medicaid Services (CMS) released a report Monday morning that found more than 1 million consumers have coverage through HealthCare.gov that costs $10 or less per month.
The findings underscore the financial impact of the advance payments of premium tax credits (APTC) introduced through the American Rescue Plan (ARP), which President Joe Biden signed into law in March.”

Humana to acquire onehome in bid to expand value-based home care: “Humana will acquire One Homecare Solutions, or onehome, in a bid to grow its value-based home healthcare offerings…
The home health company has provided care to Humana members since 2015 and has pioneered a value-based model in both Texas and Florida.”

Centene to pay more than $140M to settle Medicaid overpayment allegations in Ohio, Mississippi: “Centene will pay $143 million to settle allegations from attorneys general in two states that a pharmacy benefit manager subsidiary misrepresented costs to obtain Medicaid overpayments.”


About hospitals and health systems

Hospitals held for ransom by flood of robocalls: 5 details: “Robocalls are the No. 1 consumer complaint filed with the Federal Communications Commission, and robocalls to hospitals are a significant portion of the problem, creating a new type of ransomware attack on hospitals and a threat to public safety.
The illegal calls flood hospital networks and are often perpetuating fraud. The nonstop flow of calls undermines hospitals' ability to perform patient care by keeping staff on phone lines unnecessarily and impairing operational capacity, according to a June 11 FCC news release.

How America’s top hospitals hound patients with predatory billing: A really good investigative piece in Axios. Some highlights:
—”Just 10 hospitals are responsible for 97% of court actions against patients” By far, the most actions are by VCU Medical Center in Richmond, VA
—”The top 100 hospitals, on average, charged patients 7x the cost of service, with markup calculated from the American Hospital Directory's cost-to-charge ratio. And private, for-profit hospitals average nearly a 12x markup.”
Check the Figures as well.

Best Children’s Hospitals by Specialty: From US News.

Early Hospital Compliance With Federal Requirements for Price Transparency: “As of March 2021, a small proportion of US hospitals were compliant with the major requirements of the new federal rule requiring disclosure of negotiated prices. Hospitals exhibited selectively higher compliance with the requirement of a price estimator for patients to view personalized out-of-pocket costs for shoppable services; a smaller proportion made their data fully accessible to the public by posting a machine-readable file with payer-specific negotiated rates.
Selective compliance was especially pronounced for the 100 highest-revenue hospitals, a low proportion of which fully disclosed their negotiated rates despite high compliance with the price estimator tool requirement.”

California lawmakers blast HCA-owned hospital, allege dangerous staffing levels, hostile management: “The letter, signed by state Sen. Dave Cortese, Assemblyman Ash Kalra and Assemblyman Alex Lee, accuses Good Samaritan of having dangerous staffing levels despite its parent company reporting a $3.7 billion profit last year.”

About healthcare IT

Health Union Acquires WEGO Health: From the press release: “ Health Union, the leader in building online health solutions for people living with chronic conditions, today announced that it has acquired WEGO Health, the world's largest network of patient leaders - advocates, community leaders, creators and influencers. Combining Health Union's targeted scale and depth in the condition experience with WEGO Health's breadth of patient leaders in nearly all health conditions, Health Union aims to change the face of social health, connecting people in meaningful and innovative ways.”