Today's News and Commentary

About the public’s health

Oxford malaria vaccine maintains bite after booster; Researchers hope for shot approval in 2023 “New phase 2b findings show an investigational malaria vaccine booster from the University of Oxford maintained high efficacy levels a year after the initial three-shot regimen—a feat in a disease area that scientists have long struggled to develop effective vaccines and therapies.
The vaccine, dubbed R21/Matrix-M, was developed by the University of Oxford and includes Novavax's proprietary saponin-based Matrix-M adjuvant. R21 is also being studied in a phase 3 trial aimed at licensing the shot for widespread use by 2023, with topline results anticipated later this year.”

Distance to supermarkets is a risk factor for CKD, hypertension, diabetes development The headline is the message.

About healthcare IT

 Remote vs In-home Physician Visits for Hospital-Level Care at Home “In this 2-site randomized clinical trial of 172 patients, the mean adverse event count was 6.8 per 100 patients for patients receiving remote care vs 3.9 per 100 patients for control patients, for a difference of 2.8, supporting noninferiority, although 19% of patients receiving remote care required in-home physician visits. Patient experience was noninferior.”

Electronic Connectivity Among US Hospitals Treating Shared Patients “In total, hospitals in our sample participated in 127 HIE networks. Thirty-two of these were vendor/national HIE networks and 95 were community HIE networks. Seventy-nine percent of hospitals participated in at least one HIE network, with 61% participating in a vendor/national network and 58% participating in a community network. On average, each hospital participated in 1.6 networks: 1.0 vendor/national networks and 0.6 community networks.”

Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks From the HHS OIG: “We identified 1,714 providers whose billing for telehealth services during the first year of the pandemic poses a high risk to Medicare. These providers billed for telehealth services for about half a million beneficiaries. They received a total of $127.7 million in Medicare fee-for-service payments.
Each of these 1,714 providers had concerning billing on at least 1 of 7 measures we developed that may indicate fraud, waste, or abuse of telehealth services. All of these providers warrant further scrutiny. For example, they may be billing for telehealth services that are not medically necessary or were never provided.
In addition, more than half of the high-risk providers we identified are a part of a medical practice with at least one other provider whose billing poses a high risk to Medicare. This may indicate that certain practices are encouraging such billing among their associated providers. Further, 41 providers whose billing poses a high risk appear to be associated with telehealth companies; however, there is currently no systematic way to identify these companies in the Medicare data.”
See the report for recommendations.

About healthcare finance

 R1 RCM gets $2.3B in financing “Capital One Commercial Bank said Sept. 7 that it was the joint lead arranger for an amended and restated credit facility for R1 RCM.  
The facility increased R1 RCM's borrowing capacity from $1.2 billion to $2.3 billion, according to a Capital One news release emailed to Becker's…”

Today's News and Commentary

About health insurance/insurers

Judge invalidates parts of the ACA that mandate health coverage of many preventive services and drugs He’s at it again: “Judge Reed O’Connor also said the ACA’s requirement that health plans cover HIV pre-exposure prophylaxis, or PrEP, at no cost violates religious freedom law.
The decision, released Wednesday, is a temporary win for the plaintiffs, which include Steven Hotze, a physician and conservative activist who has campaigned against the ACA and previously called same-sex marriage a ‘wicked, evil movement.’ The Department of Health and Human Services did not immediately say if it would appeal the decision, although an appeal is considered likely.”

Where Does Your Health Care Dollar Go A nice summary with graphics from AHIP.

MedPAC explores standardized plan options in Medicare Advantage “The Medicare Payment Advisory Commission (MedPAC), which advises Congress on Medicare issues, is researching how standardized benefit options would work for MA. The goal is to include the findings in an annual report to Congress next year and explore how standardization could help simplify choice for seniors.”
Comment: This idea is a good one. It would make plan selection easier and would mimic the Medicare Supplement market.

Walmart And UnitedHealth Group Launch Medicare Advantage Partnership “Walmart and UnitedHealth Group are rolling out a major partnership to provide healthcare services and “improve the patient experience” for Medicare Advantage enrollees in certain markets across the country.
The 10-year collaboration announced Wednesday between the retail giant’s fast-growing Walmart Health business and UnitedHealth’s Optum health services will begin in 2023 in Florida and Georgia where Walmart Health has a combined 15 locations. Eventually, the collaboration will be expanded across the U.S., serving Medicare Advantage health plan enrollees no matter which health plan seniors choose.”

 New Survey Highlights What Americans Are Willing to Pay More for in Healthcare “Respondents were asked: "When you seek out healthcare, are you willing to pay more or less for any of the following factors?" The survey of more than 2000 Americans ranked factors that impact their healthcare provider choice with regards to costs, with quality of care being the top influencing factor:

• Quality of care (57%)

• Ability to work with care team of choice (47%)

• Ability to work with hospitals of choice (41%)

• Location proximity or convenience (41%)

• Ability to get an appointment quickly (40%)”

  NOTE: The referenced websites are proprietary. The article does not say how much people are willing to pay for those features.

About hospitals and healthcare systems

 FTC Investigating Amazon Deal to Buy One Medical Network of Health Clinics “The Federal Trade Commission is investigating Amazon.com Inc.’s $3.9 billion deal to buy 1Life Healthcare Inc., which operates One Medical primary care clinics in 25 U.S. markets.
1Life, which went public in 2020, disclosed the investigation in a securities filing. The disclosure says One Medical and Amazon each received a request on Friday for additional information about the deal from the FTC.”

About pharma

 Bayer to pay $40m to resolve claims over alleged kickbacks and false statements “The Justice Department said Laurie Simpson, a former Bayer employee who worked in its marketing department, filed two lawsuits against the company.

• In one, Simpson alleged Bayer paid kickbacks to hospitals and physicians to induce them to prescribe the drugs Trasylol and Avelox, marketed these drugs for off-label uses that were not "reasonable and necessary" and downplayed the safety risks of Trasylol.

• The lawsuit alleged Bayer's actions caused the submission of false Medicare and Medicaid claims and violated the laws of 20 states and the District of Columbia.

• The second lawsuit filed by Simpson alleged the company knowingly downplayed the drug Baycol’s risks of causing rhabdomyolysis and misrepresented its efficacy compared to other drugs of its kind.

• Bayer subsequently withdrew Trasylol and Baycol from the market for safety reasons.”

About the public’s health

 US states with the highest smoking rates in 2022 “Researchers found that, at 23.8%, West Virginia had the highest smoking rate and the highest number of smoking-related deaths, at 241 per 100,000 people.
On the other end of the spectrum, Utah had the lowest smoking rates of any U.S. state, with 7.9% of the population maintaining the habit. It also had the fewest smoking-related deaths, at 39 per 100,000 people.”

Trends in Parents’ Confidence in Childhood Vaccines During the COVID-19 Pandemic “From April 2020 to March 2022, the percentage of parents who agreed with the ‘important benefits’ and ‘useful and effective’ statements remained stable and high, ranging from 89.5 to 92.5% and from 89.3 to 93.2%, respectively... By contrast, the percentage of parents who agreed with the illness or death and harmful side effects statements increased significantly by 13.2% (95% confidence interval [CI]: 9.4% to 16.9%) and 6.1% (95% CI: 2.2% to 9.9%), respectively…. Statistically significant increases were observed for most parent subgroups (with overlapping CIs noted, suggesting no statistically significant differences between subgroups).”

Racial Differences in Detection of Fever Using Temporal vs Oral Temperature Measurements in Hospitalized Patients “In this multicenter study, temporal compared with oral temperature measurement was associated with a lower odds of identifying fever in Black patients, while there was no significant difference in White patients.”
This data joins problems with accuracy of pulse oximetry in black patients. The implications of those findings could significantly affect the “wearable technology” sector.

The Forgotten Middle: Housing & Care Options for Middle-Income Seniors in 2033 “Summary of Findings [emphases in the original]:
Over the next decade, the number of middle-income seniors will almost double—reaching 16M adults ages 75+ by 2033.

• This group will be more racially and ethnically diverse, including 22% who are people of color.
Many seniors will have health needs, like mobility limitations and cognitive impairments, that make it hard to live independently.

• Middle-income seniors may be more reliant on paid caregiving since a majority of them will be unmarried in 2033, and many do not have children living nearby.

Without selling their homes, three-quarters of middle-income seniors (11.5M) have insufficient resources to pay for private assisted living.

• Many seniors are reluctant to sell their homes either because their spouse still lives there or because it is a “nest egg” to protect against unforeseen expenses or pass to their children.

• Even with home equity, 6M (39%) middle-income seniors cannot pay for assisted living.

The research does not offer solutions to these problems.

About healthcare IT

 eClinicalWorks moves EHR to Microsoft cloud in $100M deal “eClinicalWorks is moving its EHR to Microsoft Azure and plans to invest $100 million in the tech giant.
The EHR vendor was looking for a cloud solution that was ‘scalable, secure and HIPAA-compliant’ to help reach its goals of digitizing its EHR, more quickly deploying new applications and improving customer satisfaction, said Bharat Satyanarayan, vice president of technology and quality assurance for eClinicalWorks…”

About healthcare personnel

 Travel nurses' gold rush is over. Now, some are joining other nurses in leaving the profession altogether “During the Covid pandemic, nurses tripled their pay by moving from job to job. But the short-lived boom was a temporary fix for a long-term decline in the nursing profession.”
A really good piece about the recent history of this travel nurses. 

About health technology

 EU blocks merger of US firms in cancer screening sector  “The European Union’s anti-trust watchdog announced on Tuesday that it is blocking the buyout of cancer-screening company GRAIL by biotech giant Illumina in a rare move by European regulators against two U.S. companies.
Illumina is a major supplier of next-generation sequencing (NGS) systems for genetic and genomic analysis, while GRAIL is a health company developing blood tests to try to catch cancer early. Illumina announced an $8 billion acquisition of GRAIL in 2020.”
The US recently cleared the deal.

Today's News and Commentary

About Covid-19

CDC recommends reformulated coronavirus booster shot for fall “The Centers for Disease Control and Prevention recommended Thursday that millions of eligible Americans, including those as young as 12, get an updated omicron-targeting booster shot to bolster defenses against serious illness and death during a potential fall or winter rise in covid-19 cases.
CDC Director Rochelle Walensky endorsed a recommendation by an advisory panel, paving the way for some clinicians, pharmacies and other providers to begin administering the shots as early as this weekend. The Advisory Committee on Immunization Practices voted 13-1 to recommend updated shots from Moderna, for those 18 and older, and from Pfizer-BioNTech, for people 12 and older.”

 White House signals most people will only need annual Covid booster “‘It is becoming increasingly clear, that looking forward with the Covid-19 pandemic, in the absence of a dramatically different variant, we likely are moving towards a path with a vaccination cadence similar to that of the annual influenza vaccine, with annual updated Covid-19 shots matched to the currently circulating strains for most of the population,’ Anthony Fauci, the country’s top infectious disease official, said at the briefing.”

About health insurance/insurers

 CVS Health to Acquire Signify Health From the press announcement: “ CVS Health and Signify Health ("Signify") have entered into a definitive agreement under which CVS Health will acquire Signify Health for $30.50 per share in cash, representing a total transaction value of approximately $8 billion.
Signify Health is a leader in Health Risk Assessments, value-based care and provider enablement. With a network of more than 10,000 clinicians across all 50 states and a nationwide value-based provider network, combined with its proprietary analytics and technology platforms, Signify Health is improving patient engagement, patient outcomes and care coordination for stakeholders across the health care system. Signify Health's clinicians and providers can have an even greater impact by engaging with CVS Health's unique collection of assets and connecting patients to care how and when they need it.”

Patient groups sue feds to crack down on insurer, PBM copay adjustment programs “A 2019 rule issued by the Trump administration blocks insurers from applying the drugmaker coupons to out-of-pocket limits like deductibles if there is a generic drug version on the market. However, the Trump administration decided to not enforce the rule in 2020 after complaints of confusion from stakeholders.
The 2021 Notice of Benefit and Payment Parameters rule—which outlines insurance regulations for Affordable Care Act exchange plans—enabled insurers to decide how to interpret cost-sharing. An insurer could “either include or exclude copay assistance from cost-sharing calculations,” according to a release on the lawsuit. 
The groups also charged that the Department of Health and Human Services (HHS) abandoned the 2019 copay accumulator policy that enabled assistance to count toward a deductible or out-of-pocket cost responsibility except for a brand-name drug that has a generic version.
The complaint asserts that the HHS rule violates federal law and directly contradicts the government’s own definition of cost-sharing.”
Comment: These actions were necessary because pharma companies raised prices and then gave coupons for discounts. Patients paid at the same rate as generics but insurers paid significantly more. Inevitably premiums will need to be raised if these consumer demand are met.
Maximus Awarded Centers for Medicare & Medicaid Services Contract for Contact Center Operations “Maximus… announced that it has been awarded a contract for a base period for transition plus nine (one year) option periods with a total value of $6.6 billion by the Centers for Medicare & Medicaid Services (CMS) for Contact Center Operations (CCO). Under the contract, Maximus will continue supporting CMS’ contact center operations that help 75 million Americans seeking vital information about their Medicare benefits as well as navigating insurance programs available through the Federal Marketplace established by the Affordable Care Act (ACA).”

Social Risk Adjustment In The Hospital Readmissions Reduction Program: A Systematic Review And Implications For Policy “We reviewed fourteen studies of social risk adjustment in Medicare’s Hospital Readmissions Reduction Program (HRRP), a value-based payment model that initially did not adjust for social risk factors but subsequently began to do so…
These findings support the use of social risk adjustment to improve provider payment equity and highlight opportunities to enhance social risk adjustment in value-based payment programs.”

13 Novus Healthcare Fraud Defendants Sentenced to Combined 84 Years in Prison “According to plea papers and evidence presented to a jury, Novus Health Services, a Dallas-based hospice agency, defrauded Medicare by submitting materially false claims for hospice services, providing kickbacks for referrals, and violating HIPAA to recruit beneficiaries.  Novus employees also dispensed Schedule II controlled substances to patients without the guidance of medical professionals and moved patients to a new hospice company in order to avoid a Medicare suspension.”

About hospitals and healthcare systems

Cybersecurity investments could go by the wayside at cash-strapped hospitals, Fitch warns “More not-for-profit hospitals will likely become susceptible to cyberattacks as slimming margins keep hard-hit organizations from making the necessary investments and preparations…
Although a handful of recent industry trends are increasing the costs of protecting hospitals from attack, the agency warned that a successful breach would only add to a hospitals’ financial woes and potentially affect their credit ratings.”

About pharma

In blow to public health, judge tosses FDA lawsuit targeting a clinic offering unproven stem cell treatments “A federal judge in Riverside declared a California stem cell treatment firm to be exempt from Food and Drug Administration regulations, opening the door to the further proliferation of clinics offering therapies the FDA says are scientifically unproven and potentially dangerous…
[Judge] Bernal accepted the center’s position that its treatments qualified for an exception from FDA regulations, in part because they were tantamount to surgical procedures.”
Read the entire article. This decision is not only scientifically and legally wrong [see the FDA definition of a drug] but will be harmful to the public. I hope it will be appealed soon.

Walgreens Boots Alliance Completes Majority Share Acquisition of CareCentrix “Walgreens Boots Alliance, Inc… announced it has completed its previously announced majority share acquisition of CareCentrix, Inc.—the leading independent home-centered platform that coordinates care to the home for health plans, patients and providers. The majority investment in CareCentrix accelerates Walgreens Health’s capabilities in delivering quality healthcare across a spectrum of settings including primary care, specialty pharmacy care, post-acute care and home care.”

About the public’s health

 Juul to pay $439 million in settlement over marketing to teens “E-cigarette company Juul, which at the height of its success dominated the market with its sweet flavors, has agreed to pay $438.5 million in a settlement with 33 states and one territory over marketing its product to teens.
Connecticut Attorney General William Tong (D), who led the plaintiff effort, said in a statement that the settlement will send millions of dollars to programs aimed at reducing tobacco use.”

About healthcare IT

Assessment of Clinician Diagnostic Concordance With Video Telemedicine in the Integrated Multispecialty Practice at Mayo Clinic During the Beginning of COVID-19 Pandemic From March to June 2020 “Findings  In this diagnostic study of 2393 patients who underwent a video telemedicine consultation followed by an in-person outpatient visit for the same clinical problem in the same specialty within a 90-day window, the provisional diagnosis established over video telemedicine visit matched the in-person reference standard diagnosis in 86.9% of cases.
Meaning  These findings suggest that video telemedicine visits yield a high degree of diagnostic concordance to in-person visits for most new clinical concerns.”

Amazon Care is dead, but the tech giant’s health-care ambitions live on An excellent summary of Amazon’s recent healthcare activities.

Medical Record Closure Practices of Physicians Before and After the Use of Medical Scribes “This [study] suggests that the use of scribes may not be a solution to clinical documentation burdens.”

Medicare Boosts Incentives for Hospitals to Provide Data to Public Health Agencies “A final rule announced Aug. 1 by the Centers for Medicare & Medicaid Services (CMS) makes changes for hospitals participating in the Medicare Promoting Interoperability Program that should result in better data to help improve responses to public health threats. The rule, which takes effect Oct. 1, gives hospitals greater financial incentives to report information electronically about patient illnesses, injuries, and treatments to state and local health departments.” 

About healthcare personnel

Association of Private Equity Acquisition of Physician Practices With Changes in Health Care Spending and Utilization “Question What are the implications of private equity acquisition of physician practices for health care spending and utilization?
Findings  This difference-in-differences event study of 578 private equity−acquired dermatology, gastroenterology, and ophthalmology physician practices and 2874 similar independent practices found that spending, new and unique patient volume, and total encounters increased differentially compared with controls. The share of outpatient visits longer than 30 minutes increased, and there were modest differences along key outcomes within specialties.
Meaning The findings of this economic evaluation suggest that among a large commercially insured population, private equity acquisitions of physician practices were associated with increased health care spending and several measures of utilization.”

 Private Equity Acquisitions Of Ambulatory Surgical Centers Were Not Associated With Quality, Cost, Or Volume Changes “There was no statistically significant observed change in the probability of an unplanned hospital visit, total costs, or total encounters after acquisition by private equity relative to acquisition by non–private equity entities. When we compared private equity–acquired ASCs with matched ASCs that were never acquired, we also found no statistically significant relative change in the probability of an unplanned hospital visit, total costs, or total encounters. Regulators should ensure that data on private equity acquisitions are transparent and that data are available to track the long-term quality and financial implications of these acquisitions.” 

About health technology

Illumina wins case against FTC in bid to hold onto early cancer detection company Grail “Sequencing behemoth Illumina on Thursday won its case against the Federal Trade Commission in its bid to hold onto Grail, a Bay Area early cancer detection company that the genomics giant acquired for $8 billion last year.
An administrative law judge rejected the FTC’s argument that the San Diego company’s acquisition of Grail would quash competition in the nascent market for multi-cancer early detection…”

Today's News and Commentary

About Covid-19

 F.D.A. Authorizes Updated Covid Booster Shots, Targeting Omicron Subvariants “The Food and Drug Administration on Wednesday authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week.
The agency cleared two options aimed at the BA.5 variant of Omicron that is now dominant: one made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older. The doses can be given at least two months since people last received a booster dose or completed their initial series of vaccinations.”

FDA takes N95 respirators off medical device shortage list “The Food and Drug Administration has taken N95 respirators off of the medical device shortage list as increased manufacturing has helped build a sufficient supply of the devices.”

About health insurance/insurers

 CMS: ACOs saved Medicare $1.6B overall in 2021 as big changes on the horizon “Accountable care organizations saved Medicare $1.66 billion last year as value-based care providers brace for potential major changes to the program like new health equity measures…
CMS reported that 99% of all ACOs in the Medicare Shared Savings Program (MSSP) met quality standards, and approximately 58% earned shared savings for abiding by spending targets. An ACO agrees to take on a certain degree of financial risk and to meet spending and quality benchmarks.”

About pharma

 Novartis' Entresto infringes on university patents, lawsuit claims “Novartis was served with a federal lawsuit earlier this week in the Northern District of California, alleging that its heart failure treatment Entresto infringes a patent jointly held by the University of Michigan and the University of South Florida related to ‘engineering crystals for the design of new drug compounds.’
According to the 10-page complaint, the universities allege that the US patent and trademark office issued a patent on April 28, 2020 to three inventors: Michael Zaworotko, Brian Moulton and Nair Rodríguez-Hornedo. Zaworotko and Moulton assigned their rights as inventors to the University of South Florida Board of Trustees, as did Rodríguez-Hornedo to the Regents of the University of Michigan.”

About the public’s health

 Marijuana use is outpacing cigarette use for the first time on record “More people in the U.S. are now smoking marijuana than cigarettes, according to a Gallup poll.
Cigarette use has been trending downward during the past decades, with only 11% of Americans saying they smoke them in a poll conducted July 5 to 26, compared to 45% in the mid-1950s.
Sixteen percent of Americans say they smoke marijuana, with 48% saying they have tried it at some point in their lives. In 1969, only 4% of Americans said they smoked marijuana.”

Nearly 30% of US Cancer Deaths Linked to Smoking “Nearly 123,000 cancer deaths – or almost 30% of all cancer deaths – in the United States in 2019 were linked to cigarette smoking, a new analysis suggests.
That corresponds to more than 2 million person-years of lost life and nearly $21 billion in annual lost earnings.”

Association of an Automated Blood Pressure Measurement Quality Improvement Program With Terminal Digit Preference and Recorded Mean Blood Pressure in 11 Clinics “In this quality improvement study of 1 541 227 BP measurements from 225 504 patients, when aneroid sphygmomanometers were replaced with automated monitors, terminal digit preference decreased, mean systolic BP immediately increased, and during the subsequent 3 years, the proportion of patients with the diagnosis of hypertension increased from 19.1% to 23.4%…
Conclusions and Relevance In this quality improvement study, automated BP measurement was associated with decreased terminal digit preference and significantly higher mean BP levels. The method of BP measurement was also associated with the rate at which hypertension was diagnosed. These findings may have implications for pay-for-performance programs, which may create an incentive to record BP levels that meet a particular goal and a disincentive to adopt automated measurement of BP.”

Today's News and Commentary

About Covid-19

Administration of Anti–SARS-CoV-2 Monoclonal Antibodies After US Food and Drug Administration Deauthorization “According to the results of this serial cross-sectional study, hospitals and health systems administered more than 158 000 anti–SARS-CoV-2 mAb doses in early 2022, despite FDA deauthorization because of a lack of efficacy against the Omicron variant. Medicare payments for mAb administration range from $450 to $750 per dose, indicating that spending on these deauthorized treatments likely exceeds $71 million.”

California Approves Bill to Punish Doctors Who Spread False Information ”The legislation, if signed by Gov. Gavin Newsom, would make the state the first to try to legislate a remedy to a problem that the American Medical Association, among other medical groups and experts, says has worsened the impact of the pandemic, resulting in thousands of unnecessary hospitalizations and deaths.
The law would designate spreading false or misleading medical information to patients as “unprofessional conduct,” subject to punishment by the agency that licenses doctors, the Medical Board of California. That could include suspending or revoking a doctor’s license to practice medicine in the state.”

About health insurance/insurers

'Not so optimistic:' Surprise billing arbitrations cause frustration  “Mediators have decided just 1200 out of 46000 claims.”

Blue Cross Blue Shield of Michigan Files More Deeply Reduced Premiums for ACA Individual Plans Thanks to Extension of Federal Subsidy Program File this article under “spin.” Recall that last week MIchigan’s governor required planss to lower their premiums because of the subsidies. This announcement basically says “We have complied.”

About hospitals and healthcare systems

National Hospital Flash Report: August 2022 “U.S. hospitals and health systems are experiencing some of the worst margins since the beginning of the pandemic, and 2022 continues to be on pace to be the worst year of the pandemic in terms of financial performance. The gains hospitals saw in recent months reversed themselves in July, as lagging outpatient volumes shrunk revenues and expenses jumped up from June. Hospitals can no longer count on supplemental federal funding to buffer these mounting losses, as they did in previous pandemic years. The situation is so dire that on August 16 Fitch Ratings revised its sector outlook for U.S. not-for-profit hospitals and health systems to ‘deteriorating.’”
Read the entire summary on page 4.

 Cleveland Clinic reports $1B loss in first half of this year “Cleveland Clinic's revenue was down year over year in the second quarter of this year, and the health system ended the period with a loss, according to financial documents released Aug. 29. 
The health system's revenue totaled $3.1 billion in the three-month period ended June 30, down from $3.2 billion in the same quarter last year. 
Cleveland Clinic reported expenses of $3.1 billion in the second quarter of this year, up from $2.7 billion in the same period last year. The system saw expenses rise across all categories, including supplies and salaries, wages and benefits.”

 About healthcare quality

PATIENT ACCESS AND VALUE-BASED OUTCOMES AMID THE GREAT ATTRITION “Data from the survey found that revenue from value-based contracts accounted for varying amounts of total medical revenue in 2021 among reporting practices:

• 6.74% in primary care specialties • 5.54% in surgical specialties
• 14.74% in nonsurgical specialties.

Across all practices, the median revenue amount from value-based contracts was $30,922 per FTE provider.

About the public’s health

White House to make all federally funded research immediately accessible “The White House… issued a new policy that will require all federally funded research to be immediately — and freely — available to the public upon publication starting no later than 2026.
Why it matters: The memorandum, issued by the Office of Science and Technology Policy (OSTP), will end journals' abilities to put the results from federally funded research behind paywalls for up to one year and will increase the public's immediate access to such research.”

US Signs $11 Million Deal to Fund Monkeypox Vaccines Grand River Aseptic Manufacturing, Inc. in Michigan will produce the vaccine.

About healthcare IT

 Privacy bill triggers lobbying surge by data brokers “Congress has never been closer to passing a federal data privacy law — and the brokers that profit from information on billions of people are spending big to nudge the legislation in their favor.
Five prominent data brokers boosted their collective spending on lobbying by roughly 11 percent in the second quarter of this year compared with the same period a year ago, according to lobbying disclosure records reviewed by POLITICO. The $180,000 lobbying bump came as House Democrats and Republicans reached a compromise on a bipartisan bill aimed at giving consumers new powers to limit the collection and sharing of their data.”

Feds sue firm for selling data that could track people at abortion clinics “The Federal Trade Commission sued an app analytics company on Monday for selling cell phone location data that the agency said could be used to track people to sensitive locations like abortion clinics, domestic violence facilities and places of worship. 
Kochava, an Idaho-based firm, has been ordered to delete the data and stop collecting it in the future, according to the antitrust and consumer protection regulator.”

About healthcare finance

 InterWell Health finalizes $2.4B kidney care merger to combine tech, value-based care capabilities “InterWell Health completed a three-way merger with Fresenius Health Partners and Cricket Health to create a kidney care powerhouse on track to have $11 billion in costs under management by 2025. 
The three big players in kidney care announced in March plans to form a new value-based care company focused on services for the earlier stages of kidney disease.
The deal creates a company valued at $2.4 billion, according to the companies.”

Today's News and Commentary

About Covid-19

 COVID DATA TRACKER WEEKLY REVIEW From the CDC: “As of August 24, 2022, the current 7-day moving average of daily new cases (90,676) decreased 6.7% compared with the previous 7-day moving average (97,184). A total of 93,777,133 COVID-19 cases have been reported in the United States as of August 24, 2022.” 

Secret Service recovers $286 million in stolen Covid relief funds “The Secret Service said Friday that it has recovered $286 million in Covid relief funds that were meant for small businesses but were siphoned off by fraudsters using thousands of stolen or fake identities.
The conspirators used fake identities to apply for Covid relief funds known as Economic Injury Disaster Loans (EIDL), and created 15,000 accounts at Green Dot Bank, an online institution in Texas, to try to access the money using debit cards. Green Dot notified the Secret Service when it discovered suspicious accounts, and the EIDL money was returned to the Small Business Administration, which had administered the relief funds.”

About health insurance/insurers

 CMS indefinitely delays controversial radiation oncology model The Biden administration has finalized a rule that indefinitely delays the controversial radiation oncology payment model, which generated significant pushback from providers.
The Centers for Medicare & Medicaid Services (CMS) issued a final rule… surrounding the payment model that intended to reimburse oncology practices and outpatient sites for a total episode of care. It would also develop site-neutral payments for certain radiation therapies.”

Today's News and Commentary

About Covid-19

 Twitter labeled factual information about covid-19 as misinformation “Over the past week, Twitter has flagged dozens of tweets with factual information about covid-19 as misinformation and in some cases has suspended the accounts of doctors, scientists, and patient advocates in response to their posts warning people about the illness’s dangers.
Many of the tweets have since had the misinformation labels removed, and the suspended accounts have been restored. But the episode has shaken many scientific and medical professionals, who say Twitter is a key way they try to publicize the continuing risk of covid to a population that has grown weary of more than two years of shifting claims about the illness.”

Laboratory-Confirmed COVID-19–Associated Hospitalizations Among Adults During SARS-CoV-2 Omicron BA.2 Variant Predominance — COVID-19–Associated Hospitalization Surveillance Network, 14 States, June 20, 2021–May 31, 2022 From the CDC: “Increased hospitalization rates among adults aged ≥65 years compared with rates among younger adults were most pronounced during the Omicron BA.2–predominant period. Among hospitalized nonpregnant patients, 44.1% had received primary vaccination and ≥1 booster or additional dose. Hospitalization rates among unvaccinated adults were approximately triple those of vaccinated adults.”

About health insurance/insurers

 Association of Medicare Advantage Premiums With Measures of Quality and Patient Experience 
”Findings  This retrospective cross-sectional study found statistically significant but small-to-medium sized (1-3 points of 100) improvements for most clinical and patient experience quality measures with higher premiums. There was a negative association for 1 measure; in contrast, at each premium level, there was substantial variation (≥5 points) in the quality of care among Medicare Advantage plans.
Meaning  These findings suggest that although there were modest improvements in the mean quality of care offered by high-premium Medicare Advantage plans, plans with high quality of care are available at every premium level.”
Read, also, the accompanying editorial: Getting the Most From Payments to Medicare Advantage Health Plans—Thoughts on the Controversy

Overall inflation has not yet flowed through to the health sector “While medical care prices increased by 4.8% between July 2021 and July 2022, the prices of many other consumer goods increased by significantly more.” Read this excellent summary by KFF with its usually well-done graphics.

About hospitals and healthcare systems

 CHS faces class-action fraud suit “The lawsuit alleges CHS misstated its financial position in documents provided to investors. In refusing to dismiss the action on Aug. 17, Judge Eli J. Richardson said the complaint adequately pleaded fraud, according to the report. 
The for-profit hospital operator allegedly used unreasonable accounting practices to produce financial documents that were unlikely to trigger defaults. The question of whether the practices were actually unreasonable is a question for the jury, the judge said.”

About pharma

 Moderna sues Pfizer and BioNTech for infringing on mRNA vaccine patents used in blockbuster Covid shots “Moderna alleges that Pfizer and BioNTech’s Covid-19 vaccine copied parts of its vaccine technology that it had patented between 2010 and 2016, when it was developing an mRNA vaccine for MERS. Moderna filed its lawsuit in a US district court in Massachusetts and the Regional Court of Düsseldorf in Germany, it said in a press release.
The lawsuit centers around two components of the mRNA vaccines and their three related patents. First, Moderna says that Pfizer and BioNTech made the same chemical modification to the mRNA to help it evade the immune system. And second, it says that Pfizer and BioNTech also used the full-length spike protein in its vaccine, which is a design Moderna says it patented.”

Drug manufacturers must submit reports on quality problems to FDA. Almost half of sites still don't, new report finds “The reports, known as Field Alert Reports (FARs), are crucial for the agency to root out manufacturing issues that can cause recalls or lead to harm.
But a new report from the agency found that of the 1,143 manufacturing sites that were eligible to submit a FAR  from 2018 to 2021, almost half (49%) of the sites did not submit a report.
Sites that did not submit FARs tend to be foreign, producing non-sterile products, and have fewer approved applications, the agency said.” 

Today's News and Commentary

About Covid-19

 Nirmatrelvir [Paxlovid] Use and Severe Covid-19 Outcomes during the Omicron Surge “Among patients 65 years of age or older, the rates of hospitalization and death due to Covid-19 were significantly lower among those who received nirmatrelvir than among those who did not. No evidence of benefit was found in younger adults.” 

About health insurance/insurers

Amazon plans to shut Amazon Care service amid One Medical overlap “Amazon.com Inc. is closing its primary care and telehealth service, a sudden move that follows the company’s deal to buy the One Medical chain of clinics.
Amazon Care, which was launched in 2019, will close by the end of the year, Senior Vice President Neil Lindsay said in an email to the company’s health care team…
’Although our enrolled members have loved many aspects of Amazon Care, it is not a complete enough offering for the large enterprise customers we have been targeting, and wasn’t going to work long-term.’

Medicare Advantage in 2022: Enrollment Update and Key Trends An excellent update from the KFF. Two statistics stand out: 48% of Medicare eligibles now belong to a MA plan; that number is expected to grow to 61% by 2032.

Evaluation of Spending Differences Between Beneficiaries in Medicare Advantage and the Medicare Shared Savings Program “In this economic evaluation of 15 763 MA and MSSP beneficiaries between 2014 and 2018, spending was 22% to 26% higher for MSSP beneficiaries than for MA beneficiaries even after controlling for detailed clinical risk factors. This was accounted for by higher outpatient hospital spending for MSSP beneficiaries.”

 NO SURPRISES ACT QPA CALCULATION QUESTIONED FOR VIOLATION IN NEW STUDY “In possible violation of the No Surprises Act, health insurance company calculations of qualified payment amounts (QPA) for anesthesiology, emergency medicine, and radiology services likely include rates from primary care provider (PCP) contracts, a new study says…
This method may violate the No Surprises Act law and produce insurer-calculated QPAs that do not represent typical payments for these services, the study said.”

About pharma

Novartis to spin off generics business Sandoz next year “Novartis plans to spin off its underperforming generics unit Sandoz to sharpen its focus on its patented prescription medicines, the Swiss group said on Thursday, acknowledging it had not received any formal offers for the business to date.”
And in the Financial Times: Founded by the Sandoz family, the business merged with Ciba-Geigy to create Novartis in 1996. Drugs manufactured by Sandoz, which employs about 20,000 people and generates almost $10bn in annual sales, are a staple of medicine cabinets in Germany, Austria and Switzerland.”

 Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder: A Randomized Clinical Trial “In this double-blind randomized clinical trial with 93 participants, the percentage of heavy drinking days during 32 weeks of follow-up was significantly lower in the psilocybin group than in the diphenhydramine group.
Meaning  The results in this trial showed that psilocybin administered in combination with psychotherapy produced robust decreases in the percentage of heavy drinking days compared with those produced by active placebo and psychotherapy.” 

About the public’s health

Pfizer Announces Positive Top-Line Data from Phase 3 Trial of Older Adults for its Bivalent Respiratory Syncytial Virus (RSV) Vaccine Candidate “Vaccine efficacy of 85.7% was observed in participants with more severe disease primary endpoint of lower respiratory tract illness (LRTI-RSV) defined by analysis of three or more RSV-associated symptoms
—Investigational vaccine was well-tolerated with no safety concerns
—Based on the findings of this pre-planned, interim efficacy analysis, Pfizer intends to submitfor regulatory approval in fall 2022”

Mental Health Care: Last Week Tonight with John Oliver Excellent review of problems addressing mental health delivery in the US.

Judge blocks part of Idaho’s abortion law from taking effect “The Biden administration on Wednesday scored its first legal victory since the Supreme Court overturned Roe v. Wade, convincing a judge to block the portion of an Idaho law that criminalizes performing an abortion on a woman to protect her health.
The law, which was set to take effect on Thursday, bans abortions except in cases involving rape, incest or when a woman’s life is in danger — and does not contain an exception for when a pregnant person’s health is at risk…
In a ruling late Wednesday, U.S. District Judge B. Lynn Winmill said the statute violates a federal act that requires hospitals participating in the federally funded Medicare program to provide medical care when a person’s life or health is at stake.”

About healthcare IT

 2022 Healthcare Data Breach Report Here are the major takeaways from data collected over the first six months of 2022:

• The total number of breaches is down 6% when comparing the first half of 2022 with the first half of 2021. Total breaches have declined for three consecutive six-month periods, and 2022 may see the first decline in annual breaches since Critical Insight began tracking the data. But, the yearly total is still expected to be above pre- pandemic levels.

• Attackers seem to be shifting their focus away from large healthcare facilities, big targets that might yield the most data but also tend to have the strongest defenses, to smaller hospital systems and specialty clinics that might not have the same level of security preparedness, staff size, or budget. Hackers are also targeting physician groups. The number of attacks on physician groups has increased from 2% of total breaches in the first half of 2021 to 12% in the first half of 2022. 

• 􏰀 Consolidation within the industry (multiple healthcare systems using the same electronic medical record (EMR) vendors, for example), has led to millions of exposed records as a result of attacks against third-party service providers. Electronic medical records (EMR) systems have emerged as a serious target for hackers, and increasingly breaches are occurring on third- party business associates, rather than on providers themselves.”

Surescripts Joins Civitas Networks for Health Surescripts has joined Civitas Networks for Health as a strategic business and technology partner to continue leveraging healthcare interoperability nationwide, providing better informed patient care and lower healthcare costs.
Civitas is the largest national network of its kind that includes member organizations working to use health information exchange, health data and multi-stakeholder, cross-sector approaches to improve health.

About healthcare finance

 Fresenius completes $2.4B merger with digital health startup “Fresenius Health Partners, InterWell Health and Cricket Health have completed a three-way merger to create an independent $2.4 billion company…
The new company will bring together the provider and payer relationships of InterWell Health, the technology and digital platform of Cricket Health and Fresenius's value-based care arm to deliver kidney disease care, according to the press release.”

Today's News and Commentary

About Covid-19

Moderna seeks FDA nod for booster shot aimed at Omicron BA.4, BA.5 “Moderna In on Tuesday sought U.S. authorization for its COVID-19 booster shot tailored against the BA.4 and BA.5 subvariants of Omicron and said if cleared it would be ready to deliver the doses in September.
Its application with the U.S. Food and Drug Administration (FDA) is based on pre-clinical data for the so-called bivalent dose that contains the dominant BA.4/BA.5 variants along with the original coronavirus strain. 

Pfizer COVID shots appear 73% effective in children under 5 The headline is the story

House investigates Trump’s ‘inappropriate’ pressure on FDA during the pandemic “The 69-page report found that the Trump White House “exerted extreme and inappropriate pressure” on FDA and former FDA commissioner Stephen Hahn to not only reauthorize hydroxychloroquine’s EUA, but deliver misleadingly positive news about convalescent plasma on the eve of the 2020 Republican National Convention, and to block the issuance of Covid-19 vaccine guidance, which the agency had to unilaterally release to require additional safety data.”

About health insurance

Michigan governor orders all payers to lower 2023 rates “Michigan Gov. Gretchen Whitmer sent a letter Aug. 18 to the Michigan Department of Insurance and Financial Services that requires all payers in the state to lower their already filed 2023 health insurance rates.
Ms. Whitmer said the order comes after the Inflation Reduction Act extended ACA premium subsidies through 2025.
’The new law extended insurance premium subsidies, which are currently saving hundreds of thousands of Michiganders nearly $800 a year,’ she wrote in the letter. ‘Today, I am instructing DIFS to require all insurers that offer coverage on HealthCare.gov to submit revised rates that reflect the cost savings as a result of enhanced subsidies.’”
Fascinating! Could this action be the harbinger of other state-based rate reductions?

 Cancer Now Top Driver of Employer Health Care Costs From the Business Group on Health: “Cancer has overtaken musculoskeletal conditions as the top driver of large companies’ health care costs, according to the Business Group on Health’s 2023 Large Employers’ Health Care Strategy and Plan Design Survey.
While the top three conditions fueling health care costs remained the same from last year – they include cardiovascular disease, in addition to cancer and musculoskeletal conditions – 13% of employers said they have seen more late-stage cancers and another 44% anticipate seeing such an increase in the future, likely due to pandemic-related delays in care.”

Common mistakes and helpful tips for parties initiating an IDR dispute More information from CMS on the Independent Dispute Resolution process for surprise bills.

About hospitals and healthcare systems

Mercy Mourns the Passing of Sister Mary Roch Rocklage “Sister Mary Roch Rocklage, the modern day foundress of the Mercy health care system who served the ministry for 65 years, passed away on Tuesday, August 23, 2022 following a long illness she endured with grace and tenacity. She was 87.”
You should read the entire obituary- she was such an important force in the healthcare field.

 UPMC's 6-month operating income drops 86% alongside $866M investment loss “The Pennsylvania-based organization reported Tuesday nearly $12.5 billion in total operating revenues and over $12.4 billion in total operating expenses during the first half of 2022, yielding a net operating income of $82 million (0.7% operating margin).
Year over year, those numbers reflect a 2.5% increase in revenues, a 6.7% increase in expenses and an 86.4% plummet in operating income following the prior year’s 5% operating margin.
The negative pressure on operations came from the provider side of UPMC’s business. Its six-month operating margin fell $577 million compared to the year prior for a $101 million loss.”

Merger with SCL Health spurs Intermountain to $2.7B in net income “Dive Brief:

• Intermountain Healthcare reported net income of $2.7 billion in the first six months of the year, despite a heavy loss on investments and flagging operating income.

• The 46% year-over-year jump in net income for the Utah-based nonprofit was spurred by more than $4 billion in contribution from its merger with SCL Health that closed in April, according to recent financial documents.

• By comparison, Intermountain brought in annual net income of $1.2 billion in 2020, $1.1 billion in 2019 and $599 million in 2018.”

About the public’s health

Life expectancy drops by almost 2 years “Overall life expectancy in the United States dropped by 1.8 years from 2019 to 2020, new data shows. The decline affected all 50 states and Washington, D.C., according to a new National Vital Statistics report [see Figure 4 for state-by-state statistics on these decreases], and ranged from as little as 0.2 years in some states to as many as 3 years in others…
The drop is the largest year-to-year change in more than 75 years…”
The study is full of statistics and mathematical models, but does not offer an explanation for the findings.

Judge in Texas blocks Biden administration emergency abortion guidance “A federal judge in Texas blocked the Biden administration late on Tuesday from enforcing new guidance in the Republican-led state requiring hospitals to provide emergency abortions to women regardless of state bans on the procedure…
 The judge declined to enjoin the guidance nationwide and instead only barred HHS from enforcing it and its interpretation of the Emergency Medical Treatment and Active Labor Act in Texas and against two anti-abortion groups of doctors.”
The federal government claims EMTALA mandates treatment in emergencies- including providing abortion services.  

Today's News and Commentary

About Covid-19

 COVID DATA TRACKER WEEKLY REVIEW “As of August 17, 2022, the current 7-day moving average of daily new cases (95,652) decreased 9.9% compared with the previous 7-day moving average (106,116). A total of 93,124,238 COVID-19 cases have been reported in the United States as of August 17, 2022.” 

About health insurance

 CMS approves first measures to track social determinants at federal level “The measure set, proposed by the Physicians Foundation, was adopted for use earlier this month in the Hospital Inpatient Prospective Payment System rule, effective 2023…
These measures are based on the foundation’s framework for addressing SDOH, published last year. An optional set is also being considered for physicians separately by CMS, the nonprofit organization told Fierce Healthcare.”
See, also, Meaningful Measures 2.0: Moving from Measure Reduction to Modernization

Judge rules CMS unfairly overturned Georgia's Medicaid work requirements program “A federal judge has sided with Georgia that the Biden administration unfairly struck down the state’s Medicaid work requirements program.
The ruling, issued late Friday, overturns the Centers for Medicare & Medicaid Services’ (CMS') decision to a controversial program first approved by the Trump administration.”
If upheld, this ruling could have major implications in other states that implemented such requirements.

About hospitals and healthcare systems

 Advocate Aurora reports $600.8M loss in first half of year “Advocate Aurora Health… reported revenue of $7.1 billion in the first two quarters of this year, up from $6.7 billion in the same period a year earlier. 
The health system's expenses were also up. Expenses climbed 9 percent year over year to $7 billion in the first six months of this year. Expenses increased across all categories, including salaries, wages and benefits…
After factoring in nonoperating items, the health system reported a net loss of $600.8 million in the first half of this year, compared to net income of $1.1 billion in the same period a year earlier.”

About pharma

 Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021 “ In this cohort study, among new drug indications approved through the accelerated approval or conditional marketing authorization pathways in the US and Europe from 2007 to 2021, 38.9% and 37.5%, respectively, demonstrated high therapeutic value. A substantially lower proportion of cancer indications than noncancer indications were rated as having high therapeutic value. Policy makers and regulators should increase enforcement of timely postapproval study completion for drugs qualifying for these pathways.”

About the public’s health

 1 in 3 American women have already lost abortion access. More restrictive laws are coming. “Two months after the Supreme Court overturned Roe v. Wade, about 20.9 million women have lost access to nearly all elective abortions in their home states, and a slate of strict new trigger laws expected to take effect in the coming days will shut out even more.
Texas, Tennessee and Idaho all have existing restrictions on abortion, but the laws slated to begin Thursday will either outlaw the procedure entirely or heighten penalties for doctors who perform an abortion, contributing to a seismic shift in who can access abortion in their home states.”

Wyoming confirms 1st monkeypox case; outbreak reaches all 50 states “With its confirmation, Wyoming becomes the 50th state to diagnose at least one monkeypox infection in the current outbreak, according to the U.S. Centers for Disease Control and Prevention. Puerto Rico and Washington, D.C., have also reported infections, it said.”

Statin Use for the Primary Prevention of Cardiovascular Disease in Adults “The USPSTF recommends that clinicians prescribe a statin for the primary prevention of CVD for adults aged 40 to 75 years who have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD risk of 10% or greater. (B recommendation) The USPSTF recommends that clinicians selectively offer a statin for the primary prevention of CVD for adults aged 40 to 75 years who have 1 or more of these CVD risk factors and an estimated 10-year CVD risk of 7.5% to less than 10%. The likelihood of benefit is smaller in this group than in persons with a 10-year risk of 10% or greater. (C recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating a statin for the primary prevention of CVD events and mortality in adults 76 years or older. (I statement).”
Read one of the accompanying editorials: Statin Usage in Primary Prevention—Comparing the USPSTF Recommendations With the AHA/ACC/Multisociety Guidelines

Today's News and Commentary

Fauci plans to step down in December after half a century in government “Anthony S. Fauci, the nation’s preeminent infectious-disease expert who achieved unprecedented fame while enduring withering political attacks as the face of the coronavirus pandemic response under two presidents, plans to step down in December after more than a half-century of public service, he announced Monday.
Fauci, 81, has led the National Institute of Allergy and Infectious Diseases since 1984. He joined the parent agency, the National Institutes of Health, in 1968 as a 27-year-old doctor who had just finished medical residency and was quickly identified as a rising star…
Fauci emphasized that he is not exiting the public square. He said he hopes to teach, lecture, write — perhaps a book, along with essays and other types of writing — and use his experience to inspire and teach a younger generation of scientists.”

About Covid-19

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine “Pfizer Inc. and BioNTech SE today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine to address the continued evolution of SARS-CoV-2. Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.”

Creating a Roadmap for the End of the COVID-19 Public Health Emergency “CMS has developed a roadmap for the eventual end of the Medicare PHE waivers and flexibilities, and is sharing information on what health care facilities and providers can do to prepare for future events. Similar to the guidance CMS has made available to states, CMS is releasing fact sheets that will help the health care sector transition to operations once the PHE ends, whenever that may occur….
The fact sheets we are releasing… summarize the current status of Medicare Blanket waivers and flexibilities by provider type as well as flexibilities applicable to the Medicaid community.”

 Everyone over 12 expected to be eligible for new boosters, White House official says The headline is the story.

 FDA authorizes Novavax Covid-19 vaccine for emergency use in ages 12-17 The headline is the story.

About health insurance/Costs

REQUIREMENTS RELATED TO SURPRISE BILLING: FINAL RULES Fact Sheet from the Department of Labor

An early look at what is driving health costs in 2023 ACA markets “We find that insurers in this market are proposing to raise premiums by more than in recent years. The median proposed premium increase is 10% across these 72 insurers. The main contributor to premium growth is health cost trend, which reflects rising prices paid to providers and pharmaceutical companies as well as a rebound in utilization. While our analysis focuses on the ACA markets, the main premium drivers we identified (prices and utilization) are systemic and not specific to the ACA markets.”

 Aon: U.S. Employer Health Care Costs Projected to Increase 6.5 Percent Next Year “Average costs for U.S. employers that pay for their employees' health care will increase 6.5 percent to more than $13,800 per employee in 2023, according to Aon…
This projection is more than double the 3 percent increase to health care budgets which employers experienced from 2021 to 2022; but is significantly below the 9.1 inflation figure reported through the Consumer Price Index…
Medical claims were suppressed for most employers during the first year of the COVID-19 pandemic, during which time much care was postponed or skipped during quarantines. Employers have seen the medical claims experience return to more typical levels of growth and anticipate inflationary cost pressures in the coming year.”

CMS Releases Proposed Rule to Improve Medicaid & CHIP Quality Reporting Across States “This rule proposes requirements for mandatory annual state reporting of three different quality measure sets:

• the Core Set of Children’s Health Care Quality Measures for Medicaid and CHIP;

• the behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid; and

• the Core Sets of Health Home Quality Measures for Medicaid.

These Core Sets are designed to measure the overall national quality of care for beneficiaries, monitor performance at the state level, and improve the quality of health care.”

About hospitals and healthcare systems

 Failed Medicaid expansion negotiations reveal N.C. hospitals' might  The expansion had bipartisan support, but the state hospital association successfully quashed the effort because in contained a provision pulling back on the certificate of need (CON)law; in other words, it could have increased competition for hospitals.
For an update of CON laws, see: Certificate of Need (CON) State Laws

About pharma

 Pharma ad spending up just 1% this year as the slow move away from TV into digital continues For “the first six months of 2022, the pharma industry spent $5.5 billion on all ads for its products, most of which was on its drug products.  
While that’s a huge figure, it actually represents a slow drop in growth from previous years, with only a slight 1% lift during January to June 2022 versus the same time last year.
Ad spend for prescription drugs, which accounts for 88% of pharma category dollars ($4.8 billion), in fact fell 2% year on year. On the other hand, ad expenses for over-the-counter medicines and remedies jumped 23% during the same period.“  

FDA accepts Astellas menopause drug NDA “Tokyo-based Astellas Pharma announced this week that the U.S. FDA has accepted its New Drug Application for fezolinetant, an investigational new drug for the treatment of menopause-associated symptoms such as hot flashes or night sweats.
The indicated PDUFA date is February 22, 2023, as Astellas is also employing a priority review voucher. The NDA acceptance hinged on three phase 3 trials which enrolled 2,800 women from across the U.S., Canada and Europe. The trials evaluated the efficacy and safety of the drug for the treatment of moderate to severe vasomotor symptoms (VMS) caused by menopause or sex-related hormone disorders.”
However, this March: Astellas' menopause drug suffers rare setback as failed Asian trial blots previously pristine record “Astellas’ $550 million bet on menopause drug fezolinetant has hit unexpected turbulence. After acing a pair of phase 3 clinical trials and racing to regulators, Astellas has reported the failure of fezolinetant to beat placebo in a late-stage study of patients in Asia.”
This case highlights the vagaries of the FDA approval process.

About the public’s health

 The global burden of cancer attributable to risk factors, 2010–19: a systematic analysis for the Global Burden of Disease Study 2019 “The leading risk factors at the most detailed level globally for risk-attributable cancer deaths and DALYs in 2019 for both sexes combined were smoking, followed by alcohol use and high BMI. Risk-attributable cancer burden varied by world region and Socio-demographic Index (SDI), with smoking, unsafe sex, and alcohol use being the three leading risk factors for risk-attributable cancer DALYs in low SDI locations in 2019, whereas DALYs in high SDI locations mirrored the top three global risk factor rankings.” 

Low-temperature mineralization of perfluorocarboxylic acids “Per- and polyfluoroalkyl substances (PFAS) are persistent, bioaccumulative pollutants found in water resources at concentrations harmful to human health. Whereas current PFAS destruction strategies use nonselective destruction mechanisms, we found that perfluoroalkyl carboxylic acids (PFCAs) could be mineralized through a sodium hydroxide–mediated defluorination pathway. PFCA decarboxylation in polar aprotic solvents produced reactive perfluoroalkyl ion intermediates that degraded to fluoride ions (78 to ~100%) within 24 hours.”
A potentially low-cost, effective means to address this important solution problem.

WHO says monkeypox vaccine ‘not a silver bullet’ as breakthrough cases reported “There is limited data on the efficacy of the vaccine, and what is available has been drawn from animal studies. The main study used to indicate efficacy dates back to the 1980s and looked at a different type of smallpox vaccine — potentially more powerful than the safer vaccines that have since been developed. That study showed 85 percent protection against monkeypox.”

High-Contact Object and Surface Contamination in a Household of Persons with Monkeypox VirusInfection — Utah, June 2022 “Monkeypox virus DNA was detected from many objects and surfaces sampled indicating that some level of contamination occurred in the household environment. However, the inability to detect viable virus suggests that virus viability might have decayed over time or through chemical or environmental inactivation. Although both patients were symptomatic and isolated in their home for >3 weeks, their cleaning and disinfection practices during this period might have limited the level of contamination within the household. These data are limited, and additional studies are needed to assess the presence and degree of surface contamination and investigate the potential for indirect transmission of Monkeypox virus in household environments.”

About healthcare IT

 NIH ANNOUNCES 4 TELEHEALTH RESEARCH CENTERS OF EXCELLENCE FOR CANCER CARE “The National Institutes of Health's National Cancer Institute (NCI) has designated four health systems as national centers for excellence for their work in using telehealth to improve cancer treatment and care management. The four programs will split $23 million over the next five years to establish the NCI's Telehealth Research Centers of Excellence (TRACE) initiative, which is being supported by the Cancer Moonshot, launched in 2016 and restarted earlier this year by President Joe Biden.”

Electronic Public Health Reporting & Recording of Social & Behavioral Determinants of Health Among Office-Based Physicians, 2019 “HIGHLIGHTS:

• In 2019, less than one in five primary care physicians electronically exchanged (i.e., sent or received) health information with PHAs.

• Nearly half of primary care physicians reported electronically searching or querying for vaccination or immunization history from sources outside their health care organization.

• Most physicians electronically recorded social and behavioral determinants of health data.

• Physicians who engaged in interoperability were more likely to electronically: exchange information with PHAs; search for vaccination information; and record social and behavioral determinants of health data.

• Certified health IT use is associated with higher rates of electronic public health reporting and electronic recording of social and behavioral determinants of health data.

• Public health reporting and recording capabilities varied by EHR developer market share…

• In 2019, about one in ten (12%) office-based physicians nationally electronically exchanged patient health information with PHAs, including the Centers for Disease Control and Prevention (CDC), state or local public health authorities..

• Electronic exchange capabilities were higher among primary care physicians (18%) compared to physicians nationally, ranging from 12% of general/family practice primary care physicians to 24% of internal medicine and 26% of pediatric primary care physicians.

• Overall, about a quarter of physicians nationally did not know whether their practice electronically exchanged patient health information with PHAs.”

More than 80 health systems hit by cybersecurity breaches in August FYI

About healthcare personnel

 CommonSpirit readies launch of nation’s largest nursing residency program According to CEO Wright Lassiter: “ We’re creating this inner nationwide staffing company to create a platform whereby nurses can work in 21 states with out having to depart the employer, with out having to lose seniority, with out being outdoors the profit and mission halo of the group.”

About health technology

 Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy Read the FDA notice about this Class 1 recall.
And in a related article: Medical Device Recalls Hit Two-Year Record in Q2 “Medical device recalls reached their highest level in two years during the second quarter of 2022 with 268 events, a 34 percent increase from the 200 recalls in the first quarter…” 

Today's News and Commentary

About health insurance

 Customers Perceive Shortfall in Medicare Advantage Plan Coverage of Mental Health and Substance Abuse Services, J.D. Power Finds “Following are some of the key findings of the 2022 study:

• Overall member satisfaction with Medicare Advantage plans rises: Overall customer satisfaction with Medicare Advantage plans is 809 (on a 1,000-point scale), which is up 3 points from 2021 and up 15 points during the past five years.

• Missing the mark on mental health and substance abuse disorder services: Just 38% of Medicare Advantage plan members say they have enough coverage for mental health treatment, down from 39% a year ago. Just 27% of members say they have enough coverage for substance use disorder services. These numbers compare with 91% of members who say they have enough coverage for routine diagnostics and 89% who say they have enough coverage for preventive and wellness services.

• Telemedicine usage declines, despite largely positive experiences: Just 24% of Medicare Advantage plan members used telemedicine during the past year, down from 35% in 2021. Among those who have used the technology, however, 48% say they are very likely to use it again, an increase of five percentage points from last year.

• Health plan portals still show promise, but breaking inertia is hard: A strong majority (82%) of Medicare Advantage members are registered for their health plan’s member portal—up four percentage points from a year ago. However, 14% have registered for the portal but never logged in. Overall customer satisfaction scores are 72 points higher (823) when customers register and log-in to the portal than when they do neither (751).” 

About hospitals and healthcare systems

 Fitch: Nonprofit hospitals' outlook 'deteriorating' for remainder of 2022 “Fitch Ratings adjusted its outlook for nonprofit hospitals from ‘neutral’ to ‘deteriorating’ halfway through what has proven to be a rough year for the industry…
’While severe volume disruption to operations appears to be waning, elevated expense pressure remains pronounced,’ Kevin Holloran, senior director at Fitch Ratings, said in a release accompanying the outlook report. ‘Even if macro inflation cools, labor expenses may be reset at a permanently higher level for the rest of 2022 and likely well beyond.’
Fitch anticipates nonprofit hospitals’ operating margins will reflect those pressures through the back half of the year, although many organizations will be able to somewhat weather the storm with the record levels of cash they accumulated last year. Still, asset price corrections in the market are substantially trimming the investment portfolios built up during 2021’s strong markets, the agency noted.”
And in a related story: Inflation Reduction Act may help ease payers' Medicaid losses if public health emergency ends, Fitch says “Payers with large Medicaid operations are expected to face negative pressure on revenues if the federal public health emergency ends in October, but the total impact on profits is likely to be small because of coverage alternatives offered by the Inflation Reduction Act, according to an Aug. 11 analysis Fitch Ratings shared with Becker's.
If the public health emergency is allowed to end October 13, a redetermination process will begin a major disenrollment of Medicaid beneficiaries, likely over the course of a year.
All payers operating Medicaid plans will be affected, but those with higher enrollments are expected to be more impacted. The loss of beneficiaries will be mitigated through the Inflation Reduction Act's extensionof ACA premium tax credits through the end of 2025, which will allow some to regain coverage in the individual market.”

Hospital collection rates for self-pay patient accounts ”As out-of-pocket payment responsibilities continue to rise for patients, hospitals employ more and different efforts to collect these self-pay amounts. But Crowe analytics are showing that after the patient portion reaches into the thousands of dollars, collectability drops off starkly. And that “vanishing point” threshold is now $7,500…
Self-pay after insurance accounts for almost 58% of bad debt.” 

About pharma

 Walmart, CVS and Walgreens ordered to pay $650 million to Ohio counties for opioid crisis “U.S. District Court Judge Dan Aaron Polster ordered Walmart, CVS Pharmacy and Walgreens to pay a total of $650.5 million to Lake County and Trumbull County over the next 15 years. In the lawsuit, the companies were accused of oversupplying opioids through their pharmacies, contributing to the opioid crisis.”

FDA Approves Citrate-Free, High Concentration of Biosimilar Hadlima “The Food and Drug Administration (FDA) has approved a citrate-free, high concentration formulation of 100mg/mL of Hadlima™(adalimumab-bwwd), a biosimilar to Humira®(adalimumab).” No information is yet available about the price.

About the public’s health

 Monkeypox cases jump 20% in 1 week, WHO finds: 5 updates  FYI. Among the most worrisome statistic is t “The U.S. accounts for more than 38 percent of global cases.”
And in a related article: Monkeypox Vaccine Maker Seeks Partners in Race to Meet Demand “Bavarian Nordic A/S, the only company with an approved vaccine for monkeypox, said it’s no longer certain it can meet demand and is talking to multiple production partners as cases rise across the world. 
The Danish company is exploring the possibility of outsourcing some of its production, including a technology transfer to a US contract manufacturer, to meet accelerating demand.”
Breaking news: Deal struck to expedite production of monkeypox vaccines in U.S. “Under the arrangement, Denmark-based Bavarian Nordic will work with Michigan-based Grand River Aseptic Manufacturing to package 2.5 million doses of vaccine that the United States had ordered in July.”

About healthcare IT

 Satisfaction with modes of telemedicine delivery during COVID-19: A randomized, single-blind, parallel group, noninferiority trial “Among a group of diverse, established older or underserved patients the satisfaction rate for phone-only was noninferior to video visits. These findings could impact practice and policies governing telemedicine.” 

NY Billing Company Suffers Ransomware Attack, 942K Impacted “New York-based medical billing and practice management company Practice Resources, LLC (PRL) began notifying 942,138 individuals of a ransomware attack that impacted 26 of its healthcare organization clients.
According to a notice posted on the California Attorney General’s Office website, PRL suffered a ransomware attack on April 12, 2022. PRL immediately took steps to secure its systems and gained assistance from third-party experts.
The information involved in the attack potentially included names, addresses, health plan numbers, dates of treatment, and medical record numbers.”
This case highlights the importance of “Business Associate” agreements.

About health technology

 Raymond Damadian, Creator of the First M.R.I. Scanner, Dies at 86 

New Method Improves Speed and Cost of Birth Defect Testing “After 10 years of effort, medical researchers at Columbia University have developed a very fast and cheap way to detect the extra or missing chromosomes that most often cause miscarriages or severe birth defects.
The method, described Wednesday in the New England Journal of Medicine, takes less than two hours using a palm-size device and costs $200 per use. With current testing procedures, women can end up paying $1,000 to $2,000, often out of pocket.
The technique, developed by Dr. Zev Williams, director of the Columbia University Fertility Center, and his colleagues, uses cells and tissues obtained from existing prenatal screening procedures of embryos and fetuses, or tissue obtained after miscarriages. Its key advantage is that the cells or tissue do not have to be sent to a testing lab — the analysis can be done in the same office that obtained the material, and results are ready in hours rather than days or weeks.”

Guardant Health’s Liquid Biopsy Test Reveal Gets Expanded Clearance “Guardant Health’s Reveal liquid biopsy test received an expanded clearance from the FDA to include patients with breast and lung cancers.
The test works by detecting circulating tumor DNA in the blood after surgery to identify patients with minimal residual disease who have a higher risk for recurrence and may benefit from additional therapy.”

Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application “Is self-monitoring of blood pressure using an enhanced device that pairs with a connected smartphone application more effective in reducing systolic blood pressure than self-monitoring using a standard device?” The short answer is “No.”
”In this randomized clinical trial of 2101 patients with uncontrolled blood pressure, patients were randomly assigned to standard or enhanced self-monitoring of their blood pressure and mailed a self-monitoring device, after which usual care and in-person clinic blood pressure measurements from ambulatory visits during 6 months of follow-up were used to compare changes from baseline. The mean (SD) change in systolic blood pressure was −10.8 (18) mm Hg vs −10.6 (18) mm Hg in enhanced vs standard groups.”

Today's News and Commentary

About Covid-19

 Biden administration will stop buying Covid-19 vaccines, treatments and tests as early as this fall, Jha says “‘My hope is that in 2023, you're going to see the commercialization of almost all of these products. Some of that is actually going to begin this fall, in the days and weeks ahead. You're going to see commercialization of some of these things,’ he said.”

About health insurance

 CMS discontinues medical device forms to ease physician administrative burdens “The Centers for Medicare and Medicaid Services announced Wednesday it will discontinue the certificates of medical necessity (CMN) and durable medical equipment information forms (DIF) starting in 2023. 
Both forms are currently needed to get reimbursement for medical equipment to ensure they are medically necessary. However, CMS rethought the need for the forms recently…
Earlier this month, CMS suspended prior authorization requirements under certain circumstances for orthopedic medical equipment like prosthetics. Congress is also considering legislation that would mandate electronic prior authorization processes for Medicare Advantage plans and streamline a process that physicians say consumes too much of their time.”

About hospitals and healthcare systems

 NRC Health Consumer Loyalty Award 2022 Award Winners  FYI

About pharma

FDA approves one of the priciest new treatments of all time — bluebird's gene therapy for beta thalassemia “And while bluebird said it will charge up to $2.8 million for the therapy, drug pricing watchdog ICER previously said the therapy would be cost-effective up to $3 million per dose, Thomas Klima, chief commercial officer at bluebird told Endpoints News in an interview earlier this week. He said the price makes sense considering it can cost $6.4 million for a lifetime of transfusions…
 Bluebird is also saying it will provide up to an 80% rebate if the patient doesn’t hit or maintain transfusion independence.” 

Endo files for Chapter 11 as it looks to finish off its opioid litigation ”The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.”

Since Biden took over, Big Pharma has spent $205 million to protect drug price status quo, analysis finds “Since 2020, the year Biden moved into the White House, the industry has spent more than $205 million battling to preserve the status quo, an analysis from Accountable.US finds. The figure includes $149 million in lobbying efforts aimed specifically at drug pricing and more than $57 million in television, cable, radio and social media ads opposing Medicare price negotiations.”

J&J Unit Tells Appeals Court Only Bankruptcy Can Settle Talc Claims “The subsidiary, LTL Management LLC, said in court papers filed on Monday that chapter 11 is the only option for compensating all claimants relatively quickly.
LTL, which J&J created last year to move mass talc litigation to bankruptcy, laid-out a defense of its strategy in its filing in the Third U.S. Circuit Court of Appeals, which is considering a request by injury claimants to have the subsidiary’s chapter 11 bankruptcy thrown out of court.”

About the public’s health

 CDC, under fire, lays out plan to become more nimble and accountable “A background briefing document shared with The Washington Post spells out some of CDC’s most pressing problems and proposed solutions.
Some measures, such as new authority to mandate state data reporting, hire people faster and offer competitive salaries to recruit and retain top people, will require action from Congress. Others are internal changes that Walensky can make, such as having science and laboratory sciences offices, two key divisions that would be out front on a public health crisis, report directly to her. And some will require negotiations with unions.”
Read the article for more details.

About healthcare personnel

 Primary Care Matters Medi-Cal Study “Key Findings

• The level of investment in primary care — defined as the percentage of a health plan’s overall spending dedicated to primary care services — varied widely among the 13 Medi-Cal managed care plans that participated in the study, with a low of 5% to a high of 19%. The average was roughly 11%.

• A significant statistical relationship was observed between plans with higher primary care spending percentages and those that scored higher on the Aggregated Quality Factor Score, a composite measure of overall care quality, which includes the percentage of plan members who complete well-child visits, receive immunizations, have control of their diabetes, and receive recommended cancer screenings, among other measures.

• When individual measures of quality were studied, a relationship was found between plans with a higher percentage of spending on primary care and better performance on 9 of 11 measures. Three of these measures met criteria for statistical significance.

• Plans that spend a higher percentage on primary care were more likely to get a better plan rating from the National Committee for Quality Assurance. NCQA evaluates health plans on the quality of care patients receive, measures of patient experience, and health plans’ efforts to keep improving.”

Today's News and Commentary

Biden Signs Expansive Health, Climate and Tax Law “President Biden on Tuesday signed a long-awaited bill meant to reduce health costs, reduce greenhouse gas emissions and raise taxes on corporations and wealthy investors, capping more than a year of on-again, off-again negotiations and cementing his early economic legacy…
The bill, which Democrats named the Inflation Reduction Act, invests $370 billion in spending and tax credits in low-emission forms of energy to fight climate change. It extends federal health-insurance subsidies, allows the government to negotiate prescription drug prices for seniors on Medicare and is expected to reduce the federal budget deficit by about $300 billion over 10 years.”

About Covid-19

Profiling post-COVID syndrome across different variants of SARS-CoV-2 This preprint paper posits several different types of post-Covid syndrome:
”We identified distinct profiles of symptoms for post-COVID syndrome within and across variants: four endotypes were identified for infections due to the wild-type variant; seven for the alpha variant; and five for delta. Across all variants, a cardiorespiratory cluster of symptoms was identified. A second cluster related to central neurological, and a third to cases with the most severe and debilitating multi-organ symptoms. Gastrointestinal symptoms clustered in no more than two specific phenotypes per viral variant. The three main clusters were confirmed in an independent testing sample, and their functional impact was assessed.”

 Multiple Shots of the Bacillus Calmette-Guerin (BCG) Vaccine Protect Patients with Type 1 Diabetes from COVID-19 “Researchers at Massachusetts General Hospital (MGH), published a new paper in Cell Reports Medicine demonstrating the protective potential of multiple doses of the Bacillus Calmette-Guerin (BCG) vaccine against COVID-19 and other infectious diseases.
In a double-blind, placebo-controlled study of patients with type 1 diabetes conducted at the start of the pandemic (before COVID-specific vaccines were available), the researchers found that 12.5% of placebo-treated individuals and 1% of BCG-treated individuals met criteria for confirmed COVID-19, yielding a vaccine effectiveness of 92%.
The BCG-vaccinated group also displayed protective effects against other infectious diseases, including fewer symptoms, lesser severity and fewer infectious disease events per patient. No BCG-related systemic adverse events occurred.” 

About health insurance

 Healthcare billing fraud: 10 recent cases FYI

About hospitals and healthcare systems

 The 10 Largest Health Systems in the US FYI

FTC warns states against laws permitting hospital mergers under special conditions “The Federal Trade Commission (FTC) is warning states away from certificates of public advantage (COPAs) legislation, cautioning that hospital mergers permitted under these laws still bring many of the detrimental effects of consolidation they purport to prevent.
State-level COPA laws allow hospitals to avoid federal antitrust enforcement should they demonstrate that a merger’s benefits outweigh the negative impacts of reduced market competition, such as higher prices and reduced quality of care.
The laws often come with specific terms such as price controls or mechanisms to pass along cost savings and efficiencies and are supervised by state departments of health and attorneys' general offices.
In a policy paper released Monday by the FTC, the agency said it has seen a ‘resurgence’ of the laws in recent years, including those passed by state legislatures ‘with the intent of exempting specific proposed hospital mergers from anticipated antitrust challenges.’”

About pharma

Newly launched U.S. drugs head toward record-high prices in 2022 “The median annual price of 13 novel drugs approved for chronic conditions by the U.S. Food and Drug Administration so far this year is $257,000, Reuters found.
They were in good company: seven other newly-launched drugs were priced above $200,000. Three other drugs launched in 2022 are used only intermittently and were not included in the calculation.”

Analysts rule out major industry impact from drug pricing negotiations “While it is hard to predict which drugs Medicare will target, BofA estimates that negotiations will lead to a 25% price reduction for the 25 drugs the program spends the most in 2026 and beyond. The firm does not expect the bill to cause a significant impact on industry growth.
Meanwhile, noting the limited scope of the provisions, UBS argues that Medicare negotiations under the bill are unlikely to be the worst-case scenario for the industry.”
The law’s initial impact will obviously not be immediate: however we will need to see how much else is implemented in the future, especially, purchasing Part B drugs and expansion of government limits to the private sector.

 Merck bets big on circular RNA, paying $150M and dangling $3.5B in biobucks to work with Orna “The Big Pharma is making the upfront payment and committing to up to $3.5 billion in milestones to work with Orna to advance programs including engineered circular RNA (oRNA) vaccines and therapeutics against infectious diseases and cancers. Orna will retain rights to its oRNA-LNP platform and continue to advance other wholly owned programs internally.”

About the public’s health

FDA moves to make over-the-counter hearing aids available to millions “The Food and Drug Administration on Tuesday moved to make hearing aids available to consumers to buy over the counter without a prescription or medical exam…
‘As early as mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country,’ President Biden said…”

U.S. to provide states with up to 442,000 Jynneos doses to combat monkeypox “The U.S. government said on Monday it will provide states with up to 442,000 doses of Bavarian Nordic's Jynneos vaccine to combat the outbreak of monkeypox disease.
The allocation, as part of the Phase 3 of the national vaccine strategy, is double the number of doses originally anticipated, the Department of Health and Human Services said.
The government was initially planning to dispatch the doses in two segment but combined it together after the Food and Drug Administration last week allowed administering the shot intradermally…” 

About healthcare IT

 Facebook tracker compromised PHI of 1.3M Novant Health patients “Novant Health notified patients Aug. 12 that their protected health information may have been improperly disclosed because of a Facebook tracking tool used in a May 2020 marketing campaign. 
In May, Novant Health launched a promotional campaign involving Facebook advertisements and a Meta tracking pixel which was placed on the health system's website, according to a press release from Novant. 
The tracking tool was intended to help Novant Health track the campaign's success, but ended up allowing certain private information to be transmitted to Facebook's parent company Meta from the Novant Health website and MyChart patient portal. Novant discovered the possible disclosures June 17.”

About healthcare personnel

 Revisiting the Time Needed to Provide Adult Primary Care “PCPs were estimated to require 26.7 h/day, comprising of 14.1 h/day for preventive care, 7.2 h/day for chronic disease care, 2.2 h/day for acute care, and 3.2 h/day for documentation and inbox management. With team-based care, PCPs were estimated to require 9.3 h per day (2.0 h/day for preventive care and 3.6 h/day for chronic disease care, 1.1 h/day for acute care, and 2.6 h/day for documentation and inbox management).”
Are there organizational and/or technical changes that would enhance efficiencies? Are all  requirements equally productive?

Today's News and Commentary

A neuro-metabolic account of why daylong cognitive work alters the control of economic decisions A fascinating (and bizarre) article about the brain chemistry guiding human behavior.
”Highlights

•Cognitive fatigue is explored with magnetic resonance spectroscopy during a workday

•Hard cognitive work leads to glutamate accumulation in the lateral prefrontal cortex

•The need for glutamate regulation reduces the control exerted over decision-making

•Reduced control favors the choice of low-effort actions with short-term rewards”

About Covid-19

 UK becomes first country to approve Omicron-specific Covid booster “The UK has become the first country to authorise a Covid-19 vaccine tailored to the Omicron variant, setting the stage for an autumn booster campaign using Moderna’s two-strain shot. The Medicines and Healthcare products Regulatory Authority — which was the first in the world to approve an original Covid-19 jab — has granted conditional authorisation to the vaccine, which targets both the original strain of the virus and Omicron BA.1. The vaccine is authorised for use in people aged 18 and over but, to prepare for an expected rise in cases over the winter, the UK plans to focus its booster programme on the over-fifties and those at higher clinical risk of developing severe Covid.”

To Avoid Paxlovid Rebound, Some Experts Call for Longer Courses of Treatment The extension would be three to five days.

  CDC Back Control of Pandemic Hospitalization Data Despite Criticism ”The US won’t renew its contract with TeleTracking Technologies Inc., a private company that took over Covid-19 hospitalization data collection from CDC in 2020, according to an email seen by Bloomberg News. Hospitals will resume reporting the data to the CDC in mid-December, with TeleTracking’s contract expiring on Dec. 31.” 

About the public’s health

 WHO renames two monkeypox variants to avoid geographic references “The World Health Organization (WHO) announced Saturday that it renamed variants of the virus monkeypox as it looks to counter concerns about the original naming conventions.
’Newly identified viruses, related diseases & virus variants are given names to avoid causing offence to any cultural, social, national, regional, professional, or ethnic groups, & minimize the negative impact on trade, travel, tourism, or animal welfare,’ the WHO said in its announcement. 
The Congo Basin and West African variants were reclassified as Clade I and Clade II, the latter of which has two subclades. The new names go into effect immediately.”

Person-years of life lost and lost earnings from cigarette smoking-attributable cancer deaths, United States, 2019 “Here, using state-specific population data and census data on annual median earnings, the authors estimated the number of smoking-attributable deaths and potentially avoidable losses in earnings for 2019. Analyses indicate that in 2019, for persons age 25 to 79, cigarette smoking-attributable cancer deaths accounted for 2.2 million person-years of life lost (PYLL) and approximately $21 billion in lost earnings. Analyses further suggest that greater than half of PYLL and lost earnings were avoidable.”

Risk of hip fracture in meat-eaters, pescatarians, and vegetarians: results from the UK Women’s Cohort Study “Amongst 26,318 women, 822 hip fracture cases were observed (556,331 person-years). After adjustment for confounders, vegetarians (HR (95% CI) 1.33 (1.03, 1.71)) but not occasional meat-eaters (1.00 (0.85, 1.18)) or pescatarians (0.97 (0.75, 1.26)) had a greater risk of hip fracture than regular meat-eaters. There was no clear evidence of effect modification by BMI in any diet group (p-interaction = 0.3).”

About healthcare quality

The Joint Commission to add health equity standards to accreditations “As of Jan. 1, accreditation programs for primary care clinics, behavioral health centers, critical access facilities and hospitals will include new mandates for their leaders.
 The updated standards include designating an officer to lead a strategy for reducing health disparities and screening patients for social determinants of health.
The Oakbrook Terrace-based commission is also requiring accredited organizations to add demographic breakdowns to quality and safety data. The stratifications will assist organizations in identifying disparities in health outcomes, which the accreditation group will require them to use to develop an action plan to eliminate [them].”

Today's News and Commentary

About Covid-19

 FDA recommends repeat at-home Covid tests to reduce risk of false negatives Further explanations of the new guidelines: The FDA issued guidance “recommending that people testing themselves for COVID-19 at home take a repeat test within 48 hours to rule out a potential false negative.
In its guidance, the FDA noted that at-home tests are less likely to detect the coronavirus than PCR lab tests. This inaccuracy is more likely to occur early on in the infection in people who display no symptoms…
The FDA recommended that people take one initial test if they suspect they may be infected or exposed to COVID-19. If they test negative and have some symptoms, then they should test again 48 hours after the first test. If the second test is still negative, a laboratory molecular-based test should be considered.
If a person has no COVID-19 symptoms but believes they have been exposed to the virus, the FDA said they should also test themselves a second time, also 48 hours after their first at-home test. If the second test is negative, they should take an additional third test another 48 hours afterward.”

About health insurance

Trends in the Source of New Enrollees to Medicare Advantage [MA] From 2012 to 2019 “This study found that from 2012 to 2019, growth in MA enrollment was primarily attributable to TM [traditional Medicare] beneficiaries who switched to MA rather than to newly eligible Medicare beneficiaries enrolling in MA. Also, beneficiaries who switched from TM were more likely to have a disability or to be dually eligible for Medicaid than were new enrollees.”
The authors speculated on reasons for these findings but neglected to mention lower overall beneficiary costs for MA plans, particularly for those need frequent services.

 Humana Completes Divestiture of Majority Interest in Kindred at Home Hospice and Personal Care Divisions to CD&R “Humana Inc. today announced that it has successfully completed its previously-announced transaction with private investment firm Clayton, Dubilier & Rice (‘CD&R’) to divest a majority interest [60%] in the Hospice and Personal Care divisions of Humana’s Kindred at Home subsidiary (‘KAH Hospice’). These divisions include patient-centered services for Hospice, Palliative, Community and Personal Care. Upon closing, the Hospice and Personal Care divisions have been restructured into a new standalone company.”
The $2.8 billion deal was first announced in April.

Health Care Service Corporation to Acquire Trustmark Health Benefits “ Health Care Service Corporation (HCSC) has signed a definitive agreement with Trustco Holdings, Inc. (Trustmark) to purchase its wholly owned subsidiary, Trustmark Health Benefits (Health Benefits), which is a leading third-party administrator of health benefits. The acquisition will provide HCSC with additional capabilities to serve a broader set of customers seeking customizable and flexible health benefit solutions.”

Oscar Health sees big enrollment growth in Q2, will pause +Oscar deals As usual, the “good news” is reported first- higher enrollment and higher revenue. It is only in point three that we get to the important information: “The company lost $112.1 million in the second quarter. In the first six months of the year, the company lost $189.4 million, rising 16.8 percent from a loss of $162.2 million year over year.”
The loss did not come from spending on patient care, since: “The company's medical loss ratio in the second quarter was 82.2 percent, which was only slightly different from 82.4 percent during the same period last year.”
Perhaps the company has a failed business model?

About the public’s health

 Polio virus is found in New York City wastewater “Health authorities announced Friday that polio virus has been found in New York City wastewater, a discovery that extends the known presence of the virus from the region’s northern suburbs to the nation’s largest city.
City and state health departments offered no details of where in New York City the virus was discovered but said there were six positive samples collected in June and July. They said the finding suggests ‘likely local circulation of the virus.’”
Officials suggest checking/updating immunization status. The next question is whether other cities should also test their waste waters?

J&J to remove talc products from shelves worldwide, replacing with cornstarch-based portfolio Finally: “After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.
J&J is beginning the transition to an all cornstarch-based baby powder portfolio...”

The Implications of the Supreme Court Decision to Overturn Roe v Wade for Women With Pregnancy-Associated Cancers The headline explains the article’s content. It is well-written and thoughtful.

About health technology

NEW STUDY SHOWS ABBOTT'S BLOOD TEST FOR CONCUSSION COULD PREDICT OUTCOMES FROM BRAIN INJURY AND INFORM TREATMENT INTERVENTIONS “A new study published in The Lancet Neurology demonstrates the ability of two blood-based biomarkers to predict how someone will recover from traumatic brain injury (TBI). Testing for these two biomarkers in the immediate aftermath of an injury can help health care providers determine the best way to treat and care for patients.
This research shows that when a clinician conducts a blood test for these brain proteins soon after a possible injury, they quickly get a more accurate picture of how severe the injury is, the expected course of recovery and the longer-term implications of the TBI. The markers were measured using Abbott's i-STAT™ TBI Plasma test, as well as on the company's ARCHITECT core laboratory instrument using research prototype assays, both of which helped predict recovery…
The day-of-injury blood tests had a high probability of predicting death at six months, 87% for GFAP and 89% for UCH-L1; and a high probability of predicting severe disability at the same timepoint, 86% for both GFAP and UCH-L1.”
The test is an important breakthrough in addressing TBI; however, it will need to be priced low enough to gain widespread use- think about high school football games.

Today's News and Commentary

About Covid-19

 The US is on a Covid plateau, and no one's sure what will happen next “The United States seems to have hit a Covid-19 plateau, with more than 40,000 people hospitalized and more than 400 deaths a day consistently over the past month or so…
 ‘We've never really cracked that: why these surges go up and down, how long it stays up and how fast it comes down,’ said Dr. Eric Topol, a cardiologist and professor of molecular medicine at Scripps Research. ‘All these things are still somewhat of a mystery.’
BA.5 remains the dominant subvariant in the US for now, causing most new cases as it has since the last week of June.”

CDC eases Covid-19 quarantine and testing guidelines as it marks a new phase in pandemic “People who are not up to date with their Covid-19 vaccines and who are exposed to someone infected with the coronavirus no longer need to quarantine, according to updated recommendations issued Thursday by the Centers for Disease Control and Prevention.
Instead, they should just wear a mask for 10 days in indoor settings and test on day 5,  according to the guidance. They were previously recommended to stay home.
The new guidelines could also ease the testing burden on schools. While people showing symptoms of Covid should be tested, the recommendations say broader screening “might not be cost-effective in general community settings, especially if Covid-19 prevalence is low.” Such widespread testing could still be done in certain settings like long-term care facilities, correctional facilities, and homeless shelters.”

About health insurance

 Eight Charged in Alleged $150M Crestar Labs Fraud Scheme “According to the U.S. Department of Justice (DOJ) announcement, the individuals charged, including the owner of a series of Tennessee-based labs known as Crestar Labs, LLC, were allegedly involved in a scheme in which marketers signed fake contracts and were paid kickbacks to target elderly beneficiaries of federal healthcare programs at senior health fairs, nursing homes, and other locations for their genetic material and urine analysis samples.
That material was then used in genetic testing approved by telehealth doctors who had no interaction with the patients. In many cases, the patients and the doctors actually treating them never received the test results, the DOJ alleges. Crestar Labs’ owner and the others involved in the scheme allegedly paid bribes and kickbacks for tests and doctor’s orders “without regard to medical necessity” and falsely billed Medicare and Medicaid more than $150 million, the DOJ statement adds.”

FTC Action Against Benefytt Results in $100 Million in Refunds for Consumers Tricked into Sham Health Plans and Charged Exorbitant Junk Fees “The Federal Trade Commission is taking action against healthcare company Benefytt Technologies, two subsidiaries, former CEO Gavin Southwell, and former vice president of sales Amy Brady, for lying to consumers about their sham health insurance plans and using deceptive lead generation websites to lure them in. According to the FTC complaint, Benefytt also illegally charged people exorbitant junk fees for unwanted add-on products without their permission. The proposed court orders require Benefytt to pay $100 million in refunds and prohibit the company from lying about their products or charging illegal junk fees. Southwell and Brady will be permanently banned from selling or marketing any healthcare-related product, and Brady will also be banned from telemarketing.”

Judge rejects New York doctor's challenge to surprise billing ban “A New York doctor has lost a challenge to the recently enacted federal law prohibiting surprise medical bills for out-of-network services.
U.S. District Judge Ann Donnelly in Brooklyn late Wednesday denied surgeon Daniel Haller's motion for an injunction blocking the law, which took effect in January, and dismissed his lawsuit claiming that it is unconstitutional.”

About hospitals and healthcare systems

 Colorado's new hospital price transparency law adds 'real teeth' to weak federal enforcement, experts say “The bipartisan “Prohibit Collection Hospital Not Disclosing Prices” was signed into law by Colorado Governor Jared Polis in June and went into effect Wednesday.
It prevents hospitals or their collectors from initiating or pursuing debt collection from a patient if the hospital’s website was not in compliance with the Centers for Medicare and Medicaid Services (CMS)’ price transparency requirements at the time services were delivered, according to the bill’s text.”
Perhaps state-level actions will correct federal inaction in addressing widespread non-compliance (see yesterday’s blog).

About pharma

 New drug candidate fights off more than 300 drug-resistant bacteria “Urinary tract infections are common, yet are increasingly tough to treat because the bacteria that cause them are becoming resistant to many antibiotics. Now, in ACS Central Science, researchers report a new molecule that inhibits drug-resistant bacteria in lab experiments, as well as in mice with pneumonia and urinary tract infections. The researchers say that this compound, fabimycin, could one day be used to treat challenging infections in humans…
 The team started with an antibiotic that was active against gram-positive bacteria and made a series of structural modifications that they believed would allow it to act against gram-negative strains. One of the modified compounds, dubbed fabimycin, proved potent against more than 300 drug-resistant clinical isolates, while remaining relatively inactive toward certain gram-positive pathogens and some typically harmless bacteria that live in or on the human body. In addition, the new molecule reduced the amount of drug-resistant bacteria in mice with pneumonia or urinary tract infections to pre-infection levels or below, performing as well as or better than existing antibiotics at similar doses. The researchers say the results show that fabimycin could one day be an effective treatment for stubborn infections.”

About the public’s health

Federal Health Agencies Unveil National Tool to Measure Health Impacts of Environmental Burdens The “Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR), in partnership with the Department of Health and Human Services’ Office of Environmental Justice, announce the release of the Environmental Justice Index (EJI). The EJI builds off existing environmental justice indexes to provide a single environmental justice score for local communities across the United States so that public health officials can identify and map areas most at risk for the health impacts of environmental burden.
It is the first national, geographic-driven tool designed to measure the cumulative impacts of environmental burden through the lenses of human health and health equity. Cumulative impacts are the total harm to human health that occurs from the combination of environmental burden such as pollution and poor environmental conditions, pre-existing health conditions, and social factors.”

 Monkeypox vaccine maker voices concerns on U.S. dose-splitting plan “The manufacturer of the only vaccine approved by the Food and Drug Administration to protect against monkeypox privately warned senior Biden health officials about their plan to split doses and change how the shots are delivered…
 ‘It would have been prudent’ to conduct further studies before overhauling the nation’s monkeypox vaccine strategy, [Bavarian Nordic CEO Paul] Chaplin said, adding that his company had been ‘inundated with calls from U.S. state government officials with questions and concerns’ about how to implement the new plan.
In interviews Wednesday, Biden administration officials acknowledged Bavarian Nordic’s concerns but said they would not affect their vaccine strategy.”

Longitudinal Assessments of Neurocognitive Performance and Brain Structure Associated With Initiation of Tobacco Use in Children, 2016 to 2021 “In this national cohort study of 17 073 children with neuroimaging outcomes, a significant association was found of early-age initiation of tobacco use with lower crystalized cognition composite score and impaired brain development in total cortical area and volume. Region of interest analysis also revealed smaller cortical area and volume across frontal, parietal, and temporal lobes.
Meaning  These findings suggest that initiation of tobacco use is associated with inferior neurocognitive functions; evidence-based intervention strategies and tobacco control policies should prevent tobacco initiation at a young age.”

About healthcare IT

Telehealth Utilization Grew 10.2 Percent Nationally in May 2022 “n May 2022, for the second straight month, telehealth utilization, as measured by telehealth's share of all medical claim lines, grew nationally and in every US census region (Midwest, Northeast, South, West), according to FAIR Health's Monthly Telehealth Regional Tracker.1 National telehealth utilization increased 10.2 percent, from 4.9 percent of medical claim lines in April to 5.4 percent in May. Regionally, the greatest increase was in the Midwest, where telehealth utilization grew 17.6 percent in May. The data represent the privately insured population, including Medicare Advantage and excluding Medicare Fee-for-Service and Medicaid.”

July-reported healthcare breaches exposed data on nearly 4M patients “About 3.9 million patients had data compromised in healthcare data breaches reported to the federal government last month, nearly half of which were attributed to a cyberattack at one payment vendor.” 

Digital Divide Consults and Devices for VA Video Connect [VVC] Appointments A report from the VA’s OIG.
The VA spent $11.3 million to purchase mobile devices for beneficiaries who could not afford to by them. The purpose was to facilitate appointment scheduling and telehealth appointments. The OIG found that, among other things, “About 49 Percent of the Patients Who Were Sent a Device Went on to Complete a VVC Appointment” and the money was not wisely spent.

About healthcare personnel

 Biden to name Monica Bertagnolli as National Cancer Institute director “Harvard Medical School surgeon Dr. Monica Bertagnolli is poised to become the first woman to lead the National Cancer Institute after President Joe Biden said on Wednesday he plans to appoint her to the position.
Bertagnolli currently serves as the Richard E. Wilson professor of surgery in the field of surgical oncology at Harvard as well as a surgeon at Brigham and Women's Hospital.”

Today's News and Commentary

About Covid-19

 Ancestral SARS-CoV-2, but not Omicron, replicates less efficiently in primary pediatric nasal epithelial cells  Many critics of Covid immunizations for the young base their arguments on low infection/severity rates in that population. This article explains why this finding was true for the delta variant, but emphasizes the protective mechanism does not hold for newer variants. Childhood Covid Immunization is, therefore, important.

About health insurance

 Judge Approves Blue Cross’s $2.67 Billion Antitrust Settlement “A federal judge approved Blue Cross Blue Shield companies’ settlement of a sweeping antitrust suit filed on behalf of their customers, with the insurers agreeing to pay $2.67 billion and change certain practices that allegedly limited competition…
There are currently 34 companies that own Blue Cross Blue Shield health plans, with many operating as nonprofits. Together, the Blue insurers cover more than 100 million Americans…
The suit alleged that the companies acted like a cartel, illegally conspiring to divvy up markets and avoid competing against one another, driving up customers’ prices.
Under the settlement, the Blue insurers would drop a Blue Cross Blue Shield Association rule that limits the share of each company’s total national revenue that can come from business that isn’t under Blue brands.
That change could increase competition among the companies if they choose to expand their non-Blue lines of business in one another’s geographies, insurance experts said.”

About hospitals and healthcare systems

Third Semi-Annual Hospital Price Transparency Report August 2022 “Under the authority of the Affordable Care Act (ACA), a federal hospital price transparency rule took effect January 1, 2021, requiring hospitals to post all prices online, easily accessible and searchable without having to submit personal identifying information. Prices are required to be in the form of:
• A single machine-readable standard charges file for all items and services for all payers and all plans as well as all discounted cash prices.
• A standard charges display with actual prices or a price estimator tool for the 300 most common shoppable services…
Of the 2,000 total hospitals reviewed, we found:
• Only 319 (16.0%) were complying with the rule.
• 101 hospitals (5.1%) did not post any standard charges file and were in total noncompliance.
• Although 793 (39.7%) of hospitals posted negotiated prices clearly associated with payers and plans, 407 of the 793 (51.3%) failed compliance because the majority of their pricing data was missing or incomplete.
• Of the three largest hospital systems in the country, HCA Healthcare and Ascension continued to flout the law with zero compliance, while 45 of 111 hospitals owned by CommonSpirit Health, the second largest hospital system, are now in compliance.”

 ByteDance Pays $1.5 Billion for China Hospital Chain in Health Foray “TikTok owner joins tech giants in seeking growth in the area.” More evidence that cross category diversification in healthcare is international.

 HCA Healthcare, J&J explore better outcomes, nurse training, early cancer detection in new partnership “HCA Healthcare and Johnson & Johnson outlined Tuesday morning three areas in which the former’s 35 million annual patient encounters and 93,000 nurses could benefit from the latter’s research and development knowhow.
First, the companies will be collaborating on a ‘scalable program’ to detect early-stage lung cancer among Black patients, kicking off with an early identification pilot program they will begin to build “in the coming months.”
Second, HCA will be incorporating Johnson & Johnson’s nursing resources within its facilities and affiliate Galen College of Nursing. The two will also jointly build nurse education programs intended to address health equity, build nurses’ skills and improve patient outcomes.
Finally, the hospital chain’s HCA Healthcare Research Institute will be working with Johnson & Johnson on various cardiovascular health research projects. Among those teased were a retrospective analysis of heart arrhythmia patients and an investigation on how digital health technology could impact coronary artery disease and peripheral artery disease outcomes.”

About pharma

In warranty program, Pfizer will refund up to $50K for patients who discontinue use of rare disease drug 
Last year the pharma giant introduced its first warranty program, using it to promote lung cancer drug Xalkori. Now Pfizer has opened a similar program for newly approved Panzyga, which treats the rare disorder chronic inflammatory demyelinating polyneuropathy (CIPD).”
This trend of refunding costs for expensive, ineffective drugs is continuing.

Walmart has a new policy denying some telehealth prescriptions for controlled drugs. It's implicating patients in recovery “Walmart did not respond to multiple requests for comment, but one Walmart pharmacy employee confirmed the existence of the policy applicable to all Walmart and Sam’s Club pharmacies that began in July.”

BREAKING: Walgreens Fueled SF Opioid Epidemic, Judge Rules “ Pharmacy giant Walgreens dispensed hundreds of thousands of suspicious prescriptions for narcotic painkillers in San Francisco without proper screening and is liable for ensuing opioid problems in the Bay Area, a California federal judge ruled Wednesday. The ruling from U. S. District Judge Charles R. Breyer followed a bench trial earlier this year that initially featured several drug companies but gradually generated several settlements, leaving Walgreens as the sole defendant.”

Faced with thousands of opioid lawsuits, Endo says it will likely file for bankruptcy 'imminently' “The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that ‘these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.’”

About the public’s health

China discovers potentially fatal new virus passed to humans from shrews “China has discovered a potentially fatal new virus that is believed to have been passed to humans by shrews, as reported Independent on Tuesday.
The Langya henipavirus has infected 35 people, although no one has died or suffered a serious illness, said Taiwan's Centers for Disease Control.
There is no vaccine and, in severe cases, it can have a fatality rate of up to 75%, according to the World Health Organization.”

Todays News and Commentary

About health insurance

3.7 Million People Would Gain Health Coverage in 2023 if the Remaining 12 States Were to Expand Medicaid Eligibility From the RWJF: “Key Findings:

• Black individuals, young adults, and women—particularly women of reproductive age—would realize the largest coverage gains. 

• Federal spending on Medicaid and marketplaces in the 12 non-expansion states would be partially offset by $2.6 billion in federal government savings on uncompensated care.

  • State spending on Medicaid in those states would be partially offset by $1.7 billion.

  • Comprehensive analyses of states that expanded Medicaid demonstrate that expansion generated savings and increased revenues to outweigh any new spending.”

Illinois customers sue health insurance giant Centene “The lawsuit, filed in the U.S. District Court for the Eastern Division of the Northern District of Illinois on Friday, alleges that Centene, through its subsidiaries, sold ‘fraudulent health insurance policies’ to millions of consumers across 26 states, including Illinois, since 2013…
The primary issue consumers raise in the complaint is that many members of Ambetter, Centene's consumer-facing insurance plans, have difficulty finding an in-network provider and, in some cases, have been unable to find any provider that takes Ambetter plans.
As a result, some Ambetter members have suffered delays in treatment, been unable to find treatment, been forced to travel hundreds of miles to in-network providers and pay out-of-pocket fees. The complaint also alleges that Ambetter plans refuse to pay for some services they advertised covering.”

About hospitals and healthcare systems

 Kaiser posts $1.3B loss in Q2 “Kaiser, which provides healthcare and health plans, reported operating revenue of $23.47 billion in the second quarter of 2022, down from $23.69 billion in the same quarter of 2021. The organization's expenses climbed from $23.34 billion in the second quarter of last year to $23.38 billion in the same period this year. 
‘Much like the entire health care industry, we continue to address deferred care while navigating COVID-19 surges and associated expenses,’ Kathy Lancaster, Kaiser executive vice president and CFO, said in an Aug. 5 earnings release.
Kaiser ended the second quarter of this year with operating income of $89 million, down from $349 million a year earlier.”

About pharma

 GSK bets $1.3B on Mersana’s preclinical ADC and chance to expand portfolio beyond Blenrep “GSK has paid out $100 million cash to Mersana Therapeutics for the potential to add a second antibody-drug conjugate (ADC) to its portfolio, which currently consists of approved multiple myeloma drug Blenrep. The new deal encompasses XMT-2056, Mersana’s preclinical ADC asset aimed at treating a range of HER-2 cancers.   
The global agreement gives GSK an exclusive option to co-develop and commercialize XMT-2056. If GSK exercises the option, Mersana could make up to $1.36 billion in biobucks, making the deal one of the largest to date for a preclinical ADC asset.”

Pfizer to buy Global Blood Therapeutics under $5.4-billion deal “Pfizer agreed to buy Global Blood Therapeutics (GBT) for $68.50 per share in cash, or a total enterprise value of approximately $5.4 billion, the companies said Monday… The boards of both drugmakers have unanimously approved the transaction, which represents a premium of nearly 43% to GBT's closing share price on August 4…
The purchase will give Pfizer rights to GBT's sickle cell disease therapy Oxbryta (voxelotor), which is approved in a number of markets, including the US and Europe, and generated sales of around $195 million last year. Pfizer said it ‘plans to accelerate’ distribution of Oxbryta to parts of the world most impacted by sickle cell disease.”

To avoid shortage of Merck's diabetes drug, FDA allows higher impurity levels temporarily “The FDA said Tuesday that it recently became aware of a nitrosamine impurity, Nitroso-STG-19 or NTTP, in certain samples of Merck’s type 2 diabetes drug Januvia.
To avoid a shortage of the drug that pulled in more than $10.5 billion for Merck in 2020 and 2021, and to help ensure patients have access to an adequate supply, the FDA said it will not object to the temporary distribution of sitagliptin containing the impurity above the acceptable intake limit.
Typically, if a drug contains levels of nitrosamines above the acceptable daily intake limit, the FDA recommends the manufacturer conduct a recall.”
I have never seen this permission before for any drug.

About the public’s health

Limited monkeypox vaccine supply would be stretched under FDA plan “The strategy, first described publicly by Food and Drug Administration Commissioner Robert Califf last week, would allow the Biden administration to stretch its limited supply of monkeypox vaccines by changing how those shots are administered. Rather than inject doses of Jynneos subcutaneously, a traditional way of delivering vaccines into the fatty tissue under the skin, the doses would instead be injected under the top layer of the skin. This approach, known as an intradermal injection, uses a thinner needle and less vaccine, but leads to a small bubble forming on the surface of the skin that can scar.”

 Group of 23 states tells U.S. court CDC lacks authority to set transit mask rules “A group of 23 state attorneys general led by Florida told a federal court on Monday that the U.S. Centers for Disease Control and Prevention (CDC) lacks the legal authority to impose a nationwide transportation mask mandate to address COVID-19…
 A group of 17 Republican U.S. lawmakers including Senator Rand Paul and Representative Thomas Massie also filed a brief Monday arguing the CDC lacked the authority to impose masking requirements.”

A Huge Amount of Data From Cancer Trials Remains Hidden, Researchers Warn “Data from more than half of cancer trials underpinning drug approvals remains inaccessible, according to a shocking new study that audited over 300 clinical trials backing anti-cancer medicines approved by the US drug regulator over the last 10 years.
Of the 304 industry-sponsored clinical trials that provided data for 115 anti-cancer drugs approved by the US Food and Drug Administration (FDA) between 2011 and 2021, only 45 percent had publicly shared patient-level data – or said they would do so when the researchers enquired about accessing data.
What's more, less than one-tenth of trials cited on product labels of three of the top-selling anti-cancer drugs made individual patient data available, the study found.”

About healthcare IT

 Predicting Race And Ethnicity To Ensure Equitable Algorithms For Health Care Decision Making [From Health Affairs, subscription required] “Algorithms are currently used to assist in a wide array of health care decisions. Despite the general utility of these health care algorithms, there is growing recognition that they may lead to unintended racially discriminatory practices, raising concerns about the potential for algorithmic bias. An intuitive precaution against such bias is to remove race and ethnicity information as an input to health care algorithms, mimicking the idea of ‘race-blind’ decisions. However, we argue that this approach is misguided. Knowledge, not ignorance, of race and ethnicity is necessary to combat algorithmic bias….
 We describe two applications in which imputation of race and ethnicity can help mitigate potential algorithmic biases: equitable disease screening algorithms using machine learning and equitable pay-for-performance incentives.”

The Impact of Telemedicine on Physicians’ After-hours Electronic Health Record “Work Outside Work” During the COVID-19 Pandemic: Retrospective Cohort Study “Taking physicians’ clinical load into account, physicians who devoted a higher proportion of their clinical time to telemedicine throughout various stages of the pandemic engaged in higher levels of EHR-based after-hours work compared to those who used telemedicine less intensively. This suggests that telemedicine, as currently delivered, may be less efficient than in-person–based care and may increase the after-hours work burden of physicians.” 

About health technology

Pathogenic variants damage cell composition and single cell transcription in cardiomyopathies “The cellular and molecular architectures that induce heart failure are both shared and distinct across genotypes. These data provide candidate therapeutic targets for future research and interventional opportunities to improve and personalize treatments for cardiomyopathies and heart failure.” 

Hydrogel keeps vaccines alive “Most vaccines require constant refrigeration during shipment to remain effective. An international research team led by ETH Zurich has now developed a special hydrogel that vastly improves the shelf life of vaccines, even without refrigeration. The development could save many lives and lower the cost of cold chains.” 

Today's News and Commentary

Senate approves Inflation Reduction Act, clinching long-delayed health and climate bill Some healthcare implications (in addition to climate control measures): “The prescription drug pricing reforms aim to help cut costs for seniors enrolled in Medicare. It caps their out-of-pocket costs at $2,000 annually, while allowing the U.S. government to negotiate the price of a small set of medicines beginning in 2026. The landmark proposal is expected to save elderly Americans money and achieve billions in savings for Washington over the next decade. Pharmaceutical giants, which forcefully opposed the bill, also would be required to pay “rebates” to the federal government if they raise Medicare drug prices beyond the rate of inflation.
But Democrats did not accomplish everything they sought. An attempt to lower and cap the price of insulin, for example, faltered after Republicans on Sunday stripped it from the bill. Their opposition appeared to doom the plan for the remainder of the year, because a bipartisan attempt to reduce the cost of the lifesaving diabetes drug previously failed to secure GOP support…
The bill also includes $64 billion to stave off health insurance premium increases for about 13 million Americans who buy coverage through state and federal exchanges under the Affordable Care Act. These beneficiaries currently receive discounted coverage under a coronavirus-era program set to expire this year, threatening them with premium increases into hundreds of dollars next month.”

About Covid-19

 COVID DATA TRACKER WEEKLY REVIEW  “As of August 3, 2022, the current 7-day moving average of daily new cases (117,351) decreased 7.3% compared with the previous 7-day moving average (126,537). A total of 91,676,264 COVID-19 cases have been reported in the United States as of August 3, 2022.”
And globally:  COVID cases drop 9% globally last week, deaths stable

BioNTech expects Omicron-adapted vaccine deliveries as soon as October”BioNTech expects to begin deliveries of two Omicron-adapted vaccines as soon as October, which will help spur demand in the fourth quarter, the German biotech firm said on Monday as it reaffirmed its vaccine-revenue forecast for the year.
Demand for the vaccine, 3.6 billion doses of which have been shipped globally, is waning as most people in the Western world have received three or four shots already.”
In a related story: With COVID vaccine demand in free fall, BioNTech's revenue plummets nearly 50% in second quarter “After four consecutive quarters in which revenue topped 5 billion euros ($5.1 billion)—nearly all of it attributed to sales of its Pfizer-partnered COVID-19 vaccine—BioNTech is coming to grips with a decline in demand for the shot, known commercially as Comirnaty.
And the fall is coming quicker than expected. On Monday, the German company reported revenue of 3.2 billion euros ($3.3 billion) for the second quarter. It was a 40% decline from the same period last year and nearly a 50% drop from the company's first quarter revenue figure of 6.4 billion euros.”

Post–COVID-19 Symptoms and Conditions Among Children and Adolescents — United States, March 1, 2020–January 31, 2022 “Compared with patients aged 0–17 years without previous COVID-19, those with previous COVID-19 had higher rates of acute pulmonary embolism (adjusted hazard ratio = 2.01), myocarditis and cardiomyopathy (1.99), venous thromboembolic event (1.87), acute and unspecified renal failure (1.32), and type 1 diabetes (1.23), all of which were rare or uncommon in this study population.”

About health insurance

 CVS Plans to Bid for Signify Health “CVS Health Corp. is seeking to buy Signify Health Inc., according to people familiar with the matter, as the drugstore and insurance giant looks to expand in home-health services.
Signify Health is exploring strategic alternatives including a sale, The Wall Street Journal reported this past week. Initial bids are due this coming week and CVS is planning to enter one, some of the people said. Others also are in the mix, they said, and CVS could face competition from other managed-care providers and private-equity firms.
There is no guarantee any of them will reach a deal for Signify, which has a market value of around $4.7 billion after its shares rose on the news of a potential sale.”

Analysis of Recent National Trends in Medicaid and CHIP Enrollment “After declines in enrollment from 2017 through 2019, preliminary data for April 2022 show that total Medicaid/CHIP enrollment grew to 88.3 million, an increase of 17.0 million from enrollment in February 2020 (23.9%), right before the pandemic and when enrollment began to steadily increase (Figure 1).1Increases in enrollment may reflect changes in the economy, changes in policy (like recent adoption of the Medicaid expansion in the Affordable Care Act), and the temporary continuous enrollment requirement created by the Families First Coronavirus Response Act (FFCRA).”
The article has great graphics displaying trends.

About pharma

The most significant FDA citations of 2021-2022 FYI

How 6 drugmakers fared in Q2 FYI

Jury finds MN pharmacist did not discriminate in denying emergency contraception “An Aitkin County jury on Friday found that a central Minnesota pharmacist did not discriminate when he refused to provide emergency contraceptives to a woman in 2019.
Andrea Anderson of McGregor Minn., sought to fill her prescription for Ella, which is used to stop a pregnancy before it starts, after a condom broke during intercourse. 
She had the prescription sent to a nearby Thrifty White pharmacy, but when she called to confirm, pharmacist George Badeaux told her he would not fill it due to ‘personal reasons.’
According to the lawsuit, he said a colleague might be willing to fill it, but with a snowstorm imminent that person may not make it into work. Anderson got the prescription filled in Brainerd, but it required a 100-mile drive round trip in a snowstorm that allegedly took Anderson more than three hours.”

About the public’s health

 Over half of known human pathogenic diseases can be aggravated by climate change “It is relatively well accepted that climate change can affect human pathogenic diseases; however, the full extent of this risk remains poorly quantified. Here we carried out a systematic search for empirical examples about the impacts of ten climatic hazards sensitive to greenhouse gas (GHG) emissions on each known human pathogenic disease. We found that 58% (that is, 218 out of 375) of infectious diseases confronted by humanity worldwide have been at some point aggravated by climatic hazards; 16% were at times diminished. Empirical cases revealed 1,006 unique pathways in which climatic hazards, via different transmission types, led to pathogenic diseases. The human pathogenic diseases and transmission pathways aggravated by climatic hazards are too numerous for comprehensive societal adaptations, highlighting the urgent need to work at the source of the problem: reducing GHG emissions.” 

Abortion law in Indiana leads to fallout for state, politics “Indiana’s new sweeping ban on abortion produced immediate political and economic fallout Saturday, as some of the state’s biggest employers objected to the restrictions, Democratic leaders strategized ways to amend or repeal the law, and abortion rights activists made plans to arrange alternative locations for women seeking procedures.”