Today's News and Commentary

About Covid-19

 Biden signs bill ending national COVID-19 emergency “President Biden on Monday signed a GOP-led resolution bringing an end to the national emergency over the COVID-19 pandemic, the White House said.
The resolution passed the House despite almost 200 House Democrats voting against it after the White House said it strongly opposed the measure, though it did not threaten to veto it if the bill passed.”
As a reminder of the impact of repeal of the Public Health Emergency, see: The Impact of the COVID-19 Public Health Emergency Expiration on All Types of Health Coverage

About health insurance/insurers

 CMS pitches inpatient payment rule for 2024: 10 things to know A good summary of the rule. These measures are still awaiting results from the comment period.

Consistency of Physician Data Across Health Insurer Directories “In examining directory entries for more than 40% of US physicians, inconsistencies were found in 81% of entries across 5 large national health insurers. These results were driven by inconsistencies in addresses among physicians listed as practicing at multiple locations, which is concordant with prior research suggesting that most address errors stem from group practices reporting all physicians at all practice locations to insurers, irrespective of each individual physician’s practice locations.”

Reconciliation Payments in the Bundled Payments for Care Improvement [BPCI] Advanced Program and Reductions in Clinical Spending Needed for CMS to Avoid Financial Losses “This study examined the magnitude of reconciliation payments and clinical spending reductions necessary for CMS to break even in the first 4 performance periods of the BPCI-A…
This study found that reconciliation payments paid to hospitals and physician groups in the BPCI-A program were large and would require substantial clinical spending reductions for CMS to break even. Such reductions in clinical spending—ranging from 3.7% to 8.2%—are much higher than the 0.53% reductions observed in the first 2 performance periods of the BPCI-A and are generally higher than the 3.8% reductions observed in evaluations of bundled payments for joint replacement. Reconciliation payments were too high because target prices were miscalibrated and too easily achieved. [Emphasis added] Reconciliation payments may have been relatively higher in performance period 3 due to decreases in utilization of postacute care during the COVID-19 pandemic.”

About hospitals and healthcare systems

 FYI:
25 hospitals where charity care exceeds tax breaks 
25 hospitals where charity care falls behind tax breaks 

About pharma

 DOJ to appeal major abortion pill ruling, and HHS won't ignore it after pleas from Democrats  “The Biden administration will appeal a landmark ruling that suspends Food and Drug Administration approval of the abortion drug mifepristone, but it will not heed calls to ignore the ruling entirely. 
The Justice Department’s decision Monday comes after a Texas judge threw approval of the more than 20-year-old drug into doubt on Friday. A conflicting ruling issued later that night from a judge in Washington sought to preserve the drug’s approval for more than a dozen blue states.”

About the public’s health

Electronic cigarette menthol flavoring is associated with increased inhaled micro and sub-micron particles and worse lung function in combustion cigarette smokers “Our results reveal an association between enhanced inhaled particle due to menthol addition to ECs and worse lung function indices. Detailed causal relation remains to be demonstrated in future large-scale prospective clinical studies.” 

About healthcare IT

CommonSpirit Health revealed that cybersecurity breach was much larger than initially thought, reaching 100 facilities in 13 states “More than half a year after CommonSpirit Health revealed that it has been the target of a ransomware attack from September 16 to October 3, 2022, the health system informed the public that the attack was larger than initially announced. 
Over 100 current and former CommonSpirit facilities located in 13 states may have been touched by the attack, the Catholic system said last week. The statement is a notable expansion from the facilities located in Washington state, Tennessee and Nebraska that were initially believed to be victims of the attack.”

Today's News and Commentary

About Covid-19

 CDC: Omicron Subvariant XBB.1.5 Responsible for 88% of New COVID-19 Infections “XBB.1.5 was responsible for 88% of new infections this week, according to CDC estimates. The subvariant plateaued in recent weeks and declined 1 percentage point from the previous week.
Another omicron subvariant, XBB.1.9.1, has started to show slight growth, increasing from 4% of cases last week to 5% this week as coronavirus infections and hospitalizations continue to decline in the U.S.”
Comment: According to the CDC: “the bivalent COVID-19 vaccine provides added protection against symptomatic infection with Omicron XBB/XBB.1.5-related variants in people who had previously received 2–4 doses of the monovalent COVID-19 vaccine.”

White House launching $5 billion program to speed coronavirus vaccines “‘Project Next Gen’ — the long-anticipated follow-up to ‘Operation Warp Speed,’ the Trump-era program that sped coronavirus vaccines to patients in 2020 — would take a similar approach to partnering with private sector companies to expedite development of vaccines and therapies. Scientists, public heath experts and politicians have called for the initiative, warning that existing therapies have steadily lost their effectiveness and new ones are needed.”

About health insurance/insurers

Extended Medicare Advantage VBID Model Will Address SDOH, Health Equity “CMS has extended the Medicare Advantage value-based insurance design (VBID) model for an additional five years, with plans to implement changes that address beneficiaries’ social determinants of health, improve care coordination, and advance health equity.
Within the Medicare Advantage program, plans can use the VBID model to structure cost-sharing and other benefit designs to encourage beneficiaries to seek high-value healthcare services. The model tests various Medicare Advantage service delivery and payment approaches that aim to lower costs and improve care quality for beneficiaries.
The model also includes a Hospice Benefit Component to help patients requiring end-of-life care transition to hospice care if they choose that option.”

AHIP Report: Understanding the Value and Benefit of Medicare Supplement Coverage for 14.5 Million Americans “Key takeaways from the report included:

• The percentage of original Medicare enrollees purchasing Medicare Supplement coverage grew from 35% to 41% between December 2017 and December 2021.

• More than half (54%) of all original Medicare enrollees without any additional coverage chose a Medicare Supplement plan in 2020.

• Medicare enrollees with Medicare Supplement coverage were 3 times less likely to have problems paying medical bills compared to enrollees without Medicare Supplement policies. Only 3% of enrollees with Medicare Supplement coverage reported having difficulty paying medical bills in the last 12 months, compared to 8% of original Medicare enrollees without Medicare Supplement coverage.

• A majority of Medicare Supplement (57%) are women, while 42% are 75 years old or older.”

• A significant percentage of Medicare Supplement enrollees are people with lower incomes. For example, 11% have annual household incomes below $20,000, and 24% have incomes below $30,000.

About hospitals and healthcare systems

 Hospitals Face ‘Make-or-Break Year’ After Bleak 2022, Fitch Says “Last year is shaping up to be the worst year ever for the finances of US nonprofit hospitals — and 2023 isn’t looking much better, according to Fitch Ratings. 
’2023 is going to be the make-or-break year’ for stemming financial declines, senior director Kevin Holloran said during a presentation Wednesday on the challenges facing nonprofit hospitals.
Those trials include labor costs and shortages, inflation, a higher cost of capital, investment losses and the end of billions in federal pandemic funds. While the need for expensive traveling nurses has declined, basic wages have jumped.”

About pharma

 Pfizer escapes proposed class action lawsuit over patient copay assistance “Two months after taking a loss in a U.S. Supreme Court appeal, which preventsPfizer from implementing a cost-sharing assistance program for its heart disease drugs Vyndaqel and Vyndamax, the company has gotten a win in a parallel case in a different court in Washington, D.C.
In U.S. District Court, Pfizer has prevailed over five collection companies which sought to bring a potential class action lawsuit alleging that Pfizer illegally induced patients to a select group of drugs.  
The five plaintiffs—including MSP Recovery Claims, Series LLC—are companies that seek to recover overpayments on behalf of private insurers that administer Medicare and Medicaid programs. The plaintiffs alleged that they were damaged by a “conspiratorial scheme to increase the unit price” of several drugs from 2012 to 2016.
Pfizer did it, the companies alleged, by donating to the Patient Access Network Foundation and Advanced Care Scripts to help cover the cost of patients’ co-pays. This in turn induced patients to use Pfizer drugs when less expensive alternatives were available, according to the complaint.”

Gavin Newsom wanted California to cut ties with Walgreens. Then federal law got in the way. “Gov. Gavin Newsom declared last month that California was “done” doing business with Walgreens after the pharmacy chain said it would not distribute an abortion pill in 21 states where Republicans threatened legal action. Since then, KHN has learned that the Democratic governor must compromise on his hard-line tweet.
California is legally bound to continue doing business with Walgreens through the state’s massive Medicaid program, health law experts said…
Newsom’s administration confirmed it will ‘continue to comply’ with federal law by paying Walgreens through Medi-Cal, which provides health coverage to roughly 15 million residents with low incomes and disabilities.”

About the public’s health

 EPA seeks to restrict a toxic sterilizer, despite industry red flags “Acting in response to community health experts and environmental justice advocates, the Environmental Protection Agency is proposing tougher standards on several toxic chemicals, including ethylene oxide, widely used for sterilizing medical equipment and other purposes.” 

Sex Matters: Uncovering the Brain’s Role in Obesity for Men and Women “A UCLA study published in Brain Communications has identified sex-specific brain signals that influence obesity development in men and women. By combining MRI data with clinical features and personal histories, researchers found differences in several brain networks associated with early life adversity, mental health quality, and sensory stimulation experiences. The study showed that women’s obesity tends to be linked to emotion-related and compulsive eating, while men’s eating behavior is more affected by gut sensations and visceral responses. The findings may help in developing more targeted obesity interventions based on an individual’s sex and improve understanding of obesity-related drives and behaviors.”

Low vaccination rates lead to global surge in vaccine-derived polio “Key takeaways:
—There was a 694% increase in paralytic cases of type 1 circulating vaccine-derived polio from 2021 to 2022.
—The new oral vaccine for type 2 poliovirus resulted in a 46% decrease in paralytic cases from that type.
—Lower vaccination rates led to a global surge in cases of one type of vaccine-derived polio last year”

About healthcare IT

Video Telemedicine Experiences In COVID-19 Were Positive, But Physicians And Patients Prefer In-Person Care For The Future “To help inform policy discussions about postpandemic telemedicine reimbursement and regulations, we conducted dual nationally representative surveys among primary care physicians and patients. Although majorities of both populations reported satisfaction with video visits during the pandemic, 80 percent of physicians would prefer to provide only a small share of care or no care via telemedicine in the future, and only 36 percent of patients would prefer to seek care by video or phone. Most physicians (60 percent) felt that the quality of video telemedicine care was generally inferior to the quality of in-person care, and both patients and physicians cited the lack of physical exam as a key reason (90 percent and 92 percent, respectively).” 

Microsoft receives court order to disrupt infrastructure from ransomware groups targeting hospitals “Software giant Microsoft received a court order from the U.S. District Court for the Eastern District of New York that will allow the company to disrupt infrastructure used by ransomware gangs during hospital attacks.
The court order allows Microsoft to cut off communication between hackers and a fake version of the cybersecurity software Cobalt Strike, used by hackers to breach hospital systems.”

Today's News and Commentary

About health insurance/insurers

 Medicare Advantage (MA) Competitive Enrollment Dashboard  Choose your state and the map will display MA penetration data.

About pharma

 Cuban's pharmacy picks up J&J brand-name drugs “After breaking into the brand-name market in March — over a year since launching its online wholesaler company — Cost Plus Drugs offers three brand-name products made by Janssen, a Johnson & Johnson business. Cost Plus Drugs sells about 1,000 generics and four brand-name drugs. 
The three products are Invokana (canagliflozin), Invokamet (canagliflozin-metformin HCl) and Invokamet XR (canagliflozin-metformin HCl), according to a Cost Plus Drugs tweet.”

FDA to require mail-back envelopes for unused opioids “Drugmakers will soon have to provide patients with postage-paid envelopes to send back unused opioids for safe disposal under a new requirement announced by the US Food and Drug Administration (FDA) as part of its Opioids Analgesic Risk Evaluation and Mitigations Strategy (REMS) program. This plan is scheduled to take effect next year.”
 
About healthcare quality and safety

Reports of serious adverse events rose in 2022: Joint Commission “Here are a few takeaways:
—The total number of reported sentinel events increased by 19% in 2022 compared with 2021, and by 78% compared with 2020. Most events were voluntarily self-reported to the Joint Commission by accredited or certified healthcare entities.
—Of the reported sentinel events, 20% were associated with patient death, 44% with severe temporary harm and 13% with unexpected additional treatments or procedures.
—The number of reported events involving falls rose from 173 in 2020 to 611 in 2022. Last year, 40% were due to patients walking, 23% involved patients falling out of bed and 10% happened while patients used the restroom.
—The Joint Commission cited a lack of fall-risk assessments and inadequate communication between staff during care transitions as root causes for the increased number of falls.
—In the delayed treatment category, 46% of events were related to a delay in care, 38% to a missed diagnosis, 14% to an abnormal test result not being addressed and 2% to an incorrect diagnosis.
—Among the sentinel events related to treatment delays, 66% resulted in death, 17% in severe harm and 14% in permanent harm.
—Nearly 90% of reported sentinel events in 2022 occurred in hospital settings.
—In the home care setting, 43% of reported serious adverse events involved fires related to medical equipment.
—The top sentinel event in ambulatory care settings was wrong-site surgeries at 25% of reported events.”
Comment: These reports answer “What” but not “Why.”

 About health technology

 FDA Clears Bot Image’s AI Software for Prostate Cancer Screening “The FDA has granted clearance to Bot Image’s ProstatID AI software for analysis of non-contrast ‘short form’ magnetic resonance imaging (MRI) scans to screen for prostate cancer.
The AI software eliminates the use of MRI contrast dye that uses gadolinium, a known toxic metal, that can potentially build up in the brain and kidneys with possible side effects.
Eliminating the contrast dye from prostate cancer MRIs enables more frequent, low-cost scans for active surveillance, the company said.
Clinical studies showed that the ProstatID algorithm has an accuracy of 93.6 percent for detection of prostate cancer.”

Today's News and Commentary

About Covid-19

 FDA to okay second omicron-targeting booster for some, officials say “Federal regulators have decided to authorize a second omicron-specific coronavirus vaccine booster shot for people who are at least 65 or have weak immune systems — an effort to provide additional protection to high-risk individuals, according to several officials familiar with the plan.
The Food and Drug Administration is expected to announce the step in the next few weeks, and the Centers for Disease Control and Prevention is expected to move quickly to endorse it, said the officials, who spoke on the condition of anonymity because they were not authorized to publicly discuss internal discussions.”

Coronavirus variant XBB.1.16 spotted in 18 US states “The new SARS-CoV-2 omicron variant XBB.1.16 has spurred increased hospitalizations and deaths in some countries. In the U.S., the dominant variant is still XBB.1.5, but health officials say other variants are on the rise.”

About health insurance/insurers

 Changes in Marketplace Premiums and Insurer Participation, 2022-2023 “KEY TAKEAWAYS
We find that premiums increased by 3.4% nationally between 2022 and 2023, following several years of small declines. The increase is largely due to the strong economic growth and inflationary pressures; increases were dampened by the anticipated extension of Inflation Reduction Act premium subsidies and their effect on risk pools.
The wide variation in premiums across states remains and is largely explained by the amount of competition and the presence of Medicaid insurers. For example, areas with large numbers of insurers tended to have lower premiums and areas with more limited competition such as rural areas and small states had higher premiums.
We also found an increase in insurer participation among large commercial insurers who have reentered marketplaces in large numbers. There has also been an increase in participation by provider sponsored insurers.”

About hospitals and healthcare systems

Most hospital websites routinely transfer patient data via tracking tools “Nearly all (98.6%) hospital websites leverage third-party tracking code that routinely transfers patient data to large technology companies, social media giants, advertising firms, and data brokers, in likely violation of federal privacy laws…” 

 Trustee Compensation And Charity Care Provision In US Nonprofit Hospitals “In 2019 more than one-third of US nonprofit hospitals compensated their trustees. These hospitals provided less charity care than nonprofit hospitals that did not compensate their trustees. We found that trustee compensation was negatively associated with hospitals’ charity care provision and that it may affect the self-selection of trustees and their fulfillment of their fiduciary duties.”

States Step In as Telehealth and Clinic Patients Get Blindsided by Hospital Fees “Millions of Americans are … blindsided by hospital bills for doctor appointments that didn’t require setting foot inside a hospital. Hospitals argue that facility fees are needed to pay for staff and overhead expenses, particularly when hospitals don’t employ their own physicians. But consumer advocates say there’s no reason hospitals should charge more than independent clinics for the same services…
At least eight states agree such charges are questionable. They have implemented limits on facility fees or are moving to clamp down on the charges. Among them are Connecticut, which already limits facility fees, and Colorado, where lawmakers are considering a similar measure. Together, the initiatives could signal a wave of restrictions similar to the movement that led to a federal law to ban surprise bills, which took effect last year…
Research suggests that when hospitals acquire physician practices and hire those doctors, the physicians’ professional fees go up and, with the addition of facility fees, the total cost of care to the patient increases, as well.”
Comment: As I have written before, these fees need to be eliminated.

About pharma

 J&J opens its wallet with whopping $8.9B talc settlement offer “The drugmaker on Tuesday said it’s offering $8.9 billion over 25 years to resolve all lawsuits claiming that the company’s talc-containing baby powders caused cancer. The deal proposal comes after years of litigation and a high profile, $2 billion verdict which J&J unsuccessfully appealed all the way to the Supreme Court.”

About the public’s health

 Social Security trust funds depletion date moves one year earlier to 2034, Treasury says “KEY POINTS

• Social Security’s combined funds that pay retirement, disability and family benefits will be able to pay scheduled benefits until 2034, according to the program’s annual trustees report released on Friday.

• At that time, the program will be able to pay 80% of scheduled benefits.

• The new projection date is one year earlier than the forecast from last year, prompting retirement advocates to call on Congress to fix both Social Security and Medicare.”

White House rolls out new cancer initiative to help implement ‘Moonshot’ “Federal health officials on Monday outlined a new framework aimed at helping to implement the White House ‘Cancer Moonshot’ initiative.
One of the main goals of the Moonshot initiative is to reduce cancer mortality by at least 50 percent over the next 25 years. To accomplish that, the new National Cancer Plan includes eight distinct goals to prevent cancer, reduce mortality and maximize quality of life for people living with it. 
The recommendations in the plan are written as broad aspirational statements and include pursuing new vaccines to prevent cancers, eliminating tobacco exposure and maximizing equitable access to proven treatments.”

EU recommendations for 2023-2024 seasonal flu vaccine composition A reminder of how early the composition is set.

About healthcare personnel

 More state lawmakers push to end 'exorbitant' contract labor prices “A growing number of state legislators want to prevent staffing agencies from gouging health systems that use temporary workers.”
So far, eleven states have introduced such legislation.

Today's News and Commentary

Happy National Public Health Week

About health insurance/insurers

Medicare Trustees: Hospital insurance fund will run out in 2031 “According to the Trustees of the Social Security and Medicare trust funds' new report published March 31, the hospital insurance fund is not adequately financed over the next 10 years, with income anticipated to be higher than last year's estimates as the number of covered workers and average wages are both expected to be higher. 
Once the fund is depleted in 2031, the program's income will only be able to provide 89 percent of scheduled benefits to Medicare enrollees.”

DOJ appeals decision to strike down free preventive health services under Obamacare As expected…
And in a related story: Despite court ruling, insurers say they will continue to offer ACA-mandated free preventive services

Differences In Use Of Services And Quality Of Care In Medicare Advantage And Traditional Medicare, 2010 And 2017 “We compared quality and utilization measures in Medicare Advantage and traditional Medicare in 2010 and 2017. Clinical quality performance was higher in MA health maintenance organizations (HMOs) and preferred provider organizations (PPOs) than in traditional Medicare for almost all measures in both years. MA HMOs outperformed traditional Medicare on all measures in 2017. MA HMOs’ performance on nearly all seven patient-reported quality measures improved, and MA HMOs outperformed traditional Medicare on five of those measures in 2017. MA PPOs performed the same as or better than traditional Medicare on all but one patient-reported quality measure in 2010 and 2017. The number of emergency department visits was 30 percent lower, the number of elective hip and knee replacements was approximately 10 percent lower, and the number of back surgeries was almost 30 percent lower in MA HMOs than in traditional Medicare in 2017. Utilization trends were similar in MA PPOs, but differences from traditional Medicare were narrower. Despite increased enrollment, overall utilization remains lower in Medicare Advantage than in traditional Medicare, whereas quality performance is the same or higher.” Emphasis added.

About hospitals and healthcare systems

The Relationships Among Cash Prices, Negotiated Rates, And Chargemaster Prices For Shoppable Hospital Services “Examining prices reported by 2,379 hospitals as of September 9, 2022, we found that a given hospital’s cash prices and commercial negotiated rates both tended to reflect a predetermined and consistent percentage discount from its chargemaster prices. On average, cash prices and commercial negotiated rates were 64 percent and 58 percent of the corresponding chargemaster prices for the same procedures at the same hospital and in the same service setting, respectively. Cash prices were lower than the median commercial negotiated rates in 47 percent of instances, and most likely so at hospitals with government or nonprofit ownership, located outside of metropolitan areas, or located in counties with relatively high uninsurance rates or low median household incomes. Hospitals with stronger market power were most likely to offer cash prices below their median negotiated rates, whereas hospitals in areas where insurers had stronger market power were less likely to do so.” 

About pharma

 After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits “Friday, J&J took another courtroom defeat as the U.S. Court of Appeals for the 3rd Circuit rejected its bid to delay an order dismissing the bankruptcy. The company had hoped for a stay, pending an appeal with the Supreme Court. The decision allows more than 38,000 cases pending against J&J to proceed in court.”

About the public’s health

Association Between Daily Alcohol Intake and Risk of All-Cause MortalityA Systematic Review and Meta-analyses “ This systematic review and meta-analysis of 107 cohort studies involving more than 4.8 million participants found no significant reductions in risk of all-cause mortality for drinkers who drank less than 25 g of ethanol per day (about 2 Canadian standard drinks compared with lifetime nondrinkers) after adjustment for key study characteristics such as median age and sex of study cohorts. There was a significantly increased risk of all-cause mortality among female drinkers who drank 25 or more grams per day and among male drinkers who drank 45 or more grams per day.”

About healthcare IT

AI Chatbots Can Diagnose Medical Conditions at Home. How Good Are They? A good discussion of the topic in Scientific American. This article is part of an ongoing series on generative AI in medicine.
And in a related article:
Epic to use Microsoft's GPT-4 in EHRs “Epic said it will use Microsoft's generative AI-based technoology GPT-4 in its EHRs. 
Seth Hain, senior vice president of research and development at Epic said the company see's promise in the new AI-based application and dubbed it as ‘transformational’ for the healthcare industry.”

 GAO Says $661M In IT Buys For VA Skipped Officer Approval “The U. S. Government Accountability Office reported that the U. S. Department of Veterans Affairs procured about $661. 4 million in information technology in a roughly three-year period without chief information officer approval, saying the full view of the department's IT investments had been obscured. . . .”

About health technology

FTC reverses course, orders Illumina to unravel Grail deal “The Federal Trade Commission is reversing a decision from last fall where Illumina had won a small legal battle to keep its hold on the cancer blood test developer Grail.
Now, the DNA sequencing giant has six months to completely divest its holdings in the company. The $8 billion acquisition deal closed in August 2021 before receiving a final sign-off from regulators. Illumina has maintained that it has kept Grail’s operations at an arms’ length.”

DaVita, Medtronic raise the curtain on tech company, Mozarc Medical, aiming to bring innovation to kidney care “​DaVita and medical device company Medtronic launched their new venture, Mozarc Medical, to develop new kidney care technologies with a specific focus on at-home treatments.
Announced nearly a year ago, the company is co-owned by Medtronic and DaVita, each with equal equity stakes.”

Today's News and Commentary

About Covid-19

 End of a Declared Public Health Emergency — Implications for U.S. Emergency Use Authorizations “Despite the planned ending of the Covid-19 public health emergency in the United States, medical products approved under emergency use authorizations will remain available for the foreseeable future.” 

About health insurance/insurers

CMS to raise Medicare Advantage pay rates by 3.3% in 2024; phase in risk adjustment changes “The Biden administration finalized a proposal to raise Medicare Advantage payments by 3.32% in 2024, slightly above the 1% raise that it proposed. 
The final payment rule released Friday comes after an intense lobbying campaign from insurers who claimed that the original advance notice released in February would amount to a cut to plans. The agency also finalized changes to the MA risk adjustment model, but will instead phase the changes in over three years as opposed to implementation next year…
CMS will still transition the coding system from Internal Classification of Diseases (ICD)-9 to ICD-10 more commonly used by physicians.”

Medicaid redeterminations begin April 1 “After more than three years, the nation's continuous Medicaid enrollment policy has come to an end, setting off a pivotal redetermination period that will present unprecedented challenges for payers, health systems, and state Medicaid agencies alike.
The redetermination process threatens the nation's record low uninsured rate of 8 percent, with the most recent studies estimating that up to 18 million people could lose Medicaid coverage over the next 12 to 14 months, including more than 6 million children — 3.8 million people are estimated to remain uninsured entirely. Not only are commercial payers facing a loss of members through their managed care programs, hospitals could encounter millions of newly uninsured patients.”

CVS-Oak Street deal clears federal regulatory hurdle “The Justice Department and Federal Trade Commission allowed the antitrust waiting period to lapse on Monday without taking action to prevent the two companies from combining, Chicago-based primary care provider Oak Street reported in a filing to the Securities and Exchange Commission Thursday. That doesn't prevent those regulators from taking action at a later time, but it does clear the way for the deal to advance.”

Changes in Medicare Accountable Care Organization Spending, Utilization, and Quality Performance 2 Years Into the COVID-19 Pandemic “In Medicare’s largest ACO program, non–COVID-19 health care spending per capita in 2021 recovered to the pre–COVID-19 baseline after a steep decline in 2020 but with a relative shift from acute inpatient to outpatient spending. The $1.7 billion in net savings to Medicare compared with MSSP [Medicare Shared Savings Program] cost targets seem to come from sustained reductions in inpatient, postacute facility, and ED utilization into year 2 of the COVID-19 pandemic. Despite a decrease in postacute facility discharges, the lack of statistical reduction in postacute care spending is explained in part by a coinciding increase in hospice spending. Notably, initial concerns about a post–COVID-19 surge in admissions from delayed care have thus far not materialized in the MSSP.
Quality performance decreased in 2021 vs 2019, reflecting a reduction in patient experience scores (reintroduced for 2021 after a 2020 suspension due to the COVID-19 pandemic). Notable declines occurred in scores for timely care, specialist access, and shared decision-making, which may reflect system challenges with managing the rebound in outpatient utilization amid workforce shortages and fatigued clinicians. Nevertheless, 99% of ACOs met the quality threshold for shared savings eligibility.”

About pharma

Vanda Prevails in Jet Lag Litigation Against the FDA “On March 27, 2023 a federal court granted final judgment in favor of Vanda in its Freedom of Information Act ("FOIA") case requesting records created by the Food and Drug Administration ("FDA") during its review of Vanda's application seeking approval of a new use for its drug, Hetlioz® (tasimelteon)…
Vanda had repeatedly attempted to obtain these records from the FDA pursuant to a FOIA request it submitted in December 2019, but the FDA had refused to disclose those records, invoking the deliberative process exemption under FOIA.
The court rejected the FDA's claim that it would suffer ‘foreseeable harm’ if it disclosed to Vanda its reviews relating to Vanda's sNDA. In particular, the court held that in the context of this case, contrary to the FDA's assertion, ‘[d]isclosure cannot chill’ the ‘deliberations’ of agency staff.”
Comment: The specifics of the care are far less important than the precedent it sets for release of such records.

About the public’s health

 MPP Inks Licensing Pacts With Three Generic Drugmakers Over HIV PrEP Drug “The Medicines Patent Pool (MPP) has signed licensing agreements with Aurobindo, Cipla and Viatris to manufacture generic versions of cabotegravir, ViiV Healthcare’s long-acting drug for HIV pre-exposure prophylaxis (PrEP).
MPP is a United Nations initiative aimed at facilitating the development of life-saving medicines for low- and middle-income countries through voluntary licensing and patent pooling.”

About healthcare IT

 FDA Says New Applications for Cyber Devices Need a Security Plan “Starting March 29, new applications to the FDA for a ‘cyber device’ must identify any vulnerabilities and include a plan for ongoing security throughout the device’s life, the FDA said in a final guidance released yesterday.
’Cyber device’ means a device that includes software, can connect to the internet and has any technology that could be vulnerable to cybersecurity threats.”

About healthcare personnel

Association of Clinician Practice Ownership With Ability of Primary Care Practices to Improve Quality Without Increasing Burnout “In this cross-sectional study, clinician-owned practices were more likely to achieve improvements in cardiovascular quality outcomes without increasing staff member burnout than were practices owned by a hospital or health system. Given increasing health care consolidation, our findings suggest the value of studying cultural features of clinician-owned practices that may be associated with positive quality and experience outcomes.” 

Today's News and Commentary

Happy National Doctors' Day!

About Covid-19

 COVID-19 national emergency could end sooner than May “The Senate passed a resolution March 29 that would expedite the end of the COVID-19 national emergency from its planned May 11 deadline to immediately upon the signature of the president, and President Joe Biden has reportedly indicated he will sign it.”
Comment: It is not clear how this measure will move up action that affects Covid-19-specific laws.

About health insurance/insurers

 Obamacare coverage mandate blocked for preventative care for HIV, cancer, diabetes and depression “A federal judge in Texas on Thursday blocked Obamacare's mandate that health insurance plans cover preventive care, including pre-exposure prophylaxis against HIV (PrEP) and screenings for cancer, diabetes and depression at no cost to patients.
U.S. District Judge Reed O'Connor in Fort Worth, Texas, previously found that the PrEP mandate violated a federal religious freedom law and that other preventive care mandates were based on recommendations by an illegally appointed task force.
The judge has now blocked the federal government from enforcing the mandates, a victory for conservative businesses and individuals that sued to challenge them in 2020.”
Comment: This ruling was a foregone decision, given the Texas venue. It will undoubtedly be appealed to the Supreme Court.

About hospitals and healthcare systems

Select Financial, Operating and Patient Characteristics of Physician Owned Hospitals Compared to Non-Physician Owned Hospitals Congress is considering lifting the near-total ban on physician-owned hospitals. The American Hospital Association (AHA) and the Federation of American Hospitals (FAH) are obviously opposing this action. These organizations hired a firm to do a comparison between physician-owned and non-physician-owned hospitals. The charts provide a quick comparison. In interpreting the data, bear in mind that the number of the former are about 5% of the latter and that many are specialty hospitals that only deal with one “organ system,” usually cardiovascular or orthopedic. 

About pharma

 Clinical trial diversity craters out to lowest level in 10 years, IQVIA finds “despite recent efforts from the FDA, Big Pharmas, biotechs and sponsors alike, U.S. clinical trial diversity dropped to its lowest level of the decade, according to IQVIA’s report ‘Global Trends in R&D 2023.’”

States are moving to cap insulin prices A good summary of states’ actions to limit insulin costs. Also discussed are insulin-related supplies, like syringes and alcohol wipes. The article also delivers an important caveat: “State-level insulin caps can only apply to state-regulated plans, such as health plans for state employees, fully insured plans usually offered by smaller employers and some insurance policies sold on the Affordable Care Act marketplaces. They generally leave out people with self-insured employer coverage (typically offered by big companies) as well as the uninsured. Medicaid beneficiaries aren’t usually affected either, because they already pay little to nothing for their insulin.”

About the public’s health

Unravelling the commercial determinants of health This editorial from the Lancet presents an overview of a series of special articles on the commercial determinants of health. “The headline findings are startling: four industries (tobacco, unhealthy food, fossil fuel, and alcohol) are responsible for at least a third of global deaths per year. Yet much of the work to understand the harmful (or beneficial) impact of commercial actors has to date been done in health research silos. Each field faces many of the same tactical battles and strategies without a unified agenda to protect health. There is a lack of consensus across fields of health to define and understand the commercial determinants of health. The Lancet Series seeks to remedy this long-standing and complex situation with a consensus definition of the commercial determinants of health (“systems, practices, and pathways through which commercial actors drive health and equity”), a framing to understand commercial entities' impact on health, and a commitment to address its challenges in a holistic way.”

Evaluation of behavioral economic strategies to raise influenza vaccination rates across a health system: Results from a randomized clinical trial “After adjusting for age, gender, insurance, race, ethnicity, and prior influenza vaccination, none of the interventions increased vaccination rates. We conclude that patient portal interventions to remind patients to receive influenza vaccine during the COVID-19 pandemic did not raise influenza immunization rates. More intensive or tailored interventions are needed beyond portal innovations to increase influenza vaccination.”
Comment: Individualized messaging, like texts and phone calls, works to increase receipt flu shots.

Trends in the Prevalence of Lean Diabetes Among U.S. Adults, 2015–2020 “Diabetes increased significantly among lean adults with BMI of <25 kg/m2 from 4.5% (95% CI 4.3–4.7) in 2015 to 5.3% (95% CI 5.0–5.7) in 2020, representing a 17.8% increase (odds ratio 1.21; 95% CI 1.12–1.31), with no significant change among overweight/obese adults. Increases in diabetes prevalence among lean adults varied by subgroup with Black, Hispanic, and female populations seeing the largest growth.”
Comment: This data means we need to look more closely at the quality of diets and genetics in these populations.

 Child and Teen Firearm Mortality in the U.S. and Peer Countries “Firearms recently became the number one cause of death for children and teens in the United States, surpassing motor vehicle deaths and those caused by other injuries…
We find that the United States is alone among peer nations in the number of child and teen firearm deaths. In no other similarly large or wealthy country are firearm deaths in the top 4 causes of mortality let alone the number 1 cause of death among children and teens.”
Comment: Do children have the right to life after they are born? How many must die before prudent and enforceable firearm laws are enacted?

About health technology

 Scientists find 'ultracool' tiny needle that could someday deliver gene editing therapies “Gene editing has been limited to a few sites in the body because of restrictive delivery mechanisms. Scientists have now discovered a tiny needle that a bacterium uses to kill insect cells that could someday widen the world of gene editing therapeutics. 
Researchers from the Broad Institute of MIT and Harvard and the McGovern Institute for Brain Research at MIT have found a way to use a natural bacterial system to create a new protein delivery system that could have applications for gene editing therapies such as those based on CRISPR-Cas9 as well as cancer treatments. The scientists…detailed their work in the journal Nature on Wednesday afternoon, describing a system that could be used to deliver a variety of proteins.”

Today's News and Commentary

About Covid-19

 Frequently Asked Questions about COVID-19 Vaccination Updated today. One item of particular interest: “CDC recommends 1 updated booster dose at this time. FDA has not authorized receiving more than 1 updated booster.”

About health insurance/insurers

 Dreaded Medical Paperwork Required by Health Insurers to Be Trimmed “UnitedHealth Group Inc.’s UnitedHealthcare, the largest health insurer in the U.S., said Wednesday it would cut its use of the prior authorization process. Starting in the third quarter, it will remove many procedures and medical devices from its list of services requiring the signoff.
The insurer also said it would eliminate, starting next year, many prior-authorization requirements for so-called gold-card doctors and hospitals whose requests it nearly always approves. And it aims to automate and speed up prior authorization, though that will likely take a few years…
 Cigna Group, another large insurer, said it was reducing prior authorization, including removing the requirement for about 500 services and devices since 2020…
Meantime, CVS Health Corp.’s Aetna health insurance arm said it was working to automate and simplify prior authorization.”

About pharma

 Amazon Pharmacy integrates coupons in latest bid to target affordability of branded drugs “Amazon rolled out a new feature to automatically apply drug manufacturer-sponsored coupons directly when consumers order brand-name medications through the online pharmacy.
Amazon Pharmacy is working with GSK, Kaléo, Novo Nordisk and Dexcom to integrate coupons for their branded medications—including Trelegy, AUVI-Q, Wegovy and G6/G7 sensors and transmitters, respectively—directly into the checkout experience on its website and app.”

About the public’s health

 Drug overdose antidote Narcan goes over-the-counter “Narcan, the lifesaving nasal spray that reverses opioid overdoses, has been approved for purchase without a prescription, the Food and Drug Administration announced on Wednesday.”

Biden administration warns of $35 billion shortfall for health emergency stockpile “The nation's efforts to develop and stockpile key medicines for guarding against public health threats are underfunded by some $35 billion, the Biden administration warned Congress on Monday, forcing officials to make risky trade-offs that could leave the U.S. unprepared for the next emergency. 
Over the next five years, the Department of Health and Human Services estimates that the U.S. will need $64 billion overall to fund the work of an array of agencies tasked with "medical countermeasures" for threats ranging from COVID-19 to nuclear attacks.”

About health technology

 Global Trends in R&D 2023 “Key findings:

• The past year saw a restoration of pre-pandemic investment flows to life sciences companies in the U.S. after two years of heightened levels during the pandemic.

• The research and development pipeline remained flat in 2022 with ongoing oncology focus and continued share gain in rare, next-generation, Chinese and EBP segments of the pipeline.

• Clinical trial activity was remarkably resilient even as the pandemic stretched through 2022, with a 1% decline in non-COVID trial activity over 2021, but a restoration of pre-pandemic growth rates with an 8% increase over 2019.

• A growing share of new launches in 2022 were first-in-class, reflecting the increasing availability of novel science for patients.

• Clinical development productivity — a composite metric of success rates, clinical trial complexity and trial duration — rebounded in 2022, reversing a 10-year downward trend. Trial complexity returned to the previous trend after an outlier high in 2021, while overall success rates improved slightly.

• As technology and data advances take hold across the pharmaceutical development pipeline, productivity is being impacted by a range of trade-off effects on complexity, timing, and probability of success.”

Today's News and Commentary

About Covid-19

 U.S. court upholds block on Biden's vaccine order for federal workers “A federal appeals court in New Orleans on Thursday upheld a judge's ruling blocking enforcement of President Joe Biden's 2021 executive order requiring all federal employees take a COVID-19 vaccine.” 

About health insurance/insurers

Reducing Medicare Advantage Benchmarks Will Decrease Plan Generosity, But Those Effects Will Likely Be Modest “We assessed the relationships between MA benchmarks and plan generosity and benefits. We estimated that a $1,000 per year decrease in benchmarks would lead to small increases in annual premiums of about $60 and increases in annual deductibles of about $27. Copays would also increase modestly, and the propensity to offer benefits would generally decline by less than 5 percentage points, with the greatest impact being on the availability of dental, hearing, and vision benefits. These results suggest that although cuts to MA benchmarks would adversely affect plan generosity, those effects would be modest.”

 UPMC for You partners to offer Medicaid redetermination coverage in laundromats “Ahead of Medicaid redeterminations on April 1, UPMC's Medicaid managed care plan has announced a partnership with Fabric Health to provide on-site health support and social services access in certain laundromats. 
The initiative with UPMC's Medicaid plan UPMC for You, will provide WiFi access as Fabric Health staff in laundromats help individuals navigate access to preventative and other healthcare coverage, apply for assistance programs, including Medicaid, SNAP and LIHEAP, and connect with other support services, UPMC said. 
With over 32 million Americans using a laundromat each week, these businesses provide opportunities to connect with individuals who may need support, according to Fabric Health, that provides engagement in laundromats.”
Comment: The outreaches to such organizations as churches and barber shops are well-know. However, this program is very creative and, to my knowledge, unique. Are there other commonly used site that could be useful?

CVS set to close $8B deal for health services company Signify Health FYI

How Cigna Saves Millions by Having Its Doctors Reject Claims Without Reading Them An exposé by ProPublica well-worth reading. This essence of the article is: Cigna “has built a system that allows its doctors to instantly reject a claim on medical grounds without opening the patient file, leaving people with unexpected bills, according to corporate documents and interviews with former Cigna officials. Over a period of two months last year, Cigna doctors denied over 300,000 requests for payments using this method, spending an average of 1.2 seconds on each case, the documents show.”

9 in 10 employers plan to change health and wellbeing vendors in next two years, WTW survey finds
“…the survey of 232 U.S. employers found nearly nine in 10 respondents (88%) are planning to make changes to their vendor partnerships either this year or next. Such changes include adding, enhancing or ending various solutions and services, or working with a different vendor in the foreseeable future.”
Comment: More details about types of vendors are in the article. While these these turnover numbers are extraordinarily high, the reasons for these changes are not clear. The article hints a link to ROI, which means companies are not finding these programs cost-effective, or even effective.

TWO OUT OF THREE PATIENTS HAVE NEVER DISPUTED A MEDICAL BILL “Almost two-thirds of respondents (64%) said they have never disputed the accuracy or validity of a bill, which was the case for 78% of uninsured individuals.
While 78% of respondents reported getting charges reduced or removed when they did contest a bill, it sometimes took more than six months for it to be resolved.”
Comment: One reasons patients do not challenge bills is that they do not understand them. Also, with the increased use of EMRs, copy and paste notes often do not accurately reflect the visit—leading to incorrect billing.

About healthcare quality

Consultation With Reduction in Adverse Postoperative Outcomes and Use of Processes of Care Among Residents of Ontario, Canada “In this cohort study, preoperative medical consultation was not associated with a reduction but rather with an increase in adverse postoperative outcomes, suggesting a need for further refinement of target populations, processes, and interventions related to preoperative medical consultation. These findings highlight the need for further research and suggest that referral for preoperative medical consultation and subsequent testing should be carefully guided by individual-level consideration of risks and benefits.”
Comment: As an accompanying editorial states: “Given the potential risks of preoperative evaluation, follow-up testing, procedures, and treatment, as well as its role in delaying needed surgeries, randomized clinical trials are urgently needed to document the risks and benefits of this common process.”

About hospitals and healthcare systems

MARCH 2023 National Hospital Flash Report “Key Takeaways:

1. A new normal continues to emerge.
   Hospital margins in February were down slightly from the previous month. This represents the eighth straight month in which the variation in month-to-month margins has decreased relative to the last three years. Due to external economic factors, relatively flat margins are likely to continue in the near term.

2. Volumes stay relatively steady.
   Due to the shorter month, discharges, patient days, and ED visits were all down slightly in February compared to January. On a per-day basis, however, hospitals experienced moderate growth in volumes in February. Average length of stay in the hospital was down, and patients continued to shift to ambulatory settings, with ambulatory surgery centers and outpatient operating rooms minutes seeing volume increases last month.

3. Outpatient settings drive revenue.
   The onset of the COVID-19 pandemic kickstarted a shift in patient behavior that continues today. Patients continue to seek more of their care away from inpatient settings. This is illustrated in outpatient revenues continuing to grow in early 2023.

4. Costs of goods and services are increasing faster than labor.
   Hospitals continue to face labor shortages. Labor expenses, however, appear to be holding steady indicating less dependence on contract labor. Meanwhile, inflation and pricing pressures are leading to significant cost increases in goods and services. This represents a change in what is driving hospital expenses from labor to the costs of goods and services.”

What’s Behind Losses At Large Nonprofit Health Systems? “We collected the most recent quarterly financial statements from 10 nonprofit hospital systems:  Advent, Ascension, Advocate Aurora, CommonSpirit, Mass General Brigham, Sutter, Trinity, UPMC, Northwell, and Providence. Financial statements were downloaded from each hospital system’s website. These systems were selected due to their size and the public availability of their financial reports. While this did not constitute a statistically representative sample, it did provide insight into the financial profiles of some of the nation’s largest systems and the most important factors behind those profiles.
All 10 hospital systems reported negative overall profit margins (net income divided by revenue). Average overall profit margin fell from 9 percent in 2021 to -6 percent in 2022.
Large nonprofit health systems are reporting financial strain, even as the worst of the pandemic has passed. This financial strain is driven primarily by investment losses. [Emphasis added] Stock markets struggled in 2022, with the S&P 500 declining in value by approximately 20 percent. Hospital systems that invest heavily in stock markets, like many large nonprofit organizations, may be particularly exposed to these financial headwinds. Hospital systems that also invest in private equity funds, such as Ascension, are also subject to the financial risks of their specific funds.”

About pharma

Genomadix Genetic Test for Potential Drug Effectiveness Cleared  “Genomadix has received FDA clearance for its Cube CYP2C19 test for assessing the potential effectiveness of drugs metabolized by the CYP450 2C19 genetic pathway.
The polymerase chain reaction test, which determines the presence of several gene mutations from swab taken from inside the mouth, delivers results in about an hour.”
Comment: This metabolism pathway for many drugs can guide dosing of some medications. The question is: Is it necessary and cost-effective. Past research on Coumadin (warfarin) showed that testing for CYP450 did not add to efficacy or reduce side effects.

Top 10 pharma R&D budgets in 2022 FYI

About the public’s health

 Minnesota suit against e-cigarette maker Juul goes to trial “Minnesota Attorney General Keith Ellison is slated to lead off opening statements expected for Tuesday in his state’s lawsuit against Juul Labs – marking the first time any of the thousands of cases against the e-cigarette maker over its alleged marketing to young people is going to play out in a courtroom.” 

US FDA seeks to allow salt substitutes in everyday foods “The U.S. Food and Drug Administration (FDA) on Friday said it was proposing a rule to allow the use of salt substitutes in everyday foods including cheese, frozen peas and canned tuna, in a bid to cut Americans' salt consumption.”

About healthcare IT

 FDA outlines plan for digital health technologies for clinical trials “The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year. While it has issued guidances on digital health products generally, there is still concern about whether such products are accurate and reliable enough to gather data for the drug development process.
 As part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA VII), the agency published a framework on 23 March on how it plans to address long-standing questions on the use of DHTs in drug clinical trials.”

Digital Access Coordinator Program Pilot Site Launches at Mass General “Mass General Brigham has launched a Digital Access Coordinator (DAC) Program pilot site at Mass General – a United Against Racism initiative to address gaps in digital literacy and increase patient access to tools, including Patient Gateway and virtual visits.”
Comment: While this announcement was published last June, I just found it and thought it was a very creative solution.

FBI Internet Crime Report 2022 Well worth scanning, particularly because among infrastructure sectors victimized by ransomware, healthcare is far and away the most frequently affected (see page 14).
Also, see page 18—losses are directly correlated to age. 

About healthcare personnel

Healthcare employment rebounds to pre-pandemic levels “Contrary to widespread reports of staffing shortages, healthcare employment reached pre-pandemic levels with the addition of 44,200 jobs in February, according to a recent report from Altarum.” 

About health technology

Combining Acoustic Bioprinting with AI-Assisted Raman Spectroscopy for High-Throughput Identification of Bacteria in Blood  Don’t let the title dissuade you from scanning this article. This technology allows rapid identification of pathogens- which can guide early treatment.

Today's News and Commentary

About Covid-19

Moderna expects to price its COVID vaccine at about $130 in the US “Moderna previously said it was considering pricing its COVID vaccine in a range of $110 to $130 per dose in the United States, similar to the range Pfizer Inc said in October it was considering for its rival COVID shots sold in partnership with BioNTech.”

 COVID-19 Deaths in U.S. Drop to Near Pandemic Low “The week ending in March 15 saw 1,706 coronavirus deaths – the lowest number reported since March 25, 2020, shortly after the World Health Organization first called the coronavirus a pandemic. That week, which was only the second week of the pandemic that the CDC tracker offered death numbers, saw 1,119 deaths.
Coronavirus cases and hospitalizations are also on the decline. Weekly infections are the lowest reported since the summer of 2021, but experts caution that the data is a drastic undercount as many rely on at-home testing that doesn’t get reported to health departments.”

About health insurance/insurers

 DOJ Quietly Abandons UnitedHealth Merger Appeal “ The U. S. Department of Justice on Monday gave up on getting the D. C. Circuit to revive its challenge to UnitedHealth Group Inc. 's $13. 8 billion purchase of Change Healthcare Inc. , summarily dropping the case after four months of docket silence and six months after a D. C. federal judge rejected the lawsuit….”

Physician, pharmacist sentenced for a $515M pain cream scheme “A physician and pharmacist were sentenced in a pain cream scheme that cost healthcare benefit providers more than $515 million in Mississippi, Clarion Ledger March 10.
Gregory Auzenne, MD, entered a guilty plea for a misdemeanor charge of fraudulent failure to disclose information involving a federal healthcare program. He admitted to not notifying authorities of questionable activity done by former pharmacist Marco Moran.
Mr. Moran was sentenced to 10 years in prison for his involvement in the healthcare fraud.
Dr. Auzenne was sentenced to five years of probation and ordered to pay a $20,000 fine and about $116,623 in restitution.”

About hospitals and healthcare systems

 Banner Health reports $16.6M operating income as labor costs decline  The specific system is not as important as the news that labor costs are declining. Recall that, in the past year or so, labor and supply costs have been largely responsible for hospital losses.

 Research: What Happens When Private Equity [PE] Firms Buy Hospitals? This HBR article is a really good review of the topic, discussing financial as well as quality outcomes. Much more research needs to be done to clarify issues around PE hospital purchases. In reading the article, be aware that the topic is not about hospital systems or mergers, which have very different cost and quality profiles.

About pharma

MACPAC calls for states to have power to restrict Medicaid coverage of some accelerated approval drugs “Congress should give states the power to not pay full price under Medicaid for drugs approved under the Food and Drug Administration’s accelerated approval pathway, a key advisory panel said. 
The Medicaid and CHIP Payment and Access Commission (MACPAC) released proposals for Congress as part of its March report last week. One of the key recommendations is to limit state coverage under Medicaid of drugs cleared via accelerated approval that have not completed a confirmatory trial. The recommendation is the latest tension point between Medicare and Medicaid regulators and the accelerated approval pathway.”
Comment: Private companies find it hard to turn down coverage for FDA drugs approved through the accelerated pathways and end up paying “full” prices (or at least PBM-set prices). Of course, this process results in higher customer premiums. 

US FDA official says agency needs to start using accelerated approval for gene therapies - report “The U.S. Food and Drug Administration needs to start using accelerated approval for advancing gene therapies for rare diseases, STAT News reported on Monday, citing agency official Peter Marks.
Accelerated approval would be particularly important for ultra-rare diseases, for which there are too few patients to run placebo-controlled studies, the report said, quoting Marks, who heads the agency’s Center for Biologics Evaluation and Research.”

About the public’s health

World Obesity Atlas 2023 “The estimates for global levels of overweight and obesity (BMI ≥25kg/m2), also referred to as high BMI throughout this Atlas, suggest that over 4 billion people may be affected by 2035, compared with over 2.6 billion in 2020. This reflects an increase from 38% of the world’s population in 2020 to over 50% by 2035 (figures exclude children under 5 years old).
The prevalence of obesity (BMI ≥30kg/m2) alone is anticipated to rise from 14% to 24% of the population over the same period, affecting nearly 2 billion adults, children and adolescents by 2035.
The rising prevalence of obesity is expected to be steepest among children and adolescents, rising from 10% to 20% of the world’s boys during the period 2020 to 2035, and rising from 8% to 18% of the world’s girls.” 

Justice Jackson Dissents Over End Result in Teen’s Abortion Case “Justice Ketanji Brown Jackson dissented Monday from the US Supreme Court’s decision to erase what could be seen as a pro-abortion appeals court ruling from the books.
At issue in the case was a decision by the US Court of Appeals for the Eighth Circuit affirming that a court clerk had to defend a lawsuit alleging that she violated a teenager’s civil rights by refusing to let her proceed with an abortion judicial bypass procedure without first notifying her parents. Judicial bypass is a way for minors to obtain a judge’s permission to have an abortion without involving her parents….”

About healthcare IT

 Microsoft’s Nuance adds GPT-4 AI to its medical note-taking tool “An AI medical scribe platform is the latest entrant into the AI arms race. On Monday, Microsoft-owned Nuance Communications announced it is integrating GPT-4 into its Dragon Ambient Intelligence platform, which is used by hospitals around the country to ease doctor workloads by using AI to listen to patient-provider conversations and write medical visit notes.
Starting this summer, all providers currently using DAX or Dragon Medical One will be eligible to apply for an early adopter program for DAX Express, which bypasses the human reviewer used as a quality control in the current DAX product, and returns fully AI-generated notes within minutes of a patient visit. This move marks a decisive acceleration of Nuance’s timeline for transferring all of the responsibility of drafting notes to AI.”

Perspectives of Patients About Immediate Access to Test Results Through an Online Patient Portal “In this survey study of 8139 respondents at 4 US academic medical centers, 96% of patients preferred receiving immediately released test results online even if their health care practitioner had not yet reviewed the result. A subset of respondents experienced increased worry after receiving abnormal results.”
This study is now moot, since hospitals are required to release results once available; however it is interesting that so many want results, even if they don’t know how to interpret them. Of course, many results are obviously “normal.”

FTC highlights the hidden impacts of pixel tracking in healthcare “The FTC issued a deep dive on pixel tracking technology and how the tools can negatively impact healthcare and consumer data. 
In a March 16 post, the FTC listed four concerns about pixel tracking technology:

1. Consumers may not realize that tracking pixels exist as they're invisibly embedded within web pages that users might interact with.

2. Pixels can collect and share any type of personal and identifying information.

3. Some pixels may try to remove personal information from being collected, but may still obtain enough information to identify an individual.

4. The FTC said companies or organizations using pixel tracking technology that discloses an individual's personal information to third parties may be violating the FTC Act, the FTC's Health Breach Notification Rule, the HIPAA Privacy, Security and Breach Notification Rule.” 

About healthcare personnel

Match Day Breaks Records for Numbers of Positions and Applicants FYI

About health technology

A new Medicare ruling could give virtual reality companies an easier path to payment “AppliedVR, a company targeting chronic pain, has become the first digital therapeutic to find an easy way to secure reimbursement from the Centers for Medicare and Medicaid Services.
CMS granted AppliedVR a unique code for its flagship product, RelieVRx, and placed it in an existing benefit category: durable medical equipment. The device, which consists of a headset and software guiding patients in pain management exercises, received Food and Drug Administration authorization to treat chronic lower back pain in 2021. Starting in April, providers will be able to bill for AppliedVR’s device as durable medical equipment.”

FDA grants clearance for fast, point-of-care STI test for women “Key takeaways:
—This STI test from Visby Medical provides test results for chlamydia, gonorrhoeae and trichomonas in less than 30 minutes.
—The FDA clearance will allow women to receive test results in a single office visit.”

Zoll alerts 1M wearable defibrillator users to data breach that exposed Social Security numbers “The names, addresses, birthdates and Social Security numbers of more than 1 million users of Zoll Medical’s wearable cardioverter defibrillators may have been exposed in a recent hacking attack.”
Comment: The hackability of such devices and peripherals is well-known.

ICER Aims to Consider Health Equity in Its Product Value Assessments “The Institute for Clinical and Economic Review (ICER) plans to take health equity into account in its product value assessments and has come up with some ideas for how to do that.
ICER convened an advisory group made up of patient advocates, payers, health technology and policy experts to help identify ways to evaluate diversity of patients in clinical trials and the opportunities to reduce health disparities.”

Today's News and Commentary

About Covid-19

Long-covid symptoms are less common now than earlier in the pandemic “The analysis of nearly 5 million U.S. patients who had covid, a study based on a collaboration between The Washington Post and research partners, shows that 1 in 16 people with omicron received medical care for symptoms associated with long covid within several months of being infected. Patients exposed to the coronavirus during the first wave of pandemic illness — from early 2020 to late spring 2021 — were most prone to develop long covid, with 1 in 12 suffering persistent symptoms.”

 What we know about the origin of covid-19, and what remains a mystery A great review of the subject. “The most recent discovery, first reported by the Atlantic, involves new data suggesting that raccoon dogs sold in the Huanan Seafood Market could have been the source of the viral spillover. Raccoon dogs are small, fox-like mammals that have been sold illegally in Chinese markets.”

About health insurance/insurers

 CMS instructs billing dispute arbitrators to resume processing all decisions “The Centers for Medicare & Medicaid Services on March 17 gave arbitrators the all-clear to resume determinations on out-of-network payment disputes alongside the release of its updated August 2022 final rules.
CMS had been forced to pause Independent Dispute Resolution (IDR) after a Feb. 6 court ruling from the U.S. District Court for the Eastern District of Texas ruled in favor of providers.”

About hospitals and healthcare systems

 HHS sued by hospitals over 'delayed' Medicare DSH payments About 40 hospitals across five states have filed a lawsuit against HHS Secretary Xavier Becerra, alleging that yearslong delays in correcting Medicare disproportionate share hospital payments have cost them "tens of millions" of dollars.
The safety-net hospitals in California, Arizona, Nevada, Hawaii and Minnesota filed the lawsuit March 14 in a Washington, D.C., district court.”  

Hospital ‘Black Boxes’ Put Surgical Practices Under the Microscope “The OR Black Box, a system of sensors and software, is being used in operating rooms in 24 hospitals in the U.S., Canada and Western Europe. Video, audio, patient vital signs and data from surgical devices are among the information being captured.
The technology is being used primarily to analyze operating-room practices in hopes of reducing medical errors, improving patient safety and making operating rooms more efficient. It can also help hospitals figure out what happened if an operation goes wrong.”

About pharma

 3 major insulin makers have now slashed the price of the life-saving drug. Here's why. “Amid consumer angst and political pressure over the cost of life-saving insulin, Sanofi announced Thursday it would slash the price of its most-prescribed insulin, Lantus. 

Sanofi was the final holdout among three companies that make up 90% of the world's insulin market by value. Earlier in the week, Novo Nordisk followed Eli Lilly Co.'s plans to slash U.S. prices by up to 75% and 70%, respectively.
Sanofi said it will cut the price of Lantus by 78% and short-acting Apidra by 70% as of Jan. 1, 2024.”

California, drugmaker partner to produce affordable insulin “The state of California and a generic drug manufacturer announced a 10-year partnership Saturday to produce affordable, state-branded insulin that they hope will rival longtime producers and push down prices for a medication used by millions of Americans…
The state and its partner, the nonprofit Civica, have yet to locate a California-based manufacturing facility. Regulatory approvals will be needed. Newsom said a 10- milliliter vial of the state-branded insulin would sell for $30, but it’s possible competitors could slash their prices and undercut the state product.”

About the public’s health

 PATIENTS LIKELY TO SKIP PREVENTIVE CARE IF ACA RULING HOLDS “KEY TAKEAWAYS

Morning Consult polled a survey of 2,199 American adults to better understand if preventive service utilization would be affected by a recent court ruling eliminating coverage in the Affordable Care Act.
At least two in five respondents say they are not willing to pay for 11 of the 12 preventive services, with cancer screenings chosen as the service most likely to be paid for.
Half of respondents skipped or delayed medical care because of cost, with three in 10 saying they did so in the past year.”

About healthcare IT

 VA looking to renegotiate its $10B contract with Oracle Cerner “The Department of Veterans Affairs is trying to negotiate a five-year option period for its $10 billion contract with Oracle Cerner as the EHR modernization program has been troubled since its rollout in 2020…”

IBM, Cleveland Clinic Install World's First Quantum Computer for Health Care Research “Academic medical center Cleveland Clinic today installed the first quantum computer in the world that is uniquely dedicated to health care research – IBM’s Quantum System One. It’s also the first on-site IBM-managed quantum computer for the private sector in the United States.
Cleveland Clinic unveiled the quantum computer in the Lerner Research Institute on its main campus in Cleveland. Jerry Chow, fellow and director of quantum infrastructure research at IBM, noted the company’s quantum computer can be deployed in different environments, and typical research institutes have the ability to meet the environmental requirements.”

American Telemedicine Association announced telehealth innovators challenge victors FYI. It is interesting to see in what areas these innovators are working.

The letter grades EHR vendors get for interoperability FYI

About healthcare personnel

Emergency Department Labor Costs Climb in Early 2023, According to Latest Syntellis Performance Solutions Report “Emergency department (ED) labor costs are on the rise, climbing 50% over the past three years and reaching $186 per visit in January, according to the report which draws data from more than 1,300 hospitals and 135,000 physicians. This trend provides just one example of the long-term effects of inflation, labor shortages, and other economic challenges that continue to strain U.S. healthcare providers in 2023 following a very difficult year in 2022.”

Today's News and Commentary

About Covid-19

 FDA authorizes Pfizer’s Covid omicron booster as fourth shot for kids under 5 “KEY POINTS

• The U.S. Food and Drug Administration authorized Pfizer’s omicron booster shot for kids younger than five who were previously vaccinated with three doses of the company’s original vaccine.  

• Children six months through four years old who completed their three-dose primary series with Pfizer and BioNTech’s monovalent shots more than two months ago are now eligible to receive a single booster dose of the updated shot.”

COVID-19 rebound not linked to Paxlovid, FDA says “The FDA reviewed Pfizer's mid-to-late stage clinical trials of Paxlovid and found "no evidence of a higher rate of symptom rebound or moderate symptom rebound."

About health insurance/insurers

Medicaid Redetermination Coverage Transitions “Overall, our modeling finds that in nearly all states, the majority of individuals will transition to employer-provided coverage (EPC). Variation across states ranges from the lowest proportion (48.9%) in Georgia, to the highest proportion (57.1%) in Delaware, enrolling in EPC.
Notably, approximately 3.8 million (or 21.2%) of people who lose Medicaid coverage during redetermination are estimated to become uninsured. Variation ranges from 17.7% in Massachusetts to 26.2% in South Dakota.”
The first line above highlights how expensive EPC is— these individuals would rather accept the limitations of Medicaid rather than enroll in their workplace plan.

March 2023 Report to the Congress: Medicare Payment Policy From MedPAC. Read (or scan) the 25- page executive summary, it touches on all aspects of Medicare payments. Remember, MedPAC’s recommendations are only advisory. It is also important to note that: “Because of standard data lags, the most recent complete data we have for most payment adequacyindicators are from 2021.”

Association of Participation in a Value-Based Insurance Design [VBID] Program With Health Care Spending and Utilization “This retrospective cohort study included 94 127 enrollees in commercial health plans. The VBID cohort was associated with significantly higher spending on or use of primary care physicians and immunizations, lower inpatient admissions and surgical procedures, and similar changes in overall spending compared with a non-VBID cohort in 2019 or 2020.”

About hospitals and healthcare systems

 The Estimated Value of Tax Exemption for Nonprofit Hospitals Was Nearly $28 Billion in 2020 “The total estimated value of tax exemption for nonprofit hospitals was nearly $28 billion in 2020 (Figure 1). This represented over two-fifths (43%) of net income (i.e., revenues minus expenses) earned by nonprofit facilities in that year. To put the value of tax exemption in perspective, our estimate is similar to the total value of Medicare and Medicaid disproportionate share hospital (DSH) payments in the same year ($31.9 billion in fiscal year 2020)…”

17 called-off hospital deals FYI

About pharma

Factors Associated With Public Trust in Pharmaceutical Manufacturers This cross-sectional study used a nationally representative survey of 2867 individuals at risk of cardiovascular disease (mean [SD] age, 54 [7] years; 1324 women [46%] and 2119 White individuals [74%]). A total of 1145 individuals (40%) considered pharmaceutical manufacturers to be sometimes (1036 [36%]) or always (109 [4%]) trustworthy….
Excellent health (OR, 1.70 [95% CI, 1.05-2.75]; P = .03) and having a regular source of care (OR, 1.19 [95% CI, 1.01-1.40]; P = .03) were associated with higher trust in pharmaceutical manufacturers…Individuals with Democratic (OR, 1.35 [95% CI, 1.15-1.61]; P < .001) or Republican party affiliation (OR, 1.27 [95% CI, 1.09-1.49]; P = .003) had higher trust relative to those with Independent affiliation. Relative to the west, individuals in the northeast had higher trust (OR, 1.43 [95% C, 1.16-1.77]; P = .001). There were no differences across gender, race and ethnicity, age, income, or educational level.”
Check the tables in the article.

FACT SHEET: Seniors Across the Country Are Saving Millions of Dollars in Health Care Costs Because of President Biden’s Prescription Drug Law This Whitehouse statement, stripped of the political rhetoric, lists 27 drugs whose prices rose faster than inflation and whose manufacturers are subject to fines.

About the public’s health

2023’s  Most Overweight and Obese Cities in the U.S. FYI

 Many Americans Are Likely to Skip Preventive Care if ACA Coverage Falls Through In September, [Judge Reed] O’Connor ruled that it is unconstitutional to require insurers to cover preventive services, with no cost-sharing for patients, that are recommended by an independent adviser. The judge did not issue a remedy at the time of the ruling, however, and still has yet to release one…
At least 2 in 5 U.S. adults said they are not willing to pay for 11 of the 12 preventive services currently covered by the ACA, according to a new Morning Consult survey. Furthermore, at least half said they would not pay out of pocket for preventive services such as tobacco cessation or screenings for HIV, depression and unhealthy drug use.”
 
Incidence of Aggressive End-of-Life Care Among Older Adults With Metastatic Cancer Living in Nursing Homes and Community Settings “Question  Is receipt of aggressive end-of-life (EOL) care for older adults with metastatic cancer more common among nursing home (NH) residents or their community-dwelling counterparts?
Findings  This cohort study of 146 329 older adults found that aggressive EOL care was more common for NH residents than for community-dwelling residents (64% vs 58%). The key markers associated with the higher prevalence of aggressive EOL care were more than 1 hospital admission in the last 30 days of life and in-hospital death.”

West Nile, Lyme, and other diseases are on the rise with climate change. Experts warn the U.S. is not prepared “Tick-borne diseases comprise the largest share of vector-borne diseases by far — over 80% of reported cases are caused by ticks. Longer summers, rising temperatures, and the expanding ranges of tick species such as Ixodes scapularis, the black-legged tick, and Amblyomma americanum, the lone star tick, are leading to an increased chance of human exposure to pathogens over a larger geographic area.

Remote Cardiovascular Hypertension Program Enhanced Blood Pressure Control During the COVID‐19 Pandemic “A remote clinical management program was successfully adapted and delivered significant improvements in BP control and increased home BP monitoring despite a nationally observed disruption of traditional hypertension care. Such programs have the potential to transform hypertension management and care delivery.”
From the patient perspective, the remote technology improves cost, quality and access. However, from the provider standpoint, there needs to be a business model for such care, e.g., telemedicine charges or capitation.

About healthcare IT

 Associations Between Natural Language Processing–Enriched Social Determinants of Health and Suicide Death Among US Veterans  “Question  Are social determinants of health (SDOHs), extracted from both structured and unstructured clinical data, associated with an increased risk of suicide death among US veterans?
Findings  In this case-control study of 8821 cases and 35 284 matched controls, SDOHs from both structured data and unstructured data (extracted using a natural language processing system) were associated with an increased risk of suicide death.
Meaning  The findings of this study suggest that SDOHs are risk factors for suicide among the US veterans and that natural language processing can be leveraged to extract SDOH information from unstructured data.”

2023’s Largest Health Data Breach So Far Brings Legal Flurry “Regal Medical Group disclosed last month that over 3.3 million patients had their personal and health information exposed in a December 2022 ransomware cyberattack. The US Department of Health and Human Services says the breach is currently the biggest reported to it in 2023. The agency’s Office for Civil Rights is also investigating it.
At least 11 lawsuits, all in California, were filed in the three weeks following Regal’s February disclosure, according to a Bloomberg Law analysis of court dockets. They seek monetary damages ranging between $100 and $3,000 per class member, and several want Regal and its affiliates to ensure they will prevent similar incidents from happening again.”

Google launches Open Health Stack for app developers, unveils new AI partnerships

Yesterday, Google “unveiled new AI partnerships focused on cancer screenings and maternal health and efforts to give Fitbit users easier access to health and wellness data from their devices…
The company also announced that it’s making it easier for people to find affordable healthcare centers near them. Consumers will be able to see providers that identify as community health centers offering free or low-cost care…”

About health technology

 Poll Says American Consumers Want FDA Regulation of Medical Device Repair “According to a new poll, 77 percent of American consumers think that the FDA should regulate medical device service and repair conducted by either original equipment manufacturers or independent third-party companies.”
Never thought about the fact that an FDA-approved device can malfunction and be “fixed” by someone with questionable skills.

PerkinElmer completes $2.45B spinoff to create new diagnostics, life sciences company “PerkinElmer has completed the split it announced last August, selling off its applied science, food and enterprise services businesses to private equity firm New Mountain Capital and combining the remaining life sciences and diagnostics businesses into a new, standalone company.
While the businesses sold to New Mountain will retain the PerkinElmer name, the newly formed medtech supplier will go by a different moniker—though its name, logo and ticker symbol have yet to be announced.

Today's News and Commentary

About Covid-19

 FDA authorizes Pfizer’s Covid omicron booster as fourth shot for kids under 5 “KEY POINTS

• The U.S. Food and Drug Administration authorized Pfizer’s omicron booster shot for kids younger than five who were previously vaccinated with three doses of the company’s original vaccine.  

• Children six months through four years old who completed their three-dose primary series with Pfizer and BioNTech’s monovalent shots more than two months ago are now eligible to receive a single booster dose of the updated shot.”

COVID-19 rebound not linked to Paxlovid, FDA says “The FDA reviewed Pfizer's mid-to-late stage clinical trials of Paxlovid and found "no evidence of a higher rate of symptom rebound or moderate symptom rebound."

About health insurance/insurers

Medicaid Redetermination Coverage Transitions “Overall, our modeling finds that in nearly all states, the majority of individuals will transition to employer-provided coverage (EPC). Variation across states ranges from the lowest proportion (48.9%) in Georgia, to the highest proportion (57.1%) in Delaware, enrolling in EPC.
Notably, approximately 3.8 million (or 21.2%) of people who lose Medicaid coverage during redetermination are estimated to become uninsured. Variation ranges from 17.7% in Massachusetts to 26.2% in South Dakota.”
The first line above highlights how expensive EPC is— these individuals would rather accept the limitations of Medicaid rather than enroll in their workplace plan.

March 2023 Report to the Congress: Medicare Payment Policy From MedPAC. Read (or scan) the 25- page executive summary, it touches on all aspects of Medicare payments. Remember, MedPAC’s recommendations are only advisory. It is also important to note that: “Because of standard data lags, the most recent complete data we have for most payment adequacyindicators are from 2021.”

Association of Participation in a Value-Based Insurance Design [VBID] Program With Health Care Spending and Utilization “This retrospective cohort study included 94 127 enrollees in commercial health plans. The VBID cohort was associated with significantly higher spending on or use of primary care physicians and immunizations, lower inpatient admissions and surgical procedures, and similar changes in overall spending compared with a non-VBID cohort in 2019 or 2020.”

About hospitals and healthcare systems

 The Estimated Value of Tax Exemption for Nonprofit Hospitals Was Nearly $28 Billion in 2020 “The total estimated value of tax exemption for nonprofit hospitals was nearly $28 billion in 2020 (Figure 1). This represented over two-fifths (43%) of net income (i.e., revenues minus expenses) earned by nonprofit facilities in that year. To put the value of tax exemption in perspective, our estimate is similar to the total value of Medicare and Medicaid disproportionate share hospital (DSH) payments in the same year ($31.9 billion in fiscal year 2020)…”

17 called-off hospital deals FYI

About pharma

Factors Associated With Public Trust in Pharmaceutical Manufacturers This cross-sectional study used a nationally representative survey of 2867 individuals at risk of cardiovascular disease (mean [SD] age, 54 [7] years; 1324 women [46%] and 2119 White individuals [74%]). A total of 1145 individuals (40%) considered pharmaceutical manufacturers to be sometimes (1036 [36%]) or always (109 [4%]) trustworthy….
Excellent health (OR, 1.70 [95% CI, 1.05-2.75]; P = .03) and having a regular source of care (OR, 1.19 [95% CI, 1.01-1.40]; P = .03) were associated with higher trust in pharmaceutical manufacturers…Individuals with Democratic (OR, 1.35 [95% CI, 1.15-1.61]; P < .001) or Republican party affiliation (OR, 1.27 [95% CI, 1.09-1.49]; P = .003) had higher trust relative to those with Independent affiliation. Relative to the west, individuals in the northeast had higher trust (OR, 1.43 [95% C, 1.16-1.77]; P = .001). There were no differences across gender, race and ethnicity, age, income, or educational level.”
Check the tables in the article.

FACT SHEET: Seniors Across the Country Are Saving Millions of Dollars in Health Care Costs Because of President Biden’s Prescription Drug Law This Whitehouse statement, stripped of the political rhetoric, lists 27 drugs whose prices rose faster than inflation and whose manufacturers are subject to fines.

About the public’s health

2023’s  Most Overweight and Obese Cities in the U.S. FYI

 Many Americans Are Likely to Skip Preventive Care if ACA Coverage Falls Through In September, [Judge Reed] O’Connor ruled that it is unconstitutional to require insurers to cover preventive services, with no cost-sharing for patients, that are recommended by an independent adviser. The judge did not issue a remedy at the time of the ruling, however, and still has yet to release one…
At least 2 in 5 U.S. adults said they are not willing to pay for 11 of the 12 preventive services currently covered by the ACA, according to a new Morning Consult survey. Furthermore, at least half said they would not pay out of pocket for preventive services such as tobacco cessation or screenings for HIV, depression and unhealthy drug use.”
 
Incidence of Aggressive End-of-Life Care Among Older Adults With Metastatic Cancer Living in Nursing Homes and Community Settings “Question  Is receipt of aggressive end-of-life (EOL) care for older adults with metastatic cancer more common among nursing home (NH) residents or their community-dwelling counterparts?
Findings  This cohort study of 146 329 older adults found that aggressive EOL care was more common for NH residents than for community-dwelling residents (64% vs 58%). The key markers associated with the higher prevalence of aggressive EOL care were more than 1 hospital admission in the last 30 days of life and in-hospital death.”

West Nile, Lyme, and other diseases are on the rise with climate change. Experts warn the U.S. is not prepared “Tick-borne diseases comprise the largest share of vector-borne diseases by far — over 80% of reported cases are caused by ticks. Longer summers, rising temperatures, and the expanding ranges of tick species such as Ixodes scapularis, the black-legged tick, and Amblyomma americanum, the lone star tick, are leading to an increased chance of human exposure to pathogens over a larger geographic area.

Remote Cardiovascular Hypertension Program Enhanced Blood Pressure Control During the COVID‐19 Pandemic “A remote clinical management program was successfully adapted and delivered significant improvements in BP control and increased home BP monitoring despite a nationally observed disruption of traditional hypertension care. Such programs have the potential to transform hypertension management and care delivery.”
From the patient perspective, the remote technology improves cost, quality and access. However, from the provider standpoint, there needs to be a business model for such care, e.g., telemedicine charges or capitation.

About healthcare IT

 Associations Between Natural Language Processing–Enriched Social Determinants of Health and Suicide Death Among US Veterans  “Question  Are social determinants of health (SDOHs), extracted from both structured and unstructured clinical data, associated with an increased risk of suicide death among US veterans?
Findings  In this case-control study of 8821 cases and 35 284 matched controls, SDOHs from both structured data and unstructured data (extracted using a natural language processing system) were associated with an increased risk of suicide death.
Meaning  The findings of this study suggest that SDOHs are risk factors for suicide among the US veterans and that natural language processing can be leveraged to extract SDOH information from unstructured data.”

2023’s Largest Health Data Breach So Far Brings Legal Flurry “Regal Medical Group disclosed last month that over 3.3 million patients had their personal and health information exposed in a December 2022 ransomware cyberattack. The US Department of Health and Human Services says the breach is currently the biggest reported to it in 2023. The agency’s Office for Civil Rights is also investigating it.
At least 11 lawsuits, all in California, were filed in the three weeks following Regal’s February disclosure, according to a Bloomberg Law analysis of court dockets. They seek monetary damages ranging between $100 and $3,000 per class member, and several want Regal and its affiliates to ensure they will prevent similar incidents from happening again.”

Google launches Open Health Stack for app developers, unveils new AI partnerships

Yesterday, Google “unveiled new AI partnerships focused on cancer screenings and maternal health and efforts to give Fitbit users easier access to health and wellness data from their devices…
The company also announced that it’s making it easier for people to find affordable healthcare centers near them. Consumers will be able to see providers that identify as community health centers offering free or low-cost care…”

About health technology

 Poll Says American Consumers Want FDA Regulation of Medical Device Repair “According to a new poll, 77 percent of American consumers think that the FDA should regulate medical device service and repair conducted by either original equipment manufacturers or independent third-party companies.”
Never thought about the fact that an FDA-approved device can malfunction and be “fixed” by someone with questionable skills.

PerkinElmer completes $2.45B spinoff to create new diagnostics, life sciences company “PerkinElmer has completed the split it announced last August, selling off its applied science, food and enterprise services businesses to private equity firm New Mountain Capital and combining the remaining life sciences and diagnostics businesses into a new, standalone company.
While the businesses sold to New Mountain will retain the PerkinElmer name, the newly formed medtech supplier will go by a different moniker—though its name, logo and ticker symbol have yet to be announced.

Today's News and Commentary

About Covid-19

A meta-analysis of the associations between insufficient sleep duration and antibody response to vaccination “Highlights
—Insufficient sleep (<6 hours/night) around vaccination reduces the antibody response
—The reduction is similar to the waning of COVID-19 vaccine antibodies over 2 months
—The association seems robust in men, but more data are needed in women
—Optimizing sleep duration around the time of vaccination may boost antibody response”

COVID-19 and Outpatient Antibiotic Prescriptions in the United States: A County-level Analysis “[Overall] antibiotic prescribing fell 26.8% in 2020 compared to prior years…
The positive association of COVID-19 cases with prescribing for all ages and the negative association for children indicates increases in prescribing occurred primarily among adults. The rarity of bacterial co-infection in COVID-19 patients suggests a fraction of these prescriptions may have been inappropriate. Facemasks and school closures were correlated with reductions in prescribing among children, possibly due to the prevention of other upper respiratory infections. The strongest predictors of prescribing were prior years’ prescribing trends, suggesting the possibility that behavioral norms are an important driver of prescribing practices.”

About health insurance/insurers

Inside the mind of criminals: How to brazenly steal $100 billion from Medicare and Medicaid “Taxpayers are losing more than $100 billion a year to Medicare and Medicaid fraud, according to estimates from the National Health Care Anti-Fraud Association.”
The article provides examples of the ease with which fraud is committed. 

Consistency of Physician Data Across Health Insurer Directories “In examining directory entries for more than 40% of US physicians, inconsistencies were found in 81% of entries across 5 large national health insurers. These results were driven by inconsistencies in addresses among physicians listed as practicing at multiple locations, which is concordant with prior research suggesting that most address errors stem from group practices reporting all physicians at all practice locations to insurers, irrespective of each individual physician’s practice locations.”

About hospitals and healthcare systems

Hospital Vitals: Financial and Operational Trends “The latest Hospital Vitals report — published in partnership with the American Hospital Association (AHA) — shares year-end 2022 data from 1,300+ hospitals and health systems. Key findings comparing hospitals’ 2022 performance to 2019 include:   
—Total Contract Labor Expense skyrocketed 257.9%  
—Contract Labor FTEs jumped 138.5%  
—Median Contract Wage Rate paid to staffing firms rose 56.8% 
—Emergency Overtime Hours per ED Visit increased 22%”

Patient Safety Excellence Award 2023 View hospitals by state.

About pharma

Novo Nordisk follows Eli Lilly's lead, slashing insulin prices in the US “On Tuesday, the Danish company said it would reduce the list price of its NovoLog insulin by 75% and slice the cost of Novolin and Levemir by 65%. The cuts will kick in on Jan. 1 of 2024, the drugmaker said.
The company also will drop the price of its unbranded biologics to match the reduced prices of the branded insulins.”
Why wait so long?

United States Files Complaint Alleging that Rite Aid Dispensed Controlled Substances in Violation of the False Claims Act and the Controlled Substances Act “ ‘We allege that Rite Aid filled hundreds of thousands of prescriptions that did not meet legal requirements,’ said Associate Attorney General Vanita Gupta. ‘According to our complaint, Rite Aid’s pharmacists repeatedly filled prescriptions for controlled substances with obvious red flags, and Rite Aid intentionally deleted internal notes about suspicious prescribers. These practices opened the floodgates for millions of opioid pills and other controlled substances to flow illegally out of Rite Aid’s stores.’”

About the public’s health

 EPA proposes rules to limit ‘forever chemicals’ in drinking water “The Environmental Protection Agency is proposing the nation’s first-ever drinking-water standards for a group of human-made chemicals — commonplace in consumer items — that pose a greater danger to human health than scientists once thought.
The proposal could force water utilities to spend billions of dollars to comply with the EPA’s planned limits on polyfluoroalkyl and perfluoroalkyl substances, or PFAS, even though those limits are less stringent than advisory levels for safe consumption the agency set last year. Officials say that small and rural utilities will have access to federal subsidies and assistance, blunting the financial impact of the rule, if enacted.”

About healthcare personnel

 Docs diverge on DTC, with survey showing support among the young “Among the healthcare professionals who see value in DTC marketing, more than 50% of the respondents said increased patient knowledge of medications helps with diagnosis and 70% said it boosts treatment adherence. The upshot? Campaigns that create informed patients could potentially improve outcomes. 
Support diverges by age. Two-thirds of people aged 25 to 34 have no issues with the practice, compared to less than 40% of practitioners aged 45 and older. The data suggest views on DTC ads are shifting.” 

Poll Finds More Americans Worried About Health Care Understaffing “More than a third (35%) of people noticed or had been affected by health care staffing shortages at the time of the February poll, up from 25% last November, noted Kathy Steinberg, vice president of media and communications research at the Harris Poll.
By comparison, 24% had been affected by staffing shortages in education in February, up from 17% in November.”

About health technology

 Apple AirPods could be getting health features soon “Apple's AirPods and AirPods Pro might be used to monitor heart rates and characterize blood flow in consumer's ear skin, Apple Insider reported March 12. 
Apple has filed patents and patent applications for a biometric sensing capability for the AirPods package, according to the report, suggesting that the company might use the device's ear and a photoplethysmogram sensor to monitor health conditions.”

About healthcare finance

 Seeking to boost shareholder returns, Novartis readies new $11B buyback round “Novartis is preparing to kick off a share buyback round aimed at repurchasing up to 10 billion Swiss francs ($11 billion) worth of company shares in the next three years.
The new initiative, greenlighted at Novartis’ annual general meeting last week, will see the Swiss pharma buy up to 10% of its own registered stock.”

Today's News and Commentary

About Covid-19

 House votes to declassify info about origins of COVID-19 The House voted unanimously Friday to declassify U.S. intelligence information about the origins of COVID-19, a sweeping show of bipartisan support near the third anniversary of the start of the deadly pandemic.
The 419-0 vote was final congressional approval of the bill, sending it to President Joe Biden’s desk. It’s unclear whether the president will sign the measure into law, and the White House said the matter was under review.”

QuidelOrtho Gains De Novo Authorization for COVID-19 Test “QuidelOrtho has received FDA’s de novo authorization for its Sofia 2 SARS Antigen+ FIA rapid test for COVID-19 — making it the first antigen test for COVID-19 to gain a full authorization rather than an emergency use authorization from the agency.”
Emphasis added.
Hard to believe this is the first non-EUA 3 years after the pandemic was declared.

About quality and safety

Pediatric mental health, workplace violence are top 2023 safety concerns: ECRI It is well worth following this report annually, not only to focus on the current list, but to compare it with previous years’ lists. The article goes back to 2020. It is not only a reflection of current science as well as prevalent social factors.

About hospitals and healthcare systems

 Hospitals Barred From Suing HHS Over Uncompensated Care Pay “Forty-five hospitals that the HHS allegedly underpaid for providing uncompensated care to low-income people can’t challenge the agency’s methodology for calculating those payments.
The Medicare Act bars agency and judicial review of the US Health and Human Services Department’s estimates for determining hospitals’ disproportionate share payments, the US Court of Appeals for the D.C. Circuit said Friday.
It also renders unreviewable HHS’ instructions for auditing a form that hospitals use to report their uncompensated care for the ultimate purpose of calculating DHS payments, the court said.”

Ascension operating margin falls to -2.9% “St. Louis-based Ascension saw its operating margin fall to -2.9 percent in the six months ending Dec. 31, 2022, down from 0.2 percent for the same period in 2021 and 5.7 percent in 2020, according to its most recent financial report.
The 139-hospital system recorded a $410 million operating loss in the second half of 2022, compared with an operating income of $31 million during the same period last year.”

About pharma

More than one-third of Americans haven’t filled a prescription due to cost: survey “That’s according to a poll completed by 1,500 U.S. adults in March 2023. Of these, 37 percent said they’ve not filled a prescription due to cost. Another 10 percent preferred not to answer the query. 
Both women and individuals with an annual family income less than $50,000 were more likely to say they’ve skipped filling prescriptions due to cost, at 43 percent and 44 percent, respectively.
However, similar shares of Democrats and Republicans said they’ve had this experience, poll results show.”
Highlights the need for pharma payment reform. Generics have saved billion of dollars but some people need expensive medications to live. Charging high rates for non-discretionary services is cruel and counterproductive, as noncompliance often results in the need for more expensive care. 

Medicare Part D Coverage of Antiobesity Medications — Challenges and Uncertainty Ahead “The Institute for Clinical and Economic Review (ICER), a nonprofit health technology assessment organization based in the United States, recently evaluated the cost-effectiveness of lifetime use of semaglutide and three other antiobesity-medication regimens (brand-name liraglutide, phentermine–topiramate, and bupropion–naltrexone; including generic versions of phentermine and topiramate, and bupropion and naltrexone) for a 45-year-old patient as compared with lifestyle modification alone. ICER’s evaluation concluded that semaglutide wasn’t cost-effective, with an estimated cost of $237,000 per quality-adjusted life-year gained…
Under current U.S. thresholds, the annual $13,618 price of semaglutide would need to decrease to $7,500 to $9,700 for the drug to be cost-effective as compared with lifestyle modification alone.In that price range, however, it still wouldn’t be cost-effective as compared with generic phentermine and topiramate. Even with such discounted prices, the budgetary effects for Medicare could be substantial.”
Bottom line is a $26.8B annual price tag for one drug.

 Gambian child deaths fuel alarm over rules in ‘world’s biggest pharmacy’ India  Although this article uses examples from Gambia, the “deaths have sparked concerns about quality control in India, the self-styled pharmacy of the world, as well as under-resourced regulatory agencies in low-income nations…
India, which has 20 per cent of the global market for generic drugs, supplies more than 50 per cent of generic drugs sold in Africa, according to Invest India, the government’s national investment promotion and facilitation agency.”
The FDA does not have enough personnel or money to comprehensively cover foreign sources of food and drugs.

The top 10 drugs losing US exclusivity in 2023 To get an idea of the impact of generic equivalents, subtract about 15% from biologics (frequently ending in “ab” or “ib”) and 80% from non-biologic products. The caveat is that, like any other goods, there has to be sufficient competition to bring those numbers down.

Veterans Health Administration will cover the newest Alzheimer’s drug “In an unexpected move, the Veterans Health Administration announced Monday that it will widely cover a new Alzheimer’s treatment, even as Medicare has decided to wait for additional data about the medicine before taking the same step.
The VA will provide coverage to veterans who meet agency criteria for using the medicine — called Leqembi — as well as stipulations on the product labeling, according to a statement from Eisai, which is partnering with Biogen to market the treatment. About 80% to 90% of veterans who clear these hurdles may be eligible for the treatment, but the exact number is uncertain…”

About the public’s health

Long-term intensive endurance exercise training is associated to reduced markers of cellular senescence in the colon mucosa of older adults “Our data suggest that chronic high-volume high-intensity endurance exercise can play a role in preventing the accumulation of senescent cells in cancer-prone tissues like colon mucosa with age. Future studies are warranted to elucidate if other tissues are also affected, and what are the molecular and cellular mechanisms that mediate the senopreventative effects of different forms of exercise training.”

Massachusetts could become the next state to allow aid in dying A really good review of the topic, including legal status among the states.

E-Cigarette Screening in Primary Care “Overall rates of e-cigarette screening were significantly lower than that of other substances. Use of combustible tobacco or illicit substances was associated with an increased likelihood of being screened. This finding may be due to the relatively recent proliferation of e-cigarettes, the recent addition of e-cigarette documentation to the electronic health record, or a lack of training on screening for e-cigarette use.”

About healthcare IT

 Commercially available AI tool could reduce radiologist workloads by 10% or more “The AI tool was able to correctly classify 28% of the images labeled as normal. This equates to approximately 7.8% of the entire cohort that could be safely classified using AI alone. 
The tool’s sensitivity was recorded as 99.1% for abnormal radiographs and 99.8% for critical radiographs—better than two board-certified radiologists who also interpreted the exams.”
A reminder about how good AI is getting at reading images.

Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need Really good discussion of the topic. In short: “Behind the scenes, insurers are using unregulated predictive algorithms, under the guise of scientific rigor, to pinpoint the precise moment when they can plausibly cut off payment for an older patient’s treatment. The denials that follow are setting off heated disputes between doctors and insurers, often delaying treatment of seriously ill patients who are neither aware of the algorithms, nor able to question their calculations.”

About healthcare finance

 With $43B buyout, Pfizer sees cancer specialist Seagen as a 'goose' laying 'golden eggs' “It is the largest acquisition in biopharma since June of 2019, when AbbVie acquired Allergan for $63 billion. Five months before that, Bristol Myers Squibb pulled off the biggest transaction in industry history with its $74 billion purchase of Celgene.
Seagen, long considered one of the world’s most attractive biotech targets, brings four commercial medicines and a deep pipeline full of antibody-drug conjugate (ADC) candidates.”

Sanofi throws down $2.9B to acquire diabetes partner Provention Bio “The deal gives Sanofi access to Provention’s approved immunotherapy Tzield, greenlighted in November, which is designed to stall progression of type 1 diabetes.”

Today's News and Commentary

Biden's $6.8T budget: 15 healthcare takeaways A good, short summary of the proposals.
See, also, a related article: What Biden's proposed budget means for Medicare Advantage

About healthcare quality

 Accounting for Person- vs Neighborhood-Level Social Risk in Quality Measurement A good discussion of the pros and cons of each method. The article is a commentary on another article in the same journal issue.
The crux of the analysis is: “ Ultimately, 3 social risk factors were identified, one of which was a patient-level variable (Medicare-Medicaid dual-enrollment status) and 2 of which were community-level measures of social risk, including low Agency for Healthcare Research and Quality Socioeconomic Status (AHRQ SES) Index (an aggregated score of neighborhood vulnerability based on employment, income, education, and housing) and low physician-specialist density (a marker for reduced access to specialty care).”

About health insurance/insurers

 Medicaid Health Plans Try to Protect Members — And Profits — During Unwinding “The plans have a strong financial incentive to keep their members enrolled because states pay them per member, per month: The more people they cover, the more money they get.
The Biden administration estimates that 15 million of the more than 91 million Medicaid enrollees will fall off the rolls, nearly half because their income exceeds program limits and the rest because they fail to complete the reenrollment paperwork.
Of the people losing eligibility, about two-thirds will enroll in a workplace health plan, health insurers predict, and the other third will be evenly divided between ACA plans and being left uninsured…
Investor-owned companies earn pretax profit margins of about 3% on average from Medicaid managed care, slightly below what they make on ACA marketplace business, he said. So moving members to an ACA plan could boost the profits of these companies.”

Industry groups form coalition to avoid coverage lapses as Medicaid redeterminations loom “The Connecting to Coverage Coalition is spearheaded by AHIP, the health insurance industry's largest lobbying group, and its other founding members include the American Cancer Society Cancer Action Network, the Federation of American Hospitals, the Blue Cross Blue Shield Association and the Association for Community Affiliated Plans.
The national effort is seeking to provide a single source for information about the redetermination process and to build solutions that ensure people are able to find the coverage the works best for them and their families, according to an announcement.”

How Obamacare Enabled a Multibillion-Dollar Christian Health Care Cash Grab Ever wonder how the “Health Sharing Ministries” are legally able to operate health plans, despite the negative news about their performances? Their enablement was written into the ACA. This ProPublica article provides a great insight into these plans.

About hospitals and healthcare systems

 Providence reports $1.7B operating loss in 2022 “Renton, Wash.-based Providence, a 51-hospital system, has reported a $1.7 billion operating loss for fiscal 2022 amid labor and inflationary pressures as well as delayed reimbursements. Investment losses also further dragged the system's performance down.” 

About the public’s health

 WHO global report on sodium intake reduction The report can be downloaded from this site. Briefly: “The largest number of diet-related deaths, an estimated 1.89 million each year, is associated with excessive intake of sodium, a well-established cause of raised blood pressure and increased risk of cardiovascular disease. The global average sodium intake is estimated to be 4310 mg/day (10.78 g of salt per day), which far exceeds the physiological requirement and is more than double the World Health Organization (WHO) recommendation of <2000 mg of sodium (equivalent to <5 g of salt) per day in adults.
Reducing sodium intake is one of the most cost-effective ways to improve health and reduce the burden of noncommunicable diseases, as it can avert a large number of cardiovascular events and deaths at very low total programme costs. WHO recommends several sodium-related best buys policies as practical actions that should be undertaken immediately, to prevent cardiovascular disease and its associated costs. These include lowering sodium content in food products; implementing front-of-pack labelling to help consumers select food products
with lower sodium content; conducting mass media campaigns to alter consumer behaviour around sodium; and implementing public food procurement and service policies to reduce sodium content in food served or sold.
All 194 Member States committed to reducing population sodium intake by 30% by 2025, demonstrating strong consensus on sodium reduction as a life-saving strategy.”

FDA mandates breast density information with mammography results “The U.S. Food and Drug Administration said on Thursday all mammography facilities in the country will be required to notify patients about the density of their breast tissues, as that can potentially make detection of tumors more difficult…
The agency recommends patients with dense breasts, a normal and common finding in mammograms, to discuss their individual situation with their respective healthcare providers.”
Comment: While more informed patients is a laudable goal, without clear criteria for making this determination, the number of unnecessary extra tests (and costs) will skyrocket.

Smoking, snuff use in pregnancy raises risk for sudden infant death syndrome “Children of mothers who used snuff or smoked during pregnancy had higher risks for postneonatal mortality, sudden infant death syndrome and sudden unexpected infant death, according to study results published in Pediatric Research.”

Covid backlash hobbles public health and future pandemic response “At least 30 states, nearly all led by Republican legislatures, have passed laws since 2020 that limit public health authority, according to a Washington Post analysis of laws collected by Kaiser Health News and the Associated Press as well as the Association of State and Territorial Health Officials and the Center for Public Health Law Research at Temple University.
Health officials and governors in more than half the country are now restricted from issuing mask mandates, ordering school closures and imposing other protective measures or must seek permission from their state legislatures before renewing emergency orders, the analysis showed.”

Association of Primary Care Visit Length With Potentially Inappropriate Prescribing “In this cross-sectional study of 4 360 445 patients, those who were younger, publicly insured, Hispanic, or non-Hispanic Black had shorter primary care physician visits. Shorter visits were associated with a higher likelihood of inappropriate antibiotic prescribing for patients with upper respiratory tract infections and coprescribing of opioids and benzodiazepines for patients with painful conditions.”

About healthcare IT

 Cerner contributes $1.5B to Oracle's Q3 revenue EHR vendor Cerner contributed $1.5 billion to software giant Oracle's $12.4 billion in third-quarter revenue; analysts at FactSet had expected $12.43 billion in revenue. 
The company's quarterly revenue was up 18 percent year-over-year. Cloud revenue contributed $4.1 billion to the total third-quarter revenue, according to an Oracle March 9 news release.”

3.2 million patients caught in Cerebral data breach “More than 3 million patients were affected in a data breach involving telemental health company Cerebral, according to a notice to HHS' Office of Civil Rights.
Cerebral, whose clinicians prescribe medications for depression and anxiety via telehealth, started notifying patients March 6 that some of their data may have been sent to social media companies via consumer-tracking pixel tools.”

Today's News and Commentary

The 2023 Healthcare Marketers Trend Report: A trim off the top “…per the MM+M/Swoop 2023 Healthcare Marketers Survey, marketing budgets slid by 8%.
The average marketing budget fell to $7.6 million, down from $8.3 million in last year’s survey. That spending level is a long way off the pre-pandemic boom times of 2019, when the average budget reached a peak of $12.5 million…
One exception to the belt-tightening trend is physician outreach, as 51% of respondents reported that they’d fattened those budgets. The result: Spending aimed at HCPs [health care personnel] now accounts for 53% of the marketing pie.”
Well worth a read for those interested in marketing.

About Covid-19

Diabetes drug proves beneficial in preventing long COVID in clinical trials “COVID-19 patients who took the diabetes drug metformin for two weeks after a diagnosis were less likely to develop long COVID-19 symptoms, according to results from a clinical trial.
The trial enrolled about a thousand participants who were symptomatic with a COVID-19 infection for less than a week. Participants were randomly selected to receive a placebo or one of three drugs: metformin, ivermectin or fluvoxamine.
About 6 percent of people who took metformin later developed long COVID-19, as determined by a medical diagnosis. In the placebo group, 10.6 percent of participants developed long COVID-19.”

About hospitals and healthcare systems

 10 health systems reporting profits in 2022  Amidst all the losses, this article is some good news.

About pharma

WeightWatchers buys Sequence to expand into remote prescribing of hot weight loss drugs “The well-known weight loss company has entered into a definitive agreement to acquire Weekend Health, the corporate name of Sequence. Clinicians use the platform to provide clinical care, including prescriptions, for patients navigating chronic weight management. Sequence also claims to help patients traverse the insurance approval process.” 

Pain Clinic Owners Sentenced for Unlawfully Distributing Opioids and Multimillion-Dollar Health Care Fraud While these cases are, sadly, too common, this one is especially large.
"According to court documents and evidence presented at trial, Mark Murphy and Jennifer Murphy owned and operated North Alabama Pain Services (NAPS), which closed its Decatur and Madison offices in early 2017…. Over the approximately five-year period leading up to the clinic closing its Alabama locations, the evidence at sentencing showed, Murphy wrote prescriptions for more than ten million opioid pills, including millions of oxycodone 30 mg tablets.  During the same five-year period, Murphy and his wife Jennifer, who helped run the clinics, ordered tens of millions of dollars of unnecessary items and services that were paid by taxpayer-funded and private insurance programs. The Murphys received kickbacks for those orders and prescriptions.  In all, Medicare, TRICARE, and Blue Cross Blue Shield of Alabama were billed more than $280 million as a result of the fraud and kickback schemes, and paid more than $50 million.  Mark Murphy and Jennifer Murphy were each ordered to pay more than $50 million in restitution. Jennifer Murphy was also convicted of tax-related charges for underreporting clinic income.”
Emphasis added.

FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt “Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s ‘protracted’ approval process for its financial problems.
Now the FDA has released a rare comment clarifying what happened during its authorization process. The new details are raising hopes among other home-test manufacturers that the FDA is becoming more flexible about its requirements for approving at-home flu test kits.
The FDA ultimately authorized Lucira’s test with fewer samples than the agency had previously said it would require for approval…”

About the public’s health

 What running does to the knees, according to a large survey of marathon runners “A new study found that runners were not more likely to develop hip or knee osteoarthritis the longer, faster and more frequently they ran.” 

Biden administration requests $20 billion cash infusion to bolster public health “In its budget request to Congress on Thursday, the White House asked for $20 billion over five years to support pandemic preparedness efforts at the Administration for Strategic Preparedness and Response, Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration. The request aligns with the White House’s National Biodefense Plan.”

About healthcare IT

 Healthcare data breaches “2022 has 717 reported breaches so far, just surpassing 2021's total of 715.”
The article lists the top 10 by people affected. 

And in a related story: Data breach hits 'hundreds' of lawmakers and staff on Capitol Hill “A top House official said that a ‘significant data breach’ at the health insurance marketplace for Washington, D.C., on Tuesday potentially exposed personal identifiable information of hundreds of lawmakers and staff.
In a letter obtained by NBC News, Chief Administrative Officer Catherine L. Szpindor said Wednesday that the U.S. Capitol Police and the FBI had alerted her to a data breach at DC Health Link, the Affordable Care Act online marketplace that administers health care plans for members of Congress and certain Capitol Hill staff.”

HHS Partners with the Private Sector to Enhance Cybersecurity across Health Systems and Address Future Vulnerabilities Yesterday, “the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), released a cybersecurity implementation guide to help the public and private health care sectors prevent cybersecurity incidents. The Cybersecurity Framework Implementation Guide provides specific steps that health care organizations can take immediately to manage cyber risks to their information technology systems…
[The guide] was jointly developed by HHS ASPR and the Health Sector Coordinating Council (HSCC) Cybersecurity Working Group, a public-private partnership under Presidential Policy Directive 21.  The National Institute for Standards and Technology (NIST) and other federal agencies contributed substantially to its content. Recent high-profile cyberattacks reinforce the need for companies and organizations to assess their cyber health and resilience and take actions to improve cybersecurity.”
About healthcare personnel

 Job Cuts Hit 77,770 In February 2023; Highest YTD Since 2009 “The Health Care/Products space, which includes hospitals and health care products manufacturers, announced the second-most cuts in February with 9,749, for a total of 16,482 this year. That is an 85% increase from the 8,928 cuts announced during the same time last year.” 

Patient perspectives: How patients find and pick their doctors “Here are 3 key takeaways from this year’s findings
An online presence is non-negotiable for attracting new patients
3 in 4 people look online to find out about doctors, dentists, or medical
care — and it’s especially important when people are searching for new care providers. A website is just the start; pay attention to reviews, online directories, and other digital touchpoints.
Text message is still the most popular way to contact patients about appointments Patients appreciate when their healthcare provider keeps them informed about appointments (when they need to be scheduled, when they’re coming up, follow-up information, etc.). For most of these reminders, patients prefer digital interactions, including text messaging.
Patients would engage in social media with providers if they could
Only 18% of respondents said they follow their doctor’s office on social media, but 45% said they would if their doctor posted regularly. Social media is a missed opportunity for practices to engage with patients outside the office.”

About healthcare finance

Fierce Biotech Fundraising Tracker '23 FYI “Like last year's tracker, we will continue to include any fundraising rounds north of $30 million. We'll still profile exciting new companies and larger rounds in-depth, but we’re hoping to focus more coverage on clinical trial results, special reports and enterprise stories…”

Today's News and Commentary

About health insurance/insurers

 Moody's: Insurers should expect slower earnings growth this year “The report found that earnings before interest, taxes, depreciation and amortization growth for publicly traded insurers was 12% for the full year 2022. Their financial performance got a boost from suspended Medicaid redeterminations, reduced COVID-19 costs and strong growth on the Affordable Care Act's (ACA's) exchanges.
The analysts expect that earnings growth this year will slow compared to 2022 as the redeterminations resume but that Medicare Advantage (MA) will remain a bright spot.”

Medicaid/CHIP Enrollment Will Grow To Nearly 95M by the End of March, Analysis Predicts “By the end of March, Medicaid/CHIP enrollment will have grown by 23.3 million members since the start of the pandemic, according to a Kaiser Family Foundation report. This is largely due to the continuous enrollment provision enacted during the pandemic, which barred states from disenrolling members and is set to expire March 31.”

About pharma

 Accelerated approval drug labels often lack information for clinical decision making “253 clinical indications corresponding to 146 drugs received accelerated approval. We identified a total of 110 accelerated approval indications across 62 drugs that had not received full approval by December 31, 2020. A total of 13% of labels for accelerated approved indications lacked sufficient information that approval was via the accelerated approval or based on surrogate outcome measures: 7% did not mention accelerated approval but described surrogate markers, 4% did not mention accelerated approval nor describe surrogate markers, and 2% mentioned accelerated approval but did not describe surrogate markers. No label described the clinical outcomes being evaluated in post-approval commitment trials.”

About the public’s health

 Trust In US Federal, State, And Local Public Health Agencies During COVID-19: Responses And Policy Implications “Public health agencies’ ability to protect health in the wake of COVID-19 largely depends on public trust. In February 2022 we conducted a first-of-its-kind nationally representative survey of 4,208 US adults to learn the public’s reported reasons for trust in federal, state, and local public health agencies. Among respondents who expressed a ‘great deal’ of trust, that trust was not related primarily to agencies’ ability to control the spread of COVID-19 but, rather, to beliefs that those agencies made clear, science-based recommendations and provided protective resources. Scientific expertise was a more commonly reported reason for “a great deal” of trust at the federal level, whereas perceptions of hard work, compassionate policy, and direct services were emphasized more at the state and local levels. Although trust in public health agencies was not especially high, few respondents indicated that they had no trust. Lower trust was related primarily to respondents’ beliefs that health recommendations were politically influenced and inconsistent. The least trusting respondents also endorsed concerns about private-sector influence and excessive restrictions and had low trust in government overall. Our findings suggest the need to support a robust federal, state, and local public health communications infrastructure; ensure agencies’ authority to make science-based recommendations; and develop strategies for engaging different segments of the public.” Emphasis added.

About health technology

 U.S. FDA clears Abbott's blood test for concussions “The U.S. Food and Drug Administration has cleared Abbott Laboratories' blood test that would help doctors assess traumatic brain injury (TBI), commonly known as concussions, the company said on Tuesday.
The clearance marks the first commercially available laboratory blood test for TBI, according to the company, helping the doctors to rule out need for a CT scan in patients with mild TBI.”

Today's News and Commentary

About Covid-19

 U.S. to lift covid testing requirements on travelers from China “U.S. officials are set to relax coronavirus testing requirements on travelers from China as soon as Friday, a decision that comes amid declining covid cases in that country, according to three officials who spoke on the condition of anonymity to describe the plan.
The White House declined to comment on the plan, which the officials said was being finalized on Tuesday.” 

About health insurance/insurers

Joe Biden: My Plan to Extend Medicare for Another Generation Basically comes down to increasing negotiations to lower pharmaceutical costs and raising taxes on unearned income.

CMS ISSUES PAYMENT AND COVERAGE GUIDANCE AS PANDEMIC WAIVERS APPROACH EXPIRATION This article is a good summary of the many changes after the PHE expires.

The Challenges of Choosing Medicare Coverage: Views from Insurance Brokers and Agents “Most brokers and agents said they personally would choose traditional Medicare with Medigap, believing that combination offers better coverage and choices than Medicare Advantage, particularly as people age.”

 10 Medicare Advantage startups with the most venture funding FYI. It will be difficult to find profitability data as many of these companies become part of larger corporations. Recently, Bright Health reported a net loss of $1.4 billion in 2022, compared to a $1.2 billion loss a year prior. Oscar Health recorded a net loss of $606 million in 2022, compared to a net loss of $572 million in 2021.

About pharma

 Cuban breaks into brand-name drug market “Mark Cuban Cost Plus Drug Co. has entered into an agreement with IBSA Pharma to sell Tirosint, a medication for hypothyroidism. It will be the first brand-name drug offered by Mr. Cuban's pharmacy.”

California to not do business with Walgreens over abortion pills issue, Governor says “California will not do business with Walgreens Boots Alliance Inc state Governor Gavin Newsom said in a tweet on Monday, days after the pharmacy chain said it would not dispense abortion pills in some Republican-dominated states.
The state refuses to do business with Walgreens or ‘any company that cowers to the extremists and puts women's lives at risk,’ said Newsom, a Democrat.
A spokesperson for the governor said ‘all relationships’ between Walgreens and the state were now under review but declined to detail how business ties might change.”

From one store in Massachusetts to $105B healthcare giant: A timeline of CVS' disruption FYI

FDA Grants Leqembi Priority Review for Full Approval “The FDA has granted priority review to Eisai’s and Biogen’s supplemental biologics license application (sBLA) for their Alzheimer’s treatment candidate Leqembi (lecanemab-irmb), supporting the biologic’s conversion from Accelerated Approval (AA) to traditional approval.”

About the public’s health

 Vitamin D supplementation and incident dementia: Effects of sex, APOE, and baseline cognitive status “Across all formulations, vitamin D exposure was associated with significantly longer dementia-free survival and lower dementia incidence rate than no exposure (hazard ratio = 0.60, 95% confidence interval: 0.55–0.65). The effect of vitamin D on incidence rate differed significantly across the strata of sex, cognitive status, and APOE ε4 status.”

About healthcare IT

 Key Drivers of Clinician EHR Satisfaction “Similar to a net promoter score, the NEES [Net EHR Experience Score] represents the overall landscape of clinician satisfaction with the EHR…”
Look at the charts for the essential findings of the survey. For example, the top two areas for improvement are system efficiency enablement and response time.

About health technology

A Novel Breakthrough in Wrist-Worn Transdermal Troponin-I-Sensor Assessment for Acute Myocardial Infarction Troponin is assayed in the blood when a patient is suspected of having a heart attack.
The test is almost always done the the ER or hospital. This technology would allow a non-invasive test to be used in the patient’s everyday environment.
”A wrist-worn transdermal infrared spectrophotometric sensor is clinically feasible for rapid, bloodless prediction of elevated hs-cTnI in real-world settings. It may have a role in establishing a point-of-care biomarker diagnosis of myocardial infarction and impact triaging patients with suspected [heart attack].

Today's News and Commentary

About Covid-19

 CDC: XBB.1.5 Responsible for 90% of New Coronavirus Infections “According to updated estimates from the Centers for Disease Control and Prevention, XBB.1.5 caused nearly 90% of new coronavirus cases this week. That’s up from 85% of cases last week. It’s the only strain showing significant growth.
Coronavirus cases, hospitalizations and deaths are on the decline, signaling that the U.S. has avoided a large seasonal COVID-19 surge like it saw the past two years. The main reason is likely the high level of immunity across the population whether through vaccination, infection or both.
Still, nearly half of U.S. counties are experiencing a “high” level of COVID-19 transmission, according to CDC data.”
 
Parental Nonadherence to Health Policy Recommendations for Prevention of COVID-19 Transmission Among Children “In this survey study of US parents, one-quarter engaged in misrepresentation or nonadherence regarding PHMs for their children. The most common reason was to preserve parental autonomy. Additional reasons included wanting to resume a normal life for their child and the inability to miss work or other responsibilities, among other reasons.
These results suggest that some PHMs implemented to limit the spread of COVID-19 may have been compromised due to misrepresentation and nonadherence by parents on behalf of their children, contributing to COVID-19–related morbidity and mortality. In addition, some children appear to have received a vaccine that was not fully tested and approved in their age group.”

About health insurance/insurers

 Date Set for Restoring Medicaid Benefits in Covid-19 Rule Row “States that ended or modified Medicaid benefits due to a likely defunct HHS rule must restore benefit levels to those that were in effect at the time they were terminated, a federal court said.
Judge Michael P. Shea clarified a Jan. 31 order in which he certified a beneficiary class and told US Health and Human Services Secretary Xavier Becerra to reinstate previous guidance issued under the Families First Coronavirus Response Act.
The guidance prohibited states from kicking people off Medicaid or reducing their benefits in exchange for additional Medicaid money provided by HHS during the pandemic.”

About pharma

OGD sees higher approvals in 2022 “The number of US generic drug approvals rebounded in 2022 after a drop in 2021. In calendar year 2022, the US Food and Drug Administration (FDA) approved or tentatively approved 917 abbreviated new drug applications (ANDAs).
 In 2021, FDA approved or tentatively approved 776 ANDAs for generic drugs, down from 948 in 2020 and 1,014 in 2019. The latest figures are part of FDA’s Office of Generic Drugs (OGD) 2022 Annual Report.”

 About the public’s health

 Rates of congenital syphilis are skyrocketing in the US. Here’s why “Over the past decade, ‘there’s been about a 700% increase in the cases of congenital syphilis in the United States,’ said Dr. Robert McDonald of the US Centers for Disease Control and Prevention’s Division of STD Prevention, Surveillance and Data Management…
Rates of congenital syphilis, meaning the number of cases for every 100,000 live births, are highest in the South and Southwest, in states such as Arizona, New Mexico, Louisiana, Mississippi and Texas, according to a CNN analysis of CDC data.”
The multiple reasons for this surge, especially funding cutbacks, are discussed.

Cardiovascular Risk Factor Prevalence, Treatment, and Control in US Adults Aged 20 to 44 Years, 2009 to March 2020 “In this serial cross-sectional study of 12 924 adults aged 20 to 44 years, there were increases in the prevalence of diabetes (from 3.0% to 4.1%) and obesity (from 32.7% to 40.9%), no improvement in the prevalence of hypertension (from 9.3% to 11.5%), and a decrease in the prevalence of hyperlipidemia (from 40.5% to 36.1%) from 2009-2010 to 2017-2020. Black young adults had the highest rates of hypertension over the study period, and increases in hypertension were observed among Mexican American and other Hispanic adults, while Mexican American adults experienced a significant rise in diabetes. Blood pressure control did not significantly change among young adults treated for hypertension, while glycemic control remained suboptimal throughout the study period.”

About healthcare IT

 Teladoc-owned BetterHelp to pay $7.8M to online therapy users for alleged data misuse, per FTC order “ As part of a proposed order announced Thursday, BetterHelp is banned from sharing consumers’ health data, including sensitive information about mental health challenges, with third parties for marketing and ad targeting.
BetterHelp also agreed to pay $7.8 million to consumers to settle charges that it revealed consumers’ sensitive data with third parties for advertising after promising to keep such data private, according to a FTC press release.”

About health technology

FDA warns of false negative results for food allergies after skin test recall “All skin tests doctors commonly use to check for food allergies can provide false negative results, the Food and Drug Administration has concluded — meaning people with potentially life-threatening allergies could mistakenly be told they are not at risk. The tests will now be required to include a warning urging doctors to consider double-checking the test with more accurate approaches.
The FDA's new mandated warning, announced Friday, comes after a recall in December of some skin tests used for testing food allergies.” 

 Precision medicine company Tempus inks 3rd major pharma deal, securing nearly $1B revenue boost “As part of a multiyear strategic collaboration, Pfizer will tap multiple parts of Tempus' AI platform and its data library to advance clinical discovery.
In the past two years, Tempus has notched partnerships with global pharmaceutical companies to boost its work in drug discovery and precision oncology. The company has an expanded collaboration with GSK to enable the U.K. pharma giant to leverage its AI-enabled patient data platform. GSK recently paid Tempus $70 million upfront for three more years of partnership.
Tempus also inked a partnership with AstraZeneca to use its AI technologies to advance cancer drug development.
These three pharma deals collectively represent approximately $700 million in revenue over the next few years, according to Tempus executives.”