Today's News and Commentary

About Covid-19

Pfizer, BioNTech find updated COVID booster protects against Omicron in trial “In a joint statement on Thursday, the companies said data from roughly 80 adult patients showed the booster dose led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after one week.”

Biden administration extends COVID public health emergency “The Biden administration said Thursday that the COVID-19 public health emergency will continue through Jan. 11…”

 11.5M Americans have received updated COVID booster: CDC “About 11.5 million Americans have received the updated bivalent COVID-19 booster, according to data from the Centers for Disease Control and Prevention.”

About health insurance/insurers

 UnitedHealth Group reports $5.3B in Q3 profit, revenues up 12% year over year “UnitedHealth Group said the boost in revenue reflects significant growth at both UnitedHealthcare and Optum. At UnitedHealthcare, revenues grew 11% year over year to $62 billion. The number of people served by UnitedHealthcare has grown by 850,000 over the first three quarters, including 185,000 new lives added in the third quarter.” 

Medicare open enrollment starts Oct. 15. Here’s what’s new for 2023. “Lower premiums, insulin price caps, free shingles vaccines: There are some noteworthy changes to Medicare for 2023, and the annual open enrollment period is a good time to check them out.”

Lawsuit by KHN Prompts Government to Release Medicare Advantage Audits Federal health officials have agreed to make public 90 audits of private Medicare Advantage health plans for seniors that are expected to reveal hundreds of millions of dollars in overcharges to the government.
The Centers for Medicare & Medicaid Services agreed to release the records to settle a lawsuit filed by Kaiser Health News against the agency in September 2019 under the Freedom of Information Act'.”

About pharma

 Walgreens aims to rapidly scale US healthcare business next year “Despite the rosy outlook, WBA's financial results lagged behind last year. The company's fourth quarter sales were down 5.3 percent to $32.4 billion, and net loss from continuing operations was $415 million, compared to $358 million net income for the same period last year. Sales from continuing operations were slightly up to $132.7 billion for the full year.
In the fourth quarter, U.S. digital sales were up 14 percent, and the company's myWalgreens membership topped 102 million members. It's continuing to roll out VillageMD with 342 total clinics — 82 opened in the last year — and 152 co-located clinics open. By the end of the calendar year, the company is on track to have 200 co-located clinics.”

2022 Biosimilar Trends Report An excellent review of the current state of the industry. 

About healthcare IT

 Samsung partners with HealthTap to bring virtual primary care to smart TVs “Through a new partnership with virtual primary care company HealthTap, Samsung Smart TV users can connect to the company's healthcare platform and visit with a doctor of their choice using the built-in camera on their television, according to the companies in a press release.
Consumers can review doctor bios, credentials and video interviews to select a doctor and easily schedule an appointment, often within the same week. 
HealthTap developed its platform to provide members access to a long-term primary care doctor to address ongoing health conditions as well as preventive care and referrals. At a cost of $15 per month, consumers get access to free texting with their doctor, $39 video appointments and $59 visits for 24/7 urgent care with the first available clinic doctor. The platform also includes a network of 90,000 volunteer U.S. doctors across 147 specialties providing free informational answers to health questions from HealthTap members.
The company says it serves tens of millions of consumers online and provides many thousands of doctor visits each year. The company has raised $88 million to date, according to Crunchbase.”

Today's News and Commentary

About hospitals and healthcare systems

 Fitch: Children's hospitals showing stronger liquidity, profitability than adult providers “Standalone nonprofit children’s hospitals have largely rebuffed the pandemic’s financial disruptions and are in a better position to "weather expected and unexpected challenges” including high labor costs, according to a new Fitch Ratings report.
Among a sample of 23 organizations, children’s hospitals increased their median days cash on hand from 396.1 days in fiscal 2020 to 416 days in fiscal 2021, the agency’s analysts wrote. Median cash to debt rose from 249.1% to 323.5%, they wrote.”

About pharma

 Medicare Drug Negotiation and Rebate Group Formally Organized “The Biden administration has formally established the Medicare Drug Rebate and Negotiations Group to implement Medicare drug price negotiations and the inflation rebate program authorized under the Inflation Reduction Act of 2022.
Operating within the Center for Medicare, the new group, and the reorganization it required, was approved by HHS Secretary Xavier Becerra and took effect Oct. 8, according to a summary document released Wednesday that will be published in the Federal Register Oct. 14.”

About the public’s health

USDA awards $110M toward improving rural healthcare “The U.S. Department of Agriculture has invested $110 million toward healthcare facilities in rural areas. 
The grant will affect 208 rural facilities and help provide services to 5 million people across 43 states. Funds will go toward renovating, building and equipping facilities and be distributed through the American Rescue Plan Act, according to an Oct. 12 news release.”

HHS Announces Initiatives to Address Language Barriers in Care Access “The US Department of Health and Human Services (HHS) has announcedseveral commitments to ease language barriers preventing care access…
As a first step, HHS announced it will relaunch its Language Access Steering Committee (Steering Committee) to enhance communication with LEP [limited English proficiency] patients. Alongside the Steering Committee, HHS will require all agencies to update their language access plans. 
In concert with the committee relaunch, the HHS Office of Minority Health (OMH) announced it will distribute more than $4 million in grants to 11 organizations for an initiative called Promoting Equitable Access to Language Services in Health and Human Services.
Through the three-year initiative, organizations will develop and test methods for informing patients with LEP about accessibility to language services in healthcare-related settings.”

GSK says RSV vaccine offers "exceptional" protection in older adults “GSK announced Thursday that its experimental vaccine RSVPreF3 OA demonstrated overall efficacy of 82.6% against respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD) in adults aged 60 years and above. The company said earlier this year that the primary endpoint of the Phase III AReSVi 006 study was "exceeded," without providing further details at the time.”

About health technology

 Skip the doctor's office? Quest Diagnostics pitches consumer testing in new ad campaign “Quest Diagnostics’ line-up of 50+ tests, from sexually transmitted disease screenings to allergy and metabolic panels, lets people skip the line at doctors’ offices and get results at home. And now it’s launching its largest inaugural consumer marketing campaign in support…
The 30-second commercial directs viewers to the Quest Health website where they can browse and purchase its more than 50 tests — from $39 for gout or cholesterol information to $349 suites of men’s or women’s assessments. Interested shoppers’ tests are ordered by a physician digitally, scheduled at their nearby Quest Diagnostic labs, and results are then delivered to their private MyQuest portal, said Ryan Anderson, Quest’s executive director of consumer marketing. Its biggest selling category to date? STD tests. While people can’t use traditional insurance for the Quest Health tests, they can use funds from health flexible spending accounts (FSAs).”

Today's News and Commentary

About Covid-19

 FDA authorizes adolescent use of Omicron-specific boosters “The FDA has authorized Pfizer and BioNTech’s booster in children ages 5 through 11, the companies announced on Wednesday, as well as Moderna’s formulation in kids 6 through 17 years old. Both shots are specific to the Omicron BA.4/BA.5 subvariants, which account for more than 80% of cases in the US, according to Pfizer.”

About health insurance/insurers

 Biden administration's 'family glitch' fix kicks in soon “Individuals who do not have access to affordable health insurance through their employers can qualify for subsidies to purchase plans through the ACA marketplace. These affordability definitions only applied to individuals, not families, meaning many people were not eligible for subsidies. 
The IRS and Treasury Department are implementing the final rule designed to fix the glitch, according to a White House press release issued Oct. 11. 
Starting next month, people can sign up for subsidies for families if they cannot receive affordable insurance from their employer, according to the release.”
 

About hospitals and healthcare systems

 Expansion of the Veterans Health Administration Network and Surgical Outcomes “In this nonrandomized regression discontinuity study of 615 473 unique surgical procedures among 498 427 patients, expanded access to care was associated with a greater proportion of surgical procedures in a community setting, and this proportion varied by procedure type. However, no difference in postoperative emergency department visits, inpatient readmissions, or mortality was found between VHA-provided and VHA-paid procedures in the community setting.
Meaning  Expanding access to health care outside of the VHA was associated with a shift in the location of surgical procedures among veterans but had no association with postoperative outcomes; these findings may assuage concerns of worsened patient outcomes resulting from care coordination issues when care is expanded outside of a single health care system.” 

About the public’s health

 NOWHERE TO GO: MATERNITY CARE DESERTS ACROSS THE U.S. (2022 REPORT) Report from The March of Dimes: “THE NEW FINDINGS:

  • Areas where there is low or no access affect up to 6.9 million women and almost 500,000 births across the U.S.

  • This includes a five percent increase in counties that have less maternity access since 2020.

  • In maternity care deserts alone, approximately 2.2 million women of childbearing age and almost 150,000 babies are affected.

  • There’s a two percent increase in counties that are maternity care deserts since our 2020 report. That’s 1,119 counties and an additional 15,933 women with no maternity care.

  • Florida had the most women impacted by improvements to maternity care access (more than 92,000).

  • Ohio had the most women impacted by overall reductions in access to care (over 97,000).”

About healthcare IT

 Survey Finds Majority of Healthcare Consumers Conditioned to Not Shop Around for the Best Price “6 in 10 Americans have never tried to research pricing for services; 58% of Americans would shop around for optimal pricing in healthcare if pricing data is provided prior to service needed.”

 25% of ransomware attacks cause healthcare organizations to halt operations, study says “A new study from cybersecurity company Trend Micro Incorporated found that 25 percent of healthcare organizations hit by ransomware attacks were forced to halt operations completely.
The study also revealed that 86 percent of global healthcare organizations affected by ransomware attacks suffered operational outages, according to the Oct. 11 Trend Micro news release.”

Today's News and Commentary

About Covid-19

 Nasal version of Oxford/AstraZeneca Covid vaccine fails in trial “A nasal version of the Oxford/AstraZeneca Covid-19 vaccine has failed in an early-stage trial, dealing a blow to hopes for a more effective way to prevent transmission of the virus. Oxford university said on Tuesday a nasal formulation of the vaccine elicited mucosal antibody responses in a ‘minority of participants’ and systemic immune responses were weaker compared with intramuscular vaccination.”

About health insurance/insurers

 Centene barred from growing some Medicare Advantage plans “Centene will not be allowed to expand its Medicare Advantage footprint in certain geographies next year after its plans consistently received poor scores in the federal quality ratings program. 
The insurer will be unable to expand nine of its 108 contracts in 2024, according to an analysis by HealthMine, a consultancy for health insurance companies. About 84,000, or 5%, of Centene’s 1.5 million Medicare Advantage members with Part D prescription drug coverage are enrolled in the nine plans, which cover counties in Ohio, North Carolina, Arizona, Connecticut and Nevada.”

Health plans say texting could help reach underserved patients. But a federal rule is getting in their way “Health plans trying to reach low-income and underserved customers say they’re being stymied by a decades-old federal rule limiting texting — and they’re framing it as a health equity issue in their bid to change it. 
Low-income and underserved patients, they say, are more likely to see and respond to texts about their health than they are to answer calls from unknown numbers or to receive mailed notices, especially if they’re at work or move frequently. But a 1991 law designed to protect consumers from unwanted telemarketing blocks health plans contracting with Medicaid from texting patients without their prior consent, meaning that they can’t send reminders about services like mammograms or well-child visits unless they’ve reached the patient by phone or mail first.”

Healthcare billing fraud: 10 recent cases Nine of ten are explicitly Medicare and/or Medicaid.

About pharma

 For $392M, Walgreens to fully acquire CareCentrix “About a month after acquiring a majority stake in CareCentrix, Walgreens Boots Alliance said Oct. 11 it plans to fully own the home healthcare company for $392 million. 
Walgreens said the acquisition of CareCentrix, which reported sales of $1.5 billion in 2021, will be completed by March 2023.”

Rite Aid, Google Cloud partner to create the 'modern pharmacy' “Rite Aid will partner with Google Cloud to introduce Google's Anthos platform to its more than 2,350 pharmacies, the companies said Oct. 11. 
The yearslong partnership is "defining the modern pharmacy," Carrie Tharp, vice president of retail and consumer solutions of Google Cloud, said in a statement. 
With Google Cloud, the retail pharmacy plans to transition its "vaccine scheduling tool, customer messaging infrastructure and digital engagement platform" into an app.”

About the public’s health

 Walmart's Healthcare Research Institute Launches With Mission To Improve Care for Underserved Communities Through Research “Today, Walmart is announcing the launch of the Walmart Healthcare Research Institute SM (WHRI) to increase community access to healthcare research that may help lead to safer, higher quality and more equitable healthcare.
WHRI will be focused on innovative interventions and medications that can make a difference in underrepresented communities including older adults, rural residents, women and minority populations. WHRI initially is focused on inclusion in studies on treatments for chronic conditions and innovative treatments that should include members from these communities.”

Screening for Depression and Suicide Risk in Children and Adolescents “The USPSTF concludes with moderate certainty that screening for MDD [major depressive disorders] in adolescents aged 12 to 18 years has a moderate net benefit. The USPSTF concludes that the evidence is insufficient on screening for MDD in children 11 years or younger. The USPSTF concludes that the evidence is insufficient on the benefit and harms of screening for suicide risk in children and adolescents owing to a lack of evidence.”

About healthcare IT

 Risks are low for sharing patient data, study finds “Between September 2016 and September 2021, there were no instances of deidentified data being reidentified, according to the review of more than 10,000 U.S. media publications. During the same period, more than 100 million health records were stolen in data breaches from supposedly secure systems.” 

Today's News and Commentary

About Covid-19

 Few Americans get new covid booster shot ahead of projected winter surge “Only about 105 million U.S. adults — roughly 40 percent — have received the third shot of vaccine initially offered a year ago, according to federal data, a far lower rate than countries like the United Kingdom, where more than 70 percent of adults have gotten a third dose. That figure is also well behind the 200 million U.S. adults who completed their primary series of shots.”  

About health insurance/insurers

The Role Of Administrative Waste In Excess US Health Spending  “Per the research summarized…, administrative spending accounts for between 15 and 30 percent of medical spending. Some of these estimates encompass only billing- and insurance-related expenses and, as a result, are lower than those that include both billing- and insurance-related and non–billing- and insurance-related costs. Even at the lower end of estimates, US spending on administrative costs annually accounts for twice the spending on care for cardiovascular disease and three times the spending for cancer care…
if administrative spending is about 15–30 percent of national health spending, then wasteful administrative spending comprises half of that, or 7.5–15 percent of national health spending (or $285–$570 billion in 2019).” 

About pharma

 EU says Teva likely breached antitrust rules to delay Copaxone competition “The European Commission on Monday said that Teva likely breached antitrust rules in an effort to delay competition to its multiple sclerosis (MS) drug Copaxone (glatiramer acetate). The Commission noted that Teva ‘artificially’ extended patent protection for Copaxone and spread "misleading" information about a competing product.” 

About the public’s health

 FDA authorizes Abbott’s monkeypox PCR test for emergency use “The FDA has issued an emergency use authorization to Abbott Molecular for its real-time PCR test for monkeypox using lesion swab specimens from those with suspected virus infection.
The PCR test (Alinity m MPXV) is the first commercial test to be authorized for detection of monkeypox and is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, according to an FDA press release.”

FDA Approves Boostrix for Whooping Cough Prevention “The FDA has approved GlaxoSmithKline’s Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) vaccine for immunization during the third trimester of pregnancy to prevent pertussis, or whooping cough, in infants younger than two months of age.”

Today's News and Commentary

About Covid-19

Evusheld Likely Not Effective Against Omicron, FDA Says “The FDA has updated its fact sheet for healthcare providers for the use of AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) which is authorized for emergency use for treatment of COVID-19 infections.
The agency warned that the injectable treatment might not be able to neutralize certain SARS-CoV-2 viral variants and that Evusheld might not be effective at preventing COVID-19 caused by the variants.”

Merck Covid antiviral pill did not cut hospitalisation risk, study finds “Results from a UK pivotal trial showed that Merck & Co.'s COVID-19 antiviral pill Lagevrio (molnupiravir) failed to lower the risk of hospitalisation and death among adults at higher risk from the disease, reported Financial Times.”

APIC urges members to disregard new CDC masking guidelines “The recent relaxation of masking guidelines for healthcare professionals by the Centers for Disease Control and Prevention (CDC) seems a bit premature to one professional organization.
In fact, infection preventionists should disregard the CDC’s updated recommendation and maintain mandatory masking requirements for healthcare workers who come into contact with patients, states the Association for Professionals in Infection Control and Epidemiology (APIC) in a press release.”

Newsom signs bill to police California doctors on COVID-19 misinformation “California doctors will be subject to discipline and possible suspension of their licenses to practice for spreading misinformation about the COVID-19 pandemic to patients, following Gov. Gavin Newsom’s signature of one of the most controversial pieces of pandemic legislation lawmakers sent to his desk.
AB 2098 by Assemblyman Evan Low, D-Campbell, was co-sponsored by the California Medical Association to tamp down COVID-19 misinformation, often spread through social media, promoting untested or ineffective treatments and cures and questioning the effectiveness of face masks and vaccines.”

 CDC ends daily reporting of COVID case and death data, in shift to weekly updates “After more than two years of publishing data on COVID-19 cases and deaths on a daily basis, the Centers for Disease Control and Prevention announced Thursday it would shift to weekly updates to its nationwide tracking of the virus.”

About health insurance/insurers

Readmission Reduction as a Hospital Quality MeasureTime to Move on to More Pressing Concerns? A good, thoughtful review of the topic.

Elevance Health faces Medicare Advantage fraud suit “Elevance Health is facing a federal lawsuit alleging the insurer received more than $100 million in overpayments from CMS after a judge declined to dismiss the suit, the Indianapolis Business Journal reported Oct. 5.”

 Comparison of Health Care Utilization by Medicare Advantage and Traditional Medicare Beneficiaries With Complex Care NeedsQuestion  Do rates of health care utilization for beneficiaries with complex care needs differ between traditional Medicare and Medicare Advantage (MA)?
Findings  In this cross-sectional study of 1 844 326 Medicare beneficiaries, those enrolled in MA had lower rates of hospital stays, emergency department visits, and 30-day readmissions. The largest relative differences were observed for hospital stays, which ranged from −9.3% to −11.9% across different cohorts of beneficiaries with complex care needs.”

About hospitals and healthcare systems

 CommonSpirit Health seeks to raise $1.5B from bond issues “CommonSpirit Health has issued a pair of bonds as it aims to raise $1.5 billion to cover past and future expenses.
Chicago-based CommonSpirit will use the proceeds to refinance prior debt, reimburse prior capital expenditures and fund general corporate purposes…”

About pharma

FDA Awards $1.3 Million Grant to Biologics & Biosimilars Collective Intelligence Consortium “The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) announced… that it has received a major grant from the Food & Drug Administration (FDA) in support of biosimilars research. The award provides $1.3 million over two years for a new BBCIC study focused on increasing the efficiency of biosimilar drug development and review.
The study—entitled "Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data to Produce Real-World Evidence"—reflects BBCIC's longstanding commitment to evaluating the safety and effectiveness of biologics, including biosimilars, through the generation of reliable, real- world data (RWD) and evidence (RWE).”

 Mark Cuban Cost Plus Drug Company announces first health plan partner, Capital Blue Cross “Beginning this month, the Pennsylvania-based plan and Mark Cuban's drug company (MCCPDC) will begin to let members and community organizations know about their collaboration and how they can access low-cost drugs, according to a press release. In 2023, Capital Blue Cross members will be able to use their insurance cards at the company's online pharmacy.”

Novo Nordisk ready to submit once-weekly insulin to FDA after scoring final phase 3 win “Icodec demonstrated non-inferiority in reducing hemoglobin A1c, a measure of blood sugar, in patients with type 2 diabetes at week 52 when compared with once-daily basal insulin analogs. Specifically, participants who received Icodec saw an HbA1c reduction of 1.68% points, compared with 1.31% for patients who received once-daily basal insulins.”

HHS: Specialty drug costs up more than $300 billion since 2016 “Key takeaways:

--HHS released two reports that showed the U.S. health care system spent about $603 billion on prescription drugs in 2021.

--The cost of specialty drugs has continued to grow, increasing 43% since 2016 and representing 50% of total drug spending in 2021.

--HHS said the reports highlight the potential benefits of the Inflation Reduction Act. If the legislation had been in place from July 2021 to July 2022, at least 1,200 drugs may have been subjected to a provision that now requires manufacturers to pay Medicare rebates if they implement a price increase that is higher than drug inflation.”

US considers first over-the-counter birth control pill “Two US Food and Drug Administration advisory committees will in November consider an application by HRA Pharma, a subsidiary of Perrigo Company, to sell a previously prescription-only oral contraceptive pill over the counter. It is the first such application to be considered by the agency, which is also in talks with another company, Cadence Health, over its plan to sell contraceptive pills in the same manner.”

About the public’s health

Smoking Costs U.S. Economy Almost $900 Billion a Year  “Smoking isn't only costly in terms of health risks, it also cost the U.S. economy $891 billion in 2020.
That was almost 10 times the cigarette industry's $92 billion revenue, according to the authors of a new American Cancer Society study.”

2022 National Survey: Attitudes about Influenza and Pneumococcal Disease, and the Impacts of COVID-19 “The National Foundation for Infectious Diseases (NFID) commissioned an annual survey to better understand beliefs about influenza (flu) and pneumococcal disease, as well as attitudes and practices around vaccination, including the impacts of the COVID-19 pandemic…”
Some highlights:
--"69% agree that annual flu vaccination is the best preventive measure against flu-related deaths and hospitalizations but only 49% plan to get a flu vaccine during the 2022-2023 flu season
--Of concern, about 1 in 5 (22%) who are at higher risk2 for flu-related complications said they were not planning to get vaccinated this season”

Guide to Evidence for Health-Related Social Needs Interventions: 2022 Update “This updated evidence guide is intended for users of the Return on Investment (ROI) Calculator for Partnerships to Address the Social Determinants of Health, sponsored by the Commonwealth Fund. It summarizes our most recent assessment of the evidence available for the calculator to establish a business case for sustainable financial arrangements between health care and community-based organizations serving adults with complex health and social needs.”
This monograph is an excellent resource evidence-based SDOH interventions.

About healthcare IT

Google Cloud introduces digital suite for medical imaging “Google Cloud is rolling out a set of tools specifically for digital imaging, designed to make diagnostic data more accessible and interoperable.
The company’s Medical Imaging Suite will also serve as a gateway for the development and implementation of artificial intelligence programs for quickly parsing patient scans and potentially finding hidden details.”

Call it data liberation day: Patients can now access all their health records digitally “Under federal rules taking effect Thursday, health care organizations must give patients unfettered access to their full health records in digital format. No more long delays. No more fax machines. No more exorbitant charges for printed pages.”

About health technology

 Natera’s Blood Test for Ovarian Cancer Relapse Shows Promise in Study “Natera’s Signatera circulating tumor DNA (ctDNA) test outperformed the cancer antigen CA 125 test by one month and radiological imaging by 10 months in identifying patients with the highest risk of recurrence of epithelial ovarian cancer (EOC), researchers reported in the journal Gynecologic Oncology.

Today's News and Commentary

About Covid-19

 CDC revises 'up to date' term on COVID-19 vaccination “The CDC revised its "up to date" COVID-19 vaccination term Sept. 30 to include the primary series and the recently authorized omicron-targeting booster.”

Supreme Court declines 10 states' challenge to CMS' vaccine mandate “The U.S. Supreme Court on Oct. 3 declined a case brought by 10 states challenging the Biden administration's rule that requires employees to be vaccinated against COVID-19 if they work in healthcare facilities that receive federal funding.”

U.S. CDC ends country-specific COVID travel health notices “The Centers for Disease Control and Prevention (CDC) said on Monday it had ended its COVID-19 country travel health notices as fewer countries reported enough data for accurate assessments.”

About health insurance/insurers

 A boost for biosimilars payments unveiled by CMS “CMS announced Monday that it had started to implement a temporary reimbursement boost for biosimilars that is mandated in the Inflation Reduction Act.
Under the law, the add-on payment for biosimilars administered in physician offices, hospital outpatient departments, and ambulatory surgical centers will be 8% of the average sales price (ASP) or the reference drug. Prior to enactment of the IRA, the add-on payment for biosimilars was 6% of the reference product’s ASP.”
Comment: Physicians will still be incentivized to use the most expensive products.

Federal employee health-care premiums to rise 8.7 percent on average “Premiums in the health-care program for federal employees and retirees will increase by 8.7 percent on average for 2023 — the largest increase in more than a decade, the government announced Friday.
That change in Federal Employees Health Benefits Program premiums is significantly larger than the 3.8 percent average increase for 2022, although closer to the 5-7 percent range of most other recent years.
The cost increase is a reflection of rising prices for some drugs and higher uses of professional services and outpatient treatments, said the Office of Personnel Management.”

About hospitals and healthcare systems

 7-hospital system files for bankruptcy “Pipeline Health System, which includes seven hospitals in three states, filed for Chapter 11 bankruptcy Oct. 2. 
El Segundo, Calif.-based Pipeline said the decision to enter bankruptcy was prompted by several factors, including financial challenges tied to skyrocketing costs and delayed payments from insurance plans.”

Trinity Health reports $1.4B annual loss “Higher labor costs put pressure on Trinity Health's margins in fiscal year 2022, according to financial documents released Sept. 30. 
Livonia, Mich.-based Trinity Health posted revenue of $19.93 billion in the 12 months ended June 30, down from $20.16 billion a year earlier. The health system said net patient service revenue was up 1.8 percent year over year, primarily because of increased outpatient volume and payment rates.”

About pharma

 OIG raises concerns about accelerated approval pathway “More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years past their confirmatory trial deadlines, according to a recent report released by the US Department of Health and Human Services Office of Inspector General (OIG)…
OIG’s report examined 278 drugs approved by the FDA Center for Drug Evaluation and Research (CDER) between 1992 and December 2021 to estimate the number of drug applications that completed confirmatory trials. The authors of the report also evaluated Medicare and Medicaid claims data between 2018 and 2021 for drug applications that received accelerated approval but had not yet completed confirmatory trials.
The authors of the report found 104 drug applications (37.8%) have not completed confirmatory trials, 35 drug applications (33.6%) had one or more trials that missed a completion date, and 4 drug applications had significantly passed the originally-planned clinical trial completion date by between 5–12 years. For the 139 drug applications (50.0%) where confirmatory trials were completed, the average time to completion was 48 months.”

Today's News and Commentary

About health insurance/insurers

 18 payers to join CMS value-based Medicare Advantage model for 2023 “CMS' Value-Based Insurance Design program for Medicare Advantage plans is growing for 2023, expanding to 52 participating organizations, the agency said Sept. 29. 
CMS estimates the number of enrollees covered by the program will increase by 24 percent this year with the new participating organizations, according to a news release. 
The model, started in 2017, is designed to test improvements in care quality for Medicare Advantage plan enrollees, including people with low income and those dually eligible for Medicare and Medicaid. 
Medicare Advantage plans participating in the test can offer supplemental benefits like nutrition and transportation assistance, reduced cost sharing, or other incentives designed to promote healthy behavior and health equity.”

Optum, Change Healthcare complete $7.8B merger “Optum has completed its $7.8 billion merger with Change Healthcare. 
Optum's parent company, UnitedHealth Group, completed the acquisition Oct. 3, which merges Optum with healthcare data and analytics giant Change Healthcare, according to an Oct. 3 press release. The acquisition allows Optum to gain access to data from millions of healthcare transactions covering a broad swath of the U.S. population.”

Health care costs in retirement: They could exceed $300K for women, $264K for men “A healthy 65-year-old man can expect to incur up to $264,000 in health care expenses during retirement, while a woman retiring at age 65 may spend up to $300,000, according to a projection by consulting and actuarial firm Milliman Inc.
The 2022 Retiree Health Cost Index projects total premiums and out-of-pocket expenses for medical and prescription drug costs in retirement and looks at cost variations across sex, geography and the two most common coverage options for Medicare-eligible retirees.
According to Milliman, a healthy 65-year-old man with a Medicare Advantage plus Part D (MAPD) plan will spend $137,000 in health care expenses, while the same retiree with Original Medicare with Medigap (Plan G) and Part D is projected to spend $264,000. A corresponding woman on MAPD will spend $158,000 and on Original Medicare will spend $300,000. That equates to savings needed of between $92,000 and $177,000 for a man and $103,000 and $194,000 for a woman. Higher health care costs for women are largely the result of longer life expectancy when compared to men.”

About hospitals and healthcare systems

 September 2022 National Hospital Flash Report Highlights:
1.Volumes were higher in August than in July, boosting revenue. However, costs still climbed slightly month-over-month as hospitals and health systems continue to shoulder heightened expense loads.

2. Expenses rose, but not as much as revenue. Supplies and expensive drugs contributed to this uptick more than labor costs, which remain elevated.

3. Outpatient revenue slightly drove up margin. This metric is substantially higher than it was in August of 2021. It demonstrated the most growth month-over-month as patients scheduled more elective procedures.

4. Hospitals are still facing extreme difficulty. Nine months into a challenging year, margins have fluctuated wildly. Although most metrics improved from July to August, organizations are still operating with negative margins and well below pre-pandemic levels.

5. New market entrants present strategic challenges. As disruptors chip away at outpatient volume, hospitals should reimagine how to deliver care in non- hospital settings as part of their long-term planning.

About pharma

Amylyx's ALS drug will cost $158K for annual supply “A recently approved amyotrophic lateral sclerosis treatment will be $158,000 for a year's supply, the product's manufacturer said in a Sept. 30 investor conference call, according to The New York Times.”

Rite Aid lost $331M in Q2 “Rite Aid reported a loss of nearly $331.3 million in its second fiscal quarter, which is three times more than its loss in its 2021's second quarter…
the Philadelphia-based retail pharmacy chain attributed the most recent financial results to inflationary pressures.”

HHS: Price of more than 1,200 drugs outpaced inflation “Between July 2021 and July 2022, the prices for 1,216 drugs rose more than the 8.6 percent rate of inflation, with these products having an average price increase of 31.6 percent. The price increases observed in 2022 were affected by the high rate of general inflation this year. The HHS report noted that most drug price increases occur in either January or July.
The prices for some drugs rose by more than 500 percent in 2022. The antifungal fluconazole, a common medicine, saw increases of 1101 percent, with the price of one 150 mg tablet rising from $2 to $28.
Some of the drugs that saw the highest dollar amount increases in 2022 include lymphoma medications like Tecartus, Yescarta and Zevalin as well as diabetes medications like Korylm, though the overall percentage increases were small due to the already enormous cost of these drugs.”

About healthcare IT

 Prevalence and Sources of Duplicate Information in the Electronic Medical Record “In this cross-sectional analysis of 104 456 653 routinely generated clinical notes, 16 523 851 210 words (50.1% of the total count of 32 991 489 889 words) were duplicated from prior documentation. Duplicate content was prevalent in notes written by physicians at all levels of training, nurses, and therapists and was evenly divided between intra-author and inter-author duplication.” 

Today's News and Commentary

About health insurance/insurers

 Biden-Harris Administration Announces Lower Premiums for Medicare Advantage and Prescription Drug Plans in 2023 “he projected average premium for 2023 Medicare Advantage plans is $18 per month, a decline of nearly 8% from the 2022 average premium of $19.52. Medicare Advantage plans will continue to offer a wide range of supplemental benefits in 2023, including eyewear, hearing aids, preventive and comprehensive dental benefits, access to meals (for a limited duration), over-the-counter items, and fitness benefits.
In addition, more than 1,200 Medicare Advantage plans will participate in the CMS Innovation Center’s Medicare Advantage Value-Based Insurance Design (VBID) Model in 2023, which tests the effect of customized benefits that are designed to better manage diseases and meet a wide range of health-related social needs, from food insecurity to social isolation. The benefits under this model are projected to be offered to 6 million people.”

Understanding Medicare Advantage Payment A really good summary of the issues around Medicare Advantage plans, along with recommendations for correction of problems.

Association of Oncologist Participation in Medicare’s Oncology Care Model With Patient Receipt of Novel Cancer Therapies Question  Was implementation of Medicare’s Oncology Care Model in 2016 associated with a decrease in patient receipt of novel cancer therapies?
Findings  This cohort study included 2839 patients with cancer who were eligible to receive a novel cancer therapy. The start of the Oncology Care Model did not correspond with a decreased likelihood of receiving a novel therapy.”

The State of U.S. Health Insurance in 2022: Findings from the Commonwealth Fund Biennial Health Insurance SurveySurvey Highlights

  • Forty-three percent of working-age adults were inadequately insured in 2022. These individuals were uninsured (9%), had a gap in coverage over the past year (11%), or were insured all year but were underinsured, meaning that their coverage didn’t provide them with affordable access to health care (23%).

  • Twenty-nine percent of people with employer coverage and 44 percent of those with coverage purchased through the individual market and marketplaces were underinsured.

  • Forty-six percent of respondents said they had skipped or delayed care because of the cost, and 42 percent said they had problems paying medical bills or were paying off medical debt.

  • Half (49%) said they would be unable to pay for an unexpected $1,000 medical bill within 30 days, including 68 percent of adults with low income, 69 percent of Black adults, and 63 percent of Latinx/Hispanic adults.

  • Sixty-eight percent of Democrats, 55 percent of Independents, and 46 percent of Republicans said President Biden and Congress should make health care costs a top priority in the coming year.”

About pharma

 FDA hits Lupin with another warning notice for troubled API plant “Lupin is having continued difficulty solving problems at its factory in Tarapur, India, and has received another warning letter from the FDA, the generics producer revealed in a regulatory filing.
This comes on top of the FDA slapping Lupin with a Form 483 letter in April after the regulator inspected the active pharmaceutical ingredient (API) plant from March 22 to April 4.”
See yesterday’s API comment.

About health technology

 Illumina pitches $200 genomes with new line of DNA sequencers “Now, for only the cost of a few dozen cheeseburgers, you could have a fully sequenced human genome. Illumina is rolling out a new line of DNA analyzers that it says can read a person’s genetic code for a cost of about $200.
The company unveiled a new line of sequencers this week, dubbed the NovaSeq X Series, designed to parse DNA strings 2.5 times faster than previous models. Fully supplied, a single machine could generate data on more than 20,000 whole genomes per year.”

Today's News and Commentary

About pharma

FDA approves first ALS drug in 5 years after pleas from patients “The newly approved therapy, which will be sold under the brand name Relyvrio, is designed to slow the disease by protecting nerve cells in the brain and spinal cord destroyed by ALS — amyotrophic lateral sclerosis.” 

 FDA blasts Chinese drug ingredients outfit for subpar impurity testing and poor equipment hygiene The FDA has scolded Zhejiang Tianyu Pharmaceutical in the wake of an inspection at the company’s plant in the Chinese province of Zhejiang between Feb. 28 and March 4, 2022. In FDA’s warning letter, dated Aug. 17, the regulator laid out a laundry list of complaints tied to lapses in Tianyu’s active pharmaceutical ingredient (API) production, which the company failed to amply address in its response to an earlier Form 483.
Making matters worse, the FDA raised similar concerns more than three years back. Now, it’s urging Tianyu to summon outside help to get its manufacturing operations in order.  
Up top, the FDA critiqued Tianyu’s investigation into impurities found in an unnamed drug ingredient.”
Recall most APIs come from China and India.

SK Capital buys generics producer Apotex, troubled since the murder of founder Barry Sherman “Private investment firm SK Capital has bought the Toronto-based, family-owned company. Terms of the sale for Canada’s largest producer of generic drugs were not disclosed. In 2019, when the company hired a financial advisor to review its options, Apotex was said to be worth up to $3 billion.”

The 340B Drama Continues “The American Hospital Association and others brought suit against HHS for its 2018 outpatient drugs reimbursement policy for 340B hospitals. Prior to 2018, CMS paid all hospitals (i.e., 340B hospitals and non-340B hospitals) Average Sale Price (ASP) + 6% for outpatient drugs. In 2018, the Trump administration reduced the reimbursement rate to 340B hospitals to ASP – 22.5% to account for the average minimum 340B discount these hospitals receive from manufacturers. The Supreme Court found these cuts to be illegal because, under the statute’s plain language, CMS must conduct a survey of acquisition costs prior to establishing varying payment amounts among hospitals. There is, however, still an open question as to remedy, which the Supreme Court did not address.”

About the public’s health

 White House reveals $8B in private sector spending to fight hunger with focus on nutrition and chronic illness “The White House announced today more than $8 billion in commitments to the "food is medicine" movement linking nutrition and chronic illness.
The announcement coincided with the White House Conference on Hunger, Nutrition, and Health, held for the first time in more than 50 years. After a call to action this summer, over 100 private and public sector contributors offered funds and services to catalyze healthcare delivery in addressing health equity.
Of the committed funds, $2.5 billion will be invested in startup companies addressing food and nutrition insecurity, and $4 billion will be directed toward initiatives improving access to nutritious food and philanthropy promoting healthy choices and increasing physical activity.”

The FDA announces a new definition of what’s ‘healthy’ “The Food and Drug Administration announced new rules Wednesday for nutrition labels that can go on the front of food packages to indicate that they are ‘healthy.’
Under the proposal, manufacturers can label their products ‘healthy’ if they contain a meaningful amount of food from at least one of the food groups or subgroups (such as fruit, vegetable or dairy) recommended by the dietary guidelines. They must also adhere to specific limits for certain nutrients, such as saturated fat, sodium and added sugars. For example, a cereal would need to contain three-quarters of an ounce of whole grains and no more than 1 gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars per serving for a food manufacturer to use the word ‘healthy’ on the label.
The labels are aimed at helping consumers more easily navigate nutrition labels and make better choices at the grocery store. The proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans, the FDA said.”

 USPSTF Advises to Keep Screening for Syphilis as Cases Soar “Nonpregnant teens and adults who have ever been sexually active and are at increased risk for syphilis should still be screened for the sexually transmitted infection, the U.S. Preventive Services Task Force (USPSTF) said on Tuesday.
The final recommendations garnered an "A" grade, and are firmly in line with the draft guidance posted earlier this year and the Task Force's 2016 recommendation on the matter, according to Carol Mangione, MD, MSPH, of the University of California Los Angeles, and other members of the USPSTF. (Pregnant women should continue to follow separate recommendations for syphilis screening most recently released in 2018.)

About healthcare IT

 CHIME Leads Request for HHS to Delay Information Blocking Deadline “The College of Healthcare Information Management Executives (CHIME) and nine other healthcare industry groups have called on HHS to postpone the approaching information blocking compliance deadline, which is set to go into effect on October 6, 2022.
The Cures Act Final Rule, commonly known as the Information Blocking Final Rule, published by ONC in May of 2020, was passed to prevent information blocking practices by providers, health IT developers, health information exchanges (HIEs), and health information networks.
When the Cures Act Final Rule was published, the scope of electronic health information (EHI) was limited to the United States Core Data for Interoperability (USCDI) version 1, which includes information such as clinical notes. 
Anticipating an October 6, 2022, start date, the definition of EHI will expand well beyond the current USCDI version 1, and stakeholders will be expected to share all EHI. Notably, EHI will now include unstructured data.”

Your Clinical Decision Support Software: Is It a Medical Device? If you are currently or, in the future, may be involved in IT healthcare applications this FDA document is a must-read. 

About health technology

 Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes “In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level.”

Today's News and Commentary

About Covid-19

CDC no longer recommends universal masking in health facilities “The Centers for Disease Control and Prevention no longer recommends universal masking in health care settings, unless the facilities are in areas of high COVID-19 transmission.
The agency quietly issued the updates as part of an overhaul to its infection control guidance for health workers published late Friday afternoon. It marks a major departure from the agency’s previous recommendation for universal masking.”

We wear 'black robes, not white coats': Court overturns ruling compelling UPMC to give ivermectin “A Pennsylvania appeals court on Sept. 22 overturned an injunction that required a Pittsburgh-based UPMC hospital to administer ivermectin to a COVID-19 patient, court documents show. 
In January, a county court issued a preliminary injunction, directing UPMC Harrisburg (Pa.) to allow two physicians — who were not credentialed at the hospital — to give a critically ill COVID-19 patient ivermectin at the request of his power of attorney. UPMC appealed the ruling, and the patient, who was in intensive care, died in February before the issue was resolved. 
In its ruling, the appeals court rebuked the lower court for the injunction, saying courts do not have the legal authority to compel a healthcare organization to administer a treatment contrary to physicians' professional judgment and outside the standard of care.”

HHS to pay for 60K doses of Eli Lilly's COVID-19 drug following its commercialization “The federal government said Sept. 23 that it will cover the cost for 60,000 doses of bebtelovimab, Eli Lilly's COVID-19 antibody drug. The news comes about a month after the drugmaker started selling the treatment commercially for $2,000 per dose.
The initiative is intended to help uninsured and underinsured patients, as health systems and hospitals that bought bebtelovimab can now have HHS replace the dose for free for eligible patients, according to the department.”

Coronavirus (COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types “The updated policy describes the FDA’s intent to review only a small subset of new emergency use authorization (EUA) requests for diagnostic tests and encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways.”

About health insurance/insurers

Strengthen States’ Oversight of Medicaid Managed Care Plans’ Reporting of Medical Loss Ratios From the HHS OIG: “States reported that most Medicaid managed care plans submitted MLR reports as required. However, we found that 49 percent of the 495 MLR reports reviewed were incomplete. These incomplete MLR reports were missing at least one of seven numeric data elements that are essential to the MLR calculation. This missing data occurred across four of the seven MLR report data elements—non-claims costs; taxes and fees; member months; and quality-improvement activity expenses. Two-thirds of the incomplete MLR reports did not contain fields for plans to even enter amounts for at least one of these data elements.
The data element for non-claims costs, generally defined as plans’ expenses for administrative services, accounted for the majority of incomplete MLR reports.”
Read the report for proposed solutions.

 Medicare Part B premiums to decrease for the first time in over a decade “The Centers for Medicare & Medicaid Services (CMS) announced that Medicare Part B premiums would be lowered by three percent, or $5.20, going from $170.10 a month to $164.90. The program’s annual deductible will also fall by $7, from $233 to $226…”
However, it is not a true decrease because:
”In 2022, Medicare Part B premiums rose by 14.5 percent, one of the largest annual increases ever seen in the program’s history. A major factor in this increase was the inclusion of Aduhelm, the first Alzheimer’s medication approved by the Food and Drug Administration in 20 years.
The drug was highly scrutinized due to questions regarding its efficacy in treating Alzheimer’s disease as well as its sky-high price. Aduhelm initially cost $56,000 before its manufacturer Biogen announced it was halving the price to $28,200.”

 OIG finds fewer Medicare improper payments to acute care hospitals in latest audit “Acute care hospitals generated $39.3 million in Medicare Part B improper payments over four years but faced a steep drop after the federal government implemented new tools to root out such errors.”

Review Identifies “Noteworthy” Differences in Effects on Patients of Traditional Medicare vs Medicare Advantage Well-worth reading to understand the quality and cost differences between the plans.

About hospitals and healthcare systems

THE ECONOMIC AND SOCIAL BENEFITS OF PHYSICIAN-LED HOSPITALS A good in-depth monograph on the topic.

CommonSpirit Health weathers $1.85B net loss in fiscal 2022, eyes dual challenges of staffing and inflation “The Catholic healthcare giant said Friday it saw a nearly $1.3 billion operating loss (-3.8% operating margin) and a $1.85 billion net loss across the full year. During the previous fiscal year, it had brought in almost $1 billion in operating income (3% operating margin) and experienced a $5.45 billion net gain….
Similar to other systems, CommonSpirit’s $551 million nonoperating loss was fueled by dicey investment markets. The organization reported a $971 million net loss attributed to its investments, a contrast to the $3.4 billion it enjoyed during last year’s swelling markets.”
Additionally, CommonSpirit has received $1.6 billion in CARES Act grants as of June 30, most of which were awarded in 2020 and 2021.

About pharma

Mark Cuban's pharmacy on track to make profit in 2023 Mark Cuban's pharmacy, Cost Plus Drugs, is expected to be profitable in 2023, Forbes reported Sept. 26.
Mr. Cuban says the company has more than a million customers with roughly a 10 percent growth rate each week. Although no official revenue reports have been released, Forbes estimates Cost Plus has made at least $25 million in sales during the first nine months.”

 Experimental Alzheimer’s drug slows cognitive decline in trial, firms say “An experimental Alzheimer’s drug slowed cognitive and functional decline by 27 percent in a closely watched clinical trial, the sponsors of the medication said Tuesday, increasing the therapy’s chance for approval as soon as early next year.
Japanese drugmaker Eisai and its American partner, Biogen, in a news release said the slowing of deterioration, compared with a placebo, was “highly statistically significant.” They said the drug, called lecanemab, had met the primary and secondary goals of the 18-month late-stage study. The trial results have not undergone peer review.

Biogen finalizes $900M deal to settle whistleblower’s long-running MS kickback suit “Biogen has finalized an agreement to pay $900 million to resolve a lawsuit in which a former employee alleged that the Massachusetts biotech paid kickbacks to doctors over a five-year span starting in 2009 to boost sales of its multiple sclerosis drugs, the Department of Justice said Monday. Biogen in July said it had reached the $900 million deal in principle.”

 Association of Research and Development Investments With Treatment Costs for New Drugs Approved From 2009 to 2018 “In this cross-sectional study of 60 new therapeutic agents approved by the US Food and Drug Administration from 2009 to 2018, there was no association between estimated research and development investments and treatment costs based on list prices at the launch of the product or based on net prices a year after launch.”

About the public’s health

Opioid-Reversal Drug Access to Ease Under Relaxed FDA Rules Harm reduction programs distributing the opioid-reversal drug naloxone are exempt from certain federal product tracing requirements in an effort to better expand supply, the FDA said Thursday. 
The Food and Drug Administration said in guidance that it won’t enforce certain Drug Supply Chain Security Act requirements on programs distributing FDA-approved naloxone to underserved communities while an opioid public health emergency declaration is in place.

About healthcare IT

 Comparison of Quality Performance Measures for Patients Receiving In-Person vs Telemedicine Primary Care in a Large Integrated Health System “In this cohort study of 526 874 patients, telemedicine exposure was associated with significantly better performance or no difference in 13 of 16 comparisons, mostly in testing-based and counseling-based quality measures. Patients with office-only visits had modestly better performance in 3 of 5 medication-based quality measures.” 

Public Health Emergencies: Data Management Challenges Impact National Response From the GAO: “Longstanding challenges in the federal government’s management of public health data undermine the nation’s ability to quickly respond to public health emergencies like COVID-19 and monkeypox. These challenges include the lack of:

  • common data standards—requirements for public health entitles to collect certain data elements, such as patient characteristics (e.g., name, sex, and race) and clinical information (e.g., diagnosis and test results) in a specific way;

  • interoperability—the ability of data collection systems to exchange information with and process information from other systems; and

  • public health IT infrastructure—the computer software, hardware, networks, and policies that enable public health entities to report and retrieve data and information.”

    See the report for recommendations.

Today's News and Commentary

About Covid-19

 U.S. CDC expects Omicron COVID boosters for kids by mid-October “The U.S. Centers for Disease Control and Prevention expects COVID-19 vaccine boosters targeting circulating variants of the virus to be available for children aged 5-11 years by mid-October.
The CDC said in a document released on Tuesday that it expects to make a recommendation in early- to mid-October on the use of the new bivalent vaccines in the group, if they are authorized by the U.S. Food and Drug Administration (FDA).”

Pfizer to Supply Global Fund Up to 6 Million PAXLOVID™ Treatment Courses for Low-and-Middle-Income Countries “Treatment courses will be available for procurement by 132 Global Fund-eligible low-and-middle-income countries in all regions of the world beginning in 2022, subject to local regulatory approval or authorization.”

FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing From the HHS OIG: “FDA's decision to accept all EUA requests resulted in a record number of submissions-often low-quality and from developers lacking experience with FDA's processes. In response, FDA took steps to support developers and ease its workload, which included issuing EUA guidance, updating templates (submission guides for developers requesting EUA), and adjusting its EUA review process, among others. Some developers still reported being frustrated and confused.”
See the report for recommendations to correct the problems.

About health insurance/insurers

 Impending changes to the methodology used to calculate Medicare Advantage Star ratings could make it difficult for highly rated plans to retain those ratings in 2023 and 2024 A good review of the changes Medicare is making to its Star system.

About hospitals and healthcare systems

 Biden vows to crack down on poorest-performing nursing homes “The White House on Monday announced plans to boost nursing home staffing and oversight, blaming some of the 200,000-plus covid deaths of nursing home residents and staff during the pandemic on inadequate conditions.
Officials said the plan would set minimum staffing levels, reduce the use of shared rooms and crack down on the poorest-performing nursing homes to reduce the risk of residents contracting infectious diseases. The White House also said it planned to scrutinize the role of private equity firms, citing data that their ownership was linked with worse outcomes and higher costs.”

About pharma

 Aetna: Aduhelm is medically necessary “The payer will require pre-authorization for all providers and members covered under plans where the new policy applies.
Under the new policy, the drug must also be prescribed by or in consultation with a gerontologist, neurologist, psychiatrist or neuropsychiatrist.
The move follows CMS' decision in April to only cover Aduhelm for Medicare members participating in clinical trials. In May, UnitedHealthcare deemed it "unproven and not medically necessary" and said it would only cover the drug for members in clinical trials who have received prior authorization.”

About the public’s health

 AACR CANCER PROGRESS REPORT 2022 An excellent update of the progress in cancer research and treatment.

Most Global Deaths Are From Preventable Noncommunicable Diseases “A new global report by the World Health Organization finds noncommunicable diseases now outnumber infectious diseases as the top killers globally. Each year, it says 17 million people under age 70 die prematurely from noncommunicable diseases or NCD. The biggest killers are cardiovascular diseases, followed by cancers, chronic respiratory diseases, and diabetes.”

About healthcare IT

 Receipt of Out-of-State Telemedicine Visits Among Medicare Beneficiaries During the COVID-19 Pandemic “ In this cross-sectional study of telemedicine visits in the first half of 2021 among patients with Medicare, 422 547 patients had an out-of-state telemedicine visit; these visits were most common among those who lived near a state border and were largely for primary care and mental health treatment. In 62.6% of all out-of-state visits, a prior in-person visit occurred between the same patient and clinician.
Meaning  Limitations on out-of-state telemedicine care may disrupt many existing patient-clinician relationships in primary care and mental health treatment.”

Exploring EHR Satisfaction by Provider Specialty “Physicians and advanced practice providers who are very satisfied with the EHR are almost five times more likely to report plans to stay at their organization, compared to peers who are very dissatisfied…” See the chart for data by specialty.

Today's News and Commentary

About Covid-19

U.S. delivers over 25 mln COVID boosters; Moderna's shot in limited supply “The United States government has sent out over 25 million of the updated COVID-19 booster shots, mostly from Pfizer/BioNTech, as production of the Moderna shot continues to ramp up, a federal health agency said on Tuesday.
Some U.S. pharmacies like CVS Health and Walgreens Boots Alliance also reported on Tuesday that government supply of Moderna’s updated shot remains limited, causing appointments for the product to vary across the country.
Both CVS and Walgreens said they are working with the government to acquire more Moderna doses and have not seen any supply issues for the Pfizer/BioNTech booster.”

Safety of COVID-19 vaccine challenge in patients with immediate adverse reactions to prior doses: A multi-centre cohort study “Severe immediate adverse events following immunization (AEFI) with COVID-19 vaccines have been reported in up to 2.5 per 10,000 vaccinations…
In this cohort study of patients reporting immediate AEFI post-COVID vaccination, 61.2% of the 116 had negative vaccine challenge with a further 34.4% developing mild, subjective symptoms post-vaccination. Thus, 95.6% of the cohort were able to be re-vaccinated safely with 4.3% developing objective signs of a possible immune AEFI, consistent with international experience.”

2 omicron offshoots to keep an eye on “While BA.5 is still the nation's dominant strain, its prevalence has fallen over the past two weeks, according to the CDC's latest estimates
The subvariant now accounts for 84.8 percent of all U.S. COVID-19 cases — down slightly from 86 percent a week prior, according to estimates for the week ending Sept. 17. 
At the same time, the proportion of other omicron offshoots is rising…”

About health insurance/insurers

 OIG: Medicare Part B overpaid critical access hospitals and docs for same services “Medicare paid critical access hospitals and providers more than $1 million for duplicate claims in 2019, according to a federal watchdog that called for reforms to detect such errors.
The Department of Health and Human Services’ Office of Inspector General’s (OIG's) report, released Tuesday, called for the Centers for Medicare & Medicaid Services (CMS) to create post-payment reviews of claims.”

Doctor, hospital lobbies move to dismiss lawsuit over surprise billing ban “The American Medical Association and the American Hospital Association are seeking to dismiss their own lawsuit against the federal government over its implementation of The No Surprises Act.
The two lobbying groups filed a motion on Tuesday in federal court seeking to dismiss their claims, along with co-plaintiffs Renown Health, UMass Memorial Health Care and physicians Stuart Squires and Victor Kubit. The motion comes before a status hearing Wednesday.
The groups filed suit over the interim file rule, which was released last year.”

About pharma

 Walgreens to acquire remaining stake in Shields Health for $1.37B, announces exec moves “Walgreens Boots Alliance on Tuesday said it will buy the remaining stake in specialty pharmacy company Shields Health Solutions for approximately $1.37 billion.
Walgreens last year spent $970 million to increase its stake in the company to 71%, according to Reuters, with the possibility of taking full ownership over the pharmacy company.
The transaction is expected to be completed by the end of the year.”

In Zantac litigation at state level, drugmakers face claims for cancer types not covered in federal action “Multidistrict litigation is looming for several pharma companies—including GSK, Sanofi, Pfizer, Boehringer Ingelheim and Thermo Fisher—that manufactured and marketed Zantac. The federal litigation targets five types of cancers allegedly caused by consumption of the heartburn medicine.
But now, in state-level litigation, plaintiffs who used Zantac are filing lawsuits that cover other types of cancers, ramping up the concern for the companies already faced with the daunting task of defending themselves in federal court.
In the multidistrict litigation, plaintiffs originally identified 10 cancer types. But that list was pared to five types—bladder, esophageal, gastrointestinal, liver and pancreatic. Many of those who were pared from the multidistrict litigation—including plaintiffs with breast, kidney, colorectal, prostate and lung cancers—are now pursuing their cases in state courts…
 Two years ago, Zantac was pulled from the market when it was linked to unacceptable levels of N-nitrosodimethylamine, a potential cancer-causing agent, sparking a wave of litigation.”

The Inflation Reduction Act aims to lower drug costs — but here’s how Big Pharma could get around it “The Inflation Reduction Act is set to lower drug prices for millions of people in the U.S. — but experts fear pharmaceutical companies could exploit loopholes in the bill, ultimately keeping prescription costs high for many.

The law takes aim at insulin costs, caps out-of-pocket spending for Medicare beneficiaries, and allows the federal government to negotiate prices on the costliest prescription drugs. It also will require drugmakers to pay a rebate to Medicare if they raise prices too sharply.
These provisions won’t be implemented all at once.  Instead, they’ll go into effect gradually over the next several years, beginning with insulin price caps and rebates in 2023, out-of-pocket caps in 2025, and finally drug negotiations in 2026.
Because of the four-year gap before the law is fully implemented, policy and legal experts fear that pharmaceutical companies may have ample time to go on the offense and — if they don’t try to get the law thrown out in court — figure out ways to sidestep provisions that affect their ability to maintain their high profits.”

Current and Resolved Drug Shortages and Discontinuations Reported to FDA Some examples: Cefazolin Injection, Dextrose injections (several concentrations), Diltiazem injection, Furosemide injection, and 119 more.

Today's News and Commentary

About health insurance/insurers

 The US Medicaid ProgramCoverage, Financing, Reforms, and Implications for Health Equity A really good summary of the Medicaid system. Highlights: In 2022, Medicaid insured approximately 80.6 million individuals (56.4% from racial and ethnic minority groups in 2019). In 2020, estimated Medicaid spending was $671.2 billion (16.3% of total US health spending). The proportion of beneficiaries enrolled in Medicaid managed care was 69.5% in 2019, 45 states have pursued 139 Medicaid delivery system reforms from 2003 to 2019, and 38 states and Washington, DC, have expanded Medicaid under the Affordable Care Act. Racial and ethnic health disparities are common within Medicaid, and evidence on the association of Medicaid policies and reforms with achieving racial health equity remains limited.”
The Medicare Financing Conundrum An excellent analysis of the Medicare funding problem from the Urban Institute. Some conclusions:
”Although creating a new dedicated financing source could close a given Medicare financing shortfall, it is hard to match future growth in Medicare spending needs exactly with growth in a particular financing source.

It is easier to enact reforms consistent with the goals of tax or budget policy through general revenue financing than through dedicated financing.

Dedicated financing via a trust fund can work when it covers all costs and imposes budgetary rigor on matching spending and receipts, but the HI trust fund is not set up to work that way.

Broadening the base of an existing dedicated tax, such as subjecting employer-sponsored health insurance to the HI payroll tax, would follow the tax policy principle of horizontal equity without necessarily adding to the complex array of Medicare financing sources.

Addressing HI and SMI financing issues together would help confront longer-term Medicare financial challenges and allow fairer and more efficient financing and spending trade-offs to be made within HI, SMI, and the broader tax system.”

Centene to Pay $166 Million to Texas in Medicaid Drug Pricing Settlement “Health insurance giant Centene Corp. has agreed to pay $165.6 million to Texas to resolve claims that it overcharged the state’s Medicaid program for pharmacy services.
It’s the biggest known payout by the nation’s largest Medicaid insurer over its drug pricing practices. The deal was signed July 11 but hadn’t been publicly announced until Monday after KHN obtained a copy of the settlement through a Texas public records request and began asking questions.
The agreement makes Texas at least the 12th state to settle pharmacy billing claims with St. Louis-based Centene.”

About hospitals and healthcare systems

 Ascension Health closes 2022 with $1.8B loss, -3.1% operating margin “Ascension Health closed its 2022 fiscal year with an $879.1 million operating loss and net loss of more than $1.8 billion, according to investor disclosures for the period ended June 30.
A nearly $2.1 billion rise in operating expenses and $1.2 billion in net losses from investments drove the 144-hospital system’s poor performance, according to the financial documents.
The losses are a turnaround from the previous year’s $676 million operating income and almost $5.7 billion net gain.”

About pharma

 A $3M gene therapy: Bluebird bio breaks its own pricing record with FDA approval of Skysona “On the heels of an FDA go-ahead for gene therapy Zynteglo, bluebird bio has won an FDA accelerated approval for Skysona, or eli-cel, for the rare neurological disorder cerebral adrenoleukodystrophy (CALD), the company said Friday. The company is charging $3 million per treatment with Skysona, higher than Zynteglo’s $2.8 million, making it the priciest therapy in the world.”

About the public’s health

 Association of improved air quality with lower dementia risk in older women “In this study on a geographically diverse cohort of US community-dwelling older women, we found that long-term improvement in ambient air quality in late life was associated with reduced dementia risk. The associations did not significantly differ by age, education, geographic region, Apolipoprotein E e4 genotypes, or cardiovascular risk factors. These findings strengthen the causal association between late-life exposure to air pollution and dementia risk.”

In a first, health panel calls for routine anxiety screening in adults “In a nod to the nation’s pressing mental health crisis, an influential group of medical experts for the first time is recommending that adults under age 65 get screened for anxiety.
The draft recommendations, from the U.S. Preventive Services Task Force, are designed to help primary care clinicians identify early signs of anxiety during routine care, using questionnaires and other screening tools.”

Today's News and Commentary

About Covid-19

 Biden says ‘pandemic is over’ “President Biden declared the coronavirus pandemic ‘over,’ in apparently off-the-cuff remarks that reflect the growing sentiment that the threat of the virus has receded, even as hundreds of Americans continue to die of covid each day.
’We still have a problem with covid,’ Biden said on ‘60 Minutes,’ which aired Sunday night. ‘We’re still doing a lot of work on it … but the pandemic is over.’”

About health insurance/insurers

UnitedHealth Beats Class Suit Over Office Surgery Facility Fees “UnitedHealth Group. Inc. defeated a class action by more than 200 doctors who say they weren’t paid facility fees for office-based surgeries, when a New York federal judge ruled that the insurer used reasonable payment systems and followed ERISA plan terms.
“[Judge] Oetken’s ruling, issued after a five-day nonjury trial, also blessed UnitedHealth’s ‘C Flag process,’ which internally flags physician offices submitting claims for facility fees and sends these offices a letter inviting them to submit proof of facility licensure. This was a ‘reasonable way to ensure that benefits are administered consistent with plan terms,’ he said.”

Humana raises profit outlook as it looks to regain footing in Medicare Advantage market “Humana is bullish on future growth in Medicare Advantage (MA), its main line of business, in 2023 to bounce back from lackluster performance this year.
The insurer also raised its profit outlook for 2022, sending its shares up some 8% since the news Thursday.
The company projected it will grow its adjusted profits at a 14% annual rate over the next three years, executives told investors.”

Humana looks to buy clinics from PE partner for up to $550M “Humana expects to pay between $450 million and $550 million to acquire the first group of senior-focused primary care centers that it developed through a joint venture with Welsh, Carson, Anderson & Stowe, Chief Financial Officer Susan Diamond said Friday during the insurer’s investor day.

  • The agreement inked with Welsh Carson in 2020 included options for Humana to acquire the private equity firm’s interest in the joint venture in stages over the next five to 10 years. The venture was expected to open 67 clinics by early 2023. “We are planning for the full acquisition of centers built in partnership with Welsh Carson through our put and call options beginning in 2025,” Diamond said.

  • In mid-May, Humana and Welsh Carson announced a second joint venture that will spend up to $1.2 billion to open about 100 new value-based primary care clinics for Medicare patients between 2023 and 2025 under the CenterWell Senior Primary Care brand.”

 Beneficiary Experience, Affordability, Utilization, and Quality in Medicare Advantage and Traditional Medicare: A Review of the Literature “We found few differences between Medicare Advantage and traditional Medicare that are supported by strong evidence or have been replicated across multiple studies. Both Medicare Advantage and traditional Medicare beneficiaries reported similar rates of satisfaction with their care and overall measures of care coordination. Medicare Advantage outperformed traditional Medicare on some measures, such as use of preventive services, having a usual source of care, and lower hospital readmission rates. However, traditional Medicare outperformed Medicare Advantage on other measures, such as receiving care in the highest-rated hospitals for cancer care or in the highest-quality skilled nursing facilities and home health agencies. Additionally, a somewhat smaller share of traditional Medicare beneficiaries than Medicare Advantage enrollees experienced a cost-related problem, mainly due to lower rates of cost-related problems among traditional Medicare beneficiaries with supplemental coverage. Several studies found lower use of post-acute care among Medicare Advantage enrollees but were inconclusive as to whether that was associated with better or worse outcomes. Findings related to the use of other health care services, including hospital care and prescription drugs, and condition-specific quality of care measures varied – likely due to differences in data and methodology across studies.”

Medicare is using one of its biggest hammers to try to fix the dialysis system: how providers are paid “The new End-Stage Renal Disease Treatment Choices (ETC) model is the largest such experiment in the history of American health care, signaling to some a more aggressive federal approach to improving dialysis. This program, unlike previous voluntary ones, mandates about 30% of dialysis providers in the country participate, and the other 70% are used as a control group…
The ETC model is a two-part incentive system on top of the existing payment system. The first incentives, which rolled out in 2021, were focused on increasing home dialysis use exclusively — centers got a boost in payments for home dialysis use relative to in-center dialysis. The second part of the incentive is payment increases or decreases depending on how dialysis facilities perform in home dialysis, waitlisting patients for organ transplant, and living donor kidney transplantation rates, relative to control facilities…
The ETC model is slated to run through the middle of 2026. After that, it’s up to Medicare to decide whether the program continues or not.”

UnitedHealth beats Justice Dept on $13 billion merger “UnitedHealth Group's $13 billion acquisition of Change Healthcare will proceed, after a federal judge on Monday denied the Justice Department's efforts to block the deal on antitrust grounds.”

About hospitals and healthcare systems

 The Current State of Hospital Finances: Fall 2022 Update Highlights:

  1. “Margins remain depressed relative to pre-pandemic levels. After a difficult first half of 2022, optimistic projections for the rest of the year indicate margins will be down 37% relative to pre-pandemic levels.

  2. More than half of hospitals are projected to have negative margins through 2022. Projections for the remainder of the year demonstrate an increase in hospitals with negative margins relative to pre-pandemic levels, to 53%.

  3. Expenses are significantly elevated from pre-pandemic levels. Expenses are projected to increase throughout the rest of 2022, leading to an increase of nearly $135 billion over 2021 levels. Labor expenses are projected to increase by $86 billion, while non-labor expenses are projected to increase by $49 billion.

  4. Hospitals have faced a profound financial toll. Hospitals have incurred serious losses in 2022 relative to pre-pandemic levels and future federal support is uncertain.”

NCQA Unveils 2022 Health Plan Ratings FYI: “The 2022 Health Plan Ratings are based on data from calendar year 2021, when 203 million people were enrolled in health plans that reported Healthcare Effectiveness Data and Information Set (HEDIS®) results to NCQA. Plans are rated on a 0–5 stars scale. Six out of 1,048 health plans that earned a numerical rating achieved 5 stars—the highest possible rating.”

Social Risk Adjustment In The Hospital Readmissions Reduction Program: A Systematic Review And Implications For Policy “These findings support the use of social risk adjustment to improve provider payment equity and highlight opportunities to enhance social risk adjustment in value-based payment programs.”

About pharma

Curbing patent abuse: Tackling the root of the drug pricing crisis Highlights:
■ “On average, there are 74 granted patents on each of America’s ten top selling drugs, providing major drugmakers substantial advantage to keep generic and biosimilar competitors off the market.
■ Drugmakers filed more than 140 patent applications on average per drug; on average 66% of patent applications were filed after the FDA approved the drug to be on the market.
■ Nearly one-third of Revlimid’s cumulative sales in the U.S. have occurred after its primary patents expired, and over two-thirds of Humira’s U.S. sales have come after the expiration of its primary patents.
■ On average, four times as many patents are granted on the top ten drugs in the U.S. compared to Europe.
■ Lower-cost generic and biosimilar versions of three top selling drugs - Humira, Eliquis, and Enbrel - launched in Europe an average of 7.7 years earlier than their expected U.S. entry. During this time, without generic or biosimilar competition Americans will spend an estimated $167 Billion on branded versions of just these three drugs. To date, these drugs still do not have generic or biosimilar competition in the U.S.”

 McKesson to acquire private pharmacy tech company “Pharmaceutical and medical supply company McKesson signed an agreement Sept. 19 to acquire Rx Savings Solutions, a tech insights business that aims to lower drug costs, for up to $875 million.”

About health technology

FDA slaps Class I tag on Baxter recall of Clearlink chemotherapy delivery sets “After uncovering a handful of patient safety and cybersecurity risks in many of its infusion pumps over the last year, Baxter has now begun a recall of yet another product that works alongside those pumps.
The medtech giant’s latest recall concerns some of its solution sets, also known as IV sets, which connect patients to their prescribed IV bags and bottles of medications. It’s specifically focused on the Clearlink Basic Solution Sets with Duovent, a drug that’s used to open the airways.
According to Baxter, which first issued the recall notice (PDF) in early August, the company has received an increased number of reports of leaks in the Clearlink IV sets. As of this week, the FDA has categorized the recall as Class I, indicating a high risk of patient injury or death.”

About healthcare finance

AmerisourceBergen (ABC) to Buy Germany's PharmaLex for $1.3B “AmerisourceBergen Corporation announced that it has signed a definitive agreement to acquire Germany-based PharmaLex Holding GmbH for €1.28 billion (approximately $1.3 billion) in cash.
PharmaLex is a leading provider of specialized services for the life sciences industry that is owned by funds advised by AUCTUS Capital Partners AG. The company consists of a global team of scientific, regulatory, and safety and compliance experts who provide strategic guidance and regulatory support to biopharma companies throughout a product’s lifecycle.”

Today's News and Commentary

About Covid-19

End of COVID pandemic is 'in sight' -WHO chief “The world has never been in a better position to end the COVID-19 pandemic, the head of the World Health Organization said on Wednesday, his most optimistic outlook yet on the years-long health crisis which has killed over six million people.
‘We are not there yet. But the end is in sight,’ WHO Director-General Tedros Adhanom Ghebreyesus told reporters at a virtual press conference.”

About health insurance/insurers

 Lowell Nurse Pleads Guilty in $100 Million Home Health Care Fraud and Kickback Scheme “According to the indictment, from January 2013 to January 2017, Newton was part owner and operator of Arbor Homecare Services LLC. Waruru was a Licensed Practical Nurse employed as a home health nurse at Arbor. Waruru and, allegedly, Newton engaged in a conspiracy to use Arbor to defraud MassHealth and Medicare of at least $100 million by committing health care fraud and paying kickbacks to induce referrals. Newton then allegedly laundered the ill-gotten gains.
Specifically, it is alleged that Arbor, through Newton and others, including Waruru, failed to train staff, billed for home health services that were never provided or were not medically necessary and billed for home health services that were not authorized. Arbor, through Newton and others, developed employment relationships as way to pay kickbacks for patient referrals, regardless of medical necessity requirements. They also allegedly entered sham employment relationships with patients’ family members to provide home health aide services that were not medically necessary and routinely billed for fictitious visits that did not occur. As alleged in the civil complaint, Newton either directly or through Arbor, targeted particularly vulnerable patients who were low-income, on disability and/or suffering from depression and/or addiction.”

About hospitals and healthcare systems

 World's Best Smart Hospitals 2023 and World's Best Specialized Hospitals 2023 Both from Newsweek, FYI.

 About healthcare quality

Joint Commission Official Statement on Standards Review Tuesday “we announced the beginning of a review of all Joint Commission ‘above-and-beyond’ requirements, those that go beyond the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (CoPs) and are not on crosswalks to the CoPs.
During the COVID-19 public health emergency (PHE), CMS put many requirements on hold. As the PHE nears its end, CMS has been reviewing the waived requirements to determine whether some should be permanently retired. The Joint Commission will similarly address the necessity of our own unique requirements. 
Specifically, we will review each requirement to answer:

  • Does the requirement still address an important quality and safety issue?

  • Is the requirement redundant?

  • Are the time and resources needed to comply with the requirement commensurate with the estimated benefit to patient care and health outcomes?

In addition to a direct review of each requirement, we will conduct quantitative analyses of scoring patterns and tests for redundancy. Where necessary, we also will conduct literature and field reviews and engage experts within the field.”

About pharma

 Novartis headquarters raided in Swiss competition authority's patent probe “The Swiss Competition Commission (COMCO) said it has opened an investigation into an unnamed pharma company about possible unlawful use of a patent to stymie competition. As part of the probe, the agency conducted an early morning raid of the company’s offices on Tuesday, the agency said Thursday.
Novartis then identified itself as the target in its own statement Thursday…
The exact drug under question remains unknown. Among Novartis’ offerings, the one skin drug that might come close to a dominant status is psoriasis treatment Cosentyx.”

About the public’s health

 Biden admin officials worried about potential polio spread “The high-level meetings and the involvement of national security officials speak to the concern Biden officials have about the possible spread of a potentially deadly virus that until recently had not been recorded in the United States for decades.
New York has recorded one polio case but has found additional poliovirus samples in the state’s wastewater, prompting Gov. Kathy Hochul last week to declare a public health emergency.”

Today's News and Commentary

About Covid-19

HHS expected to renew COVID-19 PHE for 11th time “HHS is set to extend the COVID-19 public health emergency by its standing deadline of Oct. 13.
HHS last renewed the PHE July 15 for another increment of 90 days with a pledge to provide states with 60 days' notice if it decided to terminate the declaration or allow it to expire. Aug. 14, the date in which states would have 60 days' notice, came and went without updates or notifications from the agency, suggesting the declaration will extend.
If renewed on the deadline of Oct. 13, the next deadline would be Jan. 11, 2023…
For an overview of the flexibilities tied to the PHE and what occurs when the declaration ends, check out a comprehensive brief from Kaiser Family Foundation here.”

 Americans are moving on from COVID-19 despite acknowledged risks Some highlights of the survey:

  • The share of Americans who report being concerned about COVID-19 (57%) is among the lowest captured throughout the pandemic. Of those who are concerned, a plurality is more concerned about spreading the virus to people who are at higher risk of serious illness (28%) than for themselves, whether it’s developing long COVID (18%), being hospitalized (12%), or dying (11%).

  • Nearly two in three (65%) say there is a small risk or no risk in returning to their normal, pre-COVID life.

  • More Americans now say they already have returned to their normal, pre-COVID life (46%) than at any point during the pandemic.

  • Still, just 11% say there is no risk of them contracting COVID. 

  • The share of Americans that report occasionally or never wearing a mask outside their home has remained consistent since June (around 63%) but is significantly higher than during height of Omicron in mid-January 2022 (27%).

  • Nearly two in three (65%) support federal, state, and local governments lifting all COVID-19 restrictions.

  • Despite the program ending earlier this month, 83% support the federal government mailing free at-home COVID-19 tests to anyone who wants one.

  • Similarly, 87% support the federal government providing COVID-19 vaccines and treatments for free, regardless of health insurance status.”

About health insurance/insurers

Health Insurance Coverage in the United States: 2021-Current Population Reports From the US Census Bureau: Highlights:
--”More people were insured in 2021 than 2020. In 2021, 8.3 percent of people, or 27.2 million, did not have health insurance at any point during the year, representing a decrease in the uninsured rate and number of uninsured from 2020 (8.6 percent or 28.3 million).
--In 2021, private health insurance coverage continued to be more prevalent than public coverage, at 66.0 percent and 35.7 percent, respectively.
--Of the subtypes of health insurance coverage, employer- based insurance was the most common, covering 54.3 percent of the population for some or all of the calendar year, followed by Medicaid (18.9 percent), Medicare (18.4 percent), direct-purchase coverage (10.2 percent), TRICARE (2.5 percent), and VA and CHAMPVA coverage (1.0 per- cent).
--Overall, public coverage increased between 2020 and 2021. In 2021, 35.7 percent of people held public coverage for some or all of the year, marking a 1.2 percentage- point increase from 2020.
--Between 2020 and 2021, the rate of Medicaid coverage increased by 0.9 percentage points to cover 18.9 percent of people.
--The uninsured rate among children under the age of 19 decreased 0.6 percentage points to 5.0 percent between 2020 and 2021, driven in part by an increase in public coverage.
--In 2021, 7.9 percent of full- time, year-round workers had public health insurance, up 1.8 percentage points from 2020. Among less than full- time, year-round workers, the percentage with public coverage increased 1.6 percentage points to 22.6 percent during this period.”
This annual document is a great resource for health insurance information.

How State Surprise Billing Protections Increased ED Visits, 2007-2018: Potential Implications for the No Surprises Act Results: By analyzing 15 state-level bans, we find that the bans reduced spending per visit by 14% but spurred a demand response, an increase of 3 percentage points in ED visits, which wiped away the cost savings. Based on an ED severity index, these extra ED visits were 9% less urgent than prior to the bans.
Conclusions: We predict that the federal ban will result in $5.1 billion in savings but 3.5 million more ED visits at $4.2 billion in extra spending per year, largely negating expected savings. Health plans must be prepared to manage this spike in ED visits as the No Surprises Act takes effect.”

 Top 10 Accountable Care Organizations by Medicare Shared Savings  FYI

AMA, 2 state medical societies join class-action suit against Cigna “The American Medical Association (AMA) has joined a class-action lawsuit against Cigna, alleging the insurer underpaid for claims filed by providers in the contracted MultiPlan network.
MultiPlan is the country's largest third-party network, and Cigna contracts with it to access providers. According to the lawsuit, which was initially filed in June, Cigna reimbursed for claims from providers in MultiPlan's network at its non-participating providers rate rather than at the rate expected for a MultiPlan contract.
As such, the insurer ‘significantly underpaid claims, and put patients at risk of balance billing,’ the plaintiffs claim.”

The number of Americans with past-due medical bills is unchanged since 2015 “The report explores the relationship between past-due medical bills and demographics. Among the key findings:

  • Since 2015, the percentage of Americans who reported past-due medical bills has remained in the low 20% range, down from 26% in 2012.

  • Compared with other sources of debt, Americans were less likely to report that they had past-due medical bills.

  • Women were slightly more likely than men to report that they had past-due medical bills.

  • The likelihood of having past-due medical bills increased with age for younger adults but decreased with age for older adults.

  • Black adults were more likely than other race and ethnicity groups to report that they had past-due medical bills.

  • Adults with a high school degree or less were more likely than those with a college or graduate degree to report that they had past-due medical bills.

  • As income increased, the odds of having past-due medical bills decreased.

  • Health insurance and living in a Medicaid expansion state reduced the percentage of individuals reporting that they had past-due medical bills.

  • Past-due medical bills were highly correlated with a lower level of use of health care services.

  • Individuals with past-due medical bills were more likely than those without them to report several other financial challenges.”

About hospitals and healthcare systems

 Illinois delays Atrium, Advocate Aurora merger “The Illinois Health Facilities and Services Review Board voted Sept. 13 to postpone a vote on the change of ownership for 10 Advocate Aurora facilities in the state covered by the system's plan to merge with Charlotte, N.C.-based Atrium Health. 
Atrium and Advocate Aurora, dually headquartered in Milwaukee and Downers Grove, Ill., announced plans to merge into a 67-hospital system with upward of $27 billion in revenue in May.” 

About pharma

 Rebate walls may thwart biosimilar savings: Biosimilars of AbbVie's Humira are expected to reduce annual pharmaceutical expenditures by $5 billion, but they may be delayed by rebate strategies. “Several biosimilars for the world’s top-selling drug are slated to hit the market next year, but the potential billions of dollars in savings may not materialize until at least 2024. 
Humira, the rheumatoid arthritis and anti-inflammatory biologic that has netted AbbVie nearly $200 billion in sales, has benefited from nearly two decades of exclusivity, allowing the manufacturer to hike the price 470% since the drug was introduced. The monopoly will end with the introduction of several Food and Drug Administration-approved copycat versions slated to hit the market in 2023, and more are on the way. 
Humira’s biosimilars will save the healthcare system an estimated $5 billion or so a year, cutting costs for providers and patients. Biosimilars will likely be about half the price of Humira, which is $84,000 for a year of treatment. 
But AbbVie may manipulate the rebates associated with Humira to limit competition and the potential savings from lower-cost biosimilars.”

About healthcare IT

 Increased Mortality Rates Linked to Cyber-Attacks Against Healthcare Organizations “Cyber–attacks against healthcare organizations cause more than 20% to experience increased mortality rates, suggests new research by Proofpoint’s Ponemon Institute.
The report, which surveyed 641 healthcare IT and security practitioners, also found that 89% of them experienced an average of 43 attacks in the past 12 months, with more than 20% suffering one of the following types of attacks: cloud compromise, ransomware, supply chain, and phishing….
he most common consequences of these attacks were delayed procedures that resulted in poor patient outcomes for 57% of the healthcare providers and increased complications from medical procedures for roughly half of them.
The attack type most likely to negatively impact patient care was ransomware, leading to procedure or test delays in 64% of cases and longer patient stays (59%).”

Doximity expands access to telehealth service free of charge to thousands of clinics “Doximity, a digital platform for medical professionals, is expanding access to its telehealth service, Dialer Pro, to free medical clinics across the U.S. at no cost.
The telehealth platform is accessible to the purported 1,007 free clinics that offer medical care at zero cost to the patient. Such patients are estimated to total 1.8 million nationwide. The platform’s pilot program was utilized by 48 clinics and roughly 1,000 clinicians in various communities throughout the country.”
The question now is: Do these clinics’ patients have access to the hardware and software to access telemedicine?

About healthcare personnel

 2022 Survey of Physician Appointment Wait Times and Medicare and Medicaid Acceptance Rates “Average physician appointment wait times have increased significantly since the survey was last conducted in 2017 and first conducted in 2004. The average wait time for a physician appointment for the 15 large metro markets surveyed in 2022 is 26.0 days, up from is 24.1 days in 2017, an 8% increase, and up from 20.9 days in 2004, a 24% increase….
The average rate of physician Medicare acceptance is 82.4% for all 15 metropolitan areas, down from 84.5% in 2017, a decrease of 4%.
The average rate of physician Medicaid acceptance is 54.1% in all 15 metropolitan areas, up from 53% in 2017, an increase of 2%.”
See the study for specialty and location-specific data.

About health technology

Estimated Cost of Developing a Therapeutic Complex Medical Device in the US “In this economic evaluation study using data from public and proprietary sources, an analytical cost model found that the estimated mean expected capitalized development cost per therapeutic complex medical device was $522 million. The nonclinical development stage accounted for 85% of this cost, whereas the US Food and Drug Administration submission, review, and approval stage comprised 0.5%.”

 Baxter reportedly considering shedding dialysis businesses: Bloomberg “Following its blockbuster buy of medtech manufacturer Hillrom late last year, Baxter may now be preparing to trim some of the fat from its newly expanded product portfolio.
The devicemaker is said to be considering a sale of two units within its kidney care division, Bloomberg reports. Unnamed sources familiar with the considerations told the outlet that Baxter is working with advisers to explore the potential sale of its renal care services and hemodialysis divisions.”

Sony dives into nascent over-the-counter hearing aid market with WS Audiology partnership “The consumer electronics giant said it plans to provide a device that users can buy, fit and program themselves, without requiring a visit to a hearing specialist. Sony will work with the Denmark-based WS Audiology, and the development of their first product under the Sony brand is already underway, the companies disclosed in their announcement.
The FDA finalized its long-awaited regulatory rule in August to allow adults with mild to moderate hearing loss to purchase certain types of hearing aids online and in retail stores without a prescription—specifically air-conduction amplifiers that don’t require a surgical implant and can be worn in or behind the ear. The rule takes full effect in mid-October.”

“Human vs Machine” Validation of a Deep Learning Algorithm for Pediatric Middle Ear Infection Diagnosis “We compared the diagnostic performance of human clinicians with that of a neural network algorithm developed using a library of tympanic membrane images derived from children taken to the operating room with the intent of performing myringotomy and possible tube placement for recurrent acute otitis media (AOM) or otitis media with effusion (OME)…
Our model achieved a mean prediction accuracy of 80.8% (95% CI, 77.0%-84.6%). The Google model achieved a prediction accuracy of 85.4%. In a validation survey of 39 clinicians analyzing a sample of 22 endoscopic ear images, the average diagnostic accuracy was 65.0%. On the same data set, our model achieved an accuracy of 95.5%.
Conclusion
Our model outperformed certain groups of human clinicians in assessing images of tympanic membranes for effusions in children. Reduced diagnostic error rates using machine learning models may have implications in reducing rates of misdiagnosis, potentially leading to fewer missed diagnoses, unnecessary antibiotic prescriptions, and surgical procedures.”
Think about the implications for home diagnostics.

Today's News and Commentary

About Covid-19

 COVID-19 Economic Injury Disaster Loan Applications Submitted from Foreign IP Addresses “We evaluated the U.S. Small Business Administration’s (SBA) controls to flag or prevent potentially fraudulent Coronavirus Disease 2019 (COVID-19) Economic Injury Disaster Loan (EIDL) applications submitted from foreign Internet Protocol (IP) addresses.
Although the agency implemented several layers of controls to prevent or reduce fraud from foreign countries, individuals at foreign IP addresses were able to access the COVID-19 EIDL application system. SBA received millions of attempts to submit COVID-19 EIDL applications from foreign IP addresses and stopped most of them; however, the agency processed more than 233,000 of these applications from March 20, 2020 to November 12, 2021, our review period. Of this amount, SBA approved and disbursed 41,638 COVID-19 EIDLs, advances, and grants for $1.3 billion.”

About health insurance/insurers

AMA Releases 2023 CPT Code Set, Aims to Reduce E/M Coding Burden The article provides a good summary of the changes.

 Support for greater government role in health care for older adults “Expanding Medicare coverage of certain services is… popular across age groups, racial and ethnic groups, and party identification. More than 8 in 10 adults think Medicare coverage should be expanded to cover dental care (87%), eye examinations for prescription glasses (87%), hearing aids (86%), and long-term care (81%). 
Public satisfaction with the current state of health care—overall and for older adults—is quite low. Just 12% of adults think health care in general is handled very or extremely well in the United States, and few think health care for older adults, community support and resources for older adults, and the quality of care at nursing homes are handled well.
Overall, 66% of adults think it is the federal government’s responsibility to make sure all Americans have health insurance coverage. Those age 18-49 are more likely to say so than those age 50 and older (73% vs. 58%). While those age 50 and older are more supportive of government policies to address the costs of care for older adults, younger adults are more supportive of a single-payer health care system for all Americans (47% vs. 38%).”
See the poll for more results.

About hospitals and healthcare systems

 Purchaser Business Group on Health Announces Five-Year Plan, Goals to Reduce and Reallocate Health Care Spending in Push for Higher Value Care for its Members The Purchaser Business Group on Health (PBGH), a nonprofit coalition of nearly 40 large, private employers and public health care purchasers committed to transforming health care nationwide, today announced a series of strategic goals that will guide the organization over the next five years. Additionally, the organization is launching a new public purchaser advisory committee to help better illuminate and address the unique needs of public purchasers, while enhancing its long-standing work aligning public and private efforts to reform health care payment. ..
Specifically, PBGH’s newly announced goals are to address:

  • Affordability by redirecting existing health care spend to high-quality, equitable and evidence-based care while holding total cost flat

  • Health by redirecting purchasing to support whole-person health (the full spectrum of medical, behavioral, socioeconomic and needs) and
    create accountability for health and well-being outcomes

  • Equity by eliminating disparities in care delivery and in health outcomes.

In a related article:EmsanaRx and Cleveland Clinic Collaborate to Bring Transparency to Pharmacy Benefits “EmsanaRx, a public benefit corporation, and Cleveland Clinic have announced a first-of-its-kind strategic affiliation today. This collaboration will align EmsanaRx with Cleveland Clinic to further both organizations’ mission of providing cost-effective, high-quality care.
Cleveland Clinic will advise clinicians and multidisciplinary teams at EmsanaRx to support the company’s formulary development and utilization management programs and inform some of its benefit offerings…
EmsanaRx is the first company launched by Emsana Health, an innovation studio created by the Purchaser Business Group on Health (PBGH) to tackle the largest problems facing employers today.”

About pharma

 Examining 340B Hospital Price Transparency, Drug Profits, and Incentives Highlights:

  • “340B hospitals’ own self-reported pricing data reveals that they price the top oncology drugs at 4.9 times their 340B acquisition costs, assuming a 34.7 percent discount, which is a conservative estimate…

  • Hospitals remain slow to adopt biosimilars. For certain products, up to 26 percent of hospitals were found to only list prices for an innovator product but not its biosimilar and only 10 hospitals carry all of the biosimilars studied.

  • Cash paying patients, of whom many may be uninsured, receiving care at 340B hospitals do not seem to receive discounts on their drugs.”

About the public’s health

 First US death due to monkeypox confirmed in Los Angeles County “A Los Angeles County resident's death has been attributed to monkeypox, the county Department of Public Health said Monday, the first known death from the virus in the US.
The department and the US Centers for Disease Control and Prevention confirmed the link and said the person had a severely weakened immune system and had been hospitalized.”

Food Insecurity for Families With Children Reached Two-Decade Low in 2021 “Food insecurity for households with children declined to its lowest rate in two decades last year, the Agriculture Department said on Wednesday, as government assistance programs continued to blunt the effect of the coronavirus on the economy.
The department’s findings were in line with data last year showing that vast expansions of government aid helped reduce hunger. But experts warned that picture was almost certain to change as pandemic-era programs expire and inflation remains high.”

Biden touts cancer ‘moonshot’ at JFK Library, despite setbacks “Leaning into the symbolism of President John F. Kennedy’s aspirational effort to send a man to the moon, President Biden on Monday sought to give a renewed boost to his own “cancer moonshot” initiative, aimed at cutting the U.S. death toll from the disease in half over the next 25 years…
Biden on Monday also signed an executive order for a biotechnology initiative that the White House hopes will make the U.S. less dependent on foreign countries for the tools and raw materials needed for medical progress.”

Screening for Prediabetes and Type 2 Diabetes in Children and Adolescents “The USPSTF concludes that the evidence is insufficient to assess the balance of benefits and harms of screening for type 2 diabetes in children and adolescents. There is a lack of evidence on the effect of screening for, and early detection and treatment of, type 2 diabetes on health outcomes in youth, and the balance of benefits and harms cannot be determined.”

FROM 2016 TO 2020, MENTAL HEALTH INEQUITIES COST NEARLY 117K LIVES, REPORT FINDS “KEY TAKEAWAYS

From 2016 to 2020, the costs associated with premature mental and behavioral health-related deaths among indigenous populations and racial and ethnic groups linked to mental illness, substance abuse, and suicide were $278 billion.
Solutions for mental health inequities include development of socio-culturally crafted approaches to mental and behavioral health services as well as tackling the social and political determinants of health inequities.”

About healthcare personnel

 Physician Salaries Ranked by Hourly Rate Compare these hourlies to partners at a law firm.

 Nurse practitioner will be fastest-growing job over next decadeThe occupation with the highest projected percent change of employment in the U.S. between 2021 and 2031 is nurse practitioner, according to the latest data from the Bureau of Labor Statistics.  
The bureau estimates that employment of nurse practitioners will grow by 46 percent during that period, from 246,700 to 359,400.
Other healthcare occupations among the 20 with the highest projected percent change of employment in the U.S. between 2021 and 2031 are:       

  • Medical and health services managers (28 percent)

  • Physician assistants (28 percent)

  • Physical therapist assistants (26 percent)”

Doctor Wait Times Average Almost Four Weeks In Big Cities “Patients are waiting an average of 26 days for a scheduled appointment with a doctor, according to a study of commonly used specialty physicians in 15 major U.S. cities.
The survey by Merritt Hawkins, a unit of healthcare staffing firm AMN Healthcare, polled more than 1,000 physician offices looking at average wait times among family medicine, dermatology, obstetrics/gynecology, orthopedic surgery and cardiology.
The average wait time is up 8% from 24.1 days in 2017, ‘the last year the survey was conducted, and up from 21 days in 2004, when the survey first was conducted,’ according to Merritt Hawkins and AMN Healthcare…
Though the analysis looked at major U.S. cities, the wait times are likely worse elsewhere in the country given large markets tend to have more physicians because they are home to academic medical centers and high concentrations of healthcare facilities generally.”

Today's News and Commentary

About Covid-19

COVID DATA TRACKER WEEKLY REVIEW “As of September 7, 2022, the current 7-day moving average of daily new cases (70,488) decreased 18.8% compared with the previous 7-day moving average (86,853). A total of 94,888,931 COVID-19 cases have been reported in the United States as of September 7, 2022.”

 Antiviral agents found to be effective against Omicron BA.2.75 “Researchers say multiple COVID-19 drugs that have been approved in Japan show efficacy against the Omicron BA.2.75 subvariant.
They say the antiviral agents remdesivir, molnupiravir and nirmatrelvir may be effective against BA.2.75 [however],…The virus-neutralizing antibodies casirivimab-imdevimab and sotrovimab were found to be significantly less effective against the variant.
But the researchers do say that tixagevimab-cilgavimab, approved last month, did show neutralizing activity.”

A single-administration therapeutic interfering particle reduces SARS-CoV-2 viral shedding and pathogenesis in hamsters “Recently, we reported the discovery of a single-administration antiviral therapeutic interfering particle (TIP) against SARS-CoV-2 that prevents severe disease in hamsters and exhibits a high genetic barrier to the evolution of resistance. Here, we report that TIP intervention also reduces SARS-CoV-2 transmission between hamsters.”

About health insurance/insurers

 Blue Cross $2.7B antitrust settlement appealed by Home Depot, others  “Three employers have appealed a $2.67 billion antitrust settlement with the Blue Cross and Blue Shield Association, potentially altering the terms of the landmark federal agreement and extending the timeline of the 10-year case. 
Retailer Home Depot filed its appeal Thursday while design consultancy Topographic and benefits providers Employee Services Inc. appealed the settlement the day before, according to filings submitted to the U.S. District Court for the Northern District of Alabama. 
None of the companies’ legal briefs explain why they are appealing Judge David Proctor’s decision to approve the deal last month. Home Depot, Topographic, Employee Services and the Blue Cross and Blue Shield Association didn't immediately responded to interview requests.”

HCSC teams with Teladoc to roll out virtual primary care next year “HCSC, the country's largest customer-owned health insurer, will begin offering the virtual care service to some midsize and large employer groups in Illinois and Texas starting Jan. 1, 2023.
The virtual primary care model is designed to help employers with employees scattered across diverse geographies get timely and convenient access to a trusted online care team—all while managing healthcare outcomes and costs, executives said.”

About pharma

 Providers spent $44B on 340B drugs in 2021 “The 30-year-old program that allows hospitals to buy drugs directly from manufacturers to avoid inflated prices, 340B, cost providers $43.9 billion in 2021, according to HHS' Health Resources and Services Administration. 
Most of that spending — more than $34 billion — was from disproportionate share hospitals. Health center programs bought more than $2 billion worth of 340B drugs, children's hospitals about $1.3 billion and critical access hospitals nearly $621 million.”

Effects of Real-time Prescription Benefit Recommendations on Patient Out-of-Pocket Costs Question  Do real-time prescription benefit (RTPB) recommendations for clinically appropriate, lower-cost alternatives at the point of prescribing reduce patient medication out-of-pocket costs?
Findings  This cluster randomized clinical trial found that RTPB recommendations led to a 11% reduction in patient out-of-pocket costs for ordered medications. Among high-cost drug classes, the intervention led to a 40% reduction in out-of-pocket costs; however, RTPB recommendations were made for only a small proportion of orders.”

About health technology

 President Biden Announces Intent to Appoint Dr. Renee Wegrzyn as Inaugural Director of Advanced Research Projects Agency for Health (ARPA-H) The headline is the story.

GE Healthcare to spin off in January “GE Healthcare is set to spin off as a standalone public company in the first week of January.”

Today's News and Commentary

About Covid-19

 New Covid boosters look a lot like the old ones. Doctors worry that could lead to errors. “As updated Covid booster shots roll out across the nation, many experts are raising an eyebrow — and perhaps squinting at the label. That's because the new doses come in capped vials that look strikingly similar to the old ones.
It's a design decision, experts say, that could result in some people mistakenly receiving the wrong dose.”

COVID-19-Associated Hospitalizations Among Vaccinated and Unvaccinated Adults 18 Years or Older in 13 US States, January 2021 to April 2022 “In this cross-sectional study of US adults hospitalized with COVID-19 during January 2022 to April 2022 (during Omicron variant predominance), COVID-19-associated hospitalization rates were 10.5 times higher in unvaccinated persons and 2.5 times higher in vaccinated persons with no booster dose, respectively, compared with those who had received a booster dose. Compared with unvaccinated hospitalized persons, vaccinated hospitalized persons were more likely to be older and have more underlying medical conditions.”

Covid Rebound Symptoms, Positive Tests After Paxlovid Are Common, Study Says “Resurgence of Covid-19 symptoms in patients treated with Pfizer Inc.’s Paxlovid appeared far more common than has been reported, and rebounding patients still risked spreading the disease, doctors said in a report on a series of cases in a top medical journal.
The article published Wednesday in the New England Journal of Medicine documented 13 fully vaccinated patients whose rapid Covid tests turned strongly positive and symptoms reappeared several days after finishing five-day courses of Paxlovid.”

RADx reloaded: NIH puts out the call for more effective, easier-to-use COVID tests “In the two-and-a-half years of the COVID-19 pandemic, diagnostic test makers have fine-tuned their development and manufacturing processes to quickly roll out countless tests for the virus, many of them helped along by infusions of federal funding specifically set aside for innovative new testing approaches.
And the government isn’t done yet. With its sights set on the endemic stage of the coronavirus, the National Institutes of Health has re-upped its call for new and improved COVID diagnostics, it announced Thursday.
The summons arrives via the Rapid Acceleration of Diagnostics Tech program, or RADx, which launched in the early days of the pandemic with an initial commitment of $1.5 billion and a ‘Shark Tank’-style competition to quickly develop both at-home and point-of-care tests for the virus.”

About health insurance/insurers

 Comparison of Low-Value Services Among Medicare Advantage and Traditional Medicare Beneficiaries Question  Do rates of low-value care differ between traditional Medicare (TM) and Medicare Advantage (MA), and, if so, what elements of insurance design are associated with the differences?
Findings  In this cross-sectional study of 2 470 199 Medicare beneficiaries, those enrolled in MA received 9.2% fewer low-value services than those in TM (23.1 vs 25.4 total low-value services per 100 beneficiaries). The MA beneficiaries in health maintenance organizations and those in primary care organizations reimbursed within advanced value-based payment models had the lowest rates of low-value care.”

UnitedHealth Deal Is 'Not A Merger To Monopoly,' Judge SaysThe D. C. federal judge who will decide the fate of UnitedHealth's $13. 8 billion bid for Change Healthcare challenged the U. S. Department of Justice during closing arguments Thursday on its assertions that the deal will create a monopoly for health insurance claims processing technology, repeatedly noting plans to divest the sole overlapping business unit.”

About hospitals and healthcare systems

 Hospitals Divert Primary Care Patients to Health Center ‘Look-Alikes’ to Boost Finances “A growing number of hospitals are outsourcing often-unprofitable outpatient services for their poorest patients by setting up independent, nonprofit organizations to provide primary care.
 Medicare and Medicaid pay these clinics, known as federally qualified health center look-alikes, significantly more than they would if the sites were owned by hospitals.
Like the nearly 1,400 federally qualified health centers — which get those additional dollars as well — a clinic designated by the government as a ‘look-alike’ is also eligible for federal programs that could help reduce costs and recruit providers. They allow the clinics to obtain prescription drugs at deep discounts and attract doctors by making them eligible for a government program that helps them pay off their student debt if they work in an area with a shortage of medical providers.
But unlike the community health centers, the look-alikes do not get an annual federal grant to cover operational costs. Nor do the look-alikes get the financial benefit in which the federal government covers their malpractice risks.”

National Alliance Helps Employers Get to Fair Price for Hospital Services “ To support employers and other healthcare purchasers in efforts to stop paying indefensible hospital prices, the National Alliance of Healthcare Purchaser Coalitions (National Alliance) released a new resource for plan sponsors to map out strategies to identify and negotiate fair market prices for hospitals.
Recent data indicates that for most hospitals a “fair price” for patients privately insured by employers is 140%-200% of what Medicare pays for the exact same products, procedures and services at the exact same facilities. Some hospitals charge 250% more for those services, with others even higher at 500% or more over Medicare. A fair price should allow for a reasonable markup from costs and a price that is competitive with peer hospitals…
The playbook, “Beyond Hospital Transparency: Getting to Fair Price,” helps purchasers navigate and understand how to best leverage newly available hospital price and quality transparency data and tools from Sage Transparency which incorporates content from RAND Corporation, the National Academy for State Health Policy(NASHP), and other sources. It also offers guidance on rights and responsibilities as plan sponsor fiduciaries to determine fair prices for hospital services, market- and policy-based strategies, and ways to work individually and through coalitions to achieve fair pricing for hospital services.
While there isn’t a one-size-fits-all approach as available data and market conditions vary among regions and states, the methodology and action steps in the playbook to help plan sponsors determine and achieve a fair price include:

  • Identify breakeven costs – Uncover what hospitals need to charge commercial customers to break even considering all other incomes and expenses plus a reasonable margin.

  • Compare costs among peer hospital systems – Determine how hospital charges compare to other hospitals with similar services and quality.

  • Determine a fair market price – Use data from Sage Transparency to negotiate fees based on a reasonable markup of hospital costs.”

Nursing facilities and debt collectors “The Consumer Financial Protection Bureau (CFPB) and the Centers for Medicare & Medicaid Services (CMS) remind you of your responsibilities under the Nursing Home Reform Act (NHRA), Fair Debt Collections Practices Act (FDCPA), and Fair Credit Reporting Act (FCRA).
The NHRA prohibits nursing facilities from requesting or requiring that a third party personally guarantee payment to the facility as a condition of a resident’s admission or continued stay in the facility. Contract terms that conflict with the NHRA are unlawful, and alleged debts resulting from such unlawful contract terms are invalid and unenforceable. Some nursing facilities have attempted to evade this prohibition by creating admission contracts that attempt to hold third parties liable for a resident’s debt. When a nursing facility claims that a non-resident is personally financially responsible for a resident’s bill and engages a third-party debt collector to collect the debt, the debt collector may violate the FDCPA by attempting to collect debts that are invalid under the NHRA. They may also violate the FCRA by furnishing information regarding such invalid debts to consumer reporting agencies.”

About pharma

 US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018 “In this cohort study, the FDA granted accelerated approval of 48 drugs for 57 nononcology indications from 1992 to 2018 with a median time to regular approval of 53.1 (95% CI, 38.7-70.2) months. Nine postapproval confirmatory trials failed to verify clinical efficacy, but only 1 indication was withdrawn due to a failed confirmatory trial 136 months after approval.” 

About the public’s health

 DHS unwinds Trump-era 'public charge' rule for immigrants “The Department of Homeland Security on Thursday finalized a regulation rolling back a policy instituted under former President Donald Trump that sought to limit immigration benefits for those likely to rely on government aid.
The new law unravels the Trump-era public-charge rule, under which immigrants could be denied permanent resident status if they had received or were expected to receive food assistance, Medicaid, housing assistance, or other public benefits.”

Artificial sweeteners and risk of cardiovascular diseases: results from the prospective NutriNet-Santé cohortThe findings from this large scale prospective cohort study suggest a potential direct association between higher artificial sweetener consumption (especially aspartame, acesulfame potassium, and sucralose) and increased cardiovascular disease risk. Artificial sweeteners are present in thousands of food and beverage brands worldwide, however they remain a controversial topic and are currently being re-evaluated by the European Food Safety Authority, the World Health Organization, and other health agencies.”

About healthcare IT

Medical breaches accounted for 342 million leaked records from 2009 to 2022 The entire report is worth reading.
”Key findings:

  • 4,746 medical breaches recorded from 2009 to June 2022

  • 342,017,215 individual records were affected as a result of these breaches

  • 2020 was the biggest year for medical breaches with 803 reported (the second-highest was 2021 with 711)

  • 2015 saw the highest number of records affected with over 112 million in total

  • In 2021 and 2022 (so far), specialist clinics (clinics that specialize in a certain field of medicine–e.g. cardiology or radiology, etc.) account for the most data breaches (15 percent) with 130 breached entities in total, but hospital networks account for the most breached records with 8.8 million affected in total (16 percent of the overall records affected)

  • In 2021 and 2022 (so far), hacking was the most common type of breach, accounting for 40 percent of breaches (353 out of 862)”

 Cyber Insecurity in Healthcare “According to the research, 89 percent of organizations in this research experienced cyberattacks in the past 12 months. For organizations in that group, the average number of attacks was 43. We asked respondents to estimate the single most expensive cyberattack in the past 12 months from a range of less than $10,000 to more than $25 million. Based on the responses, the average total cost for the most expensive cyberattack experienced was $4.4 million. This included all direct cash outlays, direct labor expenditures, indirect labor costs, overhead costs and lost business opportunities.
At an average cost of $1.1 million, lost productivity was the most significant financial consequence from the cyberattack. However, despite the connection between cyberattacks and patient safety, the least amount of cost following a cyberattack was the time required to ensure the impact on patient care was corrected ($664,350).”
This study is also worth reading in its entirety.

About healthcare personnel

 More DOs Join Physician Ranks as Osteopathic Pipeline Heats Up “The number of doctors of osteopathic medicine (DOs) is enjoying a significant growth pattern. This year alone, 7300 osteopathic physicians are entering the workforce, and they make up more than 25% of the medical student population. The pipeline of future DOs is at an all-time high of 36,500 students, according to the American Osteopathic Association (AOA).”

About healthcare finance

Alphabet's Verily Raises $1 Billion and Shakes Up Leadership Team “Verily, the Alphabet Inc. life sciences unit that experimented with diabetes-detecting contact lenses and launched Covid-19 testing programs, said it raised $1 billion in new investments led by its parent company, padding its war chest as the health-tech market heats up.”