Today's News and Commentary

About Covid-19

Gene variant may be why some test positive for virus with no covid symptoms “During the nine-month study period, 1,428 unvaccinated individuals reported a positive coronavirus test, and 136 of them had no symptoms. Among the asymptomatic participants, 20 percent carried a common HLA variant called HLA-B*15:01. People carrying two copies of this variant — one passed down from each parent — were more than eight times more likely to remain asymptomatic than those carrying other HLA variants.”

About health insurance/insurers

 2 brothers plead guilty to roles in $67M Medicare fraud scheme “Daniel M. Carver owned and managed call centers that he used to target Medicare beneficiaries, talking the individuals into paying for unnecessary genetic testing and durable medical equipment, the DOJ said. Meanwhile, his brother, Louis, worked the phones at the call centers and pretended to own a laboratory where false genetic testing claims were submitted, according to the release.”
Comment: When did you last hear about such fraud occurring with a private insurance company?

Elevance Health grows profits 13.2% in Q2, reaching $1.9B “The company reported $1.6 billion in the prior year quarter, according to its earnings report released Wednesday morning. Revenues also grew by double digits, increasing by 13% to $43.7 billion in the second quarter from $38.6 billion in the second quarter of 2022. The results both surpassed Wall Street's expectations, according to Zacks Investment Research.”
Comment: Despite the resumption of pre-Covid elective procedures, insurance companies continue to be very profitable.

About pharma

 Cost Plus Drugs could be selling drugs to hospitals by this fall “Mark Cuban Cost Plus Drug Co. plans to be selling drugs to hospitals and clinics by September or October, the company's CEO and co-founder Alex Oshmyansky, MD, PhD, told Dallas-based D Magazine
The pharmaceutical company launched its mail-order pharmacy services in January 2022 with about 100 drugs. It now sells more than 1,000 generics and 10 brand-name medications, has a network of independent pharmacies spanning 38 states, and partners with pharmacy benefit managers and Capital Blue Cross.”

About the public’s health

They're illegal. So why is it so easy to buy the disposable vapes favored by teens? A very informative piece from NPR. Read the entire article. One interesting fact: “Nearly all the world's e-cigarettes — 90% — come from factories in Shenzhen, China…”

Extreme heat drives $1B in excess healthcare utilization per year, study estimates “The study—released online Monday and currently being submitted for publication in a scientific journal—found between 2016 and 2020 an average of roughly 234,000 excess emergency department visits across the country tied to heat event days. Excess hospital admissions averaged just over 56,000, according to the study conducted by Virginia Commonwealth University (VCU) and the Center for American Progress, a nonpartisan public policy advocacy group.”
Comment: Another cost of global warming.

Screening for Lipid Disorders in Children and AdolescentsUpdated Evidence Report and Systematic Review for the US Preventive Services Task Force “No direct evidence on the benefits or harms of pediatric lipid screening was identified. While multifactorial dyslipidemia is common, no evidence was found that treatment is effective for this condition. In contrast, FH [familial hypercholesterolemia] is relatively rare; evidence shows that statins reduce lipid levels in children with FH, and observational studies suggest that such treatment has long-term benefit for this condition.”

About healthcare IT

Teladoc doubles down on Microsoft partnership to bring AI, voice tech into telehealth visits “Teladoc and Microsoft teamed up in 2021, during the height of the COVID-19 pandemic, to streamline the technology and administrative processes associated with virtual care and integrate the company's Solo enterprise platform within Microsoft Teams.
The company is taking that collaboration a step further and leveraging Microsoft's 2022 acquisition of speech recognition tech company Nuance to bring Azure OpenAI Service, Azure Cognitive Services and the Nuance Dragon Ambient eXperience into its virtual care solution for hospitals and health systems.”

About healthcare personnel

 Should nurses with doctorates be called doctor? Lawsuit targets Calif. rule.  “…last month, Palmer and two other nurses with doctorates of nursing practice sued the California attorney general and leaders of the Medical Board of California and California Board of Registered Nursing, arguing that they have a right to call themselves doctors. The lawsuit seeks to permanently prevent the state from enforcing the law.”
Comment: Physician Assistants are still lobbying to change their designation to Physician Associates.

Association of Established Primary Care Use With Postoperative Mortality Following Emergency General Surgery ProceduresAbout health technologyQuestion  Is preoperative primary care utilization associated with postoperative mortality following an emergency general surgery operation?
Findings  In this cohort study of 102 384 Medicare patients, those with preoperative primary care exposure had significantly lower rates of in-hospital, 30-day, 60-day, 90-day, and 180-day mortality following an emergency general surgery operation.
Meaning  Preoperative primary care utilization was associated with lower odds of postoperative mortality; this protective association may be due to improved diagnosis and management of medical comorbidities.”

About healthcare technology

 Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy The story is in the headline from the FDA. Other news media estimate there are 350,000 units subject to the recall.

Today's News and Commentary

About healthcare quality and safety

 Burden of serious harms from diagnostic error in the USA “An estimated 795 000 Americans become permanently disabled or die annually across care settings because dangerous diseases are misdiagnosed. Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined.”

FDA announces Class I recall of nearly 8,000 heart attack tests due to inaccurate resultsThe U.S. Food and Drug Administration (FDA) has announced that Quidel Cardiovascular Inc. is recalling certain blood tests used to detect myocardial infarctions. The agency has categorized this as a Class 1 recall, which means using these devices “may cause serious injuries or death.”
The Quidel Triage Cardiac Panel is a blood test designed to identify amounts of different enzymes and proteins associated with a heightened risk of myocardial infarctions or other potentially fatal cardiac conditions. The recall is in place because there have been multiple reports of inaccurate tests.”

About hospitals and healthcare systems

Ochsner Health, Novant Health Announce Partnership to Expand Patient-Centered Senior Care “The partners plan to build 65 Plus clinics throughout the Southeast, giving older adult patients access to extended visits with their primary care physician and a multidisciplinary team to design a customized care plan to meet individual needs. Each clinic will have several service offerings to encourage patients to live active, healthier lives well into their senior years. Beyond medical needs, 65 Plus clinics will offer a community environment with regular social events, fitness centers, health coaching and more.”

About pharma

Donanemab in Early Symptomatic Alzheimer Disease The TRAILBLAZER-ALZ 2 Randomized Clinical Trial “Question  Does donanemab, a monoclonal antibody designed to clear brain amyloid plaque, provide clinical benefit in early symptomatic Alzheimer disease?
Findings  In this randomized clinical trial that included 1736 participants with early symptomatic Alzheimer disease and amyloid and tau pathology, the least-squares mean change in the integrated Alzheimer Disease Rating Scale score (range, 0-144; lower score indicates greater impairment) at 76 weeks was −6.02 in the donanemab group and −9.27 in the placebo group for the low/medium tau population and −10.19 in the donanemab group and −13.11 in the placebo group in the combined study population, both of which were significant differences.
Meaning 
Among participants with early symptomatic Alzheimer disease and amyloid and tau pathology, donanemab treatment significantly slowed clinical progression at 76 weeks.”
In a related article: Eli Lilly’s experimental Alzheimer’s drug slows disease, data show

An innovation supply chain: Pfizer taps Flagship for 10-program pipeline pact worth $7B in biobucks “Pfizer and Flagship Pioneering have each put down $50 million to build a new pipeline of 10 programs, with the Big Pharma offering the VC firm and its bioplatform companies the chance to make up to $700 million in biobucks for each successful drug.”

Sanofi taps Scribe for in vivo partnership worth more than $1.2B biobucks aimed at sickle cell and beyond The new collaboration gives Sanofi exclusive access to Scribe’s gene editing tech to develop new therapies, including for sickle cell disease, in exchange for $40 million in upfront cash and up to $1.2 billion in biobucks. Back in September 2022, Sanofi tapped up Scribe to develop ex vivo therapies—where edits are made to cells in a lab before being given to patients—handing over $25 million upfront.”

Johnson & Johnson sues to stop Medicare negotiation “Pharmaceutical giant Johnson & Johnson on Tuesday became the third drugmaker to sue the Biden administration over its new Medicare drug price negotiation program.”

About healthcare IT

 EHR vendor NextGen to pay $31 million to settle False Claims Act allegations  “Electronic health record vendor NextGen Healthcare on Friday agreed to pay $31 million to settle allegations that it violated the False Claims Act by misrepresenting versions of its product and providing illegal incentives to induce referrals to its software, according to the Department of Justice.
In a complaint filed along with the settlement, the DOJ contends that NextGen improperly sought HHS certification for its software by using an “auxiliary product” designed only to perform the certification, thereby concealing that its product lacked “critical functionality.”
NextGen also violated the Anti-Kickback Statute by providing “remuneration” to clients — with tickets to sporting events and credits worth up to $10,000 — to incentivize purchases and referrals of NextGen’s software, according to the DOJ.”

PETERSON CENTER ON HEALTHCARE LAUNCHES NEW $50 MILLION INSTITUTE TO EVALUATE DIGITAL HEALTH TECHNOLOGIES “The Peterson Center on Healthcare today launched the Peterson Health Technology Institute (PHTI), a nonprofit organization that provides independent evaluations of innovative healthcare technologies to improve health and lower costs. Launched with a commitment of $50 million, PHTI will deliver rigorous, evidence-based assessments that will analyze the clinical benefits and economic impact of digital health solutions, as well as their effects on health equity, privacy, and security.”

About healthcare finance

FTC Sues to Block IQVIA’s Acquisition of Propel Media to Prevent Increased Concentration in Health Care Programmatic Advertising “The Federal Trade Commission is seeking to block IQVIA Holdings Inc. (IQVIA), the world’s largest health care data provider, from acquiring Propel Media, Inc. (PMI), alleging in an administrative complaint (link to redacted complaint when made available) that the proposed acquisition would give IQVIA a market- leading position in programmatic advertising for health care products, namely prescription drugs, to doctors and other health care professionals. The merger would also increase IQVIA’s incentive to withhold key information to prevent rival companies and potential entrants from effectively competing, the complaint states.”

Today's News and Commentary

About Covid-19

 Moderna submits authorisation application for coronavirus vaccine Spikevax XBB.1.5  “Moderna Switzerland GmbH has submitted an application to Swissmedic, the Swiss Agency for Therapeutic Products, for authorisation of its updated monovalent COVID-19 vaccine. It encodes the spike protein for Omicron subvariant XBB.1.5 of SARS-CoV-2.”

About health insurance/insurers

Blue Cross Blue Shield plans in California evaded $170 million in taxes, whistleblower says Blue Shield of California evaded $111 million in taxes between 2016 and 2020, according to a complaint that was filed with the Internal Revenue Service on June 27. Elevance Health, the parent company of Anthem Blue Cross in California, evaded $60 million in taxes during the same time period, according to a separate complaint filed with the IRS.”

Medicaid Enrollment and Unwinding Tracker “At least 2,181,000 Medicaid enrollees have been disenrolled as of July 14, 2023, based on the most current data from 30 states and the District of Columbia. Overall, 37% of people with a completed renewal were disenrolled in reporting states while 63%, or 3.4 million enrollees, had their coverage renewed (four of the reporting states do not provide data on renewed enrollees). Because not all states have publicly available data on total disenrollments, the data reported here undercount the actual number of disenrollments.”

Obamacare Eligibility Match Program to Be Re-Established “Verification of eligibility to enroll in Obamacare plans and get subsidies will be re-established, the Department of Health and Human Services said Friday.
A ‘matching program’ between the Centers for Medicare & Medicaid Services and the Social Security Administration will be re-established for an initial term of 18 months from Sept. 9 to March 8, 2025, and may be renewed for an additional year if no changes are made, the notice said. Comments may be submitted. The notice will be published in the July 17 Federal Register.”

About hospitals and healthcare systems

 Changes in US Hospital Financial Performance During the COVID-19 Public Health Emergency  “Question  How did the financial position of hospitals change during the COVID-19 public health emergency?
Findings  In this national cohort study of 4423 hospitals, 3337 (75%) hospitals had a positive net operating income during 2020/2021, and 720 (16%) experienced new financial distress. Hospitals serving Hispanic populations were more likely to experience financial distress, even after receiving public health emergency funding; however, COVID-19 relief funding aided in hospital net operating margins reaching all-time highs.
Meaning  Although the majority of US hospitals were financially healthy across 2020 and 2021, partly due to the provision of COVID-19 relief funds, the size of COVID-19 relief funds may have been larger than was necessary for many hospitals.”

CMS to raise hospital payments to buy N95 masks, proposes 2.7% pay hike for facilities “The Biden administration is proposing a 2.7% increase to outpatient payment rates for hospitals for 2023 and an enhanced payment if a facility buys domestically manufactured N95 respirator masks.”

Hospital M&A deal volume returns to pre-pandemic levels as systems seek out complementary services “Twenty new deals were announced from April to June, up from the 15 of the first quarter and squarely above the 14 announced in the second quarter of 2020 along with the 14 and 13 transactions announced in the second quartesr of 2021 and 2022, respectively, healthcare consultancy Kaufman Hall wrote in an analysis released Thursday. The most recent count is in line with the 21 deals tallied by the firm in the second quarter of 2018 and the 19 deals that were inked in the second quarter of 2019.
Deal size, on the other hand, remains elevated compared to the years leading up to the pandemic. Second-quarter average deal size, as measured by the smaller organization’s revenue, was $664 million—down from the second quarter of 2022’s $852 million average but still above every other year dating back at least to 2017, Kaufman Hall wrote.”

About pharma

 A stroke of good luck for Sangamo: Biotech snags $1B+ biobucks deal with Lilly’s Prevail after layoffs, 2 other deals dissolve Prevail is set to pay Sangamo an undisclosed upfront payment for providing the capsids for evaluation. If the Lilly unit moves forward with certain capsids, it would take the lead on all further development, manufacturing and commercialization activities. If Prevail decides to exercise its option for all targets and a Prevail product is approved in the U.S. and Europe for each target, Sangamo could receive developmental milestones of up to $415 million and commercial payments of up to $775 million, plus tiered royalties.”

About the public’s health

First RSV antibody treatment to protect all infants approved in the U.S. “Federal regulators on Monday approved a shot to protect healthy babies and some vulnerable toddlers against the respiratory ailment RSV, the leading cause of hospitalization among young children in the United States.
The preventive shot, called Beyfortus, isn’t a vaccine, but it works in a similar way, delivering a temporary shield of protection that lasts for a single winter respiratory virus season. It is made up of laboratory-brewed antibodies that block the virus from entering cells.”

About health technology

 They Lost Their Legs. Doctors and Health Care Giants Profited. This NY Times article is well-worth reading if you can get access. It combines the principles of the link between fincanial incentives and actions as well as the technological imperative.

About healthcare finance

FTC asks Pfizer, Seagen for more information on proposed $43B merger “The Federal Trade Commission (FTC) has asked Pfizer and Seagen for more information on their proposed $43 billion merger, the Seattle biotech revealed(PDF) in a Securities and Exchange Comission (SEC) filing Friday.
This is the second round of documentation the antitrust regulator has requested from the companies since their deal was announced in March.”

Lilly to boost obesity drug portfolio with $1.93-billion Versanis buy “Eli Lilly announced Friday that it will acquire Versanis for potentially up to $1.93 billion in cash, gaining the latter's lead drug bimagrumab, which is under development for obesity.”

Today's News and Commentary

About Covid-19

 Biden administration to provide free Covid vaccines to uninsured Americans this fall through end of 2024  “The Biden administration on Thursday announced a program to provide free Covid vaccines to uninsured Americans through December 2024 after the federal government’s supply of shots runs out this fall.
Those free shots, which the government is purchasing at a discount, will be available to the uninsured at pharmacies and 64 state and local health departments.”

About health insurance/insurers

CMS outlines 2.8% pay increase for outpatient facilities, ASCs in 2024 proposed rule “In the proposed calendar year 2024 rule, set to be published in the Federal Register, CMS floated payment rates for hospitals that meet applicable requirements for quality reporting at 2.8%, reflecting a projected 3% hospital market basket increase reduced by 0.2% percentage points for a required productivity adjustment.”

CMS proposes payment cuts in physician fee schedule, and docs are crying foul “The Biden administration has released the proposed physician fee schedule for 2024, and a 3.34% decrease in the conversion factor is likely to draw plenty of ire from docs.
The agency said in a press release that under the proposed rule, payments overall would decrease by 1.25% compared to 2023. However, the Centers for Medicare & Medicaid Services (CMS) set the conversion factor at $32.75, down $1.14 or 3.34% from last year.”

FIRST ANNUAL NO SURPRISES ACT REPORT RELEASED “The Department of Health and Human Services' (HHS) Office of the Assistant Secretary for Planning and Evaluation recently released the first annual report on the impact of the No Surprises Act.
According to the report, there was a downward trend in out-of-network claims prior to the No Surprises Act implementation. The prevalence of claims that were out-of-network decreased from 6.0 percent to 4.7 percent from 2012 to 2020. In addition, the share of total payments that were out-of-network declined over this period from 9.2 percent in 2012 to 6.8 percent in 2020, the report said.
The report also says that during that time, out-of-network billing was highly concentrated among a small percentage of physicians from certain specialties.”

UnitedHealth kicks off Q2 earnings with $5.5B in profit, double-digit revenue growth “Profits were up year over year, as the company posted $5.1 billion in profit for the second quarter of 2022. Revenues grew by 16% from the prior year quarter, reaching $92.9 billion compared to $80.3 billion. Both figures surpassed Wall Street analysts' projections…
UnitedHealth Group's double-digit revenue growth overall was bolstered by double-digit gains at both UnitedHealthcare and Optum, according to the report. Revenues at UnitedHealthcare were up 13%, hitting $70.2 billion…
Revenues at Optum were up 25% in the second quarter, reaching $56.3 billion. The Optum arm has been a major growth engine for UnitedHealth Group in recent quarters.”

About hospitals and healthcare systems

 Why hospitals are cutting ties with Moody’s rating agency “Not-for-profit hospitals have been cutting ties with Moody’s Investors Service in recent years, citing the high cost and time commitment required to maintain their relationships with the rating agency.
With labor and supply costs inflated and margins thin following the Covid-19 pandemic, hospitals are eager to trim any expenses they can. Increasingly, that means cutting a bond rating. It’s common for health systems to have their bonds rated by just two or even one of the three major credit rating agencies —Moody’s, S&P Global Ratings, and Fitch Ratings.
But when deciding which one to ditch, data show they’ve more commonly targeted Moody’s in recent years. At least 10 health systems have ended their agreements with Moody’s since July 2020…”

About pharma

Ozempic demand is driving up care costs nationwide The headline is the story.

About the public’s health

Medicare proposes coverage for PrEP without patient cost sharing “The Centers for Medicare & Medicaid Services (CMS) is recommending preexposure prophylaxis (PrEP) with oral or injectable antiretroviral therapy to people at risk of HIV without patient cost sharing.
In addition, CMS is proposing to cover the administration of injectable PrEP and up to seven individual counseling visits every 12 months that include HIV risk assessment, reduction and medication adherence. The agency is also pitching coverage for HIV screening up to seven times annually and a single screening for hepatitis B virus, according to a press release.”

White House planning to tap retired general to lead new pandemic office “Maj. Gen. Paul Friedrichs, who retired from the military this summer and joined the National Security Council to work on biodefense and global health security, is the planned selection to lead the White House’s Office of Pandemic Preparedness and Response Policy, according to three people who spoke on the condition of anonymity to discuss a pending personnel move.”

About healthcare finance

 Hungry for more, Lilly tops off weight loss pipeline with $1.9B deal to acquire Versanis “The Indianapolis-based company has signed off on a $1.92 billion deal, which covers an upfront payment and potential milestones, for Boston-based Versanis and lead asset bimagrumab.
The monoclonal antibody is already in a phase 2 trial both alone and in combination with semaglutide in adults who are overweight or obese.”

Today's News and Commentary

About hospitals and healthcare systems

 Aspirus Health, St. Luke's Duluth unveil plans to form 19-hospital Midwest nonprofit system “St. Luke’s Duluth in Minnesota is working on a deal to join Wisconsin-based nonprofit Aspirus Health, representing the latest in a string of Midwest hospital consolidation deals currently in the works.
The organizations announced Wednesday that they have signed a letter of intent for the two-hospital Minnesota system to become an affiliate of the 17-hospital Aspirus Health. They said they expect the deal to close in early 2024 pending due diligence, regulatory reviews and other approvals.”

About pharma

FDA clears first over-the-counter oral contraceptive “The FDA on Thursday approved Perrigo's Opill for over-the-counter (OTC) use, making it the first hormonal oral contraceptive available in the US without a prescription. "When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy," stated Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research.”

 A Small Number of Drugs Account for a Large Share of Medicare Part D Spending FYI. Eliquis is by far the most costly as far as total spending.

Chamber of Commerce asks judge to block Medicare drug price negotiations before October
The U.S. Chamber of Commerce on Wednesday asked a federal judge in Ohio to block Medicare’s new powers to negotiate drug prices before October 1.
—The Chamber argued that the negotiations violate the due process clause under the Fifth Amendment of the U.S. Constitution.
—Drugmaker Abbvie, a chamber member, is worried its blood cancer drug Imbruvica will be selected for price negotiations this fall.

Leqembi could cost Medicare up to $17.8B “Eisai and Biogen, the manufacturer of Leqembi, estimated around 100,000 individuals will be prescribed the drug by year three of its approval. At this rate of uptake, it would cost Medicare $2.7 billion each year, KFF found.”
And, in a related article: How are insurers handling the Alzheimer’s drug Leqembi and related scans? A week after the Food and Drug Administration granted full, traditional approval to a new Alzheimer’s treatment, insurers are finalizing their plans to cover it as well as associated scans and diagnostic tests.
Medicare will cover most patients eligible for Leqembi, a new treatment developed by Eisai and Biogen to help slow the progression of Alzheimer’s disease. The drug, which has modest benefits, has potentially serious side effects for some patients including brain swelling and bleeding.
Medicare told STAT that it would cover brain scans and genetic testing that will help screen for and monitor potential side effects. Medicare already covers one amyloid PET scan per lifetime, but the agency is reconsidering that policy and plans to release a new proposed policy ‘soon,’ an agency spokesperson said.”

CVS Caremark, GoodRx team up on prescription discounts “The two companies announced on Wednesday the launch of Caremark Cost Saver. In the program, eligible Caremark members will able to automatically access GoodRx's pricing, which will allow them to pay lower prices on generic medications when applicable.”

Recursion Announces Collaboration and $50 Million Investment from NVIDIA to Accelerate Groundbreaking Foundation Models in AI-Enabled Drug Discovery “Recursion plans to utilize its vast proprietary biological and chemical dataset, which exceeds 23 petabytes and 3 trillion searchable gene and compound relationships, to accelerate the training of foundation models on NVIDIA DGX™ Cloud for possible commercial license/release on BioNeMo, NVIDIA’s cloud service for generative AI in drug discovery. NVIDIA will also help optimize and scale Recursion foundation models leveraging the NVIDIA AI stack and NVIDIA’s full-stack computing expertise. BioNeMo was announced earlier this year as a cloud service for generative AI in drug discovery, offering tools to quickly customize and deploy domain-specific, state-of-the-art biomolecular models at-scale through cloud APIs. Recursion anticipates using this software to support its internal pipeline as well as its current and future partners.”

About the public’s health

 Johnson & Johnson sues researchers who linked talc to cancer “J&J alleges researchers used ‘junk science’ to disparage company's products…
J&J's subsidiary LTL Management, which absorbed the company's talc liability in a controversial 2021 spinoff, last week filed a lawsuit in New Jersey federal court asking it to force three researchers to "retract and/or issue a correction" of a study that said asbestos-contaminated consumer talc products sometimes caused patients to develop mesothelioma.”

About healthcare IT

Hacker claims to have posted HCA data for saleA hacker has claimed responsibility for a data theft incident at Nashville, Tenn.-based HCA Healthcare and has allegedly stolen and posted more than 27 million records for sale on the dark web, DMagazine reported July 11.”

Today's News and Commentary

About health insurance/insurers

HHS: Medicare Part D enrollees will save $400 on average in 2025 “Caps on Medicare prescription drug costs will save Part D enrollees a collective $7.4 billion in 2025, according to a report from HHS' Office of the Assistant Secretary for Planning and Evaluation. 
The report, published July 7, broke down expected savings from price caps by state. An estimated 18.7 million people, around 1 in 3 Medicare Part D enrollees, will save on drug costs in 2025. The average annual saving per person is estimated at $396.08.”

Federal inquiry aims to protect consumers against predatory medical debt and collection practices “The Consumer Financial Protection Bureau (CFPB) is launching an inquiry into a practice used to coax patients into paying for routine care with medical credit cards and installment loans.
In partnership with the Department of Health and Human Services (HHS) and the Department of the Treasury, the three agencies hope to examine patients’ experiences with credit cards and loans as well as healthcare providers’ incentives to offer high-cost products.”
 

About hospitals and healthcare systems

 US News won't rank honor roll hospitals “The publication will no longer attribute ordinal rankings to its honor roll hospitals, it said in a July 11 letter addressed to hospital leaders…
Ordinal rankings will still be listed for the 15 specialties U.S. News gauges, as well as the regions where it publishes.”
 
About pharma

Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report “The new lawsuits add to a complex web of ongoing mRNA patent litigation. The legal melee began last August when Moderna filed patent infringement lawsuits in the U.S. and Germany. Separately, Moderna has also sued Pfizer and its German partner BioNTech in the Netherlands, plus the U.K.
Moderna’s goal isn’t to remove Pfizer’s shot Comirnaty from the market, nor is it trying to target Pfizer’s sales in low- and middle-income countries covered by the COVAX initiative, the company insists. Instead, Moderna is pursuing compensation and damages to make up for Pfizer-BioNTech’s alleged trampling of patents detailing lipid nanoparticle delivery, spike protein encoding and more.”

About the public’s health

Millions of homes, schools may have to eliminate lead dust under EPA plan “In one of its strongest measures yet against a contaminant that poisons children, the Environmental Protection Agency on Wednesday proposed tougher standards on lead in paint in older homes and schools, potentially triggering its removal in millions of buildings.
The new rules would almost completely prohibit lead dust in older buildings. The only contamination allowed would be the lowest levels that current removal efforts can’t eliminate, the agency said. It estimates that those requirements each year would reduce lead exposures for 250,000 to 500,000 children younger than 6.
The rules apply to homes, schools, day-care centers and other facilities.” 

About healthcare IT

Digital health funding settles down in 2023 with fewer deals, lower check sizes “In the first six months of 2023, U.S. digital health startups raised $6.1 billion across 244 deals, with an average deal size of $24.8 million, according to an analysis by Rock Health, a venture fund dedicated to digital health. While that $6 billion seems like a hefty amount of cash, that's down considerably from $10.4 billion raised in the first half of 2022 and an eye-popping $15.1 billion raised in the first six months of 2021.”

About healthcare personnel

MONETIZING MEDICINE: PRIVATE EQUITY AND COMPETITION IN PHYSICIAN PRACTICE MARKETS  “SUMMARY OF MAJOR CONCLUSIONS
●  PE acquisitions of physician practices are increasing. We find that private equity (PE) firms have been increasingly acquiring physician practices across a number of physician specialties since 2012, increasing from 75 deals in 2012 to 484 deals in 2021, or more than six-fold increase in only 10 years.
●  PE firms are amassing high market shares in local physician practice markets. At the local level, we find that individual PE firms are acquiring competitively significant shares of physician practice markets. In particular, in 28% of metropolitan statistical areas (MSAs), a single PE firm has more than 30% market share by full-time-equivalent physicians, and in 13% of MSAs, the single PE firm market share exceeds 50%.
●  PE acquisitions are associated with price and expenditure increases. In 8 of the 10 physician practice specialties we study, we find statistically significant price increases associated with PE’s acquisition of a practice. These price increases range from 16% in oncology to 4% in primary care and dermatology. PE acquisitions are also associated with per-patient expenditure increases for 6 of 10 specialties, ranging from 4% to 16% depending on the specialty.
●  Price increases associated with PE acquisitions are exceptionally high where a PE firm controls a competitively significant share of the local market. When we focus our analysis on markets where a single PE firm controls more than 30% of the market, we find further elevated prices associated with PE acquisitions in each of the 3 specialties with statistically significant results, for gastroenterology (18%), obstetrics and gynecology (16%), and dermatology (13%).”  

About health technology

 Illumina hit with record $476 million EU antitrust fine over Grail deal “U.S. genetic testing company Illumina was fined a record 432-million-euro ($476 million) by the EU on Wednesday for closing its takeover of cancer test maker Grail before securing EU antitrust approval.
Illumina has been fighting the EU competition watchdog on several fronts since it was forced to seek its approval in 2021 despite the deal falling short of the EU turnover threshold for scrutiny.”

Today's News and Commentary

About health insurance/insurers/costs

 Healthy Marketplace Index Using nearly 4.3 billion commercial claims from 2017 to 2021, HCCI [Health Care Cost Institute]tracks drivers of health care spending across 183 U.S. cities through the Healthy Marketplace Index (HMI) project.” You can enter your location on this interactive site. It is set to Chicago as default.

Employers are increasingly suing their health plan for claims data “Lawsuits from large companies and employers are increasingly being filed against third-party health plan administrators in an effort to access complete employee medical claims data. 
Through lawsuits recently filed against Aetna, Elevance Health and BCBS Massachusetts, employers claim payers have breached their fiduciary duties by not allowing complete access to claims data and how claims are processed.
In a June 30 complaint, Kraft Heinz alleged Aetna has used its role as its TPA "to enrich itself to Kraft Heinz's detriment" through undisclosed fees and processing medical and dental claims without human review.”

Medicaid work requirements resurface, threatening health A really good review of the topic.

Who Enrolls in Medicare Advantage vs. Medicare Fee-for-Service Excerpts:
Demographically, MA enrollees differ meaningfully from FFS enrollees (Table 1). MA has a slightly higher proportion of males. Compared to FFS, those in MA are also twice as likely to be non-white, and much more likely to be Black, Hispanic, or Asian…
—Perhaps the starkest difference between the two groups is in the types of commercial plans in which they were enrolled, pre-65: MA enrollees are over 50% more likely than those in FFS to have been enrolled in an HMO plan (recall that 100% of both groups were in commercial coverage, pre-65). Given that MA plans tend to have relatively more restrictive care management policies, it makes sense that individuals who have previous exposure to care management would be more comfortable with that type of coverage under MA…
—The average income of an FFS enrollee (based on their corresponding ZIP9) is $85,085, compared to $76,720 for an MA enrollee. This gap arises from the relative lack of MA enrollees in the most affluent segments: while 35.5% of FFS enrollees live in a ZIP9 with incomes above $100,000, this is true for only 23.8% of MA enrollees. The average MA enrollee has a net worth that is only 74.2% of that of the average FFS enrollee…
—MA enrollees are more likely to face many other socioeconomic disadvantages relative to their FFS enrollee counterparts. Those in their near neighborhood are more likely to have only a high school education or less and slightly more likely to live in a high unemployment area, though the latter comparison is not statistically significant. They are less likely to own their home, to be married, and to own a vehicle, and more likely to have difficulty speaking English. Additionally, based on two aggregate measures of social risk, the Area Deprivation Index and the Socioeconomic Status (SES) index, MA enrollees are more socioeconomically disadvantaged than those in FFS.
—We find that, immediately prior to enrollment, those going into MA are modestly less sick than their FFS enrollee counterparts, having about 10% lower Hierarchical condition category (HCC) risk scores (0.566 vs 0.517) and Charlson Comorbidity Index (CCI) scores (0.853 vs. 0.751).
—MA and FFS enrollees have similar prevalence of the top chronic conditions among Medicare beneficiaries including hypertension and hyperlipidemia. FFS enrollees are more likely to have certain conditions, including cancer, joint issues (rheumatoid arthritis, osteoarthritis, and osteoporosis), and heart issues (ischemic heart disease and prior experience with heart failure). On the other hand, MA enrollees are more likely to have diabetes.”

About hospitals and healthcare systems

 CMS to return $9B to 340B hospitals under new plan The CMS’ long-awaited fix to repay hospitals for what the Supreme Court last year determined to be years of underpayments in the 340B drug discount program is garnering a mixed reaction from hospital groups.
The remedy proposed by regulators Friday would have Medicare send $9 billion in lump-sum payments to more than 1,600 hospitals that participate in 340B. To pay for the proposal, which needs to be budget-neutral, the CMS would cut payments to all hospitals for non-drug items and services by 0.5% over the next 16 years.”

About the public’s health

What is the cost-effectiveness of menu calorie labelling on reducing obesity-associated cancer burdens? An economic evaluation of a federal policy intervention among 235 million adults in the USA “Considering consumer behaviour alone, this policy was associated with 28 000 (95% UI 16 300 to 39 100) new cancer cases and 16 700 (9610 to 23 600) cancer deaths averted, 111 000 (64 800 to 158 000) QALYs gained, and US$1480 (884 to 2080) million saved in cancer-related medical costs among US adults. The policy was associated with net cost savings of US$1460 (864 to 2060) million and US$1350 (486 to 2260) million from healthcare and societal perspectives, respectively. Additional industry reformulation would substantially increase policy impact. Greater health gains and cost savings were predicted among young adults, Hispanic and non-Hispanic Black individuals.” 

Half of US adults skip common health screenings, including tests for certain diseases, survey finds “Americans are likely to skip important health screenings, and women have a less positive outlook than men regarding their current and future health prospects, according to a survey released by Aflac.
The survey, based on about 2,000 employed adults, examined attitudes, habits and opinions about health and preventive care and found that half of adults have avoided at least one common health screening. These screenings include tests for certain diseases.
But for the 51% of respondents who said they have had cancer, that diagnosis came following a routine checkup or screening. For Hispanic survey respondents, 72% of individuals said a diagnosis was discovered at a routine checkup.”

About healthcare IT

Two Years After Coding Changes Sought to Decrease Documentation, Notes Remain ‘Bloated’ “We evaluated 1.7 billion clinical notes written by 166,318 outpatient providers in the U.S. from May 2020 to April 2023 to determine the average length in characters for each note. We found that the average note length across all clinical notes has increased 8.1%, from 4,628 characters in May 2020 to 5,002 characters in April 2023…
However, despite these increases in note length, the average time spent writing notes decreased 11.1% over this same period, from an average of 5.4 minutes per note to 4.8 minutes per note. Additionally, providers are spending less time in clinical review activities in the EHR…
These findings align with previous research that found increased use of SmartTools and copy/paste functions were correlated with longer notes.”

HCA Healthcare Reports Data Security IncidentHCA Healthcare, Inc..recently discovered that a list of certain information with respect to some of its patients was made available by an unknown and unauthorized party on an online forum. [It is estimated that about 11 million people are affected.] The list includes:

  • Patient name, city, state, and zip code;

  • Patient email, telephone number, date of birth, gender; and

  • Patient service date, location and next appointment date.”

About healthcare personnel

 THE EMPLOYMENT SITUATION — JUNE 2023 From the Bureau of Labor statistics. “Health care added 41,000 jobs in June. Job growth occurred in hospitals (+15,000), nursing and residential care facilities (+12,000), and home health care services (+9,000). Offices of dentists lost 7,000 jobs. Health care has added an average of 42,000 jobs per month thus far this year, similar to the average gain of 46,000 per month in 2022.”

Today's News and Commentary

About health insurance/insurers

Biden administration aims to crack down on short-term health plans, surprise medical billing The Biden administration announced plans on Friday to tamp down on short-term health plans and surprise medical fees as part of an ongoing effort to lower healthcare costs.
Under the new rules, if finalized, plans that claim to be “short-term” health insurance would be limited to just three months, or a maximum of four months, if extended – instead of the current three-year maximum. And, under the proposed rules, plans are required to provide consumers with a clear disclaimer that explains the limits of their benefits, including to existing consumers currently enrolled in these plans…
And, nonparticipating providers and nonparticipating emergency facilities cannot evade the protections of the No Surprises Act, including the prohibition on balance billing, by renaming charges otherwise prohibited under the No Surprises Act as ‘facility fees,’ the White House said.”

A Closer Look at the Five Largest Publicly Traded Companies Operating Medicaid Managed Care Plans FYI.

About hospitals and healthcare systems

CMS Hospital Value-Based Programs: Refinements Are Needed To Reduce Health Disparities And Improve Outcomes Note that the study was sponsored by the Federation of American Hospitals.
“We found statistically significant positive relationships between hospital penalties and several factors that affect hospital performance but that hospitals cannot control—namely, medical complexity (as measured by Hierarchical Condition Categories scores), uncompensated care, and the portion of hospital catchment area populations who live alone. Moreover, these environmental conditions can be worse for hospitals that operate in areas with historically underserved populations. This suggests that the CMS programs might not adequately account for health equity factors at the community level. Refinements to these programs (including an explicit incorporation of patient and community health equity risk factors) and continued monitoring will help ensure that the programs work as intended in a fair and equitable fashion.”

About pharma

Association of Advisory Committee Votes With US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021 In this qualitative study, there was consistent alignment between advisory votes and FDA action across years and subject areas, but the number of meetings decreased over time. Discordance between FDA actions and advisory committee votes was most frequently an approval after a negative vote. This study demonstrated that these committees have played a key role in the FDA’s decision-making process but that the FDA sought independent expert advice less frequently over time even as it continued to follow it. The role of advisory committees in the current regulatory landscape should be more clearly and publicly defined.”

About healthcare IT

A Buyer’s Guide to Digitally-Assisted Provider Documentation Look at the chart in the article. The value of the method must take into account the time reduction benefit. That said, the scribe systems have a higher value than “Tech-enabled humans” or “Intelligent documentation.” 

About health technology

Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices  Question  Are medical devices that are marketed as enabled for artificial intelligence (AI) or machine learning (ML) being appropriately approved for AI or ML capabilities in their US Food and Drug Administration (FDA) 510(k) clearance?
Findings  In this systematic review of 119 public 510(k) application summaries and corresponding marketing materials, devices with significant software components similar to devices flagged in the FDA’s published list of AI- or ML-enabled devices were defined and taxonomized into categories of adherent, contentious, and discrepant devices. Of 119 devices queried, 12.6% were considered discrepant, 6.7% were considered contentious, and 80.6% were consistent between marketing and FDA 510(k) clearance summaries.
Meaning  These findings suggest that there were discrepancies between the marketing and 510(k) clearance of AI- or ML-enabled medical devices, with some devices marketed as having such capabilities not approved by the FDA for use of AI or ML.”

About healthcare finance

Coloplast casts $1.3B to reel in fish skin-based wound care company Kerecis “The Danish medtech announced plans on Friday to acquire Kerecis, which uses fish skin as the basis of its wound care products for humans.
Coloplast has offered up 8.9 billion Danish kroner, or around $1.3 billion, in the deal. The vast majority—8.2 billion kroner ($1.2 billion)—will be doled out as an upfront cash payment. Coloplast intends to finance the acquisition with help from an equity capital raise.”

Today's News and Commentary

About Covid-19

Performance of Rapid Antigen Tests [(Ag-RDTs]to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection “The performance of Ag-RDTs was optimized when asymptomatic participants tested 3 times at 48-hour intervals and when symptomatic participants tested 2 times separated by 48 hours.”

About health insurance/insurers

The Medicare Advantage Quality Bonus Program The Urban Institute points out flaws in this Program and suggests remedies. Among the findings: While clinical quality measures account for over half of the measures used in the star rating system, after weighting, about two-thirds of a contract’s star rating is determined by beneficiary experience with care and MA administrative effectiveness. On review, however, we find that:
—measures of beneficiary experience do not permit meaningful distinctions across MA contracts and
—administrative effectiveness measures do not target important deficiencies regulators have identified within MA organizations.”

About hospitals and healthcare systems

 13 healthcare mergers and acquisitions making headlines in June  FYI

About pharma

FDA approves first Alzheimer’s therapy shown to clearly slow cognitive decline “The Food and Drug Administration on Thursday granted full approval to the first therapy for Alzheimer’s disease clearly shown to slow the cognitive decline associated with the disease — a milestone in treatment, even if the benefits are modest.
The drug, called Leqembi, was developed by Eisai, the Japanese pharmaceutical company, and sold in partnership with Biogen. It previously secured conditional approval in January. The FDA’s decision will broaden patient access to the drug under the Medicare program and is likely to boost sales, even as Leqembi’s benefits and safety risks continue to be a source of debate.”

Location, Location, Location: Spending Differences for Biologic and Biosimilar Medications by Site of Treatment Highlights:
“With the exception of biosimilars for Neupogen, the market share for the innovator biologics was between 65 percent and 87 percent in 2020…
For all seven innovator biologics examined, allowed charges were higher in HOPDs [hospital outpatient departments] than in POs [physician offices.] HOPD markups on innovator biologics are roughly doubling costs for employers and minimizing savings that could be achieved through biosimilar competition. Allowed charges were about double in 2019, averaging 98 percent higher. In 2020, allowed charges were more than twice as high in HOPDs, averaging 121 percent.
In 2020, the HOPD markup ranged from 75 percent to 183 percent. The HOPD markup increased between 2019 and 2020 for all innovator biologics examined.”

Sarepta sells FDA priority review voucher to mystery buyer for $102M as prices continue to slip “While the price of just about everything has increased over the last six years in the U.S., the same can’t be said for the cost of an FDA priority review voucher. Just ask Sarepta Therapeutics.
Since 2017, the Massachusetts rare disease specialist has sold off three PRVs—getting less in return for each one.
The most recent sale came Wednesday as Sarepta revealed a $102 million deal for its PRV that came along with the FDA’s endorsement two weeks ago of the company’s latest Duchenne muscular dystrophy (DMD) treatment, gene therapy Elevidys.”

AbbVie's Skyrizi retakes TV drug ad spenders' crown in June as overall spend falls by $40M “AbbVie remained at the top of the TV drug ad spenders ranking for yet another month in June, although its immunology drug Skyrizi replaced Rinvoq, its other blockbuster medication, which held the top spot in May.
Skyrizi was in fact up two places in June from May, with AbbVie spending $26.6 million on all TV ads for the drug last month. That was $1.3 million more than it spent on Rinvoq.”

 Takeda adds another F-Star collab to constellation, this time for $1B in biobucks “Takeda and F-Star Therapeutics are tacking on another bispecific antibody deal worth $1 billion in potential milestones, marking the third time the two have partnered up in a year. 
Few details were disclosed in the companies’ announcement Wednesday, beyond the $1 billion in potential biobucks being on the table. The two drug developers will jointly research and develop antibodies for new immuno-oncology targets, with Takeda having an exclusive option to take select candidates forward.  

About the public’s health

 Study says drinking water from nearly half of US faucets contains potentially harmful chemicals “Drinking water from nearly half of U.S. faucets likely contains “forever chemicals” that may cause cancer and other health problems, according to a government study released Wednesday.
The synthetic compounds known collectively as PFAS are contaminating drinking water to varying extents in large cities and small towns — and in private wells and public systems, the U.S. Geological Survey said.”

Supplemental Nutrition Assistance Program Access and Racial Disparities in Food Insecurity
Findings In this cross-sectional study of 4974 US households, Black and multiracial households had higher rates of food insecurity than White households in adjusted analyses. This disparity was not found among households that had access to SNAP benefits.
Meaning  These findings suggest that SNAP likely plays a key role in addressing food insecurity, but there are racial disparities in food insecurity among those not participating in the program.”

CDC to Reduce Funding for States’ Child Vaccination Programs “The reduction comes from a federal immunization grant — totaling about $680 million in the latest year — that supports vaccination programs for children, according to the Association of Immunization Managers…
The debt deal rescinded about $27 billion in unspent federal money that had been allocated to fight covid. It also led the CDC to remove $400 million in funding to states for workers who fight the spread of sexually transmitted infections, according to an email obtained by CQ Roll Call.”

About healthcare IT

10 largest healthcare data breaches so far in '23 FYI

 HL7, WHO Partner to Drive Global Interoperability Standards Adoption “Standards-development organization Health Level Seven International (HL7) and The World Health Organization (WHO) have signed a Project Collaboration Agreement to support the global adoption of open interoperability standards.
Adopting interoperability standards is critical for consistently representing health data and information to support data exchange, regardless of the software used.
The Global Strategy on Digital Health 2020-2025 outlines a call for WHO to provide global guidance on interoperability standards adoption.”

Digital Therapeutics Alliance and Health Advances Release Definitive Framework and Definitions for Classifying Digital Health Technologies Look at the graphic- it is a useful conceptual framework for healthcare IT.

About healthcare personnel

Healthcare job cuts up 97% from 1st half of 2022 “Healthcare/products companies and manufacturers, including hospitals, announced the fourth-most job cuts among 30 industries and sectors measured in the first half of 2023, according to one new analysis.
The finding comes from a July 6 report from Challenger, Gray & Christmas…”

About healthcare finance

Eli Lilly Surpasses UnitedHealth as World’s Biggest Health-Care Firm “The drugmaker gained 0.9% on Wednesday, extending its advance after four straight months of gains while adding more than $94 billion to its value this year. Lilly ended June at a record high…
UnitedHealth closed down 1.4% and has fallen 11% so far this year.”

 Thermo Fisher fronts over $900M for data intelligence company as M&A strategy takes shape “The deal will see the life sciences giant hand over $912.5 million for the Waltham, Massachusetts-based company. CorEvitas, which oversees around 300 employees, has developed a multi-therapeutic data intelligence platform to gather structured patient clinical data spanning more than 400 investigator sites and over 100,000 patients. It does this by managing 12 clinical registries, including nine autoimmune and inflammatory syndicated registries.”

Today's News and Commentary

About Covid-19

How many Americans still haven't caught COVID-19? CDC publishes final 2022 estimates “Virtually every American ages 16 and older — 96.7% — had antibodies either from getting vaccinated, surviving the virus or some combination of the two by December, the CDC now estimates. The study found 77.5% had at least some of their immunity from a prior infection.
Of all age groups, seniors have the smallest share of Americans with at least one prior infection, at 56.5% of people ages 65 and over. Young adults and teens had the largest proportion of people with a prior infection, at 87.1% of people ages 16 to 29.” 

About health insurance/insurers

 CMS proposes $375M cut to home health Medicare payments in 2024 “The Biden administration issued a proposal Friday to cut reimbursements to home health providers by 2.2% next year, or an estimated $375 million less than 2023 payment levels.”

Healthcare billing fraud: 11 recent cases FYI

National Health Expenditure Projections, 2022–31: Growth To Stabilize Once The COVID-19 Public Health Emergency Ends “National health expenditures are projected to grow 5.4 percent, on average, over the course of 2022–31 and to account for roughly 20 percent of the economy by the end of that period. The insured share of the population is anticipated to exceed 92 percent through 2023, in part as a result of record-high Medicaid enrollment, and then decline toward 90 percent as coverage requirements related to the COVID-19 public health emergency expire. The prescription drug provisions of the Inflation Reduction Act of 2022 are anticipated to lower out-of-pocket spending for Medicare Part D enrollees beginning in 2024 and to result in savings to Medicare beginning in 2031.”

About hospitals and healthcare systems

 Some Hospitals That Spent Big on Nurses During Pandemic Are Now Short on Cash “Hospitals have disclosed some kind of repayment difficulty for more than $10 billion in municipal bonds in the past 12 months, according to Municipal Market Analytics. Overall, about $12 billion in hospital bonds is impaired—nearly 4% of all hospital muni debt outstanding. That is the most in the past 15 years, including during the 2008-09 financial crisis.”

About pharma

 Pfizer taps Samsung Biologics in manufacturing deals worth $897 million “Pfizer has finalised a pair of deals worth a combined $897 million for Samsung Biologics to manufacture products for the pharmaceutical company. Samsung Biologics made the disclosures on Tuesday, saying the arrangements would see it produce biosimilar products at its new Plant 4 facility in South Korea.”

Moderna strikes deal worth up to $1B to develop, produce mRNA drugs in China: reports “In a deal that could be worth up to $1 billion, Massachusetts-based Moderna inked a memorandum of understanding, plus a land collaboration agreement, to identify opportunities to research, develop and manufacture mRNA medicines in China, Yicai Global, Reuters and others have reported.”

 Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry FYI from the FDA

About the public’s health

Low-Density Lipoprotein Cholesterol Levels in Adults With Coronary Artery Disease in the US, January 2015 to March 2020 “Achievement of guideline-directed targets for LDL-C among adults with reported CAD was low, with almost 3 in 4 participants not meeting ACC/AHA guideline targets and 9 in 10 not meeting ESC guideline targets. Rates of statin use in adults with reported CAD were suboptimal.
Even among adults receiving statins, rates of achieving guideline goals for LDL-C were low. This is concerning because evidence suggests LDL-C levels are improving in the overall population. Factors contributing to low rates of attaining guideline goals may include inadequate statin treatment intensification, insufficient add-on therapy use (eg, ezetimibe), and low use of novel therapies (monoclonal antibody PCSK-9 inhibitors, inclisiran, and bempedoic acid). Low rates of statin use and intensification may relate to prescriber or patient hesitation.”

A Blood Test Predicts Pre-eclampsia in Pregnant Women “The Food and Drug Administration has approved a blood test that can identify pregnant women who are at imminent risk of developing a severe form of high blood pressure called pre-eclampsia, a leading cause of disability and death among childbearing women…
The new blood test, made by Thermo Fisher Scientific, has been available in Europe for several years. It is intended for pregnant women who are hospitalized for a blood pressure disorder in the 23rd to 35th weeks of gestation.
The test can tell, with up to 96 percent accuracy, who will not develop pre-eclampsia within the next two weeks and so can safely be discharged from the hospital. Two-thirds of the women who get a positive result, on the other hand, will progress to severe pre-eclampsia in that time, and their babies may need to be delivered early.”
 

About healthcare IT

 Need to Get Plan B or an HIV Test Online? Facebook May Know About It “An investigation by The Markup and KFF Health News found trackers on CVS.com telling some of the biggest social media and advertising platforms the products customers viewed.
And CVS is not the only pharmacy sharing this kind of sensitive data.
We found trackers collecting browsing- and purchase-related data on websites of 12 of the U.S.’ biggest drugstores, including grocery store chains with pharmacies, and sharing the sensitive information with companies like Meta (formerly Facebook); Google, through its advertising and analytics products; and Microsoft, through its search engine, Bing.”

About health technology

 Illumina faces record European Union fine over Grail deal next week - report “Illumina faces a record fine from the European Union as early as next week after completing its purchase of cancer-screening company Grail without the antitrust regulator's approval.
The fine may be as much as $453 million, or 10% of the company's revenue…”

Abbott reels in FDA approval for dual-chamber leadless pacemaker “Just a few weeks after Abbott presented the successful results of a trial of its Aveir DR dual-chamber leadless pacemaker system—data that it said had been promptly submitted for regulatory review—the company has secured FDA approval for the technology.”

Medtronic finds hacking risk in heart device data management system “Medtronic has identified a vulnerability that could potentially allow hackers to access the cardiac device data stored in its Paceart Optima data workflow systems.
The technology is used by healthcare providers as a single place to compile the health data of patients using heart devices. It accepts transmissions from implants, programmers and remote monitoring devices made by both Medtronic and competitors like Boston Scientific and Abbott, including data gathered in the clinic and at a patient’s own home.”

Today's News and Commentary

About health insurance/insurers

 Molina to acquire Bright Health's Medicare Advantage business in $600M deal “Molina Healthcare will purchase Bright Health Group's California Medicare Advantage business for $600 million, the two businesses said June 30. 
The sale marks Bright Health's exit from the insurance business. The company, which has faced several financial challenges in the past year, ended all of its insurance offerings outside of California at the end of 2022. 
Bright Health will use the proceeds from the sale to pay off its debts and pay liabilities remaining from its shuttered individual insurance business, the company said in a news release. The company breached its minimum liquidity requirements in the first quarter of 2023.”

About hospitals and healthcare systems

 Monthly Healthcare Industry Financial Benchmarks May’s Hospital Financial Performance “The nation’s hospitals continued to stabilize in May as higher patient volumes contributed to increases in revenues and margins. Key trends for the month include:

  • Median hospital operating margins rose for the first time since breaking into the black in March after 15 straight months of negative operating margins

  • Outpatient revenues had sizable, double-digit increases, marking the biggest jump in the metric in more than a year as patients increasingly opt for outpatient services

  • Patient volumes continued to grow with increases in both inpatient and outpatient metrics, including higher surgery volumes 

  • Total expenses remained on the rise while per-patient expenses decreased across most metrics, signaling that hospitals are better managing expenses relative to rising patient volumes”

About pharma

Gilead and Teva defeat antitrust lawsuit that claimed prices for HIV medicines were unfairly kept high “In a setback to AIDS activists, a federal court jury on Friday cleared Gilead Sciences and Teva Pharmaceuticals of allegations that the companies struck an illegal deal that inflated prices for HIV medicines.
A lawsuit filed four years ago accused Gilead of using a range of controversial business tactics that led the U.S. health care system to overspend for HIV medicines. These included so-called pay-to-delay settlements of patent litigation and moves that purportedly stalled development of safer versions of medicines that had years left of patent protection.”

 U.S. will allow drugmakers to discuss Medicare drug price negotiations The U.S. government on Friday revised its guidance for its Medicare drug price negotiation process, allowing drug companies to publicly discuss the talks, but did not make major changes likely to convince drugmakers to end their suits seeking to halt the program…
In September, the U.S. Centers for Medicare and Medicaid Services (CMS) will select 10 of the Medicare program's costliest prescription medicines and negotiate price cuts to go into effect for 2026.”

About healthcare IT

CMS slated to introduce nearly 400 new CPT codes in OctoberThe Centers for Medicare and Medicaid Services is slated to roll out nearly 400 new current procedural terminology (CPT) codes this coming fall, according to a June 16 announcement. 

The upcoming changes include a total of 395 new codes, 25 deletions and 13 revisions. Additionally, hundreds of changes have been made to the tabular instructions for the fiscal year 2024. 
Here’s a quick rundown of some of the impending changes: 

  • Of the 395 new codes, 123 pertain to the external causes of morbidity chapter of the ICD-10-CM manual, with many of those specific to documenting accidents and injuries.  

  • Social determinants of health will be addressed with 30 new diagnosis codes that take factors influencing health status and patient contact with health services into consideration. The updates include new guidance instructing coders to report various risk factors of HIV, in addition to several changes related to patients’ upbringing (family support, death/disappearance of family, divorce/separation, etc.), history of stressful life events and military service backgrounds. 

  • Several changes have been made related to osteoporosis with fractures, retinopathy and muscle entrapment in the eye and disease of the nervous system, including five new codes pertaining specifically to Parkinson’s disease. 

  • New inclusion terms have been added to the segment on gender identity disorders. 

  • Coding instructions for coagulation related to COVID-19 have been updated. 

The 2024 ICD-10-CM codes will go into effect on October 1, 2023 and will be used for discharges and patient encounters occurring between that date and September 30, 2024.”

 GAO Statement on Protest of Systems Plus, Inc., B-419956 et al. “On Thursday, June 29, 2023, the U.S. Government Accountability Office (GAO) sustained 98 protests filed by 64 offerors whose proposals were eliminated from the competition conducted by the Department of Health and Human Services (HHS), National Institutes of Health (NIH) … which was issued for the award of multiple indefinite-delivery, indefinite-quantity (IDIQ) governmentwide acquisition contracts for information technology services, known as Chief Information Officer-Solutions and Partners (CIO‑SP4). 
The RFP sought proposals to provide information technology solutions and services in the areas of health, biomedical, scientific, administrative, operational, managerial, and information systems requirements.  The solicitation advised that the agency will award approximately 305 to 510 IDIQ contracts across multiple socioeconomic groups.  The solicitation provided for a 3‑phase evaluation, wherein a proposal must successfully pass each phase to be eligible for award.  Each awarded contract will have a base period of performance of 5 years with one 5‑year option, and a maximum ordering value of $50 billion.
In the challenges filed at GAO, the protesters argued that the agency unreasonably failed to advance their proposals past phase 1 of the evaluation, thereby eliminating them from the competition.”

About healthcare personnel

Payers? Big Tech? Who acquired the most physicians in past 5 years, per AHA “As payers, retailers and Big Tech companies gobble up medical practices, private equity is the type of entity most likely to buy a physician office, the American Hospital Association found.

Here is who acquired the most physicians from 2019 to 2023, per the June 26 AHA analysis:

1. Private equity: 65 percent

2. Physician medical groups: 14 percent

3. Payers: 11 percent

4. Hospitals and health systems: 8 percent

5. Other: 4 percent 

About health technology

 First-gen mRNA flu vaccines 'will not win,' Sanofi execs admit as they retool strategy “First-generation mRNA vaccines for flu “will not win,” Sanofi executives have admitted as they set out plans to develop more advanced candidates they believe will overcome the technology’s existing shortfalls.
The biggest names in messenger RNA like Moderna, Pfizer and CureVac are all working on their own influenza candidates, but Sanofi used a vaccines investor event [Thursday] to spell out bluntly why those initial attempts to target the technology on flu just won’t work.”

Roche nabs FDA nod for another pair of CSF biomarker tests for Alzheimer's disease “For the second time in less than a year, the company has scored FDA clearance for a pair of assays that can be used together to help spot signs of Alzheimer’s disease.
The duo comprises the Elecsys Beta-Amyloid (1-42) CSF II, or Abeta42, and Elecsys Total-Tau CSF, or tTau, assays. The tests can run on any of Roche’s Cobas immunoassay analyzers, and both, as the names suggest, are cerebrospinal fluid assays. They analyze CSF samples to measure the concentration of beta-amyloid and tau proteins, respectively—two biomarkers linked to the development of Alzheimer’s.”

FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes “U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current repeated episodes of severe hypoglycemia (low blood sugar) despite intensive diabetes management and education.”

Today's news and Commentary

About health insurance/insurers

Medical cost trend: Behind the numbers 2024​ PwC’s Health Research Institute “projects medical cost trend to be 7.0% in 2024, up from 6.0% in 2023.”
Comment: Tread the study to learn the “why” of the predicted increase.

Analysis of Medicare Advantage Enrollee Demographics, Utilization, Spending, and Quality Compared to Fee-for-Service Medicare Among Enrollees with Chronic Conditions An Avalere study:“Key Findings
—Among beneficiaries with 1 or more of the 3 conditions studied, MA had a higher proportion of beneficiaries who identify as racial and ethnic minorities than FFS (28.1% in MA vs. 12.8% in FFS) or who were enrolled in Medicare due to a disability (27.0% in MA vs. 21.6% in FFS).
—Beneficiaries in MA had lower rates of inpatient utilization and ER visits, and higher rates of physician visits. The average length of inpatient stay was higher for beneficiaries in MA than in FFS.
—Regardless of the specific chronic condition, MA beneficiaries in these subgroups had lower overall healthcare spending than FFS beneficiaries, on a PMPM basis across all expenditure types in the analysis (including acute inpatient, ambulatory outpatient, prescription drug, and all other medical costs).
—Quality was similar between MA and FFS beneficiaries on several measures, including all-cause readmissions and adherence of certain medications.
—Differences between dual-eligible beneficiaries in MA and FFS were also analyzed. Trends in utilization, spending, and quality among dual-eligible beneficiaries in MA and FFS across all the 3 studied condition subgroups were similar to MA and FFS beneficiaries in the full sample population.

 How Often Do Health Insurers Say No to Patients? No One Knows. “ProPublica, in collaboration with The Capitol Forum, has been examining the hidden world of insurance denials. A previous story detailed how one of the nation’s largest insurers flagged expensive claims for special scrutiny; a second story showed how a different top insurer used a computer program to bulk-deny claims for some common procedures with little or no review.
The findings revealed how little consumers know about the way their claims are reviewed — and denied — by the insurers they pay to cover their medical costs.
When ProPublica set out to find information on insurers’ denial rates, we hit a confounding series of roadblocks….
The limited government data available suggests that, overall, insurers deny between 10% and 20% of the claims they receive. Aggregate numbers, however, shed no light on how denial rates may vary from plan to plan or across types of medical services.”
Comment: The entire article is worth reading.

11 charged in $2B telehealth fraud schemeThe Justice Department has charged 11 individuals in connection with telehealth fraud schemes that resulted in more than $2 billion in false claims.
The fraud schemes, which occurred in two different states with multiple different individuals, included:

  • One in the Southern District of Florida in which the Justice Department alleged that the CEO, former CEO and vice president of business development at purported software companies generated and sold templates of clinicians' orders for orthotic braces and pain creams that were not medically necessary and not eligible for Medicare reimbursement. The scheme resulted in "the submission of $1.9 billion in false and fraudulent claims to Medicare," according to a June 28 press release from the Justice Department. The scam involved a telemarketing operation that targeted elderly and disabled people.

  • The second case occurred in the Eastern District of Washington, where a licensed physician was accused of signing more than 2,800 fraudulent orders for orthotic braces. The physician signed the orders in less than 40 seconds and included orders for patients who had already undergone limb amputations, according to the Justice Department.

Medical equipment company owner found guilty in $24M fraud scheme A federal jury found a California woman guilty of leading a scheme that billed Medicare more than $24 million in fraudulent claims for medically unnecessary durable medical equipment and repairs. 
Tamara Motley, 54, of Redondo Beach, was found guilty on 20 counts of healthcare fraud, two counts of aggravated identity theft and one count of conspiracy to commit money laundering, according to a June 27 Justice Department news release.”

UnitedHealthcare to waive cost-sharing in 24/7 Virtual Visit program for some fully insured plans “UnitedHealthcare will nix out-of-pocket costs for its 24/7 Virtual Visits in some of its fully insured plans beginning July 1.
The insurance giant revealed the change through a notice to its brokers about the new offering. The $0 cost for these urgent care visits will become available upon renewal or at new enrollment for the eligible plans, according to the alert…
The changes to cost-sharing will extend to people in high-deductible health plans, which can offer ease of mind for members and families who have yet to meet their deductible for the year.”

About hospitals and healthcare systems

 FTC floats changes to merger review process that could slow down deal-approval timelines “Newly proposed changes to the Federal Trade Commission’s (FTC's) pre-merger notification requirements would give regulators more information to review during a deal’s initial waiting period—likely giving the agency more fuel to block mergers it views as anticompetitive.
The proposed changes also would nearly quadruple the per-hour filing burden on merging organizations…
The 133-page proposed amendments document also cites multiple deals and articles related to healthcare industry mergers and acquisitions within its footnotes.
Major changes included in the proposal include requirements that merging entities provide:

  • More details on the rationale of their transaction as well as any surrounding investment vehicles or corporate relationships

  • Information related to horizontal products or services and non-horizontal business relationships

  • Projected revenue streams, descriptions of market conditions and the structure of involved entities

  • Details regarding prior acquisitions

  • Disclosures of information that would help screen for labor market concerns”

 Demand for urgent care facilities is increasing “Increased investment in urgent care centers is needed as health care delivery models change and patients with non-life-threatening conditions opt for ease of access, according to a recent analysis by Colliers.
The analysis notes several data points to back up its message. The Urgent Care Association found that since 2019 patient volume has spiked by 60%, while Data Bridge Market Research has predicted a compound annual growth rate of 5.35% between 2022 and 2029…
The surge is being driven by the convenience and accessibility of urgent care centers which are often located in high traffic retail locations and offer extended operating hours...”

About pharma

  BioMarin scores long-awaited US nod for Roctavian gene therapy “BioMarin Pharmaceutical said Thursday it has received FDA approval for Roctavian (valoctocogene roxaparvovec-rvox), making it the first gene therapy cleared in the US to treat adults with severe haemophilia A. The one-time treatment was authorised for the same condition last year in the EU, where the product's net price is estimated to be about €1.5 million ($1.6 million).
Roctavian works by delivering a functional copy of the missing gene that would help haemophilia A patients make FVIII blood-clotting protein.” 

About the public’s health

An update on the air quality problem: Over 80 million are under air quality alerts as smoke from Canada wildfires drifts into the US “More than 80 million people from the Midwest to the East Coast are under air quality alerts as smoke from Canadian wildfires sweeps across parts of the US, prompting beach closures, warnings of reduced visibility, and calls for people to stay indoors.
Canada is seeing its worst fire season on record with hundreds of wildfires raging across the country – more than 250 of them burning ‘out of control,’ according to the Canadian Interagency Forest Fire Centre. The wildfires have led to the highest annual emissions on record for the country, according to a Tuesday report from Copernicus, a division of the European Union's space program.”

CDC Recommends RSV Vaccine For Older Adults “CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendations for use of new Respiratory Syncytial Virus (RSV) vaccines from GSK and Pfizer for people ages 60 years and older, using shared clinical decision-making. This means these individuals may receive a single dose of the vaccine based on discussions with their healthcare provider about whether RSV vaccination is right for them.
Adults at the highest risk for severe RSV illness include older adults, adults with chronic heart or lung disease, adults with weakened immune systems, and adults living in nursing homes or long-term care facilities. CDC estimates that every year, RSV causes approximately 60,000–160,000 hospitalizations and 6,000–10,000 deaths among older adults.”

Hepatitis C Virus Clearance Cascade — United States, 2013–2022 From the CDC: “An analysis of the HCV clearance cascade using 2013–2022 national HCV testing data found that the prevalence of viral clearance among persons with diagnosed hepatitis C was only 34% overall and was even lower (16%) among persons aged 20–39 years with other payor (client or self-pay) insurance.
What are the implications for public health practice?
Increased access to diagnosis, treatment, and prevention services for persons with hepatitis C would prevent progression of disease and ongoing transmission and achieve national hepatitis C elimination goals.”

Quantifying Quantified Health Data from wearables reveal lifestyle factors that affect health care utilization.
This actuarial study links data from wearables (exercise duration and intensity, sleep times and pulse) to risk of hospitalizations. You should, at least look at the graphs.

Aspartame sweetener used in Diet Coke a possible carcinogen, WHO’s cancer research agency to say - sources “Aspartame, used in products from Coca-Cola diet sodas to Mars' Extra chewing gum and some Snapple drinks, will be listed in July as ‘possibly carcinogenic to humans’ for the first time by the International Agency for Research on Cancer (IARC), the World Health Organization's (WHO) cancer research arm, the sources said.”

Opioid analgesia for acute low back pain and neck pain (the OPAL trial): a randomised placebo-controlled trial “Opioids should not be recommended for acute non-specific low back pain or neck pain given that we found no significant difference in pain severity compared with placebo. This finding calls for a change in the frequent use of opioids for these conditions.” 

About healthcare personnel

Supreme Court strikes down affirmative action in college admissions, and Biden ‘strongly’ disagrees “The Supreme Court on Thursday struck down affirmative action in college admissions, declaring race cannot be a factor and forcing institutions of higher education to look for new ways to achieve diverse student bodies.
The court’s conservative majority overturned admissions plans at Harvard and the University of North Carolina, the nation’s oldest private and public colleges, respectively.
Chief Justice John Roberts said that for too long universities have ‘concluded, wrongly, that the touchstone of an individual’s identity is not challenges bested, skills built, or lessons learned but the color of their skin. Our constitutional history does not tolerate that choice.”
Comment: While the rulings were about undergraduate admissions, the same principles will apply to professional schools, e.g., medicine, nursing, pharmacy, etc.

About healthcare finance

 Lilly agrees to acquire cell therapy developer Sigilon for up to $310 million “Eli Lilly on Thursday announced a definitive agreement to acquire Sigilon Therapeutics, which is working on non-viral engineered cell-based therapies aimed at offering functional cures for patients with acute and chronic diseases.”

Today's News and Commentary

About Covid-19

 The Great Grift: More than $200 billion in COVID-19 aid may have been stolen, federal watchdog says The numbers issued Tuesday by the U.S. Small Business Administration inspector general are much greater than the office’s previous projections and underscore how vulnerable the Paycheck Protection and COVID-19 Economic Injury Disaster Loan programs were to fraudsters, particularly during the early stages of the coronavirus pandemic.
The inspector general’s report said ‘at least 17 percent of all COVID-EIDL and PPP funds were disbursed to potentially fraudulent actors.’ The fraud estimate for the COVID-19 Economic Injury Disaster Loan program is more than $136 billion, which represents 33 percent of the total money spent on that program, according to the report. The Paycheck Protection fraud estimate is $64 billion, the inspector general said.” 

About health insurance/insurers

CMS's Oversight of Medicare Payments for the Highest Paid Molecular Pathology Genetic Test Was Not Adequate To Reduce the Risk of up to $888 Million in Improper Payments The headline is the story.

 Push to tie Medicaid to work is making a comeback. Georgia is at forefront. Rather than requiring Medicaid recipients to work, this program allows “impoverished adults in the state who had never qualified for Medicaid to join — but only if they prove every month they meet the same kind of requirements.”

About pharma
Walgreens slashes financial outlook, ramps up efforts to drive profitability in healthcare unit “For the latest quarter, Walgreens brought in a net profit of $118 million, or 14 cents per share unadjusted, down 59% from a net profit of $289 million…
The company's healthcare segment [primary care provider VillageMD; Summit Health/CityMD, a provider of primary, specialty and urgent care; CareCentrix, a post-acute and home care provider; specialty pharmacy Shields Health; and Walgreens Health]…took an adjusted EBITDA loss of $113 million in the quarter, reflecting new clinic expansions at VillageMD and fewer patient visits at CityMD clinics.”

Addressing Pharmacy Benefit Management Misalignment See, particularly page 5, headed: “Economics and Conflicts of Pharmacy Benefit Management” The entire document is a great review of PBMs.

About the public’s health

 Pickleball Injuries May Cost Americans Nearly $400 Million This Year, According to UBS The headline is the story. Research shows that “pickleball players go to emergency departments at a rate of about 0.27%, with the majority of injuries occurring among those 60 years or older. Not surprisingly, the most common injuries are strains, sprains, and fractures, with the wrest and lower leg the areas most likely to be injured.”

 Pregnant workers may get longer breaks, more time off and other accommodations as new law takes effect “Millions of pregnant and postpartum workers across the country could be legally entitled to longer breaks, shorter hours and time off for medical appointments and recovery from childbirth beginning Tuesday, when the Pregnant Workers Fairness Act takes effect.
The new law mandates that employers with at least 15 employees provide "reasonable accommodations" to workers who need them due to pregnancy, childbirth or related medical conditions, according to the Equal Employment Opportunity Commission, which is tasked with enforcing the law.”

About healthcare IT

 CBO: Bipartisan telehealth bill will cost $5B over next decade “Bipartisan legislation that would give people with high-deductible health plans permanent access to telehealth services without having to meet a minimum deductible will cost $5 billion over the next decade, according to the Congressional Budget Office (CBO).
The Telehealth Expansion Act, led by Sens. Steve Daines (R-Mont.) and Catherine Cortez Masto (D-Nev.), would make permanent a provision from the pandemic-era CARES Act of 2020.
The provision allowed employers and health plans to cover telehealth visits for individuals with high-deductible health plans coupled with health savings accounts, without the individuals needing to meet a deductible first.”

About health technology

MCED Test Can Aid Cancer Diagnosis in Symptomatic Patients A methylation-based multicancer early detection (MCED) test can aid cancer diagnosis in patients who present with non-specific symptoms, according to a study published in The Lancet Oncology
The researchers used the MCED test in 5461 patients with non-specific symptoms or symptoms potentially due to gynecologic, lung, or gastrointestinal cancers. The median age of patients was 61.9 years, and 66.1% were women. The most common symptoms in these patients were unexpected weight loss (24.1%), change in bowel habits (22.0%), post-menopausal bleeding (16.0%), rectal bleeding (15.7%), abdominal pain (14.5%), and pain (10.6%)…
Cancer diagnoses were recorded in 368 patients (6.7%). The most common diagnoses were colorectal (37.2%), lung (22.0%), uterine (8.2%) and esophago-gastric (6.0%) cancers. About half (53%) of cancers were diagnosed as stage III or IV.
The MCED test detected a cancer signal in 323 patients, and 244 of those patients had a cancer diagnosis. The test had a sensitivity of 66.3% and a specificity of 98.4%. The test had its highest sensitivity (80.4%) and negative predictive value (99.1%) in patients with symptoms requiring investigation for upper gastrointestinal cancer.
The sensitivity of the MCED test increased with increasing age and cancer stage, except in upper gastrointestinal cancer. Overall, the sensitivity of the MCED test was 24.2% with stage I cancer and increased to 95.3% with stage IV disease.”

GSK receives US FDA Fast Track designation for investigational vaccine against gonorrhoea “Fast Track designation accelerates the vaccine candidate’s path to US FDA submission for the prevention of Neisseria gonorrhoeae infection…
Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to existing treatments is increasing"

Today's News and Commentary

About health insurance/insurers

 How Highmark Health Is Battling Food Insecurity “Highmark Health has been launching a series of initiatives to support the "food as medicine" movement, including a program that provides some West Virginia residents with debit cards to purchase healthy food at Dollar General stores.”

Association of a Medicare Advantage Posthospitalization Home Meal Delivery Benefit With Rehospitalization and Death “In this comparative cohort study including 4032 older adults with hospital admission for heart failure and 7944 with non–heart failure admission, the Medicare Advantage home-delivered meals benefit was associated with lower odds of 30-day rehospitalization and death.”

Medicare Advantage Disenrollment Patterns Among Beneficiaries With Multiple Chronic Conditions “Although MA disenrollment rates decreased over time, having multiple chronic conditions was not associated with switching between MA and FFS between 2010 and 2019…
Several reasons may explain the study findings. First, the current risk-adjusted payments may have mitigated MA plans’ incentives to avoid high-risk enrollees. Second, MA plans may make efforts to retain sicker people from whom they can generate larger revenue from risk-adjusted payments. Third, MA plans have lower out-of-pocket costs with supplemental benefits to manage chronic conditions that are particularly helpful for those with multiple conditions.”

About hospitals and healthcare systems

New Health Care Equity Certification Program “Effective July 1, 2023, a new Health Care Equity (HCE) certification program will be available from The Joint Commission. This certification program will recognize hospitals and critical access hospitals that strive for excellence in their efforts to provide equitable care, treatment, and services. The HCE certification is available for all Joint Commission–accredited hospitals and critical access hospitals and non-Joint Commission–accredited hospitals and critical access hospitals that comply with applicable federal laws, including Centers for Medicare & Medicaid Services’ (CMS) Conditions of Participation.”

 JUNE 2023 National Hospital Flash Report “Key Takeaways

  1. Hospitals’ operating margins moved back into positive territory in May.

    However, operating margins continue to stand well below historical norms.

  2. People are becoming more comfortable with inpatient care.

    Discharges, emergency department visits and operating room minutes all climbed, although very modestly on a year-to-date basis.

  3. There is a sizeable and growing gap between primary hospital revenue sources.

    Revenue from outpatient care is increasing at a much greater rate than revenue from inpatient care.

  4. Labor expenses are beginning to decline.

    While labor costs remain significant, expenses in May were well below comparable levels from May 2022.”

About pharma

 Oncology group revises guidance amid cancer drug shortage “With about a dozen cancer drugs on back order and no clear end to the shortages, the American Society of Clinical Oncology and the Society of Gynecologic Oncology recently advised clinicians to ration chemotherapy supplies. 
The updated guidelines recommend curbing or halting pharmaceutical treatment for patients with ‘recurrent, agent-resistant cancers’ — which means saving therapies for patients with a better chance of surviving. 

About healthcare personnel

 Green-Card Backlog Fuels Shortage of Nurses at Hospitals, Nursing Homes “Foreign nurses can’t get green cards to work in the U.S., alarming hospitals, nursing homes and other medical providers who have relied on them to help alleviate staffing shortages.  
Some nursing-home associations say facilities already operating on thin margins could be forced to close or be unable to accept seniors transitioning to care following hospitalizations. Hospitals say the shortage triggered by the backlog could undermine patient care.”

Today's News and Commentary

About health insurance/insurers

 Association Between a Bundled Payment Program for Lower Extremity Joint Replacement and Patient Outcomes Among Medicare Advantage Beneficiaries Findings  In this cross-sectional study of 23 034 lower extremity joint replacement surgical episodes, physician practice participation in a bundled payment program was associated with a 2.7% reduction in episode spending without changes in quality.
Meaning  This study found that bundled payments offered by private insurers, including Medicare Advantage plans, may have the ability to reduce spending for lower extremity joint replacement episodes while maintaining quality of care.”

Growth of Medicare Advantage After Plan Payment Reductions “Findings  In this cohort study using a difference-in-differences analysis of 3138 counties with 37 639 county-year observations, during the 8 years following the Affordable Care Act, counties with larger cuts to Medicare Advantage plan payments had similar Medicare Advantage enrollment growth as counties facing smaller cuts.
Meaning  Payment cuts of the magnitude imposed by the Affordable Care Act did not appear to reduce enrollment growth in Medicare Advantage; modest plan payment cuts may reduce federal spending without compromising access to Medicare Advantage.”
However, read the accompanying editorial, which has many caveats about accepting the results: What Will Cuts to Medicare Advantage Payments Do to Enrollment?

About hospitals and healthcare systems

Comparison of Commercial Negotiated Price and Cash Price Between Physician-Owned Hospitals [POHs] and Other Hospitals in the Same Hospital Referral Region “This cross-sectional study found that nationwide median commercial negotiated prices and cash prices were lower for general acute-care POHs than for non-POHs in the same market for most common hospital procedures. POHs served fewer Medicaid patients and provided less charity care, which might enable them to accept lower commercial prices (these factors were controlled for in the regression models).”

About pharma

GSK settles first Zantac lawsuit due to go before jury in US “GSK said Friday that it reached a confidential agreement to settle the first lawsuit scheduled to go to trial in the US over allegations related to Zantac (ranitidine). The news sent shares in the company up nearly 6%.
The case, brought by Californian resident James Goetz, was due to go to trial on July 24 and would have been the first test of how claims that Zantac caused a variety of cancers would fare before a jury…
The UK drugmaker, along with Boehringer Ingelheim, Pfizer and Sanofi, are facing thousands of such lawsuits in the US over Zantac. A small number of cases are pending in California, while more than 75,000 cases are in state court in Delaware, with hearings likely in January.
Bank of America analysts said they continue to see the Zantac litigation risk as low in absolute terms…”

 CMS announces new details of plan to cover new Alzheimer’s drugs “Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry. Clinicians will be able to submit this information through a nationwide, CMS-facilitated portal. The portal will be available when any product gains traditional approval and will collect information via an easy-to-use format.”

About the public’s health

E-cigarette sales surge to more than 22 million units per month “E-cigarette sales in the United States surged by nearly 47% from 2020 to 2022 to more than 22 million units per month, according to study findings published Thursday in MMWR.
During the study period, there were increases in both the number of brands and in the sales of disposable devices and flavors that are popular among youth, the CDC noted.”

CDC advisors give nod to 20-valent pneumococcal vaccine for children “CDC advisors on Thursday unanimously supported the addition of Pfizer’s 20-valent pneumococcal vaccine as an option for children in the United States.”

Providing diabetes care that does not meet guidelines increases health costs for patients “Key takeaways:

  • From 2016 to 2018, about 12% of patients with diabetes received care that did not align with American Diabetes Association guidelines.

  • The annual burden of improper diabetes care may be as high as $16 billion.”

About healthcare IT

 Digital health company Babylon Health to go private in merger with brain tech company MindMaze “Beleaguered digital health company Babylon Health finalized plans to go private and will combine with digital therapeutics company MindMaze.
The take-private proposal comes from investment manager AlbaCore Capital, and the transaction provides for a new capital structure with a significant reduction of pro forma company debt, the company said in a press release.” 

About healthcare finance

UnitedHealth outbids Option Care Health for Amedisys in $3.3B deal “Amedisys on Monday agreed to be acquired by UnitedHealth's Optum unit in an all-cash deal while also scraping a previous all-stock deal offer from Option Care Health.
Optum is buying the company for $101 per share, which is a dollar higher than its previous offer and above the $97.38 per share all-stock deal with Option Care in May.
The deal values the company at roughly $3.7 billion, a 10.7% premium to Amedisys’ most recent closing price of $91.21…”

Today's News and Insights

About health insurance/insurers

Fidelity® Releases 2023 Retiree Health Care Cost Estimate: For the First Time in Nearly a Decade, Retirees See Relief as Estimate Stays Flat Year-Over-Year  “Fidelity Investments®… shared its 22nd annual Retiree Health Care Cost Estimate, revealing that a 65-year-old retiring this year can expect to spend an average of $157,500 in health care and medical expenses throughout retirement. Fidelity’s 2023 estimate remains the same as last year, due to expected limits to retiree out of pocket costs for prescription drugs starting in 2025. This is the first time in nearly a decade that the anticipated health care costs for retirees have stayed flat year-over-year.”

Fiscal Implications for Medicaid of Enhanced Federal Funding and Continuous Enrollment “For a three-year period, states provided continuous enrollment in Medicaid in exchange for an increase in the percentage of Medicaid spending that is paid for by the federal government (the Federal Medical Assistance Percentage or ‘FMAP’)…

Key findings include:

  • State spending dipped below pre-pandemic levels even as Medicaid enrollment increased by 23 million during the continuous enrollment period. With the substantial enrollment growth, total spending increased, including significant increases in federal Medicaid spending due to the enhanced FMAP.

  • We estimate states received over $117 billion from the increased FMAP during the continuous enrollment period, with enhanced federal funds comprising a larger share of total Medicaid spending in states that had not adopted Medicaid expansion through the Affordable Care Act (ACA).

  • Although the magnitude is uncertain, significant decreases in Medicaid enrollment are expected during the unwinding of the continuous enrollment provision, which will result in lower Medicaid spending. Even with lower enrollment, state spending will likely increase as the enhanced FMAP expires.

  • The phase down of the enhanced FMAP was designed to provide continued financial support to states during the unwinding process and to mitigate sharp increases in state Medicaid spending. How much state Medicaid spending increases as the enhanced FMAP phases down and is ultimately eliminated next year will depend on how many and how quickly people are disenrolled, how many new people come on to Medicaid, and how spending per person in the Medicaid program will change.”

June is the month each year when MedPAC and MACPAC make their annual recommendations to Congress.
While summarizing these extensive documents is not possible, here are a few of the major recommendations:
1. Align Medicare fee-for-service payment rates across all ambulatory settings, meaning eliminating the facility fee for hospital affiliated practices
2. Shifting telehealth payments back to the lower facility rate
3. Giving the Department of Health and Human Services greater authority to set price limits for Part B-covered drugs. Recall the lawsuits by pharma companies and PhRMA to block price regulation.
This article has a more extensive narrative.
Caveat:These Committees only advise Congress. Their recommendations are not binding. Whether or not they are adopted is highly dependent on the political process.

About hospitals and healthcare systems

'You're not God': Doctors and patient families say HCA hospitals push hospice care “…new criticisms are arising related to HCA’s palliative and end-of-life care for patients, according to some physicians and nurses who have worked in its facilities. They say HCA officials press staff to persuade families of ailing patients to initiate such care, as Salas says she experienced with her daughter. Although this can harm patients by withdrawing lifesaving treatments, the push can benefit HCA two ways, the doctors and nurses said, and an internal hospital document confirms. It reduces in-hospital mortality rates, a closely watched quality measure, and can free up a hospital bed more quickly for HCA, potentially generating more insurance reimbursements from a new patient. 
This article is based on interviews with six nurses and 27 doctors who currently practice at 16 HCA hospitals in seven states or did so previously.”

 Best Children's Hospitals Honor Roll FYI from US News.

Consolidation And Mergers Among Health Systems In 2021: New Data From The AHRQ Compendium
Some highlights:
1. “Larger percentages of providers were affiliated with vertically integrated health care systems in 2021 than in 2018, with three-quarters of hospitals and half of all physicians in one of the 635 identified systems…
2.Merger and acquisition activity that resulted in new systems in 2021 was entirely concentrated in the top and bottom thirds of the system size distribution.”
The entire article is worth reading.

About pharma

CENTER FOR DRUG EVALUATION AND RESEARCH [CDER] Fiscal Year 2022 Report on the State of Pharmaceutical Quality “Key Takeaways

  • CDER’s Product Catalog contains over 140,000 application and non- application products.

  • Nearly 90% of essential medicine, medical countermeasures and critical inputs (EM) [Essential Medicine] products have at least one domestic finished dosage form manufacturer; however, 52% of EM products are completely reliant on foreign sites for active pharmaceutical ingredient manufacturing. [Emphasis aded]

  • Field Alert Reports decreased by 15%, due in part to a decline in the use of injectable products related to COVID-19.”

About the public’s health

CDC advisory panel backs use of GSK and Pfizer RSV vaccines in adults 60 and older “An advisory committee to the Centers for Disease Control and Prevention on Wednesday recommended that adults ages 60 and above, after consulting their doctors, receive a single dose of RSV vaccines from Pfizer and GSK.
The panel said seniors should use “shared clinical decision-making,” which involves working with their healthcare provider to decide how much they will benefit from a shot.
Outgoing CDC director Rochelle Walensky will decide whether to finalize the recommendation.”

2023 Scorecard on State Health System Performance From The Commonwealth Fund: “Scorecard Highlights:

  • Massachusetts, Hawaii, and New Hampshire top the 2023 State Scorecardrankings for health system performance, based on 58 measures of health care access, quality, use of services, costs, health disparities, reproductive care and women’s health, and health outcomes. The lowest-performing states were Oklahoma, West Virginia, and Mississippi.

  • Deaths from COVID-19 — as well as premature, avoidable deaths from causes like drug overdoses, firearms, and certain treatable chronic conditions — rose dramatically during the first two years of the pandemic, lowering life expectancy across the United States.

  • There was wide state variation on the Scorecard’s new measures of health outcomes and access to care for women, mothers, and infants. Maternal mortality and deaths related to substance use rose quickly among women of reproductive age during the pandemic — a particular concern given new state policies limiting reproductive care access.

  • Temporary federal policies during the COVID-19 pandemic drove uninsured rates to record lows, with nearly all states realizing gains in health coverage. But some of those policies have ended, and high health costs still saddle millions of Americans with medical debt.

  • There are ways the nation could improve health outcomes and lessen variation from state to state. Federal and state governments could: close the coverage gaps that remain and enroll uninsured people who are eligible for subsidized coverage; improve the cost protections of insurance plans; and lower barriers to reproductive health, preventive health, and behavioral health care, particularly for the most vulnerable.”

A National Survey of OBGYNs’ Experiences After Dobbs This KFF survey has a number of categories of questions and is worth reading in its entirety. One highlight (or lowlight): “Most OBGYNs (68%) say the ruling has worsened their ability to manage pregnancy-related emergencies. Large shares also believe that the Dobbs decision has worsened pregnancy-related mortality (64%), racial and ethnic inequities in maternal health (70%) and the ability to attract new OBGYNs to the field (55%).”

BREAKING: 3M Strikes Deal Worth Up To $12.5B Over PFAS Contamination Claims “Attorneys representing public water systems on Thursday announced that 3M has agreed to pay up to $12.5 billion to end claims over contamination from so-called forever chemicals in firefighting foam, in what they say is the largest settlement over drinking water in U.S. history.”

About healthcare IT

Amazon launches $100M generative AI center, targeting healthcare “Amazon debuted a $100 million generative artificial intelligence center June 22 to help customers harness the new technology.
The AWS Generative AI Innovation Center will connect AI and machine learning experts with the company's cloud clients to build generative AI products and services.”

Today's News and Commentary

About Covid-19

 Pfizer, Moderna and Novavax gear up for fall Covid vaccine rollout with an important head start “KEY POINTS
—The U.S. Food and Drug Administration’s Covid strain selection for the next round of shots is a decisive win for Pfizer, Moderna and Novavax.
—The FDA advised the three pharmaceutical companies to manufacture single-strain jabs targeting the omicron subvariant XBB.1.5.
—The agency’s decision puts the vaccine makers on track to deliver updated coronavirus jabs in time for the fall and winter.”

About health insurance/insurers

Value-Based Purchasing Design And Effect: A Systematic Review And Analysis “This systematic review qualitatively characterized the financial and nonfinancial features of VBP programs and examined how such features combine to create a level of program intensity that relates to desired quality and spending outcomes. Higher-intensity VBP programs are more frequently associated with desired quality processes, utilization measures, and spending reductions than lower-intensity programs. Thus, although there may be reasons for payers and providers to opt for lower-intensity programs (for example, to increase voluntary participation), these choices apparently have consequences for spending and quality outcomes.”

About hospitals and healthcare systems

 Washington Health System to merge with UPMC “The boards of Washington (Pa.) Health System and Pittsburgh-based UPMC signed a letter of intent to negotiate a deal that would integrate WHS into UPMC. 
The signing of the letter of intent means WHS and UPMC have agreed to conditions of affiliation. In the coming months, both entities will engage in due diligence, research and discussions to work towards a definitive agreement.”

Medicare Beneficiaries’ Perspectives on the Quality of Hospital Care and Their Implications for Value-Based Payment “In this survey study of 1025 Medicare beneficiaries, clinical outcomes was the most important quality domain when choosing a hospital (weight, 49%), followed by safety (weight, 22%), patient experience (weight, 21%), and efficiency (weight, 8%).
Meaning  These findings suggest that current HVBP program value weights do not reflect the preferences of Medicare beneficiaries, and using beneficiary preferences may exacerbate disparities by rewarding larger, high-volume hospitals.”

San Francisco questions legality of US News hospital rankings “David Chiu, San Francisco's city attorney, sent a letter to U.S. News & World Report June 20 demanding that the media outlet explain its methodology, how it intends to address apparent biases, and immediately publicly disclose the revenue it receives from hospitals.
’Consumers use these rankings to make consequential healthcare decisions, and yet there is little understanding that the rankings are fraught and that U.S. News has financial relationships with the hospitals it ranks,’ Mr. Chiu said in a news release issued from his office. 
‘The hospital rankings appear to be biased towards providing treatment for wealthy, white patients, to the detriment of poorer, sicker, or more diverse populations. Perverse incentives in the rankings risk warping our healthcare system,’ Mr. Chiu said. ‘Hospitals are treating to the test by investing in specialties that rack up the most points rather than in primary care or other worthy specialties.’”

About pharma

Pharmaceutical trade group sues US over Medicare drug price negotiation plans “The Pharmaceutical Research and Manufacturers of America (PhRMA), the leading industry lobby group, and two other organizations on Wednesday said they were suing the U.S. government to block enforcement of a program that gives Medicare the power to negotiate drug prices.
In a complaint filed in a federal court in Texas, PhRMA along with the National Infusion Center Association and the Global Colon Cancer Association, which counts PhRMA and some drug companies as members, said the drug price negotiation program was unconstitutional.”

The Rise and Fall of the Insulin Pricing Bubble Read the whole article- it covers more than insulin prices.
Here are a couple highlights:
—“…from 2012 to 2019, gross sales for 4 leading insulin products in the US more than doubled (from $13 billion to $27 billion), while net sales after rebates and other confidential discounts dropped by approximately 40% (from $8 billion to $5 billion). This growing bubble between list prices and net prices was fueled by price concessions that exceeded 80% by 2019. More than two-thirds of these price concessions were negotiated between manufacturers and commercial or Medicare Part D plans, while the remainder were required under law, including statutory discounts in Medicaid, Medicare, and the 340B Drug Pricing Program…”
—"Other new federal policies, including those in Inflation Reduction Act (IRA) of 2022, could affect pricing behavior for even more brand-name drugs…But, there are at least 2 reasons why the IRA may actually contribute to higher gross-to-net–price ratios. First, because drug companies will be penalized for raising prices each year, they may launch new drugs at even higher list prices and offer higher rebates to insurance plans and PBMs. Second, when a drug in one class is selected for Medicare negotiation, manufacturers of other drugs in that class may seek to compete for formulary placement by offering higher rebates.”

About the public’s health

Gas and Propane Combustion from Stoves Emits Benzene and Increases Indoor Air Pollution “To our knowledge, however, no research has quantified the formation of benzene indoors from gas combustion by stoves. Across 87 homes in California and Colorado, natural gas and propane combustion emitted detectable and repeatable levels of benzene that in some homes raised indoor benzene concentrations above well-established health benchmarks. Mean benzene emissions from gas and propane burners on high and ovens set to 350 °F ranged from 2.8 to 6.5 μg min−1, 10 to 25 times higher than emissions from electric coil and radiant alternatives; neither induction stoves nor the food being cooked emitted detectable benzene. Benzene produced by gas and propane stoves also migrated throughout homes, in some cases elevating bedroom benzene concentrations above chronic health benchmarks for hours after the stove was turned off. Combustion of gas and propane from stoves may be a substantial benzene exposure pathway and can reduce indoor air quality.”

About healthcare IT

 Rule on Copyrights Must Be Reviewed, Right to Repair Appeal Brief Argues “The National Association of Manufacturers (NAM) and the Washington Legal Foundation (WLF) have entered the “right to repair” legal fray, questioning the Library of Congress’s (LOC) ability to grant copyright exemptions to third-party repair companies without the opportunity for judicial review.
In their briefs supporting an appeal of the recent circuit court “right-to-repair” ruling, the organizations argue that the LOC’s actions erode copyright protections when it comes to medical device repairs.
The issue concerns whether third-party entities should have access to copyrighted software so they are able to repair FDA-regulated medical devices.”

About health technology

 MDIC aims to encourage, fund advanced manufacturing with online clearing house “Medical device makers that use novel, developing or already established technologies in a way that uniquely advances the manufacturing of their products can now apply to an online clearing house where they can share the story of their journey with other companies and the US Food and Drug Administration (FDA) – and get funding of up to $300,000 for their efforts.
 The goal of the Advanced Manufacturing Clearing House from the Medical Device Innovation Consortium (MDIC) is to find ways to get devices on shelves and to patients faster, as well as avoid product shortages like those seen during the COVID-19 pandemic. Examples of technologies used in advanced manufacturing include artificial intelligence (AI), machine learning (ML), virtual modeling and simulation, and digital twins—a virtual representation of a system—just to name a few.”

FDA pilot program aims to lower risks of using lab-developed tests to select cancer drugs “FDA announced the creation of a voluntary pilot program that will assist clinicians in selecting the appropriate treatment for patients with cancer through the use of laboratory-developed tests…
According to the press release, the FDA has become concerned that lab-made tests the agency did not authorize may not provide accurate and reliable results, which can negatively impact treatment decisions.
The new pilot program seeks to assist in reducing the risk of using laboratory-developed tests for oncology drug treatment decisions while the FDA continues work on a broader approach for their use.”

About healthcare finance

 BD sells off surgical instruments unit to Steris for $540M BD announced Tuesday that it has inked a deal with Steris, an Irish maker of medical equipment used for sterilization and surgical procedures, to sell off its surgical instrumentation unit.
Under the terms of their agreement, Steris will take on not only BD’s V. Mueller, Snowden-Pencer and Genesis product lines but also a trio of manufacturing facilities in Missouri, Ohio and Germany as well as the 360 BD employees who work within the business unit. The newly purchased assets will slot into Steris’ healthcare segment, according to the announcement.”

Health services: US Deals 2023 midyear outlook “Health services deal volumes in the 12 months ending May 15, 2023 declined a modest 4% from levels seen in 2022. However, volumes remain at nearly twice the levels seen from 2018 to 2020. Deal values declined by a more meaningful 15%, a continuation of the trend seen in 2022 where a greater portion of deal volume is being driven by smaller value roll-up and add-on transactions as opposed to transformational platform deals and megadeals.”
The article has examples of recent deals.

Today's news and Commentary

About health insurance/insurers

 Healthcare billing fraud: 10 recent cases  FYI. Notice the prevalence Medicare/Medicaid cases.

More than 1 million people are dropped from Medicaid as states start a post-pandemic purge of rolls An update on this process: “More than 1 million people have been dropped from Medicaid in the past couple months as some states moved swiftly to halt health care coverage following the end of the coronavirus pandemic.
Most got dropped for not filling out paperwork…
Already, about 1.5 million people have been removed from Medicaid in more than two dozen states that started the process in April or May, according to publicly available reports and data obtained by The Associated Press.”

Major payers' large size propels them to 'stable' outlook: Fitch “The sheer size of the country's largest health plans positions them well for a ‘stable’ business outlook, according to analysts at Fitch Ratings.
The report digs into the outlook for four companies: UnitedHealth, Cigna, Elevance Health and Humana. Each of these insurers benefits from strong market share across multiple metropolitan areas, the analysts said. And while none owns a majority of the market share in the U.S., their penetration in individual regions can be very high.
This gives them very strong positioning when they come to the negotiating table with providers, according to the report.”
About hospitals and healthcare systems

 35 health systems ranked by revenue FYI. Note: These figures are more indicative of patient care activity, since many of these organizations have recently had negative “bottom lines.”

About pharma

‘It’s beyond unethical’: Opaque conflicts of interest permeate prescription drug benefits “Employers across the country — from big names like Boeing and UPS to local school systems — pay consulting firms to handle a straightforward task with their prescription drug coverage: Get the best deals possible, and make sure the industry’s middlemen, known as pharmacy benefit managers, aren’t ripping them off with unfair contracts.
But a largely hidden flow of money between major consulting conglomerates and PBMs compromises that relationship, a STAT investigation shows. Some consulting firms often are getting paid more — a lot more — by the PBMs and health insurance carriers that they are supposed to scrutinize than by companies they are supposed to be looking out for. 
Consulting firms can collect at least $1 per prescription from the largest PBMs, according to more than a dozen independent drug benefits consultants and attorneys involved with employers’ PBM contracts. That can go as high as $5 per prescription in extreme cases, three of those people said.” 

Walgreens, CVS issue new rules to stop denials, delays for lawful reproductive drugs “Walgreens and CVS are voluntarily implementing new procedures designed to improve timely access to medications that, while they can be used for abortion, have been prescribed for other purposes, according to a statement Friday from a federal agency.
Following confusion brought on by the overturning of Roe v. Wade, the U.S. Department of Health & Human Services Office for Civil Rights said it received complaints that pharmacies had delayed or denied filling prescriptions for lawful access to medications, such as methotrexate and misoprostol, and for accessing emergency contraceptives, the HHS OCR statement said…
The pharmacies' new procedures include use of special teams to provide internal guidance and respond to complaints, creating direct paths for customers to submit complaints, new training of reproductive health care and monitoring denials of medication related to reproductive health care, OCR's statement said.”

About the public’s health

Heavy drinkers really don’t ‘handle their liquor,’ study says “It’s a misnomer that heavy drinkers can ‘hold their liquor,’ a new study found.
Instead, people with alcohol use disorder — what used to be called alcoholism — were significantly impaired on cognitive and motor tests up to three hours after downing an alcoholic drink designed to mimic their typical habits.”

Depression and Suicide Risk ScreeningUpdated Evidence Report and Systematic Review for the US Preventive Services Task Force “Direct evidence indicated that screening programs improved depression outcomes. In addition, robust indirect evidence exists that screening tools feasible to administer in primary care settings have reasonable accuracy and that treatment is effective. The direct evidence is more equivocal than the indirect evidence, being based on a smaller number of studies and having fewer statistically significant findings. The presence of additional program components beyond screening in many of the depression screening studies made it difficult to isolate the specific effects of screening alone in these studies…
While there is likely an important role for health care settings, only 1 trial reporting direct evidence on suicide risk screening among primary care patients was found, and it was limited to patients who had screened positive for depression. The findings were inconclusive. This review was scoped to include evidence on screening in broad populations (not only those who screen positive for depression), but no such evidence was found. In addition, there was minimal evidence on the test performance of suicide risk screening instruments; no instrument was addressed in more than 1 study.”
Comment: Read the entire study. It reveals how much we do not know about our screening techniques and whether or not acting on them is effective.
And in a related article: Screening for Anxiety Disorders in AdultsUS Preventive Services Task Force Recommendation Statement “The USPSTF recommends screening for anxiety disorders in adults, including pregnant and postpartum persons. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for anxiety disorders in older adults. (I statement).”

About healthcare IT

Experiences with information blocking in the United States: a national survey of hospitals “Overall, 42% of hospitals reported observing some behavior they perceived to be information blocking. Thirty-six percent of responding hospitals perceived that healthcare providers either sometimes or often engaged in practices that may constitute information blocking, while 17% and 19% perceived that health IT developers (such as EHR developers) and State, regional and/or local health information exchanges did the same, respectively. Prevalence varied by health IT developer market share, hospital for-profit status, and health system market share.”
Note: Per the Cures Act, such blocking is illegal.

Racial and Ethnic Bias in Risk Prediction Models for Colorectal Cancer Recurrence When Race and Ethnicity Are Omitted as Predictors “In this prognostic study of the racial bias in a cancer recurrence risk algorithm, removing race and ethnicity as a predictor worsened algorithmic fairness [emphasis added] in multiple measures, which could lead to inappropriate care recommendations for patients who belong to minoritized racial and ethnic groups. Clinical algorithm development should include evaluation of fairness criteria to understand the potential consequences of removing race and ethnicity for health inequities.”
Comment: A great deal of attention has been focused on measures bias due to inclusion of racial differences. This article is important because it emphasizes the need to evaluate each measure before racial difference inclusions are assumed to be detrimental.

About healthcare finance

Medtech firm Surgalign files for Chapter 11 bankruptcy “Surgalign filed for the bankruptcy with estimated assets and liabilities in the range of $50 million to $100 million in the Bankruptcy Court for the Southern District of Texas.”

Eli Lilly boosts immunology business with $2.4 billion deal for Dice “Eli Lilly and Co. will buy Dice Therapeutics Inc for about $2.4 billion in cash, the company said on Tuesday, bolstering its immune disease-related portfolio with an experimental pill to treat psoriasis.
The company has been looking to bulk up its immunology pipeline, even as it bets on potential blockbuster obesity drug tirzepatide, also known as Mounjaro, to drive future growth.”

Today's News and Commentary

About Covid-19

 FDA advisers back updated COVID vaccine targeting dominant variant “Advisers to the U.S. Food and Drug Administration on Thursday unanimously recommended that updated COVID-19 shots being developed for a fall vaccination campaign target one of the currently dominant XBB coronavirus variants.
The panel voted 21-0 in favor of XBB-targeted shots, and the committee's discussion indicated that the XBB.1.5 Omicron subvariant would be preferred.
FDA official Dr. Peter Marks indicated the agency was likely to settle on XBB.1.5, which manufacturers suggested could be ready for inoculations soonest.”

About health insurance/insurers

High Court Backs Broad FCA Dismissal Authority For Gov't The U.S. Supreme Court on Friday ruled that the federal government has the authority to dismiss whistleblower False Claims Act cases it initially declines to intervene in, but said it must reasonably explain why it is seeking to dismiss the suit.

 Humana joins UnitedHealth in rising medical cost warning “Humana is anticipating its medical loss ratio will be at the top end of its full-year projected range of 86.3 percent to 87.3 percent, according to a June 16 SEC filing. 
The company said the expectation is primarily driven by ‘higher than anticipated non-inpatient utilization trends, predominantly in the categories of emergency room, outpatient surgeries and dental services, as well as inpatient trends that have been stronger than anticipated in recent weeks, diverging from historical seasonality patterns.’”

About hospitals and healthcare systems

 Premier Inc. carving off non-healthcare group purchasing business in $800M cash deal “Premier Inc. announced Wednesday a definitive agreement to offload its non-healthcare group purchasing operations for about $800 million cash, a deal that aims to satisfy stockholders and allow the company to focus its attention on growth in its core healthcare business.
The deal with fellow group purchasing organization (GPO) OMNIA Partners is expected to close in early August subject to regulatory approval and other conditions.”

About pharma

Walgreens inks another deal for clinical trials business as CVS exits research recruitment “Retail pharmacy giant Walgreens inked another partnership to recruit participants for research as it continues to build out its clinical trials business.
The company signed a deal with biotech startup Freenome to advance clinical trials of its blood-based tests for the early detection of cancer.
It marks the sixth contract that Walgreens has publicly disclosed for its year-old clinical trials business unit. The pharmacy chain launched the unit back in June 2022 as the company's healthcare ambitions continue to grow.”

About the public’s health

 Public Health Reporting, Data Sharing Nearly Ubiquitous in Hospitals  Public health reporting by acute care hospitals has seen significant improvement, reaching a 96 percent participation rate in 2022. This is an increase from the previous year, according to the 2022 American Hospital Association (AHA) Information Technology published by the Office of the National Coordinator (ONC) for Health IT.”

National, State-Level, and County-Level Prevalence Estimates of Adults Aged ≥18 Years Self-Reporting a Lifetime Diagnosis of Depression — United States, 2020 From the CDC: “During 2020, 18.4% of U.S. adults reported having ever been diagnosed with depression; state-level age-standardized estimates ranged from 12.7% in Hawaii to 27.5% in West Virginia. Model-based age-standardized county-level prevalence estimates ranged from 10.7% to 31.9%, and there was considerable state-level and county-level variability.
What are implications for public health practice?
Decision-makers can use these estimates to guide resource allocation to areas where the need is greatest, possibly by implementing practices such as those recommended by The Guide to Community Preventive Services Task Force and the Substance Abuse and Mental Health Services Administration.”

About healthcare IT

 Accuracy of a Generative Artificial Intelligence Model in a Complex Diagnostic Challenge “A generative AI model provided the correct diagnosis in its differential in 64% of challenging cases and as its top diagnosis in 39%. The finding compares favorably with existing differential diagnosis generators.”
And in a related article: When AI Overrules the Nurses Caring for You Well worth the read if you can access The Wall Street Journal.

Digital health should brace for 'significant amount of churn' as hospitals reconsider COVID-era tech contracts “A substantial number of hospitals are ready to rip and replace digital tools such as telemedicine and remote patient monitoring platforms that were rapidly adopted with the onset of the pandemic as many three-year contracts will soon expire…
Panda Health’s March survey polled 100 hospital and health system executives on how the pandemic influenced their adoption of digital health offerings…
Nearly half said they were either ‘not satisfied’ or ‘moderately satisfied’ with their current platform, and 30% said those contracts are set to expire between now and the end of 2024.”

About health technology

 Americans’ use of healthcare wearables expanding rapidly, survey says  “Dive Brief:

  • U.S. consumers doubled their use of wearable healthcare devices, including smartwatches, wearable monitors and fitness trackers, between 2020 and 2021, according to a new survey from AnalyticsIQ.

  • Among wearable monitors, blood pressure devices were the most popular, used by 59% of survey respondents, followed by sleep monitors (21%) and ECG monitors (11%). Biosensors such as glucose monitors, hormone monitors, fall detectors and respiratory monitors were used by 8% of consumers in the survey, followed by use of smart clothing items at 6%.

  • The wearable biosensors niche alone grew from $150 million globally in 2016 to $25 billion in 2021, the data analytics firm said.”

Today's News and Commentary

ICYMI yesterday: US health spending to top $7.2T by 2031

About health insurance/insurers

 KFF Survey of Consumer Experiences with Health Insurance Key Findings

  • Most insured adults give their health insurance positive ratings, though people in poorer health tend to give lower ratings. Most insured adults (81%) give their health insurance an overall rating of ‘excellent’ or ‘good,’ though ratings vary based on health status: 84% of people who describe their physical health status as at least ‘good’ rate insurance positively, compared to 68% of people in ‘fair’ or ‘poor’ health. Ratings are positive across insurance types, though higher shares of adults on Medicare rate their insurance positively (91%) and somewhat lower shares of those with Affordable Care Act (ACA) Marketplace coverage give their insurance a positive rating (73%).

  • Despite rating their insurance positively, most insured adults report experiencing problems using their health coverage; people in poorer health are more likely to report problems. A majority of insured adults (58%) say they have experienced a problem using their health insurance in the past 12 months – such as denied claims, provider network problems, and pre-authorization problems. Looking at responses by health status, two-thirds (67%) of adults in fair or poor health experienced problems with their insurance, compared to 56% of adults who say they are in at least ‘good’ physical health. Notably, about three in four insured adults who received mental health care in the past year, or who use a lot of health care (defined as more than ten provider visits in a year) experienced insurance problems. At least half of adults across insurance types say they experienced a problem, though the nature of problems people experienced varied somewhat more based on their type of coverage.

  • Nearly half of insured adults who had insurance problems were unable to satisfactorily resolve them, with some reporting serious consequences. Half of consumers with insurance problems say their problem was resolved to their satisfaction. Among the 58% of insured adults who had a problem with their insurance in the past year, about one in six (17%) say they were unable to receive recommended care as a direct result of their problems; 15% say they experienced a decline in their health and about three in ten (28%) say they paid more than they expected for care all as a direct result of their problems.

  • Among those with the greatest mental health needs, many adults across insurance types find their coverage lacking and report forgoing needed care. Among insured adults who report being in ‘fair’ or ‘poor’ mental health, four in ten (43%) say there was a time in the past year when they did not get mental health services or medication they thought they needed, and a similar share (45%) give their insurance a negative rating when it comes to the availability of mental health providers. One in five of this group (19%) say there was a time in the past year when a particular mental health service or treatment they needed was not covered by their plan. People with Medicare – who are less likely overall to say they are in fair or poor mental health – are also somewhat less likely than adults with other types of insurance to say a needed mental health therapist or treatment was not covered by their insurance. Adults with Marketplace and Medicaid coverage are more likely than those with employer-sponsored insurance (ESI) or Medicare to negatively rate their insurance when it comes to the availability of mental health providers.

  • Affordability of premiums and out-of-pocket costs are a concern, particularly for those with private health coverage, and for some, contributed to not getting care. About half of adults with Marketplace plans (55%) or ESI (46%) rate their insurance negatively when it comes to premiums, compared to 27% of people with Medicare and 10% of Medicaid enrollees. Four-in-ten insured adults say they skipped or delayed some type of care in the past year due to cost. One in six insured adults (16%), including larger shares of those at lower income levels, say they had problems paying medical bills in the past year.

  • Insured adults overwhelmingly support public policies to make insurance simpler to understand and to help them avoid or resolve insurance problems. About nine in ten say they support requirements on insurers to maintain accurate and up-to-date provider directories, provide simpler, easier-to read EOBs, disclose their claims denial rates to regulators and the public, and provide in advance, upon request, information about whether care is covered and their out-of-pocket cost liability. Nearly eight in ten say they would be likely to use the services of a publicly established consumer assistance program (CAP) when they encounter insurance problems. All of these public policies have already been enacted, though not all have been fully implemented or funded. The survey did not probe trade-offs that might be involved in implementing existing or future consumer protections in these areas, such as administrative costs.”

Look at the graphs as well.

At Least 1.7M Americans Use Health Sharing Arrangements, Despite Lack of Protections “Under the arrangements, members, who usually share some religious beliefs, agree to send money each month to cover other members’ health care bills. At least 11 of the sharing plans that reported data operated in or advertised plans in all 50 states in 2021.
Sharing plans do not guarantee payment for health services and are not held to the same standards and consumer protections as health insurance plans. Sharing plans are not required to cover preexisting conditions or provide the minimum health benefits mandated by the Affordable Care Act. And unlike health insurance, sharing plans can place annual or lifetime caps on payments. A single catastrophic health event can easily exceed a sharing plan’s limits.”
Comment: These plans do not meet even the most basic definition of insurance— indemnification against catastrophic loss.

About hospitals and healthcare systems

 AdventHealth becomes latest health system to exit skilled nursing “AdventHealth had 10 facilities — eight in Florida and one each in Kansas and Texas. Over the last month, California-based CareTrust REIT announced acquisitions of two of those nursing homes.
But AdventHealth confirmed to McKnight’s Long-Term Care News on Tuesday that it is exiting the skilled nursing sector all together.”
Comment:Is this action part of a de-vertical integration strategy?

About pharma

 JUNE 2023 CANCER DRUG PRICES REPORT “The analysis found [that as a result of the Inflation Reduction Act]:

  • Out of the 61,968 people with traditional Medicare who get a brand-name cancer drug through Medicare Part D, 99% will experience savings from the $2,000 out-of-pocket cap.

  • On average, this group of people on Medicare will save $7,590 annually, with some saving as much as $19,296.

  • Of the blockbuster medications studied in this report, people who take Revlimid and Pomalyst will realize the greatest annual savings ($8,989 and $8,635 respectively).”

About the public’s health

Youth, young adults are dying from suicide and homicide at highest rates in decades, CDC report says
In 2021, suicide and homicide rates for children and young adults ages 10 to 24 in the US were the highest they’ve been in decades, according to a new report [will be publicly released 6/19]from the US Centers for Disease Control and Prevention.
Suicide and homicide were the second and third leading causes of death for this age group, both causing about 11 deaths for every 100,000 people ages 10 to 24. The homicide rate for this age group in 2021 was the highest it’s been since 1997, and the suicide rate was the highest on record, since 1968.
Suicide rates surpassed homicide rates for this age group in 2010 and have continued rising for the past decade. But a large spike in homicide rates during the first year of the Covid-19 pandemic brought the rates for both types of violent death together for the first time in a decade.”

In-home Visits and Subsequent Health Outcomesin Medicare Advantage Beneficiaries With Coronary Artery Disease, Diabetes, Hypertension, and Depression “Among those eligible to receive an in-home visit, a total of 48,566 patients had an in-home visit in 2018 (the ‘Exposure’ group), and 36,549 beneficiaries constituted the ‘Wait List’ control group. Receiving an in-home visit early was associated with a greater decrease in inpatient stays for all 4 conditions (change score range for any stay: −5.22% to −2.47%) (P<0.001, depression <0.05); decrease in emergency visits (change score range for any stay: −4.39% to −3.67%) (P<0.0.001, depression <0.05); and fewer major adverse cardiovascular events for coronary artery disease and depression (P<0.001 and <0.025, respectively) 1 year later. Minimal differences were noted for change in ambulatory and primary care visits, with no consistent increase in quality-of-care metrics. Time-to-first primary care visit was shorter for the ‘Exposure’ versus the Wait List control group in all conditions (difference between 2.45 and 4.95 d).”

About healthcare IT

Just a reminder that these large breaches are still occurring:

Trinity Health hit with class action alleging 'inadequate safeguarding' to blame for March data breach 
Lawsuit accuses Harvard Pilgrim of 'negligently failing' to protect members' data following breach