Today's News and Commentary

About health insurance/insurers

Change Healthcare to begin processing $14B in claims “Change Healthcare said March 22 it plans to restore its biggest clearinghouse platforms over the weekend and start processing $14 billion in claims.
The UnitedHealth Group subsidiary said it brought the Assurance claims preparation system back online March 18 and intends to reinstate Relay Exchange, its largest clearinghouse, the weekend of March 23.”

Taxpayers Were Overcharged for Patient Meds. Then Came the Lawyers. Suits against PBM overcharges, “which now total nearly $1 billion, [appear to have been ] driven by state governments cracking down on a company that had ripped off taxpayers.
But a New York Times investigation, drawing on thousands of pages of court documents, emails and other public records in multiple states, reveals that the case against Centene was conceived and executed by a group of powerful private lawyers who used their political connections to go after millions of dollars in contingency fees….
So far, the lawyers have been awarded at least $108 million in fees.”

About hospitals and healthcare systems

 Hospitals Are Adding Billions in ‘Facility’ Fees for Routine Care  A great article in The Wall Street Journal that highlights the increased costs of facility fees that hospitals (but not independent physician offices) can and do charge.

About the public’s health

Requiring ugly images of smoking’s harm on cigarettes won’t breach First Amendment, court says “A federal requirement that cigarette packs and advertising include graphic images demonstrating the effects of smoking — including pictures of smoke-damaged lungs and feet blackened by diminished blood flow — does not violate the First Amendment, an appeals court ruled Thursday.
The ruling from a three-judge panel of the 5th U.S. Circuit Court of Appeals was a partial victory for federal regulators seeking to toughen warning labels. But the court kept alive a tobacco industry challenge of the rule, saying a lower court should review whether it was adopted in accordance with the federal Administrative Procedure Act, which governs the development of regulations.
The 5th Circuit panel rejected industry arguments that the rule violates free speech rights or that it requires images and lettering that take up so much space that they overcome branding and messaging on packages and advertisements.”

US exceptionalism? International trends in midlife mortality Background Rising midlife mortality in the USA has raised concerns, particularly the increase in ‘deaths of despair’ (due to drugs, alcohol and suicide). Life expectancy is also stalling in other countries such as the UK, but how trends in midlife mortality are evolving outside the USA is less understood. We provide a synthesis of cause-specific mortality trends in midlife (25–64 years of age) for the USA and the UK as well as other high-income and Central and Eastern European (CEE) countries.
Results US midlife mortality rates have worsened since 1990 for several causes of death including drug-related, alcohol-related, suicide, metabolic diseases, nervous system diseases, respiratory diseases and infectious/parasitic diseases. Deaths due to homicide, transport accidents and cardiovascular diseases have declined since 1990 but saw recent increases or stalling of improvements. Midlife mortality also increased in the UK for people aged 45–54 year and in Canada, Poland and Sweden among for those aged 25–44 years.”

Healthcare Quality and Safety

J&J's Abiomed sees serious Impella recall linked to heart perforations, 49 deaths “Johnson & Johnson MedTech’s Abiomed division has another serious recall on its hands stemming from its line of miniaturized Impella heart pumps, following reports that the devices could pierce and cut through the wall of the left ventricle during operation.
The FDA reported this week that it was aware of 49 patient deaths related to the issue, among 129 records of severe injuries.”

BD boosts U.S. production as FDA warns against using plastic syringes from China “The FDA last week re-upped its recommendations that healthcare providers avoid using plastic syringes made in China wherever possible, while it continues to investigate growing quality concerns. In response, BD said it would be increasing U.S. production of the ubiquitous drug delivery hardware to help cover the gap.
The agency first made its worries public late last November, after it collected reports of leaks, breakages and other problems.”

FDA elevates recall of 6.6M Vyaire Medical emergency bag valve masks “The FDA is getting the word out on an ongoing recall of millions of hand-powered bag valve masks, which may not deliver enough oxygen to a patient in need of resuscitation.
The disposable emergency devices, stocked in ambulances and kept at hospital bedsides, are used to force air into the lungs to help counter insufficient breathing or respiratory arrest.
The recall covers different sizes and accessories of Vyaire Medical’s AirLife adult manual resuscitators, spanning some 6.6 million devices. The FDA said that a manufacturing defect—present only in equipment produced in 2017 or before—could result in patients not receiving enough ventilation, or any at all.”

Medicaid Health Plan Will Reimburse Health Equity Certification “Meridian Health Plan of Illinois, Inc.—a wholly-owned subsidiary of Centene Corporation that offers Medicaid coverage—announced that it will cover part of the fee hospitals must pay to undergo health equity certification through the Joint Commission.”

About healthcare IT

Digital Diabetes Management Solutions “Digital diabetes management solutions in the remote patient monitoring and behavior and lifestyle modification categories do not deliver meaningful clinical benefits, and they increase healthcare spending relative to usual care. The evidence showed that improvements in glycemic control for patients using digital diabetes management solutions were minimal and short-term.”

About healthcare finance

 Novo Nordisk inks $1B Cardior buyout to pump up heart failure plans Novo Nordisk is pumping up its heart failure plans. The drugmaker, swelled by its GLP-1 windfall, has decided to buy Cardior Pharmaceuticals and its midphase prospect in a deal that could top out above 1 billion euros ($1.1 billion).
Cardior is developing an antisense oligonucleotide to inhibit a piece of non-coding RNA, miR-132, that is implicated in heart failure. Upregulation of the RNA when certain cells are stressed can lead to changes in the size and shape of the heart. Blocking elevated miR-132 could therefore prevent or reverse changes that are associated with poor prognosis in patients who have heart attacks.”

Today's News and Commentary

Tomorrow (March 23) is the 14th anniversary of passage of the first part of the Patient Protection and Affordable Care Act (AKA Obamacare). [The law was amended by the Health Care and Education Reconciliation Act on March 30, 2010.]

Congress unveils $1.2 trillion plan to avert federal shutdown and bring budget fight to a close First read this overview from the AP. Then look at the Democratic summary and the Republican summary.
The former has good details about the healthcare and human services provisions while the latter focuses more on items like the defense budget.
In related news: House-passed bill instructs Congressional Budget Office to take longer view when grading preventive health laws “Tuesday, the House of Representatives passed a bill that would allow lawmakers to request the Congressional Budget Office (CBO) to generate budgetary savings estimates of prospective preventive healthcare legislation over a 30-year window as opposed to the current 10-year scoring window.”

About health insurance/insurers

 Republican majorities block efforts to expand Medicaid in Georgia and Kansas “ Plans to expand Medicaid coverage to over half a million more people in Georgia and Kansas were defeated by Republican-led committees in the states’ legislatures Thursday.
There are currently only 10 states that don’t cover people with incomes up to 138% of the federal poverty line, after North Carolina began offering Medicaid to uninsured adults last December.”

Providers 'wasted' $10.6B in 2022 overturning claims denials, survey finds “Providers spent nearly $20 billion in 2022 pursuing delays and denials across all payer types, yet those efforts are substantially more costly on average when dealing with private plans, Premier, a group purchasing organization, wrote in a recent blog post on the new data.
Just over half of the total comes from denied claims that are eventually paid out, meaning that about $10.6 billion is ‘wasted arguing over claims that should have been paid at the time of submission,’ Premier wrote.”

About pharma

 GSK to cap out-of-pocket inhaler costs in US  “British pharmaceutical giant GSK said on Wednesday it would cap out-of-pocket costs for all its inhaled asthma and chronic lung disease medicines at $35 per month for eligible patients in the United States, following similar moves by two of its rivals.
GSK said the decision will take effect by Jan. 1, 2025.
The cost cap would apply to all of its asthma and chronic obstructive pulmonary disease (COPD) medicines, including Advair Diskus, Advair HFA, and Trelegy Ellipta, and would apply to patients whose monthly costs currently exceed $35.”

Arches Medical Partners buys 11 primary care clinics from VillageMD “Walgreens-owned VillageMD sold 11 primary care clinics in Rhode Island to Boston-based Arches Medical Partners.
The deal establishes the medical group management company's presence in the Providence metro area while continuing to provide access to high-quality care with experienced providers to approximately 75,000 patients, according to the company in a press release…
VillageMD continues to shed clinics across the country as part of Walgreens' aggressive $1 billion cost-saving strategy as it looks to boost profitability in its healthcare business. That effort also includes slashing capital expenditures by about $600 million.
The companies did not disclose the financial details.”

About the public’s health

 Drug overdoses reach another record with almost 108,000 Americans in 2022, CDC says “Nearly 108,000 Americans died of drug overdoses in 2022, according to final federal figures released Thursday.
Over the last two decades, the number of U.S. overdose deaths has risen almost every year and continued to break annual records — making it the worst overdose epidemici n American history.
The official number for 2022 was 107,941, the U.S. Centers for Disease Control and Prevention said, which is about 1% higher than the nearly 107,000 overdose deaths in 2021.”

House committee launches investigation into organ transplant network “The House Committee on Energy and Commerce has launched a bipartisan investigation into the U.S. organ transplant system – the latest scrutiny of the system following reports from the Senate and whistleblowers alleging its failures and mismanagement.
The move by the committee aims to "ensure successful implementation" of a bipartisan bill that was signed into law by President Joe Biden last September. The law was aimed at breaking up the monopoly system that allowed a private nonprofit --- the United Network for Organ Sharing -- to be the sole contractor managing the country's Organ Procurement and Transplantation Network (OPTN) for over 40 years.”

About health technology

 US surgeons transplant a gene-edited pig kidney into a patient for the first time “Doctors in Boston have transplanted a pig kidney into a 62-year-old patient, the latest experiment in the quest to use animal organs in humans.
Massachusetts General Hospital said Thursday that it’s the first time a genetically modified pig kidney has been transplanted into a living person. Previously, pig kidneys have been temporarily transplanted into brain-dead donors. Also, two men received heart transplants from pigs, although both died within months.”

Today's News and Commentary

About health insurance/insurers

 Medicare creates coverage path for anti-obesity meds “The US Centers for Medicare and Medicaid Services (CMS) confirmed to FirstWord Thursday that Medicare Part D plans can cover the cost of obesity drugs if – like Novo Nordisk's Wegovy (semaglutide) – they have received FDA approval for an additional ‘medically accepted indication’ such as preventing heart attacks and strokes.”

About pharma

Orchard settles on $4.25M US price tag for leukodystrophy gene therapy “Orchard Therapeutics disclosed Wednesday that its metachromatic leukodystrophy (MLD) gene therapy Lenmeldy (atidarsagene autotemcel) will carry a wholesale acquisition cost of $4.25 million in the US. The company said that the price of the one-time treatment – which makes it the most expensive drug ever – reflects its ‘clinical, economic and societal value.’”

Novel Oral Antihypertensive Gets FDA's Blessing “The FDA has approved aprocitentan (Tryvio), making it the first endothelin receptor antagonist for the treatment of high blood pressure (BP), Idorsia Pharmaceuticals announced on Wednesday.
The once-daily oral medication is indicated in combination with other antihypertensive drugs to lower BP in adult patients who do not have their BP controlled with other therapies.”

About the public’s health

A distinct Fusobacterium nucleatum clade dominates the colorectal cancer niche Fusobacterium nucleatum (Fn), a bacterium present in the human oral cavity and rarely found in the lower gastrointestinal tract of healthy individuals, is enriched in human colorectal cancer (CRC) tumours. High intratumoural Fn loads are associated with recurrence, metastases and poorer patient prognosis.”

Global fertility rates to plunge in decades ahead, new report says “A new study projects that global fertility rates, which have been declining in all countries since 1950, will continue to plummet through the end of the century, resulting in a profound demographic shift.
The fertility rate is the average number of children born to a woman in her lifetime. Globally, that number has gone from 4.84 in 1950 to 2.23 in 2021 and will continue to drop to 1.59 by 2100, according to the new analysis, which was based on the Global Burden of Diseases, Injuries, and Risk Factors Study 2021, a research effort led by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. The study was published Wednesday in the journal the Lancet.”

Mortality in the United States, 2022 Data from the National Vital Statistics System

  • Life expectancy for the U.S. population in 2022 was 77.5 years, an increase of 1.1 years from 2021.

  • The age-adjusted death rate decreased by 9.2% from 879.7 deaths per 100,000 standard population in 2021 to 798.8 in 2022.

  • Age-specific death rates increased from 2021 to 2022 for age groups 1–4 and 5–14 years and decreased for all age groups 15 years and older.

  • The 10 leading causes of death in 2022 remained the same as in 2021, although some causes changed ranks. Heart disease and cancer remained the top 2 leading causes in 2022.

  • The infant mortality rate was 560.4 infant deaths per 100,000 live births in 2022, an increase of 3.1% from the rate in 2021 (543.6).”

 

About healthcare IT

 Providers file class action lawsuits over fallout from Change Healthcare cyberattack “On the heels of proposed class action lawsuits from patients, providers are also filing legal challenges against UnitedHealth Group in the wake of the cyberattack on Change Healthcare.”
The article has several example of groups filing suits.

Key Issues as Wearable Digital Health Technologies Enter Clinical Care This NEJM article requires subscription but it is well-worth reading if you can access it. The authors summarize their findings: “…we identify six interlocking and vexing issues at the foundation of delivering DHT-informed care: data ownership; patient trust, literacy, and access; standards and interoperability; integration of DHTs into clinical care; patient empowerment and agency; and reimbursement and a return on investment for health care systems.” 

Today's News and Commentary

About health insurance/insurers

 The 10 best health insurance companies of 2024 FYI

About the public’s health

 Biden Administration Announces Rules Aimed at Phasing Out Gas Cars “The Biden administration on Wednesday issued one of the most significant climate regulations in the nation’s history, a rule designed to ensure that the majority of new passenger cars and light trucks sold in the United States are all-electric or hybrids by 2032…
The rule increasingly limits the amount of pollution allowed from tailpipes over time so that, by 2032, more than half the new cars sold in the United States would most likely be zero-emissions vehicles in order for carmakers to meet the standards.”

About healthcare IT

 Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates This OCR update is worth reading. In summary: “Regulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of PHI to tracking technology vendors or any other violations of the HIPAA Rules. For example, disclosures of PHI to tracking technology vendors for marketing purposes, without individuals’ HIPAA-compliant authorizations, would constitute impermissible disclosures.”

Today's News and Commentary

About health insurance/insurers

 Highmark Health hits $27B in revenue and net income exceeds half-billion following layoffs “Highmark Health recorded $27.1 billion in revenue and a net income of $533 million for 2023, the company announced during its fourth-quarter results Monday.
The company reported an operating margin of $338 million, though there was an operating loss of of $117 million during 2023 for the Allegheny Health Network as the system recovers from the pandemic. That was offset by gains seen in health insurance and other investments.”

 About pharma

 Kroger to sell specialty pharmacy business to Elevance Health's CarelonRx  “Grocer Kroger said on Monday it had entered a definitive agreement for the sale of its specialty pharmacy business to CarelonRx, a unit of U.S. health insurer Elevance Health .
The financial terms of the deal were not disclosed…
Kroger Specialty Pharmacy is separate from other Kroger Family of Pharmacies, including in-store retail pharmacies and The Little Clinics, which are not included in the deal.”

AstraZeneca to pay $2B to buy radiopharmaceuticals partner “AstraZeneca is making its first major purchase in the radiopharmaceuticals space, forking out around $2 billion to buy Fusion Pharmaceuticals and its pipeline of assets based on actinium-225. The companies first joined forces in 2020 to develop next-generation alpha-emitting radiopharmaceuticals and combination therapies for the treatment of cancer.”

AstraZeneca to cap out-of-pocket inhaler costs in US, following rival Boehringer's move “Drugmaker AstraZeneca (AZN.L), opens new tab said on Monday it would cap out-of-pocket costs for its inhaled respiratory products at $35 per month in the United States from June, following a similar move by rival Boehringer Ingelheim earlier in the month.”

Online sales begin for first over-the-counter birth control pill in US “Online sales began Monday for the first over-the-counter birth control pill approved in the U.S. 
The product, Opill, can be bought online at Amazon and directly from Opill.com, said Sara Young, senior vice president and chief consumer officer at Perrigo, the pill’s manufacturer. Once the drugs are in stock, Walgreens and Walmart will sell them online, as well. Orders will be fulfilled within 24 to 48 hours, according to Young, and will usually arrive in three to five business days.”

About the public’s health

After calling on Congress to fund women's health, Biden directs agencies to boost R&D “Ten days after asking Congress to fund women’s health research with $12 billion, President Joe Biden is doing what he can to boost investment via an executive order to expand and improve research on women’s health.
The orders come with 20 new actions across federal agencies such as the Department of Health and Human Services, under which the FDA sits. Within the actions is a $200 million National Institutes of Health initiative for fiscal year 2025 to fund new women’s health research. This would be the first step in the call to action issued by Biden at the State of the Union on March 8.”

8-hour time-restricted eating linked to a 91% higher risk of cardiovascular death Research Highlights:

  • A study of over 20,000 adults found that those who followed an 8-hour time-restricted eating schedule, a type of intermittent fasting, had a 91% higher risk of death from cardiovascular disease.

  • People with heart disease or cancer also had an increased risk of cardiovascular death.

  • Compared with a standard schedule of eating across 12-16 hours per day, limiting food intake to less than 8 hours per day was not associated with living longer.”

CDC urges vaccination amid rise in measles cases in the US and globally “US health officials are warning doctors about the dramatic rise in measles cases around the world, and advising families traveling to a measles-affected country to get babies as young as 6 months vaccinated before they go.”

About healthcare IT

STATE OF CPS SECURITY REPORT Healthcare 2023 “The Cybersecurity and Infrastructure Security Agency (CISA) maintains a growing catalog of Known Exploited Vulnerabilities (KEVs). KEVs that exist on hospital networks are particularly alarming, because
these exposures have exploits written to compromise them, and are therefore easily compromisable. 63% of KEVs tracked by CISA can be found on healthcare networks, while 23% of medical devices—including imaging devices, clinical IoT devices, and surgery devices—have at least one known exploited vulnerability. Complicating matters is that users must contend with 360 medical device manufacturer (MDM) patch certification programs to ensure compliance requirements and verify that products provide reasonable protection against risk…
[For example:] From our research, 4% of devices used in surgeries can be accessible via a hospital’s guest network.”

The new era of consumer engagement: Insights from Rock Health’s ninth annual Consumer Adoption Survey A great summary of consumer preferences for IT use.

Today's News and Commentary

About health insurance/insurers

 From today’s STAT newsletter re: UnitedHealth’s loan program due to the Change hack: “Eleven providers and provider lobbying groups told [STAT that] UnitedHealth was handing out minuscule amounts in its initial loan program. Many loans were in the three-figure range. Mike Gebhart, CFO of Highlands Oncology Group in Arkansas, told [STAT] his practice was offered $59,000 — less than 1% of the $7 million per week in claims the group normally gets. But UnitedHealth has since rolled out another program, where providers tell the company what their shortfall is. Gebhart got a loan offer that he described as ‘exactly what we needed.’”
In a related post: UnitedHealth has paid out $2B in advanced payments following cyberattack “In its latest update on the response to the cyberattack on Change Healthcare, UnitedHealth Group said that it will begin today to release medical claims preparation software, a move it says is a critical step in restoring services.
The software will be rolled out to thousands of customers in the next several days, according to the announcement. UHG said that it intends to have third-party attestations available before services are fully online.”

Medicare Payment Policy [March, 2024 MedPAC report] An excellent summary of current status and recommendations for the Medicare program. For example: “We estimate that Medicare spends 22 percent more for [Medicare Advantage] enrollees than it would spend if those beneficiaries were enrolled in [traditional] Medicare, a difference that translates into a projected $83 billion in 2024 … the many iterations of full-risk contracting with private plans have never yielded aggregate savings for the Medicare program.”
Absolutely worth a least a skim.

About pharma

 The top 10 pharma R&D budgets for 2023  FYI Merck earned the top spot with $30.53 billion.

About the public’s health

Toxic asbestos is now fully banned, a move that EPA calls ‘historic’ “ The Environmental Protection Agency on Monday finalized a ban on chrysotile asbestos, part of a family of toxic minerals linked to lung cancer and other illnesses that the agency estimates is responsible for about 40,000 U.S. deaths each year.
The federal ban comes more than 30 years after EPA first tried to rid the nation of asbestos, but was blocked by a federal judge. While the use of asbestos in manufacturing and construction has declined since, it remains a significant health threat.”

National HIV self-testing program finds high demand, many testing for first time “…from March 2023 to December 2023…181,558 orders were placed — most (86%) for two tests — and a total of 337,812 tests were shipped.
Sixty percent of orders included enough information to describe people ordering the tests in terms of priority populations: 61% were men who reporting having sex with male partners in the previous 12 months — 18% Black and 33% Hispanic — 10.7% were gender diverse people and 10% were Black women.
Most participants (62%) ordered tests through messages and in-app buttons in the Grindr app — seven out of 10 orders were placed through a social media or dating app — and most people who ordered tests either had never had an HIV test (26%) or did not have a test in more than 12 months (27%).”

About healthcare personnel

Nurses report wage, staffing dissatisfaction but most say they'll stick around until retirement, report finds  “…nearly a quarter of nurses say they are very likely to leave their role this year. Though nurses are slightly less dissatisfied with current staffing levels compared to 2023, 88% believe that patient care is being negatively impacted by staffing shortages. More than half of nurses (63%) are assigned to care for too many patients at a time. Nearly a quarter reported they were required to perform tasks outside of their job description due to staffing shortages.”

NRMP® Celebrates Match Day for the 2024 Main Residency Match®, Releases Results for Over 44,000 Applicants and Almost 6,400 Residency Programs FYI. Concerns remain about primary care numbers.

Today's News and Commentary

About health insurance/insurers

 ‘Site-neutral’ payments for chemotherapy could save Medicare billions “At issue is how Medicare pays for drugs delivered by medical providers, such as chemotherapy for cancer or infusions used to treat autoimmune diseases. Under current law, Medicare pays two to three times as much for these treatments if they are given in a hospital rather than a doctor’s office. The medicines and the means of administering them are the same; only the price is different.”
The savings would be more than $3.7 billion over the next decade, according to the Congressional Budget Office. And beneficiaries’ co-payments would go down, too — by $40 a visit. The next thing that needs to happen is for the Senate to follow [the House’s vote that passed the measure].”

About the public’s health

California lawmaker introduces bill to remove artificial dyes from cereals, baked goods and other foods served in school “Assembly Bill 2316 would prohibit school cafeterias from offering foods containing six artificial food dyes that have been linked to hyperactivity and behavioral issues in some children. It would also outlaw titanium dioxide, a whitening agent used in candies and other products that is banned by the European Union because of concerns that it is potentially genotoxic, meaning it may damage DNA and cause cancer.
The bill, which was first shared with NBC News, would affect certain cereals, condiments and baked goods, among other foods, and it would make California the first state to ban the additives from schools. It was introduced by Democratic Assemblymember Jesse Gabriel.”

Global, regional, and national burden of disorders affecting the nervous system, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021Globally, the 37 conditions affecting the nervous system were collectively ranked as the leading group cause of DALYs in 2021 (443 million, 95% UI 378–521), affecting 3·40 billion (3·20–3·62) individuals (43·1%, 40·5–45·9 of the global population); global DALY counts attributed to these conditions increased by 18·2% (8·7–26·7) between 1990 and 2021. Age-standardised rates of deaths per 100 000 people attributed to these conditions decreased from 1990 to 2021 by 33·6% (27·6–38·8), and age-standardised rates of DALYs attributed to these conditions decreased by 27·0% (21·5–32·4). Age-standardised prevalence was almost stable, with a change of 1·5% (0·7–2·4). The ten conditions with the highest age-standardised DALYs in 2021 were stroke, neonatal encephalopathy, migraine, Alzheimer's disease and other dementias, diabetic neuropathy, meningitis, epilepsy, neurological complications due to preterm birth, autism spectrum disorder, and nervous system cancer.”

About healthcare IT

Why UnitedHealth, Change Healthcare were targeted by ransomware hackers, and more cybercrime will hit patients, doctors  “Cybersecurity researcher Jeremiah Fowler said on the dark web, medical records sell for $60 compared to $15 for a Social Security number and $3 for a credit card. Compounding that is the fact that there’s a chronic shortage of staffing, and as the Change Healthcare uproar has shown, there’s tremendous pressure to restore access quickly.”

UnitedHealth: Change's Pharmacy Network is back online “The company said Wednesday that all of its major pharmacy and payment systems are up again and "99% of pre-incident claim volume is flowing." The cyberattack was first announced on Feb. 21, and has caused major disruption in claims processing nationwide over the past three weeks.”

Today's News and Commentary

About Covid-19

On 4-year anniversary of the WHO declaring COVID a pandemic, a look at the virus by the numbers “Since the pandemic began, more than 1.18 million Americans have died from COVID-19, according to CDC data. The U.S. crossed the 1 million markon May 12, 2022.
During the week of March 2, there were 576 weekly deaths, which is the lowest number recorded since summer 2023 and several times lower than the peak of 25,974 weekly deaths recorded the week ending Jan. 9, 2021.”

About hospitals and healthcare systems

 Change Healthcare attack costing hospitals $2B a week: Report “Provider claims to payers have dropped by more than a third in the wake of the Change Healthcare cyber attack, according to a March 13 news release from Kodiak Solutions. 
Kodiak's revenue cycle analytics software monitors patient financial transactions from more than 1,850 hospitals and 250,000 physicians nationwide.
The cash flow effects of those delayed claims have ranged from $1.84 billion in the first week to $2.53 billion in the lastest full week when compared with the average weekly estimated cash value of claims from Jan. 1 through Feb. 17, according to the release. Change Healthcare, which processes 1 in 3 healthcare claims in the U.S., was hacked by a ransomware group on Feb. 21.
Through March 9, the total estimated cash flow impact for hospitals reporting data to Kodiak is $6.3 billion in delayed payments, according to the release.”

About pharma

 AstraZeneca inks $800M buyout of French biotech to snag phase 3 rare disease drug “AstraZeneca is paying $800 million to expand into rare endocrinology, snagging itself a phase 3 candidate through the acquisition of French biotech Amolyt Pharma. The deal features $250 million in milestones tied to a regulatory event.
Buying Amolyt will give AstraZeneca control of eneboparatide, a PTHR1 agonist that the biotech moved into phase 3 in June. Eneboparatide is designed to produce sustained and stable levels of calcium, which falls to low levels in patients with hypoparathyroidism, while preventing kidney disease and restoring bone turnover.”

Appeals court affirms Arkansas law against drugmakers' 340B contract pharmacy restrictions “A federal appellate court upheld an Arkansas law prohibiting drugmakers from restricting 340B drug discounts for providers using contract pharmacies, potentially setting up other states to pass similar legislation.
The ruling was handed down Tuesday by the U.S. Court of Appeals for the Eighth Circuit’s three-judge panel. The judges disagreed with a pharmaceutical industry group’s argument that Arkansas’ 340B Drug Pricing Nondiscrimination Act passed in 2021 is preempted by existing federal law outlining the program, which requires drug manufacturers to sell drugs at a discount to safety-net providers.”
 

About the public’s health

Maternal mortality in the United States: are the high and rising rates due to changes in obstetrical factors, maternal medical conditions, or maternal mortality surveillance? “The high and rising rates of maternal mortality in the United States are a consequence of changes in maternal mortality surveillance, with reliance on the pregnancy checkbox leading to an increase in misclassified maternal deaths. Identifying maternal deaths by requiring mention of pregnancy among the multiple causes of death shows lower, stable maternal mortality rates and declines in maternal deaths from direct obstetrical causes.” 

GE HealthCare launches philanthropic foundation aimed at maternal health “GE HealthCare has set up its own philanthropic arm and given it the goal of helping to bring precision medicine to underserved communities, with a first focus on improving maternal mortality.
The company pointed to a recent report from the United Nations and World Health Organization showing that a person dies every two minutes due to pregnancy or childbirth and that statistics have estimated about 287,000 maternal deaths worldwide in 2020.
Incorporated as a separate charitable organization, the GE HealthCare Foundation will also work to address an international shortage of primary care clinicians, nurses and midwife professionals.”

About healthcare IT

The buzz at HIMSS '24? 6 takeaways FYI

Europe one step away from landmark AI rules after lawmakers' vote  “The legislation will regulate high-impact, general-purpose AI models and high-risk AI systems which will have to comply with specific transparency obligations and EU copyright laws.
It restricts governments' use of real-time biometric surveillance in public spaces to cases of certain crimes, prevention of genuine threats, such as terrorist attacks, and searches for people suspected of the most serious crimes.”

Microsoft, 16 health systems to operationalize AI under new partner network “Sixteen health systems, Microsoft and other healthcare technology organizations are the latest to band together and hammer out best practices and standards for AI in care.
Calling itself the Trustworthy & Responsible AI Network (TRAIN), the latest provider-tech AI collaboration aims to improve the quality and trustworthiness of novel AI capabilities coming to healthcare.”

About health technology

A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening In the quest for “liquid” biopsies and diagnoses, avoidance of colonoscopy has high priority. The results of this technology show: “In an average-risk screening population, this cfDNA blood-based test had 83% sensitivity for colorectal cancer, 90% specificity for advanced neoplasia…” However, it only had “13% sensitivity for advanced precancerous lesions,” meaning it wasn’t that good at early detection.

Today's News and Commentary

About Covid-19

COVID-19 Rebound After VV116 vs Nirmatrelvir-Ritonavir Treatment “Viral load rebound and symptom rebound are both common and not significantly different after a standard 5-day course of treatment with either VV116 or nirmatrelvir-ritonavir for mild-to-moderate COVID-19.”

About health insurance/insurers

Primary Care Physicians In Medicare Advantage Were Less Costly, Provided Similar Quality Versus Regional Average “Assessing primary care physician costliness based on the gap between observed and predicted costs for their traditional Medicare patients, we found that the average primary care physician in MA networks was $433 less costly per patient (2.9 percent of baseline) compared with the regional mean, with less costly primary care physicians included in more networks than more costly ones. Favorable selection of patients by MA primary care physicians contributed partially to this result. The quality measures of MA primary care physicians were similar to the regional mean. In contrast, primary care physicians excluded from all MA networks were $1,617 (13.8 percent) costlier than the regional mean, with lower quality. Primary care physicians in narrow networks were $212 (1.4 percent) less costly than those in wide networks, but their quality was slightly lower. These findings highlight the potential role of selective contracting in reducing costs in the MA program.”

Medicare Index Report for 2024 Coverage “Highlights
--Average premium for Medicare Advantage plans is unchanged year over year: $9 is the average monthly premium among Medicare Advantage selected by eHealth customers during the AEP for 2024 coverage, a figure unchanged from the previous year.

--Demand for $0-premium Medicare Advantage plans is stable: For the second year in a row, 84% of those selecting Medicare Advantage plans at eHealth during AEP chose plans with a $0 monthly premium.

--Average deductible for Medicare Advantage plans drops below $100: For the first time since eHealth began tracking it, the average annual deductible for Medicare Advantage plans selected by eHealth customers during AEP fell below $100 (to $95).

--Average Part D plan premium is down but average deductible is up: $29 is the average monthly premium for stand-alone Medicare Part D plans selected by eHealth customers during AEP, down 9% from the year prior ($32); meanwhile the average deductible for Part D plans increased 14%, from $389 to $445.

--Average premium for Medicare Supplement plans is up this year: Though enrollment in Medicare Supplement (Medigap) plans is not governed by AEP, the average premium for plans selected by eHealth customers during this period is up 9% year over year, from $173 to $189 per month.”

About pharma

The efficacy of GLP-1s, compared FYI

Eli Lilly partners with Amazon Pharmacy for home delivery of its weight loss, diabetes and migraine drugs “Eli Lilly is partnering with Amazon's pharmacy unit to offer home delivery for diabetes, migraine and obesity medications, including GLP-1 weight loss drug Zepbound.
The drugmaker launched its direct-to-consumer service, LillyDirect, in January to provide consumers access to telehealth and pharmacy services and the ability to get some medications directly from the company via online pharmacies.
Lilly selected Aazon Pharmacy to serve as a third-party dispensing provider for LillyDirect Pharmacy Solutions, delivering prescribed Lilly medications directly to a patient’s home, according to an Amazon Pharmacy blog post.” 

About the public’s health

 Adolescent Δ8-THC and Marijuana Use in the US “In this nationally representative 2023 survey, 11.4% of 2186 US 12th-grade students self-reported Δ8-THC use and 30.4% self-reported marijuana use in the past year. Δ8-THC use prevalence was higher in the South and Midwest US and in states without legal adult-use marijuana or Δ8-THC regulations. Marijuana use prevalence did not differ by cannabis policies.” 

About healthcare IT

 FBI Internet Crime Report 2023 Once again, healthcare entities top the list of targeted organizations.

Today's News and Commentary

Breaking down Biden's $7.3T proposed budget for 2025: Here are his top health priorities Good summary of budget allocations for healthcare.

About hospitals and healthcare systems

Healthgrades Announces 2024 Top Hospitals in Patient Experience and Patient Safety FYI

About pharma

 US proposes scrapping biosimilar interchangeability requirement “In an effort to boost uptake of biosimilars in the US, the government’s budget for 2025 includes a provision that would allow substitution without the need for an interchangeable designation from the FDA. According to the budget documents, the move would ‘deem all approved biosimilars to be interchangeable with their respective reference products.’”

About the public’s health

 WHO HIV drug resistance – brief report 2024 “Levels of observed DTG resistance in real world populations receiving ART appear to be higher than anticipated from clinical trials. WHO recommends that countries routinely implement standardised surveillance of HIVDR to follow the prevalence and patterns of resistance among people not achieving suppressed viral load.”

About healthcare IT

 Healthcare continues to make gains in data exchange with 49% jump in electronic prior authorization “At the end of 2023, 1.29 million prescribers were using e-prescribing, a nearly 5% increase from 2022, and 83.2% of these clinicians were also enabled for electronic prescribing for controlled substances (EPCS), according to Surescripts' latest national progress report…”

Today's News and Commentary

About quality and safety

Top 10 Patient Safety Concerns 2024  “The [ECRI] List for 2024

1. Challenges Transitioning Newly Trained Clinicians from Education into Practice

2. Workarounds with Barcode Medication Administration Systems

3. Barriers to Access Maternal and Perinatal Care

4. Unintended Consequences of Technology Adoption

5. Decline in Physical and Emotional Well-Being of Healthcare Workers

6. Complexity of Preventing Diagnostic Error

7. Providing Equitable Care for People with Physical and Intellectual Disabilities

8. Delay in Care Resulting from Drug, Supply, and Equipment Shortages

9. Misuse of Parenteral Syringes to Administer Oral Liquid Medications

10. Ongoing Challenges with Preventing Patient Falls”

About health insurance/insurers

Medicare announces emergency funds for doctors affected by Change Healthcare hack “Federal health officials on Saturday said they would offer emergency funding to physicians, physical therapists and other professionals that provide outpatient health care, following a cyberattack that crippled the nation’s largest processor of medical claims and left many organizations in financial distress.
The Centers for Medicare and Medicaid Services also announced that it would make advance payments available to suppliers that bill through Medicare Part B, which serves a wide array of health-care organizations.”

United’s surreptitious surgery center buying spree “UnitedHealth Group is so big that it doesn’t have to publicly announce a vast majority of its acquisitions. But a STAT analysis of company financial documents shows the health care conglomerate quietly acquired dozens of outpatient facilities in 2023, with a particular focus on surgery centers. 
And it’s not adding random surgery centers, either. There seems to be an explicit strategy: Many of UnitedHealth’s new centers sit in geographic areas where the company is the biggest Medicare Advantage player, based on the latest insurance market share data. That overlap reinforces how UnitedHealth is looking to funnel more of its insurance members toward providers that it owns, with the overarching goal of capturing more profit.
One of the biggest undisclosed transactions came this past December, when UnitedHealth bought National Cardiovascular Partners from Fresenius Medical Care. The only mention of NCP is buried within UnitedHealth’s annual report for investors, where the company listed “NCP Investment Holdings, Inc.” as a new subsidiary. Fresenius confirmed to its investors in January that it sold NCP, which operates 21 cardiac cath and vascular labs. But Fresenius never disclosed the buyer and erased NCP information from its website. And wouldn’t ya know it: NCP’s facilities are located in places like Phoenix and large metro areas in Texas where UnitedHealth has the biggest MA market share.”

 CBO’s Approach to Estimating the Budgetary Effects of the No Surprises Act of 2021 “In CBO’s estimation, prohibiting surprise billing:
 Reduces insurers’ spending for previously covered out-of-network care;
 Increases spending on previously uncovered out-of-network services—both directly (by increasing what is covered) and indirectly (because patients consume more care); and
 Reduces negotiated prices for all in-network care. Setting the benchmark amount for payment disputes at the median in-network rate reduces in-network prices.”

Tunneling and Hidden Profits in Health Care “This study examines “tunneling” practices through which health care providers covertly extract profitby making inflated payments for goods and services to commonly-owned related parties. While incentivesto tunnel exist across sectors, health care providers may find it uniquely advantageous to do so. Maskingprofits as costs, thereby obscuring true profitability, may dissuade regulators from imposing stricterquality standards and encourage public payers to increase reimbursement rates. Likewise, tunnelingeffectively “shields” assets from malpractice liability risk, by moving them off the firm’s balance sheet.Using uniquely detailed financial data on the nursing home industry, we apply a difference-in-differencesapproach to study how firms’ stated costs change when they start transacting with a related party,allowing us to infer by how much these payments are inflated. We find evidence of widespread tunnelingthrough inflated rents and management fees paid to related parties. Extrapolating these markups to allfirms’ related party transactions, our estimates suggest that in 2019, 63% of nursing home profits werehidden and tunneled to related parties through inflated transfer prices.”
Comment: This research raises n important issue in evaluating insurance company medical loss ratios. If a company creates a related subsidiary and pays excess fees, the higher MLR will protect it from penalties.
This issue was discussed in a paper last year from USC- Brookings:Medicare Advantage spending, medical loss ratios, and related businesses: An initial investigation. The authors found: “Transfer prices among related parties for multi-entity health care enterprises are typically not publicly available…. the increased health cost spending reduces profits from MA business, but transactions with related parties can still represent profits to the parent company, especially if higher transfer prices allow the plans to evade the MLR regulations.” The authors estimates this effect over several years.

About hospitals and healthcare systems

From -6.8% to 12.2%: 34 health systems ranked by operating margins FYI

Hackensack Meridian hospitals first to attain Joint Commission's new sustainability certification “Four Hackensack Meridian Health (HMH) hospitals are the first in the country to achieve the Joint Commission’s sustainable healthcare certification. 
The voluntary program for hospitals went into effect at the start of this year and provides a framework to help organizations tackle decarbonization efforts. Attaining the certification means the hospitals have met rigorous standards and elements of performance to accelerate the sector’s sustainability efforts, according to a joint press release.”

About pharma

The top 10 drugs losing US exclusivity in 2024 FYI

Colorado isn’t giving up on its drug importation dream “The FDA has rebuffed Colorado’s appeals for help with its drug importation plan.”

About the public’s health

 Except for flu, US respiratory virus levels continue to ebb “Last week, 20 jurisdictions reported high or very high respiratory illness activity, down from 26 the previous week, the CDC said in its latest respiratory virus snapshot. Emergency department visits for flu, COVID, and respiratory syncytial virus (RSV) all declined last week.” 

Measles outbreak threatens US status of ‘eliminating’ virus “The rash of measles outbreaks around the country has sparked concerns that the U.S. risks losing its status as a country where the disease has been eliminated, a distinction held since 2000.
As of last week, 41 measles cases have been confirmed across 15 states and New York City, according to the Centers for Disease Control and Prevention (CDC). That puts the nation already on track to surpassing the 58 total cases that were detected in 2023.”

Today's News and Commentary

Remarks of President Joe Biden — State of the Union Address As Prepared for Delivery This link is to the entire speech.
Biden's State of the Union: 13 healthcare takeaways A good summary of the health topics in the speech.

Large health system vs. payer profits in 2023 FYI

About health insurance/insurers

Cigna to help health plans limit costs amid boom in weight-loss drugs “Cigna's Evernorth unit will offer its clients a guarantee that it will limit annual increases in GLP-1 drug costs at 15%, a spokesperson said. The company aims to achieve this through various measures, including helping people with obesity and diabetes get lifestyle modification and coaching support.
Evernorth will also take on a financial risk with the guarantee, the spokesperson said.
This, in turn, would help ensure access to the drugs for appropriate patients, according to Cigna.”

What to Know About How Medicare Pays Physicians The following is a summary of the latest changes: “The 3.4% decrease to the conversion factor finalized for 2024 reflects the following adjustments to these three factors: (1) a -2.18% budget neutrality adjustment, (2) a 0% statutory increase under MACRA for 2024, and (3) -1.25% reduction in temporary payments provided by Congress for 2024 under the Consolidated Appropriations Act of 2023.
The combined impact of these changes is a -1.25% decrease in overall payments under the physician fee schedule relative to 2023, according to CMS. Payment changes are expected to vary by specialty, however. For example, clinicians most directly impacted by service-specific changes, such as those in primary care and behavioral health, are projected to see a net increase in payments, while clinicians in radiology, physical and occupational therapy, and some surgical specialties are projected to see the largest net decrease.
Congress is expected to vote on pending legislation which would mitigate the 3.4% decrease to the fee schedule conversion factor, a change which is expected to result in a modest increase to physician payment rates across all specialties, relative to current law.”
Comment: This monograph is an excellent source of information about the history and methodology behind Medicare physician payments.

About hospitals and healthcare systems

 UnitedHealth offers timeline on restoring Change Healthcare's key systems “nitedHealth Group late Thursday detailed a timeline for restoring Change Healthcare's systems, which have been down for more than two weeks following the cyberattack.
The company noted that electronic prescribing services were previously restored, and that claim submission and payment transmission services were restored as of Thursday. It added that it had taken steps to ensure patients could access prescriptions in the meantime, such as having Optum Rx pharmacies send out the medications based on the date.
Change's electronic payment functionality will be back online March 15, UHG said, and it expects to begin testing connectivity to claims network and software beginning March 18. It expects to restore service that week.”

About pharma

F.D.A. Delays Action on Closely Watched Alzheimer’s Drug “Eli Lilly’s donanemab was expected to be approved this month, but the agency has decided to convene a panel of independent experts to evaluate the drug’s safety and efficacy.” 

Mark Cuban's drug company inks first health system partnership to sell directly to Community Health Systems “Mark Cuban Cost Plus Drug Company has found its first national health system buyer for hospital drugs currently in short supply.
Franklin, Tennessee-based for-profit Community Health Systems has signed onto a partnership with the billionaire-backed manufacturer to purchase pharmaceuticals like epinephrine and norepinephrine for its affiliate hospitals in Texas and Pennsylvania. The products are often used in emergency departments and intensive care units, with epinephrine currently listed on the Food and Drug Administration’s list of ongoing drug shortages.”

Gilead, Merck & Co.’s oral once-weekly HIV therapy maintains viral suppression “Results for the primary endpoint showed that at week 24, only one participant in the Sunlenca-islatravir group had a viral load >50 copies/mL which was subsequently suppressed by week 30, whereas none of the Biktarvy-treated participants exceeded this threshold. Meanwhile, participants switched to the Sunlenca-islatravir combination maintained high rates of HIV suppression at week 24 comparable to Biktarvy, with rates of 94.2% in both the groups.
In terms of safety, there were no occurrences of serious adverse events in either of the groups. Gilead and Merck noted that the trial will continue through week 48, with longer-term data expected to be presented at future scientific conferences.”

Novo Nordisk's Wegovy wins FDA nod for heart health benefits “US regulators have approved a label expansion for Novo Nordisk's weight-loss drug Wegovy (semaglutide) to include reduced risk of major adverse cardiovascular events (MACE), including heart attacks and strokes. The decision could potentially broaden insurance coverage for the GLP-1 agonist and similar treatments for obesity.”

About healthcare IT

 Charges for emails with doctors and other healthcare providers “The typical cost for an email messaging claim was $39 in 2021, including both the portion paid by insurance and that paid by patients. Although the health plan covered the full cost for most of these claims (82%), those patients with at least some out-of-pocket costs typically paid $25.” 

About healthcare personnel

 Projecting Health Workforce Supply and Demand An excellent source of information from HRSA. One of the main findings is: “Over the next 15 years (through 2036), NCHWA projects an overall shortage of 139,940 physicians.” This number includes about 68,000 primary care physicians. 

Today's News and Commentary

About health insurance/insurers

 NeueHealth reports a nearly quarter-billion net loss during Q4 earnings “NeueHealth posted a $242 million net loss during its fourth-quarter earnings March 6, as the insurtech attempts to turn a corner after a tumultuous 2023.
The company recorded a net loss of $1.2 billion last year, but it achieved $292 million in revenue last quarter, up 29% year-over-year, and $1.2 billion in full-year consolidated revenue, a 55% increase year-over-year. Earnings per share came in at a loss of $30.47, though that jumps to $19.54 in the black once it excluded discontinued operations.
NeueHealth rebranded from Bright Health in January, attempting to put its past troubles in the rearview mirror.”

About hospitals and healthcare systems

UPMC reports almost $200M operating loss as expenses rise “Pittsburgh-based UPMC, a 40-hospital system, has reported a 2023 operating loss of $198.3 million (-0.7% operating margin) on revenue of $27.7 billion. 
Those figures compare with a $162.1 million operating gain on revenue of $25.5 billion in 2022. Expenses in 2023, totaling $27.9 billion, were approximately 10% up on 2022. That included a 13.6% jump in insurance claims expenses. 
The healthcare system's measure of inpatient activity grew 3% over the previous year while average outpatient revenue per workday rose 10% and average physician revenue per weekday grew by 9%.”

Mayo Clinic closed out 2023 with $18B in revenue, 6% operating margin “Rochester, Minnesota-based Mayo Clinic reported revenue of $17.9 billion in 2023, outpacing expenses by over $1 billion and resulting in what the health system called a “mission-sustaining” 6% operating margin.
The revenue figure, which compared with $16.3 billion in 2022, included investments totaling $536 million which were used to support current operating activities, the health system recently reported in financial disclosures.
The organization saw its net medical service revenue grow 8.8% year over year to $15.1 billion.
Though revenue outpaced expenses, the health system's expenses were up 7.4% compared to 2022, totaling $16.9 billion for the year. Mayo Clinic said it welcomed 14,000 new staffing roles into the system in 2023, up almost 5% from 2022.”

Trauma Center Hospitals Charged Higher Prices For Some Nontrauma Care Than Non–Trauma Center Hospitals, 2012–18 “Hospitals serving as trauma centers are often endowed by regulators with monopoly power over trauma services in their geographic areas, and this monopoly power may spill over to nontrauma services. This study focused on the growing number of designated trauma centers and how trauma center status affects hospital prices for other, nontrauma services. We found that hospitals designated as trauma centers charged higher prices for nontrauma inpatient admissions and nontrauma emergency department visits when compared with hospitals that were not designated as trauma centers, even after controlling for potential confounders.” 

About pharma

 Drugmakers take Biden health-care win to court today “A federal judge in New Jersey accepted Bristol Myers Squibb, Novo Nordisk, Novartis and Johnson & Johnson’s request to present oral arguments jointly, citing the “overlapping nature” of their claims. Notably, each defendant manufactures one of the 10 drugs selected for Medicare’s inaugural round of price negotiations.”

Another day, another win for Novo in obesity, as early oral med appears to beat Wegovy “Novo Nordisk appears to have blown its own drug Wegovy out of the water. The Danish pharma reported early results for a next-gen oral weight loss drug called amycretin, showing 13.1% weight loss after 12 weeks.
Reporting the early phase 1 results during a capital markets day Thursday, Novo was sparse on details but still generated significant excitement.
Amycretin is a GLP-1 and amylin receptor agonist that Novo is hoping will show additive benefits with a differentiated mode of action from its comparable GLP-1 drug semaglutide, marketed as Wegovy for weight loss and Ozempic for diabetes. The therapy is dosed once daily—which could prove to be a huge improvement over the weekly injections of Wegovy and competitor Zepbound, which is marketed by Eli Lilly.”

Medicare Part D Plans Greatly Increased Utilization Restrictions On Prescription Drugs, 2011–20 “We examined trends in the prevalence of utilization restrictions on non-protected-class compounds in Medicare Part D plans during the period 2011–20, including prior authorization and step therapy requirements as well as formulary exclusions. Part D plans became significantly more restrictive over time, rising from an average of 31.9 percent of compounds restricted in 2011 to 44.4 percent restricted in 2020. The prevalence of formulary exclusions grew particularly fast: By 2020, plan formularies excluded an average of 44.7 percent of brand-name-only compounds. Formulary restrictions were more common among brand-name-only compared with generic-available compounds, among more expensive compounds, and in stand-alone compared with Medicare Advantage prescription drug plans.”

Boehringer Ingelheim to cap asthma inhaler out-of-pocket costs at $35 “Facing criticism over its pricing, Boehringer Ingelheim plans to cap out-of-pocket costs at $35 a month for its entire line of inhalers that are used to combat asthma and chronic obstructive pulmonary disease.
The program, which begins on June 1, is directed at Americans with commercial health insurance, but also at those who lack insurance and, therefore, must pay cash for their inhalers. In taking this step, the company cast its efforts as a bid to assist ‘vulnerable’ patients at a time when an increasing number of people are complaining about the cost of prescription drugs.”

About the public’s health

Do the associations of daily steps with mortality and incident cardiovascular disease differ by sedentary time levels? A device-based cohort study “Any amount of daily steps above the referent 2200 steps/day was associated with lower mortality and incident CVD risk, for low and high sedentary time. Accruing 9000–10 500 steps/day was associated with the lowest mortality risk independent of sedentary time. For a roughly equivalent number of steps/day, the risk of incident CVD was lower for low sedentary time compared with high sedentary time.” 

Cancer-causing chemical found in Clinique, Clearasil acne treatments, US lab reports “High levels of cancer-causing chemical benzene were detected in some acne treatments from brands including Estee Lauder's Clinique, Target's Up & Up and Reckitt Benckiser-owned Clearasil, said independent U.S. laboratory Valisure.
Valisure has also filed a petition with the U.S. Food and Drug Administration, calling on the regulator to recall the products, conduct an investigation and revise industry guidance, the New Haven, Connecticut-based lab said on Wednesday.”

Plastics, Fossil Carbon, and the Heart “In this issue of the [New England Journal of Medicine], the results of the prospective study by Marfella et al. on the asso- ciation of microplastics and nanoplastics with cardiovascular outcomes further expand our understanding of the health hazards posed by plastics. This study, which included 312 patients who underwent carotid endarterectomy, showed that microplastics and nanoplastics were detect- able in the excised plaque of 58% of the patients. The presence of microplastics or nanoplastics in carotid artery plaque was associated with a sub- sequent risk of nonfatal myocardial infarction, nonfatal stroke, or death from any cause that was 2.1 times that in patients whose plaques did not contain microplastics or nanoplastics. Patients with microplastics or nanoplastics in their plaque tissue also had elevated expression of circulating inflammatory markers…
Previous investigations have detected micro- plastics and nanoplastics in multiple tissues, including colon, placenta, liver, spleen, and lymph node tissues. Animal studies indicate that micro- plastics and nanoplastics can cause toxic effects at multiple sites, potentially by inducing oxidative stress…
What can physicians and other health professionals do? The first step is to recognize that the low cost and convenience of plastics are deceptive and that, in fact, they mask great harms, such as the potential contribution by plastics to outcomes associated with atherosclerotic plaque. We need to encourage our patients to reduce their use of plastics, especially unnecessary single-use items. We need to inventory our own and our institutions’ use of plastics and identify areas for reduction. We need to express our strong support for the United Nations Global Plastics Treaty. We need to argue for inclusion in the treaty of a mandatory global cap on plastic production, with targets and timetables, restrictions on single-use plastics, and comprehensive regulation of plastic chemicals.”

Today's News and Commentary

Issue Request for Public Input as Part of Inquiry into Impacts of Corporate Ownership Trend in Health Care “The Justice Department’s Antitrust Division, Federal Trade Commission (FTC) and Department of Health and Human Services (HHS) jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over health care.
Private equity firms and other corporate owners are increasingly involved in health care system transactions and, at times, those transactions may lead to a maximizing of profits at the expense of quality care. The cross-government inquiry seeks to understand how certain health care market transactions may increase consolidation and generate profits for firms while threatening patients’ health, workers’ safety, quality of care and affordable health care for patients and taxpayers.
The agencies issued a Request for Information (RFI) requesting public comment on deals conducted by health systems, private payers, private equity funds and other alternative asset managers that involve health care providers, facilities or ancillary products or services. The RFI also requests information on transactions that would not be reported to the Justice Department or FTC for antitrust review under the Hart-Scott-Rodino Antitrust Improvements Act.”

About Covid-19

A reminder:
USPS will stop accepting orders for free COVID tests on March 8 “Two government-run efforts to distribute free COVID-19 tests and to offer free courses of Pfizer's Paxlovid antiviral are set to end Friday, as trends of the virus have largely slowed.
The Administration for Strategic Preparedness and Response, or ASPR, will stop accepting orders to ship COVID-19 tests to all households through the U.S. Postal Service, an agency spokesperson confirmed, marking an end to this season's round of shipments.”

Updated COVID shot expected this fall, says CDC director “Researchers are working on selecting a strain for the upcoming version, and will probably wait until May to pick one to target with vaccines, Centers for Disease Control and Prevention Director Mandy Cohen said in an interview at Bloomberg’s offices in Washington.” 

About health insurance/insurers

HHS Statement Regarding the Cyberattack on Change Healthcare “Today, HHS is announcing immediate steps that the Centers for Medicare & Medicaid Services (CMS) is taking to assist providers to continue to serve patients. CMS will continue to communicate with the health care community and assist, as appropriate. Providers should continue to work with all their payers for the latest updates on how to receive timely payments.

Affected parties should be aware of the following flexibilities in place:

  • Medicare providers needing to change clearinghouses that they use for claims processing during these outages should contact their Medicare Administrative Contractor (MAC) to request a new electronic data interchange (EDI) enrollment for the switch. The MAC will provide instructions based on the specific request to expedite the new EDI enrollment. CMS has instructed the MACs to expedite this process and move all provider and facility requests into production and ready to bill claims quickly. CMS is strongly encouraging other payers, including state Medicaid and Children’s Health Insurance Program (CHIP) agencies and Medicaid and CHIP managed care plans, to waive or expedite solutions for this requirement.

  • CMS will issue guidance to Medicare Advantage (MA) organizations and Part D sponsors encouraging them to remove or relax prior authorization, other utilization management, and timely filing requirements during these system outages. CMS is also encouraging MA plans to offer advance funding to providers most affected by this cyberattack.

  • CMS strongly encourages Medicaid and CHIP managed care plans to adopt the same strategies of removing or relaxing prior authorization and utilization management requirements, and consider offering advance funding to providers, on behalf of Medicaid and CHIP managed care enrollees to the extent permitted by the State. 

  • If Medicare providers are having trouble filing claims or other necessary notices or other submissions, they should contact their MAC for details on exceptions, waivers, or extensions, or contact CMS regarding quality reporting programs.

  • CMS has contacted all of the MACs to make sure they are prepared to accept paper claims from providers who need to file them. While we recognize that electronic billing is preferable for everyone, the MACs must accept paper submissions if a provider needs to file claims in that method.”

Comment: Strongly encouraging and issuing guidance does not help providers get paid.

The Medicare Advantage Quality Bonus Program New Ideas and New Conversations Really good summary from The Urban Institute.
“Based on a review of the literature and interviews with six prominent experts in quality measurement and Medicare performance, we suggest a revised structure for ensuring adequate administrative performance and quality in MA. We recommend the following policies be implemented to replace the QBP:

1. Implement enhanced, more stringent Centers for Medicare & Medicaid Services oversight of MA plans to ensure adherence to their contractual obligations on various administrative responsibilities, concentrating on areas of demonstrated substandard performance, like prior authorization and claims denials.
2. Use a limited number of validated quality measures to identify exceptional and poor MA plan performance in areas of interest. These measures would be focused on prevention activities and, where possible, patient-reported outcomes and patient experiences with their health plan. Measurement would be limited to identifying exceptionally strong and poor performance, not broadly rating or ranking MA plans, and need not be made public.
3. Replace the current regime of external performance measurement that provides overly generous rewards without penalties with a program that encourages or requires MA plans to implement quality improvement projects or adopt continuous quality improvement methods.”

 The state canceling $2B in medical debt “Up to 1 million residents in Arizona may have their medical debt forgiven through a new program the state's governor announced March 4. 
Arizona Gov. Katie Hobbs said the state has partnered with RIP Medical Debt, a nonprofit that buys and eliminates debt, to cancel approximately $2 billion in residents' medical debt. Through the partnership, Arizona will make up to $30 million in COVID-19 relief funds available for the nonprofit to use for debt purchasing.”

About pharma

 Gilead tries new triple-target T-cell engagers in $1.5B-plus Merus collab “Gilead and Merus have inked a partnership worth more than $1.5 billion to discover trispecific T-cell engagers, the companies announced Wednesday. In exchange for $56 million in upfront cash plus a $25 million equity investment from Gilead, Merus will lead early-stage research on two programs, with the potential for a third.” 

About the public’s health

 FDA advisory panel recommends a streamlined flu vaccine for next fall “Experts who advise the Food and Drug Administration on vaccine-related issues voted unanimously on Tuesday to recommend that the FDA approve trivalent flu vaccines for the 2024-2025 season, instead of the quadrivalent, or four-in-one, shots that have been the industry standard for the past decade or so.
The Vaccines and Related Biological Products Advisory Committee — VRBPAC, as it’s known — has been pushing for the removal of one of the influenza B components in flu vaccines, the portion that targeted B/Yamagata viruses, for some time now. B/Yamagata viruses haven’t been detected anywhere in the world since late March 2020, when Covid pandemic lockdowns and social distancing appeared to have halted circulation of this family of lineage of flu B.”

PrEP Discontinuation In A US National Cohort Of Sexual And Gender Minority Populations, 2017–22 “We found a high annual rate of discontinuation (35–40 percent) after PrEP initiation. Multivariable analysis with 6,410 person-years identified housing instability and prior history of PrEP discontinuation as predictors of discontinuation. Conversely, older age, clinical indication for PrEP, and having health insurance were associated with ongoing PrEP use. To promote sustained PrEP use, strategies should focus on supporting those at high risk for discontinuation, such as younger people, those without stable housing or health insurance, and prior PrEP discontinuers.”

About healthcare IT

 GE HealthCare, Vanderbilt AI models predict immunotherapy responses among cancer patients “GE HealthCare said its artificial intelligence programs were able to help predict cancer patients’ responses to immunotherapies by finding patterns within routinely collected clinical data.
Developed through a yearslong collaboration with Vanderbilt University Medical Center (VUMC), the models were able to parse electronic medical records and digest real-world information such as diagnosis codes and certain medication regimens; additional, manually entered inputs included the patient’s smoking history and the number of previous immune checkpoint inhibitor drugs they had taken.
According to the company, the algorithms were able to deliver 70% to 80% accuracy in forecasting efficacy outcomes and the likelihood of unwanted side effects—across a range of different cancer types, including melanoma and lung or genitourinary cancers—by analyzing deidentified demographic, genomic, tumor, cellular, proteomic and imaging data collected from more than 2,200 VUMC patients.”

About health technology

 FDA Clears First Over-the-Counter Continuous Glucose Monitor “U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition.”

About healthcare finance

 Healthcare M&A: 10-point status update A good update on this activity.

Morningstar Indexes Selected by IMX Health for First Healthcare Futures Exchange Product Offering “ Morningstar, Inc…. announced that the Intelligent Medicine Exchange (“IMX”), the first futures and options exchange focused on the healthcare economy, has aligned with Morningstar Indexes to offer its first futures product. The IMX exchange was designated by the Commodity Futures Trading Commission in January of this year.
Healthcare represents nearly 20% of U.S. GDP but until IMX there was no dedicated derivatives market specifically focused on managing healthcare risk.
The new futures product from IMX Health will be based on the Morningstar US Healthcare Index, which measures the performance of approximately 170 U.S. public healthcare companies representing biotechnology, pharmaceuticals, research services, home healthcare, hospitals, long-term care facilities and medical equipment and supplies. This market capitalization-weighted index is designed for optimal tradability and liquidity. Among the largest current holdings in the index are household names like UnitedHealth, Eli Lilly, and Johnson & Johnson.”

Today's News and Commentary

Congress reaches spending deal with doc pay bump, delayed DSH cuts and more Good summary of the health provisions.

White House turns to health care in Biden’s latest move against ‘corporate greed’ “The White House plans to announce a new federal task force focused on easing health care costs, according to three people with direct knowledge of the matter.
The move comes as President Joe Biden seeks new ways to show voters he’s cracking down on the so-called corporate greed that he has increasingly blamed for high prices — a message he is expected to highlight during his State of the Union address on Thursday.”

About Covid-19

U.S. suspending free COVID test distribution once again “Orders for free tests placed on or before Friday will be delivered, per HHS.

About health insurance/insurers

Mounting headwinds in Medicare Advantage market haven’t stopped growth From a Chartis Report: “The following changes are shaping the market:  

  • Enrollment trends: Half of Medicare-eligible individuals are now in Medicare Advantage plans. The market grew by 1.7 million beneficiaries (+5.4%), slowing down from the previous year’s record growth of 2.7 million (+9.4%). Notably, for-profit carriers like United, Humana, and Aetna collectively captured 1.4 million new members: 86% of the total market’s growth.

  • Special Needs Plan (SNP) growth: SNP enrollment has surged, adding 1.2 million members. Nearly 7 in 10 new Medicare Advantage enrollees opted for SNPs. This growth is particularly pronounced in Chronic Condition SNPs (C-SNPs). The top 5 plans now represent 77% of the SNP market.

  • Plan options and preferences: The number of plan options are roughly flat from the previous year, with the average senior having access to 44 plans. In contrast, the trend of the past five years has been 80% growth. Preferred provider organizations (PPOs) have increased, constituting 43% of all plans offered, up from 31% in 2019.

  • Market dynamics and quality: Medicare Advantage enrollment and social vulnerability are related. Counties with higher vulnerability scores show greater penetration rates (53%) compared to counties with lower scores (45%). Meanwhile, quality remains a concern as plans struggle to maintain quality scores. Average star ratings continued their decline and this year approximately one-quarter of beneficiaries are enrolled in a plan with less than four stars.

  • Market outlook and executive sentiment: Health plans face recent market challenges, including declining payment rates, growing medical cost pressures, and an expanding regulatory burden. But 79% of plan executives express optimism about the next five years, expecting neutral or positive overall outcomes. 84% anticipate membership growth equal to or greater than the current year, indicating confidence in the stability and growth potential of the market.”

About hospitals and healthcare systems

 Nonprofits Aspirus Health, St. Luke's Duluth close 19-hospital merger “Wausau, Wisconsin-based Aspirus Health and Duluth, Minnesota-based St. Luke's have closed their merger and are now a 19-hospital entity spread across Minnesota, Wisconsin and Michigan's Upper Peninsula…” 

Providers losing $100M daily over Change Healthcare hack: Report “Some larger health systems are bleeding over $100 million daily because of the interruptions to the Optum subsidiary's payer systems, cybersecurity company First Health Advisory told multiple news outlets.”

About pharma

 Ohio Fines CVS $1.5 Million Over Safety and Staffing Issues “CVS Health, the nation’s largest pharmacy chain with more than 9,000 locations, has been fined more than $1.5 million by Ohio regulators over problems connected to understaffing and patient safety, officials said.
The fines are part of a settlement of 27 cases involving various safety concerns that were uncovered during a series of inspections of 22 pharmacies between 2020 and 2023, the State of Ohio Board of Pharmacy said in a statement on Thursday.
The board said that it found, among other things, improper drug security, errors dispensing drugs, prescription delays, lack of general cleanliness, understaffing and failure to report losses of controlled substances.”

Mark Cuban says Cost Plus Drugs targeting generic meds in short supply as it opens manufacturing facilityMark Cuban Cost Plus Drug Company will begin manufacturing its own generic medications this week, starting with sterile injectables, founder and CEO Alex Oshmyansky, M.D., Ph.D., said Monday during a White House roundtable on lowering healthcare costs.
The company, which launched just two years ago, will first manufacture commercial batches of epinephrine and norepinephrine for patients in the intensive care unit…”

Drugmakers send counter offers for U.S. Medicare price negotiations, Biden says “The manufacturers of 10 high-cost drugs selected for the U.S. Medicare program's first-ever pricing negotiations have submitted counter offers to the U.S. government's initial proposal, U.S. President Joe Biden said on Monday.
The negotiation program, passed as part of 2022's Inflation Reduction Act, allows Medicare to negotiate prices for the high-cost drugs. Medicare covers Americans aged 65 and above.”

About the public’s health

Screen Time and Parent-Child Talk When Children Are Aged 12 to 36 Months Findings  This cohort study found a negative association between screen time and measures of parent-child talk across those early years. For every additional minute of screen time, children heard fewer adult words, spoke fewer vocalizations, and engaged in fewer back-and-forth interactions.
Meaning  This study suggests that screen time is a mechanism that may be getting in the way of children experiencing a language-rich home environment during the early years; interventions aiming to promote early use of language should include support to manage screen time.”

About healthcare IT

 Sixth Semi-Annual Hospital Price Transparency Report February 2024 “Our latest review, conducted three years after the Hospital Price Transparency Rule took effect, analyzed the websites of 2,000 U.S. hospitals and found only 34.5% of them (689) to be fully compliant with all requirements of the rule. Although the majority of hospitals have posted files, the widespread noncompliance of 65.5% of hospitals is due to files being incomplete or not having prices clearly associated with both payer and plan. Eighty-seven of the hospitals reviewed for this report had no usable standard charges file.”
Comment: Where is the federal enforcement?

About health technology

 Epigenetic silencing lasts long-term in mice, bolstering case for therapeutic use “Mouse data from a new study published Feb. 28 in Nature and sponsored in part by Chroma Medicine suggest that epigenetic gene silencing can suppress the target gene for nearly a year, providing new evidence for the lasting effects of these therapies…
Epigenetic silencing is similar to gene editing in that both methods act directly on a gene. However, unlike gene editing, epigenetic silencing doesn’t fundamentally change the underlying DNA sequence; it works by “decorating” a gene with compounds, often methyl groups, to stop it from functioning. That makes it possible to reverse epigenetic modifications, as well as to avoid the pitfalls of DNA breakage.”

About healthcare finance

 Healthcare real estate companies close $21B merger “Denver-based Healthpeak Properties has closed its $21 billion all-stock merger with Milwaukee-based Physicians Realty Trust. The companies will operate under the name Healthpeak Properties…
The combined company will feature a portfolio of 52 million square feet with footprints in more than 30 markets, including 40 million square feet of outpatient medical settings in high-growth markets such as Houston, Nashville, Tenn., Denver, Phoenix and Dallas with hospital and health system affiliations.”

Today's News and Commentary

7 healthcare trends we're watching now A thoughtful summary. Highly recommended.

About Covid-19

 Interim Effectiveness of Updated 2023–2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalization Among Immunocompetent Adults Aged ≥18 Years — VISION and IVY Networks, September 2023–January 2024  The vaccine lowers urgent care visits and hospitalizations by about 50% compared to no vaccination.

About health insurance/insurers

 ObamaCare faces key hearing after Texas ruling “A federal appeals court is set to hear arguments Monday on the Biden administration’s appeal of a case that threatens the Affordable Care Act’s (ACA) promise of free preventive care to more than 150 million people.  
A federal judge in Texas last year ruled that the law’s mandate requiring employers and insurers to cover a host of preventive services, like certain cancer screenings and HIV prevention, was unconstitutional.”

Why Medicare is adding prior authorization requirements as others cut back “Medicare is taking the rare step of adding pre-treatment approval requirements before patients can get care at certain outpatient surgical facilities that have seen a sharp uptick in billings…
The new requirements apply to 40 services related to five procedures,including rhinoplasty, eyelid lifts and varicose vein treatments.”

Primary Care Physicians In Medicare Advantage Were Less Costly, Provided Similar Quality Versus Regional Average “Assessing primary care physician costliness based on the gap between observed and predicted costs for their traditional Medicare patients, we found that the average primary care physician in MA networks was $433 less costly per patient (2.9 percent of baseline) compared with the regional mean, with less costly primary care physicians included in more networks than more costly ones. Favorable selection of patients by MA primary care physicians contributed partially to this result. The quality measures of MA primary care physicians were similar to the regional mean. In contrast, primary care physicians excluded from all MA networks were $1,617 (13.8 percent) costlier than the regional mean, with lower quality. Primary care physicians in narrow networks were $212 (1.4 percent) less costly than those in wide networks, but their quality was slightly lower. These findings highlight the potential role of selective contracting in reducing costs in the MA program.”

About hospitals and healthcare systems

 Hospital Facility Prices Declined As A Result Of Oregon’s Hospital Payment Cap  “In October 2019, the Oregon state employee health insurance plan instituted a cap on hospital payments…
The cap was associated with a significant reduction in outpatient facility prices over the course of the first twenty-seven months of the policy (−$130.50 per procedure). We estimated $107.5 million (or 4 percent of total plan spending) in savings to the state employee plan during the first two years. The hospital payment cap successfully reduced hospital prices for enrollees in that plan.”

About pharma

 1 in 3 independent pharmacies to close this year: Survey “Thirty-two percent of independent pharmacy owners plan to shutter their businesses by the end of 2024, according to a February survey
Local pharmacies are facing a plethora of headwinds, including dwindling reimbursements and struggles with pharmacy benefit managers, the National Community Pharmacists Association said Feb. 27.”

AstraZeneca's challenge to IRA price negotiations is rejectedLess than three weeks after a Texas judge tossed a lawsuit by industry lobbying group PhRMA that challenged the constitutionality of the Inflation Reduction Act (IRA), a federal court in Delaware has done the same with a similar action brought by AstraZeneca.
The company brought the suit in August of last year after its diabetes, kidney and heart drug Farxiga was named one of 10 products that will face Medicare price negotiations in 2026. Several other companies with drugs on the list have also filed lawsuits.”

Retail pharmacies to begin selling OTC birth control within weeks “Almost eight months after the FDA approved Opill, the first over-the-counter birth control pill, it will soon be available for purchase without a prescription at pharmacies like CVS and Walgreens in weeks…”

Drugs like Ozempic and Wegovy could boost the US economy by a trillion dollars in a few years, Goldman Sachs predicts  “The US economy is set to reap considerable benefits from Americans taking popular medications used for weight loss, including Ozempic and Wegovy, Goldman Sachs analysts wrote in a recent research report…
The Wall Street bank estimates that GLP-1s could add 0.4% to America’s gross domestic product, a broad measure of all the goods and services produced in the economy, ‘in a baseline scenario where 30 million users take the drugs and 70% experience benefits,’ and as much as 1% if 60 million Americans take those drugs regularly.
The US economy overall was about $28 trillion in the fourth quarter, so if Goldman’s bullish case bears out, that means GLP-1 drugs alone could boost output by a trillion dollars over the next four years, more or less.”
Comment: On the other hand, consider how much the drugs could add to health care costs.

About healthcare personnel

 Private Equity–Acquired Physician Practices And Market Penetration Increased Substantially, 2012–21  “PE-acquired physician practice sites increased from 816 across 119 MSAs in 2012 to 5,779 across 307 MSAs in 2021. Single PE firms had significant market share, exceeding 30 percent in 108 MSA specialty markets and exceeding 50 percent in 50 of those markets. The findings raise concerns about competition and call for closer scrutiny by the Federal Trade Commission, state regulators, and policy makers.”

About health technology

 Health tech Q4 earnings recap FYI

In a first, fetal cell organoids generated from amniotic fluid, new study reports “…researchers working in the U.K. have discovered that some [amniotic fluid] cells are still alive, and they can be grown up into three-dimensional organoids — mini lung, kidney, and small intestines — providing a possible new tool to study and even diagnose congenital fetal diseases.”

Today's News and Commentary

About Covid-19

 Where Did Covid Come From? “In the four years since the SARS-CoV-2 virus was unleashed on the world, data have steadily accumulated supporting the hypothesis that it emerged from a laboratory. The latest information, released last month, makes a formidable case that the virus is the product of laboratory synthesis, not of nature.”
Comment: Excellent review of the evidence.

CDC eases isolation guidance for Covid and other respiratory illnessesThe Centers for Disease Control and Prevention is “sunsetting” its advice that people sick with Covid-19 isolate themselves for five days. The agency published new guidance Friday for Covid and other respiratory illnesses, suggesting people who are sick should stay at home until they are fever-free for 24 hours and their symptoms have been improving for the same period of time.
The new guidance recommends that in the five days that follow, recovering people should take measures such as masking and keeping a physical distance from others to try to reduce the risk that they will spread their illness.”

About health insurance/insurers

With Medical Debt Burdening Millions, a Financial Regulator Steps In to Help “In the past two years, the CFPB has penalized medical debt collectors, issued stern warnings to health care providers and lenders that target patients, and published reams of reports on how the health care system is undermining the financial security of Americans.
In its most ambitious move to date, the agency is developing rules to bar medical debt from consumer credit reports, a sweeping change that could make it easier for Americans burdened by medical debt to rent a home, buy a car, even get a job. Those rules are expected to be unveiled later this year.”

About hospitals and healthcare systems

 Cleveland Clinic back in the black “Cleveland Clinic posted an operating income of $64.3 million in 2023 after posting a $211.3 million loss in 2022, according to its financial report released Feb. 29. 
The health system had a 0.4% operating margin for the year ended Dec. 31 after posting a -1.6% margin in 2022, according to the report.”

Tenet's hospital selling spree “Dallas-based Tenet Healthcare has started 2024 with a flurry of hospital sales. The for-profit system announced Feb. 1 it completed its $2.4 billion sale of three South Carolina hospitals to Winston-Salem, N.C.-based Novant Health. Also that day, Tenet announced it reached a definitive agreement to sell four Southern California hospitals and associated outpatient locations to Orange, Calif.-based UCI Health for $975 million. That deal is expected to close in the spring.”

About pharma

US judge rules against AstraZeneca in Medicare price talks challenge “AstraZeneca's attempt to stop Medicare from negotiating prices on its diabetes treatment Farxiga (dapagliflozin) was shut down in US federal court on Friday when a judge upheld a law mandating certain drugmakers to take part in price-capping negotiations with Medicare.”

CVS and Walgreens Will Begin Selling Abortion Pills This Month “The two largest pharmacy chains in the United States will start dispensing the abortion pill mifepristone this month, a step that could make access easier for some patients.
Officials at CVS and Walgreens said in interviews on Friday that they had received certification to dispense mifepristone under guidelines that the Food and Drug Administration issued last year. The chains plan to make the medication available in stores in a handful of states at first. They will not be providing the medication by mail.
Both chains said they would gradually expand to all other states where abortion was legal and where pharmacies were legally able to dispense abortion pills — about half of the states.”

AbbVie and OSE Immunotherapeutics Announce Partnership to Develop a Novel Monoclonal Antibody for the Treatment of Chronic Inflammation “AbbVie Inc. and OSE Immunotherapeutics SA, a clinical-stage immunotherapy company, today announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to resolve chronic and severe inflammation, currently in the pre-clinical development stage.
OSE-230 is a first-in-class monoclonal antibody designed to activate ChemR23, a G-Protein Coupled Receptor (GPCR) target. Activation of ChemR23 may offer a novel mechanism for the resolution of chronic inflammation, modulating functions of both macrophages and neutrophils…
Under the terms of the agreement, AbbVie will receive an exclusive global license to develop, manufacture and commercialize OSE-230. OSE Immunotherapeutics will receive a $48 million upfront payment and will be eligible to receive up to an additional $665 million in clinical development, regulatory and commercial milestones. In addition, OSE Immunotherapeutics will be eligible to receive potential tiered royalties on global net sales of OSE-230.”

Sandoz settles for $265M in US generic drug price fixing fallout “Sandoz will pay $265 million to settle certain claims against the company alleging both product-specific and industry-wide conspiracies to fix generic drug prices in the US. The drugmaker said Thursday that the agreement, which contains no admission of wrongdoing, resolves all claims of the direct purchaser class plaintiffs against it and its Fougera Pharmaceuticals unit.”

Pfizer aims for 8 blockbuster cancer drugs by 2030 “‘Pfizer hopes to have at least eight blockbuster cancer drugs on the market by 2030 as it looks to build on the recent $43-billion acquisition of Seagen, which doubled the size of its oncology pipeline.’ Chris Boshoff, Pfizer’s chief oncology officer, noted that its cancer portfolio is expected to be ‘a critical driver of potential long-term sustainable sales and profit growth…through the end of the decade.’
Sales of the company’s current top-selling cancer drug Ibrance, as well as revenue from Astellas-partnered Xtandi, are set to come under pressure as both products start to lose market exclusivity in 2027. To counter this, the purchase of Seagen added a number of antibody-drug conjugates (ADCs), including Adcetris and Padcev, which are predicted to add a combined $3.1 billion in revenue this year.
Along with ADCs, Pfizer said that it will focus oncology development on small molecules and bispecific antibodies, including other immuno-oncology biologics, across four main cancer types. These comprise: breast cancer; genitourinary cancer, including prostate and urothelial cancers; haematology-oncology, including multiple myeloma and lymphomas; and thoracic cancers, which includes lung, and head and neck cancers.”

Biden-Harris Administration Issues Final Guidance to Help People with Medicare Prescription Drug Coverage Manage Prescription Drug Costs “Continuing the ongoing implementation of President Biden’s prescription drug pricing law, the Inflation Reduction Act of 2022, the Centers for Medicare & Medicaid Services (CMS) released the final part one guidance for the new Medicare Prescription Payment Plan
The Medicare Prescription Payment Plan complements the Inflation Reduction Act’s other provisions that lower prescription drug and health care costs. The pieces of the law work together to lower drug costs and make them more manageable for people in Medicare.

  • As of January 1, 2024, people enrolled in Medicare Part D who have very high drug costs will, for the first time, no longer have to pay cost sharing for their prescription drugs in the catastrophic phase of the program.

  • Starting in 2025, all individuals with Medicare Part D will have their out-of-pocket prescription drug costs capped at $2,000.

  • On January 1, 2024, the law also expanded eligibility for full benefits under the Low-Income Subsidy program (LIS or “Extra Help”) under Medicare Part D. Nearly 300,000 people with low and modest incomes currently enrolled in LIS are now benefiting from the program’s expansion including lowering drug costs such as no deductible, no premiums, and fixed, lowered copayments for certain medications. An additional 3 million people could benefit from the Extra Help program now who are not currently enrolled.

  • The law also ensures people with Medicare Part D and people with Part B who receive insulin delivered through a pump pay no more than $35 for a month’s supply of each covered insulin product.

  • It also provides coverage without patient cost sharing of recommended vaccines for people who have Medicare Part D.”

About the public’s health

Alabama lawmakers pass legislation to protect IVF treatment “The Alabama legislature voted Thursday to protect providers and patients doing in vitro fertilization from criminal or civil liability if embryos they create are subsequently damaged or destroyed.
The fast action by both the House and Senate on bills to shield IVF came less than two weeks after the state’s Supreme Court ruled that frozen embryos are people and that individuals could be liable for destroying them.”

Deaths from Excessive Alcohol Use — United States, 2016–2021 “Average annual number of deaths from excessive alcohol use, including partially and fully alcohol-attributable conditions, increased approximately 29% from 137,927 during 2016–2017 to 178,307 during 2020–2021, and age-standardized death rates increased from approximately 38 to 48 per 100,000 population. During this time, deaths from excessive drinking among males increased approximately 27%, from 94,362 per year to 119,606, and among females increased approximately 35%, from 43,565 per year to 58,701.
What are the implications for public health practice? Evidence-based alcohol policies (e.g., reducing the number and concentration of places selling alcohol and increasing alcohol taxes) could help reverse increasing alcohol-attributable death rates.”

More than a billion people worldwide are obese, WHO study finds “More than a billion people globally are now considered obese, a condition linked to an increased risk of numerous serious health problems, according to updated estimates from the World Health Organization and an international group of researchers.
Obesity is so prevalent it has become more common than being underweight in most nations, including many low and-middle income countries that have previously struggled with undernourishment.”

IQVIA Study Highlights the Importance of Adult Vaccination in the US “The investigators found that rates for the flu vaccine in this [Medicaid] group are nearly 8%-10% lower than the general population, with that rate increasing to 30% when compared to individuals with Medicare coverage.”

Today's News and Commentary

About Covid-19

Cognition and Memory after Covid-19 in a Large Community Sample “Participants with resolved persistent symptoms after Covid-19 had objectively measured cognitive function similar to that in participants with shorter-duration symptoms, although short-duration Covid-19 was still associated with small cognitive deficits after recovery. Longer-term persistence of cognitive deficits and any clinical implications remain uncertain.” 

About health insurance/insurers

Change Healthcare cyberattack outage could persist for weeks, UnitedHealth Group executive suggests “The outage caused by the Change Healthcare cyberattack could last weeks, a top UnitedHealth executive suggested in a Tuesday conference call with hospital cybersecurity officers, according to a recording obtained by STAT.
UnitedHealth Group Chief Operating Officer Dirk McMahon said the company is setting up a loan program to help providers who can’t submit insurance claims while Change is offline. He said that program will last ‘for the next couple of weeks as this continues to go on.’”

MA Advance Notice Does Not Offset Rising Medical Costs and Could Lead to Reduced Healthcare Value for Beneficiaries Look at the two figures for state-by-state projected changes in monthly MA payments.

GAO: Billions wasted on federal health insurance program “The Office of Personnel Management, which oversees health insurance for 8 million federal workers and their families at a cost of more than $60 billion a year, has never checked the eligibility of those on its rolls, according to a report from the Government Accountability Office, which has been pushing OPM for years to improve its oversight. And that failure is costing taxpayers billions and raising premiums for millions of civil servants.”

Drawing the line on patient responsibility collection rates An excellent summary of the status of patient collections. In summary:Hospitals, health systems, and medical practices are collecting only about half of what patients owe them, and those relatively small dollar amounts are adding up to millions of dollars in lost revenue….
$17.4 B- Dollar value of total bad debt write-offs in 2023.”

About hospitals and healthcare systems

 Northwell Health, Nuvance Health unveil 28-hospital merger deal “Danbury, Connecticut-based Nuvance Health is joining Northwell Health, New York’s largest provider and private employer, under a strategic merger agreement unveiled Wednesday.
The deal, which still requires regulatory signoffs, would create a healthcare network of more than 28 hospitals, over 1,000 care sites, nearly 100,000 staff and 14,500 employed providers, the two nonprofits said in their joint announcement.”

Universal Health Services beats on earnings, revenues and projects 'conservative' earnings growth for 2024 “Universal Health Services (UHS) beat estimates for the fourth quarter and is forecasting higher, though still ‘conservative,’ full-year earnings for 2024.
The King of Prussia, Pennsylvania-based for-profit health system reported $216.4 million net income ($3.16 per diluted share) during the fourth quarter, an improvement over last year’s $174.8 million ($2.43 per diluted share) and $0.25 higher than the consensus estimate, according to numbers released after market close on Tuesday.
Net revenues for the quarter rose 7.4% year over year to $3.70 billion, which was also above the consensus estimate of $3.66 billion.”

FEBRUARY 2024 National Hospital Flash Report “Key Takeaways
1. Margins improved in January relative to previous years. While margins declined
slightly from December, they were higher in January relative to the same periods in 2022 and 2021.
2. Net revenue has not risen as fast as gross revenue. This might reflect payers negotiating more aggressively and a shift to value-based payment models.
3. Total expenses on a volume-adjusted basis have improved. Though there’s been continued growth in drugs and supply expenses, labor expenses have improved.” 

Hospital expenses per inpatient day across 50 states FYI. For example:
National average 
Nonprofit hospitals: $3,167
For-profit hospitals: $2,383 
State/local government hospitals: $2,857

About pharma

Bankrupt Endo To Pay $2B To Resolve Opioid Claims “Bankrupt drugmaker Endo International has agreed to pay approximately $2 billion to resolve criminal and civil allegations related to its sales and marketing of a powerful opioid, with a group of secured lenders set to operate the company under a new corporate structure.”

Association of Cannabis Use With Cardiovascular Outcomes Among US Adults “Cannabis use is associated with adverse cardiovascular outcomes, with heavier use (more days per month) associated with higher odds of adverse outcomes.”

Walgreens' VillageMD to close all Illinois clinics “Walgreens' VillageMD plans to close all its primary care clinics in Illinois in April, abandoning an expansion that was underway in its home state.
The six clinics that will close April 19 are all in the Chicago area, according to VillageMD's website. Five are standalone locations and one is attached to a Walgreens store. The one co-located clinic in Elk Grove opened just six months ago
the number of locations that have already closed or plan to close has exceeded 80 clinics.”

About the public’s health

Ultra-processed food exposure and adverse health outcomes: umbrella review of epidemiological meta-analyses The summary provides further evidence of the deleterious effects of ultra-processed foods. For example: “Overall, direct associations were found between exposure to ultra-processed foods and 32 (71%) health parameters spanning mortality, cancer, and mental, respiratory, cardiovascular, gastrointestinal, and metabolic health outcomes. Based on the pre-specified evidence classification criteria, convincing evidence (class I) supported direct associations between greater ultra-processed food exposure and higher risks of incident cardiovascular disease related mortality (risk ratio 1.50, 95% confidence interval 1.37 to 1.63; GRADE=very low) and type 2 diabetes (dose-response risk ratio 1.12, 1.11 to 1.13; moderate), as well as higher risks of prevalent anxiety outcomes (odds ratio 1.48, 1.37 to 1.59; low) and combined common mental disorder outcomes (odds ratio 1.53, 1.43 to 1.63; low).”

Certain types of ‘forever chemicals’ will no longer be used in US food packaging, FDA says
Certain kinds of greaseproofing “forever” chemicals called per- and polyfluoroalkyl substances, or PFAS, will no longer be used in food packaging in the US, the US Food and Drug Administration announced Wednesday.
The FDA’s food studies have shown that food packaging materials like fast-food wrappers, microwave popcorn bags and take-out pizza boxes were a major source of dietary exposure to certain types of PFAS, hormone-disrupting chemicals that may persist in the body and the environment.”

CDC braces for shortage after tetanus shot discontinued, issues new guidance “The Centers for Disease Control and Prevention is urging doctors to conserve shots of a kind of tetanus vaccine, as the agency braces for a potential shortage of those shots this year.
Doctors should switch from using the so-called Td vaccine – the immunization that protects against both tetanus and diphtheria infections – to giving the broader Tdap vaccine instead whenever possible, the CDC now says. In addition to tetanus and diphtheria, the Tdap vaccine also offers protection against pertussis, the infection also known as ‘whooping cough.’
This year's shortage risk stems from a decision by nonprofit vaccinemaker MassBiologics to discontinue production of its Td vaccine, branded as TdVax.”

Flu shots are doing OK vs. virus, US numbers indicate “The vaccines were around 40% effective in preventing adults from getting sick enough from the flu that they had to go to a doctor’s office, clinic or hospital, health officials said during a Centers for Disease Control and Prevention vaccines meeting Wednesday. Children who were vaccinated were roughly 60% less likely to get treatment at a doctor’s office or hospital, CDC officials said.
Officials generally are pleased if a flu vaccine is 40% to 60% effective.”

About healthcare IT

Ransomware group leader told hackers to attack hospitals, FBI, HHS say “The ransomware group linked to the cyberattack on Change Healthcare is also targeting hospitals, the FBI and HHS warned Feb. 27.
The BlackCat hacker gang has been focusing its attacks on the healthcare sector, with most of its 70 victims since December coming from that industry, according to the notice. The group's administrator encouraged affiliates to attack hospitals that month after the FBI infiltrated its operations.”

A Snapshot of Artificial Intelligence in Healtcare Based on research from Premier executives. It is interesting to contrast the priorities between the executive and physicians. The former see the best use of AI is in clinical care, while the latter see AI helping with administrative tasks. (See yesterday’s Blog post.)

Today's News and Commentary

About Covid-19

CDC recommends older adults get 2nd updated coronavirus shot “A CDC recommendation means that those who are eligible for a second shot will have that additional dose covered by insurance. Eligible consumers should be able to get the additional dose within a day or twofrom pharmacies or health-care providers stocking the vaccines. There are no supply shortages, CDC officials said.” 

About health insurance/insurers

U.S. Opens UnitedHealth Antitrust Probe “The Justice Department has launched an antitrust investigation into UnitedHealth, owner of the biggest U.S. health insurer, a leading manager of drug benefits and a sprawling network of doctor groups.
The investigators have in recent weeks been interviewing healthcare-industry representatives in sectors where UnitedHealth competes, including doctor groups, according to people with knowledge of the meetings.
During their interviews, investigators have asked about issues including certain relationships between the company’s UnitedHealthcare insurance unit and its Optum health-services arm, which owns physician groups, among other assets. 
Investigators have asked about the possible effects of the company’s doctor-group acquisitions on rivals and consumers, the people said.”

2023 Consumer Engagement in Health Care Survey An excellent annually-published report. Read the Key Findings sections.

About hospitals and healthcare systems

 World's Best Hospitals 2024 FYI. From Newsweek.

Mayo posts $1.1B operating income, 6% margin “Mayo Clinic saw financial and operational improvements in 2023 that lifted its net operating income to $1.1 billion, according to financial results released Feb. 27. 
The Rochester, Minn.-based system recorded revenue of $17.9 billion against expenses of $16.8 billion in 2023, resulting in net operating income of $1.1 billion and a 6% operating margin.
The latest results mark a comeback for Mayo, which has seen cyclical losses and gains in the past few years. It reported operating income of $595 million for 2022 compared to a $1.2 billion gain in 2021. Mayo cared for more than 1.3 million patients from more than 130 countries in 2023.”

Trinity Health nearly wipes last year's operating losses, grows revenue by over 11% “Livonia, Michigan-based Trinity Health brought its six-month operating losses down from last year’s $270.3 million (-2.6% operating margin) to $38.6 million (-0.3% operating margin) thanks to higher volumes and ‘several revenue and cost management initiatives…’
Though Trinity reports its financials on a year-to-date basis, the faith-based provider noted that the trajectory of its margins improved from a loss in the first fiscal quarter, ended Sept. 30, to a gain in its most recent, ended Dec. 31. Its six-month bottom line has also risen year over year from a $70.5 million loss to a $669.1 million net income.”

About pharma

 PBMs not complying with federal probe: FTC “In June 2022, the Federal Trade Commission launched a probe into the business practices of pharmacy benefit managers and how they affect drug affordability and access. No PBM has fully complied with the probe, FTC Chair Lina Khan said in a recent letter obtained by Axios.”

Spotlight On: Pharma’s fastest-growing drugs in 2023 FYI. Not a surprise, at the top spot is Ozempic.

Five Companies Won’t Delist Orange Book Patents Challenged by FTC, Three Others Will “While three of the companies warned of inappropriate Orange Book patent listings by the FTC are delisting all the challenged patents, according to the U.S. legislators who led the action, five others refused to delist.
The companies who refused to delist certain patents said all of their challenged patents were appropriately filed, and had never been used to stifle generics competition.”

About the public’s health

Emhoff unveiling $1.7B in new commitments to Biden anti-hunger initiative “Second gentleman Doug Emhoff unveiled nearly $1.7 billion in new commitments to the Biden administration’s efforts to end hunger by the end of the decade.
The list includes more than 140 commitments from nonprofits, insurers, health systems, local officials and academia. Sixteen cities across the country have pledged to create task forces and action plans to end hunger and reduce diet-related diseases by 2030.”

About healthcare IT

AI AND THE FUTURE OF HEALTHCARE Worth a read. For example, a couple findings:
—Investors spent $31.5B in healthcare AI-related technology between 2019 and 2022, and these technologies are expected to fuel more investments, and influence valuations and market value for healthcare organizations moving forward. Recent research finds that wider adoption of AI could lead to savings of 5% to 10% in US healthcare spending–roughly $200 billion to $360 billion annually in 2019 dollars.
—Only four in ten overall respondents indicate their organizations are reviewing or planning to review AI regulatory guidance. Despite this, a majority remain confident about regulators’ abilities to develop adequate safeguards.”

The Emerging Landscape of Augmented Intelligence in Health Care A good review for those who need an introduction to the topic. What I found most interesting is the data in Figure 5 (page 13). By far, physicians want AI to help with “administrative burdens.”

FTC’s Khan warns tech industry that agency will strictly enforce AI data privacy “Artificial intelligence tools will be vigorously regulated by the Federal Trade Commission (FTC), with an eye on consumer privacy, its Chair Lina Khan told an audience of tech executives and startup founders at a conference Tuesday.
‘We’re crafting easily administrable remedies with bright-line rules on the development, use and management of AI inputs,’ Khan said during a speech. “That means making clear that some data, particularly peoples’ sensitive health data, geolocation data and browsing data is simply off limits for model training.”

About healthcare personnel

Only 37% of Medical Practices Receive Value-Based Care Payments, Black Book Survey Reveals “While the shift towards value-based care (VBC) is underway, a recent Black Book survey reveals that only 37% of medical practices are currently receiving payments from upside-risk arrangements and shared savings, while 12% receive payments from full risk.
This leaves a significant portion, over 50%, still relying on traditional Fee-For-Service models.”

About health technology

Epigenetic silencing lasts long-term in mice, bolstering case for therapeutic useMouse data from a new study published Feb. 28 in Nature and sponsored in part by Chroma Medicine suggest that epigenetic gene silencing can suppress the target gene for nearly a year, providing new evidence for the lasting effects of these therapies.”

Today's News and Commentary

About Covid-19

 The Top COVID-19 Hot Spots in the U.S. FYI. Check the interactive map for your county.

About health insurance/insurers

Congress Sidesteps Site-Neutral Hospital Payment Reform in Upcoming Funding Package “In a move that has reignited the debate over healthcare affordability and equity, Congress has decided not to include a site-neutral hospital pay policy in the next government funding package. This decision has broad implications for how outpatient services are billed across the United States, potentially affecting the cost of healthcare for millions of Americans. At its core, the debate centers on whether hospitals should receive higher payments than standalone physicians’ offices for the same outpatient services, a practice that the site-neutral policy sought to eliminate.”

MA Advance Notice Does Not Offset Rising Medical Costs and Could Lead to Reduced Healthcare Value for BeneficiariesBRG forecasts how the three major impacts to 2025 payment could affect MA buy-down of premiums, cost sharing, and supplemental benefit offerings:
(1) Net risk scores will drop by 2.9% due to changes in normalization factors and the continued phase-in of the new risk model V28
2) Star rating changes will lower payment by 0.5%
(3) Growth factor will increase by 2.4%
One main reason why BRG expects a larger reduction than CMS estimates is that BRG expects medical inflation for MA plans to increase by 4% to 6% in 2025. Medical costs per MA member per month grew by an estimated 7.3% for the first nine months of 2023, based on analysis of NAIC1 statutory filing data for plans that represent 85% of MA lives. The fourth quarter of 2023 had similar growth for MA plans…”

About hospitals and healthcare systems

20 hospitals that won the most NIH money in 2023 — and how much they got FYI. Five of the top ten are in Boston.

About pharma

 FDA Approves Humira Biosimilar Adalimumab-ryvk “The US Food and Drug Administration (FDA) has approved adalimumab-ryvk (Simlandi), the first interchangeable, high-concentration, citrate-free biosimilar to adalimumab (Humira), according to a press release published by Alvotech and Teva Pharmaceuticals.1 The tumor necrosis factor (TNF) inhibitor is approved for the treatment of a variety of autoimmune conditions, including rheumatoid arthritis (RA), juvenile idiopathic arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, uveitis, and hidradenitis suppurativa.”
Comment: Humor sales have been strong despite the other available generics. Perhaps this one, being interchangeable, will make a dent in the brand’s sales.

US pharmacy outage triggered by 'Blackcat' ransomware at UnitedHealth unit, sources say “Hackers working for the 'Blackcat' ransomware gang are behind the outage at UnitedHealth's technology unit that has snarled prescription deliveries for six days, two people familiar with the matter told Reuters on Monday.
The problems began last week after hackers gained access to Change Healthcare's information technology systems and has led to disruptions at pharmacies across the United States.”
Comment: Change Healthcare says service should be restored in the next day or so.

Novo Nordisk joins protein degradation race in $1.4B+ deal with Neomorph “Novo Nordisk signed its first protein degradation deal Monday and is looking to take the molecular glue modality – most often used in oncology – into the cardiometabolic and rare disease spaces. The Danish drugmaker partnered with Neomorph in a multi-target deal worth $1.46 billion in biobucks…
Under the deal – the recently launched biotech’s first – Neomorph will lead discovery and preclinical activities against selected targets, and Novo Nordisk will have the right to exclusively pursue further clinical development and commercialisation of the compounds.”

About the public’s health

Biden-Harris Administration Announces New Funding to Increase Capacity for Behavioral Health Services “Today, the U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $36.9 million in notices of funding opportunities for grant programs supporting behavioral health services across the country. Additionally, HHS, through the Centers for Medicare & Medicaid Services (CMS), issued guidance that allows states to expand the pool of behavioral health care providers eligible for enhanced federal Medicaid funding, which will better support this critical workforce as well as improve access to care. The guidance also allows states to claim federal dollars for nurse advice lines.”
The announcement also details the spend on each activity.

About healthcare IT

 HHS Delivers Reports to Congress on HIPAA Compliance, Enforcement “The HHS Office for Civil Rights (OCR) delivered two reports to Congress on HIPAA compliance and enforcement efforts logged by the department during the 2022 calendar year. HHS is required to submit these reports to Congress each year under the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009…
OCR received more than 30,000 new complaints alleging HIPAA violations in 2022, and resolved more than 32,000 cases in the 2022 calendar year. OCR also completed 846 compliance reviews and required entities to take corrective actions or pay a monetary penalty in 80 percent of those investigations.
OCR has seen a 17 percent increase in HIPAA complaints received from 2018 to 2022 and a 107 percent increase in large breaches reported in that timeframe.”