Today's News and Commentary

About health insurance/insurers

Man charged in $70M Medicare fraud scheme “A Mississippi man faces up to 25 years in prison for his alleged role in a Medicare fraud scheme exceeding $70 million…
 Prosecutors claim he used the companies to bill Medicare for orthotic braces obtained by the use of fraudulent physician orders, which were generated by contacting Medicare beneficiaries and obtaining ​​personally identifiable information through call centers. The indictment alleges that kickbacks and bribes were also used to obtain medical providers' signatures, generating the fraudulent physician orders. Mr. French also allegedly paid for physicians' orders for orthotic braces that were then sold to suppliers and brokers in exchange for millions in kickbacks and bribes.”
Comment: Never ceases to amaze me how Medicare lets this magnitude of fraud get by for so long.

Are employees getting fed up with high-deductible health plans? “According to ValuePenguin, a financial resource platform by LendingTree, HDHP enrollment has dropped by 2%, the first decline since 2013. While nearly 56% of American private-sector workers were enrolled in HDHPs as of 2021, that number fell to just under 54% in 2022, marking a small but possibly significant shift in U.S. healthcare. Overall, 32 states saw decreased HDHP enrollment…
Notably, large employers seem intent on offering a more diverse array of health plans. In 2018, 22% of employers with 20,000 employees or more offered only HDHPs — that number dropped to 9% in 2022….
According to exclusive research by EBN's parent company Arizent, employees with HDHPs are 30% less confident they will know what their healthcare costs will be, at least most of the time, compared to employees with preferred provider organization plans, or PPOs, which usually have lower deductibles. Unsurprisingly, Arizent found that 70% of HDHP users found their healthcare costs too expensive, versus 50% of PPO users.”

About pharma

Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus “One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said.
A subcutaneous formulation of Ocrevus helped 97% of MS patients achieve no relapse up to 48 weeks of treatment, according to updated data from the phase 3 OCARINA II study presented at the American Academy of Neurology (AAN) annual meeting.
Besides lowering the annual relapse rate to an estimated 0.04, subcutaneous Ocrevus also suppressed brain lesions as shown on MRI imaging by 97%. Most patients had no T1 gadolinium-enhancing lesions or worsening T2 lesions, which are markers of active inflammation and burden of disease, respectively.”

Top 15 specialty pharmacies by 2023 revenue FYI

 AbbVie links up with Medincell for $2B injectables deal “AbbVie said Tuesday it will pay Medincell $35 million upfront to co-develop up to six therapies using the latter’s BEPO platform for long-acting injectables. 
Medincell is eligible for up to $315 million in development and commercial milestones for each programme, for a total of $1.9 billion, plus mid-single- to low-double-digit royalties.
While the pharma said the partnership covers “multiple therapeutic areas and indications,” details were sparse on whether the injectable therapies will be reformulations of existing AbbVie drugs, or novel therapeutics. 
Medincell’s platform enables bioresorbable delivery of a drug at therapeutic levels for several days, weeks or months from one injection.”

Takeda bets up to $1.2B on Kumquat's immuno-oncology candidate “akeda has entered into a strategic collaboration and exclusive global licensing agreement with Kumquat Biosciences potentially worth over $1.2 billion to develop and commercialise an oral immuno-oncology small molecule inhibitor.
As part of the deal announced Tuesday, Kumquat will receive up to $130 million in near-term payments from Takeda. It is also eligible for over $1.2 billion in future clinical, regulatory, and commercial milestones, as well as tiered royalties on net sales of any approved products resulting from the tie-up.
Kumquat will lead research efforts and fund early clinical development through Phase I testing of the undisclosed cancer candidate, which can be developed as a monotherapy or in combination with other drugs. Subject to Kumquat's option, Takeda will assume and fund all development and commercialisation activities beyond Phase I activities led by the San Diego-based biotech.”

Sandoz bucks trend with “explosion” in US prescriptions for Humira biosimilar “CVS Caremark’s decision to replace AbbVie’s Humira (adalimumab) with biosimilar versions of the anti-TNF-α monoclonal antibody has led to a recent “explosion” in new prescriptions for Sandoz’s Hyrimoz (adalimumab-adaz). The numbers, detailed in a recent analyst note from Evercore ISI, signal that biosimilars may be able to finally break Humira's market dominance in the US.
Humira lost patent protection in the US at the start of 2023 and currently faces competition from nine biosimilars, including interchangeable versions in Boehringer Ingelheim's Cyltezo (adalimumab-adbm) and more recently Teva/Alvotech's Simlandi (adalimumab-ryvk). However, Evercore ISI analysts noted that as of the end of March, AbbVie’s drug still held on to around 95% market share for new prescriptions.”

About the public’s health

New long-term data show Shingrix continues to provide high protection against shingles in adults aged 50 and over for more than a decade Summary:
—”End-of-trial data show 79.7% efficacy in participants aged 50 years and over, six to 11 years after vaccination1
—Vaccine efficacy remains high at 82.0% at year 11 after initial vaccination1
—No new safety concerns were identified during the follow-up period.” 

About healthcare personnel

 New AACN Data Points to Enrollment Challenges Facing U.S. Schools of Nursing “New data released today by the show that sustaining student enrollment in baccalaureate and graduate programs continues to be a challenge at U.S. schools of nursing. Though enrollment in programs designed to prepare entry-level registered nurses held steady (up 0.3%), fewer students are entering baccalaureate degree-completion, master’s, and PhD programs, which poses a threat to meeting the nation’s healthcare needs.”
See the article for further details.

About healthcare finance

Private equity healthcare bankruptcies are on the rise: 8 things to know One interesting fact is that: “About 460 U.S. hospitals are owned by private equity firms. That represents 8% of all private hospitals and 22% of all proprietary for-profit hospitals… At least 26% of private equity-owned hospitals serve rural populations.”

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About health insurance/insurers

 UnitedHealth Group posts $1.4B loss in Q1 amid Change cyberattack fallout “UnitedHealth Group released its first-quarter earnings Tuesday morning as the industry continues to reel from the massive cyberattack on its Change Healthcare unit.
UHG reported a loss of $1.4 billion in the quarter, compared to $5.6 billion in profit for the first quarter of 2023. Revenues reached $99.8 billion, up from $91.9 billion in the prior-year quarter. The hack was a major factor in the company's performance, along with the sale of its Brazil-based business Amil, which drove $7 billion charge in the quarter.”

Hackers leak Change Healthcare contracts, patient data “Hackers leaked contracts and patient records purportedly stolen in the Change Healthcare cyberattack, TechCrunch reported April 15.
Ransomware group RansomHub posted files on its dark web leak site April 15 comprising personal and protected health information on patients whose data was taken in the Change hack, according to the story. The files also include contracts and agreements between Change and its clients. It marked the first time hackers have posted data from the cyberattack.”

HSAs Reduce Use of Outpatient Services and Prescription Drugs, Increase Use of Inpatient Services; Overall Spending Unaffected A few highlights:
“• Office visits shifted from specialist visits to primary care visits among HSA plan enrollees.
• HSA plan enrollees filled fewer prescriptions as compared with PPO enrollees.
• Overall, HSA plan enrollment had no impact on total spending — there was no statistically significant difference in overall spending between HSA plan and PPO enrollees. However, spending was $60.30 or 2 percent lower PMPY among HSA plan enrollees with no health conditions as compared with PPO enrollees, but spending was $2,490 or 6 percent higher PMPY among HSA plan enrollees with two or more health conditions. This higher spending was driven by 21 percent higher spending on inpatient services.”

CMS delays implementation of new Medicare, Medicaid data rules “CMS will delay implementation of new policies designed to heighten security around Medicare and Medicaid data that drew criticism from researchers. 
On April 15, the agency said it will delay implementation of the policies, originally slated to take effect in August, to 2025 at the earliest. CMS also extended the deadline for public comment on the rules to May 15. 
The new proposal would up starting costs for Medicare and Medicaid data to $35,000 and allow only one researcher access to the requested data, which will be stored on a CMS platform. In January, more than 300 researchers signed a draft letter opposing the change, writing it would have a ‘catastrophic impact’ on health policy research, limiting access to data to institutions able to pay higher costs for it.”

Elevance Health strikes primary care deal with private equity firm “Elevance Health will enter a partnership with private equity firm Clayton, Dubilier & Rice to develop advanced primary care models. 
The joint effort will operate across multiple states and commercial, individual, Medicare and Medicaid markets, according to an April 15 news release. The payer-agnostic platform will serve more than 1 million members, the companies said. 
The deal is financed primarily "through a combination of cash and our equity interest in certain care delivery and enablement assets of Carelon Health," according to the news release. The two companies did not disclose the financial terms of the deal, and it is not expected to have a material impact on Elevance's 2024 earnings.”

About pharma

CVS' Oak Street Health to open clinics at retail pharmacies “CVS Health is opening Oak Street Health primary care clinics at its retail pharmacy stores — a move that hasn’t always worked out for competitors.
CVS acquired Chicago-based primary care provider Oak Street in May for $10.6 billion and announced plans to add 50 to 60 Oak Street clinics in 2024. Most of those clinics are expected to be standalone locations, including some located in closed CVS stores. But CVS also is piloting a setup that replaces much of the retail space in existing stores with clinics.”
Comment: It is unclear how this strategy/management will differ from the failing VillageMD efforts of Walgreens.

About the public’s health

 Biden administration announces new partnership with 50 countries to stifle future pandemics “U.S. government officials will offer support in the countries, most of them located in Africa and Asia, to develop better testing, surveillance, communication, and preparedness for such outbreaks in those countries.”

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About Covid-19

Executive Order on COVID-⁠19 and Public Health Preparedness and Response “At this stage of my Administration’s response to COVID-19, I have determined that certain Executive Orders are no longer necessary and that certain roles and responsibilities established by other Executive Orders related to COVID-19 should be transferred to the OPPR[Office of Pandemic Preparedness and Response Policy]…
Revocations.  Executive Order 13910 of March 23, 2020 (Preventing Hoarding of Health and Medical Resources to Respond to the Spread of COVID-19), Executive Order 13991 of January 20, 2021 (Protecting the Federal Workforce and Requiring Mask-Wearing), and Executive Order 13998 of January 21, 2021 (Promoting COVID-19 Safety in Domestic and International Travel), are hereby revoked.”

About healthcare quality

 Groups unveil value-based care playbook “AHIP, the American Medical Association and the National Association of ACOs have released a playbook of voluntary best practices for value-based care payment arrangements…
The voluntary best practices are broken into seven domains:

  1. Patient attribution

  2. Benchmarking 

  3. Risk adjustment

  4. Quality performance impact on payment 

  5. Levels of financial risk 

  6. Payment timing and accuracy 

  7. Incentivizing for value-based care practice participant performance”

About health insurance/insurers

CMS officials say agency is monitoring concerns from ACOs about DME costs “The National Association of ACOs (NAACOS) told the feds that a review of data from CMS' Virtual Research Data Center found a spike in payments related to two billing codes. Payments for urinary catheters grew from $153 million in 2021 to an eye-popping $2.1 billion in 2023.”

 Healthcare billing fraud: 12 recent cases FYI

Medicaid Enrollment and Unwinding TrackerAt Least 20,104,000 Medicaid Enrollees Have Been Disenrolled and 43,640,000 Have Had Their Coverage Renewed, as of April 11, 2024.”

About pharma

 The top 20 pharma companies by 2023 revenue FYI. J&J replaced Pfizer at the top spot.

 About healthcare personnel

Updated Report: Hospital and Corporate Acquisition of Physician Practices and Physician Employment 2019-2023 Summary:
●  “Employment by hospitals and corporate entities is nearing 80%.
19,100 additional physicians became employees of hospitals or other corporate entities over the last two years
● This represents a 5.1% increase in the percentage of employed physicians since 2022
● Hospitals and other corporate entities acquired 8,100 additional physician practices over the last two years
● This represents a 6.0% increase in the percentage of hospital or corporate-owned practices since 2022”

Life Cycle of Private Equity Investments in Physician Practices: An Overview of Private Equity Exits “Private equity firms acquire and grow physician practices through add-on consolidation, generating outsized returns on the sale of the acquisition in 3-8 years (“exit”). PE’s abbreviated investment timeline and exit incentives may deter long-term investments in care delivery and workforce needed for high quality care…
Of 807 acquisitions, over half (51.6%) of PE-acquired practices underwent an exit within 3 years of initial investment. In nearly all instances (97.8%), PE firms exited investments through secondary buyouts, where physician practices were resold to other PE firms with larger investment funds. Between investment and exit, PE firms increased the number of physician practices affiliated with the PE firm by an average of 595% in 3 years.”

About health technology

Alzheimer's blood test from Roche, Eli Lilly nabs FDA breakthrough tag “After more than a year in the works, Roche and Eli Lilly have taken a step closer to delivering their blood test designed to aid in the diagnosis of earlier cases of Alzheimer’s disease.
The FDA has granted their work a breakthrough designation to help accelerate its development. Roche’s Elecsys plasma assay searches for and quantifies phosphorylated fragments of the brain protein tau, known as pTau-217, with the goal of capturing a biomarker that can distinguish Alzheimer’s from other neurodegenerative disorders.”

 Illumina gets go-ahead from European Commission to part ways with Grail “Illumina has received a green light from the European Commission to proceed with unwinding its ownership of Grail, though the details of that plan have yet to be unveiled.
The DNA sequencing giant still has the freedom to choose between selling the cancer blood test developer to another party outright or supporting its journey to the public markets as an independent spinout—and previously set a deadline for that decision at the end of June, after missing out on appeal in U.S. courts last December.
The commission officially ordered Illumina to cut ties with Grail last October, more than a year after the companies completed their $8 billion takeover deal ahead of clearing the European Union’s antitrust review process. The U.S. Federal Trade Commission delivered a similar edict last year on its side of the pond.”

Today's News and Commentary

About health insurance/insurers

CMS pitches inpatient payment rule for 2025: 8 things to know FYI from CMS

About hospitals and healthcare systems

M&A Quarterly Activity Report: Q1 2024 “With 20 announced transactions, Q1 2024 showed a significant uptick in M&A activity and represents the strongest Q1 we have seen since 2020.
Of the 20 announced transactions, four were “mega mergers” (transactions in which the smaller party has annual revenues of $1 billion or more).This is one of the highest numbers of mega mergers we have seen and contributed to average seller size and total transacted revenue figures that remain at historically high levels.Academic health systems also had an active quarter, acting as the acquirer (or larger party) in six of the 20 announced transactions.”

User Information Sharing and Hospital Website Privacy Policies “In this cross-sectional analysis of a nationally representative sample of 100 nonfederal acute care hospitals, 96.0% of hospital websites transmitted user information to third parties, whereas 71.0% of websites included a publicly accessible privacy policy. Of 71 privacy policies, 40 (56.3%) disclosed specific third-party companies receiving user information.”

One Year After Medicaid Unwinding Began, Community Health Centers, Their Patients, and Their Communities are Feeling the Impact “This analysis confirms that consistent with the nationwide unwinding process, patient disenrollment is experienced by virtually all community health centers. An estimated one in four health center patients has lost coverage to date…
If these coverage loss estimates (disenrollment of 1 in 4 health center patients) remain consistent as unwinding continues into 2024, CHCs can expect that more than 3.5 million patients will experience coverage disruptions. Similarly, if the low reenrollment rate seen here remains constant, then three-fourths of all patients losing Medicaid will remain disenrolled, leading to disruption not only in coverage but in care itself, along with substantial revenue loss that will further affect ongoing CHC operations. Most concerning, perhaps, is disruption in pediatric coverage…” 

State public option plans don't reduce premiums, result in low enrollment: industry-backed study “Instead of enacting public option plans, states should target reinsurance programs, a new report from the Partnership for America's Health Care Future argues…
States with public options fail to curb premium spending and fail to meet reimbursement rate targets, the analysis contends.
Public option advocates believe widespread implementation will reduce premiums and expand coverage. State public option plans rely on insurers to administer plans.”

About the public’s health

Recent increase in measles cases threatens elimination status in the US, CDC says “More than 100 cases of measles have been reported in the United States since the start of the year, and the US Centers for Disease Control and Prevention warns that a rapid rise in cases — significantly more than in recent years — poses a renewed threat to the country’s disease elimination status.” 

Today's News and Commentary

About health insurance/insurers

 CMS proposes 2.6% bump to inpatient pay in fiscal 2025 “The Biden administration is proposing a 2.6% increase for inpatient hospitals’ payments for the coming fiscal year, a $3.3 billion increase over the current year’s payout, as well as other policy adjustments intended to shore up surgical care coordination, drug supply, emergency preparedness monitoring, maternal health and care for the underserved.”

About hospitals and healthcare systems

 472 hospitals honored for patient safety, price transparency FYI

 About pharma

Drugmakers race to find alternative suppliers as US cracks down on Chinese biotech “Western pharmaceutical companies are in talks with alternative suppliers in response to draft US legislation seeking to restrict an important Chinese drug developer and manufacturer over national security concerns. The Biosecure Act would prohibit US companies receiving federal grant money from working with four Chinese biotech companies, including WuXi AppTec and its sister company WuXi Biologics, which produce active pharmaceutical ingredients (API) for hundreds of US and European drugmakers. Companies, including US-based Eli Lilly, Vertex Pharmaceuticals and BeiGene in Switzerland, have been talking with rival contract manufacturers to diversify production away from WuXi companies, according to several people familiar with discussions.”

Medicare expects to spend $3.5 billion on new Alzheimer’s drug in 2025 “Medicare’s actuaries expect the drug Leqembi, made by the Japanese drugmaker Eisai and sold in partnership with Biogen, to cost the traditional Medicare program around $550 million in 2024, and the entire Medicare program $3.5 billion in 2025, a spokesperson for the Centers for Medicare and Medicaid Services confirmed to STAT. That projection forecasts a large increase in uptake over the next year and a half.
The estimate was buried in a new CMS document that addressed questions about next year’s payments for Medicare Advantage plans…”

Drug Shortages Statistics Summary

  • Ongoing and active shortages are the highest number (323) since we began tracking data in 2001.

  • Basic and life-saving products are in short supply including oxytocin, Rho(D) immune globulin, standard of care chemotherapy, pain and sedation medications, and ADHD medications.

  • New DEA quota changes, along with allocation practices established after opioid legal settlements, are exacerbating shortages of controlled substances (12% of all active shortages).

  • Workload required to manage shortages, including work to change pharmacy automation and electronic health records, adds to the challenges of pharmacy staff shortages.” 

 

About the public’s health

Lunchables under fire after reports of concerning lead, sodium levels “Consumer Reports is calling for the removal of Lunchables from school trays across the country after discovering concerning levels of lead and sodium and a potentially harmful chemical in their packaging in products sold in stores.
A petition lobbying the U.S. Department of Agriculture to get rid of the Kraft Heinz products from the National School Lunch Program has more than 14,000 signatures…
Consumer Reports’ findings follow a Washington Post investigation last year that showed how powerful food companies get ultra-processed foods such as Lunchables to qualify for the National School Lunch Program through years of extensive lobbying to lower government nutrition standards.”

About healthcare personnel

Top Factors in Nurses Ending Health Care Employment Between 2018 and 2021 “In this cross-sectional study of 7887 nurses who were employed in a non–health care job, not currently employed, or retired, the top contributing factors for leaving health care employment were planned retirement (39% of nurses), burnout (26%), insufficient staffing (21%), and family obligations (18%). Age distributions of nurses not employed in health care were similar to nurses currently employed in health care.”

Top 5 Reasons for Medical Malpractice Lawsuits “There are numerous reasons a patient or caregiver might name physicians in a medical malpractice lawsuit, but these were the top five cited and the percentage of claims they comprised in the 2023 survey vs. the 2021 report:

  1. Failure to diagnose or delayed diagnosis: 35%, up from 31%

  2. Complications from treatment or surgery: 27%, down from 29%

  3. Failure to treat or delayed treatment: 22%, up considerably from 16%

  4. Poor outcomes or disease progression: 20%, down from 26%

  5. Wrongful death: 15%, up from 13%”

About healthcare finance

Data for Alpine’s kidney disease candidate drive Vertex’s $4.9B takeover “Alpine Immune Sciences’ pivot away from cancer in 2022 has proven to be a profitable choice. After doubling down on its autoimmune and inflammatory disease pipeline, the biotech on Wednesday shared new data for its kidney disease programme — and announced a $4.9 billion buyout by Vertex Pharmaceuticals.”

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About pharma

Top PBMs by 2023 market share
“CVS Caremark: 34%
Express Scripts: 23%
OptumRx (UnitedHealth): 22%
Humana Pharmacy Solutions: 7%
MedImpact Healthcare Systems: 5%
Prime Therapeutics: 3%
All other PBMs and cash pay: 6% “

About the public’s health

 EPA to crack down on toxic emissions from more than 200 chemical plants “The Environmental Protection Agency (EPA) finalized rules Tuesday that it said would dramatically reduce the number of people facing elevated cancer risks because of their exposure to air pollution. 
The number of people who have elevated cancer risks because they live within 6 miles of a chemical plant would drop by 96 percent, the EPA said. Cancer cases within about 31 miles of facilities that release toxic pollution into the air are expected to fall by about 60 percent under the rule.
That’s because the new regulations on 218 chemical plants are expected to cause them to reduce their releases of toxic pollution by more than 6,200 tons per year.”

In a first, EPA sets limit for ‘forever chemicals’ in drinking water “The Environmental Protection Agency has finalized the nation’s first drinking water standard for “forever chemicals,” a group of persistent human-made chemicals that can pose a health risk to people at even the smallest detectable levels of exposure.
The new rules are part of the Biden administration’s efforts to limit pollution from these per- and polyfluoroalkyl substances, or PFAS, which can persist in the environment for centuries. Exposure to PFAS has been linked to an increased risk of certain types of cancer, low birth weights, high cholesterol, and negative effects on the liver, thyroid and immune system.”

The Nature of the Rural-Urban Mortality Gap “The 2019 age-adjusted natural-cause mortality (NCM) rate for the prime working-age population (aged 25–54) was 43 percent higher in rural (nonmetropolitan) areas than in urban (metropolitan) areas. This is a shift from 25 years ago when NCM rates in urban and rural areas were similar for this age group. As a first step to understanding the increasing gap between rural and urban NCM rates, this report examines natural (disease-related) deaths for prime working-age adults in rural and urban areas between 1999 and 2019 using data from the U.S. Department of Health and Human Services, Centers for Disease Control’s Wide-ranging Online Data for Epidemiology Research (WONDER).”

Long-Term Effect of Salt Substitution for Cardiovascular Outcomes: A Systematic Review and Meta-Analysis  “Salt substitution may reduce all-cause or cardiovascular mortality, but the evidence for reducing cardiovascular events and for not increasing serious adverse events is uncertain, particularly for a Western population. The certainty of evidence is higher among populations at higher cardiovascular risk and/or following a Chinese diet.”

About healthcare IT

 Healthcare Should Look to Other Industries to Drive Digital Transformation, J.D. Power Says “Navigating health insurance digital channels is not easy. A surprising 42% of insured adults say they have experienced a problem using their health insurance website and/or app the past 12 months,1 and according to the inaugural J.D. Power U.S. Healthcare Digital Experience Study,SM released today, the websites and digital apps provided by commercial member health plans and Medicare Advantage plans are not helping matters. In fact, nearly one-third (32%) of health insurance websites and apps don’t meet the foundational level of functionality and intuitive organization of information.”

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About health insurance/insurers

The Effects of Medical Debt Relief: Evidence from Two Randomized Experiments “Two in five Americans have medical debt, nearly half of whom owe at least $2,500. Concerned by this burden, governments and private donors have undertaken large, high-profile efforts to relieve medical debt. We partnered with RIP Medical Debt to conduct two randomized experiments that relieved medical debt with a face value of $169 million for 83,401 people between 2018 and 2020. We track outcomes using credit reports, collections account data, and a multimodal survey. There are three sets of results. First, we find no impact of debt relief on credit access, utilization, and financial distress on average. Second, we estimate that debt relief causes a moderate but statistically significant reduction in payment of existing medical bills. Third, we find no effect of medical debt relief on mental health on average, with detrimental effects for some groups in pre-registered heterogeneity analysis.”

MA enrollees like breadth of plan options, Harvard research finds “Previous research from Harvard and Inovalon has found that MA enrollees have fewer hospitalizations, have greater challenge in overcoming social determinants of health, and have fewer inpatient hospital stays.
This white paper (PDF) also looks at enrollees in health maintenance organizations (HMOs), finding these individuals are three times more likely to be nonwhite than people in MA preferred provider organizations (PPO) plans. Additionally, utilization in HMOs is 29% lower than comparable MA PPO populations, meaning nearly $2,500 lower utilization per person.”

About hospitals and healthcare systems

How labor costs are tracking at 30 health systems FYI

About pharma

Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval “ In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did not improve overall survival or quality of life in confirmatory trials after more than 5 years of follow-up, with results not yet available for another 15% (7/46). Among drugs converted to regular approval, 60% (29/48) of conversions relied on surrogate measures.”

About healthcare IT

 One-third of Healthcare Websites Still Use Meta Pixel Tracking Code “A recent analysis of healthcare websites by Lokker found widespread use of Meta Pixel tracking code. 33% of the analyzed healthcare websites still use Meta pixel tracking code, despite the risk of lawsuits, data breaches, and fines for non-compliance with the HIPAA Rules.”

How Regenstrief and HL7 are driving SDOH data standards “Launched in 2019, the Gravity Project is a national public-private collaborative aimed at creating consensus-based data standards for SDOH interoperability across the health, social services, public health and research sectors.
The community includes over 2,500 stakeholders across healthcare, health IT, payers, community-based organizations, government agencies and research institutions like Regenstrief Institute…
A new $4.4 million grant from the Regenstrief Foundation is looking to take the Gravity Project to the next level by standardizing social risk factors in appropriate terminologies…”

Surescripts exploring a sale: report Dive Brief:

  • Healthcare IT giant Surescripts is looking for a buyer, according to a Tuesday report from Business Insider. 

  • The electronic prescribing company has hired healthcare investment bank TripleTree to explore a sale — potentially to a private equity firm, according to the Business Insider report, citing sources familiar. 

  • A private equity deal is logical, as a sale to a strategic player — like a payer with its own pharmacy benefit manager — could raise antitrust concerns, one expert told Healthcare Dive.”

Another ransomware group is seeking a payout from Change Healthcare, according to cybersecurity analysts “After the hackers responsible for the cyberattack on Change Healthcare took the ransom and ran in a reported exit scam, cybersecurity experts have found a new post that is seeking a payout from UnitedHealth Group to recover the data.
A post from RansomHub claims to have four terabytes of data stolen from Change, according to analyst Dominic Alvieri. The listing alleges that the administration of BlackCat, or ALPHV, stole a $22 million ransom payment made to recover the data.
Neither UnitedHealth nor Optum have confirmed that the payment was made, but researchers have identified payment logs that suggest the money changed hands.”

Today's News and Commentary

About quality and safety

Safety in healthcare 2024 From PressGaney: “Key safety takeaways for 2024: 

  • The gap in patient perceptions of safety in inpatient and outpatient settings is now 2.5x wider than pre-pandemic. While patients in medical practices and ambulatory settings felt substantially safer in 2023 (81.9%) compared to pre-pandemic levels (78.1%), perceptions of safety in hospitals fell 5.1%.   

  • Following record lows in 2021, workplace safety culture is increasing. Employee views of safety within their organization have risen 1.2% over the last two years, but nearly half still report low perceptions of safety culture.  

  • Reported assaults against nursing personnel jumped 5% YOY. In 2023, the rate of reported assaults against nurses increased to 2.71 per 100 nursing personnel, from 2.59 the previous year.  

  • Safety outcomes show continued momentum. The biggest improvement was seen in catheter-associated urinary tract infection (CAUTI) rates, which are now better than pre-pandemic levels.”

About health insurance/insurers

In Battle Over Health Care Costs, Private Equity Plays Both Sides An excellent article worth reading in its entirety. An excerpt:
”Insurance companies have long blamed private-equity-owned hospitals and physician groups for exorbitant billing that drives up health care costs. But a tool backed by private equity is helping insurers make billions of dollars and shift costs to patients.
The tool, Data iSight, is the premier offering of a cost-containment firm called MultiPlan that has attracted round after round of private equity investment since positioning itself as a central player in the lucrative medical payments field. Today Hellman & Friedman, the California-based private equity giant, and the Saudi Arabian government’s sovereign wealth fund are among the firm’s largest investors.
The evolution of Data iSight, which recommends how much of each medical bill should be paid, is an untold chapter in the story of private equity’s influence on American health care.”
See, also: Insurers Reap Hidden Fees by Slashing Payments. You May Get the Bill.

Contract Year 2025 Medicare Advantage and Part D Final Rule (CMS-4205-F) From CMS. Well-wroth skimming the major points.

Medicare billing forms are running out of space for growing health care prices “CMS last month said it was adding two digits to the Medicare claims processing system for hospital and doctor office charges, called the Fiscal Intermediary Shared System, so that it can now accommodate prices just a penny shy of $100 million.”

Healthcare services ranked by Medicare Advantage utilization increases “Medicare Advantage plans saw utilization rates rise 8.1% in the fourth quarter of 2023, primarily driven by outpatient and emergency room services, according to an AHIP survey.”
The article details specific service changes.

About hospitals and healthcare systems

 HHS pitches rewards for hospitals with drug shortage solutions “Every year, U.S. hospitals spend at least $600 million to mitigate drug shortages, according to HHS. On April 2, the department proposed financial incentives for hospitals with resilient drug supplies. 
In an 18-page policy recommendation, HHS recommended a Manufacturer Resiliency Assessment Program and a Hospital Resilient Supply Program. The programs, which HHS defined as long-term solutions, would assess and rank drug manufacturers based on their reliability. 
Hospitals would then be rewarded for buying drugs from diverse and reliable suppliers.”
See, also:Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States

From -6.8% to 12.2%: 42 health systems ranked by operating margins FYI

March 2024 National Hospital Flash Report “Key Takeaways
1. Margins this month were at 3.96%, continuing a strong start to 2024. However, data this month do not reflect the full impact of the Change Healthcare outage, which began February 21st.
2. Gross revenue continues to rise at a faster rate than net revenue, highlighting payer mix changes. Bad debt and charity care have also risen over the last few years.
3. Revenue growth is primarily being driven from the outpatient setting. There continues to be a decline in inpatient revenue and increase in outpatient revenue.”

About pharma

Sanofi agrees to settle thousands of Zantac cancer claimsSanofi confirmed to FirstWord on Friday that it reached a deal in principle to settle approximately 4000 personal injury lawsuits accusing the company of selling the now-discontinued heartburn medicine Zantac (ranitidine) without warning patients that it could potentially cause cancer.
The settlement, which marks the first major resolution of cases related to the product, will apply to litigation pending in courts in US states other than Delaware, where the company is still facing some 20,000 lawsuits.”

 Healthy Returns: Weight loss, diabetes drug ad spending tops $1 billion “Companies spent more than $1 billion on ads for weight loss and diabetes medicines in 2023, up 51% from the prior year, according to new data from advertising analytics firm MediaRadar. That’s nearly 15% of drugmakers’ $7.6 billion in ad spending for prescription drugs last year.
Diabetes treatments accounted for nearly $790 million in ad spending in 2023, while weight loss drugs made up almost $264 million.”

Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval Question  What is the clinical benefit of cancer drugs granted accelerated approval, and on what basis are they converted to regular approval?
Findings  In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did not improve overall survival or quality of life in confirmatory trials after more than 5 years of follow-up, with results not yet available for another 15% (7/46). Among drugs converted to regular approval, 60% (29/48) of conversions relied on surrogate measures.”

Patient Out-of-Pocket [OOP] Costs for Biologic Drugs After Biosimilar Competition “In this cohort study of 190 364 outpatients with 1.7 million claims for 7 biologics between 2009 and 2022, annual OOP spending did not decrease after the start of biosimilar competition, and OOP costs were similar for biosimilars and their reference biologics.”
See, also: Revisiting Expectations of US Biosimilars—Panacea or One Piece of the Puzzle?

About healthcare finance

 Johnson & Johnson adds Shockwave Medical to its cardiovascular collection with $13.1B deal “J&J MedTech sees Shockwave’s pioneering portfolio of intravascular lithotripsy catheters—minimally invasive devices that use acoustic energy to shatter the hard, calcified blockages found deep within coronary and peripheral arteries—as the ticket to its 13th priority platform: one that will join its pantheon of products that each claim more than $1 billion in annual sales.
The deal follows up on 2023’s integration of the miniature heart pump maker Abiomed, a $16.6 billion buy, as well as J&J’s $400 million purchase of cardiac implant developer Laminar, aimed at reducing a person’s long-term risk of stroke linked to atrial fibrillation.”

Healthcare Dealmakers—Elevance to acquire Kroger Specialty Pharmacy; Optum to buy Steward's physician group and more FYI

Today's News and Commentary

NIH’s Role in Sustaining the U.S. Economy “In Fiscal Year 2023, the $37.81 billion NIH awarded to researchers in the 50 U.S. states and the District of Columbia supported 412,041 jobs and $92.89 billion in economic activity.”

About Covid-19

 The new COVID-19 drug “The medication, Pemgarda, is a monoclonal antibody that targets the SARS-CoV-2 spike protein, and it is indicated for patients 12 and older. The authorization is not an approval, meaning the FDA greenlit the medicine ‘based on a reasonable belief that the product may be effective based on the best evidence available at the time,’ its website says, ‘without waiting for all the information that would be needed for an FDA approval.’”

About health insurance/insurers

Medicare Spending on Ozempic and Other GLP-1s Is Skyrocketing “KFF’s analysis of newly released Medicare Part D spending data from CMS shows that total gross Medicare spending on these medications has skyrocketed in recent years, rising from $57 million in 2018 to $5.7 billion in 2022 (Figure 1). (Gross spending does not account for rebates that would result in lower net spending.) As of 2022, Part D covered three GLP-1s for diabetes: Ozempic (semaglutide injection), approved in December 2017; Rybelsus (semaglutide tablets), approved in September 2019; and Mounjaro (tirzepatide) approved in May 2022.”

Medicaid disenrollments surpass 18M, exceeding HHS projections “The Families First Coronavirus Response Act required Medicaid to provide continuous coverage for beneficiaries throughout the COVID-19 pandemic. With disenrollments paused, Medicaid and the Children’s Health Insurance Program (CHIP) enrollment grew by over 23 million beneficiaries.
The continuous coverage policy ended with the public health emergency, and states could begin coverage redeterminations on April 1, 2023. HHS had projected that 15 million beneficiaries would lose Medicaid coverage. However, as of March 20, 2024, more than 18 million people have been disenrolled. What’s more, 35 million beneficiaries’ eligibility redeterminations have either still not been completed or have not been reported.”

About hospitals and healthcare systems

 FAIR SHARE SPENDING Are hospitals giving back as much as they take? “KEY TAKEAWAYS

  • Of 2,425 nonprofit hospitals evaluated, 80% spent less on financial assistance and community investment than the estimated value of their tax breaks (what we call a fair share deficit).

  • The combined fair share deficit for all hospitals studied is $25.7 billion for 2021. That’s enough to erase 29% of the country’s medical debt (as reported on the CFPB’s Consumer Credit Panel).

  • The ten hospitals with the largest fair share deficits also reported at least one hundred million dollars in net income in 2021.

  • Hospitals spent 3.87% of their budget on community investments, on average, but this proportion varied widely. For example, the Hospital of the University of Pennsylvania (0.25%) would have spent $248 million more in community investments had it spent at the rate of North Shore University Hospital (8.84%).

  • Five Catholic health systems are among the ten systems with the greatest fair share deficits: Providence, CommonSpirit, Trinity, Ascension, and Bon Secours Mercy.

  • There are only five states in which a majority of hospitals have a fair share surplus: Delaware, Montana, Maryland, Texas, and Utah.

  • These five states have 97% or more hospitals with a fair share deficit: Michigan, West Virginia, Louisiana, Washington, Rhode Island.” 

About pharma

Pharmaceutical company Amgen sues Colorado over price-setting prescription drug board “Amgen, the multinational pharmaceutical company that makes the blockbuster arthritis drug Enbrel, has sued Colorado over a state board’s efforts to possibly cap the price of the drug.
In a lawsuit filed Friday in U.S. District Court in Denver, Amgen argues that the actions of Colorado’s Prescription Drug Affordability Board are unconstitutional because they conflict with federal laws and because they violate rights to due process. The company is seeking not just to overturn the board’s recent decisions about Enbrel but also to strike down major parts of the law creating the board.”
Other drugs are being considered as well. For more analysis, see: Colorado is pushing to cap drug prices. It’s likely to be in for a fight.

Association of State Insulin Out-of-Pocket [OOP] Caps With Insulin Cost-Sharing and Use Among Commercially Insured Patients With Diabetes “State insulin caps were not associated with changes in insulin use in the overall population (relative change in fills per month, 1.8% [95% CI, −3.2% to 6.9%]). Insulin users in intervention states saw a 17.4% (CI, −23.9% to −10.9%) relative reduction in insulin OOP costs, largely driven by reductions among HSA enrollees; there was no difference in OOP costs among nonaccount plan members. More generous ($25 to $30) state insulin OOP caps were associated with insulin OOP cost reductions of 40.0% (CI, −62.5% to −17.6%), again primarily driven by a larger reduction in the subgroup with HSA plans.”

Merck & Co.’s Winrevair nabs highly-anticipated approval in PAH “After Merck & Co. posted data last year showing the extent to which Winrevair (sotatercept-csrk) can boost exercise capacity and prolong survival, the FDA's approval Tuesday of the first-in-class activin signalling inhibitor to treat adults with pulmonary arterial hypertension (PAH) took few by surprise. The outstanding question, however, is how and when the disease-modifying therapy gets incorporated into PAH treatment regimens that haven’t seen a drug with a novel mechanism of action in years.”

About the public’s health

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.” 

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.”