Today's News and Commentary

About health insurance/insurers/costs

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

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

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

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

About hospitals and healthcare systems

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

About the public’s health

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

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

About healthcare IT

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

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

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

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

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

About healthcare personnel

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

Today's News and Commentary

About health insurance/insurers

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

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

About hospitals and healthcare systems

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

About pharma

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

About healthcare IT

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

About health technology

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

About healthcare finance

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

Today's News and Commentary

About Covid-19

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

About health insurance/insurers

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

About hospitals and healthcare systems

 13 healthcare mergers and acquisitions making headlines in June  FYI

About pharma

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

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

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

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

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

About the public’s health

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

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

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

About healthcare IT

10 largest healthcare data breaches so far in '23 FYI

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

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

About healthcare personnel

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

About healthcare finance

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

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

Today's News and Commentary

About Covid-19

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

About health insurance/insurers

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

Healthcare billing fraud: 11 recent cases FYI

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

About hospitals and healthcare systems

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

About pharma

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

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

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

About the public’s health

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

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

About healthcare IT

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

About health technology

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

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

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

Today's News and Commentary

About health insurance/insurers

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

About hospitals and healthcare systems

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

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

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

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

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

About pharma

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

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

About healthcare IT

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

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

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

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

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

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

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

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

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

About healthcare personnel

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

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

1. Private equity: 65 percent

2. Physician medical groups: 14 percent

3. Payers: 11 percent

4. Hospitals and health systems: 8 percent

5. Other: 4 percent 

About health technology

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

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

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

Today's news and Commentary

About health insurance/insurers

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

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

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

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

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

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

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

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

About hospitals and healthcare systems

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

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

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

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

  • Details regarding prior acquisitions

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

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

About pharma

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

About the public’s health

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

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

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

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

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

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

About healthcare personnel

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

About healthcare finance

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

Today's News and Commentary

About Covid-19

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

About health insurance/insurers

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

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

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

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

About the public’s health

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

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

About healthcare IT

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

About health technology

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

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

Today's News and Commentary

About health insurance/insurers

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

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

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

About hospitals and healthcare systems

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

 JUNE 2023 National Hospital Flash Report “Key Takeaways

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

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

  2. People are becoming more comfortable with inpatient care.

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

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

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

  4. Labor expenses are beginning to decline.

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

About pharma

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

About healthcare personnel

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

Today's News and Commentary

About health insurance/insurers

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

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

About hospitals and healthcare systems

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

About pharma

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

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

About the public’s health

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

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

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

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

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

About healthcare IT

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

About healthcare finance

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

Today's News and Insights

About health insurance/insurers

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

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

Key findings include:

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

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

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

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

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

About hospitals and healthcare systems

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

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

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

About pharma

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

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

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

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

About the public’s health

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

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

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

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

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

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

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

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

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

About healthcare IT

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

Today's News and Commentary

About Covid-19

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

About health insurance/insurers

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

About hospitals and healthcare systems

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

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

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

About pharma

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

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

About the public’s health

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

About healthcare IT

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

About health technology

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

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

About healthcare finance

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

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

Today's news and Commentary

About health insurance/insurers

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

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

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

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

About pharma

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

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

About the public’s health

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

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

About healthcare IT

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

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

About healthcare finance

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

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

Today's News and Commentary

About Covid-19

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

About health insurance/insurers

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

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

About hospitals and healthcare systems

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

About pharma

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

About the public’s health

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

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

About healthcare IT

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

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

About health technology

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

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

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

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

Today's News and Commentary

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

About health insurance/insurers

 KFF Survey of Consumer Experiences with Health Insurance Key Findings

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

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

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

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

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

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

Look at the graphs as well.

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

About hospitals and healthcare systems

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

About pharma

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

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

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

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

About the public’s health

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

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

About healthcare IT

Just a reminder that these large breaches are still occurring:

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

Today's News and Commentary

National Health Expenditure Projections, 2022-2031
Health Affairs periodically updates expenditure projections and provides an analysis for them.
Read this article in its entirety.

About health insurance/insurers

Appeals court grants partial stay in ACA preventive care case “A panel of judges at the Fifth Circuit Court of Appeals issued a stay Tuesday that partially halts a lower court ruling striking down the mandate. As part of the order, the Biden administration can continue to enforce the preventive service mandate nationwide aside from against the case's named plaintiffs.”

Medicare Advantage Enrolls Lower-Spending People, Leading to Large Overpayments Key Takeaways

  • Beneficiaries with lower-than-average expenditures than those with similar risk factors were significantly more likely to switch from Fee-for-Service (FFS) to Medicare Advantage (MA).

  • As a result, risk-score-adjusted expenditures for the 16.9 million beneficiaries who switched from FFS to MA between 2006–2019 were substantially below average. Plans were overpaid because MA rates are intended for beneficiaries with average—not systematically below average—expenditures.

  • MA plans in 2020 were overpaid by 14.4% due to this favorable selection phenomenon; when combined with the 6% overpayment reported by MedPAC for coding intensity and other factors, total MA overpayments were on the order of 20%.

  • Basing MA payment benchmarks on FFS expenditures is increasingly problematic as FFS enrollment continues to decline – underscoring the need for reforming how MA payments are set such as by decoupling MA payments from FFS benchmarks or instituting competitive bidding.”

Bottom line is that overpayments in MA could top $75 billion in 2023, or 20%.

Older adults are finally catching up on delayed surgeries. That means pain for health insurers, gains for hospital operators. “The trend was revealed by executives at Dow component UnitedHealth Group Inc. at a Goldman Sachs investor conference held on Tuesday. The revelation dented UnitedHealth shares by 5.6% in premarket trade, while shares of rivals also saw steep declines. Humana Inc. shares dropped 8% premarket, while Elevance Health Inc. shares dropped 4.8% and Cigna Group fell 4%.
Shares of hospital and surgical-center operators, meanwhile, profited from insurers’ pain. Shares of Surgery Partners Inc. , an operator of surgical facilities and related services, gained 7.4% premarket, while shares of hospital operator Community Health Systems Inc. jumped more than 10% and shares of hospital giant HCA Healthcare Inc. gained 3%.”

About hospitals and healthcare systems

 No nonprofit health systems downgraded in May, S&P Global says “While there were some outlook revisions, no nonprofit healthcare system was downgraded in May, the first time that has happened since October 2021, S&P Global said.
There were also three upgrades during the month on two health systems and one standalone hospital, the ratings agency said. Two of those ratings were due to the strength of the newly consolidated Charlotte, N.C.-based Advocate Health following the combination of Downers Grove, Ill., and Milwaukee-based Advocate Aurora Health and Charlotte-based Atrium Health, according to S&P Global.”

About pharma

 Pfizer expects to run out of some antibiotic supply for children soon “Supply of the pediatric version of the drug, Bicillin L-A, is expected to be exhausted by the end of this quarter, the company said in a letter to the U.S. health regulator dated Monday. Pfizer said in an email on Tuesday that the pediatric formulations of the antibiotic are not widely used.”

Top 20 Most Commonly Prescribed Medications FYI

About the public’s health

 Racial, Ethnic, and Socioeconomic Differences in Food Allergies in the US “In this survey study of 51 819 households, Asian, Black, and Hispanic individuals were more likely to report having food allergies compared with White individuals. The prevalence of food allergies was lowest among households in the highest income bracket.”

About healthcare personnel

 Demand for behavioral health services outstrips supply of providers, driving higher costs, analysis finds “In the first year of the pandemic, the global prevalence of anxiety and depression increased by a massive 25%, according to research from the World Health Organization. The pandemic also catalyzed investments in digital health capabilities, such as expanding virtual therapy and e-prescribing, in response to unprecedented demand.
Despite increased awareness and attention to behavioral health challenges, there continues to be a shortage of mental health providers. According to data from the Kaiser Family Foundation, 47% of the U.S. population in 2022 was living in a mental health workforce shortage area, with some states requiring up to 700 more practitioners to remove this designation.”

Comparison of Work Patterns Between Physicians and Advanced Practice Practitioners in Primary Care and Specialty Practice Settings Question  How do work patterns of physicians and advanced practice practitioners (APPs; ie, nurse practitioners and physician assistants) vary by specialty?
Findings  In this cross-sectional study of 217 924 clinicians, medical and surgical specialty physicians saw 6.7 and 7.4 percentage points more new patient visits, respectively, than their APP counterparts, whereas primary care physicians saw 2.8 percentage points fewer new patient visits compared with APPs. Medical and surgical physicians spent 34.3 and 45.8 fewer minutes per day, respectively, using the electronic health record than did APPs in their specialties, whereas primary care physicians spent 17.7 more minutes per day than did APPs.”

About health technology

 Federal advisory group rejects proposal to make medical device tracking easier “Every medical device has its own unique code, allowing manufacturers to keep track of their products once they enter the market. But while these codes are critical for recalling faulty devices or issuing updates, they rarely make their way into health records.
For years, experts have argued for a simple fix: adding device identifiers to insurance claims forms, which doctors use to request reimbursement for medical services. That, they say, would make it easier to reach patients at risk of flawed devices, and allow long-term study of device efficacy, safety, and cost.
But the idea is being held up by the slow-moving process of updating Medicare claims forms. It suffered another setback on Wednesday when the National Committee on Vital and Health Statistics, a group that advises the federal health department, voted not to recommend a slew of updates to claims forms — including the device identifier addition.”

Today's News and Commentary

About Covid-19

 COVID shots should target XBB variants in 2023-24 campaign, US FDA staff say “COVID-19 vaccines being developed and manufactured for the 2023-2024 campaign should target one of the currently dominant XBB variants, the U.S. Food and Drug Administration's (FDA) staff reviewers said on Monday.
The comments were made in documents posted ahead of Thursday's meeting of a panel of FDA's independent experts, who are expected to make recommendations on what strain an updated COVID-19 booster should target.”

About health insurance/insurers

Medicaid Enrollment and Unwinding Tracker “At least 1,027,000 Medicaid enrollees have been disenrolled as of June 12, 2023, based on the most current data from 20 states. Another 1.5 million enrollees had their coverage renewed, though four of the 20 reporting states do not provide data on renewed enrollees. At least 2.5 million total renewals were completed across the 20 states. However, these data undercount the actual number of disenrollments because not all states have publicly available data on total disenrollments.
The median disenrollment rate is 40%, but there is wide variation across states ranging from 12% in Nebraska to 73% in Idaho.”
In a related piece: Letter to U.S. Governors from HHS Secretary Xavier Becerra on Medicaid Redeterminations “Given the high number of people losing coverage due to administrative processes, I urge you to review your state’s currently elected flexibilities and consider going further to take up existing and new policy options that we have offered to protect eligible individuals and families from procedural termination.  I am pleased to announce several new options for states to consider adopting, such as allowing states to use their managed care plans to help beneficiaries complete these forms.  These new options build on existing flexibilities we have already offered states, such as:

  • Spreading renewals for all populations out over 12 months, which will provide more time to run a smooth process and prevent systems from getting backlogged.  A smooth process reduces burden not only on individuals and families, but also on state eligibility systems. Taking the time to do the process correctly will ensure those eligible for continued coverage do not experience a gap in care and those no longer eligible easily transition to other sources of coverage.

  • Maximizing the use of data sources, such as renewing individuals on the basis of their eligibility for other programs, such as the Supplemental Nutrition Assistance Program (SNAP) or Temporary Assistance for Needy Families (TANF).  This will help reduce the need for some individuals to fill out and return a Medicaid renewal form.

  • Partnering with managed care plans and using data available from the United States Postal Service to update people’s contact information so that they actually receive the renewal forms states are sending out.

These are just a few of the options that help to maintain coverage for eligible people – there are many more, and we welcome the opportunity to provide technical assistance to implement these policies.
A full list of available state strategies is available here.

Health Care Affordability Improved Between 2019 and 2022 Under Pandemic Health Coverage Policies “The share of adults reporting difficulty paying medical bills decreased from 18.7 percent to 15 percent from 2019 to 2022. The share of adults who reported forgoing needed medical care due to cost in the past year declined by more than 4.5 percent (18.5% to 13.9%). The share of Black and Hispanic adults reporting difficulty paying medical bills and forgoing needed medical care due to its cost fell sharply, reaching rates closer to those of White adults by 2022.”

CMS grows outreach of Part D Extra Help program ahead of 2024 expansion “The feds expanded eligibility for the Extra Help program as part of the Inflation Reduction Act, effective Jan. 1, 2024. Under the law, Medicare beneficiaries with limited resources and incomes of up to 150% of the federal poverty level can sign up for the full low-income subsidy.
That subsidy can be used to pay for Part D premiums as well as cost-sharing for medications. The Department of Health and Human Services (HHS) said in a fact sheet that 300,000 people currently enrolled in the program stand to benefit from the expansion, and they could save nearly $300 per year on average.
HHS estimates that up to 3 million seniors and people with disabilities could stand to benefit from Extra Help but are not currently enrolled."

Compromise struck to preserve Obamacare’s preventive care mandate “The agreement, which still needs approval from the 5th U.S. Circuit Court of Appeals, keeps coverage intact nationwide while the case proceeds. The Biden administration, in exchange, pledged not to enforce the mandate to cover HIV prevention drugs and other preventive care services against the employers and individual workers who sued claiming that doing so violated their religious beliefs. This means that even if the Affordable Care Act rules are upheld on appeal, the government can’t penalize the challengers for refusing to cover required services.”

About pharma

 Not covering emerging Alzheimer's drugs could cost Medicare billions: study “Emerging Alzheimer’s disease medications come with high price tags, but researchers with the University of Chicago calculate that in the long run, it’s much less costly to cover these therapies for Medicare beneficiaries.
Providing coverage for these drugs would save the public payers between $13.1 billion and $545.6 billion in healthcare costs over the course of 17 years, according to the white paper…
Part of the additional costs under CMS’ current policy would stem from an increase in private and public healthcare spending by $6.8 billion to $284.5 billion, according to the study.
’For Medicare, the value lost ranges from $3.1 billion to $128 billion for CMS delay of 0 to 17 years, and for Medicaid the range is $1.3 billion to $54.1 billion,’ the white paper said. ‘Combining Medicare and Medicaid, the value lost to public insurance would range from $4.4 billion to $182.1 billion.’”
And in a related story: European Alzheimer's experts unconvinced by new Eisai, Biogen drug “Alzheimer's disease experts in Europe weighing potential use of a new drug from Eisai and Biogen say its ability to slow cognitive decline may not outweigh its health risks, or be worth the toll on scarce healthcare resources.”

Sanders vows to oppose NIH nominee until Biden produces drug-pricing plan “Sen. Bernie Sanders (I-Vt.), chairman of the Senate health panel, is vowing to not move forward with President Biden’s nominee to lead the National Institutes of Health — or any health nominee — until he receives the administration’s ‘comprehensive’ plan on lowering drug prices.”

Some Cancer Patients Must Travel Hundreds of Miles for Medication “Health emergency’s end means independent cancer doctors can’t send prescriptions directly to their Medicare patients…
The Centers for Medicare and Medicaid Services in September 2021 posted a list of frequently asked questions that said independent oncologists can dispense prescriptions only to a patient who is physically in the doctor’s office at the time. 
Sending oral chemotherapy drugs by mail violates the Stark law, the agency said. The law bans doctors from making referrals of Medicare and Medicaid patients to other organizations or medical businesses where they have a financial stake. The restriction also applies to other independent practices, such as urology, that have an on-site dispensing pharmacy.”
These excuses for why patients need to get their medication from physicians’ offices seems specious: “But oncologists say that allowing Medicare patients to get cancer drugs from third-party specialty pharmacies doesn’t solve the problem, leads to waste and drives up costs. The pharmacies, they say, are often run by pharmacy-benefit managers that have lately been under fire from congressional lawmakers who assert they drive up prices. [Comment: But patients may pay more for drugs with PBMs. The article does not compare physician dispensed prices agains those obtained through the Part D plan.]
Many such pharmacies provide 90-day prescriptions, they say, and cancer patients often need shorter prescriptions because their treatment may change frequently in response to how a patient is responding. [Comment: PBMs can furnish any amount the physician orders. Also, the article did not say how many of these patients could not get these drugs from a local pharmacy. Nor did it comment on the fact that physicians were making a nice profit on selling these drugs.]
In a related article: Cancer drug shortage is complicating treatment, survey findsThe ongoing shortages of numerous oncology medications are causing delays in care for patients at cancer centers, according to a study from the National Comprehensive Cancer Network.”

About the public’s health

Reduced Stress-Related Neural Network Activity Mediates the Effect of Alcohol on Cardiovascular Risk “Chronic stress associates with major adverse cardiovascular events (MACE) via increased stress-related neural network activity (SNA). Light/moderate alcohol consumption (ACl/m) has been linked to lower MACE risk, but the mechanisms are unclear…
ACl/m associates with reduced MACE risk, in part, by lowering activity of an stress-related brain network known for its association with cardiovascular disease. Given alcohol’s potential health detriments, new interventions with similar effects on SNA are needed.”

 Brain responses to nutrients are severely impaired and not reversed by weight loss in humans with obesity: a randomized crossover study “We show that intragastric glucose and lipid infusions induce orosensory-independent and preference-independent, nutrient-specific cerebral neuronal activity and striatal dopamine release in lean participants. In contrast, participants with obesity have severely impaired brain responses to post-ingestive nutrients. Importantly, the impaired neuronal responses are not restored after diet-induced weight loss. Impaired neuronal responses to nutritional signals may contribute to overeating and obesity, and ongoing resistance to post-ingestive nutrient signals after significant weight loss may in part explain the high rate of weight regain after successful weight loss.”
Comment: The article title is more understandable than the Abstract excerpt. What is important is that this study contributes to the literature that obesity has physiologic causes beyond behavioral ones.

AMA asks doctors to de-emphasize use of BMI in gauging health and obesity “A subcommittee of the AMA wrote in a report leading up to the vote that BMI doesn’t differentiate between fat and lean mass and doesn’t account for body fat location. Studies have shown that fat that accumulates around the abdomen may be more dangerous than fat that gathers in the legs and thighs, hence why waist circumference or the waist-to-hip ratio could be useful measurements.
Additionally, BMI cutoffs don’t appropriately represent risks across racial groups, the subcommittee wrote. For example studies have shown that Asian, Hispanic and Black people have a higher risk of developing type 2 diabetes at lower BMIs than white people.”

About healthcare IT

 Suicide hotlines promise anonymity. Dozens of their websites send sensitive data to Facebook Great piece of investigative journalism. “Websites for mental health crisis resources across the country — which promise anonymity for visitors, many of whom are at a desperate moment in their lives — have been quietly sending sensitive visitor data to Facebook, The Markup has found.”

About healthcare personnel

 29 physician specialties ranked by student debt burden “ The emergency medicine specialty has the highest percentage of physicians who are still paying off student debt, according to Medscape's ‘Physician Wealth & Debt Report’ published June 9.”
Comment: Post medical school debt is said to be one factor in specialty choice; however, this list does not seem to correlate low debt with higher paying specialties. For example, Plastic and General Surgery both have scores of 23% while Diabetes and endocrinology come is at 11 percent.

Today's News and Commentary

About Covid-19

Outpatient treatment of COVID-19 and incidence of post-COVID-19 condition over 10 months (COVID-OUT): a multicentre, randomised, quadruple-blind, parallel-group, phase 3 trial “Outpatient treatment with metformin reduced long COVID incidence by about 41%, with an absolute reduction of 4·1%, compared with placebo. Metformin has clinical benefits when used as outpatient treatment for COVID-19 and is globally available, low-cost, and safe.”
Comment: I did not find the words “side effect” or “complication” in a word search of the article.

The Great Grift: How billions in COVID-19 relief aid was stolen or wasted Due to inadequate oversite: “An Associated Press analysis found that fraudsters potentially stole more than $280 billion in COVID-19 relief funding; another $123 billion was wasted or misspent. Combined, the loss represents 10% of the $4.2 trillion the U.S. government has so far disbursed in COVID relief aid.
That number is certain to grow as investigators dig deeper into thousands of potential schemes.”
Great piece of investigative reporting.

About health insurance/insurers

Primary Care Spending in the US Population “Primary care spending in 2019 totaled $439 per person. Spending was highest for the Medicare population ($736) and lowest for the uninsured population ($78); spending was $461 for those with group private insurance.
The percentage of medical spending on primary care was 7.0% for the population and was lower for those 65 years or older (5.1%), those in worse health (5.6%), and those with Medicare (5.3%). Nearly 41% of the population had 0 primary care spending. This percentage was higher for Hispanic (52.7%), non-Hispanic Black (49.0%), and non-Hispanic other (44.3%) individuals and 79.9% for uninsured individuals... 
Primary care spending varied significantly by insurance type and area.”

About hospitals and healthcare systems

Intermountain Health has 'AA+' ratings affirmed, highest in nonprofit healthcare Salt Lake City-based Intermountain Health had an "AA+" rating on several bonds affirmed as the 33-hospital system continues to enjoy a strong financial profile and relatively low debt, S&P Global said June 8.
Such ratings are the highest in the U.S. nonprofit healthcare sector, the report said. Intermountain Health also had an "AA" rating assigned on 2019 bonds, and the outlook for all such debt is stable.”

About pharma

 Governments get nearly $19 billion more in opioid lawsuit settlements “States and local governments will receive an additional $18.75 billion from pharmacy chains and drug manufacturers to settle lawsuits over their roles in flooding the country with painkillers — money meant to help communities still grappling with an unparalleled addiction and overdose crisis, attorneys announced Friday.
The settlements are to be paid by drug manufacturers Allergan and Teva, plus CVS and Walgreens. The settlements also include Walmart, which is expected to finalize its deal shortly.
The agreements emerge more than a year after pharmaceutical company Johnson & Johnson, along with drug distributors AmerisourceBergen, Cardinal Health and McKesson, agreed to pay about $26 billion to settle. In total, more than $50 billion has been allocated to settle waves of lawsuits meant to hold accountable companies that failed to stop the flow and abuse of prescription pills in the 2000s and 2010s.”

US Chamber of Commerce sues over government's drug pricing power “In a complaint filed in federal court in Dayton, Ohio, the chamber said the pricing program violated drugmakers' due process rights under the U.S. Constitution by giving the government ‘unfettered discretion’ to dictate maximum prices.
It also said the program would impose exorbitant penalties on drugmakers that don't accept those prices, and amounted to an ultimatum: agree to whatever price the government names, or we'll smash up your business.’”
Comment: This action reveals the dilemma of this organization. It doesn’t want government interfering with business; however, this governmental program would lower healthcare costs that these same firms find so expensive.
In a related article: U.S. government sets penalties on 43 drugs over price hikes “The Biden administration on Friday announced it would impose inflation penalties on 43 drugs for the third quarter of 2023, having fined 27 earlier this year, in a move it said would lower costs for older Americans by as much as $449 per dose.
Drugmakers hiked the price of these 43 drugs by more than the rate of inflation and are required to pay the difference of those medicines to Medicare, the federal health program for Americans over age 65.”

Use of Non-Psychiatric Medications With Potential Depressive Symptom Side Effects and Level of Depressive Symptoms in Major Depressive Disorder [MDD] “Individuals treated for MDD frequently use non-psychiatric medications for comorbid medical conditions that are associated with an increased risk of depressive symptoms. In evaluating the response to antidepressant medication treatment, side effects of concomitantly used medications should be considered.”

Walgreens sells remaining stake in Option Care Health for $330M in latest divestiture move “The drugstore chain announced Thursday it sold 10.8 million shares of Option Care Health and plans to use the proceeds primarily for debt paydown, continued support of the company's strategic priorities and to help fund its healthcare-focused business initiatives, according to a press release.”

Novartis inks $3.2B Chinook buyout to lift kidney disease plan “While working to generate phase 3 data on its own IgA nephropathy candidate, the Swiss drugmaker has seized the chance to buy Chinook Therapeutics for a pair of late-stage programs targeting the rare, progressive chronic kidney disease.
Chinook has accepted a buyout bid worth $3.2 billion upfront, plus $300 million payable if it hits certain regulatory milestones.” 

About healthcare personnel

HHS Announces New $15 Million Loan Repayment Program to Strengthen the Pediatric Health Care Workforce The “U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), launched the new Pediatric Specialty Loan Repayment Program, a $15 million investment to recruit and retain clinicians who provide health care to children and adolescents.
In exchange for three years of service working in a health professional shortage area, medically underserved area, or providing care to a medically underserved population, the Pediatric Specialty Loan Repayment Program provides up to $100,000 to eligible clinicians providing pediatric medical subspecialty, pediatric surgical specialty, or child and adolescent behavioral health care, including substance use prevention and treatment services.”

 Early 2023 healthcare wage inflation eases “Early 2023 data is showing that healthcare labor costs are subsiding compared to 2021 and 2022, according to a new report from credit ratings agency Fitch.
Despite the good news for hospitals, the 2023 average hourly earnings growth of 4.7 percent still outpaces the 2.4 percent average increase in hourly pay for healthcare workers from 2010 to 2019. 
Fitch attributed the jump in earnings to the conversion of contract labor to full-time workers, according to the June 12 report.”

Today's News and Commentary

About Covid-19

 White House COVID czar Ashish Jha stepping down “White House COVID-19 response coordinator Ashish Jha is stepping down from his position on June 15 to return to his previous role as dean of the Brown University School of Public Health…
Jha's role will be replaced by the newly created Office of Pandemic Preparedness and Response, which currently has no leader and no staff.”

Safety Monitoring of mRNA COVID-19 Vaccine Third Doses Among Children Aged 6 Months–5 Years — United States, June 17, 2022–May 7, 2023
What is already known about this topic?
All children aged 6 months–5 years are recommended to receive ≥1 bivalent mRNA COVID-19 vaccine dose; approximately 550,000 children in these age groups have received a third monovalent or bivalent mRNA vaccine dose.
What is added by this report?
In v-safe, 38% of children had no reported reactions after a third dose; most reported reactions were mild and transient. Vaccination errors accounted for 78% of events reported to the Vaccine Adverse Event Reporting System.
What are the implications for public health practice?
Findings after receipt of a third mRNA vaccine dose among young children were similar to those described after receipt of 1 and 2 doses; no new safety concerns were identified.”

About health insurance/insurers

CMS announces new decade-long primary care payment experiment How it works: The Centers for Medicare and Medicaid Services envisions running Making Care Primary between July 1, 2024, and December 31, 2034.

  • It's designed to draw providers with little or no experience in value-based care.

  • Participants will receive enhanced payment and tools from CMS to coordinate care with specialists and support care integration.

  • CMS will test the program in Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington. Provider applications open later this summer.”

Here are more details from CMS:
MCP’s three progressive tracks are designed to recognize participants’ varying experience in value-based care—from under-resourced participants to those with existing advanced primary care experience in alternative payment models. MCP aims to give these organizations flexibility, allowing them to choose their participation track and receive payments that reflect each participant’s experience towards accountable care. Again, MCP is a three-track model with one track reserved for organizations with no prior value-based care experience. 

  • Track 1 –Building Infrastructure: Participants will begin to develop the foundation for implementing advanced primary care services such as risk-stratifying their population, reviewing data, building out workflows, identifying staff for chronic disease management, and conducting health-related social needs screening and referral. Payment for primary care will remain fee-for-service (FFS), while CMS provides additional financial support to help participants develop care transformation infrastructure and build advanced care delivery capabilities. Participants can begin earning financial rewards for improving patient health outcomes in this track.

  • Track 2 – Implementing Advanced Primary Care: As participants progress to Track 2, they will build upon the Track 1 requirements by partnering with social service providers and specialists, implementing care management services, and systematically screening for behavioral health conditions. Payment for primary care will shift to a 50/50 blend of prospective, population-based payments and FFS payments. CMS will continue to provide additional financial support at a lower level than Track 1, as participants continue to build advanced care delivery capabilities. Participants will be able to earn increased financial rewards for improving patient health outcomes. 

  • Track 3 – Optimizing Care and Partnerships: In Track 3, participants will expand upon the requirements of Tracks 1 and 2 by using quality improvement frameworks to optimize and improve workflows, address silos to improve care integration, develop social services and specialty care partnerships, and deepen connections to community resources. Payment for primary care will shift to fully prospective, population-based payment while CMS will continue to provide additional financial support, at a lower level than Track 2, to sustain care delivery activities while participants have the opportunity to earn greater financial rewards for improving patient”

Comment: Look at the payment systems. It appears that Track 1 is fee-for-service (FFS) with incentives. The exact population-based payment mechanisms for Tracks 2 and 3 are unclear. Is it capitation or a different kind of FFS? Research has shown that if providers do not have downside risk, the desired behaviors are unlikely to occur. Further, if ACOs are any indication, providers are reluctant to assume risk, in this case, it might mean going into Step 3. Additionally, the country has a shortage of primary care physicians (PCPs), particularly if you remove hospitalists (many of whom are internists and pediatricians) from the equation. Finally, a 5 or 10% increase for primary care physicians does not put them anywhere near the ballpark of procedural or imaging practitioners, e.g., surgeons and radiologists, respectively. In other words, it will not provide enough of an incentive to recruit PCPs from medical school.
So…is this program “old wine in new bottles?” let’s wait to see how it plays out.

The Facts About Medicare Spending A must read from the KFF.

 Supreme Court upholds right to sue public nursing homes The Supreme Court upheld an individual right to sue public nursing homes for violated rights protected under a federal law that sets standards for these institutions. 
The court affirmed an appeals court ruling in a 7-2 decision that found a private individual can sue for rights protected by the Federal Nursing Home Reform Act through Section 1983 of the federal code, which allows someone to sue for their federal civil rights.”

About hospitals and healthcare systems

Top 100 critical access hospitals, state by state FYI.

About pharma

 FDA panel unanimously endorses Leqembi for full approval “An FDA advisory panel has voted 6-0 in favour of recommending that Eisai and Biogen's Alzheimer's drug Leqembi be granted full approval. The drug secured accelerated approval back in January based on Phase II results indicating that it helped reduce amyloid plaques in the brain, with the committee meeting on Friday to discuss whether that should be converted to a traditional nod in light of the Phase III Clarity AD trial, which showed that it slowed cognitive decline in early Alzheimer's patients by 27% versus placebo.”
Comment: Now comes the real controversy—figuring out how to pay for it.

About the public’s health

F.D.A. Panel Recommends R.S.V. Shot to Protect Infants “A Food and Drug Administration advisory panel recommended approval of a monoclonal antibody shot aimed at preventing a potentially lethal pathogen, respiratory syncytial virus, or R.S.V., in infants and vulnerable toddlers…
The 21-member panel voted unanimously in favor of giving the treatment to infants born during or entering their first R.S.V. season. The advisers voted 19-2 for giving the shot to children up to 24 months of age who remain vulnerable to severe disease.”

The 2023 nonhormone therapy position statement of The North American Menopause Society “Evidence-based review of the literature resulted in several nonhormone options for the treatment of vasomotor symptoms. Recommended: Cognitive-behavioral therapy, clinical hypnosis, selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors, gabapentin, fezolinetant (Level I); oxybutynin (Levels I-II); weight loss, stellate ganglion block (Levels II-III). Not recommended: Paced respiration (Level I); supplements/herbal remedies (Levels I-II); cooling techniques, avoiding triggers, exercise, yoga, mindfulness-based intervention, relaxation, suvorexant, soy foods and soy extracts, soy metabolite equol, cannabinoids, acupuncture, calibration of neural oscillations (Level II); chiropractic interventions, clonidine; (Levels I-III); dietary modification and pregabalin (Level III).”

HHS Releases First-Ever STI Federal Implementation Plan Thursday, “the U.S. Department of Health and Human Services (HHS) released the STI Federal Implementation Plan to detail how various agencies and departments across the federal government are taking a comprehensive approach to making meaningful and substantive progress in improving public health…
The STI Federal Implementation Plan highlights more than 200 actions that federal stakeholders will take to achieve its five goals:
Goal 1: Prevent New STIs
Goal 2: Improve the Health of People by Reducing Adverse Outcomes of STIs
Goal 3: Accelerate Progress in STI Research, Technology, and Innovation
Goal 4: Reduce STI-Related Health Disparities and Health Inequities
Goal 5: Achieve Integrated, Coordinated Efforts That Address the STI Epidemic”

PEPFAR at 20—Looking Back and Looking Ahead “In his State of the Union Address on January 28, 2003, President Bush announced the creation of the United States President’s Emergency Plan for AIDS Relief (PEPFAR)—with $15 billion provided over a 5-year plan to combat AIDS in the countries with the greatest disease burden…
By any global health metric, PEPFAR has surpassed every milestone imagined. More than 25 million lives have been saved, 5.5 million infants have been born HIV-free, and today more than 75% of the 38.4 million people living with HIV/AIDS globally are taking ART. Wide-scale treatment has also meant that annual transmission rates have dropped by 52% since 2010, largely attributable to durable viral suppression preventing onward transmission, demonstrating the impact of treatment as prevention.”
Read the article to understand where the program goes from here.

Today's News and Commentary

About health insurance/insurers

Fitch: Large payer finances stable, but pressures mounting in 2023 “Three notes:
—For the seven largest payers, revenues increased 10.5 percent in the first quarter year over year. Profits rose 7.7 percent in the first quarter compared to 7.6 percent during the same period in 2022.
—Large, geographically diverse payers are seeing stable performances, while less diversified insurers are more varied and subject to local market conditions.
—Financial leverage for large insurers increased to 43 percent in the first quarter, compared to 41 percent year over year, or an increase of 11 percent in outstanding debt to $167 billion.”

SCAN, CareOregon fund $110M in medical debt relief “SCAN Group and CareOregon have issued grants to RIP Medical Debt that will wipe out millions in patients' medical debt.
The two nonprofit insurers, which are in the midst of merging, will together donate $345,000 to the organization, funding debt relief for 67,000 people across Arizona, California, Nevada, Oregon and Texas, where the health plans operate, according to an announcement issued Wednesday morning.
The grant will abolish $110 million in medical debt, and all of the beneficiaries have incomes that are at or below 400% of the federal poverty level, or their debt represents 5% or more of their household income.”

About hospitals and healthcare facilities

BREAKING: Justices Allow Private Suits Under Fed. Nursing Home LawThe U.S. Supreme Court on Thursday ruled that a nursing home resident does indeed have a private right of action under the Federal Nursing Home Reform Act, in a suit accusing an Indiana care facility of negligently giving a resident psychotropic drugs and trying to transfer him without family consent.” 

Nonprofit Hospitals: Profits And Cash Reserves Grow, Charity Care Does Not “Mean hospital profits grew from 2012 to 2019, but this increase was not associated with the provision of more charity care by nonprofit hospitals, even though their cash reserve balances increased. In contrast, although charity care is not required for for-profit hospitals, an increase in profit was associated with an increase in charity care for them; this may be because spending on charity care is tax deductible.”

About pharma

 US Military Is So Worried About Drug Safety It Wants to Test Widely Used Medicines “Defense officials are in talks with Valisure, an independent lab, to test the quality and safety of generic drugs it purchases for millions of military members and their families, according to several people familiar with the matter who asked not to be named as the details aren’t public.”

About the public’s health

 Given the Canadian fires, check this site for an update on the air quality in your zip code.

Today's News and Commentary

Book Recommendation:
Jellyfish Age Backwards: Nature’s Secrets to Longevity by Nicklas Brendborg
A very well-written, evidence-based book about the science and possible “treatments” of aging.

About Covid-19

 Moderna, Pfizer hit with new patent lawsuits over COVID vaccines 

  • “Promosome sued Moderna, Pfizer and BioNTech in federal court in San Diego on Tuesday, accusing their COVID-19 vaccines of infringing a patent related to mRNA technology, as reported in Fidelity.

  • The biotech firm accused the companies of copying technology that allows for doses of mRNA that are small enough to use safely and effectively in the vaccines. It is asking the court for a share of royalties from the shots.

  • Pfizer earned $37.8 billion from sales of its BioNTech-partnered COVID-19 vaccine Comirnaty last year, while Moderna made $18.4 billion from its vaccine Spikevax.

  • Promosome said its technology enables the immune system to produce sufficient proteins to fight the virus with small doses of mRNA.

  • The lawsuits claim Promosome met with Moderna between 2013 and 2016 to discuss licensing the technology and that Promosome's president demonstrated it to a senior BioNTech scientist in 2015, although it said neither company agreed to a license.”

About health insurance/insurers

 Health Insurance Coverage and Postpartum Outcomes in the US  The presence of insurance does not always improve health: “The findings of this systematic review suggest that evidence evaluating insurance coverage and postpartum visit attendance and unplanned care utilization is, at best, of moderate SoE [Strength of evidence]. Future research should evaluate clinical outcomes associated with more comprehensive insurance coverage.”

Humana opens 250th primary care center as it continues to focus on growth “The Medicare Advantage giant has established a multiyear effort to continue scaling CenterWell and expects to open between 30 and 50 centers per year through 2025. In addition to the senior-focused primary care clinics, CenterWell also houses Humana's home health business, another key strategic focus, and is sister to the Conviva Care Center brand.
Collectively, Humana's Primary Care Organization cares for 266,000 seniors across its markets.”

Judge certifies class action in Aetna, Optum 'dummy code' lawsuit “A federal judge in North Carolina certified class action status June 5 in a lawsuit alleging Aetna and OptumHealth Care Solutions conspired to use "dummy code" to make administrative fees appear to be billable medical charges.
The lawsuit, which was originally filed in 2015, alleges the two insurers tricked plaintiff Sandra Peters, other patients similarly situated and their employers into paying administrative fees by disguising them as medical expenses. The lawsuit alleges the defendants violated the Employee Retirement Income Security Act.”

About hospitals and healthcare systems

Racial, Ethnic, and Payer Disparities in Adverse Safety Events: Are there Differences across Leapfrog Hospital Safety Grades? The highlights are on page 6 and are as you would expect; however, this finding was a bit of a surprise:
”Relative to privately insured patients, Medicare patients averaged significantly higher rates of adverse safety events on 10 of 11 PSIs [patient safety indicators]and statistically similar rates on 1 PSI. Relative to privately insured patients, Medicaid patients had significantly higher rates of adverse safety events on 8 of 11 PSIs and statistically similar rates on the remaining 3 PSIs. Again, we observed little pattern between a hospital’s overall letter grade and the size of the difference in adverse safety events between patients with Medicare or Medicaid coverage and those with private insurance.”

About the public’s health

 U.S. Gun Violence in 2021 [Published June, 2023] “In 2021, for the second straight year, gun deaths reached the highest number ever recorded. Nearly 49,000 people died from gun violence in the U.S. in 2021. Each day, an average of 134 people died from gun violence—one death every 11 minutes.
Gun homicides continued to rise in 2021, increasing 7.6% over the previous year. Gun suicides reached record levels, increasing 8.3%, the largest one-year increase recorded in over four decades. Guns, once again, were the leading cause of death among children and teens in 2021 accounting for more deaths than COVID-19, car crashes, or cancers.”