Monday Roundup

U.S. Healthcare

Monday Roundup

David Ermer–ACA, Congress, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Capitol Hill front —

  • Roll Call and Govexec bring us up to date on the lame-duck session’s agenda.
  • The Washington Post tells us about the Administration’s plans to include $10 billion in Covid funding in the omnibus appropriations bill that Congress must pass or extend by December 16.
  • The Wall Street Journal reports “Republicans have won 217 House seats to the Democrats’ 205, according to the Associated Press tally. A party needs 218 for a majority in the chamber, and Republicans were on track for a very narrow margin after they won seats Monday in Arizona, California and New York. ” This development increases the likelihood that Congress will pass an omnibus appropriations bill before year-end.
  • The Congressional Budget Office posted a presentation on its recommended policy approaches to reduce commercial health Insurer payments for hospitals’ and physicians’ services. The presentation is worth a gander because the American Hospital Association, among others, is not pleased with the CBO’s recommendations.

The Federal Employee Benefits Open Season started today, and Govexec offers a checklist to help decision-makers.

From the conferences’ front —

  • The American Medical Association shares developments from its interim meeting which concludes tomorrow.
  • Fierce Healthcare offers a news feed from the HLTH 2022 conference.

From the Affordable Care Act front, the Internal Revenue Service announced the PCORI support fee that health plans must pay for policy years and plan years that end on or after October 1, 2022, and before October 1, 2023. In short, the dollar amount that calendar year plans such as the FEHB plan must pay next July 31 is $3.00 times the average number of covered lives.

From the Alzheimer’s Disease and dementia front, Medscape reports

  • “Dementia prevalence is dropping in the United States, new research shows.”
  • “Of the more than 6 million Alzheimer’s patients in the U.S. age 65 or older, nearly two-thirds are women. A new study may help explain the gender gap — and offer clues to new treatments for helping patients of both sexes fight back.” The FEHBlog has been taking a continuing legal education course on eldercare, and the practicing lawyers teaching the court remarked that 95% of the clients for whom Medicaid nursing home coverage is sought are husbands.
  • “Among older adults who use the US Supplemental Nutrition Assistance Program (SNAP), rates of memory decline appear to be slower than among those who don’t use the program, new research shows.”

The Wall Street Journal informs us

An experimental Alzheimer’s drug from Roche Holding AG failed to significantly slow cognitive decline in long-awaited trials, the latest in a long line of setbacks for a field that has seen little progress in decades.

The drug, called gantenerumab, slightly reduced cognitive decline in people with early Alzheimer’s compared with a placebo across two large and lengthy trials, but the difference wasn’t statistically significant, Roche said Monday. The trials, which lasted more than two years and involved nearly 2,000 participants, compared scores of cognition and function in areas such as memory, orientation and problem-solving. * * *

The news comes just weeks after clinical trial results from a drug developed jointly by Biogen Inc. and Eisai Co. infused fresh hope into a field that has been marked by failure. The Biogen and Eisai drug, called lecanemab, reduced cognitive and functional decline by 27% compared with a placebo. The companies say they plan to provide more detailed study results at an upcoming research conference.

Like lecanemab, Roche’s gantenerumab targets accumulations of beta-amyloid, a protein that is found in the brains of people with Alzheimer’s and is thought to be linked to the disease. Several earlier beta-amyloid-targeting drugs had failed in clinical trials, although each drug acts slightly differently.

Roche Chief Executive Severin Schwan said last month that the Biogen and Eisai results were encouraging, but cautioned that they didn’t shed any light on the likely success of gantenerumab. Roche said Monday that the level of beta-amyloid removal by gantenerumab was lower than expected in the trials.

In other news —

  • Per Fierce Healthcare, Aetna announced a new advanced price care program in cooperation with Crossover Health. The program will launch next January 1 in the Seattle Washington region. “The new hybrid care model is integrated into a health plan and aims to tackle the rising access issues and costs of healthcare with a fixed fee, value-based payment model, executives said.”
  • Milliman offers its thoughts on mental health challenges facing employers.

Weekend Update

David Ermer–CDC, Congress, Federal employment benefits, OPM, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

The Wall Street Journal reports that in last week’s Congressional election

Democrats retained control of the Senate after Sen. Catherine Cortez Masto won a tight race in Nevada over Republican Adam Laxalt, giving the party the 50 seats it needs for a majority, and disappointing Republicans who believed they had a strong chance to flip the chamber.

The GOP appeared on track toward winning the barest of House majorities, nonpartisan analysts said, but the final outcome hinged on races, mostly on the West Coast, that remain too close to call.

HR Dive recounts the outcome of state ballot initiatives that relate to employer-employee relations.

The lame-duck session of the current Congress kicks off tomorrow with floor voting in the Senate and House and Committee business.

The Federal Employees Benefits Open Season starts tomorrow and ends on December 12, 2022.

The American Medical Association’s Interim Meeting started yesterday and ends on Tuesday, November 15, in Honolulu, Hawaii.

The Centers for Disease Control marks Antibiotic Awareness Week this week with a focus on prevention.

Every year, CDC honors U.S. Antibiotic Awareness Week to raise awareness and share information on the importance of improving antibiotic and antifungal use.

Antibiotics and antifungals save lives, but any time they are used, they can cause side effects and can contribute to the development of resistance.

Prevention puts a “pause” on antimicrobial resistance (AR), and we all have a role in combating AR.

McKinsey and Company offers guidance on preparing for the next pandemic.

COVID-19 won’t be the last pandemic, but is the world prepared for the next one? COVID-19 exposed underlying vulnerabilities in public health systems that made them less resilient to acute threats than expected. The learning: there’s much work to be done. McKinsey partner Matt Craven, and senior partners Matt Wilson and Lieven Van der Veken, identified four areas where governments can focus their efforts to build greater confidence in readiness. Learn more about this strategic approach to managing future threats, and dive deeper with these insights on vaccine innovation and resilience, boosting COVID-19 vaccine uptake in Africa, improving social determinants of health, strengthening the public health workforce, and more.

Fierce Healthcare informs us

The Biden administration is pushing to resolve big gaps in the quality and accuracy of data on health equity as it installs new requirements for payers and providers.

The Centers for Medicare & Medicaid Services (CMS) released a blog post late Thursday outlining steps to address data issues such as aligning standards for collection and gradually implementing equity scores.

“Data can tell a story, but if the data is incomplete or unaligned, the story is also incomplete,” wrote LaShawn McIver, M.D., director of CMS’ Office of Minority Health. “To work to advance health equity, we must improve our data, especially our health equity data.”

The Department of Health and Human Services (HHS) has made closing equity gaps a key pillar of the Biden administration, including pursuing new equity requirements in health plans and value-based care payment models.

A recent framework released by CMS detailed the need for increasing the collection of data on social determinants of health (SDOH) to better identify equity gaps.

“CMS recognizes that progress has been made but is committed to resolving the major gaps in data quality, accuracy and completeness,” McIver wrote. 

The FEHBlog would be happy if OPM started sharing SDOH data with FEHB carriers.

Health Payer Intelligence discusses steps that health plans are taking to make explaining benefits more understandable to members.

Happy Veterans’ Day

David Ermer–CDC, COVID-19, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare–

To those who followed our Nation’s colors, thanks for your service. Here’s a Veteran’s Day message from the Veterans Administration Secretary Denis McDonough and the OPM Director Kiran Ahuja.

FedWeek informs us about a recent OPM Inspector General report about the Federal Long Term Care Insurance Program contract.

Projected future income from premiums in the Federal Long-Term Care Insurance Program is not enough to cover projected future claims, an audit by the inspector general’s office at the OPM has found.

It said that while the program over 2017-2019 took in about $2.2 million more than it paid out, boosting a trust fund held by the contractor (the John Hancock insurance company), under current projections those reserves will be depleted by 2048. That’s due to lower long-term interest rates than previously assumed and “higher claims utilization due to longer life expectancies (especially with dementia patients).”

It says that participants “will likely see a large increase in premiums and/or decrease to benefits for the next contract period to help reduce the deficit. As demonstrated at the start of this contract period in 2016, FLTCIP’s large one-time premium increase and/or benefit decrease caused an unexpected hardship to its participants.” That contract is to expire in 2023. * * *

In response, the carrier pointed out that in a letter to participants with the option to purchase additional inflation protection it said “there is a strong likelihood that premium rates for many enrollees may need to increase” while OPM noted that earlier this year it told the carrier to stop active marketing efforts to prospective applicants.

The FEHBlog is glad that this problem is not on his plate.

Because today is a federal holiday, the Centers for Disease Control did not issue an interpretative report on its Covid statistics for this week.

Medscape tells us

Global deaths due to COVID-19 have dropped almost 90% since February, the head of the World Health Organization said Wednesday.

Last week, 9,400 deaths were reported linked to the coronavirus, Director-General Tedros Adhanom Ghebreyesus said.

That’s down from 75,000 a week in February. * * *

The Associated Press reported that more than 2.1 million new cases were reported to WHO for the week ending Sunday. That’s down 15% from the prior week, and the number of weekly deaths fell 10% compared to the prior week.

Beckers Payer Issues adds

The U.S. will extend the COVID-19 public health emergency through at least April 11, 2023, Biden administration officials confirmed to CNBC Nov. 11.

A 12th extension of the PHE since the first in January 2020 is further ensured by a lack of public statement from HHS warning about a termination. The agency last renewed the PHE Oct. 13 for an additional 90 days to Jan. 11, 2023 — it also told states it would provide a notice 60 days before if it did decide to end it, or Nov. 11.

The PHE allows the country to continue operating under pandemic-era policies, which led to a complete overhaul of telehealth and who can use it, fast-tracked approvals of COVID-19 vaccines and treatments, and preserved healthcare coverage for millions of Medicaid beneficiaries nationwide.

The CDC did update its FluView page on November 10 for November 4

Influenza activity continues to increase. Regions 4 (Southeast) and 6 (South-Central) are reporting the highest levels of flu activity, followed by regions 3 (Mid-Atlantic) and 9 (south-central West Coast).

Three influenza-associated pediatric deaths were reported this week.

CDC estimates that, so far this season, there have been at least 2.8 million illnesses, 23,000 hospitalizations, and 1,300 deaths from flu.

The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 44 during every previous season since 2010-2011.

The RSV epidemic has not subsided according to MedPage Today

Children’s hospitals aren’t the only ones drowning in patients with respiratory illness — it’s also general emergency departments (EDs), urgent care clinics, and pediatrician’s offices.

Hit by a surge of respiratory syncytial virus (RSV), flu, and COVID-19, physicians and nurses across the country are calling for help and asking parents to keep children home unless they’re seriously ill.

“It’s just important that people recognize that when you step back and look at the healthcare system as a whole, that volume is high everywhere,” Katie Lockwood, MD, MEd, a primary care physician at Children’s Hospital of Philadelphia, told MedPage Today.

“It’s not as simple as saying, ‘Oh, you shouldn’t go to the ER because we’re busy, or the ER saying you should go to primary care because we’re busy. Everybody is busy,” she added. “One of the things that I had been hearing from my own patients … was how long they were having to wait when they did go to an emergency department, and urgent cares were really full, and we were seeing a lot of volume in [my] office.”

Physicians say that seasonal increases in respiratory illness, which are expected, normally come later in the year. This year’s early surge in RSV-associated hospitalization, according to the CDC, is higher than December and January peak rates in recent years.

From the mental healthcare front, the American Hospital Association reports

The Substance Abuse and Mental Health Services Administration yesterday [Thursday] released National Guidelines for Child and Youth Behavioral Health Crisis Care, which offer guidance and strategies to help communities address gaps in behavioral health crisis services for children and youth. The guidelines recommend that youth in crisis from mental health and substance use disorders receive care in the least restrictive setting possible, and if safe, at home and in the community. They also recommend crisis response systems partner with schools, community organizations and others across the continuum of care; be trained to respond to diverse needs; and reflect the diverse communities they serve.

AHA last year joined the Children’s Hospital Association, American Academy of Pediatrics and the American Academy of Child and Adolescent Psychiatry as a partner in Sound the Alarm for Kids, an initiative urging Congress to enact legislation and increase funding to better support mental health for children and teens.

The 10-digit National Suicide Prevention Lifeline in July transitioned to the 988 Suicide and Crisis Lifeline, meaning individuals experiencing a suicide, mental health or substance use crisis can simply call, chat or text 988 to connect with a trained crisis counselor. For more information, visit the AHA’s 988 resources page. 

From the Rx coverage front, EndPoints discusses the importance of the FDA’s interchangeability tag in facilitating biosimilar competition.

With the growth in biologics spending, the biosimilar market is going to have to find new ways to keep up.

One avenue may open up with new interchangeable biosimilars that can be substituted without a doctor’s note, and which could help bring costs down for some pricier, patient-administered therapies. FDA officials discussed key flexibilities that they can make around the development of interchangeable biosimilars at an Association for Accessible Medicines’ industry conference yesterday in Bethesda, Md.

While the FDA has only signed off on three interchangeable biosimilars so far — Viatris’ insulin Semglee, Boehringer Ingelheim’s Humira interchangeable Cyltezo (launching next year), and Coherus’ Lucentis interchangeable Cimerli — Jacqueline Corrigan-Curay, CDER’s principal deputy center director, explained to the Association of Accessible Medicines’ industry conference yesterday that the agency is willing to work with industry where the science is justified.

From the artificial intelligence front, Health IT Analytics relates

A recent study published in the American Journal of Managed Care found that identifying high-cost members was made easier through the implementation of artificial intelligence (AI) and the analysis of patient demographics.

Identifying high-cost members is essential for payers and providers, as it offers them information on preventing excessive spending. Traditionally, payers and care delivery organizations rely on care management efforts to reduce medical expenditure; however, this can often be challenging due to the limitations of incorporating other data sources, according to the study authors.

In the study, researchers aimed to implement a risk prediction model that uses AI to analyze information such as claims data, demographics, social determinants of health (SDOH) data, and admission, discharge, and transfer alerts (ADT) to better identify high-cost members. * * *

Researchers used data from a Medicaid accountable care organization (ACO) gathered from 61,850 members enrolled between May 2018 and April 2019.

Researchers then estimated risk scores for each member using two separate models. The first model was developed by Medical Home Network and relied on AI to analyze data related to SDOH, and activity related to ADT, along with claims and demographic characteristics. However, the second model, known as the Chronic Illness and Disability Payment System (CDPS) , only used demographic and claims information.

Based on this information, the researchers found that the AI model could perform a more accurate analysis of the highest-risk members and their spending. In addition, they found that those the AI model identified as high-risk had higher spending than those identified by the CDPS model.

Despite these conclusions, researchers noted a few limitations, mainly related to the data coming from a single ACO from a single geographic area and a single 12-month period.

Useful insights.

Thursday Miscellany

David Ermer–CDC, COVID-19, Federal employment benefits, Medicare, Mental health care, OPM, U.S. Healthcare–

The HCP-LAN, which promotes alternate / value-based payment methods, held a summit this week. RevCycle Intelligence reports

Photo by Josh Mills on Unsplash

Value-based payment levels barely moved in 2021, with some movement in the downside financial risk category, according to the latest data from the Health Care Payment Learning and Action Network (HCP LAN).

The majority of healthcare payments—59.5 percent—from 63 commercial plans, five state Medicaid programs, and Medicare were tied to value and quality in some capacity, the annual APM Measurement Effort report showed this year. The remaining 40.5 percent of payments stemmed from fee-for-service models.

The proportion of healthcare payments in fee-for-service models is actually up slightly from the 2020 results when 39.3 percent of payments were tied to the models. However, this does not indicate a backslide for the healthcare industry, according to value-based care expert Andréa E. Caballero, MPA.

America’s Health Insurance Plans (AHIP) and the Alliance of Community Health Plans also offer their perspectives on the LAN Summit.

Healthcare Dive looks forward to the HLTH conference that will be held in Las Vegas next week. “Representatives from major healthcare players will discuss private equity, value-based care, digital health funding and more at the fifth annual conference.”

From the Federal Employees Benefits Open Season front, FedWeek discusses the interaction of FEHB and Medicare.

From the public health front

The American Hospital Association reports

Infants under 6 months old had the highest COVID-19 hospitalization rates among Americans under age 65 during March 20-Aug. 31, when the omicron BA.2 and BA.5 variants predominated, the Centers for Disease Control and Prevention reported today. Based on data from the COVID-19-Associated Hospitalization Surveillance Network, the study found infants under 6 months old had hospitalization rates similar to adults aged 65-74. 

“COVID-19 vaccination during pregnancy might provide protection to infants younger than 6 months old who are currently ineligible for vaccination,” CDC said. “To protect themselves and their infants, people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future should stay up to date on COVID-19 vaccinations, as recommended by CDC and the American College of Obstetricians and Gynecologists.”

The Wall Street Journal adds

High rates of hospitalization with RSV are hitting the youngest children especially hard, part of an unseasonably early surge in respiratory infections. 

Some 3.0 people for every 100,000 were hospitalized with respiratory syncytial virus the week ended Nov. 5, according to federal data from 12 states. The rate is the highest since the winter just before the pandemic, when some 2.7 people per 100,000 were hospitalized in January 2020. The hospitalization rate declined from 3.4 hospitalizations per 100,000 in the week ended Oct. 29.

Babies under six months old have the highest RSV-related hospitalization rate, data from the Centers for Disease Control and Prevention show, at 145 hospitalizations per 100,000 infants. Infants six to 12 months old were hospitalized at a rate of 63 for every 100,000 children that age. For adults, the hospitalization rate is 0.6 per 100,000 people.

RSV is a common virus that most children encounter by their second birthday. Reinfections can occur at any age. Most people experience mild, cold-like symptoms and recover in a week or two. But RSV can be serious for some infants and older adults, causing bronchitis and pneumonia.

The Journal also informs us

AstraZeneca PLC said it had dropped plans to submit its Covid-19 vaccine to the Food and Drug Administration for approval, ending a long-running ambition to eventually sell the shot in the U.S. despite initial setbacks.

The Cambridge, England-based pharmaceutical company said Thursday that there would likely be a lack of demand in the U.S., where it said primary vaccination needs had been met. It would continue to focus its efforts on ensuring the availability of the vaccine, called Vaxzevria, elsewhere, including seeking its approval as a booster shot, the company said.

HealthDay tells us

The risk for death from infective endocarditis (IE) increased twofold among young U.S. residents aged 15 to 44 years during 1999 to 2020, according to a research letter published online Nov. 9 in the Journal of Internal Medicine.

Laura McLaughlin, M.D., from the Columbia University Irving Medical Center in New York City, and colleagues characterized trends in mortality rates from IE among young U.S. residents (aged 15 to 44 years) and in relation to drug abuse using the Multiple Cause of Death Data from the U.S. Centers for Disease Control and Prevention between 1999 and 2000. Age-adjusted mortality rates standardized to 2000 U.S. census per 100,000 persons were reported. * * *

“The number of young people in the United States who die of infective endocarditis is increasing, and the ongoing opioid epidemic, specifically injectable drug abuse, appears to be a significant cause,” a coauthor said in a statement.

The Centers for Disease Control released its current / 2021 National and State Healthcare-Associated Infections (HAI) Progress Report.

From the plan design front, the International Foundation of Employee Benefit Plans offers suggestions from an expert panel on four steps for evaluating your plan’s diabetes coverage.

From the mental healthcare front, the Senate Finance Committee released its “Fourth Bipartisan Discussion Draft on Mental Health Proposes More Integration Between Mental and Physical Health Care, Bolsters Crisis Care.” The bill appears to focus on Medicare and Medicaid coverage. The Committee explains

This discussion draft on the mental health integration is the fourth legislative draft the Finance Committee has released since kicking off its bipartisan mental health initiative. The first, released in May, focused on telehealth policies. The second, released in June, focused on youth mental health. The third, released in September, focused on expanding the mental health care workforce. Other discussion drafts may be released. The committee is committed to fully paying for any mental health package with bipartisan, consensus-driven offsets. 

The Associated Press reports

Mindfulness meditation worked as well as a standard drug for treating anxiety in the first head-to-head comparison.

The study tested a widely used mindfulness program that includes 2 1/2 hours of classes weekly and 45 minutes of daily practice at home. Participants were randomly assigned to the program or daily use of a generic drug sold under the brand name Lexapro for depression and anxiety.

After two months, anxiety as measured on a severity scale declined by about 30% in both groups and continued to decrease during the following four months. 

Study results, published Wednesday in the journal JAMA Psychiatry, are timely. In September, an influential U.S. health task force recommended routine anxiety screening for adults, and numerous reports suggest global anxiety rates have increased recently, related to worries over the pandemic, political and racial unrest, climate change and financial uncertainties.

Intriguing findings.

Midweek Update

David Ermer–AHRQ, CDC, COVID-19, COVID-19 vaccine, FDA, Rx coverage, U.S. Healthcare–

Forbes reports

As the polls pretty much predicted, Tuesday’s midterms turned out to be very close in terms of the balance of power between the two parties. As of this writing [Wednesday evening] it’s still not clear which party controls the House and Senate. But in several states, there were important healthcare issues on the ballot that were settled more decisively. In South Dakota, voters approved an expansion of Medicaid benefits, adding itself to the list of many other states that have bypassed legislatures to expand the program by ballot initiative. Voters in Michigan, California and Vermont approved Constitutional amendments protecting abortion rights while voters in Kentucky rejected an amendment that would have stated abortion rights are not protected in the state. Meanwhile, in Arizona many of the headline races are still too close to call as of this writing, but one vote that isn’t is an overwhelming “Yes” for Proposition 209, which expands property and assets that can’t be collected against medical debt and also reduces the interest rate that can be charged on it. 

From the Omicron and siblings front, protein-based Covid vaccine manufacturer Novovax reports on its third-quarter earnings and the value of its vaccine as a booster. In addition, Novovax says that it has delivered over 94 million doses of its vaccine worldwide.

From the U.S. healthcare business front, we have a trifecta from Healthcare Dive.

Healthcare Dive informs us

More than 30 healthcare associations and advocacy groups joined the American College of Emergency Physicians in asking President Joe Biden to prioritize finding solutions to the problem of overcrowded hospital emergency rooms.

Strained emergency departments are coping with an increase in boarding, a term for when patients are held in the ED longer than they should be because of a lack of available inpatient beds. The problem has led to gridlocked EDs filled with patients waiting, sometimes in life-threatening situations, the ACEP and other groups warned Monday in a letter to the president. “Boarding has become its own public health emergency,” the letter said.

The organizations urged the Biden administration to convene a summit of stakeholders from across the healthcare system to identify immediate and long-term solutions to the boarding problem.

Holy cow!

Healthcare Dive tells us

Elevance Health inked a deal to acquire a specialty pharmacy that caters to patients with complex and chronic conditions like cancer and multiple sclerosis.

The insurer said BioPlus will complement its existing pharmacy benefit manager, IngenioRx, providing patients with specialty drugs and a whole-health approach.

After closing and integrating BioPlus into operations, the company will be able to leverage the insights from both pharmacy and medical benefits, Elevance announced on Wednesday.

Working together, BioPlus’ pharmacy team will be able to identify “a patient who may need behavioral health support or in-home care services” and “seamlessly connect that patient to services to address their whole health needs,” Elevance said.

The deal is expected to close in the first half of 2023. Financial terms of the deal were not disclosed.

Healthcare Dive also explains why Cigna invested $2.5 billion in Walgreen’s combined Village MD / Summit Health primary care company.

Unlike many other primary care physician groups, VillageMD is focused on the commercial market, which brings in two-thirds of its revenue. That plays to Cigna’s strength in the employer market, as the majority of its customers are commercial employers, according to Credit Suisse analyst A.J. Rice.

As part of its investment, Evernorth will develop value-based agreements with VillageMD. The two will work together to optimize sites of care and patient outcomes through VillageMD’s physician network and Evernorth’s health services businesses, which include pharmacy benefit manager Express Scripts, specialty pharmacy Accredo and virtual care provider MDLive.

Beckers Hospital Review discusses how CVS, Amazon and Walgreens are pushing into primary care, and home health care.

From the healthcare quality front

The HHS Agency for Healthcare Quality and Research’s Director offers a blog post about how “AHRQ’s Research and Tools Help Transform Delivery of Primary Care.”

Patient Engagement HIT relates

Personal health record (PHR) use is key to driving patient engagement, with recent JMIR Cancer data showing PHR use among colorectal cancer survivors increasing access to follow-up care and screening by more than 30 percentage points.

Additionally, PHR use increased the proportion of survivors who believed access to certain follow-up cancer screenings was important to their health and well-being, according to researchers from the Regenstrief Institute, the VA, and Indiana University’s schools of medicine and nursing.

PHRs are different from EHRs in that they are patient-facing and give users insights into their own health information. Most PHRs, particularly PHRs “tethered” to the EHR, come with some secure messaging and patient notification systems, giving the technologies even more patient engagement power.

Revcycle Intelligence reports

Hospitals work hard to avoid “never events,” or serious, largely preventable, and harmful events identified by the National Quality Forum (NQF). These never events include performing surgery on the wrong patient or accidentally leaving an item in a patient after an invasive procedure. However, some industry experts are now calling onthe healthcare industry to consider a new set of never events that are administrative in nature, such as aggressive medical debt collection.

Dave A. Chokshi, MD, MSc, FACP, senior scholar at CUNY School of Public Health and Health Policy and former Commissioner at the New York City Department of Health and Mental Hygiene, and Adam L. Beckman, BS, of Harvard’s Medical and Business Schools, identify five new hospital never events in a new JAMA Health Forum article. They say that hospitals should never:

  1. Aggressively pursue medical debt against patients who cannot afford their bills
  2. Spend less on community benefits than it earns in tax breaks from non-profit status
  3. Flout federal requirements for hospitals to be transparent with patients about costs
  4. Compensate hospital workers less than a living wage
  5. Deliver racially segregated care

That approach could get the attention of hospitals.

Finally, Med City News informs us

More than three quarters, or 77%, of reproductive-aged women want birth control pills to be made available without a prescription, provided that research proves the pills safe and effective, a new survey shows.

“Oral contraceptives are the most commonly used method of reversible contraception in the U.S., and studies suggest that [over-the-counter] access would increase use of contraception and facilitate continuity of use in addition to saving time spent on travel, at a doctor’s office, and off work,” the report stated.

Under the Affordable Care Act, most private health insurance plans are required to cover FDA-approved birth control, but it must be prescribed. However, 41% of women at reproductive age are not aware of this. About 70% of women with private insurance said their health plan fully covered their birth control, but about a quarter said they had to pay some out-of-pocket.

The ACA rule also applies to FEHB plans. The FEHBlog is metaphysically certain the ACA regulators would extend this rule to over the counter contraceptive if the Food and Drug Administration can get its act together.

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Federal Employee Benefits Open Season front, FedSmith provides advice to federal and postal employees and FedWeek provides guidance to all interested parties.

In the Federal Times, Reg Jones answers a reader’s question about whether an annuitant can suspend their FEHBP coverage.

From the Omicron and flu front –

MedPage Today expresses expert views that developing vaccines that prevent the spread of Covid require human challenge trials in which fully informed, vaccinated people are exposed to Omicron.

[M]any experts agree: we need new vaccines to limit the spread of the virus. The current generation of vaccines offers strong protection against serious illness and death, but their edge has dulled against new variants, and they do not always prevent infection and transmission of the virus.

The White House hosted a summit on the issue in July, showcasing the myriad ways researchers are going about developing new vaccines. There are hundreds of candidates in early stages around the world, but the resources devoted to COVID-19 vaccine research are a fraction of what they were 2 years ago. Human challenge trials can greatly speed the selection of the most promising in this field of candidates, providing scientific and economic benefits over uniform reliance on large field studies.

Time will tell.

The Wall Street Journal provides a background story of this year’s flu that compares the spread of the flu vs. the spread of Covid.

How contagious is flu?

Covid-19 is more contagious than influenza, doctors say. One reason is that most people have had flu multiple times and many have gotten multiple flu shots over the years. 

The most common calculation of a virus’s infectiousness is a measure called the R0 (pronounced “R naught”). This metric estimates how many people one contagious person will infect on average. The R0 of influenza is between one and two. R0 data for Covid-19 isn’t definitive, especially as the virus continues to mutate, but studies indicate the number for many Covid strains is higher than for flu. 

From the tidbits department

  • Healthcare Dive offers “five takeaways from the FDA’s list of AI-enabled medical devices. As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates.”
  • The Patient-Centered Outcomes Research Institute (PCORI), which the Affordable Care Act requires health insurers and plans to fund, shares its strategic plan.
  • The Segal Company helpfully reminds cafeteria plan sponsors that “As part of COVID-19 relief, the Consolidated Appropriations Act, 2021 (CAA) permitted plan sponsors to immediately implement certain mid-year changes to their cafeteria plans during the 2020 and/or 2021 plan years without first having to adopt plan amendments. Employers that implemented such relief are required to adopt certain retroactive plan amendments by December 31, 2022.”
  • The Centers for Disease Control calls attention to its U.S. Diabetes Surveillance System website. Check it out.
  • Beckers Hospital Review lists the ten most expensive States for healthcare. The only state with a top 10 population included on Becker’s list is Florida.

Monday Roundup

David Ermer–AHRQ, CDC, COVID treatment, COVID-19, FDA, Federal employment benefits, Mental health care, NIH, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, the Federal Times offers a detailed report on FEHB infertility coverage. The article answered one of the FEHBlog’s outstanding questions:

In October, the White House Office of Personnel Management, which acts the human relations department for the federal workforce, unveiled four new plan options that will provide some form of assisted reproductive technology, or ART, for a total of 18 FEHB plan options in 2023.

Those are offered by carriers Triple S-Salud, UPMC Health Plan, Indiana University Health Plan, Foreign Service Benefit Plan, and Health Net of California Southern.

One new plan option, under CDPHP, will provide a non-FEHB benefit for discounted ART.

From the Omicron and siblings front —

The New York Times tells us “People who took the antiviral drug Paxlovid within a few days after being infected with the coronavirus were less likely to be experiencing long Covid several months later, a large new study found.” The federal government should be promoting Paxlovid and flu treatments at least as much as it promotes vaccines.

Because winter is coming the Centers for Disease Control reminds us about the importance of home ventilation.

Improving ventilation can help you reduce virus particles in your home and keep COVID-19 from spreading. You may or may not know if someone in your home or if a visitor to your home has COVID-19 or other respiratory viruses. Good ventilation, along with other preventive actions, can help prevent you and others from getting and spreading COVID-19 and other respiratory viruses.

Health IT Analytics reports

Researchers from New York University’s Machine Learning for Good Laboratory (ML4G Lab), Carnegie Mellon University, and the New York City Department of Health and Mental Hygiene (NYC DOHMH) have developed an automated machine-learning system designed to detect rare or previously unseen disease clusters.

According to the press release shared with HealthITAnalytics via email, current automated systems used to identify public health threats rely on “syndromic surveillance” to detect existing threats but can fall short of identifying new ones.

“Existing systems are good at detecting outbreaks of diseases that we already know about and are actively looking for, like flu or COVID,” said NYU Professor Daniel B. Neill, PhD, director of the ML4G Lab, in the press release. “But what happens when something new and scary comes along? Pre-syndromic surveillance provides a safety net to identify emerging threats that other systems would fail to detect.”

Bravo.

With the new year less than two months away, Med City New informs us “Consumer research firm Forrester recently predicted major trends that would shape healthcare in 2023. Healthcare stakeholders should prepare for key changes, such as care becoming even more inaccessible for rural patients[, more remote patient monitoring for chronically ill patients] and additional retail entrants into the clinic space.

On a related note, Becker’s Hospital Review identifies the ten states with the most rural hospitals at immediate risk of closure — 1. Mississippi 24; 2. Tennessee 17, and 3. Kansas 16.

In other U.S. healthcare business news

Healthcare Dive reports

  • VillageMD has agreed to acquire medical practice Summit Health for $8.9 billion including debt, the primary care provider announced Monday.
  • VillageMD, which is majority owned by pharmacy chain Walgreens, and Summit Health, the parent company of CityMD, plan to combine their provider locations and VillageMD’s experience with value-based care to help accelerate the transition to risk for payer clients.
  • Cigna’s health services division Evernorth is also taking a stake in the deal, and will become a minority owner in VillageMD at the deal’s close, expected in the first quarter of 2023.

Fierce Healthcare summarizes 3rd quarter earnings reports from major health insurers.

Fierce Healthcare also announced its ten 2022 Women of Influence in Health award winners.

This year’s honorees cover the breadth of the industry, from providers to payers to health tech, and represent some of the industry’s largest companies as well as up-and-coming innovators. Each has been pivotal in helping their organizations—and their patients—navigate some of the most complicated years that we’ve ever faced.

Kudos to the winners.

The Goverment Accountability Office released a report titled “Private Health Insurance: Markets Remained Concentrated through 2020, with Increases in the Individual and Small Group Markets.”

Several companies may be selling health insurance in a given market, but, as we previously reported, most people usually enroll with one of a small number of insurers. Known as market concentration, this can result in higher premiums due to less competition in the market.

We found this pattern continued in 2019 and 2020, with the markets for individuals and for small employers generally becoming more concentrated. Specifically, three or fewer health insurers held at least 80% of the market share for both of these markets in at least 42 states.

From the healthcare quality front, the HHS Agency for Healthcare Quality and Research released

  • a draft Evidence Map of Social and Structural Determinants of Health Risk Factors for Maternal Morbidity and Mortality; the public comment deadline is December 4, 2022.

Also, Fierce Healthcare tells us

The Center for Medicare and Medicaid Innovation (CMMI) released a report Monday updating its strategic vision for implementing value-based care, including detailing its progress since the vision was released last year. One of the key new strategies focused on creating greater care coordination between primary care doctors and specialists, especially surrounding the types of models the center puts out.

From the mental healthcare front, the National Institutes of Health’s NIH in the News for November 2022 features an article on clinical depression for patients.

From the medical device front, the Wall Street Journal reports

A Medtronic PLC medical device reduced the blood pressure of people with tough-to-treat hypertension in a closely watched study, but not significantly beyond what medications achieved.

The device cut a crucial measure of blood pressure by only about two points more than the average reduction in study volunteers who didn’t get the procedure, researchers said Monday.

Despite falling short of the study’s main efficacy goal, Medtronic said it has completed its application to the Food and Drug Administration for approval of the device, based on its safety and ability to meet certain secondary goals in the latest study as well as positive data from earlier studies.

If the FDA approves it, the device could offer a new, nonmedication treatment option for people with blood pressure that remains high despite treatment with drugs. It could also be a big-selling product for Medtronic. * * *

Medtronic’s experimental device, Symplicity Spyral, is used to perform a minimally invasive procedure known as renal denervation. 

In renal denervation, doctors insert a spiral-shaped catheter into an artery near the patient’s groin, through which a generator delivers radio-frequency energy to nerves in arteries near the kidneys. These nerves can become overactive and fuel high blood pressure. The device essentially burns these nerves so that they don’t contribute to high blood pressure.

Renal denervation has potential to be a one-time treatment, though researchers are still following patients to see how the benefit lasts.

Weekend update

David Ermer–Congress, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

Congressional election day is Tuesday. The lame duck session will be next Monday.

Also next Monday, the Federal Employee Benefit Open Season will kick off. OPM has made the 2023 FEHBP and FEDVIP plan comparison tools available. Check them out.

Govexec reports on OPM Director Kiran Ahuja’s speech last Wednesday Wednesday at the annual meeting of the National Academy of Public Administration.” Ms. Ahuja said “the federal government’s HR agency is hard at work finding ways to improve the federal government’s personnel systems and shifting toward becoming a modern leader on strategic human capital issues.”

From the Rx coverage front, NPR Shots tells us

If you were prescribed medicine to lower your risk of a heart attack or stroke, would you take it? 

Millions of Americans are prescribed statins such as Lipitor, Crestor or generic formulations to lower their cholesterol. But lots of people are hesitant to start the medication. 

Some people fret over potential side effects such as leg cramps, which may be – or may not be – linked to the drug. As an alternative, dietary supplements, often marketed to promote heart health, including fish oil and other omega-3 supplements (Omega-3’s are essential fatty acids found in fish and flaxseed), are growing in popularity. 

So, which is most effective? Researchers at the Cleveland Clinic set out to answer this question by comparing statins to supplements in a clinical trial. They tracked the outcomes of 190 adults, ages 40 to 75. Some participants were given a 5 mg daily dose of rosuvastatin, a statin that is sold under the brand name Crestor for 28 days. Others were given supplements, including fish oil, cinnamon, garlic, turmeric, plant sterols or red yeast rice for the same period.

The maker of Crestor, Astra Zeneca sponsored the study, but the researchers worked independently to design the study and run the statistical analysis.

“What we found was that rosuvastatin lowered LDL cholesterol by almost 38% and that was vastly superior to placebo and any of the six supplements studied in the trial,” study author Luke Laffin, M.D. of the Cleveland Clinic’s Heart, Vascular & Thoracic Institute told NPR. He says this level of reduction is enough to lower the risk of heart attacks and strokes. The findings are published in the Journal of the American College of Cardiology.

“Oftentimes these supplements are marketed as ‘natural ways’ to lower your cholesterol,” says Laffin. But he says none of the dietary supplements demonstrated any significant decrease in LDL cholesterol compared with a placebo. LDL cholesterol is considered the ‘bad cholesterol’ because it can contribute to plaque build-up in the artery walls – which can narrow the arteries, and set the stage for heart attacks and strokes.

“Clearly, statins do what they’re intended to do,” the study’s senior author Steve Nissen, M.D., a cardiologist and Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic told NPR.

Forbes informs us

In healthcare contexts, American consumers have historically tended to abandon their consumerism skills, often entering the doctor’s office or insurance process helpless, overwhelmed, and at the mercy of the system. Even when consumers have high expectations for their healthcare experiences, they’re often disappointed.

New research suggests that those days may be over. According to the 2022 Patient Access Journey Report, released last week from Kyruus, “Patients are consumers first.”

For the sixth year in a row, Kyruus has surveyed 1,000 consumers across geographies and generations to understand their preferences for selecting and accessing healthcare services. This year’s report focuses on three aspects of the healthcare consumer experience: search, selection, and action. 

The latest findings suggest consumers, in fact, now weigh similar factors in choosing their healthcare providers and service sites as they do with other types of services. * * *

Healthcare provider websites have a two-to-one advantage in consumer trust compared with health insurance sites. Forty-four percent of consumers surveyed said that they view healthcare provider websites as the most trustworthy source for information about healthcare providers or services, compared with 20% who rated health insurance providers as the most trustworthy. But the percentage of respondents who said health insurance providers were the most trustworthy sources of information jumped nine points since 2021.

From the miscellany department

  • NPR Shots explains what to watch for in the RSV surge and answers about treatment options
  • MedPage Today calls our attention to models leading to a favorable Covid conclusion

The U.S. probably won’t see a major surge in COVID deaths this winter, according to new models from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Seattle.

By Feb. 1, 2023, daily deaths are projected to be at a high point of 335, which pales in comparison to the approximate 2,500 daily deaths seen during the Omicron surge around the same time last year, according to a recently published IHME policy brief.

  • The Wall Street Journal discusses the Menty B (mental breakdown) hashtag in use in Instagram and Tik Tok and a boarding high school in Massachusetts which replaced their students smart phones with light phones. The school also banned teachers from using smart phones while teaching. Everyone’s happier.

Friday Stats and More

David Ermer–ACA, CDC, COVID-19, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

The Wall Street Journal again warns us about an impending tripledemic of Covid, the flu, and RSV.

The New York Times adds

As it gets colder and more people move their activities indoors, the recent decline in Covid-19 cases across the United States has started to level off. Coronavirus-related hospitalizations are ticking up in a number of states, including Arizona, Indiana, Illinois, Nevada, Nebraska, Oklahoma, South Dakota and Wisconsin. And there have been a variety of unnerving headlines about the immune evasion and increased transmissibility of the next round of coronavirus subvariants.

At least half a dozen versions of the virus are competing to become the next dominant strain in the United States, but they are part of the same family tree. “They are all offspring of Omicron,” said Dr. Albert Ko, a physician and epidemiologist at the Yale School of Public Health. Though each subvariant has slightly different mutations, none of them seem to be creating significant waves just yet, the way the Delta and Omicron variants did when they first appeared, Dr. Ko said.

From the Omicron and siblings front, the Center for Disease Control’s weekly interpretation of its Covid statistics tells us

Cases

As of November 2, 2022, the current 7-day average of weekly new cases (39,016) increased 4.7% compared with the previous 7-day average (37,261). A total of 97,604,763 COVID-19 cases have been reported in the United States as of November 2, 2022.

Variant Proportions

CDC Nowcast projections for the week ending November 5, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. 

The Wall Street Journal points out

Two BA.5 offshoots, BQ.1 and BQ.1.1, are gaining ground in the U.S., now accounting for an estimated 35% of cases this past week, CDC data show. Researchers and health officials have flagged both BQ variants and another variant called XBB as strains to watch, in part because they might heighten the risk for reinfection or evade certain treatments.

Hospitalizations

The current 7-day daily average for October 26–November 1, 2022, was 3,272. This is a 1.0% decrease from the prior 7-day average (3,306) from October 19–25, 2022.

Deaths

The current 7-day average of new deaths (358) decreased 3.0% compared with the previous 7-day average (369). As of November 2, 2022, a total of 1,068,667 COVID-19 deaths have been reported in the United States.

Vaccinations

As of November 2, 2022, 640.9 million vaccine doses have been administered in the United States. Overall, about 266.4 million people, or 80.2% of the total U.S. population, have received at least one dose of vaccine. About 227.4 million people, or 68.5% of the total U.S. population, have completed a primary series.

Of those who have completed a primary series, about 112.5 million people have received a booster dose, and more than 26.38 million people have received an updated (bivalent) booster dose. But 49.1% of the total booster-eligible population has not yet received a booster dose. 

STAT News adds

New data from Pfizer and BioNTech on their bivalent Covid-19 vaccine suggests the updated product may be more protective against more recent Omicron subvariants than the original version of the vaccine, the companies said in a statement released Friday.

The companies said the levels of neutralizing antibodies that target the BA.4 and BA.5 subvariants of the SARS-CoV-2 virus were four-fold higher in people aged 55 and older who received the bivalent booster than in similarly aged people who received a monovalent booster. 

The CDC’s Fluview tells us that for the week ended last Saturday

Early increases in seasonal influenza activity continue nationwide. The southeastern and south-central areas of the country are reporting the highest levels of activity followed by the Mid-Atlantic and the south-central West Coast regions.

CDC estimates that, so far this season, there have been at least 1,600,000 illnesses, 13,000 hospitalizations, and 730 deaths from flu.

The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 43 during every previous season since 2010-2011.An annual flu vaccine is the best way to protect against flu.

Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with flu.

CDC recommends that everyone ages 6 months and older get a flu vaccine annually.

There are also prescription flu antiviral drugs that can be used to treat flu illness; those need to be started as early as possible.

Forbes informs us about the availability of an RSV immune agent

While clinical trials are currently underway to provide RSV vaccines to pregnant women in order to protect their soon-to-be newborns from RSV infections, pediatric specialists have been administering an RSV “vaccine” for years. This vaccine, called palivizumab (Synagis) isn’t actually a vaccine. It is a preventative monoclonal antibody injection which has been available to high-risk infants since 1998. 

This therapy is administered as an injectable agent, thus was given the vernacular “vaccine” term, even though it is not a vaccine, nor does it act as one. It is an immune agent, providing antibody protection from severe RSV infections in vulnerable infants. It is given as an injection every month for five consecutive months. It was shown to reduce hospitalization by an average of 50% in two large placebo-controlled double-blind studies which included a total of nearly 3,000 high-risk babies. 

[T]he American Academy of Pediatrics has presented updated guidelines for use of Synagis during any time where a particular region is experiencing a surge of RSV cases:

“With the shift in seasonality noted in 2021 and the current regional variability in interseason RSV cases, the AAP continues to support the use of palivizumab in eligible infants in any region experiencing rates of RSV activity at any time in 2022 similar to a typical fall-winter season. The AAP recommends initiating the standard administration of palivizumab, which consists of 5 consecutive monthly doses.”

From the healthcare cost front, Employee Benefits News reports

The Business Group on Health named cancer as the top driver of employer healthcare costs, a spot previously held by musculoskeletal conditions. In fact, 13% of employers surveyed say they have seen more late-stage cancers impacting their workforce, and 44% predict they will see an increase in cancer diagnoses in the future. 

Again, Kelsay points out that delays in screenings, such as mammograms and prostate exams, left many Americans to unknowingly live with cancer. An estimated 64% of Americans deferred cancer screenings in 2021, according to the American Society of Clinical Oncology. And as a condition that can take months or years to treat, cancer is incredibly costly. The National Cancer Institute estimates the average cost of medical care and drugs is approximately $42,000 in the year following a cancer diagnosis.

“A lot of cancer treatments require immunotherapies, which are very expensive pharmaceuticals, as well as hospital stays and surgeries,” says Kelsay. “Cancer is just a terribly expensive condition to have.”

EBRI offers a detailed report on out of pocket spending in employer sponsored plans.

From the U.S. healthcare business front, Fierce Healthcare relates

Kaiser Permanente posted a $1.6 billion profit for the third quarter, which is down by nearly half from the $3 billion it generated in the previous quarter.

The 39-hospital system and health plan’s earnings, reported Friday, were affected by a major surge of COVID-19 that caused expenses to increase. Kaiser Permanente’s hospital system and health plan reported total operating revenue of $23.2 billion and expenses of $23 billion.

From the virtual care front, mHelath Intelligence reports

 Recent survey results released by Elevance Health found that most Americans who participated in virtual primary care said their experience was satisfactory and that the service effectively enabled them to manage their health.

Formerly known as Anthem Inc., Elevance Health is a health insurer. Through the survey, Elevance aimed to gather data on virtual primary care, its outcomes, and what patients think. The payer commissioned the Harris Poll to conduct an online survey of more than 5,000 US adults aged 18 and over.

Researchers found that 79 percent of study participants believed virtual primary care allowed them to take charge of their health, and 94 percent were satisfied with their experience. * * *

These survey findings come on the heels of a report released at the end of October, which found that telehealth was highly used among those engaging in primary care and mental health services. It also showed that patient satisfaction with telehealth was high.

From the miscellany department, The New York Times offers advice to insomniacs.

A good night’s sleep can make us more empathetic, more creative, better parents and better partners, according to Aric Prather, a psychologist at the University of California, San Francisco who treats insomnia and is the author of the new book “The Sleep Prescription.” Sleep can help us manage stress; it can make us competent and capable and better able to take on the day. But Dr. Prather says we too often view sleep as an afterthought — until we find ourselves frozen in the middle of the night, our thoughts racing, fumbling for rest or relief.

Thursday Miscellany

David Ermer–CDC, Congress, Federal employment benefits, OPM, Rx coverage, Telehealth, U.S. Healthcare–

From the Federal Employee Benefits Open Season front, we find guidance from FedSmith, FedWeek, and My Federal Retirement.

From the unusual viruses front —

The American Hospital Association reports that

The Department of Health and Human Services today renewed the nation’s monkeypox public health emergency declaration for another 90 days. When the PHE was announced in August, Centers for Disease Control and Prevention Director Rochelle Walensky, M.D., said the declaration would provide access to resources and flexibilities, expedite state data sharing, and provide more detailed data on testing and hospitalizations. CDC yesterday reported over 28,000 U.S. monkeypox cases since the first confirmed case May 18.

For a more current information on monkeypox, check out these articles from the Hill and MedPage Today.

From the Rx coverage front., Bloomberg reports

Hundreds of community pharmacies are having trouble filling prescriptions for amoxicillin, a common antibiotic that’s often used to treat bacterial infections in children.

Two-thirds of 333 pharmacy owners and managers who responded at the end of October to a National Community Pharmacists Association survey about drug shortages said they were having difficulty getting the antibiotic. The liquid form of the drug has been in limited supply in the US since October, according to the Food and Drug Administration, and it’s also in shortage in other countries

 

Another Bloomberg article attributes the shortage to demand due the RSV epidemic and school age children illnesses plus the generic drug’s low price.

“A lot of that risk is driven by market factors, particularly price,” explained Matt Christian, USP’s director of supply chain insights. In general, antibiotics are generic drugs that have existed for years and tend to be cheaper and have lower margins than newer drugs. That means drug companies have a lot less incentive to set up robust, resilient supply chains  and may be caught short if something goes wrong at a competing supplier.

“Lower priced drugs have a higher risk of shortage,” Christian said. “No margin, no inventory.”

An analysis by the FDA found a similar correlation: Drugs in short supply typically cost less than other medicines. * * *

“If you run out of an antibiotic as ubiquitous as amoxicillin, there is a concern that unnecessarily moving [to a more aggressive antibiotic] can further cause antimicrobial resistance,” Christian said.

Why doesn’t the federal government manufacture amoxicillin?

In other medical development news —

MedPage Today tells us

Hard thresholds for pain medication doses and duration are no longer promoted through the CDC’s new Clinical Practice Guideline for Prescribing Opioids for Pain.

The new guidance — which covers acute, subacute, and chronic pain for primary care and other clinicians — updates and replaces the controversial 2016 CDC opioid guideline for chronic pain. The 2016 guideline was interpreted as imposing strict opioid dose and duration limits and was misapplied by some organizations, leading the guideline authors to clarify their recommendations in 2019.

The 2022 recommendations are voluntary and give clinicians and patients flexibility to support individual care, said Christopher Jones, PharmD, DrPH, MPH, acting director of CDC’s National Center for Injury Prevention and Control in a CDC press briefing. They should not be used as an inflexible, one-size-fits-all policy or law, or applied as a rigid standard of care, or replace clinical judgement about personalized treatment, he emphasized.

More details can be found in the STAT News article.

Bloomberg informs us

In just 15 minutes, a small, handheld blood test can tell doctors whether a patient has likely suffered a concussion or traumatic brain injury — no brain scan required.    

After more than a decade of research, the Abbott Laboratories test is being used for the first time in a real-world setting to evaluate patients at Tampa General Hospital in Florida. Doctors using the test say it’s better at evaluating concussions than the brain scans that have been widely used for the last 30 years.  * * *

[Abbott Labs’] test, called the i-STAT TBI Plasma test, was greenlit by the Food and Drug Administration in 2021 to rule out the need for a CT scan when evaluating mild traumatic brain injuries. * * *

Though Abbott’s test is not yet ready to be used on the sidelines of sporting events, the ultimate goal for Abbott is for every hospital, urgent care clinic, ambulance, school and sporting event to have a portable test available. The company is also working on research that will help doctors know the severity of a concussion or brain injury, for both adults and kids, to aid in diagnoses.

Abbott worked with the Department of Defense to develop the test, which supported development with millions of dollars in funding. More than 450,000 US service members were diagnosed with a traumatic brain injury from 2000 to 2021, according to the CDC. It’s an area the DOD is “very concerned about,” said Beth McQuiston, a neurologist and chief medical officer for Abbott’s diagnostic business.  

Bravo.

From the U.S. healthcare business front

Beckers Payer Issues reports

Cigna raised its annual earnings outlook and reported a 70 percent boost in third quarter profits compared to the same period last year, according to the company’s earnings report published Nov. 3.

“We built on our momentum from the first half of 2022 with strong execution in the third quarter across our businesses and a continued focus on serving customers and clients with our differentiated health and well-being solutions,” CEO David Cordani said.

Healthcare Dive offers an M&A perspective on the Cigna announcement.

The Wall Street Journal reports

Moderna Inc.’s third-quarter revenue fell by nearly a third and the pharmaceutical company cut its outlook, saying as part of its earnings report that supply constraints for its Covid-19 vaccines might sap as much as $3 billion in sales this year.

The Cambridge, Mass.-based company said Thursday that higher costs and a decline in demand for its original Covid-19 vaccine also hit its performance.

Moderna, which three months ago said it projected $21 billion in product sales of its Spikevax vaccine for anticipated delivery this year, now expects between $18 billion and $19 billion. The company said short-term supply constraints will delay some sales into 2023.

Beckers Hospital Review cautions

The third quarter brought little relief to hospitals in what is shaping up to be one of their worst financial years.  

Kaufman Hall’s October National Hospital Flash Report — based on data from more than 900 hospitals — found slightly lower hospital expenses in September did not outweigh lower revenue across the board, with decreases in discharges, inpatient minutes and operating minutes.

The median year-to-date operating margin index for hospitals was -0.1 percent in September, marking a ninth straight month of negative operating margins and a dimmer outlook for their climb back into the black by year’s end. 

Kaufman Hall noted that expense pressures and volume and revenue declines could force hospitals to make “difficult decisions” about service reductions and cuts. 

Meanwhile according to MedCity News, the American Medical Association “blasted the Centers for Medicare and Medicaid Services Tuesday for its 2023 Physician Fee Schedule final rule, which would cut the Medicare payment rate to physicians by nearly 4.5%.” The AMA is demanding that Congress prevent the cut from occuring January 1, 2023.

The article adds

[O]ther organizations applauded it for areas that reflected their respective priorities. For instance, the National Association of ACOs (NAACOS) praised changes to the Medicare Shared Savings Program for 2023 that included providing more time to Accountable Care Organizations before they have to assume financial risk. The final rule also gave advance shared savings payments to ACOs that care for underserved communities. CMS said it expects these changes to increase participation in rural and underserved areas. * * *

[T]he final rule made changes to policies related to telehealth. This includes extending several telehealth services that were temporarily made available during the public health emergency through at least 2023. This will “allow additional time for the collection of data that may support their inclusion as permanent additions to the Medicare Telehealth Services List,” CMS said. The change is in line with comments CMS Administrator Chiquita Brooks-LaSure made at a recent conference. 

The Telehealth Access for America (TAFA), which includes the American Hospital Association, applauded the changes to telehealth, though the group called on Congress to make permanent actions.

In other telehealth news, Healthcare Dive reports

  • COVID-19 diagnoses fell by about 1% to 2% as a share of telehealth claims nationally in August, according to Fair Health’s monthly tracker data out Thursday.
  • In the South and West, COVID-19 fell from the second top diagnosis to the third from July to August. It remained in second place in the Midwest and Northeast.
  • Mental health conditions stayed as the top telehealth diagnoses nationally and in every region, and one hour of psychotherapy remained the top telehealth procedure code.