Thursday Miscellany

FDA

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The American Hospital Association News tells us
    • “The House Energy and Commerce Committee today held a hearing on legislative proposals to prevent and respond to generic drug shortages. In comments submitted last month, AHA urged the committee to reject provisions in its draft legislation proposals that would limit patient access to 340B drugs and consider additional proposals that would protect the supply chain for essential medications.
    • “Witnesses at today’s hearing included representatives from Civica, the American Society for Health System Pharmacists, Healthcare Supply Chain Association, Healthcare Distribution Alliance, and Association for Accessible Medicines.”
  • STAT News adds,
    • “Although shortages are not new, the number of drugs in short supply has grown steadily for about two years. Shortages also have become more difficult to predict and are affecting drugs that are more critical.
    • “Most concerning are the shortages of cancer drugs, which until recently hadn’t been much of a problem for at least a decade. There are 15 cancer drugs currently in short supply, according to the Food and Drug Administration, though the White House this week said one of the key shortage chemotherapies, cisplatin, is nearly back to pre-shortage levels.
    • “Civica Rx members choose which drugs it brings to market. So far, the nonprofit contracts for cyclophosphamide, a chemotherapy that helps treat multiple cancers, and there’s a heightened urgency to determine whether to add more cancer drugs to the list.
    • “Given the drug shortage situation for cancer drugs, we have a working group now,” said Allan Coukell, senior vice president of public policy at Civica Rx. “We’re looking at what would a portfolio of those drugs be.”

From the Rx coverage front,

  • Forbes reports
    • “Despite misleading headlines, such as “Sudafed, Benadryl and most decongestants don’t work,” * * * [t]here are branded products that include the names Sudafed and Benadryl that do work as nasal decongestants. These contain the active ingredient pseudoephedrine. But because the dangerous illicit substance methamphetamine can be made in illegal laboratories with pseudoephedrine these products were placed behind the counter years ago. In 2005, Congress passed the Combat Methamphetamine Epidemic Act, which requires that pharmacies and other retail stores maintain purchase logs for products that include pseudoephedrine, and it limits the amount of those products an individual can purchase per day. Pseudoephedrine-based drugs are not affected by the FDA panel’s vote. They will remain available behind the counter.”
  • Per Healthcare Dive,
    • “GoodRx has notched a third partnership with a pharmacy benefit manager to integrate its drug coupons at the point of sale, further expanding GoodRx’s access to the commercially insured PBM market.
    • “For eligible members filling a generic medication starting in 2024, the new program will compare GoodRx’s discount price with their price through insurance and apply the lowest cost. The payment will be automatically applied to consumers’ deductibles.
    • “With MedImpact and existing deals with CVS Caremark and Cigna-owned Express Scripts, GoodRx now reaches more than 60% of insured lives through the partnerships, the company said Wednesday.”
  • The Institute for Clinical and Economic Research published an evidence report for gene therapy to treat Metachromatic Leukodystrophy.
    • “Currently available evidence provides greater certainty of substantial net health benefit in pre-symptomatic MLD; evidence also suggests that individuals with early symptomatic disease benefit from treatment —
      • “Using weighted analyses across all patient subpopulations, arsa-cel would achieve common thresholds for cost-effectiveness if priced between $2.3M – $3.9M —
      • “At the September 29 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatment’s comparative clinical effectiveness, other potential benefits, and long-term value for money.”

From the U.S. public health front,

  • Healio points out
    • Results from the American Association for Cancer Research’s annual Cancer Progress Report revealed that the age-adjusted overall cancer death rate in the U.S. fell by 33% between 1991 and 2020.
    • The report also detailed FDA approvals related to anticancer therapeutics over the past year, the impact of immunotherapy on cancer care in the 21st century and key challenges needed to overcome obstacles patients with cancer still face moving forward.
  • McKinsey notes” “Orthopedic care is among the largest categories in US healthcare; improvements could have far-reaching positive effects. We analyze care pathways to spot opportunities for better coordination.” Check it out.
  • Per Fierce Healthcare,
    • “Xylazine, a powerful veterinary tranquilizer, was detected in drug tests in 34 states from every region of the country, according to a new analysis.
    • “The analysis was conducted by national drug testing lab Millennium Health, looking at more than 160,000 de-identified urine drug test results from more than 73,000 unique patients collected between mid-April and mid-July 2023. 
    • “Xylazine, also known as “tranq,” is a sedative that prolongs and enhances the euphoric effects of illicit fentanyl. Xylazine-associated deaths are on the rise, and nearly all involve illicit fentanyl or fentanyl analogs. The Biden administration designated fentanyl combined with xylazine an emerging threat in April. “
  • and
    • “Loneliness can have major impacts on seniors’ health, worsening comorbidies and even driving mortality, according to a white paper by the Elevance Health Public Policy Institute.
    • “Loneliness in older adults increases the likelihood of depression and dementia as well as worsening outcomes for individuals with hypertension, heart disease and stroke, according to the white paper.
    • “In a survey, the researchers researchers found that:
      • About 28% of respondents had a mental health condition.
      • About 1 in 4 reported having both depression and another mental health condition.
      • Individuals with a mental health diagnosis were more likely to live alone.
      • Individuals with a mental health diagnosis cited limitations to social activities in the past month because of poor health.
    • “Elevance Health hired research and consulting company Health Management Associates to describe the characteristics of 16,000 Medicare beneficiaries with a mental health diagnosis using the 2018 Medicare Current Beneficiary Survey. Some beneficiaries were covered by traditional fee-for-service Medicare, others by Medicare Advantage (MA).”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Medical services provided in outpatient settings are notably pricier when delivered in hospital-owned departments compared with ambulatory surgery centers or physicians’ offices, according to a new analysis from a Blue Cross Blue Shield Association subsidiary.
    • “The report, based on data for 133 million Blues members found from 2017 to 2022, also found prices generally grew more rapidly at hospital outpatient departments than at non-hospital outpatient settings.
    • “Researchers said their data supports site-neutral proposals to make care costs the same regardless of where it’s provided. Momentum is building in Congress around the policies, but they face fierce opposition from hospital groups.”
  • and
    • “Out-of-network ground ambulance rides made up a larger percentage of total claim lines than in-network rides between 2018 to 2022, exposing patients to a higher risk of surprise bills, according to an analysis by Fair Health. 
    • “Out-of-network rides made up almost 64% of all ground ambulance claim lines in 2018, decreasing slightly to over 59% in 2022. 
    • “Advanced life support (ALS) services, which provide a higher level of care than basic life support (BLS), comprised a larger share of ground ambulance claims than basic life support services from 2018 to 2022 — another factor that could drive up costs, the research found. About 51% to 52% of ground ambulance claim lines were associated with ALS during the study period.”

In Social Security and Medicare news,

  • The Detroit Free Press reports,
    • “The odds moved up, based on the latest inflation data, that Social Security benefitscould see a 3.2% cost-of-living adjustment next year. Not sky high but a bit better than average.
    • “To be sure, we’ll need to see one more month of data before the exact inflation adjustment will be known. The next round of Consumer Price Index data for September will be released by the U.S. Bureau of Labor Statistics on Oct. 12.”
  • Per CNET,
    • “Starting in 2024, Medicare Premium costs will be changing — Medicare Part B costs are expected to get more expensive, while Medicare Part D prices are projected to decrease. We’ll tell you how much below. * * *
    • “Due to a new Alzheimer’s treatment coming to the market (Leqembi, from pharmaceutical companies Eisai and Biogen), Medicare beneficiaries are expected to pick up the cost. Therefore, Medicare Part B prices are expected to increase in 2024. The costs are projected to go up from the current $164.90 to $174.80, a nearly $10 increase per month. 
    • “While you may not see a huge difference in the amount you’re paying for Medicare Part D, it still could be slightly lower. The average total monthly Part D premium is projected to decrease from $56.49 in 2023 to $55.50 in 2024, according to the Centers for Medicare & Medicaid Services (CMS). That’s nearly $1 each month.” 

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal reports, “House Speaker Kevin McCarthy laid out a map for passing legislation to keep the government funded past Oct. 1, but immediately ran into new roadblocks from spending hawks and fresh grumbling that he should be ousted from his post.” The FEHBlog anticipates that Congress will pass a continuing resolution before the end of the month.
  • The Centers for Medicare and Medicaid Services announced,
    • “the list of 34 prescription drugs for which Part B beneficiary coinsurances may be lower between October 1 – December 31, 2023. Some people with Medicare who take these drugs may save between $1 and $618 per average dose starting October 1, 2023, depending on their individual coverage.  * * *
    • “CMS has released information about these 34 Part B drugs and biological products in the quarterly Average Sales Price (ASP) public files, available here. A fact sheet is available here.”
  • Healthcare Dive informs us,
    • “Healthcare legislation being hashed out on the Hill is taking aim at pharmacy benefit managers, but the policies — while potentially worthwhile — are unlikely to have more than modest effects on the cost of prescription drugs in the U.S., experts say. us,
    • “Eliminating all PBM profits would only reduce total drug-related spending by “several percentage points,” since operating margins for the three biggest PBMs averaged roughly 4% of revenues last year, according to a new report from the Brookings Schaeffer Initiative on Health Policy.
    • “Lowering spending further would require “fundamental market changes” like changing drug patent protections or the way drug prices are regulated, the report says — measures sure to face heavy opposition from pharmaceutical companies.”
  • Per Becker’s Hospital Review,
    • “Cisplatin, a drug used for multiple types of cancer that’s been in a severe shortage for months, is close to returning to 100 percent of pre-shortage supply levels, the White House said Sept. 12. * * *
    • “In June and July, the FDA allowed China-based Qilu Pharmaceutical to temporarily import cisplatin. These lots have already been distributed, according to the FDA. The agency also worked with domestic drugmakers to increase their manufacturing capacity. 
    • “These actions brought the cisplatin supply back to nearly 100 percent of the pre-shortage levels and are greatly alleviating the shortages of carboplatin,” according to a post from the White House’s Office of Science and Technology Policy.”
  • The Federal Times writes about the impending premium increases in the Federal Long Term Care Insurance Program.

From the public health and research front,

  • The American Medical Association released a letter supporting the CDC’s “universal recommendation for the 2023-2024 COVID-19, XBB.1.5 containing vaccine.”
  • The National Cancer Institute informs us
    • “Testing for the presence of cancer-causing types of the human papillomavirus (HPV) is now a standard part of screening for cervical cancer, sometimes with simultaneous Pap tests (known as co-testing). But cervical cancer screening is recommended to stop at age 65 in many places and, for a variety of reasons, many older adults stop getting screened for cervical cancer well before that age. 
    • “Results from a population-based study conducted in Denmark, however, suggest that it may be worthwhile for some individuals between ages 65 and 69 to get tested for HPV: those who haven’t had cervical cancer screening for at least 5 years.
    • “In the new study, about 62% of women who were invited to undergo this “catch-up” testing for HPV (intervention group) had a test within the next year. In a comparison group of women not invited for catch-up testing, only about 2% had either a Pap test or an HPV test over the next year.”
  • The Wall Street Journal reports
    • “The first artificial womb to gestate a human baby is fast approaching reality.
    • “Food and Drug Administration regulators will weigh next week how scientists should conduct the first human tests of bag-like wombs, meant to nurture babies born so premature that modern medicine struggles to keep them healthy. * * *
    • “Philadelphia-based Vitara Biomedical has said that it is working on an artificial womb and is close to human clinical trials. A company executive said at a biotech symposium last year that the firm is commercializing the research of one of two U.S. groups known to be testing the technology on lambs. The other U.S. group says it is still a few years off from human trials.”
  • Forbes notes, “The Marcus Autism Center in Atlanta has launched its biomarker-based device that has been authorized by the FDA to aid in the diagnosis of autism in children between 16 and 30 months of age.” 

From the U.S. healthcare business front,

  • BioPharma Dive tells us,
    • “After pulling off a biomedical triumph with its COVID-19 vaccine, Moderna on Wednesday put out a roadmap for investors that promises billions of dollars from new medicines.
    • “The company aims to launch as many as 15 new products in the next five years, including four by 2025. In 2027, Moderna expects $8 billion to $15 billion in respiratory product sales. And on Wednesday, it forecast another $10 billion to $15 billion in annual sales from new treatments for cancer and rare and latent diseases it hopes to introduce by 2028.”
  • Beckers Payer Issues points out,
    • “Humana, Aetna and Molina are not renewing their contracts with senior companionship company Papa following allegations of abuse against patients or company employees, Bloomberg reported Sept. 11.
    • “In May, Bloomberg Businessweek published a report detailing allegations of abuse against seniors and Papa employees based on 1,200 complaints submitted to the company. The complaints included allegations of sexual abuse and assault, harassment, or unsafe living conditions.
    • “A spokesperson for Papa declined to provide a comment to Bloomberg about specific contracts, but said the company has grown its client base this year and is selling programs for next year.” 

Tuesday Tidbits

David Ermer–CDC, CMS, COVID-19, COVID-19 vaccine, FDA, HSA, Medical / Rx research, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us
    • “As authorized yesterday by the Food and Drug Administration and recommended by its vaccine advisory committee, the Centers for Disease Control and Prevention today recommended a single dose of the updated Moderna and Pfizer COVID-19 vaccines for Americans aged 12 and older, and one or two doses of the updated vaccines for previously vaccinated children aged six months through 4, at least two months after receipt of their last dose. The agency also recommended three doses of the updated Pfizer vaccine and two doses of the updated Moderna vaccine for unvaccinated children under age 5, as authorized by the FDA and recommended by the committee. CDC anticipates the updated vaccines will be available later this week.
    • “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “We very much encourage those who are eligible to consider getting vaccinated.”
  • and
    • The Food and Drug Administration’s independent Nonprescription Drugs Advisory Committee Sept. 12, by unanimous vote, declared oral phenylephrine ineffective as a decongestant. Phenylephrine is a common active ingredient in over-the-counter medications sold under the Nyquil, Tylenol, Advil, Robitussin, Sudafed and Benadryl brands, to name a few. FDA is not bound to the committee’s recommendations, but the agency’s own analysis presented prior to the panel’s meeting concluded that oral phenylephrine formulations are safe but ineffective at standard or even higher doses. The vote paves the way for products containing oral phenylephrine potentially being pulled from shelves until reformulated versions are offered.
  • FEHBlog observation — The class action lawyers should be revving up the old turbobiller.
  • The U.S. Census Bureau announced
    • “The percentage of working-age adults ages 19 to 64 with health insurance coverage increased from 2021 to 2022, primarily driven by an increase in employment-based coverage. This resulted in uninsured rates dropping from 11.6% to 10.8% according to U.S. Census Bureau data released today [September 12]. 
    • “The Health Insurance Coverage in the United States: 2022 report shows that the share of working-age adults with coverage rose across many race and ethnic groups, regions and employment status.”
  • Beckers Hospital Review informs us
    • CMS fined two more hospitals for alleged price transparency violations Sept. 5, marking the third consecutive month the agency has levied fines on noncompliant hospitals.   
    • “According to CMS’ price transparency website:
      • Washington, D.C.-based Saint Elizabeths Hospital was fined $677,440. 
      • Silver Spring, Md.-based Holy Cross Hospital was fined $325,710.
      • Additionally, CMS’ Sept. 8 update of its price transparency website included information of another hospital fined Aug. 22 that was not previously uploaded to the site. Doctors’ Center Hospital Bayamón (Puerto Rico) was fined $102,200.
    • The hospitals have 30 days from the issuance date to appeal the fines. 
    • CMS has now fined 14 hospitals for price transparency violations. To date, three hospitals have appealed their penalties and are under review, according to CMS.”  
  • ICD Monitor relates
    • “To help improve the collection of the social determinants of health (SDoH) Z codes, the Centers for Medicare & Medicaid Services (CMS) Office of Minority Health last week released a new Z code infographic. 
    • “CMS’s goal is to assist providers with understanding and using SDoH terminology in their documentation that will allow for greater alignment for ICD-10-CM Z code capture.  As discussed, CMS believes that greater Z code capture will enhance quality improvement activities and provide further insights into the existing health inequities that hospitals and their community are facing.” 

From the public health and medical research front,

  • The Wall Street Journal has updated its report on the fall vaccination season.
  • MedTech Dive lets us know,
    • A prospective study published in the journal Lancet Digital Health found that an AI tool paired with a double reading by one radiologist was as good at detecting breast cancer as a double reading by two radiologists, the current standard of care.
    • Researchers at the Capio Sankt Göran Hospital in Stockholm, Sweden, and the Karolinska Institute said the results suggest that AI “has potential for controlled implementation, which would include risk management and real-world follow-up of performance.” 
    • The study used the Insight MMG system for breast cancer detection, made by Seoul, South Korea-based Lunit. The company helped fund the research, in addition to grants from the Swedish Research Council, the Swedish Cancer Society, and Region Stockholm.
  • The American Hospital Association News reports,
    • “The U.S. infant mortality rate was essentially unchanged in 2021, but the number of deaths rose 2% to 19,928, the Centers for Disease Control and Prevention reported Sept. 12. The mortality rate increased for infants of Asian women and declined for infants of Dominican women. Infants of Black women had the highest mortality rate by race at 10.55 per 1,000 live births, while infants born before 28 weeks of gestation had the highest rate by age (353.76). The five leading causes of death were unchanged from 2020, with declines for disorders related to short gestation and low birth weight. Infant mortality rates by state ranged from a low of 2.77 in North Dakota to a high of 9.39 in Mississippi. The U.S. infant mortality rate has generally trended downward since 1995 and has declined 21% since 2005, the most recent high (6.86).”
  • STAT News is now offering a new generation weight loss drug tracker.
    • “STAT has created a new database to track the significant obesity drugs that are on the market and in development. The tracker, which will be updated with developments each quarter, gives a sense of what new mechanisms could hit the market, how they would be taken and how often, and which companies are running the most trials.
    • “A related article details the strategies and challenges of some of these companies.”
    • Roughly seventy drugs are on the tracker currently.

From the U.S. healthcare business front,

  • Fierce Healthcare tells us, “Shareholders in home health company Amedisys have approved its $3.3 billion union with Optum, even as the feds take a closer look at the deal.”
  • Per Healthcare Dive,
    • “Walgreens is partnering with startup Pearl Health to help primary care physicians manage value-based care, in a bid to expand its reach with community-based providers.
    • “The partnership announced Tuesday [September 12] marries Pearl’s provider enablement technology with Walgreens’ care delivery assets and pharmacy services in an attempt to make it easier for clinical teams to provide the personalized treatment necessary in value-based arrangements, according to the companies.
    • “Walgreens and Pearl will help doctors manage value-based care in traditional Medicare’s accountable care organization program, called ACO REACH, starting in 2024. The two plan to eventually expand to Medicare Advantage and potentially commercial payers and Medicaid down the line.”
  • Per Employee Benefits News,
    • “Saving for retirement is a life-long challenge, and one that seems to be harder for women. While they live on average five years longer than men, they’re saving less.
    • “Bank of America analyzed 565,000 health savings accounts (HSAs), looking at utilization trends across genders and generations. Women’s HSA balances are 15% lower than men’s, with women more likely to spend their HSA savings before retirement and contribute less to their accounts. Overall, men’s average net HSA savings was $128 higher in 2022, and over the years that gap begins to add up.” * * *
    • “Lisa Margeson, managing director of retirement research and insights at Bank of America,  advises employers to at the very least educate their employees on the power of HSAs and how they can use them as retirement savings vehicles. Employer HSA contributions, caregiving benefits and flexibility will also help ensure women can maintain successful careers and save for their future. 
    • “As for women, Margeson encourages them to start their HSAs early, try to put at least a little aside each month and eventually invest that money according to their bank’s capabilities. For those who are uncomfortable with a high-deductible health plan, Margeson points to emergency savings accounts or an interest-bearing savings account as a companion to their retirement plans.”
  • The Society for Human Resource Management offers a breakdown of compensation expenses over the second quarter of this year.
    • “According to the latest Employer Costs for Employee Compensation report, released September 12 by the U.S. Bureau of Labor Statistics (BLS), employers spent just 0.59 percent more on wages and benefits in June 2023 compared to March 2023.
    • “Total employer compensation costs for private-industry workers averaged $41.03 per hour worked. Wages and salaries averaged $28.97 per hour worked, accounting for 70.6 percent of employer costs, while benefits costs averaged $12.06 per hour worked, accounting for the remaining 29.4 percent, according to the report.”

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medicare, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC,

  • The Office of Personnel Management issued a Benefit Administration Letter providing guidance about an Enrollee Decision Period for Federal Long Term Care Insurance Program enrollees. The Enrollee Decision Period started today and ends on November 9, 2023.
  • The Food and Drug Administration announced
    • “approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.”
  • Roll Call adds
    • “Advisers to the Centers for Disease Control and Prevention are scheduled to discuss on Tuesday recommendations for who should receive the vaccines and when, with CDC Director Mandy Cohen expected to sign off shortly thereafter. 
    • “Drugmakers say they’re ready to begin shipping the shots immediately in accordance with the CDC’s pending guidelines.”
  • STAT News tells us, “Sen. Bernie Sanders (I-Vt.) will hold a confirmation hearing next month for Dr. Monica Bertagnolli, President Biden’s nominee to run the National Institutes of Health, he said Friday.”

From the public health front,

  • MedPage Today reports
    • “Anesthesiologists are sharply divided over how to handle the growing number of surgical patients on GLP-1 receptor agonists, given that the drugs can raise the risk of aspiration during surgery.
    • “While the leading U.S. anesthesiology society suggests that patients stop taking injectable versions of the medications for 7 days ahead of surgeryopens in a new tab or window, some anesthesiologists are turning to alternative strategies such as intubating all at-risk patients, even for minor procedures.
    • “Other anesthesiologists are calling for patients to stay off the drugs for weeks, not days, or titrate down to lower doses.
    • “This topic is being heavily discussed in the anesthesia community right now, and it’s very polarizing,” Michael Gulak, MD, a resident anesthesiologist at the University of Toronto, told MedPage Today.”

From the U.S. healthcare business front,

  • Beckers Hospital Review informs us
    • “Nonprofit hospital expenses continued to grow last year while liquidity fell to pre-pandemic levels, according to Moody’s Investor Services. 
    • “In a Sept. 7 report, Moody’s outlined 2022 fiscal year trends based on data from 218 health systems. The report noted operating margins fell to”unsustainable levels” as median operating cash flow margin was 4.9 percent and median operating margin was -0.3 percent amid labor shortages and inconsistent patient volumes.
    • “While the industry shows signs of stabilizing in 2023, the labor environment will remain challenging,” the report states.”
  • Per Benefits Pro,
    • “Hospitals in the United States faced unprecedented challenges during the COVID-19 pandemic, and those challenges have left them floundering in the face of increased costs and workforce shortages. According to the most recent Costs of Caring report from the American Hospital Association, this combination of factors has resulted in a 17.5% increase in overall hospital expenses between 2019 and 2022. “Further exacerbating the situation is the fact that the staggering expense increases have been met with woefully inadequate increases in government reimbursement,” the report states, leading to consistently negative margins and over half of hospitals ending 2022 at a financial loss.
    • “Even so, hospital expenses per inpatient day have been steadily trending upwards for years in the U.S., whether for-profit, non-profit, or state/local government. Research from KFF shows that in 1999, the average adjusted expenses per inpatient day for state/local government hospitals was $1,004. Non-profits were at $1,139, and for-profits were at $999. As of 2021, state/local government stands at $2,742—a 173% increase. Non-profits are at $3,013 (164.5%) and for-profits at $2,296 (129.8%).”
  • MedCity News points out
    • While there are fewer rural residents enrolled in Medicare Advantage plans than micropolitan or metropolitan residents, MA enrollment in rural areas is growing much more rapidly, new research shows.
    • The KFF report, published Thursday [September 7], defines rural areas as having less than 10,000 people, micropolitan areas as having 10,000 to 50,000 people and metropolitan areas as having at least 50,000 people. The findings come when Medicare Advantage growth overall is on the rise, accounting for more than half of eligible Medicare beneficiaries in 2023.
  • Healthcare Dive relates
    • Walmart is considering buying a majority stake in value-based medical chain ChenMed, according to a Bloomberg report published Friday.
    • The retail giant is in discussions with ChenMed regarding a transaction that would value the Miami-based primary care clinic operator at several billion dollars, Bloomberg reported, citing sources familiar.
    • Terms of the deal aren’t finalized, and talks could fall through or a different buyer could emerge, Bloomberg’s sources said.
    • If a deal is announced, Walmart would become the latest retail operator to bag a primary care operator, following in the footsteps of rivals including CVS, Amazon and Walgreens.
    • ChenMed operates a network of more than 125 clinics for Medicare-eligible seniors in 15 states, according to the company’s website.

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Government Contracting, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Federal News Network offers its periodic update on the bills pending before Congress of interest to federal employees.
  • American Hospital Association News tells us that today
    • “The Department of Health and Human Services’ Office for Civil Rights released a proposed rule intended to update and clarify requirements under Section 504 of the Rehabilitation Act that prohibit discrimination on the basis of disability in programs receiving financial assistance from the department, including health care. According to HHS, the proposed rule would ensure that medical treatment decisions are not based on biases or stereotypes about individuals with disabilities; prohibit the use of value assessment methods that place a lower value on life-extension for individuals with disabilities when used to limit access or to deny aids, benefits and services; establish enforceable standards for accessible medical diagnostic equipment; and clarify obligations for accessible web and mobile applications and obligations to provide services in the most integrated setting appropriate to an individual’s needs. The rule will be published in the Sept. 14 Federal Register, with comments accepted for 60 days.”
  • The Federal Times points out
    • “The Office of Personnel Management received a small surge of retirement claims in July and August after applications had been falling steadily for months since January.
    • “The time it took the government to process retirements increased sharply in July to 85 days before falling back down to 74 days in August, according to data kept by OPM.
    • “Overall, the agency is sitting on an inventory of nearly 18,000 cases after it reduced its working caseload to new lows this year. About this time last year, there were 29,000 pending cases.
    • “Still, despite efforts to dispatch focus teams to address backlogs, the agency is failing to hit its target time or inventory goals, leaving retirees to wonder whether their case will be one that ends up sitting in limbo for longer. Ideally, retirement applications are processed in 60 days or fewer.”
  • CMS released its 2022 report on covered entity compliance with the HIPAA electronic transactions.
    • The transaction types experiencing the most violations during the 2020 and 2021 compliance reviews were specific to 835 [the claim transaction], 271 [Health Care Eligibility Response], and 277 [Claim Status Response] transactions. This changed slightly in 2022 as the most common transaction types experiencing violations are now 835, 271, and 834 [EOB] transactions.
    • CMS is sharing updated 2022 violation findings insights to inform and educate the industry, encourage widespread compliance, and assist covered entities with preparing for compliance reviews.
  • The Society for Human Resource Management relates,
    • The U.S. Equal Employment Opportunity Commission (EEOC) has released an updated deadline for employers to submit their demographic data. The EEO-1 Component 1 data collection for 2022 will start on Oct. 31, and the deadline for employers to file their EEO-1 reports is Dec. 5.
    • All private employers that have at least 100 employees are required to file the EEO-1 form annually, detailing the racial, ethnic and gender composition of their workforce by specific job categories.
    • Likewise, federal government contractors and first-tier subcontractors with 50 or more employees and at least $50,000 in contracts must file EEO-1 reports. State and local governments and public school systems are exempt.
  • KFF reports
    • “Over the past two years, the federal government has provided about $1 billion from the American Rescue Plan and Bipartisan Safer Communities Acts to launch the number, designed as an alternative to 911 for those experiencing a mental health crisis. After that infusion runs out, it’s up to states to foot the bill for their call centers.
    • “We don’t know what Congress will allocate in the future,” said Danielle Bennett, a spokesperson for the federal Substance Abuse and Mental Health Services Administration, which oversees 988. “But the hope is that there will be continued strong bipartisan support for funding 988 at the level it needs to be funded at and that states will also create funding mechanisms that make sense for their states.”
    • “Only eight states have enacted legislation to sustain 988 through phone fees, according to the National Alliance on Mental Illness, which is tracking state funding for the system. Others have budgeted short-term funding. But many predominantly rural states, where mental health services are in short supply and suicide rates are often higher than in more urban states, have not made long-term plans to provide support.”
  • MedPage reports,
    • When pseudoephedrine moved “behind-the-counter” nearly 20 years ago, it left oral phenylephrine (with brands including Sudafed PE and Suphedrine PE) as the only nasal decongestant available without pharmacy assistance. But there’s one big problem: phenylephrine doesn’t work, the FDA has finally determined.
    • FDA reviewers released the results of their long-running review of the evidence this week as background for a meeting of the Nonprescription Drugs Advisory Committee to be held on September 11 and 12.
    • The article explains the conundrum this finding creates for the FDA.

From the public health front,

  • MedPage reports that “the global incidence of early-onset cancer has increased by 79% over the past three decades, researchers reported.
    • “In a comment posted on Science Media Centre, Dorothy C. Bennett, MA, PhD, of St. George’s, University of London, cautioned that the increase in new cases of early-onset cancer is based on absolute numbers, rather than age-standardized rates.
    • “The world human population increased by 46% between 1990 and 2019, which explains part of the increase in total case numbers,” she said, adding that the increase in numbers of cancer deaths in this age group (28%) was notably lower than the number of new diagnoses, “which is below the increases in total population and case numbers, indicating a fall in the average cancer death rate in this group.”
  • Per the American Heart Association,
    • Obesity-related cardiovascular disease deaths tripled between 1999 and 2020 in the U.S.
    • Such deaths were higher among Black individuals (highest among Black women) compared with any other racial group, followed by American Indian/Alaska Native people.
    • Black adults who lived in urban communities experienced more obesity-related cardiovascular disease deaths than those living in rural areas, whereas the reverse was true for all other racial groups.
  • McKinsey Health offers a podcast about getting to the bottom of the teen health crisis.

From the U.S. healthcare business front,

  • Fierce Healthcare notes, “Employers’ health benefits costs are set to rise 5.4% next year, but this spike isn’t as high as may have been feared given inflationary pressures in the broader economy, according to a new analysis from Mercer.”
  • STAT News interviews “Amazon’s chief medical officers on where the company’s health care bets are headed next.”
  • Healthcare Dive informs us,
    • “Telehealth sessions comprised 5.4% of claim lines in June, the same amount as the prior month, according to Fair Health’s Monthly Telehealth Regional Tracker.
    • “Mental health conditions continued to top the list of Fair Health’s five most common telehealth diagnoses for June. The median allowed amount billed for a one-hour psychotherapy visit was $103.
    • “But Fair Health’s tracker showed regional variations. Although telehealth use decreased overall by 2.4% in the Midwest, asynchronous telehealth claim lines for mental health conditions more than doubled in the region from 15.9% in May to 36% in June. In asynchronous telehealth, providers collect data or medical images for review, instead of meeting with a patient in real time.” 
  • Per Health Affairs,
    • “Intensive care units (ICUs) are increasingly used for hospital care, yet out-of-pocket spending for ICU hospitalizations remains poorly understood, particularly among the nearly half of the US population with commercial health insurance. Using 2008–19 MarketScan data, we compared 1,441,810 hospitalizations involving ICU services with 13,011,208 hospitalizations that did not involve ICU services.
    • “Average cost sharing, adjusted for patient and admission factors, increased from $1,137 per hospitalization in 2008 to $1,539 in 2019, or a 34 percent increase. This was driven by increasing deductibles, which rose by 163 percent.
    • “Across twenty clinical conditions whose hospitalizations commonly occurred in both ICU and non-ICU settings, ICU admission was associated with $155 higher cost-sharing (13.0 percent higher) relative to cost sharing in non-ICU hospitalizations.
    • “Patients with high-deductible plans faced the highest cost-sharing relative to those with other plan types.
    • “Patients who received out-of-network hospital care encountered higher cost-sharing relative to those admitted to in-network hospitals with in-network clinicians.”

Midweek update

David Ermer–FDA, Generative AI, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC,

  • “Today, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra declared a Public Health Emergency (PHE) for the state of Florida to address the health impacts of Hurricane Idalia and the Administration for Strategic Preparedness and Response (ASPR) deployed approximately 68 emergency response personnel to the state. At President Biden’s direction, HHS is aiding impacted communities through the Administration’s whole-of-government response effort.”
  • The Society for Human Resource Management informs us,
    • “The Department of Labor (DOL) has proposed an increase to the Fair Labor Standards Act’s (FLSA’s) annual salary-level threshold to $55,068 from $35,568 for white-collar exemptions to overtime requirements. The department also is proposing automatic increases every three years to the overtime threshold. * * * *
    • “To be exempt from overtime under the FLSA’s “white-collar” executive, administrative and professional exemptions, employees must be paid a salary of at least the threshold amount and meet certain duties tests. If they are paid less or do not meet the tests, they must be paid 1 and a half times their regular hourly rate for hours worked in excess of 40 in a workweek. * * *
    • “Under the new rule, approximately 300,000 more manufacturing workers would be entitled to overtime pay, the Labor Department reports. A similar number of retail workers would be eligible, along with 180,000 hospitality and leisure workers, and 600,000 in the health care and social services sector.” 
  • MedCity News relates,
    • “A Bristol Myers drug that treats anemia caused by a type of blood cancer now has an FDA approval that moves it up in the hierarchy of treatments, expanding the eligible patient population and positioning the therapy to achieve its blockbuster expectations.
    • “The drug, Reblozyl, treats myelodysplastic syndromes (MDS), a group of cancers in which the immature blood cells in bone marrow do not mature to become healthy blood cells. In 2020, the FDA approved Reblozyl as a second-line treatment for the anemia resulting from MDS. The FDA decision announced late Monday makes it a first-line therapy.”
  • The National Institutes of Health announced,
    • “In a study of 152 deceased athletes less than 30 years old who were exposed to repeated head injury through contact sports, brain examination demonstrated that 63 (41%) had chronic traumatic encephalopathy (CTE), a degenerative brain disorder associated with exposure to head trauma. Neuropsychological symptoms were severe in both those with and without evidence of CTE. Suicide was the most common cause of death in both groups, followed by unintentional overdose.
    • “Among the brain donors found to have CTE, 71% had played contact sports at a non-professional level (youth, high school, or college competition). Common sports included American football, ice hockey, soccer, rugby, and wrestling. The study, published in JAMA Neurology, confirms that CTE can occur even in young athletes exposed to repetitive head impacts. The research was supported in part by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.” 

From the public health, medical research and Rx coverage fronts,

  • STAT News reports,
    • “The first Alzheimer’s therapy to clearly slow cognitive decline, approved in the United States last month, lifted the hope of patients and their families. But creating access to the program is a painfully slow process, even in Massachusetts, where large hospital systems have been preparing for months to administer the much-anticipated medicine.
    • “Thousands of patients are stuck on waiting lists across the state and nationally as hospitals struggle to ramp up infusion centers and monitoring processes for the drug, called Leqembi, while neurologists grapple with workforce and capacity constraints. * * *
    • “Hospitals say the backlog is temporary, reflecting the challenge of building from scratch a treatment infrastructure for new Alzheimer’s drugs. Leqembi, developed by Biogen and its Japanese partner, Eisai, was the first such treatment to be green-lighted by the Food and Drug Administration. The agency will evaluate a second therapy, Eli Lilly’s donanemab, later this year.”
  • and
    • “KRAS, one of the most common genetic mutations in cancer, has been one of the most tantalizing oncogenic targets for drug developers since its discovery four decades ago. An altered KRAS gene can drive cells to divide uncontrollably, propelling them down the path towards malignancy. But for most of the last four decades, any attempt to target KRAS failed, leading many researchers to doom the protein as “undruggable.”
    • “In the last few years, that attitude has sharply turned around. In 2013, Kevan Shokat, a biologist at the University of California, San Francisco, discovered a key chemical vulnerability in a specific subset of mutant oncogenic KRAS that made it possible to design small molecules that would bind to the protein. This discovery catalyzed a frenzy of drug development around KRAS inhibitors, which eventually led to the first approved KRAS drugs in the last couple of years. Those successes are now driving a new wave of early-stage innovation around the target.
    • “It broke the code for us, for KRAS,” said Ravi Salgia, chair of medical oncology and therapeutics research at the City of Hope. “That gives us more hope to say we’ve spent more than 30 years studying it. Now, great breakthroughs have occurred. Let’s keep going forward.”
    • “That includes work around new small molecules for other subsets of mutant KRAS as well as immunotherapy approaches for targeting the oncogene. These therapies could potentially treat a wide range of different KRAS-mutant cancers including lung, pancreas, and colorectal cancers.”
  • CNN tells us,
    • “A group of novel synthetic opioids emerging in illicit drugs in the United States may be more powerful than fentanyl, 1,000 times more potent than morphine, and may even require more doses of the medication naloxone to reverse an overdose, a new study suggests.
    • “Nitazenes are a synthetic opioid, like fentanyl, although the two drugs are not structurally related. In the small study published Tuesday in the journal JAMA Network Open most of the patients who overdosed on nitazenes received two or more doses of the opioid overdose reversal drug naloxone, whereas most patients who overdosed on fentanyl received only a single dose of naloxone.
    • “Clinicians should be aware of these opioids in the drug supply so they are adequately prepared to care for these patients and anticipate needing to use multiple doses of naloxone,” the researchers, from the Icahn School of Medicine at Mount Sinai in New York, Lehigh Valley Health Network based in Pennsylvania, and other US institutions, wrote in the study. “In addition, to date there has been a lack of bystander education on repeat naloxone dosing.”

From the U.S. healthcare business front,

  • Per Healthcare Dive, and the FEHBlog agrees,
    • “Ensuring workers can find and access high-quality providers is key to tamping down healthcare costs and improving outcomes in the employer-sponsored insurer market, according to a study by Morgan Health and Embold Health published in NEJM Catalyst. 
    • “Employers can now access more data on the quality of care provided by clinicians, so they should take a larger role in health plan network design and steer workers toward higher-performing providers, according to the report. 
    • “Clinician quality can drive poor outcomes, missed treatments and unnecessary care, the report said. For example, among the top 10% of about 800 cardiologists in Ohio by quality rank, an average of 73% of patients with coronary artery disease were taking cholesterol-lowering statins regularly, compared with only 39% for the bottom 10% of clinicians.” 
  • The Wall Street Journal reports
    • “In a male-dominated industry, female surgeons spend more time in the operating room, and their patients endure fewer postoperative complications.
    • “That’s the conclusion of two research studies published Wednesday in JAMA Surgery. Researchers found better outcomes for patients treated by female surgeons in the sweeping reviews of millions of procedures in Canada and Sweden. 
    • “In the first study, 17 researchers in the U.S. and Canada followed the outcomes for 1.2 million patients in Canada undergoing common surgeries between 2007 and 2020.
    • “The study authors found that at both 90 days and one year following surgery, patients treated by female surgeons were less likely to experience adverse postoperative issues, including death. The outcome differences were modest, but consistent.”
  • Fierce Healthcare relates,
    • “Earlier this year, Anthem Blue Cross and Blue Shield unveiled a new virtual-first plan that harnesses artificial intelligence to streamline health services for members, the insurer announced.
    • “Now, it’s making that plan available in several additional states beginning Jan. 1. Large group fully insured or self-funding employer clients in Connecticut and Virginia can select Anthem Link Virtual First plans, which harness the power of the insurer’s Sydney app to connect members with benefits details, cost transparency information and more around the clock.
    • “Stephanie DuBois, a spokesperson for Anthem Blue Cross and Blue Shield in Connecticut, told Fierce Healthcare in an email that the plans first became available to large group self-insured employers in California, Missouri and New York as well as large group self-funded and fully insured employers in Georgia starting in July.
    • “Members can access Anthem Link Virtual First plans through Sydney Health, which is a digital member engagement platform that includes access to benefits, tools, resources and provider care 24/7,” DuBois said. “Sydney Health also offers an AI-driven symptom checker that intuitively uses the information members provide to narrow down millions of medical data points and assess specific symptoms before seeing a doctor.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the No Surprises Act front,

  • The American Hospital Association informs us,
    • “The U.S. District Court for the Eastern District of Texas, for a third time, ruled to set aside certain regulations implementing the No Surprises Act. In this case, the Texas Medical Association, joined by several air ambulance providers and supported by an amicus filed by the AHA, successfully argued that the methodology for how insurers calculate the qualifying payment amount tilts the arbitration process in insurers’ favor.” 
  • The Centers for Medicare and Medicaid Services adds,
    • “On August 24, 2023, the U.S. District Court for the Eastern District of Texas issued an opinion and order in Texas Medical Association, et al. v. United States Department of Health and Human Services, Case No. 6:22-cv-450-JDK (TMA III), vacating certain portions of 86 Fed. Reg. 36,872, 45 C.F.R. § 149.130 and 149.140 , 26 C.F.R. § 54.9816-6T and 54.9817-1T, 29 C.F.R. § 2590.716-6 and 2590.717-1, and 5 C.F.R. § 890.114(a) as well as certain portions of several guidance documents. As a result of the TMA III decision, effective immediately, the Departments have temporarily suspended all Federal IDR process operations until the Departments can provide additional instructions. Disputing parties should continue to engage in open negotiation.”
  • The FEHBlog hopes that the federal regulators move to stay this decision pending appeal to the U.S. Court of Appeals for the Fifth Circuit. That court is already reviewing Judge Kernodle’s first decision modifying the final No Surprises Act implementing rule (No. 23-40217).

From Washington, DC —

  • STAT News tells us,
    • “With last fall’s chaotic early start to the respiratory virus season still fresh in the public memory, federal health authorities are trying to move quickly to convey the impression that this year will be different.
    • “In a briefing for reporters Thursday, senior officials of the Centers for Disease Control and Prevention [CDC] and the Food and Drug Administration [FDA] detailed the various countermeasures available to combat COVID-19, RSV, and influenza, and discussed the expected timing on the rollouts of these tools. They spoke on condition that their names and titles would not be disclosed.
    • “We are in our strongest position yet to be able to fight COVID-19 as well as the other viruses that are responsible for the majority of fall and winter hospitalizations,” one CDC official said. “We also have more tools, including … for the first time ever, vaccines for all three of the major fall and winter respiratory viruses — influenza, Covid, and RSV. Our goal, our imperative, our task is to make sure we’re using those tools.”
    • “The updated Covid vaccines have not yet been cleared by the FDA, but that must be coming in the next two and a half weeks or so, because a meeting of the CDC’s expert vaccine panel, the Advisory Committee on Immunization Practices, has been slated for Sept. 12. ACIP must vote on whether to recommend the updated vaccines — and the recommendation must be endorsed by CDC Director Mandy Cohen — before they can begin to be used. The federal officials said the vaccine rollout would begin by mid-September.”
  • The CDC also updated flu vaccine information for the 2023-24 flu season.
  • Per the U.S. Department of Justice,
    • “[On Wednesday, August 23, 2023,] Deputy Attorney General Lisa O. Monaco delivered opening remarks at a roundtable meeting of senior Justice Department officials and investigative partners to announce the results of a coordinated, nationwide enforcement action to combat COVID-19 fraud, which included 718 enforcement actions – including federal criminal charges against 371 defendants – for offenses related to over $836 million in alleged COVID-19 fraud. Deputy Attorney General Monaco also announced the launch of two additional COVID-19 Fraud Enforcement Strike Forces: one at the U.S. Attorney’s Office for the District of Colorado and one at the U.S. Attorney’s Office for the District of New Jersey. These two strike forces add to the three strike forces launched in September 2022 in the Eastern and Central Districts of California, the Southern District of Florida, and the District of Maryland.”

From the medical and Rx research fronts —

  • BioPharma Dive reports,
    • “Two weeks ago, Danish drugmaker Novo Nordisk released results of a large trial showing its weight loss drug Wegovy can help prevent heart attacks and strokes in overweight people with cardiovascular disease. It followed up on those landmark data Friday with further evidence the injectable drug helps protect the heart.
    • “In people with a form of heart failure, Wegovy reduced disease symptoms and improved quality of life and exercise duration by more than placebo, according to results from the trial, codenamed “STEP-HFpEF.” The data were released at the European Society of Cardiology meeting and published in The New England Journal of Medicine.
    • “The newly released data could further help Novo persuade insurers to provide broader coverage for Wegovy, which carries a list price of more than $17,000 a year. Insurers might be more open to offering coverage if they know the shot can avert expensive hospitalizations and episodes of care.
    • “Broad coverage also could help Novo retain its lead over rival Eli Lilly, which has a similarly acting drug Mounjaro that is approved to treat diabetes but not yet weight loss.”
  • MedPage Today points out,
    • A novel 14-year risk score helped identify people from age 50 onward at risk for all-cause dementia, a large U.K. study showed.
    • The tool, called the U.K. Biobank Dementia Risk Score (UKBDRS), was developed and validated in two U.K. cohorts, reported Raihaan Patel, Ph.D., of the University of Oxford in England, and co-authors.

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • Employers will pay more than $15,000 on average for each employee’s healthcare in 2024, according to an analysis from consulting firm Aon. 
    • Employer-sponsored insurance costs will rise 8.5 percent in 2024, up from an average of $13,906 per employee in 2023, according to Aon’s estimates published August 22.
    • Read the full report here.
  • Fortunately, OPM’s decision to allow FEHB carriers to offer Medicare Part D EGWP arrangements in 2024 will offset the factors discussed in the Aon report.
  • Beckers Hospital Review reports,
    • “Ongoing increases in expenses were part of the drive behind lower hospital operating margins in July, according to a Syntellis report.
    • “While such margins remained positive, they contracted for the first time since rising into the black in March, the report showed. The operating margin median for July was 1.1 percent compared to 2 percent in June, but still higher than the March through May period and 2.6 percentage points higher than July 2022.
    • “While overall expenses were up 3.6 percent on the same period in 2022, labor expenses increased 2.1 percent. Supplies and drug costs were both up over 5 percent, the report said.”
  • Per Healthcare Dive,
    • “A new brief from out Wednesday from research firm KFF explores the potential of consumer cost changes and antitrust regulation when healthcare systems engage in cross-market mergers, including a body of research indicating possible healthcare price increases.
    • “Antitrust agencies have historically focused on mergers between hospitals and health systems that operate in the same geographic market, the KFF brief noted. The Federal Trade Commission has never formally challenged a cross-market merger and antitrust agencies have not developed guidelines for evaluating them.
    • “Regulating cross-market mergers, will be “on the radar” of policymakers and regulators as they become increasingly common, KFF said. Between 2010 and 2019, cross-market mergers made up 55% of hospital M&A ventures, and drove at least nine large-scale mergers since June 2021.”

Quick Takes

David Ermer–ACA, CDC, CMS, FDA, Medicare, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Mercer Consulting informs us,
    • “The Affordable Care Act (ACA) benchmark for determining the affordability of employer-sponsored health coverage will drop significantly to 8.39% of an employee’s household income for the 2024 plan year — down from the 2023 plan-year level of 9.12%, according to IRS Rev. Proc. 2023-29. This affordability percentage can affect individuals’ eligibility for federally subsidized coverage from a public exchange, as well as employers’ potential liability for shared responsibility (or “play or pay”) assessments. Importantly, employers that use the exact safe harbor dollar amount to set employee contributions will need to reduce the current employee contribution for the lowest-cost, self-only option for the 2024 plan year.”
  • The Food and Drug Administration has “approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).”
  • Per the American Hospital Association
    • The Centers for Disease Control and Prevention Aug. 24 announced the launch of its Hospital Sepsis Program Core Elements initiative, a new program to provide hospitals with a blueprint for managing medical emergencies stemming from sepsis. The program, which is modeled after a similar effort for antibiotic stewardship, is intended as a “manager’s guide” to organizing staff and making the resources available to improve sepsis care and bring survival rates up.”
  • CMS tells us that
    • “The Medicare Shared Savings Program saved money for Medicare while continuing to support high-quality care. Specifically, the program saved Medicare $1.8 billion in 2022 compared to spending targets for the year. This marks the sixth consecutive year the program has generated overall savings and high-quality performance results. This represents the second-highest annual savings accrued for Medicare since the program’s inception more than ten years ago.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • Cigna is the latest health insurer to roll back prior authorization requirements, announcing Thursday that it will no longer require the approvals for nearly 25% of medical services.
    • Cigna plans to remove more than 600 prior authorization codes in its commercial plans, bringing Cigna’s total prior authorization removals to more than 1,100 since 2020, the payer said.
    • Cigna plans to nix another 500 or so codes for its Medicare Advantage plans before the end of this year.

Midweek update

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC –

  • STAT News informs us,
    • “The Centers for Disease Control and Prevention said Wednesday it’s too early to tell whether a new version of the SARS-CoV-2 virus that has triggered some international concern will actually prove to be disruptive.
    • “In a preliminary statement about the BA.2.86 subvariant, the CDC also revealed that updated Covid-19 vaccines should be available across the country as early as mid-September, earlier than previous estimates have placed the start of the fall booster campaign.
    • “The vaccines, made by Pfizer, Moderna, and Novavax, must first be authorized by the Food and Drug Administration and recommended by the CDC’s expert vaccine panel, the Advisory Committee on Immunization Practices, and the CDC itself. The three manufacturers have said they have doses at the ready for when the FDA and CDC sign-offs come.”
  • The National Institutes of Health announced,
    • “An international research team has generated the first truly complete sequence of a human Y chromosome, the final human chromosome to be fully sequenced. The new sequence, which fills in gaps across more than 50% of the Y chromosome’s length, uncovers important genomic features with implications for fertility, such as factors in sperm production. The study, led by the Telomere-to-Telomere (T2T) Consortium, a team of researchers funded by the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, was published today in Nature.”
  • Levita Magnetics, “whose mission is to help more patients get access to better surgery,” tells us,
    • “U.S. Food and Drug Administration (FDA) gave Levita clearance for its MARS™ platform.
    • “The Levita MARS system is a first-of-its-kind minimally invasive surgical platform aimed at the high-volume abdominal surgery market. Harnessing the power of both magnets and machines, MARS reduces the number of incisions and enables surgeons to have complete control during laparoscopic procedures, all in a compact footprint designed to fit into existing operating rooms.
    • “Building on the success of its first commercial product, the Levita Magnetic Surgical System®, Levita designed MARS to deliver the same patient benefits as Magnetic Surgery®, while empowering surgeons with increased control of surgical instruments and providing an efficient way for hospitals and ambulatory surgery centers (ASCs) to incorporate this new technology.”

From the public health front,

  • Ovia Health released a white paper “externally validating Ovia’s preterm birth reduction programming.
  • STAT News discusses steps being taken to cure a “severe shortage of doctors who actually specialize in treating obesity” in the United States.
    • “To ensure that all 115 million Americans with obesity have access to care, the field should focus on empowering primary care providers to treat “simple obesity,” or uncomplicated cases, said Kimberly Gudzune, medical director of the American Board of Obesity Medicine. “That, hopefully, prevents the development of some of the complications.”
    • “And this work begins in medical school and residency. For instance, [Juliana] Simonetti [,an obesity doctor at the University of Utah,] has proposed a one-month elective course on obesity at the University of Utah School of Medicine, and Freshwater has been working with the Obesity Medicine Association to incorporate education into training programs nationwide, including the local family medicine residency in Boise.”

From the Rx coverage front,

  • BioPharma Dive points out,
    • “A closely watched, experimental Roche medicine may be helping lung cancer patients live longer, spurring renewed optimism about an emerging class of immunotherapy treatments.
    • “The data come from an interim analysis of a Phase 3 trial pairing the drug, tiragolumab, with a marketed Roche immunotherapy called Tecentriq in patients with non-small cell lung cancer. Roche completed the analysis in February, but never publicly disclosed its findings, which were inadvertently released on its website Tuesday night and discovered by Wall Street analysts. The company is expected to provide the final study results either late this year or early next.”
  • Per Fierce Healthcare,
    • “CVS Health has launched a new segment that aims to work with drugmakers to bring additional biosimilars to market.
    • “The new, wholly owned subsidiary, called Cordavis, aims to develop a biosimilar portfolio with the goal of expanding access to these drugs across the country. Increased uptake of biosimilars can drive down costs of pricey brand drugs that otherwise lack market competition, CVS said.”

From the U.S. healthcare business front,

  • Forbes delves into Amazon’s recently expanded Amazon Clinic product.
    • “With Amazon Clinic, one of the world’s biggest technology companies is looking to infuse the black box of healthcare pricing with some actual transparency. Login to the site and you’ll see that a person who tests positive for Covid-19 in Wyoming can pay $35 for a message-based conversation with a doctor, who will respond within an hour and 45 minutes. Or $40 to get a response in 30 minutes. A video visit costs $74 with a wait time of around an hour and 30 minutes.
    • “Amazon isn’t directly providing the medical services. Instead, the tech giant has contracted with four different startups to provide message and video appointments for around 30 medical conditions. The result is a dynamic marketplace where customers can see pricing, wait times and the typical number of prescription refills upfront. “If you want the lower cost provider, you can choose that. If you are actually prioritizing the speed at which someone is getting back to you, you can prioritize that as well,” Nworah Ayogu, chief medical officer and general manager of Amazon Clinic tells Forbes. “We think really being able to surface different options for different customers lets them choose what’s important to them.”
  • Per Fierce Healthcare,
    • “Most Americans support the idea of value-based care but don’t understand or resonate with the term, according to new research from United States of Care. 
    • “USofCare is a self-described nonpartisan think tank focused on building a more equitable healthcare system. Its latest research relied on (PDF) virtual focus groups with a dozen participants, a national survey that reached 1,000 respondents and a “ReMesh” session, or an AI-driven feedback collection platform that engaged 100 participants more deeply.”

Tuesday Tidbits

David Ermer–CDC, Electronic health records, FDA, Generative AI, Medicare, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Healio informs us,
    • “An FDA panel voted that for adults with uncontrolled hypertension, the benefits of an ultrasound renal denervation device outweigh its risks.
    • Concerns about long-term durability of effect were expressed.”
  • The Department of Health and Human Services announced
    • “award[ing] more than $1.4 billion for Project NextGen to support the development of a new generation of tools and technologies to protect against COVID-19 for years to come.
    • “The awards announced today follow extensive coordination with industry partners and include support for clinical trials that will enable the rapid development of even more effective and longer-lasting coronavirus vaccines, a new monoclonal antibody, and transformative technologies to streamline manufacturing processes.”
  • The U.S. Preventive Services Task Force reaffirmed its 2019 Grade A recommendation that “clinicians prescribe preexposure prophylaxis using effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV.”
  • The Centers for Disease Control lets us know, based on a survey,
    • About 20% of women reported mistreatment while receiving maternity care.
    • About 30% of Black, Hispanic, and multiracial women reported mistreatment. 
    • Almost half (45%) of women held back from asking questions or sharing concerns during their maternity. * * *
    • Mistreatment was reported most often by Black, Hispanic, and multiracial moms and those with public insurance or no insurance.
  • That’s a big bowl of wrong. The CDC observes,
    • Respectful maternity care is free from harm and mistreatment, maintains privacy, confidentiality, and dignity, and allows for shared decision-making and continuous support.
  • The Department of Justice announced yesterday,
    • [“D]eferred prosecution agreements resolving criminal antitrust charges against Teva Pharmaceuticals USA, Inc. and Glenmark Pharmaceuticals Inc., USA. As part of those agreements, both companies will divest a key business line involved in the misconduct, and as an additional remedial measure, Teva will make a $50 million drug donation to humanitarian organizations. Teva will pay a $225 million criminal penalty — the largest to date for a domestic antitrust cartel — and Glenmark will pay a $30 million criminal penalty. Both companies will face prosecution if they violate the terms of the agreements, and if convicted, would likely face mandatory debarment from federal health care programs.
    • “The agreements each require the companies to undertake remedial measures, including the timely divestiture of their respective drug lines for pravastatin, a widely used cholesterol medicine that was a core part of the companies’ price-fixing conspiracy. This extraordinary remedy forces the companies to divest a business line that was central to the misconduct. Teva must also donate $50 million worth of clotrimazole and tobramycin, two additional drugs with prices affected by Teva’s criminal schemes, to humanitarian organizations that provide medication to Americans in need. Both Teva and Glenmark have agreed, among other things, to cooperate with the department in the ongoing criminal investigations and resulting prosecutions, report to the department on their compliance programs, and modify those compliance programs where necessary and appropriate.” 
  • Federal New Network reports that OPM released guidance for hybrid teleworkers who are covered under the Fair Labor Standards Act.
  • The Equal Employment Opportunity Commission released its new strategic plan for fiscal years 2022 through 2026
    • “The new Strategic Plan reflects our thoughtful assessment of the agency’s mission, goals, and objectives in light of current conditions and what we expect in the next few years,” said EEOC Chair Charlotte A Burrows. “It emphasizes expanding the EEOC’s capacity to eliminate systemic barriers to equal opportunity in the workplace, using technology and other tools to improve our services to the public, and achieving organizational excellence with a culture of accountability, inclusivity, and accessibility. I am grateful for the hard work of our staff across the agency who assisted in developing this plan and look forward to its successful implementation.”.

From the public health front,

  • The Washington Post explains
    • how to address the factors that may underlie the growing number of women under age 40 who are afflicted with breast cancer,
  • and
    • how to guard against germs in leafy green salads.

From the U.S. healthcare business front,

  • The FEHBlog was surprised to read in the Wall Street Journal that
    • “America’s nursing homes are fading away.
    • “The U.S. has at least 600 fewer nursing homes than it did six years ago, according to a Wall Street Journal analysis of federal data. More senior care is happening at home, and the Covid-19 pandemic caused many families to shun nursing homes while draining workers from an already short-staffed industry.
    • “The result? Frail elderly patients are stuck in hospitals, a dangerous place for seniors, waiting for somewhere to go—sometimes for months. Beds are disappearing while the need for senior care is growing. The American population 65 and older is expected to swell from 56 million in 2020 to 81 million by 2040.
  • MedPage Today notes.
    • “States that recently adopted less-restrictive policies surrounding the use of telepharmacy had fewer pharmacy deserts in the following year, a cohort study involving a dozen states showed.
    • “Compared with nearby states that made no changes, states that formally implemented or updated pro-telepharmacy policies had a 4.5% relative decrease (95% CI 1.6-7.4) in the percentage of regions defined as pharmacy deserts (P=0.001) and an 11.1% relative decrease (95% CI 2.4-22.6) in the proportion of people living in one of these deserts (P=0.03).
    • “And in general, telepharmacies tended to serve areas of high medical need, reported Jessica Adams, PharmD, of TelePharm in Iowa City, Iowa, and colleagues.
    • “As pharmacy closures and socioeconomic factors persist, pharmacy deserts are likely to expand unless policies are implemented to ensure continued access to pharmacy services,” the researchers wrote in JAMA Network Open
  • The Business Group on Health points out,
    • “Mental health needs among workforces continued to climb this year, with 77% of large employers reporting an increase and another 16% anticipating one in the future, according to Business Group on Health’s 2024 Large Employer Health Care Strategy Survey.
    • “This represents a 33 percentage-point surge over last year, when 44% of employers saw an increase in employee mental health concerns.
    • “The Business Group survey, released today in Washington, DC, also showed that cancer was still the top driver of large companies’ health care costs while rising prescription drug costs also proved to be a leading concern. Cancer overtook musculoskeletal conditions last year as the top driver of large companies’ healthcare costs and shows no sign of abating in the coming years.
    • “Yet as businesses respond to the increase in mental health needs, grapple with soaring health care costs and address issues of health equity and affordability, they will continue to invest strategically in diverse health and well-being offerings for the upcoming year, the survey also showed.”
  • Axios reports that “Middle-class Americans [who earn $50,000 to $100,000 annually] are the most likely to be saddled with medical debt, with nearly 1 in 4 — or roughly 17 million people — having unpaid medical bills, according to a report shared first with Axios from center-left think tank Third Way.”
  • Per Healthcare Dive,
    • “Epic and Microsoft announced on Tuesday an expanded collaboration focused on integrating generative artificial intelligence tools in the vendor’s electronic health records system. 
    • “The partners are working to “rapidly deploy dozens” of AI technologies, including clinical note summarization, medical coding suggestions and data exploration tools that aim to fill gaps in clinical evidence by using real-world data. 
    • “The expanded partnership is intended to speed the development of AI tools in healthcare, bringing the technology as “quickly as possible, responsibly and in partnership with providers,” according to a blog post by Eric Boyd, corporate vice president of AI platform at Microsoft.”