Weekend update

U.S. Healthcare

Weekend update

David Ermer–Congress, COVID-19 vaccine, OPM, U.S. Healthcare–

From Washington, DC,

  • The Senate and the House of Representatives will be in session for Committee business and floor voting this week.
  • The New York Time adds,
    • “Speaker Kevin McCarthy said on Sunday that he intended to resurrect a stalled Pentagon spending measure and try to push it to the House floor this week despite pledges by members of the far-right Freedom Caucus to oppose the move unless their sweeping demands on spending were met. * * *
    • “Other House Republican leaders joined Mr. McCarthy in saying that some progress had been made in weekend talks toward resolving their internal differences over their spending strategy, and that they hoped to break the logjam this week.
    • “We are working through this, and I’m optimistic that we will continue to move the appropriations process forward,” Representative Elise Stefanik, Republican of New York and a member of the leadership team, said in a separate interview on “Fox News Sunday.”
  • Govexec tells us,
    • “The Office of Personnel Management on Friday announced that it is proposing new regulations aimed at hamstringing future administrations from reviving a controversial plan to strip tens of thousands of federal workers of their civil service protections, potentially accelerating a long-simmering battle between good government groups and conservative Republican activists. ***
    • “OPM’s newly proposed regulations, which will be published Monday in the Federal Register, seek to at least slow down a future administration from reviving Schedule F. It stipulates that when a federal employee’s job is converted from the competitive service to the excepted service, the employee retains “the status and civil service protections they had already accrued,” unless they voluntarily transfer into an excepted service position.”
    • Here’s a link to the OPM press release.

From the public health front,

  • The Washington Post reports,
    • “Women who live to age 90, 95 or even 100 experience what’s known as “exceptional longevity.” An analysis published last month found one factor linking those long lives: maintaining a stable body weight over decades.
    • “The study, published in the Journals of Gerontology: Series A, looked at data about 54,437 women from the Women’s Health Initiative, a long-term study that began in the 1990s. The women studied were born on or before Feb. 19, 1932, and the researchers looked at their weight when they began the program, in Year 3, and in Year 10 of the program, then followed up on their survival status as of Feb. 19, 2022.
    • “They found that the women whose body weight stayed stable over the years had 1.2 and 2 times the odds of surviving to 90 and beyond than those who lost weight.
    • “Women who lost 5 percent or more of their body weight over the first three years studied had 33 percent lower odds of surviving to 90, 35 percent lower odds of surviving to 95 and 38 percent lower odds of surviving to 100 than their counterparts whose weight remained stable.”
  • The new Covid shots and the flu vaccines will be available this week. The New York Times observes, and the FEHBlog agrees,
    • “Some experts believe that spreading out your shots might make sense if you can time them to just before each virus peaks. So while you may get the Covid vaccine this month, as cases rise in parts of the United States, you could consider waiting until later in the fall to get the flu shot. Flu cases typically peak between December and February; you can monitor flu activity in your state through the Centers for Disease Control and Prevention’s influenza surveillance reports for more detailed information. A doctor can also help you decide the best strategy, especially if you have a high risk of severe disease or are immunocompromised.”

From the business front,

  • The Wall Street Journal reports,
    • “Does M&A work? The latest research says it’s a tossup.
    • “Business-school students are often taught that successful mergers and acquisitions are a long shot. One influential Harvard Business Review article, dating from 2011, says a range of studies show roughly 70% to 90% of deals fail to create value for the buyer.
    • And many investors worry that takeovers are more reliably lucrative for investment banks—which LSEG says earned some $13.1 billion in M&A fees in the first half of this year—than for the acquiring companies and their shareholders.
    • But more recent research from academics and consultants puts the success rate closer to even. Companies that do frequent smaller deals, as well as making bigger bets, tend to outperform, advisers say. That is because they hone their ability to identify targets, integrate those businesses and reap the intended financial benefits. 
    • Companies should always weigh up deal making against alternative uses of funds, said Barry Weir, Citigroup’s co-head of European mergers and acquisitions. 
    • “If the risk-adjusted return from M&A is higher than the benefits from returning cash to shareholders or some other lower-risk alternative, then it makes sense,” Weir said. “If it doesn’t meet this hurdle then you shouldn’t be doing M&A.”
  • HR Dive considers the occasions on which employees subject to the Fair Labor Standards Act are entitled to be paid for commuting to the office.

Friday Factoids

David Ermer–Congress, Medical / Rx research, Mental health care, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Fierce Healthcare tells us,
    • Key Senate panels have reached a bipartisan deal on a bill that aims to bolster primary care.
    • “The package would invest more than $26 billion into primary care programs as well as initiatives to grow the healthcare workforce. The bill is cosponsored by Sen. Bernie Sanders, I-Vermont, who chairs the Senate Health, Education, Labor and Pensions committee, and Sen. Roger Marshall, R-Kansas, the ranking member of the Subcommittee on Primary Health and Retirement Security.”
  • BioPharma Dive reports
    • Under a policy statement that the commission approved Thursday, the Federal Trade Commission will “use its full legal authority” against drugmakers that impede competition by improperly listing patents in a government database that controls how generic manufacturers can enter the market.
    • According to FTC Chair Lina Khan, pharma companies can “weaponize” the database, called the Food and Drug Administration Orange Book, because any generic maker that applies for approval of a drug with a listed Orange Book patent can be sued by the branded manufacturer and blocked from entry for 30 months.
    • The policy statement highlights the antitrust regulator’s tightening scrutiny of drugmakers’ marketing, patent and acquisition practices. The FTC recently slowed Amgen’s $27.8 billion acquisition of Horizon Therapeutics until Amgen agreed to safeguards against the “bundling” of drugs in the combined company. The agency is also carefully reviewing Pfizer’s planned $43 billion takeout of Seagen.
  • Per Healthcare Dive,
    • “The CMS agency that tests value-based payment models hopes to announce two new behavioral health and maternal health models later this year, according to Liz Fowler, director of the Center for Medicare and Medicaid Innovation.
    • “Both upcoming models have “a heavy role” for the Medicaid program, Fowler said Thursday during a Health Affairs policy briefing. The behavioral health model, which is currently going through clearance, will also involve Medicare.
    • “The CMMI is also working on strategies to better integrate specialty care with primary care, a priority Fowler called “a hard nut to crack.”

From the public health and research front,

  • The New York Times informs us,
    • “MDMA-assisted therapy seems to be effective in reducing symptoms of post-traumatic stress disorder, according to a study published on Thursday.
    • “The research is the final trial conducted by MAPS Public Benefit Corporation, a company that is developing prescription psychedelics. It plans to submit the results to the Food and Drug Administration as part of an application for approval to market MDMA, the psychedelic drug, as a treatment for PTSD, when paired with talk therapy.
    • “If approved, “MDMA-assisted therapy would be the first novel treatment for PTSD in over two decades,” said Berra Yazar-Klosinski, the senior author of the study, which was published in Nature Medicine, and the chief scientific officer at the company. “PTSD patients can feel some hope.”
  • Healio interviews “Kevin C. Oeffinger, MD, professor in the department of medicine and a member of the Duke Cancer Institute (DCI), founding director of the DCI Center for Onco-Primary Care and director of the DCI Supportive Care and Survivorship Center.” Check it out.
  • AHIP discusses health insurers’ efforts to improve access to mental health care providers.
    • “A recent AHIP survey of health insurance providers offering commercial health insurance coverage found that there is meaningful access to a wide range of professionals who deliver mental health support within plan networks. This survey also showed that the number of in-network mental health providers has increased by 48% in three years among commercial health plans.”

From the U.S. healthcare business front,

  • Following up on the news about the FDA’s issues with certain over the counter decongestants, Reuters points out,
    • “Procter & Gamble (PG.N), Walgreens (WBA.O) and Johnson & Johnson’s (JNJ.N) former consumer business are among several companies accused in lawsuits of deceiving consumers about cold medicines containing an ingredient that a unanimous U.S. Food and Drug Administration advisory panel declared ineffective.
    • Proposed class actions were filed on Wednesday and Thursday, after the panel reviewed several studies and concluded this week that the ingredient phenylephrine marketed as a decongestant was essentially no better than a placebo.”
  • Beckers Hospital Review notes,
    • “Over a 6-year period 25 percent of U.S. health visits were conducted by a non-physician, according to Harvard Medical School researchers. 
    • “Advanced care delivered by nurse practitioner and physician assistant roles first emerged in the 1960s, and now, in 2023, nurse practitioner is the fastest growing career nationwide, according to the Bureau of Labor Statistics. Physician assistants also landed on the list of the nation’s fastest-growing careers, taking the 17th spot. 
    • “For the study, which was published Sept. 14 in the British Medical Journal, researchers analyzed data from 276 million patient visits between 2013 and 2019 and found that during this time frame, there was an 89 percent increase in visits conducted by nurse practitioners and a 60 percent increase in visits conducted by physician assistants.”
  • Per Fierce Healthcare,
    • “Ascension closed out its 2023 fiscal year with a $2.66 billion net loss, according to financial disclosures for the period ended June 30.
    • “The St. Louis-based nonprofit health system’s tough year, which ended June 30, came from a combination of high expenses, “sustained revenue challenges” and a one-time non-cash impairment loss of almost $1.5 billion, management wrote in the filing.
    • “Ascension’s operating loss for the year came in at $3.04 billion, or $1.55 billion (-5.6% margin) without the impairment losses.
    • “The numbers follow what was a difficult fiscal 2022, in which Ascension logged an $879 million operating loss and a $1.84 billion net loss. * * *
    • “Ascension is among the country’s largest health systems with 140 hospitals and 40 senior living facilities. The Catholic giant employs roughly 134,000 people across 19 states and the District of Columbia and reported $28 billion in total revenue during its 2022 fiscal year.
    • “Higher volumes and expenses have been a recurring takeaway in other nonprofit systems’ recent quarterly financial statements. Providence, a fellow Catholic nonprofit aiming to dig its way out of last year’s losses, reported last month that it had managed to trim its six-month operating losses from $424 million to $202 million thanks to returning patients and operational restructuring.”

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.

Friday Factoids

David Ermer–CDC, CMS, HSA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The American Hospital Association informs us
    • “The 988 Suicide & Crisis Lifeline now offers American Sign Language services for people who are deaf and hard of hearing, the Department of Health and Human Services announced.
    • “This new service is one more critical step towards making mental health support more accessible and inclusive for all,” said Miriam Delphin-Rittmon, HHS assistant secretary for mental health and substance use.”
  • and
    • “A new Centers for Medicare & Medicaid Services fact sheet reviews how the agency selected the first 10 Part D drugs to include in the Medicare Drug Price Negotiation Program, its process for negotiating with the companies that make the drugs, opportunities for public input and key dates for implementation. CMS last week announced the first 10 drugs for the program and plans to publish the negotiated prices by next September, which would take effect in 2026.”
  • The Department of Health and Human Services announced
    • “new details of its agreement with Regeneron to extend its public-private partnership to develop life-saving monoclonal antibodies as part of Project NextGen enhancing our preparedness for COVID-19 strains and variants.
    • “The HHS is committed to lowering drug costs for all Americans. As part of that commitment, HHS and Regeneron announced an extension of their long-standing partnership to develop life-saving monoclonal antibodies. That modification to Regeneron’s contract with the Administration for Strategic Preparedness and Response’s (ASPR’s) Biomedical Advanced Research and Development Authority is valued at $326M and supports the advanced development of a next-generation monoclonal antibody for COVID-19 prevention under HHS’s Project NextGen.
    • “This agreement included a clause where Regeneron committed that if a new product is commercialized, its list price in the United States will be equal to or less than its retail price in comparable markets globally. Inclusion of this clause is the result of HHS’s and Regeneron’s shared interest in ensuring enduring and equitable access to therapeutics developed under public-private partnerships for all Americans.”

From the public health front,

  • The American Hospital Association tells us
    • “This season’s flu vaccines for the Southern Hemisphere have reduced the risk of being hospitalized for flu by 52%, based on mid-season data from five countries, suggesting the U.S. vaccines could provide similar protection if similar viruses continue to predominate, the Centers for Disease Control and Prevention reports. Both hemispheres used similar flu vaccine formations. The CDC recommends all Americans aged 6 months and older get the seasonal flu vaccine in September or October.”
  • Per Health Day,
    • “The mpox vaccine appears to show effectiveness against the virus, new research shows
    • “Among 37 gay and bisexual men who were either reinfected or had received their mpox vaccine, the disease was less severe
    • “The findings show that the vaccine is a valuable addition to treatments used for mpox infection.”
  • and
    • “Standard Pap tests may miss a deadly type of cervical cancer 
    • “A new screening tool could pick up more of those cancers as well as lesions that may progress into cancer, its developers say
    • “The findings must now be confirmed by clinical trials”
  • More details are available in the Health Day articles.
  • A Wall Street Journal reporter explains what he learned from trying to live a perfect life for a day based on expert advice.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS Health shuffled responsibilities for its leadership bench on Thursday in a bid to better align business segments, as the retail health giant undergoes corporate restructuring following flagging earnings.
    • “CVS named CFO Shawn Guertin president of its health services segment, and said former Humana CFO Brian Kane will join this week as president of Aetna health benefits arm. CVS first announced Kane would be joining CVS in April.
    • “CVS’ care delivery businesses Oak Street Health and Signify Health will continue to operate under health services umbrella. Their respective heads, Mike Pykosz and Kyle Armbrester, will now report directly to Guertin.”
  • Beckers Payer Issues notes,
    • “AHIP has named its general counsel, Julie Simon Miller, to serve as interim CEO, effective Oct. 2.
    • “AHIP President and CEO Matt Eyles is stepping down from his role at the end of September, and the trade association is currently searching for a permanent chief executive, according to a Sept. 7 news release.
    • “Ms. Miller has served as general counsel since 2015 and has been with the association for more than 18 years.”
  • The Employee Benefit Research Institute points out,
    • “IRS Notice 2019-45 allows health savings account (HSA)-eligible health plans the flexibility to cover 14 medications and services used to prevent the exacerbation of chronic conditions prior to meeting the plan deductible. A 2021 Employee Benefit Research Institute (EBRI) survey of employers collected information on their response to the 2019 guidance and found that many employers added pre-deductible coverage as a result of the IRS notice. A recent EBRI report based on claims data from about 2 million HSA-eligible health plan enrollees confirmed the findings from the 2021 EBRI survey — fewer enrollees in HSA-eligible health plans have deductibles for services impacted by the IRS notice, and cost sharing has shifted from deductibles to copayments and coinsurance.”
  • Per Fierce Healthcare,
    • “Prior authorization will become less of a hassle for physicians in Blue Cross Blue Shield of Michigan’s network, BCBSM officials hope, as they roll out an effort to relax about 20% of prior authorization requirements.
    • “This is part of Blue Cross’ ongoing effort to improve healthcare quality, experience, access and affordability for members, while also reducing administrative tasks for clinicians,” BCBSM said in a press release.”

From the Rx coverage and research front,

  • BioPharma Dive reports,
    • “Seagen is committing $60 million to develop a new type of cancer drug, striking a multi-year alliance with biotechnology company Nurix that aims to combine their respective technologies.
    • “Per terms of the deal announced by Nurix Thursday, Seagen could pay as much as $3.4 billion more if certain research, development, regulatory and commercial milestones are met. Nurix retains an option to co-market and share profits on two products that emerge from the partnership.
    • “The companies plan to pair Seagen’s antibody expertise with Nurix’s protein degradation technology to create “degrader-antibody conjugates,” akin in some ways to Seagen’s approved antibody-drug conjugates. The collaboration comes as Pfizer works to close its $43 billion acquisition of Seagen.”
  • and
    • “Verge Genomics, a biotechnology company using artificial intelligence to develop therapies for diseases of the nervous system, announced on Friday a four-year partnership with AstraZeneca’s rare disease unit Alexion to identify new drug targets.
    • “As part of the agreement, Verge will receive up to $42 million in upfront, equity and near-term payments. The company also could receive as much as $840 million in milestone payments over the deal, along with royalties on any resulting products.
    • “The partnership seeks to find and validate new drug targets for uncommon neurodegenerative and neuromuscular diseases. The companies plan to do this by using Verge’s technology, which uses both AI and human tissue data to predict what drug targets are most likely to succeed in clinical testing.”

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–CDC, CMS, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The American Hospital Association informs us,
    • “Republicans on the House Energy and Commerce, Ways and Means, and Education & Workforce Committees have released a summary of draft legislation the committees could introduce as soon as this week. The Lower Costs, More Transparency Act includes provisions focused on health care price transparency, site-neutral payment cuts, and extending certain funding set to expire Sept. 30 for Community Health Centers, the National Health Service Corps and the Teaching Health Centers Graduate Medical Education Program. The bill also would delay for two years the start of Medicaid Disproportionate Share Hospital cuts scheduled to take effect on Oct. 1.”
  • CMS changed its No Surprises Act announcement to read
    • Effective September 5, 2023, the Departments have directed certified IDR entities to proceed with eligibility determinations for single and bundled disputes submitted on or before August 3, 2023.  All other aspects of Federal IDR process operations remain suspended. Disputing parties may continue to engage in open negotiation. 
  • The FEHBlog noticed on reginfo.gov that the following two No Surprises Act proposed regulations were submitted for Office of Information and Regulatory Affairs review on August 29:
    • AGENCY: HHS-CMS RIN: 0938-AV15 Status: Pending Review
    • TITLE: Independent Dispute Resolution Operations (CMS-9897)
    • STAGE: Proposed Rule SECTION 3(f)(1) SIGNIFICANT: Yes
    • RECEIVED DATE: 08/29/2023 LEGAL DEADLINE: None
    • and
    • AGENCY: HHS-CMS RIN: 0938-AV39 Status: Pending Review
    • TITLE: Federal Independent Dispute Resolution Process Fees (CMS-9890)
    • STAGE: Proposed Rule SECTION 3(f)(1) SIGNIFICANT: Yes
    • RECEIVED DATE: 08/29/2023 LEGAL DEADLINE: None
  • The first Interested party meetings with OIRA are scheduled for September 8.

From the public health front,

  • The American Hospital Association tells us
    • “The Centers for Disease Control and Prevention Sept. 5 alerted clinicians to a recent increase in respiratory syncytial virus in the Southeastern U.S., which could signal the beginning of the 2023-2024 RSV season nationally. CDC encourages clinicians to prepare to implement prevention options, including the new long-acting monoclonal antibody to protect infants and some young children at higher risk for severe disease and two new vaccines to protect older adults from severe disease.”
  • Per STAT News
    • “More older adults have been hospitalized for COVID-19 over the past several weeks, according to internal data reviewed by health insurance giant Humana.
    • “Humana, which mostly provides health insurance to those 65 and older and who are therefore more vulnerable to the worst effects of Covid, expected more Covid cases and hospitalizations this year. But it didn’t expect the uptick to come during the waning summer months.”
  • BioPharma Dive reports,
    • Moderna said that an updated COVID shot it’s developing can protect against a form of the coronavirus known as BA.2.86, or Pirola, adding to early evidence the emerging variant may not be as troublesome as scientists had feared.
    • The data, delivered in a press release on Wednesday, show that the vaccine helped spur an immune response in humans against Pirola. It follows an announcement by Moderna last month that the same vaccine appears protective against other currently circulating strains known as Eris and Formax.
    • The Food and Drug Administration is currently reviewing the booster shot, with a decision expected shortly.
  • MedPage Today explains how to navigate the fall vaccine season for COVID-19, the flu, and RSV.

From the U.S healthcare business front,

  • Health Payer Intelligence points out four essential components of chronic disease management strategies.
  • Healthcare Dive relates,
    • Salt Lake City-based Intermountain Health last week reported $184 million in operating income for the first half of 2023, a 35% decrease from the prior-year period when the health system posted an operating income of $285 million. 
    • Expenses climbed to a total of $7.4 billion, offsetting a 22% year-over-year increase in revenue. Intermountain logged nearly $8 billion of revenue for the first six months of the year. 
    • The nonprofit operator still inked nearly $1.1 billion in net gain in the first half of the year, driven by investment income of $909 million.
  • Per MedTech Dive,
    • “Abbott reached an agreement to acquire Bigfoot Biomedical, a company that makes smart insulin pen caps that can sync with continuous glucose monitors to provide dose recommendations.
    • “The companies did not disclose the price of the acquisition, but plan to close it in the third quarter, they said in a Tuesday announcement. 
    • “The planned purchase would be Abbott’s first insulin delivery technology, adding to its position as one of the top CGM makers.” 

Happy Labor Day!

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

Way back in the day, OPM routinely would announce the next year’s FEHB premiums around Labor Day. The announcement was known as OPM’s Labor Day press release. Currently, the announcement is made in the last week of September.

Tammy Flanagan writes in Govexec about federal employee benefit issues confronting couples who both work for Uncle Sam, specifically

  • “Should we carry two self only plans under the Federal Employees Health Benefits program or one self plus one plan if we don’t need to cover children?
  • “Do we need to provide survivor annuities for each other?”

Check it out.

The Senate returns from its August State work break tomorrow for a shortened week of Committee business and floor voting. The House of Representatives returns to the Nation’s Capital next Tuesday.

From the public health front,

  • The Washington Post reports
    • “The Centers for Disease Control and Prevention on Friday [September 1] issued a national alert warning health-care professionals to watch out for infections of Vibrio vulnificus, a rare flesh-eating bacteria that has killed at least 13 people on the Eastern Seaboard this year.
    • “Although infections from the bacteria have been mostly reported in the Gulf Coast, infections in the eastern United States rose eightfold from 1988 to 2018, the CDC said. In the same period, the northern geographic range of infections has increased by 30 miles every year. This year’s infections came during a period of above-average coastal sea surface temperatures, the agency said.
    • “Up to 200 people in the United States every year report Vibrio vulnificus infections to the CDC. A fifth of the cases are fatal, sometimes within one or two days of the onset of illness, according to the agency.”
  • The Wall Street Journal tells us
    • “A two-decade decline in [prostate cancer] death rates has stalled. Some doctors worry deaths could rise in coming years.
    • “We’re finding them with disease not contained in the prostate but also in the bones, in the lymph nodes,” said Dr. James Porter, a urological surgeon in Seattle. “That’s a recent phenomenon.” 
    • “The pendulum swing hits at a fundamental problem in screening for all cancers: Testing too many people leads to more invasive procedures some patients don’t need. Testing too few misses opportunities to catch cases while there is a better chance treatment will work.
    • “Groups including the American Cancer Society are reviewing their own guidance for prostate-cancer screening. Many doctors want to better target the test, limiting screening for some men while encouraging high-risk groups including Black men or those with a strong family history to get testing earlier. 
    • “PSA recommendations have been ping-ponging back and forth, and what’s been lost in that is the high-risk people,” said Dr. Heather Cheng, director of the Prostate Cancer Genetics Clinic at Fred Hutchinson Cancer Center in Seattle. She is helping to review the American Cancer Society’s prostate-cancer screening guidelines. 
    • “Cheng and other doctors working to better calibrate screening said the risks of overdiagnosis have declined. More doctors now monitor low-risk tumors for growth before rushing a man into surgery or radiation. Better imaging tools have reduced biopsies.”
  • In other words, the problem is not necessarily the screening test; rather the problem may be the reaction of the medical community to screening results.  
  • NPR Shots informs us,
    • “The idea of food as medicine dates back to the ancient Greek doctor Hippocrates, and a new study adds to the evidence that a diet full of fruits and vegetables can help improve heart health. The research comes amid an epidemic of  diet-related disease, which competes with smoking as a leading cause of death.
    • “Researchers evaluated the impact of “produce prescriptions,” which provide free fruits and vegetables to people with diet related diseases including diabetes, obesity and hypertension. The study included nearly 4,000 people in 12 states who struggle to afford healthy food. They received vouchers, averaging $63 a month, for up to 10 months, which could be redeemed for produce at retail stores or farmers markets, depending on the location. 
    • “Health care providers tracked changes in weight, blood pressure and blood sugar among the participants. “We were excited to see improvements,” says study author Kurt Hager, an instructor at UMass Chan Medical School.
    • “Among adults with hypertension, we saw that systolic blood pressure decreased by 8 mm Hg and diastolic blood pressure decreased by about 5 mm Hg, which could have a meaningful impact on health outcomes,” Hager says.
    • “Among people with uncontrolled diabetes, their A1C levels, which is a 2-3 month average of their blood sugar, also declined significantly, by about .6 percent. “The reductions we saw in blood sugar were roughly half of that of commonly prescribed medications, which is really encouraging for just a simple change in diet,” Hager says.” 
  • Fortune Well explains how to deal with the uncertainty that serves as the root of anxiety.
    • “Uncertainty is life’s promise to us all. For more than twenty years, I have watched people rise from unspeakable pain to venture again into a future that withholds all certainty. I work with people who have endured shocking traumas and, predictably, our early conversations are filled with interrogative pleas for a certain safety: “How can I be absolutely sure nothing like this will ever happen again?” they ask me.
    • “The answer is: they cannot.
    • “After many years, the thing that still takes my breath away is the grace and courage of people who accept this truth and say: I rise again not because I know for sure, but because I hope anyway.”
  • The New York Times offers a reminder about how to use at home COVID tests effectively. Bear in mind that Paxlovid should be taken within five day after showing Covid symptoms.