Friday Factoids

Congress

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.” 

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.”

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.

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Congress remains on its August State/District workbreak this week. The Senate reconvenes on September 5, and the House reconvenes the following Tuesday, September 12.
  • The Hill adds
    • “Speaker Kevin McCarthy (R-Calif.) said on Sunday he does not want short-term stopgap funding to butt up to the holidays as lawmakers struggle to come to an agreement over appropriations levels in the midst of a push by conservatives cut federal spending.” 

From the public health front —

  • The Wall Street Journal reports
    • “Scientists obsessed with aging are sketching a road map of how our bodies change as we grow old in the hopes that it will lead to treatments that could help us live longer, healthier lives.
    • “They call this road map the “hallmarks of aging”—a set of biological features and mechanisms linked to our inexorable march toward death. Over the past decade, the hallmarks have helped guide the development of drugs that clear away cells that have stopped dividing and gene therapies that appear to restore cells to a more youthful state.
    • “Scientists in Europe codified nine hallmarks in a 2013 paper in the journal Cell that is widely cited in the aging field. They include shortening of telomeres (DNA segments at the ends of chromosomes); cell senescence, when cells stop dividing; and breakdowns in how cells regulate nutrients.
    • “The hallmarks appear to manifest with age and accelerate aging when enhanced. They are interconnected in ways researchers are trying to understand. Some believe this could unlock insights into why we age.” 
  • Becker’s Payers Issues explains how health insurers have responded to the tragic Maui wildfire.

From the FEHB front,

  • Federal News Network updates us on a fertility coverage issue that has attracted the attention of Democrat members of Congress. The FEHBlog expects that in 2024, common sense will prevail here because OPM has mandated unlimited coverage of artificial and intrauterine insemination. OPM can always clarify the situation with one of its carrier letters.

From the U.S. healthcare business front,

Weekend update

David Ermer–CDC, Congress, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC

  • Congress remains on its State/district work break, with one hearing scheduled to be held in Guam.
  • The Centers for Disease Control reminds us that August is National Immunization Awareness Month by pointing out its immunization guidance website.

From the public health front,

  • Fortune Well discusses skin cancer prevention and identifies “five nutrients that ‘help keep brains in top condition at all ages,’ researchers say.
    •  Lycopene: An antioxidant that could help protect cells from damage, lycopene gives some fruits and vegetables—like tomatoes, watermelon, red oranges, pink grapefruits, apricots, and guavas—their red hue.
    • Retinol: A form of Vitamin A that helps the immune system work properly, retinol helps you see in dim lighting and keeps skin healthy. It’s found in foods like cheese, eggs, oily fish, milk, yogurt, and liver. The body can convert beta-carotene into retinol, so indirect sources include yellow, red, and green leafy vegetables like spinach, carrots, sweet potatoes, and red peppers, as well as yellow fruits like mangos, papaya, and apricots.
    • Lutein: Often referred to as the “eye vitamin,” lutein is thought to protect eye tissue from sun damage. You can find it in foods like egg yolks, spinach, kale, corn, orange peppers, kiwis, grapes, zucchini, and squash.
    • Zeaxanthin: An antioxidant, zeaxanthin is known to protect eye tissues from the sun. It’s found in eggs, oranges, grapes, corn, goji berries, mango, and orange peppers.
    • Vitamin E: Also an antioxidant, Vitamin E keeps free radicals in check, improves immune function, and can prevent clots from forming in the arteries of the heart. It can be found in plant-based oils, nuts, seeds, fruits, and vegetables like sunflower oil, soybean oil, almonds, peanuts, spinach, pumpkin, red bell peppers, asparagus, mangoes, and avocados.
  • CNN reports
    • “As rates of sexually transmitted infections continue to skyrocket across the United States, a growing number of physicians are prescribing a commonly used antibiotic as a way to prevent chlamydia, gonorrhea and syphilis infections in gay and bisexual men and transgender women.
    • “Doxycycline is a class of medications traditionally used to treat bacterial STIs after someone has been infected. Yet recent research suggests that one 200mg dose of the drug can be effective in preventing such infections among men who have sex with men if taken within 72 hours after unprotected sex.
    • “This approach, called doxyPEP, has garnered so much attention that the US Centers for Disease Control and Prevention is expected to post draft guidance for public comment in the next several weeks on how healthcare workers may deploy the preventative treatment, such as how many pills should go into a prescription or which people could benefit most from the drug.”
  • NPR Shots explains how to keep your home’s air clean.
    • Maximize fresh air.
    • Control the source of pollutants.
    • Purify the air.
  • The Wall Street Journal points out seven exercises to improve your hands’ grip.
    • As we age, a firm handshake implies far more than confidence.
    • A strong grip is a great proxy for longevity. Feeble handgrip strength has been shown to be a better predictor of adverse health events like cardiovascular disease and stroke than systolic blood pressure.
    • Your grip involves everything from your forearm muscles to the muscles in your hands, all of which allow us to move our finger joints. A strong grip allows us to hold securely on to things, such as the railing of a staircase, and open stubborn jars of peanut butter or pickles. 

From the U.S. healthcare business front,

  • Fierce Healthcare reports
    • Cigna has launched a new tool that will allow its members to use their smartphones to check for dental health issues, including gum disease and cavities.
    • The insurer announced Thursday morning that the online service, which is backed by Dental.com, will be available for free. It offers guided steps for members to take five photos of their teeth and mouth, which will be analyzed by the SmartScan technology. A Cigna network dentist will then review the scans.
    • The tool will provide members with an oral health score as well as personalized dental care tips. It will also identify any concerns and connect the user with either virtual or in-person follow-ups for treatment.
    • The program is available starting [August 17] to more than 16.5 million Cigna members in employer-sponsored or Affordable Care Act exchange plans, the insurer said.

Midweek Update

David Ermer–Congress, COVID-19, Government Contracting, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Manasvita S on Unsplash

From Washington DC,

  • Govexec informs us,
    • “The House and Senate appeared headed for a short-term spending deal when lawmakers return to Washington following the August recess, with leaders from both chambers suggesting they are pursuing that path to avoid a shutdown in October. 
    • “The continuing resolution would keep agencies funded at their current levels through early December, House Speaker Kevin McCarthy, R-Calif., told his caucus this week. Senate Majority Leader Chuck Schumer, D-N.Y., said on Wednesday he met with McCarthy a few weeks ago, and the two leaders agreed to pass a stopgap that would last “a few months.” 
    • “I thought that was a good sign,” Schumer told MSNBC. 
    • “Separately on Tuesday, Schumer said the short-term measure would allow lawmakers to come together on full-year appropriations.”
  • Federal News Network says,
    • For the second year in a row, the General Services Administration announced an increase to per diem lodging rates for federal employees.
    • Starting Oct. 1, base daily traveling allowances for feds will increase to $166 from $157 last year. That increase is thanks to an uptick in the standard per diem lodging rate for the Continental United States (CONUS), which will increase from $98 to $107. GSA did not make any changes to the per diem tiers for meals and incidental expenses. Those will remain in the range of $59 to $79, with the standard rate remaining at $59. * * *
    • GSA also offers a calculator tool to let feds search by city, state, zip code or map to figure out the exact amount of their per diem.
  • The Federal Acquisition Regulation cost principles apply these per diems to official travel by FEHB experience-rated carriers.

From the public health front,

  • The Washington Post reports,
    • Most cancers in the United States are found in people age 65 and older, but a new study shows a concerning trend: Cancer among younger Americans, particularly women, is on the rise, with gastrointestinal, endocrine and breast cancers climbing at the fastest rates.
    • A study published Wednesday in JAMA Network Open showed that while cancers among older adults have declined, cancers among people younger than 50 have increased slightly overall, with the largest increases among those aged 30 to 39.
    • “This is a population that has had less focus in cancer research, and their numbers are getting bigger, so it’s important to do more research to understand why this is happening,” said Paul Oberstein, director of the Gastrointestinal Medical Oncology Program at NYU Langone’s Perlmutter Cancer Center, who was not involved in the study.
  • STAT News points out
    • “Cancer patients, doctors, and patient advocates alike are struggling with the wide-ranging effects of the ongoing chemotherapy drug shortages. The platinum-based drugs carboplatin and cisplatin have been hard to keep in stock for months now, affecting most U.S. cancer centers: 93% have reported carboplatin shortages, and 70% have reported shortages of cisplatin.
    • “While patients with various types of cancer have been impacted by the shortages, those with ovarian cancer are among the groups most affected — both because the disease is relatively common, with women having a 1 in 78 chance of getting it in their lifetime, and because the drugs that are most effective in treating it are the ones now in short supply.
    • “While there are alternatives to the use of platinum drugs to treat ovarian cancer, none of them work quite as well. Carboplatin, in particular — in combination with the chemotherapy drug paclitaxel — has remained unchallenged as the go-to for ovarian cancer, in particular when the treatment could be curative rather than palliative.
  • Forbes relates
    • “New Covid omicron subvariant EG.5, or “Eris,” is now the dominant strain in the U.S., surpassing XBB.1.16 (or “Arcturus”), according to new data from the Centers for Disease Control and Prevention.
    • “EG.5 made up 17.3% of all cases in the two-week period from July 23 to August 5, a large jump from the 0.4% of cases it made up between April 30 and May 13.
    • “The World Health Organization classified EG.5 as a “variant of interest” Wednesday, which is a step below a variant of concern—WHO previously labeled it a “variant under monitoring” on July 19.
    • “While EG.5 may cause an increase in cases, WHO said it poses a low risk to public health in comparison to other omicron offspring because there’s no evidence it causes more severe cases.
    • “It is a recombinant strain—the result of two Covid variants combining during the replication process, which can occur if a person is infected with two variants at the same time—of the omicron family and a descendant of another strain labeled XBB.1.9.2.
    • “EG.5 has an extra mutation on its spike called mutation 465, which is present in about 35% of coronavirus sequences worldwide—a lot of the XBB variants have mutation 465, though experts don’t know what comes with the mutation.”

From the judicial front,

  • The Wall Street Journal reports,
    • “A federal appeals panel ruled that the Food and Drug Administration improperly expanded access to the widely used abortion pill mifepristone over the last seven years but left in place the drug’s original approval, teeing up the issue for review by the Supreme Court. 
    • “The ruling by a three-judge panel of the New Orleans-based Fifth U.S. Circuit Court of Appeals is the latest twist in a case that has at times threatened to pull the pill from the market nationwide.
    • “The appeals panel said pill opponents who sued the FDA had likely waited too long to challenge the drug’s original approval in 2000, and it also left in place the agency’s 2019 approval of the generic version of the pill. But the court said the FDA failed to properly scrutinize changes that eased access to mifepristone in recent years, such as allowing the drug to be administered without an in-person visit with a medical provider. * * *
    • “The appeals court decision doesn’t have immediate practical consequences because the Supreme Court in April issued an order allowing current broad levels of access to mifepristone while litigation proceeds. That is likely to ensure availability for months.”

From the U.S. healthcare business front,

  • Per Forbes
    • “Demand for nurse practitioners and primary care physicians is escalating along with their compensation as retailers from Amazon and CVS Health to Walmart and Walgreens build primary care clinics across the country.
    • “A new report from AMN Healthcare shows nurse practitioners—not doctors—topped the staffing company’s list of “most requested search engagements for the third consecutive year,” according to an annual report released Monday from AMN Healthcare’s Physician Solutions division, formerly known as Merritt Hawkins.
    • “Demand for NPs is being driven by a growing number of ‘convenient care’ providers, including retail clinics, urgent care centers and telemedicine platforms, which employ large numbers of NPs,” the report said.”
  • Beckers Hospital Review notes,
    • “Ozempic might find itself in CMS’ hands soon.
    • “Sales of the Type 2 diabetes drug in the U.S. have reached more than $3 billion so far in 2023, according to an Aug. 10 quarterly report from the drug’s maker, Novo Nordisk. CMS might try to influence the company to lower the medication’s cost, which sits at about $1,000 per month.
    • “In August 2022, President Joe Biden signed the Inflation Reduction Act, which gave Medicare Parts B and D negotiation powers for costly drugs with no generic or biosimilar competition. CMS said it will reveal by Sept. 1 which are the first 10 drugs that will see price negotiations, which are effective in 2026. This allowance will add more drugs each year. 
    • “Researchers from the Washington, D.C.-based West Health Policy Center and the University of California San Diego predicted Ozempic would be chosen for these negotiations in 2027 — when it passes 10 years on the market, one of the rules of the Inflation Reduction Act provision — according to a study published in March.”
  • Business Insurance adds,
    • “The U.S. Department of Justice has contested the Chamber of Commerce’s move to block the Medicare drug price negotiation program, stating the Chamber lacks the standing for the lawsuit and that halting the program would be detrimental to the public, The Hill reports. The Chamber had previously filed for an injunction against the program, citing potential harm to businesses and patients.”
  • Fierce Healthcare identifies “22 health systems that are charging for certain patient-provider electronic messages as of Aug. 16.” These systems are trying to squeeze the last golden egg out of the goose, in the FEHBlog’s opinion.

 

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, FDA, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • Roll Call reports,
    • “House Republicans are planning to take up a short-term stopgap funding measure next month to avoid a partial government shutdown, Speaker Kevin McCarthy, R-Calif., told members of his conference during a Monday night call, sources familiar with the conversation said. 
    • “The continuing resolution is expected to extend current funding until early December, giving lawmakers a few extra months past the Sept. 30 deadline to complete fiscal 2024 appropriations. McCarthy said Monday that he did not want to have a continuing resolution run up to the Christmas recess, sources said. 
    • “The speaker’s announcement, which came as little surprise, served as an acknowledgment that the clock had run out for completing appropriations on time for the fiscal year that begins Oct. 1.”
  • Govexec says,
    • “Although President Biden and congressional appropriators appear to be in accord on the White House’s plan to grant federal employees their largest annual raise in more than two decades in 2024, there is still work to be done to make it a reality.
    • “Biden first proposed an average 5.2% pay increase for civilian federal workers and members of the military next year when he unveiled his fiscal 2024 budget plan. That figure marks the highest annual pay increase federal employees have seen since President Carter authorized a 9.1% raise in 1980.
    • “And although the administration and Senate Democrats have been butting heads with GOP appropriators in the House on a variety of funding issues in recent months, neither the House nor the Senate have included language in their respective spending packages to overrule the pay raise plan.”
  • The article explains the legal steps that the President must take this year to implement his pay raise plan.
  • Federal News Network informs us,
    • “In another effort to try to usher young talent into the federal workforce, the Office of Personnel Management is proposing changes to decade-old parameters for the Pathways Program.
    • “The new proposed regulations from OPM, in part, look to expand eligibility for the recent graduates’ Pathways Program, to include individuals who may not have a college degree, but who have completed different “technical education programs.” By counting experience in the Peace Corps, AmeriCorps, Job Corps and the Registered Apprenticeship Program, OPM said it hopes to make the program overall more inclusive, and help agencies attract a broader, more diverse pool of early-career applicants.”
  • Fierce Healthcare tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) recently published new changes to further advance health equity and increase participation under the ACO REACH model.
    • “National Association of ACOs President and CEO Clif Gaus said the changes will “satisfy many concerns and stabilize future participation.” * * *
    • “Currently, there are 132 participants under ACO REACH, a value-based care model that began in January and replaced the Direct Contracting Model. The new model pushes providers to form accountable care organizations, or ACOs, for fee-for-service Medicare enrollees, and allows for providers to take on more financial risk. Participants are required to implement a health equity plan identifying disparities in care.”
  • A STAT News explains,
    • “The Inflation Reduction Act passed and signed into law a year ago attempts to deal with high drug prices paid by the U.S. government, allowing Medicare to negotiate the prices of some medicines after they have been on the market for years. (Industry would say it’s not negotiation but price-fixing.) But while the IRA is desperately needed — branded medicines cost 2.4 times more in the U.S. than in other developed countries, according to the RAND Corporation — there are ways in which it makes the situation worse.
    • “Here is the problem. The process of testing new experimental medicines takes a long time, sometimes a decade or more, and it is much longer for some objectives, such as preventing heart attacks, than others, like slightly extending the lives of terminal cancer patients.
    • “If one got to design a drug-pricing system from a blank slate, allowing drug prices to spike and then be cut after a few years would look less than ideal. It would be far better to set a lower price at the outset and not raise it but to allow a company to sell a drug for longer so the manufacturer has an incentive to fully study the benefits and risks of its medicines. * * *
    • “There are alternative models of how the drug pricing system can work. Take vaccines, for instance. They are not made nearly as expensive as, say, cancer drugs. But, in most cases, drug companies can trust that the market for them will be long and stable.
    • “This brings us back to the cancer drug shortage. All of the medicines in shortage are treatments that are generic, made into commodities by Hatch-Waxman. This problem could be changed if, say, hospitals were in a position to pay more to manufacturers who were seen as having a more stable supply.
    • “All of it is a reminder that the health care system in the U.S. is a Rube Goldberg machine created by past decisions that were made as much out of expediency as sober planning. The IRA, in particular, is another one of these decisions, pushed through a partisan Congress after the pharmaceutical lobby spent decades avoiding real change. It’s not surprising that a bill that has to be ushered in along partisan lines is not fully thought out or that many of the details are left to bureaucrats.
    • “At some point, we might want to actually design something sensible. Until then, we’d be better served by being more conscious of the mess we’re in.”

From the public health front —

  • Medscape points out,
    • “The newest version of the COVID-19 vaccine will be available by the end of September, according to the CDC. 
    • “The updated vaccine still needs final sign-offs from the FDA and the CDC.
    • “We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast last week hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”
    • “For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6 to 8 months since their last dose. For all other people, it’s OK to wait for the new version.”
  • AHA News adds,
    • “Receiving a COVID-19 mRNA vaccine or booster during pregnancy can benefit pregnant people and their newborn infants, according to findings from a federally funded study published in Vaccine. The study looked at 167 pregnant people who received a primary or booster vaccine, which generated antibodies that crossed to the cord blood and likely conferred some protection in their newborns. Participants who received a booster dose had substantially more antibodies in their own blood and in their cord blood, suggesting that boosting increased their newborns’ immune defenses against COVID-19.
  • STAT News reports
    • “Every year, doctors get better tools to fight cancer. Engineered cancer-killing cells, immunotherapies, targeted drugs, and more are helping clinicians cure more patients. Increasingly, though, oncologists are trying to use less radiation, long one of the main pillars of cancer therapy. In some cases, they are even keeping certain patients with low-risk tumors off radiation entirely.
    • “We are in an era of radiation omission or de-escalation,” said Corey Speers, vice chair of radiation oncology at the University Hospitals Seidman Cancer Center and Case Western Reserve University. “Radiation is perhaps one of the most precise and most effective cancer therapies we have, so it will always play an important role in cancer management, but there are situations now on an individual patient basis where radiation may not be needed.”
  • MedPage Today notes that “Incident dementia was tied to exposure to fine particulate matter, especially air pollution from wildfires and agriculture, an observational study of 28,000 adults over age 50 suggested.”

From the judicial front,

  • A unanimous panel of the U.S. Court of Appeals for the 10th Circuit ruled today that ERISA and Medicare Part D preempt certain provisions of an Oklahoma PBM reform law that purport to apply to contracts between PBMs and ERISA and Part D plans. The opinion is helpful to the FEHB Program because the “relates to” clause in the ERISA state law preemption clause, 29 U.S.C. Sec. 1144, is read. analogously or “in pari materia” with the “relates to” clause in the FEHB Act’s state law preemption clause, 5 U.S.C. Sec. 8902(m)(1). Hopefully, this new precedent will pick up steam for ERISA and FEHB preemption of state laws, which do help control premiums.

From the Rx coverage front,

  • Healthcare Dive relates
    • “Amazon on Tuesday added more than 15 new manufacturer-sponsored coupons for insulin brands and diabetes care products to its online pharmacy.
    • “The additions bring Amazon’s manufacturer coupons that are automatically applied during check-out for eligible customers to 36.
    • “The new coupons include some of the most commonly prescribed products from drugmakers including Novo Nordisk, Eli Lilly and Sanofi, including insulin vials, pens and continuous glucose monitors, according to a blog post on Amazon’s website.
  • BioPharma Dive calls attention to
    • “Radiopharmaceuticals for cancer: Making radiation precise
    • “More than a dozen startups are developing drugs that deliver a dose of radiation directly to tumors. Here’s where they stand, and why their progress is worth watching.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans informs us,
    • “U.S. corporate employers project a median healthcare cost increase of 7% for 2024, according to International Foundation of Employee Benefit Plans survey results. The 7% increase is on pace with cost trends projected last year in a similar survey conducted by the International Foundation.
    • “Plan sponsors shared their thoughts on the primary reasons contributing to a rise in medical plan costs for 2024. The top four responses are:
      • 22%—Utilization due to chronic health conditions (up from last year)
      • 19%—Catastrophic claims (same percentage as last year)
      • 16%—Specialty/costly prescription drugs/cell and gene therapy (new in the top four this year)
      • 14%—Medical provider costs (up from last year).
      • The effects of the pandemic appear to be waning as only 4% of responding employers indicated that the primary reason for cost increases is utilization due to delayed preventive/elective care during the pandemic (down from 12% last year).”
    • These factors will be largely offset by Medicare savings for those FEHB plans that are offering Medicare Part D plans for 2024, in the FEHBlog’s view.
  • Health Payer Intelligence explains,
    • “How Payers Are Reducing Prior Authorizations, Limiting Care Disruptions
    • “To limit patient care disruptions, payers have reduced prior authorization requirements for genetic testing, cataract surgeries, and physical therapy.”
  • and reports
    • “Payers prefer to utilize claims and administration platforms from vendors that are efficient, manage multiple business lines, and can meet their complex needs, according to a KLAS report.
    • “The Payer Claims & Administration Platforms 2023 report includes KLAS Decision Insights data and KLAS performance data, which reflects information about vendors and feedback from healthcare organizations.
    • “Among 28 payer organizations, 14 considered using HealthEdge’s claims and administration solutions. The vendor received an overall performance score of 76.5 on a 100-point scale. Twelve organizations considered using Cognizant, which received a score of 74.7.”
  • Healthcare Dive relates
    • “More than three years after the onset of the COVID-19 pandemic, only 1% of primary care clinicians surveyed by the Larry A. Green Center and the Primary Care Collaborative believe their practice has fully recovered from its impacts, and 61% characterize U.S. primary care as “crumbling.”
    • “Nearly 80% of respondents felt the current workforce is undersized to meet patient needs, and just 19% of clinicians report their practices are fully staffed.
    • “The results are emblematic of a “larger national crisis,” and policymakers must act to reinforce primary care, said Rebecca Etz, co-director of the Larry A. Green Center, in a statement. “ … It is not a matter of if, but when there will be another pandemic … If we don’t act soon, primary care won’t be there when it happens.”

Weekend update

David Ermer–CDC, Congress, Medical / Rx research, Mental health care, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The lede item necessarily is this Fortune Well warning dated August 13

  • “Patients who take blockbuster drugs like Wegovy or Ozempic for weight loss may face life-threatening complications if they need surgery or other procedures that require empty stomachs for anesthesia. This summer’s guidance to halt the medication for up to a week may not go far enough, either.
  • “Some anesthesiologists in the U.S. and Canada say they’ve seen growing numbers of patients on the weight-loss drugs who inhaled food and liquid into their lungs while sedated because their stomachs were still full — even after following standard instructions to stop eating for six to eight hours in advance.”
  • The drugs can slow digestion so much that it puts patients at increased risk for the problem called pulmonary aspiration, which can cause dangerous lung damage, infections and even death, said Dr. Ion Hobai, an anesthesiologist at Massachusetts General Hospital in Boston.
  • “This is such a serious sort of potential complication that everybody who takes this drug should know about it,” said Hobai, who was among the first to flag the issue.

From the healthcare policy front —

  • Congress is on a State/District work break this week. There are no out-of-town hearings scheduled.
  • NPR Shots predicts that a recently proposed rule will improve hospital price transparency. Fingers crossed.

From the public health front –

  • Fortune Well identifies and explains the four daily habits of “truly happy” people.
  • The Drug Enforcement Administration’s public education website explains the dangers of
    • “Xylazine – often called “tranq” – is a drug adulterant that DEA has detected in a growing number of overdose deaths, despite the FDA authorizing it only for veterinary use.
    • “Illicitly-used xylazine is most often reported in combinations with two or more substances present, such as fentanyl, cocaine, or heroin, and can increase the potential for these drugs to cause fatal overdoses.”
  • Cardiovascular Business points out that,
    • “The U.S. Food and Drug Administration (FDA) has announced that Datascope, a subsidiary of Getinge, is recalling certain Cardiosave intra-aortic balloon pumps (IABPs) due to a risk that the devices could stop working unexpectedly. This is a Class I recall, which means the FDA believes using one of these IABPs “may cause serious injuries or death.” 
    • “These devices are designed to provide temporary support to a patient’s left ventricle. Electrical failures have caused some of them to turn off with no warning, however, putting the patient’s health at immediate risk. 
    • “Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death,” according to the FDA’s advisory.”
    • This is the fourth cardiac care device to be recalled in 2023.
  • mHealth Intelligence says that “Using survey data on patient attitudes toward mental health services and depression screening, a new study indicated that Black American Women are comfortable with using voice or video calls to communicate with mental health providers.”
  • Patient Engagement HIT informs us,
    • Only a fifth of the nearly 2.5 million adults with opioid use disorder received medication for the disease 2021, leaving millions without access to addiction treatment, according to new data from the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC).
    • The report, published as a research note in JAMA Network Open, also showed sociodemographic health disparities in opioid use disorder treatment access, with Black people, women, individuals who were unemployed, and those in non-metropolitan areas being less likely to receive treatment.
    • The study looked particularly at medication-assisted treatment, or MAT, which is considered the gold standard in OUD therapy. Drugs like buprenorphine, methadone, and naltrexone have all proven effective for OUD treatment.

In early medical/drug research news,

  • Precision Vaccinations reports
    • While the U.S. government has recently licensed monoclonal antibody therapies (LEQEMBI®), anti-amyloid vaccines may offer a convenient, affordable, and accessible means of preventing and treating Alzheimer’s Disease (AD).
    • The Lancet’s eBioMedicine recently published a paper that concludes that an immunotherapeutic vaccine candidate targeting toxic forms of aggregated beta-amyloid in the brain to treat and prevent AD.
    • Published on July 29, 2023, this research paper concludes Vaxxinity, Inc. UB-311 is an active immunotherapy, “was safe and well-tolerated,” with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer’s disease (AD).
    • And UB-311 could offer multiple competitive advantages over licensed passive immunotherapies, including less frequent dosing, a more convenient mode of administration, improved accessibility, and cost-effectiveness.

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “Federal spending on Medicare Advantage bonus payments has risen every year since 2015, and will reach at least $12.8 billion this year — an increase of nearly 30% from 2022, according a new KFF analysis.
    • “Rapid growth in bonus payments has implications for Medicare spending and beneficiary premiums, especially since spending on the bonuses has grown faster than MA enrollment overall, researchers said.
    • “UnitedHealthcare — the biggest MA insurer — will receive the largest total payments at $3.9 billion. Kaiser Permanente has the highest per-enrollee bonuses at $523.”
  • and
    • “The Department of Justice is requesting more data from Amedisys regarding its proposed $3.3 billion acquisition by UnitedHealth, a move that will push back the timeline of the deal.
    • “The home health and hospice provider disclosed in a filing with the SEC on Thursday that it received a second request for information from regulators on August 4 regarding the merger.
    • “UnitedHealth announced plans to acquire Amedisys in June, after the Louisiana-based provider reneged on an existing merger agreement with Option Care Health.”