Midweek Update

David Ermer–FDA, Medicare, NIH, No Surprises Act, Patient safety, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

From Washington, DC,

  • The No Surprises Act regulators alert us,
    • “On October 6, 2023, the Departments and OPM issued FAQs About Consolidated Appropriations Act, 2021 Implementation Part 62 (FAQs Part 62). In FAQs Part 62, the Departments and OPM acknowledged the impact of the TMA III decision on QPAs and the significant resources and challenges associated with recalculating QPAs. Therefore, the FAQs stated that the Departments and OPM would exercise their enforcement discretion under the relevant No Surprises Act provisions for any plan or issuer, or party to a payment dispute in the Federal IDR process, that uses a QPA calculated in accordance with the methodology under the July 2021 interim final rules and guidance in effect immediately before the decision in TMA III, for items and services furnished before May 1, 2024, the first day of the calendar month that is 6 months after the issuance of FAQs Part 62. Under FAQs Part 62, this exercise of enforcement discretion applies to QPAs for purposes of patient cost sharing, providing required disclosures with an initial payment or notice of denial of payment, and providing required disclosures and submissions under the Federal IDR process.
    • “FAQs Part 62 stated that HHS would also exercise enforcement discretion under the relevant No Surprises Act provisions for a provider, facility, or provider of air ambulance services that bills, or holds liable, a participant, beneficiary, or enrollee for a cost-sharing amount based on a QPA calculated using the aforementioned method.”
    • The regulators have extended the safe harbor to services or supplies rendered before November 1, 2024. The regulators do not expect to further extend the safe harbor.
  • The Wall Street Journal reports,
    • “As part of the government’s quest to improve American eating habits, the Food and Drug Administration is considering requiring food manufacturers to put new labels on the front of packages. The labels might flag certain health risks, such as high levels of salt, sugar or saturated fat.
    • “Don’t expect to see a warning label in your grocery store soon, because the FDA is still weighing its approach. But the agency hopes that clearer food labeling could help us make healthier choices as it tackles the rise of diet-related health problems such as Type 2 diabetes and cardiovascular disease.” 
  • Fierce Healthcare discusses the new HHS rule here.

From the public health and medical research front,

  • The Washington Post reports,
    • “More than two decades ago, the shocking results of a major women’s health study challenged the safety of menopause hormones, and overnight, millions of women and their doctors abandoned the drugs — a reluctance that lingers today.
    • “Now, a long-term follow-up of the Women’s Health Initiative (WHI) shows that the reaction was largely overblown. The new research found that for many younger menopausal women — typically those under 60 — the benefits of the drugs probably outweigh the risks for the short-term treatment of menopause symptoms, including hot flashes and night sweats.
    • “The new analysis, published in JAMA, shows that younger women starting menopause and experiencing symptoms can take hormone treatments for several years with a lower likelihood of adverse effects.
    • “Women in early menopause with bothersome symptoms should not be afraid to take hormone therapy to treat them, and clinicians should not be afraid to prescribe them,” said JoAnn Manson, chief of the division of preventive medicine at Brigham and Women’s Hospital and the paper’s first author.”
  • The New York Times informs us,
    • “Baby aspirin is routinely prescribed to people who survive heart attacks. But there’s another vulnerable group who benefit from daily low-dose aspirin: pregnant women at risk of developing pre-eclampsia, life-threatening high blood pressure.
    • “It’s a factor in up to one in 20 pregnancies in the United States, and one of the leading causes of maternal mortality nationwide. Pre-eclampsia is the top cause of maternal death among Black women, who die of pregnancy-related complications at rates almost triple those of white women.
    • “But not enough pregnant women are getting the word that low-dose aspirin can help. Now leading experts are hoping to change that.”
  • STAT News tells us,
    • “Extensive testing of pasteurized commercially purchased milk and other dairy products from 38 states has found no evidence of live H5N1 bird flu virus, Food and Drug Administration officials said at a press briefing Wednesday.
    • “The results confirmed findings of earlier testing of a more limited number of samples and add weight to the FDA’s conclusion that pasteurized milk products are safe for consumption despite a widespread outbreak of cows infected with H5N1.
    • “These additional, preliminary results further affirm the safety of the U.S. commercial milk supply,” Donald Prater, acting director of the FDA’s Center of Food Safety and Applied Nutrition, told reporters.”
  • The National Institutes of Health announced,
    • “Recurring feelings of anger may increase a person’s risk of developing heart disease by limiting the blood vessels’ ability to open, according to a new study supported by the National Institutes of Health. The study, published in the Journal of the American Heart Association (JAHA), shows for the first time that anger is linked to this vascular impairment — a precursor to the kind of long-term damage that can lead to heart attack and stroke.
    • “We’ve long suspected, based on observational studies, that anger can negatively affect the heart. This study in healthy adults helps fill a real knowledge gap and shows how this might occur,” said Laurie Friedman Donze, Ph.D., a psychologist and program officer in the Clinical Applications and Prevention Branch of the National Heart, Lung, and Blood Institute (NHLBI), which funded the study. “It also opens the door to promoting anger management interventions as a way to potentially help stave off heart disease, the leading cause of death in this country.”
    • “While a brief spurt of occasional anger is normal and generally has a benign impact on the heart, it is recurring or frequent anger the researchers said raises concern. “If you’re a person who gets angry all the time, you’re having chronic injuries to your blood vessels,” said study leader Daichi Shimbo, M.D., a cardiologist at Columbia University Irving Medical Center in New York City. “It’s these chronic injuries over time that may eventually cause irreversible effects on vascular health and eventually increase your heart disease risk.”

From the U.S. healthcare business front,

  • Healthcare Dive notes,
    • “CVS had a significantly worse first quarter than the healthcare giant — or Wall Street — expected, after its insurance arm failed to adequately prepare for seniors’ high use of medical care, especially in inpatient facilities.
    • “The Rhode Island-based company’s health services segment — usually a reliable driver of growth — also saw its revenue and income fall in the quarter as its pharmacy benefit manager adjusted to the loss of a major contract with insurer Centene.
    • “CVS slashed its earnings expectations for 2024 on Wednesday following the results. It’s the second time the company has lowered financial expectations this calendar year.” 
  • Fierce Healthcare adds,
    • “CVS has quietly acquired Hella Health, a startup Medicare Advantage (MA) broker based in New York City, according to a post on LinkedIn.
    • “Financial terms of the deal were not disclosed, but Hella Health CEO and founder Rafal Walkiewicz wrote in the post that the combination allows the healthcare giant to further bolster its suite of technology platforms, especially those offered directly to the senior population.
    • “Through this combination, CVS Health will expand its multi-payer technology platform to include a wide range of insurance offerings, supported by trusted advisors and agents, to provide a simple, direct-to-consumer Medicare shopping and enrollment experience,” Walkiewicz wrote.”
  • The Leapfrog Group released its Spring 2024 Hospital Safety Grades.
  • Per BioPharma Dive,
    • “GSK on Wednesday raised its financial forecasts for the year following strong quarterly sales of its vaccines and HIV medicines. 
    • “GSK said vaccine sales surged 16% compared to the same period a year ago, a number driven by revenue totals for its shingles shot Shingrix and RSV vaccine Arexvy. New public immunization programs in Europe and other international market drove sales of Shingrix, while Arexvy continued to take more market share than Pfizer’s rival RSV shot Abrysvo.  
    • “The company now expects its 2024 sales to grow at the higher end of the 5% to 7% range it previously projected, and for annual adjusted earnings per share to climb 8% to 10%. Still, GSK warned that growth could slow later this year amid shifting seasonal patterns for vaccinations and changes in market dynamics.”