From Washington, DC

• The U.S. Office of Personnel Management’s proposed supplemental Postal Service Health Benefits Program (PSHBP) rule appears in todays’ Federal Register. The public comment deadline is June 24.

• The proposed rule includes a requirement that PSHBP annuitants eligible for Medicare Parts A or B must participate in their PSHB plans’ Medicare Part D EGWP. Those who opt out will not be eligible for their PSHB plans’ regular prescription drug benefits. Here is a link to the proposed rule’s preamble where OPM lays out it thought process.

• Healthcare Dive tells us,
  • “The House Budget Committee met Thursday to discuss the impact of healthcare mergers and acquisitions on cost, quality and access and arrived at a bipartisan consensus: Something needs to be done to halt the rampant pace of consolidation before it inflates medical costs further.
  • “What, exactly, remains unclear, though lawmakers and witnesses during the hearing expressed support for standardizing Medicare payments between hospital-owned outpatient sites and independent physician offices for the same services.
  • “Such site-neutral policies are “very bipartisan,” testified Sophia Tripoli, the senior director of health policy at patient advocacy group Families USA. “It is a no brainer.”
  • “Congress has been increasingly interested in tamping down on healthcare consolidation amid a mountain of evidence it increases costswithout a corresponding increase in care quality, harming Americans’ ability to access and afford medical care. After a merger, hospitals can jack up their prices anywhere from 3% to 65%, according to a Rand review from 2022.
  • “We just can’t afford to have this continued increase in prices,” said Rep. Ron Estes, R-Kan., during the hearing.”

• BioPharma Dive lets us know,
  • “A top Food and Drug Administration official on Friday again advocated for the speedy approval of gene therapies for rare diseases. But he didn’t drop any clues on where the agency stands on a coming decision to possibly broaden use of one of them, a Duchenne muscular dystrophy treatment the regulator cleared last year.
  • “At a meeting hosted by the patient advocacy group CureDuchenne, Peter Marks, head of the FDA office that reviews gene therapies, said the agency’s thinking has changed in recent years to become more patient focused. That mindset has led it to more aggressively look for ways to speed the development of rare disease gene therapies.
  • “Although we’re a regulatory agency,” he said, the regulations “have to ultimately serve getting products to patients. So we’re trying to focus on the patient, and use that to negotiate the regulations to get there as rapidly as possible.”
  • “Those comments build on points Marks has made before. Last year, at a meeting held by a different advocacy group, he advocated for flexibility in reviewing rare disease gene therapies while fighting off criticism about accelerated approvals, which allow drugmakers to bring therapies to market based on interim measures of benefit. On Friday, he again threw support behind speedy clearances, noting that they are a “very important” tool in bringing forward rare disease treatments.”

• Tammy Flanagan writes in Govexec about “What is the retirement age for federal employees?”

From the public health and medical research front,

• The Centers for Disease Control informs us today,
  • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains low nationally.
  • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are at low levels.
  • “Nationally, COVID-19, influenza, and RSV test positivity remained stable at low levels compared to the previous week.
  • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, is minimal.”

• STAT News reports
  • “Stroke prevalence has been climbing over the past decade, reversing a steady decline among all Americans while rising the most among adults under 65, a new CDC analysis reports.
  • “Strokes still strike more adults older than 65, but the increase at younger ages mirrors another recent turnaround: rates of heart failure deaths, which had been dipping, are rising the most in adults under 45.
  • “The rising prevalence comes even though medicines to tamp down such risk factors as hypertension and high cholesterol, as well as technologies to treat strokes, are much more available in wealthier countries like the U.S. than elsewhere around the world.
  • “Stroke rates in the United States had fallen by 3.7% during a five-year stretch ending in 2010, but they headed back up by 7.8% through 2022. The increase was nearly double — 15% — for adults younger than 65. Thursday’s Morbidity and Mortality Weekly Report broke it down further to a jump of 14.6% among adults age 18 to 44 and 15.7% among those age 45 to 64.”
• and
  • “Novo Nordisk’s Ozempic cut the risk of death in a trial of patients with type 2 diabetes and chronic kidney disease, suggesting it may offer some added benefits over other classes of drugs approved to treat this population.
  • “Specifically, the diabetes drug cut the risk of cardiovascular-related deaths by 29% and all-cause deaths by 20%. Given the study parameters, this implies that over three years, 39 people would need to be treated to prevent one death from any cause, according to new results presented Friday at a meeting of the European Renal Association and published in the New England Journal of Medicine.
  • “Ozempic also lowered the risk of major heart complications — including cardiovascular-related death, heart attack, or stroke — by 18%, driven primarily by the reduced rate of heart-linked death.
  • “The full results of this trial, called FLOW, affirm the primary result reported earlier this year that Ozempic reduced the risk of major kidney events — including kidney failure, reduction in kidney function, or death from kidney or heart causes — by 24%.”

• The New York Times relates,
  • “Colorectal cancer rates are rapidly rising among adults in their 20s, 30s and 40s, and the most common warning sign for the disease is passing blood in the stool, according to a new scientific review.
  • “Rectal bleeding is associated with a fivefold increased risk of colorectal cancer, according to the new analysis, which looked at 81 studies that included nearly 25 million adults under 50 from around the world.
  • “Abdominal pain, changes in bowel habits and anemia are other common warning signs of the disease and should not be ignored, said the researchers, who published the paper on Thursday in the journal JAMA Network Open.”

From the U.S. healthcare business front,

• Per BioPharma Dive,
  • “Eli Lilly plans to spend another $5.3 billion building production capacity for its popular obesity and diabetes drugs, responding to immense demand for the medicines with what it claims is now the largest investment of its kind in U.S. history.
  • “The commitment announced by Lilly Friday adds to $3.7 billion the drugmaker already planned to invest in a manufacturing site it’s constructing in Lebanon, Indiana, some 30 miles from its corporate headquarters in Indianapolis.
  • “The site will help Lilly make the active drug ingredient tirzepatide, which is in its weight loss shot Zepbound and diabetes treatment Mounjaro. Despite pressing hard to expand manufacturing capacity, Lilly has so far had trouble keeping the drugs in steady supply. Certain dose strengths of both products are currently listed as in shortage by the Food and Drug Administration, with limited availability at least through the end of June.”

• Beckers Behavioral Health points out,
  • “UnitedHealth Group’s Optum has acquired Plymouth, Minn.-based CARE Counseling, the Star Tribune reported May 23. 
  • “CARE Counseling has 10 locations in the Minneapolis area, and employs over 200 clinicians. 
  • “Expanding and diversifying our behavioral health care delivery capabilities through this combination will build on a strong foundation of patient-centered, high-quality and affordable care in an environment that supports and enables the talented clinicians delivering these critical services,” UnitedHealth Group told the Star Tribune. “We look forward to working with CARE Counseling to build on their deep roots in the community.”

• Reuters reports,
  • “CVS Health Corp (CVS.N), opens new tab has been seeking a private equity partner to fund growth at Oak Street Health, a primary care provider it bought a year ago, Bloomberg News reported on Thursday.
  • “The company has been working with financial advisers to help find capital to back new clinics that will be opened by Oak Street, the report said, citing people familiar with the matter.
  • “The deliberations are in a preliminary stage and the structure could change, while there is no guarantee a deal will be reached, according to the report.”