From Washington, DC,

• Today, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury released a 500+ page long final rule significantly modifying the regulations governing the federal mental health and substance use disorder parity rule.

• The agencies explain that the rule generally becomes applicable to health plans and issuers on the first day of the plan year beginning next year. The rule also specifies exceptions as to which the applicability date falls in 2026, but trust the FEHBlog, it’s hard to figure out what takes effect next year.

• The Labor Department is holding an introductory webinar on September 19, 2024, at 2 pm ET. You can register at this link.

• “AHIP, the Association of Behavioral Health and Wellness (ABHW), the Blue Cross Blue Shield Association (BCBSA), and The ERISA Industry Committee (ERIC) react to the Tri-Departments’ final mental health and substance use disorder parity rule released today.”
  • “The final Mental Health Parity and Addiction Equity Act (MHPAEA) rule will have severe unintended consequences that will raise costs and jeopardize patients’ access to safe, effective, and medically necessary mental health support. With nearly 50 million Americans experiencing a mental illness, there’s no question that addressing the shortage of mental health providers must be a top priority. There are proven solutions to increase access to mental health and substance use disorder care, including more effectively connecting patients to available providers, expanding telehealth resources and improving training for primary care providers. However, this rule promotes none of these solutions. Instead of expanding the workforce or meaningfully improving access to mental health support, the final rule will complicate compliance so much that it will be impossible to operationalize, resulting in worse patient outcomes.” 
  • “The organizations support the intent of mental health parity and are committed to strengthening compliance. We recognize that the Tri-Departments made changes to the proposed rule in response to public comments. However, this rule goes beyond the intent of the 2008 Mental Health Parity law, and we are concerned that it will negatively impact health outcomes, quality, and, ultimately, the cost of care.”

• The FEHBlog heartily agrees with these organizations.

• Fierce Healthcare adds,
  • “As ERIC evaluates this rule and assesses the implications for its member companies, we will consider all possibilities to prevent further harm to employer offering behavioral health benefits, and the employees and families who count on them—up to and including litigation,” said Mellissa Bartlett, senior vice president of health policy for ERIC.”

• The American Hospital Association (AHA) News points out,
  • “The AHA Sept. 9 urged the Centers for Medicare & Medicaid Services to work with Congress on providing a pay increase for physicians in 2025 and develop a long-term plan for sustainable physician payment. AHA expressed its concerns to CMS while commenting on the agency’s calendar year 2025 physician fee schedule proposed rule, in which the proposed payment update would reduce payments approximately 2.8% from CY 2024 levels.”

• Healio adds,
  • “A letter from AMA’s executive vice president called for CMS to be “fully transparent” on the impact that payment cuts in the 2025 Physician Fee Schedule will have on patients and physicians. * * *
  • “[This] proposed rule is silent on the impact of the growing gap between what Medicare pays for care and what it costs to provide that care,” the letter said. “A chorus of authorities on the Medicare program has expressed concern about the ability of patients to continue receiving high-quality care as physician payments erode.”
  • “Physician payments have declined by 29% from 2001 to 2024, the release noted.”

• The AHA News further notes,
  • “A [federal] district court in Baltimore Sept. 5 ruled against drug companies and PhRMA, denying their attempt to obtain a preliminary injunction against 340B pricing for contract pharmacy arrangements in Maryland, according to Reuters. The AHA filed amicus briefs defending Maryland’s law against this drug industry challenge July 29 and Aug. 2, in addition to similar briefs filed in Missouri Aug. 29 and West Virginia Aug. 16.”
     
• Govexec announces the 2024 winners of the ‘Oscars’ of government service. Kudos to them.

From the public health and medical research front,

• Per Health Day,
  • “An epidemic of high blood pressure is occurring in young adults and children in the United States, a pair of new studies show.
  • “Nearly a quarter of people ages 18 to 39 have high blood pressure, with readings above the healthy level of 130/80, the first study found.
  • “Blood pressure is even a problem for school-age children, according to the second study. Nearly 14% of children ages 8 to 19 have elevated or high blood pressure, researchers found.
  • ‘Both studies were presented Friday at the American Heart Association (AHA) scientific sessions in Chicago. Such research should be considered preliminary until published in a peer-reviewed journal.
  • “The prevalence of hypertension in young adults is stark, and social determinants of health amplify the risk for hypertension and subsequent premature cardiovascular disease,” said Dr. Bonita Falkner, chair of the writing committee for the AHA’s 2023 scientific statement on pediatric hypertension.”

• Consumer Reports writing in The Washington Post informs us,
  • “If you spot a blacklegged tick crawling up your leg — or worse, attached to your skin — you might be worried about getting Lyme disease. That’s reasonable because Lyme is the most commonly reported illness spread by ticks. But it is far from the only one: The blacklegged ticks that carry Lyme can spread at least six different illnesses.
  • “The tick-borne illness babesiosis is one of the next most common after Lyme. And it is on the rise, especially in the Northeast, according to a 2023 report by the Centers for Disease Control and Prevention.
  • “Babesiosis is less common than Lyme disease but tracks in the same areas,” said Paul Auwaerter, a professor of medicine and clinical director of the division of infectious diseases at the Johns Hopkins University School of Medicine in Baltimore. And it’s worth knowing about because it can be serious, especially for people who are immunocompromised, he said.”

• The Wall Street Journal warns that American men are eating too much meat for their own good.

• The Food and Drug Administration has created a website that discusses how much caffeine is too much.

• STAT News reports,
  • “Relay Therapeutics disclosed encouraging results for its key breast cancer drug and plans to advance the experimental treatment, called RLY-2608, to a late-stage clinical trial, the biotech firm said on Monday.” * * *
  • “The new data come from an open label phase 1/2 trial on RLY-2608 combined with fulvestrant, an endocrine therapy for breast cancer, showing a third of patients with measurable disease responded to the treatment. The data were put out in a press release from Cambridge, Mass.-based Relay, and haven’t been published in a peer reviewed journal.
  • “RLY-2608 works on cancers that carry mutations in a gene called PIK3CA, which encodes a piece of the PI3K-alpha protein. This molecular pathway helps to control cell growth and division, and errors in it can drive a variety of cancers including breast cancer. It’s one of the most common mutations driving cancers and is implicated in 20% to 40% of breast cancer cases. 
  • “There are two approved drugs targeting this pathway, alpelisib or Piqray from Novartis and capivasertib or Truqap from AstraZeneca. Relay hopes its treatment will have an advantage over the existing therapies through improved efficacy or less toxicity.”

• Per BioPharma Dive,
  • “An experimental weight loss pill developed by biotechnology company Terns Pharmaceuticals helped some people with obesity lose more than 5% of their body weight in a small Phase 1 trial, supporting plans to move the drug into mid-stage testing next year, the company said Monday.
  • “Trial volunteers who received the highest tested dose of Terns’ drug lost nearly 5 percentage points more weight than those who received a placebo over 28 days, the company said. Two-thirds lost over 5% of their body weight, suggesting the effects could be more substantial if the drug were to be taken over a longer period of time.
  • “The trial results indicate Terns could become a competitor in the race to develop pills for obesity. Injectable drug from Novo Nordisk and Eli Lilly currently dominate the market, but they and others, among them Pfizer and Roche, are vying to develop oral alternatives.”

From the U.S. healthcare business front,

• Fierce Healthcare announced for the second year its Fierce 50 composed of “the people and companies who are driving meaningful change in healthcare, pharma and biotech.” Kudos to them.

• STAT News reports,
  • “Apple on Monday announced a new Apple Watch feature that will warn users they may have sleep apnea. It’s the latest advance in the company’s decade-long effort to sell its wearable as a tool that can help people live healthier lives.
  • “Additionally, the company announced more hearing health features for its wireless earbuds. The company’s AirPods will be able to conduct a hearing test and later this fall will be able to be used as a “clinical grade over-the-counter hearing aid,” Apple’s vice president of health Sumbul Desai said in a prerecorded announcement video.” * * *
  • “Christine Lemke, the CEO of consumer health data company Evidation Health, said that a wearable’s sensors are probably best suited to screening rather than definitive diagnosis. 
  • “Still, she said, “It’s impactful to receive a proactive alert to explore this more with your physician. This seems like a moment in time where the sensors are good enough to provide valuable information for pre-screening purposes.”

• Per Fierce Healthcare,
  • “Labor costs and availability were major pain points for hospital and health system operations during the pandemic but finally look to be leveling out even as demand for care services remains high, Fitch Ratings wrote in a recent report.
  • “Wage growth among hospitals had spiked in late 2021 and through much of 2022, when year-over-year average hourly earnings hovered at or above 8%, per U.S. Bureau of Labor Statistics cited in the agency’s report.
  • “During that time, hospitals had ramped up their salary offerings “to reverse persistently high turnover and external contract labor use,” Fitch wrote in its report.
  • ‘From January through July of this year, that same metric has now fallen to an average of about 3%, which is also above the 4.2% average of 2023.”