What Happened, What You Missed: December 11-15, 2023

HHS Finalizes Rule on Interoperability, AI Transparency 

A newly finalized rule from the Department of Health and Human Services (HHS) marks the federal government’s first attempt to regulate the use of artificial intelligence (AI) in health care.  Specifically, the rule establishes transparency requirements for AI and predictive algorithms that are used to support clinical decision support (CDS) and decision support interventions (DSIs).  HHS says the rule will support the widespread use of AI in health care, which proponents say could help reduce administrative and clinical burden.  The rule will also support interoperability by requiring developers of certified health IT to report certain metrics, which will better inform how health IT is used in health care delivery. 

GAO Reports on No Surprises Act’s Rocky Implementation 

The federal government is seeing far more disputes between commercial insurers and health care providers over out-of-network bills than anticipated, according to a report by the Government Accountability Office (GAO).  Enacted in 2021, the No Surprises Act established a baseball-style independent dispute resolution (IDR) process for insures and providers to settle payment disagreements to protect patients from receiving unexpected balance bills.  As of June 2023, the federal government has received nearly 490,000 payment disputes – a far cry from the initially projected figure of 22,000.  Nearly 61% of these disputes remain unresolved, which the GAO attributes to the difficulty of determining which disputes are eligible for the federal IDR process.  The federal government has proposed that insurers and providers submit more information up front to help address the high volume of disputes.   

FDA to Consider Psychedelic Drugs for PTSD Treatment 

The Food and Drug Administration (FDA) will consider approval of the psychedelic drug MDMA in conjunction with other intervention to help treat post-traumatic stress disorder (PTSD), according to the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC), which recently filed a new drug application (NDA) with the agency.  If the new treatment is approved, the Drug Enforcement Administration would be required to reschedule MDMA to make it available for prescription use.  Also known as ecstasy, MDMA has been studied since the 1970s to help patients process certain experiences and emotions.  The company’s NDA focuses on two lates-stage clinical trial studies showing patients receiving three doses of MDMA saw a higher reduction of PTSD symptoms than those receiving a placebo. 

CMS: Health Spending Returns to Pre-Pandemic Levels 

Health care spending in the US increased 4.1% in 2022 to $4.5 trillion, or $13,493 per person, according to new data from the Centers for Medicare and Medicaid Services (CMS).  This growth rate is within range of a 4.4% average growth in spending between 2016 and 2019, signifying a return to pre-pandemic health care trends.  Health care spending growth spiked to 10.6% in 2020 before declining to 3.2% the following year.  The data also found a record high of 92% of Americans were insured last year, although this record may not last due to declining Medicaid enrollment as states continue their Medicaid redetermination process.  As far as goods and services go, prescription drug spending increased the most in 2022 at 8.4%, while spending on physician and clinical services jumped 2.7%.   

ICYMI: Ex-Speaker McCarthy Bids Adieu to Congress 

Rep. Kevin McCarthy (R-CA) gave his final floor speech on Thursday.  The floor speech was delivered in what’s likely to be McCarthy’s last legislative day in Congress, as the California Republican is expected to officially resign by the end of 2023.  McCarthy notably expressed no regrets about his decision to advance a clean continuing resolution on the House floor in September, which ultimately lead to his ouster from the speakership.  While McCarthy delivered his remarks before a largely empty House chamber, two close allies – Reps. Patrick McHenry (R-NC) and French Hill (R-AR) – were in attendance to offer their well wishes. 

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